chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (developed shingles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.      The patient's past medical history included No adverse event (No medical reported history).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced HERPES ZOSTER (developed shingles). At the time of the report, HERPES ZOSTER (developed shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     No relevant concomitant medications were reported.   No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of Herpes Zoster, a causal relationship cannot be excluded.
covid vaccine breakthrough case  dose 1 Pfizer 1/28/21  EL9265 dose 2 Pfizer 2/25/21  EN6202
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PROPRANOLOL, start date: 01May2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID-19 Treatment; (14Sep2022) Positive, notes: 6 days after finishing Paxlovid I have symptoms again and am positive on the test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti viral drug PAXLOVID was taken from 03Sep2022 to 08Sep2022 for the treatment of COVID-19   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The mother of patient called the morning of the 24th, 12-14 hrs after receiving the vaccination of GARDASIL. She said that he had awoken in the am with "hives all the way around his waist and on his knees". She gave him BENADRYL and sent him off to school She was asked if there was any redness or swelling around the injection site. There was none. Patient has allergies to pollen, but nothing else of which she knows. She was advised to let her medical provider know about the rash. The mom was contacted again on Thursday. She said that the rash was resolving and patient just had a small amount of rash remaining.
Extreme hives and rashing approximately 12 days after the booster shot. It is almost 2 months later, and I am still suffering from this condition.
Severe red rash over my entire body, fast heartbeat, dizziness, weakness, vomiting,  diarrhea, and severe headache.  I took Benadryl and tylenol.  After the 3rd day my symptoms started to get better oj the 3rd day.
Fever 99 F after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 99 F after 2nd shot) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever 99 F after 2nd shot). On 20-Apr-2021, PYREXIA (Fever 99 F after 2nd shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Apr-2021, Body temperature: 99 (High) Fever 99 F after 2nd shot.         No Concomitant product use was reported. No treatment information was provided.  After the second dose, the patient's temperature went up to a maximum of 99F and he did not had a fever.   This case was linked to MOD-2021-375559, MOD-2021-374581 (Patient Link).
patient got 3 doses of the moderna covid vaccine. on 5/22/21, on 6/19/21, and today on 6/22/21. He showed up today with a vaccine card that only had one dose listed on it so we gave him what we thought was his second shot. he then called back three hours later to tell us he got his second shot on 6/19 he just didn't have his card with him so it never got put on the card, and todays dose was dose number 3. he has no side effects as of now, and we told him to go to the er if he starts feeling bad.
pt recv vax & exp a failure to seroconvert w/a sigma ELISA test result of 0.11;MD reported 5 pt;
Hives mainly on torso, spread down to legs. Zytec 10 mg was taken. Symptoms have yet to resolve
Patient was supposed to receive second dose of Pfizer Biotech Covid-19 MONOVALENT 6mos-4y, but instead received Pfizer Biotech Covid-19 BIVALENT 6mos-4y. Patient did not have a reaction to the bivalent vaccine. Pharmacist consulted and recommended patient continues on with regular schedule.
flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th July 2020, the patient received the 1st dose of Shingrix. In July 2020, 8 hrs after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experiencing flu-like symptoms beginning 8 hours after administration and lasting approximately 48 hours. Limited information was available. The reporter consented to follow up. For tolerances of 2nd dose refer case US2020197294, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020197294:same reporter
Extreme nausea, vomiting and petechiae under eyes. Continued nausea/vomting for four (4) days. Nausea is received by ondansetron
Constant ringing in the ears -  primary care put me on antihistamine and if problem does not resolve immediately sending me to ear, nose, throat specialist
inadvertently administered monovalent instead of bivalent. no detrimental effects to the patient
unknown. Per patient: Patient was in the hospital for blood clots after having her Covid booster and wanted the incident to be reported.  Risk manager reviewed the hospitalization record and did not see any documentation correlating the clots with vaccine.
2 1/2x 1 1/2 inch erythema. 1x1 inch induration.
PATIENT DEVELOPED SHARP CHEST PAIN ON THE RIGHT SIDE WITHIN 15 MINUTES OF RECEIVING BOOSTER.  NO SHORTNESS OF BREATH.  PATIENT TRANSFERRED TO THE ED
RECEIVED HALF DOSE FOR THEIR  BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 59 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s vaccination from an unspecified manufacturer (suspension for injection, route of admin not reported, batch number: unknown expiry: UNKNOWN) dose was not reported, 1 in total administered, (dose number in series: 1) for prophylactic vaccination and it was unknown whether patient had any adverse events. The patient received covid-19 vaccine ad26.cov2.s booster dose (suspension for injection, route of admin not reported, batch number: 1822809 OR 211A21A expiry: UNKNOWN) dose was not reported, 1 total administered (dose number in series: 2) on 28-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-NOV-2021, following vaccination with booster dose of covid-19 vaccine ad26.cov2.s, the patient received half dose for their booster dose and off label use (dose number in series: 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received half dose for their booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211202250, 20211201046, 20211201082, 20211201228, 20211201168, 20211200752, 20211201351, 20211200994, 20211201450, 20211202199, 20211202469, 20211201286, 20211204104, 20211202379, 20211201179, 20211201443, 20211220146, 20211220262, 20211220250, 20211220145, 20211220619, 20211220129, 20211219871 and 20211220152.
expired diluent was used with Act Hib and was administered to a patient, with no AE; Initial information received on 02-Jul-2021 regarding an unsolicited valid non-serious case received from an other health care professional via physician via Medical Information (MI) number: 00667467.  This case involves a six months old male patient who was administered with expired diluent used with HIB (PRP/T) VACCINE [ACT-HIB] by a physician (Expired product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) [PREVNAR 13] and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID [PEDIARIX] for prophylactic vaccination respectively.  On 17-Jun-2021, the patient received a 0.5 ml second dose of suspect HIB (PRP/T) (HAEMOPHILUS TYPE B (HIB) VACCINE lot number UJ320AAB, expiry date: 13-Jun-2021 via an unknown route in the right thigh for prophylactic vaccination.   It was case of an actual medication error due to expired vaccine used (latency: same day).  It was reported "Medical Assistant (MA) says that expired diluent was used with Act-HIB and administered to a patient. She has questions about next steps. A patient was given Act-HIB vaccine in the right thigh. The Act-HIB expired on 13Jun2021 due to the diluent portion being expired on that date. Product used : Used and Still using product : No".  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Patient inadvertently received vaccine after published expiration date. Moderna Company analyzed lot 007B21A and advised vaccine maintained activity needed to protect against covid 19 on date vaccine was administered. Also patient did not call in to complain of advise event.  This is administative error without adverse event.
Vaccine given on 7/14/23 however, vaccine was OUT OF USE date as of 7/10/23.  No adverse effect reported.  Vaccine pulled from stock and patient to be notified once connect with company for further direction.  This was her 3rd vaccine after receiving Dose #1 and #2 in 2021.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (left arm still hurts, six weeks after first dose), loss of personal independence in daily activities (can't hardly lift anything with his left arm) and insomnia (hurts to lay and sleep on his left-side) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included chemotherapy (every two weeks) since an unknown date. On Aug 5, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 10, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain in extremity (left arm still hurts, six weeks after first dose), loss of personal independence in daily activities (can't hardly lift anything with his left arm) and insomnia (hurts to lay and sleep on his left-side). At the time of the report, pain in extremity (left arm still hurts, six weeks after first dose), loss of personal independence in daily activities (can't hardly lift anything with his left arm) and insomnia (hurts to lay and sleep on his left-side) outcome unknown. No concomitant medications or treatment information reported. This case linked to MOD-2021-318419 (patient link).
Swollen lymph node in left armpit reoccured ~4 weeks after shot, lasting for at least 12 days.  Lymph nodes were swollen and painful on day of shot as well for 2-3 days, but had subsided.  No fever at any point.  Fatigue with both events.
Administration Error: 12 children, including this patient, at a recent community vaccination event erroneously received ~25.7mcg of the adult Pfizer formulation instead of the intended 10mcg dose. In this case, the vaccine mixer pulled the Pfizer vaccine for adults/adolescents (purple top; for 12 years +) from the cooler instead of the intended Pfizer Pediatric (orange top; for 5-11 years).  He proceeded to prepare the Adult Pfizer vials following the Pediatric Pfizer instructions (diluted with 1.3mL diluent and prepared 0.2mL into syringe).  These doses were administered to 12 patients before the error was identified.  All patients did not report any adverse effects during the immediate observation phase, or during phone call follow-up several days following the event.  All patients/parents have been notified of the error, advised that the CDC considers this a valid 1st dose, and will proceed to receive the 2nd dose as scheduled.  Mixing procedures and workflows have been evaluated and adjusted per our safety action plan as a result of this error.
RN injected patient's right deltoid until needle fully in muscle, pushed plunger and noticed 1-2 drops of vaccine leak from faulty connection between syringe and needle, continued to push plunger (no vaccine leakage) until syringe contents emptied, and attempted to withdraw syringe from patient's arm. While pulling on syringe, syringe separated from needle (syringe in RN's hand, needle in patient's arm). RN immediately removed needle from patient's arm with no incident and applied Band-Aid (no blood present). No complaints from patient regarding pain. RN later (same day) informed patient and patient's daughter (authorized representative) who agreed for patient to be revaccinated on 1/18/23 based on CDC guidelines to revaccinate immediately (no minimum interval) if patient received dose that is less than recommended per manufacturer.
30 hours after last immunization pt developed a rash consistent with erythema multiforme.
PT REPORTS SHE HAD CHILLS BEGINNING THE DAY AFTER RECEIVEING THE FLU VACCINE. PT ALSO REPORTS WHEN ATTEMPTING TO USE THE RESTROOM  HER BLADDER EMPTYING PRIOR TO MAKING IT TO THE TOILET. PT SAYS IT SEEMS AS IF SOMEONE CUT OPEN HER BLADDER AND EMPTIED EVERYWHERE. PT REPORTS  SHE HAS ALWAYS RECEIVED THE FLU VACCINE BUT HAS NEVER EXPERICED ANY SIDE EFFECTS. PT WAS COUNSELED THAT SHE MAY EXPERIENCE FEVER OR CHILLS AFTER RECEIVING THE VACCINE.
This case was reported by a physician and described the occurrence of diarrhea in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included PENTACEL; Merck; unknown; unknown given on 17 February 2010. On 17 February 2010 at 10:30 the subject received 1st dose of ROTRARIX (oral). On 18 February 2010, approximately 24 hours after vaccination with ROTARIX, the subject experienced diarrhea and loose stools. The physician reported the subject received a ROTARIX vaccination and approximately 24 hours later the subject developed diarrhea with about six or seven loose stools a day. The physician reported the subject was not in any discomfort. The subject has had the loose stools since the day of vaccination without worsening or resolution. The subject is on a formula and breast fed, but has not experienced diarrhea prior to the vaccination. At the time of reporting the diarrhea and loose stools were resolved. The physician considered the events probably related to vaccination with ROTARIX.
pt devel ataxia, irritability 5-7 days p/MMR; pt also on oral steroids @ time of MMR;
Mild rash all over the body the evening post-vaccination. Alleviated by diphenhydramine. Heart palpitations for 2 days post-vaccination
Pharmacists administer the wrong   Engerix B 10cmg (pediatrict ) instead of Engerix B 20mcg (adult)
Pt recvd 3 doses of Engerix-B & 25NOV91 it was determined that pt did not respond to the vax series;
Got the second shot and she has been experiencing fever from like twelve days; This is a spontaneous report from a non-contactable consumer (patient's parent). A 22-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, (Lot number was not reported, Expiry date was unknown)), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported, Expiry date was unknown) as dose 1, single for COVID-19 immunization. On an unspecified date, the patient got the second shot, and she has been experiencing fever from like twelve days. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
States that her rheumatoid arthritis was in remission and there are several reasons why she may have been taken out of remission, but It could be because of receiving the Pfizer COVID vaccine.; States that her rheumatoid arthritis was in remission and there are several reasons why she may have been taken out of remission, but It could be because of receiving the Pfizer COVID vaccine.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient medical history included rheumatoid arthritis. The patient's concomitant medications were not reported. On unspecified date the patient stated that her rheumatoid arthritis was in remission and there are several reasons why she may have been taken out of remission, but It could be because of receiving the Pfizer COVID vaccine. The outcome of the event was unknown.    The lot number for BNT162B2 was not provided and will be requested during follow up.
Pt seen here on 11/03/2008. Received a MENACTRA injection last week by another MD. Was given SC on (L) forearm. Pt presented with redness, swelling area hot to touch, Pt febrile, (R) (L) axillary node. Dx with cellulitis. Rx ed with vom, IV ROCEPHIN X 3 QD and Keflex PO x 10 days.
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 28-JUL-2016, the patient was vaccinated with improperly stored dose of VARIVAX (dose, route of administration and injection site were not provided)(lot # M009765, expiration date: 25-FEB-2018). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt recvd 1st dose of Engerix-B & 24MAR92 pt exp shooting pain up the neck on side of body that inject was administered; localized reaction; discomfort in back & generalized weakness; pt went to ER 24MAR92 & 25MAR92; seen by ER MD:
Received shots on 9/15/03 at well baby visit. Back her 9/16/03 for irritability, fever 104.2 R. Injection site was red. Pt given Motrin(?) while here, looking better before leaving.
FIRST SHOT 03/17/2021 AWAKENED WITH CHAPPED LIPS AND SLIGHT PEELING. 2ND SHOT AWAKENED TO LIPS PEELING LAYER AFTER LAYER OF SKIN BURNING , CRACKING  BOTTOM LIP SWELLING VERY LARGE THEN DAY LATER TOP LIP  SWELLING VERY UNCOMFORTABLE. IT HAS BEEN A WEEK AND i STILL HAVE ALL SYMPTOMS
Patient received double dose of flu vaccine. 1st vaccine: 11-12-13 2nd vaccine: 1-16-14.
Tinnitus in both ears.  Appeared shortly after second shot.  Popped up and took me a bit to correlate it to the vaccine.  Never had Tinnitus before.
pt. recvd dose M-M-R II & exp. "mumps-like synd".
Reporter indicated 5 pts recvd Engerix-B & had tinnitis, dizziness;
pt began w/fever of 101 16JUL & by 19JUL lite rash on face & stomach noted; 20JUL began w/103 fever; brought pt to Er 23JUL; pt found to have mild ear infection;
10pm experienced nausea, 11pm -2am uncontrollable chills and shivering, nausea,  aching, 2am-vomiting, fever, aching 3am-diarrhea, nausea, aching, fever until 11am. 12pm following day, fever decreased, able to eat,  persistent exhaustion,  weakness,  chills, aching continued until  7am  the third day.
Thursday 9/15 - sore arms Friday 9/16 - sore/swollen arms and headache  Saturday- Headache and dizziness  Sunday- Headache, dizziness, tingling all over my body Monday- Headache, dizziness/numbness, tingling/cold all over body, unable to drive since feeling faint and disoriented unable to concentrate and speak clearly and  fatigue  since Thursday
Developed s/s of COVID 6/30, tested positive for COVID 7/2/2021. Pt is currently pregnant, but was not pregnant at the time of vaccination
tested positive for COVID-19; chills; Sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19), CHILLS (chills) and VACCINATION SITE PAIN (Sore arm at injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 010M20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at injection site). On 24-Feb-2021, the patient experienced COVID-19 (tested positive for COVID-19) and CHILLS (chills). At the time of the report, COVID-19 (tested positive for COVID-19), CHILLS (chills) and VACCINATION SITE PAIN (Sore arm at injection site) outcome was unknown.            No treatment information was provided.   This case was linked to MOD-2021-033338 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Additional information received on 20-Jul-2021 and included no new information.