chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 23-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose number unknown (booster), single (Lot number: unknown) at the age of 22 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Peppermint" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID-19 Treatment". This case was reported as non-serious. The patient treatment included Paxlovid from 31Aug2023 to 01Sep2023. Therapeutic measures were taken as a result of drug ineffective, covid-19. 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.
Tendon inflammation starting in forearm, gradually moving up arm to injection site over 2 weeks time.
1415 Patient's mom called stating he had fainted at work & he Kept asking her the same question over & over. I asked her to take him to the ER immediately. I asked her to Please call back. 1615 called & spoke with Patient he seemed show to respond to question. He did say he Just vomited. Mom Not there spoke with Aunt they had not taken him to ER. Encouraged Them again, Told Them he could have concussion. 9/3 spoke with patient he states he is doing really good. He reports in ER give IV (which really helped) CT & EKG done.
Information has been received from a physician concerning an approximately 60 year old male who was vaccinated with a dose of Zostavax. Subsequently six months after vaccination, the patient experienced an outbreak of ophthalmic shingles. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2007. Follow-up information from the physician and registered nurse indicated that on 03-APR-2007 the patient developed herpes zoster.  He saw his opthalmologist at the onset of the right eye irritation and rash on forehead with a diagnosis of herpes zoster.  On 06-APR-2007 the patient was seen by the opthamologist and he had right eye irritation and inflammation at the lid margin.  The assessment was herpes zoster opthalmic, dendritic lesion.  The plan was VALTREX 1 gm TID, LOTEMAX 1 drop right eye QID and tears.  On 16-APR-2007 the patient was seen for follow-up and his herpes zoster opthalmic in the right eye was improved.  The plan was to taper the LOTEMAX and proceed with planned cataract surgery.  On 20-APR-2007 the patient cataract surgery was performed.  On 21-APR-2007 on exam, the patient's recent herpes zoster in the left eye was improving.  Subsequently the patient recovered.  No further information is expected.
SECOND VACCINE KNOCKED PATIENT DOWN; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (SECOND VACCINE KNOCKED PATIENT DOWN) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.    Concurrent medical conditions included Psoriasis (Moderate To Severe Chronic Plaque Psoriasis).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced IMMUNISATION REACTION (SECOND VACCINE KNOCKED PATIENT DOWN). In 2021, IMMUNISATION REACTION (SECOND VACCINE KNOCKED PATIENT DOWN) had resolved.            There was no reported medical history.  Concomitant medications details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   It was reported that the second vaccine knocked the patient down completely for a week.  The reporter's causality for the event of Vaccination adverse reaction was reported as no reasonable possibility for Skyrizi.  No treatment medication were provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-623127 (Patient Link).
Vaccine expired on 26Feb2023, vial moved to refrigerator on 14 Mar2023 and administered on 15 Mar2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, vial moved to refrigerator on 14 Mar2023 and administered on 15 Mar2023) and NO ADVERSE EVENT (No adverse event) in a 38-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown that patient had ever been diagnosed with/ tested positive for COVID-19.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, vial moved to refrigerator on 14 Mar2023 and administered on 15 Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, vial moved to refrigerator on 14 Mar2023 and administered on 15 Mar2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, vial moved to refrigerator on 14 Mar2023 and administered on 15 Mar2023).    No concomitant medication details was reported. Vial size was reported as 10 dose vial. The vial was initially stored in the refrigerator on 14-MAR-2023  The vial did not undergo any temperature excursions. It was reported that HCP states that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-MAR-2023. There was potentially a second lot number that was expired and was administered to patients on 3-MAR-2023, but HCP did not have any details on this event at this time. The second potential lot was confirmed to not be used. There are a total of 82 patients involved. HCP wants to know if the vaccine administered on 15-MAR-2023 would be considered valid for the patients. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
This spontaneous report as received from a 53 year old female patient, who was also health care worker (Magnetic Resonance Imaging (MRI) technician) refers to herself. The patient had none pertinent medical history and none drug reactions or allergies. On 03-OCT-2014, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # were not reported) that had passed expiration date by two days (expiration date: approximately 01-OCT-2014). The patient did not take any concomitant medication. On 03-OCT-2014, the patient experienced soreness at the site of administration after the dose was administered. No treatment was reported. No labs diagnostics studies were performed. The reporter stated that she was recovering from adverse event, described as the site of administration was only sore if she pressed on the site. The relatedness between the event and the vaccination with ZOSTAVAX was unknown. The patient did not seek medical attention. Additional information has been requested.
This spontaneous report as received from a medical assistant 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 unknown dates, since 03-NOV-2016, the patients were vaccinated with the improperly stored (above 8 degrees Celsius but below 25 degrees Celsius (9.7 degrees Celsius) for 32 hours and 30 minutes) doses of ROTATEQ (orally; dose, lot # and expiration date were not reported) for prophylaxis. No adverse experiences and no previous excursion were reported. The call was made because of the data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004089: US-009507513-1702USA004088: US-009507513-1701USA014195: US-009507513-1702USA004091.
Headache & Myalgia,  Narrative: Patient had 2nd Covid injection on 12/20/2020. She reported on 12/31/2020 minimal redness/warmth at injection site and on 12/30/2020 had general muscle aches/headache.
Pt recvd Engerix-B on 4MAY90, 31MAY90 & 24OCT90 subsequently was found neg anti-HBS p/3 doses @ 1mo, 2mo & 6mo intervals;
I noticed a red rash on my legs, arms, and torso at about 8 pm yesterday, March 12; it is red blotches (no hives) and feels more like a sunburn .  There is a burning sensation with mild itching and red blotches/spots.  I contacted my physician who recommended OTC treatment at home and advised me to report it to VAERS.  It is mild in terms of impact but not expected four days after the vaccination date.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 01-OCT-2013 (lot # and exp.date not reported). This is one of the report from the same source, linked reports. Additional information is not expected.
PAIN IN RIGHT SHOULDER; PAIN IN RIGHT ARM; This spontaneous report received from a patient concerned an 8 decade old female. The patient's weight was 200 pounds, and height was 66 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced pain in right shoulder, and pain in right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in right shoulder, and pain in right arm. This report was non-serious.
Dose 1 given 1/29/2022 Pfizer lot # EL9264. Patient had multiple hospitalizations at local Medical Center and died 3/31/2022 from respiratory failure.
Shortness of breath; fever 102.5; extreme weakness pain all over; burning of hands and feet; elevated D-Dimer; pain all over; This is a spontaneous report from a contactable Nurse. This 46-year-old female Nurse (patient).  A 46-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 08Feb2021 (at the age of 46-year-old) as dose 1, single for COVID-19 immunization. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 18Jan2021 (at the age of 46-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes Diabetes mellitus, Osteoporosis, Obesity, Hypovitaminosis, osteopenia, COVID-19, pneumonia, Irritable bowel syndrome, anxiety and depression all from an unspecified onset to unknown ongoing and concomitant medications were not reported. Past drug event includes Morphine induced Drug hypersensitivity, Bactrim induced Drug hypersensitivity and laytex induced Drug hypersensitivity. On 09Feb2021, after the vaccination, the patient experienced Shortness of breath, fever 102.5, extreme weakness, pain all over, burning of hands and feet elevated D-Dimer. Adverse event resulted in Emergency room/department or urgent care. Treatment was received with: IV Ativan, X-ray Labs and CT scan. The patient lab data includes body temperature with a reading of 102.5-degree Fahrenheit on an unspecified date. CT scan and X-RAY on an unspecified date with unknown results. Patient was found covid positive prior vaccination and patient was not tested for covid post vaccination. The outcome of the events was recovering at the time of this report.  No follow-up attempts possible. No further information expected.
In kitchen with Dad suddenly collapsed to the ground making a snoring noise. Not responsive for 10 minutes. Eyes twitching no other body movements. Body no stiff. No warm. Taken to ED by Ambulance. Observed in ED overnight.
Fever , chills, shaking, flu like symptoms for 3 days, also severe pain at and around the injection site which has persisted .
On 12/3 - mom called clinic an stated site red and painful and swollen.  Told to give benadryl and Tylenol.  Mom did and sent child onto daycare 12/4 Daycare called - leg more swollen and child crying in pain. 12/4 office visit 130 - Right thigh 4 x 4 cellulitis red/hot swollen Tx Motrin Zyrtec Cephalexin cool compress
This spontaneous report was received from a physician via a company representative and social media reported in the article, referring to a 16 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with a dose of GARDASIL for prophylaxis (route of administration, lot number and expiration date were not reported). On an unknown date, the patient became chronically ill (general symptom) after receiving GARDASIL. Additionally, on unknown dates, the patient experienced episodes of seizure-like activity, difficulty breathing, back spasms, paralysis, dehydration, memory loss, and tremors. At the time of the report the outcome of the events episodes of seizure-like activity, difficulty breathing, back spasms, paralysis, dehydration, memory loss, , general symptom, and tremors was unknown. Additionally, the reporter did not provide a causality assessment between the all aforementioned events and therapy with GARDASIL. The reporter considered seizure-like activity, difficulty breathing, back spasms, paralysis, dehydration, memory loss, and tremors to be regular life threatening events. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1710USA005917: US-009507513-1710USA004064: US-009507513-1710USA005919: AU-MERCK-1110USA02522: AU-MERCK-1110USA02731: US-MERCK-0812USA03226: AU-MERCK-0711AUS00143: AU-MERCK-0803USA02516: US-009507513-1311USA011110:
patient started to experience uncontrollable twitching of arms and legs and severe flushing of face aprox 15 minutes after vaccine administration
sore arm at the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 3 months after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient's friend. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient commented had a mild case in 2008, but nothing since and the patient was glad to receive the dose. The patient experienced sore arms at the injection site. For tolerance of 2nd dose, refer case US2021AMR025893. The follow-up would not possible as no contact details were available. This case is one of 4 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR025865:same reporter US-GLAXOSMITHKLINE-US2021AMR025883:same reporter US-GLAXOSMITHKLINE-US2021AMR025893:same reporter
cried >3hr p/DTAP; cried intermittently excessively >12hr;
Information has been received from a physician concerning a 12-month-old female who on 18-NOV-2006 was vaccinated with a 0.5 ml dose of MMR. On 18-NOV-2006, following vaccination, the patient developed a rash with blisters at the injection site and rash with blisters on the trunk. Unspecified medical attention was sought. No outcome information was reported. No product quality complaint was involved. Additional information has been requested.
mom described 2 days of Zombic like, lethary, t102, twitchiness w/o gross sx;
pt recv vax 27OCT97 & 29OCT97 pt exp an inj site rxn described as red & bruised;
Vial expired on 07-Apr-2022/ The vial was put in Freezer and then taken out to thaw on 8-Apr-2022, which is the same day (8-Apr-2022) of administration to the patient.; administered an expired vaccine to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine to a patient) and PRODUCT STORAGE ERROR (Vial expired on 07-Apr-2022/ The vial was put in Freezer and then taken out to thaw on 8-Apr-2022, which is the same day (8-Apr-2022) of administration to the patient.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine to a patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial expired on 07-Apr-2022/ The vial was put in Freezer and then taken out to thaw on 8-Apr-2022, which is the same day (8-Apr-2022) of administration to the patient.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine to a patient) and PRODUCT STORAGE ERROR (Vial expired on 07-Apr-2022/ The vial was put in Freezer and then taken out to thaw on 8-Apr-2022, which is the same day (8-Apr-2022) of administration to the patient.) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  vial was did not undergo any temperature excursions.  No treatment medications were reported.
Right upper arm is swollen, red after DTaP on 5/06/04. Treated with Benadryl for allergic reaction Calamine lotion for itching.
Burning sensation entire arm of injection site - started roughly four hours after injection. Extremely nauseous for several days. Strong headache and fatigue. Shingles outbreak a week later on the same side as injection, lower left leg.
Employee initially reported itching at the site of vaccination. Then approx. 2 hours later was seen with complaints of itching and burning of the nose and eyes.
Headache; Slight temperature of about 100.3 Fahrenheit; Body ache; Chills; If has side effects or needs to go tested for Covid; This is a spontaneous report from a contactable consumer (wife) reported for a male patient (Husband). A male patient of unknown age received second dose of BNT162B2 (Pfizer covid vaccine, Lot number: EN6201, Expiration date: Unknown), via an unspecified route of administration on 21Feb2021 (Sunday) afternoon as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Pfizer covid vaccine) as a single dose for covid-19 immunization. On an unspecified date, patient experienced yesterday he started showing and he had a headache and a slight temperature of about 100.3 (Fahrenheit), body ache and chills. We didnt know if side effects didnt show up for like that would have been the fourth day from the time, we had the shot and this morning his chills are down, his headache is light and no temperature. Caller would like to know if it is a side effects or needs to go tested for Covid or side effect can occur after 3 or 4 days of vaccination. It was unknown if the patient received any treatment for the event. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
?? additional ?? reported; Caller stated the vaccine was administered after being improperly stored.; This spontaneous report was received from a health business professional (HBP) (reporter as other) and refers to a patient of unspecified age and gender. The patient's pertinent medical history, concomitant medications, past drug reactions or allergies were not reported.  On 11-SEP-2021, the product measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) (lot number U006313, that was verified to be a valid lot number with an expiration date reported and established as 24-AUG-2022) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes. Then on an unspecified date in 2021, the vaccine experienced another temperature excursion, this time of 5.5 degrees Fahrenheit (F) during a time frame of 24 minutes and 30 seconds.  On 05-OCT-2021, the patient was vaccinated with this improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) 0.5 milliliter (ml) (dose number, vaccination scheme frequency, route and anatomical site of administration were not reported) for prophylaxis (product storage error).   It was reported that no additional adverse event (AE) was reported (no adverse event).
CHILLS; FEVER; SPLITTING HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced chills, fever, and splitting headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and splitting headache. This report was non-serious.