chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: mild pain on the injection site/my arm hurt just a little bit; This is a spontaneous report from a contactable consumer (patient). This consumer reported same event for herself and her husband. This is the first of the two reports. An elderly female patient above 75 years old received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the arm, on an unspecified date at single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. After the first vaccination, patient experienced very mild pain on the injection site that went away the next day, patient's arm hurt just a little bit, but by the next day was fine. Patient took an acetylsalicylic acid (BABY ASPIRIN) and did not experience hematoma/bleeding on the injection site. The patient has been told that some friends experienced a higher incidence/severity of adverse events after the 2nd dose (including pain on the injection site, fever, chills, vomiting) (AER#2021092618). Patient is about to receive their 2nd dose 21 days later (this Friday). She is wondering if the diphenhydramine hydrochloride/paracetamol (TYLENOL PM) and aspirin will affect the vaccine-induced antibody response and if it is true that patients get 'sicker' after the 2nd dose. (Is the incidence of AEs higher after the 2nd dose?). She is referring to the Pfizer-BioNTech COVID-19 vaccine. Outcome of the event was recovered.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092617 same product/event, different patient.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Malaise
Clinical narrative: arms were sore; feels unwell; Tiredness; chills; this morning about 8 am I was running a fever 101.5; muscle ache; joint pain/joint aches; severe injection site pain; swelling and redness in left arm at injection site; swelling and redness in left arm at injection site; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiration date listed on the card was either 03May2021 or 31May2021), intramuscularly in left arm on 24Jan2021 13:30 at 0.3 ml single for COVID-19 immunization. Medical history included COVID from Jun2020. Concomitant medications were none. Patient received the first dose of the vaccine, initially before bed he noticed his arms were sore, about 2 a.m., his arm was so sore it woke him up when he rolled over on it. It hurt throughout the night, he started to get chills, just like when he had COVID earlier in the year and this morning about 8 a.m. he was running a fever 101.5, muscle ache and joint pain. He felt exactly how he felt, when running a fever. He was experiencing 8 of the 12 side effects, none of the allergic reactions only fever, joint aches. He was experiencing about 90% of the side effects listed on page 3 the paperwork he received. He was not having any breathing issues. He had severe injection site pain on 24Jan2021, it literally felt like he had surgery on his left arm. Since he woke up this morning around 6 a.m. he had been experiencing tiredness, muscle pain, chills, joint pain, and he had a fever of 101.5 all on 25Jan2021. He had swelling and redness in his left arm at injection site on 24Jan2021. He didn't feel any lymph node swelling and he was not sick. He felt unwell. He felt like he twisted his shoulder, he went to bed and he woke up shivering like he had the COVID virus. He had the COVID virus back in Jun2020. The injection site arm pain was severe in the middle of night, and woke him up in the middle of the night. When he rolled over, he explained that he used both arms to help get out of bed and he could barely get up to go to the restroom. He was wrapped up so the chills were pretty good, when he woke up they were racking chills (which he also experienced these type of chills when he had the COVID virus). No treatment was received. He needed a magnifying glass and to get in the light to see the lot number on the card he was given. He took a boatload of drugs. Reported the details about his medications could be obtained from this hcp. He did not know them off the top of his head. Outcome of events arms were sore and felt unwell was unknown and of other events was not resolved.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: arms were sore; feels unwell; Tiredness; chills; this morning about 8 am I was running a fever 101.5; muscle ache; joint pain/joint aches; severe injection site pain; swelling and redness in left arm at injection site; swelling and redness in left arm at injection site; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiration date listed on the card was either 03May2021 or 31May2021), intramuscularly in left arm on 24Jan2021 13:30 at 0.3 ml single for COVID-19 immunization. Medical history included COVID from Jun2020. Concomitant medications were none. Patient received the first dose of the vaccine, initially before bed he noticed his arms were sore, about 2 a.m., his arm was so sore it woke him up when he rolled over on it. It hurt throughout the night, he started to get chills, just like when he had COVID earlier in the year and this morning about 8 a.m. he was running a fever 101.5, muscle ache and joint pain. He felt exactly how he felt, when running a fever. He was experiencing 8 of the 12 side effects, none of the allergic reactions only fever, joint aches. He was experiencing about 90% of the side effects listed on page 3 the paperwork he received. He was not having any breathing issues. He had severe injection site pain on 24Jan2021, it literally felt like he had surgery on his left arm. Since he woke up this morning around 6 a.m. he had been experiencing tiredness, muscle pain, chills, joint pain, and he had a fever of 101.5 all on 25Jan2021. He had swelling and redness in his left arm at injection site on 24Jan2021. He didn't feel any lymph node swelling and he was not sick. He felt unwell. He felt like he twisted his shoulder, he went to bed and he woke up shivering like he had the COVID virus. He had the COVID virus back in Jun2020. The injection site arm pain was severe in the middle of night, and woke him up in the middle of the night. When he rolled over, he explained that he used both arms to help get out of bed and he could barely get up to go to the restroom. He was wrapped up so the chills were pretty good, when he woke up they were racking chills (which he also experienced these type of chills when he had the COVID virus). No treatment was received. He needed a magnifying glass and to get in the light to see the lot number on the card he was given. He took a boatload of drugs. Reported the details about his medications could be obtained from this hcp. He did not know them off the top of his head. Outcome of events arms were sore and felt unwell was unknown and of other events was not resolved.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: arms were sore; feels unwell; Tiredness; chills; this morning about 8 am I was running a fever 101.5; muscle ache; joint pain/joint aches; severe injection site pain; swelling and redness in left arm at injection site; swelling and redness in left arm at injection site; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiration date listed on the card was either 03May2021 or 31May2021), intramuscularly in left arm on 24Jan2021 13:30 at 0.3 ml single for COVID-19 immunization. Medical history included COVID from Jun2020. Concomitant medications were none. Patient received the first dose of the vaccine, initially before bed he noticed his arms were sore, about 2 a.m., his arm was so sore it woke him up when he rolled over on it. It hurt throughout the night, he started to get chills, just like when he had COVID earlier in the year and this morning about 8 a.m. he was running a fever 101.5, muscle ache and joint pain. He felt exactly how he felt, when running a fever. He was experiencing 8 of the 12 side effects, none of the allergic reactions only fever, joint aches. He was experiencing about 90% of the side effects listed on page 3 the paperwork he received. He was not having any breathing issues. He had severe injection site pain on 24Jan2021, it literally felt like he had surgery on his left arm. Since he woke up this morning around 6 a.m. he had been experiencing tiredness, muscle pain, chills, joint pain, and he had a fever of 101.5 all on 25Jan2021. He had swelling and redness in his left arm at injection site on 24Jan2021. He didn't feel any lymph node swelling and he was not sick. He felt unwell. He felt like he twisted his shoulder, he went to bed and he woke up shivering like he had the COVID virus. He had the COVID virus back in Jun2020. The injection site arm pain was severe in the middle of night, and woke him up in the middle of the night. When he rolled over, he explained that he used both arms to help get out of bed and he could barely get up to go to the restroom. He was wrapped up so the chills were pretty good, when he woke up they were racking chills (which he also experienced these type of chills when he had the COVID virus). No treatment was received. He needed a magnifying glass and to get in the light to see the lot number on the card he was given. He took a boatload of drugs. Reported the details about his medications could be obtained from this hcp. He did not know them off the top of his head. Outcome of events arms were sore and felt unwell was unknown and of other events was not resolved.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Feeling hot, Flushing, Hyperhidrosis
Clinical narrative: very flushed; perspiring; Feeling hot; Red face; chills; This is a spontaneous report from a contactable pharmacist reporting for herself. A 43-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacture Pfizer-BioNTech, lot# EL3249), via an unspecified route of administration, on 24Jan2021 at 14:30, at single dose, for COVID-19 immunisation. Medical history included endometriosis and migraine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included ibuprofen (MOTRIN) and unspecified oral contraceptives. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL1284), on 04Jan2021 at 01:00 PM, in left arm, for COVID-19 immunisation. The patient experienced very flushed, perspiring, feeling hot, red face and chills all on 24Jan2021 at 15:00 with outcome of recovered after about 1 hour. Since the vaccination the patient has not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Body temperature, Body temperature increased, Dizziness
Clinical narrative: dizziness; burning tongue, mouth, and lips; burning tongue, mouth, and lips; sinus pressure; no ability to smell or taste; no ability to smell or taste; bitter taste; sense of being poisoned or given some horrible drug; temperature went up to 98.9; EXTREME fatigue; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1283), via an unspecified route of administration on 22Jan2021 10:45 at single dose on left arm for covid-19 immunisation. Medical history included known allergies: sulfa, hypo thyroid, hypogammaglobulinemia, arthritis and hypertension. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included losartan, carvedilol, methylphenidate hydrochloride (RITALIN), potassium and unspecific thyroid medication. It was reported that second day after vaccination (24Jan2021), patient experienced extreme fatigue. Third day after vaccination (25Jan2021) patient experienced extreme fatigue, dizziness, burning tongue, mouth, and lips, sinus pressure, no ability to smell or taste except a bitter taste, sense of being poisoned or given some horrible drug, temperature went up to 98.9 - which is high for patient. Patient was usually 97.2. On fourth day of vaccination (26Jan2021): patient was fine. Totally back to normal. No treatment was received. The events resulted doctor or other healthcare professional office/clinic visit. This case was reported as non-serious. All events were resolved on 26Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Feeling abnormal, Oral discomfort, Paranasal sinus discomfort
Clinical narrative: dizziness; burning tongue, mouth, and lips; burning tongue, mouth, and lips; sinus pressure; no ability to smell or taste; no ability to smell or taste; bitter taste; sense of being poisoned or given some horrible drug; temperature went up to 98.9; EXTREME fatigue; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1283), via an unspecified route of administration on 22Jan2021 10:45 at single dose on left arm for covid-19 immunisation. Medical history included known allergies: sulfa, hypo thyroid, hypogammaglobulinemia, arthritis and hypertension. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included losartan, carvedilol, methylphenidate hydrochloride (RITALIN), potassium and unspecific thyroid medication. It was reported that second day after vaccination (24Jan2021), patient experienced extreme fatigue. Third day after vaccination (25Jan2021) patient experienced extreme fatigue, dizziness, burning tongue, mouth, and lips, sinus pressure, no ability to smell or taste except a bitter taste, sense of being poisoned or given some horrible drug, temperature went up to 98.9 - which is high for patient. Patient was usually 97.2. On fourth day of vaccination (26Jan2021): patient was fine. Totally back to normal. No treatment was received. The events resulted doctor or other healthcare professional office/clinic visit. This case was reported as non-serious. All events were resolved on 26Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Tongue discomfort
Clinical narrative: dizziness; burning tongue, mouth, and lips; burning tongue, mouth, and lips; sinus pressure; no ability to smell or taste; no ability to smell or taste; bitter taste; sense of being poisoned or given some horrible drug; temperature went up to 98.9; EXTREME fatigue; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1283), via an unspecified route of administration on 22Jan2021 10:45 at single dose on left arm for covid-19 immunisation. Medical history included known allergies: sulfa, hypo thyroid, hypogammaglobulinemia, arthritis and hypertension. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included losartan, carvedilol, methylphenidate hydrochloride (RITALIN), potassium and unspecific thyroid medication. It was reported that second day after vaccination (24Jan2021), patient experienced extreme fatigue. Third day after vaccination (25Jan2021) patient experienced extreme fatigue, dizziness, burning tongue, mouth, and lips, sinus pressure, no ability to smell or taste except a bitter taste, sense of being poisoned or given some horrible drug, temperature went up to 98.9 - which is high for patient. Patient was usually 97.2. On fourth day of vaccination (26Jan2021): patient was fine. Totally back to normal. No treatment was received. The events resulted doctor or other healthcare professional office/clinic visit. This case was reported as non-serious. All events were resolved on 26Jan2021.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Vision blurred
Clinical narrative: Dizzy; Unbalanced when attempting to walk; Blurry vision; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262; Expiration date was not reported) on 23Jan2021 (12:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the school or student health clinic. The patient had no relevant medical history. The patient had unspecified concomitant medications. The patient was not pregnant at the time of vaccination. On 24Jan2021 (21:00), the patient was dizzy; unbalanced when attempting to walk; and had blurry vision. It was unknown if the patient had received treatment for the reported events. The outcome of the events, 'dizzy', 'unbalanced when attempting to walk' and 'blurry vision', was not recovered. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Fatigue, Heart rate, Heart rate increased
Clinical narrative: Shortness of breath; palpitations/increased heart rate; palpitations/increased heart rate; Immediate left arm/chest pain; Immediate left arm/chest pain; fatigue; body aches; This is a spontaneous report from a contactable physician.   A 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3246), via intramuscular, on 18Jan2021 at single dose on the left arm for COVID-19 immunisation, administered at Hospital. The patient did not have a relevant medical history. No known allergies. No relevant concomitant medications were provided. No other vaccine was received in four weeks. The patient developed immediate left arm/chest pain, and fatigue/body aches. On 23Jan2021 (5 days later), he developed shortness of breath and palpitations/increased heart rate. Post-vaccination COVID test was not performed. The patient was not treated for the events. The patient was recovering from the events.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Palpitations
Clinical narrative: Shortness of breath; palpitations/increased heart rate; palpitations/increased heart rate; Immediate left arm/chest pain; Immediate left arm/chest pain; fatigue; body aches; This is a spontaneous report from a contactable physician.   A 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3246), via intramuscular, on 18Jan2021 at single dose on the left arm for COVID-19 immunisation, administered at Hospital. The patient did not have a relevant medical history. No known allergies. No relevant concomitant medications were provided. No other vaccine was received in four weeks. The patient developed immediate left arm/chest pain, and fatigue/body aches. On 23Jan2021 (5 days later), he developed shortness of breath and palpitations/increased heart rate. Post-vaccination COVID test was not performed. The patient was not treated for the events. The patient was recovering from the events.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, COVID-19, Cough, Dizziness, Malaise
Clinical narrative: looks like a cold, dizzy, slight fever, feels weakness; looks like a cold, dizzy, slight fever, feels weakness; looks like a cold, dizzy, slight fever, feels weakness; looks like a cold, dizzy, slight fever, feels weakness; I feel not so good; cough; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer reported for himself.   A 67-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot# EK9231 on 11Jan2021 at single dose for COVID-19 immunization. The second dose of vaccine was scheduled on 02Feb2021. The patient had no medical history. Concomitant medications were not reported.  Beginning on Friday, 22Jan2021, he started having symptoms that "looks like a cold, dizzy, slight fever, feels weakness", "I feel not so good" and cough. On unknown date in Jan2021 the patient was positive to SARS-CoV-2 test. The outcome of the events was recovering.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nasopharyngitis, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: looks like a cold, dizzy, slight fever, feels weakness; looks like a cold, dizzy, slight fever, feels weakness; looks like a cold, dizzy, slight fever, feels weakness; looks like a cold, dizzy, slight fever, feels weakness; I feel not so good; cough; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer reported for himself.   A 67-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot# EK9231 on 11Jan2021 at single dose for COVID-19 immunization. The second dose of vaccine was scheduled on 02Feb2021. The patient had no medical history. Concomitant medications were not reported.  Beginning on Friday, 22Jan2021, he started having symptoms that "looks like a cold, dizzy, slight fever, feels weakness", "I feel not so good" and cough. On unknown date in Jan2021 the patient was positive to SARS-CoV-2 test. The outcome of the events was recovering.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: looks like a cold, dizzy, slight fever, feels weakness; looks like a cold, dizzy, slight fever, feels weakness; looks like a cold, dizzy, slight fever, feels weakness; looks like a cold, dizzy, slight fever, feels weakness; I feel not so good; cough; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer reported for himself.   A 67-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot# EK9231 on 11Jan2021 at single dose for COVID-19 immunization. The second dose of vaccine was scheduled on 02Feb2021. The patient had no medical history. Concomitant medications were not reported.  Beginning on Friday, 22Jan2021, he started having symptoms that "looks like a cold, dizzy, slight fever, feels weakness", "I feel not so good" and cough. On unknown date in Jan2021 the patient was positive to SARS-CoV-2 test. The outcome of the events was recovering.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Fatigue, Headache, Myalgia
Clinical narrative: Muscle pain; fatigue; Headache; diarrhea; Fever 101.5; This is a spontaneous report from a non-contactable pharmacist reporting for himself. A 42-year-old male patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at right arm on 20Jan2021 02:00 PM at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm at 42 years old on Dec2020 03:00 PM for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. The patient experienced muscle pain, fatigue, headache, diarrhea, fever 101.5; all on 20Jan2021 06:00 PM. The patient required 12 hours in bed to recover. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had Covid test post_vaccination (Nasal Swab,Bi naxNow) on 23Jan2021 with negative result. Outcome of the events was recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Muscle pain; fatigue; Headache; diarrhea; Fever 101.5; This is a spontaneous report from a non-contactable pharmacist reporting for himself. A 42-year-old male patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at right arm on 20Jan2021 02:00 PM at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm at 42 years old on Dec2020 03:00 PM for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. The patient experienced muscle pain, fatigue, headache, diarrhea, fever 101.5; all on 20Jan2021 06:00 PM. The patient required 12 hours in bed to recover. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had Covid test post_vaccination (Nasal Swab,Bi naxNow) on 23Jan2021 with negative result. Outcome of the events was recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Dizziness, Fatigue, Rash
Clinical narrative: rash on my elbow; loss of appetite; tired; dizzy; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Jan2021 10:00 on Arm left at single dose (Lot # EL3246) for covid-19 immunisation. No medical history and concomitant therapy. She woke feeling dizzy on 24Jan2021, went to bed feeling dizzy and woke up feeling dizzy and the feeling isn't going away and she has a rash on her elbow on 25Jan2021. She took an antihistamine for it. She took the (Pharmacy name) off brand antihistamine. She does not know the name of it. She doesn't have an appetite on 25Jan2021. She doesn't feel sick but she usually loves her breakfast. She also maybe is a little tired on 25Jan2021. She also reports that her second vaccine dose is due today and feeling like this she doesn't know if she should get it. Outcome of the event dizzy was not recovered. Outcome of other events was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Dizziness, Rash
Clinical narrative: rash on my elbow; loss of appetite; tired; dizzy; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Jan2021 10:00 on Arm left at single dose (Lot # EL3246) for covid-19 immunisation. No medical history and concomitant therapy. She woke feeling dizzy on 24Jan2021, went to bed feeling dizzy and woke up feeling dizzy and the feeling isn't going away and she has a rash on her elbow on 25Jan2021. She took an antihistamine for it. She took the (Pharmacy name) off brand antihistamine. She does not know the name of it. She doesn't have an appetite on 25Jan2021. She doesn't feel sick but she usually loves her breakfast. She also maybe is a little tired on 25Jan2021. She also reports that her second vaccine dose is due today and feeling like this she doesn't know if she should get it. Outcome of the event dizzy was not recovered. Outcome of other events was unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Dizziness, Fatigue, Rash
Clinical narrative: rash; dizzy; loss of appetite; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was 3 weeks post vaccine and woke up feeling dizzy, had a rash on the elbow and loss of appetite. The outcome of events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Dizziness, Rash
Clinical narrative: rash; dizzy; loss of appetite; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was 3 weeks post vaccine and woke up feeling dizzy, had a rash on the elbow and loss of appetite. The outcome of events was unknown.   Information on the lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain
Clinical narrative: Very deep muscle pain, that kind of comes and goes; Joint pain, it's like just deep and very achy as opposed to like any kind of shooting pain; Joint pain, it's like just deep and very achy as opposed to like any kind of shooting pain; This is a spontaneous report from a contactable consumer, reporting for herself.  A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 (at the age of 71 years old) as a single dose for COVID-19 vaccination. Medical history was not reported. Concomitant medications were not reported, but she was taking other medications.  On 23Jan2021, the patient experienced very deep muscle pain, that kind of comes and goes. On an unspecified date in Jan2021, the patient experienced joint pain, it's like just deep and very achy as opposed to like any kind of shooting pain. The patient received treatment for the events, which included ice pack, Tiger Balm, and ibuprofen 600mg . The clinical outcome of muscle pain was not recovered, and for joint pain and ache was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Ocular discomfort, Pain in extremity
Clinical narrative: headaches; arm hurt a lot; I don't feel very well; My eyes are bothering me; This is a spontaneous report from a contactable consumer, reporting for herself.  A 65-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date in Jan2021 at 20:30 (at the age of 65 years old) as a single dose for COVID-19 vaccination. Medical history included being diabetic from an unspecified date. Concomitant medications were not reported. On an unspecified date in Jan2021, the patient experienced headaches, arm hurt a lot, don't feel very well, and her eyes are bothering her. The clinical outcome of headaches, arm hurt a lot, don't feel very well, and her eyes are bothering her was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Nausea
Clinical narrative: Nausea; Stomach discomfort/bowel discomfort; This is a spontaneous report from a contactable consumer reporting for himself.   This 20-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on unknown date at a single dose on the left arm for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included postural orthostatic tachycardia syndrome. No relevant concomitant medications were provided. On unknown date, after vaccination, the patient developed nausea and stomach discomfort/bowel discomfort. The patient was not treated for the events. Pre-vaccination and post-vaccination COVID tests were not performed. The patient was recovering from the events.  Information on the lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature fluctuation, Chills, Cough, Diarrhoea, Dizziness
Clinical narrative: constant fluctuation of burning up; sweating profusely; having chills; headache; diarrhea; dryness of mouth; runny nose; occasional coughing; dizziness; occasional fatigue; This is a spontaneous report from a contactable consumer reporting for herself. A 29-years-old non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration from 21Jan2021 09:00 (at the age of 29-years-old) at SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.  Concomitant medication included spironolactone, sertraline and bupropion. Prior to vaccination the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital. On 22Jan2021 11:00, the patient experienced constant fluctuation of burning up, sweating profusely, having chills, headache, diarrhea, dryness of mouth, runny nose, occasional coughing, dizziness and occasional fatigue.   No treatment was received for the events. The events were reported as non-serious. The patient underwent lab tests and procedures which included Rapid Antigen: pending on 24Jan2021. Outcome of the constant fluctuation of burning up, sweating profusely, having chills, headache, diarrhea, dryness of mouth, runny nose, occasional coughing, dizziness and occasional fatigue was not recovered. Since the vaccination, the patient been tested for COVID-19.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Fatigue, Headache, Hyperhidrosis, Rhinorrhoea
Clinical narrative: constant fluctuation of burning up; sweating profusely; having chills; headache; diarrhea; dryness of mouth; runny nose; occasional coughing; dizziness; occasional fatigue; This is a spontaneous report from a contactable consumer reporting for herself. A 29-years-old non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration from 21Jan2021 09:00 (at the age of 29-years-old) at SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.  Concomitant medication included spironolactone, sertraline and bupropion. Prior to vaccination the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital. On 22Jan2021 11:00, the patient experienced constant fluctuation of burning up, sweating profusely, having chills, headache, diarrhea, dryness of mouth, runny nose, occasional coughing, dizziness and occasional fatigue.   No treatment was received for the events. The events were reported as non-serious. The patient underwent lab tests and procedures which included Rapid Antigen: pending on 24Jan2021. Outcome of the constant fluctuation of burning up, sweating profusely, having chills, headache, diarrhea, dryness of mouth, runny nose, occasional coughing, dizziness and occasional fatigue was not recovered. Since the vaccination, the patient been tested for COVID-19.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: constant fluctuation of burning up; sweating profusely; having chills; headache; diarrhea; dryness of mouth; runny nose; occasional coughing; dizziness; occasional fatigue; This is a spontaneous report from a contactable consumer reporting for herself. A 29-years-old non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration from 21Jan2021 09:00 (at the age of 29-years-old) at SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.  Concomitant medication included spironolactone, sertraline and bupropion. Prior to vaccination the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital. On 22Jan2021 11:00, the patient experienced constant fluctuation of burning up, sweating profusely, having chills, headache, diarrhea, dryness of mouth, runny nose, occasional coughing, dizziness and occasional fatigue.   No treatment was received for the events. The events were reported as non-serious. The patient underwent lab tests and procedures which included Rapid Antigen: pending on 24Jan2021. Outcome of the constant fluctuation of burning up, sweating profusely, having chills, headache, diarrhea, dryness of mouth, runny nose, occasional coughing, dizziness and occasional fatigue was not recovered. Since the vaccination, the patient been tested for COVID-19.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Slight soreness in arm; This is a spontaneous report from a contactable consumer reporting for herself. A 75-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9261), via an unspecified route of administration on 22Jan2021 14:45 at single dose for covid-19 immunisation. Medical history included breast cancer from 2016 to 2016. The patient's concomitant medications were not reported. The patient experienced Slight soreness in arm. Outcome of event was unknown.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal, Headache, Influenza like illness, Malaise
Clinical narrative: vomited; felt sick; very loose stool; fever; felt like beat with baseball bat; body aches; muscle joints hurt; flu like symptoms; head pounding; this may have been a bad batch or something; This is a spontaneous report from a contactable consumer. A 59-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EL3302 , via an unspecified route of administration on 22Jan2021 10:00 (at the age of 59-years-old) as a SINGLE DOSE in the left arm for COVID-19 vaccination.  Medical history included potentially had Covid prior to receiving the vaccine from an unknown date and unknown if ongoing, he had antibodies prior to the vaccine from an unknown date and unknown if ongoing. The consumer reported he must have had Covid in the Spring because he got sick, took a Sudafed and had Afrin nose spray and was fine after that. The patient previously took pseudoephedrine hydrochloride (SUDAFED) for he got sick, oxymetazoline hydrochloride (AFRIN) nasal decongestant for he got sick.  They were giving shots out. The patient  did not receive any other vaccine within 4 weeks prior to the vaccine. On 23Jan2021, the patient experienced flu like symptoms, body aches, head pounding, muscle joints hurt, felt sick, fever, felt like beat with baseball bat, vomited, very loose stool. The consumer reported that this may have been a bad batch or something in Jan2021. The consumer reported that the body aches started at 8AM and resolved at 6PM. The consumer reported that he recovered from all other events late afternoon on Saturday. The consumer reported he vomited from noon-1PM. The consumer reported had body aches at 08:00, muscle joints hurt at 08:00, felt like he was beat with a baseball bat 08:00, felt sick at 10:00, vomited 12:00, loose stool 09:00 and fever 08:00 .The events did not require a visit to the emergency room or physician office. No treatment was received for the events. Outcome of the events flu like symptoms, body aches, head pounding, muscle joints hurt, felt sick, fever, felt like beat with baseball bat, vomited, very loose stool was recovered on 23Jan2021. Outcome of the event this may have been a bad batch or something was unknown.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain, Product quality issue, Pyrexia, Vomiting
Clinical narrative: vomited; felt sick; very loose stool; fever; felt like beat with baseball bat; body aches; muscle joints hurt; flu like symptoms; head pounding; this may have been a bad batch or something; This is a spontaneous report from a contactable consumer. A 59-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EL3302 , via an unspecified route of administration on 22Jan2021 10:00 (at the age of 59-years-old) as a SINGLE DOSE in the left arm for COVID-19 vaccination.  Medical history included potentially had Covid prior to receiving the vaccine from an unknown date and unknown if ongoing, he had antibodies prior to the vaccine from an unknown date and unknown if ongoing. The consumer reported he must have had Covid in the Spring because he got sick, took a Sudafed and had Afrin nose spray and was fine after that. The patient previously took pseudoephedrine hydrochloride (SUDAFED) for he got sick, oxymetazoline hydrochloride (AFRIN) nasal decongestant for he got sick.  They were giving shots out. The patient  did not receive any other vaccine within 4 weeks prior to the vaccine. On 23Jan2021, the patient experienced flu like symptoms, body aches, head pounding, muscle joints hurt, felt sick, fever, felt like beat with baseball bat, vomited, very loose stool. The consumer reported that this may have been a bad batch or something in Jan2021. The consumer reported that the body aches started at 8AM and resolved at 6PM. The consumer reported that he recovered from all other events late afternoon on Saturday. The consumer reported he vomited from noon-1PM. The consumer reported had body aches at 08:00, muscle joints hurt at 08:00, felt like he was beat with a baseball bat 08:00, felt sick at 10:00, vomited 12:00, loose stool 09:00 and fever 08:00 .The events did not require a visit to the emergency room or physician office. No treatment was received for the events. Outcome of the events flu like symptoms, body aches, head pounding, muscle joints hurt, felt sick, fever, felt like beat with baseball bat, vomited, very loose stool was recovered on 23Jan2021. Outcome of the event this may have been a bad batch or something was unknown.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node under my armpit on the same side of the injection; This is a spontaneous report from a contactable consumer(patient). A male patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced swollen lymph node under his armpit on the same side of the injection on 22Jan2021. The outcome of the event was unknown.   Information on the Lot/Batch number has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Noticed that a lymph node under his left arm was swollen; This is a spontaneous report from a contactable consumer. A 53-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date: 30Apr2021), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient noticed that a lymph node under his left arm was swollen on 22Jan2021. That is the same arm that he got the vaccination. Therapeutic measures included Advil. Outcome of event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: infected by covid on 07Jan; infected by covid on 07Jan; This is a spontaneous report from a contactable Other Health Professional (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient was infected by covid on 07Jan2021 and tested positive for COVID-19 on 07Jan2021. She was given Zanamivir (was not able to verify) on 12Jan2021, started with Bamlanivimab antibodies treatment on 12Jan2021 and has fully recovered from COVID in Jan2021 since then as it was a mild form only. The patient would like to get the second dose as soon as possible, second dose of the vaccine was scheduled for 12Jan2021. She is looking on guidance on pursuing the second dose of the vaccine. Serious: No.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 test positive and drug ineffective due to temporal relationship.  This case will be reassessed once additional information is available.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: rash/ugly rash; itchy rash; This is a spontaneous report from a contactable consumer (patient). This 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 13Jan2021 for COVID-19 immunisation. Medical history included patient was allergic to a lot of medication. Concomitant medication was not reported. Patient received 1st dose of vaccine on 13Jan2021.  On 20Jan2021, the patient developed a rash: got red, breaks down to smaller rash, itchy rash, "ugly rash".  Patient said she had not added any new products to her diet and no changes in her life. Patient said she was allergic to a lot of medication, and she got rashes all the time. Patient said she had not had fever, shortness of breath or difficulty breathing. Only rash reported. Patient was asking if the rash could be from the vaccine since it didn't start "right after" getting her dose. It was made patient aware that some of the other reported experiences after vaccine were reported within 7 days of dose; made patient aware there was no way to confirm or deny if her rash was from vaccine. Referred patient to speak with HCP. Patient was inquiring about getting 2nd dose of vaccine after experiencing side effect after 1 dose.  Patient had already spoken with her PCP, who encouraged the 2nd dose. It was referred patient to speak with HCP before making any medical decisions; made patient aware the only contraindication at this time, to getting doses would be severe allergic reaction to ingredients/1st dose. The outcome of events was unknown.   Information on the lot/batch number has been requested.