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Tuesday, September 13, 2016

May I please have the package insert for the flu vaccine?"

Sandra Ganey
7 hrs · Portland, OR ·

Me: "May I please have the package insert for the flu vaccine?"
Rite-Aid Pharmacist: "Why?"
Me: "So I can read it."
P: "Which one?"
Me: "The one advertised with the little banners on every aisle."
P: "I will print you the information sheet."
Me: "No, that's not the same thing."
P: "What do you want to know? I can tell you."
Me: "I would just like to read the whole thing before I consider getting one...side effects, contraindications, effectiveness, ingredients like mercury."
P: "I don't think I have any. Let me check. (checks) Sorry, I can't give you one until the box is empty, because it has to stay in the box. And there is no thimerisol in the single dose flu shot any more. I can print you the information sheet."
Pharmacy co-worker with big smile at me: "Hi, here you go, I found you one." (hands me insert).
***
Here are some things in the insert not on the store's sheet:
1. The single dose vial contains mercury at 1mcg (This is called a "trace amount" by the industry.) (The multi-vial contains 25 mcg.)
2. People with egg allergies are contraindicated.
3. "Safety and effectiveness have not been established in pregnant women, nursing mothers and children under four. There are no adequate and well-controlled studies in pregnant women. This vaccine should be used during pregnancy only if clearly needed. It is not known whether fluvarin is excreted in human milk."
4. "Fluvarin has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility."
5. "Antibody response is low in the geriatric population."
6. "Serious reactions, including anaphylactic shock, have been observed."
7. "There are no data to assess the concomitant administration of flu vaccine with other vaccines."
8. "The vaccine is associated with an increased frequency of Guillain-Barre syndrome."
9. "In some studies, fluvarin protected up to 50% of subjects."

Yes, I went back and showed the pharmacist the trace amount and he was genuinely puzzled, kept staring at it and scratching his head, thanked me for the information.

FLUVIRIN® Package Insert (injectable)
http://flu.seqirus.com/assets/files/us%20package%20insert_fluvirin%202015-2016.pdf

And the FLUVIRIN® PDF package insert also from here...

http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM123694.pdf


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