chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received 1st dose of Moderna COVID-19 vaccine on 1/27/2021 (patient did receive 2nd dose on 2/24/2021).  Patient vacations  during winter and was scheduled to come back in April of 2020, however, due to pandemic travel restrictions was unable to return home until October of 2020.  Patient was seen in ED on 2/2/21 for UTI.  On 2/4/21 patient returned to ED with chief complaint of headache.  ED note states patient was fine at previous visit but during this encounter she had an altered mental status.   Patient is admitted due to encephalopathy secondary to focal status epilepticus, for which she is discharge with a new prescription for Keppra for seizures, and possible UTI.  Test revealed high IgG for  virus (IgG is present during prolonged infections, while IgM is present at infection start and little IgM was found).  No seizure activity on EEG after initiation of anti-epileptic therapy with gradual improvement in mentation back to baseline. Etiology of seizure disorder unclear. This event followed a COVID-19 vaccine and another case of status epilepticus was seen for another patient who had just previously received the vaccine, prompting the suspicion this could be related to the vaccine.
Localized reaction - with erythema, (7 x 10 cm) induration & itching started within hours of vaccination.
-burning sensation feltpost20mins on left deltoid -vitals as follows @3:06 pm : BP 140/97 PR 118  O2Sat 100% -Client complained of nausea & lightheadedness -Client referred to, and seen by MD on duty -@ 3:40 pm BP 123/86  PR 107  O2Sat 100% -client was advised to have somebody pick her up -clients felt fine to walk -burning sensation felt post 20 mins on left deltoid -client complained of nausea & lightheadedness -initial V/S as follows : BP 140/97  ,PR 118 , O2Sat 100% , RR30 -Vital signs checked -kept comfortable. Water & hard candy provided -client referred to MD on duty, was advised to have somebody pick her up -MD walked with client around the room , client felt okay to walk -Vitals as follows before leaving : BP 123/86 , PR 107 . O2Sat 100%  RR 26 -Client health teaching provided regarding side effects VS adverse effects  with mother by her side -client was driven by her mother
PCV13 accidentally administered instead of PPSV23. PPSV23 then administered. Pt had to return to clinic to receive the PPSV23. Virtual visit to be conducted 11/19 for follow up.
Dizziness and mild disorientation within 24 hours of vaccination. Resolved on its own.
After receiving Moderna Bivalent covid-19 booster vaccine on 10/24/2022, patient experienced 2 near-syncope events around noon the following day, 10/25/22.  One occurred in his bed, and the 2nd one occurred in the bathroom which resulted in a fall.  He was transferred via ambulance to the local Hospital emergency department for evaluation and subsequently admitted with hyperkalemia, acute on chronic kidney injury, tachypnea, and tachycardia, with generalized weakness and ambulatory dysfunction. Per hospital records, it was felt that the tachycardia and tachypnea were related to the bivalent booster vaccine.
The patient has itchiness and swelling at the site of the injection. She has had the symptoms for a week and has been taking BENADRYL to treat.
This report describes the occurrence of "classic symptoms of autism" in a 13 year old female who was vaccinated with hep B vaccine (manuf unk) for prophylaxis. This report was received from the subject's mother and has not been verified by a physician or other health care professional. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On 7/25/00, the subject reportedly received her first injection of hep B vaccine (manuf unk). It was reported that the subject subsequently received her second and third injections of hep B vaccine on unspecified dates. The mother stated that at an unspecified time after the third injection of vaccine, her daughter experienced "classic symptoms of autism," which she stated, "are similar to mercury poisoning." As of 12/2/02, the symptoms reportedly persisted. The reporter declined to provide additional info and declined to grant manufacturer authorization to contact the subject's physician. Therefore, additional info will not be available. The "classic symptoms of autism" in this report are considered medically serious (OMIC).
This spontaneous report was received from a Registered Nurse regarding an unspecified patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date in January 2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (dose strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 10-JUL-2021) dose was not reported, administered on 13-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-JUL-2021, the subject experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious.
Severe chills, body aches, headache, mild fever, 9PM to 11PM, Motrin 400mg.
Patient woke up the morning of Saturday 3-19-05 and noticed a fine red raised rash to bilateral arms and upper trunk of body, after receiving tetanus shot and TB test on 3-16-05.  Patient denies any itching, shortness of breath or any other distress.
Complained of itching and warmth of upper body. No wheezing, shortness of breath, or skin eruptions noted. Benadryl 50mg given PO stat.
pt recv vax 11OCT96 & 8-9hr later pt remained sleeping;the rescue squad arrived & pt was limp;@ ER pt was OK;no tx given;pt resolved by 15OCT96;
Diarrhea; Vomiting; Nausea; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), VOMITING (Vomiting), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Clotting disorder (Blood clotting disorder since past 20 years and never had an issue before the vaccine.) and Encephalitis (Regular MRI scan was scheduled months back which detected encephalitis, stroke and stated as totally asymptomatic.). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), VOMITING (Vomiting), NAUSEA (Nausea) and CHILLS (Chills). On an unknown date, the patient experienced HEADACHE (Headache). The patient was treated with CLOPIDOGREL BISULFATE (PLAVIX) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), VOMITING (Vomiting), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (Headache) had resolved.            This case was linked to MOD-2021-101983 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up information received contains non-significant information. On 11-Jun-2021: Follow-up information received contains non-significant information.
pt recvd vax 11JAN93 @ 630PM & next morning when awakened was perspiring profusely, t101-103, chilling, aching, severe h/a, jaundiced on 15JAN93 in ER; adm to hosp 15JAN93-d/c 20JAN93;
slightly raised red area; swelling at the site of the injection; soreness in the arm; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of   in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Insulin dependent diabetic.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        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.   No treatment information was provided.  No concomitant medication was provided.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of VAQTA (25 U) (dose, route and lot not reported) and approximately 4.5 months later the patient was vaccinated with the second dose of VAQTA (dose, route and lot not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms reported. Additional information has been requested.
Sore throat, nausea, fever hoarse, coughing, sore muscles, ear pain x 4 days.
04/07/2021 evening clammy, 99.-100. fever, chills, sweats, asthma flare up started, self care of inhaler for relief and lungs constantly hurting, got sick, lethargic, and fatigue.   A week later went to the urgent care who referred to the ER. Xray and EKG and observation and waiting for the results and prescribed Phenazone.
inddividual had a reaction of hives across back and down his right arm about a week and a half after vaccination
Lesions noted 2 days prior to visit - described as different crops of lesions at one time from papular and urticaria - like to vesicles, some popped out and crusting.
This spontaneous report as received from a medical assistant refers to three unspecified patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 02-MAR-2018 to 13-APR-2018, the patients were vaccinated with improperly stored Oka-Merck PROQUAD (dosing details were not reported) (lot # N028444, expiry date: 09-APR-2019) for prophylaxis the vaccine was administered with properly stored MERCK STERILE DILUENT (product storage error). The vaccine was stored at a temperature of -14 degree Celsius to -10 Celsius (-9.9 degree Celsius) for 17 hours and 11 minutes. No previous temperature excursions reported. No adverse effects reported. No product quality complaint involved. This is one of the two reports received from the same reporter. This is non-valid report due to lack of patient identifiers. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. Follow up information was received from medical assistant on 21-JUN-2018. Patient identifier was updated. On 12-MAR-2018, the patient was vaccinated with improperly stored Oka-Merck PROQUAD (lot # N028444, expiry date: 09-APR-2019) for prophylaxis. Sender's Comments: US-009507513-1804USA007217: US-009507513-1806USA011869.
Patient came in for second dose of Moderna vaccine. on Friday 6/4/2021.  Dose administered at 10:25am.  Patient counselled to remain in area for 15 minutes.  Temperature outside 85 degrees; temperature warm in immunization tent.  Patient left immunization tent at 10:26am, passed the check-in table, immediately turned back around because he felt dizzy.  Patient passed out, grabbed metal television stand on the way down, and hit his head on the metal bar on the way down to the floor.  Patient was unconscious for 30 seconds.  Patient had a normal pulse.  Awoke and remained on floor with health care personnel for 10-15 minutes.  Patient was sweating. Moved to chair with arms for 15 min.  Drank water, cooled down, had a drink of orange juice, ate pretzel.  Patient refused ambulance.  Patient left under own power approx 11:15am.
Developed headache, nausea, dizziness, weakness.  Did not feel well enough to remain at school and was picked up by parent.  At approx 1:00 p.m., taken to ER.  ER Impression:  Drug Reaction / Anxiety.  Returned to school 2 days later on 12/9/09.
p/ pt recv vax approx 2yr later lab evaluations revealed pt failed to seroconvert
Right after giving HPV pt became light headed, pale, diaphoretic, nearly fainted.  Laid pt down and monitored x 1 hour, until she was symptom free.
At 1415, patient was experiencing tachypnea. Assessed patient and completed vitals. Patients BP 155/72, HR: 74, O2: 97%, RR:23 1418: Dr. paged, no answer 1426: Dr. paged overhead  1429: Dr. arrived at vaccine clinic and assessed patient. Gave a verbal order for Benadryl 25mg PO. 1429: BP: 133/82 HR 71 O2 97% RR: 24 1434: patient received benadryl 25 mg PO 1440: patient dry heaving Monitored patient throughout and at 1505 patient states she is feeling better and all symptoms have subsided. She states she has anxiety receiving the vaccine due to it being a mandate from her employer. Patient feels she is ready to go home.  1524: BP 123/74 HR 55 O2 99 RR 18  1525: patient discharged
began to feel foggy headed which came and went on day 2. On day 3 the foggy head also came with nausea. Persisted off and on all day. When I went to bed around 11:30 pm that day I began to feel like I was inside a closed up box. This persisted and disappeared around 3 am on the 4th morning and hasn't returned
3/9/12 Reports fever, chills, aches in back & joints. 3/10/12 Mild rash on face & trunk. Rash increased in area and color on 3/11 & 3/12. Fever & aches decreased by 3/12. Had taken Ibuprofen. 3/14/12 Rash resolved 3/12. Back ache may be due to pulled muscle.
Resident noted as having lethargy, difficulty in arousing from sleep & napping periods. No reports of pain or discomfort from resident. Resident c/o sleepy and wanted to rest. Appetite - poor; c/o nausea loose stool. Agonal breathing, pallor, no pulse note 5/28/22 in AM. Pronounced @ 9:33/AM
immunocompromised patient given 0.25ml instead of full dose; expiration date 18Mar2021; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient given 0.25ml instead of full dose) and EXPIRED PRODUCT ADMINISTERED (expiration date 18Mar2021) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 03-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient given 0.25ml instead of full dose) and EXPIRED PRODUCT ADMINISTERED (expiration date 18Mar2021). On 03-Dec-2021, ACCIDENTAL UNDERDOSE (immunocompromised patient given 0.25ml instead of full dose) and EXPIRED PRODUCT ADMINISTERED (expiration date 18Mar2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
patient is having elevated BP readings (without history of BP issues), weakness (generalized), fatigue (severe) and nausea/vomiting.
Patient received Moderna vaccination at approximately 10:30 am. After about 10 minuts she started to feel vertiginous, short of breath, had heart fluttering and itchy. She was found to be neurologically intact. Her O2 was found to be 99% on room air, her blood sugar was normal and no labored breathing was observed. She was given solumedrol and benadryl IM and symptoms improved by 1 pm. Instructed patient not to get 2nd booster covid vaccination.
I got Moderna vaccine at the end of February. I was too scared to get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I got Moderna vaccine at the end of February. I was too scared to get the second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (I got Moderna vaccine at the end of February. I was too scared to get the second dose). In February 2021, PRODUCT DOSE OMISSION ISSUE (I got Moderna vaccine at the end of February. I was too scared to get the second dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product details were provided by the reporter. No Treatment information was provided.; Sender's Comments: This is a case of a Medication error, dose omission for 2nd dose of Covid 19/mRNA 1273 vaccine. Causality for medication error not applicable.
10:00AM Varivax administered SQ outer right thigh. 4cm wheal appeared at 10:15 and was reported by mother. Doctor notified with orders to give pt 1tsp Benadryl and Moniter pt. Post 30 mins DR assessed pt and released pt with instructions of any increase  in status to come to clinic immediately.
2-3 days following the vaccine, a series of small hives appeared along the left side of body.  Specifically on the left shoulder and left hip. They appear as small bug bites and are very itchy. They are hot to the touch and only slightly risen.   Additionally, at around 10 hours following the vaccine, I experienced severe muscle aches and chills (but this was listed as a typical side effect).
catrlidge in both hips and right knee gone now, bone to bone will need surgery  started 2 weeks after shot and got worse every day, will need 2 hip replacements and right knee tendon repair, after the shot everything just went like wild fire
Within 5 hr. lost taste, then within 12 hours chills (+) fever. Body pain. Lasted for about 36 hours. After 3 days he was fine.
Initial information received on 24-Sep-2018 regarding an unsolicited valid serious case received from a nurse. This case is linked with 2018SA268932 (same reporter). This case involves a 4 years old male patient who experienced cellulitis, while he received vaccine DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Sep-2018, the patient received a fourth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5171AA, expiry date- 23-Mar-2019 via unknown route in the left deltoid. On an unknown date, patient developed a serious cellulitis few days following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant. On an unknown date patient developed a serious redness (erythema) few days  following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant. On an unknown date, developed a serious pain few days following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant. On an unknown date patient developed a serious heat (feeling hot) few days following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant. On an unknown date patient developed a serious swelling few days following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant. (Other relevant tests included No lab test.) Final diagnosis was cellulitis. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A). His parents were instructed to use cold compresses on the affected areas. The patient outcome is reported as Recovering / Resolving for cellulitis, as Recovering / Resolving for redness, as Recovering / Resolving for pain, as Recovering / Resolving for heat and as Recovering / Resolving for swelling. As events marked improvement when patient returned on 24-Sep-2018.; Sender's Comments: This case involves a 4 years old child who presented with cellulitis and associated symptoms after vaccination. Time to onset is not known. There is also no information regarding patient's medical condition at time of vaccination, identification of the causative organism, safety of the vaccination procedure and lab tests ruling out alternate etiologies. There is a possibility that the cellulitis is due to a pre-existing nidus of infection or introduction of skin commensals during inoculation. Based upon the reported information, the role of the vaccine cannot be assessed.
rt forearm-rash (spreading up arm);also appear swollen;(recv shot in lt arm 23OCT96 first time noticed rash-wakened itching early 24OCT96 2AM;
Swelled and red spot at vacinnation site. It's hard like a softball and that area is tennis ball size. It is red, hot and has fever also itches terribly. Cannot overextend my reach without pain in the swelled area.
Expected soreness after injection on 9/30. Morning of 10/2 swelling and warmth above elbow. 10/3 swelling and warmth below elbow inside of forearm. 10/4 wife reported its improved, but still present.
This spontaneous report was received from a health care professional referring to multiple unspecified patients of unknown demographics. The patients' medical history was not reported. On unknown dates, the patients were vaccinated with improperly stored VAQTA (Lot number N003401 (invalid lot number), expiration date: 13-OCT-2018), ROTATEQ orally (Lot number N005618, expiration date: 04-OCT-2018, Lot number N005617, expiration date: 03-OCT-2018 and Lot number M043836, expiration date: 17-JUN-2018), RECOMBIVAX HB (Lot numbers unspecified), GARDASIL 9 (Lot number N010497, expiration date: 15-JAN-2020, Lot number N019923, expiration date: 28-APR-2019 and Lot number N021475 (invalid lot number), expiration date: 31-JAN-2020) and PEDVAXHIB (Lot number N003537, expiration date: 17-NOV-2019, Lot number N007749, expiration date: 29-NOV-2019 and Lot number N007751, expiration date: 30-NOV-2019) all vaccines administered for prophylaxis. There were no concomitant therapies reported. It was also reported that the call was due to a data logger. The vaccines VAQTA, RECOMBIVAX HB, GARDASIL 9 and PEDVAXHIB had temperature excursion of 31 degrees Fahrenheit or colder (22 degrees Fahrenheit) for 15 hours. The vaccines of hepatitis a vaccine, VAQTA, ROTATEQ, RECOMBIVAX HB, GARDASIL 9 and PEDVAXHIB underwent a previous temperature excursion of 32 degree Fahrenheit to 35 degree Fahrenheit for 12 hours. No adverse effects reported. The case is considered to be non-valid as there are no patient identifiers, therefore it is being sent to Distribution for one last time to notify all recipients.