chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2012US017337 is an initial spontaneous report received from a nurse on 28 Aug 2012 with a follow up information received on 28 Aug 2012. This report refers to an 11-year-old female patient. The patient was vaccinated with MENVEO (batch number: M11082, expiry date: May 2014) 0.5 ml intramuscularly on 25 Aug 2012. On unknown date, the patient experienced tenderness, warmth and redness and swelling of 3 inches diameter at the injection site. The patient recovered from the events on 28 Aug 2012. Follow up information received on 28 Aug 2012: Reporter information updated.
This case was reported by a healthcare professional and described the occurrence of pain in arms and legs in a 50-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included acid reflux, bipolar disorder and heart murmur. Concurrent medications included LAMICTAL. On 29 September 2011 the subject received a dose of FLUARIX (details unknown). On 4 October 2011, 5 days after vaccination with FLUARIX, the subject experienced pain in arms and legs, upper and lower extremity weakness and fatigue. The subject sought medical attention with the reporting healthcare professional. At the time of reporting the events were unresolved.
No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  There was a prior excursion on 5/3/2022 and a recent excursion on 5/26/2022.  She said it was very likely all vaccines had been administered since the excursions occurred.; This spontaneous report has been received from a nurse, concerning a 09-weeks-old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAY-2022, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #U026664 experienced a temperature excursion of 47.3 Fahrenheit degrees (F) for 5 minutes, if a digital data logger was involved was not reported (product storage error).   Consequently, on 13-MAY-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number reported as U026664 confirmed as valid, expiration date reported and stablished as 24-FEB-2023) administered orally as prophylaxis (formulation, strength, dose, vaccination scheme were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001582: US-009507513-2206USA001583: US-009507513-2206USA001584: US-009507513-2206USA001585: US-009507513-2206USA001586: US-009507513-2206USA001587: US-009507513-2206USA001588: US-009507513-2206USA001589: US-009507513-2206USA001590: US-009507513-2206USA001591: US-009507513-2206USA001592: US-009507513-2206USA001593: US-009507513-2206USA001594: US-009507513-2206USA001595: US-009507513-2206USA001596: US-009507513-2206USA001597: US-009507513-2206USA001598: US-009507513-2206USA001599: US-009507513-2206USA001600: US-009507513-2204USA001865: US-009507513-2204USA001998: US-009507513-2204USA002052: US-009507513-2204USA001952: US-009507513-2206USA001103:
approximately 12 hours post vaccination (11pm 2/3/21) patient began to feel onset of symptoms including headache, body aches, chills, and fever. Fever was 101.2 at 12:30am on 2/4 and hovered between 100.2-100.6 until 12pm on 2/4/21. Symptoms gradually lessened throughout the day and resolved at approximately 4pm on 2/4/21.
Patient started complaining of numbness to the right upper quadrant and later developed itchiness throughout body. Patient evaluated by RN and EMS. Patient remained in observation for about 45 mins . Symptoms alleviated and was recommending to drink fluids and take benadryl over the counter at home. Patient then returned as she started developing heavy tongue and numbness to the lips while on her way home. Patient denies any shortness of breath , no chest pain, no dizziness , no nausea. At 1207 pm- Patient was evaluated by Dr. and was advised to administer Benadryl 25 mg IM and advised patient can take another 25 mg of Benadryl  PO at home. At 1214pm Paramedic administered 25 mg of Benadryl IM on right arm . 1231pm patient reports feeling better , symptoms have resolved. Patient advised MDs recommendation to take benadryl 25 mg by mouth. Patient advised if symptoms worsen and/or develop shortness of breath contact 911 or go straight to ER.
Nurse gave dose from the Moderna 6 year to 11 year old COVID vaccine vial instead of the correct vial for Moderna 6 months . Dose given was correct at 0.25 mL. Parent has been consulted and understands.
devel blistered shingles type rash @ inject site 3 days p/inject on rt ant thigh; also had fever to 101 & 102 on 16DEC;
This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 26th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, chills and pain in arm. On an unknown date, the outcome of the fever, chills and pain in arm were recovered/resolved. It was unknown if the reporter considered the fever, chills and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The case was reported by patient's wife. The patient received SHINGRIX on left arm. The patient's arm was hurt after receiving SHINGRIX vaccine. The patient also experienced fever and chills. All symptoms resolved with 2 to 3 days. The reporter did not consent to follow up and could not obtain additional information. This case has been linked with case US2019027669 (wife's case) reported by the same reporter.
Pt was observed post Covid-19 immunization for 15 minutes .  During the observation period, he experienced an adverse reaction with the following symptoms:  difficulty breathing and rapid heart rate.   Assessment : Time of assessment 1127. Alert and oriented, Anxious and Unlabored breathing. Patient reported 5-10 minutes after sitting for 15 minute observation, the feeling of his heart beating fast and hard, having SOB. He says he also has a feeling over his legs and arms of feeling "washed out."  1127: BP 139/82, P 77, Sat 100% RA (nurse felt pulse to wrist and it wasn't racing, just beating hard). Patient says his BP is usually not that high. 1129: BP 131/85, P 73 (reports feeling better) 1137: BP 120/85 P 75 (reports this is what his BP is usually running, reports feeling less better, says it's his anxiety kicking in) 1142: BP 121/78 P 72   Actions taken:  Vitals sign taken  VAERS form obtained and completed by RN.   Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for additional 15 minutes minutes. Discharged home. 1145 ambulatory out.
Improperly stored proquad or varivax; This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patients medical history, concurrent conditions, drug allergies and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # R010468, expiry date 10-APR-2020, R017641, expiry date 20-JUN-2020, R010466, expiry date 10-APR-2020) or measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot# R020814, expiry date 16-JAN-2020, R015738 expiry date 02-DEC-2019) which was reconstituted with properly stored sterile diluent. Temperature: Total time in the range 6 degree Fahrenheit to 14 degree Fahrenheit (8.8 Fahrenheit), time frame: 24 minutes. Previous temperature excursion : total time in the range 6 degree Fahrenheit to 14 degree Fahrenheit (5.9 fahrenheit) for 12 minutes, total time in range 6 degree Fahrenheit to 14 degree Fahrenheit (5.5 fahrenheit) for 6 minutes recommended frozen range minus 58 degree fahenheit to 5 degree Fahrenheit (5.1 fahrenheit) for 6 minutes total time in range 6 degree Fahrenheit to 14 degree Fahrenheit (5.5F)for 12minutes. Data logger was involved.
INCREASED SEIZURES; THREW UP; INCREASED PHLEGM / INCREASED COUGHING; This spontaneous report received from a parent concerned a 43 years old white Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included cerebral palsy, mental retardation, and epilepsy, and concurrent conditions included seizures, cough, and phlegm. Patient had no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 06-APR-2021 on right deltoid for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the patient experienced increased phlegm / increased coughing. On 07-APR-2021, the patient experienced increased seizures. On the same day, he experienced threw up. The patient usually had a cough and phlegm. On the following day of vaccination, the patient's amount of phlegm and cough was increased and he throw-up and had 2 seizures. On 08-Apr-2021, the patient had 10 seizures. The patient regularly had seizures but the number per day increased after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased seizures on 09-APR-2021, and threw up on 07-APR-2021, and had not recovered from increased phlegm / increased coughing. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210428761-covid-19 vaccine ad26.cov2.s-increased seizures. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Weakness in right hand (10/21 onset).  Slurred speech (12/21 onset).   OUTCOME:  Clinical diagnosis for ALS, April 2022.
Severe arm pain where injected with the Td vaccine. The pain has lessened, but still have deep muscle pain three months later.
Reports waking around 2am 1/31/21 with extreme chills, fever 102. About 5 am chills continue with severe headache, body aches and joint pain. Same severity of symptoms persisted on 2/1/21, symptoms lessened on 2/2/21. Injection site with erythema, induration and warmth.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE POSTPROCEDURAL DVT OF RIGHT LEG, UNSPECIFIED VEIN ACUTE DVT, UNSPECIFIED VEIN 8/2/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Fever as high as 103.6 started early AM. Late pm of 05/04 also not sleeping, poor appetite, runny nose. Clinging to mother. Crying when examined. Left TM dull-red.
0945: Patient seated in observation area. Patient speaking to mother and begins to feel lightheaded and what he later described as warm feeling in checks and then eyes begin to get dark.   0950: Patients was assisted to the floor x 3 persons on a mat. Pt was able to state name, location, and birthday. BP checked 130/80, O2 saturation 97%. HR 72 1000 Pt remained A/O x 3. BP checked 126/78, HR 70. O2 sat 98%.  Pt given snacks and juice, observed for an additional 20 minutes. Stated he is feeling fine. Per RN.
Patient received the first COVID-19 mRNA vaccine shot on January 22, 2021, and experienced palpitations on the morning of January 24, 2021. He presented to his primary care physician on January 25, 2021 for evaluation. He had an abnormal EKG (details surrounding this EKG not available at time of this report). On Jan 2, 2022, he went to the emergency department with chest pain and elevated troponin. He underwent cardiac catheterization (unremarkable), and diagnosed with myocarditis. This occurred about one month after a coronavirus infection (tested positive), but negative for COVID-19 specifically. Patient continues to experience mild exertional chest pain.
pt recv vax 6MAR96 & 26MAR97 pt devel a light case of chickenpox;pt was given DPH;pt recovered from sx;
Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media  and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's sister in law had several times before receiving shot).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The patient self reported the case. The age at vaccination was not reported. The patient stated that, the patients sister in law had never had chickenpox but she had shingles several times before she got the shot. The patient commented that, the shot does not keep one from getting the shingles ( if they once had chicken pox) but so they want get a severe case of shingles. The patient received the vaccine and got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for herpes zoster were not provided. This case has been linked to US2021AMR179072, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179072:same reporter, master case
Initial unsolicited report received from a nurse on 17 May 2018. This case involves a patient (age and gender unknown) who was vaccinated with PENTACEL (batch number, expiry date, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to inappropriate reconstitution technique. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Had a period one week after the first dose while breastfeeding. Returned to no period the next month.
Patient first dose of HPV vaccine. Patient passed out for 2 minutes after receiving vaccine. Patient's vitals were stable and denied dizziness or headaches.
elevated t103 w/APAP given every 4 hrs, for 5 days; no sz or high pitch crying; pt very listless x 5 days;
Swelling, redness, and warmth at injection site.  Patient observed in clinic for 35 minutes.  Vitals were taken every 15 minutes.  Educated patient on the use of ice packs and if symptoms return to call clinic, call with questions concerns, and to call 911 if swelling of face, tongue or airway.
Pfizer COVID-19 Vaccine EUA  Patient received Dose 1 Pfizer vaccine at 1240. Pt started not feeling well, was taken back to medical observation. Pt with grey apperance, not really comprehending commands, sweaty and hot, started to undo his jacket and flannel shirt. Patient started to go in and out of conciousness and was lowered to the floor. Pt became unconscious. Sternal rubs were performed and patient was arousable. Patient began to have generalized clonic seizure, patient was placed in left lateral decubitus position. EMS was called. BP 97/55, SpO2 100%, HR 98. Patient does have history of seizures and is not on any medications for these seizures.  1335: 75/50, 88, 100% (RA), two more additional seizures witnessed.  Patient able to regain consciousness between seizures was alert and able to answer questions appropriately.   1340: 18g IV started to left AC.  NS hung to open gravity, good flow.    1345: EMS arrived and assumed care, patient A&O x 3. Transported to the hospital. Reporter does not have access to hospital's health records.  Bilateral breath sounds CTAB, no swelling of the face/lips/tongue or rash.
Right deltoid area of redness, heat, and induration.  MOTRIN, ice, Benadryl advised
Precipatious decline in cardio health to include sever and continuing chest pain and forcing a reduction in activity as well as specialty cardiac care.
Rash on inside fold of elbow left arm. Sucks left thumb so arm bent at night unlike the right. Rash 2 in. diameter, peeled / blistered 3 days later - eczema like. Rash 3 in. patches symmetrical upper buttock area.  Child has no history of psoriasis or rashes of this type but has a history of rash with vaccination.
CLOTHES AND BODY NERVE PAIN; RIGHT EYELID TREMBLING FOR 3 WEEKS; INTENSE PAIN IN LOWER BACK; DIAGNOSED WITH HERPES ZOSTER; INTENSE PAIN IN WAIST; LEG PAIN; This spontaneous report received from a patient 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 (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 patient experienced clothes and body nerve pain, right eyelid trembling for 3 weeks, intense pain in lower back, diagnosed with herpes zoster, intense pain in waist, and leg pain. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from leg pain, clothes and body nerve pain, right eyelid trembling for 3 weeks, intense pain in lower back, diagnosed with herpes zoster, and intense pain in waist. This report was non-serious.
Got vaccinated in June (#1 6/5/21 and #2 6/26/21) Conceived in mid-July, miscarried in August when I was 8 weeks pregnant.
Beginning the night of the vaccination, had a red-flushed, hot face. Chilled. Took Alieve and went to bed. Awoke with headache from neck-up, body aches, dizziness. Took more Alieve and was able to function somewhat better. Arm is still sore today.
2/10-2/12/21 - 10pm - six hours after second dose of moderna - severe chills, severe muscle and joint aches, nauseating cough ,itching at injection site. 2/19-2/24/21 -lump and  itching at injection site. 3/15-2/17/21 -8am -  35 days after 2nd dose of Moderna - very severe chills, severe stomache cramps, persistent fever 101.1. 102.3, 103.5, muscle and joint aches, pain radiating from injection site of right arm., nauseating cough
For several days after receiving vaccine, my arm was tender and hot.  Then I think everything was OK.  On February 22, I noticed a red circular spot that  was maybe 5 or 6 inches across and was hot.  I assumed it was "covid arm"  and did nothing.
Queasiness, fever of 100 degrees, left arm bright red from shoulder until the elbow.
Pt stated that she had a rash that spread from her injection site that spread to her face, neck and torso. She also had lymph  node swelling in her armpits. She has been taking antihistamines without resolution but does not feel that it is getting worse at this time (5 days post vaccination)
Polydipsia polyurea headache fever drowsiness all In that order over the course of 30 hours
1 day post vax pt awoke w/runny nose & a yellow nasal discharge;tx w/erythromycin & extendryl SR;
Resident had no signs or symptoms.  Resident was Covid tested due to outbreak testing at facility.  Resident was tested on 8/31/21 and 9/1/21 and results were negative. Daughter requested daily aspirin during 14 day isolation.  Provider agreed and started 81mg aspirin daily x 14 days. Resident is currently in isolation and remains asymptomatic.
Pt vaccinated with DTP experienced crying more than 4 hrs given advil Ibuprohen
Immediate excessive bleeding. Immediate pain compared to previous vaccinations.  Arm and shoulder became increasingly more painful through out the next several hours.  By evening I was unable to lift arm.  Any movement resulting in extremely sharp pain.  No movement and the arm and shoulder had high degree of aching. Next day same and stayed in bed for next 3 days due to pain.  On 4th day some improvement and could move arm by lifting with other hand. 5the day slight improvement. 6 the day small improvement still can not lift objects or reach out without severe pain
COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 47 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HYDROXYCHLOROQUINE; LEVOTHYROXINE; LISINOPRIL; HYDROCHLOROTHIAZIDE; PRILOSEC [OMEPRAZOLE MAGNESIUM]; VITAMIN D [COLECALCIFEROL]; FISH OIL; SPIRONOLACTONE; AMETHYST; METHOTREXATE. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jan2022, outcome "unknown", COVID-19 (medically significant) with onset Jan2022, outcome "recovered" (2022) and all described as "COVID".It was reported that patient stated she had covid on or about 15Jan2022. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available.
Headache, Fever, flushing, arm soreness states headaches subsided after 2 days then returned on day 5 and also now has noticed a rash on her legs
1 day following immunization, noticed considerable swelling, redness, pain on upper left arm. Entire muscle was inflamed. Felt nausea. Symptoms completely resolved effective Monday, 02/08/16.
On Sunday, Oct 31st, 2021, I noticed a rash on my right leg. I was misdiagnosed as cellulites.  I followed up with my PCR on Wednesday Nov 2nd, 2021, and determined it was a rash rather than a bacterial infection.