chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dehydration, Headache, Insomnia
Clinical narrative: fever; she was dehydrated; unable to sleep until 3:30am; Headache; body aches; Chills; Pain / received the vaccine on 18Dec2020, at that time she only had symptoms of pain; This is a spontaneous report from a contactable consumer reporting for herself. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number CJ1685) via an unspecified route of administration on 18Dec2020 at single dose in the right arm for COVID-19 immunization. Medical history included gum surgery on 29Dec2020. Concomitant medication included amoxicillin trihydrate (AMOCILLINE) from 29Dec2020 post gum surgery. The patient received the vaccine on 18Dec2020. At that time she only had symptoms of pain (onset date 19Dec2020). On the night of 04Jan2021, she had chills and needed 3 blankets and 2 robes. Three hours later her chills were gone and she had a temperature of 105 degrees (fever onset date 05Jan2021). She also had a headache (headache onset date 04Jan2021). She took two paracetamol (TYLENOL) and was unable to sleep until 3:30am. She woke at 9am (05Jan2021). She checked her temperature again and it was 99.2. This was after going 12 hours without taking paracetamol. Then she had body aches (body aches onset date 04Jan2021) but no headache. She thought she was dehydrated and she drank some water. Her headache was gone. She was scheduled for the second vaccine on 08Jan2021. She was told that her body would respond stronger and the symptoms be worse since she responded 17 days after getting the vaccine. The event pain (after vaccination, on 19Dec2020) was resolved on 19Dec2020, chills was resolved on 05Jan2021, fever was resolving, headache was resolved on 05Jan2021, body aches was resolved on 05Jan2021. The outcome of "unable to sleep" and "she thought she was dehydrated" was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: fever; she was dehydrated; unable to sleep until 3:30am; Headache; body aches; Chills; Pain / received the vaccine on 18Dec2020, at that time she only had symptoms of pain; This is a spontaneous report from a contactable consumer reporting for herself. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number CJ1685) via an unspecified route of administration on 18Dec2020 at single dose in the right arm for COVID-19 immunization. Medical history included gum surgery on 29Dec2020. Concomitant medication included amoxicillin trihydrate (AMOCILLINE) from 29Dec2020 post gum surgery. The patient received the vaccine on 18Dec2020. At that time she only had symptoms of pain (onset date 19Dec2020). On the night of 04Jan2021, she had chills and needed 3 blankets and 2 robes. Three hours later her chills were gone and she had a temperature of 105 degrees (fever onset date 05Jan2021). She also had a headache (headache onset date 04Jan2021). She took two paracetamol (TYLENOL) and was unable to sleep until 3:30am. She woke at 9am (05Jan2021). She checked her temperature again and it was 99.2. This was after going 12 hours without taking paracetamol. Then she had body aches (body aches onset date 04Jan2021) but no headache. She thought she was dehydrated and she drank some water. Her headache was gone. She was scheduled for the second vaccine on 08Jan2021. She was told that her body would respond stronger and the symptoms be worse since she responded 17 days after getting the vaccine. The event pain (after vaccination, on 19Dec2020) was resolved on 19Dec2020, chills was resolved on 05Jan2021, fever was resolving, headache was resolved on 05Jan2021, body aches was resolved on 05Jan2021. The outcome of "unable to sleep" and "she thought she was dehydrated" was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Influenza like illness, Pyrexia, Swelling
Clinical narrative: swelling; Flu like symptoms; low grade fever; headache; joint pain; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for herself.  A 64-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not provided) intramuscularly in the left arm on 18Dec2020 at 12:00 am, and the second single dose intramuscularly in the left arm on 04Jan2021 at 12:00 pm (as reported), for COVID-19 vaccination. Medical history included osteoarthritis from an unknown date and unspecified if ongoing. No unknown allergies. Concomitant medication included levothyroxine sodium (SYNTHROID), hydroxychloroquine, progesterone, colecalciferol (VITAMIN D), calcium, magnesium. No other vaccine received in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced flu like symptoms, low grade fever, headache, joint pain and swelling on 05Jan2021 at 01:00 am. The events were non-serious. The patient received paracetamol (TYLENOL) and ibuprofen for the events. The patient was recovering from the events.  Information on Lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Nausea, Vaccination site pain, Vomiting
Clinical narrative: Arm soreness / soreness in the arm and shoulder; Arm soreness / soreness in the arm and shoulder; Emesis; Nausea; This is a spontaneous report from a contactable nurse. This nurse reported different events for 6 patients. This is the sixth of the six reports.  A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not provided) via an unspecified route of administration on 29Dec2020 at a single does in the left arm for COVID-19 immunization. Medical history included dementia from 10Mar2020 and ongoing. The patient's concomitant medications were not reported. The patient experienced arm soreness (soreness in the arm and shoulder), emesis and nausea on 01Jan2021. The patient received paracetamol (TYLENOL) for the soreness, nothing for the emesis and nausea. The events were all resolved on 01Jan2021.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021006274 same reporter/ drug , different patient /AE.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Hyperhidrosis, Malaise, Nausea
Clinical narrative: very dizzy/ felt like her Blood pressure dropped/she felt like she was going to faint; she felt really really sick/ didn't feel good/felt very bad; Sweating; Nauseous; loose stool; her injection site had a lump and was red; a little pain in her arm/ it was just a little sore; her injection site had a lump and was red; This is a spontaneous report from a contactable consumer reporting for herself.  A 60-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not provided) via an unspecified route of administration on 29Dec2020 11:30 at single dose in the arm for COVID-19 immunization. There were no relevant medical history and no concomitant medications. The patient received the vaccine 29Dec2020 at 11:30 am. She went to work at 11 at night and only had a little pain in her arm. At 4 am on 30Dec2020, she felt really sick. She felt like her blood pressure dropped. She was very dizzy. She was scared. She didn't feel good. She felt like she was going to faint and was sweating. She was going to try to finish her work and go home. She went to the house, and was very sick. She got into bed because she believed she needed rest. At 3 pm on 30Dec2020, nothing was wrong. She was going to rest more. That night time on 30Dec2020, she felt better. She had also got nauseous. She stated the symptoms only lasted a day, and also said the side effects only lasted from 4 o'clock to 8 o'clock when she got home. She did go to the bathroom and experienced loose stool. She felt very bad when she laid down in bed. By 10 o'clock pm (30Dec2020) she felt better. The patient said she had no problem moving her arm as it was just a little sore. When she got home from work her husband noticed her injection site had a lump and was red. Her arm recovered in a week's time. The patient stated she would go for her second shot on 13Jan2021. The symptoms which started on 30Dec2020 04:00 (dizzy/felt like her blood pressure dropped/she felt like she was going to faint, feeling sick/bad, sweating, nauseous, loose stool) were resolved on 30Dec2020. The events pain in her arm and injection site lump and red were resolved on an unspecified date in Jan2021.   Information about lot and batch number was requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Weight
Clinical narrative: very dizzy/ felt like her Blood pressure dropped/she felt like she was going to faint; she felt really really sick/ didn't feel good/felt very bad; Sweating; Nauseous; loose stool; her injection site had a lump and was red; a little pain in her arm/ it was just a little sore; her injection site had a lump and was red; This is a spontaneous report from a contactable consumer reporting for herself.  A 60-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not provided) via an unspecified route of administration on 29Dec2020 11:30 at single dose in the arm for COVID-19 immunization. There were no relevant medical history and no concomitant medications. The patient received the vaccine 29Dec2020 at 11:30 am. She went to work at 11 at night and only had a little pain in her arm. At 4 am on 30Dec2020, she felt really sick. She felt like her blood pressure dropped. She was very dizzy. She was scared. She didn't feel good. She felt like she was going to faint and was sweating. She was going to try to finish her work and go home. She went to the house, and was very sick. She got into bed because she believed she needed rest. At 3 pm on 30Dec2020, nothing was wrong. She was going to rest more. That night time on 30Dec2020, she felt better. She had also got nauseous. She stated the symptoms only lasted a day, and also said the side effects only lasted from 4 o'clock to 8 o'clock when she got home. She did go to the bathroom and experienced loose stool. She felt very bad when she laid down in bed. By 10 o'clock pm (30Dec2020) she felt better. The patient said she had no problem moving her arm as it was just a little sore. When she got home from work her husband noticed her injection site had a lump and was red. Her arm recovered in a week's time. The patient stated she would go for her second shot on 13Jan2021. The symptoms which started on 30Dec2020 04:00 (dizzy/felt like her blood pressure dropped/she felt like she was going to faint, feeling sick/bad, sweating, nauseous, loose stool) were resolved on 30Dec2020. The events pain in her arm and injection site lump and red were resolved on an unspecified date in Jan2021.   Information about lot and batch number was requested.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable other HCP via a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A patient of unspecified age and gender started to receive BNT162B2, via an unspecified route of administration from 23Dec2020 to 23Dec2020 at first single dose for COIVD-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Pharmacy student on the line who had patient who received the first dose of the COVID vaccine shot on 23Dec2020. Then the patient went home on Christmas break and later tested positive for COVID on 29Dec2020. She was calling to see how to proceed with the second dosage. Outcome of the event was unknown.  information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive for corona virus infection based on the known safety profile. However given the short duration of 6 days since the vaccine first dose, it is unlikely patient would have fully developed immunity.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable nurse. This nurse reported similar event for six patients. This is 5th out of six reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 29Dec2020 at single dose for an COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient worked in a healthcare facility and had not had COVID. The patient experienced headache on 04Jan2021 with outcome of not recovered. Treatment: none. Drug result: related.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021006274 same reporter/ drug , different patient /AE.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: nausea; chills; Headache; This is a spontaneous report from a non-contactable Other healthcare professional. A 38-year-old female (not pregnant) patient received BNT162B2 on 22Dec2020 10:00 AM intramuscular Right arm at singe dose for COVID-19 immunization. Medical history and concomitant medications were not reported. No Known allergies. Facility type vaccine was Hospital. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Patient had headache, nausea and chills on 24Dec2020. No treatment received. The outcome of the events was recovered. The seriousness was reported as no.   No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain in extremity
Clinical narrative: Malaise and extreme tiredness; Malaise and extreme tiredness; Arm soreness; This is a spontaneous report from a contactable Nurse. This Nurse reported events for 6 patients. This is a 1st of 6 reports.   A 59-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on 29Dec2020 at single dose, once by injection in the right arm, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm soreness on 30Dec2020 that lasted a few hours, malaise and extreme tiredness on 05Jan2021. Therapeutic measures were taken as a result of arm soreness included Tylenol. The patient worked in a healthcare facility and had not had COVID. The outcome of event arm soreness was recovered on 30Dec2020, and of malaise and extreme tiredness was not recovered. Reporter seriousness for arm soreness, malaise and extreme tiredness was non-serious. The reporter considered the events arm soreness, malaise and extreme tiredness were related to COVID Vaccine.  Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021006243 same reporter/ drug , different patient /AE.;US-PFIZER INC-2021006329 same reporter/ drug , different patient /AE.;US-PFIZER INC-2021006376 same reporter/ drug , different patient /AE.;US-PFIZER INC-2021006151 same reporter/ drug , different patient /AE.;US-PFIZER INC-2021005968 same reporter/ drug , different patient /AE.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Rash pruritic
Clinical narrative: moderately itchy rash on chest and burning ears about 1 hour after the vaccine. progressed to mild diffuse itching which slowly subsided over the few hours; moderately itchy rash on chest and burning ears about 1 hour after the vaccine. progressed to mild diffuse itching which slowly subsided over the few hours; This is a spontaneous report from a contactable physician (patient). A 36-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231) on 05Jan2021 06:15 PM, Intramuscularly at single dose (vaccine location: Left arm) (first dose) for COVID-19 immunization. Medical history included cellulitis of lips due to use of 5 fu (stopped 1 week prior) for actinic keratosis. Concomitant medications included sulfamethoxazole, trimethoprim (BACTRIM) from 05Jan2021; amoxicillin, clavulanic acid (AUGMENTIN) from 05Jan2021; bupropion hydrochloride (WELLBUTRIN); escitalopram oxalate (LEXAPRO); magnesium; famotidine (PEPCID); ergocalciferol (VIT D); ascorbic acid (VIT C). There were no Known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient experienced moderately itchy rash on chest and burning ears about 1 hour after the vaccine on 05Jan2021 07:30 PM, progressed to mild diffuse itching which slowly subsided over the few hours. Patient did not receive any treatment. The outcome of the events was recovering. This case was assessed non-serious by reporter. The events did not result in Death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: Headache; General not feeling well; This is a spontaneous report from a contactable nurse. This nurse reported similar events 6 patients. This is 4th of 6 reports. A 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration in the left arm on 29Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. It was reported the patient had headache and general not feeling well. Patient received the vaccine on 29Dec2020. This patient started to experience these symptoms today (05Jan2021). Reporter talked to this patient earlier he said he had taken Tylenol and she has not heard from him since. Treatment included took Tylenol. Patient was not recovered from the events. The reporter considered the events Headache and General not feeling well was related to the drug.  Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021006274 same reporter/ drug , different patient /AE.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nasopharyngitis
Clinical narrative: very mild cold like symptoms; chills; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for 2 patients. This is 2nd of two reports.   A male patient (mid 40s) received 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's medical history and concomitant medications were not reported. The patient experienced 14 days after injection very mild cold like symptoms, chills, nasal congestion no congestion. The patient had not being tested for COVID. The pharmacist was not entirely sure if they were related to the vaccine. Wanted to know if there was any data on delayed onset side effects. The outcome of the events was not reported. Serious criteria for this case was no.  Information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021005612 same reporter/drug, different patient
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Another lady said she was sick; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on unspecified date at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were not reported. It was stated that another lady (patient) said she was sick. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal
Clinical narrative: Joint pain; brain fog; This is a spontaneous report from a contactable Nurse (patient). A 54-year-old female patient (not pregnant) received BNT162B2 (Pfizer, lot number: EL0140) first dose on 29Dec2020 10:45 via intramuscular on right arm at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications in two weeks included dexlansoprazole (DEXILANT) and escitalopram oxalate (LEXAPRO). The patient had allergies to Erythromycin. No other vaccine in four weeks. Facility type vaccine was Hospital. Patient had Joint pain and Brain Fog on 31Dec2020 01:15 PM. No treatment. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the event was not recovered. The serious was reported as no.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain in extremity, Sluggishness, Vaccination site pain
Clinical narrative: Soreness at injection site and entire upper arm; Soreness at injection site and entire upper arm; Headache; Feeling sluggish and unwell; Feeling sluggish and unwell; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at right arm on 28Dec2020 10:00 at single dose for COVID-19 immunization. Medical history included none. No known allergies. Concomitant medication included Alive multivitamin which received within 2 weeks of vaccination. The patient experienced soreness at injection site and entire upper arm, headache, feeling sluggish and unwell, all on 28Dec2020 16:00. No treatment received. The most recent COVID-19 vaccine was administered at hospital. 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. This is a non-serious report. The outcome of the events was recovered on an unspecified date.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: fatigue; headache; This is a spontaneous report from a contactable consumer via Pfizer Sales Representative. A elderly patient (reported as over 80 years) of an unspecified gender received BNT162b2 (Lot/batch number and Expiration date were not provided), 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 experienced fatigue, headache on an unspecified date with outcome of unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This is spontaneous report from a contactable consume via Pfizer Sales Representative. This consumer reported similar events for 2 patients. This is a second of two reports. A 9-decade-patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown), via an unspecified route of administration on an unknown date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fatigue after use of vaccine. The outcome of the event was unknown.  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: Blood test abnormal, Cardiac monitoring, Chest X-ray, Echocardiogram normal, Electrocardiogram
Clinical narrative: Tachycardia on 4th day after vaccine, the onset started in the morning while at rest, heart rate returned to normalcy after an hour but had intermittent episodes of tachycardia.  I went to the ER on 12/30/2020 due to continued tachycardia.  An EKG, chest xray, and blood was drawn, which showed slightly elevated troponin, stayed most of the night in the EC with second lab draws. I was given a prescription of metropolol 12mg to be taken twice a day for 14 days.  Went to see a cardiologist on 1/05/2021, another EKG was preformed along with an ECHO which was normal but was placed on a heart monitor to be observed for 30 days
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Troponin increased
Clinical narrative: Tachycardia on 4th day after vaccine, the onset started in the morning while at rest, heart rate returned to normalcy after an hour but had intermittent episodes of tachycardia.  I went to the ER on 12/30/2020 due to continued tachycardia.  An EKG, chest xray, and blood was drawn, which showed slightly elevated troponin, stayed most of the night in the EC with second lab draws. I was given a prescription of metropolol 12mg to be taken twice a day for 14 days.  Went to see a cardiologist on 1/05/2021, another EKG was preformed along with an ECHO which was normal but was placed on a heart monitor to be observed for 30 days
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flushing, Palpitations, Tachycardia
Clinical narrative: Tachycardia; Palpitation; Full body flush; Full body feeling hot; This is a spontaneous report from a non-contactable nurse. A female patient of an unspecified age received 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's medical history and concomitant medications were not reported. Caller stated, "So, she said that this person, (Name) had the same effect that she had and I already reported her side effects and basically they had the full body flush with the tachycardia, palpitations and it lasted for about 5 minutes and then went away. It said, it felt like a full body flush and she said it reminds me when you get those IVs that make your full body feeling hot, so she said it's full body flush, tachycardia, palpitation and then after 5 minutes, it went away and they were all fine." The outcome of events was recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Vaccination site pain
Clinical narrative: Mild nausea shortly after injection; Injection site soreness beginning in the afternoon of that day, continuing for days; Fatigue; This is a spontaneous report from a non-contactable other HCP.  A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 12:30 at single dose for COVID-19 immunization. Medical history included endometriosis. There were no concomitant medications. The patient experienced Mild nausea shortly after injection. Injection site soreness beginning in the afternoon of that day, continuing for days and Fatigue on 04Jan2021 12:45.  Patient has not been diagnosed with COVID-19 prior to vaccination. Patient has not tested for coronavirus disease (COVID-19) since having the vaccine. Outcome of events was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: I received the vaccine on 1/7/21 and the next morning (1/8/21) I woke up with a fever of 100.5, a headache, and nausea.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fatigue; fever; chills; body aches; headache; This is spontaneous report from a contactable other hcp (patient). A 40-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) intramuscularly at right arm on 29Dec2020 11:45 at single dose for COVID-19 immunization. Medical history included anxiety/depression-mild, known allergies to penicillin (PCN), patient was diagnosis (dx) with Covid 19 on 20Nov2020. Concomitant medication included duloxetine, hydrochlorothiazide, triamterene (TRIAMTERENE AND HYDROCHLOROTHIAZID), colecalciferol (VITAMIN D), paracetamol (TYLENOL) and MV, all received within 2 weeks of vaccination. The patient experienced fatigue, fever, chills, body aches, headache that lasted about 24 hours, all started from 29Dec2020 11:45. Then continued fatigue and mild body aches since then. No treatment received. This is a non-serious report. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Chest pain, Cough, Dyspnoea, Electrocardiogram normal
Clinical narrative: Shortness of breath, coughing, some deep chest soreness.  Worse when laying down in any position. Began using Albuterol this morning (approx 3 hours ago) with no change in symptoms.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza virus test negative, Pain, SARS-CoV-2 test negative, X-ray normal
Clinical narrative: Shortness of breath, coughing, some deep chest soreness.  Worse when laying down in any position. Began using Albuterol this morning (approx 3 hours ago) with no change in symptoms.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pityriasis rosea, Rash
Clinical narrative: Patient developed a rash within 24 hours of vaccine administration.  It gradually spread from abdomen to the rest of her trunk, arms, and thighs.  It spared her face and neck, hands and feet.  I made the clinical diagnosis of pityriasis rosea.  Treatment is topical anti-itch medications only.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: C/O:  DIZZINESS.   1140:  VS:  184/98, P: 92; 02 SAT:  RA:  98%; 1152:  VS:  167/88, P:  70; 02 SAT:  RA:  98%
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Diarrhoea, Fatigue, Pain, Pain in extremity
Clinical narrative: chest tightness arm pain nausea diarrhea body aches fatigue  lost work two days
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills; body aches; high fever; This is a spontaneous report from a contactable other HCP (patient). A 45-year-old male patient received first dose of BNT162b2 (Lot number: EL0140), via an unspecified route of administration at left arm on 03Jan2021 20:00 at single dose for covid-19 immunization.  Medical history included Sleep apnoea. Concomitant medication included ramipril. The patient experienced Chills, body aches, high fever within 23 hours of vaccine administration on 04Jan2021 19:00. No treatment received. The outcome of the events was recovering.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: 01/06/2021 developed a rash, redness, itching and is warm to touch at the injection site.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Vaccination site pain
Clinical narrative: Muscle aches; joint pain; injection site pain; This is a spontaneous report from a non-contactable nurse reported for herself. A 31-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231 and expiration date unknown), via an unspecified route of administration on left arm 05:30 PM on 04Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications include escitalopram oxalate (LEXAPRO), bupropion hydrochloride (WELLBUTRIN). The patient previously took the first dose of bnt162b2 (lot number: EH9899) via an unspecified route of administration on arm left on 14Dec2020 at single dose for covid-19 immunisation. The patient experienced muscle aches, joint pain, injection site pain on 05Jan2021 04:00 AM after the second vaccine administrated, with outcome recovered. The patient received treatment for the events with Ibuprofen.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Chills, Full blood count, Headache, Metabolic function test
Clinical narrative: I saw patient on 1/6/2021 for a possible vaccine reaction. She had her vaccine on Dec 31 and had arm soreness. On the evening of 1/5/2021 she had headache, chills, and during the night sweating. She woke on 1/6/2021 with itching on wrists with a red raised rash and then noted it was also on her hips when she took a shower. In office on 1/6/2021 she had erythema on wrists (she had applied Kenalog cream and states that it was no longer raised after application of the cream) and she had small dime to quarter sized hives on bilateral hips. My colleagues and I researched and found that people can get a serum illness with any vaccine so we checked labs and a UA ? it was all normal but a little protein in her UA. I spoke with patient on 1/7/2021 and she stated that her hives had spread over her buttocks the evening of 1/6/2021 but had resolved by the time she woke on 1/7/2021 and she was not having any current symptoms yesterday late afternoon when I spoke with her. She feels sluggish on 1/8/2021 but overall feels okay. No more rash. We discussed that she can return to her next shift on Monday 1/11/2021 unless she notes any other symptoms / return of symptoms she will let us know.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pain in extremity, Protein urine present, Pruritus, Rash erythematous
Clinical narrative: I saw patient on 1/6/2021 for a possible vaccine reaction. She had her vaccine on Dec 31 and had arm soreness. On the evening of 1/5/2021 she had headache, chills, and during the night sweating. She woke on 1/6/2021 with itching on wrists with a red raised rash and then noted it was also on her hips when she took a shower. In office on 1/6/2021 she had erythema on wrists (she had applied Kenalog cream and states that it was no longer raised after application of the cream) and she had small dime to quarter sized hives on bilateral hips. My colleagues and I researched and found that people can get a serum illness with any vaccine so we checked labs and a UA ? it was all normal but a little protein in her UA. I spoke with patient on 1/7/2021 and she stated that her hives had spread over her buttocks the evening of 1/6/2021 but had resolved by the time she woke on 1/7/2021 and she was not having any current symptoms yesterday late afternoon when I spoke with her. She feels sluggish on 1/8/2021 but overall feels okay. No more rash. We discussed that she can return to her next shift on Monday 1/11/2021 unless she notes any other symptoms / return of symptoms she will let us know.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Red blood cell sedimentation rate, Urine analysis, Urticaria
Clinical narrative: I saw patient on 1/6/2021 for a possible vaccine reaction. She had her vaccine on Dec 31 and had arm soreness. On the evening of 1/5/2021 she had headache, chills, and during the night sweating. She woke on 1/6/2021 with itching on wrists with a red raised rash and then noted it was also on her hips when she took a shower. In office on 1/6/2021 she had erythema on wrists (she had applied Kenalog cream and states that it was no longer raised after application of the cream) and she had small dime to quarter sized hives on bilateral hips. My colleagues and I researched and found that people can get a serum illness with any vaccine so we checked labs and a UA ? it was all normal but a little protein in her UA. I spoke with patient on 1/7/2021 and she stated that her hives had spread over her buttocks the evening of 1/6/2021 but had resolved by the time she woke on 1/7/2021 and she was not having any current symptoms yesterday late afternoon when I spoke with her. She feels sluggish on 1/8/2021 but overall feels okay. No more rash. We discussed that she can return to her next shift on Monday 1/11/2021 unless she notes any other symptoms / return of symptoms she will let us know.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I tested positive for COVID-19; I tested positive for COVID-19; This is a spontaneous report from a contactable nurse. A 29-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular in left arm on 17Dec2020 19:45 at single dose for covid-19 immunisation. Medical history was not reported. There were no concomitant medications. The patient tested positive for COVID-19 on 03Jan2021. Outcome of event was recovering. Patient has not been diagnosed with COVID-19 prior to vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Feeling abnormal, Headache
Clinical narrative: I was like tired; Headaches which comes and goes; Straight at 99.5 and it went to 99.9; Joint Pain from head to toe; Foggy/ Weird feeling/ Back of my neck, upper-lower back my elbow it was just like my legs which is just in a lot of joint pain/ just didn't feel quite like myself; t was all expected the painful site; This is a spontaneous report from a contactable Nurse (patient). The 59-years-old female patient received first of bnt162b2 (BNT162B2, lot nunber: EH9899), unknown on an unknown date in Dec2020 at SINGLE DOSE on Left Deltoid for covid-19 immunisation. Medical history included Patient History: No. The patient's concomitant medications were not reported. It was reported "I had this vaccine, my dad gave it to me Thursday about noon and last night I became very symptomatic, I am feeling a little better today and it said to report the symptom, I mean it was all expected the painful site but I feel very fatigue I mean I was like tired, headaches which comes and goes through on 01JAN2021 and not sure I don't normally have unless it's my sinuses so this is the headache I believe the Tylenol didn't do anything for it (Further clarification was unknown) and I have been taking Tylenol and Ibuprofen, a fever I experienced last night went from straight at 99.5 and it went to 99.9 just kind feel foggy, it was just a weird feeling I experienced, Joint Pain from head to toe, I mean back of my neck, upper-lower back my elbow it was just like my legs which is just in a lot of joint pain and just didn't feel quite like myself I guess pretty much just to say. I was due to get it the 2nd one on the 19th and I was told you may have more symptoms with that one, is that correct?" The patient took Tylenol and Ibuprofen for joint pain and fever. The outcome of the events was unknown.  No follow-up attempts are needed..
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: I was like tired; Headaches which comes and goes; Straight at 99.5 and it went to 99.9; Joint Pain from head to toe; Foggy/ Weird feeling/ Back of my neck, upper-lower back my elbow it was just like my legs which is just in a lot of joint pain/ just didn't feel quite like myself; t was all expected the painful site; This is a spontaneous report from a contactable Nurse (patient). The 59-years-old female patient received first of bnt162b2 (BNT162B2, lot nunber: EH9899), unknown on an unknown date in Dec2020 at SINGLE DOSE on Left Deltoid for covid-19 immunisation. Medical history included Patient History: No. The patient's concomitant medications were not reported. It was reported "I had this vaccine, my dad gave it to me Thursday about noon and last night I became very symptomatic, I am feeling a little better today and it said to report the symptom, I mean it was all expected the painful site but I feel very fatigue I mean I was like tired, headaches which comes and goes through on 01JAN2021 and not sure I don't normally have unless it's my sinuses so this is the headache I believe the Tylenol didn't do anything for it (Further clarification was unknown) and I have been taking Tylenol and Ibuprofen, a fever I experienced last night went from straight at 99.5 and it went to 99.9 just kind feel foggy, it was just a weird feeling I experienced, Joint Pain from head to toe, I mean back of my neck, upper-lower back my elbow it was just like my legs which is just in a lot of joint pain and just didn't feel quite like myself I guess pretty much just to say. I was due to get it the 2nd one on the 19th and I was told you may have more symptoms with that one, is that correct?" The patient took Tylenol and Ibuprofen for joint pain and fever. The outcome of the events was unknown.  No follow-up attempts are needed..
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperthermia, Pyrexia, Tachycardia, Vaccination site pain
Clinical narrative: injection site soreness; chills; fever; hyperthermia; tachycardia; This is a spontaneous report from a non-contactable other HCP. A 25-year-old male patient received the first dose of BNT162b2 (lot number: ELI284), intramuscular at left arm on 04Jan2021 11:00 at single dose for covid-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient experienced injection site soreness several hours following administration. Approximately 12 hrs later, patient experienced severe chills and fever lasting for several hours, followed by several hours of hyperthermia and tachycardia. The all events were reported from 04Jan2021 23:00. No treatment received. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Agitation, Fatigue, Gastrooesophageal reflux disease, Haematochezia, Mucous stools
Clinical narrative: 2 incidents with a temporal relationship to rotavirus Rotateq vaccine; at 2 months and 4 months of age.  Patient received 1st dose of Rotateq 11/9/20.   Had blood and mucous in stool 3x on 11/11/20 within 24 hr period; resolved.  Reveived 2nd dose of Rotateq on 1/6/21,  Starting 1/7/21 patient had episodic periods of pain and fussiness with exhaustion.  Would suddenly fall asleep and arouse again as fussy.  Atypical spit up for this patient occurred.  Pt was seen and imaged at urgent care and discharged home.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Narcolepsy, Pain, Ultrasound abdomen normal, X-ray gastrointestinal tract abnormal
Clinical narrative: 2 incidents with a temporal relationship to rotavirus Rotateq vaccine; at 2 months and 4 months of age.  Patient received 1st dose of Rotateq 11/9/20.   Had blood and mucous in stool 3x on 11/11/20 within 24 hr period; resolved.  Reveived 2nd dose of Rotateq on 1/6/21,  Starting 1/7/21 patient had episodic periods of pain and fussiness with exhaustion.  Would suddenly fall asleep and arouse again as fussy.  Atypical spit up for this patient occurred.  Pt was seen and imaged at urgent care and discharged home.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Limb discomfort, Vaccination site pain
Clinical narrative: heaviness in the arm at the injection site/ left arm is in pain; heaviness in the arm at the injection site/ left arm is in pain; This is a spontaneous report from a contactable nurse reported for herself. A 34-year-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK9230 and expiration date: Apr2021), via an unspecified route of administration on left arm on 04Jan2021 at 7:40am at single dose for covid-19 immunisation. The patient medical history included food allergy from 29Jan2020 and ongoing, reported as allergic to avocado, banana, beef, cantaloupe, cashews, chicken, coconut, coffee mix, corn, cucumber, egg, fish mix, green pea, milk, onion, olive, peach, pecan, potato, rice, shrimp, strawberry, watermelon. The patient concomitant medications reported as none. The patient is a registered nurse reporting she got her Pfizer Covid vaccine shot yesterday 04Jan2021 at 7:40 am, she had heaviness in the arm at the injection site on 04Jan2021, clarifies her left arm, she already took Tylenol yesterday. When she woke up this morning, left arm is in pain, the pain will not go away it has been 24 hours. She took her temperature and it is 98.1 F. She does have a lot of food allergies. She attempted to treat the arm pain with acetaminophen, 500mg (expiration Dec2022, purhased from store, Manufacturer is unknown, states it is the generic, LOT P142171). The reporter considered the event as non serious. The outcome of the event was not recovered.  .
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Nausea
Clinical narrative: Joints and muscle aches; Joints and muscle aches; nausea; This is a spontaneous report from a contactable nurse. A 58-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in arm right on 21Dec2020 10:00 at single dose for covid-19 immunisation. Medical history included allergies to dust, grass, and some weeds. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), estradiol, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), zinc. The patient experienced Joints and muscle aches for 15 days so far, nausea mainly in the mornings for 10 days on 23Dec2020 06:00. Outcome of events was not recovered. Patient has not been diagnosed with COVID-19 prior to vaccination. Patient has not tested for coronavirus disease (COVID-19) since having the vaccine.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Local reaction
Clinical narrative: localized allergic rxn 9 days after the shot.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Fatigue; achy; chills; This is a spontaneous report from a contactable other hcp (patient). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly at left arm on 04Jan2021 14:30 at single dose for COVID-19 immunization. Medical history included known allergies to shellfish. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 for COVID-19 immunization. The patient experienced fatigue, achy, chills, all on 05Jan2021 01:15. No treatment received for the adverse events. This a non-serious report. 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 outcome of the events was recovered in Jan2021.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash papular
Clinical narrative: Red bumps and itching to arms, legs and belly; Red bumps and itching to arms, legs and belly; This is a spontaneous report from a non-contactable Other HCP (patient). A 40-year-old female patient received the first dose of BNT162b2 (Lot number: EL1284), via an unspecified route of administration at left arm on 05Jan2021 12:00 at single dose for covid-19 immunization. Medical history included Allergies to medications, food, or other products (unspecified allergies). The patient's concomitant medications were not reported. The patient experienced red bumps and itching to arms, legs and belly at 12:30 on 05Jan2021. The patient received the Benadryl as treatment. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Nausea, Pain, Pain in extremity
Clinical narrative: fever 101, arm soreness, body aches, fatigue, nausea, congestion and dry cough
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: fever 101, arm soreness, body aches, fatigue, nausea, congestion and dry cough