chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate decreased
Clinical narrative: Feelings of unable to catch a breath; Resting pulse 38 bpm, active 38-51 bpm, unable to raise pulse above 51 bpm for 2 hours after injection with walking several times >50 ft each time; This is a spontaneous report from a contactable other hcp (the patient).     A 31-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 18Aug2021 12:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation (Age at vaccination 31 years) .  The patient medical history was not reported.  There were no concomitant medications.  The patient experienced feelings of unable to catch a breath  (medically significant) on 18Aug2021 12:30 with outcome of recovered , resting pulse 38 bpm, active 38-51 bpm, unable to raise pulse above 51 bpm for 2 hours after injection with walking several times >50 ft each time  (medically significant) on 18Aug2021 12:30 with outcome of recovered.  The patient underwent lab tests and procedures which included heart rate: 38 bpm  on 18Aug2021 Resting pulse , heart rate: 38-51 bpm  on 18Aug2021.    Information about  lot number has ben requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, the causal relationship between the event Shortness of breath, Pulse decreased and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Immunisation, Off label use
Clinical narrative: I have an upset  stomach  with constant Diarra; I have an upset  stomach  with constant Diarra; off label use/ the patient received 3rd dose of vaccine; the patient received 3rd dose of vaccine; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: FC3182) via an unspecified route of administration on 01Sep2021 at 15:00 (at the age of 48-years-old) in right arm as a single dose for covid-19 immunization. Medical history included known allergies to Penicillin, Sulfa, Morphine and Vicodin all from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. The patient's concomitant medications received in two weeks included other unspecified vaccine. The patient received third dose of Pfizer vaccine on 01Sep2021 at 15:00 (coded to off label use and immunisation). The patient experienced upset stomach with constant diarrhoea on 03Sep2021 at 12:00. Treatment was reported as unknown. The outcome of the events off label use and immunisation was unknown and for all other events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Lymphadenopathy, Myocarditis, Pericarditis
Clinical narrative: I had two days of either myocarditis or pericarditis; I had two days of either myocarditis or pericarditis; stabbing pains in my chest; had stabbing pains in my chest and left temple area; lymphadenopathy; This is a spontaneous report from a contactable consumer(patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: fc3180 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 21Aug2021 11:15 (at the age 51-years-old) at dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient received other medications within 2 weeks of vaccination included cholesterol medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if patient diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The most recent COVID-19 vaccine was administered at Pharmacy or drug Store. The patient had two days of either myocarditis or pericarditis on 28Aug2021, also had stabbing pains in chest and left temple area and lymphadenopathy on 28Aug2021. The adverse event was resulted in any of the following at Doctor or other healthcare professional office/clinic visit. No treatment was given for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: a flare of her Rheumatoid Arthritis; This is a spontaneous report from a contactable consumer. A 38-year-old female patient received third dose of BNT162B2 (BNT162B2) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient's medical history and medications were not reported. The patient experienced a flare of her rheumatoid arthritis on an unspecified date. Patient reported that she did hold her Xeljanz 11mg for 5 days after she received her Covid booster as advised.  Patient reported a flare of her Rheumatoid Arthritis but is back on track. No further questions or concerns. Outcome of the event was unknown. The patient received first and second dose of BNT162B2 on unspecified dates.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Parotid gland enlargement, Salivary gland mass
Clinical narrative: Swollen parotid gland on right side.; Swollen submandibular gland.; This is a spontaneous report from a contactable other health professional (patient) received via COVID-19 Adverse Event Self-Reporting Solution (COVAES).  A 47-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 23Aug2021 at 15:00 (Lot Number: FC3182) (at the age of 47-year-old) as single dose for COVID-19 immunisation.  Medical history included fibromyalgia from an unknown date and unknown if ongoing. Prior to vaccination the patient was diagnosed with COVID-19; since the vaccination the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient took unspecified concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 23Jul2021 (Lot Number: EW0177) (at the age of 47-year-old) as single dose for COVID-19 immunisation. The patient experienced swollen parotid gland on right side and swollen submandibular gland, both on 30Aug2021. The events required doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with steroids and antibiotics. The patient outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events (Parotid gland enlargement,Salivary gland mass )and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: whole left side of my body that is numb and tingly and cold.. even my arm; feet have stronger tingle and pain when she stand; having facial numbness; tingling on left side of face/ feet have stronger tingle and pain; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0169, Expiration date: Not reported), via an unspecified route of administration in left arm on 16Aug2021 at 09:00 (at the age of 34-years-old) as dose 1, single for COVID-19 immunization in a hospital. There was no patient's medical history reported. The patient was healthy and had known allergies to codeine and latex. There were no concomitant medications/any other medications received within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination and didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Twenty five minutes after the vaccination, the patient began to have facial numbness and tingling on the left side of the face on 16Aug2021 at 09:25. Two days later on 18Aug2021, the patient's feet have stronger tingle and pain when she standup and currently after 4 weeks in Sep2021, the patient's whole left side of the body was numb, tingly and cold even in her arm. These events resulted in doctor or healthcare professional office/clinic visit and disability or permanent damage. It was unknown if the patient received treatment for these events. The outcome of the events was not recovered at the time of report.   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Eye inflammation, SARS-CoV-2 test
Clinical narrative: Severe inflammation in the left eye; This is a spontaneous report from a contactable consumer (patient himself) via COVID-19 Vaccine Adverse Event Self-Reporting Solution (COVAES) portal. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 26Apr2021 at the age of 46 years old (Batch/Lot Number: EW0171, Expiration date: unknown) as dose 1, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the public health clinic/veterans administration facility. The patient had no medical history. There were no concomitant medications. The patient had not received any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On an unspecified date in 2021, the patient experienced severe inflammation in the left eye, which started about a week, week and a half after the first dose and had been present since at different levels of severity. The reporter assessed the event as non-serious. The adverse event did result in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of severe inflammation in the left eye, which included antiviral medications (meds), antibiotics, and steroids. Since the vaccination, the patient had been tested for COVID-19; the patient underwent COVID-19 test via nasal swab: negative post vaccination on 27Aug2021. The patient was not recovered from severe inflammation in the left eye at the time of the report.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage, Maternal exposure during pregnancy, Vomiting
Clinical narrative: popped blood vessels in eyes from intensity of vomiting; vomiting for several days; Patient is pregnant; This is a spontaneous report from a contactable consumer. A 45-year-old pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 09Sep2021 (Batch/Lot number was not reported) (at the age of 45 years old) as single dose for Covid-19 immunisation. The patient medical history was not reported. It was unknown if patient had other vaccine in four weeks, and unknown if patient had other medications in two weeks. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered via intramuscular in Aug2021 for Covid-19 immunisation. The patient's concomitant medications were not reported. The patient was pregnant when she received the vaccine on 09Sep2021, she was 25 weeks pregnant. The patient reported that on 10Sep2021, she was vomiting for several days and popped blood vessels in eyes from intensity of vomiting. It was unknown if she received any treatment. Outcome of the events was recovering.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cold sweat, Hypersomnia, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: First two does he was already on oxygen support/ his O2 dropped to 85%; Fever/ fever of 101.9 for 2 days; Cold sweats; Slept for two days; This is a spontaneous report from contactable consumers (patient and patient's wife). A 50-year-old male patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (batch/lot number was not reported)  at an unknown age at vaccination, as DOSE 1, SINGLE and the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm on 03Sep2021 13:00 (batch/lot number: EW0198) at the age of 50 years old, as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history included high cholesterol, heart (heart disorder), and overweight, all from an unknown date. Patient had history of COVID-19 infection from an unknown date and had high heart rate since COVID-19. Patient had no known allergies. Concomitant medications in two weeks included acetylsalicylic acid (ASPIRIN) and colestyramine (COLESTROL), both taken for an unspecified indication, start and stop dates were not reported. Patient is also taking heart meds (unspecified). The patient did not receive other vaccine in four weeks. The patient is a Covid vent survivor; in the first two doses, he was already on oxygen support so, did not notice a dip. Patient also had fever and cold sweats and slept for two days after each dose. It was reported that on 04Sep2021, his O2 dropped to 85% at 04:00 am and required oxygen supplements. Patient had fever of 101.9 for 2 days. As his wife, the reporter was well versed at this point with his care of just implemented care as needed. They followed up with Dr after weekend to update. Therapeutic measures where taken as a result of the events. The patient recovered from the event "fever/ fever of 101.9 for 2 days" on 06Sep2021. Outcome of the other events was recovering. The event "first two does he was already on oxygen support/ his O2 dropped to 85%" was reported as medically significant. The patient was not tested for Covid-19 post vaccination.  The batch/lot number for BNT162B2 (first dose) was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: First two does he was already on oxygen support/ his O2 dropped to 85%; Fever/ fever of 101.9 for 2 days; Cold sweats; Slept for two days; This is a spontaneous report from contactable consumers (patient and patient's wife). A 50-year-old male patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (batch/lot number was not reported)  at an unknown age at vaccination, as DOSE 1, SINGLE and the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm on 03Sep2021 13:00 (batch/lot number: EW0198) at the age of 50 years old, as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history included high cholesterol, heart (heart disorder), and overweight, all from an unknown date. Patient had history of COVID-19 infection from an unknown date and had high heart rate since COVID-19. Patient had no known allergies. Concomitant medications in two weeks included acetylsalicylic acid (ASPIRIN) and colestyramine (COLESTROL), both taken for an unspecified indication, start and stop dates were not reported. Patient is also taking heart meds (unspecified). The patient did not receive other vaccine in four weeks. The patient is a Covid vent survivor; in the first two doses, he was already on oxygen support so, did not notice a dip. Patient also had fever and cold sweats and slept for two days after each dose. It was reported that on 04Sep2021, his O2 dropped to 85% at 04:00 am and required oxygen supplements. Patient had fever of 101.9 for 2 days. As his wife, the reporter was well versed at this point with his care of just implemented care as needed. They followed up with Dr after weekend to update. Therapeutic measures where taken as a result of the events. The patient recovered from the event "fever/ fever of 101.9 for 2 days" on 06Sep2021. Outcome of the other events was recovering. The event "first two does he was already on oxygen support/ his O2 dropped to 85%" was reported as medically significant. The patient was not tested for Covid-19 post vaccination.  The batch/lot number for BNT162B2 (first dose) was not provided and will be requested during follow-up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Inflammation in left hip area; This is a spontaneous report from a contactable consumer (patient).   A 51-year-old non-pregnant female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 09Sep2021 20:00, at the age of 51-years-old, (Lot Number: Ff2588) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included High blood pressure, acid reflux, and allergy.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 09Sep2021 20:00, the patient experienced inflammation in left hip area. The event involved Emergency room/department or urgent care. The event was assessed as medically significant. The outcome of the event was unknown.  Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the event (Pain med and inflammatory med).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Ear pain, Hypoaesthesia oral
Clinical narrative: Bell's Palsy/Paralyzation/Weakness of left side of face started Sept 15th around 6pm.; Pain behind left ear; numbness in lips; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0182), via an unspecified route of administration, in right arm on 12Aug2021 (at the age of 46-years-old) as dose 2, single for COVID-19 immunization. Medical history included diabetes type 2, congestive heart failure, asthma, COVID-19 and allergy to shellfish and codeine. Concomitant medication included lisinopril, metformin and glipizide. No other vaccine was given in 4 weeks. Since vaccination, the patient has not been tested for COVID-19. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0170), via an unspecified route of administration, in left arm on 14Jul2021 (at the age of 46-years-old) as dose 1, single for COVID-19 immunization. The patient experienced numbness in lips which started on or around 10Sep2021. Pain behind left ear on or around 14Sep2021. Paralyzation/ Weakness of left side of face started 15Sep2021 around 18:00. The patient went to ER fearing a stroke and was diagnosed with Bell's Palsy. Therapeutic measures taken as a result of the events included medications valacyclovir, prednisone and amoxiclav. The events resulted in emergency room/ department urgent care. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Asthma, Body temperature, Chills
Clinical narrative: Asthma but have never had an attack like that; Feeling extremely weak; Sluggish; Sleepy/I kept waking up gasping for air but I could not wake enough to move; Dizzy; Headache; Felt as though I had a cold; Severe muscle and joint pain; Severe muscle and joint pain; Trouble breathing; Could not sleep at all; Fever 100; Severe chills; Sweat; Still no energy; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm left on 13Sep2021 15:30 (at the age of 49 years old) (Batch/Lot Number: FD3183) as single dose for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included asthma, low thyroid, chronic pain, high blood pressure, depression, ADHD (Attention deficit hyperactivity disorder), Allergies: Sulfa drugs. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included celecoxib (CELEXA); morphine. The patient previously received the first dose of BNT162B2 (Lot Number: FD8448) in left arm on 30Aug2021 18:30 (at the age of 48 years old) for COVID-19 immunization. On 13Sep2021, within the first 2 hours patient started feeling extremely weak, sluggish, sleepy, dizzy, headache, felt as though she had a cold. Within 8 hours severe muscle and joint pain, headache, trouble breathing, could not sleep at all, fever 100, severe chills and sweat. What scared her the most was on the 15th at 6:30 am she kept waking up gasping for air but she could not wake enough to move. She has her asthma but have never had an attack like that. It felt as though she had been drugged. She finally tried to roll so she would fall off the bed. It did help when she hit the floor to wake enough to grab her inhaler. If she had not had one by her bed she truly do not believe she would be here. After that attack she slowly started feeling better. By that night she was feeling better. Still no energy. Treatment received for the event asthmatic attack, no treatment received for the other events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in Sep2021.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Headache, Hyperhidrosis, Hypersomnia
Clinical narrative: Asthma but have never had an attack like that; Feeling extremely weak; Sluggish; Sleepy/I kept waking up gasping for air but I could not wake enough to move; Dizzy; Headache; Felt as though I had a cold; Severe muscle and joint pain; Severe muscle and joint pain; Trouble breathing; Could not sleep at all; Fever 100; Severe chills; Sweat; Still no energy; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm left on 13Sep2021 15:30 (at the age of 49 years old) (Batch/Lot Number: FD3183) as single dose for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included asthma, low thyroid, chronic pain, high blood pressure, depression, ADHD (Attention deficit hyperactivity disorder), Allergies: Sulfa drugs. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included celecoxib (CELEXA); morphine. The patient previously received the first dose of BNT162B2 (Lot Number: FD8448) in left arm on 30Aug2021 18:30 (at the age of 48 years old) for COVID-19 immunization. On 13Sep2021, within the first 2 hours patient started feeling extremely weak, sluggish, sleepy, dizzy, headache, felt as though she had a cold. Within 8 hours severe muscle and joint pain, headache, trouble breathing, could not sleep at all, fever 100, severe chills and sweat. What scared her the most was on the 15th at 6:30 am she kept waking up gasping for air but she could not wake enough to move. She has her asthma but have never had an attack like that. It felt as though she had been drugged. She finally tried to roll so she would fall off the bed. It did help when she hit the floor to wake enough to grab her inhaler. If she had not had one by her bed she truly do not believe she would be here. After that attack she slowly started feeling better. By that night she was feeling better. Still no energy. Treatment received for the event asthmatic attack, no treatment received for the other events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in Sep2021.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Nasopharyngitis, Pyrexia, Sluggishness
Clinical narrative: Asthma but have never had an attack like that; Feeling extremely weak; Sluggish; Sleepy/I kept waking up gasping for air but I could not wake enough to move; Dizzy; Headache; Felt as though I had a cold; Severe muscle and joint pain; Severe muscle and joint pain; Trouble breathing; Could not sleep at all; Fever 100; Severe chills; Sweat; Still no energy; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm left on 13Sep2021 15:30 (at the age of 49 years old) (Batch/Lot Number: FD3183) as single dose for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included asthma, low thyroid, chronic pain, high blood pressure, depression, ADHD (Attention deficit hyperactivity disorder), Allergies: Sulfa drugs. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included celecoxib (CELEXA); morphine. The patient previously received the first dose of BNT162B2 (Lot Number: FD8448) in left arm on 30Aug2021 18:30 (at the age of 48 years old) for COVID-19 immunization. On 13Sep2021, within the first 2 hours patient started feeling extremely weak, sluggish, sleepy, dizzy, headache, felt as though she had a cold. Within 8 hours severe muscle and joint pain, headache, trouble breathing, could not sleep at all, fever 100, severe chills and sweat. What scared her the most was on the 15th at 6:30 am she kept waking up gasping for air but she could not wake enough to move. She has her asthma but have never had an attack like that. It felt as though she had been drugged. She finally tried to roll so she would fall off the bed. It did help when she hit the floor to wake enough to grab her inhaler. If she had not had one by her bed she truly do not believe she would be here. After that attack she slowly started feeling better. By that night she was feeling better. Still no energy. Treatment received for the event asthmatic attack, no treatment received for the other events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in Sep2021.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Contusion, Electrocardiogram, Fatigue, Heart rate increased
Clinical narrative: heart was shaking/fluttering; heart was shaking/fluttering; extremely exhausted; her chest has bruising; increase of heart rate; This is a spontaneous report from a contactable consumer (parent) received via COVID-19 Adverse Event Self-Reporting Solution . A 17-year-old non-pregnant female patient (reporter's daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 04Sep2021 at 10:00 AM (Batch/Lot Number: FC3182) (at the age of 17-years-old) as dose 2, single for COVID-19 immunisation. Vaccine facility type was pharmacy or drugstore. The patient was not pregnant at time of vaccination. Medical history included sickle cell trait and has known allergies to NSAIDS. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks and did not receive any other medications in two weeks. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 14Aug2021 at 03:00 PM (Batch/Lot Number: FA7485) (at the age of 17-years-old) as dose 1, single for COVID-19 immunisation. On 08Sep2021 at 10:45 PM, the patient was complaining that her heart was shaking/fluttering, extremely exhausted, and her chest has bruising. The events resulted in a doctor or other healthcare professional office/clinic visit. The patient was given treatment. Relevant test included electrocardiogram (EKG) with unknown results. The patient was now being monitored for increase of heart rate and what she's doing at the time. The patient has no COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart was shaking/fluttering; heart was shaking/fluttering; extremely exhausted; her chest has bruising; increase of heart rate; This is a spontaneous report from a contactable consumer (parent) received via COVID-19 Adverse Event Self-Reporting Solution . A 17-year-old non-pregnant female patient (reporter's daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 04Sep2021 at 10:00 AM (Batch/Lot Number: FC3182) (at the age of 17-years-old) as dose 2, single for COVID-19 immunisation. Vaccine facility type was pharmacy or drugstore. The patient was not pregnant at time of vaccination. Medical history included sickle cell trait and has known allergies to NSAIDS. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks and did not receive any other medications in two weeks. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 14Aug2021 at 03:00 PM (Batch/Lot Number: FA7485) (at the age of 17-years-old) as dose 1, single for COVID-19 immunisation. On 08Sep2021 at 10:45 PM, the patient was complaining that her heart was shaking/fluttering, extremely exhausted, and her chest has bruising. The events resulted in a doctor or other healthcare professional office/clinic visit. The patient was given treatment. Relevant test included electrocardiogram (EKG) with unknown results. The patient was now being monitored for increase of heart rate and what she's doing at the time. The patient has no COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Body temperature, Body temperature increased, Inappropriate schedule of product administration, Muscle twitching
Clinical narrative: full body muscle twitches and continue to have them; Bells Palsy incident; temp of 105 degrees; first dose was given on 21Dec2020; second dose was given on 07Jan2021; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration, administered in left arm on 07Jan2021 (at the age of 50 years old) as dose 2, single for COVID-19 immunisation. Medical history included Penicillin allergy. The patient has no history of COVID prior to vaccination. There were no concomitant medications. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in right arm on 21Dec2021 (at the age of 50 years old) for COVID-19 immunisation. No other vaccine in four week and no other medications in two weeks. Immediately following the second shot, on 07Jan2021, the patient had a temp of 105 degrees. On 12May2021, the patient had Bells Palsy incident and on Jun2021, he began having full body muscle twitches and continues to have them. The event resulted in emergency room/department or urgent care. Treatment was given in response to the events which included brain scan on an unspecified date and unspecified medications. The patient underwent lab test and procedure which included COVID test post vaccination via Nasal swab on 14Sep2021 which was negative. The outcome of the events was not recovered.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Scan brain
Clinical narrative: full body muscle twitches and continue to have them; Bells Palsy incident; temp of 105 degrees; first dose was given on 21Dec2020; second dose was given on 07Jan2021; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration, administered in left arm on 07Jan2021 (at the age of 50 years old) as dose 2, single for COVID-19 immunisation. Medical history included Penicillin allergy. The patient has no history of COVID prior to vaccination. There were no concomitant medications. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in right arm on 21Dec2021 (at the age of 50 years old) for COVID-19 immunisation. No other vaccine in four week and no other medications in two weeks. Immediately following the second shot, on 07Jan2021, the patient had a temp of 105 degrees. On 12May2021, the patient had Bells Palsy incident and on Jun2021, he began having full body muscle twitches and continues to have them. The event resulted in emergency room/department or urgent care. Treatment was given in response to the events which included brain scan on an unspecified date and unspecified medications. The patient underwent lab test and procedure which included COVID test post vaccination via Nasal swab on 14Sep2021 which was negative. The outcome of the events was not recovered.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Palpitations
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), intramuscular in left arm (also reported as left leg; pending clarification), on 04Aug2021 at 10:00 AM (at the age of 44 years), as dose 1, single, for COVID-19 immunization. The patient's medical history included atrial fibrillation (AFib) from 2016 and had an ablation to fix it in 2016. The patient's concomitant medications included lisinopril, carvedilol, omeprazole (PROTONIX), atorvastatin calcium (LIPITOR), and magnesium chloride (SLO-MAG). The patient previously took cyproheptadine hydrochloride (CYPRO), metronidazole (FLAGYL), and codeine and experienced allergies. The patient was not diagnosed with COVID-19 prior vaccination. The vaccine was administered in a pharmacy or drugstore facility. On 07Aug2021 at 01:00 PM, the patient experienced heart palpitations and chest pains. The events resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care visit. No treatment was administered for the events. The patient considered the events as non-serious. On 25Aug2021 at 10:00 AM, the patient received the second dose of BNT162B2, intramuscular in left arm. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Infection, Insomnia, Nausea
Clinical narrative: had an infection in march after my covid vaccine; chronic leg pain; headache here or there; insomnia; nausea; tired; This is a spontaneous report from a contactable other hcp.    A 42-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. Medical history included oestrogen receptor assay. Concomitant medication(s) included cetirizine (CETIRIZINE); melatonin (MELATONIN); vitamin d3 (VITAMIN D3); paroxetine hcl (PAROXETINE HCL); ondansetron hcl (ONDANSETRON HCL); fluticasone propionate (FLUTICASONE PROPIONATE); azelastine hcl (AZELASTINE HCL); metformin hcl (METFORMIN HCL. It was Reported that, patient missed 1 cycle because she had an infection in March after my covid vaccine. chronic leg pain, headache here or there, insomnia, and nausea. labs are off & pre-diabetic since covid vaccine. Tired on an unspecified date with outcome of unknown, tired (fatigue) (non-serious) on an unspecified date with outcome of 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
Clinical narrative: had an infection in march after my covid vaccine; chronic leg pain; headache here or there; insomnia; nausea; tired; This is a spontaneous report from a contactable other hcp.    A 42-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. Medical history included oestrogen receptor assay. Concomitant medication(s) included cetirizine (CETIRIZINE); melatonin (MELATONIN); vitamin d3 (VITAMIN D3); paroxetine hcl (PAROXETINE HCL); ondansetron hcl (ONDANSETRON HCL); fluticasone propionate (FLUTICASONE PROPIONATE); azelastine hcl (AZELASTINE HCL); metformin hcl (METFORMIN HCL. It was Reported that, patient missed 1 cycle because she had an infection in March after my covid vaccine. chronic leg pain, headache here or there, insomnia, and nausea. labs are off & pre-diabetic since covid vaccine. Tired on an unspecified date with outcome of unknown, tired (fatigue) (non-serious) on an unspecified date with outcome of unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cellulitis, Erythema, Fatigue, Feeling hot
Clinical narrative: sick; Tired/ exhaustion; sore throat; temperature of 99.8; Red; warm; swelling; numbness; cellulitis on her chin/face; This is a spontaneous report from a contactable other healthcare professional (HCP, patient). A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in left arm on 14Sep2021 at 15:15 (Batch/Lot Number: 2256) (at the age of 55-years-old) as dose 1, single for COVID-19 immunisation. Vaccination facility type was Pharmacy or Drug Store. The patient is not pregnant at time of vaccination. Relevant medical history was none. The patient has no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks and did not receive any other medications in two weeks. The patient has no COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. On 16Sep2021 at 06:30 pm, the patient reported that she was very sick afterward. She was tired, had sore throat, and exhaustion. Two days later (in Sep2021), she had a temperature of 99.8. Now after 48 hours, (in Sep2021), she has developed cellulitis on her chin/face; red, warm, swelling, and numbness. The patient received treatment with Benadryl. The outcome of the event was not recovered.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Considering a temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Illness, Oropharyngeal pain, Pyrexia, Swelling
Clinical narrative: sick; Tired/ exhaustion; sore throat; temperature of 99.8; Red; warm; swelling; numbness; cellulitis on her chin/face; This is a spontaneous report from a contactable other healthcare professional (HCP, patient). A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in left arm on 14Sep2021 at 15:15 (Batch/Lot Number: 2256) (at the age of 55-years-old) as dose 1, single for COVID-19 immunisation. Vaccination facility type was Pharmacy or Drug Store. The patient is not pregnant at time of vaccination. Relevant medical history was none. The patient has no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks and did not receive any other medications in two weeks. The patient has no COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. On 16Sep2021 at 06:30 pm, the patient reported that she was very sick afterward. She was tired, had sore throat, and exhaustion. Two days later (in Sep2021), she had a temperature of 99.8. Now after 48 hours, (in Sep2021), she has developed cellulitis on her chin/face; red, warm, swelling, and numbness. The patient received treatment with Benadryl. The outcome of the event was not recovered.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Considering a temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Loss of consciousness, Respiratory arrest, Respiratory distress
Clinical narrative: anaphylactic reaction; lost consciousness; She did stop breathing and came to right away, she was just out; vomiting; difficulty breathing; Respiratory distress-specifically had difficulty breathing; has a hard time with breathing and running out of breath a lot quicker; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FE3592), via an unspecified route of administration in left arm on 12Sep2021 in the afternoon (at the age of 46-years-old) as dose 2, single for COVID-19 immunization. Medical history included respiratory issues (already had respiratory issues before). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FC3181), via an unspecified route of administration in right arm on 08Aug2021 (at the age of 46-years-old) as dose 1, single for COVID-19 immunization and had a little bit of issues with the first one, but she already had respiratory issues before. The patient previously received H1N1 vaccine for Influenza immunization about 10 years ago and ended up in the ICU with neuropathy and myopathy. This was probably when it first came out about 10 years ago and she has complications due to that. The patient's concomitant medications were not reported. Patient received no other vaccines on the same day. The patient experienced anaphylactic reaction, lost consciousness, she did stop breathing and came to right away, she was just out, vomiting, difficulty breathing, respiratory distress-specifically had difficulty breathing; has a hard time with breathing and running out of breath a lot quicker on 12Sep2021. The events resulted in emergency room and physician office visit. It was reported that with second dose, within 15-20 minutes patient experienced vomiting and lost consciousness, difficulty breathing, and the ambulance was then called. She did stop breathing and came to right away, she was just out. She does remember being in the back of the ambulance and going to the hospital and they treated her with medication there to slow things down. Patient was there a couple of hours and discharged home since there was not anything more, they can do for her. She has not improved at all and was still being monitored and has a hard time with breathing and running out of breath a lot quicker. Still has breathing issues. The events required medical intervention. In the emergency room, they treated her to slow things down. Multiorgan involvement included respiratory: Respiratory distress; specifically had difficulty breathing; has a hard time with breathing and running out of breath a lot quicker. Potential anaphylactic reaction was reported to be recovering, but still has breathing issues. Patient was taking medications prior to the event being reported (details not reported). Patient still has not improved at all and is still being monitored. Outcome of events was resolving.  No follow-up attempts are possible. No further information is expected.