chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 20-MAY-2013, the patient was vaccinated with ZOSTAVAX (lot # J000443 and expiry date 11-APR-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought that the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15F and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would have been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different Lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX Lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to on an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his record didn't indicate when he received each Lot but he was calling further for the data. He also could not identify, at this time, which Lot # was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of the ZOSTAVAX which was unsupported an administrated. This is one of several reports from the same source. Additional information has been requested.
Muscle spasm muscle weakness and nerve problems preventing me from walking or sitting been out from work for 5 months Nad it keeps getting worst
He got a third shot prior to approval; Lousy; Arms hurt/sore arm; Couldn't lift his arm; felt tired; arms hurt/sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (He got a third shot prior to approval), FEELING ABNORMAL (Lousy), PAIN IN EXTREMITY (Arms hurt/sore arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't lift his arm) and FATIGUE (felt tired) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A, 004M20A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Transient ischemic attacks and Enlarged prostate. Concurrent medical conditions included High cholesterol. Concomitant products included ATORVASTATIN for High cholesterol, CLOPIDOGREL BISULFATE (PLAVIX) for Transient ischemic attacks.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (He got a third shot prior to approval), FEELING ABNORMAL (Lousy), PAIN IN EXTREMITY (Arms hurt/sore arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't lift his arm), FATIGUE (felt tired) and MYALGIA (arms hurt/sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-Sep-2021, INTENTIONAL PRODUCT USE ISSUE (He got a third shot prior to approval) had resolved. On 24-Sep-2021, FEELING ABNORMAL (Lousy), PAIN IN EXTREMITY (Arms hurt/sore arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't lift his arm), FATIGUE (felt tired) and MYALGIA (arms hurt/sore arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patients Medical History information reported possible prostate cancer issues, and several aneurysms. Treatment medication reported included arthritis strength Tylenol.
Began to have vomiting, seizure activity, mom found unresponsive.  Had to call 911 due to decreased level of consiousness.  Taken by ambulance to ER with prolonged post-ictal state  12/02/09. ER records received for DOS 9/4/09. FINAL DX: viral syndrome, HA, fever Records reveal patient experienced fever x 5 days, HA, cough, & vomiting x 2.  Unable to attend school.  Temp 102.4 in ER.  Tx w/antipyretics & IVF.  Improved & d/c to home to f/u w/PCP. 12/31/09 ED records received for DOS 11/13/09. Pt. presented with vomiting and h/o convulsion within one hour of receiving vaccination. DC home, improved. Impression: Convulsion/seizure
12/21/18 - 12/25/18 I probably had a mild-moderate reaction to the Tdap Vaccine, which I received for work at a hospital on 12/21/18. Manufacturers Lot number: 3YM7S, date 11/9/20. I had slight soreness at the site, mild to moderate weakness and dizziness. I had chills and sweats for 2 days, with occasional twinges of headache, but no elevated temperature. It seemed like my left cheek was slightly swollen, but that may have been a trick of the lighting. I had no difficulty breathing. I suspected an allergic reaction because I've been developing more allergies in recent years, so I took a BENADRYL - the symptoms decreased gradually, and were gone in 2 more days.
Severe neck pain radiating up the neck on the side that the vaccine was administered, limiting range of motion.
Patient was given vaccine. Patient passed out or fainted about 2 minutes after receiving vaccine. EMTs arrived after about 10 minutes to give vitals. Patient was stable when paramedics arrived.
Patient had the second dose of vaccine on 03/15/21. On 03/16/21 patient began to develop some feelings of cold feet and foot swelling in the evening. The following day the patient's care giver noted a purple-ish rash of the feet and ankles. By the following day the rash was progressing and more prominant.  On 03/19/21 Patient presented to the emergency department with progressive rash on legs and new rash on hands.  Patient had no other symptoms, rash was otherwise asymptomatic except for feelings of cold extremities. Rash was identified by myself as Livedo Reticularis which is a moderate sized vessel vasculitis. This can be immune complex mediated. Sent to Dermatology for same day punch biopsy. Results currently pending.
a seizure and had to be hospitalized within 24 hours of receiving the vaccine; had COVID; had COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 4220-2126614789.  A 38-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (ongoing). Concomitant medication(s) included: OCREVUS; KEPPRA [LEVETIRACETAM]. The following information was reported: SEIZURE (hospitalization, medically significant), outcome "unknown", described as "a seizure and had to be hospitalized within 24 hours of receiving the vaccine"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "had COVID".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Immunizations given 5/18/06, seen by physician on 5/18/06. As woke up with "rash" on forehead and cheeks. Rash described as papular approx. 3cm diameter. Child quarantined. No fever, rash gone within 2 days. "Back to his self in 2 days" per mother.
This case was reported by a physician and described the occurrence of not responding to therapy in a 19-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Previous vaccination included three doses of ENGERIX B (GlaxoSmithKline) given on unspecified dates. On an unspecified date the subject received 4th dose of ENGERIX B at 1 ml in the left arm. This was considered to be a maladministration (asymptomatic/extra dose given). The subject received a full three dose series "before", but now tested to have no antibodies (not responding to therapy), so the physician gave a "booster" dose of ENGERIX B. No adverse events were reported. Follow-up information was received on 05 July 2011. The 4th dose of ENGERIX B was given intramuscularly. There were no further details or events reported.
23 days after the administration of Moderna´s vaccine, as a booster. On the morning of 19 December, the patient experienced erythematous and pruritus over the upper extremities, starting in the hands and extending to the forearms and arms. The next day (20-Dec) patient consulted the emergency department where the diagnosis of urticaria was initially established, treatment with hydroxyzine and prednisolone was started. Upon persistence of the symptoms, the patient was seen by dermatology on 22-DEC and the diagnosis of vasculitis was established. A skin was performed on the same day (results are pending). Ambulatory management with prednisolone was continued. Lab work was indicated  (results are pending). The patient denies systemic symptoms, no fever, no dyspnea, no abdominal pain. There is no relevant medical history, other than benign prostatic hyperplasia, and stage 1 hypertension, for which lifestyle changes were indicated. There is no relevant family history. The patient is not currently, on any other medications.
MONOVALENT DOSE GIVEN IN ERROR INSTEAD OF NEW BIVALENT MODERNA BOOSTER.
This morning after having received my second dose of Zoster yesterday, I felt nauseous, dizzy, hot (I was dripping with perspiration) then got a head ache. I have rested much of the day. My arm has been sore. These are among the common reactions. The first one only caused soreness.
Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) 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) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Expired vaccine was administered to total of 24 patients including 15 males and 9 females. It was reported administrations were mostly for booster shots. No side effects were reported for the patient.  No treatment information was provided by the reporter.
Patient called to report experiencing tremors or uncontrollable shaking all over.  Pharmacist recommended a visit to urgent care if not resolved in 15-20 minutes
Patient began feeling lightheaded, dizzy, chills, and scratchy throat after given vaccine.  Patient was monitored for 45 minutes - given water and snacks - until feeling better.
01/02/2010 PM: Sharp, concentrated pain at the base of my skull (back, left side).   01/03/2010 PM: Continued pain at base of skull after taking OTC ibuprofen. Taste sensations change to a "soapy" taste (especially when eating) and "slick or filmy" sensation in my mouth.  01/04/2010: Continued pain at base of skull after taking more OTC ibuprofen causes difficulty sleeping. Taste sensations get worse. Left eye becomes blurry several times during the afternoon.  01/05/2010: Continued pain at base of skull and difficulty sleeping. Taste sensations changed to a metallic taste. That afternoon discover onset of facial paralysis. Continued blurry vision in left eye.   01/06/2010: 1:30pm  Appointment with my physicians assistant confirms Bells palsy diagnosis. 7pm: Started prescription regimen of Prednisone and Valtrex plus eye lubricant.  01/07/2010: Facial paralysis slightly worse mid morning, but stabilizing by the end of the day. Continued use of prescriptions, eye lubricant and eye patch. Taste begin to sporadically return to normal.  01/08/2010: Facial paralysis has plateaued. Continued use of prescriptions, etc.
Patient had a rash that started to appear a couple of hours after vaccination. Rash was initially just on armpits and upper arms Arms were hot to touch. It gradually progressed to hives, and then a burning sensation and looked like a bad sunburn, and spread to her back and breasts. Two days later , she was covered in a rash from head-to-toe that she described in appearance as similar to a heat rash or contact dermatitis. She also had little purple spots on her arms and legs. She also had malaise, fatigue, and an intermittent headache, throughout the duration of the rash, which lasted abut a week.
Burning and numbness in mid right forearm going down to thumb and finger in right hand.   Same arm I had the injection in.
SOB and hedache x2 weeks. hypoxic resp failure secondary to COVID. start decadron. out of window for remdisivir. crp <7 so not candidate for toci.  Zinc and Vit C given. O2 @ 2L.  Walk study O2 dropped to 80%, then rebounded to 90%. Physician dc notes say pt weaned to ra prior to dc.
Painful that afternoon after shot. No redness until early the next morning along with swelling and warm to touch.
This spontaneous report as received from a nurse via a company representative refers to a patient of unknown age and gender. On 05-AUG-2014, a medical assistant had inadvertently vaccinated a client with (Oka/Merck) VARIVAX (lot#, strength, dosage, route unknown) for vaccination instead of ZOSTAVAX. No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
This spontaneous report as received from a physician referred to a 63 years old female patient. The patient was vaccinated with a 0.5 ml dose of VARIVAX (Merck) (lot 1944AA; exp. 12-DEC-2013). No other co-suspects were reported. Concomitant medications included BENICAR, minocycline, metoprolol, cyclobenzaprine hydrochloride, paroxetine and doxycycline. The patient already had a rash under her breast at the time she received the vaccine. A week later, on 12-JUN-2012, the patient called the office because she had spread all over her body during the week after she got the vaccination. The doctor saw her and said that she had a papular rash all over her body. The patient sought unspecified medical attention. The patient was given prednisone, SARNA and KEFLEX as a treatment for the AE. On an unspecified date, blood cultures were performed (results not provided). The outcome of papular rash all over her body was unknown. The relatedness for papular rash all over her body was unknown for VARIVAX (Merck). Additional information has been requested.
PATIENT STATED THAT SHE EXPERIENCED DEEP THROBBING PAIN AT THE SITE OF INOCULATION ON 5/20/2009. SHE SOUGHT MEDICAL ATTENTION FROM HER PRIMARY CARE PHYSICIAN WHO PRESCRIBED MOTRIN AND WARM COMPRESS. THIS ALLEVIATED THE SYMPTOMS PAIN RETURNED AT INTERVALS.
severe vomiting; diarrheoa; severe chills; fatigue; This is a spontaneous report from a contactable consumer (patient). A 26-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown), via an unspecified route of administration, administered in Arm Left on 15Apr2021 at 16:00 (at the age of 26-years-old) as dose 2, single for covid-19 immunization. Medical history included Hashimotos and asthma; both from an unknown date and unknown if ongoing. The patient had no known allergies. The patient did not receive any other vaccine in four weeks. The patient received other medications in two weeks. The patient previously received first dose of bnt162b2 (Lot number: unknown), via an unspecified route of administration, administered in Arm Left on 25Mar2021 at 16:00 (at the age of 26-years-old) as dose 1, single for covid-19 immunization. The patient has no covid prior vaccination. On 15Apr2021 at 21:00, the patient experienced severe vomiting 30+ times and diarrhea for about 6 hours. Also had severe chills and fatigue. The patient did not receive treatment for events. The patient was not tested for covid post vaccination. The outcome of events was recovered on an unspecified date in Apr2021.  No follow-up attempts are possible. Information about Lot number/batch number cannot be obtained. No further information is expected.
Patient states that he noticed it was only drawn up to 0.1ml, the staff says it was drawn up to 0.5ml; A spontaneous report was received from a pharmacist ,concerning a 64-year-old, male patient , who received Moderna's COVID-19 vaccine(mRNA-1273) and patient states that he noticed it was only drawn up to 0.1ml,staff says it was drawn up to 0.5ml.  The patient's medical history was not reported. Concomitant medication reported was not reported.  On 21 Feb 2021, patient received their first of two planned doses of mRNA-1273(Lot/batch: unknown) vaccine through unknown route of administration, for prophylaxis of COVID-19 infection.  On 22 Mar 2021, patient received their second of two planned doses of mRNA-1273(Lot/batch:031A21A) vaccine through unknown route of administration, in the left arm, for prophylaxis of COVID-19 infection.  On 22 Mar 2021, the patient experienced event that he noticed it was only drawn up to 0.1ml , the staff says it was drawn up to 0.5ml. Treatment information was not reported.  Action taken with mRNA-1273 in response to the events was not applicable.  The event patient noticed it was only drawn up to 0.1ml, the staff says it was drawn up to 0.5ml was considered resolved on 22 Mar 2021.; Reporter's Comments: This report refers to a case of accidental under dose for mRNA-1273 with no associated AEs.
This spontaneous report was received from an office manager, concerning a multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug allergies or concomitant therapies were not reported. On unknown dates in 2017 (reported as "on or after 09-MAR-2017"), patients were vaccinated with improperly stored doses of ROTATEQ oral liquid (strength and dose were not reported) lot number: M019707, expiration date: 25-OCT-2017, orally for prophylaxis. According to the reporter, ROTATEQ dose were exposed to the following temperature excursions: 3 1 hour and 30 minutes at 31 degrees Fahrenheit (F) or below (30.2F); and 24 hours and 10 minutes between 32F to 35F. No previous temperature excursions were reported. No adverse effects were reported. A digital data logger was involved. This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA012789:
after 15 min patient developed hives on face. her arm at the injection site was hard, hot and painful for 2 weeks.
relapse of chronic inflammatory demyelinating polyneuropathy; relapse of chronic inflammatory demyelinating polyneuropathy; This is a spontaneous report from a contactable consumer (patient self). A 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, LOT number and expiration date: unknown) via an unspecified route of administration on 21Feb2021 13:30 at single dose for COVID-19 immunisation. Medical history included ongoing chronic inflammatory demyelinating polyneuropathy (CIDP). Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunisation. No Covid prior vaccination. There were no concomitant medications. The patient reported he was fine until after the second dose and he was having a relapse of chronic inflammatory demyelinating polyneuropathy on 23Feb2021 12: 00 AM. The event resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The patient was trying to get intravenous immunoglobulin (IVIG) as treatment. Covid was not tested post vaccination. The outcome of event was unknown.  Information on the Lot/batch number has been requested.
Red, swelling, heat, itching at injection site.  Still present at day 5 post-vaccination; combined with chills, severe congestion, throat pain, and fatigue.
A few hours after receiving SHINGRIX vaccine, patient called pharmacy complaining of a severe pain in her foot. She said it began abruptly and was a sharp pain. It lasted for about 6 hours, and was relieved by 2 ADVIL tablets which she took at bedtime. She woke up with very minimal pain, and said that her foot is almost completely pain free now (next day at 12:30 pm).
hives; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th November 2022, the patient received Shingrix. In November 2022, 2 days after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-Nov-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had the Shingrix vaccine Friday and had hives 2 days later. Additional supportive information: The follow-up would not possible, as no contact, details were available.
25 min after injection, pt complained of not feeling well.  Pt turned pale and lost consciousness - his eyes were open, but he was completely no responsive.  He began vomiting. He regained conscious and didn't know what had happened.  He vomited several more times, was very pale and had a high fever. His skin was clammy wet.  He was able to drink some water while we transported him ourselves to the ER.   At the ER, his first EKG showed abnormal QT.  Other labs were in normal range.  Iv fluids given. Second ekg was normal.  Discharged with referral for home EKG monitoring.
staff member/ pt.  had vaccine at 1500, no  prior allergies.  after 15 min observation, staff felt "weird" but returned to work in building.  approximately 5 minutes later felt lightheaded, dizzy & became flushed & diaphoretic.  returned to vaccine clinic for observation. was found to have BP of 143/103 on a normally normotensive person.HR 70.  Provided recliner, rest & monitoring.  BP decreased to 128/85 after 1 hr. of monitoring.  pt continued to monitor BP and self medicated at home with Benadryl & Ativan (unknown dose).  Continued to feel disoriented and unwell X 48 hrs.