chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine exposure during pregnancy; A spontaneous report was received from a consumer concerning a 33-year-old, pregnant female patient, who received Moderna's COVID-19 vaccine (mRNA-1273)/exposure during pregnancy.  The patient's medical history, as provided by the reporter, included gestational diabetes, alcohol use, subfertility (possible progesterone deficiency), breech delivery and c-section. The patient had four prior pregnancies. First and second pregnancy resulted in spontaneous abortion. The third pregnancy ended on date with a live full-term birth through breech, c-section. The fourth pregnancy ended on date with a live full-term birth through c-section. Products known to have been used by the patient, within two weeks prior to the event, included prenatal vitamins and progesterone.   On 02 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 025J202A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient received a positive pregnancy test. Patient's last menstrual period was on 21 Jan 2021 and estimated conception date was on 30 Jan 2021. The patient's estimated due date is date.  On 01 Feb 2021, the pregnant patient was exposed to the mRNA-1273 vaccine. Patient would like to be enrolled into the pregnancy registry. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event, exposure to moderna vaccine during pregnancy, was considered resolved on 01 Feb 2021.
Mother called on call physician in the evening after immunizations were given to report fever and vomiting. Parents were instructed to bring child in to office for evaluation the next morning.
PATIENT RECEIVED VACCINE THAT EXPERIENCED A TEMPERATURE EXCURSION, VACCINE WAS KEPT IN THE REFRIGERATOR FOR MORE THAN 30 DAYS. No adverse reactions reported.
I95.9 HYPOTENSION 4/27/2023 CHEST PAIN.
Patient received the RSV Arexvy vaccine as just the diluent without being mixed with the active antigen component. Patient will schedule an appointment for re-vaccination.
Received Pfizer Vaccine #1 on 3/27/21. Fifteen minutes after receiving the Vaccine, patient reported ?tingling of lips?. Was given a water bottle and feeling did not go away. Patient requested Benadryl stating ?I take Benadryl all the time.? His dad was driving him home. Benadryl 25mg PO was administered. 15 minutes after Benadryl administration, patient reported tingling of lips resolved.
Felt delirious; her ears felt full like it was gonna pop; swelling in throat and tongue which felt like an allergic reaction; swelling in throat and tongue which felt like an allergic reaction; allergic reaction; tingling all over her body, specifically in her arms, legs, back, face, head and tongue.; Pain at injection site, left arm; hives right after the injection/ she took off the band aid and had a big hive in that spot; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 31Jul2021 about 4:00 or 4:30 (Batch/Lot Number: FA7485) at the age of 48 years, as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 31Jul2021 (evening), she took off the band aid and had a big hive in that spot which cleared up in a week. On 01Aug2021, a couple of hours after the shot, around 2 AM, her arms and legs were tingling all over. Later, her tongue was tingling. She had tingling all over her body, specifically in her arms, legs, back, face, head and tongue, changes from day to day, consistent with arms, legs and back. She also had pain at injection site, left arm which was off and on throughout the day on 01Aug2021. On 03Aug2021 at 9 PM, she experienced swelling in throat and tongue that felt like an allergic reaction, different sides of throat, off and on, for which she took antihistamines. On an unspecified date, she felt delirious, and it felt like her ears were full, like they were going to pop. She really just wanted some information, as she had been having symptoms on and off for 9 weeks. The patient asked if other people have had these symptoms and if can Pfizer provide recommendations for treatment. She tried antihistamines, steroids, and a lot of different things. Cetirizine (ZYRTEC) worked and it did not work at times, famotidine (PEPCID) caused her more tingling and headaches, prednisone made her tingling worse, loratadine (CLARITIN) and levocetirizine (XYZAL) did not work, fexofenadine (ALLEGRA) seemed to work well, but she took it for a day and had side effects (not specified), and paracetamol (TYLENOL) did not work and it made her tingling worse. She was feeling desperate and would like some support. It had been 9 or 10 weeks, and she was still having symptoms. She still had arm pain. She had been to multiple doctors and will be seeing specialists next week. Her doctors were not understanding her symptoms. She wanted to know if her symptoms will go away. She felt that there was a lot of help for people who have gotten COVID, but there was not help for people that have gotten a reaction to the vaccine. She did not have the second dose. The outcome of hives right after the injection was recovered on an unspecified date; of tingling all over her body, pain at injection site, left arm, and swelling in throat and tongue felt like an allergic reaction was not recovered; and of felt delirious, and ears were full, like they were going to pop was unknown.    Follow-up attempts are completed. No further information is expected.
Headache; nausea; red face; This is a spontaneous report from a non-contactable consumer (patient) for herself. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL9265) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included known allergies: shellfish. Concomitant medications were not reported. No other vaccine in four weeks. The patient was not pregnant. The patient experienced headache, nausea, red face; all on an unspecified date. No treatment received for events. The outcome of events was resolved on an unspecified date. No COVID prior vaccination and no COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Chief Complaint  chest pain History of Present Illness  Very pleasant 29-year-old gentleman has lived in the US since 9 years old presents to the emergency room with chest pain.  Started around Thursday of last week, has been constant progressively worse sharp and worsened with deep inspiration coughing progressed to the point was so severe that he had to come to the emergency room tonight.  He denies fevers or shaking chills or any  coryza prodrome.  He received the 2 dose Pfizer vaccines February 11 and March 18 and has not had Covid  Has been monitoring serially for HIV and this has been negative including this evening In the emergency room was given aspirin initially with concern
Half of my tongue is black, mostly midway and to the back of the throat.  Some black on my right side of tongue coming towards the front. Felt fine after the shot around 10:10 a.m.  and only looked in a mirror around 4:15 p.m. and saw the area of blackness. Have no other symptoms. Arm is slightly sore.
Not sure which arm receive vaccination. I noticed after the second dose I had Tinnitus, that went away before. Symptoms didn't stop. Then after my booster the noise level went up.
This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced PRURITUS (itching). At the time of the report, PRURITUS (itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.   Reporter did not allow further contact
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. 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 recovered/resolved. The reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The reporter stated that the shot causes shingles. The follow-up would not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
27MAY93 15cmx12cm are of redness w/central pallor, w/central area of bulla 4x5cm w/bruising to entire area, tenderness to entire area lt upper arm, no fever resolving 1JUN93;
Within 12 hours I started running fever, having trouble breathing, and a cough that would not stop.  These symptoms continued to worsen over the next 48 hours.  It got to the point that the only way I could breath and grasp air was laying down on my side.  I went to the ER and was admitted within hours.  They had to put me in a medicated coma and deep lung intubate both lungs.  I had internal bleeding which the doctors could not explain.  They tested me for everything across the medical spectrum looking for some underlying health issue and found none.  Several of the doctors said there is no explanation other than I had an extreme adverse reaction to the vaccine.
I had a frozen embryo transfer on 8/31/2020. I received my first dose of Pfizer on 2/12/21 and my second dose on 3/5/21. I began experiencing swelling in my hands, feet, and face toward the beginning of March. I let my OB know and she decided to do blood work which I had done on 3/15/21. The blood work showed low platelets and high uric acid. My BP was elevated at this point but not overly high. I went into the hospital to be monitored on 3/17/21. My BP was elevated but not enough to be admitted. My protein in my urine was in the single digits. I had another appointment on 3/19/21 and my blood pressure was high. I was told to monitor my BP at home and if I had a reading over 160/90 or a headache to call immediately. On 3/20/21 I had a horrible headache and a high BP reading so I was again told to go to the hospital. At this point my BP was very high so I was admitted to the hospital. I was 31 weeks pregnant at this point. The goal was to get to 34 weeks. The protein in my urine continued to rise into the 10,000s.  On 3/22/21, I had a horrible headache while in the hospital and my BP rose into the severe range. It was determined that I developed severe preeclampsia and I had an emergency c-section at 4:30 AM. My son was born at 31 weeks 6 days and spent 37 days in the NICU. I also developed posterior reversible encephalopathy  syndrome and lost some of my vision and had hallucinations. After about a month, my BP and vision were back to normal.
Rash, erythema, and itching surrounding injection site - requiring emergency room visit plus steroid treatment course. Rash occurred two days after injection.
This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-SEP-2017, the patient was vaccinated with a dose of RECOMBIVAX HB 2.5/0.5 (units not provided) (lot # N011851, expiration date: 19-DEC-2019; dose number and route of administration were unknown) and a dose of ROTATEQ (lot # N005080 with expiration date 03-OCT-2018, or lot # reported as N0118511 with expiration date 19-FEB-2019; orally, dose number was unknown), both for prophylaxis. The doses were improperly stored at 48.6 Fahrenheit (F) degrees for 2 hours. The temperature excursion was detected by a digital data logger. There were no previous temperature excursions and no adverse effects reported. This is one of several reports received from the same reporter. Lot number N0118511 is an invalid lot number for rotavirus vaccine, live, oral, pentavalent. Sender's Comments: US-009507513-1709USA004084.
vaccination failure; COVID 19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 22Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 13Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "celiac" (unspecified if ongoing); "hypertriglyceremia" (unspecified if ongoing); "known allergies: Gluten" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; JARDIANCE; FENOFIBRATE; ATORVASTATIN; TOUJEO; PRANDIN; WELLBUTRIN; ALLEGRA; OMEPRAZOLE. Past drug history included: Nickel, reaction(s): "Known allergies: nickel". The following information was reported: VACCINATION FAILURE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered", described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) negative; (2022) positive; (unspecified date) Unknown result. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Rebound Covid on day 10 of initial isolation. 4 days after completing Paxlovid. Have negative antigen test on day 9. Day 10 developed mild symptoms and tested positive on antigen test. Other medication in 2 weeks product included Metformin, Jardiance, Fenofibrate, Atorvastatin, Toujeo, Prandin, Wellbutrin, Allegra and Omeprazole.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
he developed skin rash/ rash itches very bad; It came back as some form of edema; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. An 80-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EP7533, NDC number, expiry date: unknown) via an unspecified route of administration on 02Apr2021 in the morning (at the age of 80-years-old) in left arm as a single dose for covid-19 immunization. Medical history (including any illness at time of vaccination) included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes), obesity, allergies to penicillin and ibuprofen, stage II diabetes all from an unknown date and unknown if ongoing. He takes Glipizide 1 tablet twice daily, 5mg for diabetes. This report is related to a study or programme. No additional vaccines administered on same date of the Pfizer suspect. Concomitant medication included glipizide (GLIPIZIDE) taken for type 2 diabetes mellitus from an unspecified start date and ongoing. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine, lot number EN6208) on 12Mar2021 in the morning in left arm for covid-19 immunization. The patient experienced skin rash on an unknown date in 2021 few weeks after second dose. He tried multiple creams and ointments and shots, but nothing had helped. He tried to heal up his leg and he had hard time getting it to heal. The doctor took biopsy of his legs where the rash was, and It came back as some form of oedema. The rash itched very bad that it wakes him up at night. It was mainly on his feet, legs and some on his waist, back and stomach. He took Prednisone for 5 days and it did help a little, but once he finished it the rash came back but was somewhat improved. He read about the booster and asked if he had rash, should he get the booster and should the rash last this long. He had gone to several doctors for the rash. They have tried many different medications that don't seem to work. The adverse event required physician office visit. The patient underwent lab tests and procedures which included biopsy on an unknown date in 2021. Treatment medication included Clotrimazole cream USP 1 percent, antifungal, yellow label with no NDC/lot/expiration; Triamcinolone Acetonide ointment USP 0.25 percent, Lot: 1TT1CT0592, Feb2023; Ammonium Lactate 12 percent lotion: expiration: Aug2022, lot: 0KT0432; Augmentin cream, no NDC/lot/expiration reported; Benadryl allergy tablet 25mg tablet, he doesn't see a UPC/lot/expiration on them (over the counter); Hydrocortisone 1 percent cream no NDC/lot/expiration; Mupirocin Bactroban ointment: 22g, no NDC/lot/expiration; Prednisone 20mg tablets. The sample of the product was available to be returned. The outcome of both the events was not resolved.
per pt she developed a flat rash about 3-4 inch area. she is also experiencing  pain and fever. She has experience it for a few days
the injection caused an immediate burning sensation upon injection; some mild bleeding at the injection site; This spontaneous report was received from a registered pharmacist referring to a 38 year old female patient with no pertinent medical history or drug reactions/allergies.  No other information was provided regarding the patient's concurrent conditions.  There was no concomitant medication.    On 12-APR-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R027997 expiring on 01-OCT-2020, subcutaneously, for vaccination (immunisation) (strength, dose and site of administration were not provided).         On the same day of vaccination, the injection caused an immediate burning sensation upon injection (injection site pain ) and some mild bleeding at the injection site (injection site haemorrhage).  The patient seek medical attention through the pharmacist, who would call patient's physician.  The patient did not received any treatment and not any laboratory test was performed.  The events were not considered as cancer, disabling, life threatening or overdose.  There was no PQC present.   The patient's symptoms resolved within a few minutes, on the same date.   The reporter did not assess the causal relationship between therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and the events.
Adverse Event and Outcome: Pt came into the vaccination room with reports of high anxiety about the COVID vaccine but reports of no fear of needles at 9:50 AM. Pt was seated on the chair and counseled on the Moderna vaccine. Pt reports that she is in the process of getting diagnosed for multiple sclerosis. Pt reports that previous visit with PCP had an elevated blood pressure reading. Pt had cutis anserine (goosebumps) upon administration of the vaccine in the left deltoid and immediately felt light headed and turned pale (10:00 AM). Pt had slurred speech and was knocking in and out of consciousness. Pt reported "heart pain" and abdominal pain. Pt was coherent enough to provide information regarding emergency contact. Pt was not fit to operate a vehicle and the emergency contact had no access to a vehicle so the paramedics were contacted.  Treatment:  Pt was given water and told to stay in her seat. The supervisor, assessed the Pt and called the emergency contact. Paramedics were called and arrived on the scene at 10:10 AM to assess the pt.
After H1N1 vaccination, hives-like rash appearing on any and all parts of body--stays on arm, leg, hand, face, etc., for about 10 minutes and then disappears. Quite red, but does not appear itchy or painful.
About 4.5 hours after vaccination I started to see small hives popping up on my arms.  Over the next hour it spread to my shoulders, neck, chest, upper and middle back, blotches on my thighs and tops/small bumps turned into welts; blotches on my thighs and tops of my feet, behind,my ears and on my left temple.; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 20Feb2021 08:30 (Batch/Lot Number: EM9810) as a single dose for covid-19 immunization. Medical history included depression, anxiety and high blood pressure. Concomitant medications included sertraline and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR); both taken with-in 2 weeks of vaccination on an unknown date. No other vaccine in four weeks, no covid prior vaccination, no covid test done post vaccination and No known allergies. On 20Feb2021 at 12:45, about 4.5 hours after vaccination the patient started to see small hives popping up on her arms. Over the next hour it spread to her shoulders, neck, chest, upper and middle back, blotches on her thighs and tops of her feet, behind her ears and on her left temple. The small bumps turned into welts. Cold shower and benadryl helped as treatment and no other issues aroused. The outcome of the events was resolving.  Follow-up attempts are completed. No further information is expected.
Fever, hot/cold chills, muscle aches, sweats, nausea, headache
devel gen rash erythematous maculopapular (not urticaria) p/vax;devel generalized rash next 24-48hr;
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. In 2011, the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not provided) which had expired a year earlier, the vaccine expired some time in 2010. No adverse effect reported. Additional information has been requested.
Fatigue Fever (102.5 degrees) Chills Widespread body pain All lasted until 7am on 8/23/21
pt recvd vax & had large induration & redness noted; induration noted to be raised;
Breakthrough COVID-19 Case: It started as a sore throat and cough, I called my doctor and he prescribed Paxlovid. The symptoms subsided after 72-hours. After a few days I started to feel better.
This spontaneous report as received from a physician via a company representative refers to a 3 year old child patient of unknown gender. On an unknown date the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot #, dose, route not reported). Concomitant therapy was not reported. On an unknown date the patient developed chicken pox after receiving (Oka/Merck) VARIVAX. The patient had sought medical attention. Outcome of the event was unknown. This is one of several reports received from the same reporter (other MARRS#1406USA009700). Additional information is not expected.
Chills, heart arrhythmia or PVC's, extreme weakness, slight fever.  Admitted to hospital twice within a few days of each other. I've never experienced that level of weakness and heart PVC's before.
I had pretty intense chills and sweats in addition to significant pain in my left arm. These started a few hours after the injection, peaked at about 8 hours after the injection, and I was fine the next day