chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: very Frantic; episode of psychosis; Delusional; Dizzy; Headache; malaise; big knot there [injection arm]; itched; Could not stand up staright; had 17 or 18 falls in 2 days; slept so much after the vaccination; A spontaneous report was received from a pharmacist concerning a 70-year-old age female patient who received mRNA-1273 vaccine and experienced very frantic/delirium, episode of psychosis/psychotic disorder, Delusions/delusional perception, dizziness, Headache, malaise, knot on injection arm/vaccination site mass, itch/pruritis, could not stand up straight/dysstasia, 17 or 18 falls for 2 days, slept so much/Hypersomnia.  The medical history was anaphylactic reaction like iodine. Concomitant medications were not provided by the reporter.  On 17 Mar 2021, prior to the onset of events, the patient received the first dose of two planned doses of mRNA-1273 (Batch number: 045A21A) via Intramuscular route in the right deltoid for prophylaxis of COVID-19 infection.   After the first dose of vaccination, on an unspecified date, the experienced delusional, dizzy, and go through an episode of psychosis and was very frantic and got better and patient never had this before, had headaches and malaise, slept so much, had a big knot in her arm, itched, hard, could not stand up straight, 17 or 18 falls in 2 days. The event delirium worried about was medically significant.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event frantic was resolved. The outcome of the events episode of psychosis, delusions, dizziness, headache, malaise, knot on injection arm, itch, could not stand up straight, 17 or 18 falls for 2 days, slept so much were unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia
Clinical narrative: Patient started with blood in stool next day after receiving 1st dose; A spontaneous report was received from a consumer concerning a 43-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood in stool next day after receiving 1st dose.  The patient's medical history as provided by the reporter included hypertension. Concomitant medications reported included blood pressure medication.  On 17 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 18 Mar 2021, patient had blood in stool next day after receiving 1st dose. The event was considered medically significant.  Lab details were not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, patient started with blood in stool next day after receiving 1st dose was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Illness, Insomnia, Myalgia
Clinical narrative: Did not sleep at all as he kept staring at the clock 2-3 times every hour; Feels bad now which was similar to the time when he had covid; Whole body was moving bad; Chills; Vomiting ( " dry heaves" throwing up but nothing was coming out); Shaking was similar to having convulsions was hard; Very sick this morning; Sore injection site area; Shaking shaking so hard at 2am; A spontaneous report was received from a consumer concerning a 57-years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events shaking was similar to having convulsions was hard, very sick this morning, chills, sore injection site area, vomiting (dry heaves throwing up but nothing was coming out), whole body was moving bad, shaking so hard at 2am, did not sleep at all as he kept staring at the clock 2-3 times every hour and feels bad now which was similar to the time when he had Covid-19.   The patient's medical history included COVID-19. No relevant concomitant product use was reported.  On 25 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 048A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26 Mar 2021, the patient experienced very sick, chills, injection site sore, vomiting (dry heaves throwing up, but nothing was coming out). On the same day, the patient was shaking so hard at 2 am and the shaking was similar to having convulsions. The patient also reported that, his body was moving bad. The patient went to bathroom and laid back down, but he was unable to sleep and kept staring at the clock 2-3 times every hour. The patient also reported that, he felt bad now and it was similar to the time when he had COVID-19.  No treatment details were provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events very sick, chills, injection site sore, vomiting(dry heaves throwing up, but nothing was coming out), shaking so hard at 2 am, shaking was similar to convulsions, whole body was moving bad, did not sleep at al as he kept staring at the clock 2-3 times every hour and feels bad now which was similar to the time when he had COVID-19 were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. Further information has been requested
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure, Tremor, Vaccination site pain, Vomiting
Clinical narrative: Did not sleep at all as he kept staring at the clock 2-3 times every hour; Feels bad now which was similar to the time when he had covid; Whole body was moving bad; Chills; Vomiting ( " dry heaves" throwing up but nothing was coming out); Shaking was similar to having convulsions was hard; Very sick this morning; Sore injection site area; Shaking shaking so hard at 2am; A spontaneous report was received from a consumer concerning a 57-years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events shaking was similar to having convulsions was hard, very sick this morning, chills, sore injection site area, vomiting (dry heaves throwing up but nothing was coming out), whole body was moving bad, shaking so hard at 2am, did not sleep at all as he kept staring at the clock 2-3 times every hour and feels bad now which was similar to the time when he had Covid-19.   The patient's medical history included COVID-19. No relevant concomitant product use was reported.  On 25 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 048A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26 Mar 2021, the patient experienced very sick, chills, injection site sore, vomiting (dry heaves throwing up, but nothing was coming out). On the same day, the patient was shaking so hard at 2 am and the shaking was similar to having convulsions. The patient also reported that, his body was moving bad. The patient went to bathroom and laid back down, but he was unable to sleep and kept staring at the clock 2-3 times every hour. The patient also reported that, he felt bad now and it was similar to the time when he had COVID-19.  No treatment details were provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events very sick, chills, injection site sore, vomiting(dry heaves throwing up, but nothing was coming out), shaking so hard at 2 am, shaking was similar to convulsions, whole body was moving bad, did not sleep at al as he kept staring at the clock 2-3 times every hour and feels bad now which was similar to the time when he had COVID-19 were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. Further information has been requested
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dizziness, Dysarthria, Feeling cold, Hiccups
Clinical narrative: hard to understand when speaking; hiccups; sore throat; diagnosed with stroke; dizziness, dizziness continued to get worse, not spinning, but quickly moving from side to side; feeling cold; A spontaneous report was received from a consumer concerning a 76 year old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination and experienced a stroke (Cerebrovascular accident),, dizziness, dizziness continued to get worse, not spinning, but quickly moving from side to side/ Dizziness , hard to understand when speaking/ Speech disorder, hiccups, sore throat (Oropharyngeal pain) and feeling cold (Feeling cold).   The patient's past medical history not provided. Concomitant product use was not provided by the reporter.   On 06 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown) via intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 07 Mar 2021, the patient experienced feeling cold which lasted for 48 hours. On 08 Mar 2021, the patient started experiencing dizziness, the dizziness continued to get worse until 13 Mar 2021 when it was described as not spinning, but quickly moving from side to side, and patient was taken to the emergency room. On 14 Mar 2021, the patient was diagnosed with a stroke, was extremely hard to understand when speaking, had hiccups and sore throat. The patient had been in the hospital since 14 Mar 2021.    The action taken with mRNA-1273 in response to the events was unknown.  The outcome of feeling cold was recovered on 09 Mar 2021. The outcome of stroke, hiccups and sore throat, hard to understand when speaking, dizziness was unknown at the time of this report.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: hard to understand when speaking; hiccups; sore throat; diagnosed with stroke; dizziness, dizziness continued to get worse, not spinning, but quickly moving from side to side; feeling cold; A spontaneous report was received from a consumer concerning a 76 year old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination and experienced a stroke (Cerebrovascular accident),, dizziness, dizziness continued to get worse, not spinning, but quickly moving from side to side/ Dizziness , hard to understand when speaking/ Speech disorder, hiccups, sore throat (Oropharyngeal pain) and feeling cold (Feeling cold).   The patient's past medical history not provided. Concomitant product use was not provided by the reporter.   On 06 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown) via intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 07 Mar 2021, the patient experienced feeling cold which lasted for 48 hours. On 08 Mar 2021, the patient started experiencing dizziness, the dizziness continued to get worse until 13 Mar 2021 when it was described as not spinning, but quickly moving from side to side, and patient was taken to the emergency room. On 14 Mar 2021, the patient was diagnosed with a stroke, was extremely hard to understand when speaking, had hiccups and sore throat. The patient had been in the hospital since 14 Mar 2021.    The action taken with mRNA-1273 in response to the events was unknown.  The outcome of feeling cold was recovered on 09 Mar 2021. The outcome of stroke, hiccups and sore throat, hard to understand when speaking, dizziness was unknown at the time of this report.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac failure congestive, Dyspnoea, Pulmonary oedema, X-ray
Clinical narrative: fluid in lungs; difficulty breathing; congestive heart failure; AFib; The initial was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 19Mar2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that an 81-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9263), via an unspecified route of administration on 29Jan2021 15:00 at single dose for COVID-19 immunisation. Medical history included diabetes from 1991 and ongoing. Concomitant medications included insulin taken for diabetes, lisinopril, lovastatin, omeprazole (PRILOSEC), and piroxicam (PAXIL); all ongoing. The patient received first dose of bnt162b2 on 08Jan2021 for COVID-19 immunisation and experienced sugar out of control. On 29Jan2021, the patient experienced fluid in lungs, difficulty breathing, congestive heart failure and AFib (Atrial fibrillation). The events required a visit to the emergency room. The patient was hospitalized on an unspecified date for 5 days. The events required initiation of new medication/other treatment and procedure and many tests. The patient underwent x-rays on an unspecified date and showed fluid in lung. The patient had no other vaccinations within four weeks prior to the vaccine. Outcome of events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Petechiae, Platelet count, Platelet count decreased
Clinical narrative: This is a spontaneous report from a contactable physician. A 31-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced platelet count of 1, petechia on trunk and extremities, and epistaxis. Outcome of the events was unknown.  Information on the batch number has been requested.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case.  Company cannot completely exclude a causal relationship between the reported event and administration of vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), considering temporal relationship.  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: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fluid overload, Transplant failure
Clinical narrative: Fluid overload; shortness of breath; Graft clotted off; This is a spontaneous report from the Pfizer sponsored program. A contactable Nurse reported that a 73-year-old male patient (husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EK4176), via an unspecified route of administration, on Right Arm on 21Jan2021 at single dose for COVID-19 vaccination. Medical history included ongoing Diabetes, ongoing Vascular problems, ongoing Congestive heart failure; all (At least 15 years ago), blood thinners, dialysis from Sep2020 (husband has been on Dialysis since Sep2020. last time he was dialyzed was 11Feb2021) and Allergic to seafood and nuts. Concomitant medication(s) included clopidogrel bisulfate (PLAVIX) for blood thinner and acetylsalicylic acid (ASPIRIN) for blood thinner. The patient experienced fluid overload and shortness of breath on an unspecified date, graft clotted off on 13Feb2021. The patient was hospitalized for fluid overload from 16Feb2021 to an unknown date. She stated that her husband is on dialysis in the hospital and is going to miss the second dose appointment for the Pfizer covid 19 vaccine. She wanted to know what to do about the second dose. She wanted to know how long a person has to be off steroids before getting the vaccine and if she can reschedule the second dose appointment as he was hospitalized. Her husband is allergic to seafood and nuts. His appointment is at 10:30 (On 17Feb2021). She reported that he is on dialysis and his graft clotted and he has not had any dialysis in about a week. Her husband had fluid overload and shortness of breath. She said that he had to have an emergency port put in and they dialyzed him in the ER. He typically goes Tuesday or Thursday or Saturday. She said that he had not been dialyzed in over a week and he was getting fluid overload. She said that the last time he was dialyzed was 11Feb2021. She clarified that her husband has been on Dialysis since Sep2020. She said that when he got his Covid vaccine they checked that he was on Plavix and Aspirin. She said that they are supposed to hold the site because he has the tendency to bleed more while on blood thinners, but she does not know if that was the reason. She said that she knows what it was and he had to be dialyzed because of the fluid, but she was not told that her husband had fluid overload by the physician. She said that her husband has congestive heart failure as well. The patient was hospitalized due to Fluid overload from 16Feb2021 to ongoing. Outcome of all events was unknown and for remaining event Graft clotted off was not recovered. ; Sender's Comments: The causal assosciation between the suspect, BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) and the events, fluid overload, graft clotted, shortness of breath is unrelated. The impact of this report on 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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: low platelets- 10k; This is a spontaneous report from a contactable physician. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date, at a single dose, for covid-19 immunization. Medical history included allergies: penicillins and, ICD-10 C24.1 ampulla of vater cancer. The patient's concomitant medications were not reported. The patient previously took levofloxacin and experienced allergies. It was unknown if the patient received other vaccines within four weeks. It was unknown if the patient had covid prior vaccination. The patient developed low platelets- 10k on 19Feb2021. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received prednisone 20mg as treatment. The outcome of the event was unknown. It was unknown if the patient was covid-tested post-vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the event platelet count decreased cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dysstasia, Fatigue, Gait inability
Clinical narrative: platelets dropped again to 47; extreme fatigue; dizziness; pain; unable to stand or walk; unable to stand or walk; fast heart beat; headache; very weak; not feel good enough to go to ER/hospital; This is a spontaneous report from a contactable Consumer (patient). An 81-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL9269), second dose via an unspecified route of administration, administered in Arm Left on 06Feb2021 10:00, single dose for covid-19 immunisation. Medical history included Micropapillary high grade invasive bladder cancer, AFIB, diabetes, shellfish. The patient previously had the first dose of bnt162b2 on 16Jan2021 for covid-19 immunisation. Concomitant medications included digoxin; diltiazem; prednisone; sitagliptin (JANUVIA). The patient experienced on 07Feb2021 12:00, extreme fatigue, dizziness, pain, unable to stand or walk, fast heart beat, headache, etc. Also her platelets dropped again to 47. She still feels very weak now. This time though she did not feel good enough to go to ER/hospital. Instead she was recovering at home with help of caretaker. The dramatic drop in platelets and overall ill health impacts her greatly per she was scheduled for invasive bladder cancer surgery on 25Feb2021(radical cystectomy) and if her platelets and overall health does not get back up this will delay  the surgery (risk cancer spreading). No treatment was used for all events. The outcome of the events was recovering. The adverse event resulted in doctor or other healthcare professional office/clinic visit. No covid prior vaccination. Not covid tested post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Malaise, Pain
Clinical narrative: platelets dropped again to 47; extreme fatigue; dizziness; pain; unable to stand or walk; unable to stand or walk; fast heart beat; headache; very weak; not feel good enough to go to ER/hospital; This is a spontaneous report from a contactable Consumer (patient). An 81-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL9269), second dose via an unspecified route of administration, administered in Arm Left on 06Feb2021 10:00, single dose for covid-19 immunisation. Medical history included Micropapillary high grade invasive bladder cancer, AFIB, diabetes, shellfish. The patient previously had the first dose of bnt162b2 on 16Jan2021 for covid-19 immunisation. Concomitant medications included digoxin; diltiazem; prednisone; sitagliptin (JANUVIA). The patient experienced on 07Feb2021 12:00, extreme fatigue, dizziness, pain, unable to stand or walk, fast heart beat, headache, etc. Also her platelets dropped again to 47. She still feels very weak now. This time though she did not feel good enough to go to ER/hospital. Instead she was recovering at home with help of caretaker. The dramatic drop in platelets and overall ill health impacts her greatly per she was scheduled for invasive bladder cancer surgery on 25Feb2021(radical cystectomy) and if her platelets and overall health does not get back up this will delay  the surgery (risk cancer spreading). No treatment was used for all events. The outcome of the events was recovering. The adverse event resulted in doctor or other healthcare professional office/clinic visit. No covid prior vaccination. Not covid tested post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: platelets dropped again to 47; extreme fatigue; dizziness; pain; unable to stand or walk; unable to stand or walk; fast heart beat; headache; very weak; not feel good enough to go to ER/hospital; This is a spontaneous report from a contactable Consumer (patient). An 81-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL9269), second dose via an unspecified route of administration, administered in Arm Left on 06Feb2021 10:00, single dose for covid-19 immunisation. Medical history included Micropapillary high grade invasive bladder cancer, AFIB, diabetes, shellfish. The patient previously had the first dose of bnt162b2 on 16Jan2021 for covid-19 immunisation. Concomitant medications included digoxin; diltiazem; prednisone; sitagliptin (JANUVIA). The patient experienced on 07Feb2021 12:00, extreme fatigue, dizziness, pain, unable to stand or walk, fast heart beat, headache, etc. Also her platelets dropped again to 47. She still feels very weak now. This time though she did not feel good enough to go to ER/hospital. Instead she was recovering at home with help of caretaker. The dramatic drop in platelets and overall ill health impacts her greatly per she was scheduled for invasive bladder cancer surgery on 25Feb2021(radical cystectomy) and if her platelets and overall health does not get back up this will delay  the surgery (risk cancer spreading). No treatment was used for all events. The outcome of the events was recovering. The adverse event resulted in doctor or other healthcare professional office/clinic visit. No covid prior vaccination. Not covid tested post vaccination.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Haematochezia, Malaise
Clinical narrative: stiff neck; blood in my stool; had difficulty getting comfortable; increasing neck pain; fever; chills; major fatigue; increasing back  pain; unable to sleep due to the pain; This is a spontaneous report from a contactable consumer (occupation: other health professional), the patient. A 34-year-old male patient received second dose of BNT162B2 (COVID-19 vaccine, Solution for injection, Lot number: EM9810) via an unspecified route of administration in the left arm on 12Feb2021 at 09:00 AM as a single dose for COVID-19 immunization. Medical history included 1 kidney stone. The patient had allergies of whey (milk and cheese). Patient had no vaccination prior to COVID. Concomitant medication included Calcium supplement gummies (from two weeks). Patient did not receive any other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (COVID 19 vaccine, Solution for injection, Lot number: EC9261 or EL9261) via an unspecified route of administration in the left arm on 22Jan2021 at 02:45 PM. Since the vaccination, the patient had not been tested for COVID-19. On 12 Feb2021, the patient had no side effects for almost 12 hours (Fri 9am-9pm). After that at 21:00PM, patient had major fatigue, chills, fever as well as increasing back and neck pain. The Patient was unable to sleep friday night due to the pain and on saturday had difficulty getting comfortable. By sunday the back pain subsided but the neck pain and stiff neck remained, patient had difficulty turning the head. The patient continued to have chills and fever. Ibuprofen helped some with the symptoms. By sunday night patient had no major symptoms but had blood in stool on Sunday and Monday. Event blood in my stool was considered as medically significant. Patient had fully recovered in 2021.; Sender's Comments: Considering a plausible temporal association between the event 'Hematochezia' and the suspect drug BNT162B2, a causal relationship cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neck pain, Pyrexia, Sleep disorder
Clinical narrative: stiff neck; blood in my stool; had difficulty getting comfortable; increasing neck pain; fever; chills; major fatigue; increasing back  pain; unable to sleep due to the pain; This is a spontaneous report from a contactable consumer (occupation: other health professional), the patient. A 34-year-old male patient received second dose of BNT162B2 (COVID-19 vaccine, Solution for injection, Lot number: EM9810) via an unspecified route of administration in the left arm on 12Feb2021 at 09:00 AM as a single dose for COVID-19 immunization. Medical history included 1 kidney stone. The patient had allergies of whey (milk and cheese). Patient had no vaccination prior to COVID. Concomitant medication included Calcium supplement gummies (from two weeks). Patient did not receive any other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (COVID 19 vaccine, Solution for injection, Lot number: EC9261 or EL9261) via an unspecified route of administration in the left arm on 22Jan2021 at 02:45 PM. Since the vaccination, the patient had not been tested for COVID-19. On 12 Feb2021, the patient had no side effects for almost 12 hours (Fri 9am-9pm). After that at 21:00PM, patient had major fatigue, chills, fever as well as increasing back and neck pain. The Patient was unable to sleep friday night due to the pain and on saturday had difficulty getting comfortable. By sunday the back pain subsided but the neck pain and stiff neck remained, patient had difficulty turning the head. The patient continued to have chills and fever. Ibuprofen helped some with the symptoms. By sunday night patient had no major symptoms but had blood in stool on Sunday and Monday. Event blood in my stool was considered as medically significant. Patient had fully recovered in 2021.; Sender's Comments: Considering a plausible temporal association between the event 'Hematochezia' and the suspect drug BNT162B2, a causal relationship cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Platelet count, Platelet count decreased
Clinical narrative: Platelets dropped to 12,000/Platelet was dropped to 25 (units not specified); This is a spontaneous report from a contactable healthcare professional (female). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6201), second dose via an unspecified route of administration, administered in Arm Right on 16Feb2021 15:45, single dose for covid-19 immunisation. Medical history included ITP, from an unknown date. The patient had her first dose of bnt162b2 vaccine on an unspecified date for COVID-19 immunisation. Concomitant medication included methylphenidate hydrochloride (CONCERTA). Platelet was dropped to 25 (units not specified). Patient's platelets was dropped all the way after the second dose (16Feb2021) and she had to take Prednisone. Start date of event, Nurse stated, 4 days later. (Confirmed the date as 19Feb2021). CBC Date: Nurse stated, Last one I had it was every day since the day before the vaccine and today. Results: Nurse stated, platelets went down to 12,000. Patient is now on Prednisone, so her platelets are up. The outcome of the event was unknown.; Sender's Comments: Based on a plausible temporal association, a possible contributory role of vaccination with BNT162B2 to the reported event platelets decreased cannot be excluded. The history of ITP may have provided the contribution to the event.  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: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Platelet count decreased, Poor quality product administered
Clinical narrative: Platelets dropped to 12,000/Platelet was dropped to 25 (units not specified); This is a spontaneous report from a contactable healthcare professional (female). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6201), second dose via an unspecified route of administration, administered in Arm Right on 16Feb2021 15:45, single dose for covid-19 immunisation. Medical history included ITP, from an unknown date. The patient had her first dose of bnt162b2 vaccine on an unspecified date for COVID-19 immunisation. Concomitant medication included methylphenidate hydrochloride (CONCERTA). Platelet was dropped to 25 (units not specified). Patient's platelets was dropped all the way after the second dose (16Feb2021) and she had to take Prednisone. Start date of event, Nurse stated, 4 days later. (Confirmed the date as 19Feb2021). CBC Date: Nurse stated, Last one I had it was every day since the day before the vaccine and today. Results: Nurse stated, platelets went down to 12,000. Patient is now on Prednisone, so her platelets are up. The outcome of the event was unknown.; Sender's Comments: Based on a plausible temporal association, a possible contributory role of vaccination with BNT162B2 to the reported event platelets decreased cannot be excluded. The history of ITP may have provided the contribution to the event.  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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Palpitations
Clinical narrative: have been experiencing heart palpitations/flutter on and off for about 6-7 hours; have been experiencing heart palpitations/flutter on and off for about 6-7 hours; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EL3247), via an unspecified route of administration administered in left arm on 19Feb2021 13:15 at single dose for COVID-19 immunisation. Medical history included migraines from an unknown date and unknown if ongoing. No known allergies. Concomitant medications included clarithromycin (CLARITIN), omeprazole (PRILOSEC), sertraline hydrochloride (ZOLOFT), and statin for cholesterol. The patient previously took the first dose of bnt162b2 (Batch/Lot Number: EL3247), administered in left arm on 27Jan2021 09:15 for COVID-19 immunisation. Patient was not pregnant. Facility type vaccine was clinic. No other vaccine received in four weeks. The patient has been experiencing heart palpitations/flutter on and off for about 6-7 hours on 23Feb2021 04:00. No treatment received. No COVID prior vaccination. No COVID tested post vaccination. Outcome of the events was not recovered.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Laboratory test, Malaise
Clinical narrative: Kidney stones; Tiredness; tired all the time; Dizziness; Weakness; Feeling unwell; This is a spontaneous report from a contactable consumer (patient). This 69-year-old patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 Immunisation, the first dose was on 27Jan2021 (Lot#: EL3249), the second dose was on 20Feb2021 (Lot#: EN6200). Relevant medical history included blood pressure high but taking medication for that and that's probably about it, propranolol 20 mg; high cholesterol and taken simvastatin; gout and patient took medication for gout. Concomitant medication included allopurinol. Patient experienced kidney stones, tiredness, tired all the time, dizziness, weakness and feeling unwell maybe a day or 2 afterwards, a couple of days afterwards or something like that on both of them. The laboratory test was done for some like kidney stones like that, unknown results currently. Patient stated kidney stones still had, doctor said they were non-obstructive so they were going to let them be. Patient had a little bit on the dizziness and tired all the time seemed like and then on the chart it said feeling unwell that's what she felt like all the time. Patient got those three on the list, still going on, couple of 3 or 4 days after. The outcome of events was not recovered.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Nephrolithiasis
Clinical narrative: Kidney stones; Tiredness; tired all the time; Dizziness; Weakness; Feeling unwell; This is a spontaneous report from a contactable consumer (patient). This 69-year-old patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 Immunisation, the first dose was on 27Jan2021 (Lot#: EL3249), the second dose was on 20Feb2021 (Lot#: EN6200). Relevant medical history included blood pressure high but taking medication for that and that's probably about it, propranolol 20 mg; high cholesterol and taken simvastatin; gout and patient took medication for gout. Concomitant medication included allopurinol. Patient experienced kidney stones, tiredness, tired all the time, dizziness, weakness and feeling unwell maybe a day or 2 afterwards, a couple of days afterwards or something like that on both of them. The laboratory test was done for some like kidney stones like that, unknown results currently. Patient stated kidney stones still had, doctor said they were non-obstructive so they were going to let them be. Patient had a little bit on the dizziness and tired all the time seemed like and then on the chart it said feeling unwell that's what she felt like all the time. Patient got those three on the list, still going on, couple of 3 or 4 days after. The outcome of events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm after dose one; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received the first dose of BNT162B2 (TRADE NAME UNSPECIFIED; lot number unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced sore arm after dose one on an unspecified date. The clinical outcome of sore arm after dose one was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Eye injury, Loss of consciousness, Movement disorder, Speech disorder
Clinical narrative: unconscious; unable to talk; unable to move her body; Optical injury; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 28Jan2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 on an unspecified date for Covid-19 immunization and experienced changes in her speech and cognition and legs, after the first shot. Medical history included multiple sclerosis for about 26 years, Covid-19 from Nov2020, and diabetic. It was unknown if the patient was pregnant at the time of vaccination. The patient's concomitant medications were not reported. It was reported that the patient has been recently in a nursing home. She had Covid end of Nov2020. Once the patient recovered, the reporter (patient's daughter) was urged to get the patient vaccinated for Covid. She stated that she reluctantly agreed and wish she had not agreed. They noticed changes in the patient's speech and cognition and legs, after the first shot, but did not put two and two together, until after the second shot. In under 24 hours of receiving the second shot on 28Feb2021 at approximately 3pm, the patient could barely hold her head up and she could only move her lips, making a mumbling sound at best. She suffered optical injury, and as the hours passed unable to talk, unconscious, unable to move her body, etc. She had to receive a tracheostomy and food peg and is in a long-term acute hospital. She has since become more alert (awake versus sleeping and not responding), tracks people with her eyes, fairly consistently. As of 27Feb2021, she is tracking better but not following commands and the biggest thing is she can turn her head a little, left to right. Today, the reporter saw the patient swallow, twice (she still has a tracheostomy). They told her that the patent can only come out if she can follow commands, this do some therapy with the respiratory therapist. It was further reported that the patient received the Pfizer gene therapy shot. The patient is currently at an acute care facility. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hemiparesis
Clinical narrative: This is a spontaneous report from a contactable consumer reported for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. First time caller got second covax and for 12 days the patient had a headache and weakness on left side slowly fading. She stated she saw 2 HCP and they said nothing was wrong with her. She was asking if this was normal to feel this way after the vaccine. The outcome of events was unknown.  Information about lot/batch number has been requested.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Haematochezia
Clinical narrative: Blood in stool; stomach pains; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot#: EN6206, expiration date unknown) via an unspecified route of administration at left arm on 06Mar2021 at 10:00 AM at age of 21-year-old at single dose for COVID-19 immunization. Patient was not pregnant at time of vaccination and not pregnant at event onset. Patient had no COVID prior vaccination. COVID wasn't tested post vaccination. There was no known allergy and no other medical history. There was no other vaccine in four weeks. There was no other medications in two weeks. Patient experienced blood in stool and stomach pains, both on 07Mar2021 at 15:30. No treatment was received for both events. Outcome of both events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pain, Vaccination site mass, Vaccination site pain
Clinical narrative: 2-inch round diameter lump at the injection site and is sore; 2-inch round diameter lump at the injection site and is sore; fatigue; achiness/general body/joint pains; achiness/general body/joint pains; This is a spontaneous report from Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, on 26Feb2021 as a single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced achiness/general body/joint pains and fatigue a day after she received her first vaccine. There was also a 2-inch round diameter lump at the injection site (a day after the vaccination) which has not gone away and is sore for a while now. The patient reported that it still hurts up to today (02Mar2021). The clinical outcome of the achiness/general body/joint pains and fatigue was unknown. The clinical outcome of the 2-inch round diameter lump at the injection site which has not gone away and is sore was not recovered.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Sore arm; achyness; This is a spontaneous report received from Pfizer sponsored program COVAX  Support from a contactable male consumer (patient). A 65-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 2 via an unspecified route of administration on 26Feb2021, as a single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162b2 on an unspecified date. The patient had 2 margaritas after receiving the vaccine. The patient experienced achyness and sore arm on an unspecified date in 2021. The clinical outcome of the events sore arm and achiness was unknown.          The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: Sore arm; achyness; This is a spontaneous report received from Pfizer sponsored program COVAX  Support from a contactable male consumer (patient). A 65-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 2 via an unspecified route of administration on 26Feb2021, as a single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162b2 on an unspecified date. The patient had 2 margaritas after receiving the vaccine. The patient experienced achyness and sore arm on an unspecified date in 2021. The clinical outcome of the events sore arm and achiness was unknown.          The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: She got first dose and it hurt for 3 days/her arm hurts for 3 days after the 1st dose; She got first dose and it hurt for 3 days/her arm hurts for 3 days after the 1st dose; This is a spontaneous report from received from program. A contactable consumer, the patient, reported a female of unspecified age received COVID-19 immunisation with the first dose of BNT162b2 (solution for injection; batch/lot and expiry information not provided) as a single dose via unspecified route on 05Feb2021 and the second dose of BNT162b2 (solution for injection; batch/lot and expiry information not provided) as a single dose via unspecified route on 26Feb2021. There was no history, concomitant medications or past drug history reported. The patient inquired as to why the needle has to go that far into the muscle. The patient explained that she got her first dose and it hurt for three days. The patient commented that when she went for her second dose, they did not put it that deep in the muscle and it did not hurt much after second dose. The patient also inquired about a yearly booster for the vaccine. Treatment details, if any, were not reported. The outcome of the event got her first dose and it hurt for three days was recovered on 08Feb2021 and the outcome of the event did not hurt much after second dose was unknown.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.