chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt developed Bell's palsy within hours of vaccine administration. PCP MR received revealing a 3 yr. old in for a well-child exam on Oct. 20, 2006.   PMH consists of asthma and seasonal allergies. Only c/o is of cold sx.and runny nose x 2 days. Exam reveals Right OM effusion. Flu shot given. Acute visit of 10/23/2006 for c/o Left side of face not moving.   DX: Bells Palsy (URI probable etiology).  F/U visit of 10/27/2006 reveals some improvement, child able to smile and close eyelid more./pc 11/16/2006 Hospital MR received revealing child presenting to ER on evening of flu shot with the following sx.: L side of mouth unable to smile, L eye unable to fully close, L forehead does not wrinkle with raised eyebrow, and clear watery discharge from L eye.  DIAGNOSIS: Bell's Palsy
FEELING UNWELL; SICK; This spontaneous report received from a consumer concerned a 20 year old male. 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 not reported, batch number: Unknown) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested. No concomitant medications were reported. On 31-MAR-2021, the subject experienced sick. On 01-APR-2021, the subject experienced feeling unwell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sick, and feeling unwell. This report was non-serious.
pain in hands and feet; hives; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EWU196) via intramuscularly administered in upper Arm on 18Jun2021 11:30 as dose 2, single for covid-19 immunisation at Pharmacy or Drug store. Medical history included hypothyroid from 1996 and ongoing, psoriatic arthritis from 2016 and ongoing, UTDs from 1978 to Apr2021 Pertinent Details with on /off recurring and family medical history relevant to AE was Psoriasis, Hypothyroidism. Concomitant medication(s) included levothyroxine sodium (TIROSINT) taken for thyroid disorder and liothyronine sodium (CYTOMEL) taken for thyroid disorder both from unknown start date and ongoing. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection, Batch/Lot number: EW01ET) via an intramuscular administration on 28May2021 at 11:30 in upper arm as dose 1, single for covid-19 immunisation and experienced hives and pain in joints and visited Physician Office with treatment Aspirin and natural meds and acupuncture for pain along with Apis 200C (Homeopathic). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Jun2021 11:30 am, the patient experienced hives and on an unknown date, pain in hands and feet. The patient underwent lab tests and procedures which included blood thyroid stimulating hormone: 2.10 on 04Jun2021 results as normal and prostatic specific antigen results positive swelly on unspecified date in Jan2019, prostatic specific antigen (X-ray) positive NA on Jan2019. Patient was received Apis 200C (Homeopathic) as treatment for event hives. It was reported that On18Jun2021, 2nd dose, hives took onset away homeopathic TX fw hives fine in 2 hours, still having pains in hands and feet. The clinical outcome of event hives was recovered on 18Jun2021, while event pain in hands and feet was not recovered.  Follow-up attempts are completed. No further information is expected.
Hives, difficulty breathing, started on 12/02/99.  Vaccine administered on 11/30/99.  Mother took her to ER for treatment. Cheif complaint given as a rash. After vaccine she had welts and itching. Final diagnosis given as urticaria secondary to TD booster.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies were not provided. The pharmacist reported that on 21-AUG-2014, the patient was inadvertently vaccinated with a second dose of ZOSTAVAX via 19400 PFU, 0.65ml subcutaneous, (lot # and expiration date were not provided). No adverse experience reported. Additional information has been requested.
pt started getting swollen lymph nodes starting three days after she received the vaccines, she went to clinic.
Got mild COVID disease; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Got mild COVID disease) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Got mild COVID disease). At the time of the report, COVID-19 (Got mild COVID disease) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jun-2022, SARS-CoV-2 test: (Positive) Had Positive PCR test.         No concomitant medications were reported. No treatment details were reported. Patient had mild symptoms of COVID-19 disease, 9 months after first booster dose, PCP refused to see the patient because of symptoms so patient went to urgent care.  Company Comment:This spontaneous case concerns an 89-year-old, male patient with no medical history reported who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test) which occurred approximately 9 months after receiving the first booster dose of mRNA-1273. The patient received mRNA-1273 as primary series of COVID-19 vaccination within the recommended dosing interval with last dose taken approximately six months before the booster dose. There was no information regarding adverse event with previous COVID-19 vaccinations. The patient developed mild COVID-19 symptoms and tested positive for COVID-19 PCR test. Emergency room consultation was done but findings and treatment information were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an 89-year-old, male patient with no medical history reported who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test) which occurred approximately 9 months after receiving the first booster dose of mRNA-1273. The patient received mRNA-1273 as primary series of COVID-19 vaccination within the recommended dosing interval with last dose taken approximately six months before the booster dose. There was no information regarding adverse event with previous COVID-19 vaccinations. The patient developed mild COVID-19 symptoms and tested positive for COVID-19 PCR test. Emergency room consultation was done but findings and treatment information were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
COVID-19 vaccine Pfizer (for 5-11 year olds) given to a 12 year old patient
ATE FOUR GRAPES HALF AN HOUR AFTER HER FIRST DOSE; This spontaneous case report (PVX2019-2877) was received from a consumer on 21-Nov-2019. It described a female consumer who "ate four grapes half an hour after her first dose" (PT: Product administration error), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif on 21-Nov-2019 but ate four grapes half an hour after taking it.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: A patient had taken her first Vivotif dose and then after half an hour she ate four grapes (Product administration error). Vivotif dose should be taken one hour before a meal. Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A patient had taken her first Vivotif dose and then after half an hour she ate four grapes (Product administration error). Vivotif dose should be taken one hour before a meal. Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 53-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was an internal medicine manager.  Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the state was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment with the State.   The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
First shot given on 12/31/2020 vaccine was given in left arm About 3 days after the vaccine was given, left arm between shoulder and elbow had a red rash that was warm to the touch and the left arm hurt. Urgent Care physician put me on an antibiotic to calm down the "infection" and it did. So recovered from first injection  Second shot given 1/28/2021 vaccine was given in left arm 1/29/2021 100 degree temp (taken at home) muscles painful from below left ear down left arm small rash seems to be starting around injection site
Ct called 4/9/12 c/o increase pain. Ct in c/o pain 6 1-10 pain scale. Increase warmth & induration. Referred to urgent care. In f/u seen urgent care ultrasound done, antibiotics prescribed recommend to take ADVIL. 4/10/12 09:30 voice message left & call returned at 10:00 reports he is feeling much better & can raise arm today.
For about 24 hours, I had very sore joints and shakes in bed, not exactly feverish, but chilled as though I were feverish. I couldn't sleep all night and these effects were felt until after 4-5:00 in the afternoon - about 24 hours after receiving the second SHINGRIX shot.
The first day was expected, queasy, headache, body aches, some light fever. However, at 5 in the morning on July 21, 2021, the second day after receiving my shot, I was not able to leave my toilet, or I was going there every ten minutes. With a trash can in front of me puking out anything I had ate the day before and earlier that morning, and having explosive diarrhea on the other end. This lasted all day to the point I couldn?t eat and was sore. The next morning still having diarrhea, but fortunately able to hold down a cracker because it went right through the other end. I had COVID-19 in February 2021, and there is nothing given for these side effects, and honestly, cannot make it away from home or the toilet to make it to the doctor. I have missed now three days of work instead of the expected 1 due to these side effects.
Arm soreness at injection site Narrative:  Patient reports very slight soreness in his arm at the site of injection that has gotten better as the day has gone on. Patient reports this has NOT impacted activities of daily living in any way.
I started with a strong headache that lasted for about 5 days. I treated it with regular acetaminophen. After that, slowly and increasingly I started with tinnitus which is lasting until now. It has become worse.
Information has been received from a health professional concerning a 4 month old child who on 25-MAY-2007 was vaccinated with a first oral 2 ml dose of Rotateq. No adverse reaction was reported. No product quality complaint was involved. Additional information has been requested.
Redness and swelling at site of injection - way a delayed response and appeared on 3/31/2021 even though vaccine was administered on 3/23/2021
Approx 5 min after vacc adm. Pt was stopped at check out, seizure type movement noted as pt fell to floor. Fall somewhat blocked by another pt standing near. Pt with nausea, no vomiting. Pt alert/talking few min after episode. BP 84/52 P-48 Pt to Urgent Care Ctr in Stable condition.
ARM PAIN @ POINT OF INSERTION, MOSTLY SORE IN THE MORNING. BUT DOES COME AND GO DURING THE DAY. DOES NOT AFFECT MY ABUILITY TO DO THINGS, BUT IS PAINFUL @ TIMES. STILL HURT OVER 2 MONTH LATER
Fever, edema, cellulitis in right arm, increased white blood cells 21,000.
Severe pain in lower back/kidneys, excessive thirst and dehydration, swelling of face, joint and muscle pain, rash of white bumps on entire body, chills, headache, fatigue
I started out with aches and chills and fatigue. I went to the doctor and was prescribed a cough syrup, Prednisone, and Promethazine DM. About a week later I went back to the clinic and given a 10-day course steriod, a inhaler and cough syrup.  I went back a third time on 03/30/2023 Benzonatate for the cough and another steriod to help with the cough and whatever virus I have. During the week one I started having a cough that was worse with blood. That why we went back a second time. I cough so hard I tore something in my throat and was unable to talk for four days. My coughs followed with mucus. Now the cough is still productive. The doctor suggests that I may need to come back due to possible pneumonia tomorrow. I had no fever at all, and I have been checking. If anything, I'm clammy and under my normal temp.  I had been tested for COVID-19; Strep and Flu, all were negative. There was a lot of fatigue through this entire process. I am not over the fatigue.
Large red area (almost tennis ball area) at injection site. Dizziness, muscle aches, nausea, threw up once. No appetite even this evening. Symptoms have affected daily functioning of patient.
Pt recvd vax 5NOV91 & 2 days p/vax exhibited lt sided jerky, rhythmic movements lasting about 2 hrs; t104; mom observed did not take to hosp but gave APAP;
Had regular arm injection site pain the day of and after for 2 days with chills and aches, but this pain in the arm hurt deep down. Then it improved. Now 10 days later, the injection site is hard, swollen and painful. But more than that, my whole arm from the shoulder to the forearm is in severe pain. It especially hurts from the injection site to the elbow. It is restricting my movement because it is so painful to use or move. This is severe pain, a deep pain. It hurts even when not moving it. I am taking ibuprofen and using compresses. Massaging it. Nothing helps very much and for sure not for long.
Pt was administered with a TWINRIX vaccine that was expired. Expiration date was 09/27/2018.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen arm), PAIN (pain/sore) and SWELLING (swollen armpit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced VACCINATION SITE SWELLING (swollen arm), PAIN (pain/sore) and SWELLING (swollen armpit). At the time of the report, VACCINATION SITE SWELLING (swollen arm), PAIN (pain/sore) and SWELLING (swollen armpit) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. No treatment drug was reported.
Tdap given 7/29/15-arm has 3" area that is red and swollen. Not hot to touch.
Patient had the Jynneos vaccine too early, 22 days after the first dose, the second dose was administered.; Second dose of Jynneos administered at dose of 0.1 milliliter intradermally.; Case reference number US-BN-2022-003274 is a spontaneous case report initially received on 23-Sep-2022 from other health professional via Company (reference number: USBAV22-1513) and concerns an adult male.  The patient's medical history and concomitant medication details were not reported.  On 19-Aug-2022, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FDP00012), at a dose reported as 0.5ml, subcutaneously, for monkeypox prophylaxis.  On 10-Sep-2022, 22 days after the first dose, the patient was vaccinated with the second dose of Jynneos (batch number: FDP00012), at a dose reported as 0.1 ml, intradermally (explicitly coded as 'inappropriate schedule of vaccine administered' and 'intradermal injection').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received from Bavarian Nordic on 23-Sep-2022 included the local BN case ID.  This case is linked with US-BN-2022-003278 and US-BN-2022-003280 due to the same reporter.; Reporter's Comments: An adult male patient was vaccinated with the second dose of Jynneos, at a dose reported as 0.1 ml, intradermally, on the day 22 after the first dose, which is considered as inappropriate schedule of vaccine administered and intradermal injection. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Inappropriate schedule of product administration and intradermal injection are considered as listed per company convention. The patient's medical history and concomitant medication details were not reported. Inappropriate schedule of product administration and intradermal injection have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: An adult male patient was vaccinated with the second dose of Jynneos, at a dose reported as 0.1 ml, intradermally, on the day 22 after the first dose, which is considered as inappropriate schedule of vaccine administered and intradermal injection. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Inappropriate schedule of product administration and intradermal injection are considered as listed per company convention. The patient's medical history and concomitant medication details were not reported. Inappropriate schedule of product administration and intradermal injection have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
I had surgery on my back in July 2020. After receiving the vaccine in March of 2021, my scar started itching about 2 months after . Eventually the itchiness spread to my arms, back, legs, belly and especially my back. A bubble appeared in the palms of my hands. If it was touched, it was itchy. It then spread to my fingers. The more I rubbed them together to receive the itching, the worse it got. I went to the doctor who at first thought it was psoriasis. She then determined it might be eczema. I went home and then it got worse. I went back and the doctor prescribed triamcinolone 0.5%. I put this on the bubbles on my hands and fingers. It relieved the itching but it has dried my skin and it is now peeling. It is like when your hand is in water for a long time. Even though the itching was relieved, there is still itching present. The doctor told me to use the triamcinolone for 10 days and after the 10 days, just use as needed. The triamcinolone has overall helped. Heat makes the itching worse.
Systemic: difficulty walking, facial droop and worsening asthma-Moderate, Additional Details: Patient has experienced difficulty walking, facial droop, and worsening asthma.  Symptoms presented 4 days after injection. Patient states she was admitted to hospital and has since been discharged. Unclear how many days the patient was in the hospital or diagnosis as patient is a poor historian, but she states she has follow up doctor appointments. Patient's symptoms are ongoing.
Purpura: broken blood vessels in legs. This has never happened to her before. It is a new condition. We are concerned for where else this could be happening, including in her brain.
Information has been received from a registered nurse concerning a patient who on approximately 01-APR-2008 was vaccinated with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck). Not a PQC, human error noted. No additional information was available. There was no product quality complaint. Additional information has been requested.