chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a patient who on 5/27/99 was vaccinated with a dose of varicella virus vaccine live (lot # 629613/0285J). Subsequently, on 7/30/02, the patient developed chicken pox. The patient was seen in the office. The reporter also indicated that 30 other patients were vaccinated with varicella virus vaccine and developed chicken pox (WAES0409USA00600, 0409USA01045, 0409USA01046, 0409USA01047, 0409USA01048, 0409USA01049, 0409USA01050, 0409USA01051, 0409USA01052, 0409USA01053, 0409USA01054, 0409USA01055, 0409USA01056, 0409USA01057, 0409USA01058, 0409USA01059, 0409USA01060, 0409USA01061, 0409USA01062, 0409USA01063, 0409USA01064, 0409USA01065, 0409USA01066, 0409USA01067, 0409USA01068, 0409USA01070, 0409USA01071, 0409USA01072, 0409USA01073, 0409USA01074). No further information is expected.
Information has been received from a physician concerning a female who in approximately 1991 was vaccinated with the complete series of RECOMBIVAX HB. In approximately 2007 the patient's recent titer was performed which was negative. The patient sought medical attention in the physician's office. The patient's status was not recovered. There was product quality complaint. Additional information has been requested.
7 days p/vax had generalized clonic sz lasting 45 mins; pt w/prior    MRI head, EEG & neuro consultation;
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Oct2021 as dose 3 (booster), single (Lot number: FF8590) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (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: (unspecified date) Unknown results, notes: symptomatic and positive COVID Ag again; (06Jul2022) positive, notes: symptomatic and positive COVID Ag again. Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: No other medication in 2weeks. The patient has no known drug allergy.; Sender's Comments: Based on the known safety profile and Limited information in the case report, a casual association between reported LOE events and the suspect drug cannot be excluded.
Information has been received from a registered nurse concerning a child who recently, in approximately April 2006 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live (lot# 652545/0926R).  In approximately April 2006, the patient experienced a fever equal to or greater than 102 degrees Fahrenheit.  A product quality complaint was involved.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements and was released.  Additional information has been requested.
bruise; muscle weakness; tingling on her arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (bruise), MUSCULAR WEAKNESS (muscle weakness), PARAESTHESIA (tingling on her arm) and HEADACHE (headache) 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 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE BRUISING (bruise), MUSCULAR WEAKNESS (muscle weakness), PARAESTHESIA (tingling on her arm) and HEADACHE (headache). At the time of the report, VACCINATION SITE BRUISING (bruise), MUSCULAR WEAKNESS (muscle weakness), PARAESTHESIA (tingling on her arm) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Fever- lasting 24hrs, started 14hrs after shot Body aches- lasting 24hrs, started 12hrs after shot lightheaded/dizziness- lasting 2-4 hours, started 20hrs after shot Nausea- lasting 2-4 hours, started 20hrs after shot severe headache- lasting over 24hrs, started 12hrs after shot Fatigue- lasting over 24hrs, started 5 hours after shot
Rash on Left leg, and along Left suprapubic/waistband. Overall Rash improving No treatment needed.
dizzy; This non-serious case was reported by a consumer via call center representative and described the occurrence of dizziness in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-JUN-2023, the patient received the 2nd dose of Shingrix (intramuscular, left arm) .5 ml. On 03-JUN-2023, 2 days after receiving Shingrix, the patient experienced dizziness (Verbatim: dizzy). On 04-JUN-2023, the outcome of the dizziness was resolved (duration 1 day).   It was unknown if the reporter considered the dizziness to be related to Shingrix.     It was unknown if the company considered the dizziness to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-JUN-2023 The patient self-reported this case. The patient received 2nd dose of Shingrix, 2 days later he woke-up and was dizzy.  The dizziness resolved in the afternoon.  The patient would also report this to his doctor. The reporter did not consent to follow-up.
Patient stated she was experiencing itching/rash in the area her vaccine was injected. She continued to take Benadryl for the rash and denied any medical attention.
Case number PHEH2012US008744 is an initial spontaneous report received from a nurse on 17 Apr 2012. This report refers to multiple patients whose details were not provided. It was reported that the patients were vaccinated intramuscularly with MENVEO (batch number: A10016) that was stored below 36 degree F. It was reported that the vaccine was stored at 32 degree F on 16 Mar 2012 and 20 Mar 2012 and 33 degree F on 22 Mar 2012. The reporter stated that the vaccine did not appear to have frozen. No adverse reaction was reported following this medication error. No further details were provided.
Photosensitivity, blisters across nose, around mouth, in mouth, on the scalp, across shoulders, swelling in hands and feet, delayed healing.
Patient has been having terrible headaches, heavy cramps before her cycle now, fatigue and very heavy hairloss. She is losing hair directly from the follicle. She has been suffering from boils ever since shes gotten this shot. She gets them all the time. Her hair was always her pride. She has always had really thick and long hair. Her hair is thin and just comes out by the root. She washes her hair, the sink is full of hair, her comb, her brush same thing. She is suffering with headaches way more than I think is normal. Just seems like a different kid healthwise to me than before she got this shot. I wish I would have done more research. Had I read more into It. I would have never allowed her to get it.
14 days post vax the pt experienced papule and vesicular rash of approximately 50 lesions and a very swollen arm with a high fever of 101.7F and possible cellulitis. The injection site was described as 4 cm in diameter and growing. Pt was treated with Keflex, warm packs and elevation.
Information has been received from a medical assistant concerning a female patient age 70 years or older who "about two weeks ago" was vaccinated with a dose of Pneumovax 23 (lot # 651319/1007P). Subsequently the patient experienced injection site rash. Unspecified medical attention was sought. Additional information has been requested.
6 generalized clonic sz on 5Apr91.Extensive evaluation by Peds neurologist & began on Phenobarbital.Afebrile @ time.
Headache, severe muscle aches and cramping, difficulty breathing.  Effects lasted 6 days before subsiding.
Today 8/31, I spoke with patient  and she had received the Pfizer vaccine on 8/26/21. On 8/28 she stated she started having chest pains, very heavy, as well as heart palpitations and fatigue. I reviewed the incidence from clinical pharmacology with her, and noted that the heart related side effects are generally more prominent in the 12-29 age group, which she is in.  Additionally, I advised that she seek medical attention and pause on the second dose at this time.  Lastly, she asked if this was a permanent or temporary condition, and I told her at this time I was unable to comment on that, but most times is it treatable, but some do need to be hospitalized to treat.
Headache, Myalgia, HEADACHE, BODY ACHES, FATIGUE, CHILLS Narrative:
Follow up information received 06-MAY-2003 from the nurse practitioner provided concomitant therapy and patient outcome (recovered). A nurse practitioner reported that a 6 month old male received his 1st dose of Prevnar (penumococcal 7-valent conjugate vaccine) vaccine and his third dose of Comvax (Haemophilus b cnjugate vaccine and hepatitis B vaccine), diphtheria and tetanus toxoid an accellular pertussis vaccine adsorbed (manufacturer unknown), and Polio vaccine "Pasteur" (poliomyelitis vaccine inactivated) (Aventis) on 07-APR-2003. Concurrent history include a diaper rash. On the evening of 08-APR-2003 the child developed a rash and his parents brought him to the clinic the next day. The rash appeared more so on his distal extremities, including his legs and arms; it involved a small part of the child's trunk, and there was a "butterfly distribution" of the rash on the child's face. The rash was described as being "very pointed", with very small pustules, and "one of the pustules looked like it could blister". The parents stated that they thought the child was "lethargic", but the nurse practitioner stated that "the patient seemed to have normal energy". There was no report of treatment for the rash. The child recovered.
arms and legs got weak; breathing problems got worse; wheezing; arm swollen, knot present; felt tired; red around injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (arms and legs got weak), DYSPNEA (breathing problems got worse), WHEEZING (wheezing), PERIPHERAL SWELLING (arm swollen, knot present) and FATIGUE (felt tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Abnormal breathing (Patient had breathing problems.).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced ASTHENIA (arms and legs got weak), DYSPNEA (breathing problems got worse), WHEEZING (wheezing), PERIPHERAL SWELLING (arm swollen, knot present), FATIGUE (felt tired) and VACCINATION SITE ERYTHEMA (red around injection site). At the time of the report, ASTHENIA (arms and legs got weak), DYSPNEA (breathing problems got worse), WHEEZING (wheezing), PERIPHERAL SWELLING (arm swollen, knot present), FATIGUE (felt tired) and VACCINATION SITE ERYTHEMA (red around injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, COVID-19: other (Negative) negative. On 11-Apr-2021, Computerised tomogram: other (Negative) negative. On 11-Apr-2021, Electrocardiogram: other (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Concomitant medication was not provided by the reporter.  Treatment medication was not provided by the reporter.
kidneys' and sick; my side starting hurting; and hard to breathe; fever; This spontaneous case was reported by a consumer and describes the occurrence of KIDNEY INFECTION (kidneys' and sick) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced KIDNEY INFECTION (kidneys' and sick) (seriousness criterion medically significant), DISCOMFORT (my side starting hurting), DYSPNOEA (and hard to breathe) and PYREXIA (fever). At the time of the report, KIDNEY INFECTION (kidneys' and sick), DISCOMFORT (my side starting hurting), DYSPNOEA (and hard to breathe) and PYREXIA (fever) outcome was unknown.            Concomitant product was not provided by the reporter.  Treatment information was not provided.  Company comment: This case concerns a 62-year-old male subject who experienced the serious event of kidney infection, and non-serious events of discomfort, dyspnoea, and pyrexia. The events occurred after the administration of the second dose of Spikevax (event onset from last dose not reported). The rechallenge was not applicable as the patient had already completed the 2 recommended doses of the vaccine. The patient's medical history was not provided. Causality was not provided by the reporter. The benefit-risk relationship of the vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow-up appended as live follow up included events added; Sender's Comments: This case concerns a 62-year-old male subject who experienced the serious event of kidney infection, and non-serious events of discomfort, dyspnoea, and pyrexia. The events occurred after the administration of the second dose of Spikevax (event onset from last dose not reported). The rechallenge was not applicable as the patient had already completed the 2 recommended doses of the vaccine. The patient's medical history was not provided. Causality was not provided by the reporter. The benefit-risk relationship of the vaccine is not affected by this report.
no adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) in a 51-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-May-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 05-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    Patient ID was reported as Unknown No concomitant medications was reported. It was reported that it was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that 77 Monovalent doses administered after the BUD to patients 12 and up. Breakdown of doses is as follows- 37 doses from Lot 059H21, 26 doses from Lot 065K21A, and 12 doses from Lot 058A22-2A. No treatment drug details was reported.
Information has been received from a physician concerning a child who on 06-SEP-2007 was vaccinated with a dose of Rotateq. Concomitant therapy on the same day may have included "other vaccines." On 07-SEP-2007 the patient developed severe diarrhea and was hospitalized over the weekend. Unspecified medical attention was sought. A rotavirus test was performed and the result was negative for rotavirus. The patient's treatment was unknown. The patient was noted to be doing better and was released from the hospital. There was no product quality complaint. Additional information has been requested.
Since the first vaccine shot I have not had my period. I have a Kyleena IUD, but I used to have 3 days of bleeding every month since 2018 when I got it. Now I do not bleed at all. I also don't get sore breasts or any monthly menstrual pains.
The vaccine has caused my menstrual cycle to be irregular. I have not received a period yet which has never happened to me. I am very consistent in my cycle and receive my period every 28 days. I am now on day 30 and still have not received it. Irregular menstrual cycles should be reported as a possible side effect.
Immediately after vaccine administration became pale, hypertensive, diaphoretic, and with severe rigors. Patient refused notification of EMS system. Observed for 1 hours, returned home with husband with further instructions on when to contact EMS.
HCP calling to report AE for patient that received VARIVAX during TE.  No additional AE.  No PQC.; HCP calling to report AE for patient that received VARIVAX during TE.  No additional AE.  No PQC.; This spontaneous report was received from a registered nurse referring to a 34-year-old female patient. The patient's concurrent conditions, medical history or concomitant therapies were not reported.  On 10-AUG-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # W022293, expiry date: 13-JUN-2024, 1 dose for prophylaxis (route of administration was not provided) during temperature excursion (TE) (experienced product storage error). No additional adverse event reported.  Lot No. W022293 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck), expiration date reported as 13-JUN-2024, but upon internal validation established as 13-JUL-2024.
Patient did say before vaccine that he has fainted in the past from previous vaccines. I had a Representative administer vaccine while i stood next to patient and talked with him as a distraction from the shot. After Representative gave the vaccine patient asked "did you give vaccine?", he then immediately started to sweat very hard and said he was light headed (he was sitting down), then his eyes rolled back and he slouched down in chair, at which point I held him so he did not fall on floor. He started to jerk and twitch, perhaps was having a seizure, and was sweating very hard. I held him in chair so he would not hit his head or get hurt. After about 30 seconds he regained consciousness and asked how long he was out. His T-shirt was soaked in sweat and he said he felt very dizzy. The Representative got him an ice pack and placed at base of neck, which he said helped alot.  I sat with him for 10-15 minutes until he said he felt fine. I asked if he needed medical care and he said he did not, just needed to sit for awhile, and said this has happened before. I gave him a chair to sit in after he was fully alert and he sat for close to half an hour, at which point he said he was back to himself and felt fine.  I did offer he could stay as long as needed and I could call anyone if he needed me too, he insisted he was fine and after about 45 minutes he left. I did call him the next day to check on him and he said he was fine.
Client was vaccinated with the 1-dose Janssen vaccine for Covid on May 15, 2021.  He developed Covid symptoms on 7/20 and  tested positive for Covid with rapid test on 7/21/2021.  Reported as a breakthrough case of Covid illness s/p being fully vaccinated.
Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, lot number and expiration date unknown) for prophylaxis. Data logger issue was involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA005357: US-009507513-1702USA010273.
pain in elbow; Initial arm pain; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP6955) via an unspecified route of administration in the left arm on 13Mar2021 at 23:45 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure controlled with medication. The patient had no known allergies. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), hydrochlorothiazide (HTZ) and multivitamin (MANUFACTURER UNKNOWN) within two weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6201) via an unspecified route of administration in the left arm on 20Feb2021 at 10:30 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Initially on unknown date in Mar2021, the patient experienced pain in arm then on 20Mar2021 at 07:00, one week later, pain in elbow causing restricted arm and wrist movement for one week. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events pain in arm and pain in elbow was recovered and movement of arm without pain improved on unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Vaccine recipient had sudden and very significant cognitive decline upon waking approximately 1.5 days after receiving vaccine.
The doctor ordered Dtap for the patient, but the patient was given Tdap in error. There was no adverse reaction and the patient will continue with the regular immunization schedule.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination with CVA.
Red, watery eyes, cough, hoarseness in throat, facial/neck redness and blotching, increased HR and SOB. Treated with 60 mg of PREDNISONE x 2 days, 40 mg x 2 days, 20 mg x 2 days.