chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Poor quality sleep, Pyrexia
Clinical narrative: I got chills; shaking; the temperature sharply went up to 38.6C (101.5F).; but I got terrible headache; didn't sleep; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as single dose for COVID-19 immunization. It was unknown if patient had covid prior vaccination and unknown if tested for covid post vaccination. It was reported that after receiving the second dose of vaccine on 09Feb2021, the patient called out of work for a sick day as patient thought he/she was having a reaction to the vaccine shot and stated that 12 hours after the shot he/she got chills and was literally shaking, the temperature sharply went up to 38.6C (101.5F). It was like this the whole night, now it dropped to 38.2C (100.8F), but he/she got terrible headache. Patient did not think he/she will be able to work since he/she practically didn't sleep that day. Patient will stay home, hopefully get some sleep and will call in for the meetings. It was unknown if patient received any treatment for AE. The patient underwent lab tests and procedures which included body temperature which was sharply went up to 101.5 Fahrenheit (38.6 C) on 09Feb2021 and dropped to 100.8 Fahrenheit (38.2C) on Feb2021.  The outcome of the events was unknown.   No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: I got chills; shaking; the temperature sharply went up to 38.6C (101.5F).; but I got terrible headache; didn't sleep; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as single dose for COVID-19 immunization. It was unknown if patient had covid prior vaccination and unknown if tested for covid post vaccination. It was reported that after receiving the second dose of vaccine on 09Feb2021, the patient called out of work for a sick day as patient thought he/she was having a reaction to the vaccine shot and stated that 12 hours after the shot he/she got chills and was literally shaking, the temperature sharply went up to 38.6C (101.5F). It was like this the whole night, now it dropped to 38.2C (100.8F), but he/she got terrible headache. Patient did not think he/she will be able to work since he/she practically didn't sleep that day. Patient will stay home, hopefully get some sleep and will call in for the meetings. It was unknown if patient received any treatment for AE. The patient underwent lab tests and procedures which included body temperature which was sharply went up to 101.5 Fahrenheit (38.6 C) on 09Feb2021 and dropped to 100.8 Fahrenheit (38.2C) on Feb2021.  The outcome of the events was unknown.   No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: have been up all night with a fever; This is a spontaneous report from a non-contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as UNK, single for COVID-19 immunization. The patient medical history was not reported. The patient previously received the first dose of bnt162b2 (BNT162B2). The patient's concomitant medications were not reported. It was unknown if the patient had any other vaccines in four weeks. It was unknown if the patient had COVID prior to vaccination. It was unknown if COVID was tested post vaccination. On 09Feb2021, the patient experienced have been up all night with a fever (pyrexia). The clinical outcome of the event was unknown.  No follow-up attempts are possible. Information on lot/batch number could not be requested. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Herpes simplex, Respiratory disorder, Rhinorrhoea
Clinical narrative: chills; runny nose; Herpes Simplex 1; Upper respiratory feeling; This is a spontaneous report from a consumer. This 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unknown route of administration on 27Jan2021 at dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that her first dose vaccine was given on 27Jan2021 and on an unknown date in 2021, she had chills went into runny nose, Herpes Simplex 1. Upper respiratory feeling. HCP indicated immune response. Put her on antivirals. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (patient). A 54-years-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9267; Expiration Date: May2021, NDC number was unknown), via an unspecified route of administration, administered in left arm on 09Feb2021 at 11:00 hours as dose 2, single (at the age of 54-years-old) for COVID-19 immunisation. Patient had no medical and family medical history. Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9262; Expiration Date: May2021 and NDC number was unknown), via an unspecified route of administration, administered in left arm on 21Jan2021 at 13:00 hours as dose 1, single (at the age of 54-years-old) for COVID-19 immunisation. There were no concomitant medications received by the patient. Patient had no prior vaccinations (within 4 weeks). On 10Feb2021, when patient woke up, he experienced headache and wants to take Tylenol and asked if he can take pain killer. Patient stated that it is little better now. Patient had no physician or emergency room visit and no relevant tests were performed. The outcome of the event was recovering.   Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Rash papular
Clinical narrative: red bumps on both legs, both arms, both shoulders and back of shoulders and again are extremely itching; itching; rash; lower entire back was red as can be like I had a sunburn; This is a spontaneous report from a non-contactable consumer (patient).   A 72-year-old female patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 01Feb2021 (at the age of 72 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 01Feb2021 (also reported as a week ago Monday that afternoon), the patient experienced a bad reaction, lower entire back was red as can be like patient had a sunburn, and bumpy when hands ran over it, and itched like crazy. 02Feb2021 (also reported as by Tuesday and still ongoing), patient had red bumps on both legs, both arms, both shoulders and back of shoulders and again are extremely itching. The patient reported that it goes in streaks, its itchy then it stops and 4 hours later, it was itchy again. The patient wanted to know if she can get the second dose. The patient had an appointment with her doctor and prescribed her with prednisone not related to this issue before seeing her. The patient also reported that with her skin doctor, she went to see him and showed him the rash and said that it was related to the COVID shot and prescribed a salve to apply. The patient spoke to her primary doctor and said that it was not enough salve and prescribed prednisone. The doctor also told the patient that she should go where she got her shot as there as supposed to be people available to treat with something to prepare her for the second dose. Treatment of salve and prednisone was received as treatment of the events. The outcome of the events was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular, Swelling face
Clinical narrative: Puffy/swelling in her face; she has blotchy rashes on her face/Red blotches/hives to her face; it is itchy/ itchiness to face; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EM9810) via an unspecified route of administration, administered in Arm Left on 08Feb2021 16:45 (at the age of 51-years-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on 18Jan2021 as single dose for COVID-19 immunization. On 09Feb2021 18:30 the patient experienced she has blotchy rashes on her face/red blotches/hives to her face, it is itchy/ itchiness to face, On 10Feb2021 05:30 the patient experienced puffy/swelling in her face. Therapeutic measures were taken as a result of she has blotchy rashes on her face/red blotches/hives to her face, it is itchy/ itchiness to face, puffy/swelling in her face. Patient stated she has blotchy rashes on her face and has taken Benadryl because it is itchy and put some itch cream on it and asked if this is a common symptom. The outcome of event was not Recovered.  Follow-up attempts completed. No further information expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: fatigue; nausea; headache; fever; This is a spontaneous report from a contactable consumer, the patient. A 33-years-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 09Feb2021 (age at vaccination: 33-years-old) (Batch/Lot Number: EL9264) as DOSE 1, SINGLE for covid-19 immunization/ protection from Covid. Medical history included covid infection from an unknown date in Dec2020 to an unspecified date (caller reports that he had covid infection previously, had symptoms in late Dec2020, he was fully recovered from Covid four weeks ago), severe headaches from an unknown date and unknown if ongoing (had a CT scan of his head in Dec2020 because he had severe headaches). There were no concomitant medications. Patient wanted to know if he needed the second dose of the covid vaccine if he already had covid prior to his first vaccination dose and if he experienced side effects, which were likely a sign of already having some immunity, with administration of his first vaccine dose. Patient reported that he had covid infection previously but was then offered the covid vaccine and he received his first dose. He had since experienced fatigue, nausea, headache and fever following vaccination with the first dose and his family who had not had covid previously did not experience these side effects. Patient had Covid four weeks ago. He was required by his work to get the vaccine. He was fully recovered from Covid four weeks ago and his pulmonary system was not involved. Patient was tested for Covid and was negative. He had symptoms in late Dec2020 and tested positive on 05Jan2021. He used Tylenol and Proton Pump inhibitors for acid when he had Covid. He had a CT scan of his head in Dec2020 because he had severe headaches. The patient experienced fatigue, nausea, headache and fever on an unspecified date in Feb2021. The patient underwent lab tests and procedures which included CT scan of head: unknown results on Dec2020, Sars-Cov-2 test: negative on an unspecified date and was positive on 05Jan2021. The events were assessed as non-serious. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: fatigue; nausea; headache; fever; This is a spontaneous report from a contactable consumer, the patient. A 33-years-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 09Feb2021 (age at vaccination: 33-years-old) (Batch/Lot Number: EL9264) as DOSE 1, SINGLE for covid-19 immunization/ protection from Covid. Medical history included covid infection from an unknown date in Dec2020 to an unspecified date (caller reports that he had covid infection previously, had symptoms in late Dec2020, he was fully recovered from Covid four weeks ago), severe headaches from an unknown date and unknown if ongoing (had a CT scan of his head in Dec2020 because he had severe headaches). There were no concomitant medications. Patient wanted to know if he needed the second dose of the covid vaccine if he already had covid prior to his first vaccination dose and if he experienced side effects, which were likely a sign of already having some immunity, with administration of his first vaccine dose. Patient reported that he had covid infection previously but was then offered the covid vaccine and he received his first dose. He had since experienced fatigue, nausea, headache and fever following vaccination with the first dose and his family who had not had covid previously did not experience these side effects. Patient had Covid four weeks ago. He was required by his work to get the vaccine. He was fully recovered from Covid four weeks ago and his pulmonary system was not involved. Patient was tested for Covid and was negative. He had symptoms in late Dec2020 and tested positive on 05Jan2021. He used Tylenol and Proton Pump inhibitors for acid when he had Covid. He had a CT scan of his head in Dec2020 because he had severe headaches. The patient experienced fatigue, nausea, headache and fever on an unspecified date in Feb2021. The patient underwent lab tests and procedures which included CT scan of head: unknown results on Dec2020, Sars-Cov-2 test: negative on an unspecified date and was positive on 05Jan2021. The events were assessed as non-serious. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia oral, Rash, Rash erythematous
Clinical narrative: 23Feb2020 tingling thru out mouth and tongue, thick tongue, film back of throat; red rash on both forearms/rash on forearms, inner thighs; numbness on nose and cheeks next to nose/numbness on lips and bridge of nose/cheeks; rash with pain on forearms; This is a spontaneous report from a contactable other-healthcare professional. A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: E19261), via an unspecified route of administration, administered in arm left on 10Feb2021 at 13:45, as single dose for covid-19 immunization. Medical history included atrial fibrillation (Afib)/pacemaker (have duel chamber pacemaker), flax seed allergy and some antibiotics allergy. Concomitant medication's included dronedarone hydrochloride (MULTAQ), metoprolol succinate, apixaban (ELIQUIS) and alprazolam (XANAX). The patient previously took celebrex and cephalexin and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 10Feb2021 at 02:15 patient experienced, rash on forearms, inner thighs, numbness on nose and cheeks next to nose, rash with pain on forearms, numbness on lips and bridge of nose/cheeks rash on inner thighs. On 23Feb2020 she experienced tingling thru out mouth and tongue, thick tongue, film back of throat, lips and bridge of nose/cheeks numb. AE resulted in Doctor or other healthcare professional office/clinic visit. As treatment she received antihistamine. Outcome was resolving for red rash on both forearms/rash on forearms, inner thighs and numbness on nose and cheeks next to nose/numbness on lips and bridge of nose/cheeks and other events were resolved on an unknown date in 2021.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was a little sore; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient 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 on an unspecified date at 13:30 as dose 1, single for covid-19 immunization. The patient medical history was not reported. Concomitant medications included simvastatin (SIMVASTATIN) taken for cholesterol, start and stop date were not reported; metformin (METFORMIN) taken for diabetes, start and stop date were not reported. The patient received first dose on Sunday (unspecified date) at 13:30 and on an unknown date, the patient's arm was a little sore. The patient asking about pain relieving medication and also asking about efficacy. He was scheduled for second dose at day 25 and was told to 17-21 days. The outcome of event was unknown.  Information on the lot batch number has been requested  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Influenza like illness, Oropharyngeal pain
Clinical narrative: felt as if she had the flu; her head and throat hurts; her head and throat hurts; and that her fingers felt numb; This is a spontaneous report received from a non-contactable consumer (patient) via Medical Information Team. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number and Expiration date: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, after receiving the 1st dose, the patient felt as if she had the flu, her head and throat hurts, and that her fingers felt numb. The patient wanted to know if the reactions were associated with the vaccine. The outcome of the reported events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Oropharyngeal pain, Pain
Clinical narrative: Fever of 101; chills; fatigue; sore throat; whole body hurts; left arm hurts bad; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-years-old female patient received bnt162b2 (BNT162B2, Lot Number: EN5318), dose 2 intramuscular, administered in arm left on 08Feb2021 at 14:15 (at the age of 31-years-old) as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took amoxicillin and experienced drug allergy and bnt162b2 (Lot number: EL9261), dose 1 intramuscular, administered in arm left on 18Jan2021 at 14:30 (at the age of 30-years-old) as single for COVID-19 immunisation. The patient did not receive any other vaccine in four weeks. On 09Feb2021, the patient experienced fever of 101, chills, fatigue, sore throat, whole body hurts and left arm hurts bad. The patient underwent lab tests and procedures which included COVID-19 test (nasal swab): negative on 08Feb2021 and body temperature: fever of 101 on 09Feb2021. The patient reported that she have not felt that sick in years. The patient did not receive any treatment for the events. The outcome of all the events was not resolved.  Follow-up attempts completed. No further information expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever of 101; chills; fatigue; sore throat; whole body hurts; left arm hurts bad; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-years-old female patient received bnt162b2 (BNT162B2, Lot Number: EN5318), dose 2 intramuscular, administered in arm left on 08Feb2021 at 14:15 (at the age of 31-years-old) as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took amoxicillin and experienced drug allergy and bnt162b2 (Lot number: EL9261), dose 1 intramuscular, administered in arm left on 18Jan2021 at 14:30 (at the age of 30-years-old) as single for COVID-19 immunisation. The patient did not receive any other vaccine in four weeks. On 09Feb2021, the patient experienced fever of 101, chills, fatigue, sore throat, whole body hurts and left arm hurts bad. The patient underwent lab tests and procedures which included COVID-19 test (nasal swab): negative on 08Feb2021 and body temperature: fever of 101 on 09Feb2021. The patient reported that she have not felt that sick in years. The patient did not receive any treatment for the events. The outcome of all the events was not resolved.  Follow-up attempts completed. No further information expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling of eyelid, Visual impairment
Clinical narrative: By 10:45 pm the afforementoned affected area was significantly swollen causing some blockage of sight from my right eye; my right lower eyelid beginning to swell; This is a spontaneous report from a contactable other health care professional (Patient). A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9810, expiry date not reported), via intramuscular route, administered in Left Arm on 09Feb2021 at 09:45 (age at vaccination: 56 years) as dose 2, single for covid-19 immunisation. The patient medical history was None. There were no concomitant medications. Known allergies were reported as None. Patient did not receive other vaccines in 4 weeks. Patient did not receive other medications in 2 weeks. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982, expiry date not reported), on 19Jan2021 at 9:45 AM via intramuscular route in left arm for covid-19 immunization. The patient reported his right lower eyelid beginning to swell on 09Feb2021 at 22:30 (in the morning), by 10:45 pm the afforementoned affected area was significantly swollen causing some blockage of sight from his right eye on 09Feb2021 at 22:45 . 2 Motrin and Ice Pack placed over right eye was given as treatment for the events. The outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Muscle spasms
Clinical narrative: severe leg cramps; hard time walking; This is a spontaneous report from a contactable consumer (patient) reported for herself via Medical Information Team. A female patient of an unspecified age (70 unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 09Feb2021 (yesterday) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that today (10Feb2021) at around 9 AM started having severe leg cramps, had a hard time walking, was wondering if this could be related with the vaccine and was looking for information on taking ibuprofen for side effects of the vaccine. The outcome of the events was unknown.  Information about Batch/Lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: I had either joint or muscle pain (on her back, just one side); I had either joint or muscle pain (on her back, just one side); This is a spontaneous report received from a contactable consumer. A 73-year-old female consumer (Patient) reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, NDC Number, UPC Number, Expiry Date: Unknown), via an unspecified route of administration on 02Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got the shot and she had either joint or muscle pain (on her back, just one side). She wanted to know if she could receive dose 2. She had received the Pfizer-BioNTech COVID-19 vaccine approximately 8 days ago, her first dose. She guessed that it was the vaccine, she did not have it (prior to vaccination). She experienced similar symptoms (joint pain and/or muscle pain) was not described as a contraindication to receive the 2nd dose. She was suggested to contact her Doctor, to mention the symptoms experienced and confirm if the 2nd dose should be administered. Already called her doctor, and she was waiting for a response. Consumer was not willing to proceed with the questions, hence limited information was available on the call. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a tender arm; This is a spontaneous report from a contactable consumer. This 08-decade-old male patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: unknown) via unspecified route of administration, on 09Feb2021, as dose 1, single for covid-19 Immunization. Medical history included covid-19 on an unknown date in Oct2020 and pneumonia. Concomitant medications were not reported. The patient stated that he heard that shouldn't take OTC medication for the side effects like headache after the vaccine. On an unknown date in Feb2021, the patient experienced tender arm which was normal. The patient was enquired about after the 2nd dose they may have side effect worse than the first. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Pain, Pyrexia
Clinical narrative: fever; chills; ached all over; headache; diarrhea; This is a spontaneous report from a contactable Consumer. An elderly non-pregnant female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection), via an unspecified route of administration, administered in Arm Left on 03Feb2021 11:00 (Batch/Lot Number: EJ16986) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not tested for COVID-19. On 04Feb2021, the patient started with headache in morning then diarrhea in the evening. On 05Feb2021, patient had fever, chills and ached all over. Next day felt much better. The patient did not receive treatment for AEs. The outcome of events was recovering.   Follow-up attempts completed. No further information expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: chills; fatigue; This is a spontaneous report from a contactable consumer (patient). A 32-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: EL3247), via an unspecified route of administration, administered at Arm Left on 09Feb2021 at 11:45 AM (age at vaccination was 32 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The medical history was not reported. No known allergies reported. The concomitant medication escitalopram from on an unspecified date as other medication given in two weeks of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL3247), via an unspecified route of administration on left arm on 19Jan2021 at 11:45 AM (age at vaccination was 32 years) as DOSE 1, SINGLE for covid-19 immunisation at facility type vaccine: Workplace clinic. The patient was not received other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Feb2021 at 07:00 AM, the patient experienced chills and fatigue. The patient did not receive any treatment for events. Outcome of the event was recovering. Upon follow-up received on 11May2021, it was reported that follow-up attempts completed. No further information expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Decreased appetite, Peripheral coldness
Clinical narrative: legs are cold; she started getting a temperature of 101.3; chills; loss of appetite; This is a spontaneous report from a contactable consumer. A 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was TL9262 via an unspecified route of administration on 06Feb2021 at 14:20 in left arm (age at the time of vaccination was 83-year-old) as single dose for COVID-19 immunization. Medical history and Concomitant medications were not reported. The patient did not receive prior vaccinations within 4 weeks. On 07Feb2021, the patient experienced, she started getting a temperature of 101.3, chills, loss of appetite. On 10Feb2021, the patient experienced legs are cold. It was reported that caller stated her sister-in-law, had the vaccine on Saturday. On Sunday, she started getting a temperature of 101.3, chills, and loss of appetite and took an Advil or Tylenol. The next day she was much better, her temperature had gone down (99.4) and didn't have chills. However, she has a temperature again, it was 99.3 now. They both got the shot on Saturday. Both were fine. On Saturday her sister-in-law started getting a temperature and chills. She also had no appetite. She took a couple of Advil and Tylenol. The next day her temperature went down from 101 to 99.4 degrees. She had temperature for two days. She slept good. Today her legs are cold. She does take any other medications. Patient underwent lab test and procedure which included Body temperature 99.4 gone down on unspecified date, Body temperature 99.3 on unspecified date, Body temperature 101.3 07Feb2021. Outcome of events she started getting a temperature of 101.3 and chills was recovering, while outcome of loss of appetite was recovered on 08Feb2021 and of legs are cold was unknown.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Feeling abnormal, Headache, Hypoacusis, Lymphadenopathy
Clinical narrative: headaches; a bit of 'a punky feeling'; the left lymph node in his neck has 'blown up'. It has swollen all the way up to his left temple; affecting his hearing; When he presses on it he feels pressure on his ear/The right side was not as much; This is spontaneous report from a contactable consumer (patient). A male patient of an unknown age (Age: 61, Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on 09Feb2021 at 16:00 as DOSE 2, SINGLE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), on an unknown date dose 1, single for Covid-19 immunisation. It was reported that, patient received the second dose of the covid vaccine on 09Feb2021 at 4:00 PM (PST) and as the day progressed patient had headaches, a bit of 'a punky feeling', and the left lymph node in his neck has 'blown up'. It has swollen all the way up to his left temple, affecting his hearing. When patient presses on it he feels pressure on his ear. The right side was not as much. The outcome of the events was unknown.  Information on Lot /Batch Number has been requested. Follow-up attempts are completed.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Headache; body aches/pains; chills; fatigue; This is a spontaneous report from a contactable other hcp (Patient). A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EL3247) via an unspecified route of administration (age at vaccination 45-year) in Left Arm on 09Feb2021 at 03:15 PM as dose 2, single for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (Lot Number: EL3247) on 09Jan2021 at 03:00 PM in Left arm for COVID-19 immunization. No known allergies were reported. No COVID prior vaccination was reported. The patient not tested COVID post vaccination. On 09Feb2021 at 09:00 PM the patient experienced headache, body aches/pains, chills, fatigue. No treatment was received for the adverse events. The clinical outcome of the events was not recovered.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Influenza like illness, Pyrexia
Clinical narrative: fever reaching 100.7F; chills; not able to lift her arm or head and could not get up until midnight (described as flu-like symptoms); This is a spontaneous report from a contactable other HCP. A female patient of 52-year-old received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on 30Jan2021, at unknown dose single for COVID-19 immunization. No medical history reported. No concomitant medications reported. On 30Jan2021 patient experienced at 9 in the evening was not able to lift her arm or head and could not get up until midnight (described as flu-like symptoms), fever reaching 100.7F which went down after 3-4 days, and chills. She wants to know how often these adverse effects happen on the first dose of the vaccine. The patient underwent Body temperature test. The outcome of Events for pyrexia was recovered and for other events was unknown.  Information on Lot /Batch Number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea
Clinical narrative: headache; muscle aches; chills; feel nauseous; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received bnt162b2 (formulation: solution for injection), dose 2 via an unspecified route of administration on 09Feb2021 (NDC number, Lot number and expiry date was not reported) as dose 2, single for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient historical vaccine includes first dose bnt162b2 for covid-19 immunisation. The patient got her second COVID Vaccine Yesterday (unknown date). Last night and this morning she started to experience headache, muscle aches, chills, feel nauseous on an unknown date. Stated she can breathe and all but, she had side effects. She wanted to know if she can take Tylenol. When informed patient would have to transfer to Medical Information to potentially address her question, she got very upset. Stated she had waited for an hour and just wants her question answered. She declined to continue with safety report. She stated she just wanted to know if it was okay to take Tylenol after the second dose. She wanted to know if Tylenol will diminish the effectiveness of the vaccine. The outcome of the events was not recovered.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer. A male patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, lot# not reported, expiry date: not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unspecified date, patient vomited after receiving the BNT162B2 vaccine. The caller reported she might not be able to get her second dose of the BNT162B2 vaccine at 21 days due to a transportation issue. The caller wanted to know if she got the vaccine at 19 days, would that be ok. The caller reported the logistics for scheduling her vaccine appointment put the elderly and those without computers at a huge disadvantage. The caller heard from a healthcare worker that he vomited after receiving the BNT162B2 vaccine. The caller wanted to know more information on the side effect and wondered how long it would take for a severe allergic reaction to occur after the vaccine was administered. The caller heard on the news that patients are being watched for 15 minutes after the vaccine was given. The outcome of the event: unknown. Batch/lot number requested. Follow-up attempts completed. No further information expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Confusional state, Fatigue, Laziness, Pain in extremity
Clinical narrative: sore arm; felt very lazy; fatigued; felt anxious/feels very nervous; felt hyper; tired; confused/feels like he wants to slap, bite, and wants to scream/feels like he needs to grind his teeth; Itching/itching in his legs and arm; This is a spontaneous report from a contactable consumer or other non hcp. A 59-year-old-male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported) via intramuscular, administered in Arm Left on 09Feb2021 12:15 as (at the age of 59-years-old) dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 09Feb2021 the patient experienced sore arm and felt very lazy. On Feb2021 he experienced fatigued, felt anxious, felt hyper, tired, confused and itching. The caller asked, if his symptoms following his first vaccine are normal and what he should do about them. As he got the vaccine at around 12:15 in the afternoon, stayed for 20 minutes at the vaccination facility and 4 hours later he started having a sore arm, felt very lazy, wanting to go to sleep, went to sleep but when he woke up, he felt more fatigued and lazier. He stated that he like someone to stretch his legs, he felt anxious and had a lot of anxiety and felt hyper. He went back to sleep and got up in 5 hours and again felt anxious then fatigued and tired and confused. he also reports that he notices that he "eat a lot and then he was not burping". Caller asked how long he will feel like this. Upon fallow up received Caller said that he feels like he has fatigue, pain in his arm when he sleeps on it, feels like he needs to grind his teeth, and itching in his legs and arm. He said that he also feels like he wants to slap, bite, and wants to scream. It is bothering him. He said that he feels very nervous, but it is not because he was scared. He said that he feels bad and stated that he is tired and wants to sleep all day. Caller said that he feels fatigued along with his hands and his legs. He feels lazy and he is nervous. He said that no one has this with the first vaccine. He feels like something may have damaged his body. When asked about his concomitant medications, medical conditions and relevant tests, the caller said that he takes a lot of medications but provided no further information when queried. Patients second dose was scheduled for 02Mar2021.The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Psychomotor hyperactivity
Clinical narrative: sore arm; felt very lazy; fatigued; felt anxious/feels very nervous; felt hyper; tired; confused/feels like he wants to slap, bite, and wants to scream/feels like he needs to grind his teeth; Itching/itching in his legs and arm; This is a spontaneous report from a contactable consumer or other non hcp. A 59-year-old-male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported) via intramuscular, administered in Arm Left on 09Feb2021 12:15 as (at the age of 59-years-old) dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 09Feb2021 the patient experienced sore arm and felt very lazy. On Feb2021 he experienced fatigued, felt anxious, felt hyper, tired, confused and itching. The caller asked, if his symptoms following his first vaccine are normal and what he should do about them. As he got the vaccine at around 12:15 in the afternoon, stayed for 20 minutes at the vaccination facility and 4 hours later he started having a sore arm, felt very lazy, wanting to go to sleep, went to sleep but when he woke up, he felt more fatigued and lazier. He stated that he like someone to stretch his legs, he felt anxious and had a lot of anxiety and felt hyper. He went back to sleep and got up in 5 hours and again felt anxious then fatigued and tired and confused. he also reports that he notices that he "eat a lot and then he was not burping". Caller asked how long he will feel like this. Upon fallow up received Caller said that he feels like he has fatigue, pain in his arm when he sleeps on it, feels like he needs to grind his teeth, and itching in his legs and arm. He said that he also feels like he wants to slap, bite, and wants to scream. It is bothering him. He said that he feels very nervous, but it is not because he was scared. He said that he feels bad and stated that he is tired and wants to sleep all day. Caller said that he feels fatigued along with his hands and his legs. He feels lazy and he is nervous. He said that no one has this with the first vaccine. He feels like something may have damaged his body. When asked about his concomitant medications, medical conditions and relevant tests, the caller said that he takes a lot of medications but provided no further information when queried. Patients second dose was scheduled for 02Mar2021.The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: chills; fever (100.0F); headache; Fatigue; This is a spontaneous report from a contactable consumer. A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in left arm on 09Feb2021 at 13:30 (at the age of 31-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Historical vaccine included: first dose of BNT162B2 (COMIRANTY; Solution for injection; Batch/Lot Number: EL3247) as dose 1, single administered in left arm on 19Jan2021 (at the age of 31-years-old) for COVID-19 immunization. The patient medical and concomitant medication history were reported. COVID-19 prior vaccination was reported as no. Patient had no allergies. Patient did not received other vaccine in four weeks. Patient did not received other medications in two weeks. Facility type vaccine at Workplace clinic. Adverse event start on 10Feb2021 at 03:00 AM. The patient experienced chills, fever (100.0F), headache and fatigue. The patient underwent lab tests and procedures which included body temperature: 100.0 fahrenheit on 10Feb2021. COVID-19 tested post vaccination was reported as no. The outcome of the events were recovering.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Dizziness
Clinical narrative: Caller reports that he is scheduled for his second dose on 27Feb2021 and he noticed that it is 17 days in between first dose.; Caller reports that he began to get dizzy shortly after receiving vaccine; This is a spontaneous report from a contactable consumer. A 89-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 10Feb2021 as dose 1, single for covid-19 immunisation. Medical history included allergy to sulfa from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 10Feb2021 caller reports that he began to get dizzy shortly after receiving vaccine. Caller reports that he feels fine now. Caller reports that he is allergic to sulfa. Caller reports that he is scheduled for his second dose on 27Feb2021, and he noticed that it is 17 days in between first dose. Caller would like to know if that is okay. The outcome of the event dizzy was recovered and outcome of the event he noticed that it is 17 days in between first dose was unknown.  information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.