chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Immunization database, listed single dose Zostavax given by doctor at office. Pt was given Shingrix as first dose. later pt confirmed with doctor that she was given shingrix  and completed her 2 dose series. pharmacy confirmed with doctors office and encouraged them to correct the database to prevent further errors
Age: 10.0
Sex: M
Vaccine: HEP, HEPA, HPV9, IPV, MMRV, MNQ, TDAP, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given 2 (0.5mo) doses of Tdap, one in each deltoid. Patient's mother was notified and checked on patient on 9/6/24 and 9/16/24. Mother denied any adverse effects and states patient is doing fine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Condition aggravated, Cystitis, Febrile convulsion
Clinical narrative: Within 24 hrs of receiving immunizations, pt had febrile seizure. She was seen in ED. Of note, in ED she was found to have cystitis and  was prescribed antibiotics. Also of note, pt has hx of febrile seizures.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site nodule, Injection site swelling
Clinical narrative: patient experienced swelling , knot formed, and excessive bleeding occurred immediately after injection.  We applied pressure and ice pack to site. We had patient wait 15 minutes and then checked on her again. Bleeding had stopped and swelling and knot had decreased
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: Patient received Spikevax vaccine 3 days after CDC recommended to stop administering this vaccine in preparation for Fall 2024 Covid vaccine to come out.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AEs were reported; Pharmacist reported that a 5 year old patient received 2 doses of VARIVAX only one month apart.  The first dose was given on 7/23/2024.  No additional AEs were reported. No further information provided.  No PQC.; This spontaneous report was received from a pharmacist and refers to a 5-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 23-JUL-2024, the patient was vaccinated with first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (anatomical location, strength, lot #, expiry date, and route of administration were not provided) and on 23-AUG-2024, only one month apart, received the second dose of the vaccine (Inappropriate schedule of product administration) (no administration details). No additional adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP called to report inadvertent administration of expired MMR-II to a patient.; This spontaneous report was received from an other health professional (medical assistant) and refers to a patient of an unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 26-AUG-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, lot #X023222 (lot # was validated to be not valid for V205C and did not match any Company product), expiration date: 22-AUG-2024, administered for prophylaxis (strength, dose, anatomical location, albumin status, and route of administration were not provided). It was reported inadvertent administration of expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) to a patient (expired product administered). No additional adverse event (AE) was reported (no adverse event).  Lot# is being requested and will be submitted if received.
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Seizure like phenomena
Clinical narrative: episodes of what appeared to be siezures.; high fever; This spontaneous report has been received from a consumer, referring to a 1-year-old male patient. The information regarding the patient's concurrent conditions, concomitant therapies or medical history was not provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), administered for prophylaxis (dose, route of administration, anatomical location, therapy type, lot# and expiry date were not reported).  On 05-SEP-2024, the patient experienced a high fever and episodes of "what appeared to be seizures". He was taken to an emergency room. On an unknown date in September 2024, the patient was hospitalized due to the events. After evaluation, he was discharged from the hospital and sent home. The patient's mother speculated that measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) caused the high fever and reaction in her son.  The outcome of the events was unknown.  The reporter's causality assessment was not provided.  Upon internal review, the event of seizure like phenomena was determined to be medically significant.  Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller stated PROQUAD was administered to one patient after being stored improperly; This spontaneous report was received from an Other Health Professional and refers to a 4-year-old female. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-SEP-2024, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA (recombinant human albumin)) (PROQUAD) injection, 0.5 milliliter, lot #X014623, expiration date: 18-NOV-2024, administered for prophylaxis (strength, and route of administration were not provided).  There were no adverse effects reported. Administered dose of vaccine experienced the following temperature excursions: 01-SEP-2024: 23.4 for 13 hours 9 minutes, 02-SEP-2024: 22.8 for 7 hours 46 minutes, 03-SEP-2024: 19.6 for 3 hours 20 minutes, 04-SEP-2024: 20.7 for 5 hours 37 minutes, 05-SEP-2024: 22.5 for 10 hours 23 minutes, 02-SEP-2024: 25.7 for 15 hours 54 minutes, 07-SEP-2024:  27.5 for 21 hours 2 minutes, 08-SEP-2024:: 27.5 for 19 hours 52 minutes, 09-SEP-2024:: 26.1 for 8 hours 47 minutes. Also, prior to the vaccination the following temperature excursions: 14 degrees Fahrenheit to 46 degrees Fahrenheit (23.4F) for 13 hours 9 minutes 0 seconds, 14 degrees Fahrenheit to 46 degrees Fahrenheit (22.8F) for 7 hours 46 minutes 0 seconds, 14 degrees Fahrenheit to 46 degrees Fahrenheit (19.6F) for 3 hours 20 minutes 0 seconds, 14 degrees Fahrenheit to 46 degrees Fahrenheit (20.7F) for 5 hours 37 minutes 0 seconds, 14 degrees Fahrenheit to 46 degrees Fahrenheit (22.5F) for 10 hours 23 minutes 0 seconds, 14 degrees Fahrenheit to 46 degrees Fahrenheit (25.7F) for 15 hours 54 minutes 0 seconds, 14 degrees Fahrenheit to 46 degrees Fahrenheit (27.5F) for 21 hours 2 minutes 0 seconds, 14 degrees Fahrenheit to 46 degrees Fahrenheit (27.5F) for 19 hours 52 minutes 0 seconds, 14 degrees Fahrenheit to 46 degrees Fahrenheit (26.1F) for 8 hours 47 minutes 0 seconds. Current temperature excursion: 14 degrees Fahrenheit to 46 degrees Fahrenheit (22.1F) for 2 hours 28 minutes 0 seconds.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV9, MEN, MENB
Symptoms: Inappropriate schedule of product administration, Nodule, Skin induration
Clinical narrative: Product origin unknown; nodules/lumps in arm; This spontaneous report was received from a consumer via email from other company and refers to a 12-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On 01-AUG-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (reported as HPV vaccine) (Product origin unknown), administered for prophylactic vaccination (immunisation) (strength, dose, lot #, expiry date, anatomical location and route of administration were not provided); meningococcal vaccine b rfhbpa/fhbpb (TRUMENBA), administered for prophylactic vaccination (immunisation) (strength, formulation, dose, lot #, expiry date, and route of administration were not provided); and meningococcal vaccine a/c/y/w conj (tet tox) (MENQUADFI) solution for injection, administered for prophylactic vaccination (immunisation) (strength, dose, lot #, expiry date, and route of administration were not provided) (both meningitis vaccines were administered in the same arm and both meningitis vaccines were administered in the same day)).  On 06-AUG-2024 the patient had hard lump under her skin on her arm which she did not describe as swelling/that it's been 5 days since she received the vaccines and she had 2 lumps (nodule). It was not reported if the patient received a corrective treatment for nodule. It was unknown if there were lab data/results available.  At the time of reporting, the outcome of the event nodule was unknown. The action taken with all suspect vaccines was not applicable. The causal relationship between event nodule and HPV vaccine, other suspect vaccines were unknown.  Information on batch number corresponding to the one at time of event occurrence could not be requested/ Additional information was not expected.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called to report TE for GARDASIL 9.  TE filed: 02669891. Caller reports product was administered.  No symptoms reported.  Consent to correspond was granted. This case is related to AE cases: 02669968, 02669980, 02669985, 02669992 and 02669997. No; No additional adverse event; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #1965046, expiration date: 22-JAN-2026, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion in 8.6 degree Celsius for 10 minutes with no previous excursion (Product storage error). No additional adverse event was reported. ; Sender's Comments:  US-009507513-2409USA004203:
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; un-noticed temperature excursion occured; This spontaneous report was received from a nurse, referring to a 5-year-old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 12-AUG-2024, the patient was vaccinated with 2nd dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (therapy type: recombinant Human albumin/ rHA) (PROQUAD) subcutaneous injection, lot #Y004547, expiration date: 19-AUG-2025, administered subcutaneously on the right arm for prophylaxis (strength and dose were not provided) after temperature excursions with temperature at -12 degree Celsius for 37 minutes (Product storage error). After un-noticed temperature excursion occurred, vaccine was administered before it was cleared by manufacturer. The vaccine has been cleared for use. No adverse effects were reported (no adverse event). There was previous temperature excursion. There was no product quality compliant.
Age: 0.33
Sex: F
Vaccine: PNC15
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; HCP called to request information on  VAXNEUVANCE (PFS) if doses were given to a child too soon. HCP confirmed patient has not had any side effects. HCP did not have NDC, LOT # or expiry dates of the VAXNEUVANCE(PFS). HCP stated first dose of VAXNEUV; vaccine administered at 4 months of age instead of 2 months; This spontaneous report as received from a nurse practitioner referring to a 4-month-old female patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.     On 18-APR-2024, the patient was vaccinated with the first dose of pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE), on 11-JUN-2024, at 6 months of age, received the second dose; on 11-JUL-2024 at 7 months of age, received the third dose and on 10-SEP-2024, when the patient was 9 months old, received the fourth dose of the vaccine (dose, routes of administration, lot numbers and expiration dates not reported not either of the doses) all for prophylaxis (product administered to patient of inappropriate age and inappropriate schedule of product administration). No adverse event was reported.
Age: 40.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No additional AE/PQC; HCP called to report an adult patient who was scheduled for a dose of VAQTA on 13SEP2024, but instead inadvertently received a dose of pediatric VAQTA. Limited patient demographics provided. No additional details were known by reporter. No additional; This spontaneous report was received from a medical assistant and refers to a 40-year-old female patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On 13-SEP-2024 the patient was inadvertently vaccinated with pediatric dose of hepatitis a vaccine, inactivated (VAQTA), 0.5 milliliter for prophylaxis (dose number, route and site of administration, lot number and expiration date were not provided) (accidental underdose). No additional adverse events and product Quality complaints were reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no symptomatic event; the patient received an expired dose of PROQUAD; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On 17-JUN-2024, the patient was vaccinated an expired dose of with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) injection, 0.5 milliliter/series, administered for prophylaxis (lot#W038809, expiration date: 04-JUN-2024; strength and route of administration were not provided) (Expired product administered). It was confirmed that there were no temperature excursions on the product. No symptomatic events occurred. The sterile diluent (MERCK STERILE DILUENT) used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), lot number and expiration date was unknown. The product was supported according to the post expiry memo. No additional information was provided.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache
Clinical narrative: headache; severe chills; This non-serious case was reported by a consumer via sales rep and described the occurrence of headache in a 49-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2024-2025 season) for prophylaxis.   On 09-SEP-2024, the patient received the 1st dose of Fluarix Quadrivalent 2024-2025 season (right arm). On 09-SEP-2024, less than a day after receiving Fluarix Quadrivalent 2024-2025 season, the patient experienced headache (Verbatim: headache) and chills (Verbatim: severe chills). On 09-SEP-2024, the outcome of the headache and chills were resolved.   The reporter considered the headache and chills to be related to Fluarix Quadrivalent 2024-2025 season and Fluarix Tetra Pre-Filled Syringe Device.   The company considered the headache and chills to be related to Fluarix Quadrivalent 2024-2025 season and Fluarix Tetra 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: 09-SEP-2024 The patient received 1st dose and had severe chills and headache.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose of Shingrix well beyond the six months; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) (batch number TF9HE) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix on 11th December 2019) and Zostavax (received Zostavax on an unknown date).   On 04-SEP-2024, the patient received the 2nd dose of Shingrix. On 04-SEP-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: second dose of Shingrix well beyond the six months). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 09-SEP-2024 The other health professional (pharmacy technician) reported that the patient received their second dose of Shingrix well beyond the six months.  The patient received a dose of Zostavax at an unknown time, and their first and second Shingrix dose.  The other health professional requested information about how to proceed. The patient received second dose of Shingrix longer than the recommended interval which led to lengthening of vaccination schedule. The Vaccine Administration Facility was the same as Primary Reporter. This case was linked with US2024112049, reported by same reporter.; Sender's Comments:  US-GSK-US2024112049:Same reporter/unk patient
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Constipation
Clinical narrative: constipation; This non-serious case was reported by a consumer via call center representative and described the occurrence of constipation in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included dupilumab (Dupixent) for product used for unknown indication.   Previously administered products included Shingrix with an associated reaction of abdominal discomfort (1st dose received on 28th June 2024, refer case- US2024112638).   On 06-SEP-2024, the patient received the 2nd dose of Shingrix. In SEP-2024, the patient started Dupixent. On an unknown date, an unknown time after receiving Shingrix, the patient experienced constipation (Verbatim: constipation). The action taken with Dupixent was unknown. The outcome of the constipation was not resolved.   It was unknown if the reporter considered the constipation to be related to Shingrix.   It was unknown if the company considered the constipation to be related to Shingrix.   Linked case(s) involving the same patient: US2024112638   Additional Information: GSK Receipt Date: 10-SEP-2024 The reporter was the patient.  The patient received the second dose of Shingrix and experiencing constipation. The patient received Dupixent 3 days prior to each dose of Shingrix. The patient receives Dupixent every other Tuesday. It was unknown if the reporter considered the upset stomach, diarrhea and gastric spasm to be related to Dupixent.; Sender's Comments:  US-GSK-US2024112638:same reporter, same patient, 2nd dose case
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19, Malaise
Clinical narrative: diagnosed with Covid; felt crappy after the first vaccine of Shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of covid-19 in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28-FEB-2024, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 02-MAR-2024, 3 days after receiving Shingrix, the patient experienced feeling abnormal (Verbatim: felt crappy after the first vaccine of Shingrix). On an unknown date, the patient experienced covid-19 (Verbatim: diagnosed with Covid). On 04-MAR-2024, the outcome of the feeling abnormal was resolved (duration 2 days). The outcome of the covid-19 was not resolved.   It was unknown if the reporter considered the covid-19 and feeling abnormal to be related to Shingrix.     It was unknown if the company considered the covid-19 and feeling abnormal to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-SEP-2024 The patient had her first vaccine for Shingrix and when it was scheduled to get the 2nd injection she was diagnosed with covid.  The patient stated that she felt crappy after the first vaccine of Shingrix.  The patient was still tried to get over having covid before taking the 2nd vaccine of Shingrix, so her 2nd dose would be outside the 2 to 6 months window.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got the first dose of Shingrix a year ago and the second dose the last week; 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 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix a year ago).   In SEP-2024, the patient received the 2nd dose of Shingrix. In SEP-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: got the first dose of Shingrix a year ago and the second dose the last week). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 09-SEP-2024 The pharmacist reported that a patient got the first dose of Shingrix a year ago and the second dose the last week. The pharmacist asked if the patient needs a 3rd dose or not. The patient received second dose of Shingrix longer than the recommended interval which led to lengthening of vaccination schedule.
Sex: U
Vaccine: COVID19
Symptoms: Arrhythmia, Burning sensation, Feeling hot
Clinical narrative: CAN FEEL ARRYTHMIA; BURNING SENSATIONS ON SKIN; INTENSE HEAT DURING MIDDLE OF NIGHT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: 23% lung capacity, oxygen patient, and partial heart failure. The patient received covid-19 vaccine ad26.cov2.s (Dose in series 1) (suspension for injection, route of admin not reported, batch number: 1805020) dose was not reported, administered on 10-MAR-2021 for covid-19 prophylaxis. No concomitant medications were reported. He stated what he read about the vaccine, anyone who had crowd control weapons that throw radiation like that if weapons get in wrong hands can heat someone up until the body disintegrates causing heart attacks, strokes, things like that, someone is doing this to himself he stated. Consumer stated he was an oxygen patient and has 23% lung capacity, usually didn't like vaccines but told him if he didn't get it he won't survive so decided to take the chance. He stated he was being terrorized with electricity, target, not a conspiracy theory, electronic torture, and people with graphene in their system it was worse. He stated lot number 1805020, expiration date unknown, received March 10, 2021. He stated safety team had permission to contact himself but not his doctor because he didn't not want to sound like a psych ward. He stated this throws off his heart rhythm and can cause blood clots with heart rate high and has partial heart failure to start with, can feel arrythmia, intense heat during middle of night with burning sensations on skin particularly back of neck and around shoulders came and go usually at night felt stings and burns on skin during day but intense heat always at late hours and someone was trying to catch him when he was sleeping. On an unspecified date, the patient experienced can feel arrythmia (Dose in series 1), intense heat during middle of night (Dose in series 1), and burning sensations on skin (Dose in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the can feel arrythmia, burning sensations on skin and intense heat during middle of night was not reported. This report was serious (Other Medically Important Condition). This case, from the Others is linked to 20240917391.  It was determined that Manufacturer Case Number [20240917391] was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number [20240917263].; Sender's Comments: V0:  Arrhythmia. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: she had Moderna vaccines many times and never had anything but a sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (she had Moderna vaccines many times and never had anything but a sore arm) in a 65-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer Vaccine (Dose 1), Pfizer Vaccine (Dose 3) and Pfizer Vaccine (Dose 2). Past adverse reactions to the above products included No adverse effect with Pfizer Vaccine, Pfizer Vaccine and Pfizer Vaccine.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (she had Moderna vaccines many times and never had anything but a sore arm). At the time of the report, PAIN IN EXTREMITY (she had Moderna vaccines many times and never had anything but a sore arm) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-774091, US-MODERNATX, INC.-MOD-2024-774113 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774091:same patient but Different dose US-MODERNATX, INC.-MOD-2024-774113:Husband case
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rashes all over her body; This spontaneous case was reported by a patient and describes the occurrence of RASH (rashes all over her body) in an 87-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergy.   On an unknown date, the patient received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (rashes all over her body). At the time of the report, RASH (rashes all over her body) outcome was unknown.            No concomitant medication was reported.  Patient had 5 Moderna vaccine shots but was not sure if rashes are caused by the Moderna vaccine. She has rashes all over her body and wanted to get tested for that she needed to find out the ingredient. No treatment information was reported.
Age: 73.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Body temperature, Fatigue, Feeling abnormal, Laboratory test, Malaise
Clinical narrative: sore arm; Feeling weird, tired, run-down; Not feeling good at all; low-grade fever of 99.6F; Feeling weird, tired, run-down; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (Feeling weird, tired, run-down), MALAISE (Not feeling good at all), PYREXIA (low-grade fever of 99.6F) and FATIGUE (Feeling weird, tired, run-down) in a 73-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Previously administered products included for COVID-19 prophylaxis: moderna (dose 1), moderna (dose 3) and moderna (dose 2). Past adverse reactions to the above products included No adverse effect with moderna, moderna and moderna.   On 10-Sep-2024, the patient received fourth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) .5 milliliter and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 11-Sep-2024, the patient experienced PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (Feeling weird, tired, run-down), MALAISE (Not feeling good at all), PYREXIA (low-grade fever of 99.6F) and FATIGUE (Feeling weird, tired, run-down). At the time of the report, PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (Feeling weird, tired, run-down), MALAISE (Not feeling good at all), PYREXIA (low-grade fever of 99.6F) and FATIGUE (Feeling weird, tired, run-down) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Sep-2024, Body temperature: low-grade fever of 99.6F. On 11-Sep-2024, Laboratory test: They did no find anything.     For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant product use was not provided by the reporter. Patient woke up with a low-grade fever of 99.6F, with a sore arm and feeling weird, tired, run-down, not feeling good at all. Flu shot was received concurrently. Patient woke up on 11SEP2024 with symptoms and went to the ER a full work up was done and they did no find anything. Patient had a doctor's appointment later the same day and reports everything was fine. Reporter causality was not reported.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-773976 (E2B Linked Report). This case was linked to MOD-2021-022860 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-773976:Same reporter,people case (invalid)
Age: 73.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: sore arm; Feeling weird, tired, run-down; Not feeling good at all; low-grade fever of 99.6F; Feeling weird, tired, run-down; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (Feeling weird, tired, run-down), MALAISE (Not feeling good at all), PYREXIA (low-grade fever of 99.6F) and FATIGUE (Feeling weird, tired, run-down) in a 73-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Previously administered products included for COVID-19 prophylaxis: moderna (dose 1), moderna (dose 3) and moderna (dose 2). Past adverse reactions to the above products included No adverse effect with moderna, moderna and moderna.   On 10-Sep-2024, the patient received fourth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) .5 milliliter and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 11-Sep-2024, the patient experienced PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (Feeling weird, tired, run-down), MALAISE (Not feeling good at all), PYREXIA (low-grade fever of 99.6F) and FATIGUE (Feeling weird, tired, run-down). At the time of the report, PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (Feeling weird, tired, run-down), MALAISE (Not feeling good at all), PYREXIA (low-grade fever of 99.6F) and FATIGUE (Feeling weird, tired, run-down) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Sep-2024, Body temperature: low-grade fever of 99.6F. On 11-Sep-2024, Laboratory test: They did no find anything.     For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant product use was not provided by the reporter. Patient woke up with a low-grade fever of 99.6F, with a sore arm and feeling weird, tired, run-down, not feeling good at all. Flu shot was received concurrently. Patient woke up on 11SEP2024 with symptoms and went to the ER a full work up was done and they did no find anything. Patient had a doctor's appointment later the same day and reports everything was fine. Reporter causality was not reported.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-773976 (E2B Linked Report). This case was linked to MOD-2021-022860 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-773976:Same reporter,people case (invalid)
Age: 87.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headache) in an 87-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Previously administered products included for Product used for unknown indication: FLU [INFLUENZA VACCINE]. Past adverse reactions to the above products included Pain with FLU [INFLUENZA VACCINE].   On 10-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 11-Sep-2024, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) was resolving.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Headache, Limb discomfort, Pain
Clinical narrative: debilitating pain; burning sensation inside bad headache; extremities feel very heavy; burning sensation inside bad headache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (debilitating pain), BURNING SENSATION (burning sensation inside bad headache), LIMB DISCOMFORT (extremities feel very heavy) and HEADACHE (burning sensation inside bad headache) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Concurrent medical conditions included Fibromyalgia.    On 10-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 10-Sep-2024, the patient experienced PAIN (debilitating pain), BURNING SENSATION (burning sensation inside bad headache), LIMB DISCOMFORT (extremities feel very heavy) and HEADACHE (burning sensation inside bad headache). At the time of the report, PAIN (debilitating pain), BURNING SENSATION (burning sensation inside bad headache), LIMB DISCOMFORT (extremities feel very heavy) and HEADACHE (burning sensation inside bad headache) outcome was unknown.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect vaccine dosage text was reported as unknown. Patient had been all day to day and almost debilitating pain. Patient had severe pain and her extremities feel heavy, burning sensation inside bad headache. Reporter causality was not reported.  No treatment medication was reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast oedema, Gait disturbance, Pain in extremity
Clinical narrative: sore arm after the vaccine and the real side effects; all of her lymph nodes under armpit and right breast area swelled up; all of her lymph nodes under armpit and right breast area swelled up and were very sore; even if she walks its very sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm after the vaccine and the real side effects), AXILLARY PAIN (all of her lymph nodes under armpit and right breast area swelled up), BREAST OEDEMA (all of her lymph nodes under armpit and right breast area swelled up and were very sore) and GAIT DISTURBANCE (even if she walks its very sore) in an 80-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: flu shot (received the flu shot in the left arm and the COVID in the right arm) on 07-Sep-2024. Past adverse reactions to the above products included No adverse effect with flu shot.    On 10-Sep-2024, the patient received fifth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 10-Sep-2024, the patient experienced PAIN IN EXTREMITY (sore arm after the vaccine and the real side effects), AXILLARY PAIN (all of her lymph nodes under armpit and right breast area swelled up), BREAST OEDEMA (all of her lymph nodes under armpit and right breast area swelled up and were very sore) and GAIT DISTURBANCE (even if she walks its very sore). At the time of the report, PAIN IN EXTREMITY (sore arm after the vaccine and the real side effects), AXILLARY PAIN (all of her lymph nodes under armpit and right breast area swelled up), BREAST OEDEMA (all of her lymph nodes under armpit and right breast area swelled up and were very sore) and GAIT DISTURBANCE (even if she walks its very sore) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter.  The treatment medication was not reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Meniscus injury
Clinical narrative: torn meniscus; This spontaneous case was reported by a patient and describes the occurrence of MENISCUS INJURY (torn meniscus) in an adult patient of an unknown gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENISCUS INJURY (torn meniscus). At the time of the report, MENISCUS INJURY (torn meniscus) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  It was reported that patient had previous Moderna vaccines, and that reason for steroid injection occurred after any Moderna vaccines received and had torn meniscus.  Patient was treated with unspecified steroid injection.  Reporter causality was not reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Dyskinesia, Fatigue
Clinical narrative: feels bad every time he gets the shot/vaccine; vomited; got a fever as high as "101°F."; got "sick"; fatigue; headache; muscle pain; joint pain; chills; nausea; right hand had "involuntary movements"; was not able to eat yesterday; rash; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feels bad every time he gets the shot/vaccine), VOMITING (vomited), PYREXIA (got a fever as high as "101°F."), MALAISE (got "sick") and FATIGUE (fatigue) in a 70-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feels bad every time he gets the shot/vaccine), VOMITING (vomited), PYREXIA (got a fever as high as "101°F."), MALAISE (got "sick"), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea), DYSKINESIA (right hand had "involuntary movements"), FEEDING DISORDER (was not able to eat yesterday) and RASH (rash). At the time of the report, FEELING ABNORMAL (feels bad every time he gets the shot/vaccine), VOMITING (vomited), PYREXIA (got a fever as high as "101°F."), MALAISE (got "sick"), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea), DYSKINESIA (right hand had "involuntary movements"), FEEDING DISORDER (was not able to eat yesterday) and RASH (rash) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: fever as high as 101-degree F.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   The patient had first 2 vaccines that he had are from Pfizer but was not able to verify. No concomitant medications were provided. Dosage text for suspect product was reported as unknown. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-774018, US-MODERNATX, INC.-MOD-2024-774023 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774018:Same patient (Different product) Pfizer Biontech US-MODERNATX, INC.-MOD-2024-774023:Wife case
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Feeding disorder, Feeling abnormal, Headache, Malaise, Myalgia
Clinical narrative: feels bad every time he gets the shot/vaccine; vomited; got a fever as high as "101°F."; got "sick"; fatigue; headache; muscle pain; joint pain; chills; nausea; right hand had "involuntary movements"; was not able to eat yesterday; rash; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feels bad every time he gets the shot/vaccine), VOMITING (vomited), PYREXIA (got a fever as high as "101°F."), MALAISE (got "sick") and FATIGUE (fatigue) in a 70-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feels bad every time he gets the shot/vaccine), VOMITING (vomited), PYREXIA (got a fever as high as "101°F."), MALAISE (got "sick"), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea), DYSKINESIA (right hand had "involuntary movements"), FEEDING DISORDER (was not able to eat yesterday) and RASH (rash). At the time of the report, FEELING ABNORMAL (feels bad every time he gets the shot/vaccine), VOMITING (vomited), PYREXIA (got a fever as high as "101°F."), MALAISE (got "sick"), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea), DYSKINESIA (right hand had "involuntary movements"), FEEDING DISORDER (was not able to eat yesterday) and RASH (rash) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: fever as high as 101-degree F.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   The patient had first 2 vaccines that he had are from Pfizer but was not able to verify. No concomitant medications were provided. Dosage text for suspect product was reported as unknown. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-774018, US-MODERNATX, INC.-MOD-2024-774023 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774018:Same patient (Different product) Pfizer Biontech US-MODERNATX, INC.-MOD-2024-774023:Wife case
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Rash, Vomiting
Clinical narrative: feels bad every time he gets the shot/vaccine; vomited; got a fever as high as "101°F."; got "sick"; fatigue; headache; muscle pain; joint pain; chills; nausea; right hand had "involuntary movements"; was not able to eat yesterday; rash; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feels bad every time he gets the shot/vaccine), VOMITING (vomited), PYREXIA (got a fever as high as "101°F."), MALAISE (got "sick") and FATIGUE (fatigue) in a 70-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feels bad every time he gets the shot/vaccine), VOMITING (vomited), PYREXIA (got a fever as high as "101°F."), MALAISE (got "sick"), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea), DYSKINESIA (right hand had "involuntary movements"), FEEDING DISORDER (was not able to eat yesterday) and RASH (rash). At the time of the report, FEELING ABNORMAL (feels bad every time he gets the shot/vaccine), VOMITING (vomited), PYREXIA (got a fever as high as "101°F."), MALAISE (got "sick"), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea), DYSKINESIA (right hand had "involuntary movements"), FEEDING DISORDER (was not able to eat yesterday) and RASH (rash) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: fever as high as 101-degree F.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   The patient had first 2 vaccines that he had are from Pfizer but was not able to verify. No concomitant medications were provided. Dosage text for suspect product was reported as unknown. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-774018, US-MODERNATX, INC.-MOD-2024-774023 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774018:Same patient (Different product) Pfizer Biontech US-MODERNATX, INC.-MOD-2024-774023:Wife case