chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccination adverse reaction; Headache; Pain; Stomach pain; patient received third dose COVID-19 Vaccine manufactured by Pfizer; patient received third dose COVID-19 Vaccine manufactured by Pfizer; This is a solicited report based on information received by Pfizer (Mfr. Control No. :21K-163-4072509-00). A contactable 59-year-old female consumer (patient) reported.  A 59-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via intramuscular, administered on 01Apr2021 (at the age of 59-year-old) as dose 2, single for COVID-19 immunization. Patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via intramuscular, administered on 01Mar2021 (at the age of 59-year-old) as dose 1, single for COVID-19 immunization. Patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via intramuscular, administered on unspecified date in 2021 (at the age of 59-year-old) as dose 3, single for COVID-19 immunization. Patient received a co suspect drug Adalimumab (HUMIRA) from unspecified date to unknown ongoing (Lot Number: unknown, Expiration date: unknown) for moderate to severe rheumatoid arthritis. The patient medical history and concomitant medications were not reported. After the vaccination, the patient experienced FOUR days after second Pfizer Covid Vaccine felt terrible headache/stabbing stomach pain/ hutting from the inside out with Humira (Adalimumab). There was no reported medical history. On 08Apr2021, the patient experienced four days after second Pfizer Covid vaccine felt terrible headache/stabbing stomach pain/ hutting from the inside out. In Apr2021, the four days after second Pfizer Covid vaccine felt terrible headache/stabbing stomach pain/ hutting from the inside out resolved. Pfizer BioNTech Covid-19 Vaccine was also considered suspect. The reporter's causality for the event(s) of four days after second Pfizer Covid vaccine felt terrible headache/stabbing stomach pain/ hutting from the inside out onset 08apr2021, four days after second Pfizer Covid vaccine felt terrible headache/stabbing stomach pain/ hutting from the inside out onset 08Apr2021, four days after second Pfizer Covid vaccine felt terrible headache/stabbing stomach pain/ hutting from the inside out onset 08Apr2021 and four days after second Pfizer Covid vaccine felt terrible headache/stabbing stomach pain/ hutting from the inside out onset 08Apr2021 was not provided. The outcome of the events is recovered or resolved.  No follow-up attempts possible. No further information expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Investigation, SARS-CoV-2 test, Supraventricular tachycardia, Ventricular extrasystoles
Clinical narrative: some SVT episodes; I wore a heart monitor; PVC; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FC3181), via an unspecified route of administration, in left arm on 23Aug2021 16:00 (at the age of 34-years-old) as dose 2, single for COVID-19 immunization. Medical history included supraventricular Tachycardia (SVT) in 2004 and catheter ablation was performed, covid-19 prior to vaccination. Concomitant medication included valacyclovir, fish oil and OLLY Women's Multi. The patient had no known allergies. The patient was not pregnant at the time of vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number:EV00181), via an unspecified route of administration, in left arm on 02Aug2021 15:00 (at the age of 34-years-old) as dose 1, single for COVID-19 immunization after which the patient experienced few heart flutter episodes and shortness of breath. The patient reported that he wore a heart monitor and had some SVT episodes and PVC was noted on the reports a week after second dose in Aug2021. The patient underwent lab tests and procedures which included investigation: PVC was noted on 02Aug2021, sars-cov-2 test: negative on 02Sep2021 Nasal Swab, sars-cov-2 test: negative on 07Sep2021 Nasal Swab. The events resulted in physician office visit. The patient did not receive any treatment for the events. The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dysmenorrhoea, Dyspnoea, Injection site pain, Nausea
Clinical narrative: 11 lb weight gain; Nausea; Shortness of breath; Chest pain; vomiting; Severe menstrual cramps; Pain at her injection site Remodulin; This is a solicited report based on the information received from a contactable consumer (patient) via regulatory authority (MFR Control No: UNT-2021-017551).   A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization; treprostinil sodium (REMODULIN), intravenous from 26Aug2021 (Batch/Lot Number: 938633; Expiration Date: 28Feb2023) and ongoing, at 0.004 ug/kg for secondary pulmonary arterial hypertension. Patient medical history was unknown. Historical vaccine included BNT162B2 for COVID-19 vaccine. Concomitant medication included tadalafil taken for an unspecified indication, start and stop date were not reported. On 05Sep2021, the patient experienced the events of 11 lb weight gain and nausea. On an unreported date in 2021, after her second COVID shot she had chest pain, shortness of breath, couldn't hold anything down. The patient also had severe menstrual cramps and pain at her injection site for Remodulin. Her prescriber advised her to go to the emergency room but initially she chose not to go and then further reported to field nurse that she was feeling a little better. On 05Sep2021, 11 days after initiating IV Remodulin, the patient visited hospital emergency department and admitted to hospital with chief complaints of shortness of breath, 11 pounds weight gain, chest pain, vomiting and nausea. The action taken in response to the events for treprostinil sodium was unknown. The outcome of events weight increased, dyspnoea, chest pain, vomiting, and nausea was unknown and events dysmenorrhea and injection site pain was considered as resolving. The reporter did not provide causality for the events of weight increased, dyspnoea, chest pain, vomiting, dysmenorrhea, injection site pain and nausea.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the 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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting, Weight, Weight increased
Clinical narrative: 11 lb weight gain; Nausea; Shortness of breath; Chest pain; vomiting; Severe menstrual cramps; Pain at her injection site Remodulin; This is a solicited report based on the information received from a contactable consumer (patient) via regulatory authority (MFR Control No: UNT-2021-017551).   A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization; treprostinil sodium (REMODULIN), intravenous from 26Aug2021 (Batch/Lot Number: 938633; Expiration Date: 28Feb2023) and ongoing, at 0.004 ug/kg for secondary pulmonary arterial hypertension. Patient medical history was unknown. Historical vaccine included BNT162B2 for COVID-19 vaccine. Concomitant medication included tadalafil taken for an unspecified indication, start and stop date were not reported. On 05Sep2021, the patient experienced the events of 11 lb weight gain and nausea. On an unreported date in 2021, after her second COVID shot she had chest pain, shortness of breath, couldn't hold anything down. The patient also had severe menstrual cramps and pain at her injection site for Remodulin. Her prescriber advised her to go to the emergency room but initially she chose not to go and then further reported to field nurse that she was feeling a little better. On 05Sep2021, 11 days after initiating IV Remodulin, the patient visited hospital emergency department and admitted to hospital with chief complaints of shortness of breath, 11 pounds weight gain, chest pain, vomiting and nausea. The action taken in response to the events for treprostinil sodium was unknown. The outcome of events weight increased, dyspnoea, chest pain, vomiting, and nausea was unknown and events dysmenorrhea and injection site pain was considered as resolving. The reporter did not provide causality for the events of weight increased, dyspnoea, chest pain, vomiting, dysmenorrhea, injection site pain and nausea.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the 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.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Pneumonia, Respiratory disorder
Clinical narrative: pneumonia; pneumonia; upper respiratory issues; allergic to the Flu Vaccine, Pneumonia Vaccine; This is a spontaneous report from a contactable other healthcare professional. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at dose number unknown, single for immunization. Medical history included allergy to eggs. The patient's concomitant medications were not reported. The reporter stated that the patient was allergic to the flu vaccine and pneumonia vaccine. The patient also had upper respiratory issues and had pneumonia twice on unspecified dates. The reporter asked if the COVID vaccine was safe for the patient. Outcome of the events was unknown.  Pfizer is marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report in situations where another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile and temporal association
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Muscle spasms
Clinical narrative: Bleeding; Cramping; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm on 12Sep2021 12:00 (batch/lot number was not reported) at the age of 40 years old,  as DOSE 2, SINGLE for COVID-19 immunization. The vaccine was administered at a Pharmacy or Drug Store facility type. The patient's medical history was not reported. Patient had no history of COVID-19 infection prior to vaccination. There were no concomitant medications. Patient did not receive other vaccine in four weeks and other medications in two weeks. The patient previously took aspirin [acetylsalicylic acid] and experienced allergies. The patient previously received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm on 21Aug2021 11:45 AM (batch/lot number was not reported) at the age of 40 years old, as DOSE 1, SINGLE for COVID-19 immunization. The patient experienced cramping and bleeding which started the next day (on 13Sep2021) after the 2nd shot. It was reported that patient was still bleeding at the time of reporting (day3 post injection). The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient received treatment for the events. The patient has not recovered from the event bleeding. Outcome of the event cramping was unknown. Patient has not tested for COVID-19 post vaccination  No follow-up attempts are possible; information about the batch/lot number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Asthenia, Cerebrovascular disorder, Condition aggravated, Confusional state
Clinical narrative: This is a spontaneous report from a contactable consumer. A 65-year-old female patient received the second dose of BNT162B2 at 65-year-old, via an unspecified route of administration in arm left on 31Aug2021 11:00 (Batch/Lot Number: EWO164) at single dose for COVID-19 immunisation. Medical history included lupus, cerebrovascular white matter disease, and known allergies: Contrast dye used in Cat Scans severe anaphylaxis. Concomitant medications included acetylsalicylic acid (ASPIRIN), ascorbic acid (VIT C), colecalciferol (VIT D3), zinc, and ubidecarenone (COQ-10). Patient previously received the first dose of BNT162B2 at 65-year-old in left arm on 04Aug2021 08:00 (Lot number: EWO164) for COVID-19 immunisation and tolerated fairly well. On 31Aug2021 13:00, patient experienced bruise at injection site lasting ten day with pain, and having Lupus, it felt as though she had a lupus "flare-up" within hours of receiving the second vaccine, which she had not had this severely, in a number of years. Symptoms included fever, severe fatigue, weakness, transient nerve and muscle pain, increased arthritis pain and stiffness on left side, especially left hand and significant "brain fog", confusion and memory challenges (patient also had cerebrovascular white matter disease and second injection seemingly exacerbated symptoms). After two weeks following the second injection, symptoms decreased, but still remained at a lesser degree. For two years, patient had more or less, maintained stability with lupus symptoms, without use of medication through healthy living and daily cardiovascular exercise. After the second vaccine, there was an overwhelming feeling of a great deal of inflammation in her system. No treatment received for these events. Outcome of events bruise at injection site lasting ten day with pain was resolved, and of other events was resolving. Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Inflammation, Memory impairment, Musculoskeletal stiffness
Clinical narrative: This is a spontaneous report from a contactable consumer. A 65-year-old female patient received the second dose of BNT162B2 at 65-year-old, via an unspecified route of administration in arm left on 31Aug2021 11:00 (Batch/Lot Number: EWO164) at single dose for COVID-19 immunisation. Medical history included lupus, cerebrovascular white matter disease, and known allergies: Contrast dye used in Cat Scans severe anaphylaxis. Concomitant medications included acetylsalicylic acid (ASPIRIN), ascorbic acid (VIT C), colecalciferol (VIT D3), zinc, and ubidecarenone (COQ-10). Patient previously received the first dose of BNT162B2 at 65-year-old in left arm on 04Aug2021 08:00 (Lot number: EWO164) for COVID-19 immunisation and tolerated fairly well. On 31Aug2021 13:00, patient experienced bruise at injection site lasting ten day with pain, and having Lupus, it felt as though she had a lupus "flare-up" within hours of receiving the second vaccine, which she had not had this severely, in a number of years. Symptoms included fever, severe fatigue, weakness, transient nerve and muscle pain, increased arthritis pain and stiffness on left side, especially left hand and significant "brain fog", confusion and memory challenges (patient also had cerebrovascular white matter disease and second injection seemingly exacerbated symptoms). After two weeks following the second injection, symptoms decreased, but still remained at a lesser degree. For two years, patient had more or less, maintained stability with lupus symptoms, without use of medication through healthy living and daily cardiovascular exercise. After the second vaccine, there was an overwhelming feeling of a great deal of inflammation in her system. No treatment received for these events. Outcome of events bruise at injection site lasting ten day with pain was resolved, and of other events was resolving. Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neuralgia, Pyrexia, Systemic lupus erythematosus, Vaccination site bruising
Clinical narrative: This is a spontaneous report from a contactable consumer. A 65-year-old female patient received the second dose of BNT162B2 at 65-year-old, via an unspecified route of administration in arm left on 31Aug2021 11:00 (Batch/Lot Number: EWO164) at single dose for COVID-19 immunisation. Medical history included lupus, cerebrovascular white matter disease, and known allergies: Contrast dye used in Cat Scans severe anaphylaxis. Concomitant medications included acetylsalicylic acid (ASPIRIN), ascorbic acid (VIT C), colecalciferol (VIT D3), zinc, and ubidecarenone (COQ-10). Patient previously received the first dose of BNT162B2 at 65-year-old in left arm on 04Aug2021 08:00 (Lot number: EWO164) for COVID-19 immunisation and tolerated fairly well. On 31Aug2021 13:00, patient experienced bruise at injection site lasting ten day with pain, and having Lupus, it felt as though she had a lupus "flare-up" within hours of receiving the second vaccine, which she had not had this severely, in a number of years. Symptoms included fever, severe fatigue, weakness, transient nerve and muscle pain, increased arthritis pain and stiffness on left side, especially left hand and significant "brain fog", confusion and memory challenges (patient also had cerebrovascular white matter disease and second injection seemingly exacerbated symptoms). After two weeks following the second injection, symptoms decreased, but still remained at a lesser degree. For two years, patient had more or less, maintained stability with lupus symptoms, without use of medication through healthy living and daily cardiovascular exercise. After the second vaccine, there was an overwhelming feeling of a great deal of inflammation in her system. No treatment received for these events. Outcome of events bruise at injection site lasting ten day with pain was resolved, and of other events was resolving. Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer. A 65-year-old female patient received the second dose of BNT162B2 at 65-year-old, via an unspecified route of administration in arm left on 31Aug2021 11:00 (Batch/Lot Number: EWO164) at single dose for COVID-19 immunisation. Medical history included lupus, cerebrovascular white matter disease, and known allergies: Contrast dye used in Cat Scans severe anaphylaxis. Concomitant medications included acetylsalicylic acid (ASPIRIN), ascorbic acid (VIT C), colecalciferol (VIT D3), zinc, and ubidecarenone (COQ-10). Patient previously received the first dose of BNT162B2 at 65-year-old in left arm on 04Aug2021 08:00 (Lot number: EWO164) for COVID-19 immunisation and tolerated fairly well. On 31Aug2021 13:00, patient experienced bruise at injection site lasting ten day with pain, and having Lupus, it felt as though she had a lupus "flare-up" within hours of receiving the second vaccine, which she had not had this severely, in a number of years. Symptoms included fever, severe fatigue, weakness, transient nerve and muscle pain, increased arthritis pain and stiffness on left side, especially left hand and significant "brain fog", confusion and memory challenges (patient also had cerebrovascular white matter disease and second injection seemingly exacerbated symptoms). After two weeks following the second injection, symptoms decreased, but still remained at a lesser degree. For two years, patient had more or less, maintained stability with lupus symptoms, without use of medication through healthy living and daily cardiovascular exercise. After the second vaccine, there was an overwhelming feeling of a great deal of inflammation in her system. No treatment received for these events. Outcome of events bruise at injection site lasting ten day with pain was resolved, and of other events was resolving. Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction, Libido decreased, Testicular pain, Testicular swelling
Clinical narrative: I have noticed significant decrease in libido and inability to maintain an erection; I have noticed significant decrease in libido and inability to maintain an erection; I experienced swelling and pains in my testicles the day after each dose; I experienced swelling and pains in my testicles the day after each dose; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8732), via an unspecified route of administration, administered in left arm on 24Mar2021 15:00 (33-year-old at time of vaccination) as single dose for COVID-19 immunisation. Medical history included PTSD. The patient had no known allergies. Concomitant medications included finasteride (FINASTERIDE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported he experienced swelling and pains in his testicles the day after each dose (from 25Mar2021 after dose 1). Since then, he has noticed significant decrease in libido and inability to maintain an erection. Event onset date was also reported as 22Mar2021 08:00 (pending clarification). The events were assessed as non-serious. The adverse events did not result in doctor or other healthcare professional office/clinic visit, or emergency room/department or urgent care, or prolonged hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered: Clinic No therapeutic measures were taken as a result of the events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Investigation, Off label use, Somnolence
Clinical narrative: sleep the whole next day; Off label use; Extra dose administered; This is a spontaneous report from a contactable other HCP. This other HCP reported for a 72-year-old female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 30Aug2021 (at the age of 72-years-old) as DOSE 3, SINGLE for COVID-19 immunization. Medical history included breast cancer from an unknown date and unknown if ongoing. Concomitant medication included fulvestrant (FASLODEX) taken for an unspecified indication. Historical vaccine included second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE and also included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE both for COVID-19 immunization. It was reported that, patient was having COVID booster vaccine on 30Aug2021; extra dose administered and had to sleep the whole next day on 31Aug2021 and night then felt better. Patient has repeat scans end of this month. The patient underwent lab tests and procedures which included investigation (blood work) which was getting better each time per patient on an unspecified date. The outcome of event sleep the whole next day was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Extra dose administered, Fatigue, Headache, Off label use
Clinical narrative: dose_number=3; dose_number=3; Chills; headache; fatigue; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 61-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration, administered in Left arm on 15Sep2021 15:00 at the age of 61-years-old as dose 3, single for covid-19 immunisation. Medical history included AS (ankylosing spondylitis) from an unknown date, HD (Huntington's disease) from an unknown date and atrial tachycardia from an unknown date. The patient had no known allergies. Concomitant medications included infliximab (REMICADE) taken for an unspecified indication, start and stop date were not reported; methotrexate (METHOTREXATE) taken for an unspecified indication, start and stop date were not reported; metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported and atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported received within 2 weeks of vaccination. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unspecified date as single dose and second dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unspecified date as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 15Sep2021, the patient experienced Chills, headache, fatigue and dose_number=3 (off label use), dose_number=3 (extra dose administered) on 15Sep2021 at 15:00. The patient received treatment for the adverse events with Tylenol. Adverse events resulted in none of the above. The outcome of events, Chills, headache and fatigue was recovering, and other events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Off label use
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-healthcare professional. An 81-year-old female patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiration date not reported), at the age of 81, via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. Historical vaccine included the first dose and second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine; batch/lot# and expiration date not reported) via an unspecified route of administration, both doses on an unspecified date, both single doses, for COVID-19 immunization. Reportedly, on Sep 14, 2021 (after patient took the booster shot), she experienced side effects of slight headache and fatigue; with outcome of unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Facial paralysis
Clinical narrative: bells palsy; facial paralysis; This is a spontaneous report from a non-contactable consumer (patient). A 51-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included covid-19 from an unknown date (if covid prior vaccination: Yes). The patient's concomitant medications were not reported. The patient experienced Bell's palsy and facial paralysis on 10Aug2021. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Therapeutic measures were taken as a result of the events which included treatment with an unspecified medicine. The patient was not tested post vaccination. The patient did not recover from the events.   No follow up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Foot fracture, Influenza like illness, Limb discomfort, Myalgia, Pain in extremity
Clinical narrative: Foot fracture; Pain of extremities; Limb discomfort; Muscle pain; Flu like symptoms; This is a solicited report based on the information received by Pfizer (MFR Control No. # 21K-163-3980888-00). A contactable consumer (patient) reported that a 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVCOVID-19 immunisation; and adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at citrate free for moderate to severe rheumatoid arthritis. Medical history included rheumatoid arthritis. The patient's concomitant medications were not reported. It was unknown if patient was enrolled in a covid-19 vaccine trial. The patient experienced foot fracture in Feb2021 with outcome of not recovered; pain of extremities, limb discomfort, muscle pain and flu like symptoms all on an unspecified date in 2021. It was reported that the patient had discomfort in toe, muscle pain and flu like symptoms. She experienced aches and pain in toes and hands. In feb2021, the patient experienced foot fracture. The outcome of foot fracture, pain of extremities and limb discomfort was not recovered; while Muscle pain was recovered on an unspecified date and flu like symptoms was recovered on an unspecified date in 2021. The action taken in response to the events for adalimumab was unknown. The reporter's causality for the event(s) of foot fracture and aches and pain in toes and hands was not provided. the reporter's causality for the event(s) of discomfort in toe, muscle pain and flu like symp-toms with humira (adalimumab) was no reasonable possibility.  The reporter's assessment of the causal relationship of the events foot fracture, pain of extremities, limb discomfort, muscle pain and flu like symptoms with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the 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: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 virus test positive; Suspected COVID-19/symptoms of Covid; This is a solicited report from the marketing program facilitated collect received from a contactable consumer (patient) based on the information received by Pfizer from AbbVie manufacture number (21K-163-4072617-00).  A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, lot number and expiry date were not reported) intramuscular on 27Aug2021 (at the age of 43 years old) as dose 1, single for covid-19 vaccination; and adalimumab (HUMIRA, solution for injection in pre-filled pen), subcutaneous from 16Jun2021 to 2021, at 40 mg, weekly for moderate to severe hidradenitis suppurativa. Medical history included moderate to severe hidradenitis suppurativa from an unknown date and unknown if ongoing. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient's concomitant medications were not reported. In Sep2021, the patient experienced COVID test positive and suspected COVID-19. On 02Sep2021, the patient experienced symptoms of Covid.  The action taken in response to the events for bnt162b2 was not applicable, and for adalimumab was unknown. The outcome of the events was recovering.  Solicited report from the USA by a consumer of a 43 year old female with events of non-serious COVID POSITIVE and SYMPTOMS OF COVID with HUMIRA (ADALIMUMAB). There was no reported medical history. In Sep2021, the patient experienced COVID POSITIVE. On 02Sep2021, the patient experienced SYMPTOMS OF COVID. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 27Aug2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech, lot number unknown, expiration date unknown. Concomitant drugs and dates of administration (exclude those used to treat event): Concomitant drugs not reported. Other relevant history: Not reported. Relevant Laboratory & Other Diagnostic Tests. Sep2021 COVID TEST: Positive. Describe reactions (including relevant test/lab data): COVID-19 virus test positive (SARS-CoV-2 test positive) - Recovering/resolvingSuspected COVID-19 (Suspected COVID-19) - Recovering/resolving  The reporter's causality for the events of COVID test positive with BNT162B2 and adalimumab (HUMIRA) was no reasonable possibility. The reporter's causality for the event of suspected COVID-19/symptoms of Covid with BNT162B2 and adalimumab (HUMIRA) was not provided.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: The reported COVID test positive and suspected COVID-19 is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration. Case will be reassessed upon receipt of additional information.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chronic obstructive pulmonary disease, Dyspnoea, Internal haemorrhage
Clinical narrative: Internal bleeding; Had trouble breathing; Chronic obstructive pulmonary disease; This is a solicited report FACILITATED COLLECT from a contactable consumer (patient) based on the information received by Pfizer from (MFR Control No. 21K-163-4072803-00).   A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 15Jun2021 (Batch/Lot number was not reported) as dose 1, single at 70 years old for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported), at an unknown dose citrate free for moderate to severe chronic plaque psoriasis. The patient's medical history and concomitant medications were not reported. On unknown dates, the patient (an elderly female) experienced internal bleeding and non-serious chronic obstructive pulmonary disease. The patient had internal bleeding. She had trouble breathing and was diagnosed with chronic obstructive pulmonary disease. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken for adalimumab was unknown. The outcome of the events internal bleeding and chronic obstructive pulmonary disease was not recovered while for the event had trouble breathing was unknown.   Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the events of internal bleeding and chronic obstructive pulmonary disease was not provided. opinion is that the events of internal bleeding and chronic obstructive pulmonary disease are not assessable.  Causality for bnt162b2 for Internal bleeding and Chronic obstructive pulmonary disease: Causality as per reporter: Possible.   The reporter's assessment of the causal relationship of the event had trouble breathing with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events internal bleeding, dyspnoea and COPD cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Petechiae
Clinical narrative: little bloodshot/spots; This is a spontaneous report from a contactable consumer. A female patient (wife) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Aug2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced little bloodshot on 01Aug2021. The consumer reported that his wife received the vaccine on 01Aug2021 and has since then broke out and it has not went away. He was in fear for his wife these were not like hives but look like little bloodshot, his wife has already went to urgent care and they prescribed her a steroid and told her to get Claritin, this only made the spots fade but not go away, And at time of reporting that the steroid was finished the spots were back and slowly spreading. This all started the day she took the vaccine. The outcome of the event was not resolved.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Interchange of vaccine products, Off label use
Clinical narrative: had Moderna and got Pfizer 2 months later; had Moderna and got Pfizer 2 months later; they had to call back to the hospital for permission to be able to combine 2 drugs to flat line her a minute before they could re-start her heart properly; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (Reporter's friend). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an un-specified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. Historical vaccine included: first dose of MODERNA COVID-19 VACCINE for COVID-19 immunization. It was mentioned that, patient was looking for the 3-D form of the protein that's being formed, by our human cells. Patient want to see the quaternary form of the spike protein being formed, nothing there in the gene bank for it. Patient was upset that this information was not available to the public so that they can verify quality control measures for themselves. Patient believes these quality control measures would involve cryotransfer electromicroscopy, and crystallography. Caller was asking for more transparency, as this information should be available in protein banks and that a manual should have been created for it [COMIRNATY]" as patient having to work backwards to find the information needs. The 3-D form of the protein that's being formed, by our human cells was not available to the front line. Patient proceeded to explain the SDS to agent over the phone. Caller also reports another friend had to call the ambulance they had to call back to the hospital for permission to be able to com-bine 2 drugs to flat line a minute before they could re-start heart properly. Patient was in the telemetry unit for a week. Caller asked how exactly the spike protein gets to the surface of the cells after vaccination with COMIRNATY? It was reported that through research a Cation can form an electrostatic bound to the endosome of the muscle cell. Ribosomes would actually form spike protein. Consider the risk of these vaccines to be quite high and added feel like raped everyone with this vaccine, when did not provide all of the information to the general public and patient was asking for more decency. The outcome of the events were unknown.   The lot number was not provided. Information on lot number has been requested during follow up. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101212357 same reporter/drug, different patients.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Scleritis
Clinical narrative: Scleritis; This is a spontaneous report from a contactable other healthcare professional (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: 301208A), via an unspecified route of administration, administered in left arm on 03Sep2021 15:30 (at the age of 45 years old) as dose 1, single for COVID-19 immunisation. The patient has no medical history and has no known allergies. The patient is not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. No other vaccine was given in four weeks and no other medications in two weeks. On 07Sep2021 21:45, the patient developed scleritis in her right eye. The event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of scleritis which included Steroid eye drops every 2 hours x 14 days. The patient underwent lab tests and procedures which included COVID test post vaccination: PCR via nasal swab on 09Sep2021 which was negative. The outcome of the event was recovering.; Sender's Comments: Based on the information available and a close temporal association a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Scleritis.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diabetes mellitus, Lacrimation increased, Musculoskeletal disorder, Neuropathy peripheral
Clinical narrative: This is a Solicited report based on the information received by Pfizer from a contactable female consumer reported for herself.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation and risankizumab (SKYRIZI), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, 1x/day for psoriasis.  The patient medical history and the patient's concomitant medications were not reported. On unknown dates, the patient had diabetes and neuropathy, she had a lot of neck issues from previous car wrecks,  her arm sore for the first day of vaccination, she had sinus issues, eyes watery and a cough a day or two after. The outcome of the events was unknown.   The reporter's causality for the events of diabetes, pain/ neck issues from car wrecks unknown onset and neuropathy with Skyrizi(Risankizumab) was no reasonable possibility.   The reporter's assessment of the causal relationship of the events with bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events diabetes, neuropathy, Pain, Sinus disorder, Lacrimation increased, Cough, Musculoskeletal disorder, Road traffic accident and Pain in extremity  cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.