chrisvoncsefalvay/vaers-outcomes huggingface dataset:
going to the bathroom uncontrollably a lot; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (going to the bathroom uncontrollably a lot) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 030MZ0A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced POLLAKIURIA (going to the bathroom uncontrollably a lot). At the time of the report, POLLAKIURIA (going to the bathroom uncontrollably a lot) outcome was unknown.       Concomitant product use were not provided by the reporter.   ?No treatment information was provided. ?Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: No new information added.
Headache, Muscle pain, Tiredness, Shivering, Fever, Chills, Upset Stomach
Lump on arm; CHILLS; fatigue; Red, hard itchy arm; Red, hard itchy arm; Red, hard itchy arm; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Lump on arm), CHILLS (CHILLS), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (Red, hard itchy arm) and VACCINATION SITE INDURATION (Red, hard itchy arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MASS (Lump on arm), CHILLS (CHILLS), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (Red, hard itchy arm), VACCINATION SITE INDURATION (Red, hard itchy arm) and VACCINATION SITE PRURITUS (Red, hard itchy arm). At the time of the report, MASS (Lump on arm), CHILLS (CHILLS), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (Red, hard itchy arm), VACCINATION SITE INDURATION (Red, hard itchy arm) and VACCINATION SITE PRURITUS (Red, hard itchy arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This medically confirmed spontaneous report (initial receipt 24-MAR-2015) concerns an unknown demographics patient. ON an unspecified date, the patient received unspecified flu vaccine (manufacturer and batch number not provided). On an unspecified date, the patient experienced a bad severe reaction to an unspecified flu vaccine a few years ago. The outcome was not reported.
Wheezing, SOB, sweating, fever, disoriented, went to ER 12/8/08
I am over 30 days late on my period. The only time I?ve been late is when I was pregnancy twice. I was supposed to have my period the week of 4/11 and no period to date.
included: Muscle & joint soreness, fever/chills, nausea, diarrhea, headache, lethargy, irritability, & swelling @ the injection site that turned swollen & welted.  Member reports symptoms subsided. reported via  database system. on 8/11/23.
patient recieved adult dose of the Bivalent Pfizer vaccine instead of the Pediatric dose.  The error was caught approximately 4 hours after administration, called custodial grandmother and informed of error.  Called Pfizer healthcare information specialist for data on accidental administration of adult doses in pediatrics but no data was available.
when i was out in the sun for 45 minutes I burned extensively and after 3 weeks I am still red.; I didn't even burn my legs and they started peeling; when i was out in the sun for 45 minutes I burned extensively and after 3 weeks I am still red.; This is a spontaneous report from a contactable consumer. A 47-years-old female patient received BNT162B2 (Formulation: Solution for injection; Batch/Lot number: unknown), via an unspecified route of administration, administered in Arm Left on 17May2021 17:00 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included lamotrigine (LAMICTAL), methotrexate (METHOTREXATE), meloxicam (MELOXICAM), hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), methylprednisolone (PRED [METHYLPREDNISOLONE]) taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfa, phenargan plus for drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Jun2021 patient reported when she was out in the sun for 45 minutes she burned extensively and after 3 weeks she is still red. She peeled but my skin was scaley, it isn't the usual sunburn she gets. She didn't her sister had same issue. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 09Jun2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. The outcome of the event was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021895011 same reporter, drug and event, different patient
Within 30 minutes of receiving the vaccine, the patient began to complain of tingling to her mouth. The patient then began to complain of swelling/tingling to the throat and began to cough. The patient stated that it was the same feeling as when she had allergies to cephalexin. Patient's B/P was 138/86. The patient received 0.5 ml of epinephrine 1:1000. The patient began to have tremors, but continued to breathe and get air exchange. After approximately 5 minutes, the patient began to feel relief. The patient was alert at all times and was ambulatory under her own power as she entered the ambulance. The patient was transported to the hospital for observation and was released the same day. The patient was given Benadryl as needed.
Quarter-sized erythema at injection site. Seen 1 day, post vax, with small (.4cm) hard center, sensitive to touch. No fever. Advised to put cold compresses on as tolerated.
Patient complains of erythematous, pruritic, maculopapular rash on bilateral arms and torso that suddenly appeared after receiving pneumococcal 23 vaccine on February 7, 2022
itching two inches under breast/red dots on buttock that itch and itch scalp; itching two inches under breast/red dots on buttock that itch and itch scalp; skin flaky/scale; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (itching two inches under breast/red dots on buttock that itch and itch scalp), PRURITUS (itching two inches under breast/red dots on buttock that itch and itch scalp), SKIN EXFOLIATION (skin flaky/scale), CHILLS (Chills) and PYREXIA (Fever) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 4782589) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (itching two inches under breast/red dots on buttock that itch and itch scalp), PRURITUS (itching two inches under breast/red dots on buttock that itch and itch scalp), SKIN EXFOLIATION (skin flaky/scale), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, ERYTHEMA (itching two inches under breast/red dots on buttock that itch and itch scalp), PRURITUS (itching two inches under breast/red dots on buttock that itch and itch scalp), SKIN EXFOLIATION (skin flaky/scale), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported. The reporter causality for the event(s) of chills, fever, itching two inches under breast/red dots on buttock that itch and itch scalp unknown onset, skin flaky/scale with SKYRIZI was Not Provided. It was unknown if patient was enrolled in COVID-19-Vaccine Trial. No treatment medications were reported.
Pain, swollen, redness, tenderness in left arm where shot was administered. Patient describes a "lump".
Mild anaphylaxis, red pruritus on upper torso and neck, rapid heart rate, epi pen administered, major s/s resolved within 30 minutes, all symptoms resolved within 1 hour.
Received shot, vial (with) ice crystals in it; A spontaneous report was received from a consumer concerning a 68 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced received shot, vial (with) ice crystals in it.   The patient's medical history was not reported.  Relevant concomitant medications were reported included Cholesterol medication.  On 28th Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 010M20A) intramuscularly for prophylaxis of COVID-19 infection. The vaccine was administered from a vial with ice crystals that supervisor said was no good. Patient noted she has had no side effects or sore arm after administration. No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event vaccine was administered from a vial with ice crystals that supervisor said was no good was considered resolved on 28 Jan 2021.; Reporter's Comments: This report refers to a case of product preparation issue for mRNA-1273 (lot # unknown)  with no associated AEs reported.
Patient was given MMRV and Polio vaccines in error at this visit. No adverse effects reported. Family informed of error.
Child seen 6/26/01 for well appt & given Prevnar vaccine. Mom states 2 hrs later child with swelling face and dark circles under eyes. Mom denies giving child any medication that day or introducing new foods, soaps, lotions, plants, animals, etc. Mom reported Rxn 6/29/01
Pt complained of leg pain and ringing in her head. Started immediately after vaccines and lasted 1 week. Symptoms have completely resolved.
small blood clots in her lungs/blood clots; not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 2021, for COVID-19 immunisation. The following information was reported: PULMONARY THROMBOSIS (medically significant) with onset 23Nov2021, outcome "unknown", described as "small blood clots in her lungs/blood clots"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "not feeling well". The patient reported that she received the Pfizer vaccine both 1 and 2 and ended up getting blood clots. She reported she wasn't feeling well, and they did a computerised tomogram (CAT) scan on her and found the clots. The patient reported she never had any clots until she had that vaccine. She believed the blood clots where caused by the Pfizer vaccine that she received in early 2021 when older people where first allowed to get the vaccine. She then developed the blood clots that she believed where caused by the Pfizer vaccine on 23-Nov-2021. The patient underwent the following laboratory tests and procedures: computerised tomogram: (2021) clots. Therapeutic measures were taken as a result of pulmonary thrombosis. The patient reported that she started apixaban (ELIQUIS) for small blood clots in her lungs.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a pharmacist via company representative refers to a 73 year old female patient. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was subcutaneously vaccinated with ZOSTAVAX, 1 dose once (exact dose, anatomical location, lot # and expiration date were not reported) for prevention shingles. There was none concomitant medication reported. On an unknown date (reported as a couple of days ago), after receiving ZOSTAVAX, the patient experienced headache, gastrointestinal distress and body ache. There was no treatment given for adverse events. The outcome of the events was unknown. The relatedness between the events and the vaccination with ZOSTAVAX was not provided. Additional information has been requested.
pt recv vax;small red itchy bumps;spread all day; no fever, no oth sz;to see hlth services;rash small, red,closed bumps;pt was given atarax for pruritus;
Pt developed swelling, itching, redness, warmth in the left bicep (not at injection site) about an hour after getting PNA vaccine. Pt reported to the pharmacy the next day. She had iced it. Pt was advised to use BENADRYL, ALEVE and monitor. MD was notified.
Information has been received from a pharmacist concerning her 1-year-old son with no pertinent medical history of allergies, who on 16-JAN-2008 was vaccinated with a dose of PROQUAD.  There was no concomitant medication.  On 25-JAN-2008 the patient developed a measles like rash all over his body.  After the initial outbreak, the rash seemed to be going away, but several days later the rash appeared again all over his body.  The patient was seen by a physician.  There were no laboratory or diagnostic studies performed.  The outcome was reported as not recovered.  No product quality complaint was involved.  Additional information has been requested. This is in follo-up to report(s) previously submitted on 4/4/2008.  Follow-up information has been received from the physician who indicated that he has no further information regarding the adverse experience.  Additional information is not expected.
Resident tested positive for COVID 01/06/2021. Resident received monoclonal antibody treatment on 01/10/2021.
Initial information received from a non-healthcare professional who is the mother of the patient on 12 September 2013 via another manufacturer. This reporter also reported another adverse event which is captured in case number 2013-09546. The reporter is the patient. An unidentified male patient received an unspecified TDAP vaccine on an unreported date. The batch, dose and route were not reported. The patient experienced an unspecified severe allergic reaction after receiving TDAP. On an unspecified date, the patient experienced severe cradle cap, eczema on his face, legs and arms and projectile vomiting. The patient and mother have a history of a severe allergy to nickel. No further information was available at the time of the report. The patient outcome was not reported. Documents held by sender: None.
p/vax pt devel inj site rxn by redness; swelling; & pain; tx w/APAP & ice
Sore arm; Administration error, half of a dose administered of Moderna bivalent; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and ACCIDENTAL UNDERDOSE (Administration error, half of a dose administered of Moderna bivalent) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 vaccination.     Patient had no allergies. It was reported that patient never had COVID positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included High cholesterol (No improvement or worsening.), Seizures (No improvement or worsening.) and Epilepsy (No improvement or worsening.). Concomitant products included PRAVASTATIN, SERTRALINE and LEVETIRACETAM for an unknown indication.    On 12-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. On 12-Sep-2022, the patient experienced PAIN IN EXTREMITY (Sore arm) and ACCIDENTAL UNDERDOSE (Administration error, half of a dose administered of Moderna bivalent). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved and ACCIDENTAL UNDERDOSE (Administration error, half of a dose administered of Moderna bivalent) outcome was unknown.            No medical care took by the patient.  First dose of Moderna COVID-19 Vaccine was administered on 02-Mar-2021; lot number: 012A21A; expiration date: 17-Aug-2021. Second dose on 30-Mar-2021; lot number: 021B21A. First booster on 25-Oct-2021; lot number: 27C21A. Second booster on 01-Apr-2022; lot number: 002M21A.  No treatment medication details was reported.   This case was linked to MOD-2022-672848 (Patient Link).
flu like symptoms for 3-4 days; nurse a 9 month old; nurse a 9 month old; This is a spontaneous report from a contactable consumer (patient herself). A 29-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot Number was unknown), via an unspecified route of administration in the right arm on 20Apr2021 at 15:45 as dose 2, single for COVID-19 immunisation (at the age of 29-year-old). The patient's medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. The patient did not receive any medication within two weeks of the COVID vaccine. The patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot Number was unknown), via an unspecified route of administration and location on 30Mar2021 at 15:45 as dose 1, single for COVID-19 immunisation (at the age of 29-year-old). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was breastfeeding a 9-month-old male fetus and the baby ingested some of her blood due to latch issues at the time of vaccination. On 21Apr2021 at 04:00, the patient experienced "flu like symptoms for 3-4 days". The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the event flu like symptoms was recovered (reported with a duration of 3-4 days) on an unknown date in Apr2021.  The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up.
Information has been received from a health professional concerning a discussion of autism and vaccines on a national television talk show. An actor's wife stated that her son had autism which started after receiving a vaccine. MMR II was named as one of the vaccines the child had received. No product quality complaint was reported. No additional information was available. Upon internal review, the patient's autism was considered to be an other important medical event. Additional information is not expected.
Pt was administered the wrong vaccine. She was supposed to have been given a Hep B vaccine and she was given a Hep A in error. The provider she was seeing ordered the correct vaccine.  The CMA grabbed the wrong vaccine out of the vaccine refrigerator.
It is unknown if the decedent had any side effects.  Patient died on 3/11/2021.
Patient was found dead at his home on 2/25/2021. He was last seen at home by his sister at 8:30pm on 2/24/21.
Shivers; Burning skin; Aches; Stomach pain; Low grade temp; This case was reported by a consumer via sales rep and described the occurrence of shivers in a 55-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd October 2019, the patient received the 1st dose of Shingrix. In October 2019, 15 hrs after receiving Shingrix, the patient experienced shivers, burning skin, pain, stomach pain and low grade fever. On an unknown date, the outcome of the shivers, burning skin, pain, stomach pain and low grade fever were unknown.   It was unknown if the reporter considered the shivers, burning skin, pain, stomach pain and low grade fever to be related to Shingrix.  Additional details were provided as follows: The patient had shivers, burning skin, aches, stomach pain and low grade temperature after receiving vaccine. The patient stated that rarely ever get sick. The patient asked whether the event will be worse after the 2nd dose of vaccine.      Lab Comments: on an unknown date body temperature was recorded
Per daughter, redness and swelling at the injection sites then extended to arms and hands. The patient then presented to the pharmacy with the swelling on the right hand and near the elbow of the left arm.
Having an allergic reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Having an allergic reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jun-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced ALLERGY TO VACCINE (Having an allergic reaction). At the time of the report, ALLERGY TO VACCINE (Having an allergic reaction) outcome was unknown.            No concomitant medication was provided. No treatment medication was provided.
This report was called to VAERS on 3/27/00 at 12:30 PM. Pt received pneumovax IM in left deltoid at approximately 2:00 PM on 3/22/00. Pt experienced left arm swelling. Pt was checked by medical director and advised to take Motrin and apply warm compresses. Follow up call states that pt is improving. It is also reported that pt had a fever of 102.
My chest began feeling very heavy and it hurt like hell. I initially thought I had real bad indigestion. I began having trouble breathing
Localized redness and purplish streaks and feels hot. Dr. treated with cold pack and hydrocortisone. Redness measured 48mm ".
Pt developed an non-pruritic, erythematous rash just distal to the injection site on his right thigh 6 days post-vaccination. Symptoms are improving today when provider checked in on pt.
AFTER  SECOND DOSE OF COVID -19 VACCINE  ON APRIL 9 2021 ,HE GOT 2 TIMES HEAD ACHE AND ON APRIL 19 2021 HE DIED IN SLEEP.