chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Osteoarthritis, Pain, Pain in extremity, Rheumatoid arthritis, Swelling
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 031B2114) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Crohn's disease. The patient's past medical history included Pain in hip since 2019, Osteopenia, Stenosis, Femur fracture and Back surgery. Concurrent medical conditions included Alcohol use (occasionally) since 1959. Concomitant products included BUDESONIDE (ENTOCORT) for Crohn's disease, COBAMAMIDE (VITAMIN B12 [COBAMAMIDE]) for an unknown indication. In December 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK,1 in 2 Weeks. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2020, the patient experienced CARPAL TUNNEL SYNDROME (Carpal tunnel syndrome). In February 2021, the patient experienced SWELLING (Swelling). On 12-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis) (seriousness criterion medically significant). In April 2021, the patient experienced FATIGUE (Tiredness). In 2021, the patient experienced PAIN IN EXTREMITY (Hand pain). On an unknown date, the patient experienced HAEMORRHOIDS (Hemorrhoids), PAIN (Pain), OSTEOARTHRITIS (Osteoarthritis), ABDOMINAL PAIN UPPER (Stomach cramps) and DIARRHOEA (Diarrhea). The patient was treated with COLESTIPOL at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis), HAEMORRHOIDS (Hemorrhoids), SWELLING (Swelling), PAIN (Pain), PAIN IN EXTREMITY (Hand pain), OSTEOARTHRITIS (Osteoarthritis), ABDOMINAL PAIN UPPER (Stomach cramps) and DIARRHOEA (Diarrhea) outcome was unknown, CARPAL TUNNEL SYNDROME (Carpal tunnel syndrome) had not resolved and FATIGUE (Tiredness) had resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Very limited information regarding the events has been provided at this time.  Further information has been requested. This case was linked to MOD-2021-219975 (Patient Link).; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Burning sensation, Periorbital swelling, Swelling face
Clinical narrative: like she had Bell's Palsy again; Intense Burning Sensation Left Shoulder, Left Side of Neck, and Face; Puffy Eyes; Left Side of the patient's Face was swollen; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (like she had Bell's Palsy again) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bell's palsy (Per source, patient experienced similar symptoms like she had Bell's Palsy again.).    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced BELL'S PALSY (like she had Bell's Palsy again) (seriousness criterion medically significant), BURNING SENSATION (Intense Burning Sensation Left Shoulder, Left Side of Neck, and Face), PERIORBITAL SWELLING (Puffy Eyes) and SWELLING FACE (Left Side of the patient's Face was swollen). On 26-May-2021, BELL'S PALSY (like she had Bell's Palsy again), BURNING SENSATION (Intense Burning Sensation Left Shoulder, Left Side of Neck, and Face), PERIORBITAL SWELLING (Puffy Eyes) and SWELLING FACE (Left Side of the patient's Face was swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported.   Per source, patient's daughter noticed the left side of the patient's face was swollen like she had Bell's palsy again. It was noted that all symptoms lasted 24 hours.   Treatment information not provided.  Company comment: 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.; 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.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Cor pulmonale acute, Gastrointestinal disorder, Pulmonary embolism
Clinical narrative: suffered life threatening bilateral pulmonary emboli; acute cor pulmonale; accompanying gastrointestinal; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (suffered life threatening bilateral pulmonary emboli) and COR PULMONALE ACUTE (acute cor pulmonale) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (suffered life threatening bilateral pulmonary emboli) (seriousness criterion medically significant), COR PULMONALE ACUTE (acute cor pulmonale) (seriousness criterion medically significant) and GASTROINTESTINAL DISORDER (accompanying gastrointestinal). At the time of the report, PULMONARY EMBOLISM (suffered life threatening bilateral pulmonary emboli), COR PULMONALE ACUTE (acute cor pulmonale) and GASTROINTESTINAL DISORDER (accompanying gastrointestinal) outcome was unknown.            Concomitant product was not provided by the reporter.  Treatment information was not provided.  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.; 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.
Sex: M
Vaccine: COVID19
Symptoms: Death, Feeling abnormal, Illness
Clinical narrative: Stated going downhill; He died; Got a little sick,he stated going downhill; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (He died) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (Bladder surgery on 25 Feb.).    On 16-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced ILLNESS (Got a little sick,he stated going downhill). On an unknown date, the patient experienced FEELING ABNORMAL (Stated going downhill). The patient died on 26-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, ILLNESS (Got a little sick,he stated going downhill) and FEELING ABNORMAL (Stated going downhill) outcome was unknown.            Treatment and concomitant information was not provided by the reporter.  Patient had the modera shot on 16-Apr-2021 and he was recovering from a bladder surgery.  Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Pancreatic disorder
Clinical narrative: My pancreas on flame; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PANCREATIC DISORDER (My pancreas on flame) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PANCREATIC DISORDER (My pancreas on flame) (seriousness criterion hospitalization). The patient was hospitalized for 2 days due to PANCREATIC DISORDER. At the time of the report, PANCREATIC DISORDER (My pancreas on flame) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Sender's Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time.
Sex: U
Vaccine: COVID19
Symptoms: Infected cyst
Clinical narrative: Infected cyst on my leg; This spontaneous case was reported by a consumer and describes the occurrence of INFECTED CYST (Infected cyst on my leg) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFECTED CYST (Infected cyst on my leg) (seriousness criterion medically significant). At the time of the report, INFECTED CYST (Infected cyst on my leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  The patient wanted to know if patient could get second dose of vaccine, in instance of having an infected cyst on the leg. No treatment information was provided.  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.; 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.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis, Ultrasound scan
Clinical narrative: blood clots in his right leg; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clots in his right leg) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was reported.  Concomitant products included ENOXAPARIN for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced THROMBOSIS (blood clots in his right leg) (seriousness criterion medically significant). The patient was treated with APIXABAN (ELIQUIS) from 06-Apr-2021 to 24-May-2021 for Clot blood, at a dose of 10 milligram twice a day. At the time of the report, THROMBOSIS (blood clots in his right leg) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Ultrasound scan: confirmed blood clots (abnormal) confirmed blood clots in patient's in right leg.         Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested   This case was linked to MOD-2021-220788 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Sex: M
Vaccine: COVID19
Symptoms: Hospitalisation, Product dose omission issue
Clinical narrative: In hospital after 1st dose; 2nd dose delayed; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (In hospital after 1st dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (In hospital after 1st dose) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (2nd dose delayed). At the time of the report, HOSPITALISATION (In hospital after 1st dose) and PRODUCT DOSE OMISSION ISSUE (2nd dose delayed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company Comment: Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Nausea, Palpitations, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart Palpitations) and CHEST PAIN (Chest Pain) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Asthma. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for an unknown indication. On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-May-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea). On 02-Jun-2021, the patient experienced PALPITATIONS (Heart Palpitations) (seriousness criterion hospitalization) and CHEST PAIN (Chest Pain) (seriousness criteria hospitalization). The patient was treated with ALBUTEROL [SALBUTAMOL] at an unspecified dose and frequency. On 01-June-2021, PYREXIA (Fever) and NAUSEA (Nausea) had resolved. At the time of the report, PALPITATIONS (Heart Palpitations), CHEST PAIN (Chest Pain) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Angina pectoris
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (mild symptoms of heart pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced ANGINA PECTORIS (mild symptoms of heart pain) (seriousness criterion medically significant). At the time of the report, ANGINA PECTORIS (mild symptoms of heart pain) outcome was unknown. Action taken with mRNA-1273 vaccine due to the event was not applicable. No concomitant medications were reported. No treatment details were provided. Patient got both 1st and 2nd doses of Moderna vaccine in May and since then had mild symptoms of heart pain. Company Comment: Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Pericarditis
Clinical narrative: Chest pain; Pericarditis; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (Pericarditis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Heart disease, unspecified.   In June 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021, the patient experienced CHEST PAIN (Chest pain). In June 2021, the patient experienced PERICARDITIS (Pericarditis) (seriousness criterion medically significant). The patient was treated with IBUPROFEN for Adverse event, at a dose of High dose, qid. At the time of the report, PERICARDITIS (Pericarditis) and CHEST PAIN (Chest pain) outcome was unknown.            No relevant concomitant medications were provided.  Reportedly, the patient experienced chest pain and went to the hospital where he was diagnosed with pericarditis.  Treatment medication also included steroids.  Company Comment: This case concerns a male of unknown age hospitalized with a serious unexpected event of pericarditis, and nonserious chest pain. Event onset during the week following second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a male of unknown age hospitalized with a serious unexpected event of pericarditis, and nonserious chest pain. Event onset during the week following second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Carditis
Clinical narrative: Heart inflammation; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of CARDITIS (Heart inflammation) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDITIS (Heart inflammation) (seriousness criterion medically significant). At the time of the report, CARDITIS (Heart inflammation) outcome was unknown.      No concomitant medication reported. No treatment information was provided.  The case is based on screenshot from tweeter referring to an article posted on the Internet website. Reports describe heart inflammation appearing after second of two doses of either Pfizer or Moderna vaccines, both of which utilize messenger RNA technology.  Very limited information regarding this event have been provided at this time. Case is based on screenshot from social site referring to an article posted on the Internet website describing 800 reports of heart inflammation after second dose of COVID-vaccine utilizing mRNA technology.; Sender's Comments: Very limited information regarding this event have been provided at this time. Case is based on screenshot from social site referring to an article posted on the Internet website describing 800 reports of heart inflammation after second dose of COVID-vaccine utilizing mRNA technology.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Product dose omission issue
Clinical narrative: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (lost the pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (lost the pregnancy) (seriousness criterion medically significant), EXPOSURE DURING PREGNANCY (Vaccine exposure during Pregnancy) and PRODUCT DOSE OMISSION ISSUE (Missed second dose). At the time of the report, ABORTION SPONTANEOUS (lost the pregnancy) outcome was unknown and EXPOSURE DURING PREGNANCY (Vaccine exposure during Pregnancy) and PRODUCT DOSE OMISSION ISSUE (Missed second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.  Moderna Customer Care agent attempted a warm transfer but when retrieving the caller the caller was no longer on the line. But the agent informed that  the caller received the first dose of the Moderna COVID-19 vaccine in March. At  the time of vaccination the caller did not know they were pregnant and did not get second dose once they found out for safety reasons. The caller lost the pregnancy and now wants to know if they can get the second dose.  This is a case of product exposure during pregnancy with associated AEs for this female patient of unknown age. Patient declined further contact no further details is expected.; Sender's Comments: This is a case of product exposure during pregnancy with associated AEs for this female patient of unknown age. Patient declined further contact no further details is expected.
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: The reporter's relative had a seizure; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (The reporter's relative had a seizure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SEIZURE (The reporter's relative had a seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (The reporter's relative had a seizure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The physician (neurologist) said that several females had the same conditions that the patient with the Moderna Vaccine. The reporter's relative had a seizure.    Concomitant medications were not provided.  Treatment information was not provided.  Very limited information regarding this event has been provided at this time. Further information has been requested; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine, Cough, Influenza like illness, Respiration abnormal
Clinical narrative: Also had the second one and his allergies were much worse; He ended up having flu like symptoms 12 hours afterwards and cough.; He ended up having flu like symptoms 12 hours afterwards and cough.; The day before yesterday he had a lot of breathing issues that were so bad he had to get a updraft of Albuterol to help; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via intramuscular route of administration in left arm on 11Jan2021 (Lot number: EJ1685, Expiration Date: not reported), at the age of 28-years, as single dose for COVID-19 Immunisation. Patient medical history includes ongoing allergy. Patient concomitant medication was not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via unspecified route of administration, administered to left arm on 21Dec2020 at 8:30 AM (Lot number: EJ1685, Expiration Date: not reported), as single dose for COVID-19 Immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. After receiving second dose of vaccine patient did not think much of it and his allergies. Knows some have allergies worse than others. On an unknown date in Jan2021, patient allergies were much worse, patient experienced flu like symptoms 12 hours afterwards and cough. It is been a month and he still have cough, the day before yesterday he had a lot of breathing issues that were so bad, he had to get an updraft of Albuterol to help. Treatment received by Albuterol to help and steroid injection. Patient had to visit saw the primary care provider and she gave him a steroid injection and it seemed to help quite a bit also. He still has some other minor issues, but they are not so bad. Again, mentions the primary care provider stated the other patients had to be seen and they had delayed reactions as well. He is not so bad since he got the steroid. He enquires any other thing he should do as far as treatment he should receive. Recommended caller to consult medical provider for further medical advice. The outcome of the event breathing issues was unknown. The outcome of rest all the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Streptococcal infection
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer reported that a female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, she got the first dose and currently taking Metro prednisone and Clindamycin because of Streptococcus. Outcome of the event was unknown. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Accident at home, Disorientation, Dizziness, Fall, Head injury
Clinical narrative: On 09Feb2021 she felt dizzy which resulted in her being disoriented enough to fall and stroke her head in a metal furniture, she didn't have a concussion but a head bump, also she broke her wrist; On 09Feb2021 she felt dizzy which resulted in her being disoriented enough to fall and stroke her head in a metal furniture, she didn't have a concussion but a head bump, also she broke her wrist; On 09Feb2021 she felt dizzy which resulted in her being disoriented enough to fall and stroke her head in a metal furniture, she didn't have a concussion but a head bump, also she broke her wrist; On 09Feb2021 she felt dizzy which resulted in her being disoriented enough to fall and stroke her head in a metal furniture, she didn't have a concussion but a head bump, also she broke her wrist; On 09Feb2021 she felt dizzy which resulted in her being disoriented enough to fall and stroke her head in a metal furniture, she didn't have a concussion but a head bump, also she broke her wrist; On 09Feb2021 she felt dizzy which resulted in her being disoriented enough to fall and stroke her head in a metal furniture, she didn't have a concussion but a head bump, also she broke her wrist; This is a spontaneous report from a contactable consumer(patient). A female patient of unspecified age received bnt162b2(BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 05Feb2021 at 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 09Feb2021, the patient felt dizzy which resulted in her being disoriented enough to fall and stroke her head in a metal furniture, she didn't have a concussion but a head bump, also she broke her wrist. The patient reported that she had never felt dizzy before and she would like to report the AE and to know if there's information on if this two things could be connected and also reported that doctor told her that she should report this also to the place where she received the first dose of the vaccine and she would like to know if she should do this. The outcome of the event was reported as unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Wrist fracture
Clinical narrative: On 09Feb2021 she felt dizzy which resulted in her being disoriented enough to fall and stroke her head in a metal furniture, she didn't have a concussion but a head bump, also she broke her wrist; On 09Feb2021 she felt dizzy which resulted in her being disoriented enough to fall and stroke her head in a metal furniture, she didn't have a concussion but a head bump, also she broke her wrist; On 09Feb2021 she felt dizzy which resulted in her being disoriented enough to fall and stroke her head in a metal furniture, she didn't have a concussion but a head bump, also she broke her wrist; On 09Feb2021 she felt dizzy which resulted in her being disoriented enough to fall and stroke her head in a metal furniture, she didn't have a concussion but a head bump, also she broke her wrist; On 09Feb2021 she felt dizzy which resulted in her being disoriented enough to fall and stroke her head in a metal furniture, she didn't have a concussion but a head bump, also she broke her wrist; On 09Feb2021 she felt dizzy which resulted in her being disoriented enough to fall and stroke her head in a metal furniture, she didn't have a concussion but a head bump, also she broke her wrist; This is a spontaneous report from a contactable consumer(patient). A female patient of unspecified age received bnt162b2(BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 05Feb2021 at 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 09Feb2021, the patient felt dizzy which resulted in her being disoriented enough to fall and stroke her head in a metal furniture, she didn't have a concussion but a head bump, also she broke her wrist. The patient reported that she had never felt dizzy before and she would like to report the AE and to know if there's information on if this two things could be connected and also reported that doctor told her that she should report this also to the place where she received the first dose of the vaccine and she would like to know if she should do this. The outcome of the event was reported as unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased, Pallor
Clinical narrative: very pal; I had breathing problems/short of breath; heartbeat was fast.; This is a spontaneous report from a contactable consumer. This female consumer reported.  A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, batch/lot number and Expiration date was not reported), via an unspecified route of administration, on 23Jan2021, as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. On 23Jan2021, 10 min after getting the vaccine she was very pal, she had breathing problems, short of breath and heartbeat was fast. They took her to the ER and was given steroids. She didn't stay long. No one called her for the second shot. The patient think it's supposed to be today or tomorrow. Is it 2 weeks or 3 weeks. The patient underwent lab tests and procedure which includes heart rate with a result of fast on 23Jan2021. The outcome of the events were unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test positive
Clinical narrative: after first shot of Covid vaccine patient became ill and tested positive.; Tested positive; Ill; This is a spontaneous report from a Pfizer Sponsored Program. A contactable physician reported for a patient that:  The patient of an unspecified age and gender received bnt162b2 (solution for injection) (Batch/Lot Number: unknown) via unspecified route of administration on an unknown date as SINGLE DOSE for covid-19 immunisation. The medical history and concomitant medication were not reported. It was reported that after first shot of Covid vaccine patient became ill and tested positive. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Heart rate, Heart rate increased, SARS-CoV-2 test
Clinical narrative: SVT; Woke up about 1am with a rapid heart rate and pain in my chest/ heart rate was measured at 240bpm; Woke up about 1am with a rapid heart rate and pain in my chest; Trouble catching my breath; This is a spontaneous report from a contactable consumer (patient). A 34-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EM9810), via an unspecified route of administration in right arm on 10Feb2021 11:30 AM (at the age of 34-years-old) as a single dose for COVID-19 immunisation at the hospital. Medical history included supraventricular tachycardia with unknown reasons of causing the rapid heart rate. The patient had no allergies. Concomitant medication included (other medications in two weeks) sertraline taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL8982), via an unspecified route of administration in right arm on 20Jan2021 12:00 PM (at the age of 34-years-old) for COVID-19 immunisation. No other vaccinations in 4 weeks. No COVID prior vaccination. Tested for COVID-19 post vaccination with negative result. On 11Feb2021 01:00, the patient experienced SVT (supraventricular tachycardia), woke up about 1 am with a rapid heart rate and pain in her chest/ heart rate was measured at 240bpm, trouble catching her breath. The patient stated that the night of 10Feb2021, she felt asleep symptom free. She woke up about 1am with a rapid heart rate and pain in her chest. She got out of bed to use the techniques to bring the heart rate down on her own. Unfortunately, she was unsuccessful. After almost 30 minutes she made her way to the ER due to pain in my chest, and trouble catching my breath due to me starting to become afraid of the rapid heart rate. Upon arriving my heart rate was measured at 240bpm. The SVT was resolved with Adenosine. She wanted to point out this was the first time waking to the rapid heart rate and the first time experiencing pain in her chest from it. She normally moving or doing some form of low impact activity when the SVT is triggered, like walking, dancing, She was unaware of how long she experienced the rapid heart rate before waking up. She was not sure if the vaccine contributed to the heart rate but thought it was safer to share. The adverse event was resulted in Emergency room visit. The adverse event was treated with adenosine. The patient underwent lab tests and procedures which included heart rate: 240bpm on 11Feb2021 and nasal swab COVID test: negative on 10Feb2021. The outcome of events was recovered on an unspecified date in 2021.  Follow-up (10Jun2021): Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Supraventricular tachycardia
Clinical narrative: SVT; Woke up about 1am with a rapid heart rate and pain in my chest/ heart rate was measured at 240bpm; Woke up about 1am with a rapid heart rate and pain in my chest; Trouble catching my breath; This is a spontaneous report from a contactable consumer (patient). A 34-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EM9810), via an unspecified route of administration in right arm on 10Feb2021 11:30 AM (at the age of 34-years-old) as a single dose for COVID-19 immunisation at the hospital. Medical history included supraventricular tachycardia with unknown reasons of causing the rapid heart rate. The patient had no allergies. Concomitant medication included (other medications in two weeks) sertraline taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL8982), via an unspecified route of administration in right arm on 20Jan2021 12:00 PM (at the age of 34-years-old) for COVID-19 immunisation. No other vaccinations in 4 weeks. No COVID prior vaccination. Tested for COVID-19 post vaccination with negative result. On 11Feb2021 01:00, the patient experienced SVT (supraventricular tachycardia), woke up about 1 am with a rapid heart rate and pain in her chest/ heart rate was measured at 240bpm, trouble catching her breath. The patient stated that the night of 10Feb2021, she felt asleep symptom free. She woke up about 1am with a rapid heart rate and pain in her chest. She got out of bed to use the techniques to bring the heart rate down on her own. Unfortunately, she was unsuccessful. After almost 30 minutes she made her way to the ER due to pain in my chest, and trouble catching my breath due to me starting to become afraid of the rapid heart rate. Upon arriving my heart rate was measured at 240bpm. The SVT was resolved with Adenosine. She wanted to point out this was the first time waking to the rapid heart rate and the first time experiencing pain in her chest from it. She normally moving or doing some form of low impact activity when the SVT is triggered, like walking, dancing, She was unaware of how long she experienced the rapid heart rate before waking up. She was not sure if the vaccine contributed to the heart rate but thought it was safer to share. The adverse event was resulted in Emergency room visit. The adverse event was treated with adenosine. The patient underwent lab tests and procedures which included heart rate: 240bpm on 11Feb2021 and nasal swab COVID test: negative on 10Feb2021. The outcome of events was recovered on an unspecified date in 2021.  Follow-up (10Jun2021): Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Throat tightness, Urticaria
Clinical narrative: throat was closing; tongue was swelling; had hives on my chest; This is a spontaneous report from a contactable consumer. This 63-year-old (non-pregnant) female consumer (patient) reported that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EK4176) via an unspecified route of administration into the left arm on 19Jan2021 10:00 AM (at the age of 63-year-old) as first dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No Covid prior vaccination nor tested post vaccination. No other vaccine in four weeks. No known allergies. On 19Jan2021, the patient reported that ten minutes after vaccination, her throat was closing and her tongue was swelling. Also, she had hives on her chest. Adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care and treatment was received with Epipen, Benadryl, Deltadone and Pepcid. The Outcome was resolved for all the events on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Chills, Drug ineffective, Headache
Clinical narrative: Tested positive for SARS-CoV-2; Tested positive for SARS-CoV-2; congestion; nausea; chills; headache; This is a spontaneous report from a contactable physician. This report was received via a sales representative. A 49-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), intramuscular on 23Dec2020 as 1st dose, single dose for covid-19 immunisation. Medical history included hypertension, hypercholesterolaemia from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin calcium, hydrochlorothiazide taken for an unspecified indication, start and stop date were not reported. On 14Feb2021 patient had congestion, nausea, chills, headache. On 16Feb2021 patient tested positive for sars-cov-2. The patient underwent lab tests and procedures which included blood test: unknown results on an unspecified date, sars-cov-2 test: positive on 16Feb2021, sars-cov-2 test: negative on 18Feb2021. The outcome of events was recovered on an unknown date in 2021.  Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Drug ineffective, COVID-19 and the suspect drug BNT162B2.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nausea, SARS-CoV-2 test
Clinical narrative: Tested positive for SARS-CoV-2; Tested positive for SARS-CoV-2; congestion; nausea; chills; headache; This is a spontaneous report from a contactable physician. This report was received via a sales representative. A 49-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), intramuscular on 23Dec2020 as 1st dose, single dose for covid-19 immunisation. Medical history included hypertension, hypercholesterolaemia from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin calcium, hydrochlorothiazide taken for an unspecified indication, start and stop date were not reported. On 14Feb2021 patient had congestion, nausea, chills, headache. On 16Feb2021 patient tested positive for sars-cov-2. The patient underwent lab tests and procedures which included blood test: unknown results on an unspecified date, sars-cov-2 test: positive on 16Feb2021, sars-cov-2 test: negative on 18Feb2021. The outcome of events was recovered on an unknown date in 2021.  Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Drug ineffective, COVID-19 and the suspect drug BNT162B2.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Nervousness, SARS-CoV-2 test, Swelling face
Clinical narrative: face hurt really bad; face swelled; she scared about the second shot; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient (no pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 09Feb2021 at 13:00 as 1st dose, single for covid-19 immunisation. Medical history included cancer (cancer face, had cancer removed reconstructive surgery have more procedure) from 22Jan2020 and ongoing. The patient had COVID-19 test with positive result on 14Oct2020. Concomitant medications were not reported. No known allergies. No other vaccine in four weeks. No other medications in two weeks. No Covid prior vaccination. No Covid tested post vaccination. On 09Feb2021 at 15:45, her face swelled and hurt really bad 3 hours after the shot, it had been 2 days and was feeling much better and swelling had gone down, she was scared about the second shot (second dose received on 02Mar2021 at 12:30). The events 'face swelled and hurt really bad' assessed as non-serious. The patient received diphenhydramine hydrochloride (BENADRYL), paracetamol (TYLENOL) as treatment for the events 'face swelled and hurt really bad'. Outcome for the events 'face swelled and hurt really bad' was recovered in 2021; of rest event was unknown.  Information about Lot/ Batch number have been requested.  Follow up (20Apr2021): Ne w information received from a contactable consumer included: medical history, lab data and reaction data (treatment details and outcome of events 'face swelled and hurt really bad' was updated from recovering to recovered).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Pleurisy, SARS-CoV-1 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 83-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3249), via an unspecified route on 19Jan2021 at 11:15 (at the age of 83-years) as 1st dose, single dose in the right arm for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 23Jan2021, the patient experienced chest pains and problems breathing and went to Emergency room and diagnosed has pleurisy. The patient received treatment for events with steroids, pain meds and muscle relaxers. The patient underwent lab tests and procedures which included nasal swab, COVID test was negative on 19Feb2021. The outcome of the events was recovering. Follow-up (14May2021): Follow-up attempts completed. No further information expected.