chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a contactable reporter. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date May2021 (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) with onset May2021, outcome "not recovered", described as "Sore arm".  Additional information: Agent states the reporter on the line states they took the first dose yesterday, clarifies his wife and his two daughters. States the reporter was experiencing side effects, body aches, nausea, and tiredness. States his wife was experiencing a sore arm. Agent states the reporter was asking if those side effects are normal and if they will be up until the second dose. Agent provided reporter with medical information team. reporter states his wife and daughters are experiencing a sore arm, states his wife was also experiencing the tiredness.Reporter really just wants to know how long these symptoms are going to last. States if they are going to last until the 21 days until the second dose, he may not get the second dose because he does not like the way he was feeling. Also wants to know how effective the vaccine was if he only gets the one dose. Reporter declines to provide information for a report at this time, states he does not have time, just wants the answers to his questions.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: can taste the vaccine, tastes kind of chemically; 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 male patient received bnt162b2 (BNT162B2), administration date 05May2021 12:20 (Lot number: EW0173) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Eczema" (ongoing), notes: Verbatim: Eczema; "Dyslexia" (unspecified if ongoing), notes: Verbatim: Dyslexia. Concomitant medication(s) included: CLOBETASOL PROPIONATE taken for eczema, start date: 2021 (ongoing). Past drug history included: Penicillin. Vaccination history included: Bnt162b2 (1ST Dose:7Apr2021. , Lot Number:EW0153), administration date: 07Apr2021, for COVID-19 IMMUNIZATION. The following information was reported: TASTE DISORDER (non-serious) with onset 05May2021, outcome "recovering", described as "can taste the vaccine, tastes kind of chemically".  Additional Information: Concomitant Clobetasol propionate he started using it 2 months ago. He stated his dermatologist thought that was eczema, and the steroid cream seemed to be working so they were thinking it was eczema. It was not officially diagnosed. No Investigation Assessment. He got the shot an hour ago and the taste started like 10 minutes ago. He stated it tasted kind of chemically, but he also had not eaten anything that day. It started 30 mins after he got the shot and had lasted for about 15 mins so far. He thought it was peaked and now going away. The patient had not received any other vaccinations within 4 weeks prior to Covid-19 vaccine.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was a little sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 14:45 (Lot number: EWB158) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "only one kidney" (ongoing), notes: Verbatim: Only one Kidney, 5 Years Ago. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 13Apr2021, outcome "recovered" (2021), described as "Arm was a little sore". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The report was not related to a study or programme. HCP consent to contact was no. Permission to contact declined; states his wife mentioned it to him today and there is nothing he can do. His first dose was 3 weeks ago and his arm was little sore with the first one, it started that night. No any treatment. Expiry date and NDC number of Covid vaccine was unknown. No any other products. No Investigation assessment. No any treatment. Caller states he can't even read the writing on his vaccine card, it is so small. Caller states his wife is getting a magnifying glass. Vaccination facility type was Other. Prior vaccinations (within 4 weeks): patient was received both doses of the Pfizer Covid vaccine. No any additional vaccines administered on same date of the Pfizer Suspect. AE(s) not required emergency room and physician office. No any relevant tests. No any relevant family medical history.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea
Clinical narrative: Her husband experienced a little weakness; One night of diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 22Apr2021 (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: ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Her husband experienced a little weakness"; DIARRHOEA (non-serious) with onset 2021, outcome "unknown", described as "One night of diarrhea".  Additional information: It was reported that, the patient was due to get the second vaccine on 17May2021. Second vaccine scheduled 25 days after the first vaccine. Her husband experienced a little weakness and one night of diarrhea. She was not sure the diarrhea was from the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk, Hypersomnia, Lethargy
Clinical narrative: Exposure during breast feeding; Sleeping continously; lethargic/sleeping continously and is not her usual self; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 23 month-old female patient was exposed to bnt162b2 (BNT162B2), transmammary administered in arm left, administration date 06May2021 18:15 (Lot number: EW0168) as dose 1, single for covid-19 immunisation. The mother of the patient was 34 years old at the time of vaccination. The patient's relevant medical history was not reported. The mother is expected to deliver a baby(s) on 18Nov2021. Concomitant medication(s) included: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]. The following information was reported: EXPOSURE VIA BREAST MILK (non-serious), outcome "unknown", described as "Exposure during breast feeding"; LETHARGY (non-serious) with onset 08May2021 15:00, outcome "not recovered", described as "lethargic/sleeping continously and is not her usual self"; HYPERSOMNIA (non-serious), outcome "unknown", described as "Sleeping continously". Therapeutic measures were not taken as a result of lethargy.  Additional information: Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Other medical history asthma not active currently. Device date was reported as 09May2021. Known allergies Ibuprofen, paracetamol. Parent last menstrual period date was reported as 10Feb2021. Delivery date was 18Nov2021. Reported event included that the mother was a breastfeeding mother of 23 months old daughter. She was also 11 weeks pregnant when she took first dose of vaccine on 06May2021. She checked with Gyn and Paediatrician before taking vaccine. Had usual muscle pain after vaccine and continued breastfeeding. Her daughter was sleeping continuously and was not her usual self since Saturday 08May. She was very lethargic. She has not taken any medication. No treatment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021516967 same reporter/drug with different AE/patient
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Gait disturbance, Headache, Impaired driving ability
Clinical narrative: Dizzy; Headache; I can't see clear; blurry; I cannot walk normal, I am changing lane if I am walking; it's like I'm driving it's like I am changing lanes/cannot drive and I have to come back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 (Lot number: EW0171) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension. Vaccination history included: Bnt162b2 (Dose 1, lot number: EP7533, Date: 02Apr2021, Anatomical site of vaccination: left arm), administration date: 02Apr2021, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 01May2021 11:30, outcome "unknown", described as "Dizzy"; HEADACHE (non-serious) with onset 01May2021 11:30, outcome "recovered" (May2021), described as "Headache"; VISION BLURRED (non-serious) with onset 01May2021 11:30, outcome "unknown", described as "I can't see clear; blurry"; GAIT DISTURBANCE (non-serious) with onset 01May2021, outcome "unknown", described as "I cannot walk normal, I am changing lane if I am walking"; IMPAIRED DRIVING ABILITY (non-serious) with onset May2021, outcome "unknown", described as "it's like I'm driving it's like I am changing lanes/cannot drive and I have to come back". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache.  Additional information: Patient took the second dose on 30Apr2021, Friday and then after that she was fine and starting Saturday 11:30 in the morning she felt dizzy and 'blurred' like headache. So, patient had the headache for 3 days and took Tylenol (treatment) and finally the headache goes away but patient was slight blurred. Patient couldn't see clear and on unspecified date in May2021 in the morning patient had to go to work and she had to come back home and it was like she was driving like changing lanes, like she was dizzy. Patient could not drive and returned to home. So, she just want to know if it is okay for a side effect like that or what should she do. Patient had the second dose and had been sick since the second one and wanted to know if it's a case of side effect and how long will it stay with her. Dose of Amlodipine was reported as "10/20 mg" (No further information). Laboratory test: Patient had blood test and everything was okay. It was confirmed that no other treatment was taken. Patient mentioned someone has to call her back and let her know or ask her how she was feeling, and they need to know what was going on with patients.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Dizzy; Headache; I can't see clear; blurry; I cannot walk normal, I am changing lane if I am walking; it's like I'm driving it's like I am changing lanes/cannot drive and I have to come back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 (Lot number: EW0171) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension. Vaccination history included: Bnt162b2 (Dose 1, lot number: EP7533, Date: 02Apr2021, Anatomical site of vaccination: left arm), administration date: 02Apr2021, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 01May2021 11:30, outcome "unknown", described as "Dizzy"; HEADACHE (non-serious) with onset 01May2021 11:30, outcome "recovered" (May2021), described as "Headache"; VISION BLURRED (non-serious) with onset 01May2021 11:30, outcome "unknown", described as "I can't see clear; blurry"; GAIT DISTURBANCE (non-serious) with onset 01May2021, outcome "unknown", described as "I cannot walk normal, I am changing lane if I am walking"; IMPAIRED DRIVING ABILITY (non-serious) with onset May2021, outcome "unknown", described as "it's like I'm driving it's like I am changing lanes/cannot drive and I have to come back". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache.  Additional information: Patient took the second dose on 30Apr2021, Friday and then after that she was fine and starting Saturday 11:30 in the morning she felt dizzy and 'blurred' like headache. So, patient had the headache for 3 days and took Tylenol (treatment) and finally the headache goes away but patient was slight blurred. Patient couldn't see clear and on unspecified date in May2021 in the morning patient had to go to work and she had to come back home and it was like she was driving like changing lanes, like she was dizzy. Patient could not drive and returned to home. So, she just want to know if it is okay for a side effect like that or what should she do. Patient had the second dose and had been sick since the second one and wanted to know if it's a case of side effect and how long will it stay with her. Dose of Amlodipine was reported as "10/20 mg" (No further information). Laboratory test: Patient had blood test and everything was okay. It was confirmed that no other treatment was taken. Patient mentioned someone has to call her back and let her know or ask her how she was feeling, and they need to know what was going on with patients.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: little bit of soreness; 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 59 year-old male patient received bnt162b2 (BNT162B2), administration date 20Mar2021 18:00 (Lot number: EN6208) at the age of 59 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: PAIN (non-serious) with onset 20Mar2021, outcome "recovered" (Mar2021), described as "little bit of soreness".  Additional information: No Prior Vaccinations (within 4 weeks). No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: mild sore arm; 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. Other Case identifier(s): US-PFIZER INC-2021536291 (Pfizer).  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 "mild sore arm".  Additional information: Patient saw that there is a blue cap/top of the bottle of the vaccine on tv, but he did not see any blue cap/top of the bottles that were administered to him. Caller stated that he got his 1st dose the other day or a couple days or a week ago. He was able to read/share. Patient was asking to review the ingredients list and if the product contained anything related to asteroid also is the propylene glycol related to glycerine response to which given was review ingredients and categorized of ingredients in attached. One view it related to steroid but directed caller to have the list reviewed by his hcp or pharmacist for conformation. Explained that the ingredients its polyethylene glycol not propylene glycol and it is a component of aliped not related to glycerine.  Patient received his first dose of the Pfizer- Biotech Covid 19 vaccine a week ago , tomorrow and stated so far so good but he reported only a mild sore arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: sore arm; couldn't really move it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 29Apr2021 (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 "sore arm"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "couldn't really move it".  Additional information: Reporter stated that last Thursday 29 APR 2021 she got her first dose of Pfizer COVID-19 vaccine and she had a really really sore arm for two days after the vaccine, she says its okay now, she couldn't really move it, but she is very active busy person. She stated that Saturday night she could feel something was changing in her body. She states that her husband called 911 and she went into the hospital. She states that her blood pressure was through the roof.  She ran into her son-in-laws chiropractor and he stated that he had a similar reaction to the caller but didn't have a reaction until Saturday either. She stated that the got his vaccine the same date as she did and he had the same symptoms except for the blood pressure.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: vasovagal response; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 28 year-old female patient received bnt162b2 (BNT162B2), administration date 06May2021 11:00 (Batch/Lot number: unknown) at the age of 28 years as dose number unknown, 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: PRESYNCOPE (non-serious) with onset 06May2021 21:00, outcome "recovering", described as "vasovagal response". Therapeutic measures were not taken as a result of presyncope.  Additional Information: I have a twin sister, who got her shot on the same day and time, and she also had a vasovagal response, but not nearly as many of the other symptoms. The patient had no known allergies. There was no covid prior vaccination. The 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Oligomenorrhoea, Vomiting
Clinical narrative: I had my Pfizer shots on 07Apr and 28Apr. My last period was 14Mar .; The last couple days I've been vomiting.; Every since my second shot I've been feeling light head and dizzy.; 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), administration date 28Apr2021 14:30 (Batch/Lot number: unknown) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (COVID vaccine details: COVID 19,, Brand: Pfizer,, Lot unknown: True,, Lot unknown reason: Other, Lot unknown reason other: Unknown, Administration time: 11:30 AM,, Dose number: 1, Vaccine location: Left arm), administration date: 07Apr2021, when the patient was 45 years old, for covid-19 immunisation, reaction(s): "My last period was 14Mar". The following information was reported: OLIGOMENORRHOEA (non-serious) with onset 29Apr2021, outcome "not recovered", described as "I had my Pfizer shots on 07Apr and 28Apr. My last period was 14Mar ."; VOMITING (non-serious) with onset 29Apr2021, outcome "not recovered", described as "The last couple days I've been vomiting."; DIZZINESS (non-serious) with onset 29Apr2021, outcome "not recovered", described as "Every since my second shot I've been feeling light head and dizzy.". Therapeutic measures were not taken as a result of oligomenorrhoea, vomiting, dizziness.  Additional Information: No other vaccine in 4 weeks. Allergy meds, Anxiety meds in 2 weeks. No Covid prior vaccination and not tested for Covid since vaccination. No Known allergies.Other medications in two weeks: Allergy meds, Anxiety meds. Other medical history:  None that know of   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Faeces discoloured, Fatigue, Headache, Somnolence
Clinical narrative: I just got tired; Headache; I just slept a lot; Stomach was feeling kind of weird; looks like I pooped out tomato soup; looks like I pooped out tomato soup; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 05May2021 (Batch/Lot number: unknown) as dose number unknown, 0.3ml, 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 "unknown", described as "I just got tired"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; SOMNOLENCE (non-serious), outcome "unknown", described as "I just slept a lot"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "Stomach was feeling kind of weird; looks like I pooped out tomato soup"; FAECES DISCOLOURED (non-serious), outcome "unknown", described as "looks like I pooped out tomato soup".  Additional Information: Patient had got the vaccination yesterday and (confirmed as 05May2021) and Patient stated I just got tired, I got a headache and I just slept a lot, I woke up this morning, I went to work and my stomach was feeling kind of weird and I got home and you know I really describe it that looks like I pooped out tomato soup and I am just trying to figure it out.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Second dose: palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 27Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sleep apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 02Apr2021, when the patient was 73 years old, for COVID-19 immunisation, reaction(s): "Sore arm". The following information was reported: PALPITATIONS (non-serious), outcome "recovered", described as "Second dose: palpitations". Therapeutic measures were taken as a result of palpitations.  Additional information: Reporter was not aware if adverse event caused to patient required emergency room or physician office visit. It was unknown if patient took any other medication or vaccine prior to vaccinations (within 4 weeks). In response to palpitations the patient just rested and put her CPAP machine on for 10-15 minutes and she was fine. The patient said she thought that was kind of strange to have with the second dose. To date and outcome of events unknown other than patient said she was fine. The last time caller spoke to the patient was on 30Apr2021 and patient said she was fine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Body temperature abnormal, Fatigue, Insomnia, Migraine
Clinical narrative: migraine; achy; temperature; nauseous; fatigue; insomnia; agitated; muscle aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 11:45 (Lot number: er8737) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing), notes: known allergies: Sulfa; "Generalized anxiety disorder" (unspecified if ongoing), notes: GAD; "Menopause" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "known allergies: steroids'" (unspecified if ongoing), notes: known allergies: steroids'. The patient took concomitant medications. Past drug history included: Codeine, reaction(s): "drug allergy", notes: known allergies: codeine; Trazodone, reaction(s): "drug allergy", notes: known allergies: trazodone. The following information was reported: MIGRAINE (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "migraine"; PAIN (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "achy"; BODY TEMPERATURE ABNORMAL (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "temperature"; NAUSEA (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "nauseous"; FATIGUE (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "fatigue"; INSOMNIA (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "insomnia"; AGITATION (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "agitated"; MYALGIA (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "muscle aches". The events "migraine", "achy", "temperature", "nauseous", "fatigue", "insomnia", "agitated" and "muscle aches" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine, pain, body temperature abnormal, nausea, fatigue, insomnia, agitation, myalgia.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with ZPAK and the patient was told to take excedrin, adevele had m and were unknown whether the patient was taking it.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, SARS-CoV-2 test
Clinical narrative: migraine; achy; temperature; nauseous; fatigue; insomnia; agitated; muscle aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 11:45 (Lot number: er8737) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing), notes: known allergies: Sulfa; "Generalized anxiety disorder" (unspecified if ongoing), notes: GAD; "Menopause" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "known allergies: steroids'" (unspecified if ongoing), notes: known allergies: steroids'. The patient took concomitant medications. Past drug history included: Codeine, reaction(s): "drug allergy", notes: known allergies: codeine; Trazodone, reaction(s): "drug allergy", notes: known allergies: trazodone. The following information was reported: MIGRAINE (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "migraine"; PAIN (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "achy"; BODY TEMPERATURE ABNORMAL (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "temperature"; NAUSEA (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "nauseous"; FATIGUE (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "fatigue"; INSOMNIA (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "insomnia"; AGITATION (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "agitated"; MYALGIA (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "muscle aches". The events "migraine", "achy", "temperature", "nauseous", "fatigue", "insomnia", "agitated" and "muscle aches" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine, pain, body temperature abnormal, nausea, fatigue, insomnia, agitation, myalgia.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with ZPAK and the patient was told to take excedrin, adevele had m and were unknown whether the patient was taking it.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose fluctuation, Blood glucose increased
Clinical narrative: High blood sugar; Her blood sugar has been going up and down.; 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 65 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 19Apr2021 12:00 (Lot number: EW0158) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (ongoing), notes: It has been years, she thinks it maybe five years ago. The patient's concomitant medications were not reported. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "High blood sugar"; BLOOD GLUCOSE FLUCTUATION (non-serious), outcome "unknown", described as "Her blood sugar has been going up and down.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Other Products was reported as, No. Clinical course was reported as, patient stated she is scheduled for the second dose of the vaccine today but when she took her blood sugar it was really high. Caller would like to know if her high blood sugar reading will affect her receiving the second dose today? She does not remember when she was diagnosed with diabetes. It has been years, she thinks it maybe five years ago. Her blood sugar has been going up and down. Sometimes, her blood sugar will be good two days in a row, and then it will go back up again. She does not know a start date. Confirmed she was reporting about Pfizer covid vaccine. Reporter seriousness for High blood sugar was unspecified.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: blisters; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Mar2021 at 02:30 pm (Lot number: EP 7533) at the age of 62 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: BLISTER (non-serious) with onset 2021, outcome "unknown", described as "blisters".  Additional information: No other vaccine in four weeks. No treatment AE. No known allergies. No COVID prior vaccination. No COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Gastroenteritis viral, Illness
Clinical narrative: Stomach virus; Illness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 17 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Apr2021 10:15 (Lot number: ER8732, Expiration Date: Aug2021) at the age of 17 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: GASTROENTERITIS VIRAL (non-serious) with onset 09May2021, outcome "recovered" (May2021), described as "Stomach virus"; ILLNESS (non-serious) with onset 09May2021, outcome "recovered" (May2021), described as "Illness". Therapeutic measures were taken as a result of gastroenteritis viral, illness.  Additional information: Reporter says her son got his first dose April 18th, and he is supposed to get his second dose today. She says she called because she was not sure if with the stomach flu he can get it or not. She says her son's first dose appointment was at 10:15 18Apr. She says that her son's stomach flu started last night because they had a family member who had it two days before then came over, and her son got it last night. AE Treatment: Caller says she gave him Imodium and some liquids like water. Caller clarified Imodium to being Imodium Multi-Symptom Relief. She says that the dosage given was Loperamide 2mg and antidiarrheal 125mg for this medication. Agent reports since callers son got first dose 18Apr2021 and since it is between doses that he is having an illness, he has transferred her to go ahead and report it.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Needle issue, Underdose
Clinical narrative: The needle separated from the syringe and the patient was given half of the dose.; Given half of the dose; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: NEEDLE ISSUE (non-serious), outcome "unknown", described as "the needle separated from the syringe and the patient was given half of the dose."; UNDERDOSE (non-serious), outcome "unknown", described as "Given half of the dose".  Additional information: One of his nurses was giving a patient the vaccine. however, in the process the needle separated from the syringe and the patient was given half of the dose. Doctor was wondering if that patient needed to be revaccinated.  .No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: minor soreness; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: PAIN (non-serious), outcome "unknown", described as "minor soreness"; FATIGUE (non-serious), outcome "unknown", described as "fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Full blood count abnormal
Clinical narrative: Her blood Counts were low and now everything is looking good; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (086396) from a Pfizer sponsored program. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Breast Cancer" (unspecified if ongoing), notes: Breast Cancer for 14 years. The patient's concomitant medications were not reported. The following information was reported: FULL BLOOD COUNT ABNORMAL (non-serious), outcome "unknown", described as "Her blood Counts were low and now everything is looking good". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient Stated " She has had Breast Cancer for 14 years and she is so happy to be alive. Her blood Counts were low and now everything is looking good. She was so thankful for Pfizer".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Keratitis
Clinical narrative: Keratitis/My symptoms flared up after the second dose of the vaccine.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PREDNISOLONE taken for ocular hyperaemia, start date: 22Dec2020; TOBRAMYCIN taken for photophobia, start date: 22Dec2020; ARTIFICIAL TEARS [GLYCEROL;HYPROMELLOSE;MACROGOL], start date: 22Dec2020; DOXYCYCLINE HYCLATE taken for inflammation, start date: 25Mar2021, stop date: 25Apr2021; RESTASIS taken for inflammation, start date: 01Jan2021 (ongoing). Vaccination history included: Bnt162b2 (dose 1, Event onset date 30Dec2020, Outcome: Not recovered), administration date: 17Dec2020, for COVID-19 immunization, reaction(s): "meibomian gland dysfunction", "Eye redness, dryness pain, photophobia", "Eye redness, dryness pain, photophobia", "Eye redness, dryness pain, photophobia", "Joint pain and swelling 3 days after the first dose. Affected joints: right elbow, right wrist and right third interdigital joint", "Joint pain and swelling 3 days after the first dose. Affected joints: right elbow, right wrist and right third interdigital joint". The following information was reported: KERATITIS (non-serious), outcome "not recovered", described as "Keratitis/My symptoms flared up after the second dose of the vaccine.". Therapeutic measures were taken as a result of keratitis.  Additional information: Diagnosed with keratitis on 26Dec2020. Treated with steroid drops and antibiotic ointment with mild improvement. Her symptoms flared up after the second dose of the vaccine. Eye just had anadditional treatment by (name withheld). She received IPL x 1 treatment and will need 3 more treatments. She received also Blex Ex treatment x 1. These therapies are not covered by her insurance. Each treatment costs Dollar 300. Her cost will be Dollar 1200. Please refer to an article. Nature scientific reports meibomian gland dysfunction is caused by the spike protein.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased
Clinical narrative: dizziness; rapid heartbeat; 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 57 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose: 01), for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious) with onset May2021, outcome "unknown", described as "dizziness"; HEART RATE INCREASED (non-serious) with onset May2021, outcome "unknown", described as "rapid heartbeat".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: pain in my arm; swelling in my my armpit; 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 female patient received bnt162b2 (BNT162B2), administration date 08May2021 (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), for Covid-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in my arm"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swelling in my my armpit".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pain
Clinical narrative: Nausea; Muscle pain; Headache; Pain from "head to toe,"; 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 male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Nausea"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; PAIN (non-serious), outcome "unknown", described as "Pain from "head to toe,"".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Ear pain, Fatigue, Gait disturbance
Clinical narrative: she couldn't walk and had to stay in bed all day; Weakness; feeling tired/So tired; ear ache; 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 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08May2021 (Batch/Lot number: unknown) at the age of 63 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1, Anatomical Location: upper right arm), administration date: 17Apr2021, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 08May2021, outcome "recovering", described as "feeling tired/So tired"; EAR PAIN (non-serious) with onset 08May2021, outcome "not recovered", described as "ear ache"; GAIT DISTURBANCE (non-serious) with onset 09May2021, outcome "recovered" (09May2021), described as "she couldn't walk and had to stay in bed all day"; ASTHENIA (non-serious) with onset 08May2021, outcome "recovering", described as "Weakness".  Additional information: Vaccine was not administered at Military Facility. No additional vaccines administered on same date of the Pfizer suspect. Adverse event did not require a visit to Emergency Room/Physician Office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Family Medical History Relevant to adverse event Patient's Medical History (including any illness at time of vaccination) and Relevant Tests were reported as none.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site soreness; 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 58 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "He lost his eye sight in service." (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site soreness".   Additional information: Patient had a question that he keeps getting asked by other people and he wants to make sure he informs people correctly. He received both doses. The first injection, he only had injection site soreness, and everything was fine, no other symptoms. On the second jab, he also had injection site soreness and onset of aches and headaches and it was linear started behind the eyes and then down toward the length of his body. 12 hours post injection. Caller states he has a question about ibuprofen or other NSAIDs. Caller stated that 12 hours after symptoms he took 400mg ibuprofen and he didn't consider how it may have blunt or depress the immune response. Attempted to clarify details provided with caller. He clarified he took the ibuprofen 24 hours post injection and 12 hours after onset of symptoms. If it blunted or adversely effected the immune response to the vaccination. He didn't necessarily question the side effects. In regards with self-administration of ibuprofen or any NSAIDS. He supposed in few weeks he could get a titer. He has concerns about the actual level of immunity developed from the second dose and if it may have blunted the effects. It shut down the aches and pains and he's concerned. Reporter details: He is totally blind unless they have talking mail. He lost his eyesight in service.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.