chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Sharp pain in his heart; Wild palpitations; Extreme erratic heart beat; wiped out; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1248), via an unspecified route of administration on 11Jan2021 at single dose at left arm for covid-19 immunisation. Medical history included Lyme's disease from 09Jun2018 and ongoing, ongoing heart issues, cholesterol lowering and swelling (He was on a water pill for swelling). Concomitant medication included atenolol for heart medication, pitavastatin calcium (LIVALO) for cholesterol lowering. Patient was calling to report a negative reaction with Covid-19 vaccine. Four hours after the injection he laid down in bed and was relaxing on 11Jan2021. He felt a sharp pain in his heart. It was about 1 to 1.5 inches to the right of his nipple. It felt like a knife being jabbed in his chest. This only happened once. His heart was having wild palpitations. He had an extreme erratic heart beat lasting 30-40 seconds. It was terrifying. He had a lot of irregular heart beats for 3-4 days. He was wiped out and unable to get out of bed for 5 days. He had an MRI on 21Jan2021. He was waiting on the results. The erratic heart beats come and go. They were not as pronounced as the first week. He was not getting the second dose. He had not had a flu shot for the last 3 years. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. Outcome of event sharp pain in his heart recovered with sequel on 11Jan2021, wild palpitations was recovered in Jan2021, extreme erratic heart beat was recovering, wiped out was recovered with sequel on 16Jan2021. The report was considered as non-serious.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer. An 89-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), glucose tolerance impaired (pre-diabetic), lung cancer, and lymphoma. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a nursing home/senior living facility. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient experienced headache on 19Jan2021. No treatment was received for the adverse event. Clinical outcome of event was recovered on an unspecified date.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore at injection site; This is a spontaneous report from a contactable consumer (patient herself). A 66-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration in the left arm on 06Jan2021 15:30 at a single dose for COVID-19 immunization. The patient was vaccinated in a doctor's office/urgent care. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient is not pregnant at the time of vaccination. On 06Jan2021 16:00, the patient experienced sore at injection site with outcome of recovered on unspecified date in Jan2021. The patient did not receive treatment for the reported event. The case was considered non-serious.  Information on the lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Palpitations, Syncope
Clinical narrative: Fainted; Dizziness; Heart racing; This is a spontaneous report from a contactable consumer reported for herself. A 22-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Jan2021 15:45 at single dose in left arm for COVID-19 immunisation. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Concomitant medication included lisdexamfetamine mesilate (VYVANSE), escitalopram oxalate (LEXAPRO), spironolactone and Birth control product. The patient experienced fainted morning after 1st dose with dizziness and heart racing on 22Jan2021 06:45 - had to go to ER. The patient received anti-nausea and heart monitor as treatment for the adverse event. Events outcome was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: he is disabled and has congestive heart failure.; This is a spontaneous report from a contactable consumer (patient). A male patient (age: 74, unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated he was disabled and had congestive heart failure. The patient stated that he read the CDC had decided to only give one shot, everything he read on the website saying designed for 2 doses of the covid 19 vaccine. He received his shot and they might not be able to give 2 doses. The outcome of event was unknown.  Information on the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chapped lips, Chills, Nausea
Clinical narrative: nausea; chills; her lips became really chapped; This is a spontaneous report from a non-contactable consumer. This female consumer (patient) with unspecified age reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization at hospital. The patient medical history and concomitant medications were not reported. Patient did not experience any problems there after waiting 15 minutes. When she got home, she started to have chills and her lips became really chapped on 21Jan2021. This morning 22Jan2021, she's having some chills and nausea. She was taking diphenhydramine (BENADRYL). Outcome of events was unknown.  No follow-up attempts are possible. Information about batch/ lot number cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from a contactable consumer (patient).  A 75-year-old female patient received bnt162b2 (BNT162B2, lot number EL3302) , via an unspecified route of administration on 21Jan2021 12:00 at single dose on left arm for covid-19 immunisation.  Medical history included none.  Concomitant medication included citalopram hydrobromide (CELEXA), zolpidem tartrate (AMBIEN). No other vaccine in four weeks. The patient experienced diarrhea on 22Jan2021 08:00. No treatment received. No covid prior vaccination, no covid tested post vaccination, no known allergies. The outcome of the event was not recovered.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: She passed out.; This is a spontaneous report from a contactable consumer (parent). A 17-year-old female patient (daughter) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL1284) on 22Jan2021 11:45 AM at left arm at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. No known allergies. Patient was not pregnant. Patient did not have COVID prior vaccination, and did not have other vaccine in four weeks, did not other medications in two weeks. The patient experienced passed out on 22Jan2021 12:00 PM. Treatment included they had her lay on the ground with her knees up and cold compresses. Patient did not test COVID post vaccination. The outcome of event was recovering.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: bad headache; chills; This is a spontaneous report from a contactable consumer. This consumer reported for a 26-year-old male patient who received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number/Exp. date unknown) on 21Jan2021 at 12:30 PM  via unknown route of administration at single dose (at the age of 26 years old) for covid-19 immunisation. Relevant medical history and concomitant medication were not provided. It was unknown if patientrecived any other vaccines within 4 weeks prior to the COVID vaccine. On unknown date, the patient reported that he got a bad headache at night which has become cyclical. He also got chills every once in a while. The events outcome was unknown. It was unknown if patient received any treatment for events. Since the vaccination, it was unknown if the patient has been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: cancerous cells; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received her first dose of PFIZER-BIONTECH COVID-19 VACCINE on 14Jan2021. She had a surgical procedure Wednesday 20Jan2021, and was prescribed a cephalosporin antibiotic for 7 days post-procedure precautionary remove cancerous cells somebody suggested, it was a doctor. She was asking if there are any drug interactions between the antibiotic and the vaccine. Also, a doctor suggested that she take a dose of ibuprofen prior to her second vaccine dose on 05Feb2021. It was also reported the patient had a little surgical procedure with the Dermatologist this week (in Jan2021) and she just wanted to know if the antibiotic, Cefadroxil, has any contraindications that would compromise her vaccine. She had to take it for 7 days and it was to prevent bacterial infections. It was a procedure on her leg and she was also given an antibiotic cream also to help. The patient felt it was more important for her with having this vaccine and that was why she was calling. The event outcome was unknown.  Information on the Batch/Lot number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Silver dollar sized swelling and redness around the injection site for 4 days; Silver dollar sized swelling and redness around the injection site for 4 days; Silver dollar sized swelling and redness around the injection site for 4 days. After 4 days the redness subsided but a knot remains under the skins surface with heat to the touch and itching; Silver dollar sized swelling and redness around the injection site for 4 days. After 4 days the redness subsided but a knot remains under the skins surface with heat to the touch and itching; Silver dollar sized swelling and redness around the injection site for 4 days. After 4 days the redness subsided but a knot remains under the skins surface with heat to the touch and itching; This is a spontaneous report from a contactable Other Health Professional (patient). A 32-years-old female patient received first dose bnt162b2 (BNT162B2, lot: EL3247), intramuscular on 14Jan2021 11:15 at SINGLE DOSE on Arm Left for covid-19 immunisation. The patient medical history was not reported. Pregnant: No. No other vaccine in four weeks. The patient's concomitant medications were none. The patient experienced Adverse event: Silver dollar sized swelling and redness around the injection site for 4 days. After 4 days the redness subsided but a knot remains under the skins surface with heat to the touch and itching since 18Jan2021. The event outcome of redness around the injection site was recovered on 22Jan2021, outcome of other events were not recovered. No treatment received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Product use issue, SARS-CoV-2 test
Clinical narrative: Head hurting - constant achiness; received other vaccine on 20Jan2021 on the left arm; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 10:00 at single dose on the left arm for COVID-19 immunization. The patient medical history included allergies: Milk. Patient took migraine medications in two weeks. Facility type vaccine was hospital. Patient was not pregnant. The patient received other vaccine on 20Jan2021 on the left arm. The patient experienced head hurting - constant achiness on 20Jan2021 16:00. The patient underwent lab tests and procedures which included Nasal Swab: Negative on 05Jan2021. COVID tested post vaccination. No treatment received. Outcome of the event head hurting - constant achiness was not recovered.  Information about batch/lot number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy
Clinical narrative: Person indicated that they felt lethargic and had a headache.; Person indicated that they felt lethargic and had a headache.; This is a spontaneous report from a non-contactable consumer (patient). A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, number: EC0142), via an unspecified route of administration on 20Jan2021 at single dose in arm left for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not have COVID prior vaccination. The patient previously received the first dose of BNT162B2 (lot number: EC 1284) in Left arm on 30Dec2020 for COVID-19 immunisation. The patient indicated that they felt lethargic and had a headache on 21Jan2021. The patient was not pregnant at the time of vaccination. COVID was not tested post vaccination. There was no treatment received for the event. Patient was recovered on an unspecified date in Jan2021.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nasopharyngitis, Pain in extremity, Rhinorrhoea, Sinus disorder
Clinical narrative: Scratchy throat; Sinus; Head cold symptoms; He experienced drainage and flowing; His total left arm, where he got the vaccine, was sore all the way down; He felt light headed; Blurry vision; This is a spontaneous report from a contactable consumer (patient). This male patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number/Exp. date unknown) on 18Jan2021 via unknown route of administration at single dose for covid-19 immunisation. Relevant medical history and concomitant medication were not provided. The patient reported that he received the covid vaccine on Monday, 18Jan2021, at which point he felt light-headed and blurry vision. He was kept for 30 minutes until it subsided. On Tuesday, 19Jan2021, his total left arm, where he got the vaccine, was sore all the way down. On Wednesday, 20Jan2021, he experienced drainage and flowing for which he took Benadryl which helped overnight. Yesterday, 21Jan2021 he reported heavy drainage, sinus or head cold symptoms. Today, 22Jan2021, he reported a scratchy throat. The outcome for events light-headed and blurry vision was recovered. The outcome for other events was unknown. The patient inquired as to what to do about his side effects after receiving the first dose of Covid-19 vaccine.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Throat irritation, Vision blurred
Clinical narrative: Scratchy throat; Sinus; Head cold symptoms; He experienced drainage and flowing; His total left arm, where he got the vaccine, was sore all the way down; He felt light headed; Blurry vision; This is a spontaneous report from a contactable consumer (patient). This male patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number/Exp. date unknown) on 18Jan2021 via unknown route of administration at single dose for covid-19 immunisation. Relevant medical history and concomitant medication were not provided. The patient reported that he received the covid vaccine on Monday, 18Jan2021, at which point he felt light-headed and blurry vision. He was kept for 30 minutes until it subsided. On Tuesday, 19Jan2021, his total left arm, where he got the vaccine, was sore all the way down. On Wednesday, 20Jan2021, he experienced drainage and flowing for which he took Benadryl which helped overnight. Yesterday, 21Jan2021 he reported heavy drainage, sinus or head cold symptoms. Today, 22Jan2021, he reported a scratchy throat. The outcome for events light-headed and blurry vision was recovered. The outcome for other events was unknown. The patient inquired as to what to do about his side effects after receiving the first dose of Covid-19 vaccine.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: Diarrhea; headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose bnt162b2 (Pfizer-Biontech covid-19 vaccine), via an unspecified route of administration on 18Jan2021 in the afternoon at SINGLE DOSE for covid-19 immunisation. Medical history included Pulmonary fibrosis, lung infection. Concomitant medication included azithromycin (AZITHROMYCIN) on Mondays, Wednesdays and Fridays to Preventative for lung infection due to Pulmonary fibrosis, ibuprofen (IBUPROFEN) for Pulmonary fibrosis and other problems, had not taken any Ibuprofen since 16Jan2021. The patient had not had any symptoms other than a headache, so she is not sure if this was because of the vaccine or not; diarrhea on 20Jan2021. This consumer wanted to know how long before and after should get the Pfizer COVID-19 Vaccine shot do you have to stop taking Ibuprofen. She has Pulmonary fibrosis and other problems that she takes Ibuprofen for. She got the first dose of Pfizer COVID-19 Vaccine 18Jan2021. They did not tell her she would be getting the Pfizer COVID-19 Vaccine until the night before: 17Jan2021. She has not taken any Ibuprofen since Saturday night: 16Jan2021. She also mentioned that she had Diarrhea for 2 days in a row on Wednesday 20Jan2021 and Thursday 21Jan2021; Diarrhea is not too unusual for her because she takes Azithromycin 1 tablet 3 days/week continuously as preventative for lung infection due to her pulmonary fibrosis; she usually will get diarrhea on the day she takes the Azithromycin, but not on the days she does not-so the 2 days in a row of diarrhea she had 20Jan2021- 21Jan2021 she wanted to know if could be a possible side effect of the Pfizer COVID-19 Vaccine. The event outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable Pharmacist.  A healthcare worker of unspecified age and gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient tested positive for covid-19 on an unspecified date with outcome of unknown.  Information about Lot/Batch has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Muscle pain; fatigue; This is a spontaneous report from a contactable consumer who is reporting for herself.  A 26-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3247), via an unspecified route of administration left arm single dose on 21Jan2021 12:30 for covid-19 immunisation. No other vaccine was received in four weeks.  The patient medical history was not reported. There were no concomitant medications. The patient experienced muscle pain on Jan2021, fatigue on Jan2021. No treatment received. The outcome was not recovered
Sex: F
Vaccine: COVID19
Symptoms: Night sweats
Clinical narrative: Night sweats; This is a spontaneous report from a non-contactable consumer reporting for herself.   A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose on 12Jan2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced night sweats on 13Jan2021. The outcome was unknown  No follow-up attempts are possible. Information on batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer (patient's husband). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated patient received the first dose of the COVID 19 vaccine and now has severe diarrhea on an unspecified date in Jan2021. The reporter stated the patient hasn't been able to leave the bedroom for two hours and he gave the patient a dose of magnesium. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Neuropathy peripheral, Tinnitus
Clinical narrative: Transient bilateral lower extremity neuropathy; periorbal and facial neuropathy; severe low back pain; tinnitus; This is a spontaneous report from a contactable other health professional (patient) reporting for herself. A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL3248), intramuscular at left arm on 20Jan2021 at single dose for covid-19 immunization. Medical history was none. No pregnant at the time of vaccination. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 via intramuscular at left arm on 30Dec2020 for covid-19 immunization. Facility where the most recent COVID-19 vaccine administered was nursing home/senior living facility. The patient experienced transient bilateral lower extremity neuropathy, tinnitus, periorbital and facial neuropathy, severe low back pain on 20Jan2021 with outcome of unknown. No treatment was received for the adverse events. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Really bad headache/it has worsened; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3247), via an unspecified route of administration on 21Jan2021 14:15 at single dose for COVID-19 immunization. Medical history reported as none. Concomitant medication included fluoxetine hydrochloride (FLUOXETINE). The patient had a small headache in the morning on 22Jan2021, he ignored it, but now it was getting worse. The outcome of event was not recovered.  Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Feeling abnormal, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: she was useless; diarrhea; vomiting; low grade fever; sore arm; Stomach cramps; didn't feel good; This is a spontaneous report from a contactable consumer (patient). The 54-years-old female patient (weight: 150lb-160lb) received first dose of bnt162b2 (BNT162B2, lot number: EL0142), via an unspecified route of administration in left arm on 14Jan2021 15:40 at SINGLE DOSE for covid-19 immunisation. Medical history included none. No Prior Vaccinations (within 4 weeks). Concomitant medication included levothyroxine sodium (SYNTHROID), omeprazole, calcium. On 20Jan2021 weds: "bad diarrhea", vomiting, low grade fever, sore arm (only the day after) and bad stomach cramps. Caller says, "if that's going to happen after 2nd dose- I wont take it". Caller referred to HCP for treatment of post vaccination side effects. She notes that at work on Wednesday she didn't feel good  on 20Jan2021 and yesterday she was useless on 21Jan2021. She does feel better today thank goodness. No AE(s) require a visit to Emergency Room or Physician Office. The outcome of the events didn't feel good, she was useless, sore arm was unknown and  was recovering for the rest events.  No follow-up attempts possible. No further information expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting, Weight
Clinical narrative: she was useless; diarrhea; vomiting; low grade fever; sore arm; Stomach cramps; didn't feel good; This is a spontaneous report from a contactable consumer (patient). The 54-years-old female patient (weight: 150lb-160lb) received first dose of bnt162b2 (BNT162B2, lot number: EL0142), via an unspecified route of administration in left arm on 14Jan2021 15:40 at SINGLE DOSE for covid-19 immunisation. Medical history included none. No Prior Vaccinations (within 4 weeks). Concomitant medication included levothyroxine sodium (SYNTHROID), omeprazole, calcium. On 20Jan2021 weds: "bad diarrhea", vomiting, low grade fever, sore arm (only the day after) and bad stomach cramps. Caller says, "if that's going to happen after 2nd dose- I wont take it". Caller referred to HCP for treatment of post vaccination side effects. She notes that at work on Wednesday she didn't feel good  on 20Jan2021 and yesterday she was useless on 21Jan2021. She does feel better today thank goodness. No AE(s) require a visit to Emergency Room or Physician Office. The outcome of the events didn't feel good, she was useless, sore arm was unknown and  was recovering for the rest events.  No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Chest discomfort, Chest pain, Dizziness, Feeling abnormal
Clinical narrative: It was hurting really bad this morning about where your heart is; felt like my chest was caving in for 5-6 hours; felt like a mule had kicked him in the chest; both sides of my ribs was hurting like I had been rodeoing/they were real sore/rib cage on both sides hurt real bad; felt drugged; dizzy feeling/lightheaded; headache; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date in Jan2021 at single dose for COVID-19 immunization. The patient medical history included blood pressure (abnormal). Concomitant medications included 5 mg of a blood pressure pill and male enhancement stuff. The patient stated he went to the health department and they sent him somewhere else to get the shot on Wednesday (Jan2021). It was the first dose of the vaccine and he had a little headache that night (Wednesday) at about 20:00 and he took a couple of aspirin. Got up on 21Jan2021 morning both sides of his ribs was hurting like he had been rodeoing, they were real sore, also reported as his rib cage on both sides hurt real bad and about 6 hours later it wore off. Thursday (Jan2021) he felt drugged, dizzy feeling and lightheaded, around 11:00 it dissipated. On 22Jan2021 morning when he got up he felt like his chest was caving in for 5-6 hours (also reported as he felt like a mule had kicked him in the chest) but he went on out and did his thing and it was 5 hours like that. It was hurting really bad on 22Jan2021 morning about where his heart was. He didn't know if he was having a heart attack. His symptoms were gone he was 98-99% better than he was. It wore itself down through the morning hours. By 10:30-11:00 it was about 50% gone and by 13:00 it was gone. He didn't think it went away, it was kind of hiding back there. It made his wonder if he should take the second shot. He had never had no Corona. The problems came when he had the shot. He took 5 mg of a blood pressure pill and male enhancement stuff that his doctor did warn him to tell them he was on it if he ever go to the ER. His second shot was scheduled for 10Feb2021. Wanted to know if this was a side effect that made him feel bad and hurt half the day and by the afternoon it's gone. Wanted to be sure since he was to get the booster. Wanted to know is this normal and what to do. The outcome of the events of the event rib pain was recovered on 21Jan2021, of the events felt drugged & dizzy feeling/lightheaded was recovered in Jan2021, of the other events was recovering.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal chest pain
Clinical narrative: It was hurting really bad this morning about where your heart is; felt like my chest was caving in for 5-6 hours; felt like a mule had kicked him in the chest; both sides of my ribs was hurting like I had been rodeoing/they were real sore/rib cage on both sides hurt real bad; felt drugged; dizzy feeling/lightheaded; headache; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date in Jan2021 at single dose for COVID-19 immunization. The patient medical history included blood pressure (abnormal). Concomitant medications included 5 mg of a blood pressure pill and male enhancement stuff. The patient stated he went to the health department and they sent him somewhere else to get the shot on Wednesday (Jan2021). It was the first dose of the vaccine and he had a little headache that night (Wednesday) at about 20:00 and he took a couple of aspirin. Got up on 21Jan2021 morning both sides of his ribs was hurting like he had been rodeoing, they were real sore, also reported as his rib cage on both sides hurt real bad and about 6 hours later it wore off. Thursday (Jan2021) he felt drugged, dizzy feeling and lightheaded, around 11:00 it dissipated. On 22Jan2021 morning when he got up he felt like his chest was caving in for 5-6 hours (also reported as he felt like a mule had kicked him in the chest) but he went on out and did his thing and it was 5 hours like that. It was hurting really bad on 22Jan2021 morning about where his heart was. He didn't know if he was having a heart attack. His symptoms were gone he was 98-99% better than he was. It wore itself down through the morning hours. By 10:30-11:00 it was about 50% gone and by 13:00 it was gone. He didn't think it went away, it was kind of hiding back there. It made his wonder if he should take the second shot. He had never had no Corona. The problems came when he had the shot. He took 5 mg of a blood pressure pill and male enhancement stuff that his doctor did warn him to tell them he was on it if he ever go to the ER. His second shot was scheduled for 10Feb2021. Wanted to know if this was a side effect that made him feel bad and hurt half the day and by the afternoon it's gone. Wanted to be sure since he was to get the booster. Wanted to know is this normal and what to do. The outcome of the events of the event rib pain was recovered on 21Jan2021, of the events felt drugged & dizzy feeling/lightheaded was recovered in Jan2021, of the other events was recovering.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: her blood pressure which was 208/189; really bad shakes a fever of 102 degrees; really bad shakes a fever of 102 degrees; This is a spontaneous report from a contactable other HCP(patient). A 46-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunization.  Medical history included COVID-19 in Nov2020/Dec2020. The patient's concomitant medications were not reported. 12 hours later the patient had really bad shakes a fever of 102 degrees and she checked her blood pressure which was 208/189. She went to the Emergency Room to get checked out and she was told that it was probably due to the vaccine. Patient wanted to know if she should receive the second dose of the vaccine since she had this type of reaction after the first dose. She had COVID-19 in Nov2020/Dec2020. She was told in the Emergency Room that since she had a previous COVID-19 infection that she would experience worse side effects from the first dose of the COVID-19 dose than the second dose. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported blood pressure increased. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Headache; Fever; Fatigue; Nausea; This is a spontaneous report from a contactable physician (patient). A 41-year-old male patient received second dose of bnt162b2 (reported as: product=COVID 19, brand=Pfizer), batch/lot no. and expiration date not provided, via an unspecified route of administration (vaccination location: left arm) on 21Jan2021 09:30 at a single dose for covid-19 immunization. Medical history included sinus tachycardia and Pvc (premature ventricular contractions). He had no allergies to medications, food, or other products. Concomitant medication included atenolol. Historical vaccine included first dose of bnt162b2 (reported as: product=COVID 19, brand=Pfizer) for covid-19 immunization on 31Dec2020 09:15 AM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The most recent COVID-19 vaccine was administered at a hospital. The patient experienced headache 24-36 hours, fever at 36 hours, fatigue, and nausea on 21Jan2021 05:00 PM. No treatment received for the adverse events. All events were assessed as non-serious (did not result to death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, and no congenital anomaly/birth defect). Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Vaccination site pain
Clinical narrative: Injection site very sore; arm swollen; Feverish; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL8982), via an unspecified route of administration in the left arm, on 21Jan2021 at 10:15 (at the age of 65-years-old) at a single dose for COVID-19 immunization. Medical history included atrial fibrillation (AFIB), shellfish allergy, allergy to pain medications, cancer, diabetes, high blood pressure, and COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications, taken within two weeks of vaccination, included amlodipine (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), and esomeprazole magnesium (ESOMEPRA). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced arm swollen and feverish on 21Jan2021 at 19:30 and injection site very sore on 23Jan2021. The events were reported as non-serious. It was reported that the injection site was very sore on the third day. Therapeutic measures were taken as a result of the events, which included paracetamol (TYLENOL) and icing arm. The clinical outcome of injection site very sore, arm swollen, and feverish was not recovered.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache
Clinical narrative: Moderate to Extreme headaches daily since injection; Extreme fatigue/tiredness/Overall feel vary tired; Moderate to Extreme body temperate changes throughout the day; This is a spontaneous report from a contactable healthcare professional (patient). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose via an unspecified route of administration in the right arm on 12Jan2021 at 08:30 at single dose for covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient had no medical history and no concomitant medications. The patient had no allergies to medications, food, or other products. The most recent COVID-19 vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not been tested for COVID-19 since the vaccination. The patient experienced moderate to extreme headaches daily since injection, extreme fatigue/tiredness and moderate to extreme body temperate changes throughout the day on 12Jan2021 at 20:30. Overall feel vary tired along with headaches since the injections. No treatment was received for the adverse events. The events were considered as non-serious as did not results in death, non-Life threatening, did not cause/prolong hospitalization, non-disabling/incapacitating and no congenital anomaly/birth defect. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vaccination site pain, Vomiting
Clinical narrative: Sore at injection site; Severe nausea; vomiting; diarrhea starting 6 hours after injection; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Pfizer brand; lot number: Ek3246), via an unspecified route of administration on 13Jan2021 10:15 on left arm at a single dose for COVID-19 immunization. Medical history included psoriasis, lymphocytic colitis and allergies to pistachios (anaphylaxis). The patient's concomitant medications were not reported. The patient experienced sore at injection site, severe nausea, vomiting and diarrhea starting 6 hours after injection (pending clarification); all on 13Jan2021 14:30 (as reported). Then the same symptoms starting 22Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was at the hospital. The report was non-serious. The outcome of the events was recovered with sequelae.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Discomfort, Fatigue, Headache
Clinical narrative: By 10am the day after vaccine the fever broke and I was just left with fatigue; 10 hours after vaccine I started with a fever that climbed to 103.3F overnight; This was joined by chills; This was joined by chills and body/joint discomfort as well as headache; body/joint discomfort; headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection lot number: EL8982), intramuscular at left arm on 21Jan2021, 08:15 at single dose for COVID-19 immunization. The patient's medical history included hypothyroidism, penicillins allergy and COVID-19 diagnosed on an unspecified date prior to vaccination. The patient's concomitant medications included levothyroxine, minerals nos, vitamins nos (PRENATAL VITAMIN), and riboflavin. The patient was not pregnant at the time of vaccination. The patient previously received the first dose of BNT162B2 (lot number: EK9231) on 30Dec2020, 12:30 PM at left arm for COVID-19 immunization. The patient has not been tested for COVID-19 since vaccination. On 21Jan2021 18:00 (10 hours after vaccine), the patient started with a fever that climbed to 103.3F overnight. This was joined by chills and body/joint discomfort as well as headache. By 10am the day after vaccine (22Jan2021), the fever broke and she was just left with fatigue. No treatment was given for the events. Facility where the most recent COVID-19 vaccine was administered was at the hospital. The outcome of the events were recovering. The events were non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Pyrexia
Clinical narrative: By 10am the day after vaccine the fever broke and I was just left with fatigue; 10 hours after vaccine I started with a fever that climbed to 103.3F overnight; This was joined by chills; This was joined by chills and body/joint discomfort as well as headache; body/joint discomfort; headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection lot number: EL8982), intramuscular at left arm on 21Jan2021, 08:15 at single dose for COVID-19 immunization. The patient's medical history included hypothyroidism, penicillins allergy and COVID-19 diagnosed on an unspecified date prior to vaccination. The patient's concomitant medications included levothyroxine, minerals nos, vitamins nos (PRENATAL VITAMIN), and riboflavin. The patient was not pregnant at the time of vaccination. The patient previously received the first dose of BNT162B2 (lot number: EK9231) on 30Dec2020, 12:30 PM at left arm for COVID-19 immunization. The patient has not been tested for COVID-19 since vaccination. On 21Jan2021 18:00 (10 hours after vaccine), the patient started with a fever that climbed to 103.3F overnight. This was joined by chills and body/joint discomfort as well as headache. By 10am the day after vaccine (22Jan2021), the fever broke and she was just left with fatigue. No treatment was given for the events. Facility where the most recent COVID-19 vaccine was administered was at the hospital. The outcome of the events were recovering. The events were non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vaccination site pain
Clinical narrative: Pain in the arm of the injection; muscle pain; fatigue; This is a spontaneous report from a contactable nurse reporting for herself. A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3249), via an unspecified route of administration on the right arm on 22Jan2021 08:45 am at single dose for COVID-19 immunisation. Medical history included hyperthyroidism, BP elevation, hyperlipidaemia and allergies to chocolate, coconuts, pineapple, and red dye from an unknown date. Patient previously took codeine, statins, Diflucan, and experienced allergies. Concomitant medication included methimazole, dexlansoprazole (DEXILANT), amlodipine, ezetimibe (ZETIA), evolocumab (REPATHA) from unspecified date and indication. On 22Jan2021 at 08:45 pm, it was reported that the patient experienced pain in the arm of the injection, muscle pain, and fatigue. No treatment was received. The events were considered as non-serious and did not resulted in death, life threatening condition, prolonged hospitalization, disability, and congenital anomaly or birth defect. The patient was not diagnosed with COVID-19 prior to the vaccination and has not been tested for COVID-19 since vaccination. No other vaccines were received within the last 4 weeks prior to receiving the COVID-19 vaccination. The patient was reported to be not pregnant at the time of vaccination. The outcome of the events were not recovered.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Area of injection site has become very large, swollen, hot to touch, and firm in the middle; Area of injection site has become very large, swollen, hot to touch, and firm in the middle; Area of injection site has become very large, swollen, hot to touch, and firm in the middle; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 53-year-old female patient received second dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on her left arm on 17Jan2021 12:45 at single dose for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included piroxicam (PAXIL), thyroid (ARMOUR THYROID), both from an unspecified date for unspecified indication. The patient previously took the first dose of bnt162b2 on 27Dec2020 at 01:00 PM on her left arm for covid-19 immunisation. On 17Jan2021 at 14:00, the patient experienced that the area of injection site has become very large, swollen, hot to touch, and firm in the middle. The events were reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.