chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report was received from a health care professional on 11/04/2003, concerning a female vaccinee of unknown age who developed a quarter sized knot which was red and a very sore arm an unspecified length of time after receiving Fluvirin on 10/16/2003. The outcome was unknown at the time of the report. There was insufficient information to determine the reporter's causality assessment. No follow up pending. Cross reference with: PJP20030785, PJP200300786 and PJP200300987.
Individual arrived to post vaccine area after receiving dose one of Pfizer COVID 19 vaccine. Individual reported feeling lightheaded and dizzy. After reporting feeling lightheaded individual had difficulty answering questions, would respond with one to two word responses slowly. Individual was lethargic and reported having episodes of difficulty responding. Vitals: BP 135/72 hr 84 O2 100%. Prior to vaccine individual was awake ambulatory and alert. Due to change in mental status EMS called for medical transport/emergency evaluation. Upon EMS arrival patient was awake, oriented x3, but still lethargic and slow to answer questions. No rash, denied, difficulty breathing, denied tongue swelling or throat complaint.
late evening 5JUN98 apnea, cyanosis p/coughing spell, gastric reflux;recv oxygen & tube feedings;discharged 14JUN98 on 02 & 12;ped zantac;
experiences swollen and sore arm; experiences swollen and sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "cholesterol" (unspecified if ongoing); "blood thinner" (unspecified if ongoing); "potassium" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "experiences swollen and sore arm".  Additional information: It was reported that patient was taking concomitant medications for blood thinner, potassium and cholesterol.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient was given an injection and the vaccinating nurse thereafter realized that the syringe did not "feel" right.  She then examined the batch of syringes that she had been given by the pharmacy and realized that there were 4 that were empty--5 including the one that the patient had just been given.  The patient was called back to the station from the observation area after  the vaccination supervisor had been notified and the situation described and explained to the individual and an actual dose thereafter given.  The pharmacy/prep area was notified .
suffering, had the vac for this/Suspected vaccination failure; suffering, had the vac for this; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-MAY-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient had the shingles vaccine but still suffering from shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Covid vaccine placed 3/4/21.        Several days later developed "clot" like lesion on lateral aspect of arm below injection.        No erythema or hardness.        No warmth or fever/chills.        fROM.        no inflammation.
VAXELIS was administered to a patient after a non-supported temp excursion. No additional AE details or PQC.; This non-serious spontaneous report with reference numbers 02271074 / 02271042 was received by partner on 19-OCT-2022 and forwarded on 20-OCT-2022 from a health care professional.   The causal relationship between Vaxelis and the reported event "non-supported temp excursion, Temperature 28.2F, 50.7F, Time frame 72 hours 45 minutes and 0 seconds, 19 hours 0 minutes and 0 seconds (RESPECTIVELY)" was assessed as not applicable due to the nature of the event.   Further information is expected.  Non-Significant follow up information was received on 17-NOV-2022 from the other health care professional.  No adverse event was reported.  The causal relationship between Vaxelis and the reported event "non-supported temp excursion, Temperature 28.2F, 50.7F, Time frame 72 hours 45 minutes and 0 seconds, 19 hours 0 minutes and 0 seconds (RESPECTIVELY)" was assessed as not applicable due to the nature of the event.  No further information is expected.
Client received extraneous and unnecessary dose of Varicella on 09/06/23 at 1546 by vaccinator.
Information has been received from a registered nurse concerning a 4 year old male with no medical history or allergies, who on 22-Nov-2000, 24-Jan-2001, and 02-Oct-2001 was vaccinated with a first, second and third dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC), respectively (third dose was 0.5 ml given into the thigh). Concomitant therapy included a fourth dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (manufacturer unknown) (+) tetanus toxoid and a first dose of varicella virus vaccine live. On 15-Feb-2005, a serum hepatitis B surface Ab and serum hepatitis B surface antigen test were performed and both were found to be non-reactive. It was reported that the patient failed to seroconvert. Unspecified medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected. It was reported that an additional patient was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast) and experienced an adverse event (WAES 0503USA01079.
Couple of weeks after my booster I started experiencing low blood sugars, getting shaky, sweaty and clammy. I would have to drink some orange juice or have some proteins to get it up. It has happened several times, then in December I had an episode where I felt like I was going to pass out, I ate a few sweets incase in was my blood sugar went to ER and my blood sugar was 52. Around a month later I had another episode like that my blood sugar 118 and my blood pressure was 128/80 something both were normal. But because of that and the episodes being the same I don't believe that it was my blood sugar. I am still experiencing low bloods sugars even after I eat.
Patient was given one dose of Janssen COVID 19 vaccine on 10/5/2021 that had expired on 10/02/2021
I started feeling tired later on that afternoon and in the middle of the night I started having chills and fever. The very next day I was so weak I couldn't get out of bed and was having a hard time breathing.  I called 911 and was taken to the hospital which resulted in being admitted.
Fever to 102.3F. Vomited x 1 yesterday. No diarrhea.
arm was a little sore; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves patient (unknown demography) experienced arm was a little sore (pain in extremity), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious arm was a little sore (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  The event outcome was unknown at the time of report.  There will be no information available on the batch number for this case.
This spontaneous report was received from a nurse prescriber and refers to a 15-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 10-OCT-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N032744, expiration date 20-NOV-2019 (also reported as 19-NOV-2020) (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 15 to 46 degrees Fahrenheit for 2 hours and 57 minutes. A digital data logger was not involved. There were no previous excursions reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1810USA006272.
Mother states that 5 days after her 2 month shots (previous shots) child stopped lifting her head for approx. 1 month.  This was not reported so no VAERS report was done.  Mother called approx. 2 months after her next set of shots (1/07/14 at 5 1/2 months) to tell us that child stopped holding bottle and seemed more "wobbly" when sitting up.  States child would roll her fingers back and pull arms back like "wings" at intervals. At time of this report (3/17/2014), child was seen in clinic and no abnormal activity was observed, child sitting normally, no finger rolling or pulling back of arms. Child made good eye contact and responded to tactile and verbal stimuli.
I started having a tickle in my throat on Saturday April 1, 2023. Then it became a cough. On Sunday I had a cough and fever. Monday I a cough fever, sore throat, headache, and body ache. I sought on Tuesday and that's when I tested positive for COVID-19. All of my symptoms continued through Thursday April 6, 2023. On Friday the sore throat and fever was gone, but cough, congested head, and runny nose was still present. I'm still coughing, and the headache comes and goes. I frequently blow my nose.
Patient was given 0.25 ml for her second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was given 0.25 ml for her second dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A and 039D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 01-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (Patient was given 0.25 ml for her second dose). On 01-Nov-2021, ACCIDENTAL UNDERDOSE (Patient was given 0.25 ml for her second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported.  No treatment medication were reported.  Patient is not immunocompromised. HCP was asking what to do and if the patient should receive another half dose.
The next morning pt went to school then had to leave w/h/a & rt hand swollen; cont to have h/a, low grade temp & swollen hand & missed school the rest of wk;
Information has been received from an 88 year old female with shingles, post herpetic neuralgia, osteoporosis and no known allergies who in July 2007, was vaccinated with Zostavax (Oka/Merck).  Concomitant therapy included EVISTA.  The patient's physician told her to get the vaccine to help with her burning and itching.  The caller stated that she has shingles on her left side on her back around to under her bust.  She stated the itchiness and burning has gotten worse in the last couple of days.  Unspecified medical attention was sought.  At the time of the report the patient had not recovered.  There was no product quality complaint involved.  Additional information has been requested.
It makes me deathly sick; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 05-DEC-2020.   This case involves a patient of unknown age and gender who experienced it makes me deathly sick (Illness), while he/she received vaccine Influenza Vaccine.   The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient reported it makes the patient deathly sick.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.  The reporter assessed the causal relationship with suspect vaccine as related.
PT WOKE UP THE DAY AFTER THE SHOTS WERE GIVEN WITH A RASH HEAD TO TOE. SOME SPOTS LOOKED LIKE SM DOTS, OTHER AREAS LOOKED LIKE HIVES. EXTREMELY ITCHY. ALSO C/O FEELING ACHY. PARENTS GAVE BENADRYL AND MOTRIN WHICH DID NOT RELIEVE SX. ATARAX 10MG EVERY SIX HOURS CALLED IN FOR PT. THEY HAD TO GIVE IT EVERY SIX HOURS FOR RELIEF. PT EVEN WOKE UP THAT NIGHT AND GAVE ATARAX AT ABOUT MIDNIGHT. THE NEXT MORNING WOKE UP WITH NO RASH AND NO SYMPTOMS.
Shivering; patient can not walk; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Shivering) and GAIT DISTURBANCE (patient can not walk) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination.     The patient's past medical history included Multiple sclerosis (Patient has 20 years history of Multiple Sclerosis.).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced CHILLS (Shivering) and GAIT DISTURBANCE (patient can not walk). At the time of the report, CHILLS (Shivering) and GAIT DISTURBANCE (patient can not walk) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided. No Treatments were reported.
lost taste; rather the taste of things is different; severe effects chills; fever; nausea; headache; body ache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (body ache), AGEUSIA (lost taste), TASTE DISORDER (rather the taste of things is different), CHILLS (severe effects chills) and PYREXIA (fever) 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.     No Medical History information was reported.   On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 01-Feb-2021, the patient experienced PAIN (body ache), CHILLS (severe effects chills), PYREXIA (fever), NAUSEA (nausea) and HEADACHE (headache). On 02-Feb-2021, the patient experienced AGEUSIA (lost taste) and TASTE DISORDER (rather the taste of things is different). At the time of the report, PAIN (body ache), AGEUSIA (lost taste), TASTE DISORDER (rather the taste of things is different), CHILLS (severe effects chills), PYREXIA (fever), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
expired dose of the Ipol was given with no reported adverse event; Initial information received on 28-Apr-2021 regarding an unsolicited valid  non-serious case from a other health professional via (inquiry reference number 00580556).  This case involves a patient (unknown age and gender) who received an expired dose of IPV (VERO) [IPOL] (lot R1B251M and expiration date:13-Mar-2021) via unknown route in unknown administration site for prophylactic vaccination on the other day (date unspecified) (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   It was an actual medication error due to expired vaccines used (same day latency).  I was reported that the practice manager called for recommendation because an expired dose of the Ipol was given to consumer the other day. She called to find out if it required or recommended to repeat the dose. At time of the call, practice manager said she does not have NDC (national drug code). Practice manager confirmed it was not her but she also refused to provide the information. Hours of operation: 9 AM to 5 PM. Practice manager refused to provide consumer information saying she was not allowed to disclose it. Thus, limited information was obtained.  It was unknown of the patient experienced any adverse event.  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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
onset of rash on face, trunk & genitalia approximately 20 hours after receiving Hep A #2 with low-grade fever (100F), now resolved. Symptoms have essentially resolved at this time. No treatment required.
12:25PM pt recv vax;1230PM c/o lightheadedness, tinnitus;BP 80/40;8oz fluids green;1240PM BP 110/50 sx abated;1PM BP 104/60;
Patient was administered the wrong dose of the booster vaccination.  Patient was given 0.5 mL of MODERNA COVID vaccine rather than 0.25 mL. No adverse reactions or side effects reported.
The first week was more of fever but went away after 2-3 days. I kind of have just had the same symptoms going on. 12/23/2022, felt like an atomic bomb went off in my lungs. There was a little amount of fluid in my lungs so I started talking steroids to try to suppress the fluid but it continued and increased. It was white, sticky fluid that began to discharge that I had to spit up. About 1-2 weeks later, my lower legs; from shin down; became completely numb and resistant to the touch. Then I started experiencing general weakness with some brain fog. My taste is wearing but my smelling is ok. I didn't have a fever again after the first initial one. I had a very painful sore throat. It was very quick lung issues but got really bad as the days went on. It felt like my entire immune system got infected.
My baby had a fever of a 101 degrees, excessive vomiting, weak eyes, excessive crying, and two seizures.
Information has been received from a health professional concerning a greater than 3 month old male who was vaccinated with ROTATEQ. No product quality complaint was involved. No other information was provided. Additional information has been requested.
minutes p/vax pt vomited & became pale & hypotonic; BP from 80 systolic to 60 systolic & became hyporesponsive lasted 20-30mins then color improved & became more active & still weak;
nerve damage in head; trigeminal neuralgia; very hard to cut things; has been shaking/whole body shaking; limbs are weak are shaking; has had really bad anxiety ever since this started; rash on both shoulders; This spontaneous case was reported by a consumer and describes the occurrence of NERVE INJURY (nerve damage in head), TRIGEMINAL NEURALGIA (trigeminal neuralgia), DISORIENTATION (very hard to cut things), TREMOR (has been shaking/whole body shaking) and ASTHENIA (limbs are weak are shaking) in a 53-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.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN, CLONIDINE, VANCOMYCIN and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 25-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NERVE INJURY (nerve damage in head), TRIGEMINAL NEURALGIA (trigeminal neuralgia), DISORIENTATION (very hard to cut things), TREMOR (has been shaking/whole body shaking), ASTHENIA (limbs are weak are shaking), ANXIETY (has had really bad anxiety ever since this started) and RASH (rash on both shoulders). At the time of the report, NERVE INJURY (nerve damage in head), TRIGEMINAL NEURALGIA (trigeminal neuralgia), DISORIENTATION (very hard to cut things), TREMOR (has been shaking/whole body shaking), ASTHENIA (limbs are weak are shaking), ANXIETY (has had really bad anxiety ever since this started) and RASH (rash on both shoulders) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2019, Computerised tomogram: other (Inconclusive) nerve damage in her head.          Treatment information was not provided.    This case was linked to MOD-2021-187508 (Patient Link).
About 1/2 hour, post vax, was flushed and had nausea with episodes of vomiting and diarrhea X 3 days. No local reaction. Vague history of shortness of breath. (First and only shot).
Patient reported that she had left shoulder pain and rash about 3 weeks ago. She took some over the counter Aleve and felt better and the rash has got better since then.
Right after injection on 12/16, the employee developed rash, hot flush on the chest. Was sent to the ER for monitoring. Took Benadryl 50mg at home at 1500. Another rash appeared on her face at 2200, took another Benadryl 25mg. On 12/18 at 0430, she developed chills, fever of 101.7, and body aches. Took Motrin and Tylenol, continued to have low grade temperature on Saturday. No more symptoms on Sunday.