chrisvoncsefalvay/vaers-outcomes huggingface dataset:
06/20/2023: 34.9F for 6 hours 34 minutes 0 seconds; This spontaneous report was received from a customer (also reported as type "other") and referred to a patient of unspecified age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 14-JUL-2023, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, at a dosage of 2 ml administered orally (strength, vaccination scheme frequency, and dose number were not reported; lot number 1968385 with an expiration date reported and established as 22-MAY-2024) (product storage error) for prophylaxis.  It was stated that the suspect vaccine had the following previously temperature excursions: 34.9 degree Fahrenheit (F) with a time frame of 6 hours and 34 minutes (on 20-JUN-2023); 51.4 F with a time frame of 7 hours and 33 minutes (on 03-JUL-2023); 51.1 F with a time frame of 24 hours (on 04-JUL-2023); and 50.7 F with a time frame of 9 hours and 27 minutes (on 05-JUL-2023).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2307USA009703: US-009507513-2307USA009726: US-009507513-2307USA010639: US-009507513-2307USA009739: US-009507513-2307USA009675: US-009507513-2307USA009613: US-009507513-2307USA009752: US-009507513-2307USA009715: US-009507513-2307USA009717: US-009507513-2307USA009693: US-009507513-2307USA009646: US-009507513-2307USA009646: US-009507513-2307USA009916: US-009507513-2307USA009764: US-009507513-2307USA010119: US-009507513-2307USA009734: US-009507513-2307USA009695: US-009507513-2307USA009885: US-009507513-2307USA009993: US-009507513-2307USA009743: US-009507513-2307USA009605: US-009507513-2307USA009630: US-009507513-2307USA009885:
A report was received from a health care professional on 12/4/03 concerning an unknown number of children less than 4 years of age and of unknown sex who inadvertently received Fluvirin on an unspecified date. On an unspecified date, an unknown number of children less than 4 years of age inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. No follow up pending, all information received.
This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), NODULE (lump) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Possible wrong site of injection: 2nd vaccine was given 3 inches below 1st dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included ACETAMINOPHEN for an unknown indication. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced ERYTHEMA (redness) and NODULE (lump). On 14-Mar-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Possible wrong site of injection: 2nd vaccine was given 3 inches below 1st dose). At the time of the report, ERYTHEMA (redness) and NODULE (lump) outcome was unknown and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Possible wrong site of injection: 2nd vaccine was given 3 inches below 1st dose) had resolved. No treatment medications were reported. This case was linked to MOD-2021-044712.
Pt devel R thigh swelling. There was vasodilat to touch and erythema at inject site. Able to bear weight.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and drug allergies were reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (Lot number L003775 and expiry date 04-FEB-2017) (dosing regimen and route unknown). No concomitant medications were reported. No adverse effects were reported. Lot number L003775 with expiry date 04-FEB-2017 has been verified to be a valid lot number for VARIVAX (Merck). Follow-up information has been received on 03-AUG-2015. Telephone call was made to the medical assistant. A voicemail message was left requesting she return the phone call. Additionally, a request was made for patient identifiers, lot number and expiration date and date of vaccination. All telephone attempts to obtain follow up information have been unsuccessful. Follow-up information has been received on 05-AUG-2015, a call was received from the certified medical assistant who reported that she would have to research the request made for patient identifiers, lot number, expiration date and dates of vaccination. The company fax number was reviewed with the reporter, if information becomes available. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 13-month-old patient of unknown gender. On 25-AUG-2015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) lot number was confirmed as L001325 with an expiry date of 04-FEB-2017. This is one of several reports received from the same source. Additional information has been requested. Patient's details, suspect details, event information and narrative were updated.
Breakthrough COVID infection. Positive test 07/07/2022. Reported feeling fatigued and weak starting 07/04/2022
This is a spontaneous report from a contactable consumer reported for him/herself. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history included pneumonia with hospitalization about three years before. Concomitant medications were not reported. The patient previously received influenza vaccine shot a couple of days before and got so sick. The patient experienced no appetite, extremely tired, and was too sick to talk on an unspecified date with outcome of unknown; the patient still have pain in the injection area with outcome of not recovered. The consumer wanted to know how long he/she was going to have these effects. The patient was blindsided with this shot, because she/he went for something else to his/her doctor and the physician just gave it to the patient who didn't even wanted.
Patient returned to the pharmacy on 4/8/19 and described her adverse reactions as the following: the injection felt like she was "being hit with a baseball bat" as the vaccine was being administered and it was more painful than any other vaccine she had ever received; when she was walking to her car the injection site felt painful and began to cause her whole arm down to her hand to become numb; as she was driving home she started feeling chills and nauseous; later in the day the pain began to radiate up her shoulder and the side of her head. She called her primary care doctor on 4/2/19 and was instructed to medicate with TYLENOL, ADVIL, and/or CLARITIN for her side effects. Patient states the numbness and pain lasted for approximately three days. As of today, 4/9/19, she states that she is still having difficulty raising her arm above her head but otherwise all other side effects have subsided.
vomited feeding (formula) at 815 -830PM; very cranky, t102.0 given APAP; up q 1/2 during noc;
Immunocompromised patient received half dose for third dose; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient received half dose for third dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In May 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In November 2021, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient received half dose for third dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient received half dose for third dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the moderately immunocompromised patient received primary series with Moderna in May 2021 (two 0.5ml, 4 weeks apart) and then received booster dose (0.25 ml) in November 2021.  No concomitant medications were reported. No treatment  medications were reported.   Reporter did not allow further contact
After the initial 12 hour period, I experienced night-time chills followed then by being too warm and night sweats.  This happened both the first and second night.  During the day I was taking Tylenol every 6 hours for aches and pain.  Mainly my neck and back have been what hurts, although my knees, elbows, hips, etc. also were achy.  The third and fourth days I still continued to have chills, no fever throughout as far as I am aware (took my temp 2-3 times).  The fourth day I was very faint and somewhat unbalanced, felt shaky and light headed and I ended up having an anxiety attack.  I mention the last symptom as I have never had an episode like this previously in my life.  Today is day 5, still feel tired, slightly nauseous, neck and back pain, headache, difficulty focusing.
Having aches; Slight diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Having aches) and DIARRHOEA (Slight diarrhea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) UNK dosage form. On an unknown date, the patient experienced PAIN (Having aches) and DIARRHOEA (Slight diarrhea). At the time of the report, PAIN (Having aches) and DIARRHOEA (Slight diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no relevant concomitant medications was reported. No treatment information was provided
vaccine Act-HIB for which cold chain break is reported with no reported adverse event; excursion vaccine was administered with no reported AE; Initial information received on 19-Apr-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves Infant and unknown gender patient who was administered HIB (PRP/T) vaccine [ACT-HIB] for which cold chain break and and excursion is reported with no reported adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (expiry date and batch number unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization) for which cold chain break and and excursion is reported with no reported adverse event (product storage error) (poor quality product administered) (same day latency). Information on the batch number was requested.  It was reported that children received doses of ActHIB that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window.  It is unknown if there were lab data/results available.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event excursion vaccine was administered with no reported adverse and was Unknown for the event act-hib for which cold chain break is reported with no reported adverse event.  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 the guidelines. 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.; Sender's Comments:  US-SA-2023SA124713:Master Case
Fever Chills Aches/Joint Pain Headache Tiredness/Lack of Energy Nausea Diarrhea  Injection Site Pain Arm Pain
tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable consumer (patient reported himself) reported that a male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 06Feb2021 at single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was tested positive for Covid on an unspecified date in Feb2021. The patient underwent lab tests and procedures which included Covid: positive in Feb2021. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Red swollen itchy 1 inch rash next to injection site and feels like a lump
arms were sore; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arms were sore".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
tender, visible left supraclavicular lymphadenopathy; This is a spontaneous report from a contactable physician. A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EK9231, intramuscular on 04Jan2021 15:00 to at a single dose on left arm for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant. The patient ha no known allergies, no prior vaccination and did not have a covid test post vaccination. Concomitant medication included sertraline, lamotrigine, melatonin and biotin. The patient experienced tender, visible left supraclavicular lymphadenopathy on 16Jan2021 12:00AM. The patient did not receive treatment for the event. The outcome of the event was unknown.
5mins post vaccination pt experienced a syncopal episode.  Pt noted dizziness and ringing in the ears.  Pt had last etten 2hrs prior but pt's father noted decreased PO intake. Vitals: 18:34 (supine) 109/54, 59, 12, 100% SpO2, 97.7F -- > 18:40 (supine) 108/61, 86, 12, 100% -- > 18:51 (sitting) 107/67, 72, 12, 100% Pt states that he has a hx of dizziness w/ flu shot last year.  Advised pt and family to notify RN/MD of need for supine administration for 2nd dose covid vaccination. Pt stable and released from the vaccination site @18:55.
HEADACHE, FEVER, ELECTRICITY THROUGHOUT THE BODY, DIARRHEA, WEAKNESS.  BUT THE WORST IS A LOT OF PAIN AND INFLAMMATION OF THE GANGLIA IN THE LEFT ARM WHERE THE VACCINE GIVEN ME
The night after I received the vaccine, I had severe leg pain they kept up much of the night.  This pain continued for 1 month and gradually lessened.  As the month went by, since that time I have had bone or muscle pain.  I don't know, in my body, my fingers, legs, toes, wrist, back, ankles hurt while at rest and while up.  I sometimes have a hard time walking.
36 hours after received first anthrax immunization, the pt complained of shaking chills, back pain, malaise. Pt was afebrile, and physical exam was normal.
Patient developed fever, chest pain w/i 2 days of vaccine.   He was admitted on 9/5/2021 to   and diagnosed with myocarditis.
Fatigued for 10 hours after COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigued for 10 hours after COVID vaccine) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, UNK. On an unknown date, the patient experienced FATIGUE (Fatigued for 10 hours after COVID vaccine). At the time of the report, FATIGUE (Fatigued for 10 hours after COVID vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was reported. On an unknown date, the patient had device issue, Humira pen misfired/ went to inject the pen, when pressed the spacer was already down/pressed downward/no movement on button/medication spilled out. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the event Fatigue was no reasonable possibility. 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.
Dizziness, Fainting feeling, Could not focus eyes for 2-3 min
On 1/20/21 I had an achy arm and a fever in my arm. it went away and then came back on 2/1 with hives. the hives are on my arm around the location of the shot. the fever is on my arm where the shot was administered.
Pt was administered KINRIX when he should have received DTaP and IPV separately, due to his age.
upset stomach; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 91 year-old male patient received bnt162b2 (BNT162B2), administration date 14Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Eliquis. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "upset stomach"; DIARRHOEA (non-serious), outcome "recovered" (2021), described as "diarrhea".  Additional information: Patient mentioned that he has pills to take including Eliquis but he will skip taking it today.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received vaccine about 5 pm. Around 8 pm, patient experienced whole body rash, swelling of face and eyelids. After undergoing treatment at asthma/allergy clinic for several weeks, rash is better, but patient still on steroids.
Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 90 but not receiving frequent care from facility and circumstances regarding his cause of death not certain. His comorbidities include advanced age, afib, cardiac pacemaker, HTN, Barrett's esophagus, HTN, and hypothyroidism.
PATIENT DIED SUDDENLY, WITHOUT WARNING ABOUT 11.5 HOURS AFTER THE VACCINATION
I am currently breastfeeding my 11 month old son. On Thursday, December 31st, 2020 (2 days after receiving my vaccine), my son developed a fever x24-36hours and diarrhea that is still on going as of today (1/4/2021). There are no known exposures for my son and his illness. I am reporting this as a possible reaction  to the Moderna COVID 19 vaccine I received that could have some how passed through the breastmilk to him.
Janssen Covid-19 Vaccine EUA  First 12 hours after the shot I experienced headaches, body aches, and chills. Within the next 24 hours all of these symptoms increased severely, and around 5pm on 4/11/21 I experienced a seizure that resulted in me being taken to the ER.
Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 13-OCT-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L008031 with expiration date of 03-AUG-2015, strength, dosage and frequency unspecified (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter.  Additional information has been requested.
Went to ER, then admitted to hospital with Mesenteric adenitis?not sure it?s related but wanted to pass on as doctor mentioned it could be as swollen lymph nodes seen in other areas after vaccine.  Spent nights in hospital with sharp abdomen discomfort, decreased kidney function, nausea, vomiting.
This 65-year-old male with a history of COPD and hypertension was brought to the ED by an ambulance for the complaints of a productive cough and shortness of breath. The patient has been having the symptoms for the last 1 week.  The symptoms got worse today and he decided to come to the ED.  He also felt warm and chills at the home.  He experiences chest pain when coughing.  He denies any nausea, vomiting or diaphoresis.  The patient appears uncomfortable at the time of this examination.
approx 30hrs p/vax pt began w/an unusual high pitched shriek cry which lasted on & off for several hrs till approx 11PM
It can go away after 3 days issues except retina detachment I did not know if retina detachment related to it, since it did not happened soon
6 weeks 5 days pregnant. Due date: April 18, 2022. Miscarriage diagnosed: Sept. 15, 2021
1/16/2014-Arms began to swell to astronomical sizes. Large red patch on left arm, 1/19/2014-Pain in Right hip began, area in size is about the size of a hand-palm to fingertips, nausea, severe headaches, pain in eyes, body aches, backache. Since 1/19/2014 daily nausea, severe headaches, pain in eyes, body aches, and severe back pain. Treatment-1/23/2014-I was seen at Clinic. Urgent Care by a doctor. I was given evaluation of reflexes and examined for areas of pain. Doctor checked for blood clots, not certain if there aren't any, will need to follow up in 5 days if pain from prescription Naproxen does not subside the pain. Doctor gave diagnose of possible Neuro Muscular Condition brought on by a combination of the 2 vaccines to include Flu Vaccine and Pneumonia Vaccine.
Covid-like symptoms and subsequent long haul symptoms.  Chest pain, fatigue, brain fog, flu symptoms (chills, aches, body tingling and weakness) for now almost 3 months.
Information has been received from a physician concerning a 12 month old male who on 5/29/04, was vaccinated with a 0.5ml dose of varicella virus vaccine live. On 6/2/04, the patient was seen in the clinic with a fever and slight rash post vaccination syndrome. Follow up information was received from the physician who indicated that the patient was vaccinated by his primary care physician. The reporter saw the patient due to a generalized rash in urgent care. Additional information has been requested.
Information has been received from a consumer concerning her daughter who became ill after received her second dose of GARDASIL.  The consumer did not want to provide demographics nor explanation of the AE.  No further information is available.
Red swelling rash around injections shot in left arm. Shoulder joint tenderness. Elbow tenderness. Left arm soreness. Left side pain.
on 07/12/2021 pt developed ocular shingles in and around right eye