chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had a reaction which was like having covid again; had a reaction which was like having covid again; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Alpha Gal", start date: 2012 (ongoing), notes: Patient was diagnosed with Alpha Gal in Jan of this year however patient actually had it since 2012; "COVID", start date: 2020 (unspecified if ongoing), notes: Patient had Covid in the fall of 2020. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had a reaction which was like having covid again". Clinical course: Patient liked to get some information about the ingredients in our Covid Vaccines. patient would like to know if there were any mammal or mammal by-products in the vaccine. The reason patient was asking was that patient was diagnosed with Alpha Gal in Jan of this year; however, actually had it since 2012 and was misdiagnosed with IBS-D. Patient had Covid in the fall of 2020 before the vaccines became available and had all of the Covid vaccines except for the 2023. With each vaccines patient had a reaction which was like having Covid again. With the last vaccine patient took in 2022 the reaction was so bad that patient could not get out of bed for 24 hours. That was why patient had been hesitant to get any vaccines since. Now that patient knew that patient had Alpha Gal, was wondering if reactions are possibly from mammal or mamma by-products being in the vaccines or a vaccine reaction. Would we also be able to send patient a list of our other vaccines that contain mammal or mammal by products that can shared with patients Alpha Gal groups. Unfortunately, mammal and mammal by products are in so many things that the medical community and public was not aware. This information would be greatly appreciated.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400175579 same patient and vaccine, different dose and AE;US-PFIZER INC-202400175581 same patient and vaccine, different dose and AE;US-PFIZER INC-202400175580 same patient and vaccine, different dose and AE;
Age: 11.0
Sex: M
Vaccine: COVID19, HPV9, MNQ
Symptoms: Bradycardia, Dizziness, Nausea, Syncope, Vomiting
Clinical narrative: Patient fainted for a duration of 1 minute after receiving 3 vaccines (MCV4, HPV9, and COVID-19). Onset occurred after removal of needle from patient's arm. Patient regained consciousness and was awake, alert, oriented to self, place, time, and situation. Patient was unable to recall what happened prior the 1 minute that he fainted, but does report remembering that he was receiving vaccines. Review of vitals in both supine and sitting positions were WNL, but pt was bradycardic with HR ranging 54-60 bpm.  Patient did report feeling lightheaded and dizzy. While being assessed by Dr.,  patient was asked to stand up, which he did without difficulty, in order to take a standing BP; his HR was in 50-60s at this time and BP was 80/50. Shortly after taking BP, pt appeared nauseated. When he sat down, he had 1 episode of non-bilious, non-bloody emesis. After he threw up, his legs were elevated while he was in seated position. After being allowed to rest for a few minutes, MD spoke with the pt and he answered all questions appropriately. Report was given to EMS upon arrival and patient was transported to Hospital Authority ER via ambulance, accompanied by his mother.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barré Syndrome
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Quality of life decreased, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis; Sick; This serious case was reported by a consumer via interactive digital media and described the occurrence of rheumatoid arthritis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 month after receiving Shingles vaccine, the patient experienced rheumatoid arthritis (Verbatim: Rheumatoid arthritis) (serious criteria GSK medically significant) and sickness (Verbatim: Sick). The outcome of the rheumatoid arthritis and sickness were not reported.   It was unknown if the reporter considered the rheumatoid arthritis and sickness to be related to Shingles vaccine.     It was unknown if the company considered the rheumatoid arthritis and sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-MAY-2024 The case was received from the patient via (social media) interactive digital media. The patient took the first shot and made him or her sick. The patient came down with a form rheumatoid arthritis a month later. The patient stated that his or her life was been messed since then.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received their first dose of Shingrix on 2019, and they got the second dose today on May 21st 2024.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) (batch number 2KD99, expiry date 18-FEB-2026) for prophylaxis.   Previously administered products included Shingrix (Received their 1st dose of Shingrix in 2019).   On 21-MAY-2024, the patient received the 2nd dose of Shingrix. On 21-MAY-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patient received their first dose of Shingrix on 2019, and they got the second dose today on May 21st 2024.). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 21-MAY-2024 The other heath professional (pharmacy intern) reported that, a patient received their 1st dose of Shingrix in 2019, and they got the 2nd dose on the day of reporting which led to lengthening of vaccination schedule.  The other heath professional did not have any patient demographics, or specific data on 1st dose (date of administration, expiration date or lot number).  The reporter denied consent to follow up.
Age: 82.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Injection site rash
Clinical narrative: patient had rash on left arm below shingles injection site, rash has lessened over 1 week but is still present
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: CSF shunt operation, Cerebral venous sinus thrombosis, Headache, Idiopathic intracranial hypertension, Surgery
Clinical narrative: Pt was admitted to hospital on 4/20 after having severe headaches & blurry vision for two weeks. Pt was vaccinated on 4/5. Symptoms of headache/blurred vision started on 4/6. Patient was diagnosed with idiopathic intracranial hypertension that required neurosurgical intervention with shunt. Pt has now been readmitted with cerebral venous sinus thrombosis.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Vision blurred
Clinical narrative: Pt was admitted to hospital on 4/20 after having severe headaches & blurry vision for two weeks. Pt was vaccinated on 4/5. Symptoms of headache/blurred vision started on 4/6. Patient was diagnosed with idiopathic intracranial hypertension that required neurosurgical intervention with shunt. Pt has now been readmitted with cerebral venous sinus thrombosis.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Gait disturbance, Haematemesis, Vertigo
Clinical narrative: Vertigo with vomiting and inability to walk unassisted  ( after fairly normal side affects day of vax) continuing with unstable gait
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Impaired gastric emptying, Panic attack, Tremor
Clinical narrative: Patient psychiatric symptoms of Panic Attacks and Medical-Gastroparesis were reported to have begun after patient received Moderna COV vaccine and persisted or worsened since vaccination. Patient began psychiatric treatment with this provider on 05/25/2022 endorsing increased anxiety with panic attacks that have persisted despite appropriate treatment. Patient reports engagement with Primary care, Neurologist for tremors and GI for Gastroparesis. Recently patient reports psychiatric and medical symptoms onset coincided with receiving Moderna COVID vaccines.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Abdominal distension, Barium enema abnormal, Blood glucose normal, Faecaloma, Fatigue
Clinical narrative: On 4/16/2024 mom noted that symptoms began around 9 am - Patient began having difficulty with feeding, decreased breastmilk intake, and increased fussiness. Subsequent feeds were followed by aversion and emesis that continued for the rest of the day. Patient began having increased fatigue, sleepiness, and less interested in feeds. Mom also noted progressively worsening abdominal distention.  Patient did stool with mucus consistently but no blood noted. Patient arrived to the Emergency Department on 4/16/2024 where a x-ray KUB had concerns for small bowel obstruction. Patient subsequently had an ultrasound abdomen and testicular which showed right inguinal hernial and bilateral hydroceles with limited abdominal visualized. Surgery was consulted and recommended NG placement for suction and admission to the PICU. Patient was admitted to PICU service for further management.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Food aversion, Full blood count normal, Hydrocele, Infant irritability, Inguinal hernia
Clinical narrative: On 4/16/2024 mom noted that symptoms began around 9 am - Patient began having difficulty with feeding, decreased breastmilk intake, and increased fussiness. Subsequent feeds were followed by aversion and emesis that continued for the rest of the day. Patient began having increased fatigue, sleepiness, and less interested in feeds. Mom also noted progressively worsening abdominal distention.  Patient did stool with mucus consistently but no blood noted. Patient arrived to the Emergency Department on 4/16/2024 where a x-ray KUB had concerns for small bowel obstruction. Patient subsequently had an ultrasound abdomen and testicular which showed right inguinal hernial and bilateral hydroceles with limited abdominal visualized. Surgery was consulted and recommended NG placement for suction and admission to the PICU. Patient was admitted to PICU service for further management.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Intensive care, Intestinal pseudo-obstruction, Metabolic function test normal, Mucous stools, Occult blood positive
Clinical narrative: On 4/16/2024 mom noted that symptoms began around 9 am - Patient began having difficulty with feeding, decreased breastmilk intake, and increased fussiness. Subsequent feeds were followed by aversion and emesis that continued for the rest of the day. Patient began having increased fatigue, sleepiness, and less interested in feeds. Mom also noted progressively worsening abdominal distention.  Patient did stool with mucus consistently but no blood noted. Patient arrived to the Emergency Department on 4/16/2024 where a x-ray KUB had concerns for small bowel obstruction. Patient subsequently had an ultrasound abdomen and testicular which showed right inguinal hernial and bilateral hydroceles with limited abdominal visualized. Surgery was consulted and recommended NG placement for suction and admission to the PICU. Patient was admitted to PICU service for further management.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Polymerase chain reaction negative, Poor feeding infant, Somnolence, Ultrasound abdomen abnormal, Ultrasound testes abnormal
Clinical narrative: On 4/16/2024 mom noted that symptoms began around 9 am - Patient began having difficulty with feeding, decreased breastmilk intake, and increased fussiness. Subsequent feeds were followed by aversion and emesis that continued for the rest of the day. Patient began having increased fatigue, sleepiness, and less interested in feeds. Mom also noted progressively worsening abdominal distention.  Patient did stool with mucus consistently but no blood noted. Patient arrived to the Emergency Department on 4/16/2024 where a x-ray KUB had concerns for small bowel obstruction. Patient subsequently had an ultrasound abdomen and testicular which showed right inguinal hernial and bilateral hydroceles with limited abdominal visualized. Surgery was consulted and recommended NG placement for suction and admission to the PICU. Patient was admitted to PICU service for further management.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Urinary system x-ray abnormal, Vomiting, X-ray with contrast upper gastrointestinal tract
Clinical narrative: On 4/16/2024 mom noted that symptoms began around 9 am - Patient began having difficulty with feeding, decreased breastmilk intake, and increased fussiness. Subsequent feeds were followed by aversion and emesis that continued for the rest of the day. Patient began having increased fatigue, sleepiness, and less interested in feeds. Mom also noted progressively worsening abdominal distention.  Patient did stool with mucus consistently but no blood noted. Patient arrived to the Emergency Department on 4/16/2024 where a x-ray KUB had concerns for small bowel obstruction. Patient subsequently had an ultrasound abdomen and testicular which showed right inguinal hernial and bilateral hydroceles with limited abdominal visualized. Surgery was consulted and recommended NG placement for suction and admission to the PICU. Patient was admitted to PICU service for further management.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysaesthesia, Electrocardiogram, Laboratory test, Malaise, Small fibre neuropathy
Clinical narrative: PFIZER #1 3/30/2021 PFIZER #2 4/20/2021 PFIZER BIVALENT #3 09/22/2021 DEVELOPED MRNA SMALL FIBER NEUROPATHY WITH DYSESTHESIAS OF HANDS AND FEET AND POST-EXERTIONAL MALAISE.  TREATED PRIMARILY WITH PROTOCOL.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient received DTAP at 11 year health care visit instead of receiving Tdap
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, PNC20
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Mom messaged on the patient portal on 5/24/2024 regarding the rash that had started on patient's right leg. Mom sent a picture from 7am and then a picture from 1745 with the rash looking worse.  Mom said that the area was warm to the touch and bothered patient.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient did not have an adverse reaction but was given her second dose too soon. Patient/ parent is aware.
Age: 0.58
Sex: F
Vaccine: UNK
Symptoms: Nausea, Syncope
Clinical narrative: NAUSEA, FAINTING EPISODES
Age: 16.0
Sex: F
Vaccine: PNC20, TD
Symptoms: Syncope
Clinical narrative: Pt fainted when making next appointment with mother by side.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient was given a vaccine that had expired 2 days before the administration date.  The patient tolerated the injection well and parent was immediately informed by the provider. The patient did not have any reaction to the vaccine and was doing well the following day.  We informed the parent to please call with any concerns or updates,
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Pt stated that she had warmth and redness and some swelling like size of a golf ball on 5/22/24. On 5/23/24 had increased redness, swelling pain, warmth and now is swollen to size of softball. Pt says she has taken NSAID's and antihistamines. Instructed pt to go to a doctor or urgent care.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Urticaria
Clinical narrative: Broke out in all over body hives within a day and a half of getting booster shot. Body swollen from hives to approximately 85% of body.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Not all components of Pentacel were given. Only the liquid portion( dtap and ipv) were given.  Patient was called to come in and receive Hib.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse events at this time. Pt notified of error and to report any adverse events to local health department or PCP.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Injection site bruising, Injection site cellulitis, Injection site erythema, Injection site induration, Injection site scab
Clinical narrative: 48 hours after the injection, the pt. had a tiny bit of bruising and a scab at the injection site when he came to our office for a PPD reading.. He was seen by the physician who noted that on the lower part of the left upper arm, there was warmth, firmness and 9.5 cm. of vertical erythema.  Non-tender, no fluctuance; hard but not firm. Pt. was seen the following day at the ER and diagnosed with cellulitis and given Keflex for 7 days. Family verbalized improvement after that.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Injection site warmth
Clinical narrative: 48 hours after the injection, the pt. had a tiny bit of bruising and a scab at the injection site when he came to our office for a PPD reading.. He was seen by the physician who noted that on the lower part of the left upper arm, there was warmth, firmness and 9.5 cm. of vertical erythema.  Non-tender, no fluctuance; hard but not firm. Pt. was seen the following day at the ER and diagnosed with cellulitis and given Keflex for 7 days. Family verbalized improvement after that.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Injection site pain, Injection site reaction, Muscle swelling, Pain, Pain in extremity
Clinical narrative: complaining of L arm pain Thursday evening, swelling of the L Deltoid muscle,  painful to touch.  Has gotten worse over the last 5 days.  Reported to primary, He can raise and lower the arm but hurts.  described as a dull ache.   Muscle warm,
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: GIVEN 2 DOSE INSTEAD OF 1
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Product storage error
Clinical narrative: On January 9, 2024 the vaccines in the clinic were moved to Health Department due to a power outage. The power came back on around 9:30a.m. when I arrived to work but I was advised by my supervisor to move the vaccine still in case it took a while for the refrigerator to return to the proper temperature. Vaccines were packed with ice packs and bubble wrap and transported by CRNP. The vaccine was transported back to Health Department that afternoon. A temperature excursion was noted on the digital data logger. Once returned to clinic the data logger was found to be beside the ice packs instead of by the vaccine. The vaccine manufacturers of the affected vaccine were notified and made aware of the temperature excursion. I notified the companies that the vaccine reached a temperature of 1.8 degrees Celsius. The max temperature that the vaccine reached during transport was 12.0 degrees Celsius. Per the vaccine companies, the only vaccine that was not recommended to use was the opened vial of IPOL and the opened MDV of Fluzone. They were discarded per the vaccine companies? recommendations.  Moving forward to April 10, 2024. The vaccine was transported again to Health Department due to inclement weather that day. Vaccine was transported by my supervisor and returned on April 12, 2024. Another temperature excursion occurred when the vaccine was transported back to the clinic. The vaccine companies were again contacted for recommendations on viability of the vaccine. When contacting the vaccine companies, I was asked if any of the vaccines had undergone a previous temperature excursion. It was then when I pulled my documentation from the previous excursion that I realized I had read the temperature log incorrectly and that the vaccine had reached a temperature of negative 1.8 degrees Celsius instead of what I reported to the vaccine companies of a +1.8 Degrees Celsius. Therefore, in fact there were two 2 temp excursions one on January 9, 2024 and the other on April 12th, 2024.  A list of all patients that received vaccines between January 9-April 12th was compiled. The list was sorted through as to what patients received the affected vaccine. Patients were notified of questionable viability of vaccines and were offered and recommended to be revaccinated if desired. Notes were added into system for outside providers.  The process of packing vaccine during transport during emergencies had been reviewed by all staff to include packaging with conditioned water bottles instead of frozen ice packs. 04/30/2024-Unsuccessful phone call was made. Reached a business number. Letter was mailed on 04/30/24. Chart is flagged needs repeat DTAP-IPV-HIB and PCV13.  Pentacel and PCV13 given  02/27/24 underwent a temperature excursion. Has upcoming appointment scheduled on August 27th that was previously scheduled. Wil counsel upon return to clinic.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Confusional state, Dizziness, Hyperhidrosis, Pallor, Syncope
Clinical narrative: Syncopal event within 5-10 minutes of vaccination. Pt c/o dizziness and confusion. Pt was pale in color, diaphoretic and collapsed to the floor without losing consciousness.   Mother denied need to go to Emergency Room.  Pt was observed for the next hour where vital signs were monitored and were in normal limits.   All symptoms resolved within 10 minutes after syncopal episode.  Patient denied having any nausea or headache.  Patient was sent home with mother and told to report any other abnormal symptoms should they occur.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: On January 9, 2024 the vaccines in the clinic were moved to County Health Department due to a power outage. The power came back on around 9:30a.m. when I arrived to work but I was advised by my supervisor to move the vaccine still in case it took a while for the refrigerator to return to the proper temperature. Vaccines were packed with ice packs and bubble wrap and transported by CRNP. The vaccine was transported back to County Health Department that afternoon. A temperature excursion was noted on the digital data logger. Once returned to clinic the data logger was found to be beside the ice packs instead of by the vaccine. The vaccine manufacturers of the affected vaccine were notified and made aware of the temperature excursion. I notified the companies that the vaccine reached a temperature of 1.8 degrees Celsius. The max temperature that the vaccine reached during transport was 12.0 degrees Celsius. Per the vaccine companies, the only vaccine that was not recommended to use was the opened vial of IPOL and the opened MDV of Fluzone. They were discarded per the vaccine companies? recommendations.  Moving forward to April 10, 2024. The vaccine was transported again to County Health Department due to inclement weather that day. Vaccine was transported by my supervisor and returned on April 12, 2024. Another temperature excursion occurred when the vaccine was transported back to the clinic. The vaccine companies were again contacted for recommendations on viability of the vaccine. When contacting the vaccine companies, I was asked if any of the vaccines had undergone a previous temperature excursion. It was then when I pulled my documentation from the previous excursion that I realized I had read the temperature log incorrectly and that the vaccine had reached a temperature of negative 1.8 degrees Celsius instead of what I reported to the vaccine companies of a +1.8 Degrees Celsius. Therefore, in fact there were two 2 temp excursions one on January 9, 2024 and the other on April 12th, 2024.  A list of all patients that received vaccines between January 9-April 12th was compiled. The list was sorted through as to what patients received the affected vaccine. Patients were notified of questionable viability of vaccines and were offered and recommended to be revaccinated if desired. Notes were added into immprint for outside providers.  The process of packing vaccine during transport during emergencies had been reviewed by all staff to include packaging with conditioned water bottles instead of frozen ice packs. 05/03/2024-Mom contacted by phone and was counseled that HPV9 and MenQuadfi vaccines need to be repeated due to temperature excursion. Mom reported she wanted to call back and schedule an appointment. No appointment has been made yet. Chart is flagged to have vaccines repeated. Child has upcoming appointment which was already scheduled on 10/01/2024. Will counsel again upon return to clinic.
Age: 37.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Skin infection, Soft tissue infection
Clinical narrative: DEVELOPED SKIN AND SOFT TISSUE INFECTION FROM THE INJECTION 3 DAYS AFTER SHOT. SHOT AREA WAS ERYTHMATOUS, INDURATED, AND INFLAMMED. PATIENT FAILED THERAPY WITH SULFAMETHOXAZOLE/TRIMETHOPRIM AND CEPHALEXIN FROM THE LOCAL WALK-IN CLINIC. PATEINT WAS EVENTUALLY ADMITTED FOR A 3 DAY IMPATIENT STAY AFTER GOING TO THE EMERGENCY ROOM.
Age: 37.0
Sex: F
Vaccine: MNQ
Symptoms: Treatment failure
Clinical narrative: DEVELOPED SKIN AND SOFT TISSUE INFECTION FROM THE INJECTION 3 DAYS AFTER SHOT. SHOT AREA WAS ERYTHMATOUS, INDURATED, AND INFLAMMED. PATIENT FAILED THERAPY WITH SULFAMETHOXAZOLE/TRIMETHOPRIM AND CEPHALEXIN FROM THE LOCAL WALK-IN CLINIC. PATEINT WAS EVENTUALLY ADMITTED FOR A 3 DAY IMPATIENT STAY AFTER GOING TO THE EMERGENCY ROOM.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pustule
Clinical narrative: Patient's husband described a 'smallpox' like mark following the administration of the vaccine. Stated, "may be infected." Discussed using alcohol wipes. Then stated that he didn't remove the Band-Aid until the following morning, approximately 15 hours following vaccine administration.
Age: 11.0
Sex: F
Vaccine: DTAP, HEPA, HPV9, MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: DTaP ordered and given to 11 year old
Age: 54.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: redness, swelling and heat at site of immunization
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction, Pain in extremity
Clinical narrative: Right after I got the vaccine my arm hurst terrible for 2 days I kept trying to excersice hoping it would go away and the 3 rd day I felt like something scract me on my back and my arm, so I went to the urgent on May the 20th abd was told I had shingles. Urgent Care (same number and place as Dr.) I was given some prescribtions.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Rash
Clinical narrative: Right after I got the vaccine my arm hurst terrible for 2 days I kept trying to excersice hoping it would go away and the 3 rd day I felt like something scract me on my back and my arm, so I went to the urgent on May the 20th abd was told I had shingles. Urgent Care (same number and place as Dr.) I was given some prescribtions.
Age: 11.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient was given Infarix instead of Boostrix.
Age: 12.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MNQ, VARCEL
Symptoms: Blood glucose normal, Depressed level of consciousness, Hypopnoea, Lethargy, Loss of consciousness
Clinical narrative: Patient vaccinated around 10:45 am. After vaccination at roughly 11:00 am, patient fainted and lost consciousness. Difficult to arouse and lethargic. Vital signs taken: BP 100/66, HR 76, SpO2 99% on RA, RR 18 shallow. Regained consciousness within 2 minutes. Denies pain. Mother states patient ate full breakfast this morning. Denies allergies, no past medical history, or history of adverse reaction to vaccines. Patient still lethargic. 2 episodes of emesis. Patient states she "feels better" but remained slumped in chair and required assistance to stay awake. EMS called per mother's request for further assessment. EMS arrived at 11:15 am reassessed patient vitals, blood glucose 116. Patient ambulated to stretcher with assistance of mother. Transported to Hospital.
Age: 12.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MNQ, VARCEL
Symptoms: Posture abnormal, Somnolence, Syncope, Vomiting
Clinical narrative: Patient vaccinated around 10:45 am. After vaccination at roughly 11:00 am, patient fainted and lost consciousness. Difficult to arouse and lethargic. Vital signs taken: BP 100/66, HR 76, SpO2 99% on RA, RR 18 shallow. Regained consciousness within 2 minutes. Denies pain. Mother states patient ate full breakfast this morning. Denies allergies, no past medical history, or history of adverse reaction to vaccines. Patient still lethargic. 2 episodes of emesis. Patient states she "feels better" but remained slumped in chair and required assistance to stay awake. EMS called per mother's request for further assessment. EMS arrived at 11:15 am reassessed patient vitals, blood glucose 116. Patient ambulated to stretcher with assistance of mother. Transported to Hospital.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Vertigo
Clinical narrative: Pt received the pneumococcal vaccine on 05/21/2024, and upon awakening the next morning, pt felt like room was spinning with positional changes.   Treatment:     1. Change positions slowly                      2. Watch the Epley Maneuver on social media                      3. Limit intake of tea, coffee, energy drinks, & sodas                      4. Take meclizine as prescribed                      5. Referral for vestibular rehab                      6. Eat balanced & healthy meals                      7. Encouraged water hydration                      8. Red Flag for ED visit discussed
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: wrong vaccine given, should have been TDAP
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2, COVID19-2
Symptoms: Angiogram, Catheterisation cardiac normal, Cerebrovascular accident, Chest pain, Dyspnoea
Clinical narrative: MODERNA #1 1/19/2021 MODERNA #2 2/23/2021 MODERNA #3 12/2/2021 MODERNA #4 5/27/2022 MODERNA #5 12/15/2022  2023 PATIENT DEVELOPED CHEST PAIN HAD HEART CATHETERIZATION AND HAD NO SIGNIFICANT LESIONS, MAY 2024 HAD SIGNIFICANT CHEST PAIN AND SOB AND WAS DIAGNOSED WITH MODERNA MRNA COVID-19 VACCINE INDUCED BILATERAL PULMONARY EMBOLI AS WELL AS A SIMULTANEOUS STROKE.   TREATED WITH ELIQUIS, HYDRALAZINE, ATORVASTATIN AND PROTOCOL.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2, COVID19-2
Symptoms: Echocardiogram, Electrocardiogram, Immunisation reaction, Laboratory test, Magnetic resonance imaging head
Clinical narrative: MODERNA #1 1/19/2021 MODERNA #2 2/23/2021 MODERNA #3 12/2/2021 MODERNA #4 5/27/2022 MODERNA #5 12/15/2022  2023 PATIENT DEVELOPED CHEST PAIN HAD HEART CATHETERIZATION AND HAD NO SIGNIFICANT LESIONS, MAY 2024 HAD SIGNIFICANT CHEST PAIN AND SOB AND WAS DIAGNOSED WITH MODERNA MRNA COVID-19 VACCINE INDUCED BILATERAL PULMONARY EMBOLI AS WELL AS A SIMULTANEOUS STROKE.   TREATED WITH ELIQUIS, HYDRALAZINE, ATORVASTATIN AND PROTOCOL.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2, COVID19-2
Symptoms: Pulmonary embolism
Clinical narrative: MODERNA #1 1/19/2021 MODERNA #2 2/23/2021 MODERNA #3 12/2/2021 MODERNA #4 5/27/2022 MODERNA #5 12/15/2022  2023 PATIENT DEVELOPED CHEST PAIN HAD HEART CATHETERIZATION AND HAD NO SIGNIFICANT LESIONS, MAY 2024 HAD SIGNIFICANT CHEST PAIN AND SOB AND WAS DIAGNOSED WITH MODERNA MRNA COVID-19 VACCINE INDUCED BILATERAL PULMONARY EMBOLI AS WELL AS A SIMULTANEOUS STROKE.   TREATED WITH ELIQUIS, HYDRALAZINE, ATORVASTATIN AND PROTOCOL.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Brain fog, Fatigue, Neuropathy peripheral, Palpitations
Clinical narrative: Excessive fatigue, neuropathy, brain fog, palpitations
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine used out of recommended age range
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Time: 1000. Mom came to Health District on 05/28 for Vaccines. Mom filled out paperwork and stated that son was 12 years. Son date of birth is 10/XX/20XX. which he was 11 years and 7 months. Nurse inadvertently gave 12+ recommended dose vaccine. Son waited 10min after vaccine administration . Son stated "feeling fine" and left with mom.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no AE reported; MMR II on 11-SEP-2019, VARIVAX on 18-SEP-2019; inappropriate schedule of vaccine administered; This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 11-SEP-2019, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 18-SEP-2019, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #S015461, expiration date: 20-MAY-2021, administered for prophylaxis (strength, and route of administration were not provided). The interval elapsed between administration of both vaccines was shorter than recommended (inappropriate schedule of product administration).  The second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was administered on 21-JUL-2023 and the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) was administered on 08-MAY-2024. No adverse event was reported.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: No other AE; Nurse reported a patient missed their second dose of GARDASIL 9 on an unknown date in February 2024. Confirmed no other AE occurred. The caller did not have the date of administration for the first dose of GARDASIL 9. No further information provided.; Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  The reporting nurse stated that the patient missed their second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on an unknown date in February 2024. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; HCP calling to report that patient received inappropriately stored PROQUAD.  No adverse effects reported.  No PQC. Please see note section for 34 associated AE cases.  PROQUAD  LOT Y003143   7/27/2025 Temp: 19.8 F Time: 20 Hours 15 Minutes  No Previo; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 09-MAY-2024, the patient was vaccinated with inappropriately stored, single dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), formulation: injection, lot # Y003143, expiration date: 27-JUL-2025 (exact dose, route of administration and anatomical location were not provided) for prophylaxis.   Administered dose of vaccine was exposed to the temperature excursion of 19.8 degrees Fahrenheit for 20 hours and 15 minutes (product storage error). No previous temperature excursion had occurred. There were no additional adverse events reported (no adverse event).  Lot number Y003143 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), with rHA albumin status.; Sender's Comments:  US-009507513-2405USA007600: US-009507513-2405USA007588:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; HCP calling to report that patient received inappropriately stored PROQUAD.; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 22-MAY-2024, the patient was vaccinated with improperly stored single dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #Y003143, expiration date was 27-JUL-2025, (strength, exact dose, route of administration, and anatomical site of vaccination were not provided) for prophylaxis (product storage error). The suspect vaccine underwent a temperature excursion of 19.8 Fahrenheit (F) degrees for 20 hours and 15 minutes. No previous temperature excursion (TE) was reported, No adverse effects was reported (no adverse event).; Sender's Comments:  US-009507513-2405USA007600:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; HCP calling to report that patient received inappropriately stored PROQUAD.; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 13-MAY-2024, the patient was vaccinated with improperly stored single dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #Y003143, expiration date was 27-JUL-2025, (strength, exact dose, route of administration, and anatomical site of vaccination were not provided) for prophylaxis (product storage error). The suspect vaccine underwent a temperature excursion of 19.8 Fahrenheit (F) degrees for 20 hours and 15 minutes. No previous temperature excursion (TE) was reported, No adverse effects was reported (no adverse event).; Sender's Comments:  US-009507513-2405USA007600:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; HCP calling to report that patient received inappropriately stored VARIVAX.  No adverse effects reported.  No PQC. Please see case 02607099 note section for 34 associated AE cases.  VARIVAX  LOT X026789   11/14/2025 Temp: 19.8 F Time: 20 Hours 15 Min; This spontaneous report was received from medical assistant and refers to an 1-year-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 15-MAY-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, single dose, lot #X026789, expiration date: 14-NOV-2025, administered for prophylaxis (strength, and route of administration were not provided). Those vaccine underwent temperature excursion in 19.8 Farenheit for 20 hours 15 minutes (Product storage error). No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2405USA007600:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; HCP calling to report that patient received inappropriately stored PROQUAD.  No adverse effects reported.  No PQC. Please see case 02607099 note section for 34 associated AE cases.  PROQUAD  LOT Y003143   7/27/2025 Temp: 19.8 F Time: 20 Hours 15 Minu; This spontaneous report has been received from a medical assistant, referring to a 4-year-old patient of unknown gender. The information regarding the patient's concurrent conditions, concomitant therapies or medical history was not reported.  On 10-MAY-2024, the patient was vaccinated with an inappropriately stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) injection, single dose, lot #Y003143, expiration date: 27-JUL-2025, administered for prophylaxis (route of administration and anatomical location were not reported) (product storage error). Temperature excursion of 19.8 degrees Fahrenheit for 20 hours and 15 minutes was reported. The vaccine had no previous temperature excursions. No adverse effects reported (No adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2405USA007600: US-009507513-2405USA007600:2405USA007600 US-009507513-2405USA007454:2405USA007454 US-009507513-2405USA007488:2405USA007488 US-009507513-2405USA007573:2405USA007573 US-009507513-2405USA007578:2405USA007578 US-009507513-2405USA007588:2405USA007588 US-009507513-2405USA007617:2405USA007617 US-009507513-2405USA007648:2405USA007648 US-009507513-2405USA007667:2405USA007667 US-009507513-2405USA007684:2405USA007684 US-009507513-2405USA007692:2405USA007692 US-009507513-2405USA007700:2405USA007700 US-009507513-2405USA007713:2405USA007713 US-009507513-2405USA007720:2405USA007720 US-009507513-2405USA007722:2405USA007722 US-009507513-2405USA007724:2405USA007724 US-009507513-2405USA007727:2405USA007727 US-009507513-2405USA007728:2405USA007728 US-009507513-2405USA007731:2405USA007731 US-009507513-2405USA007761:2405USA007761 US-009507513-2405USA007763:2405USA007763 US-009507513-2405USA007771:2405USA007771 US-009507513-2405USA007791:2405USA007791 US-009507513-2405USA007833:2405USA007833 US-009507513-2405USA007841:2405USA007841 US-009507513-2405USA007901:2405USA007901 US-009507513-2405USA007905:2405USA007905 US-009507513-2405USA007909:2405USA007909 US-009507513-2405USA007911:2405USA007911 US-009507513-2405USA007912:2405USA007912 US-009507513-2405USA007916:2405USA007916 US-009507513-2405USA007935:2405USA007935 US-009507513-2405USA008015:2405USA008015
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC15
Symptoms: Crying, Infant irritability
Clinical narrative: the infant was irritable and cried for 4 hours; the infant was irritable and cried for 4 hours; This spontaneous report was received from a physician and refers to a 9-week-old female. Her medical history, concurrent conditions and concomitant therapies were not reported.  On 21-MAR-2024, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), 0.5 milliliter injection, lot # X020316, expiration date: 18-OCT-2025, administered as vaccine by intramuscular (IM) route (dose was not provided); and diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), lot # UK015AA, expiration date: 31-MAY-2025, administered as vaccine by intramuscular route (strength and formulation were not provided).  On 21-MAR-2024, approximately 3-4 hours after the administration of both vaccines, the infant was irritable and cried for 4 hours. The HCP stated the mother was a nurse and after doing research on the internet, she considered taking infant to the emergency room, but then the patient got better and she stayed at home. On 22-MAR-2024, the patient recovered from both events. On 21-MAY-2024, the infant received second dose of diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL) by IM route as vaccine (no other administration details provided), after which no adverse issues or side effects were reported. The HCP's plan was to ensure the infant tolerated the second dose of this vaccine, and then he would consider giving the second dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) as well. The HCP stated that isolated AE was not considered severe or life-threatening, and he planned to pre-medicate with "tylenol" prior to administration of the next dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), unless contraindicated. No additional AE information was provided.   The causal relationship between the events and both vaccines was not reported.
Sex: M
Vaccine: HPV9
Symptoms: Product use in unapproved indication
Clinical narrative: Caller reports the patient received GARDASIL to treat recurrent warts on his hand/ no clarification provided on if patient received GARDASIL or GARDASIL 9; This spontaneous report was received from a nurse and a medical assistant, regarding the nurse's nephew, a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapy were not reported.  On an unknown date in 2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (also reported as GARDASIL vaccine, no clarification provided if patient received GARDASIL or GARDASIL 9, conflicting information) to treat recurrent warts on his hand (strength, dose, lot #, expiry date, and route of administration were not provided) (product use in unapproved indication).  It was confirmed that the office did suggest the patient to receive quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) to treat warts (conflicting information). The patient was not seen in the office prior to 2023. He was first seen in the office on an unspecified date in September 2023 and was last seen on 27-MAR-2024.   Lot # was being requested and would be submitted if received.  The patient had histories of thoracic operation and skin papilloma while on prior therapy with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (case # 2404USA000240). Company Causality Assessment: Based on the clinically relevant information currently available for this individual case, the reported event of congenital anomaly is considered unlikely related to GARDASIL vaccine. The evidence is not sufficient to suggest a relationship between the vaccine and the reported serious adverse event. Pre-existing congenital anomaly constitutes a more plausible alternative explanation for the event.  Company Comment- No changes to the product safety information are warranted at this time.  Merck Sharp & Dohme LLC, continues to monitor the safety profile of the product.; Sender's Comments:  US-009507513-2404USA000240:
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Received Second Dose of  Heplisav-B One Week After First Dose; Initial report received on 08-May-2024.  A pharmacist reported that a 45-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and received the second dose of HEPLISAV-B one week after the first dose.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unknown date, the patient received the first dose of HEPLISAV-B (lot #, expiration date, NDC #, route, and site not reported).   On an unknown date, "one week" after the first dose, the patient received the second dose of HEPLISAV-B (lot #, expiration date, NDC #, route, and site not reported). The patient reported that she "felt fine". No adverse effects were reported.   No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.