chrisvoncsefalvay/vaers-outcomes huggingface dataset:
History of fever (up to 103), dry heaves for 3 days before hospitilization. Admitted to hospital on 1/21 with continued fever & dry heaves, & on 1/22 developed seizures and status epilepticus, & required mechanical ventilation for approx 24 hours, & developed pneumonia.  02/15/2008 MR received for DOS 1/22-2/1/2008 with D/C Dx: Increased seizure activity.  Aspiration pneumonia. Pt presented to ER with fever, decreased po intake, dry heaves and crying. No seizures noted in admission H&P however pt developed prolonged seizure activity requiring intubation.  Pt was found to have aspiration pneumonia.  Pt was extubated after several days and remained seizure free until 1/31/2007.  Pt developed seizure activity (generalized tonic-clonic) lasting ~3 minutes. Txd with abx and seizure meds adjusted.  Seizure free and afebrile x 48hrs prior to d/c.
No symptoms or additional adverse effects reported.; Patient received first dose in MMR II immunization series that was administered past its expiry.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous durg reactions or allergies, and concomitant medications were not reported.  On 07-JUL-2020, the patient received an expired first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, at a dose of 0.5 milliliter (ml) (vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number R025335, which has been verified to be valid, expiration date reported and validated as 06-APR-2020) as prophylaxis (expired product administered).  As concomitant therapy, a sterile diluent (MERCK STERILE DILUENT) (lot number S008564 which has been verified to be valid, and expiration date reported and validated as 05-AUG-2021) was used to reconstitute the vaccine. No additional adverse effects were reported.
Between Aug90 + Nov90 pt vax 3rd hepta B from expired lot. No adverse reaction.
No additional AE; temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 12-MAY-2023, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (lot#: W014513, expiration date: 26-JAN-2025; strength, dose, route of administration, and anatomical location were not reported) for prophylaxis. The vaccine administered experienced temperature at 52.86 F for 96 hours (product storage error). No additional adverse events (AE) (no adverse event).  This case was received from the same reporter with the case 2305USA005519. ; Sender's Comments:  US-009507513-2305USA005519:
abdominal cramping, nausea, and vomiting, and headache within 1 hour of receiving the second dose of the Moderna COVID-19 vaccine.  Took Benadryl and was observed for 45 minutes.  Began feeling better 2 days later.
covid test date=22Jan2022 / covid test result=Positive; covid test date=22Jan2022 / covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 15:00 (Lot number: FJ8762) at the age of 45 years as dose 3 (booster), single, administered in arm left, administration date 19Apr2021 11:00 (Lot number: EN6208) as dose 2, single and administered in arm left, administration date 27Mar2021 11:00 (Lot number: EW0161) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Jan2022, outcome "unknown" and all described as "covid test date=22Jan2022 / covid test result=Positive". The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) unknown results; hysteroscopy: (unspecified date) unknown results; sars-cov-2 test: (22Jan2022) positive, notes: Nasal Swab; ultrasound scan: (unspecified date) unknown result. clinical course: Patient did not received any other vaccine in four weeks. Patient had no covid prior vaccination, but was diagnosed post vaccination. Patient did not had any known allergies.
I received flu vaccine (3 in 1) around 3PM 10/15/10. By 8PM that night, I was crying uncontrollably, angry, homicidal, suicidal - completely out of control - an acute psychosis of some sort. By Sunday AM 10/17/10 I was completely fine.
Flushot given around 11AM? About 3 hours after flu shot-started coughing and had a "tickle" in my throat, cough became more frequent, then heart rate up to 100-110. Felt like my throat was swollen, trouble swallowing. Gave myself 50mg of Benadryl and cough began to subside about 30min after. Swollen throat began to feel better a few hours after Benadryl. Later that evening started with fever (102-103F) and chills. Took 650mg Tylenol. Cough had completely subsided by then and throat was much better. Felt completely fine in the morning (no fever, chills, coughing, swollen throat).
Pt recvd 3 doses of Engerix-B vax & titers were checked 6 months p/last dose; titer result was 5.0, indicating a low pos response;
Extreme pain at injection site, slight redness. Pain reached peak two hours after onset and decreased in intensity 24 hours after onset. Pain disappeared 48 hours after onset.
First Moderna vaccine administered 12/23/2020. On or about 12/24/2020 paresthesia began in forearm and upper. On or about 12/28/2020 mild to moderate 5/10 began of left shoulder radiating down to left arm, x-rays were done on left shoulder and humerus. No acute findings noted. Few days later Medrol dose pak was ordered due worsening pain of left upper back, left arm and hand. 01/19/2021 telemedicine with MD to get stronger pain medication. Norco 10/325 mg was prescribed.  1/20/2021 second Moderna was given. ~pain 8/10 started morning of 1/21/2021. I used heat/ice therapy and Norco pain decreased to 7/10. Morning of 1/22/2021 pain ( upper back entire left arm and left chest wall) became unbearable thus, went to ER to rule out heart attack. I was admitted for pain management and cardiac monitoring. CT of the c-spine and t- spine was ordered. No acute findings. Discharged to home. Discharge to home with carbamazepine. My PCP, ordered MRI of c- spine and t- spine. Multiple levels of small herniations in c-spine  reported. Appt with ortho physician 1/27/2020. He recommended neck injections which is  pending at this point.   Continue with pain 7/10 and  numbness of digit 4 and 5 left hand
This spontaneous non valid report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with improperly stored dose of (Oka-Merck) PROQUAD lot # reported as N019282, expiration date 09-JAN-2019 and (Oka/Merck) VARIVAX lot # N021581, expiration date 09-AUG-2019 (for both strength, dose number, route and anatomical location were not provided). The vaccines were reconstituted with properly stored sterile diluent (MERCK). Administered dose of (Oka-Merck) PROQUAD and (Oka/Merck) VARIVAX experienced the temperature excursion of -9 Celsius degrees to 8 Celsius degrees (also reported as 7.3 Celsius degrees) for 1 hour and 9 minutes. There were no previous excursions reported. The digital data logger was involved. No adverse effects were reported. Upon receipt of follow-up information it was determined that this case is now valid because the patient identifier was received. Follow up information has been received from a nurse on 12-JUN-2018 and refers to a 4-year-old patient on an unknown gender. On 30-JAN-2018, the patient was vaccinated with improperly stored dose of (Oka-Merck) PROQUAD lot # N019828 with expiration date: 09-JAN-2019 (previously reported as N019282) and (Oka/Merck) VARIVAX lot # N021581, expiration date: 09-AUG-2019. This is one of six reports received from the same reporter. Albumin status for (Oka-Merck) PROQUAD for lot # N019828 has been verified as recombinant human albumin (rHA). Sender's Comments: US-009507513-1801USA006139: US-009507513-1806USA007939: US-009507513-1806USA007940: US-009507513-1806USA007936: US-009507513-1806USA007937.
Patient received a vaccine after it's BUD from storage in the refrigerator.  BUD was 12/21/22, Given 12/29/22, called and alerted patient. patient is fine and appreciates reach out.. Does not want to pursue getting another booster.
This spontaneous report as received from a nurse refers to unspecified patients of unkonwn demographics. No information about medical history concurrent conditions and concomitant medications was reported. The reporter stated that it is possible that GARDASIL (dose, strength, route, was not reported) dose was administered to the patients on an unspecified date after a cumulative temperature excursion of 123 hrs at 10C. No adverse effect reported. The outcome of the events reported is unknown. No product quality complaint was involved. Nurse also informed that with multiple excursion for three different sites with the vaccine reported. Nurse requested letter of evaluation data by e-mailed to her. It was also reported that adverse event was filed as one site may have administered product involved in cumulative excursion. No product quality complaint. 10C was sum or total 122.5 hours GARDASIL. No product was received January 2014. 9C for total 31 hours GARDASIL. No excursion. 1.2C for 11 hours GARDASIL Yes. This case is linked to the cases 1404USA015151, 1405USA005086, 1405USA005088 via same reporter link. Additional information is not expected.
felt " it run "up her throat and down to her chest causing chest pains; This case was reported by a consumer via call center representative and described the occurrence of chest pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received first dose on an unknown date.).   In November 2020, the patient received the 2nd dose of Shingrix (intramuscular). In November 2020, 7 hrs after receiving Shingrix, the patient experienced chest pain. The patient was treated with benadryl (nos) (Benadryl). In November 2020, the outcome of the chest pain was recovered/resolved.   It was unknown if the reporter considered the chest pain to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. About 7 hours after receiving the second vaccine, the patient felt it run up her throat and down to her chest causing chest pains. She called 911 because she thought she was experiencing a heart attack, then she reported it was not a heart attack. The event was recovered after 24 hours of vaccination. The patient was given Benadryl and sent home. The patient did not consented to follow up.
ARM IS STILL TENDER; SORE ARM; PAINFUL VACCINATION; This spontaneous report received from a patient concerned a female 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: 1805022, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 14:50 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced arm is still tender. On 12-MAR-2021, the subject experienced sore arm. On 12-MAR-2021, the subject experienced painful vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm is still tender, had not recovered from sore arm, and the outcome of painful vaccination was not reported. This report was non-serious.
Initial unsolicited report received from a consumer (patient) on 19-OCT-2017. This case involves a 56-year-old female patient who was vaccinated with a 0.5 ml single dose of FLUZONE QUADRIVALENT (batch number, expiry date and site of administration was not reported) via intramuscular route on 01-NOV-2015. The patient's medical history was not reported. No other vaccines were taken. On an unknown date, after vaccination, it was stated that patient had muscle pain and aches for one week after vaccine and two weeks later she had muscle atrophy in bilateral quadraceps and now it has spread to her arms. Patient was going to have muscle testing done as lab tests. Corrective treatment were not reported. Outcome of the event was not reported. List of documents held by sender: none.
Injury at work; Had issues getting blood with veins during iron infusions; Infusion associated discomfort; Pain; Fatigue; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENT AT WORK (Injury at work), BLOOD IRON DECREASED (Had issues getting blood with veins during iron infusions), INFUSION RELATED REACTION (Infusion associated discomfort), PAIN (Pain) and FATIGUE (Fatigue) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 06-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ACCIDENT AT WORK (Injury at work), BLOOD IRON DECREASED (Had issues getting blood with veins during iron infusions), INFUSION RELATED REACTION (Infusion associated discomfort), PAIN (Pain), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, ACCIDENT AT WORK (Injury at work), BLOOD IRON DECREASED (Had issues getting blood with veins during iron infusions) and FATIGUE (Fatigue) had not resolved, INFUSION RELATED REACTION (Infusion associated discomfort) outcome was unknown and PAIN (Pain) and VACCINATION SITE PAIN (Vaccination site pain) had resolved.     Concomitant product use was not provided by the reporter.  The patient had issues getting blood with veins during iron infusions, fatigued, cut self at work, sore after covid-19 vaccine, iron being low, and arm hurt after covid booster with Humira (Adalimumab).   On unknown dates, the patient experienced had issues getting blood with veins during iron infusions, fatigued, cut self at work, sore after covid-19 vaccine, iron being low, and arm hurt after covid booster. on unknown dates, sore after covid-19 vaccine and arm hurt after covid booster resolved.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment information was not provided.  The reporter's causality for Humira (Adalimumab) for the events of had issues getting blood with veins during iron infusions, fatigued, cut self at work, sore after covid-19 vaccine, iron being low, and arm hurt after covid booster causality was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Fever, missed 2 days of work; Chills, missed 2 days of work; missed 2 days of work; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever, chills and activities of daily living impaired. On an unknown date, the outcome of the fever and chills were unknown and the outcome of the activities of daily living impaired was recovered/resolved.   It was unknown if the reporter considered the fever, chills and activities of daily living impaired to be related to Shingles vaccine.     Additional Information: GSK receipt date: 02-OCT-2022 Reporters comment: This case was reported by a consumer via (interactive digital media  First vaccine was terrible. Fever, chills and missed 2 days of work. Almost afraid to get the second one.
Shortness of breath; extreme tiredness; sore at injection site; sweating; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 52-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 22Feb2021 at 13:45 (01:45 PM) (at the age of 52-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included COPD, asthma, adrenal insufficiency, ADHD. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within four weeks. Patient was not diagnosed with COVID prior vaccination. Patient was not COVID tested post vaccination. The patient previously took amoxicillin and experienced drug allergy. On 23Feb2021 at 06:00 AM, the patient experienced shortness of breath, extreme tiredness, sore at injection site, sweating. The patient did not receive treatment for the events. Outcome of the events was unknown.  Information of lot number is requested.  Follow-up  18May2021): Follow-up attempts completed. No further information expected.
Patient received COVID-19 vaccine for ages 5 to <12 years, dose #1 at Pharmacy on 11/11/21 and dose #2 at Affiliated Physicians on 12/06/21. Patient was noted to experience tachycardia at rest at home on 12/07/21, without any pain, fever, nor recent illness. Patient reports he has experienced this since 12/03/21, but only reported it to his parent on 12/07/21. Tachycardia to 128 was noted when seen by this reporter in the school based health center.
Pt began to feel fatigue and anorexic the day after administration.  This became progressively worse and then developed chills and rash on day 4. On day 5 awoke with swollen face, temp 101.3 in office and erythematous rash on face and slight on left upper arm and upper chest. Was seen in the office at that point and recommended to initiate Benadryl 50mg every 6 hrs for 48 hrs.  Her fever was gone the next day and the swelling and rash subsided within 2-3 days.
body aches, abdominal pain Narrative:  Reports had first covid 19 vaccine on 3/26. Reports 2 days later started having headache, dry cough, fever, sweats, body aches, and nausea and vomiting. States continues to have above symptoms, has been tolerating only clear liquids.
pallor, diaphoresis, sl dry BP w/in 1-2min, lasted <5min-responded to lying w/leg elevated;no other intervention;impression-probable vasovagal rxn;
4 inch red swelling; 4 inch red swelling; 4 inch red swelling and itching; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (4 inch red swelling), SWELLING (4 inch red swelling) and PRURITUS (4 inch red swelling and itching) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced ERYTHEMA (4 inch red swelling), SWELLING (4 inch red swelling) and PRURITUS (4 inch red swelling and itching). At the time of the report, ERYTHEMA (4 inch red swelling), SWELLING (4 inch red swelling) and PRURITUS (4 inch red swelling and itching) had resolved.            No concomitant product reported by reporter.  Patient had 4 inch red swelling and itching lasted 4 to 5 days.  No treatment medication reported by reporter.
Hives. This patient experienced another event which is captured in case number 209-05563.
Smallpox vaccination and subsequent major reaction, scab took over four weeks to detach. Following detachment, site was still erythematous and pruritic and there was persistent axillary lymphadenopathy. 4/27/03 site became indurated and was raised, however no lymphadenopathy. Evaluated by an Infectious Disease physician on 4/29/2003: 0.8 cm area of erythema on scar, indurated, raised non-tender, large flat vesicles in the area. Specimens were collected from the site and tested for vaccinia.
pt recv vax 7AUG97 & on 13AUG97 pt presented on front & back w/a varicella like rash which was described as very minute in size, almost like a drug rash;
45 minutes after the injection the patient had swelling of the upper left arm with pain. The area was 3 in x 4 in. Ice was applied to the site and the patient was referred to community care clinic where she was instructed to continue ice and was gived Motrin and Ultram for pain.
ACUTE PULMONARY EMBOLISM 2/27/2023 ANEMIA HYPOTENSION 2/22/2023 ANEMIA ACUTE PULMONARY EMBOLISM 2/27/2023 ACUTE PULMONARY EMBOLISM HYPOTENSION 2/22/2023 ACUTE PULMONARY EMBOLISM ACUTE PULMONARY EMBOLISM 2/27/2023 ADENOCARCINOMA, PANCREAS, UNSPECIFIED SITE HYPOTENSION 2/22/2023 ADENOCARCINOMA, PANCREAS, UNSPECIFIED SITE ACUTE PULMONARY EMBOLISM 2/27/2023 SUBACUTE LOW BACK PAIN 1 - 3 MONTHS HYPOTENSION 2/22/2023 SUBACUTE LOW BACK PAIN 1 - 3 MONTHS
Shakes, low fever, gi pain, diarrhea, fatigue, felt freezing cold
Patient had a small raised bump on his arm at injection site. It went down with an ice pack. Patient was not distressed and did not have any other symptoms.
A blotch red ring developed around the upper arm. The rash had localized pain and itching. painful for 2 days. Treated with Tylenol, Motrin, and Benadryl tabs.
Shortness of breath; I didn't had much of an appetite so I lost 4-5 pounds; I had cold, chills and then sweat; Coumadin number was way high, way elevated; I didn't had much of an appetite so I lost 4-5 pounds; I had cold, chills and then sweat; With the nausea I didn't had much of an appetite so I lost 4-5 pounds; Fatigue; Dull Headache; I had cold, chills and then sweat; This is a spontaneous report from a contactable consumer, the patient.  A 71-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: ER2613), via an unspecified route of administration on 20Mar2021 as dose 1, single (age at vaccination 71 years) for covid-19 immunisation. Medical history included congestive heart failure, atrial fibrillation, prediabetes , osteopetrosis since an unknown date. Concomitant medication(s) included warfarin sodium (COUMADIN); diltiazem taken for heart congestion; alendronate sodium (FOSAMAX) taken for osteopetrosis; metformin taken for glucose tolerance impaired; atorvastatin; metoprolol; lisinopril all since an unknown date. On an unknown date in 2021 the patient had shortness of breath, had nausea, and was fatigued very fatigued, had cold, chills and then sweat, had a dull headache and with the nausea didn't had much of an appetite so lost 4-5 pounds and this was over two weeks period after the second shot. The patient was also on Coumadin and she had gone in 6 days later for her regular Coumadin checkup and her Coumadin number was way high, way elevated on an unknown date in 2021. The patient underwent lab tests and procedures which included drug level number for Coumadin was way high, way elevated on an unknown date in 2021. The patient was now fine. The outcome of the events was recovered for shortness of breath and unknown for the rest of the events.  No follow-up attempts are needed. No further information is expected.