chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Morning sickness, Nausea, Pain in extremity
Clinical narrative: nauseated; morning sickness; Feeling lightheaded; Upper arm was quite sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 16:00 (Lot number: EN6200) at the age of 80 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart disease" (ongoing), notes: diagnosed for 30 years; "Stenosis", start date: 2000 (ongoing), notes: Started on the other drugs for her back when she saw the rheumatologist; "arthritis in her back", start date: 2000 (ongoing), notes: Started on the other drugs for her back when she saw the rheumatologist; "Triple heart bypass", start date: 2007 (unspecified if ongoing); "Had three separate stents in her heart" (unspecified if ongoing), notes: one in 2014, 2015, and 2018; "Hysterectomy", start date: 2001 (unspecified if ongoing); "Allergic to Penicillin" (unspecified if ongoing), notes: Diagnosed 40 years ago, had bronchitis and she broke out in hives, she has never taken it since; "Memory" (unspecified if ongoing). Concomitant medication(s) included: ISOSORBIDE taken for cardiac disorder, start date: 2019 (ongoing); METOPROLOL taken for cardiac disorder, start date: 2019 (ongoing); LOSARTAN taken for cardiac disorder, start date: 2019 (ongoing); PRAVACHOL taken for cardiac disorder, start date: 2019 (ongoing); FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE] taken for arthritis, stenosis, start date: 2015 (ongoing); OMEPRAZOLE taken for abdominal discomfort, start date: 2015 (ongoing); CELEBREX taken for back disorder, start date: 2015 (ongoing); DONEPEZIL taken for memory impairment, start date: 2020 (ongoing); BABY ASPIRIN taken for cardiac disorder, start date: 2007 (ongoing). The following information was reported: NAUSEA (non-serious) with onset 05Mar2021, outcome "recovered" (06Mar2021), described as "nauseated"; MORNING SICKNESS (non-serious) with onset 05Mar2021, outcome "recovered" (06Mar2021), described as "morning sickness"; DIZZINESS (non-serious) with onset 05Mar2021, outcome "recovered" (06Mar2021), described as "Feeling lightheaded"; PAIN IN EXTREMITY (non-serious) with onset 05Mar2021, outcome "recovered" (06Mar2021), described as "Upper arm was quite sore". The action taken for bnt162b2 was unknown. Therapeutic measures were not taken as a result of nausea, morning sickness, dizziness, pain in extremity. Additional information: Patient was taking Isosorbide, Metoprolol, losartan, Pravachol, and baby Aspirin for her heart. The patient started Flexeril taking about 5 or 6 years ago- about 2015 for arthritis and stenosis in her back, Omeprazole for stomach in order to take Celebrex, Celebrex will burn a hole in stomach so she has to take omeprazole and for her back, Donepezil for memory.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Oropharyngeal pain, Vaccination site pain
Clinical narrative: some flu-like symptoms; fatigue/tiredness; sore throat; the injection site is still sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (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: INFLUENZA LIKE ILLNESS (non-serious) with onset Mar2021, outcome "not recovered", described as "some flu-like symptoms"; FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "fatigue/tiredness"; OROPHARYNGEAL PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "sore throat"; VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "the injection site is still sore".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection Arm Soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 20 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 23Mar2021 09:30 (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: VACCINATION SITE PAIN (non-serious) with onset 24Mar2021, outcome "recovering", described as "Injection Arm Soreness". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19.No,COVID -19 tested for post vaccination. The Pfizer US Drug safety unit recently received the attached report submitted. Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events. Response: The patient in this case is my Son. He had the shot on Tuesday 23Mar2021 and I became aware of the soreness in the arm, the morning of Wednesday 24Mar2021 and reported it on Wednesday 24Mar2021 around 2 PM.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscle spasms, Myalgia
Clinical narrative: Upon awakening on 24Mar21, I experienced a charley horse in my left calf.; Muscle aches worsened slightly as the day went on; I started feeling moderate tiredness; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 14:15 (Lot number: EP6555) at the age of 56 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (product: COVID 19, brand: Pfizer BioNTech, lot number: EL3247, lot unknown: False, administration date: 04Mar2021, administration time: 10:30 AM, vaccine location: Left arm, dose number: 1), administration date: 04Mar2021, for covid-19 immunisation. The following information was reported: MUSCLE SPASMS (non-serious) with onset 24Mar2021 06:00, outcome "recovered", described as "Upon awakening on 24Mar21, I experienced a charley horse in my left calf."; MYALGIA (non-serious) with onset 24Mar2021 06:00, outcome "recovered", described as "Muscle aches worsened slightly as the day went on"; FATIGUE (non-serious) with onset 24Mar2021 06:00, outcome "recovered", described as "I started feeling moderate tiredness". Therapeutic measures were not taken as a result of muscle spasms, myalgia, fatigue.  Additional information: Upon awakening on 24Mar21, I experienced a charley horse in my left calf. Quadriceps and hamstrings were mildly sore in the morning. Muscle aches worsened slightly as the day went on and I started feeling moderate tiredness. I was able to continue with my work and daily activities. At 9:45 pm on the same day, symptoms remain the same. However, follow-up to the report submitted on 24Mar2021 it was reported, patient was recovered. Vaccine facility type was Workplace clinic. No other vaccine was administered in four weeks. Other medications in two weeks: Phillips Fiber Good Gummies, VSL #3 Probiotic Supp. No covid prior vaccination. covid was not tested post vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: Experiencing a constant smell; appears to be a "phantom" smell - not related to anything around me or on me. It is hard to describe the smell, but it is not a bad smell and is not an unpleasant smell,; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 04Mar2021 (Batch/Lot number: unknown) at the age of 58 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: PAROSMIA (non-serious) with onset 10Mar2021, outcome "not recovered", described as "Experiencing a constant smell; appears to be a "phantom" smell - not related to anything around me or on me. It is hard to describe the smell, but it is not a bad smell and is not an unpleasant smell,". Therapeutic measures were not taken as a result of parosmia.  Additional information: The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. The patient did not have COVID prior vaccination. The patient had not been tested for COVID post-vacicnation. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Vaccination site pain
Clinical narrative: Concentration problems and reduced mental performance ("foggy head") on the next day (20 hours after injection), now slowly subsiding and replaced by headache (26 hours after injection).; Concentration problems and reduced mental performance ("foggy head") on the next day (20 hours after injection), now slowly subsiding and replaced by headache (26 hours after injection).; Pain in injection site 4 hours after injection, stronger than after first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 23Mar2021 14:30 (Lot number: EP6955) at the age of 34 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot no: EP3247, Anatomical location: Arm left, Time of administration: 10:00), administration date: 01Mar2021, when the patient was 34 years old, for COVID 19 Immunisation, reaction(s): "mild pain at the injection site". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 23Mar2021 18:30, outcome "recovering", described as "Pain in injection site 4 hours after injection, stronger than after first dose"; FEELING ABNORMAL (non-serious) with onset 24Mar2021 10:30, outcome "recovering", HEADACHE (non-serious) with onset 24Mar2021 16:30, outcome "recovering" and all described as "Concentration problems and reduced mental performance ("foggy head") on the next day (20 hours after injection), now slowly subsiding and replaced by headache (26 hours after injection).". Therapeutic measures were not taken as a result of vaccination site pain, feeling abnormal, headache. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Pain
Clinical narrative: Different hurt. It only hurts when they touch it and that's a reaction you actually get with the injection; 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 82 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Mar2021 15:30 (Lot number: EN6199) at the age of 82 years as dose 1, single and intramuscular, administered in arm left, administration date 24Mar2021 15:15 (Lot number: EP6955) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Different hurt. It only hurts when they touch it and that's a reaction you actually get with the injection". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had no prior vaccinations.   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hypoacusis
Clinical narrative: I have a hearing problem; on and off dizzy/light headed; 2 very bad headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 02:30 (Lot number: EN6206) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "heart by pass" (unspecified if ongoing); "Known allergies: Seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN.  The following information was reported: DIZZINESS (non-serious) with onset 13Mar2021, outcome "not recovered", described as "on and off dizzy/lightheaded"; HEADACHE (non-serious) with onset 13Mar2021, outcome "not recovered", described as "2 very bad headaches"; HYPOACUSIS (non-serious), outcome "unknown", described as "I have a hearing problem". Therapeutic measures were not taken as a result of dizziness, headache.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The other medications the patient received within 2 weeks of vaccination included rosuvastatin. Prior to vaccination was the patient was not diagnosed with COVID-19. Since the vaccination has the patient has not been tested for COVID-19. Allergies to medications, food, or other products: seasonal allergies. Patient stated she received the Pfizer vaccine (Vaccine name not clarified, hence suspect captured as Unspecified Vaccine and is this a Pfizer product tab checked-Yes) on March 12 (not clarified) and she was still getting like on and off dizzy spells and light-headed and a couple of times and had really a bad headache on the left side. The patient further stated she have a hearing problem and she was having a really hard time in understanding what they are saying.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Anger, Emotional disorder, Fatigue, Muscle spasms, Somnolence
Clinical narrative: flexion cramp in right foot; emotional dysregulation; rage; Fatigue, with actual need to nap; Fatigue, with actual need to nap; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 29Jan2021 12:00 (Lot number: EN5318) at the age of 58 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; PROGESTERONE. Past drug history included: Doxycycline, reaction(s): "drug allergy". Vaccination history included: BNT162B2 (dose 1; Batch number: EL3246; DOSE 1, SINGLE ; Via intramuscular route in arm left; administration time: 12:00), administration date: 08Jan2021, for COVID-19 immunisation, reaction(s): "Fatigue". The following information was reported: MUSCLE SPASMS (non-serious) with onset 29Jan2021, outcome "recovered" (31Jan2021), described as "flexion cramp in right foot"; EMOTIONAL DISORDER (non-serious) with onset 29Jan2021, outcome "recovered" (31Jan2021), described as "emotional dysregulation"; ANGER (non-serious) with onset 29Jan2021, outcome "recovered" (31Jan2021), described as "rage"; FATIGUE (non-serious), SOMNOLENCE (non-serious) all with onset 29Jan2021, outcome "unknown" and all described as "Fatigue, with actual need to nap". Therapeutic measures were not taken as a result of muscle spasms, emotional disorder, anger, fatigue, somnolence.  Additional information: The patient was not pregnant at time of vaccination. The patient had no other illness and no history of daytime sleepiness. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications also included: estrogen TD and multivitamin. Clinical course: On 29Jan2021, approximately 4 hours after dose 2, the patient had a flexion cramp in right foot and emotional dysregulation and rage. It was like from a prednisone burst. It was not an effect that she had before. It lasted 48 hours. The patient also experienced fatigue, with actual need to nap since dose 1.     No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain
Clinical narrative: muscle pain; very tired; achy; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 02Mar2021 (Lot number: EN6198) at the age of 82 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: MYALGIA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "muscle pain"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "very tired"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "achy". Therapeutic measures were taken as a result of myalgia.  Additional information: After her 1st dose of the Pfizer COVID Vaccine, the patient had like a muscle pain and put ice on it and it went away. She also stated that she was also very tired and achy. She also mentioned that she lives in a senior community for age 55 and older.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Migraine, Migraine with aura, Paraesthesia
Clinical narrative: migraine headache, visual and sensory auras.; migraine headache, visual and sensory auras.; tingling at base of neck; dizziness; left sided headache; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 13Mar2021 (Batch/Lot number: unknown) at the age of 23 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Celiac Disease" (unspecified if ongoing); "MCAS" (unspecified if ongoing); "CKD" (unspecified if ongoing); "MTHFR" (unspecified if ongoing); "HLA B27+" (unspecified if ongoing); "Morton's Neuroma" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "Pancreatic Insufficiency" (unspecified if ongoing); "known allergy: wheat" (unspecified if ongoing); "known allergies: lobster, crab" (unspecified if ongoing); "known allergies: dairy" (unspecified if ongoing); "known allergies: potatoes, eggplant" (unspecified if ongoing); "known allergies: Gluten" (unspecified if ongoing); "known allergies: pineapple" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Zofran, reaction(s): "known allergies: Zofran"; Tanalbit, reaction(s): "known allergies: Tanalbit". Vaccination history included: Bnt162b2 (Dose 1, administration time 06:30 PM and vaccine location: right arm. ), administration date: 20Feb2021, for COVID-19 immunisation, reaction(s): "suspicion of a possible MCAS reaction"; Bnt162b2 (Dose 1, administration time 06:30 PM and vaccine location: right arm. ), administration date: 20Feb2021, when the patient was 23 years old, for COVID-19 immunisation, reaction(s): "Fatigue", "Tingling at the base of neck", "migraine headache with visual aura (stars)", "Dizziness", "Brain fog", "Tension".  The following information was reported: MIGRAINE (non-serious), MIGRAINE WITH AURA (non-serious) all with onset Mar2021, outcome "unknown" and all described as "migraine headache, visual and sensory auras."; PARAESTHESIA (non-serious) with onset Mar2021, outcome "unknown", described as "tingling at base of neck"; DIZZINESS (non-serious) with onset Mar2021, outcome "unknown", described as "dizziness"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "left sided headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine, migraine with aura, paraesthesia, dizziness, headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021335236 Same drug/reporter/patient, different dose
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: migraine headache, visual and sensory auras.; migraine headache, visual and sensory auras.; tingling at base of neck; dizziness; left sided headache; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 13Mar2021 (Batch/Lot number: unknown) at the age of 23 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Celiac Disease" (unspecified if ongoing); "MCAS" (unspecified if ongoing); "CKD" (unspecified if ongoing); "MTHFR" (unspecified if ongoing); "HLA B27+" (unspecified if ongoing); "Morton's Neuroma" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "Pancreatic Insufficiency" (unspecified if ongoing); "known allergy: wheat" (unspecified if ongoing); "known allergies: lobster, crab" (unspecified if ongoing); "known allergies: dairy" (unspecified if ongoing); "known allergies: potatoes, eggplant" (unspecified if ongoing); "known allergies: Gluten" (unspecified if ongoing); "known allergies: pineapple" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Zofran, reaction(s): "known allergies: Zofran"; Tanalbit, reaction(s): "known allergies: Tanalbit". Vaccination history included: Bnt162b2 (Dose 1, administration time 06:30 PM and vaccine location: right arm. ), administration date: 20Feb2021, for COVID-19 immunisation, reaction(s): "suspicion of a possible MCAS reaction"; Bnt162b2 (Dose 1, administration time 06:30 PM and vaccine location: right arm. ), administration date: 20Feb2021, when the patient was 23 years old, for COVID-19 immunisation, reaction(s): "Fatigue", "Tingling at the base of neck", "migraine headache with visual aura (stars)", "Dizziness", "Brain fog", "Tension".  The following information was reported: MIGRAINE (non-serious), MIGRAINE WITH AURA (non-serious) all with onset Mar2021, outcome "unknown" and all described as "migraine headache, visual and sensory auras."; PARAESTHESIA (non-serious) with onset Mar2021, outcome "unknown", described as "tingling at base of neck"; DIZZINESS (non-serious) with onset Mar2021, outcome "unknown", described as "dizziness"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "left sided headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine, migraine with aura, paraesthesia, dizziness, headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021335236 Same drug/reporter/patient, different dose
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: light head; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 52-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Feb2021 10:00 (Batch/Lot number: unknown) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 16Feb2021 10:30, outcome "recovered" (2021), described as "light head". Therapeutic measures were not taken as a result of dizziness.  Additional Information: Thirty minutes after the first shot, the patient felt light head. It was not too bad but a bit concerning. The patient had no allergies to medications, food, or other products. He had a history of unspecified drugs having unusual reactions in his system and had taken psychedelics in his youth but not in 30 years. The reporter classified the event as not serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and other medications within 2 weeks of vaccination. Prior to 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 number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021338140 Same patient and drug; Different dose and event
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My arm was sore; 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 03Mar2021 14:15 (Lot number: EL3247) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Iodine contrast media allergy" (unspecified if ongoing), notes: known allergies- Iodine with contrast; "Lung cancer" (unspecified if ongoing). Concomitant medication(s) included: SLYND. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "My arm was sore".  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Her arm was sore with both shots which she know was a normal side effect. The treatment for the adverse events arm was sore with first dose was not provided.   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Nausea; Headache; 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 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Mar2021 12:15 (Lot number: EN6199) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset 06Mar2021 08:00, outcome "unknown", described as "Nausea"; HEADACHE (non-serious) with onset 06Mar2021 08:00, outcome "unknown", described as "Headache". Therapeutic measures were taken as a result of nausea, headache. Additional information: Patient had no prior vaccinations (within 4 weeks) and no events following prior vaccinations. It was reported that treatment was Tylenol.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021355835 same reporter/patient/events, different dose
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Dysphonia, Speech disorder
Clinical narrative: voice sounded hoarse; experienced later a (partial) loss of her voice; could barely speak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 28 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 27Mar2021 (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: DYSPHONIA (non-serious) with onset 28Mar2021, outcome "unknown", described as "voice sounded hoarse"; APHONIA (non-serious) with onset 28Mar2021, outcome "unknown", described as "experienced later a (partial) loss of her voice"; SPEECH DISORDER (non-serious) with onset 28Mar2021, outcome "unknown", described as "could barely speak".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient). A 39-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 39, on Mar 3, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient had a headache, onset Mar 3, 2021, with outcome of recovered (Mar 2021). Additional Information: The patient had a headache for 12 hours after the first dose of the vaccine. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-2021356359 same reporter, patient, and product; different events and dose.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 29 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 17:40 (Lot number: EP7534) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Non-Hodgkin's lymphoma" (unspecified if ongoing), notes: States that she has been in remission for 6 years, was diagnosed 6 1/2 years ago. The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 26Mar2021 12:00, outcome "not recovered", described as "swollen lymph nodes". Additional information: Patient would like to know whether their side effects were related to the covid vaccine. Patient would like to know whether their side effects to the covid vaccine could possibly occur after the 1st and 2nd doses are received and would like to know whether the side at which they experience side effects to the covid vaccine matters and how prevalent this can be. Patient received her 1st dose of the Pfizer covid vaccine 1.5 weeks ago. She experienced swollen lymph nodes on the side of her neck, on the same side where she received the covid vaccine. Patient would like to know how long their side effect of swollen lymph nodes to the covid vaccine might last. She wanted to know if this is a common side effect and the prevalence of it. The event did not require visit to emergency room and physician office and patient mentioned that she will possibly be going for an evaluation. There were no prior vaccinations (within 4 weeks) and no relevant family medical history.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Lymphadenopathy
Clinical narrative: Swollen Lymph Nodes in armpit of same arm receiving shots; Diarrhea on and off since shot; 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 patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 00:45 (Lot number: ER2613) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Epilepsy" (unspecified if ongoing). Concomitant medication(s) included: OXTELLAR XR. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 26Mar2021 08:00, outcome "unknown", described as "Swollen Lymph Nodes in armpit of same arm receiving shots"; DIARRHOEA (non-serious) with onset 26Mar2021 08:00, outcome "unknown", described as "Diarrhea on and off since shot". Therapeutic measures were not taken as a result of lymphadenopathy, diarrhoea. Additional information: It was also reported that the first dose was administered on 25Mar2021 (possibly discrepant). The patient experienced swollen lymph nodes in armpit of same arm receiving shots and was still swollen after 4 days. The patient had no other vaccine in four weeks prior to the COVID vaccine. The patient had no covid prior vaccination and has not been tested post vaccination. The patient doesn't have any schedule yet for the second dose.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: cold sore; 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 39 year-old female patient received bnt162b2 (BNT162B2), administration date 28Mar2021 (Lot number: ER8130) at the age of 39 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: ORAL HERPES (non-serious) with onset Mar2021, outcome "unknown", described as "cold sore". Therapeutic measures were taken as a result of oral herpes.  Additional information: Product: PFIZER-BIONTECH COVID-19 VACCINE. The patient was a 39-year-old female who received the first dose of the Pfizer Covid 19 vaccine yesterday. Afterward, she felt a cold sore coming on and took a dose of valacyclovir. She asked if this is a problem.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Diarrhoea, Fatigue, Headache, Stool analysis
Clinical narrative: experiencing diarrhea after getting the second dose of the Pfizer BioNTech covid vaccine; headaches; fatigue; 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 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 15:10 (Lot number: EN6202) at the age of 68 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, Lot number: EM9810 for the first dose, Anatomical location: right arm), for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 03Mar2021, outcome "not recovered", described as "experiencing diarrhea after getting the second dose of the Pfizer BioNTech covid vaccine"; HEADACHE (non-serious) with onset 03Mar2021, outcome "not recovered", described as "headaches"; FATIGUE (non-serious) with onset 03Mar2021, outcome "not recovered", described as "fatigue". The event "experiencing diarrhea after getting the second dose of the pfizer biontech covid vaccine" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller stated that she got the second dose four weeks ago and since the day after the vaccine she has had pretty bad diarrhea for 4 weeks. She is just curious the main reason she is calling to see if they have heard of other people having this and is it supposed to go on this long. Diarrhea, outcome of event: She has good days and bad days, she does not think it has gotten better but some days are worse than others. Headaches, outcome: It comes and goes a lot of times in the morning she will wake up with a headache. She says it is ongoing. Fatigue: She has really bad days sometimes where she was not able to getting off the couch and then sometimes she wakes up with a little more energy, that fades really quick. The facility where the most recent COVID-19 vaccine was administered is Hagerty Center, there was a vaccine clinic set. No other vaccine was administered on same date of Pfizer vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not experience any AE prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Muscle aches; Fatigue and feeling tired; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 58-year-old male patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (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: MYALGIA (non-serious) with onset Mar2021, outcome "unknown", described as "Muscle aches"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "Fatigue and feeling tired".  Additional Information: The patient had his first shot of the Pfizer COVID vaccine last week on 24Mar2021. The patient started to experience muscle aches, fatigue, and feeling tired. He was wondering why didn't the symptoms show up sooner. He thought that if he was going to have symptoms, it would have been sooner. He was asking if he needed to call his doctor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: every day I've been lightheaded when I bend over I get real light-headed if I move my head too quick I get light-headed if I look up; 2 days after I had it I had a bad case of vertigo; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 11Mar2021 (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: DIZZINESS (non-serious), outcome "unknown", described as "every day I've been lightheaded when I bend over I get real light-headed if I move my head too quick I get light-headed if I look up"; VERTIGO (non-serious), outcome "unknown", described as "2 days after I had it I had a bad case of vertigo". Additional Information: After 2 days of the first dose, she had a bad case of vertigo and had that a couple times in the past but it only lasts for just an hour or so but this day she had it and ever since then every day she have been lightheaded when she bend over, she get real light-headed if she moved her head too quick; she get light-headed if she looked up and she was reading where there's been a lot of people that have vertigo and dizziness since they had their COVID shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: vertigo/ bad case of vertigo; lightheaded; 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 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 11Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "vertigo" (unspecified if ongoing), notes: had that a couple times in the past but it only lasts for just an hour or so. The patient's concomitant medications were not reported. The following information was reported: VERTIGO (non-serious), outcome "unknown", described as "vertigo/ bad case of vertigo"; DIZZINESS (non-serious), outcome "unknown", described as "lightheaded". Additional information: Patient had first covid shot March 11th 2 days after patient had it, patient had a bad case of vertigo. Patient have had that a couple times in the past but it only lasts for just an hour or so but this day patient had it and ever since then every day patient has been lightheaded when patient bends over, gets real lightheaded if patient moved head too quick, gets light-headed if patient looks up and was reading where there been a lot of people that have vertigo and dizziness since they had their covid shot. Patient to get second one.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: I have the headache of a lifetime, started saturday night- worse and worse on sunday-  aspirin and acetaminophen didn't help; vomiting on sunday night until ~5am, I still have a pretty crazy headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 27Mar2021 (Batch/Lot number: unknown) at the age of 44 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: VOMITING (non-serious) with onset Mar2021, outcome "unknown", described as "vomiting on sunday night until ~5am, I still have a pretty crazy headache"; HEADACHE (non-serious) with onset 27Mar2021, outcome "unknown", described as "I have the headache of a lifetime, started saturday night- worse and worse on sunday-  aspirin and acetaminophen didn't help". Therapeutic measures were taken as a result of headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A sore arm after the first dose; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (Lot number: ENG202) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "A sore arm after the first dose".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: fatigue; headache; sore arm/ pain in arm; This is a spontaneous report received from a contactable consumer from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (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: FATIGUE (non-serious), outcome "recovered", described as "fatigue"; HEADACHE (non-serious), outcome "recovered", described as "headache"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm/ pain in arm".  Additional information: The patient's age was reported as 54 (unit unspecified). The patient stated that she had side effects for 2 days after the 1st dose and then again 11 days after. On day 11, she got a sore arm. She further stated that she had side effects of pain in arm, fatigue, and headache with first "covax" that lasted 2 days and second lasted longer 3 days (not further clarified).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.