chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Breakthrough Case; Breakthrough Case; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient aged 18-64 years received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (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 DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Palpitations, Paraesthesia, Throat tightness
Clinical narrative: severe leg pains; Heart palpitations; numbness; tingling; throat tightness; This is a spontaneous report received from a contactable reporter (nurse). The reporter is the patient.  A 30 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered in arm right, administration date 30Sep2021 at 09:30 (Batch/Lot number: unknown) at the age of 30 years as dose 2, single for COVID-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162B2 (dose 1, single, Batch/Lot number: unknown, Location of injection: right arm), administration date: 09Sep2021, when the patient was 30 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 30Sep2021 09:30, outcome "recovered with sequelae," described as "severe leg pains;" PALPITATIONS (non-serious) with onset 30Sep2021 09:30, outcome "recovered with sequelae," described as "Heart palpitations;" HYPOAESTHESIA (non-serious) with onset 30Sep2021 09:30, outcome "recovered with sequelae," described as "numbness;" PARAESTHESIA (non-serious) with onset 30Sep2021 09:30, outcome "recovered with sequelae," described as "tingling;" THROAT TIGHTNESS (non-serious) with onset 30Sep2021 09:30, outcome "recovered with sequelae," described as "throat tightness." The events "severe leg pains," "heart palpitations," "numbness," "tingling," and "throat tightness" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of pain in extremity, palpitations, hypoaesthesia, paraesthesia, and throat tightness.  Additional information: The vaccination facility type was reported as the workplace clinic. The patient had no other vaccine in four weeks. There were no other medications in two weeks. The patient had no COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. The patient had no known allergies.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 60.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Myocardial infarction, Thrombosis
Clinical narrative: Thrombosis leg; Heart attack; MARKETING PROGRAM NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4113473-00 (AbbVie).  A 60 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date Sep2021 (Batch/Lot number: unknown) at the age of 60 years as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. Relevant medical history included: "BLOOD CLOT IN LEG" (unspecified if ongoing); "HEART ATTACK" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: THROMBOSIS (hospitalization, medically significant) with onset Sep2021, outcome "recovered" (2021), described as "Thrombosis leg"; MYOCARDIAL INFARCTION (medically significant) with onset 2021, outcome "unknown", described as "Heart attack". The action taken for adalimumab was unknown.  The patient suffered a heart attack but there was no damage. In Sep2021, he received covid vaccine, two days after the vaccine he developed a blood clot in his leg, and was hospitalized. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of Thrombosis leg, and Heart attack with adalimumab (HUMIRA) was no reasonable possibility. Causality as per AbbVie's opinion is that there is no reasonable possibility that the events of Thrombosis leg, and Heart attack are related to adalimumab (HUMIRA). The reporter's causality for the event(s) of Thrombosis leg and Heart attack with PFIZER BIONTECH COVID-19 VACCINE was not reported.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information in the case, the causal association between the events thrombosis, myocardial infarction and the suspect drug BNT162B2 cannot be excluded.The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Polymerase chain reaction
Clinical narrative: tested positive covid-19; tested positive covid-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a representative.  A 8 year-old patient received bnt162b2 (COMIRNATY) (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 DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome unknown. Patient tested positive covid-19 Thursday last week. The patient underwent the following laboratory tests and procedures polymerase chain reaction (23Dec2021) positive, yesterday confirmed with a positive PCR.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: had Pfizer vaccine then was exposed to a person that hasCovid. Now is the 1st day that the patient is showing symptoms; had Pfizer vaccine then was exposed to a person that hasCovid. Now is the 1st day that the patient is showing symptoms; This is a spontaneous report received from a contactable reporter(s) (Physician) for a program (159558).  A patient (no qualifiers provided) 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 SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome unknown. It was reported that caller doctor, is asking specifically for Paxlovid because he has a patient that was treated with cancer and had Pfizer vaccine then was exposed to a person that has Covid. Now is the 1st day that the patient is showing symptoms.  The lot number for bnt162b2 was not provided and will be requested during follow up. Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Hypersensitivity
Clinical narrative: did something to her heart, and if they got the second one she would die; allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 (BNT162B2) (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: CARDIAC DISORDER (medically significant), outcome "unknown", described as "did something to her heart, and if they got the second one she would die"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction". The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Investigation, Suspected COVID-19
Clinical narrative: Describing a taste test for a female adult who still does not have taste after covid (not sure if was vaccinated prior or with what vaccine); Describing a taste test for a female adult who still does not have taste after covid (not sure if was vaccinated prior or with what vaccine); This is a spontaneous report received from a contactable reporter (Consumer).  An adult female patient received bnt162b2 (BNT162B2) (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 DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome unknown. The patient underwent the following laboratory tests and procedures investigation unknown results, for a female adult who still does not have taste after covid. Drinking different items like soda and alcoholic drinks and condiments. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: break through infection wtih Rapid antigen positive on 22Dec2021; break through infection wtih Rapid antigen positive on 22Dec2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An adult female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date Sep2021 (Batch/Lot number: unknown) as dose 2, single and administration date Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included covid-19 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Dec2021, outcome not recovered. The patient underwent the following laboratory tests and procedures sars-cov-2 test (22Dec2021) positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected. Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is expected. The case will be reassessed further upon receipt of additional information.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Joint injury, Movement disorder, Pain, Vaccination site pain
Clinical narrative: soreness and difficulty for moving the arm in which she got the shot.; pain; her elbow is killing her; her elbow was sore and she can't lift anything; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP) from medical information team. The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Jun2021 (Lot number: EW0178) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose, Lot: EWD182., anatomical location: left arm, Time the Vaccination Was Given: before noon), administration date: 30May2021, when the patient was 46 years old, for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Jun2021, outcome "not recovered", described as "soreness and difficulty for moving the arm in which she got the shot."; PAIN (non-serious) with onset Jun2021, outcome "not recovered", described as "pain"; JOINT INJURY (non-serious) with onset Jun2021, outcome "not recovered", described as "her elbow is killing her"; MOVEMENT DISORDER (non-serious) with onset Jun2021, outcome "not recovered", described as "her elbow was sore and she can't lift anything". The events "soreness and difficulty for moving the arm in which she got the shot.", "pain", "her elbow is killing her" and "her elbow was sore and she can't lift anything" were evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination site pain, pain, joint injury, movement disorder.  Additional Information: Additional vaccines administered on same date was reported as none. Prior vaccination within 4 weeks and adverse events following prior vaccination was reported as none. The patient reported that that she is now feeling pain, soreness and difficulty for moving the arm in which she got the shot. Her left arm and her arm was fine before the shot and after the 2nd shot back on 20Jun2021, her 2nd dose, her elbow she can't even lift a cup. States her elbow is killing her and her doctor told her it's normal and it will go away with time. The patient stated she tried ice and heat and she did put a TENS meter, she put the pads on to see if that would help and it did not and she did that for a couple of days in Nov when it started getting worse.  No follow-up attempts are needed. No further information is expected.~
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest pain, Chills, Dyspnoea, Heart rate
Clinical narrative: fluttering of the heart; shortness of breath while laying down; Pulse was taken at rest as 58 bpm; Chest pain; fever; chills; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 21 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Dec2021 12:00 (Lot number: FJ8757) at the age of 21 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma (non-chronic)" (unspecified if ongoing), notes: Asthma (non-chronic); "Junior Rheumatoid Arthritis (non-chronic)" (unspecified if ongoing), notes: Junior Rheumatoid Arthritis (non-chronic); "Known allergies: Walnuts, Pecans" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: ER2613, Location of injection: Arm Left, Vaccine Administration Time: 08:45 AM Intramuscular), administration date: 20Mar2021, when the patient was 20 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, Batch/Lot No: EN6203, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM, Intramuscular), administration date: 27Feb2021, when the patient was 20 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 21Dec2021 12:00, outcome "unknown", described as "booster dose"; CARDIAC FLUTTER (medically significant) with onset 21Dec2021 22:00, outcome "unknown", described as "fluttering of the heart"; DYSPNOEA (non-serious) with onset 21Dec2021 22:00, outcome "unknown", described as "shortness of breath while laying down"; HEART RATE DECREASED (non-serious) with onset 21Dec2021 22:00, outcome "unknown", described as "Pulse was taken at rest as 58 bpm"; CHEST PAIN (non-serious) with onset 21Dec2021 22:00, outcome "not recovered", described as "Chest pain"; PYREXIA (non-serious) with onset 21Dec2021 22:00, outcome "recovered" (22Dec2021 02:00), described as "fever"; CHILLS (non-serious) with onset 21Dec2021 22:00, outcome "recovered" (22Dec2021 02:00), described as "chills". The patient underwent the following laboratory tests and procedures: heart rate: (unspecified date) 58 bpm, notes: Pulse was taken at rest as 58 bpm; sars-cov-2 test: (23Dec2021) pending, notes: Nasal Swab. Therapeutic measures were taken as a result of cardiac flutter, dyspnoea, heart rate decreased, chest pain, pyrexia, chills and included treatment with 1 table of 200 mg of Advil (Ibuprofen). Clinical course: Patient did not have covid prior vaccination. No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate decreased, Immunisation, Pyrexia, SARS-CoV-2 test
Clinical narrative: fluttering of the heart; shortness of breath while laying down; Pulse was taken at rest as 58 bpm; Chest pain; fever; chills; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 21 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Dec2021 12:00 (Lot number: FJ8757) at the age of 21 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma (non-chronic)" (unspecified if ongoing), notes: Asthma (non-chronic); "Junior Rheumatoid Arthritis (non-chronic)" (unspecified if ongoing), notes: Junior Rheumatoid Arthritis (non-chronic); "Known allergies: Walnuts, Pecans" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: ER2613, Location of injection: Arm Left, Vaccine Administration Time: 08:45 AM Intramuscular), administration date: 20Mar2021, when the patient was 20 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, Batch/Lot No: EN6203, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM, Intramuscular), administration date: 27Feb2021, when the patient was 20 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 21Dec2021 12:00, outcome "unknown", described as "booster dose"; CARDIAC FLUTTER (medically significant) with onset 21Dec2021 22:00, outcome "unknown", described as "fluttering of the heart"; DYSPNOEA (non-serious) with onset 21Dec2021 22:00, outcome "unknown", described as "shortness of breath while laying down"; HEART RATE DECREASED (non-serious) with onset 21Dec2021 22:00, outcome "unknown", described as "Pulse was taken at rest as 58 bpm"; CHEST PAIN (non-serious) with onset 21Dec2021 22:00, outcome "not recovered", described as "Chest pain"; PYREXIA (non-serious) with onset 21Dec2021 22:00, outcome "recovered" (22Dec2021 02:00), described as "fever"; CHILLS (non-serious) with onset 21Dec2021 22:00, outcome "recovered" (22Dec2021 02:00), described as "chills". The patient underwent the following laboratory tests and procedures: heart rate: (unspecified date) 58 bpm, notes: Pulse was taken at rest as 58 bpm; sars-cov-2 test: (23Dec2021) pending, notes: Nasal Swab. Therapeutic measures were taken as a result of cardiac flutter, dyspnoea, heart rate decreased, chest pain, pyrexia, chills and included treatment with 1 table of 200 mg of Advil (Ibuprofen). Clinical course: Patient did not have covid prior vaccination. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Booster; received positive COVID tests. Symptoms are mild and resolving; received positive COVID tests. Symptoms are mild and resolving; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a representative.  An adult female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (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: IMMUNISATION (medically significant), outcome unknown; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome unknown. The patient underwent the following laboratory tests and procedures sars-cov-2 test positive, had received positive COVID tests.  Reporter is patient's husband. Patient's age was reported as approximately 45 and had no underlying conditions. Event took place after use of product.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 antibody test
Clinical narrative: booster; had received positive COVID tests; had received positive COVID tests; This is a spontaneous report received from a non-contactable consumer from a sales representative. The reporter is the patient. A 50-year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (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 IMMUNISATION (medically significant), outcome unknown; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome unknown. The patient underwent the following laboratory tests and procedures COVID tests positive. Reporter was male and relayed that he and his wife have been vaccinated with Comirnaty, 2 doses and booster. But had received positive COVID tests. Symptoms are mild and resolving.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected. Linked Report(s) US-PFIZER INC-202101850213 different patient, same product, and events.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Immunisation
Clinical narrative: Heavy spotting the day after vaccination, 14 days into cycle.; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 20Dec2021 (Lot number: FE3590) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EW0169), administration date: 27Apr2021, when the patient was 29 years old, for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EW0150), administration date: 06Apr2021, when the patient was 29 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021, outcome "unknown", described as "Booster"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 21Dec2021, outcome "recovered", described as "Heavy spotting the day after vaccination, 14 days into cycle.". Therapeutic measures were not taken as a result of heavy menstrual bleeding.  Additional information: Prior to vaccination, the patient was not diagnosed as COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The past drug event was none. The facility type vaccine was Other. The patient experienced heavy spotting the day after vaccination, 14 days into cycle. Spotting was not a normal occurrence. The patient had not been sexually active for almost 2 years.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Immunisation, Menstruation irregular, SARS-CoV-2 test
Clinical narrative: Bell's Palsy right side of face; irregular menstrual cycle (two cycles within ten days); Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Nov2021 17:15 (Lot number: FN8030) at the age of 40 years as dose 3 (booster) single for covid-19 immunisation. Relevant medical history included: "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin; "Lumbar Spine epidural" (unspecified if ongoing). Concomitant medication(s) included: BOTOX. Past drug history included: Cephalosporin, reaction(s): "Known allergies: cephalosporin", notes: known allergies: penicillin, cephalosporin (rocephin),, benzyl salicylate; Benzyl salicylate, reaction(s): "Known allergies: benzyl salicylate", notes: known allergies: penicillin, cephalosporin (rocephin),, benzyl salicylate. Vaccination history included: Bnt162b2 (manufacturer: Pfizer (lot number: ER8732) dose 2 on 26Mar2021 02:00 PM, right arm), administration date: 26Mar2021, when the patient was 39 years old, for COVID-19 immunization; Bnt162b2 (manufacturer: Pfizer (lot number: EN6206) dose 1 on 05Mar2021 01:30 PM, right arm), administration date: 05Mar2021, when the patient was 39 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 11Nov2021 17:15, outcome "not recovered", described as "Booster"; BELL'S PALSY (medically significant) with onset 16Nov2021 15:00, outcome "not recovered", described as "Bell's Palsy right side of face"; MENSTRUATION IRREGULAR (non-serious) with onset 16Nov2021 15:00, outcome "not recovered", described as "irregular menstrual cycle (two cycles within ten days)". The events "booster", "bell's palsy right side of face" and "irregular menstrual cycle (two cycles within ten days)" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Dec2021) negative, notes: Nasal Swab; (21Dec2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of bell's palsy, menstruation irregular. Clinical course: the patient had bell's palsy right side of face, irregular menstrual cycle (two cycles within ten days). The patient did not receive any other vaccine in four weeks. The patient had no covid prior vaccination and had not been tested for covid-19 post vaccination.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Positive on rapid test; Positive on rapid test; Caller indicated booster dose 04DEC2021; 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 83 year-old male patient received bnt162b2 (BNT162B2), administration date 04Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single and administration date Jul2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 04Dec2021, outcome "unknown", described as "Caller indicated booster dose 04DEC2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Dec2021, outcome "unknown" and all described as "Positive on rapid test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Dec2021) positive. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: however both have tested positive to COVID-19.; however both have tested positive to COVID-19.; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 44-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left, administration date 02Dec2021 (Lot number: FJ8762) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pulmonary embolism", start date: Sep2021 (unspecified if ongoing); "COVID-19", start date: Apr2021 (unspecified if ongoing). There were no concomitant medications. She had a pulmonary embolism and was taking blood thinners for the pulmonary embolism that was diagnosed in Sep2021 and now as of Dec2021 she is ok and is no longer on blood thinners. The patient has no prior vaccinations (within 4 weeks). The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 22Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 22Dec2021, outcome "recovering" and all described as "however both have tested positive to COVID-19.". The event "however both have tested positive to covid-19." and "however both have tested positive to covid-19." was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Dec2021) positive, notes: by NAAT PCR TMA test. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient stated that she and her son have got their first shot of Pfizer Biontech COVID-19 vaccine. Today, they had the appointment for the second dose, however they both have tested positive to COVID-19The pharmacist told her to wait one month but she read on the Internet that she could get it after 10 days. She wanted to know if she could get the second dose of the vaccine having had a positive covid test. She was diagnosed with covid yesterday morning (22Dec2021). She went to ER yesterday and did the PCR test and the doctor told her that she tested positive for the omicron variant. She was not admitted, went there (emergency room) for a covid test. She was taking over the counter pills. The patient felt a little bit better today, yesterday was really bad. She has not received the second dose. She had covid prior in Apr2021 and wanted to take the vaccine earlier but was procrastinating. She was told that she was good after quarantine and are good to get the second dose. She went to pharmacy and they told her to go after a month. Then on the website, that she should not wait longer than 2 weeks, or it is not really good. She wanted to call Pfizer to make sure when she should get the second dose. She was advised to follow what transfer agent stated or consult with hcp. She did not get second dose yet. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101852784 same reporter/drug/AE, different patient
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Taste disorder
Clinical narrative: Major taste change; taste like it has a blood/metal/acid; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 (Lot number: ep6955) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Yes" (unspecified if ongoing). The patient took concomitant medications (other medications in two weeks). Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: en6198, Location of injection: Arm Left), administration date: 03Mar2021, when the patient was 64 years old, for COVID-19 immunization. No other vaccine in four weeks. No covid prior vaccination. Not covid tested post vaccination. The following information was reported: TASTE DISORDER (disability) with onset 25Jun2021, outcome "not recovered", described as "Major taste change"; DYSGEUSIA (disability) with onset 25Jun2021, outcome "not recovered", described as "taste like it has a blood/metal/acid". Also reported that food does not taste good. The events "major taste change" and "taste like it has a blood/metal/acid" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of taste disorder, dysgeusia. Events resulted in disability or permanent damage.  No follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: Post menopausal bleeding; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 15:15 (Batch/Lot number: unknown) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing); "Mild TBI" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "Chronic Fatigue" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE; METFORMIN ER; BUPROPION HCL. Past drug history included: Morphine, reaction(s): "known allergies: Morphine"; Amoxicillin, reaction(s): "known allergies: Amoxicillin". Vaccination history included: Bnt162b2 (Dose Number: 1, dose brand: Pfizer, lot unknown, administration time 11:45 AM, dose vaccine location: Left arm), administration date: 04Mar2021, when the patient was 51 years old, for COVID-19 immunization. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 01Oct2021, outcome "not recovered", described as "Post menopausal bleeding". The event "post menopausal bleeding" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of postmenopausal haemorrhage. Clinical course: The patient had no prior vaccination, no other vaccine in four weeks and was not tested for COVID post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: Patient experienced an unprovoked leg DVT "sometime after the second dose" in primary series; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 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: Covid-19 vaccine (dose:1, single, MANUFACTURER UNKNOWN), for COVID-19 Immunization.  The following information was reported: DEEP VEIN THROMBOSIS (medically significant), outcome "unknown", described as "Patient experienced an unprovoked leg DVT "sometime after the second dose" in primary series". Patient was asking if there was any reason for a patient not to receive the covid booster after the patient experienced an unprovoked leg dvt sometime after the second dose of the Pfizer covid vaccine. Asking if there has been any reports of dvt occurring post vaccine. She does not have time to complete report. Response received that Pfizer cannot make individual treatment recommendations for patients and deferring to HCP.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event Deep vein thrombosis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She reports testing positive for Covid 19 today. She has been vaccinated with 2 doses of the Pfizer Covid 19 vaccine; She reports testing positive for Covid 19 today. She has been vaccinated with 2 doses of the Pfizer Covid 19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group for a Pfizer sponsored program (172086). The reporter is the patient.  A 37 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 23Apr2021 (Lot number: EW0172) at the age of 36 years as dose 2, single and administered in deltoid left, administration date 02Apr2021 (Lot number: EP7533) as dose 1, single for covid-19 immunisation. Relevant medical history included: "sports induced/exercise induced asthma" (unspecified if ongoing), notes: sports induced/exercise induced asthma diagnosed when she was a teen; "overweight" (unspecified if ongoing), notes: Caller states she is otherwise pretty healthy other than being a little overweight. Concomitant medication(s) included: RITONAVIR. Vaccination history included: Flu shot, administration date: Oct2020, for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Dec2021, outcome "unknown" and all described as "She reports testing positive for Covid 19 today. She has been vaccinated with 2 doses of the Pfizer Covid 19 vaccine". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Dec2021) positive, notes: at home rapid Covid test. Reporter stated testing positive for Covid 19 today. patient had been vaccinated with 2 doses of the Pfizer Covid 19 vaccine. She states that she would like to be in the trial for vaccinated patients who test positive to receive nirmatrelvir/ritonavir (Paxlovid). In response to the query it was provided that the study appears to no longer be enrolling. Relayed to reporter to check back in time to see when this product may become available to her. For those 18 years of age and older who have COVID-19 symptoms and have tested positive for COVID-19 within the last 5 days, but do not have any health conditions putting them at risk for severe illness, or have these conditions but are fully vaccinated. No Longer Enrolling. Reporter states she tried to call for the monoclonal antibody infusion and got a 3/4 for scoring and didn't qualify No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity
Clinical narrative: Booster; Sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Dec2021 (Batch/Lot number: unknown) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: Apr2021, when the patient was 78 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: Jan2021, when the patient was 78 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (non-serious) with onset 01Dec2021, outcome "recovered" (Dec2021), described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: It was reported that, no other vaccine was received with in four weeks. Adverse event: Sore arm that persisted 3 weeks after injection. Patient was not diagnosed with COVID prior vaccination and was not tested with COVID post vaccination. Had no known allergies.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Immunisation, Rash, SARS-CoV-2 test
Clinical narrative: Rash on back; Severe lower Back pain; dose received: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 75 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Dec2021 (Batch/Lot number: unknown) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "allergies Sulpha" (unspecified if ongoing), notes: Known allergies: Sulpha. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2 Batch/lot number unknown), for COVID-19 Immunization; Bnt162b2 (Dose Number: 1 Batch/lot number unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021, outcome "unknown", described as "dose received: 3"; RASH (non-serious) with onset 22Dec2021 09:00, outcome "not recovered", described as "Rash on back"; BACK PAIN (non-serious) with onset 22Dec2021 09:00, outcome "not recovered", described as "Severe lower Back pain". The events "rash on back" and "severe lower back pain" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, back pain.  Additional Information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was Yes unknown. The Patient received treatment for the adverse event with Pain medication and antibiotic. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Hyperhidrosis, Immunisation, Swelling
Clinical narrative: I have quite a bit of fluid and swelling under my left armpit- uncomfortable.; I have quite a bit of fluid and swelling under my left armpit- uncomfortable.; I have quite a bit of fluid and swelling under my left armpit- uncomfortable.; dose received: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Dec2021 16:00 (Batch/Lot number: unknown) at the age of 42 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 14Apr2021, when the patient was 42 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6202, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 23Mar2021, when the patient was 42 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 16:00, outcome "unknown", described as "dose received: 3"; HYPERHIDROSIS (non-serious), SWELLING (non-serious), DISCOMFORT (non-serious) all with onset 22Dec2021 01:00, outcome "not recovered" and all described as "I have quite a bit of fluid and swelling under my left armpit- uncomfortable.". Therapeutic measures were not taken as a result of hyperhidrosis, swelling, discomfort.  Additional information: The patient does not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received blood pressure medicine within 2 weeks of vaccination. The patient had quite a bit of fluid and swelling under his left armpit- uncomfortable. The patient does not received treatment for AE. Prior to vaccination, was the patient does not diagnose with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient has no known allergies.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Immunisation, Myalgia, Vaccination site pain
Clinical narrative: Mild pain at site of injection; Mild pain at site of injection which switched to intense muscle aches; chill.; Intense headaches; dose received: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Dec2021 10:45 (Lot number: FH8027) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Right), administration date: 16Feb2021, when the patient was 55 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right), administration date: 26Jan2021, when the patient was 55 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 10:45, outcome "unknown", described as "dose received: 3"; VACCINATION SITE PAIN (non-serious) with onset 20Dec2021 19:00, outcome "recovered" (Dec2021), described as "Mild pain at site of injection"; MYALGIA (non-serious) with onset 20Dec2021 19:00, outcome "recovered" (Dec2021), described as "Mild pain at site of injection which switched to intense muscle aches"; CHILLS (non-serious) with onset 20Dec2021 19:00, outcome "recovered" (Dec2021), described as "chill."; HEADACHE (non-serious) with onset 20Dec2021 19:00, outcome "recovered" (Dec2021), described as "Intense headaches". Therapeutic measures were not taken as a result of vaccination site pain, myalgia, chills, headache. Additional information: The patient had mild pain at site of injection which switched to intense muscle aches and chill.  This occurred the first 24 hours after injection. Intense headaches 24-48 hours post injection. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received ibuprofen within 2 weeks of vaccination. The patient known allergies was reported as unknown. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch provided.