chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, Sensation of foreign body, Sensory disturbance
Clinical narrative: Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.)   lump in my throat; turned red on my face and neck and chest and arms; when I get nervous; between my eyes on my forehead felt like a round circle (no bump) (past the bridge above eyebrows). It didn't hurt, but I felt something; felt odd; felt like my eyes were moving back and forth; very very cold; hands were ice cold; This is a spontaneous report received a contactable consumer, the patient. A 60-year-old adult female received the first dose BNT162b2 (solution for injection; batch/lot and expiry information not reported) as a single dose via unspecified route on 14Mar2021 (at 60-years-old), for COVID-19 immunisation. Relevant medical history included high blood pressure, and diabetes. There were no concomitant medications or past drug history reported. The patient reported that she had a couple of reactions the first day, so she was afraid to take the second one. The patient stated that within eight minutes she had a lump in her throat, which she gets when she is nervous and was unsure if from shot or nervousness. The patient reported that then she turned red on her face, neck, chest, and arms. The patient reported that the redness lasted about six or seven hours and did not bother her at all. The patient explained that then between her eyes on her forehead felt like a round circle (no bump) past the bridge above eyebrows. The patient stated that it did not hurt but felt like something. The patient also stated that she felt like she was going to get headache, though did not. The patient reported that it just felt odd. The patient also stated that she felt like her eyes were moving back and forth. Though when she looked in the mirror, they were fine. The patient stated that the eyes happened three times but by the time she looked in the mirror they looked fine. The patient added that she never felt sick or anything though about six or eight hours later she got very very cold which only lasted about a minute. The patient stated that her hands were ice cold and then it all went back to normal. The outcome of the events turned red on my face and neck and chest and arms was recovered on an unspecified date in Mar2021 after 6-7 hours. The outcome of the event she got very very cold was recovered on an unspecified date in Mar2021 after one minute. The outcome of the events hands were ice cold, and felt like my eyes were moving back and forth was recovered on an unspecified date in Mar2021. The outcome of the events, lump in my throat, get nervous, between my eyes on my forehead felt like a round circle (no bump), felt something, and felt odd, 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: Fatigue, Malaise, Pyrexia
Clinical narrative: didn't feel well; slight fever; possibly fatigue; This is a spontaneous report received from a contactable consumer (reporting for his wife). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient didn't feel well after the first dose. She had a slight fever and possibly fatigue. The outcome of the events was unknown.    Information on the lot number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: 2nd dose caused some symptoms 48 hours fever with body aches and Fatigue; 2nd dose caused some symptoms 48 hours fever with body aches and Fatigue; 2nd dose caused some symptoms 48 hours fever with body aches and Fatigue; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 2 intramuscular on 25Jan2021 09:30 (Batch/Lot Number: EK5730) at Arm Right as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), intramuscular, administered in Arm Right on 05Jan2021 as SINGLE DOSE for covid-19 immunisation and causes hours fever with body aches and fatigue. On 06Jan2021 02:00, The patient reported 2nd dose caused some symptoms 48 hours fever with body aches and fatigue. The action taken in response to the event for bnt162b2 was not applicable. The outcome of events was recovered.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: Congestion; Sore throat; Feverish 98-100.8F body temperature; This is a spontaneous case received from a contactable consumer (patient). A 21-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration on 18Mar2021 (Batch/Lot number unknown) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. On 19Mar20201, the day after vaccination, the patient developed congestion, sore throat and feverish 98-100.8F body temperature. She wants to know if these symptoms are normal side effects of the vaccine or if she has an illness. The outcome of events congestion, sore throat and feverish was unknown.  No follow-up attempts possible; no request for batch number will be pursued.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: feeling dizzy; tired; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 19Mar2021 in the morning (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. By late afternoon on 19Mar2021, the patient started feeling dizzy and very tired. She felt that way all day on Saturday. On Sunday, she was feeling "so much better". The outcome of events, feeling dizzy and very tired was recovering.  No follow-up attempts are possible; information about lot number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This is a spontaneous report from a contactable consumer (patient). This male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1, via an unspecified route of administration, on 18Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After getting the first dose of the Pfizer-BioNtech Covid vaccine on 18Mar2021 he experienced a little dizziness on an unspecified date. The dizziness dissipated after a few hours.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo; This is a spontaneous report from a contactable consumer (patient's daughter), from a Pfizer sponsored program COVAX US Support. A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 26Feb2021 (at an unspecified age) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient felt dizzy. Later on, she was diagnosed with vertigo. She was hospitalized. Consumer wanted to know if it would still be safe and okay for the patient to receive the 2nd dose. Patient had already been past the 3 weeks since her 1st dose and she still has not received the 2nd dose. 12Apr2021 is her second dose. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Muscular weakness, Nausea, Neck pain, Neuralgia
Clinical narrative: Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.)   pain; It started in her neck; upper nerves in her head; now radiates down to her lower back; muscle weakness; nauseated; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration on 16Mar2021 as single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included levothyroxine, ascorbic acid (VITAMIN C), and cholecalciferol (VITAMIN D); all taken for unspecified indications, start and stop dates were not reported. The patient received the first dose of the Pfizer covid vaccine on 16Mar2021. The patient reported that she had a lot of side effects from the vaccine. She reported that on Mar2021, she was still experiencing pain after the vaccine. It started in her neck and upper nerves in her head and now radiates down to her lower back. She has been using heat and ice. She also had muscle weakness on Mar2021 but that was improving. She also was nauseated on Mar2021 but was keeping hydrated and was still able to eat. She didn't like to take over the counter medications because anytime she does that it might cause her liver enzymes to be up. The patient asked when this will go away. The patient reported that she was supposed to get her second dose on 08Apr2021 and asked if the side effects will be worse. The patient reported that she had been hearing a lot of rumors that it was not wise to get like an MRI or CAT scan after the vaccine and the patient asked if this was correct. The outcome of the event muscle weakness was recovering. The outcome of event nauseated was unknown. The outcome of the remaining events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.)   pain; It started in her neck; upper nerves in her head; now radiates down to her lower back; muscle weakness; nauseated; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration on 16Mar2021 as single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included levothyroxine, ascorbic acid (VITAMIN C), and cholecalciferol (VITAMIN D); all taken for unspecified indications, start and stop dates were not reported. The patient received the first dose of the Pfizer covid vaccine on 16Mar2021. The patient reported that she had a lot of side effects from the vaccine. She reported that on Mar2021, she was still experiencing pain after the vaccine. It started in her neck and upper nerves in her head and now radiates down to her lower back. She has been using heat and ice. She also had muscle weakness on Mar2021 but that was improving. She also was nauseated on Mar2021 but was keeping hydrated and was still able to eat. She didn't like to take over the counter medications because anytime she does that it might cause her liver enzymes to be up. The patient asked when this will go away. The patient reported that she was supposed to get her second dose on 08Apr2021 and asked if the side effects will be worse. The patient reported that she had been hearing a lot of rumors that it was not wise to get like an MRI or CAT scan after the vaccine and the patient asked if this was correct. The outcome of the event muscle weakness was recovering. The outcome of event nauseated was unknown. The outcome of the remaining events was not recovered.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest discomfort, Dyspnoea, Lip swelling, Oral mucosal roughening
Clinical narrative: lips were swelling; swelling inside of cheek as well; heaviness in chest/felt like someone was stepping on her chest; shortness of breath; really bad stomach ache; Inside of cheek felt rough; This is a spontaneous report from a contactable consumer (the patient). A 55-year-old female patient received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration (at the age of 55 years) on 22Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient reported that she was very sensitive to a lot of things, so she opted to stay for half an hour (after vaccination). Once she got in the car, she took her mask off, and realized her lips were swelling. She turned around and went back, and they let her sit for a little while longer. The swelling eventually stopped, but she did have swelling inside her cheek as well. It also felt like someone was stepping on her chest the rest of the day, she experienced shortness of breath, heaviness in chest, a really bad stomach ache, but didn't really eat much so didn't think that it was from food. Inside her cheek felt rough. The lip swelling went away without medication. The outcome of swelling inside her cheek, felt like someone was stepping on her chest, shortness of breath, heaviness in chest, a really bad stomach ache, cheek felt rough was unknown.  No follow-up attempts are possible, information on lot number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: lips were swelling; swelling inside of cheek as well; heaviness in chest/felt like someone was stepping on her chest; shortness of breath; really bad stomach ache; Inside of cheek felt rough; This is a spontaneous report from a contactable consumer (the patient). A 55-year-old female patient received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration (at the age of 55 years) on 22Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient reported that she was very sensitive to a lot of things, so she opted to stay for half an hour (after vaccination). Once she got in the car, she took her mask off, and realized her lips were swelling. She turned around and went back, and they let her sit for a little while longer. The swelling eventually stopped, but she did have swelling inside her cheek as well. It also felt like someone was stepping on her chest the rest of the day, she experienced shortness of breath, heaviness in chest, a really bad stomach ache, but didn't really eat much so didn't think that it was from food. Inside her cheek felt rough. The lip swelling went away without medication. The outcome of swelling inside her cheek, felt like someone was stepping on her chest, shortness of breath, heaviness in chest, a really bad stomach ache, cheek felt rough was unknown.  No follow-up attempts are possible, information on lot number cannot be obtained.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood pressure increased, Blood pressure measurement, Headache
Clinical narrative: blood pressure was elevated about 140-150's/80-90's; headaches; This is a spontaneous report from Pfizer-sponsored program from a contactable other healthcare professional and consumer (patient). A 63-year-old female patient received tofacitinib citrate (XELJANZ XR), via an unspecified route of administration from 28Sep2020 (Batch/Lot number was not reported) to an unspecified date, at 11 mg for an unspecified indication and BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date not reported), via an unspecified route of administration on Dec2020 as a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included unspecified covid vaccines. Side effects reported includes headaches and increased blood pressure. Patient stated from end of Dec to end of Feb, blood pressure was elevated about 140-150's/80-90's. Only thing that changes was she got her Covid vaccines in Dec. States now her blood pressure is back to normal. The action taken in response to the events for tofacitinib citrate was unknown. The outcome of event blood pressure was elevated was recovered while for other events was unknown.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: COVID-19 vaccine (BNT162B2) was added as a co-suspect drug.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Ear discomfort, Fatigue, Hypoacusis, Insomnia
Clinical narrative: main issue was hearing/ear discomfort. The patient's hearing swells and subsides, in 3- 4 quick successions. It makes sort of a vibration noise; main issue was hearing/ear discomfort. The patient's hearing swells and subsides, in 3- 4 quick successions. It makes sort of a vibration noise; main issue was hearing/ear discomfort. The patient's hearing swells and subsides, in 3- 4 quick successions. It makes sort of a vibration noise; has kept her up nights three nights; vision was double; fatigue; Arm soreness; This is a spontaneous report from a contactable consumer (patient).  A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 18Mar2021 (at the age of 42-years-old; not pregnant), at 10:00 AM (Lot Number: ER2613) as a single dose in the left arm for COVID-19 immunisation.  Medical history included eosinophilic oesophagitis and known allergies: sulfa drugs both from an unknown date and unknown if ongoing. Concomitant medications included finasteride (PROPECIA), lorazepam (ATIVAN) and fluticasone propionate (FLOVENT (reported as FLOVENT 200)); all taken from an unspecified date for an unspecified indication. On 18Mar2021 at 5:00 PM, the patient reported that the main issue was hearing/ear discomfort. The patient's hearing swells and subsides, in 3- 4 quick successions. It makes sort of a vibration noise and has kept her up nights three nights since vaccine. After the dose, the patient's vision was double, but she thought it was just because of fatigue. Patient also reported that arm soreness was going away. No treatment was received by the patient for the reported adverse events. Post vaccination COVID test: polymerase chain reaction (PCR) COVID test/ nasal swab was conducted on 18Mar2021 and the result was negative. The outcome of the event "arm soreness" was recovering and not recovered for all other events.  No follow up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus, Vaccination site pain
Clinical narrative: main issue was hearing/ear discomfort. The patient's hearing swells and subsides, in 3- 4 quick successions. It makes sort of a vibration noise; main issue was hearing/ear discomfort. The patient's hearing swells and subsides, in 3- 4 quick successions. It makes sort of a vibration noise; main issue was hearing/ear discomfort. The patient's hearing swells and subsides, in 3- 4 quick successions. It makes sort of a vibration noise; has kept her up nights three nights; vision was double; fatigue; Arm soreness; This is a spontaneous report from a contactable consumer (patient).  A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 18Mar2021 (at the age of 42-years-old; not pregnant), at 10:00 AM (Lot Number: ER2613) as a single dose in the left arm for COVID-19 immunisation.  Medical history included eosinophilic oesophagitis and known allergies: sulfa drugs both from an unknown date and unknown if ongoing. Concomitant medications included finasteride (PROPECIA), lorazepam (ATIVAN) and fluticasone propionate (FLOVENT (reported as FLOVENT 200)); all taken from an unspecified date for an unspecified indication. On 18Mar2021 at 5:00 PM, the patient reported that the main issue was hearing/ear discomfort. The patient's hearing swells and subsides, in 3- 4 quick successions. It makes sort of a vibration noise and has kept her up nights three nights since vaccine. After the dose, the patient's vision was double, but she thought it was just because of fatigue. Patient also reported that arm soreness was going away. No treatment was received by the patient for the reported adverse events. Post vaccination COVID test: polymerase chain reaction (PCR) COVID test/ nasal swab was conducted on 18Mar2021 and the result was negative. The outcome of the event "arm soreness" was recovering and not recovered for all other events.  No follow up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Limb mass, Neck mass
Clinical narrative: lumps on one hand; lumps on neck; This is a spontaneous report from a non-contactable consumer (patient). This 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Patient had no medical history. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. Four days after the vaccination on 18Mar2021, patient had lumps on neck and 6 days later on 20Mar2021, patient noticed lumps on one hand. AEs resulted in: doctor or other healthcare professional office/clinic visit. Patient is recovering. Treatment received for events was ice pack and pain killer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time, Blood magnesium, Blood pressure measurement, Blood thyroid stimulating hormone, Body temperature
Clinical narrative: nausea; diarrhea; excessive sweating; chills; hot flashes; shortness of breath; chest tightness; elevated liver enzymes; blood pressure and heart rate were high. BP was approx 180/120; heart rate were high; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in the left arm on 19Mar2021 08:15 (Batch/Lot Number: ER2613) as a single dose for covid-19 immunisation. Medical history included asthma, IBS (irritable bowel syndrome), and allergies to shellfish, fish and seafood. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medications included glucosamine and cetirizine, all indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. The COVID 19 vaccine was received in a hospital. Approximately 12:15 AM on 21Mar2021, the patient began to experience chest tightness, shortness of breath, nausea, diarrhea, excessive sweating, chills and hot flashes. The patient took himself to the emergency room (ER) on 21Mar2021. The patient also mentioned that his temperature was normal, but his blood pressure (BP) and heart rate were high. BP was approximately 180/120 (unit unspecified). The ER ran Chest X-Ray, EKG, CBC, CMP, Protime-INR, Magnesium, Troponin, Partial Thromboplastin Time and TSH. The results were normal ranges besides high heart rate and elevated liver enzymes. The adverse events required doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events received treatment for the adverse events which included albuterol-ipratropium, aspirin and IV fluids. The patient has not been covid tested post vaccination. The outcome of the events was recovering.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Chest discomfort, Chills, Diarrhoea, Dyspnoea
Clinical narrative: nausea; diarrhea; excessive sweating; chills; hot flashes; shortness of breath; chest tightness; elevated liver enzymes; blood pressure and heart rate were high. BP was approx 180/120; heart rate were high; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in the left arm on 19Mar2021 08:15 (Batch/Lot Number: ER2613) as a single dose for covid-19 immunisation. Medical history included asthma, IBS (irritable bowel syndrome), and allergies to shellfish, fish and seafood. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medications included glucosamine and cetirizine, all indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. The COVID 19 vaccine was received in a hospital. Approximately 12:15 AM on 21Mar2021, the patient began to experience chest tightness, shortness of breath, nausea, diarrhea, excessive sweating, chills and hot flashes. The patient took himself to the emergency room (ER) on 21Mar2021. The patient also mentioned that his temperature was normal, but his blood pressure (BP) and heart rate were high. BP was approximately 180/120 (unit unspecified). The ER ran Chest X-Ray, EKG, CBC, CMP, Protime-INR, Magnesium, Troponin, Partial Thromboplastin Time and TSH. The results were normal ranges besides high heart rate and elevated liver enzymes. The adverse events required doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events received treatment for the adverse events which included albuterol-ipratropium, aspirin and IV fluids. The patient has not been covid tested post vaccination. The outcome of the events was recovering.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Full blood count, Heart rate, Heart rate increased, Hepatic enzyme
Clinical narrative: nausea; diarrhea; excessive sweating; chills; hot flashes; shortness of breath; chest tightness; elevated liver enzymes; blood pressure and heart rate were high. BP was approx 180/120; heart rate were high; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in the left arm on 19Mar2021 08:15 (Batch/Lot Number: ER2613) as a single dose for covid-19 immunisation. Medical history included asthma, IBS (irritable bowel syndrome), and allergies to shellfish, fish and seafood. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medications included glucosamine and cetirizine, all indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. The COVID 19 vaccine was received in a hospital. Approximately 12:15 AM on 21Mar2021, the patient began to experience chest tightness, shortness of breath, nausea, diarrhea, excessive sweating, chills and hot flashes. The patient took himself to the emergency room (ER) on 21Mar2021. The patient also mentioned that his temperature was normal, but his blood pressure (BP) and heart rate were high. BP was approximately 180/120 (unit unspecified). The ER ran Chest X-Ray, EKG, CBC, CMP, Protime-INR, Magnesium, Troponin, Partial Thromboplastin Time and TSH. The results were normal ranges besides high heart rate and elevated liver enzymes. The adverse events required doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events received treatment for the adverse events which included albuterol-ipratropium, aspirin and IV fluids. The patient has not been covid tested post vaccination. The outcome of the events was recovering.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Hepatic enzyme increased, Hot flush, Hyperhidrosis, Hypertension, International normalised ratio
Clinical narrative: nausea; diarrhea; excessive sweating; chills; hot flashes; shortness of breath; chest tightness; elevated liver enzymes; blood pressure and heart rate were high. BP was approx 180/120; heart rate were high; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in the left arm on 19Mar2021 08:15 (Batch/Lot Number: ER2613) as a single dose for covid-19 immunisation. Medical history included asthma, IBS (irritable bowel syndrome), and allergies to shellfish, fish and seafood. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medications included glucosamine and cetirizine, all indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. The COVID 19 vaccine was received in a hospital. Approximately 12:15 AM on 21Mar2021, the patient began to experience chest tightness, shortness of breath, nausea, diarrhea, excessive sweating, chills and hot flashes. The patient took himself to the emergency room (ER) on 21Mar2021. The patient also mentioned that his temperature was normal, but his blood pressure (BP) and heart rate were high. BP was approximately 180/120 (unit unspecified). The ER ran Chest X-Ray, EKG, CBC, CMP, Protime-INR, Magnesium, Troponin, Partial Thromboplastin Time and TSH. The results were normal ranges besides high heart rate and elevated liver enzymes. The adverse events required doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events received treatment for the adverse events which included albuterol-ipratropium, aspirin and IV fluids. The patient has not been covid tested post vaccination. The outcome of the events was recovering.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test, Nausea, Troponin
Clinical narrative: nausea; diarrhea; excessive sweating; chills; hot flashes; shortness of breath; chest tightness; elevated liver enzymes; blood pressure and heart rate were high. BP was approx 180/120; heart rate were high; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in the left arm on 19Mar2021 08:15 (Batch/Lot Number: ER2613) as a single dose for covid-19 immunisation. Medical history included asthma, IBS (irritable bowel syndrome), and allergies to shellfish, fish and seafood. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medications included glucosamine and cetirizine, all indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. The COVID 19 vaccine was received in a hospital. Approximately 12:15 AM on 21Mar2021, the patient began to experience chest tightness, shortness of breath, nausea, diarrhea, excessive sweating, chills and hot flashes. The patient took himself to the emergency room (ER) on 21Mar2021. The patient also mentioned that his temperature was normal, but his blood pressure (BP) and heart rate were high. BP was approximately 180/120 (unit unspecified). The ER ran Chest X-Ray, EKG, CBC, CMP, Protime-INR, Magnesium, Troponin, Partial Thromboplastin Time and TSH. The results were normal ranges besides high heart rate and elevated liver enzymes. The adverse events required doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events received treatment for the adverse events which included albuterol-ipratropium, aspirin and IV fluids. The patient has not been covid tested post vaccination. The outcome of the events was recovering.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Tinnitus
Clinical narrative: ringing sound that is loud. Everything sounds as if it is echoing. What would be described as tenatus; same pain only it is far worse; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration, administered in he left arm on 22Mar2021 17:30  (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included Ehlers-Danlos syndrome from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included paracetamol (TYLENOL) for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162b2 on 01Mar2021 (Lot Number: En6205) in the left arm for COVID-19 immunisation (reported in Pfizer case # 2021314445). The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient reported, that on 22Mar2021 at 05:30 PM, "Immediately after injection the first dose time I had a weird pain in the left side of my head. Today, I received my second dose and I had the same pain only it is far worse. It was within 10 minutes of injection. Within 30 minutes there is a ringing sound that is loud. Everything sounds as if it is echoing. What would be described as tenatus". No treatment for the events was provided. Outcome of the events, ringing sound that is loud. Everything sounds as if it is echoing. What would be described as tenatus and same pain only it is far worse was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Emotional disorder, Headache, Illness, Neuralgia, Pruritus
Clinical narrative: headache; chin/head itches; left side face nerve pain; hand tremors; on edge emotionally; something is off neurologically--minor but enough for me to call in sick; This is a spontaneous report received from a contactable consumer (reporting on herself). A 55-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: solution for injection, Lot Number: EN 6208 and Expiration Date was not re-ported), via an unspecified route of administration in in Arm Left on 24Mar2021 16:15 as single dose for COVID-19 immunization. Medical history included restless legs syndrome from an un-known date and unknown if ongoing. Concomitant medication(s) included carbidopa, levodopa (SINEMET); levothyroxine sodium (LEVOTHYROXIN) both taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes first dose of BNT162B2 on 03Mar2021 15:30 for COVID-19 immunization and patient experience minor shingles outbreak (left side face nerve pain, headache, itching chin/head and blister on lips), exhaustion for four days, intense arm pain at injection site (pain began when shot was being given), slight nausea/light headed/dizzy on day 2. On 26Mar2021 at 06:00 patient after second shot of BNT162B2 patient experienced left side of face nerve pain (more than shot one), headache, chin/head itches, hand tremors, on edge emotionally (was fine yesterday), something is off neurologically minor but enough for me to call in sick, hope it is not another shingles outbreak. And saying hopefully in a few days this shall pass. The outcome of the events was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: headache; chin/head itches; left side face nerve pain; hand tremors; on edge emotionally; something is off neurologically--minor but enough for me to call in sick; This is a spontaneous report received from a contactable consumer (reporting on herself). A 55-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: solution for injection, Lot Number: EN 6208 and Expiration Date was not re-ported), via an unspecified route of administration in in Arm Left on 24Mar2021 16:15 as single dose for COVID-19 immunization. Medical history included restless legs syndrome from an un-known date and unknown if ongoing. Concomitant medication(s) included carbidopa, levodopa (SINEMET); levothyroxine sodium (LEVOTHYROXIN) both taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes first dose of BNT162B2 on 03Mar2021 15:30 for COVID-19 immunization and patient experience minor shingles outbreak (left side face nerve pain, headache, itching chin/head and blister on lips), exhaustion for four days, intense arm pain at injection site (pain began when shot was being given), slight nausea/light headed/dizzy on day 2. On 26Mar2021 at 06:00 patient after second shot of BNT162B2 patient experienced left side of face nerve pain (more than shot one), headache, chin/head itches, hand tremors, on edge emotionally (was fine yesterday), something is off neurologically minor but enough for me to call in sick, hope it is not another shingles outbreak. And saying hopefully in a few days this shall pass. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: Possible anxiety issues; This is a spontaneous report received from a non-contactable consumer (patient's child). A female patient of unspecified age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced possible anxiety issues. The outcome of possible anxiety issues was unknown.  No follow-up attempts are possible. Information about lot/batch cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; low-grade fever; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported a female patient of unspecified age received doses 1 and 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). Medical history and concomitant medications were not reported. The patient experienced chills and low-grade fever on an unspecified date. The outcomes of chills and low-grade fever were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pain in extremity, Pruritus, Rash
Clinical narrative: Sore arm for less than 24 hrs.; Rash on my arms and wrists that I noticed almost 24 hrs after injections; Mildly itchy; Looked like tiny blisters; This is a spontaneous report from a contactable 41-year-old female other health care professional (reported herself). A 41 year old non pregnant Caucasian women received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; lot number: EN6207), at an unknown dosage via unknown route of administration in left arm on 12Mar2021 at 15:45 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The patient did not receive any other vaccines with 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient had no allergies to medications, food, or other products. On 13Mar2021, the patient experienced sore arm for less than 24 hrs, rash on my arms and wrists that I noticed almost 24 hrs after injections, mildly itchy. Looked like tiny blisters. Last 3-4 days. As a corrective treatment for the events the patient received benadryl and applied topical OTC (over the counter) ointment. The outcome of the events was recovered.  Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Peripheral swelling
Clinical narrative: My leg was numb; Felt swollen from my right leg.; This is a spontaneous report from a contactable consumer. A 40-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Er8727), via an unspecified route of administration in Left Arm on 26Mar2021 04:30 PM as single dose for covid-19 immunization. Medical history included allergy to fish. The patient's concomitant medications were not reported. On 26Mar2021, 04:45 pm the patient reported his leg was numb and felt swollen from my right leg. Until he took a Benadryl, the feeling in leg came back after hour. The outcome of event was recovered on an unknown date in 2021.  Information on the lot/batch number has been requested.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Cough, Fatigue, Headache
Clinical narrative: blood pressure went up to 180/96; fatigue; headache; cough; This is a spontaneous report from a non-contactable consumer (patient). An 81-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EM9809), via an unspecified route of administration on 08Mar2021 11:30 (at 81-year-old) as single dose for COVID-19 immunization. Medical history included Stage 4 kidney failure, Frequent premature ventricular contractions, allergy (Allergies to medications, food, or other products:Yes), COVID-19 (Prior to vaccination, the patient diagnosed with COVID-19). The patient's concomitant medications were not reported. The patient had the expected side effects of fatigue, headache and cough from 08Mar2021 16:00 for 48 hours. But what he did not expect was that his blood pressure went up to 180/96 and stayed that way from 08Mar2021 16:00 for two days. He was not on blood pressure medication and his blood pressure has never been that high. No treatment received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event blood pressure went up to 180/96 recovered on an unspecified date (duration 2 days); while for other events was recovered on 10Mar2021 16:00.  No follow-up attempts are possible. No further information expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen supraclavicular lymph node on same side as injection; This is a spontaneous report received from a contactable consumer. This 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8727), via an unspecified route of administration on 22Mar2021 at 17:45 (at the age of 41-years-old) as single dose in left arm for COVID-19 immunisation. The patient's medical history included POTS and Hashimoto's. The patient has known allergies. Patient was not pregnant at the time of vaccination.  Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (Lot Number: EN6202) on 01Mar2021 at 05:45 PM in left arm. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced swollen supraclavicular lymph node on same side as injection. There was no treatment received for the event. The outcome of the event was not recovered.  Follow up information requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache; sore arm; This is a spontaneous report received from a contactable consumer (patient himself). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection and Lot Number: EJ1685) via an unspecified route of administration in left arm on 04Mar2021 at 15:30 (at the age of 48-year-old) for COVID-19 immunisation. Medical history included allergies to tartrazine, gluten and penicillin. Concomitant medications were not reported. Patient previously took ciprofloxacin, differin and tessalon perle and experienced with allergy for all. On 04Mar2021 (stated within 1 hour of receiving vaccine) patient had headache and on an unknown date in Mar2021 (after first dose), patient had sore arm. Treatment was not received for the adverse events. Outcome for the event headache was not recovered and was unknown for sore arm.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: Headache and 38 C fever two weeks after getting the first dose; Headache and 38 C fever two weeks after getting the first dose; This is a spontaneous report from a contactable physician (patient). A 44-year-old female patient received first dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN 6206) via an unspecified route of administration on 13Mar2021 09:00 AM at single dose in left arm for COVID-19 immunisation. Medical history was reported as none. Patient was not pregnant at the time of vaccination. Concomitant medication was not reported. The patient does not have any allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Mar2021 04:00 PM, the patient had headache, fever 38 C two weeks after getting vaccinated with first dose. The patient received paracetamol for the treatment of the above events. The outcome of the events was not recovered  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Nausea, Pain
Clinical narrative: pain at her back; fever; nausea; chills; body ache; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported a female patient of unspecified age received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 23Mar2021 at 10:00 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced some reactions which were chills, fever, body ache, headache, nausea, and pain at her back. The outcomes of chills, fever, body ache, headache, nausea, and pain at her back were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: pain at her back; fever; nausea; chills; body ache; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported a female patient of unspecified age received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 23Mar2021 at 10:00 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced some reactions which were chills, fever, body ache, headache, nausea, and pain at her back. The outcomes of chills, fever, body ache, headache, nausea, and pain at her back were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site swelling
Clinical narrative: sore arm; injection site swelling; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A female patient of unspecified age (reporter's wife) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 16Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation. The reporter called because his wife experienced sore arm and injection site swelling after the second dose of the vaccine. The clinical outcomes of sore arm and injection site swelling were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.