chrisvoncsefalvay/vaers-outcomes huggingface dataset:
since late yesterday, she started getting chills, diarrhea, upset stomach, and she is very weak; since late yesterday, she started getting chills, diarrhea, upset stomach, and she is very weak; since late yesterday, she started getting chills, diarrhea, upset stomach, and she is very weak; since late yesterday, she started getting chills, diarrhea, upset stomach, and she is very weak; couldn't sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 85 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 25Feb2021 (Batch/Lot number: unknown) at the age of 84 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood pressure" (unspecified if ongoing), notes: Verbatim: High Blood pressure. There were no concomitant medications. The following information was reported: ASTHENIA (non-serious), CHILLS (non-serious), DIARRHOEA (non-serious), ABDOMINAL DISCOMFORT (non-serious), outcome "unknown" and all described as "since late yesterday, she started getting chills, diarrhea, upset stomach, and she is very weak"; INSOMNIA (non-serious), outcome "unknown", described as "couldn't sleep".  Additional Information: The patient stated that she had an appointment for her second shot of the Pfizer COVID-19 vaccine. The patient reported that, " few days after the first dose her side effects were not severe but, since late yesterday, she started getting chills and couldn't sleep, diarrhea, upset stomach, and she is very weak". The patient said that she doesn't have any fever. The patient wanted to know if vaccination provider would give the shot even though she had those symptoms. The patient queried that, how to make another appointment for the Pfizer COIVD-19 vaccine. The patient stated that she has had so many blood draws and things lately that she doesn't remember which arm vaccine was received on. Her second dose was scheduled on 19Mar2021 at 2:15PM. The patient reported that she had problems with high blood pressure, it goes real high and she took 3 different medications for it.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
excruciating pain in the bones; sharp neck pain; Headache; sore throat; Difficulty swallowing and breathing; Difficulty swallowing and breathing; Swollen and blistered on the right leg; Swollen and blistered on the right leg; itch and hurt; itch and hurt; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) dose 2 via an unspecified route of administration in Arm Right on 04May2021 10:00 (at the age of 60 years old) as single for COVID-19 immunisation at Hospital. Medical history included lupus erythematosus, rheumatoid arthritis, fibromyalgia. Concomitant medication received within two weeks included baclofen (SOLOFEN), clonazepam (KLONOPIN), trazodone hydrochloride (TRAZODON) all taken for an unspecified indication, start and stop date were not reported and Plasma Capilar. The patient previously took tramadol and experienced allergies, ultacit and experienced allergies, ultram and experienced allergies. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Arm Right on 13Apr2021 08:00 (at the age of 60 years old) as single for COVID-19 immunisation. Patient did not have COVID prior to vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced excruciating pain in the bones, sharp neck pain, headache, sore throat, difficulty swallowing and breathing, swollen and blistered on the right leg, itch and hurt on 06May2021 16:00. Event reported as, After three days excruciating pain in the bones. Still sharp neck pain. Headache and sore throat. Difficulty swallowing and breathing. Swollen and blistered on the right leg. They itch and hurt. The pain in the neck is excruciating. Adverse events resulted in emergency room/department or urgent care. Treatment given for adverse events included toradol, sodomedrol, ataraxia, norflex. Patient did not tested for COVID post vaccination. Outcome of all the events were not recovered.  Information about/lot batch number is requested.
FLU; FELT LIKE CRAP FOR 24 HRS; FEVER; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced flu, felt like crap for 24 hrs, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu, felt like crap for 24 hrs and fever was not reported. This report was non-serious.
No adverse effects reported.; patient inadvertently received a dose of MMR II on 7/5/2019. Administrator states patient completed a pregnancy test on 7/18/2019 which was positive wilh estimated 3 to 6 weeks gestation; This spontaneous prospective pregnancy report was received from an administrator and refers to a 36-year-old female patient. The patient's concurrent conditions were not provided. Concomitant therapies included thyroid medication. She was allergic to crab and lobster.  On 05-JUL-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, subcutaneously (lot # S004120 and expiry date 11-FEB-2021, albumin status rHa; exact dose and anatomical location were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (lot # S007959 and expiry date 19-AUG-2019). On 18-JUL-2019, the patient completed pregnancy test which was positive with estimated 3 to 6 weeks gestation. Based on this information, the patient's last menstrual period (LMP) occurred on unknown date in June 2019, date of conception was on an unknown date in 2019 and estimated date of delivery (EDD) would be on an unknown date in 2020. She sought medical attention contacting the office. At the time of this report, the patient was doing fine. No adverse effects were reported. The pregnancy outcome was pending.
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4339756-00 (RA). A 43 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation; Risankizumab (SKYRIZI [RISANKIZUMAB]) (ongoing) (Batch/Lot number: unknown) for psoriasis, psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for Covid-19 Immunization. The following information was reported: VACCINATION COMPLICATION (medically significant) with onset 2021, outcome "unknown", described as "had a serious reaction to the second Covid vaccine". The action taken for Risankizumab was dosage not changed. Additional Information: The patient had Covid. He had first two doses of vaccine but not booster and in 2021, he had a serious reaction to the second vaccine. It was unknown if patient was enrolled in a Covid-19 vaccine trial. The reporter's assessment of the causal relationship of the [Vaccination adverse reaction] with the suspect product [Skyrizi (Risankizumab)] was not provided at the time of this report and the reporter's assessment of the causal relationship of the [Vaccination adverse reaction] with the suspect product bnt162b2 (BNT162B2) was not provided at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on available information and the drug temporal relationship, the causality between the event "vaccination complication" and the suspect drug "BNT162B2" cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
fatigue; light headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and HEADACHE (light headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue) and HEADACHE (light headache). At the time of the report, FATIGUE (fatigue) and HEADACHE (light headache) outcome was unknown.            No concomitant medication was reported . No treatment medication was reported .
Dizziness, blurry vision, took oral Tylenol. BPs 98/68 (pulse 58), 97/66 (pulse 59).
symptoms: dizziness, nausea, lightheadedness, clammy and cold skin
-Awoke at 3:15am the night after the vaccine with vomiting and the worse headache of my life.  Later that day, I describe the pain as if my brain felt like it was tearing. I was unable to move or hold a conversation for about 12 hours. The pain decrease that same evening and was much decreased by the next day. I did not seek official care or diagnostic testing after hearing headaches were a common symptom and not wanting to expose myself to hospitals or urgent cares during the pandemic for fear of exposure.  -after returning to work sometime in the next few day,(2-4days later) I started to notice loss of hearing completely in my right ear for as short as 30secs. to several minutes, then hearing would return completely. This was accompanied by a strange sensation, of floating or cognitive perception change, that I much later was able to identify as partial seizures which had not occurred before the severe headache I had the night after the vaccine. This feeling that was caused by the partial seizures were frequent for the next several weeks and then tapered off and eventually flared up again later. Brain scans much later identified a capillary brain hemorrhage (cavernoma) with blood at various stages of clotting around the bleed site, the oldest dating back to the timeframe of my vaccine and first symptoms.  A craniotomy was performed to remove the mass and blood clotting, at that time it was about a 4cm diameter. The procedure was successful in correcting the problem but did have the unforeseen side effect of causing a secondary stroke in another section of the brain from the surgery.   -Separately I developed exercise induced chest tightness and pain. About 1.5-3 weeks after the second vaccine dosage.  I would experience little to no chest symptoms with ADLs until going on my exercise bike, try to run or other brisk cardiovascular activity. This symptom slowly decreased and was not noticed after about 5-7 months.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced a large red area at the injection site after receiving SHINGRIX. No additional details were provided. The reporter declined to provide the patient information as he was trying to receive information pertaining to a medical question.
the temperatures the vaccines were exposed to were unknown due to the data logger was down and not recording any temperature information for 11-hours; Initial information received on 06-Jun-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves Adult patient who experienced the temperatures the vaccines were exposed to were unknown due to the data logger was down and not recording any temperature information for 11-hours, while he/she received vaccines DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    It was of actual medication error due to  incorrect product storage. There is a possibility of administration of vaccines that may have not been suitable for use after experiencing a temperature excursion. It is unknown if the event occurred due to it is unknown if the vaccines involved have been used  No adverse event was reported.  Information on the batch number was requested:  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Covid arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Covid arm) in a male patient of an unknown age 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 (Covid arm). At the time of the report, VACCINATION COMPLICATION (Covid arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Redness, swelling, itchiness, soreness. Benadryl 25 mg taken and ice applied.
Severe chills, severe headache for 2 days, lightheaded, fever for 1 day, nausea
Information has been received from a registered nurse concerning a 9-year-old male (brother 1 of 2) with seasonal allergies and amoxicillin allergy who on 17-NOV-2006 was vaccinated SC with a 0.5 mL dose of Varivax (Lot # 652450/0948R). Concomitant therapy included ALLEGRA. On 19-NOV-2006 the patient experienced a six-inch raised red sore area around injection site and sore area around the injection site. Unspecified medical attention was sought; treatment included TYLENOL and ice. No diagnostic studies were performed. NO additional information to report. There was no product quality complaint involved. It was also noted that the patient's brother was also vaccinated with Varivax on 17-NOV-2006 and experienced a raised red sore area around injection site and sore area around the injection site (WAES # 0611USA06138). Additional information has been requested.
This is a young 1-year-old female, who presented to emergency room with persistent febrile seizures. The patient received a few doses of ATIVAN. Had some respiratory distress due to the depression of the respiratory system and for that reason, she. During the process, the patient has an aspiration pneumonia and the respiratory distress increased in the emergency room. After stabilization in the emergency room, the patient was transferred to us. Basically this patient has been with intermittent fever for the last 2 days. The last fever the family says that it was 104. The patient started having some abnormal movements in the eye and the seizure lasted for at least 1 hour.
High fever for 2 days, uncontrollable shaking, body aches, pounding headache
administered with vaccine that experienced more than 1 temperature excursion; administered with vaccine that experienced more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021 at 11:44 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Feb-2021 at 11:44 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 75.64.  Concomitant medication of the patient was not reported.  Batch number 016M20A underwent temperature excursion on 08-Feb-2021 with temperature range 29 to 35 degrees Fahrenheit from 10:00 am to 11:00 AM. These vials were moved to fridge on 02-Feb-2021 and beyond use date for the vials was reported as 04-Mar-2021. The vaccines moved to clinic on 08-Feb-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and fisher brand traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.
I received my vaccine at around 12:00 and my arm stared to hurt, and I tried to massage it but it didn?t help I also noticed it was swollen as very sore. I also had a fever a little under 101 so I didn?t see a need to take any medication over the counter. This last just about 24 hours almost to the minute. My arm did stay sore foe a few days but all other symptoms went away.
everything was heightened with the 3rd one; headache; body ache; flu like symptoms; cough; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (one thing that has lingered is the cough/non-productive cough/it's a chest cough), CONDITION AGGRAVATED (everything was heightened with the 3rd one), HEADACHE (headache) and MYALGIA (body ache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062921A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included ETANERCEPT (ENBREL) and PROPRANOLOL for an unknown indication.   On 02-Sep-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (one thing that has lingered is the cough/non-productive cough/it's a chest cough), HEADACHE (headache) and MYALGIA (body ache). On an unknown date, the patient experienced CONDITION AGGRAVATED (everything was heightened with the 3rd one). On 05-Sep-2021, HEADACHE (headache) and MYALGIA (body ache) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) and CONDITION AGGRAVATED (everything was heightened with the 3rd one) outcome was unknown and COUGH (one thing that has lingered is the cough/non-productive cough/it's a chest cough) had not resolved.            No treatment details were provided.
pt. recieved the vaccine past the 12 hour expiration. No adverse events. would like revaccinated in December or January.