Sex: F
Vaccine: COVID19
Symptoms: Antibody test negative, Circumstance or information capable of leading to medication error, Fatigue, Pain in extremity, SARS-CoV-2 antibody test negative
Clinical narrative: she is worried that the vaccine they gave her was not stored in the right temperature since they only had the vaccines in a Styrofoam cooler; antibodies while she tested negative; sore arm; felt tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 04May2021 20:46 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "cystic fibrosis" (unspecified if ongoing), notes: cystic fibrosis; "serious lung disease" (unspecified if ongoing), notes: serious lung disease; "diabetes" (unspecified if ongoing), notes: diabetes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose. 04May2021 20:46:32), administration date: 04May2021, for COVID-19 immunization. The following information was reported: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "she is worried that the vaccine they gave her was not stored in the right temperature since they only had the vaccines in a Styrofoam cooler"; ANTIBODY TEST NEGATIVE (non-serious), outcome "unknown", described as "antibodies while she tested negative"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown", described as "felt tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, after 30 days, her husband tested positive for antibodies while she tested negative. She wanted to know the reason behind this. She said she was worried since she saw on the news that Covid is "so bad" in India. She also said that she was worried that the vaccine they gave her was not stored in the right temperature since they only had the vaccines in a Styrofoam cooler. The Consumer wanted to know how Pfizer tested the efficacy of the Pfizer-BioNTech Covid-19 Vaccine. She also wanted to know what type of antibody test she should take to assess the vaccine's efficacy. The reporter was also told the consumer that the efficacy of the vaccine was by the number of the of positive Covid cases after vaccination. Then, I referred her to her HCP for more information and for further guidance. The Consumer said they received the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine 4 weeks after the 1st dose. The Consumer said on the first day after receiving the Pfizer-BioNTech Covid-19 Vaccine she had a sore arm, and felt tired. She said, other than that, she did not have any other reaction. With that, she wanted to know if the vaccine was still effective if she did not have other reactions. Reporter enquired if the vaccine working if patient didn't have an adverse event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021499000 same reporter/drug with different patient, similar event