chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nerve compression, Pain in extremity
Clinical narrative: I woke up Friday kind of very something similar to sciatic nerve, like pinch nerve in my back; I started to get numbness in my whole right side, my face, my arm and my leg; My arm was a little bit sore; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 11Feb2021 in afternoon as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 12Feb2021, the patient woke up kind of very something similar to sciatic nerve, like pinch nerve in back in which the patient felt it might be just normal, it happens, it is nothing abnormal. On an unknown date in unspecified date on Feb2021, the patient arm was a little bit sore which the patient know is regular and normal, the patient arm was fine and everything but around noon, the patient started to get numbness in whole right side, face, arm and leg. So, the patient was just wondering is that something to do with the vaccine or not. The patient was informed about Pfizer Medical information department. The outcome of event I woke up Friday kind of very something similar to sciatic nerve, like pinch nerve in my back was resolved on 15feb2021 and other events were unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: blood usually come out; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient took the Vaccine and he/she noticed when they lady was giving him/her the shot, does blood usually come out questioned. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium increased, Body temperature, Chills, Fatigue, Pain
Clinical narrative: Chills; Fatigue; I just felt warm and I felt achy as my arm; I have too much potassium in my blood; my arm was hurting; I went as low as 99.1 and as high as 100.2; Took it again and it was 99.6 and in between it was 99, 98.3, 99.6, 99.1, a 100.4, 99.3, 100.2 and 99.5; fever; This is a spontaneous report from a contactable consumer or other non hcp. A 82-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL8982; Expiration Date: May2021), via an unspecified route of administration on 17Feb2021 15:30(age at vaccination 82Years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included blood cholesterol from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, gastroesophageal reflux disease from an unknown date and unknown if ongoing, vascular graft from an unknown date and unknown if ongoing, coronary artery bypass from 2016 to an unknown date. Concomitant medications included metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported; ranolazine (RANOLAZINE) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient previously took potassium pill. The patient experienced fever on 17Feb2021, chills (on an unspecified date, fatigue on an unspecified date, I went as low as 99.1 and as high as 100.2; took it again and it was 99.6 and in between it was 99, 98.3, 99.6, 99.1, a 100.4, 99.3, 100.2 and 99.5 on 17Feb2021, I just felt warm and I felt achy as my arm on an unspecified date, I have too much potassium in my blood on an unspecified date, my arm was hurting on an unspecified date. The patient underwent lab tests and procedures which included body temperature: 99.5 fahrenheit on 18Feb2021, body temperature: 100.2 fahrenheit on 18Feb2021 at 4pm, body temperature: 99.3 fahrenheit on 19Feb2021, body temperature: 100.4 fahrenheit on 20Feb2021, body temperature: 99.1 fahrenheit on 21Feb2021, body temperature: 99.1 fahrenheit on 22Feb2021, body temperature: 99.6 fahrenheit on 22Feb2021, body temperature: 99.6 fahrenheit on 23Feb2021. Therapeutic measures were taken as a result of fever, chills, fatigue, I went as low as 99.1 and as high as 100.2; took it again and it was 99.6 and in between it was 99, 98.3, 99.6, 99.1, a 100.4, 99.3, 100.2 and 99.5, my arm was hurting was Tylenol.The outcome of the events pyrexia was not recovered, the outcome of the events chills, fatigue, pain, blood pressure increased, pain in extremity was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Chills; Fatigue; I just felt warm and I felt achy as my arm; I have too much potassium in my blood; my arm was hurting; I went as low as 99.1 and as high as 100.2; Took it again and it was 99.6 and in between it was 99, 98.3, 99.6, 99.1, a 100.4, 99.3, 100.2 and 99.5; fever; This is a spontaneous report from a contactable consumer or other non hcp. A 82-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL8982; Expiration Date: May2021), via an unspecified route of administration on 17Feb2021 15:30(age at vaccination 82Years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included blood cholesterol from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, gastroesophageal reflux disease from an unknown date and unknown if ongoing, vascular graft from an unknown date and unknown if ongoing, coronary artery bypass from 2016 to an unknown date. Concomitant medications included metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported; ranolazine (RANOLAZINE) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient previously took potassium pill. The patient experienced fever on 17Feb2021, chills (on an unspecified date, fatigue on an unspecified date, I went as low as 99.1 and as high as 100.2; took it again and it was 99.6 and in between it was 99, 98.3, 99.6, 99.1, a 100.4, 99.3, 100.2 and 99.5 on 17Feb2021, I just felt warm and I felt achy as my arm on an unspecified date, I have too much potassium in my blood on an unspecified date, my arm was hurting on an unspecified date. The patient underwent lab tests and procedures which included body temperature: 99.5 fahrenheit on 18Feb2021, body temperature: 100.2 fahrenheit on 18Feb2021 at 4pm, body temperature: 99.3 fahrenheit on 19Feb2021, body temperature: 100.4 fahrenheit on 20Feb2021, body temperature: 99.1 fahrenheit on 21Feb2021, body temperature: 99.1 fahrenheit on 22Feb2021, body temperature: 99.6 fahrenheit on 22Feb2021, body temperature: 99.6 fahrenheit on 23Feb2021. Therapeutic measures were taken as a result of fever, chills, fatigue, I went as low as 99.1 and as high as 100.2; took it again and it was 99.6 and in between it was 99, 98.3, 99.6, 99.1, a 100.4, 99.3, 100.2 and 99.5, my arm was hurting was Tylenol.The outcome of the events pyrexia was not recovered, the outcome of the events chills, fatigue, pain, blood pressure increased, pain in extremity was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Headache, Loss of personal independence in daily activities, SARS-CoV-2 test
Clinical narrative: severe refractory Headache for more than one month; Cannot not bend down or perform normal ADLS; This is a spontaneous report from a non-contactable nurse (patient). An adult non-pregnant female nurse patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Dec2020 as dose number unknown, single for covid-19 immunisation. The patient's medical history reported as none and concomitant medications were not reported. No known allergies reported. No other vaccine in four weeks. No covid prior vaccination. On 20Dec2020, the patient experienced severe refractory headache for more than one month, cannot not bend down or perform normal ADLs (activities of daily livings). The patient underwent lab tests included on COVID-19 virus test with result unknown (Nasal Swab) on 11Jan2021 and CT scan; Result unknown on an unspecified date. The patient had taken Ibuprofen, and tylenol every 8 hours (treatment). The outcome of the event was recovered with sequel.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Diarrhoea, Headache, Pyrexia
Clinical narrative: abdominal pain; Diarrhea; fever; headache; chills; This is a spontaneous report from a non-contactable other hcp (Patient). A 38-years-old non- pregnant female patient received BNT162B2 (COMIRNATY; Formulation: Solution for injection, Batch/Lot Number: was not reported) via an unspecified route of administration, administered in Arm Left on an unspecified date as dose number unknown single for COVID-19 immunization. Medical history was reported as none. No other vaccine was given in four weeks. No known allergies were reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. No other concomitant medications were given in two weeks. On 05Feb2021 07:00 the patient experienced abdominal pain, diarrhea, fever, headache and chills. Patient did not receive any treatment for the events. The outcome of the patient was recovering.   No follow-up attempts are possible. Information on the lot/batch cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Pharyngeal hypoaesthesia
Clinical narrative: throat, mouth and face numbness/tingling; throat, mouth and face numbness/tingling; throat, mouth and face numbness/tingling; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number: EN6198, Expiration date: unknown), via unspecified route of administration, in the right arm, on 23Feb2021 at 11:00 (at the age of 26-years-old), as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included spironolactone taken for unspecified indication start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior vaccination. Patient was not tested for COVID post vaccination. On 23Feb2021 at 12:00, 1 hour after vaccination patient experienced the throat, mouth and face numbness/tingling, similar to an allergic reaction to food. AEs resulted in doctor or other healthcare professional office/clinic visit. Patient received the treatment for events: Benadryl. Outcome of the events was recovering.   Follow-up attempts completed. No further information expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: her right hand and sometimes the back of her bottom, they go numb; right arm goes numb periodically for hours, and occasionally at night; numbness on my backside; tingling; Her arm started to ache and got really bad; she experienced a freezing feeling on the right side of her body.; This is a spontaneous report from a Pfizer sponsored program COVAX US Support. A contactable female reporter reported that, A 80 years old female received second dose of bnt162b2 (BNT162B2, Formulation was Solution for injection, Lot Number EL9264), dose 2 via an unspecified route on 09Feb2021, DOSE 2, SINGLE as single dose for COVID-19 immunization (age at time of vaccination 80 years). The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (BNT162B2, Formulation was Solution for injection, Lot Number EL3247), dose 1 via an unspecified route on an unspecified date as single dose for COVID-19 immunization. On an unspecified date in 2021 the patient had right arm goes numb periodically for hours, and occasionally at night and had numbness on her backside she also had tingling, eight days later, she had trouble with her right hand. Her arm started to ache and got bad. She mentioned she could not pick anything, and her hand had a hard time gripping thing. n an unspecified date in 2021 she experienced a freezing feeling on the right side of her body. She wants to know if this is due to the vaccine. On19Feb2021 she started having trouble with her right hand and sometimes the back of her bottom, they go numb and today it has lasted longer she wonders if it is because of the vaccine, will it go away on its own or does she need to see her doctor. She says her bottom tingles, like in the back. She says her foot is fine, but she wants to know is that a result of the second shot she got, the Pfizer shot, will it go away on its own or should she do something about it. The outcome of all vents was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; Chills; Body ache; This is a spontaneous report from a non-contactable consumer (Patient). A 34-years-old non pregnant female patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 22Feb2021 17:15 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation (Age at vaccination 34 years). Medical history included Chronic Pleurisy, Thalassemia Beta. No other vaccine in four weeks. No other medications in two weeks. The patient's concomitant medications were not reported. No covid prior vaccination. The patient did test covid post vaccination. No known allergies. On 23Feb2021 06:00 (approximately 12 hours after vaccination) patient experienced fever, chills, body ache (all parts of the body). The patient underwent lab tests and procedures which included sars-cov-2 test: negative (Nasal Swab) on 08Feb2021. No treatment required for event. The outcome for all events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Diarrhoea, Pain, Pyrexia
Clinical narrative: fever; Chills; body aches; diarrhoea; Abdominal pain; This is a spontaneous report from a contactable nurse (Patient). A 30-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 08Jan2021 (Batch/Lot Number: EJ1685) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever, chills, body aches, diarrhoea, abdominal pain on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test which was positive on 26Dec2020. The outcome of event was unknown.  Follow-up attempts completed. No further information expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: fever; Chills; body aches; diarrhoea; Abdominal pain; This is a spontaneous report from a contactable nurse (Patient). A 30-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 08Jan2021 (Batch/Lot Number: EJ1685) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever, chills, body aches, diarrhoea, abdominal pain on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test which was positive on 26Dec2020. The outcome of event was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Freezing phenomenon, Pain, Pyrexia
Clinical narrative: temp; chills; freezing; aching; This is a spontaneous report from a contactable consumer (patient herself). A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on 03Feb2021 as dose 2, single for COVID-19 immunisation. Historical vaccine included first dose via unspecified route on an unspecified date as dose 1, single for COVID-19 immunisation. Patients medical history and concomitant medications. Patient experienced temp, chills, freezing, aching the following day 04Feb2021. Patient reported feeling better at this time. The outcome of event was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Tremor
Clinical narrative: fever; had shaking with fever; This is a spontaneous report from a contactable consumer or other non-HCP.   A 67-year-old male patient received bnt162b2 (Pfizer BioN Tech Covid-19 MRNA vaccine, Formulation: Solution for injection, Batch/Lot number: EL9265) via unspecified route of administration, administered in right arm as Dose 1, Single on 03Feb2021 (age at the time of vaccination was 67-year-old) (at 18:00) for Covid-19 immunisation. The patient medical history included he just finished Chemotherapy on 14Jan2021, ventricular tachycardia from 25Jan2021 (ongoing) and had an ablation on the same date and pancreas cancer which started from 30Jan2020 (ongoing). The patient had no family history. The patient's concomitant medications were not reported. The patient experienced fever and had shaking with fever on 16Feb2021. The patient stated that he had a highest temperature, of 101.7 and was currently at 101.0. The patient was concerned about fever and did not have fever at all while going through chemo for pancreas cancer. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Additional vaccines administered on same date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. Outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: has a pretty good size bruise at injection site; This is a spontaneous report from a contactable consumer or other non hcp.   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 07Feb2021 (Batch/Lot Number: EM9809) as DOSE NUMBER UNKNOWN SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated her dad received the Covid-19 vaccine on 07Feb2021.She had the Lot number. They were unable to provide the expiry date. She would like to know what that was. Her father also received a pretty good size bruise where it was given. Still had the bruise. Is that not uncommon. The clinical outcome of the events was unknown at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Peripheral swelling, Pyrexia, Vaccination site rash
Clinical narrative: Swollen upper arm; red rash beneath injection site; Fever; Body ache; chills; This is a spontaneous report from a contactable consumer. A 72-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Lot number: EN6203) via an unspecified route of administration, administered in Arm Left on 20Feb2021 at 12:45 (at the age of 72-years-old) as dose 2, single for Covid-19 immunization. The patient's medical history was not reported. No known allergies. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN); diclofenac (MANUFACTURER UNKNOWN); omeprazole (MANUFACTURER UNKNOWN); oxybutynin hydrochloride (MANUFACTURER UNKNOWN), all for an unspecified indication, from an unspecified date and unknown if ongoing. No other vaccine received in four weeks. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN5318) administered in arm right on 31Jan2021, 12:30 PM as dose 1 for Covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies reported. On 21Feb2021 at 18:00, patient experienced fever, body aches and chills. It was reported that swollen upper arm and red rash beneath injection site first noticed on 22Feb2021 around 7 AM. Patient did not received treatment. The outcome of the events was not resolved.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Ear disorder, Fatigue, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Tiredness; sore throat and ears such; sore throat and ears such; low grade fever; Nauseous; This is a spontaneous report from a contactable consumer or other non hcp. A non-pregnant female patient of unspecified age received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL8982) via an unspecified route of administration on 23Jan2021 10:00 as DOSE 1, SINGLE, second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9269) via an unspecified route of administration on 13Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Patient didn't receive other vaccines within 4weeks prior to vaccination. The patient medical and concomitant medications were not reported. Patient had no allergies. on 25Jan2021 02:00 the patient experienced tiredness, sore throat and ears such, low grade fever, nauseous. No therapeutic measures were taken for the events. Patient was not tested to covid to post vaccination. The outcome of the events fatigue, oropharyngeal pain, ear disorder, pyrexia, nausea was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, X-ray
Clinical narrative: Joint pain; This is a spontaneous report from a contactable consumer, the patient.  A 72-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL9263; Expiration Date: 31May2021), via an unspecified route of administration, administered in Left arm on 27Jan2021 at 15:30 as dose 1, single (at the age of 72 years), for covid-19 immunization at Hospital. The reported verbatim indication was reported as Protection from Covid. History of all previous immunization with the Pfizer vaccine considered as suspect and Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Medical history included ongoing blood pressure (blood pressure high); car accident in 2006, it knocked him unconscious, and he was wearing his seat belt, he was hit and had pain in the neck and shoulder that radiated to both arms and knees. It was better than it was. Patient's Medical History (including any illness at time of vaccination) was reported as None. He was pretty healthy. Sometimes he walks pretty good. Concomitant medication included ongoing valsartan (VALSARTAN, 80 mg, 2x/day) taken for blood pressure since unknown date in 2018. There was no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer suspect. The patient stated that, on 30Jan2021, he had been having joint pain and he thought that he had arthritis. The joint pain comes and goes. The adverse event resulted in physician office visit. He saw his doctor yesterday and had X-rays yesterday, but he did not have the results. He had called the doctor office and was waiting for a call back. It was reported that It is better than it was. Caller adds that his wife is a nurse. She told him to not take Tylenol before he gets he second dose. His doctor told him that he should take Tylenol 30 minutes to an hour before he gets the second dose. He had been using heat and cold compresses as a corrective treatment. He was scheduled to get the second dose. There was no more information. The outcome for the event was unknown at the time of report.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Oral infection, Oral mucosal blistering, Oral pain, Peripheral swelling, Swelling face
Clinical narrative: Cheeks all swollen up; Whole inside of mouth was all blistered up, infected; Whole inside of mouth was all blistered up, infected; Mouth hurting so bad; Arm swelled up; Site hurt; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Expiration date: unknown) via an unspecified route of administration in left shoulder on 10Feb2021 around 10:10 to 10:15 AM (74-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. The patient's medical history included spinal fusion surgery from Oct2020, stated that she had to reach for a pen, she was recovering from spinal fusion surgery, before the shot, in Oct2020. The patient's family medical history mentioned as only one who had a shot. There were no concomitant medications. Vaccination facility was not provided. No additional vaccines were administered on the same date of the Pfizer vaccination or prior to vaccination within 4 weeks.  The patient had no adverse events following prior vaccination. No history of all previous immunization with Pfizer vaccine. On 10Feb2021 (Wednesday), the patient experienced arm swelled up stated it was now not really swollen bad, but still hurts where shot was given. The site started hurting Wednesday night. On 12Feb2021 (Friday), the patient when she woke up in the morning her whole inside of mouth was all blistered up, infected, cheeks all swollen up, mouth hurting so bad had to go to ER and they said it was a side effect from the Pfizer shot. She stated that, she only had two teeth on bottom mouth, the rest was no teeth, so that was how it got so bad, it went from boom everything. She hasn't seen her primary care doctor, he was hard to get into, she went to the ER, she does not had time to contact the doctor, due to the holiday. The ER gave her some special Magic Mouthwash and antibiotics, she couldn't even eat anything, it hurt so bad, so she couldn't, so anything but liquid. She stated that mouth hurting seems to be improving a little bit. She stated that, they didn't write the lot really good on the vaccine card. Lot number could be EL9260 or EL9269, last digit of lot could be 0 or 9, it was down the black part of the paper that divided it. She confirmed it was first dose. Adverse events did not result to visit emergency room.  No relevant tested was provided. She stated that she had spinal fusion surgery before the shot, so she was wondering if it would happen with the second shot, not that much worried, she wanted to say it did occur, so maybe it could be put on the list of possible side effects. The outcome of the events was recovering.   Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Cheeks all swollen up; Whole inside of mouth was all blistered up, infected; Whole inside of mouth was all blistered up, infected; Mouth hurting so bad; Arm swelled up; Site hurt; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Expiration date: unknown) via an unspecified route of administration in left shoulder on 10Feb2021 around 10:10 to 10:15 AM (74-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. The patient's medical history included spinal fusion surgery from Oct2020, stated that she had to reach for a pen, she was recovering from spinal fusion surgery, before the shot, in Oct2020. The patient's family medical history mentioned as only one who had a shot. There were no concomitant medications. Vaccination facility was not provided. No additional vaccines were administered on the same date of the Pfizer vaccination or prior to vaccination within 4 weeks.  The patient had no adverse events following prior vaccination. No history of all previous immunization with Pfizer vaccine. On 10Feb2021 (Wednesday), the patient experienced arm swelled up stated it was now not really swollen bad, but still hurts where shot was given. The site started hurting Wednesday night. On 12Feb2021 (Friday), the patient when she woke up in the morning her whole inside of mouth was all blistered up, infected, cheeks all swollen up, mouth hurting so bad had to go to ER and they said it was a side effect from the Pfizer shot. She stated that, she only had two teeth on bottom mouth, the rest was no teeth, so that was how it got so bad, it went from boom everything. She hasn't seen her primary care doctor, he was hard to get into, she went to the ER, she does not had time to contact the doctor, due to the holiday. The ER gave her some special Magic Mouthwash and antibiotics, she couldn't even eat anything, it hurt so bad, so she couldn't, so anything but liquid. She stated that mouth hurting seems to be improving a little bit. She stated that, they didn't write the lot really good on the vaccine card. Lot number could be EL9260 or EL9269, last digit of lot could be 0 or 9, it was down the black part of the paper that divided it. She confirmed it was first dose. Adverse events did not result to visit emergency room.  No relevant tested was provided. She stated that she had spinal fusion surgery before the shot, so she was wondering if it would happen with the second shot, not that much worried, she wanted to say it did occur, so maybe it could be put on the list of possible side effects. The outcome of the events was recovering.   Follow-up attempts completed. No further information expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, SARS-CoV-2 test, Swelling
Clinical narrative: bad rash all over her trunk of body, her back, her stomach, upper neck; red, scary looking and itchy and looks like chicken pox; then they turn on red and itchy; then they turn on red and itchy; Big bumps all over her back and stomach; This is a spontaneous report from a contactable consumer (consumer daughter). A 23-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Lot number: EL3248), via an unspecified route of administration on 29Jan2021 (age at the vaccination 23-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had a Pfizer vaccine on 29Jan2021 and since then she broke out in a bad rash all over her trunk of body, her back, her stomach, upper neck. So, patient called her workplace where she got the shot and they told her to come in for COVID test, although she knew did not had it because she had not been isolated. So, she came back negative, but her test is on Friday of this week. We do not know with all this rash, is it safe for her to get it. I just do not know; I mean it is pretty red scary looking rash, but it did not happen until like a day or so and then they turn on red and itchy and looks like chicken pox. After vaccination two day later, she got big bumps and it continued to get worst. Big bumps all over her back and stomach on an unspecified date in 2021 and her employer told her you have to take a COVID test. She did not have COVID because she was not exposed to anybody. So, she took the COVID test, and it was negative and Friday she has another vaccine appointment. Reporter stated, patient took treatment for the adverse events Benadryl and we have been rubbing Cortisone on it. The patient underwent lab tests and procedures which included Covid test: negative on an unspecified date. The outcome of the events was unknown.  Follow-up (14May2021): Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: Elbow is very inflamed and hand; This is a spontaneous report from a contactable consumer (parent). A 38-year-old male patient received first dose of BNT162B2 (; Solution for injection; Lot number: EL9266) via an unspecified route of administration on Saturday 13Feb2021 (at the age of 38-year-old) as single dose for COVID-19 immunization. Medical history included blood pressure. Concomitant medication included Lisinopril 10 mg taken for Blood pressure, Hydrochlorothiazide 25 mg taken for blood pressure started on an unspecified date. On 14Feb2021, Sunday after receiving vaccination, patient experienced that going down his arm, his elbow was very inflamed and his hand, had pain. Patient went to an urgent care because that's where our doctors sent us, and they said that it's inflammation from the shot. Patient was given 100 Motrin/Motrin 800 mg for the inflammation and the pain. Patient was due for the second dose on 06Mar2021. Outcome of the event was unknown.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chapped lips, Lip dry, Lip swelling
Clinical narrative: She said her lip swelling has gotten worse since her first COVID-19 Vaccine dose in Jan2021; had some dry lips; cracked lips; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 67-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; #lot Number: EL1283) intramuscularly, administered in left arm on 21Jan2021 (at the age of 67-years-old) as single dose for covid-19 immunisation. The patient's medical history included that she had an issue with her lips swelling since she started wearing a face mask in Mar2020 and historical vaccine included she had her annual flu shot in either last Oct2020 or Nov2020. Patient reported that she started a low carb diet at the end of Dec2020 or beginning of Jan2021. She said her low carb diet is medically controlled by a doctor and also reported she keeps rinsing her mouth with warm salt water. She said she has been rinsing her mouth with warm salt water since Jan2021 for altered taste. The patient's concomitant medications were not reported. On unspecified date in Jan2021, the patient had some dry, cracked lips and stated her lip swelling has gotten worse since her first covid-19 vaccine dose in jan2021. Therapeutic measures were taken as a result of her lip swelling has gotten worse since her first covid-19 vaccine dose in jan2021. Patient had taken Benadryl 25 mg tablet (#lot: KGL002; Expiration Date: Jun2022; NDC#: 50580-226-50) for her lip swelling treatment. The outcome of the event lip swelling has gotten worse was not recovered and the outcome of the remaining events was unknown.  Follow-up attempts completed. No further information expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Swelling
Clinical narrative: Painful swelling and lump under left axilla; Painful swelling and lump under left axilla; This is a spontaneous report from a contactable consumer (patient) reported himself that a 43-year-old male patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: G269), via an unknown route of administration in left arm on 14Feb2021 at 10:00 (at the age of 43-year-old) as single for COVID-19 immunization. Second dose scheduled for 07Mar2021. He will still get the second dose unless he was recommended not to by a healthcare professional. The patient's medical history included about 2 years ago borderline diabetes and was ongoing. She was diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities and obesity; all were from an unknown date and unknown if ongoing. Her father died of lung cancer. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional vaccines administered on same date of the Pfizer was none. Concomitant medication included hydrochlorothiazide, lisinopril (LISINOPRIL/ HYDROCHLOROTHIAZIDE) for blood pressure from an unknown date (more than 2 years ago) to ongoing. Prior vaccinations (within 4 weeks) were none. On 16Feb2021, the patient developed painful swelling and lump under left axilla. The patient stated that in the morning when he got up this area was a little tender, not severely painful; This morning the lump really became obvious. Patient did not visit to emergency room/ physician office. Testing/investigations/bloodwork/lab work/cultures/scans/x-rays was none. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Respiratory tract congestion
Clinical narrative: rash on chest and underarms; itching; congestion; This is a spontaneous report from a non-contactable pharmacist. A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 intramuscular on 02Feb2021 (Batch/Lot Number: EL9265) as DOSE 1, SINGLE (at the age of 68-years-old) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 05Feb2021, the patient developed rash on chest and underarms 3 days after first dose of COVID-19 vaccine. The patient was already taking hydroxyzine for itching and Zyrtec for congestion before reaction. Her PCP recommended she still get the second shot but take Benadryl and Pepcid 1 hr prior to the vaccine and for every 6 hours after for 5 days. It was not known whether another vaccine in four weeks was taken by patient. Therapeutic measures were taken as a result of events. The patient received treatment for the events with hydroxyzine, Zyrtec, possibly Benadryl. It was unknown whether the patient had COVID prior vaccination and whether the patient got COVID tested post vaccination. The clinical outcome for the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Nausea
Clinical narrative: Nausea; Achy Joints; This is a spontaneous report received from a non-contactable consumer or other non hcp. A 30-years-old non-pregnant female patient received BNT162B2 (formulation: solution of injection), dose 2 via an unspecified route of administration, administered in Arm Left on 09Feb2021 12:00 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history included BNT162B2 (formulation: solution of injection), dose 1 via an unspecified route of administration, administered in Arm Left on 19Jan2021, at 13:30 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not tested for COVID post vaccination. On 10Feb2021, 12 hours after vaccination, the patient experienced nausea and achy joints. The patient did not receive any treatment for events. The patient recovered from events on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained..
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Cough, Dizziness
Clinical narrative: A lot of brain fog; I'm still feeling weak; stomach ache; very tired/I felt tired; Joint pain; body aches; headache; sore arm; dry cough/ dry hacking cough; dizziness; I kept waking up throughout the night with night sweats; This is a spontaneous report from a contactable consumer (patient). A 68-years-old non pregnant female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number unknown), dose 1 via unspecified route into left arm at 02:30 PM on 11Feb2021 as DOSE 1, SINGLE for covid-19 immunization (at the age of 68 years). The patient medical history had included osteoarthritis (Beginning stage of Rheumatoid) and Allergy for wheat and milk products. The patient concomitant medications included Ergocalciferol (VIT D,5000iu). The patient took vaccine at School or Student Health Clinic. Patient did not take any vaccination prior to covid vaccination and also did not received other vaccine in four weeks. On 11Feb2021 at 4:00 PM the patient started to experience the adverse events. It was reported, on Day 1  patient experienced very sore arm, dry cough, and dizziness and I kept waking up throughout the night with night sweats and felt like something was moving through my body. On day 2 arm felt like somebody punched her with a brick, dizziness, dry hacking cough, very tired, joint pain and body aches, headache and took a Tylenol before went to bed. On Day 3 - she felt good and took the dog for a walk, worked on an art project, and went food shopping. On day 4 - Symptoms came back and felt tired, dizzy, and achy, and stomach-ache, couldn't do much of anything except eat and rest. she stayed home all day and took a Tylenol in the late afternoon. On day 5 - Just woke up. I am feeling better but I still feel like my body is out of balance. I'm still feeling weak and dizzy with body and stomach ache. On Day 6 - A lot of brain fog, dizzy, and body ache. difficulty performing basic tasks. The patient underwent lab tests and procedures, which included Covid 19 and was diagnosed as having negative by Nasal Swab test after taking covid-19 vaccine. Therapeutic measures were taken as a result of the events dizziness, dry cough/dry hacking cough, very tired/I felt tired, joint pain, body aches, headache, stomach ache and included treatment with Tylenol. The outcome of the events were not recovered.    Follow-up (14Jun2021): Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Night sweats, Pain
Clinical narrative: A lot of brain fog; I'm still feeling weak; stomach ache; very tired/I felt tired; Joint pain; body aches; headache; sore arm; dry cough/ dry hacking cough; dizziness; I kept waking up throughout the night with night sweats; This is a spontaneous report from a contactable consumer (patient). A 68-years-old non pregnant female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number unknown), dose 1 via unspecified route into left arm at 02:30 PM on 11Feb2021 as DOSE 1, SINGLE for covid-19 immunization (at the age of 68 years). The patient medical history had included osteoarthritis (Beginning stage of Rheumatoid) and Allergy for wheat and milk products. The patient concomitant medications included Ergocalciferol (VIT D,5000iu). The patient took vaccine at School or Student Health Clinic. Patient did not take any vaccination prior to covid vaccination and also did not received other vaccine in four weeks. On 11Feb2021 at 4:00 PM the patient started to experience the adverse events. It was reported, on Day 1  patient experienced very sore arm, dry cough, and dizziness and I kept waking up throughout the night with night sweats and felt like something was moving through my body. On day 2 arm felt like somebody punched her with a brick, dizziness, dry hacking cough, very tired, joint pain and body aches, headache and took a Tylenol before went to bed. On Day 3 - she felt good and took the dog for a walk, worked on an art project, and went food shopping. On day 4 - Symptoms came back and felt tired, dizzy, and achy, and stomach-ache, couldn't do much of anything except eat and rest. she stayed home all day and took a Tylenol in the late afternoon. On day 5 - Just woke up. I am feeling better but I still feel like my body is out of balance. I'm still feeling weak and dizzy with body and stomach ache. On Day 6 - A lot of brain fog, dizzy, and body ache. difficulty performing basic tasks. The patient underwent lab tests and procedures, which included Covid 19 and was diagnosed as having negative by Nasal Swab test after taking covid-19 vaccine. Therapeutic measures were taken as a result of the events dizziness, dry cough/dry hacking cough, very tired/I felt tired, joint pain, body aches, headache, stomach ache and included treatment with Tylenol. The outcome of the events were not recovered.    Follow-up (14Jun2021): Follow-up attempts completed. No further information expected.