chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: his fever today is 101.8 F; This is a spontaneous report received from a other health care professional. A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 11Mar2021 (at the age of 57-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated, "My husband and I both had a Covid vaccine shot on the 11Mar2021, and he was having a reaction, but she was okay, and he has like underlying conditions so she just wondering if she should be concerned because his fever today was 101.8 F". Height and weight for the patient, reporter stated, he was about 5'9, 5'10 and 230 pounds probably. For further probing, reporter mentioned, "I did tell you my story after I get my questions answered about the vaccine that if I need to worry or take him to the doctor or what?". The patient underwent lab tests and procedures which included fever was 101.8 Fahrenheit on an unknown date. The outcome of the event was unknown.  No follow up activities are needed; No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Appetite disorder, Fatigue, Full blood count, Hypersensitivity, Nausea
Clinical narrative: Real strong appetite change; Episode of nausea; Achy; Fatigue; Itchy hive on my arm about 2 inches from the injection site and it itched and grew for a couple of days and then it flattened; Hives that itched on my arm; Itchy hive on my arm about 2 inches from the injection site and it itched and grew for a couple of days and then it flattened; Hives that itched on my arm; she thought she had a non-severe allergic reaction; Rash; This is a spontaneous report from a contactable consumer (patient).  A 68-years-old female patient received BNT162B2 (Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 14Feb2021 (at the age of 67 year old) as dose 2, single for COVID-19 immunisation.  Medical history included, High cholesterol, nerve disorders like chronic migraine both started 20 years ago. She is not a smoker. Concomitant medications included pravastatin for high cholesterol and nortriptyline hydrochloride (PAMELOR) for migraine and an unspecified statin for high cholesterol. Historical vaccine included first dose of BNT162B2, lot number unknown, via an unspecified route of administration on 24Jan2021 (at the age of 67 year old), as single dose for COVID-19 immunization. After the second COVID vaccine, the patient had an unusual reaction. On 14Feb2021, a couple of hours after getting the vaccine, she got a very itchy hive on her arm about 2 inches from the injection site and it itched and grew for a couple of days and then it got flattened. And by day 3 or 4, that is on 17Feb2021/18Feb2021, the hives was gone, where she thought she had a non-severe allergic reaction. After the rash went away, on 18Feb2021, she got very nauseous, achy and very fatigued for about 4 days, till 22Feb2021. She reported that she rested for 4 weeks. By 27Feb2021, she got better, where achiness gone. She also had a real strong appetite change, that she could not stand to eat flavory food or much cooked food. It was reported that, between 22Feb2021 and at the time of report,  she had about 4-5 episodes of nausea. At the time of report, it's been 4 and a half weeks, where about every 3 days (as like episode of nausea on last Friday and then on Monday) she would get very nauseous, she took Compazine or Zofran for it. Compazine was of dose 10 mg and she would take either 5 or 10 depending on how she feel. And after a day or so it goes away. She did doctor's visit on Friday and had all her laboratory test 03Mar2021, including blood test, complete blood count, urine test and all they were normal. The outcome of the event nauseous was not recovered and of Real strong appetite change was unknown and of very fatigued was recovering and of other events was recovered on an unspecified date in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash, Urine analysis, Urticaria
Clinical narrative: Real strong appetite change; Episode of nausea; Achy; Fatigue; Itchy hive on my arm about 2 inches from the injection site and it itched and grew for a couple of days and then it flattened; Hives that itched on my arm; Itchy hive on my arm about 2 inches from the injection site and it itched and grew for a couple of days and then it flattened; Hives that itched on my arm; she thought she had a non-severe allergic reaction; Rash; This is a spontaneous report from a contactable consumer (patient).  A 68-years-old female patient received BNT162B2 (Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 14Feb2021 (at the age of 67 year old) as dose 2, single for COVID-19 immunisation.  Medical history included, High cholesterol, nerve disorders like chronic migraine both started 20 years ago. She is not a smoker. Concomitant medications included pravastatin for high cholesterol and nortriptyline hydrochloride (PAMELOR) for migraine and an unspecified statin for high cholesterol. Historical vaccine included first dose of BNT162B2, lot number unknown, via an unspecified route of administration on 24Jan2021 (at the age of 67 year old), as single dose for COVID-19 immunization. After the second COVID vaccine, the patient had an unusual reaction. On 14Feb2021, a couple of hours after getting the vaccine, she got a very itchy hive on her arm about 2 inches from the injection site and it itched and grew for a couple of days and then it got flattened. And by day 3 or 4, that is on 17Feb2021/18Feb2021, the hives was gone, where she thought she had a non-severe allergic reaction. After the rash went away, on 18Feb2021, she got very nauseous, achy and very fatigued for about 4 days, till 22Feb2021. She reported that she rested for 4 weeks. By 27Feb2021, she got better, where achiness gone. She also had a real strong appetite change, that she could not stand to eat flavory food or much cooked food. It was reported that, between 22Feb2021 and at the time of report,  she had about 4-5 episodes of nausea. At the time of report, it's been 4 and a half weeks, where about every 3 days (as like episode of nausea on last Friday and then on Monday) she would get very nauseous, she took Compazine or Zofran for it. Compazine was of dose 10 mg and she would take either 5 or 10 depending on how she feel. And after a day or so it goes away. She did doctor's visit on Friday and had all her laboratory test 03Mar2021, including blood test, complete blood count, urine test and all they were normal. The outcome of the event nauseous was not recovered and of Real strong appetite change was unknown and of very fatigued was recovering and of other events was recovered on an unspecified date in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Dizziness, Fatigue
Clinical narrative: Feeling bad; The fever was a 101.1; Dizzy/Started feeling like kind of lightheaded like we have a little joint or something; I was not able to sleep last night; Felt very weak; Nauseated; Whole body had joint pain; Vaccine site is hurting where they gave the injection; Exhaustion; Muscle pain; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported),  via an unspecified route of administration, administered in Left arm on 16Mar2021 as dose 1, single for covid-19 immunization.  Medical history included osteoporosis and irritable bowel syndrome. Prior to vaccination patient previously had covid-19 in Aug2020. Patient concomitant medication included vitamins. The patient was feeling bad after the vaccination, she had the fever with temperature a 101.1 and was  dizzy ,started feeling like kind of lightheaded like we have a little joint or something, she was not able to sleep last night. The patient felt very weak and was nauseated. The whole body had joint pain and vaccine site is hurting where they gave the injection exhaustion. She had muscle pain. The patient underwent lab tests and procedures which included body temperature: 101.1 (units unspecified) and COVID-19 test with positive result in Aug2020. The outcome of the events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Injection site pain, Insomnia, Myalgia, Nausea
Clinical narrative: Feeling bad; The fever was a 101.1; Dizzy/Started feeling like kind of lightheaded like we have a little joint or something; I was not able to sleep last night; Felt very weak; Nauseated; Whole body had joint pain; Vaccine site is hurting where they gave the injection; Exhaustion; Muscle pain; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported),  via an unspecified route of administration, administered in Left arm on 16Mar2021 as dose 1, single for covid-19 immunization.  Medical history included osteoporosis and irritable bowel syndrome. Prior to vaccination patient previously had covid-19 in Aug2020. Patient concomitant medication included vitamins. The patient was feeling bad after the vaccination, she had the fever with temperature a 101.1 and was  dizzy ,started feeling like kind of lightheaded like we have a little joint or something, she was not able to sleep last night. The patient felt very weak and was nauseated. The whole body had joint pain and vaccine site is hurting where they gave the injection exhaustion. She had muscle pain. The patient underwent lab tests and procedures which included body temperature: 101.1 (units unspecified) and COVID-19 test with positive result in Aug2020. The outcome of the events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: Feeling bad; The fever was a 101.1; Dizzy/Started feeling like kind of lightheaded like we have a little joint or something; I was not able to sleep last night; Felt very weak; Nauseated; Whole body had joint pain; Vaccine site is hurting where they gave the injection; Exhaustion; Muscle pain; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported),  via an unspecified route of administration, administered in Left arm on 16Mar2021 as dose 1, single for covid-19 immunization.  Medical history included osteoporosis and irritable bowel syndrome. Prior to vaccination patient previously had covid-19 in Aug2020. Patient concomitant medication included vitamins. The patient was feeling bad after the vaccination, she had the fever with temperature a 101.1 and was  dizzy ,started feeling like kind of lightheaded like we have a little joint or something, she was not able to sleep last night. The patient felt very weak and was nauseated. The whole body had joint pain and vaccine site is hurting where they gave the injection exhaustion. She had muscle pain. The patient underwent lab tests and procedures which included body temperature: 101.1 (units unspecified) and COVID-19 test with positive result in Aug2020. The outcome of the events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Vaccination site pain
Clinical narrative: She has pain in her joints and where they gave her the injection; She is very tired/Exhaustion; started feeling like kind of lightheaded like we have a little joint or something; She has pain in her joints and where they gave her the injection/injection site is very painful; This is a spontaneous report from a contactable consumer. This consumer reported information for two different patients. This is the second of two reports. An 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported), via an unspecified route of administration, in upper left arm, on 16Mar2021 02:30, at dose 1, single for covid-19 immunization. Medical history included osteoporosis, arthritis, Afib (atrial fibrillation), blood pressure, covid in last August (as reported), thyroid. Concomitant medications included atorvastatin (LIPITOR), she is on blood thinners and blood pressure medications and 4 different medication for thyroid (unspecified). The patient had pain in her joints and where the injection was given, she is very tired/exhaustion, the injection site is very painful, started feeling like kind of lightheaded like; had a little joint or something (as reported) on an unspecified date. The outcome of the events was unknown.    No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021416521 Same reporter/drug and different patient/events
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Psoriasis
Clinical narrative: Psoriasis; joint pain; This is a spontaneous report from a contactable consumer (patient) reported himself. A 68-years-old male patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: unknown), via an unknown route of administration on an unknown date (at the age of 68-years-old) as dose number unknown, single for COVID-19 immunization. The patient's medical history was not reported. The patient also received tofacitinib citrate (XELJANZ, strength: 5 mg) for an unknown indication, start and stop dates were not reported. The patient's medical history and concomitant medication were not reported. Patient due for a refill, he stated, "I have been without medication almost two months. My Psoriasis and joint pain have become severe, and I have also received the Covid-19 vaccine." Patient was prescribed Xeljanz 5mg. The action taken in response to the event for tofacitinib citrate was unknown. The outcome of the events was unknown.  No follow-up attempts are possible; Information about Lot/Batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Vomiting
Clinical narrative: severe vomiting; diarrheoa; severe chills; fatigue; This is a spontaneous report from a contactable consumer (patient). A 26-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown), via an unspecified route of administration, administered in Arm Left on 15Apr2021 at 16:00 (at the age of 26-years-old) as dose 2, single for covid-19 immunization. Medical history included Hashimotos and asthma; both from an unknown date and unknown if ongoing. The patient had no known allergies. The patient did not receive any other vaccine in four weeks. The patient received other medications in two weeks. The patient previously received first dose of bnt162b2 (Lot number: unknown), via an unspecified route of administration, administered in Arm Left on 25Mar2021 at 16:00 (at the age of 26-years-old) as dose 1, single for covid-19 immunization. The patient has no covid prior vaccination. On 15Apr2021 at 21:00, the patient experienced severe vomiting 30+ times and diarrhea for about 6 hours. Also had severe chills and fatigue. The patient did not receive treatment for events. The patient was not tested for covid post vaccination. The outcome of events was recovered on an unspecified date in Apr2021.  No follow-up attempts are possible. Information about Lot number/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Hyperhidrosis, Pain
Clinical narrative: Achy; Thirsty; Extremely weak; Sweating; Intense arm pain at site of injection; Tired; Fever; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 49-years-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 18Apr2021 13:00 (Age at vaccination: 49-years-old) as dose 2, single for covid-19 immunization. Medical history included back pain, allergies to Dog dander, Peanuts, Dust all from an unknown date and unknown if ongoing. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 in Left arm on 30Mar2021 03:45 PM for covid-19 immunization. Patient did not receive other vaccine in four weeks. Patient did not receive Other medications in two weeks. Patient was not diagnosed with covid prior to vaccination. On 19Apr2021 16:45 patient experienced Extremely weak, thirsty, Sweating, Intense arm pain at site of injection, achy, tired, fever. Patient did not receive any treatment for the events. Patient was no tested for covid post vaccination. The patient underwent lab tests and procedures which included body temperature: fever on 19Apr2021. the outcome for the events was reported as not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Thirst, Vaccination site pain
Clinical narrative: Achy; Thirsty; Extremely weak; Sweating; Intense arm pain at site of injection; Tired; Fever; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 49-years-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 18Apr2021 13:00 (Age at vaccination: 49-years-old) as dose 2, single for covid-19 immunization. Medical history included back pain, allergies to Dog dander, Peanuts, Dust all from an unknown date and unknown if ongoing. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 in Left arm on 30Mar2021 03:45 PM for covid-19 immunization. Patient did not receive other vaccine in four weeks. Patient did not receive Other medications in two weeks. Patient was not diagnosed with covid prior to vaccination. On 19Apr2021 16:45 patient experienced Extremely weak, thirsty, Sweating, Intense arm pain at site of injection, achy, tired, fever. Patient did not receive any treatment for the events. Patient was no tested for covid post vaccination. The patient underwent lab tests and procedures which included body temperature: fever on 19Apr2021. the outcome for the events was reported as not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report from a contactable nurse via Pfizer sponsored program. A 65-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization and received ongoing tofacitinib citrate tablet (XELJANZ XR, Lot number- UNKNOWN, Expiration Date- 30Jan2023) orally from 09Apr2020, at a dose and frequency of 11 mg, 1x/day for an unspecified indication. Patient medical history included knee surgery. The concomitant medications were not reported. On an unspecified date it was reported after having knee surgery and being off Xeljanz for 3 weeks she had the COVID vaccine and 2 weeks later the patient broke out in a rash after she restarted the Xeljanz. Medical Doctor (MD) was aware. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Neuralgia
Clinical narrative: nerve pain/it continued to get worse with the second dose/three weeks later, still having pain; serious insomnia; This is a spontaneous report from a contactable consumer (patient). A 65-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN28730), dose 2 via an unspecified route of administration, administered in arm left on 28Mar2021 (at the age of 65-years-old) as DOSE 2, SINGLE for covid-19 immunisation at other facility. Medical history included old nerve condition (it appeared to exacerbate an old nerve condition that occurred after having a large tumor removed from a nerve in her back), a large tumor removed from a nerve in her back and known allergies of steroid sensitivity. There were no concomitant medications. Previously, the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205), dose 1 via an unspecified route of administration, administration in left arm on 09Mar2021, 04:00 (at the age of 65-years-old) as DOSE 1, SINGLE for covid-19 immunisation and experienced nerve pain (it appeared to exacerbate an old nerve condition that occurred after having a large tumor removed from a nerve in her back). No other vaccine in four weeks and no other medications in two weeks. No covid tested post vaccination. On unknown date in 2021, the patient experienced nerve pain/it continued to get worse with the second dose. On unknown date in 2021 (three weeks later), the patient was still having pain, and experienced serious insomnia. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment for adverse event included temporary pains meds as therapeutic measure for nerve pain/it continued to get worse with the second dose/three weeks later, still having pain. Outcome of events not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache, Nausea, Ocular hyperaemia, Skin swelling
Clinical narrative: left eyelid swollen; redness in right eye; right eyelid swollen; Headache; Nausea; She rubbed it and saw that it was puffy; Later on her right eye was sore like she had a shot in it; This is a spontaneous report from a contactable consumer (Patient). A 56-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0151 and expiration date :not reported) via an unspecified route of administration, administered in left arm on 20Apr2021 at 10:00 (Age at vaccination 56 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included diabetes mellitus and high blood pressure from 1999 to ongoing. History of all previous immunization with the Pfizer vaccine considered as suspect was None. Prior Vaccinations (within 4 weeks) was None. Family Medical History Relevant to AE(s) was None. Concomitant medication(s) included metformin (METFORMIN) 1000mg daily from Apr2021 to ongoing, insulin detemir (LEVEMIR) 46 units in the morning50 units in the evening from Dec2014 to ongoing, liraglutide (VICTOZA) 1.8units daily from 2019 to ongoing, glipizide (GLIPIZIDE) 10mg by mouth daily from 2019 to ongoing taken for diabetes mellitus, lisinopril (LISINOPRIL) 10mg by mouth daily from an unspecified start date to ongoing for blood pressure and hydrochlorothiazide (HYDROCHLOROTHIAZIDE) 25mg by mouth daily from an unspecified start date to ongoing taken for water pill. On 20Apr2021, patient experienced headache, nausea. On 22Apr2021, right eyelid swollen and redness in right eye. On 23Apr2021 patient experienced left eyelid swollen. In Apr2021, she rubbed it and saw that it was puffy and later on her right eye was sore like she had a shot in it. The right eye was red and more swollen than the left. When asked details about the swelling, she states she didn't pay attention to her face yesterday. She wiped her face and went on about her day. Later on her right eye was sore like she had a shot in it. She rubbed it and saw that it was puffy. On the day of reporting her left eyelid was swollen. The patient inquired what should she do. If it worsens should she go see a doctor. AE(s) did not require any visit to Emergency Room/ Physician Office. Relevant test was reported as none. The outcome of events Headache and Nausea was recovered in 20Apr2021, right eyelid swollen, left eyelid swollen and redness in right eye was not recovered, she rubbed it and saw that it was puffy and later on her right eye was sore like she had a shot in it was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: left eyelid swollen; redness in right eye; right eyelid swollen; Headache; Nausea; She rubbed it and saw that it was puffy; Later on her right eye was sore like she had a shot in it; This is a spontaneous report from a contactable consumer (Patient). A 56-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0151 and expiration date :not reported) via an unspecified route of administration, administered in left arm on 20Apr2021 at 10:00 (Age at vaccination 56 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included diabetes mellitus and high blood pressure from 1999 to ongoing. History of all previous immunization with the Pfizer vaccine considered as suspect was None. Prior Vaccinations (within 4 weeks) was None. Family Medical History Relevant to AE(s) was None. Concomitant medication(s) included metformin (METFORMIN) 1000mg daily from Apr2021 to ongoing, insulin detemir (LEVEMIR) 46 units in the morning50 units in the evening from Dec2014 to ongoing, liraglutide (VICTOZA) 1.8units daily from 2019 to ongoing, glipizide (GLIPIZIDE) 10mg by mouth daily from 2019 to ongoing taken for diabetes mellitus, lisinopril (LISINOPRIL) 10mg by mouth daily from an unspecified start date to ongoing for blood pressure and hydrochlorothiazide (HYDROCHLOROTHIAZIDE) 25mg by mouth daily from an unspecified start date to ongoing taken for water pill. On 20Apr2021, patient experienced headache, nausea. On 22Apr2021, right eyelid swollen and redness in right eye. On 23Apr2021 patient experienced left eyelid swollen. In Apr2021, she rubbed it and saw that it was puffy and later on her right eye was sore like she had a shot in it. The right eye was red and more swollen than the left. When asked details about the swelling, she states she didn't pay attention to her face yesterday. She wiped her face and went on about her day. Later on her right eye was sore like she had a shot in it. She rubbed it and saw that it was puffy. On the day of reporting her left eyelid was swollen. The patient inquired what should she do. If it worsens should she go see a doctor. AE(s) did not require any visit to Emergency Room/ Physician Office. Relevant test was reported as none. The outcome of events Headache and Nausea was recovered in 20Apr2021, right eyelid swollen, left eyelid swollen and redness in right eye was not recovered, she rubbed it and saw that it was puffy and later on her right eye was sore like she had a shot in it was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Arthralgia, Chills, Fatigue, Hypersensitivity
Clinical narrative: Injection site pain; tiredness; muscle pain; chills; joint pain; injection site swelling; injection site redness; feeling unwell; severe allergic reaction; rash; itching; hives; swelling in the face; loss of taste; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 58-years-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8736), via an unspecified route of administration, administered in Arm Left on 23Apr2021 09:30 (Age at vaccination: 58-years-old) as dose 1, single for covid-19 immunization. (Vaccination facility: Other). Medical history was reported as none. There were no concomitant medications. Patient did not receive other vaccine in four weeks. Patient did not receive Other medications in two weeks. Patient was not diagnosed with covid prior to vaccination. On 25Apr2021 patient experienced Injection site pain, tiredness, muscle pain, chills, joint pain, injection site swelling, injection site redness, feeling unwell, severe allergic reaction of rash itching hives, swelling in the face, loss of taste. Patient was no tested for covid post vaccination. patient did not receive any treatment for the events. The outcome for the events was reported as resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise, Myalgia
Clinical narrative: Injection site pain; tiredness; muscle pain; chills; joint pain; injection site swelling; injection site redness; feeling unwell; severe allergic reaction; rash; itching; hives; swelling in the face; loss of taste; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 58-years-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8736), via an unspecified route of administration, administered in Arm Left on 23Apr2021 09:30 (Age at vaccination: 58-years-old) as dose 1, single for covid-19 immunization. (Vaccination facility: Other). Medical history was reported as none. There were no concomitant medications. Patient did not receive other vaccine in four weeks. Patient did not receive Other medications in two weeks. Patient was not diagnosed with covid prior to vaccination. On 25Apr2021 patient experienced Injection site pain, tiredness, muscle pain, chills, joint pain, injection site swelling, injection site redness, feeling unwell, severe allergic reaction of rash itching hives, swelling in the face, loss of taste. Patient was no tested for covid post vaccination. patient did not receive any treatment for the events. The outcome for the events was reported as resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Swelling face, Urticaria
Clinical narrative: Injection site pain; tiredness; muscle pain; chills; joint pain; injection site swelling; injection site redness; feeling unwell; severe allergic reaction; rash; itching; hives; swelling in the face; loss of taste; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 58-years-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8736), via an unspecified route of administration, administered in Arm Left on 23Apr2021 09:30 (Age at vaccination: 58-years-old) as dose 1, single for covid-19 immunization. (Vaccination facility: Other). Medical history was reported as none. There were no concomitant medications. Patient did not receive other vaccine in four weeks. Patient did not receive Other medications in two weeks. Patient was not diagnosed with covid prior to vaccination. On 25Apr2021 patient experienced Injection site pain, tiredness, muscle pain, chills, joint pain, injection site swelling, injection site redness, feeling unwell, severe allergic reaction of rash itching hives, swelling in the face, loss of taste. Patient was no tested for covid post vaccination. patient did not receive any treatment for the events. The outcome for the events was reported as resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dysmenorrhoea, Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Extreme abnormal mentsrual cycle; intense cramps and bleeding; intense cramps and bleeding; Severe chest pain when lying down; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0162, Expiration Date: not reported) via an unspecified route of administration in Left Arm on 16Apr2021 18:30 as dose 1, single for COVID-19 immunization (at the age of 31-year-old, non-pregnant). Medical history included attention deficit hyperactivity disorder (ADHD) from an unknown date and unknown if ongoing. Patient had no known allergies. Patient had no covid prior vaccination and was not covid tested post vaccination. Concomitant medication(s) (in two weeks) included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for attention deficit hyperactivity disorder, start and stop date were not reported. Patient did not receive any other vaccine in four weeks. The patient experienced extreme abnormal mentsrual cycle, intense cramps and bleeding, severe chest pain when lying down on 19Apr2021. Patient was sent for two days. Ae resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the events. The outcome of the events was not recovered.  No follow up attempts are possible; no further information expected
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Eye pain, Facial pain, Headache, SARS-CoV-2 test
Clinical narrative: Headache on the left side of forehead; Pain behind left eye; pain behind my left eye and along my left face stopping at the cheek area; dose 1 and dose 2 administered on 24Mar2021; This is a spontaneous report from a contactable other HCP (the patient). A 57-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730), via an unspecified route of administration in the left arm on 24Mar2021 at 09:00 (at the age of 57-year-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162), via an unspecified route of administration in the right arm on 24Mar2021 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and right leg neuropathy. Concomitant medications included labetalol (MANUFACTURER UNKNOWN), amlodipine besilate (NORVASC), benazepril (MANUFACTURER UNKNOWN), duloxetine (MANUFACTURER UNKNOWN) and gabapentin (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient did not have a history of any past drug therapy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 12:00, the patient experienced headache on the left side of forehead, pain behind left eye and left face stopping at the cheek area. Patient did not received any treatment for the events. On 11Apr2021, the patient underwent lab tests and procedures which included atila iAMP NAAT RT-PCR COVID-19 detection (nasal swab) test and the result was negative. The clinical outcome of the events headache on the left side of forehead, pain behind left eye and left face stopping at the cheek area were not recovered.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated reporter details (occupation), updated vaccine details (start and stop time of dose 1, state and end date for dose 2) and event medically confirmed. Corresponding data field and narrative was updated to reflect that patient did not receive any treatment for events. Added event (Extra dose administered).  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Peripheral swelling, Swelling face, Swollen tongue
Clinical narrative: swollen face; swollen tongue; swollen arms; fast heart beat; This is a spontaneous report from a Pfizer sponsored program COVAX US Support contactable consumer (Patient).   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 26Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient she got the 1st dose of the vaccine on 26Feb2021and she experienced on unspecified date severe side effects and allergies like swollen face, tongue and arms and fast heart beat after taking the 1st dose. She's not yet done with the second dose and she wants to know if she needs to take it after having the side effects from the 1st dose. She also asked if she will have the same side effects for the 2nd dose. The outcome for the events swollen face, tongue and arms and fast heart beat was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report from a contactable consumer (Patient's daughter), based on information received by Pfizer (manufacturer control number: EC-2021-087951), for BNT162B2 (COMIRNATY). A female patient of an unspecified age received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation; lenvatinib mesilate (LENVIMA, Batch/Lot number was not reported), via an unspecified route of administration from 05Feb2021 to Mar2021, at 14 mg, daily for Endometrial Carcinoma; pembrolizumab (KEYTRUDA, batch/lot number was not reported), route of administration, start and stop date, and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient experienced hives on 07Apr2021 and treated with prednisone. It was reported that the patient diagnosis was endometrial carcinoma, Prescribed Lenvima 14mg daily, start 05Feb2021, stop Mar2021. Patient has stopped all treatments and therapies (stopped Lenvima in Mar2021). Patient's daughter, stated the patient had hives on 07Apr2021 which was due to her receiving the Pfizer COVID vaccination a day before her Keytruda infusion, and there was a reaction of hives. Patient had taken prednisone to treat, which she was no longer taking. The action taken in response to the event for lenvatinib mesilate was permanently withdrawn on Mar2021, for pembrolizumab was unknown. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Cough
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, reported by a contactable other HCP (patient/herself). A 65-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported, expiration date: unknown), via an unspecified route of administration, on an unspecified date, in Apr 2021, single dose, for COVID-19 immunisation. The patient also received Xeljanz XR 11 mg (tofacitinib citrate) tablet, via oral route of administration, from Dec 2020, ongoing, daily, for rheumatoid arthritis. The patient's medical history and concomitant medications not reported. On an unspecified date, patient had a cough, discomfort in chest and joint pain for couple of days. Patient reported after start of therapy may forget or miss a dose every other day or not often without change in symptoms. Doing pretty good on Xeljanz. Weather change cause symptoms to worsen (no details provided). The outcome of events recovered. No follow-up attempts needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Little soreness in arm; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced little soreness in arm. It was reported that while calling about her husband, the caller mentions that they both had a little soreness in their arm after the vaccine. Caller declined to complete full report. The clinical outcome of the event was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Headache; Muscle aches; Fever; This is a spontaneous report from a contactable consumer (patient) who reported in response to consumer letter sent via follow-up letter. A 44-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL3247) via intramuscular on 21Jan2021 at 11:00 in left arm as a single dose for covid-19 immunization. The patient's medical history, concomitant medications and prior vaccinations were reported as none. The patient experienced fever on 22Jan2021 at 06:00, headache and muscle aches on 22Jan2021 at 10:00. The events were reported as non-serious. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL3247) via intramuscular on 12Feb2021 at 10.50 in left arm as a single dose for covid-19 immunization. Relevant tests were reported as none. The outcome of all the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: I received the second dose on May 7th around 10:40 a.m. I started having chest aches, sharp pains on May 9th continuing to May 10th. It started over my heart then moved to under my throat. Now it has; This is a spontaneous report from a contactable consumer (patient herself). A 40-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: ER2613), via an unspecified route of administration, administered in Arm Left on 07May2021 10:40 (age at vaccination: 40 years) as DOSE 2, SINGLE for covid-19 immunisation in an hospital. The patient's medical history included post-traumatic stress disorder, estrogen and penicillin allergy. Concomitant medication(s) included ascorbic acid (+) biotin (+) calcium pantothenate (+) calcium phosphate dibasic (+) cyanocobalamin (+) ferrous fumarate (+) folic acid (+) magnesium oxide (+) manganese sulfate (+) nicotinamide (+) potassium sulfate (+) pyridoxine hydrochloride (+) riboflavin (+) thiamine mononitrate (+) tocopheryl acid succinate (+) zinc sulfate (MULTI VITAMINS & MINERALS) and Xenerdrine Diet Pills. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6205) via an unspecified route of administration, administered in Arm Left on 16Apr2021 09:30 as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccine in four weeks. On 09May2021 22:00, the patient received the second dose on may 7th around 10:40 and started having chest aches, sharp pains on may 9th continuing to may 10th. It started over her heart then moved to under her throat. Now it has lessen, but still there. She reached out to the hospital staff to ask if this was a symptom of the vaccine. The patient did not have covid prior to vaccination nor was tested post vaccination. The outcome of the event was recovering. The device date was 11May2021.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Severe dehydration; extreme fatigue; body aches; headache; fever-slight; This is a spontaneous report from a non-contactable consumer or other non hcp.   A 31-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 11May2021 16:30  (Age at vaccination 31 years old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was none known allergies: None. Concomitant medications included cyanocobalamin (B12-VITAMIN), zinc chloride (ZINC CHLORIDE) taken for an unspecified indication, start and stop date were not reported. Patient had covid prior vaccination. covid tested post vaccination was no.  other medications in two weeks was B12, elderberry, zinc, acid reflux medication.  On 12May2021 10:00 Severe dehydration, extreme fatigue, body aches, headache, fever-slight. Outcome of the event was not recovered.   No follow up attempts are possible. Information on Lot/batch number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Skin tightness, Swelling face
Clinical narrative: tightness on right side of face; large swelling on right side of face; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 47-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 20May2021 17:45 (Batch/Lot Number: EW0185 KCHD) as dose 1, single (age at vaccination 47-year-old) for COVID-19 immunisation. Medical history included High blood pressure and diabetes mellitus from an unknown date and unknown if ongoing. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced tightness on right side of face and large swelling on right side of face on 21May2021 17:00. It was reported that Vaccine Thursday evening, Friday evening tightness on right side of face. Saturday morning large swelling on right side of face, Video dr visit advised to go to ER, ER prescribed antibiotics. Swelling on right side of face is worse. No other symptoms no relief in very large swollen right side of face, Appointment with primary dr. Therapeutic measures were taken as a result of events. The outcome for all events was not recovered. Follow-up attempts are completed. No further information is expected.