chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 3 hours, felt extreme pain in both arms just resting, especially the shingles, moving arms was very painful. About 4 1/2 hours after I was shivering, chills and aches in my entire body, could not stop shaking and twitching. Massive headache. Entire night was awake, every hour taking temperature, was 100.3-100.5 till 9 am. then went down to 99. (My body temp is usually low, 97.) Aches and chills eventually calmed down, headache still awful, went back to bed by 10:30 a.m. slept till 3:30 pm. Spent the rest of the evening exhausted. Now on day two I'm still having a low temp fever of 99, but body aches, chills, headache etc gone. Able to get back to my work although feeling weak and a bit foggy.
Tingling began in left thumb about 10 minutes after injection. The next day my foot was tingly, today my calf is also tingly. My face has been tingly off/on, but that could be to my facial regimen/acne medicine.
About 10 days after receiving the vaccine, pt started to hear rings in left ear. Then she started to noticing hearing loss. As of today she has lost almost all hearing in her left ear. She has no other symptoms after receiving the vaccine.
Information has been received from a medical assistant on 15JUN2015 concerning a patient (age and gender not specified). The medical assistant reported that on 10JUN2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB. No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected.
small stroke; heart went to into a-fib; light and dark spots; hurting badly at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (heart went to into a-fib) and CEREBROVASCULAR ACCIDENT (small stroke) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Atrial fibrillation since an unknown date. Concurrent medical conditions included Drug allergy (Eliquis). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced ATRIAL FIBRILLATION (heart went to into a-fib) (seriousness criteria hospitalization and medically significant) and VACCINATION SITE PAIN (hurting badly at injection site). On 07-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (small stroke) (seriousness criteria hospitalization and medically significant) and VISUAL IMPAIRMENT (light and dark spots). The patient was hospitalized for 4 days due to ATRIAL FIBRILLATION and CEREBROVASCULAR ACCIDENT. At the time of the report, ATRIAL FIBRILLATION (heart went to into a-fib) and CEREBROVASCULAR ACCIDENT (small stroke) outcome was unknown, VISUAL IMPAIRMENT (light and dark spots) had resolved and VACCINATION SITE PAIN (hurting badly at injection site) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       This case was linked to US-MODERNATX, INC.-MOD-2021-060976 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060976:MOD-2021-060528 (Wife case)
Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Medical history and concurrent condition of the patient was not reported. On 10-SEP-2014 the patient was vaccinated with one dose of VAQTA (lot number reported as J009788, dose and route were unknown) which underwent an unsupported temperature excursion. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
p/ pt recv vax approx 8 days later pt devel fever of 102f, approx 15-20 lesions on face & trunk, & diarrhea. MD 8/21/98 dx w/either a virus or react
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 03-MAR-2015, the patient was vaccinated with and improperly stored dose of (wistar ra 27-3) M-M-R II 0.5ml, (HSA, lot # J006995, expiration date 14-JUN-2015). No adverse effects were reported. The specified lot number vaccine was exposed to temperature excursion eight times. The total cumulative excursion time of the first time was 304 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the second time was 344 hours with the highest recorded temperature of 6 Fahrenheit degree. The total cumulative excursion time of the third time was 40 hours with the highest recorded temperature of 8 Fahrenheit degree. The total cumulative excursion time of the fourth time was 160 hours with the highest recorded temperature of 10 Fahrenheit degree. The total cumulative excursion time of the sixth time was 72 hours with the lowest recorded temperature of 28 Fahrenheit degree. The total cumulative excursion time of the seventh time was 40 hours with the highest recorded temperature of 47 Fahrenheit degree. The total cumulative excursion time of the eighth time was 48 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria were refrigerator/freezer (R/F) and the type of excursion for this vaccine (from the second time to fifth time) was freezer (F); the type of excursion for this vaccine of the other times was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 25-FEB-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
As after all previous Moderna vaccinations, severe all-over body and joint aches, headache, fever, chills, lethargy, loss of appetite, for two days, somewhat less on 2nd day.
Fever, nausea, diarrhea, dizzy and light headed, muscle aches in body (not injection site)
Swelling, hardening in Rt deltoid; warm to touch 4 days following administration of vaccination. Prescribed ZYRTEC 10mg PO daily x7days, Ibuprofen 400mg PO TID x7days. Monitored daily. Symptoms resolved by completed of medication cycle.
Syncope episode. Vitals were taken: Temp: 97.1 B/P: 100/75 Pulse: 79 Respiration: 18 SAO2:97  Ambulance called in precaution. Vitals were checked again and patient felt good/refused transport. When conscious, stated a similar episode happened 10 years ago.
2/2/21-1000-patient presented to the local emergency room with complains of fever, shortness of breath and decreased oxygen sats. temp 101.7, pulse 102, respirations 36, BP 141/92, oxygen 94%. Lung sounds crackles bilaterally with rhonchi on the left. patient worked up for sepsis, CXR shows mild atelectasis. blood pressure dropped, and continued to drop through treatment requiring levophed drop to be initiated. Patient POA determined that this would not be her sister's wishes and made the decision to make patient comfort care status.  2/3/21- patient lethargic throughout night. 0640-patient demise.
Nerve tingle from injection site to side of neck - lasted for 45 mins, took Ibuprofen Posterior cervical neck pain/soreness - lasted for about 12 hours Headache - lasted about 12 hours  Sore upper arm - lasted for 3 days
BLIND IN RIGHT EYE; This spontaneous report received from a parent via a company representative via social media concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient go blind in his right eye. The reporter stated that "The J-and J shots made my son go blind in his right eye". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blind in right eye was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220909463-covid-19 vaccine ad26.cov2.s -blind in right eye. 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.
Patient admitted on 10/13/2021 with profound ileus vs obstruction. She had NG to suction for one day.  She had both a CT and later a small bowel follow through showing the contrast getting all the way to the colon but she was vey slow to advance in her diet. She never developed normal bowel movement but was having liquid stools and passing gas at the time she left against medical advice on 10/21/2021
- Started day of vaccination: Fever of 103 that lasted several hours (even when taking Tylenol), strong pain along length of entire spine, intense all over headache, nausea  - Insomnia/sleeplessness from day of vaccination that continued for 5 days after injection
Flu symptoms including headache, nausea, chills, joint pain and low grade fever of 99.3 Symptoms began in the middle of the morning about 10:30 - 11:00 am  while I was at work; worsened through the afternoon and night; all better by morning; symptoms completed gone
Immediately after administering the vaccine pt developed redness at the site, itchy water eyes, we gave him Benadryl 25 ml. Found out  that chidl has had previouse varicella vax therefore recieved an extra dosis.
Mother reports child developed knot on left thigh in upper. this started 2-12-03 on 2-18-03 developed rash spreading all over body. Relates rash started on legs and knot. On 2-18-03 mother contacted health department and was instructed to have child seen by HCP. Seen by HCP who dx'd ear infection.
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 7-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
This spontaneous report as received from a physician via company representative refers to a 14 or 15 year old male patient. The patient's medical history included leukemia at 5 years of age. Concurrent conditions were not reported. On 09-FEB-2015 the patient received second dose of GARDASIL (1 single shot, dose and frequency not provided). No concomitant therapy was reported. On 10-FEB-2015, the patient experienced a spasm or seizure (medically significant) which caused him to fall out of his chair. No lab diagnostics studies performed. No adverse events were reported with the first dose of GARDASIL. No treatment was given for the events. Patient did not seek medical attention. The outcome of the events was reported as recovered on 10-FEB-2015. The physician did not provide the causality between the event and the GARDASIL. Product quality complaint was not reported. Upon internal review the convulsion was considered to be medically significant. Additional information has been requested.
0.6 ML dose given; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (0.6 ML dose given) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (0.6 ML dose given). At the time of the report, ACCIDENTAL OVERDOSE (0.6 ML dose given) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's medical history  and relevant concomitant medications weren't reported Treatment information was not provided
Lack of response - Information has been received from a registered nurse concerning a 16 year old male patient who in 1988 was vaccinated with varicella virus vaccine live during a clinical trail.  On 23 Mar 2000, the patient's antibody titer was negative.  Additional information has been requested.
Pt stated that late 03/11 he experience painful large read swelling of entire upper arm and underarm.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th December 2021, the patient received the 1st dose of Shingrix (intramuscular). On 24th December 2021, 2 hrs after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On 30th December 2021, the patient experienced injection site pain and injection site erythema. In December 2021, the outcome of the injection site erythema and injection site pain were recovered/resolved. On 1st January 2022, the outcome of the injection site pain and injection site erythema were recovered/resolved.   The reporter considered the injection site erythema, injection site pain, injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient self-reported the case. The patient received her first Shingrix vaccine in her left arm and about 2 hours after the Shingrix injection she began to feel redness/soreness at the injection site.  Her left arm was very sore and redder the next day but resolved in 3 days.  The reporter said, redness/soreness reoccurred on 30th December 2021 at the injection site. 6 days after receiving Shingrix, the redness/soreness reoccurred at the injection site. The redness/soreness resolved on 1st January 2022.   The reporter said, her arm was fine right now on 3rd January 2022. The reporter did not give permission to contact healthcare professional. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR000933:Same reporter.
Fatty tumor is right where the shot went. Fatty tumor covers the muscle.; Burned like heck when went in; A spontaneous report was received from a consumer concerning a 73-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced it burned like heck when it went in the fatty tumor where the shot went in.  The patient's medical history included acid reflux, hypothyroidism, high blood pressure and type-2 diabetes.  The Patient's Concomitant medications included Omeprazole, Synthroid, Beazepril and Rybelsus.  The patient is allergic to Percocet and motrin.  On 26-FEB-2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:022M20A)  in the left arm for prophylaxis of COVID-19 infection.  On 26-FEB-2021, The patient experienced the event fatty tumor is right where the shot went.  Laboratory details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.   On unknown date, the outcome of the events fatty tumor is right where the shot went(Inappropriate route of vaccination). is recovered/resolved.  The reporter assessed the event fatty tumor is right where the shot went(Inappropriate route of vaccination) related to the study drug is unknown.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # 022M20A) with reported event of vaccination site pain.
Fever,  delirium, chills, severe arthralgias and myalgias, severe fatigue, inability to stand, dehydration
Atrial Fibrillation formally diagnosed in June 2022, first symptions about a year earlier. Cardioconversion done in July 2022; results inconclusive as of August 2022.
Mother (Foster) called reported hives on face approximately 3PM - No UR distress - Enc. to monitor, give Benadryl - Denies symptoms after 1st HepA- Denies known exposure to New soaps, foods, etc. 9/12/08 AM symptoms resolved after given Benadryl
Felt dizzy and lightheaded; Started sweating intensely; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt dizzy and lightheaded) and HYPERHIDROSIS (Started sweating intensely) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Felt dizzy and lightheaded) and HYPERHIDROSIS (Started sweating intensely). At the time of the report, DIZZINESS (Felt dizzy and lightheaded) and HYPERHIDROSIS (Started sweating intensely) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No  treatment details was provided.
Information has been received from a pharmacist referring to 3 newborns (numbered 107, 108 and 109). Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 18-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration ate of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Caller had second Moderna vaccine on Sunday.@11:00 am.  Yesterday noted to have low grade temp and red rash at site of injection.  Today @ approx. 3:45 pm noted red rash on arm and face on cheeks and between eyes leading up to fore head.  Denies breathing difficulties or swelling.  Referred to ED or Urgent are for follow up.
Patient was sitting in the observation area when bystanders and this narrator witnessed her become unresponsive in her chair. Patient slouched to her right and fell out of her chair. Bystander caught her and she was lowered to the ground. No obvious trauma noted; primary assessment reveals no open wounds or active bleeding. Patient was unconscious for approx 1 minute. Patient's initial vital signs as follows: Pulse 44 bpm, SpO2 91% on room air, BGL 93 mm/Hg, blood pressure 98/48 (manual cuff), eyes PEARRL, cap refill >3 seconds, skin pale/cool/dry.  Patient stood up and walked to school infirmary with assistance of two providers. Patient placed on infirmary bed in supine position with head and legs elevated. Patient given juice to drink and placed on continuous pulse oximetry with readings as follows; 58 bpm and 93% on room air. Repeat manual blood pressure read 100/58. Patient continued to lay supine for approx 10 minutes. Patient A/O x 4 during observation. After approx 10 minutes, patient placed in sitting position on the side of bed. Skin pink/warm/dry with cap refill <3 seconds. With assistance, patient walked under her own volition to the front lobby and placed in a vehicle as a passenger to be returned home with instructions on follow up care.  Care provided by Paramedic and nurse.
mom stated that week before death there was no apparent fever-only some fussiness & lack of appetite, formula intake from 7oz to 3-4oz per feeding;