chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Skin irritation
Clinical narrative: sharp pain R side of neck along dermatome; vesicles break out R anterior chest with mild burning and itching; vesicles break out R anterior chest with mild burning and itching; vesicles break out R anterior chest with mild burning and itching; minor shingles outbreak; skin irritation; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), intramuscularly on 17Dec2020 at 10:15 at a single dose on the left arm for COVID-19 immunization. Medical history included Afib/ flutter, ablation, and total hysterectomy. Patient had allergies to food: grapes. Concomitant medications included fish oil, zinc, and estradiol (1 mg, 2x/week) transdermal patch. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. On 20Dec2020 at 09:00, the patient experienced sharp pain R side of neck along dermatome, vesicles break out R anterior chest with mild burning and itching consistent with a minor shingles outbreak. MD had examined it and his opinion was that the minor shingles outbreak was most likely triggered by the vaccine. Very mild but skin irritation was also present. No treatment was given for the events. Since the vaccination, the patient has not tested for COVID-19. The outcome of the events was recovering at the time of the report.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This is a spontaneous report from a  contactable consumer reported a 63-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 29Dec2020 at a single dose for Covid-19 immunization.  Medical history included ongoing chronic fatigue and Epstein Barr.  The patient's concomitant medications were not reported. The patient works in a nursing home, she received her first vaccine on 29Dec2020, she said since then has had fatigue. Inquiring if this is normal and if anyone else has reported this and asking if others have reported. She is due for second dose 19Jan2021. Outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: received the first dose of vaccine in a hospital on 18Dec2020/tested positive for COVID on 01Jan2021; received the first dose of vaccine in a hospital on 18Dec2020/tested positive for COVID on 01Jan2021; This is a spontaneous report from a contactable nurse (patient) via Pfizer-sponsored program. A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EK5730, expiration 31Mar2021) , via an unspecified route of administration in left arm, on 18Dec2020 at 15:00, at 0.3 mL, single, for COVID-19 immunization.  Medical history and concomitant medications were reported as none.  The patient received the first dose of vaccine in a hospital on 18Dec2020 at 15:00 as she works in emergency room and tested positive for COVID on 01Jan2021. The patient stated that the second dose is scheduled this afternoon (08Jan2021) and wants to know if she should proceed with the vaccine. The patient is looking for guidance on whether or not to get the second dose or wait. The patient has been directed to receive second COVID vaccine. No additional vaccines administered on the same date. The event required a visit to urgent care. The patient did not have prior vaccinations within 4 weeks. No events prior to vaccination. The patient underwent lab tests and procedures which included COVID 19: positive on 01Jan2021. Outcome of the events was unknown.  The event was assessed as serious (medically significant). The event "Tested positive for COVID" was assessed as unrelated to COVID vaccine as her husband was COVID positive before her.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Oropharyngeal pain, SARS-CoV-2 test, Vomiting
Clinical narrative: Sore throat; congestion; headache; she will vomit; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program: Pfizer First Connect. A 40-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK5730, exp date: 31Mar2021), via an unspecified route of administration on 19Dec2020 for COVID-19 immunization. Medical history included being COVID positive on 16Nov2020. The patient had no other relevant history. There were no concomitant medications (no other products). She was working at a doctor's office. The patient mentioned she was due to receive the 2nd dose of the vaccine on 09Jan2021 at 9 am but currently has a sore throat, congestion and a headache (onset date: 05Jan2021). Her symptoms worsened. It started as just a headache. With the congestion now when she blows her nose, sometimes she will vomit (onset date: Jan2021). She was asking if it was okay for her to take the vaccine tomorrow and for any recommendations. She was tested for COVID the day of reporting (08Jan2021) but had no results with her; she hasn't received the COVID test result back (unknown). No investigation assessment performed. The outcome of she will vomit was unknown while the other events had not recovered.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: She reported being exposed to her husband, who tested positive for COVID, and that she tested positive following her first vaccine dose; She reported being exposed to her husband, who tested positive for COVID, and that she tested positive following her first vaccine dose; She reported being exposed to her husband, who tested positive for COVID, and that she tested positive following her first vaccine dose; This is a spontaneous report from a contactable female nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, batch/lot no. and expiry date unspecified) via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient was asking if it is safe to get the second dose of the vaccine after being exposed to or having COVID? She reported being exposed to her husband (on an unspecified date), who tested positive for COVID, and that she tested positive following her first vaccine dose. She got her Covid-19 vaccine on the 23Dec2020 and tested positive for Covid-19 on the 28Dec2020. She was scheduled to get the next dose on Wednesday and wants to know if she should still get it.  Outcome of the events drug ineffective, COVID-19 and Exposure to COVID-19 was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 23Dec2020, and COVID-19 test positive on 28Dec2020.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID test was likely associated with being exposed to her husband, who had COVID-19.  Further information is needed for full medical assessment.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dyspnoea, Rash, SARS-CoV-2 test, Tongue blistering
Clinical narrative: she had blister on the right side of the tongue /has blisters on her tongue or maybe ulcers; she had blister on the right side of the tongue /has blisters on her tongue or maybe ulcers; rash on the neck; which was burning /burning on skin where the rash is; had difficulty in breathing due to congestion in throat; had difficulty in breathing due to congestion in throat; This is a spontaneous report from a contactable consumer (patient).  A 61-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685 and expiration date not provided), via an unspecified route of administration (right arm) first dose on 07Jan2021 15:45 at single dose for covid-19 immunisation. The patient's medical history ongoing Asthma, ongoing Psoriasis, ongoing Eczema, and ongoing Osteoporosis. There were no concomitant medications. The patient stated yesterday she got the vaccine, about a half hour later her neck started to get red like a rash, and as the evening went on it felt like burning on her skin at the rash. She had a hard time breathing last night and had to sit up to sleep. Then this morning she had a blister on her tongue.The patient clarified the first dose of vaccine was on 07Jan2021 at 15:45 PM in the right arm. She noticed about 30 minutes later, a rash on the neck and then burning on the skin where the rash was that evening; then that night she had a hard time breathing and had to sit up to sleep due to congestion in her throat. She had to keep clearing her throat. This morning (08Jan2021) she noticed she has blisters on her tongue or maybe ulcers, just on the right side. Asking should she take some Benadryl? Was this expected side effects?. The patient wanted to know find out if she should get the next dose? The patient relevant tests include COVID 19 test on 07Dec2020 and it was negative. The outcome of the event Neck rash was recovering and not recovered for the remaining events.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue ulceration, Upper respiratory tract congestion
Clinical narrative: she had blister on the right side of the tongue /has blisters on her tongue or maybe ulcers; she had blister on the right side of the tongue /has blisters on her tongue or maybe ulcers; rash on the neck; which was burning /burning on skin where the rash is; had difficulty in breathing due to congestion in throat; had difficulty in breathing due to congestion in throat; This is a spontaneous report from a contactable consumer (patient).  A 61-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685 and expiration date not provided), via an unspecified route of administration (right arm) first dose on 07Jan2021 15:45 at single dose for covid-19 immunisation. The patient's medical history ongoing Asthma, ongoing Psoriasis, ongoing Eczema, and ongoing Osteoporosis. There were no concomitant medications. The patient stated yesterday she got the vaccine, about a half hour later her neck started to get red like a rash, and as the evening went on it felt like burning on her skin at the rash. She had a hard time breathing last night and had to sit up to sleep. Then this morning she had a blister on her tongue.The patient clarified the first dose of vaccine was on 07Jan2021 at 15:45 PM in the right arm. She noticed about 30 minutes later, a rash on the neck and then burning on the skin where the rash was that evening; then that night she had a hard time breathing and had to sit up to sleep due to congestion in her throat. She had to keep clearing her throat. This morning (08Jan2021) she noticed she has blisters on her tongue or maybe ulcers, just on the right side. Asking should she take some Benadryl? Was this expected side effects?. The patient wanted to know find out if she should get the next dose? The patient relevant tests include COVID 19 test on 07Dec2020 and it was negative. The outcome of the event Neck rash was recovering and not recovered for the remaining events.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: odd feeling; dizziness; This is a spontaneous report from a contactable nurse (patient herself).  A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: FL3246, expiration date unknown), intramuscularly in left arm (also reported as subcutaneously in the left deltoid muscle) on 07Jan2021 at 10:00 at a single dose for COVID-19 immunisation.  Medical history included osteoarthritis and  depression on unknown dates and other unspecified conditions diagnosed in 2012 or 2014 and also needed glasses.  Concomitant medication included bupropion as antidepressant for about six years. Family medical history was reported none. The patient experienced dizziness  on 07Jan2021 following the first dose. The patient received the first dose on 07Jan2021 (yesterday) morning. She did not have any symptoms after the injection, but by the end of the afternoon/ late afternoon or early evening, she started feeling dizzy. She was not sure if it was because of her age. In the morning of 08Jan2021, when she woke up, she was feeling more dizzy. It was not to the point where she felt she was going to fall though. She would like to know if this has been reported as a common side effect. The patient asked when will it get better and if this will affect her second dose in 3 weeks. There was no prescriber and patient went to designated vaccine site which was not a military facility. The patient further reported that the dizziness was nothing notable last night. It was not better. In the morning of 08Jan2021, she walked around a bit and ate breakfast, thinking that would take away. When sitting, she as fine. When getting up to walk, she noticed it. The room was not spinning. It was just an odd feeling. When reading the vaccine card, she said she is looking for glasses and confirmed that she needed them prior to getting the vaccine. The patient also informed that one of the side effects of bupropion was dizziness and she did not take it on 08Jan2021. She did take the dose in the night of 07Jan2021. It was in a pharmacy vial with no lot or expiration. The patient had no previous history of previous immunizations with Pfizer vaccine. There were no additional vaccines administered on same date as the BNT162B2. The event did not require ER or physician's office. There were no prior vaccinations within 4 weeks. The event  was considered non-serious by the reporter. There were no relevant tests. The outcome of the event was not recovered.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Chills, Malaise, Pain, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID; tested positive for COVID; achiness; Chills; not feeling well; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient's wife) reported similar events for four patients. This is the first of four reports.    A 48-year-old male patient received his first dose of bnt162b2 (BNT162B2 also reported as Pfizer-Biontech Covid-19 Vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on 17Dec2020 at single dose, for Covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient received the vaccine last 17Dec2020. The following day, 18Dec2020, he was not feeling well. Clarified those side effects as achiness and chills. He had been working so hard and thought initially were getting side effects from the COVID Vaccine. He was tested positive for COVID on 22Dec2020. He was in bed basically until 31Dec2020. His wife wants to know if he should get the second dose. The outcome of events was recovered.  Information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021019513 same drug, similar events, different patient;US-PFIZER INC-2021019535 same drug, similar events, different patient;US-PFIZER INC-2021019534 same drug, similar events, different patient
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Migraine, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: migraine; weakness; itchiness, redness and swelling around the injection site; itchiness, redness and swelling around the injection site; itchiness, redness and swelling around the injection site; This is a spontaneous report from a contactable nurse. A 32-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on 30Dec2020 at SINGLE DOSE at left arm for covid-19 immunization. Medical history was reported as none. There were no concomitant medications. On 30Dec2020, the patient reported migraine and became more severe on 31Dec2020, weakness, itchiness, redness and swelling around the injection site post vaccination. Caller wants to know if she can receive the second dose of the vaccine despite the redness and swelling around the injection site. The outcome of the event Itchiness, red and swollen injection site was recovered on 31Dec2020, the event migraine, weakness was recovered on 01Jan2021  Information about Lot/Batch number has been requested.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: redness and itchiness on the injection site; redness and itchiness on the injection site; This is a spontaneous report from a contactable consumer (patient). An 87-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number unknown), via an unspecified route of administration on 06Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received the COVID-19 vaccine on Wednesday (06Jan2021). Everything was fine, she sat there for fifteen to twenty minutes and then left. This morning (08Jan2021), patient woke up with redness and itchiness on the injection site where the shot was. Patient asked if her side effects are expected and will it go away, and should she be concerned. The outcome of the events was unknown.  Information on lot number/batch number was requested.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Dysgeusia, Fatigue, Hypoaesthesia, Joint range of motion decreased
Clinical narrative: she had a metallic taste in her mouth; she couldn't taste anything half an hour after receiving the first dose; fatigue that made her fall asleep for 4-5 hours; tingling sensation in the top of her head/ tingling sensation on her right arm right after the shot; nausea; numb sensation on her right arm; sore sensation so bad she could not lift her arm; sore sensation so bad she could not lift her arm; This is a spontaneous report from a contactable consumer, the patient.  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 22Dec2020 as a single dose for COVID-19 immunization.   Medical history included two strokes. The patient's concomitant medications were not reported.  On an unknown date, the patient experienced a metallic taste in her mouth, she couldn't taste anything half an hour after receiving the first dose, fatigue that made her fall asleep for 4-5 hours, tingling sensation in the top of her head/ tingling sensation on her right arm right after the shot, nausea, numb sensation on her right arm, and sore sensation so bad she could not lift her arm.  The clinical outcomes of metallic taste in her mouth, couldn't taste anything, fatigue, tingling sensation, nausea, numb sensation on her right arm, and sore sensation so bad she could not lift her arm, were unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Paraesthesia
Clinical narrative: she had a metallic taste in her mouth; she couldn't taste anything half an hour after receiving the first dose; fatigue that made her fall asleep for 4-5 hours; tingling sensation in the top of her head/ tingling sensation on her right arm right after the shot; nausea; numb sensation on her right arm; sore sensation so bad she could not lift her arm; sore sensation so bad she could not lift her arm; This is a spontaneous report from a contactable consumer, the patient.  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 22Dec2020 as a single dose for COVID-19 immunization.   Medical history included two strokes. The patient's concomitant medications were not reported.  On an unknown date, the patient experienced a metallic taste in her mouth, she couldn't taste anything half an hour after receiving the first dose, fatigue that made her fall asleep for 4-5 hours, tingling sensation in the top of her head/ tingling sensation on her right arm right after the shot, nausea, numb sensation on her right arm, and sore sensation so bad she could not lift her arm.  The clinical outcomes of metallic taste in her mouth, couldn't taste anything, fatigue, tingling sensation, nausea, numb sensation on her right arm, and sore sensation so bad she could not lift her arm, were unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Oropharyngeal pain, Pain in extremity
Clinical narrative: Sore throat; Headache/has had an off and on headache since this morning; Nausea; Sore arm/had a sore right arm; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, Pfizer First Connect. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140, expiry date: Mar2021), via an unspecified route of administration on the right arm on 04Jan2021 (between 16:00- 16:15)  at a single dose for COVID-19 immunization. Medical history included ongoing Hashimoto's disease about 7-8 years ago. She said she doesn't take medication all the time for the condition. Concomitant medication included azithromycin (Z-PAK), bifidobacterium infantis (ALIGN). Patient had nausea since 06Jan2021. Her sore arm started at around 3:00 AM on 05Jan2021 and lasted only one day. The caller asked if the nausea could be caused by the COVID-19 Vaccine, and if so, should she get the second dose of the COVID-19 vaccine. Reported the nausea is more of an annoyance, and she doesn't feel like she is going to throw up. Her nausea has been persisting since it started on 06Jan2021, but had worsened from 07Jan2021, to 08Jan2021. She said she woke up the morning of 08Jan2021 with a sore throat, and has had an off and on headache since the morning. Outcome of the event sore arm was recovered on 05Jan2021, for the remaining events was not recovered No prior vaccinations within 4 weeks. The reporter considered the event non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Urticaria
Clinical narrative: hives, headache and fever; hives, headache and fever; hives, headache and fever; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown), 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. The patient experienced hives, headache and fever after receiving the first dose of the Pfizer COVID-19 vaccine. She wanted to know if she can receive the second dose of the vaccine. She took some Benadryl for it. She mentioned she is due soon for the second dose, later clarified as, due today (08Jan2021) for the second dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, SARS-CoV-2 test positive
Clinical narrative: tested positive for SARS-COV-2; tested positive for SARS-COV-2; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect, received from a contactable nurse (patient). A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on 18Dec2020 at a single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient received first dose of vaccine on 18Dec2020 and tested positive for SARS-COV-2 20Dec2020. She reported "las major symptom" on 27Dec2020 and asked if it was okay to take the second dose. Outcome of the events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Positive SARS-COV-2 came back 2 days following the vaccine use is compatible with COVID 19 infection.  No adequate effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, Asthenia, Chills
Clinical narrative: Normal pain at site; nause; diarrea; congestion; pain both ears; headache; dizziness; weakness; cough; joint and muscle aches; joint and muscle aches; chills; loss of appetite, taste and smell; loss of appetite, taste and smell; loss of appetite, taste and smell; fever; difficulty breathing; dehydration; throught swollen; This is a spontaneous report from a contactable Other Health Professional (patient). A 50-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 30Dec2020 10:00 at single dose for COVID-19 immunization.  Medical history included covid from an unknown date and unknown if ongoing (Prior to vaccination, was the patient diagnosed with COVID-19: Yes). Known allergies: no. Other medical history: no.  Concomitant medication the patient received within 2 weeks of vaccination included bupropion, esomeprazole magnesium, lisinopril, magnesium citrate, magnesium oxide, riboflavin, tanacetum parthenium (MIGRELIEF), lisdexamfetamine mesilate (VYVANSE), Aller-itin.  If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: No. Facility where the most recent COVID-19 vaccine was administered: Other. The patient experienced normal pain at site, nause, diarrea, congestion and pain both ears, headache dizziness, weakness. cough, joint and muscle aches, chills, loss of appetite, taste and smell, fever, difficulty breathing, dehydration, throught swollen, all on 31Dec2020 05:00 with outcome of recovering. The patient received treatment for the adverse event: cold medicine fluids paracetamol (TYLENOL) and sleep. Since the vaccination, has the patient been tested for COVID-19: No. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.    Information about Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Dehydration, Diarrhoea, Dizziness
Clinical narrative: Normal pain at site; nause; diarrea; congestion; pain both ears; headache; dizziness; weakness; cough; joint and muscle aches; joint and muscle aches; chills; loss of appetite, taste and smell; loss of appetite, taste and smell; loss of appetite, taste and smell; fever; difficulty breathing; dehydration; throught swollen; This is a spontaneous report from a contactable Other Health Professional (patient). A 50-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 30Dec2020 10:00 at single dose for COVID-19 immunization.  Medical history included covid from an unknown date and unknown if ongoing (Prior to vaccination, was the patient diagnosed with COVID-19: Yes). Known allergies: no. Other medical history: no.  Concomitant medication the patient received within 2 weeks of vaccination included bupropion, esomeprazole magnesium, lisinopril, magnesium citrate, magnesium oxide, riboflavin, tanacetum parthenium (MIGRELIEF), lisdexamfetamine mesilate (VYVANSE), Aller-itin.  If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: No. Facility where the most recent COVID-19 vaccine was administered: Other. The patient experienced normal pain at site, nause, diarrea, congestion and pain both ears, headache dizziness, weakness. cough, joint and muscle aches, chills, loss of appetite, taste and smell, fever, difficulty breathing, dehydration, throught swollen, all on 31Dec2020 05:00 with outcome of recovering. The patient received treatment for the adverse event: cold medicine fluids paracetamol (TYLENOL) and sleep. Since the vaccination, has the patient been tested for COVID-19: No. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.    Information about Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Ear pain, Headache, Myalgia, Nasal congestion
Clinical narrative: Normal pain at site; nause; diarrea; congestion; pain both ears; headache; dizziness; weakness; cough; joint and muscle aches; joint and muscle aches; chills; loss of appetite, taste and smell; loss of appetite, taste and smell; loss of appetite, taste and smell; fever; difficulty breathing; dehydration; throught swollen; This is a spontaneous report from a contactable Other Health Professional (patient). A 50-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 30Dec2020 10:00 at single dose for COVID-19 immunization.  Medical history included covid from an unknown date and unknown if ongoing (Prior to vaccination, was the patient diagnosed with COVID-19: Yes). Known allergies: no. Other medical history: no.  Concomitant medication the patient received within 2 weeks of vaccination included bupropion, esomeprazole magnesium, lisinopril, magnesium citrate, magnesium oxide, riboflavin, tanacetum parthenium (MIGRELIEF), lisdexamfetamine mesilate (VYVANSE), Aller-itin.  If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: No. Facility where the most recent COVID-19 vaccine was administered: Other. The patient experienced normal pain at site, nause, diarrea, congestion and pain both ears, headache dizziness, weakness. cough, joint and muscle aches, chills, loss of appetite, taste and smell, fever, difficulty breathing, dehydration, throught swollen, all on 31Dec2020 05:00 with outcome of recovering. The patient received treatment for the adverse event: cold medicine fluids paracetamol (TYLENOL) and sleep. Since the vaccination, has the patient been tested for COVID-19: No. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.    Information about Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Swelling, Vaccination site pain
Clinical narrative: Normal pain at site; nause; diarrea; congestion; pain both ears; headache; dizziness; weakness; cough; joint and muscle aches; joint and muscle aches; chills; loss of appetite, taste and smell; loss of appetite, taste and smell; loss of appetite, taste and smell; fever; difficulty breathing; dehydration; throught swollen; This is a spontaneous report from a contactable Other Health Professional (patient). A 50-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 30Dec2020 10:00 at single dose for COVID-19 immunization.  Medical history included covid from an unknown date and unknown if ongoing (Prior to vaccination, was the patient diagnosed with COVID-19: Yes). Known allergies: no. Other medical history: no.  Concomitant medication the patient received within 2 weeks of vaccination included bupropion, esomeprazole magnesium, lisinopril, magnesium citrate, magnesium oxide, riboflavin, tanacetum parthenium (MIGRELIEF), lisdexamfetamine mesilate (VYVANSE), Aller-itin.  If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: No. Facility where the most recent COVID-19 vaccine was administered: Other. The patient experienced normal pain at site, nause, diarrea, congestion and pain both ears, headache dizziness, weakness. cough, joint and muscle aches, chills, loss of appetite, taste and smell, fever, difficulty breathing, dehydration, throught swollen, all on 31Dec2020 05:00 with outcome of recovering. The patient received treatment for the adverse event: cold medicine fluids paracetamol (TYLENOL) and sleep. Since the vaccination, has the patient been tested for COVID-19: No. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.    Information about Lot/Batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Myalgia, Nausea
Clinical narrative: injection site was swollen; headache; chills; nausea; arm was sore for a few days; muscle pain; weakness; fever; This is a spontaneous report from a contactable nurse.  A 27-year-old female patient received receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EH9899, intramuscular, in the left arm from 16Dec2020 17:45 at SINGLE DOSE for COVID-19 immunization.  Medical history included asthma, Hypothyroid, HSV (Herpes simplex virus) and Penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was not pregnant. Concomitant medication included levothyroxine sodium (SYNTHROID), cetirizine hydrochloride (ZYRTEC), and fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA).  On 17Dec2020 10:00, it was reported that the injection site was swollen for about a week. Her arm was sore for a few days and had muscle pain and weakness which also started on 17Dec2020 at 10:00. She also had headache, fever, chills, and nausea 17Dec2020 10:00. The outcome of events was reported as recovered. No treatment was received/ required due to events.  No follow-up attempts possible. No further information expected. Information on the batch/lot number has been obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site swelling
Clinical narrative: injection site was swollen; headache; chills; nausea; arm was sore for a few days; muscle pain; weakness; fever; This is a spontaneous report from a contactable nurse.  A 27-year-old female patient received receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EH9899, intramuscular, in the left arm from 16Dec2020 17:45 at SINGLE DOSE for COVID-19 immunization.  Medical history included asthma, Hypothyroid, HSV (Herpes simplex virus) and Penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was not pregnant. Concomitant medication included levothyroxine sodium (SYNTHROID), cetirizine hydrochloride (ZYRTEC), and fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA).  On 17Dec2020 10:00, it was reported that the injection site was swollen for about a week. Her arm was sore for a few days and had muscle pain and weakness which also started on 17Dec2020 at 10:00. She also had headache, fever, chills, and nausea 17Dec2020 10:00. The outcome of events was reported as recovered. No treatment was received/ required due to events.  No follow-up attempts possible. No further information expected. Information on the batch/lot number has been obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: at the injection site, it is raised, warm and red; at the injection site, it is raised, warm and red; at the injection site, it is raised, warm and red; This is a spontaneous report from a contactable other health professional (HCP). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on her right arm, on 06Jan2021 at a single dose for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. Patient received the first vaccine 2 days ago (06Jan2021) and last night (07Jan2021) at the injection site, it is raised, warm and red.  She has had no other symptoms and no fever. She was asking if it is normal for it to take time to occur and for how long will it last. On 08Jan2021, it was reported that she did see that it was normal but was asking if it is normal 48 hours later. Otherwise, she was completely fine. She works as a technician at the hospital. She just took a picture of it so she can keep track of it. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Exposure to SARS-CoV-2, Pain, Pyrexia
Clinical narrative: Fevers; Chills; he is suspecting that he got infected with the Covid-19 though he already received the 1st dose; he is suspecting that he got infected with the Covid-19 though he already received the 1st dose; Body aches; Patient suspected that he has gotten infected also from his spouse; This is a spontaneous report from a contactable physician (patient). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 (Tuesday) at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient reported body aches developing the evening of receiving the vaccine, and it has persisted for three days. Patient started to get the chills on Wednesday (06Jan2021). Patient said his wife has been tested positive after he took the 1st dose and he is suspecting that he got infected with the Covid-19 though he already received the 1st dose. Patient thought that he may have been infected by his spouse. He got the vaccine on Tuesday and on Wednesday had fever and chills and still has them. Stated that his spouse lost her sense of smell and taste and tested positive for Covid on Wednesday. Patient stated that this was the day after he received his vaccine. Patient suspected that he has gotten infected also from his spouse and was not aware when he got the vaccine. Stated that now that he is having expected side effects of fever and chills. The outcome events was not recovered. This case was reported as non-serious.  Information on the lot/batch number has been requested.; Sender's Comments: The subject received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 05Jan2021, and suspected got COVID-19 infection via exposure to COVID-19 living with his wife, who lost her sense of smell and taste and tested positive for COVID on 06Jan2021.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Further information is needed for full medical assessment.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Malaise, Nausea, SARS-CoV-2 test
Clinical narrative: Headache; Nausea; Vomiting; Diarrhea; Feeling ill; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect, received from a contactable other health care professional (patient). A female (Age: 40; Unit: Unknown) patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration first dose on 20Dec2020 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that today 08Jan2021, the patient started experiencing COVID symptoms: headache, nausea, vomiting and diarrhea. She did a COVID test today but did not get the results yet. The patient wanted to know if she should get her Dose 2, which was scheduled on 10Jan2021?. The first dose was on 20Dec2020, started feeling covid symptoms 08Jan2021, headache, nausea, vomiting, diarrhea. The patient did covid test today 08Jan2021 and expecting results on 11Jan2021, but second is scheduled for 10Jan2021. The patient was wondering if she should still have her second dose on 10Jan2021. Additionally, it was reported that o the past Friday 08Jan2021, started feeling ill (Jan2021) and got Covid-19 tested but negative results on 11Jan2021. Supposed to get a 2nd dose on Sunday, but since testing is still pending, the caller did not proceed with taking it. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Headache; Nausea; Vomiting; Diarrhea; Feeling ill; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect, received from a contactable other health care professional (patient). A female (Age: 40; Unit: Unknown) patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration first dose on 20Dec2020 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that today 08Jan2021, the patient started experiencing COVID symptoms: headache, nausea, vomiting and diarrhea. She did a COVID test today but did not get the results yet. The patient wanted to know if she should get her Dose 2, which was scheduled on 10Jan2021?. The first dose was on 20Dec2020, started feeling covid symptoms 08Jan2021, headache, nausea, vomiting, diarrhea. The patient did covid test today 08Jan2021 and expecting results on 11Jan2021, but second is scheduled for 10Jan2021. The patient was wondering if she should still have her second dose on 10Jan2021. Additionally, it was reported that o the past Friday 08Jan2021, started feeling ill (Jan2021) and got Covid-19 tested but negative results on 11Jan2021. Supposed to get a 2nd dose on Sunday, but since testing is still pending, the caller did not proceed with taking it. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Malaise, Muscular weakness
Clinical narrative: not feeling good (felt like crap); dizziness (really dizzy); weakness; shortness of breath (short of breath); arm feeling weak (arm felt weak); This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0140, expiration date 31Mar2021) via an unspecified route of administration on 08Jan2021 at a single dose in the left arm as Covid-19 vaccine due to being a front line worker. Medical history included ongoing pre-diabetic from 2015. There were no concomitant medications. The patient received the vaccine today on 08Jan2021.  Within 15 minutes (also reported as 15 minutes after the vaccine), she experienced not feeling good (felt like crap), dizziness (really dizzy), weakness, shortness of breath (short of breath), and arm feeling weak (arm felt weak) on the side where the injection was received. It's the weirdest thing, she never had issues with vaccines before. She was asking if this was normal. The outcome of the events was unknown. The nurse reported that the events were related to the suspect product.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Inappropriate schedule of product administration
Clinical narrative: headache; tiredness/ fatigue; muscle aches; nausea; feeling like crap; BNT162B2 vaccine 1st dose 18Dec2020, 2nd dose 06Jan2021; fever; body ache; joint pain; chills; This is a spontaneous report from a contactable nurse, the patient. A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 06Jan2021 (at the age of 31-years-old) as a single dose for COVID-19 immunization. Medical history was reported as none. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 18Dec2020 (at the age of 31-years-old) for COVID-19 immunization. On 06Jan2021 at 21:00, the patient experienced headache, tiredness, muscle aches, nausea, "feeling like crap", but no injection site pain. On an unspecified date in Jan2021, the patient experienced fever for three days, body ache, joint pain, chills and fatigue and "everything". Treatment was not received for the events headache, tiredness, muscle aches, nausea, "feeling like crap", body ache, joint pain, chills and fatigue.  The clinical outcomes of headache, tiredness, muscle aches, nausea, "feeling like crap", body ache, joint pain, chills and fatigue were unknown; of fever was resolved on Jan2021 and of "BNT162B2 vaccine 1st dose 18Dec2020, 2nd dose 06Jan2021" was unknown.  Information about Lot/Batch Number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: headache; tiredness/ fatigue; muscle aches; nausea; feeling like crap; BNT162B2 vaccine 1st dose 18Dec2020, 2nd dose 06Jan2021; fever; body ache; joint pain; chills; This is a spontaneous report from a contactable nurse, the patient. A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 06Jan2021 (at the age of 31-years-old) as a single dose for COVID-19 immunization. Medical history was reported as none. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 18Dec2020 (at the age of 31-years-old) for COVID-19 immunization. On 06Jan2021 at 21:00, the patient experienced headache, tiredness, muscle aches, nausea, "feeling like crap", but no injection site pain. On an unspecified date in Jan2021, the patient experienced fever for three days, body ache, joint pain, chills and fatigue and "everything". Treatment was not received for the events headache, tiredness, muscle aches, nausea, "feeling like crap", body ache, joint pain, chills and fatigue.  The clinical outcomes of headache, tiredness, muscle aches, nausea, "feeling like crap", body ache, joint pain, chills and fatigue were unknown; of fever was resolved on Jan2021 and of "BNT162B2 vaccine 1st dose 18Dec2020, 2nd dose 06Jan2021" was unknown.  Information about Lot/Batch Number has been requested.