chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore left arm; fever; nausea with 1 vomit occurrence; nausea with 1 vomit occurrence; headache; chills; tiredness; aches; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 23Apr2021 at 16:45 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within two weeks prior to the COVID-19 vaccine. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP9533) via an unspecified route of administration in the left arm on 02Apr2021 at 16:00 as a single dose for COVID-19 immunisation. On 23Apr2021 (also reported as at 02:00), the patient experienced sore left arm (getting better), fever up to 101.5 degrees (climbing to 101.5 currently), nausea with 1 vomit occurrence (no longer present), headache (somewhat better), chills (better), tiredness (somewhat better) and aches (still existed). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events included self-treatment with paracetamol (TYLENOL) and ibuprofen (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea with 1 vomit occurrence was recovered on an unknown date in Apr2021. The clinical outcome of the events sore left arm, headache, chills and tiredness were recovering while that of the event fever and aches was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Large area (approx 8cm x10 cm) of redness, induration at injection site, pain, tender to palpation noticed in afternoon, approx. 1730 on day of injection. Continuing through post-injection day 1 and 2 with decrease in size/induration and pain on day 3 but with general myalgia primarily in lower extremities. No fever or chills.
her neck and shoulders still hurt; her neck and shoulders still hurt; This is a spontaneous report from Regulatory Authority from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced her neck and shoulders still hurt on an unspecified date with outcome of not recovered. Clinical course was as follows: Patient got the first dose of the Covid19 vaccine last 06Feb2021 and scheduled to get the second dose on 27Feb2021. However, her neck and shoulders still hurt until now and the patient wanted to reschedule the appointment for later. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. presented to pharmacy with parent for second Pfizer dose; verified name and dob in database and verbally with pt. and mother; vaccine administered.  In reviewing billing, it was found that pt. dob may actually have been a year later (according to insurance, also found in database ...making the patient ineligible for the vaccine being only 11 years old. A previous VAERS report had been completed for the first dose, and a note on the patient's profile was not seen during processing of the vaccine. Unable to verify actual dob as mother may be misleading, or insurance may have it incorrect. Mother not returning calls.
Information has been received from a physician concerning a 17 year old female with no medical history and no drug allergies, who on 19-FEB-2008 was vaccinated with a 0.5mL dose of Gardasil. Concomitant vaccinations included MENACTRA and DTaP. On 19-FEB-2008 the patient fainted, fell off the table, hit her head on the ground, and had a seizure. The patient also had a cut on the bridge of her nose and gums. The patient went to the emergency room and was released the same day. The physician thought the seizure was due to the head trauma. The patient recovered on an unspecified date. No product quality complaint was involved. Upon internal review seizure was considered to be an other important medical event. Additional information has been requested.
injection site pain; burning in her arm pit; vaginal itching; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 08Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VULVOVAGINAL PRURITUS (non-serious) with onset Nov2021, outcome "unknown", described as "vaginal itching"; BURNING SENSATION (non-serious) with onset 08Nov2021, outcome "recovered" (Nov2021), described as "burning in her arm pit"; VACCINATION SITE PAIN (non-serious) with onset 09Nov2021, outcome "recovered" (2021), described as "injection site pain".  Additional information :It was reported that patient experienced injection site pain, which she realizes is expected and also experienced burning in arm pit (same side as injection) that lasted a couple days and went away, but a week after she started to get vaginal itching. Patient thought she had a yeast or fungal infection. It was reported that patient was uncomfortable receiving the second dose and asks is there something that can be documented so she don't have to receive both doses.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Developed hives on upper chest and neck, with some tightness in neck Noticed about 36 hours after injection (currently 48 hours after injection) Increased dosage of Claritin (usually take 5 mg; took 10 mg) Will contact dr in a couple days if they have not receded Had similar reaction (hives) a week after getting the Covid bivalent booster; went away in a few days
Child received Dtap(IM) to left lateral thigh on 2/22/07. Mother stated that left leg was swollen 24 hours post injection. Pt came to clinic on 2/24/07 with left thigh swelling and center warm to touch, no fever, no streaking. Child jumping and running. Left thigh treated with cold compress, motrin and prophylactic antibiotics for 7 days.
Pt recvd a series of 3 doses of Engerix-B on 13SEP90, 17OCT90, & 13MAR91; pt did not convert w/a booster dose; pt is receiving a second round of vax;
A report has been received from a Health Professional concerning, subject of unknown of gender, who had been receiving Nasal FLUMIST QUADRIVALENT, 0.2 Millilitres (frequency not reported). FLUMIST QUADRIVALENT started on 09-Mar-2016. The patient received expired dose of FLUMIST. The outcome of the event of received expired dose of FLUMIST is unknown. The report was considered to be non-serious.
Redness, swollen and itchy at site of injection.  Patient was given clindamycin for 5 days.
tested + for covid on        2-15-22  at  Center  and later on 2-21-22 at Hospital.  deceased 3-1-22
Hoarseness, eye tearing initially, then turned into an eye infection and sinus infection.  Given antibiotics by pediatrician.
After being in menopause since 2013 trigger menstrual cycle.  Cramps and bleeding
a little bit of a reaction; was kind of foggy headed/didn't see good for about a week or so/but nothing real bad; had pain in his arm for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (a little bit of a reaction), FEELING ABNORMAL (was kind of foggy headed/didn't see good for about a week or so/but nothing real bad) and PAIN IN EXTREMITY (had pain in his arm for 2 days) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (a little bit of a reaction), FEELING ABNORMAL (was kind of foggy headed/didn't see good for about a week or so/but nothing real bad) and PAIN IN EXTREMITY (had pain in his arm for 2 days). At the time of the report, VACCINATION COMPLICATION (a little bit of a reaction) and FEELING ABNORMAL (was kind of foggy headed/didn't see good for about a week or so/but nothing real bad) outcome was unknown and PAIN IN EXTREMITY (had pain in his arm for 2 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Follow up contains updated Reporter details, patient initials, gender, dose details and events details like pain in extremity and feeling abnormal.
encountered Covid back; encountered Covid back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "also had Covid before" (unspecified if ongoing), notes: minor level attack. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "recovered" and all described as "encountered Covid back". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: She had already taken 5 days of Paxlovid and tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid. Clinical course: Caller asked if she should got another Covid vaccine or should she just wait and hope her symptoms go away. Caller mentioned she had 1 booster shot last year.  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: Linked Report(s) : US-PFIZER INC-202300296425 same patient, different drug/AE;US-PFIZER INC-202300296536 same patient, different drug/AE;
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, since 01-MAR-2015, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, (dosing details and lot# not reported). No adverse effects were reported. The vaccine was exposed to high temperature of 10.3 degree Celsius for a cumulative time frame of 731 hours from 24-NOV-2015 through 26-OCT-2016. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a Medical assistant refers to a 55 year old female patient. Medical assistant wanted to administer an MMR II on 06-DEC-2013 to the 55 year old unspecified adult female patient however it was unknown if the patient had ever received MMR II in her past and physician was not going to draw titers. Additional information has been requested.
approx 12hr p/vax pt c/o upper airway swelling 20hr later pt w/uvular edema;
Arm sore pretty soon after shot Bit fuzzy-headed after an hour or 2 - hard to focus/think straight Headache started a bit after that - definitely noticeably by about 8:30 pm, lasted throughout evening Next morning -awake around 8 am, arm a bit more sore than previous day Bit of a headache by 9:30 am, but not as bad as night before Symptoms mostly gone by evening
administered expired Daptacel to a 15 month old child; Initial information received on 22-May-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 15 months old patient who had expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number not reported, expiry date May-2017) via unknown route in unknown administration site on 22-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to expired vaccine used.  It was not reported if the patient had any adverse event.  Information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender: none.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date in 2014, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Information has been received from a healthcare worker referring to unspecified patients of unkonwn age and gender. On 09-APR-2015, the patients were vaccinated with improperly stored doses of GARDASIL (lot number, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
She received ZOSTAVAX on 4/6. She called today and said she had redness, swelling and itching in the area of the shot. She was told to take Benadryl.
Joint pain (shoulders, elbows, wrists, fingers, hips, knees, ankles, toes), Muscle Spasms, Migraine, Nausea, Loss of Appetite, SOB, Lethargy, Insomnia, Parasomnia, Elevated BG (compared to normal trends), Depression, Sore Throat, Cough.
Patient states apprx 5 hrs after receiving TDAP that she broke out in welty hives - No involvement to lips, tongue or throat.
Approximately 30 minutes post vax, the pt developed a pruritic, erythematous, maculo-papular rash, facial swelling and mild wheezing with increased work of breathing. Treated with oxygen, epinephrine and Benadryl.
local rubor, pain & induration, >45mins in diameter, 72hrs p/vax
ringing in the ears; soreness at the injection site; headache; nausea; chills; fever; general fatigue; This spontaneous case was reported by a dentist and describes the occurrence of TINNITUS (ringing in the ears), VACCINATION SITE PAIN (soreness at the injection site), HEADACHE (headache), NAUSEA (nausea) and CHILLS (chills) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included COVID-19 in September 2020.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced TINNITUS (ringing in the ears), VACCINATION SITE PAIN (soreness at the injection site), HEADACHE (headache), NAUSEA (nausea), CHILLS (chills), PYREXIA (fever) and FATIGUE (general fatigue). On 10-Jan-2021, VACCINATION SITE PAIN (soreness at the injection site), HEADACHE (headache), NAUSEA (nausea), CHILLS (chills), PYREXIA (fever) and FATIGUE (general fatigue) had resolved. At the time of the report, TINNITUS (ringing in the ears) had resolved.     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.   Company Comment  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   This case was linked to MOD-2021-004639 (Patient Link).
Pt. reported that 10  hours after vaccination he developed fever and teeth chattering, felt weak and nauseated. He could not move or get up. Paramedic arrived to his home to assist him. Vitals were normal. Pt. received Cat Scan which was also normal. Pt. has been fine since then.
Patient came to ED with nausea and vomiting.  Patient admitted to hospital for Covid and treated with remdesivir.
Flu shot on 10/23/07; 10/25 laryngitis; 11/4 hands tingly & numb; 11/5 balance off, BP 180/120; 11/7 difficulty walking; 11/07 hospitalized with diagnosis of Guillain Barre; 11/12 dismissed from hospital. 12/31/07-records received for DOS 11/7-11/12/07-DC DX: Guillain-Barre syndrome. C/O progressive weakness in lower extremities with paresthesias. Developed some incoordination and balance issues. Neuro exam no focal deficits. Quite ataxic with generalized weakness.
Felt pretty lousy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt pretty lousy) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation. Concomitant products included AMLODIPINE, AMIODARONE, APIXABAN (ELIQUIS), CARVEDILOL, LOSARTAN and Vitamin & Minerals for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced FEELING ABNORMAL (Felt pretty lousy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Felt pretty lousy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Two episodes of intense screaming, the first 2 hours long, starting 2 hours after the immunizations, and the second 90 minutes long, about 16 hours after the shots.  Patient has since been fussy, and has only taken about 6 ounces of formula overnight.
During a review of the Department of Health's internal records, it was found that there might have been a possible temperature excursion with how the vaccine was stored with our mobile vendor.
First dose given 5/19/21. Second dose given 6/10/21, 22 days interval.
Arm was sore; Chills; Aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), CHILLS (Chills) and MYALGIA (Aches) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021 at 3:30 PM, 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 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore), CHILLS (Chills) and MYALGIA (Aches). On 21-Feb-2021, PAIN IN EXTREMITY (Arm was sore), CHILLS (Chills) and MYALGIA (Aches) had resolved.            No concomitant medications reported.  No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: No new information was added.
Fevers, chills, myalgias, nausea, vomiting, swelling around the area of injection 5X10 cm, redness and indurated, tender and warm.
Experienced extreme chills (borderline seizure) and poor circulation in arms around 2am after the shot.  I had to pile 5 thick blankets to stop the chills.  The symptoms almost prompted an ambulance call.  These symptoms  continued until 7am.  I experienced a headache and fogginess  for about 4 days until I took some Zinc and vitamin D.  I have also experience shortness of breather while sleeping and chest pain.  I have felt weak and get dizzy after exerting not much effort.  The chest pain is currently reduced and the shortness of breath while sleeping has gone away.
This spontaneous report was received from medical resident and refers to a 7-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported. On 16-OCT-2018, the patient was vaccinated with GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported) for prophylaxis (drug administered to patient of inappropriate age). The reported stated that the patient has experienced no adverse effects.
The vaccine is expired. We receive in May 19. 2021 at 9:00am in our clinic. The personnel was confuse with the date of expiration because the packing list the person who do the delivery put june 19, 2021 for expiration date.
Throat Closing, trouble breathing - gave him asthma meds and albuterol breathing treatments - this continued for 2 weeks. Antibiotics and then Steroids for possible infection. Called 911 after an early morning throat closing/trouble breathing. Hospital tests run - possible acid reflux. Did allergy scratch test, barium test, ultrasounds on pelvis and bladder. Symptoms are still throat closing, seeming allergies to all foods, severe acid reflux. Severe stomach pains now and frequent urination. Taking ZANTAC, BENADRYL.
Fever x 5 days, pneumonia, extreme lethargy. Was admitted to hospital.  9/16/08 Reviewed hospital medical records of 8/22-8/25/2008. FINAL DX: none provided but tx for pneumonia Records reveal patient experienced cough x 1 week. On day of vaccination patient developed fever, lethargy & wet cough when worsened over 2 days & seen by PCP.  O2 sats were 87% w/rapid breathing, spasmodic cough & chest crackles.  Tx w/nebs & sats inproved to low 90's but clinically unchanged.  Admitted for observation.  Tx s/nebs, O2, steroids, IVF, IV antibiotics.