chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pyrexia
Clinical narrative: Fever was 100.6; Myalgias; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10 year-old female patient received bnt162b2 (BNT162B2), administration date 28Nov2021 (Batch/Lot number: unknown) as dose 2, 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 1, Received the  10mcg dose), administration date: 07Nov2021, for COVID-19 immunization, reaction(s): "without any reactions". The following information was reported: PYREXIA (non-serious) with onset 29Nov2021, outcome "unknown", described as "Fever was 100.6"; MYALGIA (non-serious) with onset 29Nov2021, outcome "unknown", described as "Myalgias". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenopia, Blepharospasm
Clinical narrative: After getting the Pfizer-BioNTech COVID-19 Vaccine he had difficulty opening the eyes; had ticks of the eyes or blepharospasm; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 17 year-old male 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: ASTHENOPIA (non-serious), outcome "unknown", described as "After getting the Pfizer-BioNTech COVID-19 Vaccine he had difficulty opening the eyes"; BLEPHAROSPASM (non-serious), outcome "unknown", described as "had ticks of the eyes or blepharospasm".  Additional Information: This was two weeks after getting the covid vaccine.Reason for no lot number: of Covid Vaccine: Caller unwilling to complete the report.This has been reported to the FDA and VARES.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: had a headache 24 hours after taking the medication; had a temperature (108F) 24 hours after taking the medication; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 8 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 27Nov2021 15:00 (Lot number: FL0007) at the age of 8 years as dose 1, single for covid-19 immunisation. Relevant medical history included Allergy to Penicillin (unspecified if ongoing). There were no concomitant medications. The following information was reported HEADACHE (non-serious) with onset 29Nov2021 12:45, outcome recovered (29Nov2021); PYREXIA (non-serious) with onset 29Nov2021 12:45, outcome recovered (29Nov2021). The events had a headache 24 hours after taking the medication and had a temperature (108f) 24 hours after taking the medication were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, pyrexia.  Had a temperature(108F) and headache 24 hours after taking the medication. Temperature and headache went away within 8 hours.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: chills; fatigue; high fever; This is a literature report:  A patient (no qualifiers provided) 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. The following information was reported: CHILLS (life threatening), outcome "unknown", described as "chills"; FATIGUE (life threatening), outcome "unknown", described as "fatigue"; PYREXIA (life threatening), outcome "unknown", described as "high fever".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case , a possible causal association between the reported  events pyrexia , chills, pyrexia and the suspect drug BNT162B2 cannot be excluded.  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: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Muscle tightness, Musculoskeletal discomfort, Paraesthesia
Clinical narrative: tension headache in the lower back area of her head;; described as above her neck; kind of a tingling and numbness while at the same time feeling tight and has pressure.; described as above her neck; kind of a tingling and numbness while at the same time feeling tight and has pressure.; described as above her neck; kind of a tingling and numbness while at the same time feeling tight and has pressure.; described as above her neck; kind of a tingling and numbness while at the same time feeling tight and has pressure.; Constant headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101698066.  A 30 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 24Oct2021 13:00 (Batch/Lot number: unknown) at the age of 30 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: TENSION HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "tension headache in the lower back area of her head;"; PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious), MUSCLE TIGHTNESS (non-serious), MUSCULOSKELETAL DISCOMFORT (non-serious) all with onset 2021, outcome "not recovered" and all described as "described as above her neck; kind of a tingling and numbness while at the same time feeling tight and has pressure."; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "Constant headache". Therapeutic measures were not taken as a result of tension headache, paraesthesia, hypoaesthesia, muscle tightness, musculoskeletal discomfort, headache.  Additional information: Family Medical History Relevant to AE(s): None. Prior Vaccinations (within 4 weeks): None. AE(s) following prior vaccinations: None. History of all previous immunization with the Pfizer vaccine considered as suspect: N/A. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Since having been administered the first dose she has been getting reported events. She woke up in the middle night and the headaches were there. She went to sleep and woke up and the headaches were there. Constant headache: Began either one week or two weeks after the first dose. Serious: no. Patient was asking if this was normal with the Pfizer Covid Vaccine, because she was scared to get another dose relative to this event and wanted to call or see a doctor before getting the second dose to make sure it was not going to get worse. AE(s) require a visit to: Emergency Room and Physician Office: No. Investigation Assessment: No. Relevant Tests: None.  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: Tension headache
Clinical narrative: tension headache in the lower back area of her head;; described as above her neck; kind of a tingling and numbness while at the same time feeling tight and has pressure.; described as above her neck; kind of a tingling and numbness while at the same time feeling tight and has pressure.; described as above her neck; kind of a tingling and numbness while at the same time feeling tight and has pressure.; described as above her neck; kind of a tingling and numbness while at the same time feeling tight and has pressure.; Constant headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101698066.  A 30 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 24Oct2021 13:00 (Batch/Lot number: unknown) at the age of 30 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: TENSION HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "tension headache in the lower back area of her head;"; PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious), MUSCLE TIGHTNESS (non-serious), MUSCULOSKELETAL DISCOMFORT (non-serious) all with onset 2021, outcome "not recovered" and all described as "described as above her neck; kind of a tingling and numbness while at the same time feeling tight and has pressure."; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "Constant headache". Therapeutic measures were not taken as a result of tension headache, paraesthesia, hypoaesthesia, muscle tightness, musculoskeletal discomfort, headache.  Additional information: Family Medical History Relevant to AE(s): None. Prior Vaccinations (within 4 weeks): None. AE(s) following prior vaccinations: None. History of all previous immunization with the Pfizer vaccine considered as suspect: N/A. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Since having been administered the first dose she has been getting reported events. She woke up in the middle night and the headaches were there. She went to sleep and woke up and the headaches were there. Constant headache: Began either one week or two weeks after the first dose. Serious: no. Patient was asking if this was normal with the Pfizer Covid Vaccine, because she was scared to get another dose relative to this event and wanted to call or see a doctor before getting the second dose to make sure it was not going to get worse. AE(s) require a visit to: Emergency Room and Physician Office: No. Investigation Assessment: No. Relevant Tests: None.  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
Clinical narrative: had "more pain" on one side of her body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "cancer survivor" (unspecified if ongoing); "lupus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "had "more pain" on one side of her body".  Additional information: It was reported that patient was unaware if her reaction was due to the vaccination or if it it was an "extension" of her previous conditions, when she received the vaccine, she had "more pain" on one side of her body. She described her reaction as "livable". Upon Follow-up Agent relays that the caller is not sure if the reaction she experienced was something related to a previous illness or something from the vaccine. Agent relays the caller mentions that during the reaction one side of her body was in pain but didn't specify much about the reaction. Agent relays that she is fully vaccinated with both doses. Agent clarifies that the caller is also the patient.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Headache, Neck pain, Peripheral swelling, Rash
Clinical narrative: Severe headache; rash on my stomach; vertigo; neck pain; difficulty swallowing; my arm is swollen; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 29Nov2021 12:30 (Batch/Lot number: unknown) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "PTSD" (unspecified if ongoing); "Known allergies:Sulfa" (unspecified if ongoing); "Known allergies: Bees" (unspecified if ongoing). Concomitant medication(s) included: FLU taken for immunisation, administration date 11Oct2021; PROZAC; KLONOPIN; ASA; VITAMIN B [VITAMIN B NOS]; D3. Past drug history included: Known allergies:azithromycin, reaction(s): "Drug Allergy"; Known allergies: ees, reaction(s): "Drug allergy". The following information was reported: HEADACHE (non-serious) with onset 29Nov2021 18:30, outcome "not recovered", described as "Severe headache"; RASH (non-serious) with onset 29Nov2021 18:30, outcome "not recovered", described as "rash on my stomach"; VERTIGO (non-serious) with onset 29Nov2021 18:30, outcome "not recovered", described as "vertigo"; NECK PAIN (non-serious) with onset 29Nov2021 18:30, outcome "not recovered", described as "neck pain"; DYSPHAGIA (non-serious) with onset 29Nov2021 18:30, outcome "not recovered", described as "difficulty swallowing"; PERIPHERAL SWELLING (non-serious) with onset 29Nov2021 18:30, outcome "not recovered", described as "my arm is swollen".  Additional information: Serious: No, Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient has not 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Severe headache; rash on my stomach; vertigo; neck pain; difficulty swallowing; my arm is swollen; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 29Nov2021 12:30 (Batch/Lot number: unknown) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "PTSD" (unspecified if ongoing); "Known allergies:Sulfa" (unspecified if ongoing); "Known allergies: Bees" (unspecified if ongoing). Concomitant medication(s) included: FLU taken for immunisation, administration date 11Oct2021; PROZAC; KLONOPIN; ASA; VITAMIN B [VITAMIN B NOS]; D3. Past drug history included: Known allergies:azithromycin, reaction(s): "Drug Allergy"; Known allergies: ees, reaction(s): "Drug allergy". The following information was reported: HEADACHE (non-serious) with onset 29Nov2021 18:30, outcome "not recovered", described as "Severe headache"; RASH (non-serious) with onset 29Nov2021 18:30, outcome "not recovered", described as "rash on my stomach"; VERTIGO (non-serious) with onset 29Nov2021 18:30, outcome "not recovered", described as "vertigo"; NECK PAIN (non-serious) with onset 29Nov2021 18:30, outcome "not recovered", described as "neck pain"; DYSPHAGIA (non-serious) with onset 29Nov2021 18:30, outcome "not recovered", described as "difficulty swallowing"; PERIPHERAL SWELLING (non-serious) with onset 29Nov2021 18:30, outcome "not recovered", described as "my arm is swollen".  Additional information: Serious: No, Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient has not 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swelling of breast lymph nodes after first shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Sep2021 (Batch/Lot number: unknown) at the age of 54 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "known allergies: codeine". The following information was reported: LYMPHADENOPATHY (non-serious) with onset Sep2021, outcome "recovered" (2021), described as "Swelling of breast lymph nodes after first shot". The event "swelling of breast lymph nodes after first shot" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: facility where the most recent COVID-19 vaccine was administered was withheld. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Contusion, Oxygen saturation, Pulse abnormal, Respiration abnormal
Clinical narrative: The 1st and 2nd shot crated a large black and blue on my left leg; Contusion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Jan2021 11:00 (Lot number: EL1284) as dose 1, single and administered in arm left, administration date 26Jan2021 11:00 (Batch/Lot number: unknown) as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Severe allergy" (ongoing), notes: Start date: Years, Ongoing; "Sinus" (ongoing), notes: Start date: Years, Ongoing; "Blood Pressure" (ongoing), notes: Start date: Years, Ongoing. Concomitant medication(s) included: EQUATE [ACETYLSALICYLIC ACID] taken for sinus disorder, hypersensitivity (ongoing); AMLODIPINE taken for blood pressure measurement (ongoing); BENAZEPRIL taken for blood pressure measurement (ongoing); EPINEPHRINE; LEVAQUIN; LIDOCAINE. The following information was reported: SKIN DISCOLOURATION (non-serious) with onset 2021, outcome "unknown", described as "The 1st and 2nd shot crated a large black and blue on my left leg"; CONTUSION (non-serious) with onset 2021, outcome "unknown", described as "Contusion". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The 1st and 2nd shot (both administered on left bicep) created a large black and blue on her left leg. relevant to the emergency form each time they over. Technique: Color flow Doppler and Duplex sonographic examination of the venous system of right and left lower extremity was performed. Findings: No thrombus is identified. Impression: No evidence of deep vein thrombosis in the lower extremities.   Follow-up attempts have been completed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Temperature perception test abnormal, Ultrasound scan, X-ray
Clinical narrative: The 1st and 2nd shot crated a large black and blue on my left leg; Contusion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Jan2021 11:00 (Lot number: EL1284) as dose 1, single and administered in arm left, administration date 26Jan2021 11:00 (Batch/Lot number: unknown) as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Severe allergy" (ongoing), notes: Start date: Years, Ongoing; "Sinus" (ongoing), notes: Start date: Years, Ongoing; "Blood Pressure" (ongoing), notes: Start date: Years, Ongoing. Concomitant medication(s) included: EQUATE [ACETYLSALICYLIC ACID] taken for sinus disorder, hypersensitivity (ongoing); AMLODIPINE taken for blood pressure measurement (ongoing); BENAZEPRIL taken for blood pressure measurement (ongoing); EPINEPHRINE; LEVAQUIN; LIDOCAINE. The following information was reported: SKIN DISCOLOURATION (non-serious) with onset 2021, outcome "unknown", described as "The 1st and 2nd shot crated a large black and blue on my left leg"; CONTUSION (non-serious) with onset 2021, outcome "unknown", described as "Contusion". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The 1st and 2nd shot (both administered on left bicep) created a large black and blue on her left leg. relevant to the emergency form each time they over. Technique: Color flow Doppler and Duplex sonographic examination of the venous system of right and left lower extremity was performed. Findings: No thrombus is identified. Impression: No evidence of deep vein thrombosis in the lower extremities.   Follow-up attempts have been completed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Insomnia
Clinical narrative: My brother also experienced the same thing with me and we went together got the vaccine at the same place and he also came down with Insomnia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male 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: INSOMNIA (non-serious), outcome "unknown", described as "My brother also experienced the same thing with me and we went together got the vaccine at the same place and he also came down with Insomnia".  Additional information: COVID-19 Vaccine was a Pfizer product. This was the second case out of the 2 cases. Consumer started to experience insomnia, the last two times when Pfizer vaccine was taken. Consumer could not sleep, so went to see a psychiatrist to get medication to sleep. Then, after taking medication for like 3 months Consumer started back to get partial sleep. Now, Consumer went to take booster yesterday, and surprisingly again could not sleep the whole night again. So, consumer's  brother had already went the last time to the same site at the same time and he also came with the similar sleeping problem. All three was Pfizer, consumer did not take any other brand. Consumer further stated that second time, had to go 3 weeks later to take it (Pfizer COVID-19 Vaccine) again and finally could not sleep, the whole night and was awake. So, had to get a medication to sleep but now yesterday consumer went to take the Booster and it happened again and then could not sleep. Consumer does not know what this report was going to do just 'with another area'. Consumer was informed that this report will eventually help other patient receiving the Vaccine. Consumer confirmed that the brother also received the Pfizer COVID-19 vaccine at the same day and experienced the same event Insomnia. Consumer do not have any information about the product details (LOT# & Expiration date) of Pfizer Covid-19 Vaccine. They have concluded that this was the vaccine but then they had the benefit of doubt. May be some other factors that was causing this but then yesterday after consumer took it again and could not sleep and decided to make the call to see if the vaccine is interfering with the sleep.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Confusional state, Dizziness, Fall, Fatigue
Clinical narrative: three BPPV attacks; One of which resulted in a fall; I still have unrelenting tinnitus; also suffered from brain fog; dizziness; balance issues and confusion; balance issues and confusion; extreme fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Mar2021 11:30 (Lot number: EN6207) as dose 2, single for covid-19 immunisation. Relevant medical history included: "BPPV", start date: 2019 (ongoing), notes: 3 positional vertigo episodes prior to vaccination-(BPPV) in 2019-2020.; "Cholesterol" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing). Prior vaccinations were none. Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol (ongoing); AMLODIPINE taken for blood pressure measurement (ongoing); ASPIRIN [ACETYLSALICYLIC ACID] (ongoing). Vaccination history included: Covid-19 vaccine (Dose 1, Single, MANUFACTURER UNKNOWN, Anatomical site of injection: Right Arm; Time: 11:00 AM, Batch/Lot number: EN6202, Vaccination facility), administration date: 25Feb2021, for Covid-19 immunization. The following information was reported: VERTIGO POSITIONAL (hospitalization) with onset Mar2021, outcome "recovered" (2021), described as "three BPPV attacks"; FALL (hospitalization) with onset Mar2021, outcome "unknown", described as "One of which resulted in a fall"; TINNITUS (non-serious) with onset 20Mar2021, outcome "not recovered", described as "I still have unrelenting tinnitus"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "also suffered from brain fog"; DIZZINESS (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "dizziness"; FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "extreme fatigue"; BALANCE DISORDER (non-serious), CONFUSIONAL STATE (non-serious) all with onset Mar2021, outcome "recovered" (2021) and all described as "balance issues and confusion". The patient underwent the following laboratory tests and procedures: magnetic resonance imaging head: (May2021) negative. Therapeutic measures were taken with Hospital visit and six staples to the back of head as a result of vertigo positional, fall. Patient had no obvious side effect after 1st shot two days after the second shot tinnitus began and has not eased at all after 9 months. All side effects have subsided beginning in months 6-7. Patient was thin and healthy prior to shots. Patient did not had relevant test for thromboembolic events with thrombocytopenia.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Magnetic resonance imaging head, Tinnitus, Vertigo positional
Clinical narrative: three BPPV attacks; One of which resulted in a fall; I still have unrelenting tinnitus; also suffered from brain fog; dizziness; balance issues and confusion; balance issues and confusion; extreme fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Mar2021 11:30 (Lot number: EN6207) as dose 2, single for covid-19 immunisation. Relevant medical history included: "BPPV", start date: 2019 (ongoing), notes: 3 positional vertigo episodes prior to vaccination-(BPPV) in 2019-2020.; "Cholesterol" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing). Prior vaccinations were none. Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol (ongoing); AMLODIPINE taken for blood pressure measurement (ongoing); ASPIRIN [ACETYLSALICYLIC ACID] (ongoing). Vaccination history included: Covid-19 vaccine (Dose 1, Single, MANUFACTURER UNKNOWN, Anatomical site of injection: Right Arm; Time: 11:00 AM, Batch/Lot number: EN6202, Vaccination facility), administration date: 25Feb2021, for Covid-19 immunization. The following information was reported: VERTIGO POSITIONAL (hospitalization) with onset Mar2021, outcome "recovered" (2021), described as "three BPPV attacks"; FALL (hospitalization) with onset Mar2021, outcome "unknown", described as "One of which resulted in a fall"; TINNITUS (non-serious) with onset 20Mar2021, outcome "not recovered", described as "I still have unrelenting tinnitus"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "also suffered from brain fog"; DIZZINESS (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "dizziness"; FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "extreme fatigue"; BALANCE DISORDER (non-serious), CONFUSIONAL STATE (non-serious) all with onset Mar2021, outcome "recovered" (2021) and all described as "balance issues and confusion". The patient underwent the following laboratory tests and procedures: magnetic resonance imaging head: (May2021) negative. Therapeutic measures were taken with Hospital visit and six staples to the back of head as a result of vertigo positional, fall. Patient had no obvious side effect after 1st shot two days after the second shot tinnitus began and has not eased at all after 9 months. All side effects have subsided beginning in months 6-7. Patient was thin and healthy prior to shots. Patient did not had relevant test for thromboembolic events with thrombocytopenia.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness
Clinical narrative: massive headache; sick; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 02Aug2021 (Batch/Lot number: unknown) as dose 1, single and administration date 24Aug2021 (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: HEADACHE (non-serious) with onset Aug2021, outcome "recovering", described as "massive headache"; ILLNESS (non-serious) with onset Aug2021, outcome "recovering", described as "sick"; FATIGUE (non-serious) with onset Aug2021, outcome "recovering", described as "tired".  Additional information: Reporter mentioned that her daughter got her vaccines at the same time as the reporter. Said her daughter did okay, she was sick and tired, but she did okay. Attempted to gather more information from the reporter about her daughter's experience with the vaccines. Reporter stated that her daughter was sick, tired, had a massive headache. The second vaccine for her was the worst. Reporter stated that her daughter got better.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: She is having some allergy reaction. It is not severe. It is just like you know, not severe allergy reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17Nov2021 (Lot number: FBC5127) at the age of 10 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HYPERSENSITIVITY (non-serious) with onset Nov2021, outcome "not recovered", described as "She is having some allergy reaction. It is not severe. It is just like you know, not severe allergy reaction". Therapeutic measures were taken as a result of hypersensitivity.  Additional information: Any prior vaccinations (within 4 weeks) was reported as no.second shot date was 08Dec2021.Patient was took Benadryl ( dose like 5mg) for the adverse event.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: She did not know whether she was sick or was having a reaction. Her much younger daughter had a weekend of it.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the parent.  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: ILLNESS (non-serious), outcome "unknown", described as "She did not know whether she was sick or was having a reaction. Her much younger daughter had a weekend of it.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: head cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (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: NASOPHARYNGITIS (non-serious) with onset 02Dec2021, outcome "unknown", described as "head cold".  Additional information: The patient was scheduled to get his booster shot on 02Dec2021 and he was not sure if he should get it. Reporter asked what was the recommendation for getting the shot while he has a cold?   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: benign muscle facilitation/ constant muscle twitches at my calf's and lower Quadricep muscles.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Feb2021 (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: 1st), for Covid-19 immunization. The following information was reported: MUSCLE TWITCHING (non-serious) with onset Feb2021, outcome "not recovered", described as "benign muscle facilitation/ constant muscle twitches at my calf's and lower Quadricep muscles."  Additional information: It was reported that patient diagnosed with benign muscle facilitation since receiving covid vaccine in Feb2021. Since from second injection, patient experienced constant muscle twitches at calf's and lower Quadricep muscles. Patient never experienced anything like this prior to the vaccine and symptoms started the day after second injection. The frequency of these muscle twitches has not changed since Feb and don't seem to be regressing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: sudden sharp pains on the left side of her head close to her ear. They then began moving all over her head; had left leg pain; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. The reporter is the parent.  A 11 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 01Dec2021 18:45 (Batch/Lot number: unknown) at the age of 11 years as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01Dec2021 18:55, outcome "recovered" (2021), described as "had left leg pain"; HEADACHE (non-serious) with onset 01Dec2021 19:05, outcome "not recovered", described as "sudden sharp pains on the left side of her head close to her ear. They then began moving all over her head".  Additional information: Patient had left leg pain 10 minutes after being vaccinated . Stated that after five minutes that she had sudden sharp pains on her head. . when she got home that she had shooting head pain that kept going every 20-30 minutes.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling
Clinical narrative: Under arm pain; very little swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10 year-old female patient received bnt162b2 (BNT162B2), administration date 30Nov2021 (Batch/Lot number: unknown) at the age of 10 years 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, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: AXILLARY PAIN (non-serious) with onset 2021, outcome "unknown", described as "Under arm pain"; SWELLING (non-serious) with onset 2021, outcome "unknown", described as "very little swelling".  Optional Information: No other patient information. Twin sister received the same dose at same time no headache, and no bellyache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Follow-up (05Jan2022)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.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Pyrexia, Rash, Respiration abnormal
Clinical narrative: experiencing a temperature of 101. 5 degrees; Threw up; Slight rash; Complaining of chest pain; it feels easier to breath, almost too easy to breathe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer. The reporter is the parent.  A 13 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 13 years 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), for COVID-19 immunisation. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "experiencing a temperature of 101. 5 degrees"; VOMITING (non-serious), outcome "unknown", described as "Threw up"; RASH (non-serious), outcome "unknown", described as "Slight rash"; CHEST PAIN (non-serious), outcome "unknown", described as "Complaining of chest pain"; RESPIRATION ABNORMAL (non-serious), outcome "unknown", described as "it feels easier to breath, almost too easy to breathe". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts have been completed and no further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: experiencing a temperature of 101. 5 degrees; Threw up; Slight rash; Complaining of chest pain; it feels easier to breath, almost too easy to breathe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer. The reporter is the parent.  A 13 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 13 years 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), for COVID-19 immunisation. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "experiencing a temperature of 101. 5 degrees"; VOMITING (non-serious), outcome "unknown", described as "Threw up"; RASH (non-serious), outcome "unknown", described as "Slight rash"; CHEST PAIN (non-serious), outcome "unknown", described as "Complaining of chest pain"; RESPIRATION ABNORMAL (non-serious), outcome "unknown", described as "it feels easier to breath, almost too easy to breathe". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts have been completed and no further information is expected.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Redness and swelling about the size of a quarter at injection site; Redness and swelling about the size of a quarter at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 16:45 (Batch/Lot number: unknown) at the age of 10 years 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: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 30Nov2021, outcome "recovered" (2021) and all described as "Redness and swelling about the size of a quarter at injection site". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site erythema.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  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: F
Vaccine: COVID19
Symptoms: Back pain, Burning sensation, Gait disturbance, Inflammation
Clinical narrative: inflammatory reaction; burning; back pain; difficulty walking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program .  A 74 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 1 diabetes mellitus" (ongoing), notes: Diagnosed in her 20s. There were no concomitant medications. The following information was reported: INFLAMMATION (non-serious), outcome "unknown", described as "inflammatory reaction"; BURNING SENSATION (non-serious), outcome "unknown", described as "burning"; BACK PAIN (non-serious), outcome "unknown", described as "back pain"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "difficulty walking".  Additional information: She said that for her it slowly started after the first vaccine, after the second dose over the next couple of months she became incapacitated. Brother has had the same issue, x-rayed by doctor and nothing was found wrong and was put on pain medications. Over the holidays her sister started having the same reactions and is now on cortisone injections, patient reported that the pain makes you walk funny and then from walking funny other things start hurting.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Experiencing frequent chest pains describing it as 'headache for heart'; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 9 year-old male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 9 years 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: CHEST PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Experiencing frequent chest pains describing it as 'headache for heart'".  Additional Information: Experiencing frequent chest pains describing it as 'headache for heart' Occurring throughout the day when sitting or laying down.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation, Pain in extremity, Pyrexia
Clinical narrative: Sore arm on side of injection; mild fever; chills; fatigue; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administered in arm, administration date 26Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose no:1, MANUFACTURER: UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (Dose no:2, MANUFACTURER: UNKNOWN), for COVID-19 Immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 26Nov2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (non-serious) with onset 27Nov2021, outcome "recovered" (28Nov2021), described as "Sore arm on side of injection"; PYREXIA (non-serious) with onset 27Nov2021, outcome "recovered" (28Nov2021), described as "mild fever"; CHILLS (non-serious) with onset 27Nov2021, outcome "recovered" (28Nov2021), described as "chills"; FATIGUE (non-serious) with onset 27Nov2021, outcome "recovered" (28Nov2021), described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reportedly, the patient had sore arm on side of injection, mild fever and chills, fatigue all symptoms occurred on 27Nov, late afternoon to early evening. All symptoms were resolved by early morning of 28Nov. Reportedly, the events took place after use of the product.  The lot number for bnt162b2 was not provided and will be requested during follow up.