chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received her 2nd Hep B vaccine at 10:05 AM. She became very tense as the medication was injected. After the injection she slumped to the right side and then began to drool from her mouth. Her toes curled under and she urinated. This incident lasted approx 5 minutes. Her mother was called and a report was given to the mother. Her mother was taking her to her physician. Pt had an incident like this related to an injection this summer. Pt also stated that she had not eaten this AM.
Headache, Myalgia, Fever, Chills, Fatigue, Insomnia Narrative:  Other Relevant History:
OVERDOSE (RECEIVED 2.5ML OF THE JANSSEN COVID-19 VACCINE); This spontaneous report received from a health care professional concerned a 37 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: 14-DEC-2021) 2.5 ml, administered on 13-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-NOV-2021, the patient experienced overdose (received 2.5ml of the janssen covid-19 vaccine). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of overdose (received 2.5ml of the janssen covid-19 vaccine) was not reported. This report was non-serious. This case, from the same reporter is linked to 20211219681, 20211219953, 20211220301, 20211220527, 20211220178, 20211220177, 20211220552, 20211220619, 20211220146, 20211220754, 20211220129, 20211220764, 20211219701, 20211219871, 20211219926, 20211219714, 20211219701, 20211220145 and 20211220928.
Pt was given Tdap instead of Dtap - Parents were notified right away and HD was called. Vaccine was still valid but considered a med error. This form filled out as well as incident report. More training will be provided for MA with vaccines.
severe myositis in left shoulder leading to rhabdomyolysis, acute kidney injury, status epilepticus, and admission to the ICU.
itching; hepatotoxicity; This spontaneous case was reported by a consumer and describes the occurrence of HEPATOTOXICITY (hepatotoxicity) and PRURITUS (itching) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004m204 and 025l20a) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 05-May-2021, the patient experienced HEPATOTOXICITY (hepatotoxicity) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PRURITUS (itching) (seriousness criterion hospitalization). On 22-May-2021, HEPATOTOXICITY (hepatotoxicity) was resolving. At the time of the report, PRURITUS (itching) had not resolved.            Concomitant medication not provided.  Treatment drug included ANTIHISTAMINE ALLERGY RELIEF.  Company Comment: This case concerns a 30-year-old female patient with unknown medical history, who experienced the unexpected serious events of hepatotoxicity and pruritis. The events occurred 90 days after receiving the second dose of mRNA-1273 vaccine. The rechallenge is not applicable. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Further information has been requested.; Sender's Comments: This case concerns a 30-year-old female patient with unknown medical history, who experienced the unexpected serious events of hepatotoxicity and pruritis. The events occurred 90 days after receiving the second dose of mRNA-1273 vaccine. The rechallenge is not applicable. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Further information has been requested.
Sore arm and body aches for about a day and a half, chills for about 3-4 hours, slight fever for 1-2 hours
Patient was admitted to the hospital 12 days (3/24/21) after vaccine dose administration (3/12/21) sent in for refractory abdominal pain, nausea and vomiting. On admission, a CT Abdomen/Pelvis with contrast was largely unremarkable including reported demonstration of patent portal vein. During the course of the hospitalization the patient developed a portal vein thrombosis visualized on 3/26 by ultrasound. She also received Heparin SQ from 3/27/21 through 4/2/21 but not sent home on anticoagulation. Her course was also complicated by a seizure and Bacteroides bacteremia. MR Brain did not demonstrate thrombosis
Information has been received from a 74 year old female consumer with penicillin allergy and allergic reactions to myocins, tetracycline, quinolones and CIPRO who on 11-DEC-2010, was vaccinated with a dose of ZOSTAVAX (Merck) (lot# not reported). Concomitant therapy included lisinopril (manufacturer unknown), "generic" NORVASC, generic simvastatin (MSD), metformin, timolol (manufacturer unknown) and steroids for the eye. It was reported that the consumer experienced a burning sensation when the shot was administered. The burning sensation went away but over the next several days a raised red spot developed that grew to the size of a 50 cent piece. The spot was itchy and was still present, although it had lightened in color somewhat. It was unknown if the patient sought medical attention. On an unspecified date, the consumer recovered from burning sensation. At the time of the report, the patient's spot itchy and raised red spot that grew to the size of a 50 cent piece persisted. Additional information has been requested.
Cause of death not documented. Not information about previously COVID-19 positive, predisposing factors, hospitalization history, and co-morbidities on the electronic health record.  No adverse events during the observation period after administration of the vaccine. No primary care provider listed. Death documented on our EHR on 08/02/2021.
1-2 min after administration of Varivax/MMR, pt c/o throat feeling funny, went limp/pale and she started vomiting and foaming at the mouth. VS: Sat 95-98%, BP 86/50, Pulse 96 (0.15mg). Given Epipen-O2  06/09/2008 MR received for DOS 5/22&23/2008 including ER record with DX: Anaphylaxis. Within 1-2 minutes of MMR and Varivax pt c/o throat feeling funny, then went limp and pale. Pt began vomiting and foaming at the mouth. Epipen administered and transported to ER. TX with Benadryl and prednisone. No further sx. Seen in F/u the next day with normal exam
Pt recvd 2nd dose of Hep B vax on 20DEC91 & on 23DEC91 pt devel papular lesions in a circle around the inject site; lesions progressed to appear as pigmented papules;
I was having a sore throat and cough. I then took a COVID-19 home test because my daughter was not feeling well and tested and was positive, so I then did and was positive as well. I needed a PCR test for my work. I went into the pharmacy and got a COVID-19 PCR test and that was also positive. I had really mild cold like symptoms and none other than what is listed. I did end up hurting my back while being down with COVID-19 but that is really the most major lasting thing from this.
Ring and Pinky finger numbness at the tip of fingers. Physician recommended to monitor. Seek EMS treatment for adverse reactions such as SOB, itching, hives, etc.
Pt recvd 3rd dose of Engerix-B; on 4DEC90 & exp HBSAB neg; On 08JAN91 pt recvd booster dose vax;
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 12-NOV-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (exposed to the following temperatures and cumulative time frames colder than 36F: In September of 2015, the coldest temperature was 34F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34F for 192 hours, for a total of 1,031.3 hours (43 days)) with lot number: L018500, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Patient got vaccine at 10:15 am. He reported NKA and no prior vaccine reactions. He called and said he had rash on legs at 2pm. He also had used a new lotion so not sure of cause. He got BENADRYL and will follow up w/ MD office if symptoms worsen or don't resolve.
Client called today 4/18/06 states left arm and hand tremors developed in March, being tested for MS by DR, now concerned if vaccine associated.
Arm Soreness; Menstrual period started early/Menstrual blood looks different,bleed on and off for 10 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Soreness) and MENSTRUAL DISORDER (Menstrual period started early/Menstrual blood looks different,bleed on and off for 10 days) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 004C21A) for COVID-19 vaccination.     Concurrent medical conditions included Polycystic ovarian syndrome.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm Soreness) and MENSTRUAL DISORDER (Menstrual period started early/Menstrual blood looks different,bleed on and off for 10 days). At the time of the report, PAIN IN EXTREMITY (Arm Soreness) outcome was unknown and MENSTRUAL DISORDER (Menstrual period started early/Menstrual blood looks different,bleed on and off for 10 days) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was unknown by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Followup received on 26-may-2021 , reported contact details, AE details and and second dose start date were updated.
Lethargy, flu like symptoms, loss of appetite, chills aches, lower back pain.
This spontaneous report as received from a nurse practitioner refers to multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were unknown. On unknown dates the patients were vaccinated with improperly stored M-M-R II (dose and route were not reported) lot # M000768 and expiry date: 05-JAN-2018, lot # L011528 and expiry date: 03-APR-2017 for prophylaxis. The call was because of a data logger. There were no adverse effects reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA007517: US-009507513-1612USA007519: US-009507513-1612USA001375.
pt recv vax 26AUG97 & devel pruritus 5 days p/vax;a week p/vax pruritus intensified & pt devel a maculopapular rash on the belly & arms;pt required a visit to MD on 5SEP97;pt recv DPH, zytec, pred;
**I am assuming this issue has to do with the shot triggering a response in my body that mirrors the symptoms of Shingles.**  The same day as the shot, that night had severe pain in right thigh that felt like sores from glass or bug bites but nothing was there, no sores, no redness, etc. Nothing could rub against it without feeling pain for about 4 days. Then the pain in the nerves started. It is continuous and feels like bugs or bubbles crawling under skin with increased nerve pain that is always there. There are times when it's excruciating pain & other times manageable but it's always there. I can even feel it in my sleep & even dream of sores all over my body. The main area of pain is in the legs but it also affects the entire body as random pain & stabs occur in various areas.
Progressively worsening myalgias/muscle pain, chills/sweats, fatigue.
Severe muscle ache, immobility in limb, stiffness, extreme weakness in limb, unable to lift anything, even own arm.
Fever localized swelling with site on RT arm, vomiting, weakness, pallor, involuntary jaw slamming per mom. Small hives + on back of legs.  6/8/07 Received medical records from PCP which reveal  patient experienced viral gastroenteritis 9/06 & again 11/06, croup 12/06, pneumonia 12/06 & again 3/07.  On 5/11, day after vax, seen in office for vomiting, fever, rash & decreased urine output.  Dx w/local reaction at ProQuad site, vomiting & dehydration.  Attempted to provide IVF in office but was unable & admitted to hospital overnight for hydration.  To f/u in metabolic clinc at UNC. Labs submitted are from 3/07.  7/17/07 Received hospital medical records which reveal patient experienced painful injection sites, stomach pain, vomiting, lethargy, decreased appetite & urine output & cried all night.  Exam revealed red edematous area over DTaP site on left arm & pain over other vaccine sites.  Admitted 5/11-5/12/07 for IVF.  Improved & d/c to home. FINAL DX: Vomiting, dehydration, vaccine reaction.
my left side lower have of my body has gone numb/Upper left leg has strange numbness center of thigh; a strange itching that does not seem to go away./Itching in left butt muscle. Left hip area also itching.; left arm hurts like I got hit by a rock.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 59 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 18:45 (Lot number: FF8837) as dose 3 (booster), single for covid-19 immunisation. Family history included: "Heart stint upper left artery" (unspecified if ongoing), notes: Family medical history relevant to AE(s): Heart stint upper left artery. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st, Dose: 1st, Date/Time: 04Mar2021; Time: 11:15, Site and route of injection: Anatomical site of injection: Left upper arm, Batch/Lot number: EN6199), administration date: 04Mar2021, when the patient was 59 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2nd, Dose: 2nd, Date/Time: 01Apr2021; Time: 11:00, Site and route of injection: Anatomical site of injection: Left upper arm, Batch/Lot number: ER8737), administration date: 01Apr2021, when the patient was 59 years old, for COVID-19 immunization; Flu shot (Vaccine name: Flu shot, Manufacturer: Unknown, Batch/Lot#: Unknown, Route: Unknown, Anatomical site of injection: Left upper arm, No. of previous dose: 1 one, Date: 15Sep2021), administration date: 15Sep2021. The following information was reported: HYPOAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "my left side lower have of my body has gone numb/Upper left leg has strange numbness center of thigh"; PRURITUS (non-serious) with onset 2021, outcome "not recovered", described as "a strange itching that does not seem to go away./Itching in left butt muscle. Left hip area also itching."; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "left arm hurts like I got hit by a rock.".  Additional Information: Vaccination facility type was Pharmacy or drug store.  No follow-up attempts are possible. No further information is expected.
Immed p/vax anaphylactic rxn w/respiratory distress, increased pulse & sudden hypertension; extreme sharp throbbing pain in back of head; JUL & AUG90 "suffered almost daily" from headaches, memory loss; On 4SEP90 driving lt arm & neck pain.
Pain feels like it's in the bone. Losing control of arm. Has constant ache all the time. Has problems holding things in hand. Knows it's not right since having the shot.
I started having a severe headache within 24 hours of vaccination. I do not remember any other symptoms at this time. The following day, I called my PCP and they prescribed me 2 different migraine medications, names unknown. The headache lasted for months, moderate to severe in intensity. I did not notice any more headache after a couple of months.
The patient began having symptoms of throat itching, tongue tingling, and palms of hands red and warm to touch. The patient was giving Benadryl 25mg IM @ 1030 and Epi 0.5 mg IM @ 1105. The patient was observed by staff for 90 minutes to ensure no further treatment was needed. Patient left facility in stable condition.
FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 52 year old female. 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 26-MAR-2021 for prophylactic vaccination. The batch number was not reported . The company is unable to perform follow-up to request batch/lot numbers . No concomitant medications were reported. On 26-MAR-2021, the subject experienced headache. On 27-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 27-MAR-2021, and fatigue on 29-MAR-2021. This report was non-serious.
pt was to receive pfizer covid bival (5-11) intern pharmacist failed to dilute vial and 0.2ml of undiluted med was injected mom was called and told to monitor for side effects nothing reported
Patients  was given their 2nd dose Moderna vaccine after the ?use by date.? On 8/30/21    The manufacturer was contacted and advised that the dose was not valid and would need to be repeated.  The  Medical Information representative advised not to repeat the dose until the interval between doses was determined and that they will call back with that information. F/U Call today ? no answer yet. Will continue to follow up. Patient  was notified.
Pain in both arms (mostly left) and hands. Pain 6/10. Pain started about 1 week after vaccine was given.
Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.
The pediatric dose is given rather than an adult.  The second half was given upon discovery on the same day within 30 min.
left arm pain, axillary swelling for 4 weeks, difficulty lifting coffee cup initially, and heavier things still a month later.  Fingertips numb, different than prior carpal tunnel symptoms, which had resolved after surgery in 2013.
like a severe case of the flu and dry heat for like 6 hours; pain; Fever; vomiting; aches; headaches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (like a severe case of the flu and dry heat for like 6 hours), PAIN (pain), PYREXIA (Fever), VOMITING (vomiting) and MYALGIA (aches) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A, 042L20A and 050E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for Allergy, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, MONTELUKAST SODIUM (SINGULAIR), FAMOTIDINE and COLECALCIFEROL (VITAMIN D3) for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA (like a severe case of the flu and dry heat for like 6 hours), PAIN (pain), PYREXIA (Fever), VOMITING (vomiting), MYALGIA (aches) and HEADACHE (headaches). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, INFLUENZA (like a severe case of the flu and dry heat for like 6 hours), PAIN (pain), PYREXIA (Fever), VOMITING (vomiting), MYALGIA (aches) and HEADACHE (headaches) outcome was unknown.            This case was linked to MOD-2021-328226, MOD-2021-328265.
There was a discrepancy in between the birth dates provided by parent and listed in the database. Parent provided birth date of 7/20/2009 over the phone and on the signed consent form. This birthdate would make the child eligible for the vaccine administered. However, the birth date in the electronic record is 7/20/2010, which would deem the child ineligible and the dose would be considered a vaccine administration error. HCF was made aware of the discrepancy by Provider Outreach Specialist with the COVID-19 Vaccination task force at the Department of Health Services. In response, a call was made to the mother of the client. Notified her of the discrepancy, and she maintained that Pt's birth date is 07/20/2009, and that the Registry is incorrect. Provided her with the help desk phone number so the record can be corrected. The mother stated that pt. tolerated the second dose well.
had to go to sleep; Could not function correctly; They had headache; body aches; chills; He felt really exhausted and drained.; Pfizer Covid Vaccine first dose Date: 19 Apr 2021/Pfizer Covid Vaccine second dose Date: 03 May 2021; Pfizer Covid Vaccine first dose Date: 19 Apr 2021/Pfizer Covid Vaccine second dose Date: 03 May 2021; This is a spontaneous report from a Pfizer sponsored program COVAX US support.   A contactable 46-year-old male patient reported that who received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, (Lot Number and expiry date unknown) via an unspecified route of administration at left arm as a single dose for COVID-19 Immunisation. Past drugs included Lisinopril taken for quite some time, 3 or 4 years, Nifidipine for blood pressure. Historical vaccine BNT162B2 via an unspecified route of administration (Lot Number / Expiry Date was not reported) on 19-APR-2021 as a single dose at left arm for COVID-19 immunisation. On an unknown date patient could not function correctly the day after both shots. They had to go to sleep. He said that the headache, body aches and chills started the same day as the shot after both shots. He felt exhausted and drained. Patient did not visit physician office or emergency room visit due to the event. Outcome of the events were recovered on an unknown date.  Information on the lot/batch number has been requested.
On 6/18/10 reported flu like symptoms, but no fever, "last week". On 6/17/10 after work noted rash on back, by the morning of 6/18 rash extended to trunk and face. MOTRIN 600mg po helped aches. He was taken off duty, he returned to work 6/28/10.