Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Reaction to excipient
Clinical narrative: PEG is listed as part of an ingredient; sore arm; This is a spontaneous report from a contactable consumer. a female patient of an unspecified age re-ceived first dose of BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for Injection, Batch/Lot Number were not reported, Expiration date: unknown), via an unspecified route of admin-istration on unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced peg is listed as part of an ingre-dient (reaction to excipient), sore arm (pain in extremity).  This is a spontaneous report from a contactable consumer. This female consumer reported   Patient characteristics Sex: Female MedDRA version for reaction/event term LLT: N/A Reaction/event in terminology (LLT): Medical Information Potential AE Characterization of drug role: Suspect Active Drug substance names: PFIZER-BIONTECH COVID-19 VACCINE  Narrative case summary and further information: Originating AE Request: REQ-# Patient Age: Not mentioned Reporter Subtype: Patient PQC Present: No AE Present: Yes PQC Details:  Request Name: REQ-# Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Potential recipient of the COVID-19 vaccine (She was not sure if she may receive the Pfizer-Bio or (Other company name) vaccine asks if Polyethylene glycol and Polysorbate are ingredients of the vaccine. During the registration process she received written information, including a document that lists those ingredients.  Is the formulation of this COVID-19 vaccine similar to other vaccines (e.g. the flu vaccine, pneumonia vaccine, shingles vaccine, unknown manufacturers)? DSU: Conservative AE report for Non-Pfizer products: Patient took multiple supplements & vitamins (unknown manufacturer) and experienced a possible allergic reaction, was advised to stop all the supplements and restart them one by one. "I might have had a little reaction to Vitamin D and casein, ca-sein also contains vitamin D. I went into these 2 bottles to compare and see if they have polysorbate or PEG and the vitamin D didn't, but the casein did have Polysorbate 80".Consumer suspects she may be allergic to Polysorbate 80, was unable to find information about the manufacturer, the packaging only indicated the supplement was manufactured for Name and made in country. Response: a) Suggested to confirm if the vaccine she may receive is manufactured by Moderna or Pfizer-BioTNech. Pfizer is unable to offer medical details for Non-Pfizer products.  b) Consulted the list of ingredients in the PI/Description (LAB-1457-5.0, revised Jan2021), PEG is listed as part of an ingredient, but polysorbate is not. The attached CONS-Document with a list of inactive ingredients was sent via Email.  c) Explained that Pfizer is unable to consult the list of ingredients in unidentified flu, pneumonia, and shingles vaccine. Suggested to contact her doctor, find more information about the manufacturers of her previous vaccinations and compare the ingredients listed with "inactive ingredients".  Was referred to her Doctor for guidance before vaccination, suggested to mention all the medications/vitamins/supplements she is taking and her conditions. Request Name: REQ-# Product: NON-PFIZER PRODUCT Question: Asks if the Polysorbate 80 (listed as part of the ingredients in an unidentified Non-Pfizer supplement) is the same as Polysorbate. Response: Pfizer is unable to provide information for Non-Pfizer products. Was referred to her Pharmacy to identify and contact the manufacturer.  Follow up (12Mar2021): This is a follow up spontaneous report from a contactable consumer. This (age: 71; unit: unknown) female consumer (patient) reported that:  Patient characteristics Sex: Female  Drug(s) Information Characterization of drug role: Suspect Proprietary medicinal product name: Pfizer-BIONTECH Covid-19 Vaccine Identification of the country where the drug was obtained: Country of authorization/application: Active Substance Information  Active Drug substance names: Pfizer-BIONTECH Covid-19 Vaccine  Narrative case summary and further information: Originating AE Request: REQ-#  Attachments: 1  Patient Age: 71  Reporter Subtype: General Public  PQC Present: No  AE Present: Yes  PQC Details:   Request Name: REQ-#  Product: PFIZER-BIONTECH COVID-19 VACCINE  Question: Caller received first dose three weeks ago, to receive second dose tomorrow. States she had a sore arm, but is questioning whether she received the vaccine and if there is a way to test for it? She indicates she "heard" about empty vials and use of saline. Potential AE.  Follow-up (12Mar2021): This is a follow up spontaneous report from a contactable consumer. This consumer (patient) reported that:  Reaction(s)/Event(s) Reaction/event as reported by primary source: If they were actually injected with COVID-vaccine   Drug(s) Information Characterization of drug role: Suspect Proprietary medicinal product name: COVID-19 vaccine Batch/lot number: Unknown Action(s) taken with drug: Unknown.   Narrative case summary and further information:  Selected Report Type: Initial Is the patient also the reporter? Yes Reporter type: Consumer or other non health professional Reporter telephone: (withheld) Reporter email: (withheld)  Primary / Prescribing Healthcare Professional Info HCP postal address:  Dates for If they were actually injected with Covid vaccine: (From: Unspecified To: Unspecified)  Is Covid 19 vaccine a Pfizer product? Yes Covid 19 vaccine manufacturer: Unspecified Dates for Covid 19 vaccine: (Start: Unspecified Stop: Unspecified) NDC number of Covid 19 vaccine: Unknown UPC number of Covid 19 vaccine: Unknown Reason for no lot number: of Covid 19 vaccine: Complainant hung up abruptly/transfer incomplete Expiry Date of Covid 19 vaccine: Unknown  Additional Context: Consumer stated, "I would like to ask you, is there a way for a patient to know if they were actually injected with Covid vaccine."   The consumer was provided with the number of Pfizer Medical information. Reporter type: Consumer stated, "No, I am just a regular person."  Vaccine administered to any patient: Consumer stated, "I am the patient. Yes." Hence the tab "Is the patient also the reporter?" checked as "yes" Product details and pharmacy details could not be probed as the consumer hung up the call abruptly. Hence limited information available over the call. QR comment: AE filed conservatively. The outcome of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained