chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever of 100.3; arm became sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm became sore) and PYREXIA (fever of 100.3) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 virus test positive in December 2020.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm became sore). On 03-Feb-2021, the patient experienced PYREXIA (fever of 100.3). At the time of the report, PAIN IN EXTREMITY (arm became sore) and PYREXIA (fever of 100.3) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.3 (abnormal) 100.3. On an unknown date, Coronavirus test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
23 patients received expired dose of the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (23 patients received expired dose of the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (23 patients received expired dose of the vaccine). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (23 patients received expired dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported.  No treatment medication details was reported.  The reporter believes the vail was initially stored in the refrigerator on 19 Oct 2021. the vial had not underwent any temperature excursions.   This case was linked to MOD-2021-373198 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Follow-up received on contains non significant information
VASCULAR ISSUES; COGNITIVE ISSUES; DEPRESSION; COULD NOT MOVE FINGERS, THEY WERE LOCKED LIKE A CLAW, FINGERS NOT WORKING, FEET NOT WORKING PROPERLY; ACUTE PERIPHERAL NEUROPATHY; This spontaneous report received from a consumer concerned a 50 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient did not have any issues. It was reported that he was healthy as a horse and was not diagnosed with anything beforehand. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A and expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-JUL-2021 for covid-19 prophylaxis. Age at time of vaccination 50 years old. No concomitant medications were reported.  On 03-JUL-2021, day after receiving vaccine, patient could not move his fingers, they were locked like a claw. Patient could not walk or balance. He was a musician and was not able to play due to fingers not working. Patient could not take care of basic needs due to fingers. He went to several doctors and saw primary care physician who referred to neurologist and pediatrist because his feet were also not working properly. On an unspecified date, the patient was hospitalized for 5 days where they gave steroids and oxygen. Laboratory data (dates unspecified) included: Blood test not reported, and MRI showed demyelinating disease, 12x MRI. Patient was still seeing doctors, and was taking gabapentin (nerve medication). He was improving but still walking with cane, his fingers were moving but not normal. Patient experienced numbness and tingling in fingers and toes from vascular issues. Patient experienced cognitive issues, which caused changes in his behavior and inability to work. Patient was still having issues with dexterity, mobility, emotional stress, and depression. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from acute peripheral neuropathy, and could not move fingers, they were locked like a claw, fingers not working, feet not working properly, had not recovered from depression, and the outcome of cognitive issues and vascular issues was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220761785- covid-19 vaccine ad26.cov2.s-acute peripheral neuropathy, could not move fingers, they were locked like a claw, fingers not working, feet not working properly.  The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.  20220761785- covid-19 vaccine ad26.cov2.s- depression, cognitive issues and vascular issues . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Scalp is very itchy; Broken out in big whelps of flaky skin; whelps skin; This case was reported by a consumer via interactive digital media and described the occurrence of itchy scalp in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced itchy scalp, flaking scalp and welts. On an unknown date, the outcome of the itchy scalp, flaking scalp and welts were unknown.   It was unknown if the reporter considered the itchy scalp, flaking scalp and welts to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient itself. The age at vaccination was not reported. The age at vaccination was not reported but was captured as an adult as per vaccine indication. The patient's scalp was very itchy and has broken out in big whelps of flaky skin. The patient asked question, could this be from the injection.
Pt recvd vax & devel a sore arm & low grade fever; 2 days p/inject presented w/myalgias & an elevated CPK; pt was hospitalized for 4 days; CPK levels are decreasing but have not normalized as of yet;
A minute or 2 after receiving immunization, patient experienced dizziness/lightheadedness, warm feeling, fainting for a few seconds (less than 10 seconds, and no fall), hypotension (77/48). Donor was instructed to lie down with legs elevated, and given water and crackers. Donor's dizziness subsided shortly after fainting episode and all symptoms had resolved within 17 minutes. BP was 104/71 at that time. Donor left center with no further complaints.
Patient was siting in the observation area after received J&J vaccine. 2 minutes after talked to him and walked away from him, a  noise was heard and found patient on the flood in prone position unconscious. Quickly  reached to his side and noticed he has mild ( not violent) jerking movement.  911 was called. His ABC ( airway, breathing, circulation ) intact. No external injury was found. Patient regained consciousness   He was disoriented for a moment but soon became oriented. His initial vital signs  P 95; BP 146/64; Second one P96; BP 118/64; O2 Sat 98%. Paramedic arrived and patient was traported to hospital to be evaluated.
This case was reported by a nurse and described the occurrence of burning sensation skin in an adult female subject who was inadvertently exposed to Pediarix. On 2/24/06 at 11:30am an infant was receiving a dose of Pediarix, some of the vaccine was exposed to the mothers skin. The exposure caused burning. The skin was subsequently flushed with water. The outcome of the event to the mother was not reported.
NO Additional adverse effect reported; a patient was administered a dose of improperly stored PROQUAD that was diluted with Merck DILUENT that did not experience a temperature excursion.; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history was not reported.  On 28-JAN-2020, the patient was administered a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (lot # S012535 with expiration date: 20-OCT-2020; dose, strength and frequency were not reported) (incorrect product storage) that was diluted with merck sterile diluent (STERILE DILUENT) that did experience a temperature excursion subcutaneously for prophylaxis. No additional adverse effect reported.  The vaccine was stored under -14 Celsius degree to -10 degree (-12.6 degree) for 9 hours and 53 minutes. The previous temperature excursion was -14 degree to -10 degree (-13.00 degree) for 14 hours and 22 minutes. The digital data logger was involved.  This is 1 of 6 reports from the same reporter.; Sender's Comments:  US-009507513-2002USA001459: US-009507513-2002USA001517: US-009507513-2002USA001483: US-009507513-2002USA001480: US-009507513-2002USA001486:
The patient developed itching about 10 minutes after receiving her second dose of Moderna vaccine.  The itching spread up to her scalp and she notified the nurse.  The nurse asked her to remove her mask and her left side of her face, her lip, and her tongue had started to swell.  This progressed to some numbness on the left side of her body as well as her right hand.  She also developed a hive or two on her back.  The nurse wanted to administer epinephrine.  The patient refused, but she did accept benadryl 25 mg oral.  Then the nurse brought her next door to the emergency room.  The ER physician documented the patient was having an allergic reaction.  He administered 25 mg i.v. benadryl and gave the patient a prescription for a medrol dose pack if she needed it.  She did not end up needing it.  Her symptoms improved in the ER.  The patient was observed 90 minutes and discharged.  She states she went home and slept and when she woke she was fine.
This case was reported by a consumer and described the occurrence of Bell's palsy in a 40-year-old male subject who was vaccinated with Lymerix for prophylaxis. A physician or other health care professional has not verified this report. The reporter was the subject's mother. In 2001, the subject received the "complete series" of Lymerix (injection). In 2001, within months of vaccination with Lymerix, the subject developed Bell's palsy, depression, and dizziness. In approximately 2004 he developed diabetes, and in 2006 developed glaucoma and cataract. On an unknown date, he developed neuropathy. The reporting consumer stated that the subject "may have actually developed Lyme disease", noting that his health had deteriorated since. The consumer further reported that the subject had "not been able to work due to the toxicity caused by this vaccine..." This case was assessed as medically serious by manufacturer. At the time of reporting the events were unresolved.
On 03/10/2021 a poundinng headache began after approximately 5 hours, Tylenol was take to subside headache.  Then the following morning, 03/11/2021 I woke up with an swollen, red and irritated area surrounding the injection site. Approximately 2 inches in diameter.  Area was hard, red and swollen for the entire day and continued into the next day.  Photo was taken on 03/12/2021 of effected area.
Pt awoke this morning with redness and swelling in the upper arm that was vaccinated (left) that progressed throughout the day down to her elbow. She was seen in the ER on 6/2/13 for c/o of HA, nausea, neck pain, and swelling, redness, pain in (L) arm. Dx'd as arthus reaction.
UrticariaPruritus, Diarrhea, chills, congestion Narrative:  Other Relevant History:
negative antibody tests; This spontaneous report was received from a consumer referring to herm mother, a female patient of unknown age.      On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for prophylaxis (dose, route of administration, frequency, lot/batch # and expiration date were not reported).   The reporter referred that the patient did not make antibodies to the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) vaccine.   It was also reported that she did not make antibodies to vaccine (linked case # US-009507513-2107USA007803).  It was reported that the patient was vaccinated with PFIZER-BIONTECH COVID-19 VACCINE and finish her scheme of two doses in June 2021 (reported as "this year").  The outcome of antibody test negative was unknown.  No further clarify.   This one of two reports from the same reporter.; Sender's Comments:  US-009507513-2107USA007803:
8/26/12 -> Severe headache. 8/28/12 -> Bladder retention, weakness/numbness/tingling in legs (ascending). Admitted to hosp 8/29 -> 9/7/12. Tentative dx transverse myelitis. Readmitted 9/26 -> 10/1/12 with relapse. New MRI suggestive of transverse myelitis C3-C4.
Patient developed hive-like rash, abdomen, back, both arms both feet and legs.
patinet received doses from a vials greater than 12hrs at room temperature; patients received doses from a vial greater than 12hrs at room temperature; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (patinet received doses from a vials greater than 12hrs at room temperature) and EXPIRED PRODUCT ADMINISTERED (patients received doses from a vial greater than 12hrs at room temperature) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 07-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received doses from a vial greater than 12hrs at room temperature). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patinet received doses from a vials greater than 12hrs at room temperature). At the time of the report, PRODUCT STORAGE ERROR (patinet received doses from a vials greater than 12hrs at room temperature) and EXPIRED PRODUCT ADMINISTERED (patients received doses from a vial greater than 12hrs at room temperature) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.   The vial was initially stored in refrigerator on 14-Apr-2022. It was reported that patient received dose from vial which was at rom temperature for more than 12 hours.The vial was first punctured on 06-May-2022 around 9:30 AM and date of administration of vaccine was 07-May-2022 at 11:20 AM, 11:49 AM, 12:05 PM, and 12:30 PM. Post puncture vial was stored in room temperature.  Total amount of time the vial was exposed to room temperature range (8 degree to 25 degree Celsius which is equal to 46 degree to 77 degree Fahrenheit) was 29 hours.  No treatment medication information was given.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2022: Follow up received contains no new information
This spontaneous report was received from a registered nurse refers to 24 unspecified patients of unknown age and gender. The patient's medical history and concurrent conditions and concomitant medications were not specified. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (Merck) lot # L006383, expiry date 25-FEB-2017; lot # L005299, expiry date 17-FEB-2017, (dose and frequency not provided). No adverse effects were reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
He tried to get up from the couch to go lay down, but couldn't as he kept getting dizzy. It lasted for at least 30 mins. He eventually made it to his bed and laid down.
Within 5 minutes of receiving the vaccine my throat became itchy, my sinuses began to swell, a pressure headache began and I became congested. After about 20 minutes my face and lips became numb, my cheeks turned red and hot to the touch, my face started to swell and it felt like my blood pressure dropped, I became dizzy. I took 50mg of Benadryl within 30 minutes of the initial onset of symptoms. All symptoms were gone within an hour of taking the benadryl. Over the next couple hours I experienced discomfort/soreness at the injection site and that tattoo on the same arm as the injection site became raised, hot and itchy. As of 3/3/2021 the only symptom remaining is the soreness at the injection site.
itching at the injection site immediately following removal of needle, swollen and bruised arm, hardness at the injection site, dizziness, fatigue, headache, lack of appetite lasting 4 days (so far).
butterfly rash on her cheeks and nose; nausea; vomiting; headache; fever; swelling in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of BUTTERFLY RASH, NAUSEA, VOMITING, HEADACHE, and PYREXIA in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic. Concomitant products included INSULIN for an unknown indication.    On 06-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced BUTTERFLY RASH, NAUSEA, VOMITING, HEADACHE, PYREXIA, and VACCINATION SITE SWELLING. The patient was treated with TYLENOL for Adverse event, at an unspecified dose and frequency. At the time of the report, BUTTERFLY RASH, NAUSEA, VOMITING, HEADACHE, PYREXIA, and VACCINATION SITE SWELLING had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       Treatment included Ice.
received varicella immunization 10/2/00. office vist 9/24/06 with diagnosis of chicken pox after md assessment.  atarax for comfort
Small bowel obstruction History of DVT (deep vein thrombosis) History of anticoagulant therapy NAUSEA VOMITING BACK PAIN Leg Pain Abdominal Pain
2/5/14 - Shots given in the office PM 2/6/14 - Convulsions at home, went to ER and temp of > 104.5 degrees F around PM 2/10/14 - F/U in the office. T 101.7 F, (+) diarrhea.
This spontaneous report as received from a registered nurse refers to an unspecified number of patient of unknown gender and age. It was reported that since 24-JUL-2014, improperly stored doses of ZOSTAVAX (dose, dose number, route, lot/batch number, expiration date were not reported) were administered to unknown number of patients in approximately 2014. No adverse effects were noted. No product quality complaint (PQC) involved. This is one of several reports from the same source. Additional information has been requested.
Possible administration of expired vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Possible administration of expired vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Possible administration of expired vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Possible administration of expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Possible administration of expired vaccine).    No concomitant medications was reported. It was reported that may be possible administration of expired vaccine but want to check an expiration date for Moderna Monovalent vaccine. When asked if expired vaccine was administered HCP initially stated no, then answered that's what they were trying to find out.  No treatment drug details was reported.   Reporter did not allow further contact
ear infection; This is a spontaneous report received from a contactable consumer (Patient) or other non HCP.  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as first dose single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient had ear infection last week and he was taking antibiotic for the past five days for adverse event. patient wanted to know if it was safe to take the second dose vaccine. Patient scheduled to get the second dose of the Covid19 vaccine on 13Mar2021. The outcome of event was unknown.     No follow-up attempts are possible; information about lot/batch number cannot be obtained
Pt says her arm was sore after the injection. She states she tried to use it as instructed.   There was no redness or warmth at the site after the injection.After two weeks she was unable to lift her arm above  the shoulder. Pt has been instructed to contact her personal physician and start physical thearphy as soon as possible.
pt recvd vax on 9DEC92 & taken to ER; MD in ER said inject site was infected; placed on ATB phone call from mom states pt all better now;
Left leg red swollen from immunization 15-20cm, local reaction vs immunization reaction but getting worse. Hot packs, Duricef 250/5
SORE ARM AND WITH ACHES HOURS WITHIN RECEIVING VACCINE. TWO DAYS AFTER VACCINATION, NAUSEA/VOMITING/DIARRHEA PRESENTED WITH FEVER.
Post vax, mother described tonic clonic seizure appox 1 min in duration.