chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 04-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 6 months old patient who experienced gave an expired dose to a 6 month old as the 3rd dose in the series/no adverse event, while he/she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose 3 dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5375AA. It was a case of actual medication error due to expired vaccine used because gave an expired dose to a six month old as the third dose in the series. No adverse event was reported. The patient outcome is reported as Not Applicable for gave an expired dose to a 6 month old as the 3rd dose in the series/no 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 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. Documents held by sender: none.
Hospital admission nausea, vomiting, and dehydration post op now with COVID on admit.
This spontaneous prospective pregnancy report as received from a physician refers to a currently 18 year old pregnant female patient. There were no concomitant medications, concurrent conditions and medical history reported. Physician reports that during a routine prenatal visit on 11-SEP-2015, the patient's boyfriend stated that the patient "had received a bunch of vaccinations recently". Physician reported that one dose of GARDASIL (dose, lot number and expiration date were not reported) had been administered to the patient on 03-JUL-2015 by the patient's primary care physician who was unspecified. Physician stated that the patient was "doing well" at the time of the report. Physician stated that she provided no treatment to the patient. The patient became pregnant with last menstrual period (LMP) of 12-JUL-2015 and estimate delivery date (EDD) of 17-APR-2016. The pregnancy outcome was pending. Additional information has been requested.
Skin blotches/flare up/dry spots; Feeling unwell; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell), FATIGUE (Fatigue) and RASH MACULAR (Skin blotches/flare up/dry spots) in a 39-year-old 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 Plaque psoriasis.    There was no reported medical history.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In 2021, the patient experienced MALAISE (Feeling unwell) and FATIGUE (Fatigue). On an unknown date, the patient experienced RASH MACULAR (Skin blotches/flare up/dry spots). At the time of the report, MALAISE (Feeling unwell) and FATIGUE (Fatigue) outcome was unknown and RASH MACULAR (Skin blotches/flare up/dry spots) had not resolved.      No concomitant medication details were provided. No treatment medication details were provided.  The reporter's causality for the events fatigue and malaise with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event of rash macular with HUMIRA(ADALIMUMAB) was a reasonable possibility.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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.
PATIENT WAS VERY NERVOUS ABOUT THE VACCINE. HE FELT DIZZY AND NO CONSTRICTION OF THROAT. PHARMACIST ASKED HIM TO PUT HIS HEAD BETWEEN KNEES AND PHARMACIST KEPT CHECKING HIM. AFTER 15 MIN HE WAS STILL DIZZY AND PATIENT WAS MOVED TO LYING DOWN WITH FEET ELEVATED AND FELT BETTER LATER
I had a major stroke on 2/4/2021. The cause boy stroke was not determined
blurred vision; This case was reported by a pharmacist via call center representative and described the occurrence of blurred vision in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced blurred vision. On an unknown date, the outcome of the blurred vision was resolved with sequelae.   It was unknown if the reporter considered the blurred vision to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received the first dose of the Shingrix in an unknown deltoid, a couple of months ago from the time of reporting and experienced blurred vision for 12 hours post vaccination. Additional information was not provided.
Metal taste in mouth. Toung swollen and discolored with red and white patches. Keeped clean and rinsed with salt water. I still have the symptoms, but it does seem to be getting slightly better. It did not seem to change when I received my second shot. Second shot made me tired and I felt like I was coming down with the flu. I slept for 10.5 hours and woke up feeling much better. All the flu symptoms where gone by the following day.
Patient called pharmacy on 4/26/2021 stating that he had swelling on the face.  I advised to seek medical attention and reporting to CDC using the V-Safe app.
Fever; Headache; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown. Not Provided           No relevant concomitant medications were reported.
flu shot made sick for six weeks; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 07-Dec-2020. This case involves a patient of unknown demographics reported that flu shot made sick for six weeks (Illness), while the patient received Influenza vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient reported that flu shot made sick for six weeks (Illness) unknown period of time after the administration of influenza vaccine.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
urinary retention; arm paresthesia; leg weakness; This is a literature report.  A 31-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: URINARY RETENTION (medically significant), 1 week after the suspect product(s) administration, outcome "unknown"; PARAESTHESIA (medically significant), 1 week after the suspect product(s) administration, outcome "unknown", described as "arm paresthesia"; ASTHENIA (medically significant), 1 week after the suspect product(s) administration, outcome "unknown", described as "leg weakness". The patient underwent the following laboratory tests and procedures: CSF test: compatible with neuroinflammation; Magnetic resonance imaging: demonstrated T2 hyperintensity, notes: at T5 and T8- T9 with enhancement. Therapeutic measures were taken as a result of urinary retention, paraesthesia, asthenia.  Clinical course: Patient developed arm paresthesias, leg weakness and urinary retention one week following her first dose. She received five days methylprednisolone and IVIG. She remains wheelchair bound with urinary retention. . Other causes of transverse myelitis including neuromyelitis optica and myelin oligodendrocyte associated disease were ruled out. This case raised concern that mRNA vaccinations may be associated with neurologic complications due to heightened immune reactivity.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202201325883 Same Article/drug/event and different patient;US-PFIZER INC-202201325886 Same Article/drug/event and different patient;US-PFIZER INC-202201325885 Same Article/drug and different patient and event;US-PFIZER INC-202201325886 Same Article/drug/event and different patient;
Fatigue for about a month, weight loss, no treatment, symptoms resolved before second dose (less than a month)
Developed deep cough, day and night, sometimes coughing so hard it felt as if my ribs would crack.  Lasted until the beginning of February 2017.
Caller would like to know if it is possible that she contracted the virus while at her daughter's home; This is a spontaneous report from a Pfizer-sponsored program . A contactable 73-year-old female consumer (patient) reported that she received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 29Jan2021 at a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced caller would like to know if it is possible that she contracted the virus while at her daughter's home on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
This was an incorrect vaccine error. Patient has signed up for the bivalent vaccine but received the monovalent vaccine again. Patient did not experience and side effects.
I was working from 07:00 - 19:00 that day and went over to employee health at 11:00 to get the flu shot. At approximately 16:00, I began to experience pain in both of my breasts, which I can only describe as being similar to the engorgement I felt on occasion when I was still breastfeeding my first child. I continued to experience the pain for the duration of my shift but was unable to remove myself  from my work duties to take a look at myself. I arrived home at 21:00 (both breasts still hurting), and found that both breasts were very reddened and swollen. The swelling was markedly increased from the gradual swelling that had been present since the early weeks of my pregnancy. Additionally, my breasts felt very warm and were tender to touch. I went to sleep and woke up to find a slight decrease in redness, but the warmth, swelling, pain, and tenderness remained. I worked again from 07:00 to 19:00, and was able to call my OB/GYN and seek advice. An office nurse spoke with my OB/GYN and said that she had never heard of this occurring in relation to a flu vaccine and recommended I take 25 mg of Benadryl. As I was working, I did not feel comfortable taking the dose at that time, but did take the recommended 25 mg once I arrived home at 21:00. Additionally that day, I took my concern back to employee health, where I spoke with two nurse practitioners who also said that they had not heard of such a reaction, but they gave me the Fluzone vaccine information booklet and recommended that I report the incident. After taking the Benadryl and going to sleep that night, I awoke the next morning to find a complete relief in all symptoms at that time. However, I am still experiencing occasional returns of redness (irregardless of wearing a bra or not) and an unusual swelling of both breasts and nipples. I did not experience the redness or swelling as I am currently during my previous pregnancy and breastfeeding experience with my daughter.
Two days after vaccine pt noticed redness and swelling around injection site. The sit was warm to touch as well went to physician on 11/17 and was prescribed BACTRIM DS for an infection. After 2 days of BACTRIM, pt was doing better and injection site was clearing up.
arthritis; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer (patient) reported that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration on 26Feb2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced arthritis on an unspecified date. The patient asked if and when can she take Tylenol for arthritis. Outcome of arthritis was unknown.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Pt received vaccine...came out of vaccination room...sat down and started talking to mother...started to feel nauseous ? sat back and started to look limp...paramedics immediately contacted...pt never loss consciousness...looked pale... not feeling well...was responsive and breathing...respirations were being monitored...EMTs arrived and took over...did take pt to hospital...
Patient did not have any symptoms. Patient was tested for COVID 19 prior to surgery date. Patient was advised that he tested Positive for COVID 19
I woke up in the morning I only had pain on my arm, headache, no fever, I went to a music event two days earlier and took the test and it was negative, then I had chills and took the test again and it was positive. I called the clinic, and asked if I should take Paxlovid and they said yes, and they gave it to me.
pt brought to ED via EMS with hypoxia, O2 sats in 70s on RA; O2 supplementation; had a positive COVID test on 9/25/21; positive COVID test again in ED on 10/2/21; given remdesivir; HTN continues to be a problem; treated for HTN; DNR/DNI but continue aggressive treatment; pt went into cardiac arrest and passed away in the hospital
felt achy; sore left injection site arm; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (felt achy), VACCINATION SITE PAIN (sore left injection site arm) and FATIGUE (felt tired) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C214 and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced PAIN (felt achy), VACCINATION SITE PAIN (sore left injection site arm) and FATIGUE (felt tired). At the time of the report, PAIN (felt achy), VACCINATION SITE PAIN (sore left injection site arm) and FATIGUE (felt tired) outcome was unknown.            No concomitant medication was provided by reporter. No treatment information was provided by reporter.   This case was linked to MOD-2021-428269 (Patient Link).
blotchy rash over back, chest & shoulders appeared 5/26/99;not itchy @ present;feels warms, no other sx;6/4/99 rash persists;saw MD x 2;no fever no other signs/sx of illness;rash itchy @ times;
Chills and vomiting on the same day. Two days later fever vomiting and stomach pains.
Patient had a delayed reaction. On Sunday night, the 17th, she noticed swelling and redness. It covered about a 5" by 5" area. The area itched and was warm to the touch. She had Benadryl at home and was going to take 2-25mg tablets when she got home.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or around October 2007, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage, route of administration and anatomical location were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations and seriousness of her condition. As a result of the zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was considered to be not recovered. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event of shingles was determined to be disabling.
Pt stated that he has been sick with colds and respiratory infections several times in the last six months.  This represents an increase in frequency.
This case was reported by a healthcare professional and described the occurrence of high fever in a 4-month-old subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline). On 29 July 2014, the subject received 1st dose of PEDIARIX (.5 ml, unknown route, injection site and batch number). On an unspecified date in 2014, less than one week after vaccination with PEDIARIX, the subject experienced high fever (102 F), was screaming and did not want to eat. On 04 August 2014, the child started to eat. At the time of reporting, the outcome of the other events was unspecified. No more information was available.
rt deltoid w/redness, tenderness, & swelling around inj site, redness is about 3 centimeters @ visit 2 days p/pt recv vax;
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 01-MAY-2013, the patient was vaccinated with a unspecified series of GARDASIL (Lot number # 669308/0636AA, expiry date 11-AUG-2013, route and dose were not reported) was that was exposed to an unsupported temperature excursion. No adverse effect reported. Additional information has been requested.
pt had sz about 10min p/vax;pt was seen by MD for eval & EEG was done;child had no problem w/resp p/sz;
pt recvd vax; flushed face; difficulty breathing (hyperventilating); muscle aches 1 hr post vax;
Severe headache and shot site swelling. Next day, 100.2 Fever and severe headache.
Two series of Janssen COVID-19 Vaccine first series: COVID19(Janssen), Janssen, LOT UNK, Intramuscular, Arm side unknown 09/02/2021 second series: COVID19(Janssen), Janssen, LOT 043A21A, Intramuscular, Left Deltoid 09/12/2021 One dose recommendation. Individual received two doses All vaccines in block 17 administered on 09/02/2021 Could be typo on paperwork
Pregnant patient received second Moderna COVID-19 vaccine; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received second Moderna COVID-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received second Moderna COVID-19 vaccine). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant patient received second Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Patient was pregnant and just received her second dose of the Moderna COVID-19 vaccine.  No treatment information was provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Nauseous; Lightheadedness; very Emotional; Crying; This is a spontaneous report from a contactable consumer. A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 08:00 at single dose (Lot number= EL3246, Vaccine location=Left arm) for covid-19 immunisation. Medical history included low thyroid, high blood pressure, reflux disease, anxiety, depression, Allergies: sulfa "caflex". Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medication included calcium citrate, venlafaxine hcl, pantoprazole, nortriptyline, levothyroxine sodium (SYNTHROID), amlodipine, estrogens conjugated (PREMARIN), paracetamol (TYLENOL). No other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nauseous, lightheadedness, very emotional, crying on 16Jan2021 09:00. No treatment received for the events. Events result in clinic visit. Outcome of events was unknown. Since the vaccination, the patient had not been tested for COVID-19.
Menactra was given instead of the Meningococcal ACWY that was ordered.  Mistake in administration by Medical Assistant.