chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within our injection shot sore. No other adverse effects until 5:00 a.m. Woke up because body was very hot similar to being in a sauna. Removing for changing the blanket to a thinner one resulted in extreme chills within one minute. Covering with blanket resulted in extreme hot within 10 minutes. Repeated this cycle for several hours until fall asleep.  High discomfort throughout body. Woke up at 10:00 a.m. with mild grade fever of 99.5° (average resting temperature is 96.5).  Felt extreme cold and chills shivering body aches headache until 6:00 p.m.  felt hungry and okay enough to eat.  Main concern is the extreme hot to extreme cold cycle in early morning. It felt as though the body was not in sync. During fever throughout day/afternoon body's reaction was normal - fever meant chills and shivering, putting on a blanket meant comfortable warmth (after long periods of time).   But in early morning no no fever yet body burning hot almost suffocating sauna heat insider body, and removing the blanket a immediate and severe chills with uncontrollable shaking, instead of relief from heat... Concerned if vaccine affects body's heart regulation system (hypothalamus, thyroid, etc).  General malaise during this period is an understatement... It was not a single spot or feeling pain it was the whole body wanting to twist itself and feeling 'deprssed' and very 'ill' all over all at once.
no adverse event; improper storage of product in use; This spontaneous report was received from a nurse referring to a 12 month old male patient. Information about patient's medical history, concurrent conditions and drug reactions/allergies was not reported.  On 03-MAR-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) of lot # S015464 with an expiry date of 20-MAY-2021 (strength, dose, route and anatomical location were not provided) for prophylaxis (product storage error) which was reconstituted with properly stored sterile diluent. The vaccine underwent a temperature excursion at 15.6 degree Fahrenheit for a time frame of 1 hour 16 minutes. There was no previous temperature excursion involved. The digital data logger was involved. It was reported that the patient did not experience any adverse event. There was no product quality complaint (PQC) associated with this report.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 09-JUL-2018 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # N030965 exp date 25-AUG-2019) (dose not reported) orally. There was a data logger issue reported. The temperature of excursion was 32°F up to 35°F (multiple excursions) for a time frame of 13 hours. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1807USA004813: US-009507513-1807USA010174: US-009507513-1807USA010175: US-009507513-1807USA010176: US-009507513-1807USA010177: US-009507513-1807USA010173: US-009507513-1807USA010214.
PT had elevated heart rate, elevated blood pressure, was faint, shaking, clammy and had nausea. She was evaluated by provider given water and apple juice with salt. whole episode lasted approximal 45 to 60 minutes.  She was able to go home after this time her BP and HR normalized to her baseline, her nausea, shanking and faintness resolved.
Recipient fainted after receiving the vaccine. Stated she always faints with needles, however, did not inform us before-hand. She quickly regained consciousness and laid on the cot for an hour until someone came to pick her up. Refused 911 or going to the ED as this happens all the time.
The patient had swelling, and cellulitis at the site of injection (DTaP and Hib given in that leg). Treated with Keflex, and cool compresses. Recheck in 5 days.
Evening of 11/4 - coughing, lip felt "funny" (mucousy), felt couldn't talk, took 2 BENADRYL. Went to ER at 20:30, Dr said probably rxn to FLUZONE. Swelling of throat, coughing helped, was given DECADRON and BENADRYL in ER approximately 21:30. Felt weak/cold.
6-8 hours after vaccination was administered my son vomited in bed.  He had diarrhea for the next five days.  He vomited during his nap approximately 20 hours after the vaccination.  He got a fever of 104.7 approximately 24 hours after the vaccination.  He had a fever of approximately 101-103 for about 12 hours, 24 hours after vaccination.  He lost his appetite for the 5 days following the vaccination.
Symptoms started around a week after COVID-19 vaccine, when patient started having shortness of breath cough and nasal congestion.  He was having yellow sputum production and he had chills. Upon arrival to the hospital on 4/18 the patient was tachycardic and chest x-ray that showed cardiomegaly with fluid overload. Progressively became severely hypoxemic and had to be emergently intubated and placed on mechanical ventilation. Patient developed cardiogenic shock which may be acute myocarditis and was placed on an Impella device and norepinephrine drip. The patient continued to worsen and developed acute kidney injury and hyperkalemia and was placed on CRRT. LFTs were also elevated. Patient also went into atrial fibrillation and was started on amiodarone drip. All of the above mentioned occurred within a 12 hour period.
BLOOD CLOTS GALORE; FEELING SICK (NOT FEELING WELL); FEELING OF WOULD NOT MAKE IT AND SAYING GOODBYE TOMORROW; MUSCLE ACHES; TIRED; LETHARGIC; BODY ACHES; This spontaneous report received from a consumer concerned a 55 year old female of unknown race and ethnicity. 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: Unknown, expiry date: UNKNOWN) dose was not reported, 1 total, administered on 16-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-APR-2021 after vaccination, the patient got tired, lethargic, was not "feeling well" and body and muscles started to ache and progressed further. The consumer reported that on 08-MAY-2021, the patient was feeling sick and drove herself into the hospital. On 11-MAY-2021, the patient had blood clots galore and was on dialysis. On 12-MAY-2021, the consumer had one note stating the patient was holding steady and during night the consumer stated there's no change in patient's condition. On 13-MAY-2021, patient was going through with computerised tomography scan and told later that patient would not make it and would be saying goodbye tomorrow. On 13-MAY-2021, Laboratory data included: CT scan (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots galore, and the outcome of tired, lethargic, body aches, feeling sick (not feeling well) and muscle aches was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210529809 - Covid-19 vaccine ad26.cov2.s- blood clots galore. This event(s) is considered unassessable. 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).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included Paxlovid from 14Sep2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided. Date of Refrigeration was given as 07-May-2021.   This case was linked to MOD-2021-363032 (Patient Link).
My symptoms are shortness of breath which may mirror symptoms  of Myocarditis or Pericarditis...not every day, but sporadic and gets worse at night in bed.
Patient with some diarrhea this am, some aches. No fever no arm swelling or redness. Able to participate in activities.
Pain on Right side of neck Right Arm soreness Right side of neck soreness EMT checked Viral Signs Vital signs within normal limits Patient refused transport to hospital Referred her to call PCP or go to ER if she felt her condition worsening
At first I felt fine, my arm was just a little sore from the shot.  However, as we began to sit down at dinner my voice became hoarse, feverish, and my heart seemed to be beating a little faster.  These feelings subsided within a few hours and I felt fine by the next morning.
Information has been received from a pharmacist referring to a patient of unknown age and gender. On 13-MAR-2015 the patient was vaccinated with an expired dose of ZOSTAVAX, 19400 plaque forming unit (PFU) (lot # J013137, expiration date: 17-JAN-2015, route and dose were unknown). No adverse effects had been observed or reported. Additional information has been requested.
Information has been received from a Registered Nurse concerning a 5 year old female patient with no medical history or drug allergies, who on 05-APR-2011 was vaccinated with a dose of PROQUAD (Merck) (lot# 666752/0542Z, expiration date 07-OCT-2011) possibly via intramuscular route. Concomitant therapy included (reported as "DTaP IPV combination") on the same day. On 07-APR-2011 the patient developed redness at the site of injection. The patient's mother sent the nurse the photo of the child's injection site and the nurse noticed the approximately 2 inches diameter of redness with "scratch marks". No labs/diagnostics studies were performed. At the time of reporting, the patient's injection site redness with "scratch mark" persisted. The patient was not given treatment for the event. The patient sought unspecified medical attention. Additional information has been requested.
Lightheadedness, sweaty, clammy, pallor, bradycardia lasted 15 minutes.
Tingling in  tongue; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN 6202) via an unspecified route of administration in the left arm on 12Mar2021 at 11:30 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any medications within two weeks of vaccination. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Mar2021 at 12:15, the patient experienced tingling in tongue. The patient did not receive any treatment for the reported event. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event tingling in tongue was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Fever >101, muscle aches, joint pain, swollen lymph nodes, INCREASED HEART RATE performing normal tasks
Patient seen in the ED on 12/15/22 for shortness of breath, cough, right lower chest pain, and fever around 101 F. COVID PCR test preformed in the ED resulted positive. She was admitted 12/15/22 - 12/19/22 for acute respiratory failure with hypoxia secondary to pulmonary embolism and COVID-19 infection. Per discharge summary, the provider notes "Initially hypoxia favored from PE, rather than the COVID, however after initial improvement pt had worsening COVID sxs and return of hypoxia - Decadron initiated with improvement." Patient has received the primary COVID vaccine series.
Fever 100; diarrhea; very tired for 3 days; brain was fuzzy; couldn't think right; Sweats; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 28Apr2021 at 13:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, migrane headaches, polyps in colon, diverticulitis and compression fractures in back and allergic reaction to antibiotics (tetracycline). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), prazosin (MANUFACTURER UNKNOWN), CENTRUM SILVER VITAMINS and topiramate (TOPAS); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 08Apr2021 at 13:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. On 29Apr2021 at 02:00 the patient experienced fever, diarrhea, very tired for 3 days, brain was fuzzy, could not think right and sweats. On the same day (29Apr2021), the patient checked body temperature and the result was 100 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event very tired was resolved on 02May2021. The clinical outcome of the events fever, diarrhea, brain was fuzzy, could not think right and sweats were resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a pharmacist via a company representative referring to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot# L046900, expiration date, dose and route not reported). Concomitant therapy was not reported. On an unknown date (reported as "recently") the patient had stopped taking long term prednisone and had also just stopped chemotherapy, developed blisters on her hip the size of a silver dollar. Treatment was given to the event. The patient recovered from the event. Reporter's causality was not reported. Additional information has been requested.
felt tired, had muscle pain, a headache, shivering, fever, stomach pain, or nausea.
I have been experiencing chronic pain and burning within my sinuses and eyes. Also I have been experiencing bizarre phantom smells. In other words I'm smelling things that aren't really there. All of this started to occur after taking the moderna vaccine.
No appetite  Nausea  Vomiting Edema in abdomen  Weight loss
ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned multiple patients. 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: 201A21A expiry: 21-SEP-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious.
Vaccine-associated immune thrombocytopenia; This literature-non-study case was reported in a literature article and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Vaccine-associated immune thrombocytopenia) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.      No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (Vaccine-associated immune thrombocytopenia) (seriousness criterion medically significant). At the time of the report, IMMUNE THROMBOCYTOPENIA (Vaccine-associated immune thrombocytopenia) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered IMMUNE THROMBOCYTOPENIA (Vaccine-associated immune thrombocytopenia) to be related.    Treatment and concomitant medications were not reported  Company Comment: This is a Literature-non-study case concerning a 66-year-old female patient, with no medical history reported, who experienced the unexpected and serious (due to medically significant) AESI of Immune thrombocytopenia, which occurred on an unknown date after mRNA-1273 vaccine, administered as third dose within COVID-19 vaccination schedule. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-658059; Sender's Comments: This is a Literature-non-study case concerning a 66-year-old female patient, with no medical history reported, who experienced the unexpected and serious (due to medically significant) AESI of Immune thrombocytopenia, which occurred on an unknown date after mRNA-1273 vaccine, administered as third dose within COVID-19 vaccination schedule. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-658059:83 YO Male
Shaking chill, fever 100.0, diarrhea x 1, axilla pain day 3
First menstrual cycle after first dose, two days  late and lasted 3 days, very light First menstrual cycle after second dose, seventeen days late and lasted 5 days, moderate Second menstrual cycle after second dose, ten days early lasted 5 days, very light (Typically it is very regular.  Same time of the month, every month for sixteen years, lasts 4 days)
17 y/o inadvertently received 1st dose of Moderna 4 weeks ago.  Per CDC guidelies, 2nd dose given per recommended interval
Large local reaction within 24 hours - redness, inflammation, measuring 10 x 6.5 cm; seen by CRNP 48 hours later, recommended BENADRYL and to return if worsened; reaction subsided but two weeks later, the 10 x 6.5 patch remains discolored with some residual, minimal soreness at site.
Information has been received on 07-Oct-2003 from an elementary school licensed practical nurse concerning a 7 year old male who on 12-Jun-1996 was vaccinated with varicella virus vaccine live (site unknown). Subsequently, "within the last month," the patient developed chicken pox. The patient sough unspecified medical attention. It was also reported that five other children also developed chicken pox (WAES #0310USA01069, WAES #0310USA01244, WAES #0310USA01245, WAES #0310USA01247, and WAES #0310USA01248. Additional information has been requested.
my arms hurts; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (my arms hurts) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 MYALGIA (my arms hurts). At the time of the report, MYALGIA (my arms hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided No concomitant medications were provided
ITCHING/REDNESS AT INJECTION SITE APPROXIMATELY 15 MINUTES AFTER RECEIVING INJECTION - REMOVED BANDAID, WIPED WITH ALCOHOL SWAB - ITCHING RESOLVED WITHIN A FEW MINUTES - SPOKE WITH PATIENT AGAIN AT APPROXIMATELY 2:20 PM AND SHE SAID SHE TOOK BENADRYL AND A SHOWER, AND FELT BETTER.  PATIENT DENIED ANY BREATHING ISSUES OR ITCHING IN THROAT OR MOUTH. PATIENT WAS TOLD TO SEEK EMERGENCY TREATMENT IF SYMPTOMS INVOLVING MOUTH OR THROAT, OR MORE SYSTEMIC REACTION.
Experiencing a sore throat; Exposed to Covid by his girlfriend; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a patient (Son) that a male patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on an unspecified date. The patient experienced experiencing a sore throat and exposed to covid by his girlfriend on an unspecified date. It was stated that "caller's son took his 2nd dose of the Covid vaccine and 8 days later was exposed to Covid by his girlfriend. He is going in for a test for Covid today. Clarified if he was having symptoms of Covid, she stated he was experiencing a sore throat. She had questions such as since he has gotten both vaccines will this help him from getting Covid and numerous other questions in regard to the Covid vaccine". Outcome of the events was unknown.  Information on Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.