chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nurse calling to report VARIVAX was administered to patient while it had a temperature excursion. Exact date of administration not provided. Patient is asymptomatic. No additional AE. No PQC. Names of vaccines involved (including lot/exp) VARIVAX W03; No additional AE.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On an unknown date, the patient was administered varicella virus vaccine live (oka/merck) (VARIVAX) (1 dose, lot #W031812, expiration date: 05-OCT-2024, strength and route of administration were not provided) for prophylaxis while the vaccine had a temperature excursion (Incorrect product storage).  Administered varicella virus vaccine live (oka/merck) (VARIVAX) was stored at 24.4 degrees Fahrenheit (F) for 5 hours 51 minutes 0 seconds. There was no previous temperature excursion reported. The patient was asymptomatic. No additional adverse event (AE).
This spontaneous report was received from a medical assistant, referring to a 9 year old female patient. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided. On 04-OCT-2021, the patient was vaccinated with improper stored varicella virus vaccine live (oka/merck)(VARIVAX) (second dose, lot # T014309, expiration date 24-APR-2022, dose, strength and route were not provided) in the right deltoid for prophylaxis (product storage error). No additional adverse event reported. Operator of vaccine was healthcare professional, who was trained. This is one of two report from same reporter.; Sender's Comments: US-009507513-2110USA002299.
This spontaneous report was received from a pharmacist via touchpoint employee refers to a female patient of an unknown age. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX vial 19400 PFU (lot number/expiry date and dosage not reported). On an unknown date, the patient had an adverse event. No Product Quality Complaint (PQC) was involved. The outcome of the event was unknown. The outcome of the event was unknown. The reporter did not provide any causality assessment between event and ZOSTAVAX. Additional information has been requested.
4 hours post vax, the pt developed pain at injection site, fever, and shortness of breath.
The patients injection site was sore, hot to the touch, bumpy, swollen, and red in color
Patient received 1st dose on 23Apr2021 and 2nd dose on 26Jun2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 23Apr2021 and 2nd dose on 26Jun2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 23Apr2021 and 2nd dose on 26Jun2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 23Apr2021 and 2nd dose on 26Jun2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information was unknown   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Follow-up received contains no new information
About 13 hours after receiving booster (10:30pm on 11/19/21) I started having pain at the injection site, chills, joint aches, headache, nausea & very low energy..  During the night I had a fever between 100 & 102 and barely slept.  The fever was gone by morning, but the headache was severe and my eyes were very light sensitive.  I continued to be nauseous & have joint aches.  I rested, drank water & Gatorade.  I did not eat until approximately 3pm on 11/20/21 when I had a bowl of cereal.  I finally took 2 extra strength Tylenol at 1am on 11/21/21 and that got rid of my headache & joint aches.  I slept 3-4 hours. 11/21/21 my remaining symptoms are nausea (& stomach pain after eating) & low energy.  I also have swollen lymph nodes in left armpit.
Breakthrough case admission after 4 vaccines Pfizer 3/18/21 Lot# En6207;  Pfizer 4/8/21 Lot# Er8732;  Pfizer 10/19/21 LOt# En6207;  Moderna 5/10/22 Lot# 059M21A
Information has been received from a physician concerning a (approximately) 19 year old female who on 20-SEP-2007 was vaccinated with the 1st 0.5ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On 23-SEP-2007 the patient developed a rash on her neck and arms and led up to her cheeks. The patient eventually developed the rash all over her body and was referred to a Dermatologist. Patient did receive unspecified medical attention and at the time of this report the patient's outcome is unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007. In follow-up, the physician's office was unable to provide additional information because they were unable to identify the patient. No additional information is expected.
L Arm is numb and tingly from injection site (L deltoid) down into finger tips. Pain in elbow/hand/fingers. "Just feels weird"
Swelling of tongue. Vitals within normal limits. Had tongue tingling after 1st dose of Pfizer vaccine that resolved with Benadryl 25 mg PO. Given Benadryl 25 mg PO for this adverse event.
Information has been received from a registered nurse concerning an adult female who in 1996 was vaccinated with a dose of MMR II. In 1996, the patient developed a rash. The physician treating her at the time diagnosed it as possible chronic urticaria. In 2006, the patient also had a negative titer for mumps. Unspecified medical attention was sought. A product quality complaint was not involved. No further information is available.
Joint pain in both knees and both elbows; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 11Apr2021 at 14:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (BP), cholesterol and known allergies to non-steroidal anti-inflammatory drugs (NSAIDs). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 13Apr2021, the patient experienced joint pain in both knees and both elbows. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event joint pain in both knees and both elbows was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Initial report received from a health care professional on 22 December 2010. A 63-year-old male patient received on 22 November 2010 an injection (route and site not reported) of ADACEL, lot number not reported. The patient had a history of mild hypertension and rotator cuff tear. The patient's concomitant medications were reported as unknown. The patient had no illness at the time of vaccination and no known allergies. On 11 December 2010, the patient experienced severe low back pain and was seen in the Emergency Room (ER). On 13 December 2010, the patient was seen by a physician in the office for lumbar radiculitis with weakness of the lower extremities. The patient had an immediate magnetic resonance imaging (MRI) on 13 December 2010 which was unremarkable. On 20 December 2010, the patient experienced weakness of the lower extremities and facial paralysis (can't grin) with difficulty closing eye lids. On 20 December 2010, the patient was admitted to the hospital. Currently on 22 December 2010, he was being treated in the hospital for Guillain-Barre Syndrome. The outcome was reported as unknown. Documents held by sender: None.
Approximately 12 hours after the injection I awoke with fever, chills, severe pain wherever I was touched, nausea, and severe abdominal pain. After 24  hours the fever, chills, and severe pain wherever I was touched abated but I still had the nausea and severe abdominal pain. 4 days later I went to the emergency room with these symptoms. A CAT scan revealed a clot had blocked an artery leading to my spleen and I had a partially dead spleen. I am a heart patient and had an ejection fraction in the 40s. It was now 25-30. I also now have a pericardial effusion.
she developed 2 black and blue marks on her hands and one on her forehead; This is a spontaneous report from a contactable pharmacist via Medical information team. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on 01Apr2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After the first dose, the patient developed two black and blue marks on her hands and one on her forehead on an unspecified date. The side effect went away after a day. The pharmacist wants to know if the patient will be able to receive the second dose of the vaccine safely.The outcome of the event was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
States (L) arm sore in shoulder and along neck. Also states pain radiates down to lower back. No fever. No ROM impairment.
@ time of inject, site burned & was red; blotches @ inject site, itching all over, small rash on back, red papules on back & arms, flushed & hot skin, 2 1/2 hrs p/inject; pt had just finished eating ham, broccoli & cheese casserole;
I had a fever of 102F for about two days or so. I took an at-home COVID-19 on 12/12/2022 which came back positive. I suspected I contracted it since my wife also tested positive about two or three days prior to me testing myself. I never felt horrible or extremely fatigued/lethargic like others, but I didn't feel like myself either. The worst of my symptoms was not being able to break my fever. My doctor prescribed me Paxlovid which helped break my fever by the next day. By a couple of days time, I'm doing well and recovered.
Headache, Parkinsonism, Myalgia, Fever, Fatigue, tremors Narrative:
Rash developed papulovesicular for 2 days 2/10 and 2/11/07
pt recv vax c/o itching covering entire body;no welts, rash, SOB any other assoc sx noted;
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concomitant products included PROPRANOLOL for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced MYALGIA (sore arm). On 28-Mar-2021, MYALGIA (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information were provided.   This case was linked to MOD-2021-253071 (Patient Link).
I had body ache, fever, vomiting, a nausea. It lasted for 3 days. I went to doctor. I receive blister on my mouth.  I was in bed and couldn't take anyting.
Pt was admitted to the hospital from the ED for C.Diff infection on 4/16/21, after getting the second dose of vaccine on 4/14/21. Per guidelines, all hospitalizations should be reported.
Pain at injection site in arm, pain that lasted for months. Range of motion limited, moving arm is painful. Pain & weakness in arm that received injection.
Chest pain  on the 1st day followed by leg pain days and weeks later. Shortness of breath with exertion in July 2021
Patient appeared alert, oriented and completed everyday normal activates 3 days after receiving vaccine on a Wednesday afternoon, Jan 27th 2021 at 4:00 p.m. . Went to bed as usual on Sunday night Jan 31st 2021 at 9:30 p.m., husband found patient on couch sitting upright, unresponsive at 4:00 a.m. Patient's daughter came over to the house approx. 8 minutes later. Preformed CPR for 3-5 minutes, pt had a pulse. The ambulance was called prior to daughter arriving at the house. Ambulance arrived at 4:40 a.m. took pt to Hospital by 5:00a.m.  Pt declared "brain dead"
RECENTLY TORE RIGHT CALF MUSCLE; DEEP VEIN THROMBOSIS; This spontaneous report received from a patient concerned a 40 year old male of an unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number, expiry were not reported) dose was not reported, 1 total administered on an unspecified date in 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient reported that he recently tore his right calf muscle which resulted in a deep vein thrombosis. It was reported that more than one medical professional told the patient, that this was a very rare occurrence and due to receiving the vaccine last year they could not rule out the possibility of it indirectly or directly causing this blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the recently tore right calf muscle and deep vein thrombosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20220554269- COVID-19 VACCINE AD26.COV2.S- RECENTLY TORE RIGHT CALF MUSCLE, DEEP VEIN THROMBOSIS. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
24 hours after vaccine administered, patient developed erythema, pruritis and edema in left thigh. Patient seen 4/5/00 with same symptoms and seen 4/6/00 with some resolution of symptoms. Administered Benadryl orally.
periods of high pitched screaming 2-3x /day; duration 4 days; also was easily startled;
numb upper lip and face shortly after injection. Covid like sickness 24 hrs after injection which lasted for about 8 hrs
the roof of my mouth itched very bad; the back of my throat itched; caused me to cough pretty regularly; This is a spontaneous report from a contactable consumer (Patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Consumer stated that the covid nurse line said do not take the 2nd vaccine. The on call allergy immunologist said do not take the 2nd vaccine and take a Zyrtec and Prilosec the night before and morning of receiving the second dose. The vaccine did not affect her breathing, the roof of her mouth itched very bad and the back of her throat itched and caused her to cough pretty regularly. Her reactions started 45 minutes out and it was not due to something she ate that might have caused that. On an unspecified date, the patient experienced the roof of her mouth itched very bad, back of her throat itched and caused her to cough pretty regularly. The outcome of the events was unknown.   No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
unconsolable crying, low grade fever went ot ER in LA: onset of crying 8 hrs post inject lasted 3 days; went to hosp ER x2; no treatment advised;
Client was scheduled and wanted her Moderna booster, as her first series was moderna. Client states that she got hives on her stomach, but they went away, and she thinks they might be associated with vaccine.
it started itching; redness at the injection site, half a dollar size; swelling at the injection site, half a dollar size; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at the injection site, half a dollar size), VACCINATION SITE SWELLING (swelling at the injection site, half a dollar size) and PRURITUS (it started itching) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site, half a dollar size) and VACCINATION SITE SWELLING (swelling at the injection site, half a dollar size). On 18-Jan-2021, the patient experienced PRURITUS (it started itching). On 17-Jan-2021, VACCINATION SITE SWELLING (swelling at the injection site, half a dollar size) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (redness at the injection site, half a dollar size) and PRURITUS (it started itching) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
arm very sore. hurting  all day. a little hot. just put cold compress to ease the pain.
Cold symptoms; Cough; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold symptoms) and COUGH (Cough) in an 85-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 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold symptoms) and COUGH (Cough). At the time of the report, NASOPHARYNGITIS (Cold symptoms) and COUGH (Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       relevant concomitant products usage were not reported by the reporter. Treatment details not included.
@ 2AM mom heard pt gasping, when  checked on pt, pt was twitching "all over", eyes rolling back & stiff; no color change noted; twitching lasted approx 3 mins, then pt went limp for approx 10 mins & began crying; Taken to ER for evaluation;
Flu vaccine administration occurred as a walk in visit at our clinic.  The patient reported that the MA administering the vaccine went very high in the right upper arm, much higher than usual.  She had immediate intense pain in the area.  Later that night, she had ongoing significant pain, limited range of motion, and the pain persisted for several weeks.  I saw her in follow up in mid November for ongoing pain and limited ROM of the right shoulder. MRI ordered. Concern for SIRVA.
Soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Soreness) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced PAIN (Soreness). The patient was treated with MELOXICAM for Pain, at an unspecified dose and frequency and IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, PAIN (Soreness) had not resolved.            Concomitant product use was not provider by the reporter.  Action taken with mRNA-1273 in response to the events was not Applicable.    This case was linked to MOD-2021-080326, MOD-2021-080291, MOD-2021-080302 (Patient Link).
(R) facial swelling; No T; CT scan (+) (R) parotid inflammation. CBC ok; clindamycin, AUGMENTIN.
Maternal exposure during pregnancy; Fetus stopped growing on 09Feb21 (8w4d); no heartbeat detected; This is a spontaneous report from a contactable consumer (parent).  This consumer reported information for both mother and fetus. This is a fetus report.  A patient of unspecified age and gender (fetus) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269), transplacental on 04Feb2021 at 14:00 at single dose for COVID-19 immunisation.  The patient medical history was not reported.  Concomitant medication included ergocalciferol (VIT D), folic acid (FOLATE), ascorbic acid/betacarotene/calcium sulfate/colecalciferol/cyanocobalamin/ferrous fumarate/folic acid/ nicotinamide/pyridoxine hydrochloride/retinol acetate/riboflavin/thiamine mononitrate/tocopheryl acetate/zinc oxide (PRENATAL VITAMINS) and sertraline hydrochloride (ZOLOFT) at 25 mg, all transplacental.  It was reported that OB exam on 03Feb21 showed healthy baby at 7weeks 5days heartbeat detected 152 bpm; no abnormalities identified via ultrasound; labs and hormone levels all within normal ranges. No issues detected. Mother received 1st dose of vaccine on 04Feb2021. Per ultrasound on 20Feb2021, fetus stopped growing on 09Feb2021 (8 weeks 4 days); no heartbeat detected. Miscarriage occurred on 22Feb2021. The fetus died on 22Feb2021.  It was not reported if an autopsy was performed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021204433 same drug and reporter, different patient and event; Reported Cause(s) of Death: Fetus stopped growing on 09Feb21 (8w4d); no heartbeat detected; Mother received 1st dose of vaccine 04Feb21. Per ultrasound on 20Feb21, fetus stopped growing on 09Feb21 (8w4d); no heartbeat detected. Miscarriage occurred 22Feb21.
She reported that 5 patient's received PROQUAD vaccine that had undergone temperature excursion; No additional AE; This spontaneous report was received from a nurse referring to a currently 4 years old male patient. Information about medical history, concurrent condition and concomitant therapy was not provided.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot # U002539 with an expiration date 24-JUL-2022; strength, dose, route and frequency were not reported) for prophylaxis. The vaccine had undergone temperature excursion at 13.8 Degrees Fahrenheit for 1 hour and 48 minutes (product storage error). No previous temperature excursion. No additional adverse event (AE) reported. The outcome of product storage error was unknown.
Inflamed and swollen joints. Unable to move comfortably and raise arms. Jaw was even tight. hands and hips worst.
intense left arm pain and warm to touch 1st day, next day red arm, circular rash on arm, injection site(hot) and very itchy.  Also diarrhea since 2nd shot