chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 17 year old white female with penicillin allergy and postpartum disorder at the time of vaccination who on 05-MAY-2008 was vaccinated with GARDASIL (lot# 659182/1757U) IM in the right deltoid at 4 PM. On 06-MAY-2008 at 11 AM the patient experienced hives. The physician recommended the patient to take BENADRYL and to call if not better. At the time of reporting it was unknown if the patient had recovered. The physician discontinued GARDASIL. Additional information is not expected.
No adverse etfects reported; patient received improperly stored dose of MMR II; This spontaneous report was received from a nurse and refers to a 12-month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 06-SEP-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) albumin status rHA (lot # S004120 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), expiration date reported as 11-JAN-2021, but upon internal validation established as 11-FEB-2021) (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of above 47 degrees Fahrenheit (54 degrees Fahrenheit) for 1 hour. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA004662:
he stated he could feel numbness in his R arm and hand an electrical shock. numbness and tingling in right bicep, down into the forearm, to the top of the hand, into thumb, index finger, middle finger which continued into the next day. NSAIDs, ice, elevation and rest for the symptoms
Fever, Dizziness, Disorientation, Weakness, Stomach upset, Nausea, Vomiting, Falls X 2  The patient fell twice and hit his head forcefully both times on hard objects.
Client c/o dizziness 5 minutes after vaccination.  Care initiated by on site EMS.  B/P 128/87.  Monitored for 40 minutes.  Reported no more dizziness.  Stated "I feel better."  Declined further observation.  Exited site at 2:25 pm.
Beginning approx 36 hours post inoculation, had glandular swelling in neck under jaw, arm pits, (both sides), the concerning thing was the rear of my tough swelled and felt like it had canker sores on it, both sides back my my molars, both sides, down into my throat.   Benadryl relieves some of the swelling which would be quite bad without.
Headache and hot forehead 5+ days Nausea 10+ days Constipation
Clinical Summary Patient is a 38 y.o. female with a history of leukemia in remission and insomnia who presented to outside urgent care with worsening respiratory symptoms and transferred to hospital 12/16/2022 for COVID-19 and respiratory failure. Treated for CAP. Discharged to home 12/18/22.    1. COVID-19 Pneumonia: positive test 12/12/22. CTPA 12/16/22 negative for PE with LLL and RML opacities. Started on decadron for hypoxia. Patient declined remdesivir treatment due to outpatient trial of Paxlovid PTA.   2. CAP: Severe Sepsis POA (WBC 14.97, HR 131 and RR 24, Lactic acid 1.9.) Blood Cultures 12/16/22 NGTD. Urine Ags negative. Given IVF. Given rocephin and azithromycin in ED and transitioned to levaquin on admit. Given 5 day course of antibiotics end date 12/20/22.  3. Acute Hypoxic Respiratory Failure: RR 24 and 2 LPM placed in the ED.  No desaturation documented.  VBG showed O2 45 mmHg and CO2 51.8 mmHg with pH 7.40 on 12/16/2022.  CTPA per above. Resolved.  4. Leukocytosis: Pt clinically improved 12/18/22 although WBCs 22K. On room air and blood cultures remain NGTD. Treated for CAP as above. No other focal s/sx infection. Suspected steroid induced. Repeat CBC in one week
Fever 102 degrees F., chills, nausea, headache (lasting 36 hours)  Severe swelling and rash of left arm extending down to elbow lasting several days
Chills, shaking, fever and body aches.  Lasted from Wednesday evening to Thursday  evening. Still feeling lifeless on Friday no appetite. Saturday feeling weak. Arm is bruised and itches terrible.
Body ache, fatigue,  sore throat, mild fever, chills, headache.
Information has been received from a Nurse Practitioner (N.P) concerning an "about 40" year old male patient who on 10-DEC-2010 was vaccinated with a 0.5 mL dose of MMR II (Lot # not reported). It was reported that on 01-DEC-2010, the patient had received a dose of yellow fever vaccine at an undisclosed medical office. Provider calling because there was less than the recommended one month recommended spacing between the two live vaccines. The patient sought unspecified medical attention. The outcome of the patient was unknown at the time of the report. No adverse effects reported. Follow-up information has been received from a nurse practitioner who stated that the 42 year old female (reported before as male) patient with sulfa allergy and no illness at time of vaccination and no none adverse events following prior vaccination on 30-NOV-2010, the patient was vaccinated in the "buttocks" with a dose of YF-VAX (lot# not reported) who on 10-DEC-2010, was vaccinated SQ in the left arm with the second dose of MMR II (lot# 667247/0576Z) at 14:00. On the same day, the patient was vaccinated IM in the right deltoid with the first dose of ENGERIX-B (lot# AHBVB880B) and with the first dose of MENACTRA (lot# U3508AA), IM in the left deltoid, both vaccines were given at 14:00. It was reported that on 12-DEC-2010, the patient had a rash at the injection site of MMR II which started 2-3 days after the vaccine was given. It was raised, red and itchy rash. There was no relevant diagnostic test performed. No other symptoms were reported. The patient did not seek medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Information received from the nurse concerning a 12 year old female patient on 11-AUG-2010 was vaccinated with her second dose of VARIVAX (Merck) (lot#667820/0757Z). On 11-AUG-2010 the patient had redness, pruritus and local site reactions. The patients sought medical attention and were treated with ice pack and comfort measures. The patient recovered from redness, pruritus and local site reactions on an unspecified date. This is one of several reports received from the same source. No further information is available.
arm pain/her arm is still kind of sore and she thinks it is in the muscle area going to her neck/was not really hurting but it was kind of sore/soreness; her arm is still kind of sore and she thinks it is in the muscle area going to her neck; her arm is still kind of sore and she thinks it is in the muscle area going to her neck; This is a spontaneous report from a Pfizer-sponsored program regulatory authority. A contactable 85-year-old female consumer (patient) reported to received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL9267), via an unspecified route of administration on 18Feb2021 (on Thursday, at the age of 85-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications was reported as no. On 19Feb2021 (next day), the patient experienced arm pain/her arm is still kind of sore and she thinks it is in the muscle area going to her neck/was not really hurting but it was kind of sore/soreness, her arm is still kind of sore and she thinks it is in the muscle area going to her neck. Reported that event experienced for a week after the first dose. Patient wanted to know the duration of this adverse event. The outcome of event (arm pain/her arm is still kind of sore and she thinks it is in the muscle area going to her neck/was not really hurting but it was kind of sore/soreness) was not recovered and the outcomes of events (her arm is still kind of sore and she thinks it is in the muscle area going to her neck) were unknown.  No follow-up attempts are possible. No further information is expected.
Information has been received from a medical assistant referring to multiple patients of unknown age and gender. On unknown dates the patients were inadvertently vaccinated with doses of improperly stored RECOMBIVAX HB (lot # L048849, expiration date 04-FEB-2018, route unknown). No adverse effects were reported. Additional information has been requested.
Recieved shots 7/17/2007. After midnight 7/18/07, father was watching TB, heard baby gurgling.  Mother woke up from sleeping and found baby blue and limp.  They ran out of the house and by the time she arrived at the ER, baby was crying.  Discharge diagnoses on 10/19/07 were: 1.  Right otitis media  2.  Slow weight gain, but within normal grawth cart  3.  History of preumonia  4.  Possible reflux. Dischareged with apnea monitor. 12/23/2008 MR received for DOS 10/18-19/2008 with D/C DX:  R Otitis Media.  Slow weight gain, but within normal growth chart.  Hx of pneumonia.  Possible reflux.  Pt presented to ER after episode of gurgling, limpness and cyanosis. Crying upon arrival.  TM red and bulging. Tx-abx. Placed on apnea monitor with no further events. ? reflux. D/C on home monitor.
BODY REJECTING THE HORMONES AND STOPPED WORKING, SENDING HER INTO MENOPAUSE AGAIN; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's past medical history included: hysterectomy, and concurrent conditions included: shellfish allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced body rejecting the hormones and stopped working, sending her into menopause again. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body rejecting the hormones and stopped working, sending her into menopause again. This report was non-serious. This case, from the same reporter is linked to 20210844560.
Diarrhea; first dose on 17Feb2021/second dose on 03Mar2021; first dose on 17Feb2021/second dose on 03Mar2021; This is a spontaneous report from a contactable consumer (patient). A 69-year-old patient of unspecified gender received 2 nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration at right arm at the age of 69 years old on 03Mar2021 as single dose for COVID-19 immunization. The patient medical history included headache. Concomitant medications included ibuprofen taken for headache, start date reported as'20 years, 30 years before, not confirmed, actually 40 year before when Ibuprofen 1st came out' and Multivitamins took it regularly one tablet per day from many years, all life (as reported). The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Feb2021 (at 69 years old) in right forearm near the shoulder for covid-19 immunization with no adverse event. The patient experienced a little small amount of diarrhea on 04Mar2021 on the following day of the 2nd dose but otherwise was pretty good. No investigation assessment. No treatment received. Diarrhea was gone in couple of days. The outcome of the event diarrhea was recovered on unknown date in 2021.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Red at injection site; sore injection site; swollen injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red at injection site), VACCINATION SITE PAIN (sore injection site) and VACCINATION SITE SWELLING (swollen injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red at injection site), VACCINATION SITE PAIN (sore injection site) and VACCINATION SITE SWELLING (swollen injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red at injection site), VACCINATION SITE PAIN (sore injection site) and VACCINATION SITE SWELLING (swollen injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
p/vax pt was taking creatine;that evening pt reported felt pins & needles over entire body & that this was similar of the way felt p/vax;pt exp papular rash;MD felt resembled prickly heat;fever & rash;allerg react or contact dermatitis;
Information has been received from a case in litigation for WAES# 0810USA04095 from a physician via medical records, concerning a female who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23. Subsequently on an unspecified date the patient experienced allergy to the PNEUMOVAX 23. The patient's outcome was unknown. No further information is available.
<24hrs after receiving H1N1 vaccine in right deltoid, upper arm became inflamed, painful, red, swollen, hot to touch. Erythema extended shoulder to elbow. Tender to touch.
Worsened wrist osteoarthritis; Wrist bone spurs; No space in between wrist bones; Two wrist bones growing together; This spontaneous case was reported by an other health care professional and describes the occurrence of OSTEOARTHRITIS (Worsened wrist osteoarthritis), EXOSTOSIS (Wrist bone spurs), ARTHROPATHY (No space in between wrist bones) and BONE DISORDER (Two wrist bones growing together) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Ankylosing spondylitis and MELOXICAM for an unknown indication.    The patient's past medical history included Wrist osteoarthritis, Wrist pain, Spinal fusion surgery (In the neck) on 28-Feb-2019 and Joint replacement. Concurrent medical conditions included Seasonal allergy.   In December 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On an unknown date, the patient started MELOXICAM (unknown route) at an unspecified dose. In February 2021, the patient experienced OSTEOARTHRITIS (Worsened wrist osteoarthritis), EXOSTOSIS (Wrist bone spurs), ARTHROPATHY (No space in between wrist bones) and BONE DISORDER (Two wrist bones growing together). In March 2021, EXOSTOSIS (Wrist bone spurs) had resolved. At the time of the report, OSTEOARTHRITIS (Worsened wrist osteoarthritis), ARTHROPATHY (No space in between wrist bones) and BONE DISORDER (Two wrist bones growing together) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, X-ray limb abnormal: significantly worse osteoarthritis (Inconclusive) significantly worse osteoarthritis, two bones in wrist growing together, no space in between bones. Bone spurs in wrist.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Initial Additional-2 : VAERS (incomplete) On 24-May-2021: Email received, NNI. On 25-May-2021: Email
This spontaneous report was received from a doctor of pharmacy refers to a 59-year-old female patient. Current condition included allergic to sulfa drugs. The patient was vaccinated with, 0.65 milliliter ZOSTAVAX (lot  #0566AE, expiration date 01-APR-2013) (validation request sent) subcutaneously once on 17-SEP-2012. Concomitant medications included FLEXERIL, SYNTHROID and NAMENDA. Pharmacist reported that on 17-SEP-2012 the patient experienced numbness from the injection site down to the fingers, on her right arm after she was administered the ZOSTAVAX. Pharmacist advised the patient to call back if there was no improvement. The patient had not called back. Treatment was not given for the event. It was unspecified whether medical attention was sought by the patient. The outcome of the event was unknown. Additional information has been requested.
On January 12, 2017, a 61 year old man incorrectly received an intradermal injection of MassBiologics' Td vaccine (Lot # A092C) into the right side of his jaw instead of lidocaine; the lidocaine was intended to be used as anesthetic for a mole removal procedure that was subsequently cancelled. On the day of administration, the patient had taken his routine medications: hydrochlorothiazide, pravastatin, propranolol, and aspirin. The patient experienced same day onset of injection site erythema and one day following administration (01/13/17), the patient reported the development of an "eraser-sized" induration and paraesthesia at the injection site. The patient did not receive treatment for the adverse event. The reporter followed up with MassBiologics on January 20, 2017 and indicated that he had seen the patient on January 17, 2017 and that the patient's injection site erythema and induration had completely resolved. However, the patient was still experiencing slight tingling near the injection site and further follow-up would be required. On February 16, 2017, the reporter informed MassBiologics that during a follow-up the patient indicated that he was not experiencing any more symptoms from the adverse event; specifically, the continued injection site paraesthesia had completely resolved. During the investigation MassBiologics queried the reporter for a root cause for the administration error, the reporter explained that the Td was intended for a different patient and the syringes containing both drug products were misdirected to the wrong patients. The reporter further clarified that he had only administered approximately 0.25mL of the Td product before realizing the syringe did not contain the lidocaine product. Sender's Comments: MassBiologics assessed this adverse event as non-serious and contained both labeled reactions and unexpected reactions. The injection site reactions of local erythema and induration are listed in the package insert for Td; the injection site paraesthesia was assessed as unexpected. Due to the wrong drug being administered to the wrong patient, the route of administration for the Td vaccine was incorrect. MassBiologics' (Sender) attempted to obtain the manufacturer of the drug not administered (lidocaine) from the reporter, however the reporter could not be certain as to the specific drug not administered. The reporter provided the manufacturer of the lidocaine that his facility currently stocks (Fresenius Kabi) but could not provide assurances to the implicated product. The reporter confirmed that the event was not reported to the lidocaine manufacturer. MassBiologics sent a letter containing information regarding this event to Fresenius Kabi USA, LLC on August 25, 2017.
Covid 19 Vaccine screening questionnaire reviewed , administered Covid vaccine; patient developed coughing spells, non productive after 2-3 minutes after the vaccine administration, she states she felt like fainting. Lung sound checked - no wheezing. Pulse Oximetry checked 96%. Observed for 30 mins in the field. Intermittent coughing still noted. Pulse oximetry remained 96%, no shortness of breath or difficulty breathing. After 3 0  mins, patient continue to cough , states she feels tickles in her throat that makes her cough and she has a headache. Patient given Benadryl 25 mg p.o. and monitored for 30 mins. Patient felt better after 25 mins of observation and minimal coughing , pulse oximetry @ 96-98% denies SOB or difficulty breathing . Patient sent home with husband and advised to rest at home and call 911 if she develops SOB or difficulty breathing.  Followed up call over the phone at 5: 00 PM , patient states she fell asleep when she went home  and no cough , no SOB or difficulty breathing.
a / 44 year old was prescribed with the first dose of the Shingrix / by her doctor /hasn't yet received it / is immunocompromised; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted product prescribing error in a 44-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis (early onset) and immunocompromised.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted product prescribing error. On an unknown date, the outcome of the intercepted product prescribing error was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter thought that the patient was possibly taking a biologic for arthritis. The reporter stated that the 44 year old patient was prescribed with the first dose of the Shingrix vaccine by her doctor and the patient had not received it till the time of reporting, which led to intercepted product prescribing error. No further events were reported.
Daptacel given after the expiration date, No AE; Initial information received on 11-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves15 month male patient who was vaccinated with expired 0.5 ml first dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number: C5366AA and 07-Feb-2020) via intramuscular route in the left thigh on 10-Feb-2020 for prophylactic vaccination. It was a 4th in series dose but as a 1st Daptacel dose.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and HIB VACCINE CONJ (TET TOX) (ACT-HIB).  It was actual medication error due to expired vaccine used.  No adverse events were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
3/4/04 Mother called to report "seizure in son at 6pm". See report from hospital ER.