chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Feeling of body temperature change, Hyperaesthesia teeth, Muscular weakness, Nausea
Clinical narrative: tremor; muscle weakness; neuropathic pain; night sweats; burning and tingling skin; burning and tingling skin; tachycardia; teeth sensitivity; tinnitis; full body throbing; nausea; vomiting; loss of appetite; rapid hot and cold spells; This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Nov2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 37 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "ADD" (unspecified if ongoing); "Insomnia" (unspecified if ongoing). Concomitant medication(s) included: FLUZONE [INFLUENZA VACCINE] taken for influenza immunisation, on 18Sep2023 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: SKIN BURNING SENSATION (disability), PARAESTHESIA (disability) all with onset 20Nov2021, outcome "recovering" and all described as "burning and tingling skin"; PAIN (disability) with onset 20Nov2021, outcome "recovering", described as "full body throbing"; DECREASED APPETITE (disability) with onset 20Nov2021, outcome "recovering", described as "loss of appetite"; MUSCULAR WEAKNESS (disability) with onset 20Nov2021, outcome "recovering", described as "muscle weakness"; NAUSEA (disability) with onset 20Nov2021, outcome "recovering"; NEURALGIA (disability) with onset 20Nov2021, outcome "recovering", described as "neuropathic pain"; NIGHT SWEATS (disability) with onset 20Nov2021, outcome "recovering"; FEELING OF BODY TEMPERATURE CHANGE (disability) with onset 20Nov2021, outcome "recovering", described as "rapid hot and cold spells"; TACHYCARDIA (disability) with onset 20Nov2021, outcome "recovering"; HYPERAESTHESIA TEETH (disability) with onset 20Nov2021, outcome "recovering", described as "teeth sensitivity"; TINNITUS (disability) with onset 20Nov2021, outcome "recovering", described as "tinnitis"; TREMOR (disability) with onset 20Nov2021, outcome "recovering"; VOMITING (disability) with onset 20Nov2021, outcome "recovering". Therapeutic measures were taken as a result of tremor, muscular weakness, neuralgia, night sweats, skin burning sensation, paraesthesia, tachycardia, hyperaesthesia teeth, tinnitus, pain, nausea, vomiting, decreased appetite, feeling of body temperature change. Clinical course: Patient also received BNT162b2 (BNT162B2), on 28Sep2023 as dose 5 (booster), single (Batch/Lot number: Unknown) for covid-19 immunisation. No other vaccine same date. No other medications in two weeks. Adverse events treatment as steroid, beta blocker. Patient had no known allergies.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuralgia, Night sweats, Pain, Paraesthesia, Skin burning sensation
Clinical narrative: tremor; muscle weakness; neuropathic pain; night sweats; burning and tingling skin; burning and tingling skin; tachycardia; teeth sensitivity; tinnitis; full body throbing; nausea; vomiting; loss of appetite; rapid hot and cold spells; This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Nov2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 37 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "ADD" (unspecified if ongoing); "Insomnia" (unspecified if ongoing). Concomitant medication(s) included: FLUZONE [INFLUENZA VACCINE] taken for influenza immunisation, on 18Sep2023 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: SKIN BURNING SENSATION (disability), PARAESTHESIA (disability) all with onset 20Nov2021, outcome "recovering" and all described as "burning and tingling skin"; PAIN (disability) with onset 20Nov2021, outcome "recovering", described as "full body throbing"; DECREASED APPETITE (disability) with onset 20Nov2021, outcome "recovering", described as "loss of appetite"; MUSCULAR WEAKNESS (disability) with onset 20Nov2021, outcome "recovering", described as "muscle weakness"; NAUSEA (disability) with onset 20Nov2021, outcome "recovering"; NEURALGIA (disability) with onset 20Nov2021, outcome "recovering", described as "neuropathic pain"; NIGHT SWEATS (disability) with onset 20Nov2021, outcome "recovering"; FEELING OF BODY TEMPERATURE CHANGE (disability) with onset 20Nov2021, outcome "recovering", described as "rapid hot and cold spells"; TACHYCARDIA (disability) with onset 20Nov2021, outcome "recovering"; HYPERAESTHESIA TEETH (disability) with onset 20Nov2021, outcome "recovering", described as "teeth sensitivity"; TINNITUS (disability) with onset 20Nov2021, outcome "recovering", described as "tinnitis"; TREMOR (disability) with onset 20Nov2021, outcome "recovering"; VOMITING (disability) with onset 20Nov2021, outcome "recovering". Therapeutic measures were taken as a result of tremor, muscular weakness, neuralgia, night sweats, skin burning sensation, paraesthesia, tachycardia, hyperaesthesia teeth, tinnitus, pain, nausea, vomiting, decreased appetite, feeling of body temperature change. Clinical course: Patient also received BNT162b2 (BNT162B2), on 28Sep2023 as dose 5 (booster), single (Batch/Lot number: Unknown) for covid-19 immunisation. No other vaccine same date. No other medications in two weeks. Adverse events treatment as steroid, beta blocker. Patient had no known allergies.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia, Tinnitus, Tremor, Vomiting
Clinical narrative: tremor; muscle weakness; neuropathic pain; night sweats; burning and tingling skin; burning and tingling skin; tachycardia; teeth sensitivity; tinnitis; full body throbing; nausea; vomiting; loss of appetite; rapid hot and cold spells; This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Nov2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 37 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "ADD" (unspecified if ongoing); "Insomnia" (unspecified if ongoing). Concomitant medication(s) included: FLUZONE [INFLUENZA VACCINE] taken for influenza immunisation, on 18Sep2023 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: SKIN BURNING SENSATION (disability), PARAESTHESIA (disability) all with onset 20Nov2021, outcome "recovering" and all described as "burning and tingling skin"; PAIN (disability) with onset 20Nov2021, outcome "recovering", described as "full body throbing"; DECREASED APPETITE (disability) with onset 20Nov2021, outcome "recovering", described as "loss of appetite"; MUSCULAR WEAKNESS (disability) with onset 20Nov2021, outcome "recovering", described as "muscle weakness"; NAUSEA (disability) with onset 20Nov2021, outcome "recovering"; NEURALGIA (disability) with onset 20Nov2021, outcome "recovering", described as "neuropathic pain"; NIGHT SWEATS (disability) with onset 20Nov2021, outcome "recovering"; FEELING OF BODY TEMPERATURE CHANGE (disability) with onset 20Nov2021, outcome "recovering", described as "rapid hot and cold spells"; TACHYCARDIA (disability) with onset 20Nov2021, outcome "recovering"; HYPERAESTHESIA TEETH (disability) with onset 20Nov2021, outcome "recovering", described as "teeth sensitivity"; TINNITUS (disability) with onset 20Nov2021, outcome "recovering", described as "tinnitis"; TREMOR (disability) with onset 20Nov2021, outcome "recovering"; VOMITING (disability) with onset 20Nov2021, outcome "recovering". Therapeutic measures were taken as a result of tremor, muscular weakness, neuralgia, night sweats, skin burning sensation, paraesthesia, tachycardia, hyperaesthesia teeth, tinnitus, pain, nausea, vomiting, decreased appetite, feeling of body temperature change. Clinical course: Patient also received BNT162b2 (BNT162B2), on 28Sep2023 as dose 5 (booster), single (Batch/Lot number: Unknown) for covid-19 immunisation. No other vaccine same date. No other medications in two weeks. Adverse events treatment as steroid, beta blocker. Patient had no known allergies.
Age: 20.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse side effects were reported; PROQUAD to 20-year-old patient.; This spontaneous report was received from an Other Health Professional and referred to a 20-year-old male patient (conflict information, also reported as 30 years old).  The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 09-DEC-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #X020572, expiration date: 03-FEB-2025, administered for prophylaxis (strength, dose and route of administration were not provided) (Product administered to patient of inappropriate age); and sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion, (strength, dose, frequency, lot #, expiry date, route of administration, and indication were not provided). No additional AE.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV9, MNQ, TDAP
Symptoms: Dizziness, Hypotension, Nausea
Clinical narrative: Pt received Tdap, HPV, MCV and Influenza vaccines. Last vaccine given  was HPV. Around 1 min after vaccination, patient reported feeling dizzy/nausea. At 2 min after vaccination-  She was found to have low BP - 79/42. Pt drank water. BP  improved gradually to within normal range after 7 min of vaccination. There was no skin/mucosal involvement, respiratory compromise or gastrointestinal symptoms. No syncope.  No evidence of anaphylaxis . Dizziness  resolved after 7-8 min after vaccination.
Age: 58.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: max temperature stayed at normal range; Low: 1.81°C, for 7 minutes was administered with no reported adverse event; Initial information received on 20-Dec-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 58 years old male patient who received (punctured) IPV (VERO) [IPOL] which was exposed to temperature excursion and max temperature stayed at normal range; low: 1.81°c, for 7 minutes with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis a vaccine inact (Havrix); Diphtheria vaccine toxoid, Tetanus vaccine toxoid (Tenivac); Influenza vaccine inact split 3v (Flulaval); Hepatitis b vaccine rHBsAg (yeast) (Engerix b); and Elasomeran (Spikevax) as all for Immunisation.  On 18-Dec-2024, the patient received 0.5 ml of dose 2 of (punctured) IPV (VERO) Suspension for injection with standard strength (expiry date- 17-Nov-2025 and lot W1C741M) once via unknown route in unknown administration site for Immunization which was exposed to temperature excursion and max temperature stayed at normal range; low: 1.81°c, for 7 minutes with no reported adverse event (poor quality product administered) (same day latency).  Reportedly, Reason: Unknown. Max/low temperature reached & Duration: Unit 1 max: max temperature stayed at normal range; Low: 1.81°C, for 7 minutes, unit 2:- Max: stayed at normal range- 19-Dec-2024: Low:1.75°C for 4 minutes- 18-Dec-2024: Low: 1.75°C for 4 minutes. There was no previous excursion. Human error was unknown.   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-2024SA381522:
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AEs were reported; Medical assistant reported that 1 year old patient supposed to receive VARIVAX and MMR II vaccines but the patient received VARIVAX and PROQUAD instead on the same day.   No additional AEs were reported. No further information provided.  No PQC.; Medical assistant reported that 1 year old patient supposed to receive VARIVAX and MMR II vaccines but the patient received VARIVAX and PROQUAD instead on the same day.   No additional AEs were reported. No further information provided.  No PQC.; This spontaneous report was received from Medical Assistant referring to a 1 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.  On 16-DEC-2024, the patient supposed to receive varicella virus vaccine live (oka/merck)(VARIVAX) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) but the patient received varicella virus vaccine live (oka/merck)(VARIVAX) Lot#: y013073, expiration date: 29-JUL-2026 and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) Lot#: y014438, expiration date: 22-FEB-2026 instead on the same day (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis.   No adverse events reported.
Age: 67.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No side effects or symptoms reported; an expired dose of PNEUMOVAX 23 was administered to a single patient; This spontaneous report was received from a certified medical assistant and refers to a 67-year-old.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 19-DEC-2024, the patient was vaccinated with an expired dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 0.5 milliliter, lot #W029533, expiration date: 07-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided).  No side effects or symptoms were reported. The reporter verified that the product did not undergo any temperature excursions. The potency of the product was not supported.
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, Hepatitis B surface antibody negative
Clinical narrative: Inbound call from HCP who reports she received 3 doses of RECOMBIVAX HB as a child and didn't convert and needed an additional dose. She had an additional/booster dose while going through Med school.; This spontaneous report was received from a physician referring herself. The medical history, concurrent conditions and concomitant therapies were not reported.  On unknown dates, the patient received 3 doses of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection (administered for prophylaxis strength, dose, lot #, expiry date, and route of administration were not provided) as a child and didn't convert (Hepatitis B surface antibody negative) and needed an additional dose. She had an additional/booster dose while going through Med school. At the time of reporting, the outcome of the event was unknown. The action taken with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) regarding the event was not applicable.   The causal relationship between Hepatitis B surface antibody negative and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: got GBS from the shot; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: got GBS from the shot) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not reported.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine.     The company considered the guillain barre syndrome to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-DEC-2024 This case was reported by consumer via interactive digital media. The patient received got guillain barre syndrome from the shot. The reporter stated that be careful.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine.
Sex: U
Vaccine: COVID19, RVX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome; This serious case was reported by a other health professional via other manufacturer and described the occurrence of guillain barre syndrome in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included Tozinameran (Pfizer BioNTech COVID-19 vaccine) for prophylaxis.   Additional patient notes included The patient had no any vaccines within the past 4 weeks.   On an unknown date, the patient received RSV vaccine and Pfizer BioNTech COVID-19 vaccine (intramuscular). On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillain-Barre syndrome) (serious criteria GSK medically significant and other: serious as per reporter). The outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to RSV vaccine.  The company considered the guillain barre syndrome to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date: 13-DEC-2024 The healthcare professional reported that the Pfizer and GSK with their RSV vaccine had been shown to had sometimes very serious side effects of Guillain-Barre syndrome The reporter wanted to knew exact pharmacies or clinic where mResvia was being distributed. It was unknown if the reporter considered the Guillain barre syndrome to be related to Pfizer BioNTech COVID-19 vaccine.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine RSV vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Patient reported to pharmacist that their MD recommended they get another dose of Shingrix because they recently found out that Shingrix was improperly stored and the MD feels like that dose invalid; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of incorrect storage of drug in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   In JAN-2020, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Patient reported to pharmacist that their MD recommended they get another dose of Shingrix because they recently found out that Shingrix was improperly stored and the MD feels like that dose invalid). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 27-NOV-2024 The pharmacist reported that a patient's doctor recommended they get another dose of Shingrix because they recently found out that Shingrix was improperly stored and the doctor feels like that dose invalid. The patient came into their retail pharmacy store and wanted to get a 3rd dose of Shingrix because doctor told them the dose they got was improperly stored, which led to incorrect storage of drug and doctor was considering that dose invalid and wants to the patient to get a new dose.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site rash, Injection site urticaria, Pain in extremity
Clinical narrative: developed a large, painful welt at the injection site; Injection site rash; developed a large, painful welt at the injection site; Chills; sore arm; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: developed a large, painful welt at the injection site), injection site rash (Verbatim: Injection site rash), injection site wheal (Verbatim: developed a large, painful welt at the injection site), chills (Verbatim: Chills) and pain in arm (Verbatim: sore arm). The outcome of the injection site pain and injection site wheal were not reported and the outcome of the injection site rash, chills and pain in arm were resolved.   It was unknown if the reporter considered the injection site pain, injection site rash, injection site wheal, chills and pain in arm to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site rash, injection site wheal, chills and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-NOV-2024 The patient took the 1st dose of  Shingrix and experienced chills ,sore arm ,injection site rash, and patient developed a large, painful welt at the injection site. Information about the patient was given to the reporter by her sister who shared a text message of their conversation about her adverse event.
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Extreme shivering; This non-serious case was reported by a consumer and described the occurrence of shivering in a 59-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included hypertension and multiple allergies. Concomitant products included losartan and levocetirizine dihydrochloride (Xyzal).   On 27-NOV-2024, the patient received Shingles vaccine. On 27-NOV-2024, less than a day after receiving Shingles vaccine, the patient experienced shivering (Verbatim: Extreme shivering). On 27-NOV-2024, the outcome of the shivering was resolved.   It was unknown if the reporter considered the shivering to be related to Shingles vaccine.     It was unknown if the company considered the shivering to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-NOV-2024 The patient had extreme shivering and symptoms were not treated. The patient was taking concomitant vitamins.
Sex: F
Vaccine: VARZOS
Symptoms: Disturbance in attention, Headache, Malaise
Clinical narrative: crushing headache; general malaise; unable to focus/inability to focus; This non-serious case was reported by a consumer and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: crushing headache), general malaise (Verbatim: general malaise) and concentration loss (Verbatim: unable to focus/inability to focus). The outcome of the headache, general malaise and concentration loss were not resolved.   It was unknown if the reporter considered the headache, general malaise and concentration loss to be related to Shingrix.     It was unknown if the company considered the headache, general malaise and concentration loss to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-NOV-2024 The reporter reported that it was not surprising the way body reacted to first shingles vaccine, it took patient out all weekend.  It was something that patient had been putting off for years for no reason in particular except pure procrastination and a dread of side effects.  The specter of what was to come after January 20th, however, had lit a fire to get all the shots jabbed into patient arm.  While patient laid on the couch, half here, half not from a crushing headache and general malaise, patient try to be productive and read and give up half an hour later, unable to focus. It was reported that everything was liminal. The patient wrote that it took herout all weekend. She experienced a crushing headache, general malaise and an inability to focus.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In DEC-2018, the patient received Shingrix. In DEC-2024, more than 2 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 13-DEC-2024 Reporter stated that he/she had the Shringrix vaccine in December 2018 and this week found out that he/she had a shingles outbreak which fortunately was mild. Reporter was curious to know how long the vaccine lasts in body and if at some point he/she need to get another vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding herpes zoster were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Age: 18.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Infanrix instead of Boostrix.; Infanrix instead of Boostrix.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 18-year-old female patient who received DTPa (Infanrix) (batch number 9KB9G, expiry date 07-JUL-2026) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 05-NOV-2024, the patient received Infanrix. On an unknown date, the patient received Boostrix. On 05-NOV-2024, an unknown time after receiving Infanrix and not applicable after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: Infanrix instead of Boostrix.) and inappropriate age at vaccine administration (Verbatim: Infanrix instead of Boostrix.). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were 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: 27-NOV-2024 The medical assistant reported that they gave a Dtap to a patient that was 18 years old and the patient was supposed to receive a tdap as that the patient was supposed to receive a Boostrix, but received Infanrix instead, which led to wrong vaccine administered and inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Disappointed that Covid not happy that Maderna did not protect; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Disappointed that Covid not happy that Maderna did not protect) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu shot (Got yearly updated ones usually 2 weeks later October); for COVID-19 prophylaxis: Spikevax (Got Moderna vaccines from the very beginning and got yearly updated ones usually in October). Past adverse reactions to the above products included No adverse effect with Flu shot and Spikevax.  On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Disappointed that Covid not happy that Maderna did not protect). At the time of the report, COVID-19 (Disappointed that Covid not happy that Maderna did not protect) outcome was unknown.     Concomitant product use was not provided by the reporter.  Report was regarding disappointment of both wife and reporter about the Moderna Covid vaccine and mentioned that they were not happy cause Moderna did not protect them.   It was reported that this year both were disappointed that Covid not happy that Moderna did not protect.   It was unknown if the patient experienced any additional symptoms/events.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-780189 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-780189:Master case (Husband's case)
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Disappointed that Covid not happy that Maderna did not protect; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Disappointed that Covid not happy that Maderna did not protect) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu (Got yearly updated ones usually 2 weeks later October); for COVID-19 prophylaxis: Moderna vaccines (Got Moderna vaccines from the very beginning and got yearly updated ones usually in October). Past adverse reactions to the above products included No adverse effect with Flu and Moderna vaccines.  On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Disappointed that Covid not happy that Maderna did not protect). At the time of the report, COVID-19 (Disappointed that Covid not happy that Maderna did not protect) outcome was unknown.     Concomitant product use was not provided by the reporter.  Report was regarding disappointment of both wife and reporter about the Moderna Covid vaccine and mentioned that they were not happy cause Moderna did not protect them.   It was reported that this year both were disappointed that Covid not happy that Moderna did not protect.   It was unknown if the patient experienced any additional symptoms/events.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-780190 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-780190:Master case (Wife's case)
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I got mine in Nov.and now I have been sick for 2 weeks with flu; Initial information received on 14-Dec-2024 regarding an unsolicited valid Social Media non-serious case received from patient.  This case involves Adult female patient who received in influenza vaccine in November and now have been sick for 2 weeks with flu.  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date in November 2024, the patient received unknown dose of suspect influenza vaccine (Unknown strength, lot and expiry date) produced by unknown manufacturer via unknown route in unknown administration site for Prophylactic vaccination (immunization).  On an unknown date the patient have been sick for 2 weeks with flu (influenza) (unknown latency) following the administration of influenza vaccine.  Information on the batch number was requested corresponding to the one at time of event occurrence.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event.
Age: 1.33
Sex: M
Vaccine: DTAP, DTAPIPVHIB, HIBV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was administered PENTACEL and ACTHIB instead of DAPTACEL only with no reported adverse event; Initial information received on 19-Dec-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 16 months old male patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] and HIB (PRP/T) vaccine [ACT-HIB] instead of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] only 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 PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (20-VALENT, ADSORBED) for Immunisation.  On 19-Dec-2024, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Powder and suspension for suspension for injection (lot UK022AA and Expiration date: 30-Apr-2025) and HIB (PRP/T) vaccine, Powder and solvent for solution for injection (lot X028614; Expiration date: 05-Jul-2026) via intramuscular route in the left leg instead of Daptacel only with no reported adverse event (wrong product administered).  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: M
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: received FLUZONE previously about 7 plus years ago and had an allergic reaction; Initial information received on 18-Dec-2024 regarding an unsolicited valid non-serious case received from a Non health care professional.  This case involves a 19 years old male patient who had received Influenza Usp Trival A-B Subvirion No Preservative Vaccine [FLUZONE] previously about 7 plus years ago and had an allergic reaction.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Food allergy.   On an unknown date, the patient received a dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine Suspension for injection (lot UT8488KA) (unknown strength, dosage, expiry date) via intradermal route in unknown administration site for immunization.  On an unknown date the patient received Influenza Usp Trival A-B Subvirion No Preservative Vaccine previously about 7 plus years ago and had an allergic reaction (drug hypersensitivity) (unknown latency).  Reportedly, The patient's mother called stating that she would like to knowif FLUZONE NP does contain gelatin as his son was allergic to gelatin. Mother reported that the doctor assured her that the vaccine does not contain gelatin but would just like to make sure.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: incorrect diluent used in reconstituting ACTHIB. The same ACTHIB dose was administered to a patient with no reported AE; incorrect diluent used in reconstituting ACTHIB. The same ACTHIB dose was administered to a patient with no reported AE; Initial information received on 18-Dec-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who received incorrect diluent used reconstituted hib (prp/t) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received 0.5 mL dose of incorrect diluent used reconstituted hib (prp/t) vaccine with no reported adverse event (product preparation error) (latency: unknown) and (poor quality product administered) (latency: same day) (Powder and solvent for solution for injection) (Frequency: Once) (Strength: Standard) (lot number and expiry date not reported) via unknown route in unknown administration site for Immunization.  Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was 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 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: 0.42
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: had a 5 month old child who received FLUZONE NP for influenza with no reported adverse event; Initial information received on 20-Dec-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 5 months old male patient who had received INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] 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 18-Nov-2024, the patient received a  dose of 0.5 ml of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (Suspension for injection) lot UT8488KA, Expiry date: 30-Jun-2025, strength was unknown via intramuscular route in the left thigh for Influenza and had a 5 month old child who received fluzone np for influenza with no reported adverse event (product administered to patient of inappropriate age) (latency : same day).  Reportedly ". The child returned on 18Dec2024 for the 2nd dose and that is when they realized that the initial dose was given too early for his age. She is asking if the child should get a 3rd dose for the season."   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: 10.0
Sex: M
Vaccine: IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: reports that an 10 year old child received the IPOL extra dose within a month with no reported adverse event; Initial information received on 20-Dec-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 10 years old male patient who received the IPV (VERO) [IPOL] extra dose within a month with no reported adverse event.  The patient's past vaccination(s) included PEDIARIX on 07-MAY-2014, IPV on 05-MAR-2014, 30-JAN-2014 and 09-AUG-2018. The patient's past medical history, medical treatment(s) and family history were not provided.   On 07-Oct-2024 and 23-Oct-2024, the patient of 10 year old age received two 0.5 ml dose of suspect IPV (VERO) (lot W1C751M, Expiry: 18-Nov-2025, Strength: 0.5 mL) via subcutaneous route in the left arm within a month with no reported adverse event (extra dose administered) (Latency: 16 days) with the first dose and (Latency: same day) with the second dose.   Reportedly, The patient was new to the practice and there were no vaccine records. Nurse stated that it was brought to her attention. They were first informed that patient has no immunization history from the parent.  They looked it up online but they there was no history there. So the provider did order and give IPV on 07-OCT-2024. The patient came back on 23-OCT-2024, again as per checking there was no information so they gave another dose of the IPV. Then they got the records which were not scanned and informed that patient actually had previous doses of IPV.   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: 27.0
Sex: U
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: eceived the DAPTACEL shot yesterday in their office instead of the Tdap with no reported AE; Initial information received on 24-Dec-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 27 years old and unknown gender patient who received the diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] shot yesterday in their office instead of the Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid [Tdap] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 23-Dec-2024, the patient received an unknown dose of Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid Suspension for injection (strength- unknown, expiry date- 30-Sep-2025 and lot 3CA03C3) via unknown route in unknown administration site as Immunization yesterday in their office instead of the Tdap (formulation, strength, expiry date and lot not reported) with no reported adverse event (wrong 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: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pruritus, Rash
Clinical narrative: rash itchy pain
Age: 8.0
Sex: M
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administration error - vaccine given to pt under 10 years of age.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Dyspnoea, Hypoxia, Pneumonia
Clinical narrative: Discharge Summary DO (Physician) General Medicine BRIEF OVERVIEW: Admission Date: 12/10/2024 Discharge Date: Dec 13, 2024 Discharge Disposition:  home  Active Issues Requiring Follow-up:  #Acute hypoxic respiratory failure due to L lung Community acquired PNA, with superimposed COVID viral infection - Hypoxia has resolved. Patient stable on RA. - c/w doxycycline for 4 more days - c/w decadron 6 mg for 7 days - follow up outpatient with PCP  #HTN - resume lasix - hold amlodipine and HCTZ in setting of normotension - follow up with PCP - encourage home BP checks.  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypoxia [R09.02] Sepsis (HCC) [A41.9] Pneumonia of left lower lobe due to infectious organism [J18.9] COVID [U07.1] Acute hypoxic respiratory failure (HCC) [J96.01] Acute respiratory failure (HCC) [J96.00]  HOSPITAL COURSE: 84 y/o male with an extensive PMH DMII, Pacemaker in situ, Hypothyroidism, hypertension,  CKD Stage 3b, Diabetic neuropathy, Mild cognitive impairment who presents due to increasing shortness of breath and increased work of breathing.   In the ED patient was hypoxic with an SPO2 of 69% he was placed on a non-re breather will little effect, subsequently BiPAP was initiated with positive results.    Patient was admitted for mixed acute hypoxic respiratory failure in the setting of COVID-19.   Patient was weaned off bipap and Oxygen. He was initially placed on remdesivir, ceftriaxone and doxy for CAP coverage. However, due to worsening kidney function remdesivir was discontinued. Patient's kidney function slowly improved.   He was medically optimized and hemodynamically stable at time of discharge.   Discharged to Home.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Positive airway pressure therapy
Clinical narrative: Discharge Summary DO (Physician) General Medicine BRIEF OVERVIEW: Admission Date: 12/10/2024 Discharge Date: Dec 13, 2024 Discharge Disposition:  home  Active Issues Requiring Follow-up:  #Acute hypoxic respiratory failure due to L lung Community acquired PNA, with superimposed COVID viral infection - Hypoxia has resolved. Patient stable on RA. - c/w doxycycline for 4 more days - c/w decadron 6 mg for 7 days - follow up outpatient with PCP  #HTN - resume lasix - hold amlodipine and HCTZ in setting of normotension - follow up with PCP - encourage home BP checks.  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypoxia [R09.02] Sepsis (HCC) [A41.9] Pneumonia of left lower lobe due to infectious organism [J18.9] COVID [U07.1] Acute hypoxic respiratory failure (HCC) [J96.01] Acute respiratory failure (HCC) [J96.00]  HOSPITAL COURSE: 84 y/o male with an extensive PMH DMII, Pacemaker in situ, Hypothyroidism, hypertension,  CKD Stage 3b, Diabetic neuropathy, Mild cognitive impairment who presents due to increasing shortness of breath and increased work of breathing.   In the ED patient was hypoxic with an SPO2 of 69% he was placed on a non-re breather will little effect, subsequently BiPAP was initiated with positive results.    Patient was admitted for mixed acute hypoxic respiratory failure in the setting of COVID-19.   Patient was weaned off bipap and Oxygen. He was initially placed on remdesivir, ceftriaxone and doxy for CAP coverage. However, due to worsening kidney function remdesivir was discontinued. Patient's kidney function slowly improved.   He was medically optimized and hemodynamically stable at time of discharge.   Discharged to Home.
Age: 1.25
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: None stated.