chrisvoncsefalvay/vaers-outcomes huggingface dataset:
69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment information was provided.  Between 06-Jan-2022 and 11-Jan-2022, there were a total of 69 administered doses of Lot 012H21B. Of these, 68 doses were boosters and 1 dose was a first dose.
HEADACHE; FEVER; SORE THROAT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid-19 pneumonia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced fever. On 07-MAR-2021, the subject experienced sore throat. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and fever, and the outcome of sore throat was not reported. This report was non-serious.
started at 3 am 4/8/2021- stuperous, mind fog, forgetfulness, inability to walk, joint pain, lethargic, metal taste in my mouth, sensitivity to light, intense brain pressure like a migraine but not  this lasted 3 days.
Severe hives began 6 days after the injection. I had a 40 mg injection of Kenelog on the 5th day after the hives began.  I am still breaking out in hives.  I have been taking Allegra twice a day to  control the itching and hive breakouts.
Pt was vaccinated with Smallpox, pt returned to clinic for take-check follow up and noticed satellite lesions around the vaccination site. Mild axillary lymphadenopathy and erythema surrounding vaccination.
2 days after TDAP received, child developed red welt covering half of upper arm.  Also has pruritis (this began 1 day afterwards; redness began 2 days after vaccine given).
About 5 minutes after receiving vaccine, patient became light headed and had brief loss of consciousness- a few seconds. Was sitting in chair in waiting room and slumped over. After she regained consciousness and was given water, she vomited 1 time. BP was 98/60 and HR was 70 immediately after. Patient stated she felt fine shortly after vomiting. She stayed another 15 minutes in the clinic with no further events. Stated she felt normal before leaving.
Left side of face swollen and puffy could only be controlled by taking benedryl.  Severe full body joint pain. Swollen joints to the point of not being able to walk around unassisted. Severe neuralgia nerve pain that lasted in multiple 6 hour or more periods. Vertigo, nausea, extreme fatigue. 2nd dose effects are worse than first. Most of my Lupus, RA and neurological problems were heightened during this time after receiving the vaccine.
1.5 hours after getting vaccines patient broke out with a rash, swelling of ears. Rash to abdomen, hands, face, ears, bottom. Started with cough. Mom gave pt TYLENOL after onset of symptoms. Rash started resolving about 2 hours after onset.
Pt. received smallpox vaccination 1/08/08 R arm.  On 1/20/08 Pt. noted a reddened raised area located on R temporal area of head. Pt. thought this was a acne pimple and a topical prep containing benzoyl peroxide.  Evening of 1/20 Pt. noted reddened area developed a blister.  Pt. denied any C/O drainage from site and denied any other lesions on any other part of her body.  Pt. presented to Medical Group 1/22.  Area on temple measures 5mm x 2mm.  The area is scabbed over and no drainage noted.  Advised pt to keep this area covered and to treat area as if it were vaccine related.  Further advised pt. to see her PMD for evaluation.
Dizziness, nausea, leg pain(left), migraines, diarrhea (ongoing),chills, unable to regulate body temperature(ongoing), severe fatigue (also ongoing), difficulty working, inappetince... Spoke with doctor.  No help. No treatments.
This spontaneous report as received from consumer via a pharmacist refers to a 71 year old husband. The consumer reported that her husband started the ZOSTAVAX (lot # J001697) a single 0.65 ml dose subcutaneously in the upper left arm on 18-JUL-2013 for prevention of shingles. The patient has no relevant medical history and the patient's relevant past drug history include: PROPECIA and hydrochlorothiazide, losartan potassium 100/25 once daily. The patient's relevant past drug history was unknown. Within the last 48 hours or since approximately the 13-OCT-2013, the consumer's husband started to experience the red bumps on his tongue, he had not slept, had pain in the mouth and had not been able to eat; he was dizzy and walked into a wall, had no energy and these symptoms continue. Last night on the 14-OCT-2013, his wife had him take off his night clothes because they were so wet from sweating and as of 15-OCT-2013, the sweating has resolved. On 15-OCT-2013, the consumer took her husband to the doctor and she reported to the pharmacist that her husband was diagnosed with shingles on his tongue and for treatment, they started him on an antiviral called ZOVIRAX 800mg three times a day, for seven days along with oxycodone 5/325 for the pain every 6 hours, AMBIEN 10mg because he had not slept in two days and lidocaine swish and swallow so he can eat. The consumer also reported that her husband was home right now in bed "freezing" and shaking like he was cold. It was unknown if there was any relevant laboratory data. As of 15-OCT-2013, it was unknown if the consumer's husband would continue to take the ZOSTAVAX and he continued to experience "freezing" and shaking like he was cold, red bumps on his tongue, he had not slept, had pain in the mouth and had not been able to eat, dizziness and had no energy. The sweating had resolved and it was unknown if he continued to walk into the wall. Additional information has been requested.
No adverse event; Received 0.25ml instead of 0.5ml of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster).    No concomitant medications were reported.  It was reported that 20 adult patients received 0.25ml instead of 0.5ml of Bivalent Moderna COVID-19 Booster from end of August to middle of October 2022.   No treatment medications were reported.  This case contains information for the 18th of 20 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-662871, US-MODERNATX, INC.-MOD-2022-662860, US-MODERNATX, INC.-MOD-2022-662881, US-MODERNATX, INC.-MOD-2022-663016, US-MODERNATX, INC.-MOD-2022-663014, US-MODERNATX, INC.-MOD-2022-662866 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662871:9 th patient US-MODERNATX, INC.-MOD-2022-662860:3 rd patient US-MODERNATX, INC.-MOD-2022-663016:Patient 18 US-MODERNATX, INC.-MOD-2022-662881:Patient 18 US-MODERNATX, INC.-MOD-2022-663014: US-MODERNATX, INC.-MOD-2022-662866:Patient 17
DEATH; BLOOD CLOTS; SUSPECTED CLINICAL VACCINATION FAILURE; COVID RELATED ISSUES; This spontaneous report received from a company representative concerned a 50year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. According to the hearsay, a patient died after taking the Janssen Covid 19 shot some time ago. On an unspecified date, the patient died with Covid related issues (suspected clinical vaccination failure) and he had blood clots. On an unspecified date, the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of covid related issues, blood clots and suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20210829189-COVID-19 VACCINE AD26.COV2.S-death, blood clots. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210829189-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear 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; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
swelling in front of ear to jaw lasting 3 days; (had MMR 12NOV92-swelling started 3DEC92; MD dx as mumps reaction from vax; given ATB;
6AUG93 pt stopped breathing mouth to mouth given t104.7, sz; CSF & blood OK; 10AUG94 fine erythematous generalized rash dx rosella;
Sometime around Noon, I started to experience a headache, stomach cramping, and light nausea, but ignored it because it wasn't that bad and I thought I might just be hungry. By 3pm my intestines began gurgling and by 5pm I had diarrhea (lasting 18 hours).  By midnight I was doubled up in cramps. At about 2am on 12/03/2009, I had experienced diarrhea, nausea, vomiting, and dizziness so bad I could hardly function. I also started running a 100.8 fever. At 5am I called my HMO's 24/7 Nurse Helpline. I was told that it's not flu, but likely a (very rare) adverse reaction to the shot itself. She pointed me to the CDC website and said to report my symptoms and if it gets any worse or if I have additional symptoms as listed on the site as "severe," to call my doctor or head to the hospital. (FYI, I've never had adverse reactions to any of the flu shots before, but she said they could start at any time in any given person of the population.) She said I could take OTC meds if I wanted to, but I decided to monitor my symptoms while letting it ride out its course.  At approximately 24 hours after the shot was administered my symptoms improved and as of 2pm today I have been able to keep down food and liquids and all symptoms (except for the dizziness) have subsided.
Hospitalized 5/24/22-6/1/22 Fall,  hip fx, cough, hypoxia, PNA,
This spontaneous report was received from a licensed practical nurse regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 25-AUG-2015, the patient was vaccinated with GARDASIL 9 dose 1, lot # L007560, expiration date 15-JUN-2017 (strength, route and anatomical location of administration were not reported). On 16-DEC-2015, the patient was vaccinated with GARDASIL 9, dose 2, lot # L0255737, expiration date 27-JUL-2017 (strength, route and anatomical location of administration were not reported). On 16-FEB-2016, the patient was vaccinated with GARDASIL 9, dose 3, lot # L045711, expiration date 08-MAY-2017 (strength, route and anatomical location of administration were not reported). The nurse reported that the patient received doses of GARDASIL 9 outside the recommended series schedule intervals. No adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Information has been received from a nurse concerning a 10 week old male patient who on 03-Aug-2009 was vaccinated with a dose of ROTATEQ (lot number 663903/0088Y). On 04-Aug-2009 the patient developed diarrhea. It was noted that the patient has had 1-2 episodes of diarrhea since the vaccine was given. Medical attention was sought via an office visit with the physician. It was unspecified if lab studies were performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Janssen COVID-19 Vaccine EUA About two to five minutes after taking the vaccine, I began to feel as if I was going to pass out. I collapsed twice, but never went unconscious. My arm was very sore, and I was very weak and dizzy and clammy. I got only a little better as the night went on. Today, I have had flu-like symptoms and my body aches very much. I hadn?t seen a lot symptoms involving nearly immediately passing out, so I thought I should report my side effects.
Initial information received on 06-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient of unknown demographics who received vaccine FLUZONE QUADRIVALENT. (Suspension for injection) inadvertently after there was a temperature excursion. The patient's past medical history and concomitant therapy were not provided. On an unknown date, the patient received a dose of suspect Influenza Quadrival A-B Vaccine lot number not reported via unknown route in unknown administration site. It was a case of actual medication error due to incorrect product storage. It was reported that FLUZONE QUADRIVALENT had been exposed to temperatures below 0 degrees Celsius, and then inadvertently administered to a patient. It was unknown whether adverse event occurred. 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 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. Documents held by sender: none.
Headache; Pain in upper arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in upper arm) and HEADACHE (Headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 1. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in upper arm). On 13-Feb-2021, the patient experienced HEADACHE (Headache). On 13-Feb-2021, HEADACHE (Headache) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in upper arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       She took Tylenol on15 Feb 2021 for the arm pain.   Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2021: No specific follow-up information recorded.
On Jan 23, 2015 (1 month to the date of my sons flu vaccine) he wouldn't stop banging his head.  He was unresponsive  to his name being called, he wouldn't eat, smile, drink or  play and he was very irritable.  All of which, was totally out of character for him. Soon after  he started having separation anxiety.  Soon after that he became aggressive with his classmates and began having OCD.
On 6/12/19 pt developed itchy macular rash.  Seen at local ER and diagnosed with Acute viral syndrome and Dermatitis.
Severe stomach pain, passed out cutting chin, neck, bruised windpipe, vomiting and chillls
10 hours after injection #2, I couldn?t speak or walk. That lasted about 12 hours. It?s happened to me when I get a cold or illness, but never from an injection. About a day after that, I developed a full body rash which lasted about a week. No reaction at all except a sore arm to injection #1 which was given in the left arm.
Developed urticarial itchy rash all over body 2 days after immunizations. Treatment with Hydrocortisone 2.5% cream.
Severe pain at injection site left arm; Cannot move left arm; fingers tingling left arm; fingers involuntary movement left arm; fingers were numb; pain extends from injection site and surrounding area Left arm; immediate pain in left arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Severe pain at injection site left arm), MOVEMENT DISORDER (Cannot move left arm), PARAESTHESIA (fingers tingling left arm), DYSKINESIA (fingers involuntary movement left arm) and HYPOAESTHESIA (fingers were numb) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Severe pain at injection site left arm), MOVEMENT DISORDER (Cannot move left arm), PARAESTHESIA (fingers tingling left arm), DYSKINESIA (fingers involuntary movement left arm), HYPOAESTHESIA (fingers were numb), VACCINATION SITE PAIN (pain extends from injection site and surrounding area Left arm) and PAIN IN EXTREMITY (immediate pain in left arm). At the time of the report, VACCINATION SITE PAIN (Severe pain at injection site left arm), MOVEMENT DISORDER (Cannot move left arm), PARAESTHESIA (fingers tingling left arm), DYSKINESIA (fingers involuntary movement left arm), HYPOAESTHESIA (fingers were numb), VACCINATION SITE PAIN (pain extends from injection site and surrounding area Left arm) and PAIN IN EXTREMITY (immediate pain in left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
A 41 year old female medical assistant reportedly was not taught how to properly administer Oncotice and as a result, during an administration to a patient, accidentally and amount sprayed in her throat. Results of tuberculosis test were neg, but less than two weeks later she developed a bump on her left forearm, which blistered and peeled. Her initial physician felt it was only a reaction to Oncotice exposure. Reportedly the bump and the surrounding area now looks like a burn and the woman was referred to another physician for further treatment and evaluation. Follow up received on 11/10/2005 female stated the bump on her forearm continues to grow and is now the size of a dime. It is still red, raised and blistering. She consulted with her primary care physician who conducted a lung X ray approx three weeks ago. Results were neg for any findings.
VACCINE WAS DRAWN UP BEFORE THE 30 MINIUTES RONCONSTITUTION TIME.
Information has been received from a licensed practical nurse (LPN) concerning a child who on 14-JUN-2006 and 15-AUG-2006 was vaccinated PO with the first and second dose, respectively, of Rotateq (human-bovine). The LPN reported that the patient subsequently developed diarrhea, an ear infection and a cold. Unspecified medical attention was sought. It was noted that the third dose of Rotateq (human-bovine) was not given at the recommended schedule due to the child's events (no symptoms noted from not getting 3rd dose at recommended schedule). At the time of this report, the outcome was unknown. Additional information has been requested.
IPOL due to completing inventory; temperature excursion was 1.8C to 0.8C; total time of excursion was 35 minutes; IPOL was administered to 1 patient post-excursion with no reported adverse event; the patient received 4 doses previously, and the dose she received on 02Mar2022 would have been her 5th with no reported adverse eveent; Initial information received on 11-Mar-2022 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 4 years old female patient in whom ipol was administered post-excursion with no reported adverse event, the patient received 4 doses previously; the dose she received on 02-Mar-2022 would have been her 5th with no reported adverse event and the temperature excursion of IPOL was 1.8c to 0.8c; total time of excursion was 35 minutes due to completing inventory while receiving vaccine IPV (Vero) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Dtap); Measles, Mumps, Rubella Vaccine (MMR) and Varicella Zoster Vaccine (Varicella Vaccine) for Prophylactic immunization.  On 02-Mar-2022, the patient received 0.5ml dose of suspect IPV (VERO) vaccine suspension for injection (lot: T1E871M, expiry date: 10-Oct-2022) via intramuscular route in left vastus lateralis for immunization.  On 02-MAR-2022, the ipol was administered to patient post-excursion with no reported adverse event (poor quality product administered), received 4 doses previously and the dose she received on 02-Mar-2022 would have been her 5th with no reported adverse event (inappropriate schedule of product administration) (latency: same day) following the administration of IPV (VERO). On an unknown date the temperature excursion of IPOL was 1.8c to 0.8c; total time of excursion was 35 minutes due to completing inventory (product storage error) (unknown latency) following the administration of IPV (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event (poor quality product administered, product storage error and inappropriate schedule of product administration).  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 guidelines. 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.