chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Less than 24 hours after receiving her vaccines, my daughter complained of feeling dizzy, lightheaded, and thought she might pass out.  About 20 minutes later, she had a tonic-clonic seizure for about 30-45 seconds.  Afterward, she was very confused, disoriented, and was not making sense.  She also vomited several times.  She was taken to a hospital by ambulance.  During the post-ictal period, she was unsresponsive, had a migraine with vomiting, chills (no fever), somnolence, and the doctors could not perform a neuro exam because she would not wake up.  They admitted her overnight.
Patient potentially received higher than the recommended 0.3ml dose of the Pfizer vaccine. As of Sunday 4/4, patient reports arm soreness at injection site.
Site became red, swollen, warm to touch, the injection site was tender to touch and stiff. As of 7/11/11, arm is no longer tender but site remains red, swollen, warm to touch, and now itches.
Slow onset of allergic reaction including angioedema.  Was treated in the ER on 8/16/2015 for allergic reaction including Epinephrine, Prednisone, Pepcid with continued oral prednisone following discharge.  ER physician and followup with primary care physician suspect allergic reacting to the meningitis vaccination.  Patient received both TDAP and MCV4 vaccine.
OFF LABEL USE; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced off label use, and product administered to subject of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product administered to patient of inappropriate age and off label use was not reported. This report was non-serious.     .
Large bulls eye rash to injection site that developed almost 10 days after vaccination and progressively worsened.  3.5 inches x 4 inches    Looks like a fried egg.
Next day after vaccine:  headache, some chills, some fatigue. Second day after vaccine:  extreme fatigue until mid-afternoon.
Information has been received from a mother regarding her 12 month old daughter. on 14-SEP-2001, at 5 months of age, she received her third dose of Prevnar. On 16-MAR-2002, she developed a unilateral ear infection. No further information was available at the date of this report.
After receiving the ZOSTAVAX immunization pts lymphedema acted up to point where she had to start wrapping legs again. Went to lymphedema specialist for examination. Arm/injection site red & swollen for approx 7 days.
Left thigh with large local reaction. 16x19cm area of erythema with central induration and warmth. Areas of clearing at margins. Non-tender. Slowly resolved over 9-10 days.
1) Within 1 minutes of receiving the vaccine my arm around the injection site became sore.  I also had a metallic taste in my mouth for 20-30 minutes. 2) Within about 30 minutes after receiving the vaccine, I started to get a headache.  The headache increased in intensity over the next couple of hours, then remained at a constant level.  The next day it started to wane. 3) About 10-12 hours after receiving the vaccine I got a fever that went to 1.9 deg F higher than my normal temperature.  I also got muscle aches in my shoulders and mid back.  I started taking Tylenol about every 6 hours at this time.  The fever lasted about 18-20 hours.  I don't know if it went away due to the Tylenol, or if the fever went away on its own. 4) My muscle aches started to wane after about 24 hours.
The patient's past medical history included Rash (Reaction occurred after administration of shingles vaccine). Previously administered products included for an unreported indication: SHINGRIX (Shingles vaccine) on 28-Jan-2013. Concurrent medical conditions included Drug allergy (Macrobid-dizzy).   On 15-Jan-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021 at 8:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE RASH (Huge rash (3-4inches)/rash:pimply & ring shaped), VACCINATION SITE PRURITUS (Itching/ pruritis) and VACCINATION SITE ERYTHEMA (Redness/ erythema). The patient was treated with CORTISONE (topical) for Itching, at a dose of 1 dosage form. On 05-Feb-2021, VACCINATION SITE RASH (Huge rash (3-4inches)/rash:pimply & ring shaped), VACCINATION SITE PRURITUS (Itching/ pruritis) and VACCINATION SITE ERYTHEMA (Redness/ erythema) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: follow up report attached on 06-05-2021 which updated Event details, second dose details,medical history details and patient details.
I had the vaccine in November of 2021 and in January of 2022 I developed Migraines and Tachycardia.
no additional AEs; it was reported multiple temperature excursion 16-NOV-2022 and 09-DEC-2022 and were administered PEDVAXHIB, ROTATEQ and VAQTA; This spontaneous report was received from a medical assistant and refers to an unspecified group of patients of unknown age and gender. Their medical history, concurrent conditions and concomitant therapies were not reported.  On 16-NOV-2022 and 09-DEC-2022, the patients were vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot number: U029144 and expiration date: 31-MAR-2024; with Hepatitis A Vaccine, Inactivated (VAQTA) lot number: W015191 and expiration date: 27-OCT-2023; and with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number: U038854 and expiration date: 20-APR-2023. The vaccines were administered only once for prophylaxis, but dosage regimens, route of administrations and anatomical locations were not reported.  It was reported that the vaccines were administered after multiple temperature excursions (product storage error). Temperature was above 47 Fahrenheit (F) degree (50.0 F) for 0 hours 12 minutes and 0 seconds on 16-NOV-2022 and above 47 F (47.6F) for 0 hours 15 minutes and 0 seconds. Time frame was total 27 minutes. Additionally, no previous temperature excursion was reported. No other adverse event was reported (no adverse event).  Follow-up information was received from the medical assistant on 28-DEC-2022. This report refers to a 2 year old patient who was vaccinated on 30-NOV-2022 with Hepatitis A Vaccine, Inactivated (VAQTA) lot number: W015191 and expiration date: 27-OCT-2023, intramuscular (IM). The primary thermometer displayed out of range temperature for less than 15 minutes. The back-up thermometer did not display max. that was out of range. Log was ran and the temperatures were within range. The primary thermometer was re-calibrated.  Patients' identifiers were missing in the previous report but have now been provided.
34 yo female who had previously been vaccinated against smallpox as a child, vaccinated initailly on 3/17/03 (no take) and revaccinated on 3/24/03 which was again read as a no-take.  She does report that she had some intermittent eipsodes of flushing and itching which lasted 5-6 minutes each a few days after the second vaccination.  Otherwise she did well post-vaccination.  On 5/19 she awoke in the morning with pain in both eyes and "injection."  No ocular discharge or tearing.  Initially, no changes in vision.  She was seen by an ophthalmologist at an eye clinic who diagnosed anterior iritis (uveitis). According to the patient, several tests were done to rule out other conditions commonly associated with uveitis including toxoplasmosis, sarcoid, TB, and RA all of which were negative.  The ophthalmologist told her that the uveitis may be related to her smallpox vaccination since all other tests were negative.  She was started on steroid eye drops (Predforte) initially qid for one week then tapering to bid for one more week.  Later in the day on 5/19 after starting the steroid eye drops the vaccinee developed "foggy, blurry vision" which persisted for approximately 2 weeks.  The visual changes had resolved by the beginning of June.  The ocular pain and redness resolved in 3 days after starting steroid eyedrops.  She is scheduled to follow-up again with her ophthalmologist on 6/9.
No other AE reported.; Patient administered VARIVAX during a temperature excursion; This spontaneous report was received from an office manager and refers to a patient of unknown age or gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and pertinent medical history was not provided. On 09-FEB-2021, the patient received a dose of an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) dose  reported as 0.5 ml, lot # T021826, expiry date 25-JUN-2022, for prophylaxis. (formulation, concentration, dose number, route of administration and frequency were not reported).  Digital data logger was involved. The vaccine underwent the temperature excursion at range - 9.51 degree of Celsius (C) for 56 minutes. There was no previous temperature excursion. No adverse symptoms were reported. No product quality complaint (PQC) was involved.  This is one of the reports received from the same reporter.; Sender's Comments:  US-009507513-2102USA004947: US-009507513-2102USA005061: US-009507513-2102USA004607:
Got vaccine from  a already thawed vial.; A spontaneous report was received from a health care professional concerning a unspecified years old, male patient who experienced got vaccine from a already thawed vial/PT: wrong product administered.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.   On an unknown date in 2021, the patient received their first/second (not specified) of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection.    The patient experienced got vaccine from a already thawed vial on an unknown date in 2021. The reported event was considered medication error.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of event  got vaccine from a already thawed vial was considered resolved.; Reporter's Comments: This report refers to a case of wrong product administered for mRNA-1273, with no associated AEs.
arm rash; headache; lack of energy; voice is almost gone; feels horrible; sore throat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPHONIA (voice is almost gone), FEELING ABNORMAL (feels horrible), OROPHARYNGEAL PAIN (sore throat), RASH (arm rash) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPHONIA (voice is almost gone), FEELING ABNORMAL (feels horrible), OROPHARYNGEAL PAIN (sore throat), RASH (arm rash), HEADACHE (headache) and FATIGUE (lack of energy). At the time of the report, DYSPHONIA (voice is almost gone), FEELING ABNORMAL (feels horrible), OROPHARYNGEAL PAIN (sore throat), RASH (arm rash), HEADACHE (headache) and FATIGUE (lack of energy) outcome was unknown.            No relevant concomitant medications were reported.     Treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Received first vaccine 11 FEB 2021: Initially had no issues. On 01 Mar 2021, felt myalgias and fatigue with temperature up to 99.2F and patient insists his basal core temp is 97.5F.    Received his second vaccine on 04 Mar 2021 with temp < 100F therefore staff encouraged him that he had no contraindication. Same day, noted aches, pains, N/V, decreased appetite, loss of taste. Subsequently noted increased temperature up to 100.4F (single true fever) on 09 Mar 2021. Developed cough on 13 Mar 2021.  His remaining symptoms are fatigue, loss of taste, decreased energy.  The patient also noticed acute onset Rt chest wall pain after an episode of coughing ? states that it feels like a similar episode previously with known prior Dx of rib fracture. Not worse with exertion or relieved by rest. Not associated with meals. Worse with contact and position changes. He is taking ASA-325, 2 tabs each morning for pain, then 2 x 200mg Motrin tablets at night.
RESTLESS SLEEP; FELT COLD; INJECTION SITE SORENESS; TIRED; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 47 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced restless sleep. On 15-MAY-2021, the subject experienced felt cold. On 15-MAY-2021, the subject experienced injection site soreness. On 15-MAY-2021, the subject experienced tired. On 15-MAY-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 99.4 (unit unspecified). On 16-MAY-2021, Laboratory data included: Body temperature (NR: not provided) normal. The action taken with covid-19 vaccine  was not applicable. The patient recovered from restless sleep, felt cold, and low grade fever on 16-MAY-2021, injection site soreness on 19-MAY-2021, and tired on 17-MAY-2021. This report was non-serious.
This case was reported by a physician via call center representative and described the occurrence of death in sleep in a 18-month-old female patient who received PEDIARIX. Co-suspect products included PEDVAXHIB and PREVNAR. Previously administered products included PEDIARIX (at age of 2 months, which went uncomplicated) and PEDIARIX (at age of 4 months, which went uncomplicated). On 18th November 2014, the patient received the 3rd dose of PEDIARIX .5 ml, PEDVAXHIB and PREVNAR. On 18th November 2014, less than a day after receiving PEDIARIX, the patient experienced death in sleep (serious criteria death and GSK medically significant). On an unknown date, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the death in sleep was fatal and the outcome of the drug dose administration interval too long was unknown. The patient died on 18th November 2014. An autopsy was performed. It was unknown if the reporter considered the death in sleep to be related to PEDIARIX. Additional details were provided: It was unknown if the patient had concomitant medication or relevant medical history. All previous vaccinations went uncomplicated. It was unknown if the subject was hospitalized. The patient died at home. On 18 November 2014, the patient was vaccinated during the office hours, that evening she died and never woke up from a nap. The physician was waiting for an autopsy report which has not yet been completed. The physician reported that the parents requested a delayed dosing schedule: the 3rd dose be given at 18 months, rather than 6 months. The physician was available to contact.
Complains of left shoulder swelling. Shot was given about 2-3 fingers down from shoulder.
Severe headache, severe chills, could not move(full body stiffness).  Extreme thirst.   Subsided after 5.5 hours.
3-4 days p/vax pt c/o itchy rash covering area on 2-3inch diameter in area where shot given;denies pain swelling, or any other sx;
Patient fainted in store about 5 minutes after receiving vaccination, patient seemed anxious when vaccine was given
myocarditis- elevated troponins and chest tightness  Ibuprofen 600mg q8hrs
Gradual onset of soreness beginning about an hour post-vaccine and worsening throughout day. By the evening, left arm pain was too uncomfortable to wash dishes and lift household objects. Pain woke me up at 3am that night and I could not push the covers off of me, dress or undress, and I experienced severe pain with slight movement (7/10). Nausea and cold sweats began around 5am and lasted for 45min. I contacted the nurse via messaging system and was told to take OTC nausea medicine and Tylenol. I took the maximum dosage for Tylenol that day but could not do my normal school functions. The next day I was still limited by pain but did not require medication to cope. By day three, I had full range of motion back and minimal pain. Day four I am back to exercising normally.
Rec'd covid vaccine dose 1 @ 1430. c/o nausea, dizzy, tachy @1440. taken from theater chair to gurney@1443 HR 114 Left BP 134/94 sats 94% on RA. 1446 given apple juice box, fruit snacks and water LEFT BP 136/94 HR 104 sats 94%increased drowsiness, bilateral arm tremor, nauseous, able to answer all questions, aaox3 however drifting to sleep eyes closed often during conversation. pt stated takes depakote, chart review revealed depakote, cogen, plenate with h/o schizophrenia. 1459 BP LEFT while sitting up on gurneu 129/94 HR 120 RA 96% no longer dizzy or nauseous. 1502 sitting up, talking, recovered. 1504 LEFT BP 113/100 RA 94% ambulated to parking lot without assistance to depart in handivan.
within 12 hours of the vaccine, developed and hives; 24 hour later wheezing - mild.   took benedryl, Zyrtec, Pepcid - symptoms continued Sought care at Urgent Care - 12/27/2020 - was given an inhaler.  Symptoms lasting at least 10 days
Got the vaccine, had sore arm immediately.  Thought she was fine.  Husband had the same vaccine, and had the splotch and soreness, but then around 1/23/21.  The shoulder started to hurt after about 3 days, and put a heating pad on it, and finally the pain and discomfort gradually subsided.  She is not having any problems now.
Patient presented to the ER 5 hours after receiving the vaccine in the pharmacy with swelling of lips and face.
loss of smell; loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (loss of smell) and AGEUSIA (loss of taste) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANOSMIA (loss of smell) and AGEUSIA (loss of taste). At the time of the report, ANOSMIA (loss of smell) and AGEUSIA (loss of taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  This is a regulatory authority case concerning  a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected non-serious events of  Anosmia and Ageusia. The events occurred approximately on an unknown day after the unknown dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as information about further dosing was not disclosed. The events outcome were reported as unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: This is a regulatory authority case concerning  a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected non-serious events of  Anosmia and Ageusia. The events occurred approximately on an unknown day after the unknown dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as information about further dosing was not disclosed. The events outcome were reported as unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Pt received his second dose of Pfizer vaccine on 5/06. He has a history of COVID 19 infection in Sept 2020. He  Was admitted to our hospital on 6/09 with a massive PE/saddle embolus and RLE dvt  resulting in cardiac arrest, pt  was resuscitated and remains with anoxic brain injury.  No prior history or family history of PE/dvt.  Mom did report a  knee injury playing golf in the last month prior to presentation and his urine drug screen was positive for cocaine as other etiologies. Has a genetic hypercoag panel pending. Neg for Antiphospholipid ab.
This spontaneous report as received from a non pregnant female physician of an unknown age via company representative reporting on herself. On an unknown date the patient was vaccinated with ZOSTAVAX, dose 0.65ml, subcutaneous (lot number and expiration date not reported). On an unknown date the patient experienced redness and swelling at the injection site after receiving ZOSTAVAX. At the time of the report the outcome of the events was reported as recovered. It was unknown if the patient sought medical attention.  Additional information has been requested.
breast area and throat inflamed; Body was lethargic; Feverish feeling; Bad Headache; Deep Soreness even to touch; Lymph node tender; felt very depleted; This spontaneous case was reported by a consumer and describes the occurrence of BREAST DISCOMFORT (breast area and throat inflamed), LETHARGY (Body was lethargic), PYREXIA (Feverish feeling), HEADACHE (Bad Headache) and MYALGIA (Deep Soreness even to touch) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) and HERBS FOR YOUR SKIN for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced BREAST DISCOMFORT (breast area and throat inflamed), LETHARGY (Body was lethargic), PYREXIA (Feverish feeling), HEADACHE (Bad Headache), MYALGIA (Deep Soreness even to touch), LYMPH NODE PAIN (Lymph node tender) and FATIGUE (felt very depleted). At the time of the report, BREAST DISCOMFORT (breast area and throat inflamed), LETHARGY (Body was lethargic), PYREXIA (Feverish feeling), HEADACHE (Bad Headache), MYALGIA (Deep Soreness even to touch), LYMPH NODE PAIN (Lymph node tender) and FATIGUE (felt very depleted) outcome was unknown.            Treatment includes Advil. Action taken with mRNA-1273 in responsible to the events were not applicable   Reporter did not allow further contact