chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC13
Symptoms: Paralysis
Clinical narrative: reaction to it was kind of like reaction  where she had like a type of palsy; Initial information received on 15-Apr-2025 regarding an unsolicited valid serious courtesy case received from a other health professional.  This case involves a 15 months old female patient who experienced reaction to it was kind of like reaction where she had like a type of palsy after receiving pneumococcal vaccine CONJ 13V (CRM197) [Prevnar 13], hepatitis B vaccine,HIB (PRP/T) Vaccine [ACT-HIB] and Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid [Dtap].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection, an unknown dose hepatitis B vaccine produced by unknown manufacturer via unknown route in unknown administration site, received an unknown dose of Prevnar 13 not produced by Sanofi Pasteur via unknown route in unknown administration site, and received an unknown dose of Dtap not produced by Sanofi Pasteur (formulation not reported) (strength, expiry date and lot number not reported for all) via unknown route in unknown administration site as all for Immunization.   On an unknown date the patient developed a reaction to it was kind of like reaction  where she had like a type of palsy (paralysis) (unknown latency).   Reportedly, the patient was followed by an allergist and this made the allergist think there was an egg or animal component that could had caused the episode. Caller was unable to clarify palsy further to include location on body.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.   At time of reporting, the outcome was Unknown for the event.   Seriousness criteria: This event was assessed as medically significant.  Additional information was received on 06-May-2025 from consumer/non-healthcare professional. Trade name of non-company suspect updated to Prevenar13. Narrative amended accordingly.  Additional information was received on 09-Jun-2025 from consumer/non-healthcare professional- Suspect- HIB (PRP/T) Vaccine [ACT-HIB] has been added. Narrative amended accordingly.; Sender's Comments: Sanofi company comment for follow up dated 09-JUN-2025: This case involves a 15 months old female patient who experienced reaction to it was kind of like reaction where she had like a type of palsy after receiving pneumococcal vaccine CONJ 13V (CRM197) [Prevnar 13], hepatitis B vaccine,HIB (PRP/T) Vaccine [ACT-HIB] and Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid [Dtap]. Further information regarding concurrent condition during vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Injected limb mobility decreased
Clinical narrative: Right shoulder pain and immobility. Treatment consists of rest, ice and NSAIDS. Outcome still being monitored.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Skin warm
Clinical narrative: upper arm erythema, warmth, no overt ball
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Pain
Clinical narrative: per visit note Hx from patient and her mother. She had a HPV vaccine 2 months ago and developed pain at the injection site on her left arm. There was a small amount of redness after the injection for about 1 week, it resolved. No swelling. She continue to complain about pain in her left shoulder over the deltoid. Pain has improved a lot but still occurs with movement of her left arm, especially when reaching up and behind. Pain is mild and improving. No color change, numbness or tingling
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Rash macular
Clinical narrative: The patient was given vaccinations at 11:10 a.m.  After the patient was given all of the vaccines, gotten dressed, and was about to exit the exam room, at 11:20 a.m., mom opened up the door and showed us the baby's head. I noticed the top of the infant' s head appeared with red blotchy spots over the entire head/crown.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Wrong patient
Clinical narrative: Patient came in with the sibling for his 11 year immunizations.  The CMA gave the Covid vaccine that was intended for the 14 year old sibling.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Heart rate increased, Myocarditis, Palpitations, Sleep disorder
Clinical narrative: pt got 1st dose in April and 2nd dose with in about 3 weeks. She states she is very athletic and after 1st dose she woke up around 2 am and her heart was hurting and pounding with a very rapid heart beat. This happened regularly in the middle of the night waking her up. This slowly went away after a year or year and half.  She states this was myocarditis and that it could have been life threating at the time when she was having these symptoms and now realizes it was life threatening.  She did not seek medical treatment.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Crying, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt got Vaxelis vaccine around 10:15 am on 6/13/25. Administered into right thigh, pt originally tolerated well, with no immediate adverse reaction. Around 1:30 after sleeping most of the morning, pt woke up and was inconsolable, thigh was red, swollen and warm to the touch. Parents checked temp rectally, no reported fever, gave one dose of Tylenol.  Redness on thigh continued to expand to knee and hip. Parents brought baby into office to have us check vaccine site. By our measurements, area is 10 cm tall x 9 cm wide, does extend beyond knee or hip.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Nausea
Clinical narrative: Raised bump at injection sight, patient experienced profound nausea
Age: 16.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting for ~10 days
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product label issue
Clinical narrative: Mislabeled expired vaccine administered 3 days after expiration date. Unknown adverse outcomes.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Cold sweat, Hyperhidrosis, Musculoskeletal stiffness, Pallor, Seizure
Clinical narrative: Pt was walking out post vaccine and Pt started convulsing.  Pt went stiff and arm shaking for approx 30 secs.  Pt was guided to chair.  Pt sweaty and clammy and pale.   Pt recovered approx 15 min.  Pt examined by provider and discharged home with precautions.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Tremor
Clinical narrative: Pt was walking out post vaccine and Pt started convulsing.  Pt went stiff and arm shaking for approx 30 secs.  Pt was guided to chair.  Pt sweaty and clammy and pale.   Pt recovered approx 15 min.  Pt examined by provider and discharged home with precautions.
Age: 37.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reactions noted.  Vaccine was Expired at time of injection.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Allodynia, Burning sensation, Fine motor skill dysfunction, Hyperaesthesia, Injection site pain
Clinical narrative: In left arm (injection site) onset within days after injection- Ongoing and increased burning pain beneath deltoid, running down arm, intense and ongoing burning pain in hand and fingers, Allodynia, Hyperalgesia, hand contractures, stiffness, loss of fine motor, weakness. Ruled out cervical radiculopathy and carpal tunnel so far, ongoing rule out CRPS after vaccine injection
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Magnetic resonance imaging neck, Muscle contracture, Musculoskeletal stiffness, Pain
Clinical narrative: In left arm (injection site) onset within days after injection- Ongoing and increased burning pain beneath deltoid, running down arm, intense and ongoing burning pain in hand and fingers, Allodynia, Hyperalgesia, hand contractures, stiffness, loss of fine motor, weakness. Ruled out cervical radiculopathy and carpal tunnel so far, ongoing rule out CRPS after vaccine injection
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received Engerix-B indicated for 20+ years old and patient was 17 years old at time of administration.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: instead of the liquid portion of the Pentacel vaccine being administered, the ActHib portion was administered after being reconstituted with sterile water, with no reported adverse event; Initial information received on 10-Jun-2025 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 1 years old female patient who had instead of the liquid portion of the diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (Vero)] being administered, the acthib portion was administered after being reconstituted with sterile water, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-May-2025, the patient received liquid portion of a dose 4 (0.25 mL to 2 mL for immunizations or 0.1 mL for TB skin test) of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine (lot UK199AA with unknown strength, formulation and expiry date) via intramuscular route in the right thigh for Immunization; being administered, the acthib portion was administered after being reconstituted with sterile water, with no reported adverse event (single component of a two-component product administered) (latency: same day).  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received Engerix-B that's indicated for 20+ years old when he was 17 years old. Patient did not have any adverse reactions.
Age: 16.0
Sex: F
Vaccine: MNQ, MEN
Symptoms: Autopsy, Bacterial test negative, Biopsy bone, Biopsy bone marrow, Blood test
Clinical narrative: Received Monday 5/19, started feeling bad, head ache, slight fever 5/21, higher fever 5/23, multiple Dr visits over the weekend, primary care 5/27, hospitalized & intubated 5/28, dx HLH unknown trigger-all tests for virus, bacteria etc were negative. Ecmo 6/2, deceased 6/3. Autopsy mult organ damage-unknown, extensive testing being performed.
Age: 16.0
Sex: F
Vaccine: MNQ, MEN
Symptoms: Computerised tomogram, Death, Endotracheal intubation, Feeling abnormal, Haemofiltration
Clinical narrative: Received Monday 5/19, started feeling bad, head ache, slight fever 5/21, higher fever 5/23, multiple Dr visits over the weekend, primary care 5/27, hospitalized & intubated 5/28, dx HLH unknown trigger-all tests for virus, bacteria etc were negative. Ecmo 6/2, deceased 6/3. Autopsy mult organ damage-unknown, extensive testing being performed.
Age: 16.0
Sex: F
Vaccine: MNQ, MEN
Symptoms: Haemophagocytic lymphohistiocytosis, Headache, Lumbar puncture, Lung assist device therapy, Mechanical ventilation
Clinical narrative: Received Monday 5/19, started feeling bad, head ache, slight fever 5/21, higher fever 5/23, multiple Dr visits over the weekend, primary care 5/27, hospitalized & intubated 5/28, dx HLH unknown trigger-all tests for virus, bacteria etc were negative. Ecmo 6/2, deceased 6/3. Autopsy mult organ damage-unknown, extensive testing being performed.
Age: 16.0
Sex: F
Vaccine: MNQ, MEN
Symptoms: Multi-organ disorder, Plasmapheresis, Pyrexia, Viral test negative, X-ray
Clinical narrative: Received Monday 5/19, started feeling bad, head ache, slight fever 5/21, higher fever 5/23, multiple Dr visits over the weekend, primary care 5/27, hospitalized & intubated 5/28, dx HLH unknown trigger-all tests for virus, bacteria etc were negative. Ecmo 6/2, deceased 6/3. Autopsy mult organ damage-unknown, extensive testing being performed.
Age: 16.0
Sex: F
Vaccine: MNQ, MEN
Symptoms: Bacterial test negative, Biopsy bone, Biopsy bone marrow, Blood test, Computerised tomogram
Clinical narrative: Received Monday 5/19, started feeling bad, head ache, slight fever 5/21, higher fever 5/23, multiple Dr visits over the weekend, primary care 5/27, hospitalized & intubated 5/28, dx HLH unknown trigger-all tests for virus, bacteria etc were negative. Ecmo 6/2, deceased 6/3. Autopsy mult organ damage-unknown, extensive testing being performed.
Age: 16.0
Sex: F
Vaccine: MNQ, MEN
Symptoms: Death, Endotracheal intubation, Feeling abnormal, Haemophagocytic lymphohistiocytosis, Headache
Clinical narrative: Received Monday 5/19, started feeling bad, head ache, slight fever 5/21, higher fever 5/23, multiple Dr visits over the weekend, primary care 5/27, hospitalized & intubated 5/28, dx HLH unknown trigger-all tests for virus, bacteria etc were negative. Ecmo 6/2, deceased 6/3. Autopsy mult organ damage-unknown, extensive testing being performed.
Age: 16.0
Sex: F
Vaccine: MNQ, MEN
Symptoms: Lumbar puncture, Lung assist device therapy, Mechanical ventilation, Plasmapheresis, Pyrexia
Clinical narrative: Received Monday 5/19, started feeling bad, head ache, slight fever 5/21, higher fever 5/23, multiple Dr visits over the weekend, primary care 5/27, hospitalized & intubated 5/28, dx HLH unknown trigger-all tests for virus, bacteria etc were negative. Ecmo 6/2, deceased 6/3. Autopsy mult organ damage-unknown, extensive testing being performed.
Age: 16.0
Sex: F
Vaccine: MNQ, MEN
Symptoms: Viral test negative, X-ray
Clinical narrative: Received Monday 5/19, started feeling bad, head ache, slight fever 5/21, higher fever 5/23, multiple Dr visits over the weekend, primary care 5/27, hospitalized & intubated 5/28, dx HLH unknown trigger-all tests for virus, bacteria etc were negative. Ecmo 6/2, deceased 6/3. Autopsy mult organ damage-unknown, extensive testing being performed.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Nausea, Pyrexia
Clinical narrative: patient has experienced discomfort at injection sight, fever, and nausea...
Age: 1.08
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired HIB vaccines was accidentally administered to a patient with no reported adverse event; Initial information received on 12-Jun-2025 regarding an unsolicited valid non-serious case received from an other healthcare professional.  This case involves a 13 months old female patient who accidentally got administered expired HIB (PRP/T) Vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis a vaccine for Immunisation.  On 07-Jun-2025, the patient accidentally administered expired dose 4 of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (strength- standard) once lot UK016AC and expiry date- 31-MAY-2025 via intramuscular route in the right thigh for immunization with no reported adverse event (expired product administered) (latency- same day).  Action taken- as not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No side effects or symptoms reported; HCP called to report a 25-year-old patient received their first does of VARIVAX in 2018 (exact date unknown, lot and exp date unknown) and did not receive their second dose until 06/03/2025. No side effects or symptoms reported. No Additional AE/ No; This spontaneous report was received from a pharmacist and refers to a 25-year-old female patient.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   In 2018, the patient was vaccinated with the first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) as prophylaxis (dose, route of administration, anatomical location, lot # and expiration date were not reported). Then on 03-JUN-2025, the patient was vaccinated with the second dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) at a dose of 0.5 mL as prophylaxis (valid lot #Y015100, expiration date: 06-SEP-2026) (inappropriate schedule of product administration). Both reconstituted with sterile diluent (dose, lot number, anatomical location, and indication were not provided).  No side effects or symptoms reported (no adverse event).   Lot # is being requested and will be submitted if received (dose #1)
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: one patient received his first dose before the age of 18, then an additional dose after 18; no AEs; This spontaneous report was received from a Pharmacist and refers to a male patient of unknown age.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot # and expiration date were not reported) for prophylaxis.   The Pharmacist reported that the patient received his first dose before the age of 18, then an additional dose after 18, outside of the PI's recommended age range. The patient experienced no Adverse Events.   At the reporting time, the outcome of the events 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.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: reports not feeling well for a day or so after each dose; This non-serious case was reported by a consumer via sales rep and described the occurrence of feeling unwell in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (received 1st dose on an unknown date, for tolerance of 1st dose of Shingrix, refer case US2025AMR072293).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling unwell (Verbatim: reports not feeling well for a day or so after each dose). Rechallenge with Shingrix was positive. The outcome of the feeling unwell was resolved (duration 1 day).   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.     It was unknown if the company considered the feeling unwell to be related to Shingrix.   Linked case(s) involving the same patient:US2025AMR072293   Additional Information: GSK Receipt Date: 02-JUN-2025 The Patient reported that he had a dose of Shingrix. The patient reported not feeling well for a day or so after each dose.; Sender's Comments:  US-GSK-US2025AMR072293:Same Patient/ 1st dose
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 63-year-old patient was accidentally administered a dose of Menveo; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 63-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 9x7cd, expiry date 31-JAN-2026) for prophylaxis.   On 06-JUN-2025, the patient received the 1st dose of Menveo. On 06-JUN-2025, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: a 63-year-old patient was accidentally administered a dose of Menveo). The outcome of the inappropriate age at vaccine administration was not applicable.   Additional Information: GSK Receipt Date: 06-JUN-2025 A pharmacist called in to report that a 63-year-old patient was accidentally administered a dose of Menveo and requested recommendations, which led to Inappropriate age at vaccine administration. The reporter was consented to Follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Loss of personal independence in daily activities
Clinical narrative: weakness; not being able to perform normal tasks; This is a spontaneous report received from a Consumer or other non HCP.  An elderly male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Jun2025 as dose 1, 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: ASTHENIA (non-serious), outcome "recovering", described as "weakness"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "recovering", described as "not being able to perform normal tasks". Therapeutic measures were not taken as a result of asthenia, loss of personal independence in daily activities.  Additional Information: the patient did not receive any other vaccines on the same date as the suspect vaccine and he was taking other medications within 2 weeks of the event starting. The patient reported weakness to the extent of not being able to perform normal tasks after receiving the vaccine.     The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Fall, Feeling abnormal, Loss of consciousness, Syncope
Clinical narrative: Administered vaccine to patient at approximately 4:20 pm. Patient walked to cash register shortly after administration, and while standing, 3 to 5 minutes after vaccination, pt told her mom she did not feel good. Mom told her to sit. she turned to go sit down and slowly fainted and fell on the ground. Patient returned to consciousness 15 to 30 seconds later. 911 was called. Patient recovered at the scene and declined a need for further medical intervention.
Age: 12.0
Sex: M
Vaccine: PNC15
Symptoms: Wrong product administered
Clinical narrative: The medical assistant was moving to fast and grabbed the wrong vaccine.
Age: 56.0
Sex: M
Vaccine: UNK, PNC20
Symptoms: Blood test, Chest X-ray, Chest pain, Dizziness, Vomiting
Clinical narrative: After having vaccine, started having some dizziness. The day after started  having chest pain over the heart. EMS was called and was taken the cardiology dept in the hospital. After being released from hospital, started vomiting at home. still having chest pain.
Age: 56.0
Sex: M
Vaccine: UNK, PNC20
Symptoms: Chest pain, Nausea, Pharyngeal swelling
Clinical narrative: After having vaccine, started having some dizziness. The day after started  having chest pain over the heart. EMS was called and was taken the cardiology dept in the hospital. After being released from hospital, started vomiting at home. still having chest pain.
Age: 56.0
Sex: M
Vaccine: UNK, PNC20
Symptoms: Blood test, Chest X-ray, Chest pain, Dizziness, Vomiting
Clinical narrative: Patient had no issues day of vaccination.   He called me the next day and said he had to go to the hospital with chest pains, swollen throat, nausea.  Patient did not report hives, local arm reaction, fainting.
Age: 56.0
Sex: M
Vaccine: UNK, PNC20
Symptoms: Chest pain, Nausea, Pharyngeal swelling
Clinical narrative: Patient had no issues day of vaccination.   He called me the next day and said he had to go to the hospital with chest pains, swollen throat, nausea.  Patient did not report hives, local arm reaction, fainting.
Age: 52.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Periorbital swelling, Skin erosion, Skin exfoliation
Clinical narrative: Facial skin peeling, raw feeling. Puffy eyes
Age: 1.58
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site rash
Clinical narrative: About 3 minutes after administering both vaccines patient presented  a localized rash on bilateral thighs, approximately 3 inches not urticarial (not hives), she had no other signs of reactionno shortness of breath, no lip/tongue swelling. Patient was assesed by Provider, rash was decreasing as time passed. Provider administer Benadryl to prevent worsening rash symptoms, patient was observed for 15 minutes. No other reactions observed or reported, localized rash decreased significantly; patient went home without any issues.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: It was reported through our pharmacy corporate office during an audit that patient had received Boostrix on 02/26/25 and should not have received another dose on 6/12/25. Patient was called, and she reported no side effects.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Arthritis, Rash
Clinical narrative: The patient was here to receive the Arexvy vaccine on 6/7. She called today and reported developing a rash on Monday, followed by inflammation in her thumb and index finger joints. She visited urgent care on 6/13, where she was prescribed doxycycline. She is scheduled to follow up with her primary care doctor on Wednesday.
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pain
Clinical narrative: Pt had PCV 20 on 6/6/205. Reported noticing pain and redness on 6/12/25. No blisters/pus noted. Pt reported pain and redness improved today (6/13/25). Advised pt to continue monitor sx, advised to use cold compress, return/UCC/ED precautions reviewed, pt v/u.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Atrioventricular block complete, Blood test, Echocardiogram, Electrocardiogram
Clinical narrative: I developed cardiac arrhythmias in the middle of May 2021. Upon seeing a cardiologist it was determined that I was in 3rd degree heart block and would require a permanent pacemaker.
Age: 51.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Acoustic stimulation tests abnormal, Balance disorder, Deafness neurosensory, Laboratory test normal, Labyrinthitis
Clinical narrative: Sudden sensorineural hearing loss, vertigo beginning 10/29/2024. Treated at ER, followed up with ENT, diagnosed with labyrinthitis. Oral steroids, steroid injection in ear, MRI. Balance restored to 90% but hearing loss is permanent.
Age: 51.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Magnetic resonance imaging head, Sudden hearing loss, Vertigo
Clinical narrative: Sudden sensorineural hearing loss, vertigo beginning 10/29/2024. Treated at ER, followed up with ENT, diagnosed with labyrinthitis. Oral steroids, steroid injection in ear, MRI. Balance restored to 90% but hearing loss is permanent.
Age: 29.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Dyspnoea, Urticaria
Clinical narrative: - Patient having hives within 15 minutes after heplisav and tdap vaccines - Benadryl 50mg given in office and instruction was given to provider partners to monitor for 30 min - about 20 min after administration of benadryl patient reported respiratory difficulty, 0.3mg intramuscular epi was given at that time.   - Patient endorsed improvement of symptoms, team continued to monitor patient for 30 minutes after epi administration.   - Patient reported symptoms had not returned at time of discharge, 30 min after intramuscular epi injection - Patient discharged in stable condition with strict ED precautions.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Skin indentation, Swelling, Urticaria
Clinical narrative: Per patient - Swollen, red, quarter size welts on skin with hollow pit at center.  Welts do not ooze, but are itchy. Welts go away after 4 to 5 days and have occurred following vaccination (pharmacist reporting is unsure when symptoms began) on belly, legs and both arms.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Per patient - Swollen, red, quarter size welts on skin with hollow pit at center.  Welts do not ooze, but are itchy. Welts go away after 4 to 5 days and have occurred following vaccination (pharmacist reporting is unsure when symptoms began) on belly, legs and both arms.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Dizziness, Echocardiogram, Hypertrophic cardiomyopathy, Laboratory test
Clinical narrative: started having a fib and then i ended up with serous heart issue cardiomyopathy, hypertrophic and light headness.   I have to take pills the  rest of my life just to live
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging
Clinical narrative: started having a fib and then i ended up with serous heart issue cardiomyopathy, hypertrophic and light headness.   I have to take pills the  rest of my life just to live
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Amnesia, Cardiac arrest, Cardioversion
Clinical narrative: cardiac arrest; short term memory loss; This spontaneous report was received from a Physician and refers to a 13-year-old male patient with no known history of cardiac events, family history, or reaction to 1st dose of GARDASIL-9.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 30-MAY-2025, the patient received his second dose of Human Papillomavirus 9-valent Vaccine, Recombinant intramuscular injection (GARDASIL 9), (lot # and expiration date were not reported) for prophylaxis.  On 02-JUN-2025, the patient experienced cardiac arrest at his lacrosse practice. The patient sought medical attention, was shocked 3 times and witnessed short term memory loss and has since recovered.  The causal relationship between the events and Human Papillomavirus 9-valent Vaccine, Recombinant intramuscular injection (GARDASIL 9) was not provided.   Upon internal review, the event of cardiac arrest was determined to be medically significant.   Follow up information was received by telephone on 09-Jun-2025.  It was reported that the patient had a diagnosis of Cranial stenosis as an infant. On 19-Jun-2024, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant intramuscular injection (GARDASIL 9) (lot #, expiration date, strength, route of administration, anatomical location not provided); and on 23-May-2025, he received the second dose of the vaccine (lot #, expiration date, strength, anatomical location not provided), both as prophylaxis. On this date, the patient's height was 61.5 inches, weight was 94.5 lbs and his blood pressure was 120/60 (units not provided). No other vaccinations were administered this day. On 27-May-2025, the patient experienced the events of cardiac arrest and amnesia (previously reported as 02-Jun-2025).   Lot # is being requested and will be submitted if received.; Sender's Comments: Priority : 4 , Is case serious : No , Index user : , Index date : 2025-06-09 , MNSC number : 02815081 , CLIC number : , ESTAR number : , IRMS number : US-009507513-2292076 , Central date : 2025-06-09 , Classification : DMC, Attachment description : Minimal Data Entry , Safety case number : US-009507513-2292076
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Cold sweat, Crying, Erythema, Fear, Immediate post-injection reaction
Clinical narrative: After administration of vaccines, agreed to meet family in lobby with updated vaccine records and forms. Mom did mention pateient's eyes appeared to cross briefly during administration of second (menveo) vaccine. Patient remained sitting talking to mom/nurse. When RN bringing forms out, PSR coming to back to alert me patient passed out. After stepping through door, this RN observed patient sitting leaning toward mom crying and a little red/visibly upset. Mom reports patient was sitting in chair when she passed out for a few seconds - closing her eyes, drained color, and slumped in chair. Patient verbalized disbelief about having passed out and scared about it happening again. 1445 HR 92, BP Right arm 108/76, skin a bit clammy. Patient reports vision looked funny for a moment but resolved. Given cool water. One of our doctors came out and briefly assessed patient who verbalizes feeling a little better after water. After crying stopped and consoled by mom, see pale color to face. Mom also has syncope with medical procedures such as mole treatment. Explained can happen after any vaccine and will have her sit with beverages in office for 10 minutes for any further symptoms. At 1450 HR 84, color and demeanor much improved. PCP came out & assessed & reassured patient/family. At 1455 RN checked on patient again who was standing in waiting room. Encouraged to secure shoes then accompanied out to car without any further symptoms. Mom will keep an eye on her and give her something to eat.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Loss of consciousness, Pallor, Posture abnormal, Strabismus, Visual impairment
Clinical narrative: After administration of vaccines, agreed to meet family in lobby with updated vaccine records and forms. Mom did mention pateient's eyes appeared to cross briefly during administration of second (menveo) vaccine. Patient remained sitting talking to mom/nurse. When RN bringing forms out, PSR coming to back to alert me patient passed out. After stepping through door, this RN observed patient sitting leaning toward mom crying and a little red/visibly upset. Mom reports patient was sitting in chair when she passed out for a few seconds - closing her eyes, drained color, and slumped in chair. Patient verbalized disbelief about having passed out and scared about it happening again. 1445 HR 92, BP Right arm 108/76, skin a bit clammy. Patient reports vision looked funny for a moment but resolved. Given cool water. One of our doctors came out and briefly assessed patient who verbalizes feeling a little better after water. After crying stopped and consoled by mom, see pale color to face. Mom also has syncope with medical procedures such as mole treatment. Explained can happen after any vaccine and will have her sit with beverages in office for 10 minutes for any further symptoms. At 1450 HR 84, color and demeanor much improved. PCP came out & assessed & reassured patient/family. At 1455 RN checked on patient again who was standing in waiting room. Encouraged to secure shoes then accompanied out to car without any further symptoms. Mom will keep an eye on her and give her something to eat.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Haemorrhagic stroke
Clinical narrative: On October 29, 2023 (the day after receiving the CoVID vaccine) patient suffered a hemorrhagic stroke.  She was taken to the hospital and passed away the following day, October 30.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity
Clinical narrative: prolonged arm pain since date vaccine administered
Age: 55.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: patient came into store today 6/14 and the vaccine was given on 6/10. Large area of redness from injection site to her elbow, swelling, bruising, and redness. patient reported itchiness and pain around the site, she had marked the area and area was growing throughout the week.
Age: 1.33
Sex: F
Vaccine: DTAP, HIBV, PNC20
Symptoms: Injection site nodule
Clinical narrative: Mom noted nodule to left thigh about 5 days after vaccinations were given (06/06/25). No tenderness, erythema, drainage noted. Came into office on 6/13/25 and assessment from myself (her PCP) noted ~1in subcutaneous nodule to left thigh on top. No abnormalities. Discussed mom it was from the vaccine and she does not have to do anything about it. Only to come back if causes pain or worsens.
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Culture urine, Decreased appetite, Dehydration, Eye pain
Clinical narrative: Per mom, patient got home from appointment adn started complainng of headache, abdominal pain and nausea. Then she started vomiting. Patient not wanting to eat or drink anything due to the nausea. Stating eyes hurt due to her headache. Gave Tylenol but vomited back up. Came to the office on 06/13/25 and evaluated for strep (neg) and checked urine (dehydration). Explained to parents most likely a vaccine reaction since it happened so soon after the vaccine and will not give the 2nd dose when it is due,. Prescribed ibuprofen and zofran and advised to come back to clinic in 3 days .
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Nausea, Streptococcus test negative, Urine analysis abnormal, Vomiting
Clinical narrative: Per mom, patient got home from appointment adn started complainng of headache, abdominal pain and nausea. Then she started vomiting. Patient not wanting to eat or drink anything due to the nausea. Stating eyes hurt due to her headache. Gave Tylenol but vomited back up. Came to the office on 06/13/25 and evaluated for strep (neg) and checked urine (dehydration). Explained to parents most likely a vaccine reaction since it happened so soon after the vaccine and will not give the 2nd dose when it is due,. Prescribed ibuprofen and zofran and advised to come back to clinic in 3 days .
Age: 77.0
Sex: F
Vaccine: HEPAB, RSV
Symptoms: Injection site erythema
Clinical narrative: THE PATIENT EXPERIENCED REDNESS  AT SITE OF INJECTION
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Vasovagal Syncope within 1 hr, while patient was leaving the clinic. Patient rested, drank water, vital signs stable before leaving clinic.
Age: 62.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pain, Nausea, Vomiting
Clinical narrative: N/V, Diarrhea, injection site redness / tenderness
Age: 60.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Diarrhoea, Headache, Malaise, Nausea, Vomiting
Clinical narrative: PATIENT, A 60 YEAR OLD FEMALE RECEIVED HER AREXVY AND 2ND DOSE OF SHINGRIX VACCINE ON 6/13/2025 AT 12:33 PM. SHE CALLED ON 6/14/2025 AT AROUND 12:15 PM AND STATED 4 HOURS AFTER RECEIVNG AREXVY VACCINE AND 2ND DOSE OF SHINGRIX VACCINE SHE STARTED HAVING SYMPTOMS OF NAUSEA, HEADACHE, VOMITING, AND DIARRHEA. PATIENT STATED SHE CANNOT TOLERATE EATING ANYTHING AND IS UNABLE TO TAKE HER CURRENT MAINTENANCE MEDICATIONS DUE TO NOT FEELING WELL. THE CALL WITH THE PATIENT GOT DISCONNECTED WHILE SHE WAS SPEAKING TO ME. PHARMACY MANAGER ATTEMPTED TO CALL HER BACK AND LEFT VOICE MAIL ON 6/14/2025 AT 12:21 PM.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: Fever for 3 days and headache.
Age: 3.0
Sex: M
Vaccine: MMRV
Symptoms: Blister, Erythema, Varicella
Clinical narrative: disseminated varicella vaccine chickenpox.  multiple small vesicles on erythematous base consistent with chicken pox clinically. no cough. start 6/13/25. Empiric treatment with acyclovir 5 dys course started 6/14/25.
Age: 75.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site swelling
Clinical narrative: Patient reported to pharmacy 48 hours after vaccine with a read swollen arm at injection site. swelling was increasing and she was advised to  go to urgent care she was seen 72 hours after injection and  treated with antibiotic and steroid for reaction
Age: 61.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Redness, swelling, and itching across large area of upper arm started 2 days after vaccines given and lasted 7 days.
Age: 51.0
Sex: F
Vaccine: HEP, PNC21, VARZOS
Symptoms: Furuncle, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: fever ( 101), nausea, headache, vommiting, boil on left arm
Age: 85.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: Patient received Prevnar 20 vaccine on 6/6/25 and noted no physical reactions to it in the immediate time after. Patient came to pharmacy today (6/14/25) stating he developed significant redness and itching beginning on 6/12/25 that did not improve with topical cortisone cream. He showed me his right arm which was very red about 4-inch diameter around where he had received the vaccine. He believed the redness to be expanding so I instructed him to promptly go to urgent care. Patient followed up with me and informed me he was given a steroid injection and told he was having a delayed reaction from the vaccine. In addition to the steroid injection, the prescriber sent in famotidine 40 mg to be taken once daily for 7 days.
Age: 52.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Severe redness and itching at the vaccination site, ibuprofen and Benadryl, and watching to see if the redness spreads
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC20
Symptoms: Febrile convulsion, Protein urine present, Pyrexia
Clinical narrative: Fever of 102.7, Febrile seizure within 5 hours of fever beginning
Age: 33.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site nodule, Injection site warmth
Clinical narrative: patient experienced a knot develop at the site of administration that was warm to the touch that resolved a few days after.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: This was given as an extra dose.  Patient wanted to receive Bexsero.  No adverse effects reported.  Patient will receive Bexsero at a future date.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaemia, Anti-cyclic citrullinated peptide antibody positive, Anxiety, Arthralgia, Arthritis
Clinical narrative: Shortly after receiving the COVID-19 vaccination, I experienced intermittent vague fatigue and mild joint pains which I attributed to stress and aging (in 2021 and 2022). In April of 2023, I rapidly developed a constellation of persistent and debilitating symptoms that significantly impacted my health and quality of life. These included severe joint swelling and pain, inability to use my hands for simple routine tasks, profound fatigue, persistent extreme tiredness, and a chronic cough, despite evaluation and treatment by multiple physicians. My cough only began to improve after nearly 18 months, with the initiation of antifungal therapy. In April 2023 when I began experiencing severe, joint pain in my hands and  knees. The pain came and went in flares, but during episodes it was extremely intense and disabling with inability to walk or drive. This all prompted an extensive autoimmune workup, referral to a rheumatologist, and initiation of aggressive treatment with medications such as methotrexate, high-dose prednisone, and biologic agents. I developed hypertension and elevation in my blood sugars. Additionally, I developed severe mouth ulcers.  These treatments, while necessary to manage my inflammatory joint disease, have caused their own burdens. Methotrexate, a chemotherapeutic agent, comes with significant side effects, and prolonged prednisone use has contributed to abnormal glucose levels and hypertension. Both the stress of my illness and the side effects of treatment have further impacted my metabolic health. I now require care from a multidisciplinary team that includes a rheumatologist, endocrinologist, ENT, pulmonary specialist, lipid specialist, cardiologist, and my primary care physician. Several of these providers have expressed concern that my symptoms and disease course were most likely triggered by an adverse immune reaction to the COVID-19 vaccine. This ongoing experience has been physically, emotionally, and medically overwhelming, as I continue to manage both the disease and the complex side effects of its treatment.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Autoimmune thyroiditis, Blood cholesterol increased, Blood glucose increased, Bronchiolitis
Clinical narrative: Shortly after receiving the COVID-19 vaccination, I experienced intermittent vague fatigue and mild joint pains which I attributed to stress and aging (in 2021 and 2022). In April of 2023, I rapidly developed a constellation of persistent and debilitating symptoms that significantly impacted my health and quality of life. These included severe joint swelling and pain, inability to use my hands for simple routine tasks, profound fatigue, persistent extreme tiredness, and a chronic cough, despite evaluation and treatment by multiple physicians. My cough only began to improve after nearly 18 months, with the initiation of antifungal therapy. In April 2023 when I began experiencing severe, joint pain in my hands and  knees. The pain came and went in flares, but during episodes it was extremely intense and disabling with inability to walk or drive. This all prompted an extensive autoimmune workup, referral to a rheumatologist, and initiation of aggressive treatment with medications such as methotrexate, high-dose prednisone, and biologic agents. I developed hypertension and elevation in my blood sugars. Additionally, I developed severe mouth ulcers.  These treatments, while necessary to manage my inflammatory joint disease, have caused their own burdens. Methotrexate, a chemotherapeutic agent, comes with significant side effects, and prolonged prednisone use has contributed to abnormal glucose levels and hypertension. Both the stress of my illness and the side effects of treatment have further impacted my metabolic health. I now require care from a multidisciplinary team that includes a rheumatologist, endocrinologist, ENT, pulmonary specialist, lipid specialist, cardiologist, and my primary care physician. Several of these providers have expressed concern that my symptoms and disease course were most likely triggered by an adverse immune reaction to the COVID-19 vaccine. This ongoing experience has been physically, emotionally, and medically overwhelming, as I continue to manage both the disease and the complex side effects of its treatment.