chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Overdose, Product preparation issue
Clinical narrative: mixed 0.8ml of the diluent instead of 1.8mL with Pfizer vaccine resulted in a higher dose; mixed 0.8ml of the diluent instead of 1.8mL with Pfizer vaccine resulted in a higher dose/mixed two vials incorrectly, gave it to 2 patients.; Mild Discomfort; This is a spontaneous report received from contactable reporter(s) (Physician and Consumer or other non HCP) from medical information team for a Pfizer sponsored program Support.  A 12 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 07Sep2021 16:00 (Lot number: FC3183) at the age of 12 years as dose 1, 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: OVERDOSE (non-serious) with onset 07Sep2021 15:30, outcome "unknown", described as "mixed 0.8ml of the diluent instead of 1.8mL with Pfizer vaccine resulted in a higher dose"; PRODUCT PREPARATION ISSUE (non-serious) with onset 07Sep2021 15:30, outcome "unknown", described as "mixed 0.8ml of the diluent instead of 1.8mL with Pfizer vaccine resulted in a higher dose/mixed two vials incorrectly, gave it to 2 patients."; DISCOMFORT (non-serious) with onset 07Sep2021 15:30, outcome "recovered" (Sep2021), described as "Mild Discomfort".  Additional information: It was the first dose for the one patient and as second dose for the other patient. Facility Type: doctor office. Prior vaccination: None. Concomitant medication included Ongoing Multivitamin used for Supplement via Oral route of administration. Allergies to medications, food, or other products: NA. Other illnesses at the time of vaccination and up to one month prior: None. Chronic or long-standing health condition: No. Patient was able to participate in sports same day in arm of incident. Investigation Assessment: Not Provided. Relevant test: None.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101169694 Same reporter/ drug/ event for different patients
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: 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 (COMIRNATY), administration date 31Aug2021 (Lot number: FC3180) as dose 1, single for Covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "Very dizzy". The event "very dizzy" was evaluated at the emergency room visit. Additional information: The patient reported that she had her first dose of the Pfizer-BioNTech Covid-19 vaccine a week ago today and she had been very dizzy ever since. She called her healthcare provider, her primary care, and they suggested she call Pfizer and they sent her to the Emergency Room just to make a precautionary type situation. She was on her way to the ER. She wanted to know if Pfizer had any information on dizziness after the vaccine. The report was not related to a study or programme. The reason for no lot number: of Covid-19 Vaccine was that the patient was unwilling to complete the report. The other products and investigation assessment was not provided. Consumer was unwilling to complete the report. Thus, further probing could not be done. Hence, limited information available. Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature abnormal, Fatigue, Headache, Overdose, Platelet factor 4
Clinical narrative: they have mixed 0.8ml of the diluent instead of 1.8mL with the Pfizer Biontech COVID19 vaccine which resulted in a higher dose; they have mixed 0.8ml of the diluent instead of 1.8mL with the Pfizer Biontech COVID19 vaccine which resulted in a higher dose; Pt had mild tactile temp, fatigue, mild headache symptoms; Pt had mild tactile temp, fatigue, mild headache symptoms; Pt had mild tactile temp, fatigue, mild headache symptoms; This is a spontaneous report from a contactable physician. A 12-years-old male patient received second dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: FC3183, Expiration Date: 31Oct2021), dose 2, intramuscular, administered in deltoid left on 07Sep2021 16:00 (at the age of 12 years) as single dose for COVID-19 immunisation. Medical history included asthma, mild intermittent asthma and overweight from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient did not receive any prior vaccination. The patient previously received first dose of BNT162B2 (COMIRNATY, solution for injection, Lot Number: EW0185 and expiration date was not reported), dose 1, intramuscular, administered in deltoid left on 17Aug2021 15:54 (at the age of 12 years) as single dose for COVID-19 immunisation; Hpv (Lot:T029522, Route: Intramuscular, Anatomical site: Left deltoid), administration date: 12Aug2021, when the patient was 12 years old. It was reported that they had mixed 0.8ml of the diluent instead of 1.8ml with the Pfizer BioNTech covid19 vaccine which resulted in a higher dose. On an unspecified date the patient had experienced mild tactile temperature, fatigue, mild headache. Symptoms were not different from what he experienced after first dose. The outcome for the events mild tactile temperature, fatigue, mild headache was recovered at the time of report. The patient underwent the following laboratory tests and procedures: platelet factor 4: unknown results.   Follow-up attempts completed. No further information expected.  Follow-up (07Sep2021, 28Sep2021, 04Oct2021): This is a follow-up spontaneous report from a Pfizer-sponsored program includes: Relevant medical history, lab data, product details, events and narrative were updated.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101169407 Same reporter/ drug/ event for different patients
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: they have mixed 0.8ml of the diluent instead of 1.8mL with the Pfizer Biontech COVID19 vaccine which resulted in a higher dose; they have mixed 0.8ml of the diluent instead of 1.8mL with the Pfizer Biontech COVID19 vaccine which resulted in a higher dose; Pt had mild tactile temp, fatigue, mild headache symptoms; Pt had mild tactile temp, fatigue, mild headache symptoms; Pt had mild tactile temp, fatigue, mild headache symptoms; This is a spontaneous report from a contactable physician. A 12-years-old male patient received second dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: FC3183, Expiration Date: 31Oct2021), dose 2, intramuscular, administered in deltoid left on 07Sep2021 16:00 (at the age of 12 years) as single dose for COVID-19 immunisation. Medical history included asthma, mild intermittent asthma and overweight from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient did not receive any prior vaccination. The patient previously received first dose of BNT162B2 (COMIRNATY, solution for injection, Lot Number: EW0185 and expiration date was not reported), dose 1, intramuscular, administered in deltoid left on 17Aug2021 15:54 (at the age of 12 years) as single dose for COVID-19 immunisation; Hpv (Lot:T029522, Route: Intramuscular, Anatomical site: Left deltoid), administration date: 12Aug2021, when the patient was 12 years old. It was reported that they had mixed 0.8ml of the diluent instead of 1.8ml with the Pfizer BioNTech covid19 vaccine which resulted in a higher dose. On an unspecified date the patient had experienced mild tactile temperature, fatigue, mild headache. Symptoms were not different from what he experienced after first dose. The outcome for the events mild tactile temperature, fatigue, mild headache was recovered at the time of report. The patient underwent the following laboratory tests and procedures: platelet factor 4: unknown results.   Follow-up attempts completed. No further information expected.  Follow-up (07Sep2021, 28Sep2021, 04Oct2021): This is a follow-up spontaneous report from a Pfizer-sponsored program includes: Relevant medical history, lab data, product details, events and narrative were updated.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101169407 Same reporter/ drug/ event for different patients
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (parent). A 17-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FE3592), at the age of 17, on Sep 3, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the flu shot for immunisation, reaction(s): swelling at the injection site; spot gets hot-to-touch. The patient experienced insomnia (couldn't sleep until 4 am), onset Sep 3, 2021, with outcome of unknown. The reporter's son has not had a flu shot in over 6 years. He will swell at the injection site and the spot gets hot-to-touch. He did not, however, have those problems with the COVID-19 vaccine. He stayed at the vaccine van for probably 30 mins to 1 hour. He had no signs of an allergic reaction. He tried to take the flu vaccine without the preservative. The only one he could take was the one that injects into the nose, but they since eliminated that one. That's why he stopped getting the flu vaccine because it got worse year to year. He even tried to take Benadryl as a preventative for anaphylaxis to counteract an allergic reaction to the shot. No follow-up attempts possible. No further information expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza A virus test, Influenza B virus test, Limb discomfort, Pain in extremity, SARS-CoV-2 test
Clinical narrative: arm ache/Couldnt lift arm because it hurt; dead arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 15 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Aug2021 11:00 (Lot number: EW0182) at the age of 15 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraine" (ongoing), notes: 3 years ago. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 03Aug2021, outcome "recovered" (Aug2021), described as "arm ache/Couldnt lift arm because it hurt"; LIMB DISCOMFORT (non-serious) with onset 03Aug2021, outcome "recovered" (Aug2021), described as "dead arm". The patient underwent the following laboratory tests and procedures: influenza a virus test: negative; influenza b virus test: negative; sars-cov-2 test: negative.  Additional information: Her 15 year old son had an arm ache for 2-4 days after the first COVID-19 Vaccine. First dose, experienced a dead arm in the injection arm, which was the right arm. Couldnt lift arm because it hurt. Felt like was punched in the arm.   No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: First dose, experienced a dead arm in the injection arm, which was the right arm; Couldn't lift arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Aug2021 11:00 (Lot number: EW0182) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Neurofibromatosis, type 1 (von Recklinghausen's disease)" (ongoing), notes: Diagnosed at 36 years old. Is a tumor condition inside of her body. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "recovered" (Aug2021), described as "First dose, experienced a dead arm in the injection arm, which was the right arm"; MOBILITY DECREASED (non-serious) with onset Aug2021, outcome "recovered" (Aug2021), described as "Couldn't lift arm".  Additional information: After the first dose, the patient experienced a dead arm in the injection arm, which was the right arm. Couldn't lift arm because it hurt. Felt like was punched in the arm. Was continuous. Lasted only for a few hours and passed. Recovered completely. No medicine changes. No investigations were done.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: She states she received her first dose approx. 19Aug2021 and reports having sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 19Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergy to iodine" (unspecified if ongoing); "allergy to shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "She states she received her first dose approx. 19Aug2021 and reports having sore".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthropathy, Pain
Clinical narrative: in bed with aches and pain; has two messed up knees and leg problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 64 year-old male patient received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "in bed with aches and pain"; ARTHROPATHY (non-serious) with onset 2021, outcome "unknown", described as "has two messed up knees and leg problems".  Additional information: The patient had his first dose on an around 19Aug2021 and reported that he was in bed with aches and pain afterwards. The patient had two messed up knees and leg problems and it was because of that.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (parent), for a Pfizer sponsored program (159558). A 33-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had pain in extremity (experienced arm pain), with outcome of unknown. The batch/lot number for the vaccine, BNT162B2, not provided and will be requested during follow-up. Follow-up (Oct 18, 2021): This follow-up submitted to notify the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Sluggishness
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent. A 33 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), when the patient was 33 years old, for COVID-19 immunization, reaction(s): "arm pain", "achy when lifting her arm". The following information was reported: DIARRHEA (non-serious), outcome "unknown", described as "diarrhea"; SLUGGISHNESS (non-serious), outcome "unknown", described as "sluggishness". Additional Information: Caller reports that her 33-year daughter received the COMIRNATY vaccine (does not know the date) and she experienced arm pain afterwards and it was "achy" when lifting her arm and after the second dose she reported having diarrhea after eating and sluggishness. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. Follow-up (11Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk, Methylenetetrahydrofolate reductase gene mutation
Clinical narrative: I'm breastfeeding and have MTHFR gene mutation; I'm breastfeeding and have MTHFR gene mutation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A patient (no qualifiers provided) was exposed to bnt162b2 (BNT162B2), transmammary, administration date 30Aug2021 12:00 (Lot number: FC3181) as dose 1, single for covid-19 immunisation. The mother of the patient was 33 years old at the time of vaccination. The patient's relevant medical history was not reported. Concomitant medication(s) included: ASPIRINE. The following information was reported: EXPOSURE VIA BREAST MILK (non-serious), METHYLENETETRAHYDROFOLATE REDUCTASE GENE MUTATION (non-serious) all with onset 01Sep2021, outcome "not recovered" and all described as "I'm breastfeeding and have MTHFR gene mutation". The event "i'm breastfeeding and have mthfr gene mutation" and "i'm breastfeeding and have mthfr gene mutation" was evaluated at the physician office visit. Therapeutic measures were taken as a result of exposure via breast milk, methylenetetrahydrofolate reductase gene mutation.  No follow-up attempts are possible. No further information is expected.  Additional Information: This is a spontaneous report from a contactable consumer. This consumer (mother) reported information for herself and infant. This is infant report. This report included: Facility type vaccine: Pharmacy or Drug Store. The patient mother was breastfeeding and had MTHFR gene mutation, so she was advised to double her aspirin for 90 days. Adverse event start date: 01Sep2021, AE resulted in: [Doctor or other healthcare professional office/clinic visit]. The patient mother had received treatment for the adverse events. Patient mother was not diagnosed with COVID-19 prior vaccination. Patient has not been tested for COVID-19 since vaccination.  Follow-up #01 (13Sep2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101170073 mother case
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient felt abnormal/like being pushed off something (outcome unknown). This follow-up submitted to notify the batch/lot number not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm, administration date 22Sep2020 13:00 (Lot number: P22039-0068L) as dose 2, single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (I got my first 2 vaccines in Sep2020, Dose 1, Batch/Lot number: P22-395-0068L on 01Sep2021, Administration time: 10 am, Anatomical location: Arm), administration date: 01Sep2020, for COVID-19 immunization, reaction(s): "Slight arm soreness". The following information was reported: FATIGUE (non-serious) with onset 22Sep2020, outcome "unknown", described as "slight fatigue". Additional information: Onset time of event Fatigue was between 5-6 PM. Prior vaccination was none. Family medical history relevant to AEs was None. Relevant tests was None. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm, administration date 22Sep2020 13:00 (Lot number: P22039-0068L) as dose 2, single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (I got my first 2 vaccines in Sep2020, Dose 1, Batch/Lot number: P22-395-0068L on 01Sep2021, Administration time: 10 am, Anatomical location: Arm), administration date: 01Sep2020, for COVID-19 immunization, reaction(s): "Slight arm soreness". The following information was reported: FATIGUE (non-serious) with onset 22Sep2020, outcome "unknown", described as "slight fatigue". Additional information: Onset time of event Fatigue was between 5-6 PM. Prior vaccination was none. Family medical history relevant to AEs was None. Relevant tests was None. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (patient). A male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# P22-395-0068L), in arm, on Sep 1, 2020, at 10:00, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had pain in extremity (slight arm soreness), onset Sep 1, 2020, with outcome of unknown. Additional information: Patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# P22039-0068L), in arm, on Sep 22, 2020, 01:00 pm. Patient experienced slight fatigue from dose 2 on Sep 22, 2020 (5-6 pm). Prior vaccination within 4 weeks: none. Onset date and time of event sore arm: Sep 1, 2020 (2-4 pm). Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (patient). A male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# P22-395-0068L), in arm, on Sep 1, 2020, at 10:00, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had pain in extremity (slight arm soreness), onset Sep 1, 2020, with outcome of unknown. Additional information: Patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# P22039-0068L), in arm, on Sep 22, 2020, 01:00 pm. Patient experienced slight fatigue from dose 2 on Sep 22, 2020 (5-6 pm). Prior vaccination within 4 weeks: none. Onset date and time of event sore arm: Sep 1, 2020 (2-4 pm). Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Blood thyroid stimulating hormone, Fatigue, Pain in extremity, Thyroid function test abnormal
Clinical narrative: sore arm; tired; It made my thyroid level go crazy for a couple of weeks; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "heart attack" (unspecified if ongoing), notes: I had a heart attack at 31. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "tired"; THYROID FUNCTION TEST ABNORMAL (non-serious) with onset 2021, outcome "recovered" (2021), described as "It made my thyroid level go crazy for a couple of weeks". The events "sore arm", "tired" and "it made my thyroid level go crazy for a couple of weeks" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had a sore arm and was a little tired for a few days. The patient had bloodwork done between the 2 shots. It made thyroid level go crazy for a couple of weeks (irregular thyroid level) and then it went back to normal. No effect on heart.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Blood thyroid stimulating hormone, Fatigue, Pain in extremity, Thyroid function test abnormal
Clinical narrative: sore arm; tired; irregular thyroid level; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart attack at 31" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Apr2021, for Covid-19 Immunisation, reaction(s): "tired", "Sore arm", "thyroid function abnormal". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm"; FATIGUE (non-serious), outcome "recovered", described as "tired"; THYROID FUNCTION TEST ABNORMAL (non-serious), outcome "recovered", described as "irregular thyroid level". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient cardiologist approved me using the Pfizer shot, which was done last April. Patient was monitored by a cardiologist, a hematologist, and GP during the weeks after taking it because patient had a previous reaction. No effect on patient heart.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Nausea, Pain
Clinical narrative: 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 03Sep2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Had soreness and body ache"; CONFUSIONAL STATE (non-serious), DIZZINESS (non-serious), NAUSEA (non-serious) all with onset 07Sep2021, outcome "unknown" and all described as "I was walking around and then felt like confused, dizzy and something like nausea". Additional information: Patient got first dose of the vaccine on Friday afternoon. Patient had the soreness and like body ache and that kind of stuff, today while returning to work was kind of walking around and then begins feeling, kind of confused and dizzy also something like nausea. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Nausea
Clinical narrative: I felt nauseas; lightheaded; hand numbness; 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 28 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "I felt nauseas"; DIZZINESS (non-serious), outcome "unknown", described as "lightheaded"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "hand numbness". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling drunk, Vertigo
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). Other case identifier: US-PFIZER INC-202101176813. A 72-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient had vertigo (non-serious), dizziness (patient woke up the next day and couldn't get up because he was dizzy as can be) and felt drunk (patient felt drunk-like), with outcome of unknown. Additional information: Pfizer COVID-19 vaccine patient felt drunk-like with vertigo. After the second shot was in bed for 5 days again with vertigo to the point he needed a walker to get to the bathroom. Patient wondered if he got a booster, should he expect to feel the same or worse. Patient suffered from a little bit of dementia (ongoing) prior to him being administered any doses of Pfizer COVID-19 vaccine. The batch/lot number not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: he'd been in bed with vertigo from the second dose of Pfizer Covid Vaccine for 5 days but was feeling better. His friend said his daughter had the same problem; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VERTIGO (non-serious), outcome "unknown", described as "he'd been in bed with vertigo from the second dose of Pfizer Covid Vaccine for 5 days but was feeling better. His friend said his daughter had the same problem".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Gait disturbance, Vertigo
Clinical narrative: after the second shot was in bed for 5 days again with the vertigo to the point that he needed a walker to get to the bathroom.; after the second shot was in bed for 5 days again with the vertigo to the point that he needed a walker to get to the bathroom.; after the second shot was in bed for 5 days again with the vertigo to the point that he needed a walker to get to the bathroom.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "dementia" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (first Pfizer Covid Vaccine), when the patient was 72 years old, for Covid-19 immunization, reaction(s): "felt drunk", "vertigo". The following information was reported: VERTIGO (non-serious), outcome "recovering", BEDRIDDEN (non-serious), GAIT DISTURBANCE (non-serious), outcome "unknown" and all described as "after the second shot was in bed for 5 days again with the vertigo to the point that he needed a walker to get to the bathroom.".  Additional information: it was reported that Patient was wondering whether if he gets a booster should he expect to feel the same or worse. He was suffering from a little bit of dementia that was ongoing prior to him being administered any doses of Pfizer Covid Vaccine. The patient queried if he should expect the same effect or worse if he were to get the booster dose? Patient indicated that he did intend to get the booster dose. He also stated that "after the second shot I was in bed for 5 days ". he was in bed with vertigo from the second dose of Pfizer Covid Vaccine for 5 days but was feeling better.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood iron, Blood magnesium, Blood sodium, Blood test
Clinical narrative: felt a little tired that evening, and then felt fine.; slept about 12 hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 (Lot number: EP6955) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Verbatim: acid reflux" (unspecified if ongoing), notes: Verbatim: acid reflux; "Verbatim: IBSD", start date: Sep2016 (unspecified if ongoing), notes: Verbatim: IBSD; "some hamburger broke off in his throat in 2009 and caused scar tissue", start date: 2009 (unspecified if ongoing), notes: some hamburger broke off in his throat in 2009 and caused scar tissue; "he can't stand heat" (unspecified if ongoing), notes: he can't stand heat and his food has to be soft and cold, he can't eat warm foods. There were no concomitant medications. Vaccination history included: Flu shot (Prior Vaccinations (within 4 weeks): none he gets regular flu shot, had one Sep2020 and got one yesterday), administration date: Sep2020, for immunization, reaction(s): "every muscle in his body ached"; Flu shot (following prior vaccinations: one time the year they gave swine flu vaccine he got that and next day he had a  slight temperature and every muscle in his body ached. Caller does not have NDC, lot or expiry as it was years and years ago), administration date: Sep2020, for immunization, reaction(s): "slight temperature". The following information was reported: FATIGUE (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "felt a little tired that evening, and then felt fine."; SOMNOLENCE (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "slept about 12 hours". The events "felt a little tired that evening, and then felt fine." and "slept about 12 hours" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Patient received his first dose on 17Mar2021 in his left arm around noon and he came home and felt fine until about 8 then got real tired and slept about 12 hours and then was ok.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Red blood cell abnormality, Somnolence, Thyroid function test, Vitamin B12
Clinical narrative: felt a little tired that evening, and then felt fine.; slept about 12 hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 (Lot number: EP6955) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Verbatim: acid reflux" (unspecified if ongoing), notes: Verbatim: acid reflux; "Verbatim: IBSD", start date: Sep2016 (unspecified if ongoing), notes: Verbatim: IBSD; "some hamburger broke off in his throat in 2009 and caused scar tissue", start date: 2009 (unspecified if ongoing), notes: some hamburger broke off in his throat in 2009 and caused scar tissue; "he can't stand heat" (unspecified if ongoing), notes: he can't stand heat and his food has to be soft and cold, he can't eat warm foods. There were no concomitant medications. Vaccination history included: Flu shot (Prior Vaccinations (within 4 weeks): none he gets regular flu shot, had one Sep2020 and got one yesterday), administration date: Sep2020, for immunization, reaction(s): "every muscle in his body ached"; Flu shot (following prior vaccinations: one time the year they gave swine flu vaccine he got that and next day he had a  slight temperature and every muscle in his body ached. Caller does not have NDC, lot or expiry as it was years and years ago), administration date: Sep2020, for immunization, reaction(s): "slight temperature". The following information was reported: FATIGUE (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "felt a little tired that evening, and then felt fine."; SOMNOLENCE (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "slept about 12 hours". The events "felt a little tired that evening, and then felt fine." and "slept about 12 hours" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Patient received his first dose on 17Mar2021 in his left arm around noon and he came home and felt fine until about 8 then got real tired and slept about 12 hours and then was ok.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell disorder
Clinical narrative: felt a little tired that evening, and then felt fine.; slept about 12 hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 (Lot number: EP6955) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Verbatim: acid reflux" (unspecified if ongoing), notes: Verbatim: acid reflux; "Verbatim: IBSD", start date: Sep2016 (unspecified if ongoing), notes: Verbatim: IBSD; "some hamburger broke off in his throat in 2009 and caused scar tissue", start date: 2009 (unspecified if ongoing), notes: some hamburger broke off in his throat in 2009 and caused scar tissue; "he can't stand heat" (unspecified if ongoing), notes: he can't stand heat and his food has to be soft and cold, he can't eat warm foods. There were no concomitant medications. Vaccination history included: Flu shot (Prior Vaccinations (within 4 weeks): none he gets regular flu shot, had one Sep2020 and got one yesterday), administration date: Sep2020, for immunization, reaction(s): "every muscle in his body ached"; Flu shot (following prior vaccinations: one time the year they gave swine flu vaccine he got that and next day he had a  slight temperature and every muscle in his body ached. Caller does not have NDC, lot or expiry as it was years and years ago), administration date: Sep2020, for immunization, reaction(s): "slight temperature". The following information was reported: FATIGUE (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "felt a little tired that evening, and then felt fine."; SOMNOLENCE (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "slept about 12 hours". The events "felt a little tired that evening, and then felt fine." and "slept about 12 hours" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Patient received his first dose on 17Mar2021 in his left arm around noon and he came home and felt fine until about 8 then got real tired and slept about 12 hours and then was ok.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Musculoskeletal chest pain
Clinical narrative: I was achy like between my ribs were sore as if I had the flu; I was achy like between my ribs were sore as if I had the flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 (Lot number: EW0158) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (ongoing); "Anxiety" (ongoing). Concomitant medication(s) included: Trintellix taken for depression (ongoing); Hydroxyzine taken for anxiety (ongoing). Vaccination history included: Bnt162b2 (First dose: , Time: 03:45 PM, Anatomical site of injection: Left Arm, Route of administration: Intramuscular , Batch/Lot number: ER8730, ), administration date: 24Mar2021, for COVID-19 immunization; Tdap (Anatomical site of injection: Left Arm), administration date: 31Mar2021, when the patient was 30 years old. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), MUSCULOSKELETAL CHEST PAIN (non-serious) all with onset 15Apr2021, outcome "recovered" (Apr2021) and all described as "I was achy like between my ribs were sore as if I had the flu". Therapeutic measures were not taken as a result of influenza like illness, musculoskeletal chest pain.  Additional information: A day after second shot, I was achy like between my ribs were sore as if I had the flu. After 24,solid 36 hours I felt completely fine.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Colonoscopy, Limb discomfort, Paraesthesia
Clinical narrative: nerve sensations on left calf; felt on my skin like it was being touched; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Jul2021 (Lot number: EW0196) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Ischemic colitis", start date: 28Jan2019, stop date: 02Feb2019, notes: lack of Oxygen to colon caused Pain and bleeding colonoscopy biopsy determined Ischemic colitis; "Anti Depressant" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE taken for antidepressant therapy (ongoing). The following information was reported: LIMB DISCOMFORT (non-serious) with onset 21Jul2021, outcome "recovered" (24Jul2021), described as "nerve sensations on left calf"; PARAESTHESIA (non-serious) with onset 21Jul2021, outcome "recovered" (24Jul2021), described as "felt on my skin like it was being touched". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of limb discomfort, paraesthesia. Additional information: Prior vaccinations: None. Family medical history: N/A. Comments /Narrative: After 1st shot patient's left calf ankle Experienced weird Sensations felt like Someone was tickling patient of feather was rubbing against leg Definitely felt on patient's skin like it was being touched, but nothing was on patient's leg calf ( wearing Shorts ).  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance, Loss of personal independence in daily activities
Clinical narrative: I can't get up; I cannot walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "I can't get up"; GAIT DISTURBANCE (non-serious) with onset 2021, outcome "unknown", described as "I cannot walk".  Additional information: Consumer stated, "What I am seeing is, because I see the 'doctor' wrote on my is, this is on the top is 08Sep2021, that is for the second shot. "When probed of consumer got the second shot, consumer stated, "No, I got the first one." When again clarified the concern, consumer stated, "I want to know, the date is confusing for the second one. "Scheduled date for second shot: Consumer stated, "This is what is written 'I do not know, 08Sep2021 at 03:00 PM'. When clarified if the date for second shot is 08Sept2021, consumer stated, 'I was just calling for the date" When probed if consumer missed the second dose, consumer stated, "No, I wanted to make sure if it is scheduled for today. So, it is for today, right?" Consumer was advised to take the second dose on the scheduled date. Consumer further stated, "All I wanted to know if it is for today at 3 o'clock, that's all I wanted to know. I do not know that is why I want to know if I have to call, I can't get up." Consumer was provided with the number of Pfizer Medical Information and also advised to contact vaccination Center for vaccination date and timing. Consumer further stated, "Yes, I am going to the hospital, yes." In response to further probing, consumer stated, "I cannot walk, I am (voice not clear), I am trying to know, if I find out, if it could be, (voice not clear) so I am trying to look about at."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.