chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate increased, Hypoaesthesia oral, Paraesthesia oral, Thinking abnormal
Clinical narrative: she is not thinking straight; she is able to hear her heartbeat in her ears; having a ringing in her ears; feel tingling, numbness on her tongue, lips and roof of her mouth; feel tingling, numbness on her tongue, lips and roof of her mouth; feel tingling, numbness on her tongue, lips and roof of her mouth; feel tingling, numbness on her tongue, lips and roof of her mouth; She feels fuzzy in her head; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection lot no: EN5318), intramuscular injection in left arm on 01 Feb 2021 for covid-19 immunisation. the patients' medical history included ongoing high blood pressure and High cholesterol. The patient's historic vaccine included Shingrix for shingles on unspecified date in 2020. The patients Concomitant medication included Amlodipine 5mg tablet once a day orally, Hydrochlorothiazide 12.5mg tablet once a orally, Olmesartan 40mg tablet once a day orally, Meloxicam 7.5mg small tablet orally, three times a week, Preservision Eye Vitamin one soft gel capsule by orally, probiotic two gummies once a day orally, apple cider vinegar gummy two gummies once a day orally  for Cholesterol, Citracal + D, calcium and vitamin d supplementation two tablets twice a day orally. on 01 Feb 2021, the patient experienced tingling/ numbness on tongue, lips, and roof of her mouth, felt fuzzy in her head. On 03Feb2021, she experienced Ringing in ears. The outcome of events was not recovered.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: she is not thinking straight; she is able to hear her heartbeat in her ears; having a ringing in her ears; feel tingling, numbness on her tongue, lips and roof of her mouth; feel tingling, numbness on her tongue, lips and roof of her mouth; feel tingling, numbness on her tongue, lips and roof of her mouth; feel tingling, numbness on her tongue, lips and roof of her mouth; She feels fuzzy in her head; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection lot no: EN5318), intramuscular injection in left arm on 01 Feb 2021 for covid-19 immunisation. the patients' medical history included ongoing high blood pressure and High cholesterol. The patient's historic vaccine included Shingrix for shingles on unspecified date in 2020. The patients Concomitant medication included Amlodipine 5mg tablet once a day orally, Hydrochlorothiazide 12.5mg tablet once a orally, Olmesartan 40mg tablet once a day orally, Meloxicam 7.5mg small tablet orally, three times a week, Preservision Eye Vitamin one soft gel capsule by orally, probiotic two gummies once a day orally, apple cider vinegar gummy two gummies once a day orally  for Cholesterol, Citracal + D, calcium and vitamin d supplementation two tablets twice a day orally. on 01 Feb 2021, the patient experienced tingling/ numbness on tongue, lips, and roof of her mouth, felt fuzzy in her head. On 03Feb2021, she experienced Ringing in ears. The outcome of events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: The patient got covid after both shots; The patient got covid after both shots; This is a spontaneous report from a contactable consumer. This consumer reported for a patient that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: Unknown, Expiration date : Unknown) via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical Vaccine reported as BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 Immunization. The report received as, caller states that the patient got covid after both shots. The patient underwent lab tests and procedures which included Covid-19: got covid after both shots (the patient got covid after both shots) on an unknown date. Outcome of the event was unknown.  Information on lot number/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Malaise, Oropharyngeal pain
Clinical narrative: right side sore throat on 02Feb2021 for 2 days and still slightly painful; Feeling unwell; I had the flu for 2 days on 28Jan2021; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL1283) via an unspecified route of administration in the let arm on 25Jan2021 13:00 (at the age of 76-year-old) , single for COVID-19 immunisation. The patient relevant medical history included mitral valve prolapse, Allergies to medications, food, or other products: Codeine, Dexamethasone, Keflet, Paxil, Sulfa Class, Tetracycline. Concomitant medications included propranolol hydrochloride (INDERAL); estrogens conjugated (PREMARIN); lisinopril (LISINOPRIL); digoxin (DIGOXIN) all were taken for an unspecified indication, start and stop date were not reported. Feeling unwell like I had the flu for 2 days on 28Jan2021 12:00 AM and right side sore throat on 02Feb2021 for 2 days and still slightly painful. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and Since the vaccination, patient not been tested for COVID-19. Outcome of the event right side sore throat on 02Feb2021 for 2 days and still slightly painful was recovering and Outcome of the other events was recovered on unspecified date in 2021.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.) The Caller got the first dose on 22Jan and tested positive/ Stated that she tested positive for Covid on last Sunday 31Jan; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, Expiry Date: unknown) via an unspecified route of administration on 22Jan2021 at the age of 51 years old at a single dose for COVID 19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient stated that she had her first shot of Pfizer on 22Jan2021 and is scheduled for the next one on 11Feb2021. She stated that she tested positive for Covid on last Sunday 31Jan2021 and she will be out of isolation on Tuesday 09Feb2021. She does not know if she will be able to get the second shot or not. Clarified that it is for Pfizer Covid shot. Stated that she tested positive after receiving the shot is her first dose. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she got first dose of vaccine on 11Jan2021/did a Covid test last Friday, 29Jan2021, states she was positive for Covid; she got first dose of vaccine on 11Jan2021/did a Covid test last Friday, 29Jan2021, states she was positive for Covid; This is a spontaneous report from a contactable consumer reporting for herself.  A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number EL1283), via an unspecified route of administration in right arm on 11Jan2021 (at the age of vaccination of 77-year- old) at single dose for COVID-19 immunization. Medical history included diabetes (controlled, diagnosed about 8 years ago). No concomitant medication was reported. Patient reported that she has not taken any medicine only a little Tylenol if she has a little headache or something. Patient informed that, after receiving the vaccine her daughter visited her a week later for 30 minutes and then told her she tested positive for COVID 19. On 29Jan2021, patient got tested for COVID 19 and she too was positive for COVID 19. She had no symptoms of COVID 19 and was told to quarantine for 10-12 days. She is scheduled for second dose of vaccine on Tuesday and would like to know if she should receive second dose of vaccine on Tuesday. Outcome of events was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nasopharyngitis, Oropharyngeal pain, Pain
Clinical narrative: Cold like symptoms; chills; tiredness; sleepiness; runny nose; sore/red throat; sore/red throat; complete body ache and pain during night but was gone the next morning; This is a spontaneous report from a contactable Other HCP (patient). A 75-year-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3249) via unspecified route of administration in left arm on 19Jan2021, at 15:00 (at the age of 75-year-old) as a single dose for COVID-19 immunisation. The patient medical history included vertigo, mild heart attack and glaucoma. 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 concomitant medication included glaucoma eye drops, dorzolamide and latanoprost. The patient didn't receive any vaccine within four weeks prior to vaccination. The patient previously took Fosamax and experienced light headedness (after 2 years). On an unknown date in Jan2021, the patient experienced (Night after vaccination), complete body ache and pain during night but was gone the next morning. On 01Feb2021, at 13:15 the patient had cold like symptoms starting 12 days after vaccination, chills, tiredness/sleepiness, runny nose, sore/red throat. The patient didn't receive treatment for the events. The outcome of the events complete body ache and pain during night but was gone the next morning was recovered on Jan2021 while for other events was recovering.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal erythema, Rhinorrhoea, Somnolence
Clinical narrative: Cold like symptoms; chills; tiredness; sleepiness; runny nose; sore/red throat; sore/red throat; complete body ache and pain during night but was gone the next morning; This is a spontaneous report from a contactable Other HCP (patient). A 75-year-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3249) via unspecified route of administration in left arm on 19Jan2021, at 15:00 (at the age of 75-year-old) as a single dose for COVID-19 immunisation. The patient medical history included vertigo, mild heart attack and glaucoma. 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 concomitant medication included glaucoma eye drops, dorzolamide and latanoprost. The patient didn't receive any vaccine within four weeks prior to vaccination. The patient previously took Fosamax and experienced light headedness (after 2 years). On an unknown date in Jan2021, the patient experienced (Night after vaccination), complete body ache and pain during night but was gone the next morning. On 01Feb2021, at 13:15 the patient had cold like symptoms starting 12 days after vaccination, chills, tiredness/sleepiness, runny nose, sore/red throat. The patient didn't receive treatment for the events. The outcome of the events complete body ache and pain during night but was gone the next morning was recovered on Jan2021 while for other events was recovering.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: grade 3 fevers; chills; myalgias; arthralgias; fatigue; This is a spontaneous report from a contactable Physician. This 68-years-old male Physician reported for himself that she received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 04Feb2021 (Batch/Lot Number: EN5318) as SINGLE DOSE for COVID-19 immunisation. Medical history included arteriosclerosis coronary artery from 2006 to an unknown date, osteoarthritis, hypercholesterolaemia, benign prostatic hyperplasia, upper limb fracture from 2018 to an unknown date, joint dislocation from 2018 to an unknown date, radial head dislocation from 2020 to an unknown date. Also, had a radial head replacement 3 months prior to vaccination and developed severe pain at the prosthesis site. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported; rosuvastatin (ROSUVASTATIN) taken for an unspecified indication, start and stop date were not reported; tadalafil (TADALAFIL) taken for an unspecified indication, start and stop date were not reported. On 04Feb2021 16:00 the patient experienced grade 3 fevers, chills, myalgias, arthralgias, fatigue. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was reported as recovered. The outcome of the events was reported as recovered. Therapeutic measures were taken as a result of grade 3 fevers (pyrexia), chills (chills), myalgias (myalgia), arthralgias (arthralgia), fatigue (fatigue).
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Eye swelling, Hypoaesthesia oral, Paraesthesia oral, Pruritus
Clinical narrative: At 6:45 pm my mouth started to get tingly/numb and then eyes began to swell up.  I had spots/hives on my body - not many - on the chest area.  Then my hands/fingers and feet became itchy.  throat tigh; At 6:45 pm my mouth started to get tingly/numb and then eyes began to swell up.  I had spots/hives on my body - not many - on the chest area.  Then my hands/fingers and feet became itchy.  throat tigh; At 6:45 pm my mouth started to get tingly/numb and then eyes began to swell up.  I had spots/hives on my body - not many - on the chest area.  Then my hands/fingers and feet became itchy.  throat tigh; At 6:45 pm my mouth started to get tingly/numb and then eyes began to swell up.  I had spots/hives on my body - not many - on the chest area.  Then my hands/fingers and feet became itchy.  throat tigh; At 6:45 pm my mouth started to get tingly/numb and then eyes began to swell up.  I had spots/hives on my body - not many - on the chest area.  Then my hands/fingers and feet became itchy.  throat tigh; throat tightened up due to swelling -; I couldn't breathe; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN9581), via an unspecified route of administration in left arm on 07Feb2021 at 03:00 PM as single dose for covid-19 immunisation. Medical history included none. Concomitant medication included pantoprazole at 40mg taken for an unspecified indication, start and stop date were not reported. The patient had no known allergies. The patient not had COVID-19 prior vaccination. The patient was not tested with COVID-19 post vaccination. The patient reported that his mouth started got tingly/numb and then eyes began to swell up, had spots/hives on body - not many - on the chest area, then hands/fingers and feet became itchy, throat tightened up due to swelling, but nothing serious where couldn't breathe on 07Feb2021 18:45. The outcome of events was recovered on Feb2021. Therapeutic measures were taken for the events swelling and hives with Benadryl.  Follow-up activities have been completed and no further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Throat tightness, Urticaria
Clinical narrative: At 6:45 pm my mouth started to get tingly/numb and then eyes began to swell up.  I had spots/hives on my body - not many - on the chest area.  Then my hands/fingers and feet became itchy.  throat tigh; At 6:45 pm my mouth started to get tingly/numb and then eyes began to swell up.  I had spots/hives on my body - not many - on the chest area.  Then my hands/fingers and feet became itchy.  throat tigh; At 6:45 pm my mouth started to get tingly/numb and then eyes began to swell up.  I had spots/hives on my body - not many - on the chest area.  Then my hands/fingers and feet became itchy.  throat tigh; At 6:45 pm my mouth started to get tingly/numb and then eyes began to swell up.  I had spots/hives on my body - not many - on the chest area.  Then my hands/fingers and feet became itchy.  throat tigh; At 6:45 pm my mouth started to get tingly/numb and then eyes began to swell up.  I had spots/hives on my body - not many - on the chest area.  Then my hands/fingers and feet became itchy.  throat tigh; throat tightened up due to swelling -; I couldn't breathe; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN9581), via an unspecified route of administration in left arm on 07Feb2021 at 03:00 PM as single dose for covid-19 immunisation. Medical history included none. Concomitant medication included pantoprazole at 40mg taken for an unspecified indication, start and stop date were not reported. The patient had no known allergies. The patient not had COVID-19 prior vaccination. The patient was not tested with COVID-19 post vaccination. The patient reported that his mouth started got tingly/numb and then eyes began to swell up, had spots/hives on body - not many - on the chest area, then hands/fingers and feet became itchy, throat tightened up due to swelling, but nothing serious where couldn't breathe on 07Feb2021 18:45. The outcome of events was recovered on Feb2021. Therapeutic measures were taken for the events swelling and hives with Benadryl.  Follow-up activities have been completed and no further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Fever 100.7; muscle aches; headache; swelling at injection site; This is a spontaneous report from a contactable other health professional. A 54-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via Intramuscular route of administration on Right arm on 06Feb2021 12:30 at single dose for covid-19 immunisation administered at Public Health facility. Medical history was none. Known allergies include Tetracyclines. Concomitant medications include advil [ibuprofen] (IBUPROFEN); dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL), bromazepam (NIQUIL); paracetamol (TYLENOL) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). On 06Feb2021 13:30, patient experienced Fever 100.7, muscle aches, headache, swelling at injection site. The patient did not receive any treatment for the events. 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. Covid has not been tested post vaccination. The seriousness was reported as non-serious. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure increased, Exposure to SARS-CoV-2, Nausea
Clinical narrative: he has been exposed to covid; nausea; elevated blood pressure; This is a spontaneous report from a Pfizer-. A contactable consumer (patient's wife) reported that a 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter was asking if patient will be able to get the second vaccine dose as scheduled this coming Tuesday if patient has been exposed to covid and was experiencing nausea and elevated blood pressure. The patient's wife was the one who had covid and patient was exposed to her. Outcome of events was unknown.   Information about lot and batch number was requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Fairly severe joint pain started on 06Feb, worse today, esp. in shoulders which are quite arthritic; This is a spontaneous report from a contactable consumer (patient herself) A 65-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN53.8),via an unspecified route of administration, administered in Arm Left on 03Feb2021 (Batch/Lot Number: EN5318) as SINGLE DOSE for covid-19 immunisation .Medical history included osteoarthritis from an unknown date and unknown if ongoing , hypertension from an unknown date and unknown if ongoing ,obesity from an unknown date and unknown if ongoing.The patient's concomitant medications were not reported.  The patient experienced fairly severe joint pain started on 06feb, worse today, esp. in shoulders which are quite arthritic on 06Feb2021 07:00 with outcome of not recovered.I would have been happy to help had you bothered to generate a fillable .pdf but I'm not going to try to hand write everything. This is the 21st century, time to get with the program.The events were considered as non-serious by the consumer. The outcome of the events was not recovered.    No follow up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Vaccination site pain
Clinical narrative: Minimal soreness at injection site; headache; some lethargy; This is a spontaneous report from a contactable consumer reported that: A 68-years-old female patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: EL3248; Batch/Lot Number: EK9231), dose 1 via an unspecified route of administration, administered in Arm Left on 16Jan2021 as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 06Feb2021 as single dose for covid-19 immunisation. Medical history included type 2 diabetes mellitus, patient is allergic to sulpha, tetracycline, shellfish, IV dye. The patient was not pregnant at the time of reporting, not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient received concomitant medications from unspecified date at unspecified dose frequency and an unspecified indication included: sitagliptin phosphate (JANUVIA [SITAGLIPTIN PHOSPHATE]), hydrochlorothiazide (HYDROCHLOROTHIAZIDE) phytosterols nos (CHOLESTOFF ORIGINAL), colecalciferol (VITAMIN D [COLECALCIFEROL]), acetylsalicylic acid, ascorbic acid (ASPIRIN [ACETYLSALICYLIC ACID; ASCORBIC ACID]). On 16Jan2021 08:PM, the patient experienced minimal soreness at injection site, headache, some lethargy. Outcome of the events were recovered.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Chills, Myalgia, Pyrexia
Clinical narrative: Sars-Cov-2 test positive; Fever; Chills; Muscle soreness in his left shoulder; This is a spontaneous report from a contactable consumer (patient) via the Pfizer .   A 66-year-old male patient received the first single dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL9262), via an unspecified route of administration (only injection reported), left shoulder, on 23Jan2021 (at the age of 66-years-old), for COVID-19 immunization. The patient's medical history included ongoing prostate cancer since 3 years prior to the reporting. The patient stated having fever and chills both on 26Jan2021 and 27Jan2021, at night. The patient also reported muscle soreness in his left shoulder for a couple of days after vaccination (exact onset date not specified). On 28Jan2021, a few days after vaccination, the patient tested for Sars-Cov-2 (swab). Since the results were positive on 29Jan2021, the patient went to ER. He had no respiratory or heart issues. He was treated with a 1 hour infusion of Bamlanivimab 700. The patient recovered from fever, chills and muscle soreness, while the outcome of COVID-19 was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Sars-Cov-2 test positive; Fever; Chills; Muscle soreness in his left shoulder; This is a spontaneous report from a contactable consumer (patient) via the Pfizer .   A 66-year-old male patient received the first single dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL9262), via an unspecified route of administration (only injection reported), left shoulder, on 23Jan2021 (at the age of 66-years-old), for COVID-19 immunization. The patient's medical history included ongoing prostate cancer since 3 years prior to the reporting. The patient stated having fever and chills both on 26Jan2021 and 27Jan2021, at night. The patient also reported muscle soreness in his left shoulder for a couple of days after vaccination (exact onset date not specified). On 28Jan2021, a few days after vaccination, the patient tested for Sars-Cov-2 (swab). Since the results were positive on 29Jan2021, the patient went to ER. He had no respiratory or heart issues. He was treated with a 1 hour infusion of Bamlanivimab 700. The patient recovered from fever, chills and muscle soreness, while the outcome of COVID-19 was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Nausea, Vomiting
Clinical narrative: Chills; severe diarrhea; vomiting; nausea; dizziness; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (solution for injection, Lot number: EK9231), administered in left arm via an unspecified route of administration on 03Feb2021 at single dose for covid-19 immunisation. Medical history included High blood pressure, strabismus, known allergies Sulfa antibiotics, quinolone antibiotics. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. Historical vaccine included BNT162B2 First dose: lot EJ1686, expiry Mar2021, 0.3ml single dose by injection once to left arm for covid-19 immunisation. Concomitant medications included Atorvastatin 20mg, amlodipine-benazepril 2.5-10 taken for an unspecified indication. The patient experienced chills, severe diarrhea, vomiting, nausea, dizziness on 03Feb2021 23:00. The outcome of the events was recovering. Treatment received for the adverse events as nausea medication.  Follow-up activities are completed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Positive COVID test; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number EL3246, expiration date Apr2021), via an unspecified route of administration, administered in Arm Right on 18Jan2021 (age at vaccination of 41-years-old) as single dose for covid-19 immunisation. Medical history included blood donation from an unknown date and unknown if ongoing. There were no concomitant medications.  The patient was tested positive for COVID-19 on 23Jan2021. COVID test says he is negative nowand he wants to know if he can get the second COVID-19 Vaccine. Outcome of the event was recovered on an unspecified date.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder
Clinical narrative: Movement in my right upper arm is painful; This is a spontaneous report from a contactable consumer.  A 66-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 03Feb2021 (Batch/Lot Number: en5318) as SINGLE DOSE for an unspecified indication.  Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. There were no concomitant medications.  The patient experienced movement in my right upper arm is painful (movement disorder) (non-serious) on 08Feb2021 07:00. There was not treatment received for the adverse events. The events were considered as non-serious by the other healthcare professional. The outcome of the event was reported as not recovered.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site reaction, Lethargy, Myalgia
Clinical narrative: lethargy; Chills; fever; muscle soreness; Major headache; nausea; Bad reaction at injection site; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9810), via an unspecified route of administration, administered on the Left arm on 04Feb2021 14:30 as SINGLE DOSE for covid-19 immunisation. The patient medical history was none. If other vaccine in four weeks: No. Other medications in two weeks: no. Other vaccine same date details: other vaccine same date dose number was 2. Facility type vaccine was Hospital. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: No. The patient experienced lethargy, chills, fever (pyrexia), muscle soreness (myalgia), major headache (headache), nausea and bad reaction at injection site (injection site reaction); all (non-serious) on 04Feb2021 17:30. Adverse event: Chills, fever, muscle soreness, major headache, nausea, lethargy, bad reaction at injection site. There was no treatment for AE. The outcome of events was recovered on an unspecified date in Feb2021..
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: lethargy; Chills; fever; muscle soreness; Major headache; nausea; Bad reaction at injection site; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9810), via an unspecified route of administration, administered on the Left arm on 04Feb2021 14:30 as SINGLE DOSE for covid-19 immunisation. The patient medical history was none. If other vaccine in four weeks: No. Other medications in two weeks: no. Other vaccine same date details: other vaccine same date dose number was 2. Facility type vaccine was Hospital. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: No. The patient experienced lethargy, chills, fever (pyrexia), muscle soreness (myalgia), major headache (headache), nausea and bad reaction at injection site (injection site reaction); all (non-serious) on 04Feb2021 17:30. Adverse event: Chills, fever, muscle soreness, major headache, nausea, lethargy, bad reaction at injection site. There was no treatment for AE. The outcome of events was recovered on an unspecified date in Feb2021..
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Covid vaccine and then developed Covid.; Covid vaccine and then developed Covid.; This is a spontaneous report from a Pfizer sponsored program . A contactable consumer reported that a 42-years-old male patient (Husband) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. Caller stated that she was calling for husband that received first shot 13Jan2021. Stated that since then he has tested positive for Covid. Stated that he received positive test results for Covid on 28Jan2021. Stated that his last symptom was on 29Jan2021. Stated that the next shot is scheduled for 28Feb2021. Wanted to know if should get second shot or start all over again. Is for Pfizer Covid 19 shot. Outcome of events was recovered on 29Jan2021.  Information about lot/batch number has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Hyperhidrosis, Malaise
Clinical narrative: tired; fever; general malaise; diarrhea; sweating; muscle aches; headache; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9262; Expiration Date: May2021), intramuscularly, administered in left arm on 04Feb2021 12:15 pm as SINGLE DOSE for covid-19 immunisation. Medical history included neuroendocrine tumour of the lung and ongoing chronic obstructive pulmonary disease (Diagnosed 15 or so years ago). There were no concomitant medications. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): N/A. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. Any AE(s) did not require a visit to Emergency Room and Physician Office. It was nothing severe. Prior Vaccinations (within 4 weeks) was None. AE(s) following prior vaccinations: n/a. The patient experienced headache (non-serious) on Feb2021, fever (pyrexia) (non-serious) on 06Feb2021, general malaise (malaise) (non-serious) on 06Feb2021, diarrhea (diarrhoea) (non-serious) on 06Feb2021, sweating (hyperhidrosis) (non-serious) on 06Feb2021, muscle aches (myalgia) (non-serious) on 06Feb2021 and tired (fatigue) (non-serious) on 08Feb2021. The caller is 82 years old. She received her first COVID-19 vaccine on 04Feb2021. She was fine 04Feb and 05Feb2021. On the 6th and 7th, she had muscle aches, fever, she was sweating and had general malaise. These symptoms felt important enough to report, she doesn't know if Pfizer is keeping track of it or what. When probed for consent to contact, the caller explains the doctor she had been seeing is no longer practicing, and she just started seeing this doctor. She doesn't know how much this new doctor is going to help. Caller adds that she also experienced diarrhea. She was a little bit better yesterday, but she feels fine today. She states she maybe a little tired today, but nothing else. She is fine. Her daughter had a question that she wanted the caller to ask. These symptoms do not mean she should not get the second shot? These are pretty normal side effects, aren't they? From what she has read they are. She is scheduled for her second vaccine on 26Feb2021. Vaccination Facility Type: there is a special area roped off just giving shots to public. The outcome of events was recovered on 08Feb2021 and for event (tired) was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: tired; fever; general malaise; diarrhea; sweating; muscle aches; headache; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9262; Expiration Date: May2021), intramuscularly, administered in left arm on 04Feb2021 12:15 pm as SINGLE DOSE for covid-19 immunisation. Medical history included neuroendocrine tumour of the lung and ongoing chronic obstructive pulmonary disease (Diagnosed 15 or so years ago). There were no concomitant medications. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): N/A. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. Any AE(s) did not require a visit to Emergency Room and Physician Office. It was nothing severe. Prior Vaccinations (within 4 weeks) was None. AE(s) following prior vaccinations: n/a. The patient experienced headache (non-serious) on Feb2021, fever (pyrexia) (non-serious) on 06Feb2021, general malaise (malaise) (non-serious) on 06Feb2021, diarrhea (diarrhoea) (non-serious) on 06Feb2021, sweating (hyperhidrosis) (non-serious) on 06Feb2021, muscle aches (myalgia) (non-serious) on 06Feb2021 and tired (fatigue) (non-serious) on 08Feb2021. The caller is 82 years old. She received her first COVID-19 vaccine on 04Feb2021. She was fine 04Feb and 05Feb2021. On the 6th and 7th, she had muscle aches, fever, she was sweating and had general malaise. These symptoms felt important enough to report, she doesn't know if Pfizer is keeping track of it or what. When probed for consent to contact, the caller explains the doctor she had been seeing is no longer practicing, and she just started seeing this doctor. She doesn't know how much this new doctor is going to help. Caller adds that she also experienced diarrhea. She was a little bit better yesterday, but she feels fine today. She states she maybe a little tired today, but nothing else. She is fine. Her daughter had a question that she wanted the caller to ask. These symptoms do not mean she should not get the second shot? These are pretty normal side effects, aren't they? From what she has read they are. She is scheduled for her second vaccine on 26Feb2021. Vaccination Facility Type: there is a special area roped off just giving shots to public. The outcome of events was recovered on 08Feb2021 and for event (tired) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Fatigue, Headache, Injection site pain
Clinical narrative: injection site pain; massive redness; swelling; bad headache; muscle and joint pain; muscle and joint pain; tiredness; feeling unwell; This is a spontaneous report received from a contactable consumer. A 75-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration on Right arm on 04Feb2021 02:45 PM at single dose.Patient Medical history included arthritis, hypertension, osteopenia. Historical vaccine included first dose of bnt162b2 via an unspecified route of administration (lot number: EL9265) on left arm on 14Jan2021 04:30 PM at Single Dose for COVID-19 immunisation. Concomitant medication included Amlodipine Besylate 2.5mg, Citalopram 10, captopril (METOPRIL). On 04Feb2021 22:30 patient experienced injection site pain, massive redness, swelling, bad headache, muscle and joint pain, muscle and joint pain, tiredness, feeling unwell after vaccination. patient was not pregnant, No  treatment received for AE, patient had not Covid tested post vaccination, patient had allergies to Codine. Outcome of events was recovering.   Information on the lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Swelling
Clinical narrative: injection site pain; massive redness; swelling; bad headache; muscle and joint pain; muscle and joint pain; tiredness; feeling unwell; This is a spontaneous report received from a contactable consumer. A 75-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration on Right arm on 04Feb2021 02:45 PM at single dose.Patient Medical history included arthritis, hypertension, osteopenia. Historical vaccine included first dose of bnt162b2 via an unspecified route of administration (lot number: EL9265) on left arm on 14Jan2021 04:30 PM at Single Dose for COVID-19 immunisation. Concomitant medication included Amlodipine Besylate 2.5mg, Citalopram 10, captopril (METOPRIL). On 04Feb2021 22:30 patient experienced injection site pain, massive redness, swelling, bad headache, muscle and joint pain, muscle and joint pain, tiredness, feeling unwell after vaccination. patient was not pregnant, No  treatment received for AE, patient had not Covid tested post vaccination, patient had allergies to Codine. Outcome of events was recovering.   Information on the lot/batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Decreased appetite, Fatigue, Headache, Vaccination site pain
Clinical narrative: She had no appetite; She was very tired; a headache and an upset stomach; vomiting; a headache and an upset stomach; sore arm at the site of the injection; This is a spontaneous report from a contactable consumer reported that: A 77-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 25Jan2021 (Batch/Lot Number: EL3302; Expiration Date: 31May2021) as single dose for covid-19 immunization. The patient medical history was unknown. The patient's concomitant medications were unknown. Caller is calling to see if anyone experienced a reaction like a week after having the first COVID shot. She says she didn't give it a thought because it had been a week, but her friend today suggested maybe she was having a delayed reaction. She received the shot on 25Jan2021, says she only had the sore arm on 26Jan and it was only at the site of the injection like a regular shot, and then last Monday evening 1Feb2021, she started getting headache and the next morning she felt miserable. On 02Feb2021, she had an upset stomach and was vomiting. She was very tired and that went on for a couple days. She couldn't get off the couch. She had no appetite. Gradually she got a little better and she texted the doctor's office they suggested she go. they could make her an appointment 25 minutes away to get a COVID test. She was not feeling like driving or riding in the car to get it. Or they suggested that she quarantine for 10 days which is what she has been doing. She is feeling just about back to herself, but she was curious if that could have been from the shot or maybe she just had some other bug. She thinks she was 143 last time a few months ago. The upset stomach and vomiting last also on the 03Feb which made the headache better. She says headache is gone but her head still feels little not quite itself, but the headache is gone. She says the upset stomach and vomiting have recovered completely. The tiredness is ongoing but is much better. She has not had anything else happen and she has had not been around anybody with who was sick unless they were asymptomatic and that would have been only a very few people. She wants to know if it is possible that the vaccine caused a side effect to show up 8 days later. She does not see NDC on her vaccine card. She provides lot number expiration from her vaccine card. Outcome of the events headache, tiredness, she had no appetite were recovering. Vomiting and upset stomach were recovered.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: She had no appetite; She was very tired; a headache and an upset stomach; vomiting; a headache and an upset stomach; sore arm at the site of the injection; This is a spontaneous report from a contactable consumer reported that: A 77-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 25Jan2021 (Batch/Lot Number: EL3302; Expiration Date: 31May2021) as single dose for covid-19 immunization. The patient medical history was unknown. The patient's concomitant medications were unknown. Caller is calling to see if anyone experienced a reaction like a week after having the first COVID shot. She says she didn't give it a thought because it had been a week, but her friend today suggested maybe she was having a delayed reaction. She received the shot on 25Jan2021, says she only had the sore arm on 26Jan and it was only at the site of the injection like a regular shot, and then last Monday evening 1Feb2021, she started getting headache and the next morning she felt miserable. On 02Feb2021, she had an upset stomach and was vomiting. She was very tired and that went on for a couple days. She couldn't get off the couch. She had no appetite. Gradually she got a little better and she texted the doctor's office they suggested she go. they could make her an appointment 25 minutes away to get a COVID test. She was not feeling like driving or riding in the car to get it. Or they suggested that she quarantine for 10 days which is what she has been doing. She is feeling just about back to herself, but she was curious if that could have been from the shot or maybe she just had some other bug. She thinks she was 143 last time a few months ago. The upset stomach and vomiting last also on the 03Feb which made the headache better. She says headache is gone but her head still feels little not quite itself, but the headache is gone. She says the upset stomach and vomiting have recovered completely. The tiredness is ongoing but is much better. She has not had anything else happen and she has had not been around anybody with who was sick unless they were asymptomatic and that would have been only a very few people. She wants to know if it is possible that the vaccine caused a side effect to show up 8 days later. She does not see NDC on her vaccine card. She provides lot number expiration from her vaccine card. Outcome of the events headache, tiredness, she had no appetite were recovering. Vomiting and upset stomach were recovered.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: diarrhea; vomiting; This is a spontaneous report from a contactable consumer (patient herself) A 84-years-old non female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6201 ; Expiration Date: 30Jun2021 ) dose 1 intramuscular, administered in Arm Left on 07Feb2021 as SINGLE DOSE for covid-19 immunisation .Medical history included hypertension from an unknown date and unknown if ongoing , irritable bowel syndrome from an unknown date and unknown if ongoing. Concomitant medications included amlodipine taken for hypertension from an unspecified start date and ongoing.The patient experienced diarrhea  on 08Feb2021 02:00 and  vomiting on 08Feb2021 02:00 with outcome of recovered. She did stop vomiting, but vomited about 4 times and the diarrhea kept up for a little while and then stopped.The events were considered as non-serious by consumer. The outcome of the events was not recovered.  No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Came back positive today/ had a lot of nasal congestion, cough, and a sore throat; Came back positive today/ had a lot of nasal congestion, cough, and a sore throat; This is a spontaneous report from a contactable consumer via a medical information team. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 15Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller stated her husband, son, and her had the first COVID vaccine dose on 15Jan2021. 5 days later, her husband started having some symptoms. Her son this past Tuesday (26Jan2021), had a lot of nasal congestion, cough, and a sore throat. He had a COVID test yesterday and came back positive today (29Jan2021). Caller asking if the vaccine would resolve you getting a positive test for COVID or not. Caller asking if the vaccine would cause a positive test result. On 29Jan2021, the patient underwent lab tests and procedures which included COVID test: Positive. The outcome of the events was unknown.