chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The infant reportedly "had a normal birth". He received Pedvax-Hib and inactivated poliomyelitis virus vaccine on unspecified dates. The infant received his 1st injection of Infanrix (lot DTPA941A2) on 2/24/00. The next day, he developed a fever that resolved on 2/26/00. In 3/00, at 3 months of age, it was noted that the infant "could not hold his head up". The infant received his 2nd injection of Infanrix (lot DTPA941A2) on 5/11/00. Later that month, when the parents noticed that the infant "still could not hold up his head and had low muscle tone", they took him to a physician. The physician reportedly made a dx of developmental delay and hypotonia. The infant received his 3rd injection of Infanrix (lot DTPA941A2) on 8/10/00. On an unspecified date, a SPECT (single photon emission computed tomography) scan "showed a diffuse pattern, some vascular disruption". The father stated that the radiologist interpreted these results as "normal", but the treating physician pointed out the diffuse pattern and stated that "more would be cerebral palsy but that (the infant) did not have that". On unspecified dates, the child began to exhibit "arm flapping, no speech, gazing off, no eye contact until just recently, late walking and weak trunk and arm muscles". The father considered this to be "demonstrating autistic tendencies". The father stated that no dx of autism had been made by a physician. As of 4/8/02, the developmental delay and hypotonia persisted. This report of developmental delay is considered "Medically Serious".
02/07/22 presents to ED for "dizziness". PMHx of "ESRD on CAPD, HIV, CVA, cirrhosis, Hep B, COVID, GERD"
I had a scratchy throat, change of taste that has lasted long-term, tremendous amount of congestion, a low-grade fever; initially, the first day, I had body chills even when my temperature was pretty normal. I took TYLENOL to help. I took a rapid antigen COVID-19 test on 02/09/2023 which came back positive. The next day, I was prescribed PAXLOVID the next day. I had a hematoma and concussion at the same time when I contracted COVID-19 which delayed me picking up my prescription for PAXLOVID. By about 36 hours of taking the prescription, I noticed immediate relief. By day 5-6, I made a full recovery; however, I do feel I've been having a long-term COVID-19 effects. It's been triggering restless leg syndrome episodes and additional complications to prior medical illnesses. As of now, I'm trying to determine how long-COVID-19 symptoms affect my medical history.
Patient had localized reaction at injection site. Area was red, warm, and weeping. Patient reports this developed within 36 hours of administration. Patient went to urgent care and was provided steroid cream which alleviated symptoms within 48 hours. Patient reports that urgent care provider suggested this was a 'robust uptake' and did not believe it was cellulitis. Patient returned for dose 2 of vaccine, subsequently had the same reaction which was treated with steroid cream and resolved. Patient denies any other s/s such as n/v/d, fever/chills, muscle pain.
Pharmacist reported that a patient received a 3rd dose of shingrix on Aug10th 2023.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-AUG-2023, the patient received the 3rd dose of Shingrix. On 10-AUG-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Pharmacist reported that a patient received a 3rd dose of shingrix on Aug10th 2023.). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 10-AUG-2023 The patient received 3rd dose, which led to extra dose administered. The reporter consented to follow up.
I received my first 2 doses of the Pfizer shot in April, normal side effects (soreness, fever, and body aches). In December, I got my booster but it was the Moderna shot. The shot was given on 12/10, and I started feeling the same side effects from April on 12/11. On 12/12, I started noticing a ringing in my left ear (tinnitus). It did not subside for 48 hours so I went to urgent care which led to an audiology test for hearing. It was determined that my left ear heat had been damaged and went from normal levels to mild hearing loss. Due to not being on any meds, allergies, or other outside factors, it was concluded that my hearing loss was related to the booster.
Case received from a consumer on 05 September 2013. A 44-year-old female patient, with history of allergy to silver sulfadine, Td, had received an intramuscular dose of Td (batch number "U0833AA") in the left deltoid on 25 June 2003. It was unknown if the patient was ill at time of vaccination. On 02 July 2003, the patient presented cellulitis at injection site on left deltoid, requiring a visit to ER/doctor. On an unspecified date the patient fully recovered.
pt recvd vax 27MAY92 & 12JUN92 devel fever, then status epilepticus, sz persistently w/brain atrophy & severe developmental delay;;
Information has been received on 09-FEB-2018 from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 15-FEB-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster immediately after being vaccinated. On or about 16-FEB-2016, the patient was treated at a hospital for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. The patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
The patient received vaccine after being more than 30 days stored in the fridge; No adverse event; The patient received vaccine after being more than 30 days stored in the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received vaccine after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received vaccine after being more than 30 days stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received vaccine after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient received vaccine after being more than 30 days stored in the fridge) and PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge).    Concomitant medication of the patient was not reported. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that the vaccine dose would be either 1st or 2nd. Vaccines were stored in the fridge on 30-Jun-2021.  The patient did not report any side effects. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master case
pt recvd vax; redness & swelling noted; approx 2"by 2" in size w/in 48 hrs;
Narrative:  86 year old male admitted on 1/13/22 for increasing SOB, chills, fatigue, nonproductive cough, decreased appetite and diarrhea. He had been vaccinated x 2 with Moderna vaccines (1st dose 1/19/21, 2nd dose 2/16/21). He was treated with remdesivir x 5 days and prednisone x 7 days.
pt recv vax 18AUG97 & 29AUG97 pt devel a mild case of chickenpox;
Body feeling hot and cold feet and calf feel like they are asleep Arm feels sore from injection
Information has been received from a healthcare worker referring to an unspecified number of unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of (Merck) VARIVAX (lot # K007974, expiration date 03-JUN-2016; K010336, 22-JUL-2016; K015972, expiration date 23-SEP-2016, strength, dose and route were unknown). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Unevaluable event; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Unevaluable event) in a 91-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) for Crohn's disease.    The patient's past medical history included Surgery (The patient had a fissure and needed surgery in Apr-2021. He had a previous surgery in that area.). Concurrent medical conditions included Crohn's disease (MODERATE TO SEVERE).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-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 started ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced UNEVALUABLE EVENT (Unevaluable event) (seriousness criterion medically significant). At the time of the report, UNEVALUABLE EVENT (Unevaluable event) had resolved.            The patient had a fissure and needed surgery in Apr-2021. He had a previous surgery in that area. On an unknown date, the patient experienced FISSURE.. No concomitant medication information was reported. No treatment medication information was reported. Formulation of Humira was reported as Solution for injection in pre-filled pen.  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.  Company comment-This spontaneous case concerns an elderly male patient aged 91 years with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Unevaluable event that occurred on an unknown date in the context of mRNA-1273 vaccination. Patient had a fissure and needed surgery in April 2021. No further information on clinical course, investigations and treatment received was available in the report. Patient had received initial two doses of mRNA-1273 at an interval of 31 days. Outcome of the event was resolved at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns an elderly male patient aged 91 years with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Unevaluable event that occurred on an unknown date in the context of mRNA-1273 vaccination. Patient had a fissure and needed surgery in April 2021. No further information on clinical course, investigations and treatment received was available in the report. Patient had received initial two doses of mRNA-1273 at an interval of 31 days. Outcome of the event was resolved at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement
10/05/2017 Patient called the Health Department to report that one hour after receiving vaccination, she started to itch, and then she broke out in hives. After vaccination, and before the hives she had consumed Cheese, watermelon and two chocolates. She went to Medical Center and received IV Benadryl. She went home with a prescription for a steriod. Patient was instructed by the ER Doctor to see an Allergist.
Severe fatigue, HA, nausea and dizziness since 8/17, pt received vaccine 8/16
she's been extremely itchy; itchy again; This is a spontaneous report from a contactable consumer (husband of the patient) via medical information team.    A 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: unknown) via unknown route of administration on 24Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medication were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: unknown) via unknown route of administration on 24Feb2021 as dose 1, single for covid-19 immunisation and the patient experienced itchy and was itchy for 2 weeks. On an unspecified date, the patient experienced she had been extremely itchy and itchy again. The patient first shot was on 24Feb2021 and then they postponed the second to 24Mar2021. After the first shot she was itchy and was itchy for 2 weeks. The reporter told them that, but they gave the patient the second shot and she got itchy again. They told him to go to pharmacy to get Benadryl. He went to a doctor instead but all the doctors were gone. The patient got her some children's Benadryl. The patient was like a puppy with fleas. The outcome of the events was not recovered.  No follow-up attempts were needed, information about lot/batch number cannot be obtained.
Light headed; Achiness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed) and MYALGIA (Achiness) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Light headed) and MYALGIA (Achiness). At the time of the report, DIZZINESS (Light headed) and MYALGIA (Achiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and Treatment medications were not provided by reporter.
Fever 103.1 a little later it went down to 101.3, left side numbness from head to foot, chest/back pain, headache, chills, fatigue, loss of appetite, soreness
Eight days after receiving Moderna vaccine I developed a red, inflamed rash on my arm at injection site. It was about a 3inch X 3 inch rash, itchy and burning. I still have the rash today, which is day 3.
Shingles on head approximately two weeks following vaccine; treated with Valacyclovir HCL beginning on April 22, 2021; has been about 4 months now and no other side effects noticed since then; permanent scars from the Shingles
Information has been received from a registered nurse concerning a male who was vaccinated subcutaneous with a 0.5 mL dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/30. Concomitant vaccines included PREVNAR, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified) and poliovirus vaccine. The vaccines were all given on the same office visit. On an unspecified date the patient developed swelling and redness from the waist down. The patient sought unspecified medical attention. On an unknown date the patient recovered. A product quality complaint was not involved. Additional information has been requested.
1st dose Nov2020, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received first shot in November 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 6-Feb-2023 Reporter's comment: The patient reported that she has the intention to receive a second dose soon. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Pt inadvertently sprayed MMR vax into lt eye on 14NOV90; Eye irrigated; exam w/slit lamp revealed mild conjunctival irritation; pt's slight irritation of lt eye resolved in a few hrs; @ time of report, pt was asymptomatic;
2 days p/vax pt started w/pain & redness @ inject site;migrated to entire arm, across chest, neck, shoulders, & underneath breast;felt like someone walking on chest;SOB also;felt like having heart attack;to MD 1hr later w/soreness;
General side effects, substantially gone by 3rd day (2/26):  fatigue -- first and 2nd days headache -- mild.  first and 2nd days muscle pain, joint pain -- second day.   600mg Advil helped chills -- 2nd day morning.  5 min fever -- 99.5F.  2nd day morning.  2 hrs  These side effects resembled my COVID disease symptoms in early October 2020 (10/2-10/14)
High fever of 104.7 while on ibuprofen.  High fever lasted from 7/12/14 through 7/14/14.  Then mild fever of 101-102.5 continued (while on ibuprofen).  A whole body red itchy rash started on  7/14/14 and lasted until 7/16/14.  Patient still has mild fever and slight rash as of 7/16/14.
Slight chills and headache. Developed slight fever combined with chills and headache throughout the night. By the next morning, fever and chills were gone, but headache remained.  Took ibuprofen for headache. Was still tired.  Laid down at 10 a.m. and slept until 2-2:30 p.m.  All symptoms were gone.
Contracted COVID - positive test on 13Jan2022; Contracted COVID - positive test on 13Jan2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 07Jun2021 (Lot number: EW0180) at the age of 14 years as dose 2, single and administration date 16May2021 (Lot number: EW0173) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The following information was reported: VACCINATION FAILURE (medically significant) with onset 13Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 13Jan2022, outcome "recovering" and all described as "Contracted COVID - positive test on 13Jan2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (13Jan2022) positive. Therapeutic measures were not taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.
Felt like heart was racing about 30 minutes after vaccination. BP 165/82 HR 101 and sats 99%.  Stated a little higher but not unusual. Felt okay to go home.   Observed for 30 minutes.
Doses given with punctured vial beyond 12 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses given with punctured vial beyond 12 hours) 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 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses given with punctured vial beyond 12 hours). On 04-May-2021, EXPIRED PRODUCT ADMINISTERED (Doses given with punctured vial beyond 12 hours) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported by reporter  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: fallow up received on 10-jun-2021 contains No New Information
Patient describes a raised, itching, and blistering rash on right arm extending below vaccination site. Onset occured about 4 days after administration of vaccine. She was seen by her primary care MD who prescribed "Delavil" cream for the itching. Two-weeks post vaccine, she states rash "comes and goes" now.
GAVE MONOVALENT INSTEAD OF BIVALENT. 0 TREATMENT, OUTCOME WITHOUT SIGNS OR SYMTOMS OF ADVERSE EFFECT.
Provider summary "84-year-old female with history of chronic obstructive pulmonary disease, hypertension, bladder cancer, coronary artery disease who was sent in to the hospital on 06/21 from wound clinic due to worsening right chronic heel ulcer which patient was found to have sepsis and started on antibiotics and general surgery consulted who performed debridement on 06/22 which showed evidence of osteomyelitis.  Patient required 2nd debridement right heel wound on 06/24.  Wound cultures growing several blocks including Enterococcus faecalis and ID (Dr. was contacted) who recommended vancomycin and ertapenem for 6 weeks (through 8/4) Sepsis resolved during course of hospitalization with antibiotics.  PICC line placed and home antibiotics arranged with weekly complete blood count, CMP, CRP.   Wound care took over care of patient's right heel wound from General surgery and will continue outpatient management the patient does have follow-up on 07/08 with another Dr.  During hospitalization patient was also found to have new onset DM 2 with an A1c of 6.8. Patient however with relatively poor oral intake and well-controlled blood sugars during hospitalization so did not start patient on metformin.   Patient ended up developing cough and a rhinorrhea on 06/28 and ended up testing positive for COVID although chest x-ray unremarkable and patient not hypoxic and was prescribed Paxlovid course on discharge (not available in the hospital).  I did discuss risks and benefits with patient and family regarding this medication and provided printed information about this medication."
syncopal event.  happened a few minutes after the injection.  Patient was going to get dressed and sat down then passed out.  She woke up within a minute.  Patient was fully responsive once she woke up and answered questions appropriately