chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1 patient was administered expired vaccine on 11-Apr-2022, expiration was 02-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 patient was administered expired vaccine on 11-Apr-2022, expiration was 02-Apr-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 patient was administered expired vaccine on 11-Apr-2022, expiration was 02-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 patient was administered expired vaccine on 11-Apr-2022, expiration was 02-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Flu like illness, moderate swelling to L deltoid. Approx 10cm x 5 cm. Warm to touch, fever (subjective).
pregnant woman received Adacel twice; once at 31 weeks gestation, once at 35 weeks of gestation with no adverse event; Initial information received on 08-Mar-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves adult female patient (age unknown) who was pregnant received  doses of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] twice; once at 31 weeks gestation and once at 35 weeks of gestation (exposure during pregnancy).  Data regarding this pregnancy were received prospectively. The date of last menstrual period was not reported. The estimated due date was not reported. Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. The patient had unknown number of previous pregnancy/ies.  On unknown dates, the patient received two doses of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date not reported) at 31 weeks of gestation and 35 weeks of gestation via unknown route at unknown administration site for prophylactic vaccination.  It was case of vaccine exposure during pregnancy.  At time of reporting, the outcome of the pregnancy was unknown.   Information on the lot number was requested.
pt recv vax 11MAR94 & 13MAR94 exp a h/a, aching, vomiting & devel fever; @ the time of the report pt was undergoing medical testing; The nurse reported in f/u that the pt has voiced no complaints; No further details were provided;
sore arm; little fever; local reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MIRALAX. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Just a Local reaction", "sore arm", "little fever". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; PYREXIA (non-serious), outcome "unknown", described as "little fever"; LOCAL REACTION (non-serious), outcome "unknown".  Additional information: Reporter's wife and patient took four regular doses of the Pfizer BioNTech COVID-19 monovalent vaccine. They also had one bivalent booster. They experienced nothing more than a sore arm and a little fever maybe but no rash or no breathing problems. Just a local reaction. They were eligible for the second bivalent booster however, His wife started taking Miralax for digestive problems one or two 17 gram capsules a day and it was pure polyethylene glycol. She might have developed a rash with itching with it, because it started when she started taking it and went away after she quit taking it. They think there was a risk of rash with the Pfizer BioNTech COVID-19 bivalent vaccine.  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-202300180008 same reporter/patient/product/AE, different dose;
Usual fleeting pain in injection site but ongoing deep muscular pain with shoulder involvement and some loss of mobility that did not abate quickly, with some level of pain in site still and still not 100% easy mobility (but I exercise and swim and stretch and have hope it will abate eventually). The muscle where the injection site was experiences both dull, deep (most of the time) and sometimes shooting pain. I am happy to have the vaccine and think this side effect is likely just the  injection process and not the vaccine, but many months have passed and I thought I should mention that there is still a problem, which worries me as I approach a booster in November as I cannot get injection in right arm.  I appreciate the Health Department (and Covid vaccines) and do not fault it or an individual and have hopes the inflammation or whatever it is will resolve one day. I am just sharing this information in case it is helpful. I have assumed the issue was just the method of injection, maybe needle went in wrong somehow, but a friend said I could not know that for sure and should share my experience.
Tachycardia (135 bpm) Brain Fog Trouble walking (dizzy)
sick after second dose; fever after second dose; chills after second dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick after second dose), PYREXIA (fever after second dose) and CHILLS (chills after second dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included TIA (a couple of years ago and the left side of face and arm got numb), Myocarditis in 1963 and Pericarditis in 1963. Concomitant products included LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-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 ILLNESS (sick after second dose), PYREXIA (fever after second dose) and CHILLS (chills after second dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (sick after second dose), PYREXIA (fever after second dose) and CHILLS (chills after second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Hair loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Sep2021 at 13:00 as dose 2, single (Batch/Lot number: Unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic pain neuropathy back pain" (unspecified if ongoing), notes: other medical history: Chronic pain neuropathy back pain; "Penicillin: Allergy" (unspecified if ongoing), notes: Relevant past drug history:, Penicillin and Sulpha: Allergy; "Sulpha: Allergy" (unspecified if ongoing), notes: Relevant past drug history:, Penicillin and Sulpha: Allergy. Concomitant medication(s) included: LIPITOR; VICODIN. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 08Mar2022 at 12:15, outcome "not recovered", described as "Hair loss". It was unknown if therapeutic measures were taken as a result of alopecia.  Addition information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Red spot underneath injection site; Warm spot underneath injection site; This case was reported by a pharmacist via call center representative and described the occurrence of localized erythema in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd August 2020, the patient received Shingrix. On 5th August 2020, 2 days after receiving Shingrix, the patient experienced localized erythema and feeling of warmth. On an unknown date, the outcome of the localized erythema and feeling of warmth were unknown.   It was unknown if the reporter considered the localized erythema and feeling of warmth to be related to Shingrix.  Additional details were provided as follows: The reporter was the caller. The patient received Shingrix and experienced a red, warm spot underneath the area where they got the shot.  The spot was about 1/2 inch underneath the injection site.  The reporter stated that the reaction was not at the injection site, but deeper in the tissues. The reporter did not consent to follow up. Not all information was available.
Received BEXSERO vaccine at 3pm. At 6pm he developed a fever of 102.5 and started to vomit. Vomited for 1 hour. Mother states symptoms resolved after 3 hours.
Vaccine had a low temp excursion.  Revaccinated on 11/7/2022
Initial information has been received from a licensed practical nurse concerning a 59 years old patient with an unspecified gender, pertinent medical history or drug reactions / allergies. On 11-JAN-2013, the patient was vaccinated subcutaneously with 0.5 ml (Merck) PROQUAD (lot # (H015642 exp date 06-JAN-2014) instead of (Merck) ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported. No treatment information was reported. The patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
This is a spontaneous report by a contactable nurse. A 4-year-old female child received PREVNAR 13 in the left thigh on an unknown date. Relevant medical history and concomitant medications were unknown. It was unknown if any vaccines were given on the same day. On unknown date, she experienced pain at site of injection, the site of injection got erythremic and site of injection developed a large redness. At the time of the report the clinical outcome of all the above mentioned events was unknown. Follow-up (07-JUN-2013) Follow-up attempts completed. No further information expected.
Rashes occurring at various places on body of pt with acute itching, irritation accompanying rash, usually lasting about thirty minutes at a time.
01/04/22: FEVER, COUGH, SOB, LOSS OF TASTE/SMELL, NC, CHILLS, N/V
Went to doctor for itching like fire ants and bruising, was clawing self on Sunday 16th, yellowish bruise between breasts, left thigh huge purplish bruise, both arms bruised.  Treatment PREDNISONE shot, steroid pack, hydrocortisone-Monday.  Still has bruise but no itching now
17AUg97 & 20AUG97 low grade fever, tx w/APAP on 20AUG97; devel fine rash on abd;21AUg97 rash spread completely head to toe w/raised whelps 22AUG97;trunk, upper arms & thighs solid, red & swollen rash w/splotches of red on dec legs, forearms
Adacel and Menactra was given on 09/17/2018 and again today; Initial information received on 31-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (office staff).  This case involves a 13 years old female patient who received vaccines MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] twice.  The patient's past vaccination(s) included Adacel on 17-SEP-2018 and Menactra on 17-SEP-2018.  The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medications included HPV VACCINE (HPV VACCINE) for Immunisation.  On an unknown date, the patient received a dose of suspect 0.5 ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot 2YY25 and expiry date: 28-Mar-2020 via intramuscular route in the left deltoid.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via intramuscular route in the right deltoid.  It was a case of actual medication error due to extra dose administered.  It was not reported if any adverse event occurred or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
pt recv vax & 2 hr later exp numbness in lt arm,lt side of neck & tongue,pain which radiated to lt hip,weakness & tingling in the lt arm & hand;inj site was clear but tender to touch;16APR95 seen in ER;hosp;D/T weakness;numbness lt side
Chest pain on left side by my heart since I got the shots.  Happens randomly almost everyday now.
coughing; This case was reported by a consumer via call center representative and described the occurrence of cough in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In September 2018, the patient received the 2nd dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced cough. The patient was treated with medication unknown (Inhalers (Unknown Medication)). On an unknown date, the outcome of the cough was not recovered/not resolved.   It was unknown if the reporter considered the cough to be related to Shingrix.  Additional details were provided as follows: The reporter was a friend of the patient.   In July 2018, the patient received 1st dose of Shingrix. The patient had been to multiple doctors and prescribed inhalers that did not relieve the coughing.  The patient was diagnosed with gastroesophageal reflux disease but after testing, that was ruled out. The reporter consented to follow up. No phone available.
Within 30 minutes of shot, headaches, recurrent vomited. Had 2 return visits to office and 2 visits to ER. Diagnosed ?UTI and ruptured ovarian cyst.
Exposed to daughter on Tuesday. 7/24/21 Sinus congestion and cough
No additional AE reported.; ROTATEQ was administered following a temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1742080 experienced the temperature excursion of 48.5 degrees fahrenheit (F) for 30 minutes. On 22-NOV-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1742080, expiration date 14-JUL-2022 (formulation, concentration, exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis (product storage error). There were no previous excursions reported. No adverse event was reported (no adverse event).
rash,bllsters,skin peeling In large sheets, swelling, redness, lips swollen, arms, hands,legs and feet swollen, peeling, inflamed fo2 weeks. Went to ER. Admitted to hospital for 3days, then sent home with no diagnosis or help. After another week, went to Dermatologist, got biopsy, determined itwas AGEPI Then put on Prednisone for 2weeks, off for a week, then back on for undetermined amount of time. Still can hardly walk due to pain In feet (bottoms) and toenalls and fingernails are all coming off! Hands also still difficult to usel
Approx 7-10d after vaccine, noted pain/swelling L forearm. Used otc lidocaine patches for self-management. Then started to have increased spread of pain/swelling/redness along with large tense clear blisters at edges of skin changes. This spread from wrist proximal to midhumerus. Also, patient fell asleep with bare L forearm across lower left abdomen,  and developed similar rash on abd wall. I examined patient on 9/19/22 with this presentation and started Bactrim DS, topical vaseline. One week later on 9/26/22, new blistering lesions on all webspaces of fingers, around eyelids/periorbital area, and R antecubital fossa, L popliteal fossa. Start Prednisone taper, urgent Dermatology consult pending on 10/3/22.
flashing streaks in right eye; specks "floaters" in right eye; A spontaneous report (United States) was received from a Consumer concerning a 66-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events flashing streaks in right eye(Photopsia), specks floaters in right eye(Vitreous floaters).  The patient's medical history was not provided. Concomitant medications reported were levothyroxine QD, Lipitor every other day for drug use for unknown indication.  On 12 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 015M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 16 Feb 2021 patient experienced flashing streaks in right eye, specks floaters in right eye.  Treatment details included none  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, flashing streaks in right eye, specks floaters in right eye was not reported.  Based on MSA comment Injection site warmth is coded Vaccination site warmth.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 39-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) 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 included: "Overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 15Mar2023 to 19Mar2023. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of the subject vaccine cannot be excluded for suspected LOE.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.
Patient had syncopal episode 5 minutes after vaccination. Paramedics were called for monitoring of vital signs.
Day of vaccine I didn't feel bad, just felt queasy later, I was tired the next day. I don't know when the SOB started but it continued through the month of March. I thought it was an exacerbation of my chronic issues, by Sunday 4/4/20221  I coughed up blood, and on Monday I went to the hospital and had a CT scan and was told I had a pulmonary embolism and a clot in my leg. Now I'm on an injectable blood thinner for the rest of my life and I was told it would take 3-4 months to resolve the blood clots.
administrator of the vaccine might have given a double dose of the shot, seems as if syringe has; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (administrator of the vaccine might have given a double dose of the shot, seems as if syringe has) 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 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced ACCIDENTAL OVERDOSE (administrator of the vaccine might have given a double dose of the shot, seems as if syringe has). At the time of the report, ACCIDENTAL OVERDOSE (administrator of the vaccine might have given a double dose of the shot, seems as if syringe has) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Lot number: EK4176), in left arm, on 27Jan2021 as dose 2, single (Lot number: EN5318), in left arm and on 03Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient was treated with Antiviral (Paxlovid, Lot: 6D5282) from 30Jul2022. The patient did not received any other medication in 2 weeks before receiving Paxlovid. No known allergies were reported.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure and covid-19 and BNT162B2.
Woke up this morning with swollen, painful nodule on left-side of collarbone.
1 day of Upper motor neuron findings including hyperreflexia with clonus and 2-3 joint involvement, +Babinski with 2 joint involvement, lower>upper limb weakness, severe HA, nausea, vomiting.  Concern for postvaccinia encephalomyelitis.  Symptoms largely resolving on HD 2 with supportive care, without IVIG or corticosteroids.
Pt. reported redness and swelling and heat at the injection site. Two days later the redness spread. She went to E.R. w/Dx: left upper extremity cellulitis. She was given BACTRIM & KEFLEX to treat infection.