chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 5.0
Sex: F
Vaccine: MMRV, MMRV, VARCEL
Symptoms: Erythema, Pruritus, Skin lesion, Varicella virus test
Clinical narrative: varicella-type rash that appeared in a patient after receiving VARIVAX/5 to 6 lesions appeared on the patient's extremities; This spontaneous report was received from a physician and refers to a 5-year-old female patient.  The patient's medical history was not reported. Her concurrent conditions included allergies to pistachio, walnuts, and Cashew's. Concomitant medications included epinephrine (EPIPEN) and salbutamol (ALBUTEROL). No recent exposition to chickenpox or Shingles was reported.   On 09-SEP-2023, the patient was vaccinated with measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD) injection, therapy type: rHA, valid lot #X011979, expiration date: 18-JUL-2024 (strength, route of administration, and indication were not provided) (also reported that was vaccinated with varicella virus vaccine live (OKA/MERCK) (VARIVAX) injection, 0.5 milliliter, administered for prophylaxis (strength, expiry date, and route of administration were not provided) (Lot number X011979 was an invalid lot number for VARIVAX), conflicting information).   On 17-SEP-2023, the patient experienced varicella-type rash after receiving the vaccine. 5 to 6 lesions appeared on the patient's extremities (also reported as left arm, 5 in left and 1 in right) of silver dollar size flat erythematous base. Maximum temperature was 98.3 F. No treatment was given for the event. The physician was interest in Varicella Zoster Virus (VZV) Analysis by polymerase chain reaction (PCR). Consequently, the patient was enrolled in the Program to identify if VZV was present and if it was present, to identify if it was associated with the wild-type (WT) VZV strain or with the Oka/Merck vaccine strain. On 19-SEP-2023, were collected vesicle and papule samples. On 20-SEP-2023, three samples of swab vesicles were sent to laboratory. Patient was not on antivirals at that time. On 21-SEP-2023, samples arrived at laboratory. It was reported that beta-globulin DNA was amplified, and final PCR results were negative (no VZV identified, adequate specimen). On 10-OCT-2023, physician was informed that PCR was negative and did not detect the presence of varicella zoster virus. At the time of reporting, the patient had not recovered from the event (also reported as healing area).  The causal relationship between the event, varicella virus vaccine live (OKA/MERCK) (VARIVAX), and measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD) was not provided.
Age: 5.0
Sex: F
Vaccine: MMRV, MMRV, VARCEL
Symptoms: Blister, Erythema, Papule, Polymerase chain reaction, Rash vesicular
Clinical narrative: varicella-type rash that appeared in a patient after receiving VARIVAX/5 to 6 lesions appeared on the patient's extremities; This spontaneous report was received from a physician and refers to a 5-year-old female patient.  The patient's medical history was not reported. Her concurrent conditions included allergies to pistachio, walnuts, and Cashew's. Concomitant medications included epinephrine (EPIPEN) and salbutamol (ALBUTEROL). No recent exposition to chickenpox or Shingles was reported.   On 09-SEP-2023, the patient was vaccinated with measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD) injection, therapy type: rHA, valid lot #X011979, expiration date: 18-JUL-2024 (strength, route of administration, and indication were not provided) (also reported that was vaccinated with varicella virus vaccine live (OKA/MERCK) (VARIVAX) injection, 0.5 milliliter, administered for prophylaxis (strength, expiry date, and route of administration were not provided) (Lot number X011979 was an invalid lot number for VARIVAX), conflicting information).   On 17-SEP-2023, the patient experienced varicella-type rash after receiving the vaccine. 5 to 6 lesions appeared on the patient's extremities (also reported as left arm, 5 in left and 1 in right) of silver dollar size flat erythematous base. Maximum temperature was 98.3 F. No treatment was given for the event. The physician was interest in Varicella Zoster Virus (VZV) Analysis by polymerase chain reaction (PCR). Consequently, the patient was enrolled in the Program to identify if VZV was present and if it was present, to identify if it was associated with the wild-type (WT) VZV strain or with the Oka/Merck vaccine strain. On 19-SEP-2023, were collected vesicle and papule samples. On 20-SEP-2023, three samples of swab vesicles were sent to laboratory. Patient was not on antivirals at that time. On 21-SEP-2023, samples arrived at laboratory. It was reported that beta-globulin DNA was amplified, and final PCR results were negative (no VZV identified, adequate specimen). On 10-OCT-2023, physician was informed that PCR was negative and did not detect the presence of varicella zoster virus. At the time of reporting, the patient had not recovered from the event (also reported as healing area).  The causal relationship between the event, varicella virus vaccine live (OKA/MERCK) (VARIVAX), and measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD) was not provided.
Age: 5.0
Sex: F
Vaccine: MMRV, MMRV, VARCEL
Symptoms: Skin lesion, Varicella virus test negative
Clinical narrative: varicella-type rash that appeared in a patient after receiving VARIVAX/5 to 6 lesions appeared on the patient's extremities; This spontaneous report was received from a physician and refers to a 5-year-old female patient.  The patient's medical history was not reported. Her concurrent conditions included allergies to pistachio, walnuts, and Cashew's. Concomitant medications included epinephrine (EPIPEN) and salbutamol (ALBUTEROL). No recent exposition to chickenpox or Shingles was reported.   On 09-SEP-2023, the patient was vaccinated with measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD) injection, therapy type: rHA, valid lot #X011979, expiration date: 18-JUL-2024 (strength, route of administration, and indication were not provided) (also reported that was vaccinated with varicella virus vaccine live (OKA/MERCK) (VARIVAX) injection, 0.5 milliliter, administered for prophylaxis (strength, expiry date, and route of administration were not provided) (Lot number X011979 was an invalid lot number for VARIVAX), conflicting information).   On 17-SEP-2023, the patient experienced varicella-type rash after receiving the vaccine. 5 to 6 lesions appeared on the patient's extremities (also reported as left arm, 5 in left and 1 in right) of silver dollar size flat erythematous base. Maximum temperature was 98.3 F. No treatment was given for the event. The physician was interest in Varicella Zoster Virus (VZV) Analysis by polymerase chain reaction (PCR). Consequently, the patient was enrolled in the Program to identify if VZV was present and if it was present, to identify if it was associated with the wild-type (WT) VZV strain or with the Oka/Merck vaccine strain. On 19-SEP-2023, were collected vesicle and papule samples. On 20-SEP-2023, three samples of swab vesicles were sent to laboratory. Patient was not on antivirals at that time. On 21-SEP-2023, samples arrived at laboratory. It was reported that beta-globulin DNA was amplified, and final PCR results were negative (no VZV identified, adequate specimen). On 10-OCT-2023, physician was informed that PCR was negative and did not detect the presence of varicella zoster virus. At the time of reporting, the patient had not recovered from the event (also reported as healing area).  The causal relationship between the event, varicella virus vaccine live (OKA/MERCK) (VARIVAX), and measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD) was not provided.
Age: 66.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting for 10 hours, caused her to become dehydrated and HR went up to 140s, was seen in the ED for IV fluids and antinausea medication.
Age: 66.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Dehydration, Vomiting
Clinical narrative: Vomiting for 10 hours, caused her to become dehydrated and HR went up to 140s, was seen in the ED for IV fluids and antinausea medication.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ, FLU4, MENB, MNQ
Symptoms: Dizziness, Emotional distress, Feeling abnormal, Irregular breathing, Pallor
Clinical narrative: Patient received the flu vaccine first, followed by the 2 meningitis vaccines. After the second shot, she felt unwell but by the 3rd one, she knew something was wrong. She stopped speaking and was swaying in her seat, her eyes rolled back, her legs straightened and stiffened. She was not responsive. The nurse yelled for help and I left the room to get the doctor and when I returned she had come to. They gave her some water and she ate half a biscuit. We stayed another 20 minutes to make sure she was OK. Since her vaccines she has high heart rate even when resting. Prior to vaccination her resting heart rate was around 70 bpm and now it is frequently at 100 bpm and if she stands up and walks slowly, it has gone up to 140 bpm. She feels foggy in class. She hears the teacher speaking but cannot follow or engage in instruction. She frequently needs to put more effort into breathing. She also has headaches, feels dizzy and is nauseous.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ, FLU4, MENB, MNQ
Symptoms: Posture abnormal, Syncope, Tonic clonic movements, Vomiting
Clinical narrative: Patient received the flu vaccine first, followed by the 2 meningitis vaccines. After the second shot, she felt unwell but by the 3rd one, she knew something was wrong. She stopped speaking and was swaying in her seat, her eyes rolled back, her legs straightened and stiffened. She was not responsive. The nurse yelled for help and I left the room to get the doctor and when I returned she had come to. They gave her some water and she ate half a biscuit. We stayed another 20 minutes to make sure she was OK. Since her vaccines she has high heart rate even when resting. Prior to vaccination her resting heart rate was around 70 bpm and now it is frequently at 100 bpm and if she stands up and walks slowly, it has gone up to 140 bpm. She feels foggy in class. She hears the teacher speaking but cannot follow or engage in instruction. She frequently needs to put more effort into breathing. She also has headaches, feels dizzy and is nauseous.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ, FLU4, MENB, MNQ
Symptoms: Aphasia, Brain fog, Computerised tomogram normal, Dizziness, Dyskinesia
Clinical narrative: Patient received the flu vaccine first, followed by the 2 meningitis vaccines. After the second shot, she felt unwell but by the 3rd one, she knew something was wrong. She stopped speaking and was swaying in her seat, her eyes rolled back, her legs straightened and stiffened. She was not responsive. The nurse yelled for help and I left the room to get the doctor and when I returned she had come to. They gave her some water and she ate half a biscuit. We stayed another 20 minutes to make sure she was OK. Since her vaccines she has high heart rate even when resting. Prior to vaccination her resting heart rate was around 70 bpm and now it is frequently at 100 bpm and if she stands up and walks slowly, it has gone up to 140 bpm. She feels foggy in class. She hears the teacher speaking but cannot follow or engage in instruction. She frequently needs to put more effort into breathing. She also has headaches, feels dizzy and is nauseous.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ, FLU4, MENB, MNQ
Symptoms: Dyspnoea, Eye movement disorder, Headache, Heart rate increased, Malaise
Clinical narrative: Patient received the flu vaccine first, followed by the 2 meningitis vaccines. After the second shot, she felt unwell but by the 3rd one, she knew something was wrong. She stopped speaking and was swaying in her seat, her eyes rolled back, her legs straightened and stiffened. She was not responsive. The nurse yelled for help and I left the room to get the doctor and when I returned she had come to. They gave her some water and she ate half a biscuit. We stayed another 20 minutes to make sure she was OK. Since her vaccines she has high heart rate even when resting. Prior to vaccination her resting heart rate was around 70 bpm and now it is frequently at 100 bpm and if she stands up and walks slowly, it has gone up to 140 bpm. She feels foggy in class. She hears the teacher speaking but cannot follow or engage in instruction. She frequently needs to put more effort into breathing. She also has headaches, feels dizzy and is nauseous.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ, FLU4, MENB, MNQ
Symptoms: Musculoskeletal stiffness, Nausea, Unresponsive to stimuli
Clinical narrative: Patient received the flu vaccine first, followed by the 2 meningitis vaccines. After the second shot, she felt unwell but by the 3rd one, she knew something was wrong. She stopped speaking and was swaying in her seat, her eyes rolled back, her legs straightened and stiffened. She was not responsive. The nurse yelled for help and I left the room to get the doctor and when I returned she had come to. They gave her some water and she ate half a biscuit. We stayed another 20 minutes to make sure she was OK. Since her vaccines she has high heart rate even when resting. Prior to vaccination her resting heart rate was around 70 bpm and now it is frequently at 100 bpm and if she stands up and walks slowly, it has gone up to 140 bpm. She feels foggy in class. She hears the teacher speaking but cannot follow or engage in instruction. She frequently needs to put more effort into breathing. She also has headaches, feels dizzy and is nauseous.
Sex: U
Vaccine: MMR
Symptoms: Rash morbilliform
Clinical narrative: an 18-year-old patient last year who was fully vaccinated with MMRII who presented with a measles like rash post vaccination; This spontaneous report has been received from a nurse regarding to an 18-years-old patient of an unknown gender.   The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided.   On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) (strength, dose, frequency, route of administration, indication, lot # and expiration date were not provided). Other suspect therapies included sterile diluent (STERILE DILUENT) (lot # and expiration date were not provided).  On an unknown date (also reported as last year), the patient was fully vaccinated with measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) and on an unknown date, presented with a measles like rash post vaccination (rash morbilliform). The reporter stated that the Physician who cared for the patient did not believe it was measles nor was it related to the vaccine. It was unknown if the patient sought medical attention. At the time of this report, the outcome for the event was unknown.   The causal relationship between rash morbilliform and measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) was not provided.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product use issue
Clinical narrative: FBE reported AE for HCP.  HCP reported GARDASIL 9 series was started/administered to a 53 year old male patient.  It is unknown age of patient at 2nd and 3rd doses.   No other information was provided.  No additional AEs or PQC reported. AE reported; no adverse event; This spontaneous report was received from a physician via a company representative, and refers to a 53-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date at the age of 53 years, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered as prophylaxis (Drug use in unapproved age group) ( (strength, dose description, lot #, expiry date, and route of administration were not provided). On an unspecified date, the patient received 2 and 3 doses of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No adverse events were reported.
Sex: M
Vaccine: UNK
Symptoms: Pain in extremity, Swelling
Clinical narrative: slight swelling; side effects of pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (slight swelling) and PAIN IN EXTREMITY (side effects of pain in the arm) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 06-Oct-2023, the patient experienced SWELLING (slight swelling) and PAIN IN EXTREMITY (side effects of pain in the arm). At the time of the report, SWELLING (slight swelling) and PAIN IN EXTREMITY (side effects of pain in the arm) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.  Patient received the vaccine yesterday at 6 pm and husband and wife had side effects of pain in the arm and slight swelling.   This case was linked to US-MODERNATX, INC.-MOD-2023-744894 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-744894:Wife case
Sex: U
Vaccine: COVID19
Symptoms: Sarcoidosis
Clinical narrative: There are 5 published case reports on patients developing sarcoidosis in close time proximity to COVID-19 mRNA vaccination; This is a literature report.  A patient (no qualifiers provided) received bnt162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SARCOIDOSIS (medically significant), outcome "unknown", described as "There are 5 published case reports on patients developing sarcoidosis in close time proximity to COVID-19 mRNA vaccination".; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported event SARCOIDOSIS and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.,Linked Report(s) : US-PFIZER INC-PV202300165539 same article/drug/event and different patient;US-PFIZER INC-202300319561 same article/drug/event and different patient;US-PFIZER INC-202300319562 same article/drug/event and different patient;US-PFIZER INC-PV202300165539 same article/drug/event and different patient;US-PFIZER INC-202300319563 same article/drug/event and different patient;US-PFIZER INC-202300319564 same article/drug/event and different patient;
Sex: U
Vaccine: COVID19
Symptoms: Sarcoidosis
Clinical narrative: There are 5 published case reports on patients developing sarcoidosis in close time proximity to COVID-19 mRNA vaccination; This is a literature report for the following literature source(s):   A patient (no qualifiers provided) received bnt162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SARCOIDOSIS (medically significant), outcome "unknown", described as "There are 5 published case reports on patients developing sarcoidosis in close time proximity to COVID-19 mRNA vaccination".; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event Sarcoidosis and the use of suspect product bnt162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN),  cannot be fully excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300319518 Same Article/drug/event and different patient;US-PFIZER INC-PV202300165539 same article/drug/event and different patient;
Sex: U
Vaccine: COVID19
Symptoms: Sarcoidosis
Clinical narrative: There are 5 published case reports on patients developing sarcoidosis in close time proximity to COVID-19 mRNA vaccination; This is a literature report.  A patient (no qualifiers provided) received bnt162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SARCOIDOSIS (medically significant), outcome "unknown", described as "There are 5 published case reports on patients developing sarcoidosis in close time proximity to COVID-19 mRNA vaccination".; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event Sarcoidosis and the use of suspect product bnt162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN),  cannot be fully excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300319518 Same Article/drug/event and different patient;US-PFIZER INC-PV202300165539 same article/drug/event and different patient;
Sex: U
Vaccine: COVID19
Symptoms: Sarcoidosis
Clinical narrative: There are 5 published case reports on patients developing sarcoidosis in close time proximity to COVID-19 mRNA vaccination; This is a literature report.  A patient (no qualifiers provided) received bnt162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SARCOIDOSIS (medically significant), outcome "unknown", described as "There are 5 published case reports on patients developing sarcoidosis in close time proximity to COVID-19 mRNA vaccination".  DISCUSSION: The current patient qualified for the diagnosis of clinical cardiac sarcoidosis via the 2014 HRS criteria, and while myocarditis was in the differential, the patient presented uniquely from the typical COVID19 vaccine-induced myocarditis patient. Sustained VT is not a frequently reported feature of COVID19 vaccine induced myocarditis; amongst 139 adolescents diagnosed with vaccine induced myocarditis, zero patients developed sustained VT, and non-sustained VT was rare (5%). To date, there are 5 published case reports on patients developing sarcoidosis in close time proximity to COVID-19 mRNA vaccination.; Sender's Comments: Based on the available information in the case, an association between the reported events SARCOIDOSIS and The suspected drug cannot be ruled out.  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.,Linked Report(s) : US-PFIZER INC-PV202300165539 Same Article/drug/event and different patient;US-PFIZER INC-PV202300165539 same article/drug/event and different patient;US-PFIZER INC-202300319518 same article/drug/event and different patient;
Sex: U
Vaccine: COVID19
Symptoms: Sarcoidosis
Clinical narrative: There are 5 published case reports on patients developing sarcoidosis in close time proximity to COVID-19 mRNA vaccination; This is a literature report.  A patient (no qualifiers provided) received bnt162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SARCOIDOSIS (medically significant), outcome "unknown", described as "There are 5 published case reports on patients developing sarcoidosis in close time proximity to COVID-19 mRNA vaccination".; Sender's Comments: Based on the information provided in the narrative, a causal association between the event Sarcoidosis and the suspect drug 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.,Linked Report(s) : US-PFIZER INC-PV202300165539 same article/drug/event and different patient;US-PFIZER INC-202300319518 same article/drug/event and different patient;
Sex: F
Vaccine: COVID19
Symptoms: Tooth abscess
Clinical narrative: trying to fight off abscessed teeth; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 72-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: TOOTH ABSCESS (medically significant), outcome "unknown", described as "trying to fight off abscessed teeth". Therapeutic measures were taken as a result of tooth abscess. Clinical course: Patient was a nurse and under understands the immune system. For the last week she had been trying to fight off abscessed teeth. She was scheduled an appointment for her sixth booster. It would be her sixth booster. She was trying to support her immune system. Had some teeth pulled (extraction) yesterday and was on antibiotics and immune support supplements. She was thinking she should probably not go ahead with the vaccine while she was still on antibiotics and on immune support supplements. Clarified she was doubting the efficacy of a booster while she was already under treatment for an infection. The way she understands how mRNA works, she was doubting if it would be effective. All her previous COVID-19 Vaccines were by Pfizer. Confirmed she had not gotten the latest COVID-19 Vaccine yet, she was scheduled for it tomorrow, 07Oct2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event Tooth Abscess with the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, SARS-CoV-2 test, Tinnitus
Clinical narrative: Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received bnt162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6198) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "CTCL" (unspecified if ongoing); "PCN allergy" (unspecified if ongoing); "bee venom allergy" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 10Mar2021, outcome "not recovered", described as "Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose". The events "experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus.  Additional information: The patient was evaluated by ENT and audiologist. MRI ordered; no causes identified.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300321222 same patient/AE, different drug dose;
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging normal, Tinnitus
Clinical narrative: Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received bnt162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6198) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "CTCL" (unspecified if ongoing); "PCN allergy" (unspecified if ongoing); "bee venom allergy" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 10Mar2021, outcome "not recovered", described as "Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose". The events "experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus.  Additional information: The patient was evaluated by ENT and audiologist. MRI ordered; no causes identified.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300321222 same patient/AE, different drug dose;
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 60-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: Gh9702) at the age of 59 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: ER8727), in left arm, on 14Apr2021 as dose 2, single (Lot number: ER8729), in left arm, on 08Dec2021 as dose 3 (booster), single (Lot number: Fj1620), in left arm and on 16May2022 as dose 4 (booster), single (Lot number: Fm9992), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic thoracic and cervical pain" (unspecified if ongoing); "Chronic thoracic and cervical pain" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Gabapentin caused leg cramps years ago., reaction(s): "leg cramps". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 28Sep2023 to 02Oct2023.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events Vaccination failure and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300320790 same patient, different event/ drug;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 06Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300321236 Same patient/ reporter, different drug/events;
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Vaccine brand: Pfizer/BioNTech, vaccine dose number: 2/ Vaccine brand: Moderna Booster, vaccine dose number: 3; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 26Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 03Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 13Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing); "narcolepsy" (unspecified if ongoing); "known allergies: Shell fish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Vaccine brand: Pfizer/BioNTech, vaccine dose number: 2/ Vaccine brand: Moderna Booster, vaccine dose number: 3". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 23Sep2023 to 28Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300321178 Same patient, different drug, different event;
Sex: F
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: somewhat more uncomfortable post-vaccine time; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 06Oct2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An adult female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 at 08:30 as dose 4 (booster), single (Lot number: GJ3277) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "MCS (Multiple chemical sensitivities)" (unspecified if ongoing); "graves' disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE , Site and Route of injection: Upper right arm, Route of administration: Intramuscular, Batch/Lot number: EL3247), administration date: 01Feb2021, for Covid-19 immunization, reaction(s): "somewhat more uncomfortable post-vaccine time"; bnt162b2 (DOSE 2 , SINGLE , Site and Route of injection: Upper right arm, Route of administration: Intramuscular, Batch/Lot number: EN6201), administration date: 22Feb2021, for Covid-19 immunization, reaction(s): "somewhat more uncomfortable post-vaccine time"; bnt162b2 (DOSE 3 (BOOSTER), SINGLE , Time (24hr): 13:00, Site and Route of injection: Upper right arm, Route of administration: Intramuscular, Batch/Lot number: FH8030), administration date: 02Nov2021, for Covid-19 immunization, reaction(s): "somewhat more uncomfortable post-vaccine time". The following information was reported: DISCOMFORT (non-serious), outcome "unknown", described as "somewhat more uncomfortable post-vaccine time".  Additional Information: Regarding family medical history relevant to adverse events (AES), it was reported that "nothing other than slightly heightened (for a few days) immune system reactions-no follow-up care needed from any medical facility or physician". The patient had MCS (Multiple chemical sensitivities) and Graves' disease (in remission from graves' disease), over reactive immune system in general that probably contributed to a somewhat more uncomfortable post vaccine time. She commented that she doesn't know why the form was sent to her, she had normal post-vaccine reactions (a few days only each time) each of the 4 times she was vaccinated against COVID. She had the 2 initial vaccines for the first course, and then 2 booster, a year apart.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201279899 same patient/vaccine/event, different dose;
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Moderna/Pfizer / BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Lot number: GJ2514), in left arm and on 02May2023 as dose 6 (booster), single (Lot number: GJ3270) at the age of 69 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL9264), in left arm, on 24Feb2021 as dose 2, single (Lot number: EN6200), in left arm and on 23Sep2021 as dose 3 (booster), single (Lot number: EW0187), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09May2022 as dose 4 (booster), single (Lot number: 038A22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "latex" (unspecified if ongoing), notes: Known Allergies: latex, codeine. The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Allergy", notes: Known Allergies: latex, codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna/Pfizer / BioNTech". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type 1" (unspecified if ongoing); "undifferentiated connective tissue disease" (unspecified if ongoing); "Known allergies: Sulfa Drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 26Sep2023 to 30Sep2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported event Drug ineffective and COVID 19 cannot be ruled out.    ,Linked Report(s) : US-PFIZER INC-202300320787 same patient, different event/ drug;
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received bnt162b2 (BNT162B2 NOS), on 01Oct2022 as dose 3(booster), single (Batch/Lot number: unknown) at the age of 51 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 03Aug2021 as dose 1, single (Batch/Lot number: unknown) and on 01Jan2022 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hi cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19, patient took Paxlovid from 26Sep2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.