chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), 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.
Twenty minutes after GARDASIL vaccine was given, he felt cold, dizzy, nauseated, legs felt weak: BP: 120/80; he was observed for 1 hour, at w/c time he was improved.
This spontaneous report as received from a Certified Medical Assistant refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions and concomitant medication was reported. On unknown dates, the patients were vaccinated with improperly stored doses of oral, ROTATEQ (dose and strength unknown, oral). Batch of lot# K011947 with expiration date of 07-JUN-2016 was stored at 13.2 Celsius degree for one hour and 42 minutes. Batch of lot# L020861 with expiration date of 25-JAN-2017 was stored at 14.1 Celsius degree for 2 hours and 18 minutes. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Fever and aches  next day, lasting about 24 hours. Also, 3 weeks later developed unexplained muscle spasm in the mid and lower back which I currently am experiencing.
p/vax pt w/petechia covering trunk of body & into groin area;consolable by parents;T98.3;also erythema to trunk & groin area;no nodule @ immun sites;
430PM lt leg c/o pain-not walking-crying constantly 600-t102, irritable, 130AM woke up & t104.5, screaming; leg very sore-not walking on it;
Information was received from a medical assistant regarding an unspecified number of patients (demographics not provided). On an unknown date, an unspecified amount of doses of PEDVAXHIB (route of administration not provided) that underwent temperature excursions were administered to an unspecified amount of patients. No adverse effect reported. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Narrative: Patient with breakthrough covid infection. 1 dose of Janssen vaccine received 3 days prior to positive result. Treated with monoclonal antibody.
Wasn't feeling well; Tested COVID positive; Chest pains; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Wasn't feeling well), SARS-COV-2 TEST POSITIVE (Tested COVID positive) and CHEST PAIN (Chest pains) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced FEELING ABNORMAL (Wasn't feeling well), SARS-COV-2 TEST POSITIVE (Tested COVID positive) and CHEST PAIN (Chest pains). At the time of the report, FEELING ABNORMAL (Wasn't feeling well) and CHEST PAIN (Chest pains) outcome was unknown and SARS-COV-2 TEST POSITIVE (Tested COVID positive) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: (Positive) positive.         No concomitant product use was reported. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded for the events of chest pain and wasn't feeling well. The event COVID-19 is assessed as unlikely related to mRNA-1273 since the vaccine does not contain virus capable of transmitting infection.
Chest pain, Jaw pain, Dizziness,  Chills,  Blurred Vision, Chills, Headache,
Rash near injection site is red, swollen and warm.Rash is not well demarcated. Visible bump where injection was given.
Suspectd vaccination failure; Shingles on the back and abdominal area/lingering shingles; Sores are fading; horrible abdominal pain; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis and COVID 19 MRNA VACCINE MODERNA for prophylaxis.   Previously administered products included Flu vaccine (received a dose every year for last 30 years from the date of reporting). Concomitant products included COVID-19 VACCINE MRNA (MRNA 1273) (COVID 19 MRNA VACCINE MODERNA).   On 16th November 2018, the patient received the 2nd dose of Shingrix. On 25th June 2018, the patient received the 1st dose of Shingrix. On 25th August 2021, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, the patient received the 2nd dose of COVID 19 MRNA VACCINE MODERNA. On 27th August 2021, 1015 days after receiving Shingrix, 1159 days after receiving Shingrix and not applicable after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, skin ulcer and abdominal pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and abdominal pain were not recovered/not resolved and the outcome of the skin ulcer was recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, skin ulcer and abdominal pain to be related to Shingrix and Shingrix. It was unknown if the reporter considered the shingles, skin ulcer and abdominal pain to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not reported. The patient had both shots of the Moderna Covid vaccine. On 25th August 2021, the patient received annual flu shot which the patient had every year for 30 years. On 27th August 2021, the patient broke out in shingles both on the back and abdominal area. The patient was in week 5 now with still complications; the sores were fading but horrible abdominal pain. The reporter was asking, how was that possible, as she was told that, if she got the vaccine, she would not get shingles; the same was mentioned by the commercials. The patient was asking for a reason as why she was having lingering shingles as she had thought she would at least have a mild case. It was unknown if the reporter considered the shingles, skin ulcer and abdominal pain to be related to Covid 19 MRNA vaccine Moderna. This case was considered as suspected vaccination failure, since the details regarding laboratory test confirmation of shingles was unknown at the time of reporting.   Follow up information was received by consumer on 11th October 2021: The VAERS details were updated.
rash on arm at the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash on arm at the vaccination site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash on arm at the vaccination site). At the time of the report, VACCINATION SITE RASH (rash on arm at the vaccination site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Right eye blurred vision 24-7, ongoing. Tachycardia. Brain fog. Additional vericose/spider vein showed up on right leg. Right after injection my right thumb began twitching but it abated after 24hrs.
Hives 2 days later, though also with otitis media and viral syndrome, unsure of cause.
Around 5 days after vaccine, itching on injection site arm; which I thought may be healing. Over the weekend I was very tired and slept a lot. Area on arm was red and warm and had a knot in the area of redness. By Tuesday, February 9th felt better and spot on arm was red but not as warm as previously.  Also had slight arm pain in the reddened area.  I had messages my doctor, but did not go in for visit.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient had no known allergies. There were no concomitant medications and no other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (08Dec2022) Negative, notes: Negative and no symptoms on 08Dec2022; (11Dec2022) Positive, notes: Symptoms and positive test on 11Dec2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Paxlovid from 03Dec2022 to 07Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
?Moderna COVID-19 Vaccine EUA" Fever (101.1), chills, body ache, fatigue, nose plugged: Acetaminophen taken & saline spray used for nasal relief.  Doctor visit does not appear necessary.
After a couple days leg pain increased to neuropathy. Extreme leg pains and eventually very difficult to walk.  Took months to walk again and many medical appointments.  Also had lower abdominal pain and diarrhea.  Headache on day one.  Slowly getting better.
Hives  appeared on  my forearms in the early morning, by afternoon spread to lower back.  By Saturday 01/23/21 I had hives covering forearms, hands, behind ears, behind knees, ankles and shins.
Shoulder was sore for a few days.  Tender to the touch directly on the spot, with area of tenderness reducing over time.  Very minor pain when moving injected arm above shoulder height until morning of second day after shot (Wednesday morning, April 21st, no pain when moving arm above shoulder height that day)
unconsolable crying >6hrs p/vax; glazed eyes; felt warm x 3 days;
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient was fine after she received her vaccine, we monitored her for 15 minutes and let her go home. Today on june 11, she comes in to pick up a script and she has stitches under her eyebrow, she stated that the day after she received the vaccine, she woke and developed flu like symptoms. And she said since she was 14 years old, she has had a history of fainting when she feels ill, she acknowledged that she was counseled on flu like symptoms. She fainted the next day and lacerated above her eye
Employee complained of lightheadedness/dizziness after vaccination which was at 9:15am
itchiness that the administration of the Pfizer's COVID-19 vaccine left her in the administration site; stiffness that the administration of the Pfizer's COVID-19 vaccine left her in the administration site; stiffness that the administration of the Pfizer's COVID-19 vaccine left her in the administration site; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient asked if she should use Benadryl for the itchiness and stiffness that the administration of the Pfizer's COVID-19 vaccine left her in the administration site in Jan2021. She was administered with the first dose of the vaccine yesterday 04Jan2021 and she was experiencing these symptoms after that. She was going to contact her Physician for that information. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever; Chills; muscle aches; Fatigue; Joint pain; nausea; vomiting; This is a spontaneous report from a contactable nurse (patient herself). A 33-year-old female patient (no pregnancy) received first dose of bnt162b2, intramuscularly at site of left arm at 10:00 on 18Dec2020 at single dose for COVID-19 immunization. Medical history reported none. Concomitant medication included iron, cyanocobalamin, pyridoxine hydrochloride, thiamine hydrochloride (VITAMIN B 1-6-12) (reported as vitamin B supplement) and birth control pills. The patient experienced fever, chills, muscle aches, fatigue, joint pain, nausea and vomiting at 21:00 on 18Dec2020. The outcome of events was recovering.  Information on Lot/Batch number has been requested.
pt recv vax 3JAN96 & 25JAN96 pt devel a typical varicella rash w/over 25 lesions that erupted sequentially over a period of 4 days on trunk & scalp;pt had no elevation of temp;
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. On multiple unknown dates, the patients were vaccinated with improperly stored PROQUAD (Merck) (Lot# L033692; Expiry date: 28-FEB-2017, Lot#L033696; 28-FEB-2017). No adverse effects were reported. This case is one of the two reports from the same reporter. Additional information has been requested.
Initial unsolicited report received from a physician on 19-Sep-2016. This case involves a 71-year-old female patient who was vaccinated with a dose of Fluzone HD (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on 15-Sep-2016. The patient's illness at time of vaccination was reported as none and the pre-existing physician diagnosed allergies included sulfa, PCN, Macrobid allergy and birth defects, medical conditions (specify) were reported as Vicryl sutures, breast cancer mult skin cancers, chronic sinus infections. Concomitant medications were not reported. The patient had not received any vaccinations within 4 weeks of vaccination with Fluzone HD vaccine. On 16-Sep-2016 in the am, one day after the vaccination, patient started having difficulty in breathing and hives. The patient was diagnosed with an anaphylactic reaction. The patient was taken to emergency room. Laboratory investigations were reported as none. Patient's corrective treatment included breathing treatments, steroids and Benadryl IV and was discharged with a Medrol Dose pack. The patient was not recovered from events. Upon internal review the case was considered as serious because of important medical event anaphylactic reaction. List of documents held by sender: none. Sender's Comments: Anaphylactic reactions are listed post-vaccination with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Time to onset is compatible with the role of vaccine. patient have history of allergy to Penicillin, Sulfa drugs, Macrobid, Vicryl Sutures, also have history of Breast CA and chronic sinus infections. Complementary information regarding any drug or food intake during the period between vaccination and reaction as well as allergic testings to identify the culprit antigen, patient's history of reaction after previous vaccinations is needed for complete assessment of the case.
11/11/22 presents to ED for "cough, missed HD". PMHx of "hypertension" "end-stage renal disease on hemodialysis and WF, CHF, DM, hypertension, depression"
Fever; headache; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced fever and headache for almost 10 days in Dec2020. The outcome of the events was not recovered. The reporter assessed the events as non-serious.  Information on the lot/batch number has been requested.
11/8 around 2 AM woke up with headache and cough felt run down and congested. Took COVID-19 test and it was positive. Drank lots of fluids. By 11/10 was feeling short of breath and was told to go to ER. Had violent and painful cough. Had headache and shortness of breath. My resting HR was 120 and pulse OX was 98%. Was released with prescription for cough syrup and cough pills. PCP called to follow up and prescribed PAXLOVID and ADVAIR. Symptoms began improving but wasn't fully recovered for about 3 weeks.
Patient became rigid, wide-open eyes, not responsive to mother's voice. Episode lasted approximately 7 seconds.
I awakened around midnight feeling very warm but chilled at the same time. I had rhythmic muscle contractions followed by relaxation. Not painful spasms but they were continuous and slowly abated. I took TYLENOL, slept and better in the am. Fatigued though.
Large welt at injection site, approximately 4? in diameter, itching, tenderness, warm to touch
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult female patient who received Shingrix for prophylaxis. On 24th August 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix on the left arm. The patient experienced redness, about the size described as 2 by 4 inches, which originated at the injection site. The patient reported that, the site was warm to the touch. The events had not improved. The pharmacist did not know the time to onset of symptoms after the injection.
Patient vomited once immediately after receiving the vaccine. Immunizer had patient sit down and gave her water and crackers. Pharmacist checked on well-being of patient. Patient claimed after resting for a while, she felt well and no further symptoms were shown. Patient left after observation period was over.
pt recvd vax; 3 wks later, presented w/ rt sided shingles;
Patient having pain (aching pain) in LA where PREVNAR shot was given. Pain extends from should to hand.
Patient claims immediate left arm pain that has persisted since 10/25/2018. Patient visited primacy care provider after incident who recommended physical therapy. Per patient, underwent 2 weeks of physical therapy which exacerbated arm pain.
tenderness; redness; warmth; This case was reported by a nurse via call center representative and described the occurrence of injection site tenderness in a 34-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 54T44, expiry date 30th June 2020) for prophylaxis.   On 14th October 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular) .5 ml. On 14th October 2019, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site tenderness, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site tenderness, injection site erythema and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site tenderness, injection site erythema and injection site warmth to be related to FluLaval Tetra 2019-2020 season.  Save and rerun narrative; Add sentence for discrepancy related to outcome of event (not updated by me)  Additional details were provided as follows: The patient received FluLaval Tetra 2019-2020 season in the left deltoid and within 12 hours experienced tenderness, redness and warmth at the injection site. The adverse events resolved within 24 hours. This case has been linked to US2019191760, reported by same reporter. There was a discrepancy in the reported outcomes in XML and the ones autoloaded in the database, however, outcome captured as per database.
Redness around injxn site 6 days later. Patient came to pharmacy & was examined. RPh felt site was hot to touch. Pt. was advised to go to MD.
15 year old female fainted on the 3rd dose of GARDASIL 9 on 6/13/2016; Information has been received from a physician, referring to a 15 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported On an unknown date, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot number, expiration date, anatomical location and administration route were not reported) for prophylaxis.        On 13-JUN-2016, the patient fainted (syncope) on the third dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The outcome of syncope was unknown.       The casuality assessment between the syncope and the vaccination with the third dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.
Pt developed inj. site varicella-like lesions approximately 5 days after and over following week progressed to generalized vesicular-papular rash which covered/spread over a week to (L) UE and (R) LE - >100 lesions.
swelling, redness, mild induration, pain noted lt deltoid area 4-5 x 7cm;first noted 13FEB96 AM;
This child had 1.0 ml of Hep B vaccine immediately; stiffening of all limbs, rolling of eyeballs, jerking of lower extremities, felt dizzy, and became sweaty. The initial BP increased then stabilized.;
I was seen on April 10th for the lump in my arm at the injection site. I was told I had ?covid arm? and that it should resolve over time. It?s gotten much better, but I still have a very small lump there. I was seen on April 19th for constant pounding in my left ear that started around April 12th. I was told I had pulsatile tinnitus, and I will be having a MRA scan on May 8th. I have felt some pressure in my head since then, and was told it may be related, but to just wait for the scan.