chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received 2nd dose at 6 week interval instead of 2 month; This non-serious case was reported by a other health professional via sales rep and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: received 2nd dose at 6 week interval instead of 2 month).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt date: 02-OCT-2023 The reporter asked that what should office do or the patient need to be revaccinated. The patient received 2nd dose of Shingrix at 6 week interval instead of 2 month, which led to shortening of vaccine schedule. The case was linked with case US2023133827 and US2023135142 reported by the same reporter.; Sender's Comments:  US-GSK-US2023133827:Same reporter US-GSK-US2023135142:Same reporter
Patient had a fever of 101 and flu like symptoms. Pox started to appear across the forehead and then the entire body the day after the fever started. Pox proceeded to appear and become filled with fluid and were painful and itchy. 5-6 days after the pox appeared the fluid pox ruptured and scabbed over.  Those that did not have fluid disappeared with out filling with fluid.
In late January/early February 2022, experienced an episode of acute psychosis thought to result from AutoImmune encephalitis by specialist.  Mycoplasma pneumonia infection possibly contributing as a trigger.  Being treated by Psychiatric Nurse Practioner, and Immunologist including ivig treatment.  Having to take medical leave from college after hospitalization and currently at home concentrating on improving health.
Red cheeks, fever of 101°F, gave Tylenol,  decreased appetite, excessive spitting up, continuous red cheeks,  fever 102.5, excessive sleeping throughout day, continued Tylenol and alternating ibuprofen, much less active than usual.
14 hours after shot severe chills, shaking, mild stomach pain, mild ear ringing/pain, severe headache. Fatigue for 48 hours post injection with mild headache. Severe arm pain at injection site.
lt arm; muscle pain all the time; no redness; no swelling; arm is in constant pain from shoulder-elbow; can't move arm w/o severe pain;
Moderna COVID-19 Vaccine EUA Swelling, red rash, warm to touch and itchy at vaccine site beginning 1 week after vaccination
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arms for 48hrs), ERYTHEMA (Red in bicep), SWELLING (Swollen  in her bicep area), PRURITUS (Itchy park in her bicep area) and FATIGUE (feel tired and crummy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced FATIGUE (feel tired and crummy). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arms for 48hrs), ERYTHEMA (Red in bicep), SWELLING (Swollen  in her bicep area), PRURITUS (Itchy park in her bicep area), PYREXIA (Feverish), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arms for 48hrs), ERYTHEMA (Red in bicep), SWELLING (Swollen  in her bicep area), PRURITUS (Itchy park in her bicep area), FATIGUE (feel tired and crummy), PYREXIA (Feverish), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache) had not resolved. Not Provided          The concomitant medications were not reported. The action taken with the mRNA 1273 with respective to the events was considered as not applicable.   This case was linked to MOD-2021-027246 (Patient Link).
pt had URI being treated from OM but also recv 1 dose of DTP on 8APR95; on noc of 8APR pt had generalized sz episode lasting 3-5 mins no fever; labs were no; pt was observed & discharged w/f/u w/neuro & EEG
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 20-JUN-2016, the patient was vaccinated with improperly stored doses of GARDASIL 9 (lot # L024993 and expiration date 17-OCT-2017 (strength, dose number, anatomical location and route of administration were not reported). Concomitant therapies were not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt to hosp with c/o increasing SOB, fevers, change of taste and weakness; states diagnosed with COVID last wk; positive COVID test; O2 supplementation with high flow O2 and NC; later required NRB mask; NSTEMI and poor oxygenation; BiPAP; rapid deterioration; comfort care; pt died in the hosp
This is a prospective pregnancy case. This 27-year-old female subject was enrolled in a study. The subject received BOOSTRIX (injection) .5 ml on 12th December 2014. Concurrent medical conditions included gestational diabetes. The subject's last menstrual period was on 5th May 2014 and estimated date of delivery was 9th February 2015. The subject received BOOSTRIX at week 31 of the pregnancy and during the third trimester of pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional information received on 12 December 2014: The type of conception was normal (no in-vitro fertilization). The number of gestational weeks at vaccination was 31 weeks and 4 days.
Hives started 6/6/15 approximately noon, more by 10 pm that night. Went to ED 6/7/15 0057. Was given 1 oral dose of steroids and RX for 15 mg qd x 5 d. 6/10/15 still has hives and had fever T 100.1 6/9/15 no respiratory distress. Received 15 month shots yesterday. Now starting at 1600) has skin colored raised areas essentially all over. Mom states itching at them and fussy. Will not sleep. Was given ATARAX at 2200 and TYLENOL at 2300 without relief. Spoke with her pediatric nurse practitioner and was told to bring child to them on Sunday. Mother states that since he became fussy, she brought him here. This history is provided by the mother. Patient is a 16 mos male presenting with rash. This is a new problem. The current episode stated today. The onset was sudden.
By the time I got to my car from injection, I had pain in the injection site. It began to go away and the pain moved down to my forearm about two days later. It lasted there for about a week and a half. I could barely pick up anything in my left hand. I went to urgent care on 22nd. Order ultrasound for 22nd to check for blood clot. I called pediatrician for my daughter because I was breastfeeding and the doctor's called in a medication. On the 1st of March, I was ordered an x-ray.
Patient was administered the plain Pfizer vaccine---INSTEAD of the Pfizer bi-valent vaccine.
Extreme dizziness upon waking lasting 2-5 hours each day-ongoing problem-monitor for now.
Patient fainted about 5-10 minutes after getting flu shot. We elevated legs, gave water, applied ice to head. Patient sat near pharmacy with father for 20 minutes. Denied offer to call ambulance.
This is an initial spontaneous report from a Pfizer sales representative for a contactable physician who reported for a patient. This 68 year old female patient received PREVNAR 13 (Lot# G98134, Exp. date: Dec2014) on an unknown date in Sep2013 for pneumonitis prevention. The relevant medical history and concomitant medication were unknown. At night of 09Sep2013 when the PREVNAR 13 was administered the patient experienced fever and swollen lump on her left arm. The relevant laboratory data were unknown. The therapeutic measure included cephalexin (manufacturer unknown) since an unknown date in Sep2013 at an unknown dose and frequency to red swollen lump on her left arm. It was also reported that the cephalexin did not work for the patient because the patient was still experiencing the red swollen lump on her left arm. The patient had not recovered from the event red swollen lump on her left arm, the clinical outcome of fever was unknown at the time of report. Follow-up (08Nov2013): Follow-up attempts completed. No further information expected.
The following night I was experiencing frequent diarrhea, and body aches from muscular making it painful to breathe.
Sore Arm; Malaise; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm and malaise. On an unknown date, the outcome of the pain in arm and malaise were recovered/resolved.   It was unknown if the reporter considered the pain in arm and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received Shingrix vaccine and experienced sore arm that lasted for 5 days, and feeling of malaise that lasted for 4 days. The reporter did not consent to follow-up. No further details were provided. This case was linked with case US2019090298 (husband's case), reported by the same reporter.
mom reports pt lethargic for 2 hrs p/vax; began fever 102-103 p/APAP; would suck pacifier but only 3oz in 12 hrs; tremor of limbs & eyes rolled back; hypotensive & hyporesponsive;
The injection site became swollen/firm/enflamed after the first (7/30/21) and second (8/27/21) shots. It happened within a few hours both times. The injection site is itchy and painful to the touch. Today is 2 days later and it?s not gotten better at all. Sometimes I get shooting pain down my arm but it?s bearable. My arm is weaker/more tired than usual. In general I am more tired than usual but these seem to be my only side effects.
Itchy 2" diameter lump at injection site 8 days after injection, swollen lymph node in neck on injection site.
Information has been received from a licensed practical nurse concerning a patient who on 29-OCT-2007 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) instead of a dose of zoster vaccine live (Oka/Merck). It was reported as a medical error, another nurse grabbed the wrong vaccine. No adverse experience was reported. A product quality complaint was not involved. Follow-up information has been received concerning a 72-year-old female who was vaccinated with varicella virus vaccine live (Oka/Merck) (lot# 658061/1092U). The reason for the confusion was that  one nurse pulled the vaccine out of the refrigerator and drew it up. That nurse was called away and another nurse took it and administered it. Additional information is not expected. This is one of several reports received from the same source.
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 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 at 08:00 as dose 1, single (Lot number: EN6207), in right arm, on 02Apr2021 at 08:00 as dose 2, single (Lot number: ER8732), in right arm, on 08Oct2021 at 08:00 as dose 3 (booster), single (Lot number: EW0217), in right arm and on 07Apr2022 at 16:00 as dose 4 (booster), single (Lot number: Fk9894) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: other medical history: Hypertension;; "metastatic breast cancer survivor" (unspecified if ongoing), notes: other medical history: metastatic breast cancer survivor; "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: Anti viral details: COVID 19 treatment start date was 17Jun2022 and stop date was 21Jun2022. Rebound COVID on 30Jun. Report about covid treatment: Yes.   No follow-up attempts are possible. No further information is expected.
pt recvd vax 29DEC92 & w/in 24 hrs had a large red welt the size of a softball @ the inject site; had pain & swelling in the area & also felt ill & nauseated for 3 days; also had dark red spot on arm where swelling recurred;
pt recv vax;devel "vzv-like" papules & some early vesicles;md noted 5-6 lesions on back,2 lesions on rt leg,2 on inner thigh & 2 on trunk;had no physical findings,no fever & no illness at time of vax;tx w/apap & dph;
Employee received FLULAVAL vaccine on 10/3/2011 & 10/20/11.
Five hours subsequent to receiving one dose of varicella virus vaccine live the pt developed a 101F fever. Two days post vax pt was taken to physician for a persistent fever of 100F, sore throat, and a rash on palms and bottom of feet. The physician diagnosed the symptoms as being viral but not a vaccine adverse reaction.
index devel rash on l/a & arm turned black & blue & yellow a wk later; index states that as of 2DEC94 arm still yellow;
Sever chills for approximately 90 minutes almost exactly 24 hours of receiving second vaccine shot. No fever, no cough's, no muscle or joint pain other that discomfort at the injection site. Took two Tylenol at the onset
Fever of 106+ degrees Fahrenheit the evening of 01/05/22. Extreme fatigue, muscle aches, and loss of cognitive ability.
7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant were reported.  No treatment were reported.
This case was reported by a healthcare professional and described the occurrence of allergic reaction in a 50-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4 October 2011 the subject received a dose of FLULAVAL (unknown route, right arm). On 4 October 2011, less than one day after vaccination with FLULAVAL, the subject experienced allergic reaction, injection site redness, warmness to touch at injection site, swelling injection site ("size of a penny"), injection site irritation and injection site pain. The subject was instructed to use BENADRYL by the physician. At the time of reporting the events were worse.
The morning following the vax, the child had a fever of 101. By that night, the fever had risen to 105. The fever was treated with alternating doses of acetaminophen and ibuprofen.
The muscle which the booster was shot into keeps "pulling." It's a sharp pain that sometime lingers when my arm is relaxed but severely hurts at certain angles. It started, I believe, the day after I got the booster over a week ago, and every time it starts feeling better I pull it doing small things like picking up water from the table right beside me. I've been trying to rest it, I'm going to maybe get a sling simply to restrict myself from impulsively using it. I can't be certain it's from the booster, but it's affecting my work and daily life for 8 days now so I thought I should report something. If it lasts much more than another week or two I'll make a doctor's appointment.
had 3rd dose of vax 6MAY98 & 1JUN98 noc had been swimming back was stinging welts;mom describes as heat rash on stomach & chest onto lt side;mom has changed detergent in last 2-3wk;now fine rash -had chills;
About a week after receiving the vaccine, my fingers and feet started going numb. Then both feet and fingers become very sensitive to hot and cold. My feet started to be painful - extremely painful - burning, pins and needles, sharp stabbing pain, electric like shock pain, sometimes feet feel like they are freezing. My balance is way off. I can not stand on one leg without falling over. Pain is so bad at night it is hard to walk. After seeing multiple doctors, a neurologist, having multiple blood tests and scans done, I have been diagnosed with Peripheral Neuropathy - I had none of these symptoms ever before this vaccine. I still have more tests scheduled - MRI's, an EMG, etc. I have to take medicine now to help with the nerve pain - doesn't help enough.
Sporadic dizziness.  Happens without warning.  Only lasts around 10 seconds, but is strong enough that I often must grab onto a table, chair, or wall to feel like I'm stable and will not fall.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), on 18Sep2021 as dose 2, single (Lot number: ff2589) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, lot number: fa7485, Location of injection: Left Arm), administration date: 25Aug2021, when the patient was 48-year-old, for Covid-19 Immunization. The following information was reported: DIZZINESS (non-serious) with onset Oct2021, outcome "not recovered", described as "Sporadic dizziness.  Happens without warning.  Only lasts around 10 seconds, but is strong enough that I often must grab onto a table, chair, or wall to feel like I'm stable and will not fall.". Therapeutic measures were not taken as a result of dizziness.  Additional information:  Patient was no covid prior to vaccination. Patient was covid tested post vaccination. Sporadic dizziness. Happens without warning. Only lasts around 10 seconds, but is strong enough that I often must grab onto a table, chair, or wall to feel like I'm stable and will not fall.
This spontaneous report as received from a physician via a company representative refers to a 2-month-old patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not provided. On an unknown date (reported as 2-3 years ago), the patient was vaccinated with a first dose of ROTATEQ orally (dose, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the patient went completely limp, hypertonic and went to the hospital. It was also reported that the child received an unspecified treatment for the events. The outcome of the events was unknown. The relatedness between ROTATEQ and the events was not provided.
Itchy, patchy rash developed over the course of first week after injection.  Concentrated on upper shoulders, front and back.  Some smaller patches on mid to lower back.  Rash was active still at the time of second injection (4/2/21, same location, Lot EN6208).  As of today, rash still itchy and irritating, but not increasing in intensity.  Scratching produces tearing of loose skin and bleeding.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a Pharmacist. This case is linked to case 2018SA284822. This case involves a 33 months old male patient who experienced fever, irritability, uncontrolled crying and shivering, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 06-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in the left deltoid. On an unknown date, the patient developed a non-serious fever (pyrexia), irritability (irritability), uncontrolled crying (crying), shivering (chills) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was an actual medication error due to overdose. (Other relevant tests included No lab data.) Final diagnosis was fever, irritability, uncontrolled crying and shivering. It was not reported if the patient received a corrective treatment. On an unknown date, the event outcome was reported as Unknown for fever, irritability, uncontrolled crying and shivering. 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. List of documents held by sender: none.
Since 17 December he has complained of recurrent episodes of localized itching and rashes described as raised, red, itchy whelts which can occur anywhere on his body and typically occur at sites of pressure or where his skin is scraped or scratched. Lesions last less than 24 hours, affect his palms and soles, and resolve without post-inflammatory changes. He endorses intermittent laryngeal symptoms causing difficulty breathing, especially when his symptoms first started. His symptoms led him to be seen at a local hospital where he was evaluated for possibly pulmonary embolism; he reports he developed facial swelling and difficulty breathing after he was given a ?heparin analogue?. He denies subsequent pulmonary, GI, neurologic, and cardiovascular symptoms with these episodes. Possible association with exercise. Episodes not associated with heat, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, known infections, or insect bites/stings. He received his Moderna COVID-19 vaccine booster dose on 9 December, eight days prior to onset of symptoms. He has used oral antihistamines with improvement in his symptoms. He denies constitutional symptoms. UCT score today is 6 (1, 1, 0, 2, 0, 1, 1, 0).