chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebellar stroke
Clinical narrative: bilateral cerebellar stroke/progressively got worse with vertigo/ he badged in but then fell down/he fell again, speech slurred and he started vomiting; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBELLAR STROKE (bilateral cerebellar stroke/progressively got worse with vertigo/ he badged in but then fell down/he fell again, speech slurred and he started vomiting) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Controlled hypertension.    On 20-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced CEREBELLAR STROKE (bilateral cerebellar stroke/progressively got worse with vertigo/ he badged in but then fell down/he fell again, speech slurred and he started vomiting) (seriousness criteria disability and medically significant). The patient was treated with Meclozine hydrochloride (Meclizine) at an unspecified dose and frequency. At the time of the report, CEREBELLAR STROKE (bilateral cerebellar stroke/progressively got worse with vertigo/ he badged in but then fell down/he fell again, speech slurred and he started vomiting) had not resolved.            No concomitant medications were reported. It was unknown if the patient had any additional medical history, concomitant disease or risk factor.  The reporter stated that, her husband's vertigo started after the second vaccine. He went to a couple of doctors for that, they prescribed Meclizine. Was also told it could be allergies, etc. Nothing helped and he progressively got worse with vertigo.  He drove an hour to work after 12 days off for the holidays, which was 03-Jan. Once he got to work, he badged in but then fell down. They tried to help him up and he fell again, speech slurred, and he started vomiting. They took him to the closest hospital. He suffered a bilateral cerebellar stroke. He was then permanently disabled and would never work or drive again. At the time of reporting, he was 50 years old with no quality of life.  The patient did not experience any additional symptoms/events. There were no lab data/results available.; Reporter's Comments: Concurrent medical condition  Controlled hypertension is a confounder for the event. . The benefit -risk relationship of product is not affected by this report.
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: patient ended up in the hospital after each one because patient had a very bad seizure; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "had epilepsy" (ongoing). The patient's concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "patient ended up in the hospital after each one because patient had a very bad seizure". The event required physician office visit. Clinical course: The patient has epilepsy history and when patient had the Covid vaccine (Pfizer Covid-19 vaccine), had three of them, patient ended up in the hospital after each one because patient had a very bad seizure. Patient have not had any more of those because the doctor told the risk was not worth the benefit. Patient was only in the hospital for maybe six hours with each of them and the neurologist has said the patient has not have any more of those because it's not good for people with epilepsy. Patient was asking if the Pneumonia vaccine a onetime vaccine and the other is have there been any report of side effects like seizure with the Pneumonia vaccine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500087405 Same patient/event, different dose;US-PFIZER INC-202500087406 Same patient/event, different dose;
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: I had three of them (Covid-19 Vaccine) and I ended up in the hospital after each one because I had a very bad seizure; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as does 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "epilepsy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 nos (DOES 1, SINGLE), for COVID-19 immunization, reaction(s): "Seizure". The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "I had three of them (Covid-19 Vaccine) and I ended up in the hospital after each one because I had a very bad seizure". The events "i had three of them (covid-19 vaccine) and i ended up in the hospital after each one because i had a very bad seizure" required physician office visit.  Clinical course: when patient had the Covid vaccine (Pfizer Covid-19 vaccine), patient had three of them and ended up in the hospital after each one because patient had a very bad seizure and so, patient had not had any more of those because the doctor said the risk was not worth the benefit. Patient was only in the hospital for maybe six hours with each of them. Patient had been told by the neurologist not to have any more of those because it's not good for those people with epilepsy.    No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500087121 Same patient/event, different dose;US-PFIZER INC-202500087406 Same patient/event, different dose;
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: I had three of them (Covid-19 Vaccine) and I ended up in the hospital after each one because I had a very bad seizure; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "epilepsy" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 nos (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Seizure"; Bnt162b2 nos (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "Seizure". The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "I had three of them (Covid-19 Vaccine) and I ended up in the hospital after each one because I had a very bad seizure". The events "i had three of them (covid-19 vaccine) and i ended up in the hospital after each one because i had a very bad seizure" required physician office visit and emergency room visit. Clinical course: The patient has epilepsy and when patient had the Covid vaccine (Pfizer Covid-19 vaccine), had three of them, patient ended up in the hospital after each one because patient had a very bad seizure. Patient have not had any more of those because the doctor told the risk was not worth the benefit. Patient was only in the hospital for maybe six hours with each of them and the neurologist has to not have any more of those. Patient was asking if the Pneumonia vaccine a onetime vaccine and the other is have there been any report of side effects like seizure with the Pneumonia vaccine.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500087121 Same patient/event, different dose;US-PFIZER INC-202500087405 Same patient/event, different dose;
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Cold sweat, Nausea, Syncope
Clinical narrative: Vaccine was administered at 4:36pm, Patient became faint, clammy/cool skin, slight nausea at about 4:41pm. Patient was responsive. Provided patient with a cool compress for her neck, talked to her and massaged her hand and leg to keep her stimulated, gave her water to sip. Patient verbalized she was feeling better and left the store (walked with assistance) by about 4:55 pm. I spoke with patient at approximately7:15 pm - she stated she was improving, still a little weak, resting at home.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site vesicles, Injection site warmth
Clinical narrative: Child was brought in by mother with concerns about swelling at injection site on 04/25/2025. Injection site was red, hot to the touch, hardened, and had blisters forming. Provider was consulted and child was advised to go to the ER.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Patient experienced extreme vertigo and feeling of whooziness that lasted from 04/17/25 through 04/21/25.
Age: 80.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: PATIENT RECEIVED PREVNAR 20 ON 12/16/2023 AND AGAIN ON 04/24/2025. PATIENT STATES TO HAVE NO ADVERSE EVENTS, SHE DID SAY HER ARM WAS SORE.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Blood creatinine increased, Blood immunoglobulin M increased, Chest X-ray abnormal, Cough, Erythema multiforme
Clinical narrative: Fatigue, Achy, fever, erythema multiforme rash, vomiting, with cough. Received IVF, ceftriaxone, azithromycin, and fluconazole. Discharged on Augmentin only and cetirizine rash improved. Kidney function returned to normal.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Fatigue, Pain, Pneumonia, Pyrexia, Vomiting
Clinical narrative: Fatigue, Achy, fever, erythema multiforme rash, vomiting, with cough. Received IVF, ceftriaxone, azithromycin, and fluconazole. Discharged on Augmentin only and cetirizine rash improved. Kidney function returned to normal.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Diarrhoea
Clinical narrative: began experiencing diarrhea and loose stool; This spontaneous report was received from a consumer and refers to a 31-year-old male patient.  The patient's concurrent conditions included Penicilin allergy. Concomitant therapies and medical history were not reported.   On 02-Apr-2025, the patient was vaccinated with the second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (2 injections 6 weeks apart), (dose, route of administration, anatomical site of injection, lot # and expiration date were not reported); and with the second dose of Varicella Virus Vaccine (trade name not reported), (2 injections 6 weeks apart) (dose, route of administration, anatomical site of injection, lot # and expiration date were not reported); both vaccines were reconstituted with sterile diluent (BAXTER STERILE DILUENT) and were administered for prophylaxis. The vaccines were administered around 9:30 and at around 21:00 the patient began experiencing diarrhea and loose stool. The patient worked in a freezer for almost 6 hours and didn't eat or drink after the vaccine administration. Symptoms lessened after food and water were ingested. On 03-Apr-2025, the patient recovered from the event.  The causal relationship between the event and the suspect therapies was not reported.
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No other information provided. No additional AE.; HCP calling to inform PROQUAD administration for a patient 17 years old (outside of PI). The PROQUAD was administered on 4/16/25 and patient is not symptomatic.; This spontaneous report was received from a Nurse and refers to a 17-year-old patient of unknown gender.   The patient's medical history, concurrent conditions, concomitant therapies, previous drug reactions and allergies were not reported.  On 16-Apr-2025 at the age of 17, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA [recombinant human albumin]) (PROQUAD) administered as prophylaxis (Lot No. Y014305 has been verified to be a valid lot number for [Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live], expiration date reported and upon internal validation established as 18 Feb 2026 (strength, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided); that was reconstituted with sterile diluent solution for injection (BAXTER STERILE DILUENT) (Lot number, expiration date, route of administration and indication was not provided) (product administered to patient of inappropriate age) No other information provided. No additional adverse event (No adverse event).
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; regarding an expired administration of a dose of MMR II; Information has been received from Business Partner/CRO on 24-Apr-2025.  This spontaneous report was received from a/an Nurse and refers to a(n) patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 16-Apr-2024, the patient started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #W022942, expiration date: 05-Apr-2024) 0.5 mL (0.5 mL / Two dose series),. On an unknown date, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported). The patient started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), for the treatment of Prophylaxis.  On 16-Apr-2024, the patient experienced regarding an expired administration of a dose of MMR II. On an unknown date, the patient experienced No adverse event.   At the reporting time, the outcome of regarding an expired administration of a dose of MMR II and No adverse event was unknown.   The action taken with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live and sterile diluent was reported as not applicable.
Age: 61.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site inflammation, Injection site rash
Clinical narrative: Rash (small bumps) around the injection site, redness, inflammation; Rash (small bumps) around the injection site, redness, inflammation/rash and erythema around injection site; Rash (small bumps) around the injection site, redness, inflammation/rash and erythema around injection site; This is a spontaneous report received from a Nurse.  A 61-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 15Apr2025 as dose number unknown 0.5 ml, single (Lot number: LX4483, Expiration Date: 20Feb2026) at the age of 61 years intramuscular, in left deltoid for immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: VACCINATION SITE INFLAMMATION (non-serious) with onset 15Apr2025, outcome "recovering", described as "Rash (small bumps) around the injection site, redness, inflammation"; VACCINATION SITE RASH (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 15Apr2025, outcome "recovering" and all described as "Rash (small bumps) around the injection site, redness, inflammation/rash and erythema around injection site". Therapeutic measures were taken as a result of vaccination site inflammation, vaccination site rash, vaccination site erythema.  Additional information: The patient did not received any other vaccines on the same date as the vaccine. The patient did received any other vaccines within 4 weeks PRIOR to the vaccine. The patient was taking other medications within 2 weeks of the event starting. Nurse reported 3 adverse events related to Prevnar 20 vaccine under the same lot on Pfizer portal. Physician stated a patient recently reported a side effect that came from one batch, the same lot number. She has done reporting on Pfizer portal and VAERS. Wants to know what to do with that lot. They have it quarantined and out of patient circulation. They purchase through a distributor, and she wants to see what we recommend from manufacturer; she had contacted the distributor to see if they need return it, wait for it to expire or if they can get credit. States the physician is not comfortable using that lot. States she has confirmation numbers for the patients. She also has one patient that had an adverse event with Prevnar 20 back in February with a different lot. They thought it was a one off thing. She had reported that today also online but that is a different lot.
Age: 57.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Pain at the injection site; Pain at the injection site, edema, erythema; This is a spontaneous report received from a Nurse.  A 57-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 24Feb2025 as dose number unknown, 0.5ml single (Lot number: LK6650, Expiration Date: 31May2026) at the age of 57 years intramuscular, in left deltoid for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 25Feb2025, outcome "recovered" (2025), described as "Pain at the injection site"; VACCINATION SITE ERYTHEMA (non-serious) with onset 25Feb2025, outcome "recovered" (2025), described as "Pain at the injection site, edema, erythema". Therapeutic measures were taken as a result of vaccination site pain, vaccination site erythema.  Additional information: Patient did not receive any other vaccines on the same date as the vaccine. Patient did not receive any other vaccines within 4 weeks prior to the vaccine. Patient was taking any other medications within 2 weeks of the event starting. Reporter seriousness for pain and erythema at the injection site was not serious. Patient had an adverse event with Prevnar 20 back in February with a different lot. They thought it was a one off thing. She had reported that today also online but that was a different lot. It was reported pain and erythema at the injection site was non serious. States this was not reported to her on time. She was going to say patient noted pain and erythema at the injection site the next day, 25Feb2025.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500086589 same reporter/product/event, different patient;
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Erythema, pain at the injection site, and edema.; Erythema, pain at the injection site, and edema.; Erythema, pain at the injection site, and edema.; This is a spontaneous report received from a Nurse.  A 56-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 16Apr2025 as dose number unknown (0.5 ml), single (Lot number: LX4483, Expiration Date: Feb2026) at the age of 56 years intramuscular, in left deltoid for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE OEDEMA (non-serious) all with onset 17Apr2025, outcome "recovering" and all described as "Erythema, pain at the injection site, and edema.". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site pain, vaccination site oedema.  Additional information: Patient did not received any other vaccines on the same date as the vaccine and not received any other vaccines within 4 weeks prior to the vaccine. Patient taking other medications within 2 weeks of the event starting. Reported events included erythema, pain at the injection site, and edema. On 22Apr2025, received additional context in which stated report 1 of 4 on patient. She reported 3 adverse events related to Prevnar 20 vaccine under the same lot on Pfizer portal. Physican stated a patient recently reported a side effect that came from one batch, the same lot number. Stated the physician is not comfortable using that lot. 1st patient reported erythema, pain and edema at injection site site left deltoid. Prevnar 20 given on 16Apr2025 and noted erythema, pain and edema at injection site left deltoid on 17Apr2025. Outcome was recovering. Patient has an appointment with her provider today. Seriousness criteria reported as it was mild so she doesn't think significant. It is definitely inconvenient but not life threatening.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500086599 same reporter/product/event, different patient.;US-PFIZER INC-202500086566 same reporter/product/event, different patient;
Age: 59.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Erythema, edema, and pain at the injection site.; Erythema, edema, and pain at the injection site.; Erythema, edema, and pain at the injection site.; This is a spontaneous report received from a Nurse.  A 59-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 18Apr2025 as dose number unknown, single (Lot number: LX4483, Expiration Date: Feb2026) at the age of 59 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE OEDEMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 19Apr2025, outcome "recovering" and all described as "Erythema, edema, and pain at the injection site.". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site oedema, vaccination site pain.  Additional information: The patient did not receive any other vaccines on the same date as the vaccine which is reported. The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine which is reported. The patient was taking any other medications within 2 weeks of the event starting. Reporter seriousness for erythema, pain and edema at injection site was not Serious. She reported 3 adverse events related to Prevnar 20 vaccine under the same lot on Pfizer portal. Physican stated a patient recently reported a side effect that came from one batch, the same lot number.  Wanted to know what to do with that lot. They have it quarantined and out of patient circulation. Stated the physician was not comfortable using that lot. Stated she has confirmation numbers for the patients. She also has one patient that had an adverse event with Prevnar 20 back in February with a different lot. They thought it was a one off thing. She had reported that today also online but that was a different lot. Patient called and said kind of noticed erythema, pain and edema at injection site the same day into the next day. Caller stated she would say 19Apr2025.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500086589 same reporter/product/event, different patient.;
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Did have cough, about a month, as soon as she did first injection. Cough came back within 45 minutes of first injection Apr2021; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old female patient received BNT162b2 (COMIRNATY), on 20Mar2021 as dose 1, single (Lot number: EP6955) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious) with onset Apr2021, outcome "unknown", described as "Did have cough, about a month, as soon as she did first injection. Cough came back within 45 minutes of first injection Apr2021".
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test, Streptococcus test
Clinical narrative: got Covid; got Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, 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 (previous Pfizer Covid vaccines), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2025, outcome "recovering" and all described as "got Covid". The event "got covid" required physician office visit. The patient underwent the following laboratory tests and procedures: Body temperature: (19Apr2025) slight fever over 100, notes: Saturday; (20Apr2025) fever was at 102 all day, notes: Sunday; SARS-CoV-2 test: (21Apr2025) said patient had Covid; Streptococcus test: (Apr2025) no strep. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: the patient was at (withheld) Friday morning and by Saturday night (19Apr2025) he had a slight fever over 100. By Sunday (20Apr2025) his fever was at 102 all day. He took Tylenol and Monday morning didn't have fever when he went to his doctor. The patient went to the doctor Monday morning early (21Apr2025) and got tested and said the patient had Covid. Doctor wrote a prescription for Paxlovid and he picked it up and started taking it on Monday. Got on Paxlovid and that started the up climb to better ness. The patient started feeling a lot better by Tuesday morning. He was starting to feel better within 2 days definitely didn't have severe coughing and nasal dripping. was taking Aleve cold and sinus that helps with dripping. Noticed by would say within 24 hours plus that he noticed a change in the way he was feeling. Feels a lot better today. Still has coughing and some sneezing but not as much. Some phlegm. His doctor said his lungs are clear. He had a sore throat and was tested for strep, no strep. Patient has had all Pfizer Covid vaccines and got Covid. Stated he has had all covid vaccinations from Pfizer because he has had good results with Pfizer vaccinations.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500088756 same reporter drug AE different patient;
Age: 52.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Pain, Pruritus, Pyrexia, Swelling
Clinical narrative: Visit urgent care on Saturday 4/26 and was given itching cream and antibiotics to take for 7 days
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pt is given expired  COVID vaccine,   no symptoms
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pt is given expired  dose of COVID
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Rash, Rash pruritic
Clinical narrative: Patient developed a rash on parts of his arm/chest (not around the injection site). It is itchy and burns, he is headed to urgent care to be assessed from here.
Age: 26.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Dyspnoea
Clinical narrative: Patient came in for MMR vaccine for travel.  Patient spoke to doctor about egg allergy and doctor advised patient to get vaccine even with said allergy (per patient).  Patient given MMRII and Boostrix. Sat about 10-15 minutes after vaccine talking to vaccinating technician but came back about 25 minutes after vaccine for Benadryl, then went to ER due to trouble breathing.  Patient states in ER for about 2 hours but now released.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Pain in extremity, Paraesthesia
Clinical narrative: 04/09/2025 01:50:02 PM > severe headache started 12 hours after receipt of the meningitis vaccine, reports of migraine type headache, felt a bad headache yesterday, wanted to get picked up from school, also reported arm pain and tingling, was at school today and mom is not sure if she has headache or arm tingling today, I advised mom that if headache or arm tingling is persisting to please schedule an office visit for evaluation 04/11/2025 04:14:48 PM > headache lasted until 4/10, each day headache improved, had headache for 2 days and had headache at school but was able to go to school left arm had tingling shoulder to the wrist until 4/9 in the evening, and soreness left arm ended 4/9
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Nausea, Pyrexia, Vomiting
Clinical narrative: nausea vomiting , fever , weakness
Age: 60.0
Sex: F
Vaccine: PNC21
Symptoms: Blood pressure decreased, Erythema, Loss of consciousness, Pyrexia, Swelling
Clinical narrative: Patient states redness/swelling and fever and drop in blood pressure that led to passing out and an ER trip.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: Patient said she got a fever the night of the immunization and felt sicker. She had cold chills the next day but started to feel better the next day in the evening.
Age: 97.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient's caregiver observed redness around the injection site the evening of administering the vaccine. Today (3 days after administration), the caregiver observed significantly more redness, some swelling, and warm to the touch around the vaccination site. The area of redness today appears to be nearly the size of a softball, but oval in shape going lengthways with the patient's arm. I advised the caregiver to take the patient to the local urgent care (the patient's family did not want her going to the ER).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation, Myalgia
Clinical narrative: Whole body muscle and joint pain. Increased and new inflammation of prior injuries.
Age: 2.58
Sex: F
Vaccine: UNK, UNK, UNK, UNK, UNK, UNK
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: Patient present with vaccine administrations in bilateral thigh on 04/24/2025. Mother did not bring a detailed record, just a general list of what was given. Yesterday she noticed redness surrounding a white central area that was new. Today the redness is larger, hard (not fluctuant) and erythematic. 1+ edema measures 2 inches by 2.75 inches with central pale area that measure 0.5 inch and 2 prominent puncture areas noted. Patient indicates that it is tender to touch and itchy.  The other leg has very slight pink area, no edema. Recommended Loratidine 2.5 mg daily and to reach out to PCP to share the reaction. Notified mother that she may get a call for more information, she agreed.
Age: 2.58
Sex: F
Vaccine: UNK, UNK, UNK, UNK, UNK, UNK
Symptoms: Injection site pallor, Injection site pruritus
Clinical narrative: Patient present with vaccine administrations in bilateral thigh on 04/24/2025. Mother did not bring a detailed record, just a general list of what was given. Yesterday she noticed redness surrounding a white central area that was new. Today the redness is larger, hard (not fluctuant) and erythematic. 1+ edema measures 2 inches by 2.75 inches with central pale area that measure 0.5 inch and 2 prominent puncture areas noted. Patient indicates that it is tender to touch and itchy.  The other leg has very slight pink area, no edema. Recommended Loratidine 2.5 mg daily and to reach out to PCP to share the reaction. Notified mother that she may get a call for more information, she agreed.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Delayed fontanelle closure, Poor feeding infant, Pyrexia, Somnolence
Clinical narrative: Approximately 18 hours after receiving her 4-month vaccinations, my baby began to experience swelling of the anterior fontanelle, fever, drowsiness, and poor appetite.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Giant cell arteritis, Headache, Malaise, Visual impairment
Clinical narrative: Patient felt unwell after the vaccine with intermittent headaches and ultimately was diagnosed with giant cell arteritis with partial vision loss in 8/2024.  She was treated with high dose prednisone and one infusion of Actemra.  She is currently tapering her prednisone still.  She has persistent vision loss but has not had new loss of vision.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Wrong product administered
Clinical narrative: Administered Pediarix vaccine (DTaP + Hep B + IPV) and patient should have only received DTaP vaccine.
Age: 4.0
Sex: F
Vaccine: HEPA, HEPA, MMRV, PNC15
Symptoms: Cough, Eye discharge, Irritability, Morbillivirus test positive, Rash
Clinical narrative: patient is a 4 y.o. female who presents for evaluation of a skin concern involving the face and torso that the patient's father describes as a rash. Historian : Father. This concern started within the last hour prior to arrival. She has also had a cough and runny nose for the last 48 hours.   Appearance is raised, red, and round and is pruritic (minimally). Appearance has become more wide spread over time. Associated symptoms: cough and irritability. Patient has not had contacts with similar concern. Patient has recently received the MMRV vaccine as well as DTap, IPV, Hib, HepB, HepA, and PCV15 vaccines 4/2/25. Patient has tried nothing for treatment. Father states he has to clean out mucous from patient's eyes. Temp is 99.1F, HR 133, R 18, SpO2 98% on room air, wt 16.9 kg.  Symptomatic management was recommended.
Age: 4.0
Sex: F
Vaccine: HEPA, HEPA, MMRV, PNC15
Symptoms: Rash erythematous, Rash papular, Rash pruritic, Rhinorrhoea
Clinical narrative: patient is a 4 y.o. female who presents for evaluation of a skin concern involving the face and torso that the patient's father describes as a rash. Historian : Father. This concern started within the last hour prior to arrival. She has also had a cough and runny nose for the last 48 hours.   Appearance is raised, red, and round and is pruritic (minimally). Appearance has become more wide spread over time. Associated symptoms: cough and irritability. Patient has not had contacts with similar concern. Patient has recently received the MMRV vaccine as well as DTap, IPV, Hib, HepB, HepA, and PCV15 vaccines 4/2/25. Patient has tried nothing for treatment. Father states he has to clean out mucous from patient's eyes. Temp is 99.1F, HR 133, R 18, SpO2 98% on room air, wt 16.9 kg.  Symptomatic management was recommended.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Cognitive disorder, Dyspnoea, Irritability, Malaise, Rash
Clinical narrative: First 48 hours felt sick. The next 6-8 month complete body rash resembling welts. Swelling of face, feeling of not being able to breath. Irritability, inability to think.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: First 48 hours felt sick. The next 6-8 month complete body rash resembling welts. Swelling of face, feeling of not being able to breath. Irritability, inability to think.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: SWELLING, REDNESS, TENDER TO TOUCH.   NON- PURLENT CELLULITC FOMATION.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthropathy, Brain fog, Memory impairment, Myalgia
Clinical narrative: Muscle n joint weakness   brain fog. Memory loss
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus, at first subtle and increasing in nature overtime. Tinnitus has been continuous and remains today. Sometimes not noticed when particularly active and often can be ignored but always present and varying degrees of irritation.
Age: 60.0
Sex: M
Vaccine: RSV
Symptoms: Influenza like illness
Clinical narrative: Patient  has RSV shot  7 days ago and now he stated  that he is feeling some flu-like symptoms. Pharmacist apologized to the patient.  Pharmacist advised the patient to see his doctor on Monday if he would like.
Age: 75.0
Sex: M
Vaccine: PNC20, TDAP
Symptoms: Extra dose administered
Clinical narrative: PATIENT RECEIVED A SCOND DOSE OF BOOSTRIX IN 9 MONTH PERIOD
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient stated that he had consistent pain at the injection site for almost 2 weeks
Age: 39.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Headache
Clinical narrative: Headache and joint pain lasting greater than 1 week
Age: 74.0
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Biopsy, Death, Malaise, Pancreatic carcinoma
Clinical narrative: My mom felt ill after her vaccines, but started to have more symptoms that she didn't talk about. On December 4, 2024 she was finally diagnosed with pancreatic cancer. She was dead by January 3, 2025.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Immediate post-injection reaction, Impaired work ability, Injected limb mobility decreased
Clinical narrative: I had pain immediately at sit of injection and it has not stopped since. I have loss of range of motion, severe pain radiating from my shoulder down to my fingers. It is debilitating as I am right-handed. This is unacceptable and the doctor told me there is nothing to do about it. I now have to live with this constant pain. I am supposed to be finding work and how am I going to work without full use of my dominant arm.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: I had pain immediately at sit of injection and it has not stopped since. I have loss of range of motion, severe pain radiating from my shoulder down to my fingers. It is debilitating as I am right-handed. This is unacceptable and the doctor told me there is nothing to do about it. I now have to live with this constant pain. I am supposed to be finding work and how am I going to work without full use of my dominant arm.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Continuous pain in left arm along the shoulder and at the injection site especially at night and first thing in the  morning. This is still ongoing now in April 2025 despite use of cold compression, hot compression, Tylenol and Advil. Pain ease with Tylenol and advice but then comes back again.
Age: 66.0
Sex: F
Vaccine: PNC21, VARZOS, PNC21, VARZOS
Symptoms: Deafness bilateral, Laboratory test, Pain in extremity, Scan, Vertigo
Clinical narrative: PT Got vaccine 3/18 and that night had severe pain on arms. When woke up in morning felt explosion in ER and lost hearing in both ears. She had extreme verigo and started vomiting. After 30 to 40min of vomiting called 911. PT taken to ER and had tests and scans completed she was given meclizine. She followed up with her PCP. She has no hearing in the right ear still, but some hearing in the left ear.
Age: 66.0
Sex: F
Vaccine: PNC21, VARZOS, PNC21, VARZOS
Symptoms: Vomiting
Clinical narrative: PT Got vaccine 3/18 and that night had severe pain on arms. When woke up in morning felt explosion in ER and lost hearing in both ears. She had extreme verigo and started vomiting. After 30 to 40min of vomiting called 911. PT taken to ER and had tests and scans completed she was given meclizine. She followed up with her PCP. She has no hearing in the right ear still, but some hearing in the left ear.
Age: 66.0
Sex: F
Vaccine: PNC21, VARZOS, PNC21, VARZOS
Symptoms: Asthenia, Audiogram abnormal, Deafness unilateral, Dizziness, Fatigue
Clinical narrative: PT Got vaccine 3/18 and that night had severe pain on arms. When woke up in morning felt explosion in ER and lost hearing in both ears. She had extreme verigo and started vomiting. After 30 to 40min of vomiting called 911. PT taken to ER and had tests and scans completed she was given meclizine. She followed up with her PCP. She has no hearing in the right ear still, but some hearing in the left ear.
Age: 66.0
Sex: F
Vaccine: PNC21, VARZOS, PNC21, VARZOS
Symptoms: Gait disturbance, Impaired work ability, Loss of personal independence in daily activities, Mixed deafness, Mobility decreased
Clinical narrative: PT Got vaccine 3/18 and that night had severe pain on arms. When woke up in morning felt explosion in ER and lost hearing in both ears. She had extreme verigo and started vomiting. After 30 to 40min of vomiting called 911. PT taken to ER and had tests and scans completed she was given meclizine. She followed up with her PCP. She has no hearing in the right ear still, but some hearing in the left ear.
Age: 66.0
Sex: F
Vaccine: PNC21, VARZOS, PNC21, VARZOS
Symptoms: Paraesthesia, Sudden hearing loss, Tinnitus, Tympanometry abnormal, Vertigo
Clinical narrative: PT Got vaccine 3/18 and that night had severe pain on arms. When woke up in morning felt explosion in ER and lost hearing in both ears. She had extreme verigo and started vomiting. After 30 to 40min of vomiting called 911. PT taken to ER and had tests and scans completed she was given meclizine. She followed up with her PCP. She has no hearing in the right ear still, but some hearing in the left ear.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lacrimation increased, Lip pruritus, Oral discomfort
Clinical narrative: PATIENT STATED TO START HAVING SHINGLES LIKE BLISTERS ON HER MOUTH THAT ARE ITCHY AND PAINFUL AFTER SHE GOT THE SECOND DOSE. IT LASTED FOR MORE THAN A MONTH AND WENT AWAY AFTER SHE TOOK VALACYCLOVIR TABLET COURSE, BUT SHE SAID THE SHINGLES LIKE SYMPTOMS STARTED ON HER EYES AFTER SHE COMPLETED THE VALACYCLOVIR COURSE.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oral mucosal blistering, Oral pain, Oral pruritus
Clinical narrative: PATIENT STATED TO START HAVING SHINGLES LIKE BLISTERS ON HER MOUTH THAT ARE ITCHY AND PAINFUL AFTER SHE GOT THE SECOND DOSE. IT LASTED FOR MORE THAN A MONTH AND WENT AWAY AFTER SHE TOOK VALACYCLOVIR TABLET COURSE, BUT SHE SAID THE SHINGLES LIKE SYMPTOMS STARTED ON HER EYES AFTER SHE COMPLETED THE VALACYCLOVIR COURSE.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, UNK, UNK, UNK
Symptoms: Unresponsive to stimuli
Clinical narrative: Unresponsive to stimuli; The second dose of PEDVAXHIB was administered to a 3-month-old baby; 7 antigens, 3 syringes full of different adjuvants, preservatives and stabilizers. Too much pharma poisoned this little boy; .  This spontaneous report was received from a consumer (patient's father) and refers to a 3-month-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions included Intussusception. Historical drugs included nirsevimab alip (BEYFORTUS). Concomitant therapies were not reported.   On 13-MAR-2025, the patient was vaccinated with the second dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), lot #Y013470; which has been verified to be valid for Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate), expiration date not reported but upon internal validation establish as 27-FEB-2027, administered by Intramuscular route in left thigh (strength and exact quantity volume were not provided) for prophylaxis (Inappropriate schedule of product administered) and also was vaccinated with the second dose of Pneumococcal vaccine conj 20v (CRM197) (PREVENAR 20), lot #LK6650, left thigh), administered by Intramuscular route in the left thigh (strength, exact quantity volume, indication and expiration date were not reported) and with the second dose of Diphtheria vaccine toxoid; Hepatitis b vaccine rHBsAg (yeast) (+) Pertussis vaccine acellular 3-component (+) Polio vaccine inact 3v (Vero) (+) Tetanus vaccine toxoid (PEDIARIX), lot #B532G, administered by Intramuscular route in the right thigh (strength, exact quantity volume, indication and expiration date were not reported).  On the same date (13-MAR-2025) at 7p.m., the patient experienced unresponsive to stimuli; even with cardiopulmonary resuscitation (CPR) and other interventions at the hospital when he was admitted (he was stabilized and transferred to a facility with an available pediatric provider), he never regained consciousness. Instead, he slowly declined and was no longer responsive to treatments in intensive case unit (ICU). It was also reported that "7 antigens, 3 syringes full of different adjuvants, preservatives and stabilizers" "too much pharma poisoned this little boy" (Toxicity to various agents). On 15-MAR-2023 at 8:14 a.m., he was pronounced dead. It was unknown whether an autopsy was performed.    The reporter considered the event of unresponsive to stimuli to be related to the suspect therapies meanwhile the event of toxicity to various agents was assessed as related to the suspect therapies.  Upon internal review, the event of unresponsive to stimuli was determined to be medically significant for the treatment required (ICU).; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user : (redacted)@merck.com , Index date : 2025-04-16 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : PV202500045176 , Central date : 2025-04-16 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Age: 54.0
Sex: F
Vaccine: FLU3, FLUC4
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 54.0
Sex: F
Vaccine: FLU3, FLUC4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium