chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From initial information received on 11/19/2004 from a health care professional regarding an adverse event occurring in the USA, it was reported that an 18 month old male pt received a dose of Daptacel, lot number C1699AA, administered in the RL, a dose of Act Hib,  lot number UE2161AA, adminsitered in the RL and a dose of Prevnar (manufacturer Lederle) lot number A57562A, administered in the LL on 11/15/2004. The routes of administration were not reported and the lot number provided for the Act Hib product does not match an Aventis Pasteur product. The Following day, on 11/16/2004, the pt developed redness, and swelling at the injection site, which was also warm to the touch, the pt mother reported that the area was the size of a baby;s fist. Per the reporter, it is unknown whether the patient recovered from these events. The reporter for this case is the same reporter for cases: 200403770, 200403771, 200403772, 200403773, and 200403774.
Patient complained of feeling weak immediately after the vaccine was given, he then turned pale and slumped over.
Vaccinia virus - contact transmission. 2/22 Indep pt vaccination for smallpox. 3/3 - wrestled with brother - no shirts- brother developed lesions on face and wrist (2) on 3/6. 3/7 - Pt (girlfriend of brother) was popping the lesions thinking they were ant bites. 3/14 - She developed 6 lesions on face. 3/17/06 - Presented to ER.
PATIENT STATES ARM WAS SORE DUE TO IMZ. SHE WENT TO DR AND DR DIAGNOSED HER WITH CELLULITIS.
This spontaneous case was initially received on 06-Oct-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received Influenza Vaccine. ZOSTAVAX. On an unknown date, after starting treatment with Unspecified flu vaccination the patient experienced Flu-like symptoms, Blood red injection site reaction. For relevant test results see appropriate report section.
Seizure 10 hrs after vaccine, sleep apnea, muscle spasms /100° temp. forty-eight hrs later for 48 hrs, weakness, soreness, vomiting diarrhea/injection site redness, swelling, lump/muscle spasms for app. 1 week following/injection site lump for over 1 month afterward.
2 roundish hives at injection site; tenderness; shoulder started to itch at injection site; red rash; swelling at injection site; sore arm/ pain; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (sore arm/ pain), INJECTION SITE PRURITUS (shoulder started to itch at injection site), INJECTION SITE RASH (red rash), INJECTION SITE SWELLING (swelling at injection site) and INJECTION SITE URTICARIA (2 roundish hives at injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dermatitis due to metals since an unknown date. Concomitant products included ESTROGENS CONJUGATED (PREMARIN) for Dermatitis.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE PAIN (sore arm/ pain). On 20-Jan-2021, the patient experienced INJECTION SITE PRURITUS (shoulder started to itch at injection site), INJECTION SITE RASH (red rash) and INJECTION SITE SWELLING (swelling at injection site). On 21-Jan-2021, the patient experienced TENDERNESS (tenderness). On an unknown date, the patient experienced INJECTION SITE URTICARIA (2 roundish hives at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash and Itch, at an unspecified dose and frequency. In January 2021, VACCINATION SITE PAIN (sore arm/ pain) outcome was unknown. On 22-Jan-2021, TENDERNESS (tenderness) had resolved. At the time of the report, INJECTION SITE PRURITUS (shoulder started to itch at injection site), INJECTION SITE RASH (red rash), INJECTION SITE SWELLING (swelling at injection site) and INJECTION SITE URTICARIA (2 roundish hives at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
This spontaneous report was received from a nurse, refers to an unknown amount of patients of unknown age and gender. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. Nurse reported that improperly stored ZOSTAVAX, lot # L028279, expiry date 28-OCT-2016, vaccines were administered to patients on unspecified dates after temperature excursion (temperature: 19.6 F, time range 1 hour and 30 minutes) on 13-JUL-2016. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. This is one of three reports received from the same reporter. Additional information has been requested.
pt vomited x2;  painful crying. irritable, hard stool x1, 7/19 hard stool, x1. worsening vomiting. low urine output. Admit to hosp via ER for IVF; 7/21 disch home
accidently given an adult dose of ENGERIX B; accidently given an adult dose of ENGERIX B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 4-year-old female patient who received HBV (Engerix B adult) (batch number d23d3, expiry date 15-MAR-2025) for prophylaxis.   On 18-JUL-2023, the patient received Engerix B adult. On 18-JUL-2023, an unknown time after receiving Engerix B adult, the patient experienced accidental overdose (Verbatim: accidently given an adult dose of ENGERIX B) and adult product administered to child (Verbatim: accidently given an adult dose of ENGERIX B). The outcome of the accidental overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-JUL-2023 The reporter was a medical assistant. A 4-year-old patient was accidently given an adult dose of Engerix B, which led to accidental overdose and adult product administered to child. The reporter consented to follow up.
on 17FEB devel temp of 102;no rash or redness on skin;no runny nose or breast or little;taking water;given APAP this would calm pt for 3hr & then fever went up again;fever lasted 21FEB went MD 20FEB;
flu like symptoms including sore arm, chills, headache, body aches, nausea
HEAVY FEELING IN BOTH LEGS, HEAVINESS HARDER IN RIGHT LEG; TIREDNESS; FEVER; HEADACHE; NAUSEA; CHILLS; BACK PAIN; PAIN IN BODY; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included bleeding ulcer, and concurrent conditions included non-alcohol user, non-smoker, and penicillin allergy, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 07-AUG-2021) dose was not reported, administered on 20-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-JUN-2021, the subject experienced back pain. On 20-JUN-2021, the subject experienced pain in body. On 20-JUN-2021, the subject experienced chills. On 20-JUN-2021, the subject experienced fever. On 20-JUN-2021, the subject experienced headache. On 20-JUN-2021, the subject experienced nausea. Treatment medications included: paracetamol. On 21-JUN-2021, the subject experienced tiredness. On 22-JUN-2021, the subject experienced heavy feeling in both legs, heaviness harder in right leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and nausea on 21-JUN-2021, and headache on 22-JUN-2021, had not recovered from heavy feeling in both legs, heaviness harder in right leg, and the outcome of pain in body, tiredness and back pain was not reported. This report was non-serious.
Bright red circle at site of the injection, later becoming fainter pink, with sore muscles.
I believe i have all of sudden caught the measles. i have rash on my back legs arms and chest. I went to hospital and they told me that they didnt know what it was nor where it came from. No labs were drawn just prescribed me meds and discharged me. I'm severly itching all over my body.
Had dystonic reaction after vaccine. Contractions to arms and pulling of face. Has hx of dystonic reactions following administration of oral medications. Has never had happen after a vaccine, did not have any issues following 1st dose.  Took own rescue medications of Benadryl and Ativan when felt coming on. Has additional doses if needed. Is getting better. Does not want medication from fire department or to be transported to hospital.
Couldn't put the dates in above for my vaccines, They were on 3/31/21, 4/10/21, 10/29/21, 4/22/22, 10/12/22.  Tested positive for Covid on 1/6/23. Symptoms started on 1/5. my symptoms were very mild-like a bad cold. Treated with OTC meds. Felt better by 1/10. Tested positive again on 1/11.  Negative on 1/12 and 1/14.
cervical cancer; uterine cancer; This spontaneous report was received from a physician via field representative concerning a 20 year old female patient. Information regarding the patient's medical history, concurrent conditions, concomitant medications or drug reaction/allergies were unknown by reporter.     On an unspecified date between 2011 and 2012, when the patient was 12 or 13 years old, she was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  injection for vaccination (dose, frequency, route of administration, lot number and expiration date were unknown by reporter).  On an unknown date, the patient was diagnosed with either uterine cancer or cervical cancer (cervix carcinoma). The patient sought for medical attention; however she did not receive treatment for the events and it was unknown by the reporter if any diagnostic laboratories or studies were performed due to the event. At the time of the report, the outcome of uterine cancer or cervix carcinoma was not reported. The causal relationship between the occurred events and therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided. Upon internal review, uterine cancer or cervix carcinoma were as a considered medically significant event.
WEIRD; FELT NO CIRCULATION IN THE LEG, LEG FELT FUNNY, NOT WORKING 100 %, LEG FELT THUNDER TO TOUCH, NO COLOUR, PAIN IN THE LEG, LEG FELT WEIRD, AND SORE LEG; DIZZY/LIGHT HEAD; TINY COLD; CHILLS; PAIN ON THE ARM; HEADACHE/HEADACHE LIKE PRESSURE; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced dizzy/light head. On 07-MAR-2021, the subject experienced tiny cold. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced pain on the arm. On 07-MAR-2021, the subject experienced headache/headache like pressure. On 07-MAR-2021, the subject experienced nausea. On 10-MAR-2021, Laboratory data included: COVID-19 (NR: not provided) Negative. On an unspecified date, the subject experienced felt no circulation in the leg, leg felt funny, not working 100 %, leg felt thunder to touch, no colour, pain in the leg, leg felt weird, and sore leg, and weird. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, metoclopramide, and ondansetron. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiny cold, and chills, and pain on the arm on 10-MAR-2021, and had not recovered from headache/headache like pressure, dizzy/light head, nausea, felt no circulation in the leg, leg felt funny, not working 100 %, leg felt thunder to touch, no colour, pain in the leg, leg felt weird, and sore leg, and weird. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Breakthrough COVID-19 case:  I started to have a sore throat. By that evening I had sinus congestion and took a COVID-19 home test and it came back negative. By Saturday, The congestion became severe to the point of bleeding when I would blow my nose. At this point the sore throat had subsided but I developed a cough.  I started to feel worse so I took another test and it came back negative. By Sunday I really wasnt feeling well and I took another test and it did come back positive. I sent an email to the nurse line with my symptoms and asked for advice. They advised to use over the counter medication for my symptoms. As of today 05/19/2022 I feel fine aside from a small cough and fatigued.
I have had high blood pressure but the ringing of the ears are thd worse . I also have gearing loss.
Incident details: Per Drs. email sent out on 9/1/22-"the monovalent mRNA COVID-19 vaccines are not authorized as booster doses for individuals 12 years of age and older. Any patients that are currently scheduled to receive a booster should wait until we have the bivalent booster on hand". The patient was seen in office on 9/1/22 and received a booster dose of the monovalent mRNA COVID-19 vaccine (Pfizer) by RN in error as patients are now only supposed to receive the bivalent booster per Drs. email. Patient was due for booster at the time they received it, however the bivalent booster was not yet stocked. Possible Cause: Possible cause of the incident is that an email was sent out regarding the discontinuation of monovalent Covid boosters until Private receives the bivalent booster doses. This was overlooked by management and staff, as previous changes to clinic processes is usually discussed in a meeting. Also 'monovalent' and 'bivalent' are new terms that have not previously been used when discussing booster vaccines.  Corrective Action: Corrective action included notifying staff and providers of the recent change regarding COVID vaccines and were notified to stop giving COVID booster doses until the Clinic receives the bivalent vaccines. Staff and providers were notified via email, skype, and verbally. Incident reported to VAERS.
right arm , red swollen, it hurts real bad, swollen and hard, redness is spreading,
It was not an adverse event .  I am reporting that I developed symptomatic COVID on 3/16/2021, confirmed by PCR on 3/17/2021
4 weeks after my J&J shot, I woke up in the middle of the night with vertigo.   I only had vertigo for that night, but it went away.  My balance was off for the next 2 weeks but slowly got better.  My balance seems to be back to normal at this point.  This seems to be an inner-ear issue, unrelated to the vaccine shot.  This is my first time every having vertigo / balance issues like this.
Covid monitoring documentation. PT admitted 12/25/22 documented to have positive covid. PT received Janssen 6/3/21 Lot 204A21A for dose 1. PT expired on 1/1/22 due to COVID19 and pulmonary arrest according to death summary.
Pain and inflammation at injection site that has now progressed to pain scabbing rash 16 days later.
Ill since June when he received COVID-19 vaccination and developed peeling rash with blisters of the face, arms and body.  Tested positive for Covid on 9/24/2021 as part of a pre-operative work-up Expired 9/26/2021
past due for dose two; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 26th May 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided are as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient was past due for 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not had lot number or expiration date to provide. The reporter consented to follow-up
Fatigue, headsache, warm itchy hard rash at injection site with onset of rash 3/8/21
Post vax, the pt developed autism. The pt sought unspecified medical treatment. On 9/23/98, the pt was vaccinated with a booster shot of MMR. Upon medical review, the pt's experience was considered an
Pt was admitted on 2/8 from a SNF for a shoulder arthroplasty post right proximal humeral fracture. Pt last had a COVID test when she was going to SNF on 2/2. Upon transfer back to SNF pt was tested for COVID on 2/13 and was positive but is asymptomatic.
Arm was numb; Red at injection site for several days after injection; This is a spontaneous report from a contactable consumer. An adult female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown if the patient had received any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date, the patient arm was numb and red at the injection site for several days after injection. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events arm was numb and red at injection site for several days after injection was recovered on an unknown date.  The lot number for BNT162b2 was not provided and will be requested during follow up.
No additional adverse effects; patient, five months of age, received PNEUMOVAX 23; This spontaneous report was received from a medical assistant and refers to a 5-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 08-JUN-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S029542, expiration date 10-JUN-2021, 0.5 milliliter, once (route of administration was not reported) for prophylaxis. No additional adverse effects were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S029542; expirationdate: 10-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Vaccine administered 12:15pm at 12:30 redness at vaccination site was noted.  Hands were observed to be warm , red, swollen and had rash on back of hands by RN & NP,   She was monitored over next 15 mins and rash and other symptoms disappeared. Patient returned to work after 30 mins of monitoring.  At 1:45pm she reported feeling  nauseated.  NP & RN evaluated  her and noted red rash on chest & neck.  She also stated she felt dizzy.  BP was 148/103.   Epi pen X 1 dose was administered at 1:50pm followed by 62.5mg or liquid benedryl.  EMS was called and patient was transferred to ER.  VSS at 1:55pm were 165/103, 98% O2sat on room air, temp 99.3 pulse 102, resp 16
Patient received Fluzone HD vaccine on 9/9/22 at Primary Care Physicians. Received addition high dose flu vaccine on 11/1/22 at assisted living center.
Pt developed severe pain, swelling and redness 1 day after she received vaccine. Used both ice and heat to treat sx until resolved.
Tremor / hand and head internal vibrations and recently visible hand tremors; Eye pain; Shortness of breath; Forgetfulness; Leg pain/Arm pain; Eye pain and Discomfort along with blurred vision; Blurred vision; lack of focus; Headache; Shoulder pain; Fatigued/Tiredness; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Tremor / hand and head internal vibrations and recently visible hand tremors), EYE PAIN (Eye pain), DYSPNOEA (Shortness of breath), MEMORY IMPAIRMENT (Forgetfulness) and PAIN IN EXTREMITY (Leg pain/Arm pain) in a 55-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (Tremor / hand and head internal vibrations and recently visible hand tremors), EYE PAIN (Eye pain), DYSPNOEA (Shortness of breath), MEMORY IMPAIRMENT (Forgetfulness), PAIN IN EXTREMITY (Leg pain/Arm pain), EYE PAIN (Eye pain and Discomfort along with blurred vision), VISION BLURRED (Blurred vision), DISTURBANCE IN ATTENTION (lack of focus), HEADACHE (Headache), ARTHRALGIA (Shoulder pain) and FATIGUE (Fatigued/Tiredness). At the time of the report, TREMOR (Tremor / hand and head internal vibrations and recently visible hand tremors), EYE PAIN (Eye pain), DYSPNOEA (Shortness of breath), MEMORY IMPAIRMENT (Forgetfulness), PAIN IN EXTREMITY (Leg pain/Arm pain), EYE PAIN (Eye pain and Discomfort along with blurred vision), VISION BLURRED (Blurred vision), DISTURBANCE IN ATTENTION (lack of focus), HEADACHE (Headache), ARTHRALGIA (Shoulder pain) and FATIGUE (Fatigued/Tiredness) outcome was unknown.            No concomitant and treatment medications were reported. It was reported that prior to Nov-2022 patient was healthy and jogged 5-6 days per week with no health issues. At the time of reporting, it was opposite and after two MRIs no one can tell that what was the wrong with patient. Patient wanted to know what could be causing theses issues. After the booster shot, Patient returned to work but was extremely tired, fatigued and affected much more than previous shots. Now as patient tried to write this, he had to take breaks because of shaking hands and lack of focus. Patient had headache every day without the help of any medication.   This case was linked to MOD-2023-711124 (Patient Link).
Client received dose 1 Jynneos monkeypox vaccine.  Client AOX3, ambulatory, NKA. At 1457 after 2 minutes of administering the vaccine, client complaint of chest pain, tightness around the chest radiating to neck, shortness of breath but able to speak clearly. VS taken. Legs was elevated, ice pack applied, water provided and able to tolerate well. HC and NP notified and came to checked the client. 911 activated at 1508. EMS arrived at 1519. Client was sent to Emergency room for further assessment at 1523, ambulatory accompanied by two EMS transporters.