chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, Vomiting
Clinical narrative: Passing out; Window of blurry vision before passing out for about 30 seconds; Upon regaining consciousness, patient immediately vomited; Fever; Feeling achy; Chills; Tired; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passing out) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 044B2V) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (LO LOESTRIN FE) for Birth control.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passing out) (seriousness criterion medically significant), VISION BLURRED (Window of blurry vision before passing out for about 30 seconds), VOMITING (Upon regaining consciousness, patient immediately vomited), PYREXIA (Fever), MYALGIA (Feeling achy), CHILLS (Chills) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (Passing out), VISION BLURRED (Window of blurry vision before passing out for about 30 seconds), VOMITING (Upon regaining consciousness, patient immediately vomited), PYREXIA (Fever), MYALGIA (Feeling achy), CHILLS (Chills) and FATIGUE (Tired) outcome was unknown.            Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: 26 patients received the vaccine prepared without the final inverting after diluent added; 26 patients received the vaccine prepared without the final inverting after diluent added; This case is considered as invalid as there is no indication that the patient experienced an event under suspect BNT162B2.  This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for 26 patients. This is for 5th of 26 report. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. The pharmacist wanted information about needing to revaccinate patients with the covid 19 vaccine in the instance where all preparation steps were followed except gently inverting the vial 10 times after adding the diluent. The vial color and appearance was off white with no particulate matter. 26 patients received the vaccine prepared without the final inverting after diluent added. The outcome was unknown.    Follow-up (08Feb2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Follow-up (09Feb2021): This is a follow-up spontaneous report received from a contactable Pharmacist. This Pharmacist reported in response to HCP letter sent that included: Phone Out 11:40 AM EST, 2nd attempt by phone to HCP to obtain mailing information. Phone answered by pharmacist who stated he never reported any adverse event and that the event in the report was all a confusion and everything is fine. HCP did not provide fax number or mailing address and does not wish to be contacted any further.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020521662 same reporter/drug/event, different patient
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lip blister, Malaise
Clinical narrative: Lip blistering; General malaise; This is a spontaneous report from a contactable nurse. A 53-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) intramuscular, administered in left arm on 06Jan2021 at 09:15 (at the age of 53-year-old) (Lot Number: Ek9231) as 1st dose, single dose for covid-19 immunisation. Medical history included hypothyroid, migraines, latex and sulfa allergy. Concomitant medications included armor and BCP (taken as other medications in two weeks). The patient did not receive any other vaccines within four weeks. Prior and post to the vaccination patient not tested to covid. The patient previously took Cipro and experienced allergy. On 28Jan2021, the patient experienced general malaise. On unspecified date, the patient experienced lip blistering. Treatment was not received for the events. Outcome of the event general malaise was recovering while unknown for rest of the event.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Diet refusal, Fatigue, Headache
Clinical narrative: side effects were similar to those of a flu;  diarrhea, achy, headache, fever, feeling weak and very sweaty; side effects were similar to those of a flu;  diarrhea, achy, headache, fever, feeling weak and very sweaty; side effects were similar to those of a flu;  diarrhea, achy, headache, fever, feeling weak and very sweaty; side effects were similar to those of a flu;  diarrhea, achy, headache, fever, feeling weak and very sweaty; tired; feeling weak; Sweaty; didn't want to eat; Fever; feeling sick; This is a spontaneous report from Medical Information Team. Two contactable consumers reported that a 69-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot no: EN5318) via unspecified route of administration on 29Jan2021 as single dose in right arm for protection from Covid virus. Medical history reported was ongoing myasthenia gravis. Concomitant medications reported was pyridostigmine (Tablet 60 mg ) at 60 mg four times a day and prednisolone (PREDNIFIL Tablet 10 mg) at 20 mg daily, both were ongoing from May2020 for myasthenia gravis. As per reported, caller he's been feeling sick since 31Jan2021 until today. He was recovering and didn't receive any medications, but he felt really bad. His side effects were similar to those of a flu; diarrhea, achy, headache, fever, feeling weak and very sweaty. Today he's still a little sweaty and weak. He would like to know if this is normal if the side effects are worse after the second dose of the vaccine and what should he do. The vaccine wiped him out. He was tired and weak. He was sweaty. He didn't want to eat. He had a fever. He has been sick until today. He was scheduled to take the second dose on 19Feb2021. He doesn't know if it will affect him more. The caller told the person giving the vaccine that he has Myasthenia gravis. He hasn't taken his medications since because he has been so sick. Outcome of events feeling sick, tired, feeling weak, sweaty was recovering, for event didn't want to eat was recovered on 03Feb2021 and for remaining events its unknown.  Follow-up attempts completed. No further information expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Influenza like illness, Malaise, Pain, Pyrexia
Clinical narrative: side effects were similar to those of a flu;  diarrhea, achy, headache, fever, feeling weak and very sweaty; side effects were similar to those of a flu;  diarrhea, achy, headache, fever, feeling weak and very sweaty; side effects were similar to those of a flu;  diarrhea, achy, headache, fever, feeling weak and very sweaty; side effects were similar to those of a flu;  diarrhea, achy, headache, fever, feeling weak and very sweaty; tired; feeling weak; Sweaty; didn't want to eat; Fever; feeling sick; This is a spontaneous report from Medical Information Team. Two contactable consumers reported that a 69-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot no: EN5318) via unspecified route of administration on 29Jan2021 as single dose in right arm for protection from Covid virus. Medical history reported was ongoing myasthenia gravis. Concomitant medications reported was pyridostigmine (Tablet 60 mg ) at 60 mg four times a day and prednisolone (PREDNIFIL Tablet 10 mg) at 20 mg daily, both were ongoing from May2020 for myasthenia gravis. As per reported, caller he's been feeling sick since 31Jan2021 until today. He was recovering and didn't receive any medications, but he felt really bad. His side effects were similar to those of a flu; diarrhea, achy, headache, fever, feeling weak and very sweaty. Today he's still a little sweaty and weak. He would like to know if this is normal if the side effects are worse after the second dose of the vaccine and what should he do. The vaccine wiped him out. He was tired and weak. He was sweaty. He didn't want to eat. He had a fever. He has been sick until today. He was scheduled to take the second dose on 19Feb2021. He doesn't know if it will affect him more. The caller told the person giving the vaccine that he has Myasthenia gravis. He hasn't taken his medications since because he has been so sick. Outcome of events feeling sick, tired, feeling weak, sweaty was recovering, for event didn't want to eat was recovered on 03Feb2021 and for remaining events its unknown.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Chills, Malaise, Vaccination site erythema
Clinical narrative: arthritis; mild malaise; little redness at injection site; chills; This is a spontaneous report from a contactable consumer (Patient) via medical information team. A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 04Feb2021 as 1st dose, single for COVID-19 immunization. The patient medical history and. concomitant medications were not reported. The patient experienced arthritis, mild malaise and little redness at injection site on an unspecified date and patient got the chills 2 nights after the 1st dose that lasted one hour on an unspecified date in Feb2021. The patient called and queried that can he take acetaminophen for arthritis. The outcome of the event chills was resolved on an unspecified date in Feb2021 and unknown for other events.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Heart rate, Heart rate increased, Malaise, Nausea
Clinical narrative: Unwell feeling; Nausea; diarrhea; heart beats a bit higher than normal at rest (+10 mre than usual); This is a spontaneous report from a contactable Other Healthcare Professional. A 45-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown), via an unspecified route of administration on Left arm on 11Feb2021 at 02:30 PM, (at the age of 45-years-old) as a 1st dose single for COVID-19 immunization at Public Health Clinic The patient's other medical history was not reported. Patient had Advil PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) the day before, and a Pre-workout supplement in two weeks both on unspecified dates. Patient did not have any known allergies. The patient did not receive any vaccine within 4 weeks prior to the dose of vaccine. He did not have covid prior vaccination. On 12Feb2021 patient experienced Unwell feeling. Nausea, diarrhea and heart beats a bit higher than normal at rest (+10 mre than usual). Patient did not have any treatment for the events. He had tasted for covid post vaccination for Nasal Swab, on 02Jul2020 which was Negative. The Outcome of the events was not recovered.  Information about lot/batch number has been requested.  Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Unwell feeling; Nausea; diarrhea; heart beats a bit higher than normal at rest (+10 mre than usual); This is a spontaneous report from a contactable Other Healthcare Professional. A 45-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown), via an unspecified route of administration on Left arm on 11Feb2021 at 02:30 PM, (at the age of 45-years-old) as a 1st dose single for COVID-19 immunization at Public Health Clinic The patient's other medical history was not reported. Patient had Advil PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) the day before, and a Pre-workout supplement in two weeks both on unspecified dates. Patient did not have any known allergies. The patient did not receive any vaccine within 4 weeks prior to the dose of vaccine. He did not have covid prior vaccination. On 12Feb2021 patient experienced Unwell feeling. Nausea, diarrhea and heart beats a bit higher than normal at rest (+10 mre than usual). Patient did not have any treatment for the events. He had tasted for covid post vaccination for Nasal Swab, on 02Jul2020 which was Negative. The Outcome of the events was not recovered.  Information about lot/batch number has been requested.  Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Malaise, Vomiting
Clinical narrative: feels unwell; dizziness; vomiting; This is a spontaneous report from a contactable consumer (sister) or other non hcp. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on 16Feb2021 11:00 as 1ST DOSE, SINGLE  for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced feels unwell, dizziness, vomiting on 16Feb2021. Outcome of the events was unknown.  Information on the Lot/Batch number has been requested  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Malaise
Clinical narrative: not feeling well due to being constipated; not feeling well due to being constipated; This is a spontaneous report from a contactable consumer via sponsored program COVAX.   A female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in Feb2021 (in the last 24 hours), patient was not feeling well due to being constipated. Patient wanted to know if could reschedule her second dose of the covid vaccine, scheduled for 12Feb2021. The Doctor prescribed a medication that would empty out her bowels for constipation. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Vaccination site pain
Clinical narrative: Pain to the left arm where he had the shot; Feeling sick; This is a spontaneous report from a contactable consumer (patient son). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and Expiry date was not reported), dose 1 via an unspecified route of administration, administered in left arm on 16Feb2021 (at the age of 71-year-old) as 1st dose, single dose for COVID-19 immunisation at Clinic Workplace Clinic. Medical history included ongoing back pain. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]) taken for back pain, 200 mg as needed from an unspecified start date and ongoing. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive any additional vaccines on the same date of Pfizer. Prior to vaccination, patient did not receive any immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Feb2021, patient experienced pain to the left arm where he had the shot and on an unspecified date in Feb2021, he was feeling sick. Reporter stated that patient got the vaccine yesterday and was now having pain to the left arm where he had the shot, and he was feeling sick. Further stated patient was not feeling sick. Patient had pain in his arm. The pain was mild. Reporter asked if the symptoms patient was having are normal and what should be done about the symptoms. Patient did not visit emergency room and physician office for any event. There was no investigation assessment and no relevant tests. The outcome of event feeling sick was recovered on an unspecified date in 2021 and not recovered for pain in arm where he had shot.   No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Headache, Influenza like illness, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A 64-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 16Feb2021 10:00 (Batch/Lot Number: EN 6201) as SINGLE DOSE for covid-19 immunization. Medical history included cardiac failure congestive, atrial fibrillation and prolonged issues from having Covid 19. Concomitant medication(s) included high blood pressure medications and levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient was allergic to morphine, hydrocodon, lorcet, reglan, cortisone, Diflucan and Mobic. Patient did not receive other vaccine in four weeks. On 17Feb2021, the patient experienced large sore red golf ball size knot at injection site, nausea, chills, headache, intermittent chest pains, achiness all over like the flu. The knot was still there as of 18feb2021 at 03:456pm and was still very sore and still very large. Patient did not received treatment for adverse events. The outcome of the events was not resolved.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A 64-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 16Feb2021 10:00 (Batch/Lot Number: EN 6201) as SINGLE DOSE for covid-19 immunization. Medical history included cardiac failure congestive, atrial fibrillation and prolonged issues from having Covid 19. Concomitant medication(s) included high blood pressure medications and levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient was allergic to morphine, hydrocodon, lorcet, reglan, cortisone, Diflucan and Mobic. Patient did not receive other vaccine in four weeks. On 17Feb2021, the patient experienced large sore red golf ball size knot at injection site, nausea, chills, headache, intermittent chest pains, achiness all over like the flu. The knot was still there as of 18feb2021 at 03:456pm and was still very sore and still very large. Patient did not received treatment for adverse events. The outcome of the events was not resolved.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling well; This is a spontaneous report from a Pfizer-sponsored program. A female patient of unspecified age received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE (Batch/Lot number:UNKNOWN), via an unspecified route of administration on 21Jan2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose 21Jan2021, had an appointment today for second dose. She states she was not feeling well on an unspecified date and was attempting to cancel the appointment but does not have phone number. The outcome of the events is unknown.   Information on Lot /Batch Number has been requested.   Follow-up attempts completed. No further information expected
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: daughter feeling like "poop"/felt horrible for four hours after receiving the vaccine; This is a spontaneous report form a Pfizer Sponsored Program COVAX US Support. A non-contactable consumer reported for a female patient (daughter). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Caller indicated that she has been hearing good things about Pfizer and the vaccine and that her daughter received her second dose and other than feeling like "poop" for about four hours, it went great. The patient experienced felt horrible for four hours after receiving the vaccine on an unspecified date. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Vomiting
Clinical narrative: major headache; no energy all day stayed in bed; all day throwing up; This is a spontaneous report from a contactable consumer (patient). A 71-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6200), via intramuscular route of administration in Deltoid Right on 18Feb2021 13:45 (age at vaccination of 71-years-old) as 2nd dose, single dose, for COVID-19 immunisation. The patient medical history was none; patient had no allergy. Concomitant medications were not reported. The patient did not receive other vaccine in four weeks. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL8982), via intramuscular route of administration in Right Deltoid on 28Jan2021 13:41(age at vaccination of 71-years-old) for COVID-19 immunisation. Vaccination facility type was Doctors office, urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. On 19Feb2021 at 04:00 the patient experienced major headache, no energy all day stayed in bed all day throwing up and vomiting. No treatment was given for the events. Since the vaccinations the patient has not been tested for COVID-19. The outcome of the all the events were resolved on an unspecified date.  Information on lot/batch number has been requested.  Follow-up (28May2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Follow-up (01Jun2021): New information received from a contactable reporter in response to the HCP letter sent for the patient which includes update on date, time, route of administration, anatomical site of injection, batch/lot number of the dose-1 and dose-2 COVID-19 vaccine. Vaccination facility type and address was also updated.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Tooth infection
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. Report from a contactable consumer reported for herself.  A 75-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EL1283, expiry date was not reported), via an unspecified route of administration, administered in right arm on 26Jan2021 (at the age of 75-years-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. Previously patient had started cefalexin monohydrate (KEFLEX) on 13Jan2021 for an infected tooth. Patient had first dose of the COVID-19 vaccine shot on 26Jan2021. Patient symptoms started on Saturday, 13Feb2021 but patient was diagnosed yesterday, 15Feb2021 with the infection. Patient had to go to the dentist for a tooth infection and yesterday patient started taking an antibiotic. Patient asking, second vaccine appointment was schedule on tomorrow. She inquired as- should get the second shot. Patient clarified that they put her on Keflex 4 times a day for 7 days. Patient started it last night. The outcome of event was recovering.  Follow-up attempts completed. No further information expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate irregular, Palpitations
Clinical narrative: Heart palpitations; difficulty taking a deep breath; hyperawareness of heartbeat, strong heart beat; This is a spontaneous report from a contactable consumer or other non hcp (Patient, self-reporting). A 38-years-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EM9810 and expiration dates were not reported), via an unspecified route of administration in right arm on 18Feb2021 at 13:30 (Age at time of vaccination 38-years-old) as second dose, single for COVID-19 immunization. Medical history included autoimmune thyroiditis, mitral valve prolapse from an unknown date and unknown if ongoing. The concomitant medication included levothyroxine sodium (SYNTHROID), fish oil (OMEGA 3 COMPLETE), colecalciferol (VITAMIN D), probiotics (PROBIOTICS), liothyronine sodium (CYTOMEL) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EL9264 and expiration dates were not reported), via an unspecified route of administration in right arm on 28Jan2021 at 02:00 PM as first dose, single for COVID-19 immunization. On 18Feb2021 21:00 The patient experienced heart palpitations, difficulty taking a deep breath, hyperawareness of heartbeat, strong heart beat. The patient not experienced vaccine in four week. The patient has not covid test prior and post vaccination. The treatment was no for AE. Facility type vaccine: Hospital. The outcome of event was not recovered.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular
Clinical narrative: Itch; she broke out in spots that are red and raised up; This is a spontaneous report from a contactable consumer or other non hcp.  A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 21Jan2021 16:00 (Batch/Lot Number: EL3246) as 1ST DOSE, SINGLE DOSE, dose 2 via an unspecified route of administration, administered in Arm Right on 11Feb2021 16:00 (Batch/Lot Number: EM9810) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation (COVID Prevention). Medical history included Allergic to Shellfish. The patient's concomitant medications were not reported. It was reported that on 22Jan2021 patient broke out in spots that are red and raised up. Reporter was calling about his wife. Reporter states that his wife broke out just a little with the first dose of the product, and with the second shot she broke out in 5 or 6 spots on her belly that are maybe an inch around, and raised up, like pumped up, and her skin is turning red. Reporter clarified the suspect product as the Pfizer COVID Vaccine. Reporter was wondering if this was a normal reaction. Reporter informed that the patient was 76 after the first dose of the product, and 77 when she received the second dose. It was also reported that the patient got her first dose of the product on 21Jan2021, and the spots appeared the next day. Caller reports that they thought they got bed bugs because the spots look like little bites, like welts that stay for two or three days and then they go down. Caller informs that the patient got the second dose on 11Feb2021 and the spots appeared again the day after the injection, and caller confirms they are ongoing and persisting. reporter was wondering how long the spots will last. Caller reports the patient saw a dermatologist and was given a cream. Caller also stated that patient has been using rubbing alcohol on the spots to help the itch. Reporter also stated that his brother, sister and sister-in-law have all received the vaccine and no one else has broken out so far. Patient not having previous doses of the COVID-19 vaccine prior to 21Jan2021. Outcome of the event Itch was unknown. Outcome of the other event was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: felt ill; This is a spontaneous report from a contactable other Health Care Professional. A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EK9231 and Expiry date: Unknown), dose 2 via an unspecified route of administration, on 09Jan2021 (at the age of 42 years old) as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 09Jan2021 the patient experienced felt ill. The outcome of event was unknown.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site mass
Clinical narrative: my right  shoulder started to itch; bumps; red patch; This is a spontaneous report from a contactable HCP.  A 62-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL9266 and Expire Date: unknown) on 27Feb2021 at 11:30 via unspecified route of administration as single dose for Covid -19 immunisation. Patient's medical history included Chonic Kidney D and codine allergy from an unspecified date and unknown if ongoing. Concomitant medications were none. No other vaccines were administered within four weeks and medications in two weeks. Patient had not covid prior vaccination and not covid tested post vaccination. After vaccination, she began to notice her right shoulder started to itch. She rubbed it, then felt it bumps, she looked in the mirror and noticed it was red patch on 27Feb2021 at 11:30 AM. She applied rubbing alcohol and then triple antibiotic ointment. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chills, Cough, Dyspnoea, Loss of personal independence in daily activities
Clinical narrative: have not been able to work; cough; having breathing issues  with asthma s/s; having breathing issues  with asthma s/s; fever; chills; This is a spontaneous report from a contactable other hcp (Patient). A 51-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: En5318), via an unspecified route of administration, administered in Arm Left on 27Jan2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history included cold and exercise induced asthma. The patient had no known allergies. Concomitant medications received within in two weeks of vaccination included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); colecalciferol (VITAMIN D [COLECALCIFEROL]); biotin (BIOTIN); magnesium (MAGNESIUM); cyanocobalamin (B12 [CYANOCOBALAMIN]); fexofenadine hydrochloride (ALLEGRA). Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EJI686), via an unspecified route of administration, administered in Arm Left on 06Jan2021 (at the age of 51years) as SINGLE DOSE for covid-19 immunization. The patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination.  On 28Jan2021, the patient reported that the first two days she had fever, chills, etc. and on day 4 cough started and would not stop. Patient saw doctor and was having breathing issues with asthma. Patient was having couple years ago with cold and exercise induced asthma, however never had issues with having to take steroids or breathing treatments. Patient was now on nebulizer every 4 hrs, have not been able to work, on steroids and other medicines. Patient said it was unknown if it would be a permanent issue with her lungs. Therapeutic measures were taken as a result of having breathing issues with asthma, fever, chills as medicines and nebulizers. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: have not been able to work; cough; having breathing issues  with asthma s/s; having breathing issues  with asthma s/s; fever; chills; This is a spontaneous report from a contactable other hcp (Patient). A 51-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: En5318), via an unspecified route of administration, administered in Arm Left on 27Jan2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history included cold and exercise induced asthma. The patient had no known allergies. Concomitant medications received within in two weeks of vaccination included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); colecalciferol (VITAMIN D [COLECALCIFEROL]); biotin (BIOTIN); magnesium (MAGNESIUM); cyanocobalamin (B12 [CYANOCOBALAMIN]); fexofenadine hydrochloride (ALLEGRA). Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EJI686), via an unspecified route of administration, administered in Arm Left on 06Jan2021 (at the age of 51years) as SINGLE DOSE for covid-19 immunization. The patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination.  On 28Jan2021, the patient reported that the first two days she had fever, chills, etc. and on day 4 cough started and would not stop. Patient saw doctor and was having breathing issues with asthma. Patient was having couple years ago with cold and exercise induced asthma, however never had issues with having to take steroids or breathing treatments. Patient was now on nebulizer every 4 hrs, have not been able to work, on steroids and other medicines. Patient said it was unknown if it would be a permanent issue with her lungs. Therapeutic measures were taken as a result of having breathing issues with asthma, fever, chills as medicines and nebulizers. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Pharyngeal swelling, Respiratory rate increased, Throat tightness, Urticaria
Clinical narrative: Hard to swallow like lump in throat, throat tightness/swelling feeling.; Hard to swallow like lump in throat, throat tightness/swelling feeling.; Hard to swallow like lump in throat, throat tightness/swelling feeling.; slight rapid breathing; Hives on chest; This is a spontaneous report from a contactable Consumer or other non HCP (patient, self-reporting). A 30-years-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: En6203 and expiration dates were not reported), via an unspecified route of administration in Arm Left on 01Mar2021at 17:00 as first dose, single for COVID-19 immunisation. The patient was 30 years old, non-pregnant at the time of vaccination. Medical history included Known allergies: Tree nuts. Concomitant medications included Welbutrin, vyvanse, vitamin c, vitamin d, shilajit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 01Mar2021 17:30 the patient experienced Hard to swallow like lump in throat, throat tightness/swelling feeling. Hives on chest, slight rapid breathing. The patient was treated with benedryl. Therapeutic measures were taken as a result of Hard to swallow like lump in throat, throat tightness/swelling feeling. Hives on chest, slight rapid breathing. Facility type vaccine: School or Student Health Clinic. The Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was resolved.  No follow up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: A rash on my arms, legs, chest, back and torso; This is a spontaneous report received from contactable consumer (Patient himself).. A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6198 and expiration date: Not reported), via an unspecified route of administration in the left arm 27Feb2021 at 10:30 am ad 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history included allergy to Antibiotics (Allergies to medications, food, or other products: neosporan), high blood pressure. The patient's concomitant medications were not reported. The patient concomitant medication hydrochlorothiazide at 25mg and losartan 100mg. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient 2 weeks prior vaccination included hydrochorothidzide 25mg, Lorsartan 100mg. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. On 01Mar2021, the patient developed a rash on arms, legs, torso, chest and back. The patient wanted to know how long he should go on with this event and asked whether there was any treatment or creams he can use to calm down the itching. The patient did not receive any treatment for the events. The outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Headache, Nausea
Clinical narrative: Nausea; headache; dizzy; warm hand; This is a spontaneous report from a contactable Nurse. This Nurse reported for a 20-year-old male patient. A 20-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6201 and expiration dates were not reported), via intramuscular route of administration on 11Feb2021as first dose, single for COVID-19 immunisation. The patient medical history included known allergies from risperidone. Concomitant medication included citalopram. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. It was unknown if the patient was tested for covid post vaccination. On 11Feb2021 the patient experienced nausea, headache, dizzy and warm hand. Adverse Event treatment included juice and observation. Therapeutic measures were taken as a result of nausea, headache, dizzy and warm hand. The outcome of the events was resolved.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Urticaria
Clinical narrative: inflamed lymph nodes near her left clavicle (same side that she received the vaccine on); hives; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Batch number and expiration date: Not reported) via an unspecified route of administration on 23Feb2021 (Tuesday) on the left arm as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that since last Wednesday on 24Feb2021, she developed hives that have continued since she received her first dose. Patient wanted to know if it was ok. On 28Feb2021, the patient also reported two inflamed lymph nodes near her left clavicle on the same side which she received the vaccine shot). The patient stated that two inflamed lymph nodes were also worsening. The patient stated that she was currently treating the events with benadryl. Patient wanted to know whether she should get the second dose. The outcome of the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: This is a spontaneous report from a contactable consumer (Patient). This 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 10Feb2021 (at the age of 73-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 01Mar2021 (a day before reporting), the patient came down with a cold, with the symptoms of sore throat, runny nose. Her doctor told her if it was not COVID-19, then she was ok to get the second dose tomorrow. Patient who was due for her second dose on 03Mar2021 (a day after reporting), wanted to know if it was Ok to get her second COVID-19 shot if she had cold. However, patient reported that she won't be able to get her second shot because of colds. She planned on mentioning it to the vaccination provider. Patient was Ok with further follow-up from Safety. Patient asked how long the second dose can be delayed. The outcome of all events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Tinnitus
Clinical narrative: tinnitus for several years which worsened; little tired; sore arm; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), dose 1 via unspecified route of administration on Feb2021 as single dose for COVID-19 immunisation. Medical history included ongoing tinnitus. Concomitant medications were not reported. Patient asked he would like to know if there is data on anyone who had new or worsened tinnitus after receiving the 1st dose of the Pfizer COVID vaccine. After receiving the vaccine last week, he reported a history of tinnitus for several years which worsened the morning after receiving the vaccine on an unknown date in Feb2021, when he woke up. He was also a little tired on Feb2021 and had a sore arm for the first couple of days on Feb2021. And patient would like to know if he could get the second dose of the Pfizer COVID vaccine after his experience with the 1st dose and what is considered a severe allergic reaction to the COVID vaccine and how quickly it could occur. Patient would like to know what is an example of the contraindication: had a severe allergic reaction to any ingredient of this vaccine and would like to know the efficacy of one dose of the COVID vaccine. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Pyrexia
Clinical narrative: Fever of 102; Severe nausea; chills; This is a spontaneous report from a contactable consumer reporting for herself. A 69-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration, administered in Left arm on 25Feb2021 at 18:45 as single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus. Concomitant medication(s) included metformin (GLUCOPHAGE); levothyroxine sodium (SYNTHROID); atenolol; simvastatin and QUIN. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. On 01Mar2021 at 07:00 the patient had Severe nausea, chills, and fever of 102. No treatment was received. The patient underwent lab tests and procedures which included body temperature: 102 (unit not reported) on 01Mar2021. The outcome of the events was resolved on unknown date of Mar2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable Nurse (patient). A 28-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot number: EL9262), via an unspecified route of administration on Jan2021 at 02:15 pm (at the age of 28-year-old ) on the left arm as a single dose for COVID-19 immunisation. Medical history included Ulcerative Colitis and allergy to NSAIDS. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. COVID tested post vaccination was none. Patient's other medication 2 weeks prior vaccination included Mesalamine. The patient stated that 3 days after receiving the first dose on 26Jan2021, the patient had extreme arm pain, soreness and decreased mobility in the arm. The patient stated that the pain and mobility got better. The patient further stated that it has been over 2 months and she was still experiencing arm pain and had difficulty in moving her arm above the head. The patient stated that when she checked out of the vaccination centre, there was a pocket of fluid noted where her vaccine was given. The patient had a physician office visit due to the events. The patient did not receive any treatment medication for the event. The outcome of the events was recovered on an unspecified date (with lasting effects).  No follow-up attempts are possible. No further information is expected.