chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Pain
Clinical narrative: I am disabled from a car accident and few weeks after the shots  like the pain level, everything in my body went up a little bit.; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: DEP8733), dose 2 intramuscular, administered in Arm Right on 30Mar2021 as single dose for covid-19 immunisation. Medical history included ongoing diabetes, ongoing high blood pressure, disabled from a car accident, bad arteries from an unknown date and unknown if ongoing and had bypass surgery of heart. The patients concomitant medications were not reported. Patient stated, his concern was over, he received his second shot of the vaccine on 30Mar2021, as of couple of days ago he still did not have any antibodies in him. He talked to his doctor about it. The patient had a lot of medical issues. He was disabled from a car accident (moto vehicle accident) and few weeks after the shots like the pain level, everything in his body went up a little bit on an unspecified date. Patient was concerned about how long he was going to have wait, when he started seeing antibodies in his blood. The patient underwent lab tests and procedures which included antibody test which tests negative. The outcome of the event was unknown.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: she didn't get pneumonia unless she got a pneumonia vaccine; she didn't get pneumonia unless she got a pneumonia vaccine; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose unknown, single for immunization. Medical history included bariatric surgery from 2019. The patient's concomitant medications were not reported. The patient previously took flu vaccine for Immunisation and experienced flu and she was hospitalized (She didn't get sick with the flu unless she took a flu vaccine). It was reported that the patient didn't get pneumonia unless she got a pneumonia vaccine on an unspecified date, and the patient was hospitalized. The outcome of event was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.  Information on the lot/batch number has been requested.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Pharyngeal swelling, Pruritus, Swelling face
Clinical narrative: Chest and back itch incredibly; Does feel hot; now swelling of his face or throat; now swelling of his face or throat; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient's father). An 18-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, batch/lot number: EN0187 and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 25Jun2021 14:30 (at the time of vaccination 18-years-old), as a single dose for COVID-19 immunization. The patient's medical history include sunburn and reported that he did have a sunburn 3 days ago. No concomitant medications were not reported. The caller provided other relevant medical history including but not limited to these conditions; diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient did not have any other vaccination prior to COVID vaccine (within 4 weeks). No family Medical History Relevant to adverse events. On 25Jun2021, the patient experienced chest and back itch incredibly, does feel hot, and now swelling of his face or throat. It was reported that, today (25Jun2021) the caller 18-year-old son had the Covid-19 vaccination. He had the vaccine about 2 hours ago. Everything was fine up until about 30 minutes ago. He claims his chest and back itch incredibly. He had no other symptoms and no rash. He does feel hot. He had no difficulty breathing and now swelling of his face or throat. The caller wife was a nurse. She did not feel like it was an emergency at that point but being a nurse, she wanted him to check and see if they have any Benadryl. No relevant tests. Patient did not visit to emergency room, physician office and not hospitalized. The outcome for all the events was not resolved.  Additional Information has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Cough, Dyspnoea, Heart rate
Clinical narrative: shortness of breath; Low heart rate at 38 to 45; facial swelling; cough; low blood pressure 98/52 - 98/50; generalized weakness; This is a spontaneous report from a contactable other Healthcare professional (patient) reported for himself. A 57-years-old male patient received an unknown 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 57 years) as dose number unknown, single for COVID-19 immunization. The patient did not have any relevant medical history, concurrent conditions, relevant past drug history and known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Jun2021 at 15:00 pm, the patient experienced low heart rate at 38 to 45, low blood pressure 98/52 - 98/50, generalized weakness, facial swelling, cough, shortness of breath. The patient was not hospitalized for the events. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests which included blood pressure measurement: low (98/52 - 98/50) and heart rate: low (38 to 45) on 06Jun2021. The patient received treatment with Amoxicillin, Benadryl, bedrest and oral hydration. The device date was reported as 27Jun2021. The outcome of the events at the time of last observation was resolving.  Information about lot/batch number has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate decreased, Hypotension, Swelling face
Clinical narrative: shortness of breath; Low heart rate at 38 to 45; facial swelling; cough; low blood pressure 98/52 - 98/50; generalized weakness; This is a spontaneous report from a contactable other Healthcare professional (patient) reported for himself. A 57-years-old male patient received an unknown 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 57 years) as dose number unknown, single for COVID-19 immunization. The patient did not have any relevant medical history, concurrent conditions, relevant past drug history and known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Jun2021 at 15:00 pm, the patient experienced low heart rate at 38 to 45, low blood pressure 98/52 - 98/50, generalized weakness, facial swelling, cough, shortness of breath. The patient was not hospitalized for the events. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests which included blood pressure measurement: low (98/52 - 98/50) and heart rate: low (38 to 45) on 06Jun2021. The patient received treatment with Amoxicillin, Benadryl, bedrest and oral hydration. The device date was reported as 27Jun2021. The outcome of the events at the time of last observation was resolving.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Presyncope, Ultrasound scan
Clinical narrative: almost fainted; This is a spontaneous report from a contactable consumer or other non hcp   A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number was not reported), via an unspecified route of administration on unspecified date as dose 1, single dose for covid-19 immunization. The patient medical history and concomitant medication was not reported. On an unknown date, the patient was almost fainted.The reporter stated that his half-sister had a strange side effect after Pfizer, don't know when she got the Pfizer vaccine, when she got the first dose, she almost fainted and she was taken to the hospital and her boyfriend (patient) had same effects. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dyspnoea, Fatigue, Headache
Clinical narrative: Tired/Fatigue; Headache; fever; shortness of breath; pain in the arms and shoulder; pain in the arms and shoulder; numbness; weakness; This is a spontaneous report from a contactable consumer (patient). A 42-years-old non pregnant female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EW0187, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 07May2021 11:15 as DOSE 1, SINGLE for covid-19 immunization at Pharmacy or Drug Store. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. On 18May2021, the patient experienced headache, fever, miserable condition because of shortness of breath, pain in the arms and shoulder, numbness, weakness, tired/fatigue. Since the vaccination, the patient had not been tested for COVID-19. The patient did not visit hospital due to the events. The case is considered to be non-serious. The patient was treated for fever and pain in the arms and shoulder with ibuprofen. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Pyrexia
Clinical narrative: Tired/Fatigue; Headache; fever; shortness of breath; pain in the arms and shoulder; pain in the arms and shoulder; numbness; weakness; This is a spontaneous report from a contactable consumer (patient). A 42-years-old non pregnant female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EW0187, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 07May2021 11:15 as DOSE 1, SINGLE for covid-19 immunization at Pharmacy or Drug Store. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. On 18May2021, the patient experienced headache, fever, miserable condition because of shortness of breath, pain in the arms and shoulder, numbness, weakness, tired/fatigue. Since the vaccination, the patient had not been tested for COVID-19. The patient did not visit hospital due to the events. The case is considered to be non-serious. The patient was treated for fever and pain in the arms and shoulder with ibuprofen. The outcome of the events was not recovered.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Back pain, Feeling abnormal, Headache, Tremor
Clinical narrative: the back and left side of her head hurts like she has a knot, but he doesn't feel anything there; the back and left side of her head hurts like she has a knot, but he doesn't feel anything there; the back and left side of her head hurts like she has a knot, but he doesn't feel anything there; getting the shakes; her arthritis got worse from the back of her hand to her neck and the back of her jaw; This is a spontaneous report from a contactable consumer (patient's husband). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID 19 VACCINE) via an unspecified route of administration on the left arm on 24Jun2021 between 12:10 and 12:15 PM (Batch/Lot Number: EW0187; Expiration Date: 31Aug2021) at the age of 65-year-old as 0.3 ml dose for COVID-19 immunization. Medical history included cardiac failure congestive from 2008, chronic obstructive pulmonary disease (COPD) from an unknown date, asthma from an unknown date, diabetes mellitus and it was diagnosed maybe 2 or 3 years ago, the reporter stated that the patient previously was prediabetic and now she was diabetic, pacemaker received in 2017, arthritis and the patient already had COVID and was hospitalization from 05Apr2021 to 10 Apr2021. Investigation assessment was none. The patient was on a wait list for the valve. The patient taken Pfizer BioNtech COVID-19 vaccine as her primary doctor wanted her to receive it because she already had underlying conditions. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional vaccines administration on same date of the Pfizer suspect was none. The patient did not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. AEs following prior vaccinations was none. Family medical history relevant to AEs was none. Concomitant medication included warfarin for mechanical valve from 2009. On 24Jun2021 at 12:13 PM, a couple minutes later after vaccine, the patient started getting the shakes, the patient already had arthritis, and when they got home her arthritis had gotten worse from the back of her hand to her neck and the back of her jaw about an hour after they got home from the place. On 25Jun2021 at 03:00 AM, the patient started saying the back and left side of her head hurts like she had a knot, she could not lean on the left side of her hand because it hurts, but reporter doesn't feel anything there. Reporter states the shakes started a minute or 2 after the shot. The patient stated the shakes came and gone and she shakes really bad. The reporter was told by other people that shakes was one of the side effects. The second and dose of BNT162B2 for patient will on 15Jul2021. The events was not result in emergency room and visit physician office. Relevant test was none. The outcome of events was not recovered.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood count, Blood test, Chest scan, Computerised tomogram, Investigation
Clinical narrative: the area of injection remained painful; Having swollen feet and swollen hands and it never subsided; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 23Feb2021 10:20 (Batch/Lot Number: EN6203) at the age of 48-years-old, at single dose for covid-19 immunisation. Medical history included biopsy, and allergenic. Patient did not have vaccines prior vaccination within 4 weeks. Patient had no other medical history of illness, had no medical history. The patient's concomitant medications were not reported. The patient experienced having swollen feet and swollen hands and it never subsided and also the area of injection remained painful for about 6 to 8 weeks (medically significant) in Feb2021. Patient was currently taking prednisone for swollen feet which was triggered by, may be immune vaccine and viral and something like that, historically that's what, its caused for triggered by that, was patient's experience. The patient underwent lab tests and procedures which included blood count was normal on 08May2021, blood test was little lowers, potassium level in blood matter, chest scan to make sure that there was no blood clot and was unknown results, CT scan (computerised tomogram) was no fluid or excess on 17May2021, Antigen test to make sure that there was no blood clot and was unknown results, MRI (magnetic resonance imaging) was unknown results on 08May2021, urine analysis all of patient's blood count patient's hematology was unknown results on 08May2021. Therapeutic measures were taken as a result of events. Patient was given topical medication diphenhydramine hydrochloride (BENADRYL) and ointment for anti-infection ointment and was given recently, patient received prednisone, it was for auto immune reaction. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Peripheral swelling, Urine analysis, Vaccination site pain
Clinical narrative: the area of injection remained painful; Having swollen feet and swollen hands and it never subsided; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 23Feb2021 10:20 (Batch/Lot Number: EN6203) at the age of 48-years-old, at single dose for covid-19 immunisation. Medical history included biopsy, and allergenic. Patient did not have vaccines prior vaccination within 4 weeks. Patient had no other medical history of illness, had no medical history. The patient's concomitant medications were not reported. The patient experienced having swollen feet and swollen hands and it never subsided and also the area of injection remained painful for about 6 to 8 weeks (medically significant) in Feb2021. Patient was currently taking prednisone for swollen feet which was triggered by, may be immune vaccine and viral and something like that, historically that's what, its caused for triggered by that, was patient's experience. The patient underwent lab tests and procedures which included blood count was normal on 08May2021, blood test was little lowers, potassium level in blood matter, chest scan to make sure that there was no blood clot and was unknown results, CT scan (computerised tomogram) was no fluid or excess on 17May2021, Antigen test to make sure that there was no blood clot and was unknown results, MRI (magnetic resonance imaging) was unknown results on 08May2021, urine analysis all of patient's blood count patient's hematology was unknown results on 08May2021. Therapeutic measures were taken as a result of events. Patient was given topical medication diphenhydramine hydrochloride (BENADRYL) and ointment for anti-infection ointment and was given recently, patient received prednisone, it was for auto immune reaction. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood disorder, Blood urine present, Haemorrhage urinary tract, Illness, Nasopharyngitis
Clinical narrative: passing blood clots; The blood looks like merlot wine; Lost 20 pounds; Painful; blood in urine/urinating blood; The vaccine is attacking kidneys; night sweats; colds; nauseated; sore arm; fever; sick; This is a spontaneous report from a contactable consumer.   A male patient (reporter's uncle) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced passing blood clots, the blood looks like merlot wine, lost 20 pounds, painful, blood in urine/urinating blood, the vaccine is attacking kidneys, night sweats, colds, nauseated, sore arm, fever, sick on an unspecified date.  The patient underwent lab tests and procedures which included weight: lost 20 pounds.  The outcome was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Night sweats, Pain, Pain in extremity, Pyrexia
Clinical narrative: passing blood clots; The blood looks like merlot wine; Lost 20 pounds; Painful; blood in urine/urinating blood; The vaccine is attacking kidneys; night sweats; colds; nauseated; sore arm; fever; sick; This is a spontaneous report from a contactable consumer.   A male patient (reporter's uncle) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced passing blood clots, the blood looks like merlot wine, lost 20 pounds, painful, blood in urine/urinating blood, the vaccine is attacking kidneys, night sweats, colds, nauseated, sore arm, fever, sick on an unspecified date.  The patient underwent lab tests and procedures which included weight: lost 20 pounds.  The outcome was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Renal disorder, Weight, Weight decreased
Clinical narrative: passing blood clots; The blood looks like merlot wine; Lost 20 pounds; Painful; blood in urine/urinating blood; The vaccine is attacking kidneys; night sweats; colds; nauseated; sore arm; fever; sick; This is a spontaneous report from a contactable consumer.   A male patient (reporter's uncle) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced passing blood clots, the blood looks like merlot wine, lost 20 pounds, painful, blood in urine/urinating blood, the vaccine is attacking kidneys, night sweats, colds, nauseated, sore arm, fever, sick on an unspecified date.  The patient underwent lab tests and procedures which included weight: lost 20 pounds.  The outcome was unknown.  Information about lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Feeling abnormal, Insomnia, Poor peripheral circulation, Vascular pain
Clinical narrative: left leg is struggling again with circulation; cant sleep; heart hurts; viens hurt so bad; Feels like choking on blood/ Feels like it skips a beat once every 30 minutes; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 25May2021 12:00 PM (Lot Number: EW0178) (at age of 22-year-old, not pregnant at time of vaccination) as single dose for covid-19 immunisation. Medical history included Hashimotos, Elhers Danlos, Raynaud's.     The patient received Other medications within 2 weeks of vaccination. The patient previously took first dose of BNT162B2 on 04May2021 12:00 PM (lot number: EL9269) (at age of 22-year-old) administered in Arm Left for covid-19 immunisation and experienced dizzy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient took dose 2 anyway out of FOMO, first 3 days great. In May2021, start to notice the left leg was struggling again with circulation. Viens hurt so bad that she could not make it more than a mile into her daily hike. Taking tons of antioxidants, even more tumeric. Day 7 wind up in ER because her heart hurts and she could not sleep. Feels like it skips a beat once every 30 minutes. Sent home. Day 11 ER again. Feels like choking on blood. No treatment received for AE. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, was the patient did not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. Event outcome was recovering.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Nausea, Pyrexia, Vision blurred
Clinical narrative: lost her hearing briefly for few minute this morning; Blurry vision; Fever; Nauseous/ she was sick to her stomach and she was afraid she would throw up; This is a spontaneous report from a contactable consumer. This consumer reported for a 15-year-old female patient (reporter's daughter) And This is the first case of 2 split cases.  A 15-year-old female adolescent patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8729, Expiration date: 31July2021), via unspecified route, administered in right arm on 26Jun2021 09:30 am(at the age of 15-year-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  On 26Jun2021, after the vaccination in the night, the patient experienced Fever, Nauseous, she was sick to her stomach and she was afraid she would throw up. And on 27Jun2021 the patient experienced Blurry vision, lost her hearing briefly for few minutes this morning, no treatment options were used. Reported said that this is kind of a different side effect, she did read that someone had blurred vision, but she said she also lost her hearing. The event deafness assessed the as serious. The outcome of the events blurred vision was unknown, pyrexia and nausea are not recovered and deafness is recovered in 2021.  No follow-up attempts possible. No further information expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Skin reaction
Clinical narrative: I am getting like shingles and now I am getting like some other skin issues; then also like I get almost like all over shingles at 30; I am getting like shingles and now I am getting like some other skin issues; then also like I get almost like all over shingles at 30; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8736), via an unspecified route of administration in upper left arm on 19May2021 (at the age of 31 years old) as single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8731), via an unspecified route of administration in upper left arm on 28Apr2021 (at the age of 31 years old) for covid-19 immunisation. The patient medical history was not reported. Family medical history related to adverse event: Reporter stated that not that he know of and they just took the vaccine and never had any of that. Concomitant medications included gabapentin; lisdexamfetamine mesilate (VYVANSE) for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Reporter stated that on 28May2021, after application he had little side effect for like all over a month now, he is not sure why they and know they gave him since second dose from the vaccine and he getting like shingles and now getting like some other skin issues and then also like he get almost like all over shingles at 30. He never had shingles before never really had or anything else like elementary school almost 32 now, like last when he had a hearty look like a long time. For treatment consumer stated for like shingles and stuff, they haven't really gave him anything for it. He knew they keep try to give him antibiotic so that it can do any good. No treatment was received for the event. The outcome of events was unknown.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea, Pyrexia, Vomiting, Wheezing
Clinical narrative: low grade fever of 99.8; nauseous; feeling bad; vomiting; wheezy; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0181) via an unspecified route of administration on 23Jun2021 as dose 1 single (at the age of 39-year-old) for COVID-19 immunization. Medical history included tested COVID positive approximately 90 days prior to receiving the vaccine. Concomitant medications were not reported.  It was reported that approximately one hour after receiving their first dose of Pfizer's COVID-19 vaccine they started feeling bad, started vomiting and was wheezy on 23Jun2021. On 24Jun2021 (next day), patient started running low grade fever of 99.8 and feeling nauseous. Patient's daughter also felt ill. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021791241 Same reporter/ drug, different patients/ events
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test
Clinical narrative: felt ill; This is a spontaneous report from a contactable consumer (parent reported for her daughter). A 17-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0181), via an unspecified route of administration on 23Jun2021 (at the age of 17-year-old) at a dose 1, single for COVID-19 immunization. The patient medical history included COVID-19 (in course of conversation reporter found out that both of them tested COVID positive approximately 90 days prior to receiving the vaccine). The patient concomitant medications were not reported. The patient felt ill on an unspecified date in Jun2021. Approximately one hour after receiving their first dose of Pfizer COVID-19 vaccine patient felt ill. The patient underwent lab tests and procedures which included COVID-19 test was positive on an unspecified date. Outcome of the event was unknown.  Follow up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021791190 Same reporter/ drug, different patients/ events
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: fever; extreme fatigue; This is a spontaneous report from a contactable consumer (patient). A 52-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER8735), via an unspecified route of administration in left arm on 07May2021 at 12:15 PM (at the age of 52-year-old) as first dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was allergic to Bactrim. 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 an unspecified date in May2021, the patient experienced extreme fatigue and fever for 3 days. The outcome of the events was recovered on an unspecified date in May2021.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial flutter, Chest pain, Heart rate increased, Myocarditis, SARS-CoV-2 test
Clinical narrative: Suspected heart inflammation; high heart rate; chest pain; palpation; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0183) via an unspecified route of administration in Arm Right on 11Jun2021 12:45(at the age of 37 years old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication the patient received within 2 weeks of vaccination included metoprolol tartrate (METOPROLOL TARTRATE) taken for an unspecified indication. The patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot no: EW0183) via unspecified route of administration on 24May2021 as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID. Prior to vaccination the patient was diagnosed with COVID-19. The patient experienced suspected heart inflammation, high heart rate, chest pain, and palpation on 12Jun2021 10:00. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event was colchicine. Since the vaccination the patient has not tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. Outcome of the events not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Migraine, Pain, Pyrexia
Clinical narrative: Pain was just killing me/Body aches; Extreme headache to migraine; Extreme headache to migraine; Experiencing fever of 99.6 yesterday, this morning I am experiencing 99.5; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 22-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0181 and Expiry date: Unknown), via an dose 2 intramuscular, administered in Arm Right on 20Jun2021 08:40 (at the age of 22-years-old) as Dose 2, Single for Covid-19 immunization.The patient medical history was not reported. Concomitant medication(s) included ergocalciferol (VIT D) taken for an unspecified indication from an unspecified start date and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jun2021, after 6 days of vaccination, the patient experienced pain was just killing me, extreme headache to migraine, experiencing fever of 99.6 yesterday, this morning i am experiencing 99.5, body aches. Therapeutic measures were taken as a result of pain was just killing me (pain) treatment included: took Ibuprofen 400 mg, 2 tablets, so they were 200 mg per tablet, but I took 2 because the pain was just killing. The outcome of events was not resolved.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Hallucination, Muscle spasms, Seizure
Clinical narrative: Convulsions; Hallucinations; cramping; Chest pain; This is a spontaneous report from a contactable consumer or other non health professional (parent).  A female patient of an unspecified age received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on 25Jun2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 via unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. It was reported that, reporter daughter was given a second shot today (25Jun2021) of Pfizer and it's now about 4 hours since she was given the shot and she had reacted to the shot having convulsions, hallucinations and cramping, chest pains and all that. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Weight, Weight decreased
Clinical narrative: Diarrhea; lost weight since the shot; This is a spontaneous report from a contactable consumer (patient). This 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 19May2021 11:00 (Lot Number: EW0182) (at age of 57 years old) as single dose for covid-19 immunisation. Medical history included covid-19 from Oct2020 to Oct2020. The patient's concomitant medications was none (reported as other products was no). The patient was calling about Covid shot that she had received. From the first one to the second shot she had run into a lot of health issues since the shots. She had covid prior to getting the shots, she had covid in Oct 2020. She could not keep anything in her body and had lost weight since the shot in 2021. Every time she ate anything it went right through her body, like she had diarrhea. This started after the first dose. This was ongoing and persisting. The events required physician office. Additional vaccines administered on same date of the Pfizer suspect was none. Prior vaccinations (within 4 weeks) was none aside from first dose. AEs following prior vaccinations was none. Family medical history relevant to AEs was no. Events outcome was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Impaired work ability
Clinical narrative: Unexplained chronic lower back pain which started 5-6 days after the second injection and has not resolved; now unable to do anything; This is a spontaneous report from a contactable consumer (patient).   A 49-years-old non-pregnant female (not pregnant at the time of vaccination) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0168, Pfizer NTEC), via an unspecified route of administration in left arm on 20May2021 (at the age of 49-years-old) as dose 2, single for covid-19 immunization. The most recent COVID-19 vaccine was administered: School or Student Health Clinic. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0176), via an unspecified route of administration in right arm on 26Apr2021 as dose 1, single for covid-19 immunization. The patient did not receive any other medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date on 2021, the patient experienced unexplained chronic lower back pain which started 5-6 days after the second injection and has not resolved. No other trigger. She was an extremely active person and now unable to do anything. She wished she would have never taken this vaccine. The event was reported as serious (disabling/ incapacitating). Treatment included chiropractic care, awaiting patient to begin. The outcome for the events were not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chillblains
Clinical narrative: Chillblains/Pernio following administration of rituximab concomitant to vaccination; This is a spontaneous report from a contactable Physician. A 47-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: EL3249), dose 2 intramuscular, administered in left arm on 20Jan2021 as 2nd dose, single for COVID-19 immunization (at the age of 47-years). Patient's medical history included rheumatoid arthritis and diabetes mellitus. Concomitant medications included rituximab. The patient previously took lisinopril, norvasc and clinoril and experienced drug hypersensitivity. Prior to vaccination, the patient was not diagnosed with COVID-19 and was not tested Covid-19 post vaccination. Patient Historical vaccine includes received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: EK9231), via intramuscular, administered in left arm on 30Dec2020, as a single dose for covid-19 immunization. On an unspecified date in Jan2021, the patient experienced chillblains/pernio following administration of rituximab concomitant to vaccination. Patient had Doctor visit and received steroid cream as a treatment for adverse event. The outcome of event was recovered on an unspecified date.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness for few weeks after the 2nd shot; This is a spontaneous report from a non-contactable consumer or other non-HCP (patient). A 45-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 45-years-old) as dose 2, single for covid-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, esomeprazole sodium (NEXIUM) taken for an unspecified indication, fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, vitamin c [ascorbic acid] (VITAMIN C) taken for an unspecified indication and probiotics taken for an unspecified indication. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation and within 5 minutes experienced severe, dizziness, lightheaded tingling, hot cold flashes all lasting 15-20 minutes, the next 24hrs extreme tiredness. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. After the second shot of the vaccine, the patient experienced arm soreness for few weeks. The patient not received treatment for the adverse event. The clinical outcome of the arm soreness for few weeks after the 2nd shot was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Flushing, Heart rate increased, Nausea
Clinical narrative: Vertigo; Severe dizziness / Light headedness if I get my heart rate up; Nausia; Body flushing if I lay my head down or turn my head quickly; Shortness of breath; Get my heart rate up; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0179) via an unspecified route of administration in left arm on 05May2021 at 15:00 (age at vaccination 54-year-old) at single dose for covid-19 immunization. Patient medical history included Meniere's Disease. The patient's concomitant medications included unspecified medications. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously took Levaflozin and had allergy. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0169) on 14Apr2021 (age at vaccination 54-year-old) in left arm as single dose for Covid-19 Immunization. The patient previously took the shingles vaccine and experienced shortness of breath, nausea, light headedness, vertigo, flushing and heart rate increased. Patient have Menieres Disease. Prior to the vaccine, patient not had vertigo or severe dizziness for over 6 months. On 12May2021 at 15:00, one week after second shot patient had 2 bad cases of vertigo within 2 days of each other. Patient was put on Prednisone 2 weeks after the shot to calm the reaction. Patient continued to experience nausea, dizziness, and body flushing if she lays her head down or turn her head quickly. She also experienced shortness of breath, nausea, and light headedness if she gets her heart rate up. Patient experienced this same reaction after the shingles vaccine. It lasted 12 weeks. She was hoping for the same and she was currently 6 weeks out. Adverse events resulted into Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a resukt of events with prednisone. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; Severe dizziness / Light headedness if I get my heart rate up; Nausia; Body flushing if I lay my head down or turn my head quickly; Shortness of breath; Get my heart rate up; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0179) via an unspecified route of administration in left arm on 05May2021 at 15:00 (age at vaccination 54-year-old) at single dose for covid-19 immunization. Patient medical history included Meniere's Disease. The patient's concomitant medications included unspecified medications. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously took Levaflozin and had allergy. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0169) on 14Apr2021 (age at vaccination 54-year-old) in left arm as single dose for Covid-19 Immunization. The patient previously took the shingles vaccine and experienced shortness of breath, nausea, light headedness, vertigo, flushing and heart rate increased. Patient have Menieres Disease. Prior to the vaccine, patient not had vertigo or severe dizziness for over 6 months. On 12May2021 at 15:00, one week after second shot patient had 2 bad cases of vertigo within 2 days of each other. Patient was put on Prednisone 2 weeks after the shot to calm the reaction. Patient continued to experience nausea, dizziness, and body flushing if she lays her head down or turn her head quickly. She also experienced shortness of breath, nausea, and light headedness if she gets her heart rate up. Patient experienced this same reaction after the shingles vaccine. It lasted 12 weeks. She was hoping for the same and she was currently 6 weeks out. Adverse events resulted into Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a resukt of events with prednisone. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.