chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure systolic increased, Dizziness, Heart rate increased, Lymphadenopathy, Peripheral swelling
Clinical narrative: faint; Dizziness; tachycardia; BP sys: 160; HR 120+,; This is a spontaneous report from a contactable consumer (patient himself). A 25-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration on 22Jan2021 10:00 at single dose in left arm for COVID-19 immunization. The patient previously took diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) on an unspecified date for immunization and had had reaction to this vaccine with swelling of arm and surrounding lymph nodes. The patient had no other medical history was reported. The patient's concomitant medications were none. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient experienced dizziness, tachycardia, BP sys (systolic blood pressure): 160, HR 120+, and faint on 22Jan2021 10:30 and events result in Emergency room/department or urgent care. The outcome of the events was recovering.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Tachycardia
Clinical narrative: faint; Dizziness; tachycardia; BP sys: 160; HR 120+,; This is a spontaneous report from a contactable consumer (patient himself). A 25-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration on 22Jan2021 10:00 at single dose in left arm for COVID-19 immunization. The patient previously took diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) on an unspecified date for immunization and had had reaction to this vaccine with swelling of arm and surrounding lymph nodes. The patient had no other medical history was reported. The patient's concomitant medications were none. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient experienced dizziness, tachycardia, BP sys (systolic blood pressure): 160, HR 120+, and faint on 22Jan2021 10:30 and events result in Emergency room/department or urgent care. The outcome of the events was recovering.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Peripheral swelling, Ultrasound scan abnormal
Clinical narrative: swollen left calf that was DVT, deep vein thrombosis; This is a spontaneous report from a contactable Other Health Professional.  A 49-year-old male patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3248), via an unspecified route of administration on 11Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history included hypothyroidism and high cholesterol. Patient had no known allergy. No COVID prior vaccination. No COVID tested post vaccination.  Historical vaccine included 1st dose of bnt162b2 (lot: EK5730) via intramuscular on 23Dec2020 at 15:30 at single dose on left arm for COVID-19 immunisation. Concomitant medication included levothyroxine and atorvastatin. 1 week after receiving the 2nd dose, patient woke up with a swollen left calf. Ultrasound the same day (19Jan2021) showed that was DVT, deep vein thrombosis. Patient started taking apixaban (ELIQUIS) (blood thinner) the same day. Event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the event was resolving.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Pericardial effusion, Viral infection
Clinical narrative: took 1st dose of Covid vaccine and then ended up in the hospital with fluid around her heart; took 1st dose of Covid vaccine and then ended up in the hospital with fluid around her heart which they said came out to be a virus; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program.  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)on 09Jan2021 at single dose for COVID-19 immunization.  The patient medical history included lost her taste and had a low grade fever. Concomitant medications were not reported.  This patient reported for a day and a half she lost her taste and had a low grade fever. So she went the next week (date unspecified) and was tested 2 times and came out negative (clarification of test type not provided). So on 09Jan2021 she got her first dose of the vaccine. On 14Jan2021 she ended up in the hospital with fluid on her heart which they said came out to be a virus. Outcome of the event was unknown.She was due for her second dose of the vaccine on 30Jan2021. Patient called to ask if she should or should not still get the second shot as scheduled. Information about batch/lot number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Dysarthria, Dysgeusia, Loss of consciousness, Migraine
Clinical narrative: black outs; Severe migraine; full body shakes; soured; delayed jumbled speech; loss of memory; nausea; motor control issues; This is a spontaneous report from a contactable consumer reported for herself. A 31-year-old female patient (not pregnant at the time of vaccination and event onset) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL3249, via an unspecified route of administration on 25Jan2021 10:00AM at single dose in right arm for covid-19 immunization, immunized in hospital. Medical history included obesity, anxiety, post-traumatic stress disorder (PTSD), insomnia, allergy to walnuts pecans. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), clonidine, fish oil and multi vitamin. The patient previously received the first dose of bnt162b2 lot number: EL1284, on 04Jan2021 12:00 PM at single dose in left arm for COVID-19 immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously also received morphine and codeine, experienced allergy. The patient experienced sever migraine, black outs, full body shakes, soured, delayed jumbled speech, loss of memory, nausea and motor control issues, from 26Jan2021 11:30 PM. The events resulted in emergency room/department or urgent care. It was unknown if treatment was received. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19. The case was reported as non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Motor dysfunction, Nausea, Speech disorder, Tremor
Clinical narrative: black outs; Severe migraine; full body shakes; soured; delayed jumbled speech; loss of memory; nausea; motor control issues; This is a spontaneous report from a contactable consumer reported for herself. A 31-year-old female patient (not pregnant at the time of vaccination and event onset) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL3249, via an unspecified route of administration on 25Jan2021 10:00AM at single dose in right arm for covid-19 immunization, immunized in hospital. Medical history included obesity, anxiety, post-traumatic stress disorder (PTSD), insomnia, allergy to walnuts pecans. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), clonidine, fish oil and multi vitamin. The patient previously received the first dose of bnt162b2 lot number: EL1284, on 04Jan2021 12:00 PM at single dose in left arm for COVID-19 immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously also received morphine and codeine, experienced allergy. The patient experienced sever migraine, black outs, full body shakes, soured, delayed jumbled speech, loss of memory, nausea and motor control issues, from 26Jan2021 11:30 PM. The events resulted in emergency room/department or urgent care. It was unknown if treatment was received. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19. The case was reported as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dementia, Quarantine, SARS-CoV-2 test positive
Clinical narrative: tested positive for covid-19; tested positive for covid-19; Dementia; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for her sister that a 73-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization.  The medical history and concomitant medications were not reported. The patient had tested positive for the third time for the COVID virus. The patient had Dementia in Jan2021. The patient had first dose of BNT162B2 on 03Jan2021 and tested positive for COVID on 18Jan2021. Patient was scheduled for the second dose for Thursday 28Jan2021. Since patient had an active case with symptoms the reporter was assuming patient won't get the second dose on 28Jan2021. Since patient had already had the first dose, currently in quarantine until after 01Feb, the reporter wanted to know if patient would have to start all over with getting the vaccine. The patient underwent lab tests and procedures, which included COVID virus positive twice on an unknown date, positive once on 18Jan2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest pain; This is a spontaneous report from a non-contactable Consumer.   A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 23Jan2021 at single dose for covid-19 immunization. The patient medical history was not reported.  There were no concomitant medications.  The patient experienced chest pain on 24Jan2021 . The patient was hospitalized for chest pain on an unknown date.    No follow up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Headache, Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: her face got swollen; lymph node right there it was extremely swollen and very tender and very painful; She had a lump at the site of the injection; chills; headache; flu like symptoms; This is a spontaneous report from a contactable consumer.  A 60-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot # EL8982) vaccine  , via an unspecified route of administration on  20Jan2021 at single dose  for covid-19 immunisation .  Medical history included hypertension.  Concomitant medication included telmisartan (MICARDIS). On 30Dec2021 the patient received the first dose of BNT162B2 vaccine. The patient experienced her face got swollen on an unspecified date with outcome of unknown , lymph node right there it was extremely swollen and very tender and very painful  on an unspecified date with outcome of unknown , she had a lump at the site of the injection  on an unspecified date with outcome of unknown , chills on an unspecified date with outcome of unknown , headache  on an unspecified date with outcome of unknown , flu like symptoms  on an unspecified date with outcome of unknown. The events swollen face and lymph adenopathy were considered important medical Events. The remaining events were considered non serious. The patient stated she got the second vaccine shot of Pfizer on Wednesday the 20Jan2021. She got like a weird side effect like under her armpit it got really swollen and painful, like the lymph node right there it was extremely swollen and very tender and very painful. It still is but not as much. The next day  the right side of her face was swollen   The patient received Tylenol as treatment for the events.  Follow up information has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Lymphadenopathy, Swelling face, Tenderness
Clinical narrative: her face got swollen; lymph node right there it was extremely swollen and very tender and very painful; She had a lump at the site of the injection; chills; headache; flu like symptoms; This is a spontaneous report from a contactable consumer.  A 60-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot # EL8982) vaccine  , via an unspecified route of administration on  20Jan2021 at single dose  for covid-19 immunisation .  Medical history included hypertension.  Concomitant medication included telmisartan (MICARDIS). On 30Dec2021 the patient received the first dose of BNT162B2 vaccine. The patient experienced her face got swollen on an unspecified date with outcome of unknown , lymph node right there it was extremely swollen and very tender and very painful  on an unspecified date with outcome of unknown , she had a lump at the site of the injection  on an unspecified date with outcome of unknown , chills on an unspecified date with outcome of unknown , headache  on an unspecified date with outcome of unknown , flu like symptoms  on an unspecified date with outcome of unknown. The events swollen face and lymph adenopathy were considered important medical Events. The remaining events were considered non serious. The patient stated she got the second vaccine shot of Pfizer on Wednesday the 20Jan2021. She got like a weird side effect like under her armpit it got really swollen and painful, like the lymph node right there it was extremely swollen and very tender and very painful. It still is but not as much. The next day  the right side of her face was swollen   The patient received Tylenol as treatment for the events.  Follow up information has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: patient was pregnant while taking BNT162B2; patient was pregnant while taking BNT162B2; Miscarriage 11 days post vaccine; This is a spontaneous report from a contactable Nurse. A 39-year-old female nurse reported that she received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL0142), into the left arm on 28Dec2020 at 07:30 AM at single dose for COVID-19 immunization. Medical history included asthma and eosinophilic esophagitis and allergies to Keflex ASA. Concomitant drugs were none. At the time of vaccination the patient was pregnant, her last menstrual date was on 20Nov2020, gestational period 6. The patient reported that on 08Jan2021 at 12:00 PM she had miscarriage 11 days post vaccine. The patient was seen at Doctor or other healthcare professional office/clinic visit. At the time of reporting the patient was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported miscarriage.  However, information is limited, and miscarriage is multifactorial event.  In the general population, the estimated background risk of miscarriage in clinically recognized pregnancies is 15% to 20%. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Headache, Injection site pain
Clinical narrative: diarrhea (7+ loose stools each day starting on this day); headache; severe nausea; worsened muscle pain; new joint pain morning after (Included in aforementioned, but significant stiff neck.); new joint pain morning after (Included in aforementioned, but significant stiff neck.); fatigue/malaise; fatigue/malaise; This is a spontaneous report from a contactable other HCP report for self. This 30-year-old not pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302) Intramuscular at left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included Asthma, anxiety, allergies to Acetaminophen (seizure like activity and fainting). No COVID prior vaccination. No other vaccine in four weeks. Other medications in two weeks includes fluoxetine, lorazepam, and Ibuprofen. Patient received first dose of bnt162b2 (lot number: EL0140) on 30Dec2020 and experienced injection sight tenderness, severe headache and fatigue. On 20Jan2021 5:00 PM after the second dose, patient experience headache, severe nausea, diarrhea (7+ loose stools each day starting on this day), worsened muscle pain several hours later, new joint pain morning after (Included in aforementioned, but significant stiff neck), fatigue/malaise. Patient received Ibuprofen and rest, supportive care due to events. The outcome of event was not recovered. Rapid Nasal Swab tested Negative on 21Jan2021.; Sender's Comments: The reported event diarrhea was likely causally related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship, and considering no alternative cause reported currently.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, SARS-CoV-2 test negative
Clinical narrative: diarrhea (7+ loose stools each day starting on this day); headache; severe nausea; worsened muscle pain; new joint pain morning after (Included in aforementioned, but significant stiff neck.); new joint pain morning after (Included in aforementioned, but significant stiff neck.); fatigue/malaise; fatigue/malaise; This is a spontaneous report from a contactable other HCP report for self. This 30-year-old not pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302) Intramuscular at left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included Asthma, anxiety, allergies to Acetaminophen (seizure like activity and fainting). No COVID prior vaccination. No other vaccine in four weeks. Other medications in two weeks includes fluoxetine, lorazepam, and Ibuprofen. Patient received first dose of bnt162b2 (lot number: EL0140) on 30Dec2020 and experienced injection sight tenderness, severe headache and fatigue. On 20Jan2021 5:00 PM after the second dose, patient experience headache, severe nausea, diarrhea (7+ loose stools each day starting on this day), worsened muscle pain several hours later, new joint pain morning after (Included in aforementioned, but significant stiff neck), fatigue/malaise. Patient received Ibuprofen and rest, supportive care due to events. The outcome of event was not recovered. Rapid Nasal Swab tested Negative on 21Jan2021.; Sender's Comments: The reported event diarrhea was likely causally related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship, and considering no alternative cause reported currently.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: localized injection site reaction: redness, swollen and warm to the touch; localized injection site reaction: redness, swollen and warm to the touch; localized injection site reaction: redness, swollen and warm to the touch; This is a spontaneous report from a contactable nurse. A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 21Jan2021 at SINGLE DOSE vaccine location: left arm, dose number:1 for covid-19 immunisation. Medical history and concomitant medications were none. The patient experienced localized injection site reaction: redness, swollen and warm to the touch on 23Jan2021 with outcome of not recovered considered as important medical event. The physician recommended Tylenol and cold compress as treatment. The action taken was not applicable. Caller works in an assisted living facility.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported vaccination site events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: swelling and significant bruise at injection site; swelling and significant bruise at injection site; This is a spontaneous report from two contactable nurses. A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), intramuscular into the left arm on 21Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant drugs were none. The patient developed swelling and a pretty significant bruise where the injection was given in her left arm. The caller noticed the bruise and swelling on 25Jan2021 but states it could be older. The events were reported as medically significant. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: A causal association between administration of BNT162B2 and the onset of vaccination site swelling and bruise cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray abnormal, Death, SARS-CoV-2 test positive, Unresponsive to stimuli
Clinical narrative: Xrays showed covid Poss pockets all in her lungs on 15Jan; Xrays showed covid Poss pockets all in her lungs on 15Jan; This is a spontaneous report from a contactable consumer. An 85-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunisation. Medical history included dementia. Concomitant medications were not reported. Patient popped hot 02Jan2021 along with 4 others on the hall she lived. Within 9 days 50+ patients were positive. All had the vaccine the same day. Patient was test positive on 02Jan2021. She was on day 12 of her quarantine when she started to get worse. She was unresponsive by 16Jan2021 and passed 18Jan2021. We were with her from 14Jan2021 to 18Jan2021. But had not been allowed to visit with her since Mar2020. And what post treatment pairs well with it? Publicly we hear Remdesivir and Bamlanivimab but these patients only received a general antibiotic and some vitamins. Death cause was Xrays showed covid Poss pockets all in her lungs on 15Jan2021. No autopsy was performed.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information; Reported Cause(s) of Death: Xrays showed covid Poss pockets all in her lungs on 15Jan
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Apparent life threatening event, Computerised tomogram abnormal, Computerised tomogram intestine, Death
Clinical narrative: bowel perforation; pain in her upper abdomen; This is a spontaneous report from a contactable consumer.   An 86-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2) at single dose on 13Jan2021 for Covid-19 immunisation, administerd at nursing home/senior living facility  Medical history included dementia, arthritis. No known allergies. Patient was not pregnant. Patient had not COVID prior vaccination. Concomitant medication in 2 weeks included: memantine (manufacturer unknown) 10 mg BID, diclofenac (manufacturer unknown) BID, carbidopa, levodopa (manufacturer unknown) 25-100 mg TID, quetiapine (manufacturer unknown) 12.5 mg q HS, escitalopram oxalate (LEXAPRO) 10 mg q HS, paracetamol (TYLENOL) 650 mg BID, glucosamine (manufacturer unknown) drink. The patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 24Dec2020 for Covid-19 immunisation. No other vaccine received in 4 weeks.  The patient experienced bowel perforation and pain in her upper abdomen on 18Jan2021 07:30. The events resulted in Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event), and death. On 18Jan2021 07:30 AM, less than a week after the second shot, she had pain in her upper abdomen and was taken to the ER on 18Jan2021. CT showed a bowel perforation in the small bowel. She had never had bowel surgery or diverticulitis. She had been healthy other than her dementia and arthritis. Patient received treatment for the events: hospice and pain management. COVID-19 was not tested post vaccination. The cause of death was bowel perforation.  An autopsy was not performed.  Information about lot/batch number has been requested.; Reported Cause(s) of Death: bowel perforation
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Intestinal perforation
Clinical narrative: bowel perforation; pain in her upper abdomen; This is a spontaneous report from a contactable consumer.   An 86-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2) at single dose on 13Jan2021 for Covid-19 immunisation, administerd at nursing home/senior living facility  Medical history included dementia, arthritis. No known allergies. Patient was not pregnant. Patient had not COVID prior vaccination. Concomitant medication in 2 weeks included: memantine (manufacturer unknown) 10 mg BID, diclofenac (manufacturer unknown) BID, carbidopa, levodopa (manufacturer unknown) 25-100 mg TID, quetiapine (manufacturer unknown) 12.5 mg q HS, escitalopram oxalate (LEXAPRO) 10 mg q HS, paracetamol (TYLENOL) 650 mg BID, glucosamine (manufacturer unknown) drink. The patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 24Dec2020 for Covid-19 immunisation. No other vaccine received in 4 weeks.  The patient experienced bowel perforation and pain in her upper abdomen on 18Jan2021 07:30. The events resulted in Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event), and death. On 18Jan2021 07:30 AM, less than a week after the second shot, she had pain in her upper abdomen and was taken to the ER on 18Jan2021. CT showed a bowel perforation in the small bowel. She had never had bowel surgery or diverticulitis. She had been healthy other than her dementia and arthritis. Patient received treatment for the events: hospice and pain management. COVID-19 was not tested post vaccination. The cause of death was bowel perforation.  An autopsy was not performed.  Information about lot/batch number has been requested.; Reported Cause(s) of Death: bowel perforation
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Computerised tomogram abdomen abnormal, Death, Intestinal perforation, Laboratory test
Clinical narrative: bowel perforation; pain in her upper abdomen; This is a spontaneous report from a contactable consumer.   An 86-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2) at single dose on 13Jan2021 for Covid-19 immunisation, administerd at nursing home/senior living facility  Medical history included dementia, arthritis. No known allergies. Patient was not pregnant. Patient had not COVID prior vaccination. Concomitant medication in 2 weeks included: memantine (manufacturer unknown) 10 mg BID, diclofenac (manufacturer unknown) BID, carbidopa, levodopa (manufacturer unknown) 25-100 mg TID, quetiapine (manufacturer unknown) 12.5 mg q HS, escitalopram oxalate (LEXAPRO) 10 mg q HS, paracetamol (TYLENOL) 650 mg BID, glucosamine (manufacturer unknown) drink. The patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 24Dec2020 for Covid-19 immunisation. No other vaccine received in 4 weeks.  The patient experienced bowel perforation and pain in her upper abdomen on 18Jan2021 07:30. The events resulted in Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event), and death. On 18Jan2021 07:30 AM, less than a week after the second shot, she had pain in her upper abdomen and was taken to the ER on 18Jan2021. CT showed a bowel perforation in the small bowel. She had never had bowel surgery or diverticulitis. She had been healthy other than her dementia and arthritis. Patient received treatment for the events: hospice and pain management. COVID-19 was not tested post vaccination. The cause of death was bowel perforation.  An autopsy was not performed.  Information about lot/batch number has been requested.; Reported Cause(s) of Death: bowel perforation
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Induration, Intensive care, Pulmonary embolism
Clinical narrative: my body collapsed and I had a Pulmonary embolism/I have clot in my lung; I have behind my knee like a deep wide black spot and it is hard; This is a spontaneous report from a contactable consumer (patient).  A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported.  The patient's concomitant medication included amlodipine, metformin and propranolol. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization and experienced severe headache and diarrhea. On 13Jan2021, the patient reported that: "my body collapsed, I had a pulmonary embolism. I had to go to the hospital in ambulance. When I was there, they find out that I have clot in my lung. I was in an intensive care for 2 days or 3 days and about 5 days in the hospital (from 13Jan2021 to 17Jan2021). I have behind my knee like a deep wide black spot and it is hard, my body did not have anything like that". Therapeutic measures were taken as a result of event pulmonary embolism/ clot in lung and included treatment with "some medications", one of which ELIQUIS. The patient outcome of pulmonary embolism and "clot in lung" was recovered on an unspecified date and of deep wide black spot was unknown.  The information on the batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: my body collapsed and I had a Pulmonary embolism/I have clot in my lung; I have behind my knee like a deep wide black spot and it is hard; This is a spontaneous report from a contactable consumer (patient).  A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported.  The patient's concomitant medication included amlodipine, metformin and propranolol. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization and experienced severe headache and diarrhea. On 13Jan2021, the patient reported that: "my body collapsed, I had a pulmonary embolism. I had to go to the hospital in ambulance. When I was there, they find out that I have clot in my lung. I was in an intensive care for 2 days or 3 days and about 5 days in the hospital (from 13Jan2021 to 17Jan2021). I have behind my knee like a deep wide black spot and it is hard, my body did not have anything like that". Therapeutic measures were taken as a result of event pulmonary embolism/ clot in lung and included treatment with "some medications", one of which ELIQUIS. The patient outcome of pulmonary embolism and "clot in lung" was recovered on an unspecified date and of deep wide black spot was unknown.  The information on the batch number has been requested.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Back injury, Constipation, Dizziness, Fall, Syncope
Clinical narrative: I faint anf fell twice hurt my back once; I faint anf fell twice hurt my back once; hurt my back once; Dizzy spells; Constipation; This is a spontaneous report from a contactable consumer (patient). A 91-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via an unspecified route of administration in Jan2021 (a week before reporting) at single dose in left shoulder for COVID-19 immunisation. Age at vaccination was 91 years. The patient's medical history and concomitant medications were not reported. About 24 hours after shot he started having some dizzy spells and then fainted and fell a couple of times and hurt his back once. He stated he also had had constipation since the shot and do not know if that is related or not. The patient wanted to talk to see if he could get his second shot. He is taking some pain killers for his back. With regards to Physician Office/ Emergency Room: patient stated, 'This for my back and nothing else of that'. The outcome of the events was unknown.  The information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Dizziness, Fatigue, Lymphadenopathy
Clinical narrative: tongue is a lot swollen; Dizziness; Nausea; feeling weak; tired and washed out; swollen glands; This is a spontaneous report from a contactable consumer.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at single dose for COVID-19 immunisation.  The patient medical history and the concomitant medications were not reported. The patient was experiencing dizziness and right after the vaccine had dizziness and nausea. She said that the nausea went away after eating something. She said that he also feels like his tongue was swollen. The patient said that he feels like his tongue is a lot swollen. He stated that he had the shot 4 hours and when he gets up off of the chair, he can barely stand up because he is so dizzy. He said that he is also feeling weak, tired, and washed out. He said that he also has swollen glands. The event tongue is a lot swollen was serious as Life threatening, and Emergency Room Visit and Physician Office Visit. The outcome was unknown.  Information on the Batch/Lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Swollen tongue
Clinical narrative: tongue is a lot swollen; Dizziness; Nausea; feeling weak; tired and washed out; swollen glands; This is a spontaneous report from a contactable consumer.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at single dose for COVID-19 immunisation.  The patient medical history and the concomitant medications were not reported. The patient was experiencing dizziness and right after the vaccine had dizziness and nausea. She said that the nausea went away after eating something. She said that he also feels like his tongue was swollen. The patient said that he feels like his tongue is a lot swollen. He stated that he had the shot 4 hours and when he gets up off of the chair, he can barely stand up because he is so dizzy. He said that he is also feeling weak, tired, and washed out. He said that he also has swollen glands. The event tongue is a lot swollen was serious as Life threatening, and Emergency Room Visit and Physician Office Visit. The outcome was unknown.  Information on the Batch/Lot number has been requested.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: get sick from the flu vaccine; Initial information received on 29-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer (patient).  This case involves a patient of an unknown age and gender who was sick (illness), while he/she received INFLUENZA VACCINE.  The patient's medical treatments, vaccinations, concomitant medications and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) (Unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/ events.  Medication Details and reason for taking the medicine: not provided.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for event illness.  There will be no information on the batch number for this case.
Age: 12.0
Sex: F
Vaccine: FLU3, FLUR4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A 12 year old received Flublok and not the prescribed Fluarix, no AE; A 12 year old received Flublok and not the prescribed Fluarix, no AE; Initial information regarding an unsolicited valid non-serious case was received from a Nurse via regulatory authority (Reference number- 00444333) and transmitted to Sanofi on 25-Jan-2021.  This case involves a 12 years old female patient who received 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2037, expiry: 30-Jun-2021) via unknown route in the right deltoid for prophylactic vaccination on 03-Nov-2020, instead of INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) (Wrong product administered and Product administered to patient of inappropriate age)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL), MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS) for prophylactic vaccination.  The Nurse reported that error was found out two months after administration.  It was a case of an actual medication error due to Inappropriate age at vaccine administration and Wrong vaccine administered (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 63.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: The patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Medical Information (Reference number- 00453109) and transmitted to Sanofi on 29-Jan-2021.  This case involves a 63 years old male patient who received 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot C5578AA, expiry date: 28-Jan-2021, injection) via intramuscular route in the left deltoid for prophylactic vaccination on 29-Jan-2021 (Expired product administered)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other vaccines.  It was a case of an actual medication error due to Expired vaccine used (latency same day).  The reporter stated that he gave an injection of an expired Tenivac vaccine and wanted to know what to do now. The health care professional asked for appropriate follow-up after expired vaccine was given  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain
Clinical narrative: Pain in right side of neck,nausea, No treatment, went away within 45 mins
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Itching, hard lump swelling, rash at injection site 8 days after 1st shot.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: Joint Ache at 2000 hours followed a small headache and fever followed shortly by extreme chills, shivering, and exhaustion at 2100 hours. Next morning fever and chills were gone, but headache, joint ache, sore arm, and exhaustion remains.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Joint Ache at 2000 hours followed a small headache and fever followed shortly by extreme chills, shivering, and exhaustion at 2100 hours. Next morning fever and chills were gone, but headache, joint ache, sore arm, and exhaustion remains.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: Client verbalized feeling dizzy after receiving the vaccine.  She was evaluated by onsite nurse practitioner. Client was advised to seek additional evaluation.  Client declined to be transported to the hospital for elevated blood pressure.  Client was released out at 3:51 pm accompanied by co-worker.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Feeling of body temperature change, Headache
Clinical narrative: Yesterday around 1:30PM I received my 2nd dose of the Moderna vaccine. All went well between the time I got the shot to the time I went to bed at about 10PM. I thought I had it made. At midnight I awoke with intense shivering. I absolutely couldn't stop. I wasn't cold as my body was hot. I had plenty of covers, but I was hot and shivering cold. Include a severe headache in this picture. This went on for a good hour and I finally settled down and dozed off again. This morning I have a mild headache and a really sore shoulder where I received the vaccine.
Age: 20.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Angioedema, Rash, Urticaria
Clinical narrative: Rash/hives started 1/31/2021.  Seen in clinic for this 2/2/2021 and Rx Prednisone and antihistamine and H2 blocker.  Then developed angioedema and went to ED on 2/3/2021.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Cardiac arrest, Cough, Death, Dyspnoea
Clinical narrative: Almost immediate headache per wife. Developed fever around 4 pm. Headache all day. Took Tylenol at 4 and 10 pm.  Gradual development of SOB and cough. Temp of 101.4 at 10 pm.  pulse ox 92% at 10 pm.  Went to sleep, woke up at 0050 with increasing SOB. Pulse ox 82%. Used albuterol inhaler, wife called emergency services at 0113.  EMS arrived around 0130 to patient's home. pulse ox 86%, coughing, sob, hard time breathing. Walked to stretcher. Became unresponsive.  Found to have no pulse, stopped breathing. CPR initiated at about 0140.  King airway placed in field, I/O in left tibia. Patient from PEA to asystole, to vfib, to asystole. ACLS followed. Unrecoverable asystole and patient time of death 0213.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Intraosseous access placement, Laryngeal mask airway insertion, Oxygen saturation decreased, Pulse absent
Clinical narrative: Almost immediate headache per wife. Developed fever around 4 pm. Headache all day. Took Tylenol at 4 and 10 pm.  Gradual development of SOB and cough. Temp of 101.4 at 10 pm.  pulse ox 92% at 10 pm.  Went to sleep, woke up at 0050 with increasing SOB. Pulse ox 82%. Used albuterol inhaler, wife called emergency services at 0113.  EMS arrived around 0130 to patient's home. pulse ox 86%, coughing, sob, hard time breathing. Walked to stretcher. Became unresponsive.  Found to have no pulse, stopped breathing. CPR initiated at about 0140.  King airway placed in field, I/O in left tibia. Patient from PEA to asystole, to vfib, to asystole. ACLS followed. Unrecoverable asystole and patient time of death 0213.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulseless electrical activity, Pyrexia, Respiratory arrest, Resuscitation, Unresponsive to stimuli
Clinical narrative: Almost immediate headache per wife. Developed fever around 4 pm. Headache all day. Took Tylenol at 4 and 10 pm.  Gradual development of SOB and cough. Temp of 101.4 at 10 pm.  pulse ox 92% at 10 pm.  Went to sleep, woke up at 0050 with increasing SOB. Pulse ox 82%. Used albuterol inhaler, wife called emergency services at 0113.  EMS arrived around 0130 to patient's home. pulse ox 86%, coughing, sob, hard time breathing. Walked to stretcher. Became unresponsive.  Found to have no pulse, stopped breathing. CPR initiated at about 0140.  King airway placed in field, I/O in left tibia. Patient from PEA to asystole, to vfib, to asystole. ACLS followed. Unrecoverable asystole and patient time of death 0213.