chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 07-DEC-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (exposed to the following temperatures and cumulative time frames colder than 36F: In September of 2015, the coldest temperature was 34F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34F for 192 hours, for a total of 1,031.3 hours (43 days)) with lot number: L025738, expiry date: 14-AUG-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report received from a registered nurse referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that on 07-DEC-2016, the patient received improperly stored PNEUMOVAX 23 (lot# M037669,exp. date 09-MAY-2016). No adverse effects reported. The vaccines were stored at 69F for 1 week. The call was because of data logger. Additional information has been requested.
when I first started feeling symptoms, I was achy, I wear a pain patch for my syndrome, achy all over, muscles felt like they were cramping, headaches, nauseated , tickle in my throat, and then a cough I couldn't get rid of. I gradually got sick and tested positive for Covid 19 on April 6 . I couldn't breathe, I couldn't walk. I had bilateral pneumonia
No additional AEs were reported; Pharmacist reported that adult patient received a pediatric dose of VAQTA; This spontaneous report was received from a pharmacist concerning a 28 years old adult patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 18-NOV-2022, the adult patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA), lot number w021491 with expiration date 14-DEC-2023, 0.5 millilitre (mL) dose, once for prophylaxis (strength, route of administration and anatomical location were not provided) (product administered to patient of inappropriate age). No adverse events (AEs) were reported(no adverse event).  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2212USA002459:
The pt vomited three times and had diarrhea one time the afternoon of the day the vax was given.
Chief Complaint: Left lower extremity numbness, jaw numbness  Discharge Diagnosis: Peripheral neuropathy vs transverse myelitis vs related to T9 small lesion  Discharge Condition: Fair  Discharge Diet: Regular  Discharge Activity Level: As tolerated except no driving  Plan of Treatment: Discharge home with home health and physical therapy Prednisone for 3 days Follow-up with primary provider in 1 week Refer to neurologist EMG as outpatient in 4-6 weeks, also repeat MRI T spine in 6-8 months
PATIENT'S EYES CLOSED AND THE PATIENT PROGRESS TO FALL OUT OF THE CHAIR IMMEDIATELY AFTER THE IMMUNIZATIONS. PHARMACIST AND A PARENT HELD THE PATIENT TO PREVENT FROM FALLING TO THE GROUND
Initial report received from a healthcare professional on 25 August 2014. A female patient (age not reported) had received an intramuscular dose of FLUZONE HD, (batch number, dose in series and site of administration not reported) on an unspecified date. The patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not provided. On an unspecified date, the patient developed 4x2 red patch at the site of injection and had pain and swelling. Corrective treatment and laboratory details were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none.
The patient received the Moderna COVID-19 vaccine in her left arm at 09:33 AM on 03/25/21. Approximately 8 minutes after receiving the vaccine, the patient reported feeling light headed. She patient was relieved after placing an ice pack on her neck and taking 1 glucose tablet. She reported no other symptoms.
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX into the inner aspect of the upper arm, rather than the deltoid region, lot#, dose, frequency and route unspecified. No adverse effects reported. Additional information has been requested.
This spontaneous report received from a patient concerned a 49-year-old Not Hispanic or Latino male. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine (dose number in series: 1) (suspension for injection, route of admin not reported, batch number: UNKNOWN and expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-MAR-2021 to the left shoulder for prophylactic vaccination. It was unknown whether the patient had any adverse event following vaccination with covid-19 vaccine. (Dose number in series: 1). The patient received covid-19 vaccine (dose number in series: 2) (suspension for injection, route of admin not reported, batch number: 1822811 and expiry: UNKNOWN) dose was not reported, 1 total, administered on 23-OCT-2021 to the left deltoid for prophylactic vaccination. No concomitant medications were reported. On 03-JAN-2022, following vaccination with covid-19 vaccine. the patient had a break through case of covid-19 (suspect COVID-19) and the patient also stated that he had the symptoms of headache, fever, runny nose, congestion, cough and body ache(entire body). The patient also mentioned that his smell and taste were intact. On same day patient confirmed with a binax (covid-19 rapid test) test that he had a covid (coded as suspected COVID-19 and suspected clinical vaccination failure) and on 04-JAN-2022, the patient went for a PCR (polymerase chain reaction) test, but the results were pending. (Dose number in series: 2). The action taken with covid-19 vaccine was not applicable. The outcome of the reported as suspected COVID-19 and suspected clinical vaccination failure were unknown. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint and reference number requested.; Sender's Comments: V0: 20220104537-covid-19 vaccine Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 28-APR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of -1 Fahrenheit degree. The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 0 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
One week after shot: swelling and redness from 2 inches above site down to 2 inches from elbow and left to right. Pussing from site with minimal bleeding. Went to Emergency Room and was told it was forming into absess. Was put on antibiotics. After 2 days of taking antibiotics wound started to scab and swelling and redness went away. When scab fell off on Nov 7 there was a crater formed into arm, with pin holes in skin along with oozing of puss, and minimal bleeding. I was seen by the doctor at my base and was told to continue taking the antibiotics and change bandages frequently. Rx: Keflex, 500mg, qid / Zyrtec, 10mg qd. Re-evaled at Westover on 7 Nov 2007. Dx: secondary staph infection.
Redness, swelling at site of vaccination on Wed. following vaccine began itching and cotton mouth. Began taking BENADRYL.
Information has been received from a RN concerning a 34 month old healthy male with an allergy to Amoxil and no medical history who on 03/11/02 was vaccinated with a dose of varicella virus vaccine live (Lot # 639488/0572L).  On 01/07/04 the pt developed chickenpox. The pt had spots on his back and multiple crusted areas on his chest and back and one vesicle on his chin. There were less than 50 lesions. There was no fever. Unspecified medical attention was sought and no treatment was required. It was noted that the pt had been exposed to his grandmother who had shingles. No product quality complaint was involved. It was also reported that the pt's sister was vaccinated with a dose of varicella virus vaccine live and also developed chickenpox (WAES # 0401USA00930).  Additional information has been requested.
rash over entire body/ looking like mosquito bits/being very itchy; Soreness in the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash over entire body/ looking like mosquito bits/being very itchy) and VACCINATION SITE PAIN (Soreness in the injection arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C214) for COVID-19 vaccination.     No medication history information was reported .  Concomitant products included VITAMIN E NOS, CALCIUM and VITAMINS NOS (DAILY VITAMINS) for an unknown indication.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-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 RASH PRURITIC (rash over entire body/ looking like mosquito bits/being very itchy) and VACCINATION SITE PAIN (Soreness in the injection arm). At the time of the report, RASH PRURITIC (rash over entire body/ looking like mosquito bits/being very itchy) had not resolved and VACCINATION SITE PAIN (Soreness in the injection arm) had resolved.            Concomitant medication include B-complex. Treatment medication include ointments & allergy pills.   This case was linked to MOD-2021-253215 (Patient Link).
Shingles 3 months after vaccination; This spontaneous case was reported by a physician and describes the occurrence of HERPES ZOSTER (Shingles 3 months after vaccination) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024L20A and 025021) for COVID-19 vaccination.     The patient's past medical history included Lymphoma (Patient was on Chemotherapy for approximately 5 months.). Concurrent medical conditions included Immunocompromised.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced HERPES ZOSTER (Shingles 3 months after vaccination). At the time of the report, HERPES ZOSTER (Shingles 3 months after vaccination) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
I started to develop rashes on my neck after eating certain items. I had never had any rashes prior to being vaccinated with COVID-19. Wine, dairy products, chocolate, would cause me to break out again and never had allergies to these items before and occasionally just break out having eaten nothing.
extreme weakness and malaise; extreme weakness and malaise; inability to ambulate; no appetite; She requires complete assistance with even basic Activities of daily living; This is a spontaneous report from a contactable other hcp (nurse, patient's daughter). A female patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date (Lot number and Expiry date was not reported) as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, within 6 days the patient experienced extreme weakness and malaise, inability to ambulate, no appetite and she requires complete assistance with even basic activities of daily living. She was previously independent and ambulatory. The outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
No known adverse effects; A patient received a dose of M-M-R II via the intramuscular route in error.; Information has been received from a medical assistant referring to a patient of unknown and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 21-MAR-2019 the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot# and expiration date unknown), intramuscularly, for prophylaxis (inappropriate route of vaccination). No adverse effects were reported.No product quality compliant (PQC) involved.
He experienced a fever 4 days and had 6 spots on him from the MMR shot.
Severe headache (light and sound sensitivity), lasted almost 48 hours, took over the counter ibuprofen and Tylenol.
rash at the injection site and down her arm/rash at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number M9P52, expiry date 18th December 2021) for prophylaxis.   On 8th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 5 months after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient experienced a rash at the injection site and down her arm. The rash resolved after about 1.5 weeks.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 15-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N023828 and expiration date 25-JUN-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018   was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709:
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was administered a 0.5 ml dose of PNEUMOVAX 23 with expiration date 27-SEP-2012 and LOT number 669776/0614AA on 18-JAN-2013. No adverse affects reported. Additional information has been requested.
The injection was given and I would say for about a minute and a half I was interacting with the pharmacist and my husband and I was telling them I had never had a reaction to a vaccine before and that I was sure I was fine to go home but they told me to wait 20 minutes, then all of a sudden my lips and tongue started to tingle while I was telling her I could leave and I started to taste a heavy amount of rubbing alcohol in my mouth so I started to smacking my lips and my eyes started to roll back as I became extremely dizzy and disoriented and felt like the room was tilting and spinning and the pharmacist quickly opened the door to room and asked for someone to come and help and I started to slump down in my chair and they helped lower me down to floor where I started to reach for my ears and complaining that it sounded like a freight train in my ears. They shouted to call 911 and I had a feeling I was going to vomit and that I was going to pass out and so I was concentrating on staying conscious and pharmacist went and got an EpiPen and at that point I became ballistic and told them not to come near me but I'm not sure why I became belligerent and I was terrified and told them to get away from me and they said they couldn't do anything if I was consciously refusing medical care. Paramedics came a few minutes after and at that point I started to regain composure and it felt like waves of heat was coming over me and at that point I developed hives which progressed and ringing in ears sounded like a train, but it started to subside slowly and swelling in mouth started to come back down. I didn't lose ability to breathe, but my tongue and lips swelled all the way up and bothered me. 48 hours after, the alcohol taste went away as did the hives. The paramedics checked me out and then once they had said that my blood pressure was normal that I didn't have to go to the hospital, but they did need to confirm that I was going to my PCP which I did within 24 hours. I believe he gave me a steroid to bring down the hives and after about 2 weeks everything was back to normal. My PCP didn't run any medical tests but did consult with someone else in practice who studies vaccines and their best advice was to not get the 2nd dose and he said there was a medicine he could give me but if he gave it to me now it could reduce to efficacy of the vaccine that if I did that it was all for nothing.
COVID 19 Treatment; COVID 19 Treatment; Dose Number: 5:Pfizer / Dose Number: 4:Pfizer / Dose Number: 3:Pfizer / Dose Number 2:Moderrna / Dose Number 1:Moderna; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Lot number: J6793) at the age of 36 years for covid-19 immunisation; BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Lot number: 33030BD) and in Jul2022 as dose 4 (booster), single (Lot number: FJ4989) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Mar2021 as dose 1, single (Lot number: 030A21A) and in Apr2021 as dose 2, single (Lot number: 018B21A) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ESOMEPRAZOLE MAGNESIUM, start date: Jan2021. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Nov2021, outcome "unknown", described as "Dose Number: 5:Pfizer / Dose Number: 4:Pfizer / Dose Number: 3:Pfizer / Dose Number 2:Moderrna / Dose Number 1:Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took Paxlovid on 08Nov2022 as treatment for COVID-19.
Fever, horrendous body aches even in fingers and toes, headache, sensitivity to light and sound, no appetite
RECEIVED SECOND DOSE ACCIDENTALLY; This spontaneous report received from a health care professional concerned a 75 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient reported none medical history. the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041a21a, expiry: UNKNOWN) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-JUN-2021, the subject experienced received second dose accidentally. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received second dose accidentally was not reported. This report was non-serious.
Patient is 17 years of age and received the Moderna vaccine (rated for 18+).  Pharmacy incorrectly administered her a vaccine that she should not receive at her age. She has not experienced adverse effects besides the muscle ache and fatigue following the 1st dose. Pharmacy says that they will not complete her 2nd dose due to this. Even though the website states that it is best that the Patient completes the 2nd dose of the Moderna vaccine.
Inflammation in the ear; Inappropriate Schedule of Vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of otitis in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number BP57E, expiry date 7th June 2020) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced otitis and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the otitis and circumstance or information capable of leading to medication error were unknown.   It was unknown if the reporter considered the otitis to be related to Shingrix.  Additional details was reported as follows: The age at vaccination was not reported. The patient received the first dose of Shingrix in September and then started a Prednisone therapy that lasted for three months. The patient was planning to delay the second dose for a period longer than six months after the second dose, which led to circumstance or information capable of leading to medication error. The reporter consented to follow up.
Husband called on  Friday 7/26/19 and stated his wife's arm was very red swollen and painful. Advised them to ice and take ibuprofen and benadryl.
Case number PHEH2014US021659 is an initial spontaneous report received from a nurse on 24 OCT 2014. This report refers to  48 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 1410801) intramuscularly from a multi-does vial (MDV) on 17 OCT 2014. It was reported that during vaccination, the needle separated from the syringe and the patient did not receive full dose of vaccine. No adverse events were reported following the medication error.