chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ringing in the ears; hard to sleep at night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Feb2021 (Batch/Lot number: unknown) at the age of 69 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "unknown", described as "ringing in the ears"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "hard to sleep at night".  Reported verbatim: Caller wanted to know if anyone had reported ringing in the ears as a side effect from the Pfizer COVID vaccine. She received her second dose of the vaccine on 16Feb2021. It had been three months since receiving the vaccine but four days ago she noticed a ringing in the ears that sounds like a bug was buzzing in her ear. This ringing comes and goes. Because of ringing in ears, it was hard to sleep at night because making louder noises. She had a shot in her right arm. She never had ringing in her ears before. When probed for the LOT, consumer stated, the last shot was Pfizer EN looks like a 6200. It was hand written it's hard to read.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 63 yr old female, with unk medical history, who on 13Apr06 was vaccinated (route unk) with a dose of pneumococcal 23v polysaccharide vaccine (lot651328/1046P). There was no concomitant medication. On 13Apr06 the pt developed erythema, pain and heat in a 2 3" area around the injection site. The pt was treated with hot compresses. No product quality complaint was involved. The reporting physician requested a lot check. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. In addition, a review of the quality control system revealed that there were no open quarantines registered against this lot/fill. Additional information has been requested.
On 9/3/99, the pt experienced visual disturbances that included blurred vision and "seeing lines." the pt was seen by a physician who performed an ophthalmological and physical exam which were both normal.  pt recovered without treatment.
Information has been received from a nurse practitioner concerning a 12 month old patient who on 02-NOV-2007 was vaccinated with zoster vaccine live (Oka/Merck) rather than varicella virus vaccine live (Oka/Merck). The nurse practitioner reports she was not aware of any product confusion. No problems were reported. There was no product quality complaint. Additional information is not expected.
chills and couldn''t warm up; Burning sensation; He had the booster on the 28th; booster dose did not do it the same way, squeezed the fat on his arm; Sore arm; This is a spontaneous report from a contactable consumer (patient).  A male patient of an unspecified age received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number not reported), via an unspecified route of administration, administered in Arm on 28Sep2021, as dose 3 (BOOSTER), single for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number not reported), via an unspecified route of administration on an unspecified date, as dose 1, single for covid-19 immunisation. And received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number not reported), via an unspecified route of administration on an unspecified date, as dose 2, single for covid-19 immunisation. On 28Sep2021, the patient had the booster, experienced sore arm and burning sensation. On 29Sep2021, the patient had chills and couldn't warm up. The patient got all three of his at the first two he hardly felt anything but they didn't do what she did on the 28th. What she did caused a burning sensation. He asked her and she didn't know. She pinched and squeezed the fat on his arm before giving the shot. He read that might not be the right way because the needle might not reach the muscle the patient inquired was that right. Everything else was fine. However, last night he had chills, could not warm up. Wanted to know if that was normal to occur a couple days late. He has his first two. The lady that gave him the booster dose did not do it the same way, squeezed the fat on his arm. Burning sensation. Caller: Read an article, the correct arm you should not pinch the fat if the needle is not long enough it won't reach the muscle. The chills the day after. On the day of reporting morning, it seems to be alright the patient was freezing. That one burned. The first two did not experience. On 29Sep2021, the event sore arm was recovered. The outcome of the other events was unknown.  Follow-up attempts completed. No further information is expected
Information has been received from a registered nurse concerning "about 35" female patients who were vaccinated with 0.5 ml of Gardasil and who experienced burning at the injection site. The patients sought unspecified medical attention. Therapy with Gardasil was discontinued. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Pt given MMR and within 10 minutes of injection pt developed rash on arm from site to shoulder. Pt given Benadryl and in 15 min rash had faded but spread to R cheek and upper back.
diaphoresis, lightheadedness, getting shaky and nervous, "hot flashes" Heart Palpitations, loss of appetite and diarrhea, chills, headache
Developed cellulitis at and around injection site. Treated with antibiotics for 5 days.
By 15th arm hurt really bad, 16th and 17th started noticing headache, face and arm skin sagging, pinky and ring finger numb. By 18th pain in head was horrible and face was swelling - went to ER - no treatment given - followed up w/ Dr. Antiseizure meds given. Didn't react well to.
This spontaneous report as received from a nurse prescriber refers to a 16 year old non-pregnant female patient. The patient's concurrent conditions and medical history were not reported. On approximately 04-APR-2017, the patient was vaccinated intramuscularly with GARDASIL 9, lot # M043701, expiry date 22-JUN-2019 (dose and site of administration were not provided) to prevent human papillomavirus (HPV). The patient also received meningococcal a polysaccharide vaccine (dose, route and site of administration, lot # and expiry date were not reported). Concomitant therapies included ibuprofen. On 04-APR-2017, after the meningococcal a polysaccharide vaccine was administered, the patient had a tonic-clonic seizure, and lost control of her bladder. She received first aid in the office, was laid down and her vitals were monitored. In April 2017, reported as now, the patient was in a hospital and was going to have an electroencephalogram (EEG). The patient was treated for the event. The outcome of tonic-clonic seizure was reported as recovered on an unspecified date in April 2017. The relatedness between the event and the suspect therapies was not provided. Upon internal review, the event of tonic-clonic seizure was considered to be medically significant. Additional information has been requested.
exposure to freezing temperatures; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 31-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number 24BM2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th September 2021, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, 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 case details were reported as follows: The reporter called due to their discovery that patient was inadvertently administered on 16th September 2021 the vaccines that were in the temperature excursion, which led to incorrect storage of drug. The agent informed pharmacist the vaccines should be discarded due to exposure to freezing temperatures 31.5 Fahrenheit for 13 hours. The reporter did not consent to follow up. This is 1 of 7 linked cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021198139:same reporter US-GLAXOSMITHKLINE-US2021198147:same reporter US-GLAXOSMITHKLINE-US2021198142:same reporter US-GLAXOSMITHKLINE-US2021198149:same reporter US-GLAXOSMITHKLINE-US2021198148:same reporter
2 days after shot the injection site was very red,warm and had a knot.   It is  about 3 inches long. It went away for about a week and now today 01-17-21 the same symptoms are back.
Approx. 4 days after receiving the 1st dose of Moderna Vaccine, developed a rash at the injection site (left shoulder), inner area of right bicep, inner area of both left and right thighs, around the groin area. The affected areas itched intensely. This rash lasted approximately 15 days. Used otc Zyrtec and otc cortisone cream to help control rash and itching.   After about day 12, notified my primary care physician for advice. Instructed to use otc. Pepsid 20mg 2x daily and continue otc Zyrtec.
About 23 hours after vaccine I had sudden fatigue and joint pain. I slept for 5/6 hours, woke up for a while, went to bed around midnight and woke up fine the next day.
Fever; Chills; Sweating; Body aches; muscle fatigue; Very rapid heart beat. Myresting is in the 60s, today is the 80-90s. I have stood up, walked a fewfeet, and sat back down and my heartrate was 110.; Lethargy; This is a spontaneous report from a non-contactable health care professional, the patient. A 21-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm on 22Mar2021 at 07:45 AM (at the age of 21-years-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any concomitant medication. The patient was not allergic to medications, food and other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within four weeks, prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced lethargy on 22Mar2021. The patient experienced fever, chills, sweating, body aches, muscle fatigue and very rapid heartbeat on 23Mar2021 at 03:00 AM. It was also reported that usually when the patient woke up, his heart rate was at 40s and the morning was at the 60s. Resting heart rate was 60s, but it was at 80-90s following vaccination. When the patient stood up, walked a few feet, and sat back down the heart rate was 110 (unit and reference range was not provided). The events resulted in a visit to the doctor or other healthcare professional office/clinic. The patient did not receive any treatment for the events. The clinical outcome of lethargy, fever, chills, sweating, body aches, muscle fatigue and rapid heartbeat was recovering at the time of reporting. No follow-up attempts are needed. No further information is expected.
Developed a migraine headache and extreme exhaustion on April 13 and 14, 2021. Took Tylenol and bed rest.  Felt better on April 15, 2021.
Have been losing my hair after about three months from first vaccination. Have now had both Moderna vaccinations & both Moderna boosters. Maybe, lost about 1/3 of my hair. Want to try the Novavax shot, next time, because of this problem.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Flushed / Sweating-Mild
Moderate pain at injection sight. Moderate to sever muscle aches and pain. Fatigue lasting 36 hours. Rash on chest and abdomen beginning 24 hours later.
Pt has a history of asthma, chronic diastolic CHF, and obesity. Pt presented for evaluation of nonproductive cough, rhinorrhea and hypoxia. Pt was noted to be COVID positive and was admitted with acute hypoxic respiratory failure and COVID pneumonia.
Loss of appetite; High fever; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), PYREXIA (High fever), CHILLS (Chills) and MYALGIA (Body aches) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced DECREASED APPETITE (Loss of appetite), PYREXIA (High fever), CHILLS (Chills) and MYALGIA (Body aches). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. On 25-Feb-2021, DECREASED APPETITE (Loss of appetite), PYREXIA (High fever), CHILLS (Chills) and MYALGIA (Body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication included.  No treatment medication included.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: TCR received on 28 -APR-2021 , Containing No new Information On 15-Jul-2021: TCR Received on 15 - JUL -2021 , Containing non significant information added
Nausea  Fever  Chills  Fatigue  Pain that felt like nerve pain
Extensive hives noted in office 4-30. Gave ZYRTEC (ate walnuts which prompted RAST tests). In AM 5/1 rash purplish and hurt to walk. Went to Pediatric ER and was hospitalized about 48 hours. Dx with Erythema multiforme. Given ORAPRED, BENADRYL, TYLENOL. By evening day of discharge 5/3 he was all recovered.
Information has been received from a health care facility concerning an unidentified patient who in approximately July 2000, was vaccinated with a dose of varicella virus vaccine live. Subsequently, in July 2000, the patient developed a questionable varicella like rash. The patient sought unspecified medical attention. It was reported that 2 other children in the same health care facility experienced a similar experience following exposure to varicella virus vaccine live. A lot check query was requested by the health care facility. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to 4 patients of unknown age. The patients were vaccinated with doses of (lot # 0128AE, exp date 10-JAN-2014) MMR II (dose and route not reported) on 02-JUL-2012. No other co-suspects and no concomitant medications were reported. The registered nurse reported that while checking temperature stability of multiple vaccines she noticed that four patients were vaccinated with doses of MMR II that had been exposed to 14.9 degrees Celcius for ten hours. No adverse effect was reported. No other vaccines were administered to patients. No treatment information was reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
sore in the injection site; This case was reported by a physician and described the occurrence of injection site pain in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the 1st dose and experienced sore in the injection site.  The reporter did not consent to followup.  This case has been linked with US2020204756 and US2020AMR206625 reported by same reporter. For tolerance of 2nd dose refer case US2020AMR206445.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020204756:same reporter (wife´s case 1st dose) US-GLAXOSMITHKLINE-US2020AMR206625:same reporter (wife´s case 2nd dose) US-GLAXOSMITHKLINE-US2020AMR206445:same patient, 1st dose
Moderna COVID-19 Vaccine  Eight days after my first dose, I developed an itchy red rash circling the injection sight. The rash is faint, pinkish, and about two inches in diameter.  It's not painful nor lumpy. Following the phone advise of my physician, I took an antihistamine.
Initial case was received on 19 July 2010 from the parent of the patient. A 11 year old female patient received an injection of MENACTRA (lot number not reported) and an injection of "another vaccine" (parent didn't know what vaccine) on 14 July 2010. Within minutes the patient experienced an "anaphylactic reaction" (NOS). The mother stated her daughter was taken to the emergency room and received prednisone and several ''IVs." The patient had no illness at the time of the vaccinations and had no other vaccinations within 4 weeks. Her medical history included unspecified numerous allergies. No other pre-existing medical conditions or concomitant medications were reported. The patient recovered from the "anaphylactic reaction" per reporter. Documents held by sender: None.
05/15/2021  6:00 PM CHILLS, NOT CONSTANT EVRY 30 SECONDS THAN STOPS FOR A COUPLE OF MINUTES THAN START ENDED AT MIDNIGHT,  NEXT DAY SUNDAY, 05/16/2021, SLIGHT CHILLS ON/OFF 4 PM FEVER 101 TO NORMAL CHILLS STRONGER AND LONGER, GENERAL WEAKNESS AND TIREDNESS, JOINT ACHES UNTIL 9 PM,  MONDAY, 05/17/2021,  MORNING TIREDNESS AND WEAKNESS, STILL NECK OVERALL SORENESS IN JOINTS,  DIDNT GO TO WORK
I HAD THE SECOND SHINGLES (SHINGREX) VACCINATION ON 6/29/21.  THE FIRST SHINGREX VACCINATION WAS 5/29/20 WITH NO ADVERSE REACTION.  THE NEXT MORNING, I FELT DIZZY, THE ROOM WAS SPINNING, AND I HAD TO SUPPORT MYSELF ON THE WAY TO THE BATHROOM BY HOLDING ON TO VARIOUS FURNITURE.  IN ADDITION, I FELT EXTREMELY WEAK, BUT I THOUGHT THAT IT WAS TRANSIENT.  I WAS IN THE BATHROOM BRUSHING MY TEETH AND MY WIFE NOTICED THAT I WAS THERE FOR LONGER THAN USUAL.  SHE CAME IN TO SEE IF EVERTYHTIG WAS OK AND OBSERVED THAT I WENT INTO CLONIC SEIZURES TWICE. SHE HELPED ME DOWN TO THE FLOOR.  I RESTED FOR A LITTLE WHILE AND THEN SHE ASSISTED ME TO MY BED.  WHEN I GOT UP FROM THE FLOOR I WAS DIZZY, THE ROOM WAS SPINNING. FOR 24+ HOURSE
Unresolved arm pain: Per patient, approximately 6hrs after vaccine administration, she began experiencing left arm soreness and pain 5/10 at site of injection with difficulty lifting her arm above shoulder height, but this has not resolved and has been constant for over 5 weeks. There is mild intermittent relief with Tylenol, 500mg, 1 tablet, which reduces her pain to 2/10.
No additional AE/PQC; A patient inadvertently received a dose of VARIVAX on 5/28/2021 that had a labeled expiry of 5/20/2021; This spontaneous report was received from a physician concerning a 21-year-old patient of unknown gender gender. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.  On 27-MAY-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX), 0.5 milliliter, lot number S015463 expiration date 20-MAY-2021 (route of administration was not provided) as prophylaxis.  No adverse event was reported
Urticarial rash that appeared 4 day after vaccine, no respiratory/gastrointestinal symptoms, rash improved when seen in office, had fevers on day of vaccine, rash does not blister, no bleeding or bruising.
Runny eyes, runny nose, sore throat, persistent cough (unable to control), fatigue, painful lymph nodes.
FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267226; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193.  This case involves an adult male patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-Jun-2020 via intramuscular route in the left deltoid on an unspecified date, which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other vaccine was administered.  It was a case of actual medication error due to incorrect product storage.  At the time of report 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 holders compliance with the requirements set out in Directive and Module VI of the 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.
Four days of fever/chills, myalgias, arthralgias, severe headache, anorexia. Symptoms ongoing through current time.
11/8/07 Gardasil injection given, patient reports rash on both arms & trunk.  Rash resolved after went 1 week with no treatment.
Dose number: 3; Patient had chills for two days after receiving the 3rd dose; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   A 61-year-old male patient received bnt162b2 (BNT162B2), administration date 23Dec2021 (Lot number: unknown) at the age of 61 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: Unknown; Route of administration: Unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: Unknown; Route of administration: Unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 23Dec2021, outcome "unknown", described as "Dose number: 3"; CHILLS (non-serious) with onset an unknown date in Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Patient had chills for two days after receiving the 3rd dose".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Cellulitis of left arm, started on KEFLEX oral antibiotics. Worsening cellulitis, sent to ED.
Nausea  ? Generalized Body Aches ? Cough ? Headache ? Excessive Sweating