chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Rash, Vaccination site rash
Clinical narrative: Had a bad rash that went to different parts of body, started in the injection site (shoulder), had it on legs and stomach./ was painful; Had a bad rash that went to different parts of body, started in the injection site (shoulder), had it on legs and stomach/ was painful; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-774064 (Moderna).  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 27Jun2024 as dose 1, single (Lot number: LE1811), in arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE RASH (non-serious) with onset 27Jun2024, outcome "recovered", described as "Had a bad rash that went to different parts of body, started in the injection site (shoulder), had it on legs and stomach./ was painful"; RASH (non-serious) with onset 27Jun2024, outcome "recovered", described as "Had a bad rash that went to different parts of body, started in the injection site (shoulder), had it on legs and stomach/ was painful". Additional information: Immediately had a bad rash that went to different parts of body, started in the injection site (shoulder), had it on legs and stomach.  No follow-up attempts are possible.
Age: 37.0
Sex: F
Vaccine: YF
Symptoms: Musculoskeletal stiffness, Pain, Thrombosis
Clinical narrative: had a blood clot on their leg 2 days after vaccination; stiffness; soreness/mild body ache; Initial information received on 05-Sep-2024 regarding an unsolicited valid serious case received from a consumer (patient).  This case involves a 37 years old female patient who had a blood clot on their leg 2 days after vaccination, stiffness and soreness/mild body ache after receiving Yellow fever vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE for Immunisation.  On an unknown date, the patient received a unknown (dose 1) dose of suspect Yellow fever vaccine produced by unknown manufacturer (formulation, strength, expiry date and lot number: not reported) for Immunisation.  Patient injected with yellow fever vaccine called to ask if blood clotting was a side effect of the vaccine. Patient mentioned that they had a blood clot on their leg 2 days after vaccination (thrombosis) and they did not have any personal history of it. Patient stated that they have just been from the ER (emergency room) and even their doctors were puzzled as to why the patient had a large clot since they did not change medications or got injured in any way. Patient also said that they have our information on the internet while searching for side effects of vaccinations and they wanted to know more information about it. Patient was not sure as to the brand of yellow fever vaccine that was administered to them. She also mentioned that she was also administered with Hepatitis B vaccine on the same day, and they had the usual side effects of stiffness (musculoskeletal stiffness), soreness and mild body ache (pain) (unknown events onset, latency) that was over within 24 hours. She said that it was her first time getting a yellow fever vaccine. She obtained her vaccination from. List concomitant: Hepatitis B. AE symptoms: stiffness and soreness of the sides and little bit of body aches that was over within 24 hours.  Action taken: not applicable.  Corrective treatment: not reported.  Outcome was Unknown for the event thrombosis, was Recovered / Resolved on an unknown date in 2024 for other events.  Seriousness criteria: Medically significant for event thrombosis.; Sender's Comments: Sanofi company comment dated on 20-Sep-2024: This case involves a 37 years old female patient who had a blood clot on their leg 2 days after vaccination, stiffness and soreness/mild body ache after receiving Yellow fever vaccine. Further information regarding tolerance medical history or family history, concurrent condition and concomitant medication laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.
Sex: U
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Product dispensing error
Clinical narrative: requested a diluted for the HIB, but they ended up getting the YF Vax diluent with no reported adverse event; Initial information received on 06-Sep-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an unknown age and unknown gender patient who requested a diluted for the HIB (PRP/T) Vaccine [ACT-HIB], but they ended up getting the yf vax diluent 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, a dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation and requested a diluted for the hib, but they ended up getting the yf vax diluent with no reported adverse event (product dispensing error) (unknown latency).  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: 2.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event
Clinical narrative: inappropriate use due to administration of PENTACEL to a patient with only the DTaP-IPV component as they were not able to mix it with the Hib component with no adverse event; Initial information received on 06-Sep-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 years old male patient with inappropriate use due to administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] with only the dtap-ipv component as they were not able to mix it with the hib component with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Influenza vaccine live reassort 3v (Flumist) and Hepatitis a vaccine (Hepatitis A) for Immunisation.  On 06-Sep-2024, the patient received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, Suspension for injection, dose 0.5 ml x1 (once) expiry-31-Aug-2025 with lot UK041AA via intramuscular route in the left thigh for Immunization (strength unknown) inappropriate use due to administration of PENTACEL to a patient with only the DTaP-IPV component as they were not able to mix it with the Hib component with no 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: 33.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No symptoms reported; received his first dose of GARDASIL 9 more than one year ago; This spontaneous report was received from Pharmacist and refers to a 33-year-old male. The patient's medical history, previous drug reactions or allergies and concomitant therapies were not reported.  On an unknown date (reported as more than one year ago), the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection for prophylaxis (strength, dose, route of administration, anatomical location, lot number, and expiration date were not provided).  On 03-SEP-2024, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot # W014513, expiration date: 26-JAN-2025, administered intramuscularly for prophylaxis (strength and anatomical location were not provided) (inappropriate schedule of product administration). No symptoms reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse calling to report an adverse event regarding an improperly stored and administered dose of VARIVAX.  Nurse stated that the VARIVAX was involved in a Temperature Excursion that occurred on 9/12/2024, and that a dose of VARIVAX was administered o; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.   On 12-SEP-2024, the patient was vaccinated with the second dose of an improperly stored vaccine (on the same date) varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot #Y007955 has been verified to be a valid lot number for the vaccine, expiration date was reported and validated as 17-APR-2026) administered 0.5 mL for prophylaxis (strength, route of administration and anatomical location were not provided) (product storage error). The reporter confirmed that there have been no reports of the patient involved reporting any medical concerns or symptoms after the dose was administered. No adverse event was reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Neuralgia, Vaccination failure
Clinical narrative: got the vaccine and still got shingles/Suspected vaccination failure; shingles; still severe nerve pain; miserable; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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 vaccination failure (Verbatim: got the vaccine and still got shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles), post herpetic neuralgia (Verbatim: still severe nerve pain) and feeling miserable (Verbatim: miserable). The outcome of the vaccination failure, shingles and feeling miserable were not reported and the outcome of the post herpetic neuralgia was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and feeling miserable to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, post herpetic neuralgia and feeling miserable to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-SEP-2024 This case was reported by a patient via interactive digital media. The patient got the shingles vaccine and still got shingles and had severe nerve pain after 44 days.  The patient stated that he/she was miserable. 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 shingles 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 Shingles vaccine.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Accidental underdose, Syringe issue
Clinical narrative: received less than the recommended 0.5 mL dose of Bexsero; because the liquid leaked from the syringe; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number 4293K, expiry date 31-JUL-2025) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced accidental underdose (Verbatim: received less than the recommended 0.5 mL dose of Bexsero) and syringe leak (Verbatim: because the liquid leaked from the syringe). The outcome of the accidental underdose and syringe leak were unknown.   It was unknown if the reporter considered the syringe leak to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the syringe leak to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 10-SEP-2024 A Medical Assistant called to report that they administered a dose of Bexsero to a 16 years old patient but they noticed that some of the liquid leaked from the syringe to her glove, so some of the liquid was not administered they were not sure how much of the actual vaccine the patient got which led to accidental underdose and syringe leak. She asked if she needed to repeat the dose.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient had never received second 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 26-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received on 28th April 2023, Lot number NT9X3 expiration date 9th September 2024).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: Patient had never received second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 10-SEP-2024 Pharmacist reported that an adult patient received Engerix-B first dose back on 28th April 2023. Patient had never received second dose. Till the time of reporting, the patient did not receive 2nd dose of Engerix-B , which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2023077749:Same reporter; different patient US-GSK-US2020173750:Same reporter; different patient US-GSK-US2019089052:Same reporter; different patient
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site pain, Injection site pruritus
Clinical narrative: pain and bruising at injection site; itching at the injection site; bruising at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 05-SEP-2024, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 06-SEP-2024, 1 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain and bruising at injection site), injection site itching (Verbatim: itching at the injection site) and injection site bruising (Verbatim: bruising at injection site). The outcome of the injection site pain and injection site itching were not resolved and the outcome of the injection site bruising was not reported.   It was unknown if the reporter considered the injection site pain, injection site itching and injection site bruising to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site itching and injection site bruising to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-SEP-2024 Caller was the patient and reported she received her first Shingrix vaccine in the left arm. Caller reported the next day she had pain and itching at the injection site. Caller also reported a bruise at the injection site.
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: they came back not within the time range.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   On 10-SEP-2024, the patient received the 2nd dose of Twinrix. On 10-SEP-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: they came back not within the time range.). The outcome of the drug dose administration interval too long 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: 10-SEP-2024 The pharmacist was asking regarding a patient who was coming to get Twinrix but she wanted to know if she should still provide them with the second dose, because they came back not within the time range.  The health care professional (HCP) reported patient was late for 2nd dose because they went out of country.  They received their first dose on 18th July 2024 and their 2nd dose today (on the day of reporting), which led to lengthening of vaccination schedule.  HCP had no details regarding patient or product to share upon callback.
Sex: U
Vaccine: RSV
Symptoms: Device breakage, Device material issue
Clinical narrative: Took the plastic snap adapter out of the container and tried to pop into the syringe part of the vaccine and it broke off into the, to the sharp part and goes into the vial; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 13Sep2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from an Other HCP from product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown (Lot number: H765, Expiration Date: 01Jun2028) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE MATERIAL ISSUE (non-serious) with onset Sep2024, outcome "unknown", described as "Took the plastic snap adapter out of the container and tried to pop into the syringe part of the vaccine and it broke off into the, to the sharp part and goes into the vial".  Additional information: The vial could not be punctured and they were unable to use the rsv vaccine prot.subunit pref 2v.   Causality for "took the plastic snap adapter out of the container and tried to pop into the syringe part of the vaccine and it broke off into the, to the sharp part and goes into the vial" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: have now had 4 vaccines; return a few months later; covid; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 20240861156 (Janssen Research & Development, LLC).  This spontaneous report received from a patient of unspecified age and sex, the patient's weight, height and medical history were not reported). The patient received Covid-19 vaccine ad26.cov2.s (Dose in series 1) (Suspension for injection, route of admin, and batch number was not reported and has been requested. Non-Company suspect vaccine include: elasomeran, dose, start therapy date were not reported for covid-19 prophylaxis. No concomitant medications were reported. The patient had long covid for past three and half years. The patient had 4 vaccines (J&J, Moderna and 2 Pfizer) (coded as covid -19 immunization) (dose in series) and all of them had presented similar results and all symptoms resolved with in two weeks, but then returned. The action taken with covid-19 vaccine ad26. Cov2. S was not applicable. The outcome of the return a few months later, I have now had 4 vaccines and covid was not reported. This report was serious (other medically important condition)  Company remarks (JANSSEN comments): Vaccination failure. The event is a special reporting situation and owing to its nature, it is not possible to attribute this occurrence to the suspect drug, hence the causality is considered inconsistent with vaccine administration.  Causality assessment: All events with JANSSEN COVID-19 VACCINE as possible per reporter and manufacturer (JANSSEN).   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: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective
Clinical narrative: had COVID twice; had COVID twice; had COVID twice; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-774065 (Moderna MCN).  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose number unknown), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "recovering" and all described as "had COVID twice". The patient has had COVID twice and has received all Pfizer COVID vaccines. The patient had cold which was resolving.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient was given duplicate influenza vaccines (Fluad). First was given on 09/09/2024 and the second was on 09/19/2024.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema
Clinical narrative: Patient was administered Prevnar20 vaccine on the left arm on 9/14/24. Patient called Wednesday, September 18 and reported an adverse reaction, stated that her arm was red. Pharmacist on duty asked if patient had any fever, patient denied fever. Pharmacist also advised patient to go to urgent care or take an antihistamine. Patient decided to wait for family and see doctor. Per family member daughter-in-law conversion on 9/20/24,  she stated patient is being monitored by doctor and did not want patient to have antihistamine/steroid.
Age: 1.0
Sex: F
Vaccine: COVID19, HEPA, MMR, PNC20, VARCEL
Symptoms: Injection site rash
Clinical narrative: Red rash on legs
Age: 82.0
Sex: M
Vaccine: RSV, UNK
Symptoms: Chest pain, Condition aggravated, Dyspnoea, Hyperhidrosis, Insomnia
Clinical narrative: patient stated that once he received the RVS (Arexvy) on 9/18/24,  he experienced sweating a lot and shaky.  As of today, patient still has chest pain (on and off)  and hard to breath and couldn't sleep last night. Per patient,  MD aware he has chronic heart condition and MD recommended patient to get the RSV vaccine. While speaking with the patient  one the phone, the pharmacist recommended  patient to call MD and go to ER if still having chest pain and SOB. Pt aware.
Age: 82.0
Sex: M
Vaccine: RSV, UNK
Symptoms: Nervousness
Clinical narrative: patient stated that once he received the RVS (Arexvy) on 9/18/24,  he experienced sweating a lot and shaky.  As of today, patient still has chest pain (on and off)  and hard to breath and couldn't sleep last night. Per patient,  MD aware he has chronic heart condition and MD recommended patient to get the RSV vaccine. While speaking with the patient  one the phone, the pharmacist recommended  patient to call MD and go to ER if still having chest pain and SOB. Pt aware.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: morning after presents with sore, red, swollen bump anterior of deltoid
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: Pt presented to office for 12 month well child check, provider ordered MMR. MMR and MMRV were placed next to one and other in the freezer and medical assistant grabbed MMRV instead of MMR by mistake. Medical assistant performing second check missed mistake as well. Provider was notified, provider notified parents of patient.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Adverse reaction, Feeling abnormal
Clinical narrative: Patient stated "had a horrible reaction", could not give additional details, consistently reported feeling terrible and it had to have been the vaccine that caused a horrible reaction.
Age: 74.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received two doses of the RSV vaccine (Arexvy) approx 9 months apart. He reported no side effects from either dose.
Age: 8.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Injection site rash, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Rash around injection site and non-itchy rash, pain and swelling around wrists, elbows, knees and feet.
Age: 8.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Rash
Clinical narrative: Rash around injection site and non-itchy rash, pain and swelling around wrists, elbows, knees and feet.
Age: 63.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal distension, Brain fog, Hepatitis B virus test, Inappropriate schedule of product administration, Joint swelling
Clinical narrative: Started 3 doses of Hep B Vaccine 4/23/24, 5/31/24 and 8/7/24.  Started having bad brain fog and very swollen ankles and abdomen and legs around 8/10 ish.  But STILL having these problems NOW.  Went to see Clinic as blood tests seemed to have a false positive for HEP B.  The second dose was given too close to the third dose.
Age: 63.0
Sex: F
Vaccine: HEP
Symptoms: Peripheral swelling
Clinical narrative: Started 3 doses of Hep B Vaccine 4/23/24, 5/31/24 and 8/7/24.  Started having bad brain fog and very swollen ankles and abdomen and legs around 8/10 ish.  But STILL having these problems NOW.  Went to see Clinic as blood tests seemed to have a false positive for HEP B.  The second dose was given too close to the third dose.
Age: 53.0
Sex: F
Vaccine: COVID19, FLU3, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Pyrexia
Clinical narrative: Patient said she has a mild fever on 9/17/24, but the fever resolved on 9/18/24. On 9/20/24, her arm at the injection sites became red and inflammed.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Facial erythemia, swelling and induration in a butterfly pattern.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Induration
Clinical narrative: Facial erythemia, with induration occuring in a butterfly like pattern.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient received child dose of COVID 19 dose vs adult dose. ( Moderna Covid 2024-25(6m-11y)(pf)(eua) 25 Mcg/0.25 Ml Im Syringe)
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient received child dose of Moderna COVID-19 vs adult dose. (MODERNA COVID 2024-25(6M-11Y)(PF)(EUA) 25 MCG/0.25 ML IM )
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: pt got two Flucelvax vaccines 1 month apart on 8/19/24 and 9/19/24
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Abdominal pain, Extra dose administered, Pyrexia
Clinical narrative: Vaccine was administered 8 days after the same vaccine. The initial vaccine in this series was administered 9/.9/24. Patient  reported fevers and abdominal pain on 9/18/24
Age: 14.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blood glucose decreased, Loss of consciousness
Clinical narrative: Patient had exhibited signs of anxiety upon entering vaccination room but was calm when sitting on parent's lap. Walked the patient through the vaccine process and had them take deep breaths to assist with calming. Administered the Spikevax vaccination in left deltoid with no issue. Patient was calm and proceeded to repeat process with the Flucelvax vaccination. Patient was coherent until bandage was applied then briefly lost consciousness in parent's lap. Immediately relocated patient to the floor, where consciousness was confirmed. Per protocol EMS was called to the scene. Parent administered 1 glucose tablet under the supervision of attending pharmacist. Patient was fully coherent prior to EMS arrival on scene. EMS did a brief vital check and noted that vitals were all green with the exception of blood sugar which was at 74 despite having administered a glucose tablet. Parent declined option to transport patient to the hospital stating that the patient needed to eat. Parent made note to have both twins eat a minimal snack prior to any future vaccinations.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Immediate post-injection reaction, Injection site swelling, Swelling
Clinical narrative: Immediate after flu vaccine admin 9/20/24 @12pm pt got localized swelling of her upper arm at the injection site around the size of golf ball. No respiratory concerns, no tachycardia, no fever. Patient was able to talk and comprehend. Treatment: ice pack on the affected area, 1 dose diphenhydramine 25mg PO. s/sx monitored for 2 hours before pt left for home on rideshare ride. I spoke with pt's daughter who said pt has had swollen arm with prior vaccines and also said "it ran in the family". I told daughter that we've been icing her arm -please have her continue to apply ice/cold pack until swelling resolves. Monitor blood pressure and temperature at home every few hours for the next 2-3 days. If she has any of these concerns: airway obstruction (respiratory concerns), elevated heart rate, fever, swelling does not improve or gets worse or spread, or anything unusual, send her to the ER. Daughter said she understood. 4 hours post incident, I called pt who was now at home. Pt reports swelling has gone down and she is a lot more comfortable. Reports some sleepiness most likely due to diphenhydramine dose.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: There were no adverse events indicated.
Age: 73.0
Sex: M
Vaccine: UNK
Symptoms: Extra dose administered
Clinical narrative: pt received duplicate flushot. pt received fluad on 08142024 and 09192024
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: Stiff neck and swollen arm down to elbow
Age: 35.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Balance disorder, Fall, Fatigue
Clinical narrative: While playing pickleball, suddenly lost balance and fell while standing. No loss of consciousness. Fatigue for 72+ hours.
Age: 83.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness
Clinical narrative: Patient was shopping at the grocery store and felt faint. The employees at the grocery store called the emts. She sat down and never actually fainted. When they took her blood pressure it was 100/60. The emts advised her to go to the emergency room or urgent care but she declined and had her daughter take her home. She did follow up with her doctor who did not feel it was necessary to come into the office any sooner than her next appointment in a couple of weeks. She wants to advise all older/frail patients that she feels the high dose vaccine for the flu is too strong.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Gait inability, Injection site haemorrhage, Injection site swelling, Nausea
Clinical narrative: On September 20, 2024, at approximately 4:30 PM, a patient came to the pharmacy to receive her scheduled COVID and flu vaccines. During the review, the patient reported no history of medical conditions or allergies to vaccines. She appeared fine while administering the flu vaccine, which was given first.  However, after administering the COVID vaccine, I noticed that she bled slightly and developed a bump at the injection site. As I applied pressure, I observed that the patient looked pale. I offered her water, but she was unable to drink it and began to faint. I carefully laid her on the floor and called one of my associates to contact EMS. At that time, the patient had no pulse, so I proceeded to perform CPR for about one minute.  Fortunately, she recovered but was unable to walk and felt weak and nauseous. I placed her on her side and monitored her condition until the paramedics arrived and took over. The patient was then transported to the hospital.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pallor, Pulse absent, Resuscitation, Syncope
Clinical narrative: On September 20, 2024, at approximately 4:30 PM, a patient came to the pharmacy to receive her scheduled COVID and flu vaccines. During the review, the patient reported no history of medical conditions or allergies to vaccines. She appeared fine while administering the flu vaccine, which was given first.  However, after administering the COVID vaccine, I noticed that she bled slightly and developed a bump at the injection site. As I applied pressure, I observed that the patient looked pale. I offered her water, but she was unable to drink it and began to faint. I carefully laid her on the floor and called one of my associates to contact EMS. At that time, the patient had no pulse, so I proceeded to perform CPR for about one minute.  Fortunately, she recovered but was unable to walk and felt weak and nauseous. I placed her on her side and monitored her condition until the paramedics arrived and took over. The patient was then transported to the hospital.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site
Clinical narrative: Pt stated that it was hurting her as I was injecting, and that it seemed higher than usual. I verified being an inch below the acromion process, and withdrew the needle about halfway, and continued the injection. Pt returned about 3 hours later stating she was in 8/10 pain in the shoulder and could not move it. Sensation was verified in her hand and she was able to bend elbow. I then referred patient to the local walk-in clinic.
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was inadvertently given quadracel at 2 yo instead of the individual dtap and ipv vaccines. Quadracel is recommended for ages 4-6yo. No harm was done to the patient. Pt does not need to be revaccinated.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Condition aggravated, Ear pain, Neuralgia, Oropharyngeal pain
Clinical narrative: DAY AFTER VACCINATION, PT STARTED GET WORSE NERVE PAIN ON HEAD (TOOK DULOXETINE AS SHE NORMALLY DOES) COMPARED TO NORMAL  AND PATIENT HAD SORE THROAT AND EAR PAIN LASTING 3-4 DAYS UP TO TODAY.  ON THURSDAYS (3 DAYS AFTER THE VACCINATION), PATIENT FEELS BODY ACHE WHICH SHE HAD TO TAKE TYLENOL AND ADVIL TO EASE UP.  ON 4TH DAY, PATIENT NOW HAS STOMACH PAIN THAT IS GETTING WORSE, SO PATIENT TOOK PER PANTOPRAZOLE, WHICH SHE HAS AS PRESCRIPTION BUT DOES NOT TAKE DAILY ONLY AS NEEDED.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: DAY AFTER VACCINATION, PT STARTED GET WORSE NERVE PAIN ON HEAD (TOOK DULOXETINE AS SHE NORMALLY DOES) COMPARED TO NORMAL  AND PATIENT HAD SORE THROAT AND EAR PAIN LASTING 3-4 DAYS UP TO TODAY.  ON THURSDAYS (3 DAYS AFTER THE VACCINATION), PATIENT FEELS BODY ACHE WHICH SHE HAD TO TAKE TYLENOL AND ADVIL TO EASE UP.  ON 4TH DAY, PATIENT NOW HAS STOMACH PAIN THAT IS GETTING WORSE, SO PATIENT TOOK PER PANTOPRAZOLE, WHICH SHE HAS AS PRESCRIPTION BUT DOES NOT TAKE DAILY ONLY AS NEEDED.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Alanine aminotransferase, Angiocardiogram, Angiogram, Antibody test
Clinical narrative: Severe chest pain a few days later. Ongoing chest tightness and pain. A month after I received my second shot I got symptoms of POTS and 3 months later for 6 weeks had a racing heartbeat in my sleep. I suffered daily anxiety and panic attacks. I was fatigued and could barely make it through the day my whole body was in pain. I acquired food sensitivities and MCAS. Tingling in my hands and feet. Stomach pain and side pain.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Arteriogram, Aspartate aminotransferase, Blood bilirubin, Blood calcium
Clinical narrative: Severe chest pain a few days later. Ongoing chest tightness and pain. A month after I received my second shot I got symptoms of POTS and 3 months later for 6 weeks had a racing heartbeat in my sleep. I suffered daily anxiety and panic attacks. I was fatigued and could barely make it through the day my whole body was in pain. I acquired food sensitivities and MCAS. Tingling in my hands and feet. Stomach pain and side pain.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood creatine, Blood creatinine, Blood electrolytes, Blood glucose, Blood immunoglobulin A
Clinical narrative: Severe chest pain a few days later. Ongoing chest tightness and pain. A month after I received my second shot I got symptoms of POTS and 3 months later for 6 weeks had a racing heartbeat in my sleep. I suffered daily anxiety and panic attacks. I was fatigued and could barely make it through the day my whole body was in pain. I acquired food sensitivities and MCAS. Tingling in my hands and feet. Stomach pain and side pain.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Blood magnesium, Blood thyroid stimulating hormone, Blood urea
Clinical narrative: Severe chest pain a few days later. Ongoing chest tightness and pain. A month after I received my second shot I got symptoms of POTS and 3 months later for 6 weeks had a racing heartbeat in my sleep. I suffered daily anxiety and panic attacks. I was fatigued and could barely make it through the day my whole body was in pain. I acquired food sensitivities and MCAS. Tingling in my hands and feet. Stomach pain and side pain.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Brain natriuretic peptide, C-reactive protein, Chest X-ray, Chest discomfort, Chest pain
Clinical narrative: Severe chest pain a few days later. Ongoing chest tightness and pain. A month after I received my second shot I got symptoms of POTS and 3 months later for 6 weeks had a racing heartbeat in my sleep. I suffered daily anxiety and panic attacks. I was fatigued and could barely make it through the day my whole body was in pain. I acquired food sensitivities and MCAS. Tingling in my hands and feet. Stomach pain and side pain.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Electrocardiogram ambulatory, Fatigue, Fibrin D dimer, Flank pain
Clinical narrative: Severe chest pain a few days later. Ongoing chest tightness and pain. A month after I received my second shot I got symptoms of POTS and 3 months later for 6 weeks had a racing heartbeat in my sleep. I suffered daily anxiety and panic attacks. I was fatigued and could barely make it through the day my whole body was in pain. I acquired food sensitivities and MCAS. Tingling in my hands and feet. Stomach pain and side pain.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Food allergy, Full blood count, Laboratory test, Lipase, Mast cell activation syndrome
Clinical narrative: Severe chest pain a few days later. Ongoing chest tightness and pain. A month after I received my second shot I got symptoms of POTS and 3 months later for 6 weeks had a racing heartbeat in my sleep. I suffered daily anxiety and panic attacks. I was fatigued and could barely make it through the day my whole body was in pain. I acquired food sensitivities and MCAS. Tingling in my hands and feet. Stomach pain and side pain.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Pain, Palpitations, Panic attack, Paraesthesia
Clinical narrative: Severe chest pain a few days later. Ongoing chest tightness and pain. A month after I received my second shot I got symptoms of POTS and 3 months later for 6 weeks had a racing heartbeat in my sleep. I suffered daily anxiety and panic attacks. I was fatigued and could barely make it through the day my whole body was in pain. I acquired food sensitivities and MCAS. Tingling in my hands and feet. Stomach pain and side pain.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Postural orthostatic tachycardia syndrome, Thyroxine free, Troponin
Clinical narrative: Severe chest pain a few days later. Ongoing chest tightness and pain. A month after I received my second shot I got symptoms of POTS and 3 months later for 6 weeks had a racing heartbeat in my sleep. I suffered daily anxiety and panic attacks. I was fatigued and could barely make it through the day my whole body was in pain. I acquired food sensitivities and MCAS. Tingling in my hands and feet. Stomach pain and side pain.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Musculoskeletal stiffness, Nausea, Vertigo, Vomiting
Clinical narrative: PATIENT STARTED TO GET SYMPTOMS ON THURSDAY 9/19/24 (VACCINATION WAS MONDAY 9/16/24).  PATIENT HAS NAUSEA AND VOMITED, HER RIGHT ARM (GOT VACCINATED ON LEFT ARM) IS STIFF AND NECK IS ALSO STIFF, CAN'T LOOK DOWN.  PATIENT ALSO SAYS SHE IS VERY DIZZY "THE ROOM IS SPINNING DIZZY" THE SYMPTOMS ARE LASTING THROUGH OUT TODAY (FRIDAY 9/20) AND NOT GETTING BETTER.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Rhinorrhoea, Throat irritation
Clinical narrative: On 9/19/24 patient reported having a scratchy throat and a runny nose, then on 9/20/24 patient reported having chest pain rating a 4/10 on the pain scale.
Age: 75.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Lip swelling, Skin discolouration
Clinical narrative: lip swelling on upper lip starting day of vaccination with slight "discoloration" per patient. by 9/20, 2 days later, patient reports "halfway unswollen." No shortness of breath or swelling of the tongue. Instructed to go to ER if swelling worsens or SOB.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity, Immediate post-injection reaction, Injection site induration, Injection site swelling
Clinical narrative: Injection site immediately become swollen and hard.  Patient called prescriber and is being treated for an allergic reaction with steroid pack and cream. He is also icing the area. Some of the swelling did go down before he left the pharmacy about 10 minutes later.
Age: 64.0
Sex: M
Vaccine: RSV
Symptoms: Body temperature increased, Heart rate increased, Loss of consciousness, Pain
Clinical narrative: patient states that on 9/5 he was the gas station and "blacked out", (possible seizure) was transported via air to hospital where he was kept for the next 2 weeks, states that the vaccine was the only thing different he had done recently, and drs think it may be responsible. 105 degree temperature, fast heart rate. sore afterwards
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: She received the Flu vaccine (fluad) twice (8-2-24 and 9-16-24). She reported usual arm soreness at injection site, but no other symptoms
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient had the flu vaccine on 7/26/2024, got it again on 9/19/2024. Patient has no symptoms.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Discomfort, Dyspnoea, Rash
Clinical narrative: RASH ON ARM FOR 3 DAYS, PRESSURE IN BACK, CHEST AND NECK, HARD TO BREATHE
Age: 59.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Injection site erythema, Injection site mass, Injection site warmth, Malaise, Paraesthesia
Clinical narrative: Patient stated had a bump and was red around the area vaccine was given. Started did not feel herself and at times her fingers felt tingling. Started experiencing this the day after the vaccine was administered. I spoke with her on 09/20 and she was still feeling discomfort. She stated  the area felt hot and was red. I instructed her to see her primary care.
Age: 1.08
Sex: M
Vaccine: MMR, UNK, VARCEL
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives beginning one day after vaccine starting at injection sites R thigh, then involving L thigh, becoming widespread
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: RASH - VERY ITCHY
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Rash erythematous
Clinical narrative: Round Red Cirvle - completely red (Rash)
Age: 0.6
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Urticaria
Clinical narrative: The mother indicates she was vaccinated on  8-29-24 and today 9-3-24 she woke up with hives on her body
Age: 59.0
Sex: F
Vaccine: HEP, UNK, UNK, UNK
Symptoms: Pain, Pain in extremity
Clinical narrative: LEFT ARM SWALLEN, PAIN AND UNABLE TO MOVE. VISITED MY PRIMARY DOCTOR AND SHE SEND ME FOR THERAPY, CURRENTLY I AM UNDER THERAPY TREATMENT
Age: 59.0
Sex: F
Vaccine: HEP, UNK, UNK, UNK
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: LEFT ARM SWALLEN, PAIN AND UNABLE TO MOVE. VISITED MY PRIMARY DOCTOR AND SHE SEND ME FOR THERAPY, CURRENTLY I AM UNDER THERAPY TREATMENT
Age: 70.0
Sex: F
Vaccine: FLUA4, FLU3
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Patient reported severe pain in the arm after administration with trouble moving the arm.
Age: 70.0
Sex: F
Vaccine: FLUA4, FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient reported severe pain in the arm after administration with trouble moving the arm.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swelling , shoulder pain and fever
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Pyrexia, Swelling
Clinical narrative: Swelling , shoulder pain and fever
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; Consumer's grandmother calling on behalf of customer to report patient received first dose of GARDASIL 9 on 8/19/2023, second dose on 3/6/2024, and are wanting to get her third dose. No side effects reported. No additional information/clarification; This spontaneous report was received from a consumer concerning a 17-year-old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-AUG-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).   On 06-MAR-2024, 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 (Inappropriate schedule of product administration). No adverse events were reported. The patient wanted to get the third dose.   Lot # is being requested and will be submitted if received.