chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She experienced serious body aches to the point that she could not bend her fingers. She did not sleep that night and experienced nausea, vomiting, and diarrhea. It's been four days and all of the symptoms have cleared except pain. She still feels pain in her arm and underneath her arm.
5 min after administering DTaP, IPV and MMR, Pt. developed hive above site of MMR.  Pt given Benadryl per Emergency treatment protocol and sent to Pediatrician from health department.
10/9/09 swelling rt cheek. Up Temp 101, pain, crying. Mom gave Benadryl & Tylenol that night, Fever/Pain subsided. Swelling decreased. 10/8/09 pt. seen in office. Lt cheek swollen, afebrile, no lymphadenopathy no dyspnea; no dysphasia.
Information has been received from a health professional concerning a "petite" 18 year old white female, with no medical history, known allergies, or known illness at the time of vaccination who on 30 May 2001 was vaccinated with the first 5 mcg dose of hepatitis b vaccine recombinant (yeast) (lot #635516/0426K [previously reported as lot #637847/1654K]), administered IM in the left deltoid following a physical exam. Concomitant therapy, that day, included the first TB test (one dose of tuberculin purified protein derivative) (TUBERSOL) (lot # C0824AA), administered in the left forearm. There was no other concomitant medication. Approximately 1 week later, on 06 JUN 2001 complaints of a headache, epigastric discomfort, feeling very weak, drained (fatigue), and "was sick" (malaise). Her mother reported that she got "very sick" and was "tired and run down". At that time, Epstein-Barr virus (EBV) panel was negative. The patient's symptoms continued for three weeks post vaccination. Blood work was re-drawn. Subsequently she tested positive for EBV and CMV. At that point in time, she was noted to have increased liver function tests (10 times normal) and evelated white blood count. Eight weeks post-vaccination, lab work was normal, she had no further symptoms, and she recovered. The treating physician assumed the initial symptoms were possibly from vaccination, as EBV panel was negative, and then the patient was exposed to EBV and CMV and had subsequent mono syndrome. It was also reported that another patient was vaccinated with hepatitis b vaccine recombinant (yeast), from the same lot (637847/1654K), and experienced similar events. The reporter expressed a concern with the lot. The records of testing prior to release of this lot (637847/1654K) have been checked by Biological Quality Assurance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No further information is available.
1st injection had major chest pain and feeling of squeezing tightly in my chest, hard time breathing  2nd injection have chronic debilitating headache for 3 days, extreme dizziness and cloudy focus, rash developed at injection site.
Severe headache, chills, muscle aches, soreness and redness at site of injection
pt had constant, inc pitched cry no way to soothe pt; mom stated this was a  different cry-felt warm but never checked temp was given APAP but this didn't quiet pt lasted 18 hrs;
Left hand numbness, pain, and weakness starting 2 weeks after first dose of Moderna COVID vaccine; symptoms have persisted to the present; mild true weakness of left hand/wrist/forearm muscles on exam 9/9/21 Bilateral lower extremity weakness starting same day after second dose of Moderna COVID vaccine; resolved the same day or next day
No additional AE reported; Nurse reports product that experienced temperature excursion over the weekend was administered to a patient.; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. The information about the patient's concurrent conditions, concomitant therapies or medical history was not provided.  On 13-FEB-2023 the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # W029899, expiry date 16-MAY-2024, for prophylaxis (dose, route of administration and anatomical location were not provided). The vaccine experienced temperature excursion over the weekend (13.25 degrees of Celsius, time frame: 2 hours 32 minutes and 0 seconds) (product storage error). The vaccive had no previous temperature excursion. No additional adverse event (AE) reported.
BODY ACHES AND CHILLS NIGHT OF VACCINE ADMINISTRATION, THEN STARTED EXPIRIENCING SHARP STOMACH PAINS LOWER ABDOMEN A COUPLE OF WEEKS AFTER VACCINE. DID NOT KNOW WHAT WAS CAUSING IT AND DID NOT THINK IT WOULD BE CAUSED BY THE VACCINE, STILL HAVING STOMACH PAINS.
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in an 80-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was reported that patent did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 07-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 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 drugs were not reported.  It was reported that patient received Moderna COVID-19 vaccine first dose on 09-Dec-2020 with Lot number 011J20A, second dose on 26-Jan-2021 with lot number 029L20A, third dose on 24-Aug-2021 with lot number 014C21A and fourth dose on 04-Apr-2022 with lot number 065K21A.  Treatment medications were not provided.   This case was linked to MOD-2023-719119 (Patient Link).
TESTED POSITIVE FOR COVID-19; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced tested positive for covid-19. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid-19 was not reported. This report was non-serious.
None. Expired dose was given 02-02-2022. Expired on 01-31-2022. Spoke with patient mom on 3-15-2022 .  Patient didn't have adverse events. So I administered another dose on 3-15-2022.
Large red swollen tender area surrounding vaccination site, rash or red bumps on chest back and buttocks.  Headache, Body acne fatigue and hot and cold flashes, lesions developing.  Multiform lesions in vaccination site
arthritis is improving,no pain,theumbs no longer recovered,she is happy; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (arthritis is improving,no pain,theumbs no longer recovered,she is happy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included PANTOPRAZOLE for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (arthritis is improving,no pain,theumbs no longer recovered,she is happy). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (arthritis is improving,no pain,theumbs no longer recovered,she is happy) outcome was unknown.            Caller reports that prior to getting the vaccine she had arthritis in both her thumbs. Patient reports that arthritis is improving since receiving the vaccines.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable
no adverse event; expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and NO ADVERSE EVENT (no adverse event) in a 63-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired vaccine used).    No concomitant medicine were reported. Age of the patient is 63 Year 7 Month. Patient received Moderna vaccine on 08Apr2022 and 15Dec2022. Completion date provided as 19-Jul-2022. NDC ID  No treatment medicine were reported.
Received Varivax#2 on 9/11/08. On 9/14/08, developed varicella lesions and fever to 103.2. Seen on 9/15 with approx 30-40 lesions. Seen again 9/17 with approx 100 lesions. Fever lasted 2-3 days. Had received Varivax#1 at 12m/o.
This spontaneous prospective pregnancy report was received from a currently 34 year old female medical student who was reporting on herself. The patient had no pertinent medical history and no know drug allergies. In 2015 (exact date was unknown), the patient performed a pregnancy test with negative result, and after that, on 06-MAY-2015, the patient was vaccinated with the first 0.5 ml dose of (Oka/Merck) VARIVAX, lot #, expiration date and route of administration unspecified. The patient did not take any concomitant medication. After receiving the vaccine, the patient did not have her menstrual cycle for the month of May and was concerned that she could be pregnant. On 11-MAY-2015, the patient performed another pregnancy test and its result was positive. The patient became pregnant with last menstrual period (LMP) of 12-APR-2015 and estimated due date (EDD) was calculat3ed as 17-JAN-2016. It was reported that the patient did not receive any treatment for the event. The outcome of the pregnancy was pending and the fetal outcome was unknown. The patient sought medical attention. Additional information has been requested.
she had a sore arm; This is a spontaneous report from a Pfizer-sponsored program,. A contactable consumer (patient) reported that an 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the Pfizer COVID vaccine and she felt fine but then stated that she had a sore arm. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Pt calls and says that the injection site is 3"-4" long and wide on arm of swelling and raised area.
fever controlled w/APAP 102R on APAP; hives belly, across kness & hands-day of immun; given DPH by mom;
Patient experienced pain underneath his nipples below the areola; This spontaneous case was reported by a consumer and describes the occurrence of NIPPLE PAIN (Patient experienced pain underneath his nipples below the areola) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LOVASTATIN, FAMOTIDINE, SOTALOL, OXYBUTYNIN, PREDNISOLONE ACETATE and TIMOLOL MALEATE for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-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 NIPPLE PAIN (Patient experienced pain underneath his nipples below the areola). At the time of the report, NIPPLE PAIN (Patient experienced pain underneath his nipples below the areola) had not resolved.            No Treatment information was reported.
This spontaneous report as received from a healthcare worker and a nurse refers to unspecified number of patients. Medical history and concomitant medications were unknown. It was reported that, improperly stored doses of PNEUMOVAX23 (single dose vials, route of administrations, doses, lot numbers and expiry dates were not reported) were given to unspecified patients on unspecified dates (Incorrect product storage). No adverse experience was reported. No product quality complaint (PQC) was involved. Follow up has been received from a healthcare worker on 06-JUL-2015: It was reported that on 20-JAN-2014, the patient of unknown age and gender was vaccinated with improperly stored PNEUMOVAX23 (Lot number: J010654, Expiry date: 17-OCT-2014). This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a Medical Assistant, referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 06-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot# L042265; expiration date: 26-OCT-2017 (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. The vaccine underwent a temperature excursion (10F) for a time frame of 3 hours and 16 minutes. No previous temperature excursions were reported. This is one of several reports from the same reporter. Additional information has been requested.
This case was reported by a pharmacist via sales rep and described the occurrence of shingles in a adult female patient who received SHINGRIX. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018. 14 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. The reporter considered the shingles to be unrelated to SHINGRIX. Additional details were provided as follows: The reporter did not talk to patient directly, but one of his staff pharmacists mentioned to him. The case was also reported to VAERS. The age at the vaccination was not reported, however the patient was middle aged. The patient was administered SHINGRIX vaccine sometime in early April 2018 and experienced an episode of shingles about two weeks after receipt of the vaccine dose. The reporter did not think the episode was related to vaccination, but instead that the patient was in the prodromal stages of an episode and did not know it at the time of vaccination. The reporter did not agree to be contacted on follow up.
Severe muscle cramping, pain, weakness, and very hard to walk. Symptoms started within the next two days, it is now October and I?m still in great pain lower extremities
Pt. experienced local erythematous rash on the left arm extending from shoulder to the middle of the lower arm. Rash was warm and inflamed to the touch. Pt. had to continuously take NSAIDs for pain relief.  Pt. was seen by his PCP and given a course of cephalexin. Pt. on day 4 of antibiotics.
Injection site reaction Monday AM, then headache Monday PM hurt all over, no fever, 3 days after injection arm got very red went to ER and got fluids, flu swab performed (negative).
Per pt, arm was red/irritated/inflammed, and painful/sore to the point where she had trouble lifting her arm high. Pain was severe enough for pt to have to call in to work on the 3rd day post-vaccination.
Tinnitus and ringing in ears. I knew I should have waited. Scared it will never resolve. Skipping #2.
Patient received covid booster when she should have received a flu shot.  Patient presented covid card at the time of vaccination and told vaccinator after that she was here for the flu shot
I had a sore left arm at the injection site.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (I had a sore left arm at the injection site.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A, 067F21A and 037B21A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 20-Apr-2020.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced VACCINATION SITE PAIN (I had a sore left arm at the injection site.). At the time of the report, VACCINATION SITE PAIN (I had a sore left arm at the injection site.) outcome was unknown.            The patient was less than 50 years old.   No concomitant medication was provided by reporter.  Patient also received first booster dose on 21Nov2021 and i had a sore left arm at the injection site.  No treatment medication was provided by reporter.   This case was linked to MOD-2022-650968, MOD-2022-651007 (Patient Link).
Extreme itchiness followed by a measles like rash outbreak Prescribed Steroids, Famotidine on 11/15/21, relieved itchiness temporarily  Prescribed higher dose steroids and hydroxyzine hydrochloride on 11/20/21, relieves itchiness temporarily  Measles like rash outbreak still present as of 11/21/21
headache; chills; fever; sore muscles; This is a spontaneous report from contactable Consumer (patient).A 77-years-old (non-pregnant) female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: BN5318 and expiry date was not reported) dose 2 via an unspecified route of administration in left arm on 12Feb2021 12:00 (at 77-years age) as a 2nd single dose for COVID-19 immunisation and received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: EL8982 and expiry date was not reported) dose 1 via an unspecified route of administration in left arm on 22Jan2021 12:00 as a 1st single dose for COVID-19 immunisation. The patient medical history included AFib and latex allergy. Concomitant medication(s) included rivaroxaban (XARELTO); flecainide (FLECAINIDE); amlodipine (AMLODIPINE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Feb2021 at 01:00 AM the patient experienced with headache, chills, fever and sore muscles. The patient had no covid tested post vaccination. The patient did not receive any treatment medication for the events. The outcome of the events was recovered.
Chills at 9pm (10 hours after vaccine). Chills continued for 2 days. Muscle and body aches, nausea, dizziness, tiredness, very sore at injection site, started at 8am the next day and continued for 3 more days. Vomited twice on day 3
27OCT98 sl fever (also all 4 kids sick, two w/croup);29OCT98 lost voice;1NOV98 to urgent care w/h/a ? poss sinus infect or bronchitis;arm & leg pain, neck & head pain;cough;fever 103-104;5NOV98 disoriented d/t dehydration;rash;tight chest;
husband of patient came in last week saying that patient was okay after receiving vaccine but became unresponsive the next morning when they woke up.  couple days later, he came into pharmacy and told rph what had happened and said that patient was getting better. husband comes in again today and speaks to a different rph and says that wife is in hospital and was moved to icu today and unable to eat and was still unresponsive.
Information has been received from a physician concerning a 13 year old female, the daughter of a friend, who on an unspecified date was vaccinated with a first dose of GARDASIL (route and administration site not reported).  Subsequently the patient developed intermittent paralysis.  The patient was recovering from the intermittent paralysis.  The patient was seen by her physician.  Upon internal review the intermittent paralysis was considered to be an other important medical event.  Additional information has been requested.
Exhaustion, hair loss, numbness in arms and feet, digestive and bowel issues, gas; Exhaustion, hair loss, numbness in arms and feet, digestive and bowel issues, gas; Exhaustion, hair loss, numbness in arms and feet, digestive and bowel issues, gas; Exhaustion, hair loss, numbness in arms and feet, digestive and bowel issues, gas; digestive and bowel issues, gas; This is a spontaneous report from a contactable Consumer. Female consumer (Patient) reported that:   A 68 years old non pregnant female patient received bnt162b2 (COVID 19 Pfizer brand, Formulation: Solution for injection, lot unknown reason was Unable to locate or read the details, Expiration date: unknown) via an unspecified route of administration on 28Mar2021 12:15 as dose number unknown, single for covid-19 immunisation at Pharmacy or Drug Store (age at the vaccination 68 years old). Medical history, concomitant medications were not reported and had no known allergies. The patient had not received other vaccine in four weeks and other medications in two weeks. On an unspecified date in 2021, the patient experienced exhaustion, hair loss, numbness in arms and feet, digestive and bowel issues, gas. The patient was not Covid prior vaccination and was not tested Covid post vaccination. Adverse event resulted in doctor or other healthcare professional office/clinic visit and received treatment with Celecox1B. Outcome of events were reported as not recovered.  Information on the Lot/batch number has been requested.
A report was received from a health care professional on 11/07/2003, concerning a 25 year old female vaccinee who developed a metallic taste in her mouth approximately 20 minutes after receiving Fluvirin vaccine on 11/7/03. The vaccinee recovered on 11/07/03. There was insufficient information to determine the reporter's causality assessment. Update 1, 01/09/04: Further information was received from a health care professional on 01/09/04 indicating that the vaccinee developed a metallic taste 10 minutes following vaccination and experienced a feeling of warmth 5-10 minutes following vaccination. The vaccinee's symptoms have resolved. Follow up pending.
This spontaneous report was received from a physician and refers to a patient of unknown age (also reported as "0") and gender. No information about the patient's pertinent medical history, concomitant medications and concurrent conditions was provided. On 21-APR-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ oral solution, lot # M041181 (dose, and expiry date were not specified) for prophylaxis. The administered dose of ROTATEQ underwent a temperature excursion of 48 Fahrenheit degrees for 30 minutes. No previous temperature excursion was reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all available information has been received.; Sender's Comments: US-009507513-1704USA000587: US-009507513-1704USA001660: US-009507513-1704USA001661: