chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Amnesia
Clinical narrative: acute memory loss; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AMNESIA (non-serious), outcome "unknown", described as "acute memory loss".  Additional Information:  Caller mentioned that he and his male partner received their 1st dose of the vaccine and have been experiencing acute memory loss that has not gone away. He mentions that it is vary concerning and has made him vary wary because he can't remember anything anymore such as day to day things like where he placed his keys. He mentioned that he and his partner are very healthy, don't take medication, with his partner not been having a vaccine ever since childhood, and are vegetarian. This is the first time that this has happen to them, given his old age. He is asking if this has been reported. He also mentioned that he knows that the side effects of the 2nd dose might be worse than the 1st dose as said by his community members. He also mentioned that he saw in the news today that Dr. mentioned that about 5800 people who got fully vaccinated had full blown covid and even 73 of them died.   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-2021423292 same reporter/drug/AE, different patient
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 12:00 (Lot number: ER8730) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Acid reflux and seasonal allergies to pollen" (unspecified if ongoing); "Acid reflux and seasonal allergies to pollen" (unspecified if ongoing). Concomitant medication(s) included: ALEVE; VITAMIN C ACID; BIOTIN; TURMERIC +; GINGERCALM; COLLAGEN. Vaccination history included: Bnt162b2 (Dose 1, lot number: ER8730, administration time: 14:30,, vaccine location; Left arm,, ), administration date: 25Mar2021, for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 15Apr2021, outcome "recovering", described as "Dizziness". Therapeutic measures were taken as a result of dizziness with ALEVE.  Additional information: 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. Since the vaccination, has the patient did not tested for COVID-19. Patient had no allergies to medications, food, or other products  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Panic attack
Clinical narrative: Pain to that area when lifting arm; panic attack; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jan2021 (Lot number: EL1283) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Panic disorder" (unspecified if ongoing); "Tongue cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Name of product: Pfizer BNT162B2, Reason for taking: Prevent Covid-19, Date started: 05Jan2021, Lot/Batch no: EH9899, Anatomical site: Upper right arm), administration date: 05Jan2021, for COVID-19 immunization, reaction(s): "Pain to that area when lifting arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 27Jan2021, outcome "recovered" (2021), described as "Pain to that area when lifting arm"; PANIC ATTACK (non-serious) with onset 27Jan2021, outcome "recovered" (2021), described as "panic attack"; FATIGUE (non-serious) with onset 27Jan2021, outcome "recovered" (2021), described as "tired". Therapeutic measures were not taken as a result of pain in extremity, panic attack, fatigue.  Additional information: No surgical treatment needed for the event. No other product was taken together with those indicated.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder
Clinical narrative: feels off balance, not dizzy since she received her "2nd vaccine shot for about 10 days; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), administration date: 06Mar2021, for Covid-19 immunization. The following information was reported: BALANCE DISORDER (non-serious), outcome "unknown", described as "feels off balance, not dizzy since she received her "2nd vaccine shot for about 10 days".  Additional information: Caller stated she spoke to someone about her symptoms and she stated that she had her 1st Pfizer vaccine dose on 06Mar2021 and her 2nd vaccine on 27Mar2021. She just felt off balance, not dizzy since she received her 2nd vaccine shot for about 10 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: knotted up my neck within seconds; 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 61 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown", described as "knotted up my neck within seconds". 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-2021428188 Same reporter/ drug/ event for different patients.
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm
Clinical narrative: left eye was twitching like crazy, the eyelid & eyebrow was constantly twitching all day long; 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 47 year-old female patient received bnt162b2 (BNT162B2), administration date 03Apr2021 (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: BLEPHAROSPASM (non-serious) with onset 04Apr2021, outcome "unknown", described as "left eye was twitching like crazy, the eyelid & eyebrow was constantly twitching all day long".  Additional Information: Patient received the first dose of the Pfizer-BioNTech COVID-19 Vaccine last 03Apr2021. Starting 04Apr2021, her "left eye was twitching like crazy, the eyelid & eyebrow was constantly twitching all day long". By 08Apr2021, it went away, but came back less noticeable than the first few days. From 09Apr2021 up until 16Apr2021, the eyelid is still twitching "on and off"; not whole day long. Patient tried to manage it with her sleep, coffee, stress management, and also spoke to her doctor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: He is just tired/he is just more tired in his head than anything; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (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 number: 1), for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "He is just tired/he is just more tired in his head than anything"  Additional Information: The caller stated he just got his second dose of the vaccine but is exhausted but it is "nothing like that" (when asked if he wanted to report this symptom). He stated this information is just disturbing so he is just tired when he gets upset and he is just more tired in his head than anything.  . No follow-up attempts are possible No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: feeling nauseous after eating; 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 61 year-old male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (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: NAUSEA (non-serious), outcome "unknown", described as "feeling nauseous after eating".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: feeling nauseous after eating; 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 61 year-old male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (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: NAUSEA (non-serious), outcome "unknown", described as "feeling nauseous after eating".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: nauseous; dizzy; 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 male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (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: NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nauseous"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizzy".  Additional information: Reported as, being nauseous or dizzy for 2 weeks after taking the vaccine. He had the vaccine on 31March. Since then, he does not feel right and feels dizzy and nauseous.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: nauseous; dizzy; 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 male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (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: NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nauseous"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizzy".  Additional information: Reported as, being nauseous or dizzy for 2 weeks after taking the vaccine. He had the vaccine on 31March. Since then, he does not feel right and feels dizzy and nauseous.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Achlorhydria, Fatigue, Pain, Pain in extremity
Clinical narrative: Achylia gastrica; soreness in her arm; tired; achy; 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 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Feb2021 (Lot number: EN6198) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing); "afib" (unspecified if ongoing), notes: The caller had a surgical procedure that made it stop.; "no thyroid gland" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS taken for atrial fibrillation; LIPITOR; SYNTHROID. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "soreness in her arm"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tired"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "achy"; ACHLORHYDRIA (non-serious), outcome "unknown", described as "Achylia gastrica".  Additional information: Patient stated she received the second dose of the Pfizer-BioNTech COVID-19 vaccine a month ago, and experienced "mild reactions to both injections" such as : being "tired and achy". She specified she had soreness in her arm after the first dose and it went away after a couple of days. She said after the second vaccine, however, her arm was "way more sore than the first time". She explained after a day or two it got better, but her arm never "got ok". She specified it is "70% better". She explained her arm still has a "little soreness, but it's "not debilitating", she feels discomfort when rolling/laying on it in bed, when she uses, or when she lifts it. She said she noticed the second dose seemed to have been administered in the middle of her arm, and therefore she doubts she has received it in the muscle. Again stated with the first vaccine the patient had a mild reaction- little achy lasting about a day or two, and soreness in the arm. Patient received vaccine right upper arm in the deltoid and expiration date was unknown. The patient did not take anything outside of her normal medication.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Vaccination site discomfort
Clinical narrative: Minor discomfort at shot area loss of energy for 24 hours.; Minor discomfort at shot area loss of energy for 24 hours.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Feb2021 08:15 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Stage 1 Hypertension" (unspecified if ongoing); "Type 2 diabetes" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; METFORMIN; ATENOLOL; ATORVASTATIN. The following information was reported: VACCINATION SITE DISCOMFORT (non-serious), ASTHENIA (non-serious), outcome "recovered" and all described as "Minor discomfort at shot area loss of energy for 24 hours.". Therapeutic measures were not taken as a result of vaccination site discomfort, asthenia.  Additional information: Minor discomfort at shot area loss of energy for 24 hours. Slept it off. He reported no known allergies and confirmed that he did not test covid positive after vaccination and also did not have covid prior to vaccination. It was also confirmed that no other vaccine was taken in four weeks.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: upset stomach; diarrhea; 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 91 year-old male patient received bnt162b2 (BNT162B2), administration date 14Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Eliquis. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "upset stomach"; DIARRHOEA (non-serious), outcome "recovered" (2021), described as "diarrhea".  Additional information: Patient mentioned that he has pills to take including Eliquis but he will skip taking it today.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 18 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Apr2021 14:30 (Lot number: EP6955) at the age of 18 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "pollen" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, lot number: EP6955, lot: Unknown, administration date:22Mar2021, administration time:02:30 PM), administration date: 22Mar2021, when the patient was 18 years old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 13Apr2021 17:00, outcome "recovered" (Apr2021), described as "Fatigue". Therapeutic measures were not taken as a result of fatigue.  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 COVID19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: both presented arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "both presented arm pain".  Additional information: She and her husband received the vaccine last Friday, both presented arm pain, she was in a treatment with Penicillin which she suspended last Wednesday, after receiving the vaccine the patient and her husband went to eat seafood and short after the patient began to develop an allergic skin reaction in forearms and face, she went to see 2 different physicians who have given her different opinions about her allergic reaction; one of them stated it might be a reaction of vaccine with penicillin; another stated that it might be an allergic reaction to seafood since he do not think it is a reaction to penicillin due to suspension of treatment by patient (more than 24 hours before vaccination).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Hair texture abnormal, Trichorrhexis
Clinical narrative: Hair changed dramatically after first vaccine, became very dry, brittle; became very dry, brittle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Feb2021 09:00 (Lot number: EN9263) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hashimotos Disease" (unspecified if ongoing); "CVID (immune deficiency)" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; ESTRADIOL; THIOTHIXENE [TIOTIXENE] and Multivitamin. The following information was reported: HAIR DISORDER (non-serious), outcome "not recovered", described as "Hair changed dramatically after first vaccine"; HAIR TEXTURE ABNORMAL (non-serious), outcome "not recovered", described as "became very dry, brittle". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hair disorder, hair texture abnormal was  with weekly IV fluids for six months.  Clinical course: If covid prior vaccination and if covid tested post vaccination were reported as no. No known allergies. If other vaccine in four weeks was no.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Vomiting
Clinical narrative: incredibly nauseous; throwing up; had a terrible migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 11:30 (Lot number: EN6199) at the age of 23 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Loeys Dietz Syndrome" (unspecified if ongoing); "heart surgery" (unspecified if ongoing), notes: heart surgery 4 years ago; "blind in one eye" (unspecified if ongoing), notes: blind in one eye. Concomitant medication(s) included: MIRTAZAPINE; GUANFACINE; LOSARTAN; LOESTRIN. The following information was reported: NAUSEA (non-serious) with onset 11Mar2021, outcome "unknown", described as "incredibly nauseous"; VOMITING (non-serious) with onset 11Mar2021, outcome "unknown", described as "throwing up"; MIGRAINE (non-serious) with onset 11Mar2021, outcome "unknown", described as "had a terrible migraine". Therapeutic measures were not taken as a result of nausea, vomiting, migraine.  Additional information: Facility type vaccine was reported as other. Patient had not received any other vaccine in four weeks. Treatment AE was given as no. Covid prior vaccination reported as no and patient was not tested covid post vaccination. Other medical history: Loeys Dietz Syndrome, heart surgery 4 years ago, blind in one eye.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis
Clinical narrative: conjunctivitis in both eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. The following information was reported: CONJUNCTIVITIS (non-serious) with onset 28Mar2021, outcome "not recovered", described as "conjunctivitis in both eyes". Therapeutic measures were taken as a result of conjunctivitis.  Additional information: The caller reported that that her first dose of the Pfizer COVID-19 vaccine was on 27Mar2021 and then presented with conjunctivitis in both eyes on 28Mar2021. She has been seen by an HCP a couple of times and treated for this condition. She saw her eye doctor on Thursday and was given more medication to treat the conjunctivitis and her eye doctor told her that she should be cleared up by her second dose appointment day. However, the caller states that she woke up this morning and her eyes look just as bad as they did 3 weeks ago. She would like to know if she should proceed with her second dose or not.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Migraine, Nausea
Clinical narrative: Days 1 and 2 after - severe headache. Resolved after 2 days. On day 8 woke with migrane headache that included room spinning, dizziness and nausea. Took an imitrex 50 MG then another 2 hours later.; Days 1 and 2 after - severe headache. Resolved after 2 days. On day 8 woke with migrane headache that included room spinning, dizziness and nausea. Took an imitrex 50 MG then another 2 hours later.; Days 1 and 2 after - severe headache. Resolved after 2 days. On day 8 woke with migrane headache that included room spinning, dizziness and nausea. Took an imitrex 50 MG then another 2 hours later.; Days 1 and 2 after - severe headache. Resolved after 2 days. On day 8 woke with migrane headache that included room spinning, dizziness and nausea. Took an imitrex 50 MG then another 2 hours later.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Apr2021 08:30 (Batch/Lot number: unknown) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Have previously had shingles" (unspecified if ongoing); "get occasional migraine" (unspecified if ongoing); "known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: TESTOSTERONE; BIJUVA. Past drug history included: Cephalosporins, reaction(s): "Known allergies: Cephalasporin", notes: Cephalasporin. The following information was reported: HEADACHE (non-serious), MIGRAINE (non-serious), DIZZINESS (non-serious), NAUSEA (non-serious) all with onset 17Apr2021 06:30, outcome "not recovered" and all described as "Days 1 and 2 after - severe headache. Resolved after 2 days. On day 8 woke with migrane headache that included room spinning, dizziness and nausea. Took an imitrex 50 MG then another 2 hours later.". Therapeutic measures were taken as a result of headache, migraine, dizziness, nausea.  Additional information: Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines in fourweeks. Patient did not visit emergency room and physician office visit for the events. Patient did not have covid prior vaccination and Patient do not have covid tested post vaccination  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Exposure via breast milk, Pyrexia
Clinical narrative: patient's 12 mo old infant son experienced a low grade fever; patient's 12 mo old infant son experienced a low grade fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 12 month-old male patient was exposed to bnt162b2 (BNT162B2), transmammary, administration date 08Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The mother of the patient was 39 year-old. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), EXPOSURE VIA BREAST MILK (non-serious), outcome "unknown" and all described as "patient's 12 mo old infant son experienced a low grade fever".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Injection site redness in large patch that is hot to the touch and burns; Injection site redness in large patch that is hot to the touch and burns; Injection site redness in large patch that is hot to the touch and burns; Breastfeeding my 6.5 month baby; Breastfeeding my 6.5 month baby; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 17:30 (Lot number: EW0158) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Breast feeding" (ongoing), notes: Breastfeeding 6.5-month baby; "Psoriasis" (unspecified if ongoing); "Crohn's disease" (unspecified if ongoing), notes: Chrone's disease. Concomitant medication(s) included: MESALAMINE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: ER8730; Administration site: Arm Left; Administration time: 09:00; Events: off label use and drug use in unapproved population.), administration date: 24Mar2021, when the patient was 33 years old, for COVID-19 immunisation, reaction(s): "Off label use". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 17Apr2021 12:15, outcome "not recovered" and all described as "Injection site redness in large patch that is hot to the touch and burns"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 14Apr2021 17:30, outcome "unknown" and all described as "Breastfeeding my 6.5 month baby". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site warmth, vaccination site pain.  Additional information: The patient had no known allergies to medications, food, or other products. The patient had received no other vaccines within 4 weeks prior to COVID-19 vaccination. The patient had not diagnosed with COVID-19 prior vaccination and Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patients concomitant medications included IUD (intrauterine contraceptive device) (unspecified) for unknown indication from unknown date and unknown if ongoing. The patient reported that these events occurred 67 hours after the second dose injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: The first shot was painful for a couple of days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 22:45 (Lot number: Er2613) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. Past drug history included: Penicillin for Known allergies Penicillin. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 25Mar2021, outcome "recovered" (2021), described as "The first shot was painful for a couple of days". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Patient did not have covid prior vaccination. Patient was not tested post vaccination. Patient did not receive any other vaccine in four weeks.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Caller stated after her second dose, her arm hurt.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Tylenol, notes: Caller takes a Tylenol every day. She got her second dose of the Pfizer COVID vaccine and wants to know if she can still take Tylenol after the dose. Vaccination history included: Bnt162b2 (Suspect Product(s): Covid-19 Vaccine, Verbatim and Event Description: Caller stated she takes a Tylenol every day. Today she got her first dose of the Covid vaccine), for Covid-19 Immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Caller stated after her second dose, her arm hurt.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A 32-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# ET7533), at the age of 32, on Mar 27, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had tinnitus, onset Apr 11, 2021, with outcome of unknown. No therapeutic measures taken as a result of tinnitus. Additional information: Reporter stated, "Yes, he had tinnitus/ringing in his ear." No follow-up attempts possible. No further information expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: Extremely tired; headache; Arm was sore; upper body muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 11:15 (Lot number: EP6955) at the age of 18 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (product=COVID 19,, Brand=Pfizer,, lot number=EP6955,, lot unknown=False,, administration date: 24Mar2021,, administration time: 11:30,, vaccine location: Left arm,, dose number: 1), administration date: 24Mar2021, for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 14Apr2021 22:00, outcome "recovered" (16Apr2021), described as "Extremely tired"; HEADACHE (non-serious) with onset 14Apr2021 22:00, outcome "recovered" (16Apr2021), described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 14Apr2021 22:00, outcome "recovered" (16Apr2021), described as "Arm was sore"; MYALGIA (non-serious) with onset 14Apr2021 22:00, outcome "recovered" (16Apr2021), described as "upper body muscle pain". Therapeutic measures were not taken as a result of fatigue, headache, pain in extremity, myalgia.  Additional information: Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine, patient did not take any other medications the patient received within 2 weeks of vaccination, Prior vaccination, patient was not diagnosed with COVID-19, patient does not have any allergies to medications, food, or other products.   No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Tremor
Clinical narrative: Tremble/ shake in the thumb on my right hand; Severe enough to interfere with any function of my right hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Apr2021 11:00 (Lot number: EW0153) at the age of 28 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "migraines" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Family history included: low level tremble in hands does occur periodically" (unspecified if ongoing). Concomitant medication(s) included: PROPRANOLOL; CETIRIZINE HCL. Past drug history included: Propranolol, reaction(s): "low blood pressure", notes: low blood pressure (side effect of propranolol). Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot number: EN5318, Administration date: 29Mar2021, Administration time: 09:00 AM, Dose number: 1, Vaccine location: Right arm), administration date: 29Mar2021, when the patient was 28 years old, for Covid-19 Immunization. The following information was reported: TREMOR (non-serious) with onset 17Apr2021 12:00, outcome "recovering", described as "Tremble/ shake in the thumb on my right hand"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 17Apr2021 12:00, outcome "recovering", described as "Severe enough to interfere with any function of my right hand". Therapeutic measures were not taken as a result of tremor, loss of personal independence in daily activities.  additional information: some low level tremble in hands does occur periodically and is common in patients family but does not interfere with function and patient haven't seen a physician for the issue. Patient did not receive other vaccine in four weeks. Adverse events Lasted roughly 2 hours beginning 25 hours post injection. Patient was not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Headache, Hypoaesthesia oral, Lymphadenopathy, Paraesthesia
Clinical narrative: Tingling in finger tips of arm of the injection shot; numbing of the tip of tongue; headache; tenderness of injection sight; swollen lymph nodes; tenderness of left breast and left shoulder blade; tenderness of left breast and left shoulder blade; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 13:00 (Batch/Lot number: unknown) at the age of 20 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: PARAESTHESIA (non-serious) with onset 13Apr2021 13:30, outcome "recovered", described as "Tingling in finger tips of arm of the injection shot"; HYPOAESTHESIA ORAL (non-serious) with onset 13Apr2021 13:30, outcome "recovered", described as "numbing of the tip of tongue"; HEADACHE (non-serious) with onset 13Apr2021 13:30, outcome "recovered", described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 13Apr2021 13:30, outcome "recovered", described as "tenderness of injection sight"; LYMPHADENOPATHY (non-serious) with onset 13Apr2021 13:30, outcome "recovered", described as "swollen lymph nodes"; BREAST TENDERNESS (non-serious), TENDERNESS (non-serious) all with onset 13Apr2021 13:30, outcome "recovered" and all described as "tenderness of left breast and left shoulder blade". Therapeutic measures were not taken as a result of paraesthesia, hypoaesthesia oral, headache, vaccination site pain, lymphadenopathy, breast tenderness, tenderness.  Additional information: Vaccine facility type was pharmacy or Drug store. Patient did not receive any vaccine in four weeks or Other medications in two weeks. Patient had no known allergies and did not had any other medical history. Patient had no COVID prior vaccination. COVID was not tested post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site pain
Clinical narrative: Tingling in finger tips of arm of the injection shot; numbing of the tip of tongue; headache; tenderness of injection sight; swollen lymph nodes; tenderness of left breast and left shoulder blade; tenderness of left breast and left shoulder blade; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 13:00 (Batch/Lot number: unknown) at the age of 20 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: PARAESTHESIA (non-serious) with onset 13Apr2021 13:30, outcome "recovered", described as "Tingling in finger tips of arm of the injection shot"; HYPOAESTHESIA ORAL (non-serious) with onset 13Apr2021 13:30, outcome "recovered", described as "numbing of the tip of tongue"; HEADACHE (non-serious) with onset 13Apr2021 13:30, outcome "recovered", described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 13Apr2021 13:30, outcome "recovered", described as "tenderness of injection sight"; LYMPHADENOPATHY (non-serious) with onset 13Apr2021 13:30, outcome "recovered", described as "swollen lymph nodes"; BREAST TENDERNESS (non-serious), TENDERNESS (non-serious) all with onset 13Apr2021 13:30, outcome "recovered" and all described as "tenderness of left breast and left shoulder blade". Therapeutic measures were not taken as a result of paraesthesia, hypoaesthesia oral, headache, vaccination site pain, lymphadenopathy, breast tenderness, tenderness.  Additional information: Vaccine facility type was pharmacy or Drug store. Patient did not receive any vaccine in four weeks or Other medications in two weeks. Patient had no known allergies and did not had any other medical history. Patient had no COVID prior vaccination. COVID was not tested post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Lymphadenopathy, Pain in extremity
Clinical narrative: arm pain; foggy brain; tiredness; lymph node swelling under left arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "IBS" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin; "Known allergies: chocolate" (unspecified if ongoing), notes: known allergies:chocolate. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Product; COVID 19 , Brand: Pfizer, Lot number: ER8733, Lot unknown: False, Administration date; 29Mar2021, Administration time: 08:30 AM, Vaccine location: Left arm), administration date: 29Mar2021, when the patient was 59 years old, for Covid-19 Immunisation, reaction(s): "arm pain".  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arm pain"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "foggy brain"; FATIGUE (non-serious), outcome "recovered", described as "tiredness"; LYMPHADENOPATHY (non-serious), outcome "recovered", described as "lymph node swelling under left arm". Therapeutic measures were not taken as a result of pain in extremity, feeling abnormal, fatigue, lymphadenopathy.  Additional information: No any other vaccine in four weeks. Shot 1 - arm pain - radiation up the back to neck. Last 6 hours. Shot 2 - 12- 48 hours - arm pain, foggy brain, tiredness. 3-7 days - lymph node swelling under left arm. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: left arm very tender; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Mar2021 14:00 (Batch/Lot number: unknown) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: Peaches" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "left arm very tender".  Additional information: First dose left arm very tender. There was no covid prior vaccination and the covid was not tested post vaccination. There was no other vaccine in four weeks and no other medications in two weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: headache; muscle aches; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 2021 (Batch/Lot number: unknown) 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 (product-COVID 19, administration time:02:00 PM, administrator route:Intramuscular, vaccine location:Left arm, dose number:1), administration date: 17Mar2021, when the patient was 29 years old, for Covid-19 immunization, reaction(s): "left arm very tender". The following information was reported: HEADACHE (non-serious) with onset 08Apr2021 12:00, outcome "recovered", described as "headache"; MYALGIA (non-serious) with onset 08Apr2021 12:00, outcome "recovered", described as "muscle aches". Therapeutic measures were not taken as a result of headache, myalgia.  Additional information: The patient was not tested for positive for covid, since after or before vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.