chrisvoncsefalvay/vaers-outcomes huggingface dataset:
progressed into a sore throat; taste of metal in his mouth; weird taste in my mouth; 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 26 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 18:30 (Lot number: EN6205) at the age of 26 years as dose 1 , single for covid-19 immunisation. Relevant medical history included: "Myocarditis", start date: Feb2021 (ongoing); "Wolff-Parkinson-White syndrome", start date: Feb2021 (ongoing); "COVID-19", start date: Dec2020 (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL taken for cardiac disorder. The following information was reported: TASTE DISORDER (non-serious) with onset 05Mar2021, outcome "unknown", described as "weird taste in my mouth"; OROPHARYNGEAL PAIN (non-serious) with onset 10Mar2021, outcome "not recovered", described as "progressed into a sore throat"; DYSGEUSIA (non-serious) with onset 05Mar2021, outcome "not recovered", described as "taste of metal in his mouth". The events "weird taste in my mouth", "progressed into a sore throat" and "taste of metal in his mouth" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of taste disorder, oropharyngeal pain, dysgeusia which included Zyrtec for 3 days.Zyrtec, Cetirizine antihistamine 5mg Pseudoephedrine 120mg.  Additional information: He stated that he was experiencing symptoms after his first dose of the Pfizer vaccine. The next day he had this weird taste in his mouth. 10 days it progressed into a sore throat. Then around the week after on 08Mar2021, he started getting a sore throat. It feels like metal in his mouth. Any food he ate he had this strange metal or taste like nothing. When he did have covid he did not have any symptoms regarding taste. The patient would like to know that whether he can take second dose of vaccine. He knows that sometimes symptoms from the Covid 19 virus can persist. He would like to clarify he did not have loss of taste when he had the Covid 19 virus. He did not receive any other vaccines within 4 weeks.  No follow-up attempts are possible. No further information is expected.
fully vaccinated with moderna vaccine. Tested positive for covid on 12/29/2021. Admitted to Hospital on 01/15/2022. Expired on 01/24/2022 while still hospitalized.
Body aches; I got mastitis three times following vaccination; Headache; Mild elevated temperature (99.5 degrees F)./ fever (102.5 degrees F); This is a spontaneous report received from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 20Apr2021 10:15 (Lot Number: EW0164) (at age of 34-year-old) as 1ST DOSE, SINGLE, dose 2 via an unspecified route of administration, administered in Arm Right on 11May2021 10:30 (Lot Number: EW0183) (at age of 34-year-old) as 2ND DOSE, SINGLE for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. Pregnancy at time of Vaccination was no. Medical history included postpartum, breastfeed two older children (Sep2015-Mar2018, and May2018-Feb2021). Patient had never knowingly gotten mastitis during those earlier times. No known allergies. Concomitant medications included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS), Ca/Mg citrate, both taken for an unspecified indication, start and stop date were not reported, in two weeks. Other medications in four weeks was no. Patient got mastitis three times following vaccination (she was breastfeeding a baby born 31Mar2021, prior to COVID vaccination). The first mastitis event (25Apr2021) included breast pain and redness (left breast, same side as vaccination shot), headache and mild elevated temperature (99.5 degrees F). The mastitis cleared within 48 hours with no antibiotics. The second mastitis event (10May2021) included breast pain and redness (left breast), fever (102.5 degrees F), body aches. The mastitis cleared within 36 hours with no antibiotics. The third mastitis event (17May2021) included breast pain and redness (left breast), headache, and mild elevated temperature (99.5 degrees F). The mastitis cleared within 36 hours with no antibiotics. Patient recovered from the first time mastitis in Apr2021, recovered from other events in 2021. Patient didn't receive treatment for the adverse events. The events were reported as non-serious. There was no covid prior vaccination, not tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021660641 same reporter/ product, diffrerent patient (baby case)
TEMPERATURE EXCURSION OCCURRED DUE TO THE PLACEMENT OF HAND WARMERS IN THE INSULATED BAG USED TO TRANSPORT VACCINE. ALL 81 PERSONS RECEIVING VACCINE IN LANES 5 AND 6 AT THEON 02/15/2021 BETWEEN 14:00 and 16:45 WERE NOTIFIED THEY  RECEIVED VACCINE THAT WAS OUTSIDE OF THE APPROPRIATE TEMPERATURE RANGE AND WERE RECOMMENDED TO BE REVACCINATED.
Right leg toes started to pain about 9 hrs later. on and off pain. Beginning to increase in the last few hrs.  Also have pain at the injection site and beginning to feel feverish.
Patient fainted in the aisles while shopping at store. A customer caught the patient. The patient said she was sick to her stomach and an associate said they seen her frothing at the mouth. Staff came to the patient and rested her on the floor and used a pillow to support her head. EMS was called immediately and came to escort the patient to the hospital.
BODY ACHE AND FELT ACHY; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced body ache and felt achy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache and felt achy on APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210436672.
Afebrile seizure, 2 days, post vax. 1st seizure.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient became lightheaded approximately 14 minutes after COVID19 vaccine administration, patient was still sitting in exam chair. Laid patient back to 45 degrees on exam table, gave glucose tablet, patient BP 90/60, HR90, RR16, O2 98% states has "syncope" and happens once every 2-3 months, states does not think related to COVID19 vaccine, given water and salty chips per patient request. Patient BP 100/60, HR 70, RR16, O298% after 4 minutes. Patient called mom to drive her home.
It started on Saturday evening. I was tired, really tired and had a very terrible cough. Kept waking me up all night. The next day, Sunday morning I was really fatigued and felt like I had a fever. Had a low-grade fever and that passed pretty quickly then felt decent for a bit. Up and down. I was still coughing a lot. I also had a cold, runny nose, stuffy nose. It has been so much better today. I had an interesting event a couple nights ago. I had been feeling lethargic all day and I was by myself at home. I was reading a book on my phone and suddenly, I started to get so dizzy and so spaced out. I got pins and needles up and down my arms and legs. I got nauseated but didn?t throw up. These are all the symptoms for a heart attack so my husband came home, and I went to bed and we were worried so he called 911. They came quickly and I told them I was pretty fatigued, and I did a COVID test Sunday morning, and it was negative. Everything vitals wise was normal. They noted to come with them as a precaution or follow up with a cardiologist. I just got sicker with the horrible runny nose. The next day I did make an appointment and got on a virtual call. I told him what happened, and he said it was just more COVID. He noted it wasn?t a heart attack and I noted this went on from 6-9pm. started to feel gradually better around 8:30PM and then by 9pm I felt fine and just needed to eat. Asked about the anti-viral and I got the prescription for the Paxlovid. But I didn?t take it because I started to feel better already. I haven?t taken it and he just recommended Vitamin C 3000mg and lots of water. He also suggested 40-50mg of zinc per day, but I am doing better. I decided just not to take the Paxlovid because I?m feeling so much better. I have been more energic than I had been the last 3 days, not completely normal, but getting there. No more fever except for a low grade one on Sunday. Everything was perfectly normal yesterday for the temperature. So I believe I?m on the mend.
Initial unsolicited report received from pharmacist on 20 Feb 2018. This case involves female patient who was vaccinated with 0.5 ml dose of FLUZONE HD (batch number: UI845AA, expiry date was not reported) intramuscularly in left deltoid on 30 Jan 2018. The patient's medical history and concomitant medication were not reported. On an unspecified date, following the vaccination patient had experienced swelling, erythema, pain at injection site of left arm with pain radiating 2 to 3 inches down left arm, also experiencing myalgia, and malaise. Laboratory investigation and corrective treatment were not reported. Patient was not recovered from events. Documents held by sender: none.
limited motion and pain in right upper arm/shoulder after vaccine administered on 10-8-21.  Pain is getting better with Tylenol and Nsaid otc.
Received both of the Shingrix, then got shingles very bad/Suspected vaccination failure; Then got shingles very bad; 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 02-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media. After receiving both the doses of Shingrix, the patient got shingles very bad. Other supportive information: This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible since contact details were not provided.
Fever, chills, muscle aches, fatigue. Resolved after about 48 hours
Initial and follow-up information has been received from a physician and medical record concerning a 2 month old white female with gastroesophageal reflux since 2 weeks old, no acute illness at the time of being vaccinated, and no known drug allergies, and a history of hospitalization and born via caesearan section. No family history of asthma, seizures, birth defects, seasonal allergies. On 11-DEC-2007, the patient was vaccinated with a first dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (lot # 657380/0377U) IM in the right upper thigh at approximately 9:45 AM. Concomitant therapy also given on 11-DEC-2007 included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, (PREVNAR) vaccine (CRM197), poliovirus vaccine and ROTATEQ vaccine live (human-bovine) (MSD). Other concomitant therapy included (ZANTAC). On 11-DEC-2007, approximately afternoon, the infant developed crying off and on for 48 hours, loose diarrhea for 48 hours, one episode of vomiting, was very fussy and inconsolable. There was no fever. The infant was examined by the physician. The injection sites looked good without erythema, swelling, nor drainage. Otherwise the exam was normal. The infant was referred to the emergency room because of symptoms concerning possible sepsis as the baby received hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC), vaccine lot that was recalled. The baby was evaluated and discharged home, On 13-DEC-2007, the patient became very fussy. As a precaution the patient was sent to an emergency room for evaluation. It was reported, the lot # administered was one of those in the recent recall. On 13-DEC-2007, the patient was seen in the emergency room. The emergency room record revealed that the infant was feeding well with no vomiting. BM's were normal, she wet her diaper fine, no sick contacts. Development was age appropriate. Vital signs revealed: temperature 98.9, pulse 199, repirations 24 and pulse oximetry 95%. Exam was normal, tanner stage 1. Laboratory evaluation revealed blood culture no growth after 5 days. Cell blood count and differential were performed: hemoglobin 8.7 gm/DL (low), hematocrit 25.3 % (low), red blood cell count 2.59 m/mm3 (low), neutrophild 26% (low), lymphocyte count 54% (high), monocycte count 13% (high), and eosinophil 6% (high). The rest of the CBC was normal. Impression was immunization reaction resolving, pain due to immunization, upper respiratory infection. Patient was sent home to follow-up with primary care physician as needed and to obtain results of lab tests. On 15-DEC-2007, the infant recovered. No additional information is expected'
Vaccine administered 10/7/04 right deltoid. On the evening of 10/12/04, patient had a 3" red, hot , itchy swollen area at injection site. Mom gave Benadryl with relief of symptoms.
BODYACHES; HEADACHE; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported.  On 13-JUL-2021, the subject experienced bodyaches. On 13-JUL-2021, the subject experienced headache. On 13-JUL-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever and bodyaches was not reported. This report was non-serious.
Little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Little sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PAIN (Little sore arm). At the time of the report, VACCINATION SITE PAIN (Little sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were provided. No treatment medications were provided.
From 10/30/2008 to 11/18/2008 - severe joint pain- head to toe.  No fever hurt to walk. Resolved 11/18/2008 on own- No missed work.
a-fib, had rapid heart rate after receiving the 1st dose; her legs were initially wobbly, weak; headache; I was extremely tired and my legs were initially wobbly, weak; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 24Jun2021 (at an unspecified age) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a-fib, had rapid heart rate after receiving the 1st dose on an unspecified date. The patient still had a headache everyday. She was extremely tired and her legs were initially wobbly, weak. The patient stated these last symptoms went away. The outcome of the events was recovered on an unspecified date.  Information about lot/batch number has been requested.
Light headed, convulsions , vasovagal, then passed out, then convulsion for second time. Nausea Anxiety around needles Diaphoretic Vitals 140/95, HR -70, Oxygen -98
Body aches arms, legs, back 11:00 pm Chills 12:00 midnight Fever 100.6 @ 5:00 am
Severe Chills, Temp of 102, muscle spasms in back, and minor headache  Lasted for several hours in the evening following vaccination.   Needed to sleep in a heated blanket for a few hours.   Took NyQuil for symptoms relief and sleep aid.  The headache persisted for additional 24 hours (36 hours from vaccination)
This is a spontaneous report based on the information received by Pfizer (Reference number: GL-080421). A contactable other hcp reported for a female patient of an unspecified age received bnt162b2 (BNT162B2 formulation; Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient received hyaluronic acid (RESTYLANE), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient experienced a lot of swelling on an unspecified date. It was reported that the patient injected with Restylane Kysse after receiving the COVID vaccine. The action taken in response to the event for hyaluronic acid was unknown. The outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Patient experienced fatigue for 3-4 days post-vaccination.  Approximately one week post-vaccination, parents noticed unusual amounts of hair shedding and thinning of hair. Pediatrician diagnosed telogen effluvium on 2023/04/24.  No treatment has been identified.  Hair loss continues at a steady rate, 42 days post-vaccination.  CBC, TSH and ferratin labs run on May 4th showed no clinically significant findings.  Patient has no known history of hair loss.
This spontaneous report as received from a registered nurse via company representative refers to a 6 month old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 26-SEP-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB, lot # M014926 (strength, dosing details, anatomical location and expiration date were unknown) for prophylaxis. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
Patient stated on 2/23 noticed a small red circle, 2/24 was very tired, nauseous, diarrhea, and HA.  2/27 redness bigger then a quarter, 2/28  measured 2inches width and 3 inches length with firmness, 2/29 redness larger but firmness went away, on 2/2 red mark was about the size of a tea cup saucer  Had 2nd vaccine on 2/16/21
COVID-19 Treatment/Drug ineffective; COVID-19 treatment/COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Shellfish allergy" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "HBP" (unspecified if ongoing); "OA" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL], start date: 01Apr1979; SINGULAIR, start date: 01Feb2001; VALSARTAN, start date: 12May2008; PROZAC, start date: 01Jun2015; ALPRAZOLAM, start date: 01Mar2022; MELATONIN; TRAMADOL. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "recovering", described as "COVID-19 Treatment/Drug ineffective"; COVID-19 (medically significant), outcome "recovering", described as "COVID-19 treatment/COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: COVID-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300077535 Same patient, same product, different events;
Breakthrough COVID after booster.   Patient admitted with chest pain and hospitalized 5 days.  Vaccine times 2 and booster.  COVID positive after booster 12/16/2022.  First dose 3/4/2022 EN 6198.  Second dose 3/25/2021 ER 8730 and booster 12/16/2022 FE 3594
Stiffness; Pain; This case was reported by a consumer via call center representative and described the occurrence of stiffness in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced stiffness and pain. On an unknown date, the outcome of the stiffness and pain were unknown.   It was unknown if the reporter considered the stiffness and pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not applicable for this report. The reporter stated that the unspecified number of patients had stiffness and pain after vaccination. This case has been linked with case US2020005633 and US2020AMR006218, reported for same reporter.
Abscess at site of injection 9 d after injection. Seen but has been there for about 1 day per MOC. On (R) arm - only vaccine in RA - MCV. Rx for Keflex x 10 d.
Full body rash (very itchy) with welts and bumps started 9 days after my Moderna booster shot.  My doctor treated it as an allergic reaction and prescribed Prednisone steroid.  I am on the 4th day of prednisone and the rash is not going anywhere.  It moves through the body and gets very itchy.
PATIENT CALLED PHARMACY 7-12-21 TO REPORT HAVING "NERVE DAMAGE" FROM COVID VACCINE. PATIENT STATED SHE HAD SEEN A DOCTOR WHO ADVISED IT WOULD TAKE 8 MONTHS TO GO AWAY. PATEINT REPORTED NUMBNESS/TINGLING IN ARM.  PATIENT STATES THIS HAS BEEN PERSISTENT FOR 2 MONTHS NOW AND IS NOT GOING AWAY.
pt recv vax 3JUL96 & that day devel a five inch area of redness, swelling, & warmth @ the inj site which spread around the full circumference of arm;sx resolved w/in 4 days;
Narrative:  Patient passed away due to COVID-19. He had received the COVID-19 vaccine.