chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse reactions, incorrect medication was given. patient was given pediatric moderna monovalent instead of moderna monovalent
patient claims that arm pain started soon after immunization and progressively got worse.  now difficult to move arm 5 days after immunization
Having frequent headaches, starting approx. 1 week after vaccine.  Some chest tightness/heart palpitations, Some joint pain in ankle and hips.
2 days after receiving shot on 10/14/15 lost the ability to grip right hand still undergoing treatment.
Fluish like symptoms, extreme sweats, feeling like I needed to vomit.  Started about 22 hours after vaccine. Had 3 cycles of it through the evening and overnight. Feeling better in the am of 9/11/22.
Injection given complained of feeling nauseated, given juice, sprite with relief obtained, observed for 25-30 minutes to check out, fainted-treated per internist.
This spontaneous report was received from a medical assistant referring to a 7 year old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 13-MAR-2018, the patient was administered an improperly stored (Oka/Merck) VARIVAX (lot reported as: N022978; Expiry date: 23-AUG-2019) (product storage error) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 15 °F to 46°F (32.2°F) for 9 hours and 27 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several cases received from the same reporter.
Pt recvd a 2nd dose of vax on 13Dec91 & 14Dec91 devel lt side mastitis.Seen by MD 23Dec91 who attributed mastitis to vax. Warm compresses & meds rx.30Dec91 mastitis improving "1 sore spot left".
Light headed; Leg collapse; break out in a big sweat; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed), MUSCULAR WEAKNESS (Leg collapse) and HYPERHIDROSIS (break out in a big sweat) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.  On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 12-Jan-2021, the patient experienced DIZZINESS (Light headed), MUSCULAR WEAKNESS (Leg collapse) and HYPERHIDROSIS (break out in a big sweat).   At the time of the report, DIZZINESS (Light headed), MUSCULAR WEAKNESS (Leg collapse) and HYPERHIDROSIS (break out in a big sweat) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
No adverse reactions; Varivax IM/LT; This spontaneous report was received from a nurse referring to a 12-month-old male patient. The patient had 2 brothers and 2 sisters. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. Concomitant vaccine included pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13).  On 05-JAN-2021, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose and strength were not reported, lot# T017682 has been verifies as valid, expiration date reported as 01-MAY-2022, but upon internal validation established as 21-MAY-2022) intramuscularly (IM) in the left thigh (LT) (incorrect route of product administration). The medication error occurred in the process of preparation for administration. There was no product quality complaint. The patient had no adverse reactions.  This is one of 2 reports referring to the same patient.; Sender's Comments:  US-009507513-2101USA001770:
Cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Cancer) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NEOPLASM MALIGNANT (Cancer) to be related.    No concomitant medication was reported. Suspect product dosage text was reported as unknown. It was reported that cancer rates for jabbed Moderna Cancer patients was up 300 percent. No treatment medication was reported. This case is reported for patient 20 out of 25 patients.  Company comment:  This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the Fatal serious (due to medically significant) unexpected, event of Neoplasm malignant, which occurred after the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as part of COVID-19 vaccination schedule, dose number not provided. The patient died on an unknown date, and it is unknown whether an autopsy was performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master case, Patient 1; Reported Cause(s) of Death: Cancer
arm was sore & headache right away,  half hour later felt very tired,  3 hours later my heart starting racing  &  my throat felt swollen   I didn't seek medical treatment because I have an epi pen in my house  ( i have a granddaughter allergic to peanuts)   I went to bed, woke up around 4am  heart racing & swollen throat were gone
pt recvd vax & exp shaking episode from waist up; had another episode later on 21jun94; whole body shook cried afterwards
Squeezing pain along right side of head, very much like the squeezing pain I had in my chest after the first dose. It's intermittent, not constant. Pain strong enough to stop me from what I'm doing.
That evening after receiving my vaccine I experienced sever headache, nausea, diarrhea, fatigue. On Sunday I woke up and was only seeing half words and thought I was having a stroke. I called my doctor who advised that I see my eye doctor. I saw her the next day and she stated that I had an ocular migraine. I've never had a migraine in the past. My eye doctor advised that I follow up with my regular doctor. I also experienced much more sever pain in my arm with this dose to the point that I could not even lift it.
Initial information received on 09-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 12 months old patient (gender not reported) who experienced a rash on both legs and hives, while he/she received vaccine ACT-HIB. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. On an unknown date (reported as possibly on Oct-2017), the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot number: UI764AA, expiry date, dose in series not reported) via intramuscular route in the left thigh. On an unknown date, the patient developed a non-serious a rash on both legs following the administration of HIB (PRP/T) VACCINE. On an unknown date, the patient developed a non-serious hives following the administration of HIB (PRP/T) VACCINE. Other relevant tests included No Lab data was reported. Final diagnosis was hives and a rash on both legs. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for a rash on both legs and as Unknown for hives. Documents held by the sender: none.
4FEB low grade fever - HR - vomiting, rash over stomach, chest & back; Seen by MD;
i got the hep shot on 4-22-09. it was put in my right arm. still today it still hurts and has pain in it. never had a problem until i got the shot.
COVID 19 Treatment; COVID 19 Treatment; Dose Number: 4: Pfizer / Dose Number: 3: Moderna / Dose Number: 2: Moderna/ Dose Number 1: Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jul2022 at 12:00 as dose 4 (booster), single (Lot number: FW1333) at the age of 72 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Feb2021 as dose 1, single (Lot number: 032L28A), on 08Mar2021 as dose 2, single (Lot number: 014M20A) and on 16Nov2021 at 12:00 as dose 3 (booster), single (Lot number: 014F21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: FLUOXETINE, start date: Jan1993; CRESTOR, start date: Jan2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Jul2022 at 12:00, outcome "unknown", described as "Dose Number: 4: Pfizer / Dose Number: 3: Moderna / Dose Number: 2: Moderna/ Dose Number 1: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Negative, notes: tested twice 48 hrs apart with Binax home antigen and was negative on day 9 and 11 of Covid; (Oct2022) Negative, notes: tested twice 48 hrs apart with Binax home antigen and was negative on day 9 and 11 of Covid; (Oct2022) Positive, notes: now positive 2 days later with sore throat, nasal congestion, muscle aches; (unspecified date) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient took other medications in two weeks. The patient took Anti-viral treatment from 01Oct2022 to 06Oct2022 for treatment of Covid-19.
Fever, shivers, couldn't get warm.  Shivered all night curled into a tight ball trying to stay warm.  I tend to be very warm at night, so shivering from cold on a mild evening was an extreme reaction for me.  Overall body aches and pain, fatigue and weakness.  Could barely walk to the bathroom.
Client should have received covid vaccine as a second dose, instead received different manufacturer.   Client felt well and had no complaints.  Instructions given on when to seek medical care and 24/7 contact number for agency staff given.
has been felling sick since the night of his second dose of the Moderna covid19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (has been felling sick since the night of his second dose of the Moderna covid19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (has been felling sick since the night of his second dose of the Moderna covid19 vaccine). At the time of the report, MALAISE (has been felling sick since the night of his second dose of the Moderna covid19 vaccine) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient (also a physician) via other manufacturer Pfizer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (not specified) and other pre-existing medical conditions included: The patient had no known allergy. The patient is also a HCP (health care professional). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. The patient additionally received two doses (dose number 1 and 2) (booster) of non-company suspect Moderna (spikevax) vaccine (elasomeran) (dose number in series 2) (form of admin, and route of admin were not reported, batch number were not reported, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced covid 19 infection (Dose number in series 2). The patient additionally received non company suspect Paxlovid (form of admin not reported, oral, batch number were not reported and expiry: unknown) dose was not reported, administered on 17-MAY-2022 for covid-19 treatment. Patient received last dose of Paxlovid on 22-MAY-2022.  On 29-MAY-2022, the patient experienced rebound covid infection (suspected covid-19 infection) five days after completion of paxlovid (Dose number in series 2), thus patient had suspected clinical vaccination failure (Dose number in series 1). The patient was recovering from rebound covid infection. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and action taken with Paxlovid was treatment discontinued. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20220632682- covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Only adjuvant administered, no antigen; Only adjuvant administered, no antigen; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-DEC-2022 Reporter's Comment: The reporter reported administering Shingrix adjuvant only (no antigen) to patient.  The reporter consented to follow up. Additional Supportive Information: The reporter reported administering Shingrix adjuvant only (no antigen) to patient, inappropriate preparation of medication and inappropriate dose of vaccine administered. This was 1 of 7 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022193687:Same reporter US-GSK-US2022193680:Same reporter US-GSK-US2022193682:Same reporter US-GSK-US2022193685:Same reporter US-GSK-US2022193689:Same reporter US-GSK-US2022193690:Same reporter
Had both shots, still got shingles/Suspected vaccination failure; Shingles on neck, shoulder, left ear; Shingles on neck, shoulder, left ear; Very painful; This 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 24-Feb-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient received both shingle shots and still got shingles on his/her neck and shoulder and left ear, very painful. The patient stated that would-it had been worse without the shots. The patient did not know.  Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
sinus congestion; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 02Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history included blocked ear.     The patient's concomitant medications were not reported.  The patient experienced sinus congestion on an unspecified date with outcome of unknown. Caller, (Patient name), called to say first time caller consumer had first vaccine on 02Apr2021 and is scheduled for the second 22Apr2021. She is prescribed steroids for blocked ear, she states had before the vaccine. She also had sinus congestion and was started on antibiotics after first dose, which she just finished taking. She has not started on the steroids she is asking will this interfere with her second vaccine.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Friday had a headache  after shot.  Took two Tylenol and no more headache.  Then @ 48 hours it was instant - below bottom lip a piece of skin  popped out like a blister and itched and within 5 minutes a facial nerve shot up below the right eye in the  corner and another puffy skin area appeared and then shot over to my right ear. Then went into the right side of mouth and tongue and they were completely numb and burning. Sunday called Pharmacy for advice they told her to try Zyrtec, which toned it down. But was still numb in the face all afternoon.  Then Benadryl  Sunday night took Benadryl, helped calm, but then had tingling and numbness in both hands and fingers (which started Sunday night) . Monday morning called Doctor and he reviewed chart and history put on prednisone 3 times per day for 7 days + Acyclovir 5 times per day for five days. 1/21/21 - Under right eye swelling, both hands minimal tingling, feeling back to normal.
Moderna vaccine in February and did not get the second dose until 15Jul2021; first dose of the Pfizer covid-19 vaccine by injection in February /On 15JUL2021 they received a dose of the Moderna Covid19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna vaccine in February and did not get the second dose until 15Jul2021) and INTERCHANGE OF VACCINE PRODUCTS (first dose of the Pfizer covid-19 vaccine by injection in February /On 15JUL2021 they received a dose of the Moderna Covid19 vaccine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033A21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 15-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna vaccine in February and did not get the second dose until 15Jul2021) and INTERCHANGE OF VACCINE PRODUCTS (first dose of the Pfizer covid-19 vaccine by injection in February /On 15JUL2021 they received a dose of the Moderna Covid19 vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna vaccine in February and did not get the second dose until 15Jul2021) had resolved and INTERCHANGE OF VACCINE PRODUCTS (first dose of the Pfizer covid-19 vaccine by injection in February /On 15JUL2021 they received a dose of the Moderna Covid19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drugs were reported No treatment drugs were reported.  Patient received the first dose of the Moderna vaccine in February and did not get the second dose until 15Jul2021 lot # 033A21A.  Patient did not have the dose information or exact date the first dose was given.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Significant follow-up received. Newevent added
Received vaccine 8/12 on 8/16 contacted PCP stated had fever , chills and temp at home 101  now having chest pain.  Instructed to call 911..patietn refused and wife took to ED  In Ed described chest pain as pressure and heaviness in center of chest VS Temp 36.1, pulse 102, BP 144/96 Patient admitted to hospital and discharged 8/19