chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches; Severe headache; Fever; Fatigue; A spontaneous report was received from a consumer concerning a 63-year-old female patient who received Moderna's COVID-19 vaccine and experienced severe headache/headache, body aches pain, fever/pyrexia, and fatigue.  The patient's medical history and concomitant product use were not provided by the reporter.  On 30 Dec 2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch number: 011J20A) via Intramuscular route in the left arm for COVID-19 infection prophylaxis.  On 30 Dec 2020 the patient experienced severe headache, body aches, fever, and fatigue.  The events were treated with Tylenol and after two days the events resolved.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events was recovered on 02 Jan 2021.   The reporter did not provide causality for the events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Fatigue, fever/chills, diseminated rash, vomiting, and chest pain.
Headache, Myalgia, CoughWheeze & NauseaVomiting Narrative:
This spontaneous report as received from a nurse practitioner refers to 18 patients who might have been vaccinated with doses of RECOMBIVAX HB (Lot # J000722, expiration date 17-SEP-2015) that were exposed to 31F for accumulative of 1 hour and 30 minutes between 04-OCT-2013 and 10-OCT-2013. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
pt recv vax 15OCT97 & the next day pt exp a generalized rash;pt had one episode of nausea & dizziness while had the rash;the episode lasted 15min;
Temporary paralysis right side (face, arm & leg).  Lasted approximately 4 hours.
This spontaneous report as received from a healthcare worker refers to a unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the unspecified number of patients were vaccinated with improperly stored PEDVAXHIB (dosing details were not reported) (lot # K015462 with an expiry date of 10-JUL-2017 exposed to 30 F for 40.18 hours), (lot # K026532 with an expiry date of 07-AUG-2017 exposed to 30 F for 37.68 hours), (lot # L006545 with an expiry date of 16-NOV-2017 exposed to 30 F for 27.68 hours), (lot # L012837 with an expiry date of 08-MAR-2018 exposed to 30.4 F for 10 hours) and (lot # L014426 with an expiry date of 08-MAR-2018 exposed to 30.4 F for 20.75 hours). No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
approximately 8 hours after the injection a sudden case of chattering chills come on - temperature checked soon after was 103 - followed approx. an your later by vomiting and then restless night of sleep due to body aches and stiffness in trying to get out of bed.   Following day improved but no appetite or energy and mild headache. Well by 32+ hours after incident
Temperature excursion that occurred several days ago in the Freezer; No adverse event; Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion that occurred several days ago in the Freezer) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion that occurred several days ago in the Freezer) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion that occurred several days ago in the Freezer) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion that occurred several days ago in the Freezer).    Concomitant medication was not reported.  Reporter stated that a temperature excursion occurred several days ago in the freezer which was found in an audit. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the freezer. Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question. Patient who received this vaccine did not report any adverse event. Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-675735, US-MODERNATX, INC.-MOD-2022-676064 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675735:Same reporter case/master case US-MODERNATX, INC.-MOD-2022-676064:same reporter
Vaccine was inadvertently given to patient after it was not properly stored under the conditions recommended by manufacturer.  No symptoms present. Dose will not count and will have to be repeated.
while using 1 ml/25 g / 1 inch needle  syringe NDC number 1370310161 that was sent to us we draw a full dose from  a single vial of Janssen the vaccine vial and it was administered to the patient. No harm or side effects was reported to the pharmacy until the reporting time.
I had the Varicella administered in one shoulder/arm, and the Tdap administered in the other shoulder/arm. My face has broken out with tiny clusters of blisters, my face is somewhat pink and flush. I have aches, and itching in my face, head, arms, back, and shoulders. After reading the documents provided, i realized that this may or may not be a normal temporary reaction 24 to 48 hours after the vaccines were given to me. But i started to feel off on Sunday (day 3). So, i called out of work to be safe and make sure I was improving. Today is Monday, May 2nd, and my symptoms are still here. I got ahold of my doctor's office, and they gave me a prescription for Benadryl and more time off to rest and make sure that this is going in a better direction.
1 day after vaccines (DTaP/HAV) in L arm, dev. redness/induration.  Came into clinic 5/22/08; induration (small area) + erythema (7.5 x 9cm) L arm - "Better" per mom.  No fever.
they had a friend who also had shingles after getting the vaccine; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. Medical history and concomitant medications were not reported. It was reported that, on an unknown date, the patient had shingles after getting the vaccine and she was told by her friend not to get the vaccine again since shingle was a common side effects of the vaccine. The reporter knew this patient who got shingles after the vaccine and it went in their ear too. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101317559 same reporter/drug/AE, different patient
Pt c/o mild lightheadedness w/o neuro deficits or cp/sob 45min s/p covid vaccination. BP 119/79, HR 60, SpO2 98% on RA. No signs of respiratory distress or angioedema noted. She reports sxs improvement s/p oral rehydration. Pt stayed in observation unit for additional 40min w/o additional complaints, she continued to do well. Left unit  in stable condition.
Pt came to the pharmacy on 11/2/19 with a dark bruise about 1.5 inches around the injection site.  The bruise was really dark (blackish/red) in color.  Pt will follow up wth her Dr.
Gave a 15 year old Pro Quad on 4/20/2022  on their left arm.
Pt. with several episodes of absent-like seizures lasting 15-30 sec; pt. just this day received Dose#3 (Day#7) of 4 part series for possible exposure to rabid dog (initial testing on head showed positive for rabies but tested by CDC as negative (19Dec13).
10 days swelling around injection area, bright red and raised aching pain in arm from site of injection to wrist, 4th day after injection no rash itching whole body patient took BENADRYL for 4 days then itching went away patient has had shingles: June 13, 2014 August 16, 2014 prior to vaccination.
Fatigue beginning the following morning (6AM) Fever 99.9 at 6AM treated with Ibuprofen Fever 102.2 at 7PM treated with Ibuprofen  Fever 102.8 at 8:30 PM Fever throughout the night accompanied with excessive sweating  Consistent Body and Joint aches
This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 09-JUN-2017, the patient was inadvertently vaccinated with GARDASIL 9 (lot # M037770, expiration date: 01-JUN-2019) (dose and frequency were unspecified), subcutaneously (instead of intramuscularly), for prophylaxis. No adverse effect reported. No product quality complaint was involved. Follow up information has been received from the reporting physician and a Nurse on 12-DEC-2017, concerning to a 34 year old Asian female patient. The patient's medical history/allergies and concurrent conditions included allergy to pollen and allergy to penicillin G benzathine(EXTENCILLINE) (that caused rash on an unknown date). On 09-JUN-2017 at 11:30 am, the patient was vaccinated in error with the first dose of GARDASIL 9 lot number M041213 (reported previously as "lot # M037770") in the right arm, subcutaneously at the private doctor's office/hospital. On the same date on 09-JUN-2017 at 11:35 am, the patient received also the first dose of VARIVAX in the left arm (lot # M040137, expiration date: 01-JUN-2019) (dose and frequency were unspecified), subcutaneously, for prophylaxis. It was reported that the vaccines were purchased with public funds.
given sq instead of IM; This case was reported by a other health professional via interactive digital media and described the occurrence of intramuscular formulation administered by other route in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 14-JUL-2022 Reporter's comments; This case was reported by a other health professional via interactive digital media. The patient received Shingrix via subcutaneous route instead of intramuscular route.  The reporter also asked that what should I feel the patient to expected as far as side effects were concerned. Additional supportive information: The patient received Shingrix via subcutaneous route instead of intramuscular route, which led to Intramuscular formulation administered by other route. Follow-up would not possible, as no contact, details were available.
Patient is allergic to tetanus; Initial information received on 28-May-2019 regarding an unsolicited valid non-serious case received from a physician via other company.  This case involves an unknown age patient who was allergic to vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARENICLINE (VARENICLINE).  On an unknown date, the patient received a  dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot number not reported via unknown route.  On an unknown date, , The patient developed a non-serious patient is allergic to tetanus (allergy to vaccine) <<Unknown latency>> following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE.  No lab test reported.  Final diagnosis was patient is allergic to tetanus.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as unknown for patient is allergic to tetanus.  Information on the batch number was requested:
101 fever and sever body aches 12 hours after second dose.  Extreme fatigue for another 24 hours. 36 hours after vaccine felt perfectly normal again.
A couple of days after taking first vaccine, felt achiness and myalgias that has lasted throughout, has felt weakness to arms (both) that seems to have increased over time since taking the vaccines 2 months ago (notably unable to open jars, doors feel heavy to open, etc); some relief with OTC analgesics but not as expected, even back pain that was present before taking vaccines has become more constant and using the analgesics have not relieved the pain.
Hospitalized; COVID-19 positive; Fully Vaccinated.  Discharge Provider Primary Care Provider Admission Date: 10/9/2021 Discharge Date: 10/11/2021 PRESENTING PROBLEM: Pneumonia due to COVID-19 virus COVID-19 virus infection  HOSPITAL COURSE: Patient is a 77 y.o. male with a past medical history significant for OSA, NIDDM, CKD stage 3b, Atrial fibrillation on Eliquis, HTN who presented with SOB. Symptoms initially began on 09/29/2021. He tested positive for COVID-19 infection on 10/08/2021 at his PCP office. He did receive both doses of his Pfizer vaccine. He reported associated fatigue, cough, and progressively worsening shortness of breath. He then had a decreased oxygen saturation on pulse oximetry of 77% while ambulating to the shower so presented to the ED for evaluation. In the ED the patient was noted to be hypoxic on room air with ambulation. BNP was mildly elevated at 1921. Chest radiograph demonstrated stable cardiomegaly without evidence of pulmonary vascular congestion. There was no evidence of pulmonary infiltrates bilaterally. Patient was started on DECADRON and transferred to hospital for admission.  While at Hospital, the patient remained saturating normally on room air both at rest and with activity. He remained afebrile. CRP was mildly elevated at 40.2 and D-dimer was normal. Remainder of labs remained unremarkable. He was not a candidate for remdesivir. Patient continued his home Eliquis for DVT prophylaxis while inpatient. Patient's short hospital stay was complicated by hyperglycemia, likely steroid induced. He received a dose of Lantus 10 units and was treated with moderate dose Humalog with improvement of blood sugar.  Rehab evaluated the patient on 10/11 and he was not requiring oxygen with ambulation. Given patient was feeling back to normal he was discharged without dexamethasone and referral was made to covid at home program.
Pt developed chills, sweats, nausea and syncope shortly after vaccine given. Pt was taken to ER. An exam, bloodwork, EKG, CT Scan, IV fluids were done. Results normal. Pt was discharged home and given scripts for ANTIVERT 50mg and LORTAB 5/500mg.
hive like rash shoulder to wrist. not raised. burning sensation in the neck, arm, and abdomen on one side.
Information has been received as part of a pregnancy registry from a nurse practitioner concerning a 15 year old caucasion female with food allergies to coconut and mushrooms and a of history migraines, streptococcal infection and pharyngitis who on 20, Nov 2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast), 0.5 mL by intramuscular injection, first dose (lot# 6539381/0954F). Concomitant medication included (CLARITIN) and (NASONEX). On 20, Nov 2006, the patient indicated that her last period was one week ago (13, Nov 2006). On 05, Dec 2006, the patient was seen in an clinic with complaints of nausea and dizziness and had a positive urine pregnancy test at that time. On 11, Dec 2006, the patient underwent and ultrasound which revealed that she was 7 1/2 weeks pregnant. CRL 10.4 mm, positive fetal heartbeat. Additional information is not expected.  This is in follow-up to report(s) previously submitted on 4/6/2007. On 08-JAN-2007, the patient was placed on therapy with PHENERGAN, 25mg, one every 4 to 6 hours for the treatment of nausea and vomiting. Follow-up information was received from a certified medical assistant. On 30-JUL-2007, the patient delivered a liveform female infant (8 pounds, 2 ounces). The infant was normal and there were no congenital anomalies. No further information is expected.
was given shingles vaccine 3 days after moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (was given shingles vaccine 3 days after moderna vaccine) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concomitant products included METFORMIN and GLIMEPIRIDE for Diabetes, LOSARTAN, LINACLOTIDE (LINZESS), OMEPRAZOLE, GABAPENTIN (NEURONTIN), POTASSIUM CHLORIDE, HYDROCHLOROTHIAZIDE and LEVOTHYROXINE for an unknown indication, Diclofenac.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (was given shingles vaccine 3 days after moderna vaccine). At the time of the report, HERPES ZOSTER (was given shingles vaccine 3 days after moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
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 15-OCT-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: L010595, expiry date: 12-NOV-2016 (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.
I gave injection in L deltoid.   It resulted in a little bleeding on arm.   I got it bandaged and pt had immediate reaction .   Pt got very dizzy, tingling in hands + feet,  flushing in her face .  Nurse and Dr. examined the pt .  Pulsen was Fine but some hyperventilation  .  First aid paramedics were called.
Being Covid vaccinated, break to Covid and he is positive; Being Covid vaccinated, break to Covid and he is positive; This is a spontaneous report from a contactable consumer (parent). A 16-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EP6955), dose 1 via an intramuscular route of administration on 26May2021 (at the age of 15-years-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported by primary source- Being COVID vaccinated, break to COVID and he is positive on an unspecified date. Lab test included Sars-cov-2 test positive on an unspecified date. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
lt thigh red, swollen, tender to touch & painful;APAP & subsequently APAP w/codeine;covering MD saw only swollen, not red, no induration, tender +4;slept well & improving by AM;
This spontaneous report was received from a registered nurse and refers to multiple patients of unspecified age and gender. No information regarding the patients' medical history, concurrent conditions, drug reactions or allergies was reported. On an unspecified dates, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB (lot # K008874, expiration date: 23-FEB-2017 and K026533, expiration date: 07-AUG-2017; dose, route of administration and anatomical location were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
w/in 24hrs of vax pt had t103,vomiting,diarrhea & malaise;these sx lasted 3 days;mom described pt as being very sick;mom stated would take pt to ER or MD but couldn't afford it;mom requested exempt from further vax;medical exempt given
The patient experienced a sharp "nerve" pain immediately at the injection site. She reports that the pain has radiated down her arm to her hand. She reports that this pain has been pretty consistent for the past week.
Patient wanted Shingles vaccine and received Flublock instead. Currently not having any symptoms. Has had flu vaccine in the past
Symptoms of redness, heat, swelling, and pain of right arm just below the injection site of KINRIX at approx. 7pm on the date of the injection. Symptoms progressed down the arm nearing the elbow at the time of assessment which was 8/9/18 at approx. 3:30pm. Child was evaluated in clinic and above symptoms noted were present. Child guarding arm and reluctant to allow nursing staff to assess. Mother was encouraged to used cold packs, otc pain reliever, and otc anti-histamine. Spoke with mother 8/10/18 at 8:40am, she reports child is sleeping and is slightly improved, denies fever.