chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Twinrix dose a couple of years ago and never got the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix adult) for prophylaxis.   Previously administered products included Twinrix (received 1st dose couple of years ago ). Concurrent medical conditions included substance abuse (oxi drugs injectable, heroine).   On an unknown date, the patient did not receive the 2nd dose of Twinrix adult. On an unknown date, an unknown time after receiving Twinrix adult, the patient experienced incomplete course of vaccination (Verbatim: Twinrix dose a couple of years ago and never got the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-AUG-2024 Pharmacist called to report that a homeless patient with substances abuse (oxi drugs injectable, heroine), came to the facility  for health care and mentioned that started a Twinrix dose a couple of years ago and never got the 2nd dose, which led to incomplete course of vaccination. Did not consent to follow-up.
Sex: F
Vaccine: COVID19, HEP, HEPA, UNK
Symptoms: COVID-19
Clinical narrative: Third time having covid-19; This spontaneous report was received from a consumer via other company regarding herself a female patient of unknow age.   The patient's medical history included two episodes of Coronavirus disease-19 (COVID-19). The patient's concurrent conditions included high blood pressure, anxiety, depression, blood pressure abnormal, blood cholesterol abnormal, and cardiac disorder. Concomitant medications included labetalol, sertraline, lisinopril, alprazolam, vitamin B complex, collagen, colecalciferol (VITAMINE D), bromelains (+) quercetin and linum usitatissimum oil (OMEGA 3,6,9).   On an unknown date in June 2024, the patient was vaccinated with either hepatitis B vaccine (recombinant) (manufacturer unknown) intramuscular injection, or Hepatitis A Vaccine, inactivated (manufacturer unknown) intramuscular injection both administered for prophylaxis (strengths, doses, lot #s, expiry dates, routes of administration and anatomical locations were not provided); and with tozinameran (COVID-19 VACCINE) in the left arm (strength, formulation, dose, lot #, expiry date, route of administration and indication were not provided).   On an unknown date, the patient started therapy with nirmatrelvir (+) ritonavir (PAXLOVID) (strength, formulation, dose, frequency, lot #, expiry date, route of administration, and indication were not provided).  On 17-AUG-2024, the patient experienced COVID-19 for a third time (COVID-19). At the time of reporting, the outcome of the event was unknown. The action taken with the suspect therapies was not reported.    The causal relationship between the event and the suspect therapy/vaccines was unknown.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Foetal death, Stillbirth
Clinical narrative: Fetal demise a week after immunization; This is a spontaneous report received from a Physician from a sales representative.  A female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for maternal immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FOETAL DEATH (medically significant), 1 week after the suspect product(s) administration, outcome "unknown", described as "Fetal demise a week after immunization". The pregnancy resulted in still birth. The fetal outcome is intrauterine death.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: There is not a reasonable possibility that the reported event fetal demise was related to the suspect product event most likely due to patient underlying contributory factors.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Fatigue
Clinical narrative: debilitating chest pain; shortness of breath; horrible fatigue on top of everything; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 31-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; CHEST PAIN (non-serious), outcome "unknown", described as "debilitating chest pain"; FATIGUE (non-serious), outcome "unknown", described as "horrible fatigue on top of everything". Additional information: The patient took the Pfizer vaccines in late 2021. The patient have been completely healthy up until taking the vaccines. The patient have been extremely sick after taking them suffering daily from debilitating chest pain and shortness of breath. He now have horrible fatigue on top of everything. He have been on medical leave because his health has been destroyed.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Headache, Loss of consciousness, Mass
Clinical narrative: passed out; headaches; She feel that there is a lump on her head; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA) for immunisation. The patient's relevant medical history included: "terminal cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose number unknown (booster); unknown manufacturer), for COVID-19 immunisation, reaction(s): "headaches". The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "passed out"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; MASS (non-serious), outcome "unknown", described as "She feel that there is a lump on her head". Therapeutic measures were taken as a result of loss of consciousness. Clinical course: A consumer who had terminal cancer is ranting that she very irritated because she get some reactions and headaches since she take all the boosters and the pharmacy gave her the flu shot and she passed out and been in a care home for a month. She feel that there is a lump on her head and now, she mentioned that Pfizer made another covid shot that can make another bad reaction to her again so she wanted to know on what will be the reaction of this new covid vaccine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash
Clinical narrative: bad rashes; Legs swelling; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NUS2024US113682_NC (Novartis Pharmaceuticals Corporation).  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: XOLAIR. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunisation. The following information was reported: RASH (non-serious), 6 months after the suspect product(s) administration, outcome "not recovered", described as "bad rashes"; PERIPHERAL SWELLING (non-serious), 6 months after the suspect product(s) administration, outcome "not recovered", described as "Legs swelling". Additional information: Reporter's wife had bad rashes, 2 shots Pfizer, started 6 months after vaccine and has been going on for 2 years. Xolair 1 shot a month. Reporter stated "treating vaccine injury with more vaccine, it's sickening. But no one has ever asked if she had the COVID vaccine". The reporter stated that the patient needed to do a spike detox and do 3 days fast.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Autoimmune disorder
Clinical narrative: auto immune disease/immune system to go crazy and attack my body; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), in Oct2023 as dose number unknown, single) for influenza immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "auto immune disease/immune system to go crazy and attack my body". Clinical Course: The (Withheld) said it was safe to get the flu shot and the Covid booster at the same time which patient did last Oct. Soon after patient had symptoms of an auto immune disease which started after the vaccines. Now would take two years of infusion medication to keep it in remission. Those vaccines caused patient's immune system to go crazy and attack patient's body.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: reconstituting the lyophilized ActHib component of PENTACEL with a sterile diluent with no reported adverse event; Initial information received on 16-Aug-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient with unknown demographics and is reported reconstituting the lyophilized ACT-HIB component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] with a sterile diluent with no reported adverse event  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On unknown date, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Powder and suspension for suspension for injection of (strength, lot and expiry date: not reported) via unknown route in unknown administration site for Immunization and reported reconstituting the lyophilized acthib component of pentacel with a sterile diluent with no reported adverse event (single component of a two-component product administered) (latency: on same day).  Information regarding batch number corresponding to the one at time of event occurrence is requested.  Reportedly, Pharmacist, calling on behalf of the medical center, had a question in relation to a PENTACEL incident they have. She stated that they had a patient who received only the ActHib component of PENTACEL and the ActHib was reconstituted with a sterile diluent. Pharmacist needed to know if the ActHib component is effective or do they have to revaccinate the patient with the full PENTACEL? Pharmacist confirmed that patient hasn't received the DTaP-IPV liquid component. She also asked if they reconstituted the ActHib component with the right diluent, do they only need to give the DTaP-IPV component? If so, how do they reconstitute the DTaP-IPV component?  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: U
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Adacel exposed to maximum 70F upto undetermined time due to human error with no reported adverse event; products been administered post excursion with no reported adverse event; Initial information received on 19-Aug-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to 2024SA247385.  This case involves Adult and unknown gender patient and reporter stated that Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] exposed to maximum 70f upto undetermined time due to human error with no reported adverse event and products been administered post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), Concomitant medications and family history were not provided.   On 16-Aug-2024, Reporter states that they received a shipment of 2 boxes of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] Suspension for injection (strength, expiry date, lot number not reported) for Immunization which was exposed to maximum 70F upto undetermined time due to human error with no reported adverse event (product storage error), then On 19-AUG-2024 the patient had been administered via unknown route in unknown administration site post excursion (poor quality product administered) (latency- same day).  Information on the batch number was requested corresponding to the one at time of event occurrence  Reportedly, Human error was involved. It was delivered to the front desk. It was not immediately opened. When it was opened on 19-aug-2024, at 08:00, the vaccines were "still cold" but the "dry ice" was melted. She states that shipments usually have a "temperature tracker" but this particular box did not contain one. She also reports that the ambient temperature in the room was about 70F. Approximately 64 hours elapsed between delivery of shipment and vaccines being returned to refrigeration. She states that 2 patients received the vaccine this morning already. The only information provided about those patients was that they were both adults and neither received any other vaccines.  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.; Sender's Comments:  US-SA-2024SA247385:02186178
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: patient being given the Pentacel without the HIb component (with no reported adverse event); Initial information received on 20-Aug-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case involves an unknown age and gender patient who was given the Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV (Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] without the HIB component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV (Vero)/HIB(PRP/T) Vaccine Powder and suspension for suspension for injection (lot- UK040AA,Expiration Date :31-JUL-2025)(unknown strength, route) in unknown administration site for immunization and patient was given the Pentacel without the HIB component with no reported adverse event (single component of a two-component product administered) (latency-same day).  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: 6.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: ADACEL was inadvertently administered to a 6-year-old patient, with no repored adverse event; Initial information received on 20-Aug-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6-year-old male patient whom diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was inadvertently administered, 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 B Vaccine (Hepatitis B Vaccine); and measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (WISTAR RA 27/3), varicella zoster vaccine live (OKA/MERCK) (Proquad) for Immunisation.  On 20-Aug-2024, the 6 years old patient was inadvertently administered a 0.5 ml dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection of lot U7869AA and expiry date: 18-Aug-2025 via intramuscular route in the right thigh as Immunization (product administered to patient of inappropriate age) (latency: on same day). No adverse event was reported.  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: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: possible temperature excursion of Adacel, vaccines were administered to a patient earlier this day with no reported adverse event; Initial information received on 20-Aug-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 19-year-old female patient and is reported that possible temperature excursion of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel], vaccines were administered to a patient earlier this day with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 20-Aug-2024, the patient received a 0.5 ml dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection strength; standardization and frequency: once of lot 2CA69C1 and expiry date: 20-Jul-2025 via intramuscular route in the left deltoid as Immunization and (latency: on same day) temperature excursion of adacel, vaccines were administered to a patient earlier this day with no reported adverse event (poor quality product administered).  Reportedly, She stated that it was placed on the side of the fridge door where the smaller supplies were usually placed. She had no information on the temperature and the duration of the vaccines being out of range. MIS provided the stability information for their reference if the vaccine can still be used or not. MA also stated that the vaccines were administered to a patient earlier this day (20Aug2024).  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: 9.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: DAPTACEL to a 9 year old with no reported adverse event; Initial information received on 21-Aug-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 9-year-old female patient whom diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in July 2024, 9 years old, received an unknown dose (dose 1) of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine Suspension for injection Frequency: once, Strength: standard (expiry date, lot number not reported) via unknown route in unknown administration site for immunization (product administered to patient of inappropriate age) (latency: on same day).  Information regarding batch number corresponding to the one at time of event occurrence is requested.  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 and Regulatory Authority 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.; Sender's Comments:  US-SA-2024SA250089:
Age: 11.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Rash, Rash erythematous, Skin warm
Clinical narrative: 10 x 10 cm cm erythematous painful warm rash circular right arm,
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Patient presented to pharmacy on 08/28/24 and spoke to pharmacist about the reaction. The patient experienced redness around the injection site and a hard knot under the skin at the injection site. Patient reported the effects lasted a couple of days and caused arm soreness. Pharmacist didn't see any lingering problems on 08/28. Patients concerns were addressed and pharmacist told patient that the effects would be documented. Patient felt it was more than a normal reaction should be.
Age: 10.0
Sex: F
Vaccine: SMALLMNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccine was mistakenly given to 10 year old patient by nurse. no adverse side effects noted by patient in office
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Pruritus, Urticaria
Clinical narrative: The patient reports developing hives an hour after vaccination. He denied shortness of breath, difficulty breathing and other symptoms. He stated he took benadryl but did not experience relief from itching. He came to the clinic the following day to report symptoms. Pt was advised to use hydrocortisone cream and benadryl until symptoms dissipate. Given ER precautions.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea
Clinical narrative: customer said she felt nausea
Age: 80.0
Sex: F
Vaccine: FLUA4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT REPORTED NO ADVERSE REACTIONS TO VACCINES. PATIENT WAS GIVEN 2 DOSES OF FLU VACCINE 2 WEEKS APART. IT WAS NOT DISCOVERED THAT SHE RECEIVED 2 DOSES UNTIL AFTER ADMINISTRATION OF 2ND DOSE.
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abdominal pain, Blood pressure increased, Chest pain, Dizziness, Dyspnoea
Clinical narrative: Pt received MCV, Tdap, and HPV vaccinations -- two in R deltoid and one in L deltoid. Immediately after receipt pt reported feeling abdominal pain and lightheadedness. MA provided apple juice, an ice pack, and had pt elevate legs. After approx 5 min, pt stood and reported mid-sternal pain rated as 7/10. Provider was called. Vitals obtained and pt w/ BP of 90s/50s, HR in 90s, SaO2 99%. Chest pain abated to 3/10 after approx 5 min. Recommended continued monitoring and consuming second juice box. After approx 5 more min pt reported acute escalation of chest pain again to 7/10 and associated shortness of breath. BP increased to 120s/70s and HR in 120s w/ SaO2 99%. Pt coached through deep breathing and provided water. Pt also w/ some shortness of breath, but no swelling of tongue, lips, no wheezing. Given h/o asthma, opted to administer albuterol 2 puffs which improved chest pain, resolved dyspnea, and pt denied further lightheadedness. 50 minutes after immunizations administered pt w/o further symptoms and d/c'd home.
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Immediate post-injection reaction
Clinical narrative: Pt received MCV, Tdap, and HPV vaccinations -- two in R deltoid and one in L deltoid. Immediately after receipt pt reported feeling abdominal pain and lightheadedness. MA provided apple juice, an ice pack, and had pt elevate legs. After approx 5 min, pt stood and reported mid-sternal pain rated as 7/10. Provider was called. Vitals obtained and pt w/ BP of 90s/50s, HR in 90s, SaO2 99%. Chest pain abated to 3/10 after approx 5 min. Recommended continued monitoring and consuming second juice box. After approx 5 more min pt reported acute escalation of chest pain again to 7/10 and associated shortness of breath. BP increased to 120s/70s and HR in 120s w/ SaO2 99%. Pt coached through deep breathing and provided water. Pt also w/ some shortness of breath, but no swelling of tongue, lips, no wheezing. Given h/o asthma, opted to administer albuterol 2 puffs which improved chest pain, resolved dyspnea, and pt denied further lightheadedness. 50 minutes after immunizations administered pt w/o further symptoms and d/c'd home.
Age: 64.0
Sex: M
Vaccine: FLUR4, TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: PT CAME TO PHARMCY ON 08/28/2024 LET ME KNOW HE WAS EXPERINCING HIVES AND ITCHING THOUGH HIS WHOLE BODY. LET ME KNOW HE DID SEE A PA ABOUT ISSUE. I ADIVSED TO TAKE EITHER BENADRYL OR ZYERTEC TO HELP WITH SYMPTOMS. IF SYMPTOMS GOT WORSE TO GO TO THE ER.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Developed Shingles
Age: 86.0
Sex: F
Vaccine: FLUA4
Symptoms: Blindness, Chills, Macular degeneration, Nasopharyngitis, Pain
Clinical narrative: Severe shivering, cold, Fever 103', BP 70/40, body pains, blind ( I have macular, could not see anything). No medical professional was seen.  Stayed in bed and took Tylenol
Age: 86.0
Sex: F
Vaccine: FLUA4
Symptoms: Pyrexia
Clinical narrative: Severe shivering, cold, Fever 103', BP 70/40, body pains, blind ( I have macular, could not see anything). No medical professional was seen.  Stayed in bed and took Tylenol
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: I was in between pt's I saw that this pt's age was 19yrs old and he had said yes to the Hep b vaccine. I saw he was a adult so I gave him the hep b adult dose. I had let the pt go when I ordered the vaccine and it let me know that the adult one was not for him because he was not 20 yrs. old. I let provider know about event. He stated pt will be okay he's basically receiving an extra dose of vaccine. I also let Supervisor know about even on day of event. I called pt and let him know I administered the wrong hep b vaccine. Pt had no further questions or concerns due to provider stating there should be no side effects.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Erythema
Clinical narrative: Arm very red but not swollen or painful. Looks to be a large bruise. Patient reports that it is getting better.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, IPV, PNC20, UNK
Symptoms: Bacterial test negative, Culture urine negative, Influenza virus test negative, Lethargy, Nitrite urine absent
Clinical narrative: 08/ 23/ 2024 note date. Patient is a 4-month-old female, was brought by mother to emergency department for fever last night.  Mother states patient has received 4 vaccines yesterday. Patient had a fever of 104° at 1855 yesterday, she was given Tylenol at that time.  Mother states patient has not had fever today however patient has been "lethargic " and she's not opening eyes unless she's in a dark room.  Patient is breast-fed. Mother states patient is feeding well with plenty of wet diapers.  Mother denies rash, neck stiffness, cough, runny nose, ear pulling, difficulty breathing, vomiting, diarrhea or constipation. Patient remains stable in ED. Patient is alert, happy/smiling, nontoxic appearing, not in distress with stable vital signs.  Discussed case with Dr., he recommends UA, urine culture and Covid 19/flu/RSV, discharge patient if tests are negative, he will see patient in office on Monday. Covid 19/Flu/RSV were negative. Urinalysis showed WBC 4, negative bacteria, negative leukocytes, negative nitrite, urine culture pending. Patient was breast-fed and had 3 wet diapers in ED. Mother states patient has appointment with Dr. on Monday at 0830AM.  Discussed extensively with mother regarding test results, diagnosis, treatment and ED return precautions.  Patient is stable for discharge
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, IPV, PNC20, UNK
Symptoms: Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, White blood cells urine negative
Clinical narrative: 08/ 23/ 2024 note date. Patient is a 4-month-old female, was brought by mother to emergency department for fever last night.  Mother states patient has received 4 vaccines yesterday. Patient had a fever of 104° at 1855 yesterday, she was given Tylenol at that time.  Mother states patient has not had fever today however patient has been "lethargic " and she's not opening eyes unless she's in a dark room.  Patient is breast-fed. Mother states patient is feeding well with plenty of wet diapers.  Mother denies rash, neck stiffness, cough, runny nose, ear pulling, difficulty breathing, vomiting, diarrhea or constipation. Patient remains stable in ED. Patient is alert, happy/smiling, nontoxic appearing, not in distress with stable vital signs.  Discussed case with Dr., he recommends UA, urine culture and Covid 19/flu/RSV, discharge patient if tests are negative, he will see patient in office on Monday. Covid 19/Flu/RSV were negative. Urinalysis showed WBC 4, negative bacteria, negative leukocytes, negative nitrite, urine culture pending. Patient was breast-fed and had 3 wet diapers in ED. Mother states patient has appointment with Dr. on Monday at 0830AM.  Discussed extensively with mother regarding test results, diagnosis, treatment and ED return precautions.  Patient is stable for discharge
Age: 21.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Hypotonia, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: PATIENT CHECKED IN FOR VACCINE BUT STATED THAT GETS ANXIETY WHEN GETS SHOTS, BUT ITS OKAY HE MIGHT JUST NEED TO SIT DOWN FOR A LITTLE AND MIGHT GET DIZZY.  PT GOT THE FLU AND COVID VACCINE AND IMMEDIATELY SLUMPED OVER IN SEAT THEN SLID OFF THE SEAT AND STARTED SEIZING. PT REGAINED CONSCIOUSNESS AFTER A FEW MINUTES, AND SAT UP. PARAMETICS WERE CALLED TO SCENE, PT TRIED TO REFUSE GOING TO HOSPITAL BUT FAINTED AFTER BEING QUESTIONED BY PARAMETICS. THEN WAS TAKEN TO HOSPITAL ON STRETCHER. PT RETURNED AFTER 2 HOURS AND RECEIVED TDAP VACCINE WITH NO INCIDENT
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult patient were accidentally administered with pediatric doses of Engerix-B/wrong dose; adult patient were accidentally administered with pediatric doses of Engerix-B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 57-year-old male patient who received HBV (Engerix B pediatric) (batch number 29RN7, expiry date 25-FEB-2024) and (batch number 9K74F, expiry date 27-OCT-2025) for prophylaxis.   On 15-DEC-2023, the patient received the 3rd dose of Engerix B pediatric. On 15-DEC-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: adult patient were accidentally administered with pediatric doses of Engerix-B/wrong dose) and adult use of a child product (Verbatim: adult patient were accidentally administered with pediatric doses of Engerix-B). The outcome of the underdose was unknown and the outcome of the adult use of a child product was not reported.   Additional Information: GSK Receipt date: 15-AUG-2024 An HCP reported that a patient are accidentally administered with pediatric doses of Engerix-B which led to Underdose and Adult use of child product.; Sender's Comments:  US-GSK-US2024101902:Same reporter / different patient
Age: 0.67
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20
Symptoms: Immunisation reaction, Infant irritability, Injection site erythema, Injection site induration, Local reaction
Clinical narrative: Area red where she received vaccine, spreading to inner thigh, is warm to touch, hard spot where vaccine was given. Very fussy, no appetite.
Age: 0.67
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20
Symptoms: Decreased appetite, Infant irritability, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Area red where she received vaccine, spreading to inner thigh, is warm to touch, hard spot where vaccine was given. Very fussy, no appetite.
Age: 29.0
Sex: U
Vaccine: HEP, IPV, MMR, VARCEL, HEP, IPV, MMR, VARCEL
Symptoms: Heart rate increased, Tremor
Clinical narrative: patient experienced a possible seizure; the MMR-II being improperly reconstituted with sodium chloride instead of STERILE DILUENT; the MMR-II being improperly reconstituted with sodium chloride instead of STERILE DILUENT; This spontaneous report was received from a Pharmacist and refers to a 29-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  The patient was receiving immigration vaccines. On 10-AUG-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X028613, expiration date: 13-DEC-2025, administered for prophylaxis (strength, dose and route of administration were not provided); measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) injection, lot #X026327, expiration date: 07-NOV-2025, administered for prophylaxis (strength, dose and route of administration were not provided); hepatitis b vaccine rhbsag (yeast) (ENGERIX B), (strength, dose, formulation, lot #, expiry date, route of administration, and indication were not provided); and polio vaccine inact 3v (vero) (IPOL POLIO VACCINE), (strength, dose, formulation, lot #, expiry date, route of administration, and indication were not provided).  But the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) was improperly reconstituted with sodium chloride (strength, dose, frequency, formulation, lot #, expiry date, route of administration, and indication were not provided) instead of sterile diluent solution for injection/infusion (strength, dose, frequency, lot #, expiry date, route of administration, and indication were not provided) (Product preparation error, Product administration error).  On 10-AUG-2024, after receiving all four vaccines, patient experienced a possible seizure. EMS was called on behalf of the patient and the patient "came to" quickly and denied medical attention. On an unknown date in August 2024, the patient was recovered from the event.  The causal relationship between the event and suspect products was not reported.  Upon internal review, the event possible seizure was considered to be medically significant.
Age: 29.0
Sex: U
Vaccine: HEP, IPV, MMR, VARCEL, HEP, IPV, MMR, VARCEL
Symptoms: Product administration error, Product preparation error
Clinical narrative: patient experienced a possible seizure; the MMR-II being improperly reconstituted with sodium chloride instead of STERILE DILUENT; the MMR-II being improperly reconstituted with sodium chloride instead of STERILE DILUENT; This spontaneous report was received from a Pharmacist and refers to a 29-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  The patient was receiving immigration vaccines. On 10-AUG-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X028613, expiration date: 13-DEC-2025, administered for prophylaxis (strength, dose and route of administration were not provided); measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) injection, lot #X026327, expiration date: 07-NOV-2025, administered for prophylaxis (strength, dose and route of administration were not provided); hepatitis b vaccine rhbsag (yeast) (ENGERIX B), (strength, dose, formulation, lot #, expiry date, route of administration, and indication were not provided); and polio vaccine inact 3v (vero) (IPOL POLIO VACCINE), (strength, dose, formulation, lot #, expiry date, route of administration, and indication were not provided).  But the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) was improperly reconstituted with sodium chloride (strength, dose, frequency, formulation, lot #, expiry date, route of administration, and indication were not provided) instead of sterile diluent solution for injection/infusion (strength, dose, frequency, lot #, expiry date, route of administration, and indication were not provided) (Product preparation error, Product administration error).  On 10-AUG-2024, after receiving all four vaccines, patient experienced a possible seizure. EMS was called on behalf of the patient and the patient "came to" quickly and denied medical attention. On an unknown date in August 2024, the patient was recovered from the event.  The causal relationship between the event and suspect products was not reported.  Upon internal review, the event possible seizure was considered to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a nurse realized that PROQUAD was administered to an adult patient and requested information on revaccination; No additional AE; This spontaneous report was received from Pharmacist referring to an adult patient of an unknown age and gender.   The patient's pertinent medical history, previous drug reactions or allergies and concomitant therapies were not reported.  On an unknown date, an adult patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (strength, exact dose administered, route and anatomical location of administration were not provided; lot # reported as U024229, which has been determined to be an invalid lot # for this vaccine, expiration date provided as 04-AUG-2023). It was stated that a nurse realized that this vaccine was administered to an adult patient and requested information on revaccination (product administered to patient of inappropriate age); product was not expired when administered. No adverse side effects were reported; no additional adverse event (AE) (no adverse event).
Age: 1.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Nurse confirmed that the patient has not experienced any medical concerns or symptoms after being administered the dose of GARDASIL 9/No additional AE; Nurse calling to report adverse event regarding GARDASIL 9.  Nurse reporting that a 12 month old patient was inadvertently administered GARDASIL 9 during a routine vaccine appointment today, 8/19/2024.; This spontaneous report was received from a nurse and refers to a 12-month-old patient of unknown age.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 19-AUG-2024, the patient was inadvertently vaccinated with HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #W030851, expiration date: 08-JAN-2025 (strength, frequency, route of administration, and indication were not provided) (Product administered to patient of inappropriate age) during a routine vaccine appointment. The patient had not experienced any medical concerns or symptoms after being administered the dose of the vaccine.  No additional information provided.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash, Skin mass
Clinical narrative: Patient received the vaccines on 12AUG2024 and developed a "lump behind [her] ear" and a "full body rash"; Patient received the vaccines on 12AUG2024 and developed a "lump behind [her] ear" and a "full body rash"; This spontaneous report was received from a pharmacy technician, regarding to a 45-year-old female patient. The patient's concomitant medications included hepatitis b vaccine (recombinant) (RECOMBIVAX HB); diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP); and COVID-19 vaccine. Her medical history, concurrent conditions, and previous drug reactions or allergies were not reported. On 12-AUG-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection as prevention of varicella, at 1 dose (1 dosage form) (lot number Y006523, which has been verified as valid with an expiration date reported and established as: 25-MAR-2026); and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection as prevention of measles, mumps and rubella, at 1 dose (1 dosage form) (lot number X026404, which has been verified as valid with an expiration date reported and established as: 08-NOV-2025) (strengths, doses, vaccination schemes, routes of administration, and anatomical sites of injection were not provided).   On 24-AUG-2024, the patient developed a lump behind her ear (skin mass) and a full body rash (rash). The patient sought medical attention and did not receive any treatments for the events. At the time of reporting, the patient had not recovered from the events. Additionally, it was reported that the patient was not immunocompromised.   The causal relationship between the events and suspect vaccines was not reported.   Lot number is being requested and will be submitted if received.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, Oral herpes
Clinical narrative: Inappropriate schedule of vaccine administered; Customer called to report that her son has experienced cold sores on his lips after receiving the HPV vaccine, GARDASIL 9.; This spontaneous report was received from a consumer regarding an 11-year-old male patient.   His medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were reported as none.  On an unknown date in April 2018, 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 as prevention of human papilloma virus (HPV) (dose, lot number, expiration date, route of administration and anatomical site of injection were not provided).   The reporter (patient's mother) called to say that on an unknown date in 2018 (also reported as within 6 months of getting the vaccine), the patient experienced cold sores on his lips (oral herpes). The patient sought medical attention and received a topical ointment as treatment for the event of oral herpes. Afterward, on an unknown date in May 2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered as prevention of human papilloma virus (HPV) (dose, lot number, expiration date, route of administration and anatomical site of injection were not provided) (Inappropriate schedule of product administration). At the time of the report, the patient had not recovered from the event of oral herpes.   The causal relationship between the event of oral herpes and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Received first dose, has not received second dose; Initial report received on 02-Aug-2024.  A consumer reported that he, a male patient (age, race, and ethnicity not provided), received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization two months ago but has not received the second dose yet.   Medical history, allergies, and concomitant medications were not reported.   On an unspecified date in Jun-2024, the patient received the first dose of HEPLISAV-B (Lot number, expiration date, NDC, and injection site unknown) intramuscularly. The patient did not receive the second dose of HEPLISAV-B at the time of report.   No other information was available.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Accidental underdose, Product administered to patient of inappropriate age
Clinical narrative: adult patient were accidentally administered with pediatric doses of Engerix-B/wrong dose; adult patient were accidentally administered with pediatric doses of Engerix-B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: adult patient were accidentally administered with pediatric doses of Engerix-B/wrong dose) and adult use of a child product (Verbatim: adult patient were accidentally administered with pediatric doses of Engerix-B). The outcome of the accidental underdose was unknown and the outcome of the adult use of a child product was not reported.   Additional Information: GSK receipt date: 15-AUG-2024 Healthcare professional explained that 3 adult patients were accidentally administered with pediatric doses of Engerix B which led to accidental underdose and adult use of a child product. The case is linked with US2024AMR105818, US2024101902, by same reporter.; Sender's Comments:  US-GSK-US2024101902:Same reporter / different patient