chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a 35 yr old female who was vaccinated with a first and second dose of varicella virus vaccine live 28 days apart. As a result, three titers were given which have not converted. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information was received from a woman in a physician's office who reported that the pt was not given the vaccine at her clinic. The pt was vaccinated at another facility which the reporter had no information regarding. No further information is expected.
Erythematous rash over anterior torso, groin, flexor aspect of elbows/knees/hips
At approximately 1624, patient reported feeling warm and heart racing. RN assessed patient. Patient denied signs and symptoms of anaphylaxis. Patient reported no known allergies and no current medications. At 1624, LVN  assessed patient vital signs: blood pressure 136/96 mmHg, pulse 80 beats/minute, and SpO2 100%. Patient given cool pack. Patient placed cool pack on chest. At 1628, patient denied feeling warm and heart racing. At 1630, patient given water. Patient able to drink water. At 1640, LVN  reassessed patient vital signs: blood pressure 115/77 mmHg, pulse 66 beats/minute, and SpO2 99%. Patient denied feeling warm and heart racing. LVN  educated patient on signs/symptoms of when to seek emergency care, to follow up with primary care provider, and to sign up on v-safe. At approximately 1648, patient left facility with unlabored respirations and steady gait.
09/21/2022 loss of voice, hoarse, loss of air when speaking to the point of dizziness, unable to project. Difficult to perform duties at my place of employment with regards to speaking, being heard, etc.
Symptoms 01/24/2021- numbness, weakness, tingling bilateral legs. Lost inability to walk and bladder control Admitted to hospital  01/24/2021-1/26/21. Not diagnosed. Had 4 MRIS and a lumbar puncture 02/3/2021- was in ED at hospital due vision issues/double vision- discharged same day. Repeated 4 MRIS and blood work, and lumbar puncture.  02/09/2021- patient was seen at a neurologist, due to numbness in bilateral hands and arms. And was admitted to Medical Center until 02/13/2021. Ruled out MS, GB, repeated 4 MRIS and LP. Was sent home with home health and PT. Saw PCP 02/19/2021, Did paperwork for disability and removed from work until 04/30/2021.  PCP ordered more blood work up to 35 tubes of blood done on 02/17/2021. Will not be ready until 14 days post draw. Patient is still complaining of tingling on bilateral hands and feet, and weakness. Mainly sensory nerves related symptoms.
Following the vaccine i had the ?normal? arm pain for 3 days, continued to feel low energy the whole week following vaccine, and on friday the 11th i started feeling some abdominal discomfort, likely related to ovulation. I generally have about a half day of mild discomfort during ovulation, however this time, the pain continued to increase and peaked Saturday evening before slowly improving Sunday into Monday. I am now back to ?normal? today, Tuesday the 15th. The pain on Saturday night was severe and i remained in bed through the weekend. Contemplated a trip into the ER but didnt want covid exposure and i was managing ok at home with some help. In short, it was the most painful ovulation since 2017 following an ovarian cyst-ectomy.
The first one was the day after and it was a feeling of extreme fatigue and dizziness. I laid down and fell asleep very fast and was out for 2 hours. I felt fine after that. I have had this same fatigue and dizziness virtually every day since. That has now been 4 weeks. Sometimes it is worse than others, sometimes more than once a day. I also had diarrhea for 7 days.
Chills; This is a spontaneous report received from contactable consumer (patient) reported for herself. A 47-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL3247, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 02Mar2021 08:00 am (age at vaccination was 47 years) as single dose for COVID-19 immunization. Medical history included acid reflux. The patient had a known allergy to penicillin. The patient previously took first dose of BNT162B2 (Lot number: EL3247, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 09Feb2021 13:15 pm (age at vaccination was 40 years) at a single dose for COVID-19 immunization. Concomitant medication patient received within 2 weeks of vaccination included omeprazole and famotidine, on unspecified dates and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 02Mar2021 at 20:00 PM evening the patient had symptoms of chills, same day the patient received the vaccine. The facility where the most recent COVID-19 vaccine was administered was redacted. No treatment was received for the adverse event. The outcome of the event was recovered on an unknown date.  No follow-up attempts are needed. No further information is expected.   Follow-up (08Mar2021): New information received in response to mail trail sent regarding the confirmation of below mentioned query included: Updated the start date of symptoms (02Mar2021) and details regarding the follow-up attempts.
Patient / 48 year old / mistakenly received the first dose of Shingrix; This case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in a 48-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that the patient was a 48 year old male and mistakenly received Shingrix, which led to inappropriate age at vaccine administration.  The date of the incident was unknown.   The reporter consented to follow up.
No adverse event occurred.. Vaxelis was given "off-label" to child > 4 years in order to get caught up due to delayed vaccines.  The one and only Dtap/HIB was given on 4/8/22, and the one and only IPV was given on 5/11/22.  No Hep. B ever given
This case was reported by the mother of a consumer and described the occurrence of intestinal problems in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent vaccination included DTAP vaccine (manufacturer unspecified) and unspecified vaccines (standard 2 - 3 month series) (manufacturer unspecified) given on 2 March 2010. There were no concurrent medications. On 2 March 2010 at 16:00 the subject received 1st dose of ROTARIX (oral). About 2 weeks after vaccination with ROTARIX, the subject developed intestinal problems, spitting up,high-pitched crying and refusal to eat. At the time of reporting the events were unresolved. The mother also mentioned that her daughter received a dose of ROTATEQ on 12 April 2010 and developed severe dehydration and gastrointestinal upset, described as severe intestinal issues. The mother did not have details of lot numbers and did not know which other vaccines were administered on the same dates.
Strong vertigo. cant even stand or leave the bed because of it.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Apr2021 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not aware if she had any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol/drospirenone (YASMIN) as birth control pills from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22Apr2021at 09:45, 5 days after vaccination, the patient experienced strong vertigo. The patient was not able to stand or leave the bed because of it. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event strong vertigo was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report was received from a healthcare worker regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L039660/expiration date- 04-FEB-2018. No adverse event. Excursion temperature was 51.22 F and timeframe was 92 hours. There was no previous temperature excursion. Call was because of the data logger. No concomitant medication was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse practitioner refers to a 12 month old patient of unknown gender. On 10-FEB-2014 the patient was vaccinated with first dose of VAQRIVAX (Merck) (strength, dose unit, route, lot number and expiry date unknown). On the same day patient was vaccinated with first dose of PROQUAD (Merck) (strength, dose unit, route, lot number and expiry date unknown). No adverse event reported. The outcome of 12 month old patient received a first dose of PROQUAD (Merck) and VARIVAX (Merck) on 10-FEB-2014 and no adverse event were unknown. Additional information has been requested.
pt recv vax 25MAR97 & 26MAR97 pt exp n/v/d, temp & inj site induration, erythema, & swelling;pt recovered from sx;
product dose omission; No adverse event; her first Moderna Covid -19 vaccine on April 6, 2023 patient received in her right arm lot number patient is 4 months pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (her first Moderna Covid -19 vaccine on April 6, 2023 patient received in her right arm lot number patient is 4 months pregnant), PRODUCT DOSE OMISSION ISSUE (product dose omission) and NO ADVERSE EVENT (No adverse event) in a 29-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.  On 06-Apr-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. The patient's last menstrual period was in November 2022 and the estimated date of delivery was on an unknown date. On 06-Apr-2023, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (her first Moderna Covid -19 vaccine on April 6, 2023 patient received in her right arm lot number patient is 4 months pregnant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (product dose omission) and NO ADVERSE EVENT (No adverse event). The patient received mRNA-1273 (Spikevax) beginning around the  fourth month of the pregnancy.  On 06-Apr-2023, MATERNAL EXPOSURE DURING PREGNANCY (her first Moderna Covid -19 vaccine on April 6, 2023 patient received in her right arm lot number patient is 4 months pregnant) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (product dose omission) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for MATERNAL EXPOSURE DURING PREGNANCY (her first Moderna Covid -19 vaccine on April 6, 2023 patient received in her right arm lot number patient is 4 months pregnant) and PRODUCT DOSE OMISSION ISSUE (product dose omission).    No concomitant and treatment medications were reported. Company comment: This spontaneous case concerns a 29-year-old female patient, with no medical history reported, who experienced maternal exposure during pregnancy after being vaccinated with mRNA-1273 while in 4th and 5th month of pregnancy gestation period at exposure. There was no adverse event in the case. Details on delivery and newborn status are not yet available. The vaccination included 2 doses of mRNA-1273 vaccination which were two first doses in the COVID-19 vaccination schedule; it is not clear how many days apart the doses were administered and if in the same doses. Outcome of pregnancy is unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-722441 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722441:Bivalent suspect case
Severe abdominal cramps, cold, dizzy, thirst and vomited two times.
The client has a pusy pimple on the middle finger of her left hand.  She stated that it was not painful.  She noticed the pimple on November 15, after recieving the vaccine on November 14.
Sudden onset of fever 104 R, inc resp, vomiting occuring 2 days p/vax; Seen by MD several test done; WBC inc started on Amoxicillin;
Slightly sore left arm; Patient received 1st booster dose on 15-Jul-2022/2nd booster on 07-Sep-2022; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Slightly sore left arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st booster dose on 15-Jul-2022/2nd booster on 07-Sep-2022) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     The patient's past medical history included Chemotherapy, Radiation therapy, Lumpectomy and Lymphadenectomy (lymph nodes on her left side were removed). Previously administered products included for Product used for unknown indication: Pfizer vaccine (primary series). Past adverse reactions to the above products included No adverse event with Pfizer vaccine. Concurrent medical conditions included Type 1 diabetes mellitus since 1987, Breast cancer (Left) since 2006, Hypertension and Graves' disease. Concomitant products included INSULIN GLARGINE (LANTUS), INSULIN LISPRO (HUMALOG), ATORVASTATIN, LISINOPRIL, METOPROLOL SUCCINATE, ALENDRONATE SODIUM (ALENDRONATE), AMLODIPINE, ASPIRIN [ACETYLSALICYLIC ACID] and CEPHALEXIN [CEFALEXIN] for an unknown indication.   On 07-Sep-2022, 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 07-Sep-2022, the patient experienced VACCINATION SITE PAIN (Slightly sore left arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st booster dose on 15-Jul-2022/2nd booster on 07-Sep-2022). At the time of the report, VACCINATION SITE PAIN (Slightly sore left arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st booster dose on 15-Jul-2022/2nd booster on 07-Sep-2022) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2022-674650, MOD-2022-674619 (Patient Link).
Had "COVID arm"    Large red patch over most of upper arm.  Itchy and sore, with pain radiating into shoulder and neck.   I used Benadryl and it cleared up after about four days.  I received my second COVID shot on May 14, with all the same information, except in right arm and on May 16, the same thing showed up.  I am using Benadryl again.
Case number PHEH2015US002444, is an initial spontaneous report received from a pharmacist on 02 Feb 2015. This report refers to an adult male patient. Medical history and concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 14554D) 0.5 ml intramuscular on 12 Nov 2014. On an unknown date post vaccination he developed difficulty in moving arm at the injection site, muscle pain and stiffness. Outcome of the events, seriousness and causality assessment was unknown.
Three clusters of bumps under chin within 2 hours of dose. By next day clusters behind right ear and down chin. By 9:30pm went to Emergency. Diagnosed with Shingles. Given antiviral meds.
Hospitalized cough, mylagia, fever, had positive covid test 2/25/22. Again positive 4/7/2022.
This spontaneous report was received from a registered nurse refers to a patient of unknown gender, currently 2 month old. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy were not reported. On an unknown date in 2018, the patient was vaccinated with improperly stored doses of ROTATEQ (dose, units and frequency unknown) (lot # N013884 and expiration date 05-DEC-2018) for prophylaxis. On 13-APR-2018, ROTATEQ underwent temperature excursion at 32 degree Fahrenheit (F) to 35F (35.1F) for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1804USA006915: Original Case: 1804USA006915; US-009507513-1809USA013794: Original Case: 1809USA013793; US-009507513-1809USA013793: Original Case: 1809USA013793.
Information has been received from a pharmacist referring to 5 newborns (numbered 213, 214, 215, 216 and 217). Background: Since June 2015, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time = 72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-215, there was a low temperature of 30/2F. On 22-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Patient got their second dose of shingrix just under 4 years after the 1st; 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 Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On unknown date patient received 1st dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Patient got their second dose of shingrix just under 4 years after the 1st). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 26-MAY-2023 The patient got their second dose of Shingrix just under 4 years after the 1st dose.  The reporter asked were they done with their series. The patient received their first dose at a different pharmacy. Healthcare professional disconnected from the chat so there were no additional details available regarding the patients or events. It was unknown if follow up was permissible. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.  The case is linked with US2023075222, same reporter different patient.
Hallucinations; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinations) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Alcohol addiction.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced HALLUCINATION (Hallucinations) (seriousness criterion medically significant). At the time of the report, HALLUCINATION (Hallucinations) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Slight tenderness over injection site, limited ROM left arm worsening over several days with severe swelling and tenderness over left axilla/breast/upper pec/trap/lat. Pain resolved over the next ten to fourteen days and ROM gradually improved to normal over that time. (Ice, ibuprofen, massage were helpful)  Some swelling and tenderness to palpation over left axilla and breast persist, with  continued denser breast tissue on left side.
Approximately 15-20 minutes after influenza vaccine, patient started crying and complaining of abdominal pain and headache. She vomited once. Pulse was found to be bradycardic at 52, so EPIPEN 0.15 mg was administered. She was also given BENADRYL PO 12.5 mg and 10 mg of DECADRON IV. She was given intravenous fluids with normal saline. Pulse improved to 108 after EPI. She was placed on 1 L O2 via nasal cannula for comfort only (no hypoxia). EMS was called and pt. was transported to ER for further evaluation/management.
mom states about 30min p/vax kept holding breath & started shaking;pt taken to hosp clinic;suppositories given for fever;
MYOCARDITIS; OFF LABEL USE IN UNAPPROVED AGE GROUP; This spontaneous report received from a consumer concerned a male child. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administrated, for covid-19 prophylaxis which was associated with Off label use. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced myocarditis. On an unspecified date, following vaccination the patient was hospitalized. Number of days of hospitalization was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the myocarditis and off label use in unapproved age group was not reported. This report was serious (Hospitalization Caused / Prolonged. This case is a duplicate of 20221000309.  Additional information was received from consumer on 30-SEP-2022: It was determined that Manufacturer Case Number 20221000309 was a duplicate of case 20221000293. All relevant information regarding case 20221000309 will be submitted under Manufacturer Case Number 20221000293.; Sender's Comments: V0: 20221000293-covid-19 vaccine ad26.cov2.s- Myocarditis. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.