chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My tinnitus got worse after the second shot.  The ringing in my ears got worse. The increase ringing in my years started a fews days after my second dose of the Moderna vaccine.  I went to the Ear Nose and Throat doctor in July or Early August of 2021. The doctor cleaned my ears to remove ear wax. I was also given a hearing test. My hearing was normal.  I also notice that when I drive on the interstate or a road where the speed limit is 55 or greater my tinnitus gets louder. This can also happen when I drive to the store or make short trips.   So basically my tinnitus is now is louder and very much unpredictable.  Since driving is now effecting my tinnitus I am now seeking a medical accommodation from the Administration to work from home so that I do not have to drive to work. I have a medical disability from the Administration.  This was obtain in 2016.  Also after the second dose my throat was dry. It was difficult to swallow. I had to drink a lot of water. I had to eat soup and soft foods for a few weeks. I also got constipated. The constipation lasted a few days.
This spontaneous report was received from a nurse refers to 12-month-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 31-AUG-2017, the patient was vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # M045392, expiry date: 17-NOV-2018) for prophylaxis. The lot of M-M-R II was reconstituted with properly stored sterile diluent (MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: S-009507513-1709USA000054.
This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 63-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of lethargy (1st dose received in March 2018 and experienced achy (refer case US2018100619)). On 4th June 2018, the patient received the 2nd dose of Shingrix. On 4th June 2018, less than a day after receiving Shingrix, the patient experienced injection site warmth, injection site erythema and swelling arm. In June 2018, the patient experienced pain in arm. On an unknown date, the outcome of the injection site warmth, injection site erythema and swelling arm were recovering/resolving and the outcome of the pain in arm was unknown. It was unknown if the reporter considered the injection site warmth, injection site erythema, pain in arm and swelling arm to be related to Shingrix. Additional details were provided as follows: This case was previously reported to physician. The patient received dose two on June 4th around 11 Am. The patient was given both doses in the left arm. The patient reported that she felt hot at injection site, redness, and swelling. In June 2018, less than a week after vaccination, the patient experienced arm soreness. The patient reported that a circle of about 2 inches in diameter appeared the next day at the injection site.
red blotches; Inflamed 2 inch wide and 3 inch high; This spontaneous case was reported by a patient and describes the occurrence of RASH MACULAR (red blotches) and DERMATITIS (Inflamed 2 inch wide and 3 inch high) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis and Depression.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, 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 experienced RASH MACULAR (red blotches) and DERMATITIS (Inflamed 2 inch wide and 3 inch high). At the time of the report, RASH MACULAR (red blotches) and DERMATITIS (Inflamed 2 inch wide and 3 inch high) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient reported for concomitant medications taking antidepressants, supplements for osteoporosis and medication for cholesterol.   No treatment information for the first dose events were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-067635 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067635:2nd dose
A week after vaccine started dizziness, lightheadedness, vertigo. This is day 3 of symptoms
Pt recv vax on 11/3/98; 5 min post vax pt exp throat tight, chest tight, vomiting, joint&muscle aches,  fever (101), dizzy, red/indurated area
2nd dose of Moderna COVID vaccine done on 3/5/21 at 2:00 PM in right arm. Around 2:00 AM on 3/6/21 she developed body aches and chills. Right arm did get very sore. No treatment sought, she stayed in bed most of the day. Symptoms lasted about 24 hours.
New onset of rapid change in heart rate (accompanied by dizziness/lightheadedness) upon standing noticed in May 2021. The sensation in the chest feels like heart burn but appears upon standing. Routinely heart rate will change from 66-75 BPM to 104+ BPM following a change of position from reclined to standing and only 3-5 steps.
sore throat; white saliva; sticky saliva; white tongue; nausea; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th May 2019, the patient received the 1st dose of Shingrix. On 30th May 2019, immediately after receiving Shingrix, the patient experienced nausea. On 3rd June 2019, the patient experienced sore throat, saliva discoloration, saliva viscid and tongue white. On an unknown date, the outcome of the nausea, sore throat, saliva discoloration, saliva viscid and tongue white were not recovered/not resolved.   It was unknown if the reporter considered the nausea, sore throat, saliva discoloration, saliva viscid and tongue white to be related to Shingrix.  Additional details were provided as follows: The reporter was the spouse of the patient. Right after the shot, a few hours later, the patient started having nausea. The site of the shot was never red, nor swollen, nothing. The patient did have nausea for 3 days. The nausea came and went. The patient experienced a horrible sore throat. All the saliva was white and sticky and his tongue was white like a fungus. He was being to two doctors and have sent sample of saliva to the lab and waiting on results.  The patient said that she read online that an ingredient in the Shingrix comes from a tree from a jungle. She read that ingredient might affect the lining of the mouth.
Patient presented to the ED for bradycardia and dyspnea present for one week prior to admission, he was found to have a second degree AV block.  He underwent a procedure to correct atrial lead dislodging/placement of pacemaker.  Patient was also started on anticoagulation therapy for a clot in lung. Discharged after 5 days inpatient.
Information has been received from a pharmacy student concerning a patient who on an unknown date was vaccinated with RECOMBIVAX HB. It was reported that the patient experienced syncope and shivering after administration of RECOMBIVAX HB. No further information is available.
C/O tightness right jaw after waking am of 03/04/2008 also C/O chills tiredness and feeling like she had the flu. approximately 1:00pm experienced pain in the right eye and inability to completely close eye. Temp 97.7, HR 100, R 20 skin pink in color blanching present and brisk nail beds. Referred to private physician transported by mother to Dr.
cont high pitched crying for 4+ hrs; pt could not be consoled; temp @ highest reading 103.2; parent consulted w/MD; was told to cont APAP & bring to ER if crying over 6 hrs;
neuropathic pain (tingling, numbness, shooting pain in arms, hands, legs, and feet; some facial nerve sensations); started with numbness in feet on 9/2/09 when lying in bed; over the next few days involved all extremities and occasionally face. Continues to date (9/7/09). Am treating as needed with Tylonol Arthritis Pain 650 mg extended release caplets, one per 8 hours. Had similar neuropathic pain 4/07-12/07, which gradually resolved itself through physical therapy.
Breakthrough case admission after 3 vaccines ; Pfizer 1/13/21 Lot# El3249;  Pfizer 2/9/21 Lot# EM9810;  Pfizer 10/13/21 Lot# EW0186
[The second Pfizer-BioNTech COVID19 vaccine was administered on May, 1, 2021 using Batch ER9449.] Beginning in the August 2021 timeframe, patient experienced notable, significant impairment of erectile function. The characteristics of the erectile disfunction were associated with a range and variety of disfunction including inability to obtain an erection, extended periods of time to obtain an erection, not having the erection last as long as was always typical, and flaccid conditions (erection not firm.) The erectile disfunction events started abruptly upon completion of the two doses of the COVID19 vaccination process (2 doses). The symptoms were very apparent and were consistently occurring from the period onward from August 2021.
Vaccine administered after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2022-2023 season) (batch number ZA3H9, expiry date 30-JUN-2023) for prophylaxis.   On 11-APR-2023, the patient received FluLaval Quadrivalent 2022-2023 season. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced incorrect storage of drug (Verbatim: Vaccine administered after temperature excursion). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-MAY-2023 The medical assistant reported that a patient received a Flulaval QIV that was exposed to a below temperature excursion of negative 40 degree Fahrenheit.  The healthcare professional (HCP) provided adverse event (AE) details but did not reported which season of the vaccine was. The reporter consented to follow up. The patient received a Flulaval QIV that was exposed to a below temperature excursion of negative 40 degree F, which led to incorrect storage of drug.
Shingles; A spontaneous report was received from a consumer concerning a 83-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events shingles.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 1 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A) via unknown route in left non dominant arm for prophylaxis of COVID-19 infection.  On last Friday(05 Feb 2021) or saturday, the patient experienced the event shingles.It still continues. They are starting to alleviate a little bit. I had the pain and then they started to come out open. Consent given Treatment information was include valacyclovir.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, shingles was not recovered.
This spontaneous report was received from a pharmacist refers to a 73 year old female patient. On 06-NOV-2014 the patient was vaccinated with ZOSTAVAX lot # K010628, expiration date: 30-OCT-2015 (dose and route of administration was not reported). On 07-NOV-2014 the patient experienced redness and warmth at the injection site following administration of ZOSTAVAX. The reporter mentioned the area of redness was approximately 5 inches in diameter. Patient sought medical attention (she contacted her pharmacist). She did not receive any treatment for the adverse events. There were no laboratory diagnostics studies performed. The outcome of the events was reported as recovering/resolving. Additional information has been requested.
Information has been received from a medical assistant and a physician referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # M008173 with expiration date 16-FEB-2018; dose and route were not reported). The doses of VARIVAX were exposed to 8.24 Fahrenheit for 15 days. There was no previous temperature excursion. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Next morning, 5/29, woke very achy and headache. Very similar to previous doses, so didn't think anything of it.  Felt ok later in the day and on Saturday, 4/30,  Felt poor again on Sunday and Monday with aches, headache, and congestion.  Felt ok Tuesday and Wednesday. Woke on the 7th day (5/5/2022) feeling poor again (achy and headache and some congestion)
No adverse reactions occurred.  Patient was given the vaccine too early at age 11 years old.
This spontaneous report as received from a healthcare worker refers to an unspecified group of the patients (demographics unknown). Information about patients' medical histories was not provided. On an unknown date, the patients were vaccinated with doses of PEDVAXHIB (dose, frequency, route of administration and indication were not specified) (lot # K019701, expiration date: 17-JUL-2017) which were exposed to temperatures outside of the recommended range. Concomitant medication was not reported. No adverse effect has been requested. No product quality complaint (PQC) was involved. This is one of several reports received form the same reporter. Additional information has been requested.
Patient states they woke up in the middle of the night shaking unconrollably for about 20 minutes without control of his body. States it was almost as if he was having a seizure, but had never experienced this before in his life. Patient states they felt "beat up" this morning and quite exhausted after the event, but has had no other lasting side effects. I instructed the patient to partner with their doctor to determine if any follow up is required and whether his doctor wants him to get the second shot in 2 months when it is due.
After the 1st does I had immediate pain at the injection site that lasted 2 days. Severe acne, some painful, started on day 2 and lasted 15 days. Fatigue for 16 days. Urine had a smell similar to a ca; Severe acne, some painful, started on day 2 and lasted 15 days.; Severe acne, some painful, started on day 2 and lasted 15 days.; Fatigue for 16 days.; Urine had a smell similar to a can of tuna for approximately 14 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06Aug2021 12:00 (Lot number: FA6780) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 07Aug2021 08:00, outcome "recovered" (2021), described as "After the 1st does I had immediate pain at the injection site that lasted 2 days. Severe acne, some painful, started on day 2 and lasted 15 days. Fatigue for 16 days. Urine had a smell similar to a ca"; ACNE (non-serious), PAIN (non-serious) all with onset 07Aug2021 08:00, outcome "recovered" (2021) and all described as "Severe acne, some painful, started on day 2 and lasted 15 days."; FATIGUE (non-serious) with onset 07Aug2021 08:00, outcome "recovered" (2021), described as "Fatigue for 16 days."; URINE ODOUR ABNORMAL (non-serious) with onset 07Aug2021 08:00, outcome "recovered" (2021), described as "Urine had a smell similar to a can of tuna for approximately 14 days". Therapeutic measures were not taken as a result of vaccination site pain, acne, pain, fatigue, urine odour abnormal.  Additional information: No Known allergies was reported. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
A pharmacy student reported that a patient inadvertently received an intradermal injection of Pnu-Imune and subsequently developed and injection site reaction characterized by redness and swelling. This reporter indicated that 2 patients experienced this event; however they are presently not identifiable.
First dose given on April 8. On April 17th, repeated premature ventricular contraction events began. Side effects started at 1 singular premature contraction, but by April 18th had increased to two contractions at every occurrence. Events also increased in frequency, from ~2-4 per hour up to 6-8 per minute on April 18th. Events continued at this high frequency through 1+ week.   Visited Urgent Care on April 19th (EKG did not catch cardiac event and tech did not try to catch it), and local health center on April 21. Techs there took EKG series:  first EKG showed regular rhythms, but 2nd EKG recorded PVC event. Referred to cardiologist for April 23, prescribed wearable Holter monitor for 04/30/21 through 05/09/2021.   1 week Holter study recorded 2265 ventricular ectopic beats with a burden of 0.27 %;  2261 isolated PVCs, and one 4 beat run of NSVT at 131 bpm. No PACs were recorded. Cardiologist referred me to echocardiogram. Luckily, symptoms mostly resolved (98% normal) in the 2 month waiting period for echocardiogram. Echocardiogram results came back normal.   Note: I am a former athlete in decent shape with no previous history of cardiac problems or underlying health problems (ex: diabetes, hypertension, etc). This was completely out of the blue and not initiated by stress, caffeine, alcohol, or sleep deprivation.
Moderna COVID vaccine #1 given 1/13/2021, lot #029L20A; Moderna COVID vaccine #2 given 2/11/21, lot #024M20A; pt transferred from dialysis to ED due to O2 sats being 65% and pt c/o difficulty breathing with tachycardia; in ED pt developed A Fib with RVR; found to be positive for COVID; given ABX, O2 supplementation, Decadron; while pt was hooked up to dialysis, she became hypotensive, dialysis not started; in the afternoon she developed respiratory distress, lost pulse, CPR started, pt intubated on mechanical ventilation; lost pulse 2 more times with ROSC achieved; prognosis extremely poor; family made pt a DNR but not to withdraw mechanical ventilator or vasopressors; pt passed away in the hospital; death certificate and med records sent to VAERS per VAERS request
Double vision, unable to focus: brain fog Checked for stroke at urgent care on Nov 2, 2021, eyes examined by optometrist on Nov 3, 2021, and by opthalmologist on Nov 4, 2021 No stroke, no abnormalities of the eye Able to focus at distance by the second day after shot and each day after improved until 14 days later could focus fairly well, still blurry, worse when tired. Brain fog still present when tired.
Moderna COVID-19 Vaccine EUA - Upon administering the Moderna COVID vaccine to pt, pharmacists experienced syringe failure. Pharmacist described injecting the needle into the pts arm and pushing the plunger when the medication expelled out of the barrel and onto the pts arm. Pt was revaccinated as a result.
She tested positive for COVID-19 on 20Sep2023 and is better now; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (She tested positive for COVID-19 on 20Sep2023 and is better now) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Sep-2023, the patient experienced COVID-19 (She tested positive for COVID-19 on 20Sep2023 and is better now). At the time of the report, COVID-19 (She tested positive for COVID-19 on 20Sep2023 and is better now) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Sep-2023, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Caller had received 3 previous Moderna shots. She tested positive for COVID-19 on 20Sep2023 and was better now. She was wondering when she can take the next Moderna vaccination. Treatment information was not reported.
Temperature 101.0 (rectal); Vomiting and diarrhea; Spotty rash on torso, cheek; decreased appetite.
Noticed small red "bumps" on patient's stomach spread to arms. Taken to ER - MD suspect for chicken pox - script for Acyclovir given, discontinue if "rash" does not further develop and seek PCP opinion.
Had his second shot on 5/13 and passed away on that night or morning; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Had his second shot on 5/13 and passed away on that night or morning) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-May-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) (Intramuscular) 1 dosage form. Death occurred on 13-May-2021 The patient died on 13-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            No relevant concomitant medications were reported.  It was reported that patient passed away on that night of vaccination or next morning. The patient's autopsy might be scheduled on 24-MAY-2021. No treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Sore throat, cough, injection site pain with redness and swelling.  Pt. tested for Covid-19 along with influenza A & B (both negative) and throat culture complete. Reviewed use of CPAP machine for possible cause of sore throat and cough, PRN cough drops initiated.
Information has been received from a pharmacist refers to a female patient of unknown age. On 12-JAN-2015 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (dose, route not reported, lot# reported as K018173). Concomitant medications were not provided. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.