chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was administered after was left out for 15 hours; A spontaneous report report was received from a health care professional concerning a patient unspecified age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) but vaccine was administered after was left out for 15 hours/product storage error.  The patient's medical history was not provided. Concomitant medication was not reported.  On 13 Mar 2021, the patient received a dose of mRNA-1273 via unknown route for prophylaxis of COVID-19 infection.   On 12 Mar 2021 a vial was punctured at 6:45 pm after that it stayed at room temperature for 15 minutes, ten doses were drawn into the syringes at room temperature of 67 degree F. At the end of the clinic three vaccines were left and stayed in a basket, at ambient temperature of 67 degrees F. The next day on 13 Mar 2021 one of the immunizers mistakenly took one of the 3 prefilled syringes and administered the shot. The prefilled syringe had stayed at a controlled room temperature of 67 degrees F for 15 hours (9:45 am next day) before administered to a scheduled appointment patient. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of event vaccine was administered after was left out for 15 hours, was considered as resolved on 13 Mar 2021.; Reporter's Comments: This report refers to a case of Product storage for mRNA-1273, lot #unknown with no associated AEs.
This case was reported by a consumer and described the occurrence of red rash on stomach in a 39-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included drug allergy. Concurrent medications included Birth control. On 13 November 2008 at 13:00 the subject received a dose of FLULAVAL in the right arm. Five hours after vaccination with FLULAVAL, the subject experienced a red rash on the stomach and itching. The subject started treatment with BENADRYL on 19 November 2008. At the time of reporting the events were improved.
Got 2nd shot  around 11 AM 4/15/21, Went home ate lunch and sat on couch to relax around 1:30.  Thought he was just sleeping,  tired to wake him up around 4:00.  Hard to get awake,  words garbled,  head was pounding, could not move either arm nor leg.   Called 911 Ambulance took him to hospital ER,  they ran test listed below and decided to keep him overnight.  Thought he may have had a stroke They were supposed to to MRI next mornng, 4/16.  He was better and able to finally move arms and legs,  did not do MRI let him go home  followed up with Dr PCP  on 4/19 .  Very tired with no energy for about a week after was a little forgetful for a few days.  Dr ordered more test,  he wasn't sure it was a stroke. had a lingering headache for over a week,  finally feeling a little better,  still not alot of energy
particular reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (particular reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder (autoimmune disorders).    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (particular reaction). At the time of the report, VACCINATION COMPLICATION (particular reaction) outcome was unknown.            No concomitant medications were provided by reporter. No treatment medications were provided by reporter.   Reporter did not allow further contact
Right arm swollen, red, hot, and bruised.  Advised to use ice packs on arm.  No fever.  Telephone call to Mom on 5/4 and 5/9 - not at home/left message.  Spoke with Mom by phone on 5/10- problem resolved.  No private MD visit made.
difficulty talking; unable to move his arm or leg; Massively sick; body pain; Nausea; headaches; fatigue; muscle aches and pains; chills; A spontaneous report was received from a 79-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced "unable to move his arm or leg", massively sick, nausea, headache, body pains, difficulty talking, fatigue, muscle aches and pains and chills.  The patient's medical history included Covid-19 positive on 17-OCT-2020. Concomitant product included metformin, metoprolol and rivaroxaban.  On 04-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 04-FEB-2021, one day after receiving the vaccine, the patient felt "crummy", "massively sick", nausea, headaches, fatigue, chills, muscle aches and pains and other pains. On 05-FEB-2021, the patient reported that he believed he was having a stroke. The patient was unable to move his arm or leg and had difficulty talking. The patient was taken to the emergency room for treatment. Computerized tomogram (CT) scan and magnetic resonance imaging (MRI) were taken. Later that night, after receiving treatment all his side effects subsided and none were present at the time of this report. The patient would like to know if he should get the second dose of vaccine.  Treatment information included heparin, acetaminophen and magnesium.  Action taken with mRNA-1273 was unknown.  The outcome of the events, unable to move his arm or leg, massively sick, nausea, headache, body pains, difficulty talking, fatigue, muscle aches and pains and chills, was resolved.  The reporter did not provide the assessment for the events unable to move his arm or leg, massively sick, nausea, headache, body pains, difficulty talking, fatigue, muscle aches and pains and chills.; Reporter'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.
No adverse effect reported; improperly stored PROQUAD (lot R030798 & expiration date 4/22/2020).; PROQUAD used for 18 year old patient; This spontaneous report was received from a administrator referring to a 18 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On 11-SEP-2019 the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose and route were not provided, lot#R030798, expiration date was 22-APR-2020) (Inappropriate age at vaccine administration). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was reconstituted with properly stored sterile diluent (lot# and expiration date were not provided). The temperature excursions included 6 fahrenheit degree to 14 fahrenheit degree (14 fahrenheit degree) for 200 hours and 15 fahrenheit degree to 46 fahrenheit degree (34.268 fahrenheit degree) for 18 hours (Incorrect product storage). There was no temperature previously excursion. There was a data logger involved. No adverse effects were reported.
Swelling under my left arm like a tennis ball, left elbow feels like a bowling ball, left forearm and finger itch and burn, pulling sensation in left neck area up to jaw line and ear, teeth are painful, pain in left back shoulder muscle
Threw up & diarrhea on Thursday evening; no appetite; no temp; viral gastro was suggested;
4 days after administration of smallpox vaccine patient left axilla became tender and he noted an "outbreak". On exam multiple 2-3mm pustular lesions on an erythematous base noted. DDx includes generalized vaccinia vs folliculitis. Patient advised to keep area covered and treat lesions as infectious.
No further AE reported.; patient received his first dose of MMR II today (Mar 5, 2021) at age 5; This spontaneous report was received from a registered nurse and refers to a 5-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 05-MAR-2021, the patient was vaccinated with a first dose of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) 0.5 milliliter (route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis (inappropriate schedule of vaccine administered). No adverse event was reported.
This spontaneous report was received from a physician via two company representative and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 15-JAN-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml injection, lot # K005402, expiration date 07-NOV-2015 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to the following temperature excursions (dates unspecified): the first lasting for 372 hours, with the highest recorded temperature of 59.9 degrees Fahrenheit (15.5 degrees Celsius), the second lasting for 96 hours, with the highest recorded temperature of 47.2 degrees Fahrenheit (8.444444444 degree Celsius), the third lasting for 48 hours, with the highest recorded temperature of 46.8 degrees Fahrenheit (8.222222222 degrees Celsius) and the fourth lasting for 24 hours, with the highest recorded temperature of 47.5 degrees Fahrenheit (8.611111111 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
I felt really weird pain in my lower right abdomen area. I went to bed and got a fever so I went to the ER and had emergency surgery to remove my appendix.
pt recvd 3 doses of vax & exp h/a x 3 days, horrible taste in mouth; weakness in lt hand, pain in lt knee for the past 3 months; sx are arthritis-like & are similar to sx exp when pt had Hep @ age 17;
No adverse event; 7 patients received Moderna Covid-19 monovalent vaccine in June of 2022. The vaccine expired in March 27, 2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 patients received Moderna Covid-19 monovalent vaccine in June of 2022. The vaccine expired in March 27, 2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jun-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 patients received Moderna Covid-19 monovalent vaccine in June of 2022. The vaccine expired in March 27, 2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 patients received Moderna Covid-19 monovalent vaccine in June of 2022. The vaccine expired in March 27, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (7 patients received Moderna Covid-19 monovalent vaccine in June of 2022. The vaccine expired in March 27, 2022).    No concomitant medication was reported.  The dosage text was reported as unknown. It was reported that 4 doses of the Moderna Covid-19 vaccine were administered on 18-Jun-2022 and 3 doses of Moderna Covid-19 vaccine were administered on 22-Jun-2022. The expiry date was reported as 27-Mar-2022. No treatment information was reported.  This case contains information for patient 3rd out of 7 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-731892 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731892:MASTER  CASE
Report 2001029990-1 describes an adult female of unspecified age who did not respond to the hep B immunization series. This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not specified. The vaccinee allegedly received injectoins of Engerix B on 9/16/98, 10/14/98, and 3/10/99. Lot numbers of vaccine administered were not provided. Her attorney alleged that "on or about 11/18/99, plaintiff received a letter from her employer which stated "there may have been a problem with a particular batch of hep B vaccinations" from which she received one of her injections and that she "should receive a lab test, known as a titer, to determine if she has a positive immunity to hep B or if she needed a booster injection." The vaccinee allegedly received an injection of Engerix B on 12/2/99. An unspecified hep B titer, measured on 1/13/00, was reportedly <2mIU/mL. The vaccinee then allegedly received injections of Engerix B on 2/25/00, 3/24/00 and 8/23/00; lot numbers of vaccine administered were not provided.  An unspecified hep B titer, measured on 9/25/00, was reportedly <2mIU/mL.
Pain in shoulder and arm. Can't lift arm up or out. Can't lay on right side.  Use heat, took Tylenol.  Can't lift grocery bag or other similar things unless I use other hand.
Adverse reaction from the Dtap, severe swelling of injection site and large red circle. Hot to the touch and itchy. Started 4 days post injection and has gotten progressively worse to the point where we took our daughter in to see her doctor on day 7. Was prescribed antibiotics and allergy medicin to help, so far it is still getting worse.
Corona Virus Concern     Everyone around her tested positive, and she tested postitive twice today ? Altered Mental Status     Family states she has had some altered moments     HPI Pt is a 82y F presenting to our ED with cc of COVID concern. PMHx remarkable for CHF, A.fib on Eliquis, COPD, DM, HTN and hypothyroidism. Tested COVID positive 1/3/21 at home after multiple family members were found to be positive. Per Registry, COVID vaccinations: 12/27/2021, 2/11/2021, 1/14/2021. Waxing and waning mentation, currently A&Ox0. History limited 2/2 AMS.    Review of Systems Review of systems is limited due to patient's dementia, developmental delay, altered mental status and/or inability to communicate.
This spontaneous report as received from a nurse refers to 26 infant patients of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates between 01-JAN-2014 and 27-OCT-2016, the patients were vaccinated with three doses of RECOMBIVAX HB injection, intramuscularly (lot # and dose were not provided) in following schedule: first dose at 0 months, second dose at 2 months and third dose at 4 months. There were no adverse effects reported. This is one of two reports received from the same reporter. Additional information has been requested.
Mother reports reddened area at site of injection (circumference of a grapefruit), hot to touch. No other s/s. PA at urgent care told mother this was an allergic reaction and pt. should never receive another flu shot.
Per DHA IHD guidance we are to discontinue monovalent mRNA boosters> All such boosters administered to 12+ year-old patients, after 31 AUG 2022, will need to be reported in VAERS as administration errors.
12 y/o 2 minutes after vaccination, walking to waiting area and syncopized, right side of head struck adjacent wall. Taken to chair. Nausea with dry heave. Normal neurologic exam. Minor erythema to right eyebrow. Monitored for 40 min.
Pain in the back of the right knee and discomfort in the left knee. It increased in pain level then started to recede right before getting second shot.  After the second shot the pain increased again. Any bending of the joint caused pain.  Also pain traveled up to the groin and down into feet at times.  April 12 went to ER due to added shortness of breath.
bilateral pneumonia; fever; This is a spontaneous report from a contactable Nurse. A 36-year-old female patient (non-pregnant) received BNT 162B2 (Pfizer-BioNTech Covid-19 Vaccine, solution for injection, batch/lot number EN6202 expiration date unknown) via an, intramuscular route of administration on 09Mar2021, at single dose for COVID-19 immunisation. The patient had no known allergies. The patient's medical history included Diabetes type 2. Concomitant medication was not reported. It was unknown if other vaccine was given in four weeks, other medications in two weeks was reported as yes. Patient reported a fever on 13Mar-14Mar which progressed to confirmed diagnosis of bilateral pneumonia. The adverse event start date was 13Mar2021. No covid prior to vaccination. On 15Mar2021, covid test post vaccination was performed (Nasal Swab/Antigen and PCR) the test result was Negative. Treatment received was antibiotics. The outcome of event was Not recovered/Not resolved.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events pneumonia and fever and the suspect drug. 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.
pain in the ankle joint; This is a spontaneous report from a non-contactable consumer (patient, self-reported). A 35-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3246 and expiry date was not reported), via an unspecified route of administration, on 13Jan2021 at 12:45 PM (age at vaccination: 35 years), as a single dose for COVID-19 immunization at hospital. The patient's medical history and concomitant medications were not reported. It was unknown if the patient had known allergies. It was unknown if patient had vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. It was unknown if the patient was tested for COVID post vaccination. The patient reported that he had pain in the ankle joint 1 week after taking dose 1 on an unspecified date in Jan2021. He had to go to the ER. The patient was wondering if this was a reaction to the vaccine. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
onset of itching at injection one week after injection; next day skin redness around the injection site  about the size of a large plum along with an underlying firmness under about half of the red area with increased itching; no change one day later, but today, 3-8-21, less itching, area of redness and firmness less without treatment.
104.5 fever; Upset stomach; Sore on shot site; Aches; Headache; Exhausted; Booster; This is a spontaneous report from a contactable consumer (patient). A 52-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number was not reported), via an unspecified route of administration, administered in the left arm on 23Oct2021 11:00 (at the age of 52-years-old) as dose 3 (booster), single for COVID-19 immunization. Medical history included mental health disorder, chronic obstructive pulmonary disease (COPD), diabetes, and hypertension. The patient has no known allergies. Concomitant medications included lithium, mirtazapine, ciprofloxacin hydrochloride (QUELL), quetiapine, and cefaclor (SERA). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) for dose 1 and dose 2 - both administered in the left arm on unspecified date as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks of the COVID-19 vaccine. Prior to vaccination, the patient had no COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 23Oct2021 11:00, the patient received dose 3 (booster), single of BNT162B2. On 23Oct2021 22:00, the patient experienced 104.5 fever, upset stomach, sore on shot site, aches, headache, and exhausted. Therapeutic measures were not taken as result of the events. The outcome of the events was recovering.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Received COVID-19 booster on 9/17/21, the Seasonal Flu vaccine on 9/17/21, then developed vision problems on 9/22/21. Was seen by retinal specialist on 9/22/21 and diagnosed with right branch retinal vein occlusion with macular edema. Received Lucentis 0.5 mg via intravitreal injection. Still have decreased visual acuity compared to non-affected eye. Am going through medical eval to rule out coagulopathy. Have appts to see Cardiology and attempted to set up appt. with hematology. Have had screening labs ordered via a Lab these are pending.
Patient states they received the Pfizer two dose series, first in July, second in August 2021.  Unable to provide exact dates nor the facility where she received the vaccines.   Patient presented to ED after having her AICD misfire X 5.  Did report mild congestion, cough and myalgias that began two days prior to presentation to ED.
Low grade fever, muscle aches, joint aches, flat rash over entire body, headache, tightness in chest (same symptoms as original Covid-19 infection 10/2020).
pt recvd vax;dizziness,syncope,BP 80/50 supine;90/55 sitting episode lasted approx 5 mins until pt responsive;left ambulatory 10:30am;event occured approx 10 mins p/ vax;
Patient was vaccinated on 02APR21 @ 2115 and at 2140, patient reported feeling flushed and dizzy.  Patient laid down on a cot.  At 2200, patient reports headache and fatigue.  B/P 130/82, HR72, O2 Sat. 97%.  At 2205, Patient took Benadryl 25 mg po and called a driver.  Patient went home at 2250.
1st day of pain: Extreme Pain in Lower Extremities (Right Leg, Right abdomen, right lower back) Swelling of Right Leg 3rd day: Admitted into the hospital after visiting the ER  Acute DVT in R Leg, multiple Pulmonary Embolisms 3rd-5th day in hospital: 2 Surgical Procedures to remove blood clot, on Blood thinners for a year to life
9/28/96-Right eye discharge, possible LDS (mild) and URI. 11/18/96-Mild atopic dermatitis. 2/12/99-Hypotonia throughout extremities and trunk. 7/1/99-Speech, hearing, in-toeing and poor eye contact concerns. 8/1/99-Autism and significant delay in speech.