chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 21-year-old male. Neither medical history nor concomitant medications were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009: product complaint investigation results.
A 30 year old female was vaccinated with varicella virus vaccine lives on 10/31/00. On 12/04/00, the patient received the 2nd dose of varicella vaccine live. The patient's last menstrual period was 11/10/00. The patient has been to the obstetrician gynecologist and has heard the fetal heart beat. The patient reported that her doctor had advised her to terminate the pregnancy. In follow-up, the physician reported that the patient had "terminated the pregnancy shortly after the diagnosis was made". The patient did not have a rash.
baseball size red hive on right arm on day 8 after vaccine. The vaccination site was sore on day 1-7. Day 8 i developed a baseball size red hive that was itchy and warm to the touch. It went away on around day 11 completely.
This spontaneous report was received from a pharmacist refers to an 89 year old male patient. The patient's pertinent medical history and drug reactions/allergies were not reported. On 21-MAY-2014 the patient was vaccinated with ZOSTAVAX, 0.65 ml (route and lot # not reported). The patient was then prescribed a 5 days course of prednisone (manufacturer unknown) beginning with a 50 mg dose on 30-MAY-2014 for an unspecified reason. The patient had not begun prednisone (manufacturer unknown) yet. The outcome of the event was unknown. The relationship between the event and ZOSTAVAX was not reported. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 61 year old female patient. Patient's current conditions included asthma, hypertension and allergy to penicillin. On 27-FEB-2015 the patient was vaccinated with ZOSTAVAX (lot # K016320, Expiry: 24-DEC-2015) (0.65 ml, subcutaneous, left deltoid region). Concomitant medications included unspecified asthma and blood pressure medication. On 28-FEB-2015, the patient developed inflammation and redness at her injection site that lasted "7 to 10 days" and reproted that the patient consulted her physician, who noted that her lymph nodes in her left axilla were swollen. Patient received treatment with Ibuprofen. Patient sought medical attention, consulted physician. No product quality complaint was involved. The outcome of the events inflammation and redness at her injection site and lymph nodes in her left axilla were swollen was reported as recovering. The reproter causality was not provided. No additional information was provided. Additional information has been requested.
Nine days post injection I developed a rash just below the injection site. It was itchy, red, and felt warm to the touch. The symptoms were present for about 3 days. The rash covered an area about 3 inches in circumference.
Cellulitis left deltoid region at site of inoculation. Treated with Levaquin. Good response. No sequalae.
Mother relates; after being back in class about 45 minutes, child complained of nausea and dizziness, left classroom to go the office and "blacked out after becoming extremely dizzy and paling. He remembered then getting to a table to lie down. Parents carried child to doctor at clinic who related that he probably had an adverse allergic reaction to the TD. He was treated with Benadryl there and referred to a neurologist.
After the first dose my father got what the eye doctor thought was pink eye. After treating him it didn't clear up. It was later diagnosed as herpes of the eye and he became blind in one eye. Shortly afterwards I read an article from researchers who stated they had found fragments of the herpes virus in the vaccine. After the second vaccine he was fine one day and 2 days later started having seizures. He was hospitalized for the seizures. His personality totally changed. He no longer recognized my sister. He also became hostile which is not the person he was. He was released from the hospital and brought to a new facility. Then the lights went out. he just stared off into space. A day later he was dead.
Onset of pain in the opposite arm (right arm) from the injection site, where I had pain from singles that I had some 7 years ago.  Scale of pain is like having shingles again, (8 out of 10).  No blisters present to date with this episode.
site of injection is red, swollen, and itchy; site of injection is red, swollen, and itchy; site of injection is red, swollen, and itchy; Vomiting; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (site of injection is red, swollen, and itchy), VOMITING (Vomiting), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (site of injection is red, swollen, and itchy) and VACCINATION SITE SWELLING (site of injection is red, swollen, and itchy) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced VOMITING (Vomiting) and HEADACHE (Headache). On 07-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (site of injection is red, swollen, and itchy), VACCINATION SITE ERYTHEMA (site of injection is red, swollen, and itchy) and VACCINATION SITE SWELLING (site of injection is red, swollen, and itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 01-Jan-2021, VOMITING (Vomiting) and HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE PRURITUS (site of injection is red, swollen, and itchy), VACCINATION SITE ERYTHEMA (site of injection is red, swollen, and itchy) and VACCINATION SITE SWELLING (site of injection is red, swollen, and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Elevated Blood Pressure; Elevated Pulse; DIARRHOEA; Felt like had "Flu or COVID"; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like had "Flu or COVID"), BLOOD PRESSURE INCREASED (Elevated Blood Pressure), HEART RATE INCREASED (Elevated Pulse) and DIARRHOEA (DIARRHOEA) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Pulse abnormal. Concomitant products included ALLOPURINOL (ELAVIL [ALLOPURINOL]) for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like had "Flu or COVID"), HEART RATE INCREASED (Elevated Pulse) and DIARRHOEA (DIARRHOEA). On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (Elevated Blood Pressure). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (Felt like had "Flu or COVID") and DIARRHOEA (DIARRHOEA) had resolved and BLOOD PRESSURE INCREASED (Elevated Blood Pressure) and HEART RATE INCREASED (Elevated Pulse) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 150/100 (High) 150/100. On an unknown date, Heart rate: 100 (High) 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt admitted to hosp after EMS contacted due to SOB after a fall, generalized weakness and cough; positive test for COVID; no evidence of brain hemorrhage or abnormality; COVID pneumonia; O2 supplementation ABX, remdesivir, dexamethasone, baricitinib, Lovenox; intubated; AHRF; pt's condition worsened; pt was made comfort care, extubated and died in the hospital
(R) arm swollen and red about 10 cm X 6 cm within 1-2 hours after getting vaccine - given oral steroids and Antihistamine.
Mother states that child had temperature of 106F, post vax, but can't remember if it was day of immunizations or the day after. Mother gave Tylenol and Motrin for fever and placed child in tepid bath. No seizure activity. Mother cannot remember details clearly and doesn't remember how long fever lasted. Did not seek medical attention (per telephone call with RN).
Extreme fatigue after fourth hour. Bodyaches including neck, shoulder, down my entire back. Swelling in both hand joints and soft tissue. Pain in both wrists, pain shooting down my R Arm (injection arm), wheezing/asthma symptoms. On the 5th day after the first dose, injection site is throbbing painfully, especially at night. Massage, hydrating, heat, cold compress, and CBD roll-on ointment does not alleviate the pain. Pain has been occurring nightly for 5 nights now.
Awakened next day (8/20) at 7:30 am with lightheadedness & mild vertigo.  8/21 symptoms persisted. 8/22 symptoms worsened and vomited...went to urgent care & was diagnosed with Benign Paroxysmal Vertigo, probably related to 8/20 Covid booster.  Dr. ordered Prednisone 50 mg x 5 days; Antivert tid prn; & Claritin daily.  Today, 8/23, symptoms have improved, still mild lightheadedness & vertigo unless careful with movements.
At injection site, measuring approx. 4x3", raised, red area, warm to touch, pain in extremity. Started with red "bumps" day of injection, progressed from there. Referred to private physician.
Information has been received from a registered nurse concerning a 5 year old female twin with Asthma who on 07/26/1999 was vaccinated subcutaneously with a 0.5ml dose of varicella virus vaccine live.  The RN reported that the patient subsequently developed about 10-20 varicella lesions.  The lesions were reported to be all different, some were crusted, some were vesicular and some looked like bug bites.  Unspecified medical attention was sought.  The patient was noted to be afebrile.  The patient also developed a cough, but the physician thought it was due to her Asthma.  The patient was treated with pain medicine and an unspecified Asthma medication.  No product quality complaint involved.  The physician also reported that the patient's twin sister also developed varicella after being vaccinated with varicella virus vaccine live.  Additional information has been requested.
This spontaneous prospective pregnancy report as received from a physician refers to a 32 year old female patient with no medical history and no drug allergies/reactions. The patient who was pregnant (had her last menstrual period on 15-JUN-2013) was vaccinated with a dose of VARIVAX (Merck) lot # H020248, expiration date 08-NOV-2014, 0.5 ml, subcutaneous on 19-JUL-2013. No additional adverse effects reported. There was no concomitant medication. Laboratory studies performed included "Normal metabolic panel and normal CBC". Patient sought medical attention by contacting physician. Additional information has been requested.
Not sure if this is related but wanted to report it.  Started with fullness in left ear - felt like water in ear .  Thought it would go away.  Waited over a week - maybe 2 weeks before contacting Primary Care doc because I thought it would go away.  Primary Care referred me to Ear Throat Nose Specialist.  It would take 4 wks to see the Doctor she referred.  Things got worse, losing hearing, tenitus (noises) and started having bad vertigo issues.  Called Ear Throat and Nose Specialist and Dr saw me right away.  Hearing loss test performed and was put on a medication (steroid?) to try to help with vertigo issues.   Had subsequent appointments with Dr - have had 4 steroid shots to my left ear, on low salt diet and taking water tablets.  Hearing has improved but not back to normal, no more vertigo episodes - but ear still feels pressure, tenitus is still there.  It could be Meiners Disease r Sudden Hearing Loss.  However saw article on internet of others having similar issues after vaccine shots - both in left arm and just thought I should report this.
Diarrhea; Loss of taste; Loss of smell; Feel like crap; Body chills; Aches / body pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), ILLNESS (Feel like crap) and CHILLS (Body chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Heart attack. Concurrent medical conditions included Cancer. Concomitant products included ALPRAZOLAM (XANAX) and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced DIARRHOEA (Diarrhea), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), ILLNESS (Feel like crap), CHILLS (Body chills), MYALGIA (Aches / body pain) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and BACILLUS COAGULANS, PLANTAGO OVATA HUSK (FIBERMUCIL) at a dose of 1 dosage form. At the time of the report, DIARRHOEA (Diarrhea), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), ILLNESS (Feel like crap), CHILLS (Body chills), MYALGIA (Aches / body pain) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, SARS-CoV-2 test: negative (Negative) COVID test came back Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken mRNA 1273 with the events was considered as not applicable.   This case was linked to MOD-2021-182815 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: The follow-up was received on 9-JUN-2021 and has no new information.
Pfizer COVID-19 Vaccine EUA Patient received vaccine dose #1 on 1/14/2021 and Dose #2 on 1/31/2021. Patient presented to ED on 2/1/2021 with complaints of acute mental status change. He was recently diagnosed with enterocoal/pseudomonas UTI four days prior to presenting to ED and was being treated with Augmentin and Levaquin. Patient screened positive for COVID-19, with the sample analyzed using PCR or equivalent. Patient suffered a cardiac arrest on 2/7/2021 x3, developed three pressor shock, and required maximum ventilator settings. Patient subsequently expired.
Patient reports a history of ulcerative colitis that has been controlled for 20 years until April 2021.  Patient attributes exacerbation of colitis symptoms to cessation of chronic opioid use. She started experiencing bouts of loose bowel movements. She had a colonoscopy in May 2021 which was essentially positive for proctitis.  During the summer patient was started on budesonide and mesalamine. Patient reports having "rough mornings", but symptoms subsiding throughout the day. Patient presented to the emergency room on 10/15/21 complaining of increased diarrhea for 2 weeks that had turned bloody the past 5 days. Patient was incontinent of stool and experiencing generalized weakness. Patient had received her 3rd dose of the Pfizer COVID vaccine just prior to the onset of symptoms. Patient had also recently taken amoxicillin 500mg take 4 capsules by mouth prior to visiting the dentist and reports her symptoms starting the day after amoxicillin consumption. Colonoscopy on 10/18/21 shows severe left-sided colitis compared to colonoscopy in May 2021 only being positive for proctitis. Patient is being treated with IV Solu-Medrol in addition to her home medications for ulcerative colitis which include Entocort EC and mesalamine. Plan to test for appropriate serologies and PPD in anticipation of start Remicade.
This is a spontaneous report from a contactable physician. A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on right arm, on 08Jan2021 at 12:30 at a single dose for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medications included hydrochlorothiazide, valsartan (VALSARTAN HCT), amlodipine and aripiprazole (ABILIFY). The patient received his first dose of BNT162B2 (lot number: EH9899) on left arm, on 18Dec2020 at 12:45 PM (age at vaccination: 62 years old) for COVID-19 immunization and experienced generalized muscle aches and lethargy. The patient experienced joint pain (both knees) that appears to be getting worse, upper extremity acheness and muscle weakness; all on Jan2021. Therapeutic measures were taken as a result of joint pain (both knees) that appears to be getting worse, upper extremity acheness and muscle weakness. The outcome of the events was not recovered.
Swelling, redness, and tenderness about 3 inches below injection site on bicep. Nerve pain associated with inflammation in biceps causing pressure on Nerve.
Developed Tinnitus after 2nd dose Sudden Hearing  Loss 2.5 weeks after booster (3rd) Using hearing aid.
COVID-19  Moderna Vaccine clinic held at facility for adults with autism and developmental disablities.   Client getting vaccine came in with PCA (who was also a family member).    There were several appointment no-shows due to a snow storm and when  PCA and family asked about getting a vaccine and were offered one by registration team.  The registration team and nurse administering the vaccine did not realize the PCA was not yet 18 (was 17 years and 6 months).   When error was realized the next day the family was notified and they called their primary care doctor.   No adverse outcomes noted at this time.
Patient developed swelling in her throat 20 min after injection. Dr called in to see patient .25mg Benadryl was ordered and given to patient orally with water. Patient waited additional 15 min and symptoms did not worsen. Patient left clinic with husband.
itches all over his back; This case was reported by a consumer via and described the occurrence of pruritus in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced shingles 5 years before reporting date).   On 19th October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced itches all over back. It was stated that on 21st January 2021, the patient will be receiving 2nd dose of Shingrix. The reporter denined permission for follow up.
Nov. 27-2AM: Chest pain, 10 minutes, subsided with nitroglycerin tablet. Nov. 27-Noon: Chest pain, palpitations, blood pressure 100/90 with 120 heart beat rate, subsided after two glycerin tablets, time elapsed about 10 minutes. Nov. 28-1AM: Strong Chest Pain, traveled up shoulder, left arm and neck with feeling of ground glass pressure, painful. Took two glycerin tablets 5 minutes apart and pain subsided. Experienced slight fever (Temperature 99.7 degrees F) from Nov. 25-28. Since November 29, no further ill effects from vaccination.
Vaccination given was incorrect. INFANRIX (DTaP) was given, 0.5mL in L Arm when patient was supposed to receive BOOSTRIX (TDaP) 0.5mL. Patient had no adverse reactions.
5 minutes after injection: Swelling, itching, hives, trouble breathing, throat began to close. 15 minutes after injection: Took 100 mg Benadryl. Hives became smaller but continued to itch with labored breathing. 30 minutes after injection: Pharmacist administered epinephrine.  50 minutes after injection: EMTs arrived. Conducted EKG. I went home and have been taking Benadryl when hoarseness/tightness in throat, hives and itching come back.
The next day after the shot I started having bad cramps and bleeding. It lasted for 4 days and has since resolved.
Moderna COVID?19 Vaccine EUA  About 7-8 days after receiving 1 dose of vaccine, area around injection site became swollen and hot with a light pinkness to my skin color. The following 3 days the area has continued to grow larger in diameter, turning a deeper red, continued swelling and heat.  Does not bother me very much overall, other than the concern that it continues to grow.
Guillian Barre Syndrome; flaccid paralysis; leg pain; Weakness; This serious case was reported by a consumer via regulatory authority and described the occurrence of guillain barre syndrome in a elderly male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included sciatica. Previously administered products included Penicillin. Concurrent medical conditions included hypercholesterolemia. Concomitant products included atorvastatin.   On 11-AUG-2023, the patient received Arexvy. On 26-SEP-2023, 46 days after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: Guillian Barre Syndrome) (serious criteria hospitalization and GSK medically significant), flaccid paralysis (Verbatim: flaccid paralysis) (serious criteria hospitalization and GSK medically significant), leg pain (Verbatim: leg pain) (serious criteria hospitalization) and weakness (Verbatim: Weakness) (serious criteria hospitalization). The patient was treated with immunoglobulins nos (Ivig). The outcome of the guillain barre syndrome, flaccid paralysis, leg pain and weakness were resolved.   It was unknown if the reporter considered the guillain barre syndrome, flaccid paralysis, leg pain and weakness to be related to Arexvy.  It was unknown if the company considered the guillain barre syndrome, flaccid paralysis, leg pain and weakness to be related to Arexvy.   Additional Information: GSK receipt Date:09-NOV-2023 The patient self-reported this case. The patient age was in between 65-79 years old. The patient reported that RSV vaccine given on 11th August 2023, he did not have information on which vaccine or lot number.  The patient developed B/L leg pain and weakness beginning on 26th September 2023, presented to hospital 2 days later.  The weakness got progressively worse and he was diagnosed with ascending flaccid paralysis (Guillian Barre Syndrome).  He was given 5 days of IVIG, was on ventilator and trach and peg. The patient had taken Atorvastatin 40mg daily vit D 3 1000 units daily. The onset interval was 31-60 days. The patient had no prior vaccinations for this reported event. The patient did not have any current illness. The follow up would not possible as no contact details were available.
Client reports fever 101 degrees (oral) on evening of 10/15/02. Redness and swelling at injection site (pneumococcal) upper right arm and extending into right forearm. He called the physician-inst to take Benadryl 25mg q 4 hrs, apply ice. To MD 10/17-continue ssame treatment.