chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Presyncope
Clinical narrative: Pt became diaphoretic, vasovagal reaction loss of site for less than a minute occurring 10 minutes after vaccination administered in waiting room, nausea, SOB. BP 100/62, Pulse 77 4 minutes  reading. EMS called Paramedics arrived pt examined and reported at 19 minutes after  to be stable conscious with slight dizziness. Pt was initially placed on exam table supine with legs elevated.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypoaesthesia
Clinical narrative: Felt like upper arm was asleep
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: No harm, but vaccine was expired 2 days ago
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event
Clinical narrative: no adverse effects.
Age: 50.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Back pain, Chromaturia, Illness, Spinal cord disorder, Urinary incontinence
Clinical narrative: She is adamant that the Prevnar13 vaccine was blood red. She was tangential in her speech but here is a list of what her concerns/accusations are: Vaccine was blood red Made her very ill Pooping on walls Made her pee her pants (pee was dark brown) Attacked her spinal cord Coworkers who used her mobile phone and keyboard at work contracted something from her that she says is from the vaccine One committed suicide 4-21-21 as a result of illness they got from her that she believes was from the vaccine Coworker was taken from work in ambulance with back pain due something he contracted from her from the vaccine She believes the vaccine was tampered with and asked who had access to the fridge in pharmacy When she returned to work, she felt it was odd people were talking with her about feline HIV as a form of mental manipulation She said this was related to the vaccine and another reason she thinks it was tampered with Her neighbors are terrorizing her Hacking her phone Using stole bucket truck to hack her internet and electricity Broke into her locked house, hurt her dog and stole her covid card "bought" her doctor so she could not get good health care
Age: 50.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Anal incontinence, Back pain, Headache, Nausea, Pain
Clinical narrative: She is adamant that the Prevnar13 vaccine was blood red. She was tangential in her speech but here is a list of what her concerns/accusations are: Vaccine was blood red Made her very ill Pooping on walls Made her pee her pants (pee was dark brown) Attacked her spinal cord Coworkers who used her mobile phone and keyboard at work contracted something from her that she says is from the vaccine One committed suicide 4-21-21 as a result of illness they got from her that she believes was from the vaccine Coworker was taken from work in ambulance with back pain due something he contracted from her from the vaccine She believes the vaccine was tampered with and asked who had access to the fridge in pharmacy When she returned to work, she felt it was odd people were talking with her about feline HIV as a form of mental manipulation She said this was related to the vaccine and another reason she thinks it was tampered with Her neighbors are terrorizing her Hacking her phone Using stole bucket truck to hack her internet and electricity Broke into her locked house, hurt her dog and stole her covid card "bought" her doctor so she could not get good health care
Age: 50.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pyrexia, Skin discolouration
Clinical narrative: She is adamant that the Prevnar13 vaccine was blood red. She was tangential in her speech but here is a list of what her concerns/accusations are: Vaccine was blood red Made her very ill Pooping on walls Made her pee her pants (pee was dark brown) Attacked her spinal cord Coworkers who used her mobile phone and keyboard at work contracted something from her that she says is from the vaccine One committed suicide 4-21-21 as a result of illness they got from her that she believes was from the vaccine Coworker was taken from work in ambulance with back pain due something he contracted from her from the vaccine She believes the vaccine was tampered with and asked who had access to the fridge in pharmacy When she returned to work, she felt it was odd people were talking with her about feline HIV as a form of mental manipulation She said this was related to the vaccine and another reason she thinks it was tampered with Her neighbors are terrorizing her Hacking her phone Using stole bucket truck to hack her internet and electricity Broke into her locked house, hurt her dog and stole her covid card "bought" her doctor so she could not get good health care
Age: 14.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event
Clinical narrative: No Signs or symptoms. Patient did wait 15 min in lobby for any adverse reactions.
Age: 25.0
Sex: M
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Dizziness, Pallor, Presyncope
Clinical narrative: Patient and dad came to the pharmacy asking for travel vaccines, and they decided to get 4 vacines each. On questionnaire they answered no to all questions and they weren't afraid or nervous at the time of administration. After patient got the vaccines when he went outside he started feeling dizzy, pale, and almost passed out. I went outside with one of my techs, we gave him alcohol pad to smell, lie down him on his back on one of our benches, and raised his legs. We also put an ice pack on his neck, and recommended him to stay down for about 15-30 min. We also offered him to call EMS.After 10 minutes he tried to sit and he was still feeling dizzy, and nauseated  and throwed up a little bit. We checked his blood pressure, was 100/58,pulse was 68.We recommended him to remain lie down on the bench for another 15-20 min. After 20 min more we checked his blood pressure again, it was still low 98/45,pulse was over 100,but he said he want to go outside, and that that has happened to him on the past but when seen blood. Dad was close to him all times. Then, dad decided to take him to the car, when he came back we asked him and the patient was feeling better.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Intussusception, Ultrasound abdomen abnormal, X-ray gastrointestinal tract abnormal
Clinical narrative: Intussusception
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Death
Clinical narrative: Died from a major stroke 3 weeks after getting the booster.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient received her first dose of shingles (shingrix) vaccine in April and subsequently developed a one sided itchy, painful rash on her thigh, groin, and up to her stomach.  Patient sought care from her doctor who treated the rash with oral anti-virals and various topical creams.  The rash has since improved but has not completely healed.  (Patient also has psoriatic arthritis).   Please note I do not know the exact date the rash started.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Decreased appetite, Dehydration, Dizziness, Headache
Clinical narrative: Headache, Fever chills, body aches, nausea,  loss of appetite,  little stinging pains multiple places on body, light headed, dehydration and a slight cough. All of this continued to get worse by the day. Cough started on 6-10-23. Called doctor's office on 6-12-23. Advised me to continue with hydration,  pain reliever and start taking Bendryl.  I did and started to feel better the next day.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Headache, Fever chills, body aches, nausea,  loss of appetite,  little stinging pains multiple places on body, light headed, dehydration and a slight cough. All of this continued to get worse by the day. Cough started on 6-10-23. Called doctor's office on 6-12-23. Advised me to continue with hydration,  pain reliever and start taking Bendryl.  I did and started to feel better the next day.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Arm pain that lasted well beyond the normal time for a tetanus shot. It was made worse by sleeping on the side or while using that arm for exercise or heavy lifting. I had about 4 physical therapy sessions with exercises to do at home. It helped but the pain stayed for another 4 months. It is gone for the most part but can come back if I sleep on the left side for a long time.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Amnesia
Clinical narrative: PATIENT COMPLAINS OF SEVERE MEMORY LOSS MOST SPECIFICALLY SHORT TERM MEMORY.  WILL PUT A CALL IN TO HER PHYSICIAN
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Myalgia, Pain in extremity
Clinical narrative: pt came to pharmacy on 6/12/2023 complaining of muscle pain in the arm
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: low grade fever started 6/10/23 and developed rash starting 6/12/2023
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Lymphadenopathy, Parotitis, Tenderness
Clinical narrative: Right parotitis, barely tender, not red, moderately swollen, No fever No Rash
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Pain in extremity
Clinical narrative: had a sore arm; a slight half degree increase in temperature; slight headache was 20% of the intensity of the first vaccine; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (had a sore arm), PYREXIA (a slight half degree increase in temperature) and HEADACHE (slight headache was 20% of the intensity of the first vaccine) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (had a sore arm), PYREXIA (a slight half degree increase in temperature) and HEADACHE (slight headache was 20% of the intensity of the first vaccine). At the time of the report, PAIN IN EXTREMITY (had a sore arm), PYREXIA (a slight half degree increase in temperature) and HEADACHE (slight headache was 20% of the intensity of the first vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: a slight half degree increase in temperature.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. It was reported that patient received dose 1 in Apr-2021, dose 2 in May-2021, Dose 3 and dose 4 on unknown dates. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-728218 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728218:Monovalent dose case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; vaccines administered past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date).    This is case is for Patient 3 of 13 patients.  No concomitant medications were reported.   It was reported that as per the provider the vaccines were stored in a standard freezer (15°C to -25°C). Their temperatures were Max: -24C and Min: -23C. It was reported that Moderna COVID-19 Vaccine with Lot number: 060H21A was received on 27-Dec-2020 with expiration date as 28-Mar-2022 but the Date of administration was 11-Apr-2022 with doses of 13.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-728240 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2023: Live followup received and contains no significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728240:1st patient Out of 13
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; vaccines administered past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date).    This is case is for Patient 1 of 3 patients.  No concomitant medications were reported.   It was reported that as per the provider the vaccines were stored in a standard freezer (15°C to -25°C). Their temperatures were Max: -24C and Min: -23C. It was reported that Moderna Bivalent COVID-19 Vaccine with Lot number: 083B22A was received on 15-Nov-2022 with expiration date as 28-Feb-2023 but the date of administration was 05-Apr-2023 with doses of 3.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-728193 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2023: Live followup received contains no significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728193:Same reporter (Lot number 083B22A)
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electroencephalogram, Fatigue, Hyperacusis, Magnetic resonance imaging head, Migraine
Clinical narrative: Migraines, light sensitivity, hearing sensitivity and extreme fatigue.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Photophobia
Clinical narrative: Migraines, light sensitivity, hearing sensitivity and extreme fatigue.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, UNK
Symptoms: COVID-19, Delivery, SARS-CoV-2 test positive
Clinical narrative: Vaccine 2 given 6/11/2021, Moderna Booster given 12/23/21  Covid positive 1/8/22 and 1/31/22. Hospitalized 1/8/22-1/9/22.  1/22 Hospitalized for delivery of Infant female
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, COVID-19, Dysstasia, Gait disturbance, Respiratory failure
Clinical narrative: Patient was admitted to observation level of care on 8-6 with weakness and respiratory failure. Patient is noted to have tested positive for covid on 8-6 at the transferring hospital. Patient has a medical history that is significant for chronic pain syndrome on chronic opioids. Patient has been working with outpatient therapy at a HCF prior to admission. Per inpatient PT/OT assessment, patient is not able to fully stand or ambulate at this time. Placement is recommended for continued therapy
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient was admitted to observation level of care on 8-6 with weakness and respiratory failure. Patient is noted to have tested positive for covid on 8-6 at the transferring hospital. Patient has a medical history that is significant for chronic pain syndrome on chronic opioids. Patient has been working with outpatient therapy at a HCF prior to admission. Per inpatient PT/OT assessment, patient is not able to fully stand or ambulate at this time. Placement is recommended for continued therapy
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE/PQC.; Caller reported inadvertent administration of MMR-II 6 days post-expiry; This spontaneous report has been received from a medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 09-JUN-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliters (ml) and sterile diluent (dose number, frequency, vaccination scheme, route of administration, anatomical location, lot number, and expiration date were not provided) 6 days post-expiry (expired product administered) with no known temperature excursion (TE). No reported symptoms at time of call. No additional adverse event (AE).
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC.; Caller reported inadvertent administration of MMR-II 6 days post-expiry; This spontaneous report has been received from a medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 09-JUN-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliters (ml) and sterile diluent (dose number, frequency, vaccination scheme, route of administration, anatomical location, lot number, and expiration date were not provided) 6 days post-expiry (expired product administered) with no known temperature excursion (TE). No reported symptoms at time of call. No additional adverse event (AE).
Sex: U
Vaccine: PNC20
Symptoms: Erythema, Fatigue, Feeling hot
Clinical narrative: Erythema; swelling about one week after injection.; Felt hot; some fatigue; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: GN1897, Expiration Date: 31Aug2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), outcome "unknown"; SWELLING (non-serious), outcome "unknown", described as "swelling about one week after injection."; FEELING HOT (non-serious), outcome "unknown", described as "Felt hot"; FATIGUE (non-serious), outcome "unknown", described as "some fatigue". Therapeutic measures were taken as a result of erythema, swelling, feeling hot, fatigue.  Additional information: One description from the doctor (for one of the patients) Erythema, swelling about one week after injection. No fevers or chills, no drainage, no sore. Felt hot, generalized swelling, well demarcated irregular area, no respiratory symptoms. some fatigue. The caller stated but she took Benadryl so she is guessing that is the fatigue thing.
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Pericarditis; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: PERICARDITIS (medically significant), outcome "recovered". Clinical course: Complainant did not have the product with them at the time of call. Pfizer employee was at a hospital previous day for a meeting and had a pharmacist ask about pericarditis she had after having her Bivalent Booster Shot and was wondering if it was ok to get the next shot in the series. Pharmacist had pericarditis after the bivalent shot for about 5 months. Pfizer employee sent the pharmacist the information for medical vaccine information. Pharmacist was the reporter and patient. He didn't have time to get the pharmacists information previous day but he did get it that day to file the report. He didn't directly get the reporter's consent to contact but did have some contact information. End Date: Unknown but thought it resolved fairly recently. Pericarditis must have happened in the last 8 months since the Bivalent Vaccine released.  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: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 48.0
Sex: 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) (Consumer or other non HCP) from product quality group. 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 15Oct2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 48 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EL9262), in left arm, on 09Mar2021 as dose 2, single (Lot number: EN6199), in left arm and on 07Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "Hypersomnia" (unspecified if ongoing); "chronic rhinitis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "restless leg syndrome" (unspecified if ongoing); "Known allergies: red food dye" (unspecified if ongoing); "Known allergies: horse hair" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; GLUCOPHAGE XR, start date: 27Mar2023; AMOXICILLIN, start date: 30May2023, stop date: 08Jun2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "recovered" (Jun2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jun2023) Negative, notes: tested negative on day 7 after starting the prescription. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: After finishing the paxlovid, I tested negative on day 7 after starting the prescription. Two days later I started to feel a little sick again and tested positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300216472 same patient, different drug/AE.;
Sex: F
Vaccine: PNC20
Symptoms: Dyspnoea, Injection site erythema, Muscle tightness, Pyrexia, Vaccination site discomfort
Clinical narrative: Left arm site of vaccine, swelling, hard, red, tight; Left arm site of vaccine, swelling, hard, red, tight; Left arm site of vaccine, swelling, hard, red, tight; Left arm site of vaccine, swelling, hard, red, tight; perhaps some shortness of breathe; fevers; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE DISCOMFORT (non-serious), outcome "not recovered" and all described as "Left arm site of vaccine, swelling, hard, red, tight"; VACCINATION SITE INDURATION (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "Left arm site of vaccine, swelling, hard, red, tight"; DYSPNOEA (non-serious), outcome "unknown", described as "perhaps some shortness of breathe"; PYREXIA (non-serious), outcome "unknown", described as "fevers".  Additional information:  The caller provided the local reactions that were experienced with 2 patients and wanted to know if these were typical. This is the case for the other lady with Left arm site of vaccine, swelling, hard, red, tight, perhaps some shortness of breath no wheezing, no cough, fevers, continue to grow 9 days later/ get bigger. The Lot numbers were reported as GM9410 expiration 31Aug2024 and GN1897 expiration 31Aug2024.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: F
Vaccine: PNC20
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Left arm site of vaccine, swelling, hard, red, tight; Left arm site of vaccine, swelling, hard, red, tight; Left arm site of vaccine, swelling, hard, red, tight; Left arm site of vaccine, swelling, hard, red, tight; perhaps some shortness of breathe; fevers; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE DISCOMFORT (non-serious), outcome "not recovered" and all described as "Left arm site of vaccine, swelling, hard, red, tight"; VACCINATION SITE INDURATION (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "Left arm site of vaccine, swelling, hard, red, tight"; DYSPNOEA (non-serious), outcome "unknown", described as "perhaps some shortness of breathe"; PYREXIA (non-serious), outcome "unknown", described as "fevers".  Additional information:  The caller provided the local reactions that were experienced with 2 patients and wanted to know if these were typical. This is the case for the other lady with Left arm site of vaccine, swelling, hard, red, tight, perhaps some shortness of breath no wheezing, no cough, fevers, continue to grow 9 days later/ get bigger. The Lot numbers were reported as GM9410 expiration 31Aug2024 and GN1897 expiration 31Aug2024.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid-19 positive test; Covid-19 positive test; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EL3247), in left arm, on 18Mar2021 as dose 2, single (Lot number: EL3247), in left arm and on 02Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 54 years, in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. No known allergies. No other medical history. No covid prior vaccination. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jun2023, outcome "not recovered" and all described as "Covid-19 positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jun2023) Positive, notes: Nasal Swab, Flowflex Covid-19 Antigen home test. Therapeutic measures were not taken as a result of vaccination failure, covid-19. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure  (LOE) ,  Covid-19 cannot be ruled out.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: ER8733), in left arm and on 20Apr2021 as dose 2, single (Lot number: EW0164) at the age of 34 years, in left arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 05Mar2023 as dose 4 (booster), single (Lot number: O22H22A), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Dec2021 as dose 3 (booster), single (Lot number: 031H21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Dec2021, outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Positive, notes: I decided to take a home COVID test and it was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Guillain-Barre syndrome, Headache, Malaise, Muscular dystrophy
Clinical narrative: Guillain-Barre syndrome after getting the shot; could not walk properly; body stiffness; muscular dystrophy; painful neck; headaches; feeling unwell; 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.  A 64-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Guillain-Barre syndrome after getting the shot"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "could not walk properly"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "body stiffness"; MUSCULAR DYSTROPHY (non-serious), outcome "unknown"; NECK PAIN (non-serious), outcome "unknown", described as "painful neck"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; MALAISE (non-serious), outcome "unknown", described as "feeling unwell". Clinical course: Patient mentioned about side effects she had when she got the Pfizer Covid vaccine. (Body stiffness, muscular dystrophy, painful neck, headaches, feeling unwell, could not walk properly). She wants to know if it is possible to get Guillain-Barre syndrome after getting the shot. Patient confirmed she had received it on 22Oct2022 and it was the new vaccine that would fight the omicron. After referring caller back to her HCP, she answered: "well she sent me for therapy, you know, I went for 9 weeks of therapy, and I went religiously. And other things are turning up, like it started on the left side of my body which is the side that I always got the injection in and now it's starting to creep up on my right side".   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: Linked Report(s) : US-PFIZER INC-202300218569 Same patient/vaccine/event, different dose;US-PFIZER INC-202300218534 Same patient/vaccine, different dose and event;
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: Guillain-Barre syndrome after getting the shot; could not walk properly; body stiffness; muscular dystrophy; painful neck; headaches; feeling unwell; 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.  A 64-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Guillain-Barre syndrome after getting the shot"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "could not walk properly"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "body stiffness"; MUSCULAR DYSTROPHY (non-serious), outcome "unknown"; NECK PAIN (non-serious), outcome "unknown", described as "painful neck"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; MALAISE (non-serious), outcome "unknown", described as "feeling unwell". Clinical course: Patient mentioned about side effects she had when she got the Pfizer Covid vaccine. (Body stiffness, muscular dystrophy, painful neck, headaches, feeling unwell, could not walk properly). She wants to know if it is possible to get Guillain-Barre syndrome after getting the shot. Patient confirmed she had received it on 22Oct2022 and it was the new vaccine that would fight the omicron. After referring caller back to her HCP, she answered: "well she sent me for therapy, you know, I went for 9 weeks of therapy, and I went religiously. And other things are turning up, like it started on the left side of my body which is the side that I always got the injection in and now it's starting to creep up on my right side".   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: Linked Report(s) : US-PFIZER INC-202300218569 Same patient/vaccine/event, different dose;US-PFIZER INC-202300218534 Same patient/vaccine, different dose and event;
Age: 72.0
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 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 24Apr2023 at 14:00 as dose 5 (booster), single (Lot number: GL0446) at the age of 72 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EP7533), in left arm, on 29Mar2021 as dose 2, single (Lot number: EP7533), in left arm, on 30Sep2021 as dose 3 (booster), single (Lot number: RA5352), in left arm and on 31Mar2022 as dose 4 (booster), single (Lot number: FM0698), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 24May2023 to 28May2023.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received anti-viral Paxlovid as COVID 19 Treatment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Fatigue, Hypersensitivity, Illness, Job dissatisfaction
Clinical narrative: Autoimmune disease; Allergic to everything; Sick all of the time/Went from healthy to severely ill; Extreme fatigue unable to function and work.; Extreme fatigue unable to function and work.; Extreme fatigue unable to function and work.; Feel like I'm dying; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), as dose 2, single (Lot number: Fr2583) for covid-19 immunisation. The patient had no relevant medical history. No covid prior vaccination. Known allergies: Was never allergic to anything until the patient got these vaccinations now the patient allergic to everything. Other medical history: Nothing. Healthy adult until the patient was forced to get these vaccinations. There were no concomitant medications. No other vaccine in four weeks. Other medications in two weeks: No! Nothing. Healthy individual. Vaccination history included: Comirnaty (Dose Number: 1, Batch/Lot No: Fp7137), for COVID-19 IMMUNIZATION, reaction(s): "Was never allergic to anything until I got these vaccinations now I'm allergic to Everything". The following information was reported: AUTOIMMUNE DISORDER (disability, life threatening), outcome "not recovered", described as "Autoimmune disease"; HYPERSENSITIVITY (disability, life threatening), outcome "not recovered", described as "Allergic to everything"; ILLNESS (disability, life threatening), outcome "not recovered", described as "Sick all of the time/Went from healthy to severely ill"; FATIGUE (disability, life threatening), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (disability, life threatening), JOB DISSATISFACTION (disability, life threatening), outcome "not recovered" and all described as "Extreme fatigue unable to function and work."; NEAR DEATH EXPERIENCE (disability, medically significant, life threatening), outcome "not recovered", described as "Feel like I'm dying". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Covid test post vaccination Nasal Swab.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events (AUTOIMMUNE DISORDER, HYPERSENSITIVITY, ILLNESS, FATIGUE,LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES,JOB DISSATISFACTION,NEAR DEATH EXPERIENCE) and BNT162B2. 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-202300218909 same reporter/patient/drug, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Near death experience, SARS-CoV-2 test
Clinical narrative: Autoimmune disease; Allergic to everything; Sick all of the time/Went from healthy to severely ill; Extreme fatigue unable to function and work.; Extreme fatigue unable to function and work.; Extreme fatigue unable to function and work.; Feel like I'm dying; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), as dose 2, single (Lot number: Fr2583) for covid-19 immunisation. The patient had no relevant medical history. No covid prior vaccination. Known allergies: Was never allergic to anything until the patient got these vaccinations now the patient allergic to everything. Other medical history: Nothing. Healthy adult until the patient was forced to get these vaccinations. There were no concomitant medications. No other vaccine in four weeks. Other medications in two weeks: No! Nothing. Healthy individual. Vaccination history included: Comirnaty (Dose Number: 1, Batch/Lot No: Fp7137), for COVID-19 IMMUNIZATION, reaction(s): "Was never allergic to anything until I got these vaccinations now I'm allergic to Everything". The following information was reported: AUTOIMMUNE DISORDER (disability, life threatening), outcome "not recovered", described as "Autoimmune disease"; HYPERSENSITIVITY (disability, life threatening), outcome "not recovered", described as "Allergic to everything"; ILLNESS (disability, life threatening), outcome "not recovered", described as "Sick all of the time/Went from healthy to severely ill"; FATIGUE (disability, life threatening), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (disability, life threatening), JOB DISSATISFACTION (disability, life threatening), outcome "not recovered" and all described as "Extreme fatigue unable to function and work."; NEAR DEATH EXPERIENCE (disability, medically significant, life threatening), outcome "not recovered", described as "Feel like I'm dying". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Covid test post vaccination Nasal Swab.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events (AUTOIMMUNE DISORDER, HYPERSENSITIVITY, ILLNESS, FATIGUE,LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES,JOB DISSATISFACTION,NEAR DEATH EXPERIENCE) and BNT162B2. 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-202300218909 same reporter/patient/drug, different dose/event;