chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Clumsiness, Condition aggravated, Coordination abnormal, Dyskinesia, Feeling drunk
Clinical narrative: clumsy; he had trouble with coordination; Hand Eye Coordination issues; basically felt drunk; it has gotten worse; motor actions are overactive and uncontrollable; sore arm; This is a spontaneous report from a contactable consumer or other non hcp. A 66-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6202), dose 2 via an unspecified route of administration, administered in Arm Left on 04Mar2021 14:00 (age at vaccination: 66-years-old) as dose 2, single for covid-19 immunization. Medical history included diabetes from 1983, musculoskeletal disorder he was a ortho patient. Concomitant medication(s) included insulin glargine (LANTUS) taken for diabetes mellitus and insulin lispro (HUMALOG) taken for diabetes mellitus, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on unspecified date as a single dose for COVID-19 immunization. Patient received second dose on 04Mar2021 (about 2pm) and had a sore arm. patient said, on 06Mar2021, about 9:30pm. Patient experienced the clumsy, off kilter, stumbling around, hand-eye coordination involved. On Thursday 04Mar2021. Patient had no issues with the first dose of the vaccination, but on Friday 05Mar2021 about 9pm patient had trouble with coordination. Patient had trouble putting his foot down and said continuously having trouble with his hand eye coordination issues. Patient felt drunk but he was not dizzy and thought it was minor thought, but it has gotten worse. Patient stated reported, used a cane for his balance. Patient clarified it was Saturday 06Mar2021 not Friday 05Mar2021 between 9pm and 9:30 pm he started having issues with coordination. He states about 59 hours after second vaccination. Patient drove a short distance and states his fine motor skills on his feet are not what they should be, he said with his hands and texting he was hitting all the buttons but was able to call DSU on his own. Caller also reports he will not be driving any more until he was better. When putting pants on the caller reports he has to lean against something while putting pants on, he states his balance and everything are interconnected, that its almost neurological. he says its like his brain was not connected with his limbs it is ahead time of time or behind time, its more behind time. He read about a brain fog but was unsure if that is what he is feeling. Cane was taken as treatment received for event basically felt drunk. The outcome for event trouble with coordination, hand eye coordination issue and motor actions are overactive and uncontrollable was not recovered and unknown for other.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Hand-eye coordination impaired, Pain in extremity
Clinical narrative: clumsy; he had trouble with coordination; Hand Eye Coordination issues; basically felt drunk; it has gotten worse; motor actions are overactive and uncontrollable; sore arm; This is a spontaneous report from a contactable consumer or other non hcp. A 66-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6202), dose 2 via an unspecified route of administration, administered in Arm Left on 04Mar2021 14:00 (age at vaccination: 66-years-old) as dose 2, single for covid-19 immunization. Medical history included diabetes from 1983, musculoskeletal disorder he was a ortho patient. Concomitant medication(s) included insulin glargine (LANTUS) taken for diabetes mellitus and insulin lispro (HUMALOG) taken for diabetes mellitus, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on unspecified date as a single dose for COVID-19 immunization. Patient received second dose on 04Mar2021 (about 2pm) and had a sore arm. patient said, on 06Mar2021, about 9:30pm. Patient experienced the clumsy, off kilter, stumbling around, hand-eye coordination involved. On Thursday 04Mar2021. Patient had no issues with the first dose of the vaccination, but on Friday 05Mar2021 about 9pm patient had trouble with coordination. Patient had trouble putting his foot down and said continuously having trouble with his hand eye coordination issues. Patient felt drunk but he was not dizzy and thought it was minor thought, but it has gotten worse. Patient stated reported, used a cane for his balance. Patient clarified it was Saturday 06Mar2021 not Friday 05Mar2021 between 9pm and 9:30 pm he started having issues with coordination. He states about 59 hours after second vaccination. Patient drove a short distance and states his fine motor skills on his feet are not what they should be, he said with his hands and texting he was hitting all the buttons but was able to call DSU on his own. Caller also reports he will not be driving any more until he was better. When putting pants on the caller reports he has to lean against something while putting pants on, he states his balance and everything are interconnected, that its almost neurological. he says its like his brain was not connected with his limbs it is ahead time of time or behind time, its more behind time. He read about a brain fog but was unsure if that is what he is feeling. Cane was taken as treatment received for event basically felt drunk. The outcome for event trouble with coordination, hand eye coordination issue and motor actions are overactive and uncontrollable was not recovered and unknown for other.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Feeling abnormal, Headache, Neck pain, Pain in jaw
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP. An 80-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EN6203, expiration date: unknown), at the vaccination age of 80, via an unspecified route of administration, in left arm, on Mar 5, 2021, single dose, for COVID-19 immunization. The patient's medical history included neck pain; pain in the back of her neck, head, forehead and jaw. She reported she had mild pain in these areas before the vaccine. No concomitant medications reported. On Mar 5, 2021 (30 minutes) after receiving the vaccine, patient experienced pain in the back of her neck; pain in back of jaw, head and forehead. The pain got worse after the vaccine and lasted for a few hours. She felt bad. Patient mentioned she had mild pain in these areas before, but just did not pay attention at first. Then the pain got worse and lasted a few hours. Then stopped and went away completely. It did not occur to her it was from the shot as she had no side effects from shots before. She cannot take pain medicine. The outcome of  had pain in the back of neck, jaw, head and forehead; had mild pain in these areas before the vaccine; pain got worse after the vaccine and lasted for a few hours; and felt bad recovered on Mar 5, 2021. No follow-up attempts possible. No further information expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue discomfort
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP. An 80-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EN6203, expiration date: unknown), at the vaccination age of 80, via an unspecified route of administration, in left arm, on Mar 5, 2021, single dose, for COVID-19 immunization. The patient's medical history included neck pain; pain in the back of her neck, head, forehead and jaw. She reported she had mild pain in these areas before the vaccine. No concomitant medications reported. On Mar 5, 2021 (30 minutes) after receiving the vaccine, patient experienced pain in the back of her neck; pain in back of jaw, head and forehead. The pain got worse after the vaccine and lasted for a few hours. She felt bad. Patient mentioned she had mild pain in these areas before, but just did not pay attention at first. Then the pain got worse and lasted a few hours. Then stopped and went away completely. It did not occur to her it was from the shot as she had no side effects from shots before. She cannot take pain medicine. The outcome of  had pain in the back of neck, jaw, head and forehead; had mild pain in these areas before the vaccine; pain got worse after the vaccine and lasted for a few hours; and felt bad recovered on Mar 5, 2021. No follow-up attempts possible. No further information expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Diarrhoea, Muscle spasms
Clinical narrative: slight cramps; diarrhea; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number was EN6205, Expiration Date: Jun2021) as dose 1, single via an unspecified route of administration on 05Mar2021 16:00 for covid-19 immunisation. Medical history included Acid reflux from an unknown date and unknown if ongoing. Concomitant medication(s) included denosumab (PROLIA) taken for an unspecified indication, start and stop date were not reported and patient stated that patient take Acid blockers. On 07Mar2021 the patient experienced diarrhoea and on an unknown date, the patient had slight cramps. The patient underwent lab tests and procedures on 26Feb2021 which included blood test: unknown result on, computerised tomogram: unknown result. Therapeutic measures were taken as patient stated that she did not know she still have slight cramps. The patient took lot of Imodium and lot Pepto-Bismol, so was not really sure. The outcome of event diarrhoea was unknown, and outcome of event slight cramps was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: diarrhea; very sore arm; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for self that,  A 83-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EN6199) (at the age of 83-years-old), dose 1 via an unspecified route of administration, administered in arm right on 04Feb2021 as dose 1, single for covid-19 immunisation. Medical history included uterine prolapse from an unknown date and unknown if ongoing. There were no concomitant medications. It was reported that patient got diarrhea. She also stated that she went about six or seven times from about 12 o'clock until 3:30 3:45 she stopped. She felt better. She reported that she got the Pfizer COVID-19 vaccine on 04Mar2021 and had a very sore arm that went away and the day after on 05Mar2021 she had diarrhea really bad and she was wondering if that could be one of the side effects. She also reported that diarrhea began on 05Mar2021 in the evening, and it went away itself and got better without treatment. She said her arm soreness carried over to 05Mar2021 while it was getting better. The outcome for the event of very sore arm was recovering and the outcome for the event of diarrhea was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick; This is a spontaneous report from a contactable consumer via medical information team and a Pfizer sponsored program. This consumer reported similar events for 2 patients. This is 1st of 2 reports.  A 70-years-old female patient (reporter's cousin) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number, Expiry date: was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. Patient's medical history and concomitant medications were not reported. Reporter stated that patient received the 1st dose of the Pfizer COVID 19 vaccine and patient got really so sick on an unspecified date. Reporter wants to know if that was normal and how long it lasts and reporter also stated that seniors who take the vaccine were 80% effective and don't have to take the second shot, is that true, with the Pfizer. It's terrible they telling people to get vaccinated, people getting sick. Outcome of event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot been obtained.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Hot flush, SARS-CoV-2 antibody test, Thirst
Clinical narrative: awful thirsty; throat is dry/throat is a little bit dry; hot flashes; This is a spontaneous report from a contactable consumer (patient). A 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6206), dose 1 via an unspecified route of administration, administered on Arm Left on 07Mar2021 09:30 as DOSE 1, SINGLE for covid-19 immunisation (at the age 80 years). The patient medical history and concomitant medications were not reported. The patient experienced hot flashes on 07Mar2021, awful thirsty and throat is dry on an unspecified date. This consumer was administered the first dose of Pfizer COVID-19 Vaccine 07Mar2021. She reported that she did have a couple of small effects from the vaccine that she did not see on the list that she has for the vaccine. She clarified that those couple of small effects were 2 hot flashes that occurred 07Mar2021; and she mentioned her throat is a little bit dry. She did not think the throat being a little bit dry had anything to do with the vaccine, it could just be because the air where she was dry. She asked about these events relative to the vaccine and how long after having the vaccine does it took to develop antibodies. About Hot flashes it was reported as first hot flash occurred about 20:00, second hot flash occurred about 22:00. She should not be having hot flashes at 80 years old. She has not had hot flashes in years before this. She was fine now. This event almost had to be from the vaccine. Lot number: She believed this to be EN6206, although the number 2 could be the letter Z, but she though it was number 2. Second dose was scheduled for 27Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 10Feb2021. The patient had no physician's office, emergency room visit or hospitalization related to these events. The clinical outcome of the event hot flashes was recovered on 07Mar2021 and for the events awful thirsty and throat is dry, outcome was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness / Very dizzy after 36 hours of receiving vaccine; This is a spontaneous report from a contactable consumer (patient) from a program. A 56-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6204, Expiration date: Unknown), via an unspecified route of administration in left arm on 04Mar2021 at 17:00 as dose 1, single, at the age of 56-years-old for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination. The patient did not receive any other vaccine in four weeks of vaccination. The patient's medical history included hypertension/high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications included METOPROLOL, LOSARTAN, and steroid taken for an unspecified indication, start and stop date were not reported. The patient previously took CODEINE for and had known allergies CODEINE. On 06Mar2021 at 07:00, the patient experienced dizziness/very dizzy after 36 hours of receiving vaccine. It was reported that the patient had Pfizer vaccine his first one, given on Thursday. That past week, on March and Thursday night he felt good. Friday, he felt good and he woke up Saturday with severe dizziness and he still had it yet today. He had taken dramamine each day, except for today and it was not helping at all. He takes his daily medication. The outcome of the events was recovering.   No follow up attempts are possible. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Pain, Vaccination site pain
Clinical narrative: arm soreness/ache after receiving the injection; arm soreness/ache after receiving the injection; Patient was worried; This is a spontaneous report from a contactable consumer (patient wife). A 77-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 04Mar2021 (at the age of 77 years old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]), lisinopril (LISINOPRIL) at a dose of 20 mg, fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) at a dose of 2 puffs of that at bed time, pravastatin (PRAVASTATIN) at a dose of 20 mg at bed time and famotidine (PEPCID AC) at a dose of in the morning, all the drugs taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced arm soreness/ache after receiving the injection and patient was worried. Therapeutic measures were taken as a result of events arm soreness/ache after receiving the injection included treatment with Tylenol at once daily and Benadryl at a dose 0f 25 mg. The outcome of the events was unknown.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : -PFIZER INC-2021245395 Same reporter/drug/AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable Consumer or other non-HCP (patient) communicated to Pfizer sponsored Program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: Unknown), dose 1, via an unspecified route of administration on unspecified date, as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant were not reported. The patient stated, she got her second COVID Shot evening about 5:30 on 04Mar2021 (as reported on Thursday) and before she went to get it, she had a terrible headache (after the first dose) on an unspecified date, and she took two Tylenol on unspecified date. So, consumer went ahead and got the second shot, everything went fine and when she came home, she looked online something but somewhere she cannot find it now, but she read that you should not take Tylenol before you have your COVID Shot. But she did take Tylenol before getting the vaccine. Her arm was not very sore and did not have any symptoms. She was just more tired than usual. She wanted to know if that all effect the vaccine. Was that Tylenol going to tick over from the COVID, she means would the COVID Shot still going to be good. At the time of this report, the outcome of event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Rash macular
Clinical narrative: Red spot, about half an inch long and a quarter inch wide; getting bigger; burning and not going away; Red spot, about half an inch long and a quarter inch wide; getting bigger; burning and not going away; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN5318, Expiry Date: Unknown) via an unspecified route of administration in arm on 28Jan2021 (at the age of 71-year-old) as a single dose for COVID-19 immunization. Patient medical history included Cholesterol (blood cholesterol). Patient was a veteran (VA). The concomitant medications included cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) and a cholesterol medicine. It was reported that patient was taken other products. He got both vaccines through the VA. Patient received first dose on shoulder 4 inches below from where they are supposed to give it. On an unspecified date in 2021, after the first dose patient experienced red spot, about half an inch long and a quarter inch wide. It started about maybe a week or so that he had it and that was just a red spot and now it had turned into a mark about I say half an inch long and about a quarter inch wide, getting bigger, burning and not going away, it's not round it's like a rugged. Patient went back down to the VA and they were put him on 3 medications and a cream for 3 or 4 times a day and it still burns; seems like that's not even helping. First of all, they said pat it with warm water and then put this cream on. And he was just wondering, that care for these ones can get a couple of more days and could probably go back down but frankly he does not know what's going on. No investigation assessment was done. The patient was administered with second dose on 17Feb2021 with lot number: EN9581. The clinical outcome of all events was not recovered (still burning).  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Throat irritation
Clinical narrative: headache; scratchy throat; extremely tired; felt bad; This is a spontaneous report from a Pfizer Sponsored Program  Support via a contactable consumer (patient) reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in unspecified anatomical location on 03Mar2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache, scratchy throat and was extremely tired. The patient stated that she felt bad for a day and a half. The patient asked if she could continue to take the second dose. The case was assessed as non-serious. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: felt achy after the second dose; This is a spontaneous report from a Pfizer Sponsored Program via a contactable consumer (patient) reported for herself. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. On an unspecified date, the patient felt achy after the second dose. The patient took Aleve and wanted to know if that was okay. The case was assessed as non-serious. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Lymphadenopathy
Clinical narrative: Chills; fatigue; weakness; lymph nodes full/swollen; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in right arm on 23Mar2021 at 15:00 as a single dose for COVID-19 immunization (at the age of 29-year-old). The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in right arm on 02Mar2021 at 10:00 as a single dose for COVID-19 immunization (at the age of 29-year-old). No other vaccine in four weeks and no other medications in two weeks. The patient did not have COVID prior vaccination and not tested for COVID post vaccination. On 24Mar2021 at 05:30, the patient experienced chills, fatigue, weakness and lymph nodes full/swollen. No treatment was received for the events. The clinical outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Pyrexia
Clinical narrative: Low grade fever, below 100 degrees F; joint aches; chills; fatigue; This is a spontaneous report from a contactable consumer. A 63-year-old female patient (non-pregnant) received second dose of BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: en6206, Expiration date: not reported), via an unspecified route of administration, administered in Arm Left on 13Apr2021 11:30 as a dose 2 single (age at vaccination: 63-year-old) for covid-19 immunisation. Medical history included known allergy: Penecillin. The patient's concomitant medications were not reported. no other vaccine in four weeks and no other medications in two weeks. The patient is not pregnant at time of vaccination. Covid prior vaccination was No and Covid tested post vaccination was No. The patient received historical vaccine as first dose of BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: en6207, expiration date: not reported), via an unspecified route of administration, administered in Arm Left on 23Mar2021 08:30 AM as a dose 1 single (age at vaccination: 63-year-old)for covid-19 immunisation. The patient previously took macrobid [clarithromycin] and had allergies to it. On 15Apr2021 08:00 the patient experienced low grade fever, below 100 degrees f, joint aches, chills and fatigue. . Basically have it intermittently throughout every day, not preventing sleep at night. Taking Ibuprofen for symptoms of aches and fever. Has been ten days since injection and symptoms are not changing. no worse, no better. The patient underwent lab tests and procedures which included body temperature: low on 15Apr2021 Low grade fever, below 100 degrees F. No treatment was received for events. Events were reported as non- serious. The events was not recovered.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Lethargy, Neck pain
Clinical narrative: Morning after shot, fever between 100-101F; chills; aches (joints, neck, head); aches (joints, neck, head); aches (joints, neck, head); lethargy; This is a spontaneous report from a contactable consumer. A 32-year-old male patient received second dose of BNT162B2 (BNT162B2, Solution for injection, Batch/Lot Number: CR8736, Expiration date: Not reported), via an unspecified route of administration, administered in Arm Left on 24Apr2021 15:45 as a dose 2 single (age at vaccination 32-year-old) for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included ilex paraguariensis leaf/panax ginseng root/paullinia cupana seed/rhodiola rosea root (GNC HERBAL PLUS ENERGY FORMULA) taken for an unspecified indication. The patient historical vaccine includes first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0150), via an unspecified route of administration, administered in Arm Left on 03Apr2021 15:45 as a dose 1 single (age at vaccination 32-year-old) for covid-19 immunisation for covid-19 immunisation. The patient previously took amoxicillin, sulfamethoxazole (SEPTRA)trimethoprim and experienced drug allergy. On 24Apr2021 09:45 the patient experienced morning after shot, fever between 100-101f, chills, aches (joints, neck, head) and lethargy. The patient underwent lab tests and procedures which included pyrexia: 100-101 fahrenheit on 24Apr2021. Patient did not receive other vaccine in four weeks of vaccination. Patient received metabolism GNC energy and vitapak as other medications in two weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. Therapeutic measures were taken as a result of the events. Events were reported as non- serious. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Morning after shot, fever between 100-101F; chills; aches (joints, neck, head); aches (joints, neck, head); aches (joints, neck, head); lethargy; This is a spontaneous report from a contactable consumer. A 32-year-old male patient received second dose of BNT162B2 (BNT162B2, Solution for injection, Batch/Lot Number: CR8736, Expiration date: Not reported), via an unspecified route of administration, administered in Arm Left on 24Apr2021 15:45 as a dose 2 single (age at vaccination 32-year-old) for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included ilex paraguariensis leaf/panax ginseng root/paullinia cupana seed/rhodiola rosea root (GNC HERBAL PLUS ENERGY FORMULA) taken for an unspecified indication. The patient historical vaccine includes first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0150), via an unspecified route of administration, administered in Arm Left on 03Apr2021 15:45 as a dose 1 single (age at vaccination 32-year-old) for covid-19 immunisation for covid-19 immunisation. The patient previously took amoxicillin, sulfamethoxazole (SEPTRA)trimethoprim and experienced drug allergy. On 24Apr2021 09:45 the patient experienced morning after shot, fever between 100-101f, chills, aches (joints, neck, head) and lethargy. The patient underwent lab tests and procedures which included pyrexia: 100-101 fahrenheit on 24Apr2021. Patient did not receive other vaccine in four weeks of vaccination. Patient received metabolism GNC energy and vitapak as other medications in two weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. Therapeutic measures were taken as a result of the events. Events were reported as non- serious. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain
Clinical narrative: fever of 102; immediate pain at site/pain at injection site; chills; headache; aches; fatigue; This is a spontaneous report from a non-contactable consumer or other non-HCP (patient reported for self). A 65-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0158), via an unspecified route of administration, administered in left arm on 22Apr2021 09:45 at the age of 65-year-old) as DOSE 2, SINGLE (for COVID-19 immunization. Medical history included hypertension. Known allergies includes allergy to Doxycycline (Drug hypersensitivity). Concomitant medications/medication in two weeks included atorvastatin calcium (LIPITOR); amlodipine; acetylsalicylic acid (BABY ASPIRIN); ubidecarenone (COQ10 [UBIDECARENONE]); ezetimibe (ZETIA) administered in two weeks of vaccination. Facility type vaccine mentioned as Other. The patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8733), via an unspecified route of administration, administered in right arm on 30Mar2021 10:00 (at the age of 64-years-old)) as DOSE 1, SINGLE for covid-19 immunization and experienced little to no reaction. The patient did not receive any other vaccine in four weeks. The patient did not had COVID prior vaccination. On 22Apr2021 11:45, the patient experienced immediate pain at site; fever of 102 (also reported as, 10hrs post vacc), aches, chills, headache lasting 36 hours; then fatigue and pain at injection site (also reported as, 4 days post injection). The patient underwent lab tests and procedures which included body temperature: 102 (fever of 102) on 22Apr2021. Patient was not tested for COVID post vaccination. No treatment was given for the reported events. The outcome of all events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: fever of 102; immediate pain at site/pain at injection site; chills; headache; aches; fatigue; This is a spontaneous report from a non-contactable consumer or other non-HCP (patient reported for self). A 65-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0158), via an unspecified route of administration, administered in left arm on 22Apr2021 09:45 at the age of 65-year-old) as DOSE 2, SINGLE (for COVID-19 immunization. Medical history included hypertension. Known allergies includes allergy to Doxycycline (Drug hypersensitivity). Concomitant medications/medication in two weeks included atorvastatin calcium (LIPITOR); amlodipine; acetylsalicylic acid (BABY ASPIRIN); ubidecarenone (COQ10 [UBIDECARENONE]); ezetimibe (ZETIA) administered in two weeks of vaccination. Facility type vaccine mentioned as Other. The patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8733), via an unspecified route of administration, administered in right arm on 30Mar2021 10:00 (at the age of 64-years-old)) as DOSE 1, SINGLE for covid-19 immunization and experienced little to no reaction. The patient did not receive any other vaccine in four weeks. The patient did not had COVID prior vaccination. On 22Apr2021 11:45, the patient experienced immediate pain at site; fever of 102 (also reported as, 10hrs post vacc), aches, chills, headache lasting 36 hours; then fatigue and pain at injection site (also reported as, 4 days post injection). The patient underwent lab tests and procedures which included body temperature: 102 (fever of 102) on 22Apr2021. Patient was not tested for COVID post vaccination. No treatment was given for the reported events. The outcome of all events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pyrexia
Clinical narrative: Feverish; Sore shoulder; This is a spontaneous report from a contactable consumer or other non-HCP (this report is for the reporter's father). A 45-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW017, Expiry Date of COVID Vaccine: Unknown) via an unspecified route of administration administered in the arm right (reported as "right shoulder") on 21Apr2021 as DOSE 1, SINGLE (at the age of 45-years-old) for COVID-19 immunization. Medical history included ongoing blood pressure abnormal Verbatim: Blood pressure. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced feverish, sore shoulder. No treatment was given for the reported events. No investigation assessment. The outcome of event events feverish and sore shoulder were unknown.  No follow-up attempts are possible; no further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash papular
Clinical narrative: Raised rash about 2 in diameter; Red; Itchy; This is a spontaneous report from a contactable consumer (patient) reported for herself.  A 35-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6205, Expiration date: unknown), administered in Right arm on 12Mar2021 at 12:45 PM (at the age 35-years-old) as dose 1, single for covid-19 immunisation. Patient was not pregnant at the time of vaccination. The patient medical history included Hypothyroidism and HTN. Patient had allergies to Sulfa based medications, mollusks. The patient's concomitant medications included Synthroid. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Patient experienced red, itchy, raised rash about 2 in diameter lasting 2.5 weeks on 12Mar2021.  Patient did not receive any treatment. Outcome of the events was recovered on 31Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Body temperature, Disorientation, Dyspnoea
Clinical narrative: pain in my injection arm; migraine; felt Disoriented; couldn't walk; my lower back is killing me like needles are poking in my back and coming around the sides and up to around my ribcage on both sides; short of breath; My legs wouldn't hold me up; I have random pain from the tip of my toes to the top of my head.; This is a spontaneous report from a contactable consumer (patient). A 48-Years-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date (age at vaccination: 48 years), as dose 2, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single dose for COVID-19 immunization. The patient had a reaction on 29Apr2021 after receiving his 2nd Pfizer vaccine dose. The patient stated, "no reactions to the 1st vaccine dose." The patient stated that, "he woke up at 3am with seeing pain in his injection arm, like a spasm. When he opened his eyes, there was a bright light in his head, like a migraine." He felt disoriented and couldn't walk or bear weight. His legs wouldn't hold him up and he had random pain from the tip of his toes to the top of his head. His legs were jumping on him like banging on the wall. Right now, his lower back was killing him like needles were poking in his back and coming around the sides and up to around his ribcage on both sides. BP was good. He was short of breath. The patient asked could he take any pain meds. The patient underwent lab test and procedure included body temperature 99.0 and pulse was high on 29Apr2021. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Heart rate, Migraine, Pain, Vaccination site pain
Clinical narrative: pain in my injection arm; migraine; felt Disoriented; couldn't walk; my lower back is killing me like needles are poking in my back and coming around the sides and up to around my ribcage on both sides; short of breath; My legs wouldn't hold me up; I have random pain from the tip of my toes to the top of my head.; This is a spontaneous report from a contactable consumer (patient). A 48-Years-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date (age at vaccination: 48 years), as dose 2, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single dose for COVID-19 immunization. The patient had a reaction on 29Apr2021 after receiving his 2nd Pfizer vaccine dose. The patient stated, "no reactions to the 1st vaccine dose." The patient stated that, "he woke up at 3am with seeing pain in his injection arm, like a spasm. When he opened his eyes, there was a bright light in his head, like a migraine." He felt disoriented and couldn't walk or bear weight. His legs wouldn't hold him up and he had random pain from the tip of his toes to the top of his head. His legs were jumping on him like banging on the wall. Right now, his lower back was killing him like needles were poking in his back and coming around the sides and up to around his ribcage on both sides. BP was good. He was short of breath. The patient asked could he take any pain meds. The patient underwent lab test and procedure included body temperature 99.0 and pulse was high on 29Apr2021. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysmenorrhoea, Headache, Nausea, Pain
Clinical narrative: Fever; body aches; chills; headache; menstrual cramps; nausea; This is a spontaneous report from a contactable consumer or other non-HCP (patient reported for self). A 44-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Er8733), via an unspecified route of administration, administered in right arm on 25Apr2021 17:00 (at the age of 44-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included Latex sensitivity (Known allergies: Latex sensitivity). The patient's concomitant medications were not reported. Facility type vaccine mentioned as other. The patient did not receive any other vaccine in four weeks and did not receive any other medication in two weeks. The patient not had COVID prior vaccination. other medical history was reported as none. Patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Er8733), via an unspecified route of administration, administered in right arm on 31Mar2021 10:30 as DOSE 1, SINGLE (at the age of 44-years-old) for COVID-19 immunization and experienced full body rash. Lasted approximately 3 weeks. On 27Apr2021 11: 00 the patient experienced Fever, body aches, chills, headache, menstrual cramps (even though patient did not start her period for another 8 days) and nausea starting approximately 40 hours following second dose. Not tested for Covid post vaccination. No treatment was given for the reported events. The outcome of all events was reported as recovering.  No follow-up attempts are possible: No further information is excepted.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; body aches; chills; headache; menstrual cramps; nausea; This is a spontaneous report from a contactable consumer or other non-HCP (patient reported for self). A 44-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Er8733), via an unspecified route of administration, administered in right arm on 25Apr2021 17:00 (at the age of 44-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included Latex sensitivity (Known allergies: Latex sensitivity). The patient's concomitant medications were not reported. Facility type vaccine mentioned as other. The patient did not receive any other vaccine in four weeks and did not receive any other medication in two weeks. The patient not had COVID prior vaccination. other medical history was reported as none. Patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Er8733), via an unspecified route of administration, administered in right arm on 31Mar2021 10:30 as DOSE 1, SINGLE (at the age of 44-years-old) for COVID-19 immunization and experienced full body rash. Lasted approximately 3 weeks. On 27Apr2021 11: 00 the patient experienced Fever, body aches, chills, headache, menstrual cramps (even though patient did not start her period for another 8 days) and nausea starting approximately 40 hours following second dose. Not tested for Covid post vaccination. No treatment was given for the reported events. The outcome of all events was reported as recovering.  No follow-up attempts are possible: No further information is excepted.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: Low grade fever; body aches; This is a spontaneous report from a contactable consumer or other non-HCP (patient reported for self). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date (Age of vaccination: Unknown) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced low grade fever and body aches. The patient underwent lab tests and procedures which included body temperature: low grade on an unspecified date. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the 1st dose of BNT162B2 (Comirnaty, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unknown date, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On unspecified date, patient had swollen lips and facial swelling. The events resulted in emergency room visit. She did not go for 2nd dose. The outcome of the events: unknown. No follow-up attempts needed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Pain, Pyrexia
Clinical narrative: Her  side effects as of yesterday are flu like symptoms, fever of 101; lots of body aches; flu like symptoms; This is a spontaneous report from a Pfizer-sponsored program Support. A non-contactable consumer reported that a female patient of an unspecified age received BNT162B2 (BNT162B2, solution for injection, (Batch/Lot number and expiration date: was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine includes BNT162B2 (BNT162B2, solution for injection, (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. On an unspecified date the patient experienced her side effects as of yesterday are flu like symptoms, fever of 101, lots of body aches and flu like symptoms. The patient underwent lab tests and procedures which included body temperature: 101. Events were reported as non- serious. The event outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.