chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: His arm was sore at the injection site; This is a Spontaneous report from non-contactable consumer (patient), received via a Pfizer sponsored program t.  A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch No: Unknown), via an unspecified route on 24Jan 2021 fas 1st dose single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had not taken any other vaccination prior to COVID-19 vaccination. On 24Jan2021, the patient experienced (later that night) his arm was sore at the injection site. On the same day after getting the vaccine, the patient did take Tylenol when he got home that evening before bed to ease the pain in his sore arm as he thought while sleep on his arm at night it might hurt. On 25Jan2021 (next day), the sore at the injection site was gone. The soreness at the injection site was completely normal. Then he woke up and felt great and had no issues. His arm did not bother him much at all. He never had problems with shots, he took shot because of his age and stated that he will be having other vaccinations coming up, other than the second dose of the vaccine. The patient queried to double check if it is okay to get other vaccinations after getting the COVID shot. The outcome of the event sore at the injection site was recovered on 25Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Dyspnoea, Myalgia, Nausea
Clinical narrative: 5 days after first dose I had my first ever UTI. 4 days after second dose I experienced severe dry cough with some difficulty breathing, a fever ranging from 99.5-102 which lasted for 6 days, increased joint and muscle pain, severe nausea lasting 10 days with weight loss of 7 pounds. 4 visits to Urgent Care and one ER visit
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urinary tract infection, Weight decreased
Clinical narrative: 5 days after first dose I had my first ever UTI. 4 days after second dose I experienced severe dry cough with some difficulty breathing, a fever ranging from 99.5-102 which lasted for 6 days, increased joint and muscle pain, severe nausea lasting 10 days with weight loss of 7 pounds. 4 visits to Urgent Care and one ER visit
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Muscular weakness, Pain
Clinical narrative: Within a few hours developed soreness in left shoulder.  This pain has not improved since the day of the injection.  The soreness in my left shoulder is constant and certain movements cause a stabbing pain that is severe:  it is very painful to move my arm backward, either in the up or down position (as in swimming, hooking my bra, drying my back after a shower, or reaching up to grab and pull the shoulder belt in the car). I cannot swimsharp pain and weakness in left shoulder; lying down is uncomfortable as any pressure on shoulder increases dull soreness. I thought the pain would go away over time, but it has not. It actually seems to be getting slightly worse.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Throat tightness
Clinical narrative: Throat tightness, lip and mouth tingling. No wheezing, nausea, urticaria or lightheadedness. Started 1 hr after shot, controlled with Benadryl, famotidine, steroid in the ED.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Feeling abnormal, Hyperhidrosis, Nausea
Clinical narrative: I received my Moderna COVID vaccine on Thursday, May 20, 2021 and at that time I only had a slight fever and my arm was a bit sore at the injection site.     My reaction to the Moderna began in the wee hours of Friday May 21st.  I had a fever of 103.0, I did not go to walk in or my doctor because I took Tylenol and after a few minutes my fever subsided.  I went back to sleep.  Upon waking up I had body aches, a running fever, my head felt like I was in a fog that I couldn?t shake.  I was so tired that I could hardly keep awake.  My fever kept getting worse through out the day so I kept taking Advil (I had stopped taking Tylenol because it had stopped working).   Advil helped a little bit but I felt like my fever would never go away.   This happened through out the entire Friday May 21st.  Then in the middle of the night around midnight Friday into Saturday I began sweating profusely all the while having a fever and body aches and I was really really tired.  When I woke up at 5am Saturday my clothes were drenched in sweat and I felt better, but the entire weekend I had nausea and diarrhea.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: I received my Moderna COVID vaccine on Thursday, May 20, 2021 and at that time I only had a slight fever and my arm was a bit sore at the injection site.     My reaction to the Moderna began in the wee hours of Friday May 21st.  I had a fever of 103.0, I did not go to walk in or my doctor because I took Tylenol and after a few minutes my fever subsided.  I went back to sleep.  Upon waking up I had body aches, a running fever, my head felt like I was in a fog that I couldn?t shake.  I was so tired that I could hardly keep awake.  My fever kept getting worse through out the day so I kept taking Advil (I had stopped taking Tylenol because it had stopped working).   Advil helped a little bit but I felt like my fever would never go away.   This happened through out the entire Friday May 21st.  Then in the middle of the night around midnight Friday into Saturday I began sweating profusely all the while having a fever and body aches and I was really really tired.  When I woke up at 5am Saturday my clothes were drenched in sweat and I felt better, but the entire weekend I had nausea and diarrhea.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Erythema, Hypersensitivity, Pruritus, Rash
Clinical narrative: On the first day of the adverse effects I woke up to a rash on my legs. It was minor and I thought nothing of it. On the second day it had spread to my arms and was now a serious irritation. I rubbed Aloe Vera on it and that helped a little but wore off in an hour. By day three the rash was now spreading to my chest but I still wasn't sure if it was the vaccine. I took some Benedryll as an antihistamine and the rash completely dissapeared within an hour. 24 hours later at the time I had taken the Benedryll the night prior the rash reappeared and I he only possible explanation is some sort of allergic reaction to the vaccine. I have been allergic to it consistently and if it doesn't dissapeared entirely without me needing to take Benedryll I will be very concerned. The rash when it is present covers almost my entire body, spare my groin, head, neck, and some of my chest and back luckily. It itches very badly and constantly, and is very much visually present in large red splotches.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Rash macular, Skin irritation
Clinical narrative: On the first day of the adverse effects I woke up to a rash on my legs. It was minor and I thought nothing of it. On the second day it had spread to my arms and was now a serious irritation. I rubbed Aloe Vera on it and that helped a little but wore off in an hour. By day three the rash was now spreading to my chest but I still wasn't sure if it was the vaccine. I took some Benedryll as an antihistamine and the rash completely dissapeared within an hour. 24 hours later at the time I had taken the Benedryll the night prior the rash reappeared and I he only possible explanation is some sort of allergic reaction to the vaccine. I have been allergic to it consistently and if it doesn't dissapeared entirely without me needing to take Benedryll I will be very concerned. The rash when it is present covers almost my entire body, spare my groin, head, neck, and some of my chest and back luckily. It itches very badly and constantly, and is very much visually present in large red splotches.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling
Clinical narrative: The knuckle on the middle finger of my right hand has become swollen and painful. It has been this way since shortly after receiving my second dose of the vaccine.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Electrocardiogram, Infection, Myocarditis
Clinical narrative: Myocarditis. I had to go to the ER on last Monday after having chest pains. After doing EKG, chest x ray, and other tests, they determined it was myocarditis due to an infection. Pain level was an 8/10
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Vomiting
Clinical narrative: Systemic: Vomiting-Medium, Additional Details: Pt called to tell us he vomiting the morning after he received the vaccine. RPH on Duty counsled him to seek medical treatment as he said he did not feel well. RPH followed up with the pt later in the day and he had gone to urgent care where they said this is a common reaction with Moderna and instructed him to take Claritin.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Myalgia, Nausea
Clinical narrative: Moderna dose 1- After the first Moderna shot, Period was 2 weeks late,  period is always on time, never late, so this was very abnormal for my menstrual cycle. Late period had NOT occurred before the covid vaccine. I am not pregnant. Moderna dose 2- After the 2nd  Moderna shot, 13 hours later I had chills, muscle aches in my legs & felt very tired. 6 days after that, I had chills again & felt nausated.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Disturbance in attention, Dizziness, Fatigue, Flushing
Clinical narrative: Initial shot:  nausea, extreme fatigue for 5 days.  Second shot:  immediate arm pain, warm.  In the first day lightheaded,  limbs heavy feeling, unfocused, flushed, fatigue,  hives for about an hour.  Next day headache, lightheaded,  neck tightness, fatigue,  lymph node pain, arm pain, nausea.  Next day nausea,  arm pain, stomach pain, fatigue.   Next day nausea  and fatigue.   Nausea lasted 5 days.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Limb discomfort, Lymph node pain, Muscle tightness, Nausea
Clinical narrative: Initial shot:  nausea, extreme fatigue for 5 days.  Second shot:  immediate arm pain, warm.  In the first day lightheaded,  limbs heavy feeling, unfocused, flushed, fatigue,  hives for about an hour.  Next day headache, lightheaded,  neck tightness, fatigue,  lymph node pain, arm pain, nausea.  Next day nausea,  arm pain, stomach pain, fatigue.   Next day nausea  and fatigue.   Nausea lasted 5 days.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin warm, Urticaria
Clinical narrative: Initial shot:  nausea, extreme fatigue for 5 days.  Second shot:  immediate arm pain, warm.  In the first day lightheaded,  limbs heavy feeling, unfocused, flushed, fatigue,  hives for about an hour.  Next day headache, lightheaded,  neck tightness, fatigue,  lymph node pain, arm pain, nausea.  Next day nausea,  arm pain, stomach pain, fatigue.   Next day nausea  and fatigue.   Nausea lasted 5 days.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Rash
Clinical narrative: 24 hours after vaccination chills and body aches very sore left arm. 3 days after vaccination rash on left arm and chest.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Dizziness, Dysphagia, Fatigue
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Weakness-Mild, Additional Details: pt experienced fatigue diziness minor tingling of the tounge and minor tightness of chest. paramedics were called to the store however after examantion paitent decided he was fine and decided to leave
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Limb discomfort, Paraesthesia oral, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Weakness-Mild, Additional Details: pt experienced fatigue diziness minor tingling of the tounge and minor tightness of chest. paramedics were called to the store however after examantion paitent decided he was fine and decided to leave
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pain
Clinical narrative: Fatigue, body/joint pain, headaches.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Pt. c/o nausea @ 1:35pm evaluated by EMS on site.  Pt. reported of feeling better and was released.  Pt. has no history of medical problems.  Vitals 128/88,   104,  R 6, 100%
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Injection site pain, Myalgia
Clinical narrative: Moderate chills, muscle aches, joint pain beginning about 12 hours following the second dose of Pfizer vaccine.  Moderate pain at the injection site beginning about 6 hours following the second dose.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Hypoaesthesia, Paraesthesia
Clinical narrative: Complete numbing of the left upper biceps and shoulder with tingling of the left hand and fingers. Soreness in left shoulder. Has lasted since doses were given.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route on 03Feb2021 (Batch/Lot number was not reported) as an unknown 1st, single dose for covid-19 immunization. No medical history or concomitant medications were reported. It was reported that the patient had a headache after the 1st dose on 03Feb2021. Wanted to know if she could take TYLENOL. The outcome of the event was unknown. Follow-up attempts are completed. No further information is expected. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Vaccination site swelling
Clinical narrative: After the first dose of the vaccine, she had mild flu-like symptoms, headache and swelling; After the first dose of the vaccine, she had mild flu-like symptoms, headache and swelling; Swelling at injection site; This is a spontaneous report from a contactable Nurse (patient) communicated to a Pfizer sales representative. This 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as first with unknown single dose for covid-19 immunisation. Medical history included patient was being treated for hypertension (ongoing) and hyperlipidemia (ongoing). Patient had COVID-19 in June (unspecified year) and still has ongoing lost sense of taste and smell with fatigue and headaches lingering. The patient's concomitant medications were not reported. After the first dose of the vaccine, she had mild flu-like symptoms, headache and swelling at injection site. Symptoms lasted 2-3 days. Event took place after use of product. Outcome of the events was recovering.  No follow-up attempts are possible; Information about Lot/batch number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: light headache; The initial was missing the following minimum criteria: no adverse effect upon receipt of follow-up information on 19Feb2021 this case now contains all required information to be considered valid.   This is spontaneous report from a contactable consumer.  A 72-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6201) on 12Feb2021 at 15:30  at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history included Severe Peanut Allergy. The patient previous took Demerol and codeine and experienced dizziness. Concomitant medications included levothyroxine sodium, Colesevelam hydrochloride (WELCHOL), omeprazole and vitamin D3, all ongoing. On 13Feb2021 the patient experienced light headache. No treatment received for the event. The patient recovered from the event on an unspecified date.   No follow-up attempts possible. No further information expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer or other non hcp. A 67-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 27Jan2021 09:00 as 1ST DOSE, SINGLE (at the age of 67-year-old) for covid-19 immunisation. Medical history included ongoing heart, GERD and blood thinner. Concomitant medications included carvedilol (CARVEDILOL) 125 mg twice daily taken for heart taking a couple of years, ezetimibe (ZETIA) 10 mg once daily taking for a long time, omeprazole (PROTONIX [OMEPRAZOLE]) 20 mg once daily taken for GERD, rivaroxaban (RIVAROXABAN) 20 mg once daily taken for blood thinner taking for 5 years or more. Patient received the first dose of the Pfizer COVID 19 vaccine on 27Jan2021 09:00AM in an unknown site. He noticed later that day that he had headache. It is unknown if the headache has resolved. The outcome of the event was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021137831 same reporter/drug, different patient/event
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site rash, Nausea
Clinical narrative: Headache; nausea; fatigue; rash near injection site; This is a spontaneous report from a non-contactable consumer. A 25-year-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 29Jan2021 15:00 (Batch/Lot Number: EN5318) as SINGLE DOSE for covid-19 immunisation. The patient's Medical history included vitamin d deficiency from an unknown date, anaemia from an unknown date, allergies: Melons from an unknown date. The patient's Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1.5/30) taken for an unspecified indication, start and stop date were not reported. The patient previously took "BNT162B2" on 08Jan2021 at 25Years (product=COVID 19, brand=Pfizer, lot number=EL23u8, lot unknown=False, administration date=08Jan2021, administration time=03:30 PM, vaccine location=Right, dose number=1). On 29Jan2021 19:00 patient experienced headache (headache) (non-serious), nausea (nausea) (non-serious), fatigue (fatigue) (non-serious), rash near injection site (injection site rash) (non-serious). No Other vaccines in four weeks. No treatment was given for the events. The outcome for all the events was not recovered.  No follow-up attempts are possible. No further information expected
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Nausea, Pain in extremity, Rash
Clinical narrative: couldn't sleep for 4 nights; rash/red bumps along the lower part of jaw and upper part of neck; Severe soreness in arm; Headache; Nausea/she was nauseated but she didn't throw up anything; This is a spontaneous report from a contactable consumer (Patient). A 37-year-old female patient received first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, formulation: solution for injection; Batch/lot number: WTEL3247; Expiration date: 31May2021), intramuscular in the right arm on 25Jan2021 (at the age of 37 years) at single dose for COVID-19 immunization. The patient medical history included cold/sniffles and sore throat. The patient's concomitant medications were not reported. It was reported that patient had the Pfizer COVID-19 vaccine done Monday night, 25Jan2021. She had a headache and some nausea, but she never threw up or anything. She couldn't sleep for 4 nights. She was not sure if this had anything to do with the vaccine or not. It was wild. She came home from school today and noticed she had a rash. There were these little red bumps that she could felt along the lower part of her jaw and there was a little bit more on the upper part of her neck. The caller washed her face twice a day, morning and night. It was not acne. She did not had this rash or red bumps anywhere else. She mentioned she had not contacted her doctor about this. She just saw the little bumps this afternoon. The caller clarified further she received her first COVID-19 vaccine at 7:10pm. She returned home that night and had a headache. She took Tylenol. Then, she was nauseated but she didn't throw up anything. The next morning, the headache and nausea was gone. The caller stated the next morning her arm was sore. She had taken flu shots where her arm was a little sore before. This was a little more uncomfortable than the flu vaccine but she expected that. Caller stated for next day on Tuesday, she kind of experienced severe soreness in her arm. She recovered a day or two after. She first noticed two red bumps on her chin, she initially thought they were whiteheads. But after she got into better light, she saw there were many red bumps under her neck line and upper neck. There was a mass of them. There was more than 1 or 2 or 3. It was on both sides, but it is not as severe on her right side as it is on her left side. The caller stated she tested positive for COVID-19 a while back. She teaches at a school and the school is very careful. She did have like a cold/sniffles type situation and a sore throat. so she was tested. She was negative and she went to the doctor and was treated for that. The clinical outcome of the events headache and nausea was resolved on 26Jan2021, Severe soreness in arm was resolved in jan2021, for event couldn't sleep for 4 nights outcome was unknown and event rash/red bumps along the lower part of jaw and upper part of neck was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: couldn't sleep for 4 nights; rash/red bumps along the lower part of jaw and upper part of neck; Severe soreness in arm; Headache; Nausea/she was nauseated but she didn't throw up anything; This is a spontaneous report from a contactable consumer (Patient). A 37-year-old female patient received first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, formulation: solution for injection; Batch/lot number: WTEL3247; Expiration date: 31May2021), intramuscular in the right arm on 25Jan2021 (at the age of 37 years) at single dose for COVID-19 immunization. The patient medical history included cold/sniffles and sore throat. The patient's concomitant medications were not reported. It was reported that patient had the Pfizer COVID-19 vaccine done Monday night, 25Jan2021. She had a headache and some nausea, but she never threw up or anything. She couldn't sleep for 4 nights. She was not sure if this had anything to do with the vaccine or not. It was wild. She came home from school today and noticed she had a rash. There were these little red bumps that she could felt along the lower part of her jaw and there was a little bit more on the upper part of her neck. The caller washed her face twice a day, morning and night. It was not acne. She did not had this rash or red bumps anywhere else. She mentioned she had not contacted her doctor about this. She just saw the little bumps this afternoon. The caller clarified further she received her first COVID-19 vaccine at 7:10pm. She returned home that night and had a headache. She took Tylenol. Then, she was nauseated but she didn't throw up anything. The next morning, the headache and nausea was gone. The caller stated the next morning her arm was sore. She had taken flu shots where her arm was a little sore before. This was a little more uncomfortable than the flu vaccine but she expected that. Caller stated for next day on Tuesday, she kind of experienced severe soreness in her arm. She recovered a day or two after. She first noticed two red bumps on her chin, she initially thought they were whiteheads. But after she got into better light, she saw there were many red bumps under her neck line and upper neck. There was a mass of them. There was more than 1 or 2 or 3. It was on both sides, but it is not as severe on her right side as it is on her left side. The caller stated she tested positive for COVID-19 a while back. She teaches at a school and the school is very careful. She did have like a cold/sniffles type situation and a sore throat. so she was tested. She was negative and she went to the doctor and was treated for that. The clinical outcome of the events headache and nausea was resolved on 26Jan2021, Severe soreness in arm was resolved in jan2021, for event couldn't sleep for 4 nights outcome was unknown and event rash/red bumps along the lower part of jaw and upper part of neck was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain, Diarrhoea, Dizziness
Clinical narrative: abdominal pain; bloating; diarrhea; headache; nausea; dizziness; abdominal discomfort; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318 (maybe ENS318)) via an unspecified route of administration on 27Jan2021 as a single dose for Covid-19 immunisation. The patient medical history included irritable bowel syndrome (IBS) and allergic reaction to a penicillin antibiotic (previously had one allergic reaction to a penicillin antibiotic). The patient's concomitant medications were not reported. It was reported that, at 9:30 PM the night of the vaccine (Day1) on 27Jan2021, the patient suddenly got a headache, nausea, dizziness, then an hour later abdominal pain, bloating and diarrhea for several hours. Bloating and abdominal discomfort continued on Day 2 and Day 3. The patient was tested negative for Covid on 29Jan2021 post vaccination. The events were resolving at the time of report.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, SARS-CoV-2 test
Clinical narrative: abdominal pain; bloating; diarrhea; headache; nausea; dizziness; abdominal discomfort; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318 (maybe ENS318)) via an unspecified route of administration on 27Jan2021 as a single dose for Covid-19 immunisation. The patient medical history included irritable bowel syndrome (IBS) and allergic reaction to a penicillin antibiotic (previously had one allergic reaction to a penicillin antibiotic). The patient's concomitant medications were not reported. It was reported that, at 9:30 PM the night of the vaccine (Day1) on 27Jan2021, the patient suddenly got a headache, nausea, dizziness, then an hour later abdominal pain, bloating and diarrhea for several hours. Bloating and abdominal discomfort continued on Day 2 and Day 3. The patient was tested negative for Covid on 29Jan2021 post vaccination. The events were resolving at the time of report.  Follow-up attempts are completed. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: little tiny bit of swelling; The initial case was missing the following minimum criteria: All other sources. Upon receipt of follow-up information on (10Feb2021), this case now contains all required information to be considered valid.   This is a follow-up spontaneous report from a Pfizer Sponsored Program COVAX US Support. A contactable 81-year-old female consumer reported for herself that she received bnt162b2 (Formulation; Solution for injection), dose 1 via an unspecified route of administration on an unspecified date as SINGLE DSOE for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient experienced little tiny bit of swelling on an unspecified date. she had a little tiny bit of swelling which she iced and it went away.  Therapeutic measures were taken as a result of little tiny bit of swelling. The outcome of the event was resolved.  Information about lot/batch number has been requested Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain
Clinical narrative: Headaches for two days; Neck pain on right side for 2 days and then neck pain on left side for 2 days; This is a spontaneous report from a contactable consumer (patient). A non-pregnant female patient of unknown age (Age: 70; Unit: Unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 27Jan2021 10:30 AM at left arm as a single dose for COVID-19 immunisation. The patients medical history included cancer. No Known allergies were reported. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient had not been tested for COVID 19. Concomitant medications included losartan, atenolol and metformin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Jan2021 at 07:00 AM, the patient experienced Headaches for two days, neck pain on right side for 2 days and then neck pain on left side for 2 days. No therapeutic measures were received for the events. The outcome of the events were recovering. Information on the Lot/Batch Number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Fatigue, Headache, Nausea
Clinical narrative: headache; naseau; tiredness; bones aching; This is a spontaneous report from a contactable consumer or other non hcp. A 45-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25Jan2021 07:45 as 1ST DOSE, SINGLE (at the age of 45-year-old) for covid-19 immunisation. Medical history included High blood pressure from an unknown date and unknown if ongoing. Concomitant medications included losartan potassium (LOSARTIN) once daily, colecalciferol (VITAMIN D [COLECALCIFEROL]) and Men's one a day multivitamin. The patient previously took codeine, neomycin and experienced drug hypersensitivity. The patient experienced headache, naseau, tiredness, bones aching 5 days after vaccine. The outcome of the events was recovered in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache, Injection site pain
Clinical narrative: Headache; Knee pain/ Joint pain; Back pain; Pain in side of injection; This is a spontaneous report from a contactable physician. A 29-year-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 intramuscular, administered in Arm Left on 27Jan2021 14:00 (Batch/Lot number was not reported) as SINGLE DOSE for an COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. No Other vaccines in four weeks. No other medications in two weeks. No Covid prior vaccination. No Covid tested post vaccination. On 28Jan2021 patient experienced headache (headache) (non-serious), knee pain/ joint pain (arthralgia) (non-serious), back pain (back pain) (non-serious), pain in side of injection (injection site pain) (non-serious). Tylenol was given as treatment for all the events. The outcome for all the events was recovering.  Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Hypoaesthesia, Nausea, Paraesthesia
Clinical narrative: headache; a numb/tingling sensation on her face; a numb/tingling sensation on her face; nausea; vomiting; fever; diarrhea.; This is a spontaneous report from a contactable consumer (patient). A female of unknown age patient received second dose of dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection), via an unspecified route of administration on 25Jan2021 at single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) about 4 weeks ago and experienced flu-like symptoms and head ache for about 4 days. After receiving the second dose, in Jan2021, that night/the next morning patient reported headache, a numb/tingling sensation on her face, nausea and vomiting, fever, and diarrhea. She told that the fever seems to have come down, and that the vomiting stopped but the diarrhea had continued. She still had symptoms, and her HCP refuses to see her. The clinical outcome of the event diarrhea was not resolved, event vomiting was resolved on an unspecified date and for all the other events outcome was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: headache; a numb/tingling sensation on her face; a numb/tingling sensation on her face; nausea; vomiting; fever; diarrhea.; This is a spontaneous report from a contactable consumer (patient). A female of unknown age patient received second dose of dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection), via an unspecified route of administration on 25Jan2021 at single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) about 4 weeks ago and experienced flu-like symptoms and head ache for about 4 days. After receiving the second dose, in Jan2021, that night/the next morning patient reported headache, a numb/tingling sensation on her face, nausea and vomiting, fever, and diarrhea. She told that the fever seems to have come down, and that the vomiting stopped but the diarrhea had continued. She still had symptoms, and her HCP refuses to see her. The clinical outcome of the event diarrhea was not resolved, event vomiting was resolved on an unspecified date and for all the other events outcome was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, SARS-CoV-2 test
Clinical narrative: Taste problems.  Everything tastes bitter and off.  12 days later still having the bitterness.; This is a spontaneous report from a contactable consumer (patient). A 72-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via intramuscular route of administration in left arm on 29Jan2021 at 18:45 as single dose for covid-19 immunisation. Medical history included hernia, asthma and reflex. Prior to the vaccination, the patient didn't have COVID-19. Since the vaccination, the patient had been tested for COVID-19 with sars-cov-2 test and resulted negative on 07Feb2021. The patient has known allergies with metoprolol, sulpha, Macrodantin, lisinopril, levaquin, penicillin and latex. Concomitant medication included breo (BREO ELLIPTA), levothyroxine (LEVOTHYROXINE SODIUM), pantoprazole (PANTOPRAZOLE), olmesartan (OLMESARTAN), simvastatin (SIM) taken for an unspecified indication. The patient did not receive any vaccinations within 4 weeks prior to COVID-19 vaccine. On an unspecified date the patient experienced taste problems. Everything tastes bitter and off. 12 days later still having the bitterness. The patient visited emergency room due to event. The patient did not receive any treatment for the events. Outcome of the event was not recovered.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Backache; This is a spontaneous report from a contactable consume, the patient. A 26-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9269), dose 1 via an unspecified route of administration, administered in arm right on 10Feb2021 17:15 as first dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced backache on 11Feb2021 08:00. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not treatment received for the adverse event. Patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has not been tested for COVID-19. Case reported as non-serious. The outcome of the event was recovered.   Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Hypoaesthesia, Musculoskeletal stiffness, Vitamin D
Clinical narrative: diarrhea; numbness on my finger; My finger is still a little bit, it's hard to move; stomach is not settled; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262), via an unspecified route of administration on 02Feb2021 as a single dose for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283), via an unspecified route of administration on an unknown date. The patient's medical history was not reported. For concomitant medications patient stated, "Yes, I just take medication that is not really important for that. No lab work but she stated, I think I did. I checked my Vitamin D, it wasn't in two weeks may be in the month of Feb, I can't recall but it's not too long ago within the but I can't pin point the date. The patient also stated that three days after she received the second dose on 03Feb, she developed diarrhoea which has been going on for 7 days. The patient stated that her stomach was not settled and she was laying in the bed. The patient also felt numbness in her finger. She has also noticed her pinky was getting stiff. The patient stated that her finger was still a little bit hard to move but the diarrhoea part was subsiding. The outcome of the events was resolving for diarrhoea, not resolved for numbness of finger and unknown for "my finger is still a little bit, it's hard to move" and "Her stomach is not settled". On 08Mar2021, Information received from a same contactable consumer in response to Non-HCP letter sent via email included requested for additional information since can't open AER. On 12Mar2021, different start date for second dose and lot numbers were obtained as (LOT#2: 02Feb I think it's EL9262, LOT#1: EL1283).   Follow-up attempts completed. No further information expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, SARS-CoV-2 antibody test
Clinical narrative: never had difficulty breathing like he did 3 days after the vaccine; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. An 82-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 22Jan2021 01:45 AM (Batch/Lot Number: EL3247) as 1ST DOSE, SINGLE for covid-19 immunization. The patient's medical history included High Blood Pressure (hypertension); COPD (chronic obstructive pulmonary disease) and drug hypersensitivity from an unknown date and it was unknown if ongoing. Concomitant medications included lisinopril; felodipime; XARELTO (rivaroxaban); hydrochlorothiazide; zinc; folic acid; Vitamin C; pravastatin sodium; ALLEGRA (fexofenadine hydrochloride); VITRN C (ascorbic acid, ferrous fumarate); atropin; TIMOPTIC (timolol maleate); REFRESH PLUS (carmellose sodium); REFRESH PM (paraffin, liquid, white soft paraffin); BREO ELLIPTA (fluticasone furoate, vilanterol trifenatate ); FLONASE SENSIMIST ALLERGY RELIEF (fluticasone furoate) taken for an unspecified indication, start and stop date were not reported. The patient's allergic conditions included Penicillin, Tetracycline, NSAID eye meds (drug hypersensitivity). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid 19 and was not tested for COVID-19 prior vaccination. On 25Jan2021 at 12:00, the patient reported that he "never had difficulty breathing like he did 3 days after the vaccine". The patient was treated with Prednisone 10 mg, Azithromycin 250 mg, Clonidine HCL .2 mg, Albuterol Sulfate 4 mg. On 04Feb2021, the patient underwent lab test for sars-cov-2 antibody test with nasal Swab which was revealed to be negative. The outcome of event was not recovered.  No follow-up attempts are possible. Information about batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Lethargy
Clinical narrative: Mild elevated temperature (100.3 ); lethargy; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, #lot: EL3247) via an unspecified route of administration, administered in Arm Right on 12Feb2021 (at the age of 49-years-old) as single dose for covid-19 immunisation. The patient's medical history included asthma and known allergies: NSAIDs trigger asthmatic response. The patient's past drugs include received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, #lot: EL3247) via an unspecified route of administration, administered in Arm Left on 22Jan2021 (at the age of 49-years-old) as single dose for covid-19 immunisation. The patient's concomitant medication included montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC) and sertraline hydrochloride (ZOLOFT). The patient underwent lab tests and procedures which included body temperature: 100.3 on 13Feb2021 Mild elevated temperature. It was reported as mild elevated temperature (100.3) onset 27h post dose, and accompanying lethargy. abatement of symptoms 36h post dose. The patient experienced mild elevated temperature (100.3) and lethargy on 13Feb2021 13:00. The outcome of the events was recovered on an unknown date in Feb2021. The patient did not receive any treatment for the reported events.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: one had a headache and maybe a fever; one had a headache and maybe a fever; This is a spontaneous report from a non-contactable consumer via medical information team. A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the reporter who was a frontline worker, received his first dose of the Pfizer Covid vaccine on 17Jan2021. He had no side effects except for a very sore arm at the injection site which he never had with a vaccine before. Some of his work colleagues complained of fatigue and one had a headache and maybe a fever 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.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Muscle spasms
Clinical narrative: menses cycle has stopped/no menses; Pelvic area cramping; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: eld142) intramuscularly administered into left arm on 05Jan2021 00:00 (also reported as 12 AM; at the age of 48-year-old) as 1st dose, single for COVID-19 immunisation. Medical history included latex allergy and 4-5 day heavy cycle every 22- 28 days. Patient was not pregnant. The patient's concomitant medications were not reported. It was reported that on Jan2021 patient's menses cycle has stopped, she had no menses and experienced pelvic area cramping. The patient did not receive any treatment. It was reported that the patient will have an OBGYN appointment next week to check estridiol, FSH and LH as well as antiovarian and anti thyroid to see if vaccine triggered an autoimmune response. Outcome of events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Night chills; Muscle soreness; Slight fever; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old female patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection, Batch/lot number: EH9899) via an unspecified route of administration on 05Jan2021 in left arm as single dose for COVID-19 immunization. The patient's medical history was reported as none and concomitant medications were not reported. The same day (on 05Jan2021) the patient experienced night chills, muscle soreness and slight fever. The patient received her second dose of COVID Vaccine (Lot number: E19262, NDC number and Expiry Date: unknown) on 26Jan2021 in left arm. She did not have issues with the second dose, but she had issues with the first dose. On an unknown date in Jan2021 she had a rapid COVID test, and the result was negative. On 06Jan2021, all the events recovered. Investigation Assessment: No.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a non-contactable consumer (patient). A 55-year-old male patient received at clinic BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), via unspecified route of administration in left arm on unspecified date in Feb2021 09:30 AM as 2nd dose, single for COVID-19 immunisation. The patient's medical history was reported as none. No known allergies reported. The patient did not have COVID prior vaccination. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), via unspecified route of administration in left arm on unspecified date in Jan2021 09:30 AM (at the age of 54-year-old) as 1st dose, single for COVID-19 immunisation. The patient did not receive any other vaccine in 4 weeks. On 18Feb2021 05:00 AM the patient experienced fever, chills, and pain at injection site. No treatment was received due to event. The patient was not tested for COVID post vaccination. The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.