chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12 hours out of expiration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 hours out of expiration) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 049E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 hours out of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (12 hours out of expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-350532 (Patient Link).
Positive Bianax Now COVID test; Positive Bianax Now COVID test on 30Dec2021.; Congestion; sinus pain; headache; fatigue; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 27Nov2021 (Lot number: FH 8028) as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, dose number unknown), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE with onset 30Dec2021, outcome "unknown", described as "Positive Bianax Now COVID test"; COVID-19 with onset 30Dec2021, outcome "unknown", described as "Positive Bianax Now COVID test on 30Dec2021."; IMMUNISATION with onset 27Nov2021, outcome "unknown", described as "Booster"; NASAL CONGESTION (non-serious) with onset 27Dec2021, outcome "unknown", described as "Congestion"; SINUS PAIN (non-serious) with onset 27Dec2021, outcome "unknown", described as "sinus pain"; HEADACHE (non-serious) with onset 27Dec2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset 27Dec2021, outcome "unknown", described as "fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive, notes: Bianax. Clinical courses: Consumer was around unvaccinated individual that became sick.  No follow-up attempts are possible. No further information is expected.
Initial unsolicited report received from a pharmacist on 12-Oct-2016. This case was linked with cases 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847 (Same vaccine). This case involves a patient (gender and age not reported) who was vaccinated with a dose of Fluzone Quadrivalent via intramuscular route (Batch number: UI669AA, expiry date: 30-Jun-2017, dose, dose in series and site of administration were not reported) on 04-Oct-2016. Patient's medical history was reported that Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was unknown. Illness at the time of vaccination was also reported as unknown. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On an unknown date, unspecified timeframe following the vaccination, the patient reported that actual injection hurt more than in past, plus my arm was definitely more sore than usual following the injection. Small area about size of quarter at injection site, reddened, raised and warm to touch. Patient required emergency room (ER)/ doctor visit. Laboratory investigations and corrective treatment were not reported. The patient recovered from the events on 07-Oct-2016 (reported as each day it was continually improved and as 06-Oct-2016 the injection site was just light pink and as on 07-Oct-2016, appeared completely gone). List of documents held by sender: none.
On February 9th 2021 the morning after the second vaccine I had tingling in my toes up the back of my leg to my knee and continue to experience a tingling sensation to today.
This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 190 pounds, and height was 65 inches. The patient's concurrent conditions included hereditary hypertension, seasonal allergy, non-smoker, and non-alcoholic, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage and uses cbd edibles for sleep. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 10:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced elevated temperature. On 16-MAR-2021, the subject experienced headache. On 16-MAR-2021, the subject experienced fatigue (conked/worn out). Laboratory data included: Body temperature (NR: not provided) 99 to 99.2 F, 99 to 101.4 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and had not recovered from elevated temperature, and fatigue (conked/worn out). This report was non-serious.
dizzy; She is very upset; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 for covid-19 immunization. The patient wanted to know does the second dose have the same amount of ingredients as the first. Do people get dizzy from the vaccine. She was very upset; she has been transferred 3 times now and has been on the phone for 2 hours on an unspecified date. Outcome of events was unknown.  No Follow-up attempts are possible. Information about lot/batch cannot be obtained.
He related that 2-3 weeks after his 2nd Moderna vaccination he experienced low back pain, left lower and right upper extremity pain, and whole body aching type pain. Blood clots were found in his left lower and right upper extremities. As of 3/30/23 he tells me he's never been the same since the 2nd vaccination and his  health has seriously gone downhill since then.   His first Moderna vaccination was 02/11/2021 lot # 03M20A R arm at the same pharmacy
moderate muscle aches over the whole body.   1-2 fever. treated with tylenol and lasted about 30 hours
About an hour after she started having hives around the vaccine sight. It started to move up her arm and her arm swell. Fainting feeling and in overall pain.
PATIENT HAD SYNCOPE AND PALENESS AND PASSED OUT---ALERT AFTER 10 SECONDS.  LET PATIENT REST WITH COOL CLOTH TO HEAD. PATIENT STATED DID NOT SLEEP WELL NIGHT BEFORE AND WAS TIRED.    AFTER RESTING FOR 30 MINUTES PATIENT UP AND VOICING NO COMPLAINTS--  WENT HOME WITH MOM.
SUBJECTIVE: This is a 67-year-old man who received a Pneumovax injection in his left shoulder two days ago. Shortly thereafter, he developed a significant upper arm redness and swelling. The redness and swelling has extended down to his left elbow and to his left axilla. He has had no fevers, chills, or sweats. He comes in today for evaluation.  OBJECTIVE: Blood pressure 122/77, temperature 98. He appears in no acute distress. There is diffuse anteromedial swelling, erythema, and induration. It extends down to the level of the elbow. There is some diffuse but nonlocalized tenderness. No fluctuance.  ASSESSMENT: Localized reaction to the Pneumovax vaccine. Doubt cellulitis, but cannot entirely exclude. PLAN:  1.  Advised ice, elevation, and ibuprofen p.r.n. 2.  I am going to place him on an empiric course of cephalexin. 3.  He knows to call or return if he develops fevers, chills, sweats,     increased erythema, or swelling.
t104 afternoon of vax; admitted to acute hosp to r/o sepsis; cultures neg, treated meds x 3 days then sent home on no meds;
3 months out from vaccine patient continues to have erythema at site of injection with occasional pain. Denies itching, will use occasional Benadryl with provide occasional symptom relief. Otherwise does not have shortness of breath or airway compromise.
lightheaded, dizziness, "salivating" like she going to throw up. Evaluated by EMS-Cleared
Temp 103 x 18 hours at time of appointment. When tem up, vomited at peak. No other symptoms noted. TX Infant acetaminophen 15 mg 1 x g Q 4-5 hours x 24 hours.
Patient came in today after received DTaP on 9/8/2009. Has red, warm circle (baseball size) on upper right arm mom didn't want on left arm. Instructed patient to use ice on and off for 15 minutes and use TYLENOL. Return if not improved. Improving from yesterday.
Dizziness; Nausea; Chills; Fever of 102.3; Shakes all night; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever of 102.3) and TREMOR (Shakes all night) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018-B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021. Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced DIZZINESS (Dizziness), NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever of 102.3) and TREMOR (Shakes all night). At the time of the report, DIZZINESS (Dizziness), NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever of 102.3) and TREMOR (Shakes all night) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Body temperature: 102.3 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications were not reported  The treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow-up was received on 26-MAY-2021 and has no new information.
PT CAME IN FOR SECOND MODERNA DOSE AT HIS CORRECT TIME (28 DAYS LATER). TALKING WITH PT REGARDING NON-MEDICAL RELATED ITEMS AND INCORRECTLY GAVE HIM PFIZER 0.3ML INJECTION. DISCOVERED IMMEDIATELY AND REPORTED TO PATIENT AND PHARMACY MANAGER AND DIVISION OFFICE. CONTACTED PATIENT APPROXIMATELY 8 HOURS LATER AND HE FEEL FINE. NO REPORTED PROBLEMS AT THIS TIME. INSTRUCTED PATIENT TO CALL PHARMACY WITH ANY ISSUES THAT COME UP REGARDING THIS SITUATION. TOLD PT I WOULD CONTACT HIM TOMORROW TO FOLLOW UP AS WELL.  CURRENTLY NO ADVERSE EVENT/REACTION REPORTED BY THE PATIENT.
Taste metallic; This is a spontaneous report from a contactable health care professional (patient, a Psychologist). This 38-year-old female patient received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730) at single dose via an unknown route at left arm on 04Jan2021 15:45 for Covid-19 immunization. Medical history included sinus infection before getting the covid vaccine and this has never happened; the sinus infection was still ongoing at the moment, it started in Dec2020, she was prescribed amoxicillin for it and she was still completing it. Additional medical history included pernicious anemia, Celiac disease, Hashimoto's disease, Sulfa allergy, and Stevens Johnson syndrome.  Patient also reported "she hasn't had symptoms at all". She further reported that in the past she has had a reaction to Sulfa, it was about 3 years, due to this she got Steven Johnsons' Syndrome , she was hospitalized because of this, it was not fun 0 out of 0 she would not recommend. She has had no positive test for Covid Prior to the vaccine. She has had 1 negative test, it was May2020. She had no issues with vaccines in the past. She did have an issue with the TB Test, explaining that about 6 years ago, the issue was that she got a reaction from getting the TB Test, she got dermatographic urticaria, she was instructed to never get the test again and to get X rays instead. Patient confirms allergy was to Sulfa like the antibiotic. She had no Lot or Exp it has been discarded. Concomitant drugs included ongoing amoxicillin  500mg 1 capsule by mouth twice a day from 28Dec2020 for sinus infection. Patient began to notice the metallic taste within 15 minutes of receiving the vaccine (onset date on 04Jan2021). She didn't think anything of it till she noticed it stuck around. She just had a bad taste in the mouth. It tastes weirdly metallic.  Outcome of the event was not resolved.
Patient received first dose of vaccine at 1508.  Pt complained of scratchy throat , coughing, and shortness of breath.  Patient states "my throat feels like it is closing".  Patient placed on all monitors and O2 at 4L per nasal cannula.  Patient received epi via epipen auto-injector at 1516.   Patient received benadryl 25mg at 1518.  Patient verbalized that her "throat was feeling better" at 1521.  Ambulance contacted and arrived at 1530 to transport patient to emergency room.
pt recvd vax & 24 hrs later exp a red & swollen (6 x 7cm) deltoid w/induration; resolved in 4-7 days;
maculopapular rash on torso & face which devel 9 days p/vax;8 days p/vax pt had coryza, irritability;pt has very mild conjunctivitis;macules are roughly ovoid 3-7mm long axis w/some having a central papule just barely off the skin surface;
About 10 minutes after my shot, I felt my blood pressure tanking. They wheeled me into the back on a bed chair and had me lie down for about 10 minutes. I sat up, felt okay, and went out to my car. I sat in my car for a few minutes, breathing in fresh air outside, and ate an orange. I went home, and felt completely drained of energy for the rest of the day and all of the following day. I worked for four hours on the day after that, and still wasn?t feeling 100%, but was better. On the Monday after the shot that had been on Friday, I was pretty close to normal, maybe 85%.
This spontaneous report was received from a consumer referring to a young patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with GARDASIL (anatomical route of vaccination, lot number and expiration date were not provided). The patient's concomitant medications were not reported. The reported stated, that after watching TV news, heard about a young child who collapsed and died after receiving GARDASIL. At the time of the report, the outcome was reported as fatal. Relatedness between the adverse event and vaccination with GARDASIL was not provided. This is one of several cases received from the same source. MARRS: 1605USA003026. Additional information has been requested.
Patient with prescription for Shingrix first dose at 40 years; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted product prescribing error in a 40-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient had recurrent cases of shingles in the past).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted product prescribing error. On an unknown date, the outcome of the intercepted product prescribing error was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report.   The patient was not immunocompromised but had recurrent cases of shingles. The patient was prescribed Shingrix vaccine at 40 years of age, which led to intercepted product prescribing error. The vaccine was not administered till the time of reporting.  The patient did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021193314:Same reporter.
17JUL94 started w/tiredness, nausea, diarrhea, cramping, achiness, pain up neck, could not move arm & soreness of arm, hips & knees; c/o chilling & h/a;
Injection area muscle soreness, first sign, continued down my arm over 24 hrs, extreme burning weakness entire arm, neck pain,  unable to move arm and terrible pain.  Tylenol did not help.  Went to ER  prescribed norco lightest dosage, advised to cut in half, rest, sleep.  Went to my doctor two days later, still some pain, not nearly as bad, given naproxen and stopped norco   My doctor said to report to VAERS adverse REACTION
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old male patient received bnt162b2 (BNT162B2), on 17Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 16Aug2023 to 21Aug2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300296470 Same reporter/patient, different drug/event.;
This spontaneous prospective pregnancy report was received from a register nurse and refers to a 25 year old female patient with BACTRIM allergy. There was no patient's pertinent medical history. On 17-JUL-2051, the pregnant female patient was vaccinated with VARIVAX (Merck) (lot number: L000455, expiry date: 06-JAN-2017, dose: 0.5 ml, subcutaneous). There was no concomitant therapy. The last menstrual period (LMP) and estimated date of delivery (EDD) were not reported. The patient sought medical attention (office visit). There was no treatment given for adverse event and no lab diagnostic test performed. At the time of the report, the pregnancy outcome was unknown. Additional information has been requested.
Information has been received from a medical assistant concerning a 17year old white female student who was vaccinated with a three doses of RECOMBIVAX HB (manufacturer unknown) when she was 6 years old. Subsequently the patient's hepatitis b titer came back negative. Medical attention was sought through the doctor. The patient's recovery status was unknown. There was no product quality complaint. Follow-up information ahs been received from a physician's office. The physician and a medical record indicating that the 3 doses of hepatitis B virus vaccine rHBsAg were given at another office, and feel there was no adverse event. On 15-AUG-2007 at 06:40 a hepatitis B screen for the patient's job application revealed a negative result for antibodies. No further information is available.
(L) deltoid area, red (+) warm 3.5x4cm induration. (+) 5x6 cm redness. Warm compress and observe.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-APR-2015 the patient was vaccinated with a dose of expired MMR II, therapy type: HSA, lot # J004201, expiry date: 12-APR-2015 (site, route of administration were not reported). No adverse event was reported. Additional information has been requested.
Patient reported approximately 2-3 days following dose 1 of Moderna COVID-19 vaccination ,she developed pressure and light sensitivity in left eye, along with a headache. Upon examination from optometrist, they concluded it to be either shingles or Bell's Palsy. Upon follow up with PCP, she was diagnosed with ocular shingles. She has a positive history of detached retina in that eye as well.
unable to sleep; I could barely see out of eyes"; uncontrollable shaking; "I was so sick, It was so bad."; "I had the chills so bad, I was uncontrollable shaking"; severe fatigue; muscle pain; joint pain; Severe Headache; fever was 102.5 for two days; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (unable to sleep), VISION BLURRED (I could barely see out of eyes"), TREMOR (uncontrollable shaking), ILLNESS ("I was so sick, It was so bad.") and CHILLS ("I had the chills so bad, I was uncontrollable shaking") in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced INSOMNIA (unable to sleep), VISION BLURRED (I could barely see out of eyes"), TREMOR (uncontrollable shaking), ILLNESS ("I was so sick, It was so bad."), CHILLS ("I had the chills so bad, I was uncontrollable shaking"), FATIGUE (severe fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (Severe Headache) and PYREXIA (fever was 102.5 for two days). On 24-Apr-2021, INSOMNIA (unable to sleep), VISION BLURRED (I could barely see out of eyes"), TREMOR (uncontrollable shaking), ILLNESS ("I was so sick, It was so bad."), CHILLS ("I had the chills so bad, I was uncontrollable shaking"), FATIGUE (severe fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (Severe Headache) and PYREXIA (fever was 102.5 for two days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2021, Body temperature: 102.5 High.         No concomitant medication were reported. Treatment medication included Tylenol and Advil to help relieve side effects.   This case was linked to MOD-2021-090359 (Patient Link).
Had itching at (R) deltoid after vaccine. Family noticed redness a couple of days ago and getting worse. 4-5-17 - presented to office today with (R) deltoid cellulitis.
pain @ site of inject which progressed to shoulders & cervical spine; This porgression occurred in 2-3 dasy time & has been ongoing; antiinflammatory meds have been used w/o much benefit; ROM is limited;