chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12/16/2021 I had a rash break out that went from top of my arm to my elbow. I went to my doctor's but it was after hours and got a cream to soothe the rash. On 02/05/2021 went to doctor on in impromptu visit and after talking to the Nurse, and considering my issues, I was sent to ER straight away. Once there, I was sent through a battery of test and they discovered Rhabdomyolysis. I had a IV flush with Saline and was switch to a sodium bicarb IV drip when my numbers wasn't dropping to safe levels. I was removed from taking simvastatin and itraconazole, which started my whole issue according to my doctors. Currently, I still have a balance problem, ongoing and will be needing physical therapy.
DIAGNOSED WITH STAPH AT THE INJECTION SITE. ON 10/23/2013 MY LOW FEVER PROGRESSED TO 102 DEGREES BY MIDNIGHT. INJECTION SITE RED & SWOLLEN APX 2 INCHES DIAMETER. ON 10/25/2013 THIS PROGRESSED TO A 4 INCH HARD, RED WELT SURROUNDED WITH REDNESS 10CM X 14CM AS MEASURED BY DOCTOR. REDNESS EXCEEDED THIS MEASUREMENT BY 10/26 & 10/27. ON 10/25 I WAS PRESCRIBED AN ORAL ANTIBOTIC & GIVEN AN ANTIBOTIC INJECTION WHICH WAS REPEATED 10/26 & 10/27.  REDNESS STARTED TO RECEDE BY 10/28. MOST REDNESS IS GONE AS OF 10/29 BUT AS OF 10/30 THERE IS STILL A RED/PINK AREA ABOUT 4 INCHES X 5 INCHES.
Information has been received from a medical assistant concerning a 11 year old white male weighing 108 kg and height of 59.8 inches with no illness at time of vaccination and no pre-existing medical history who on 29-JUL-1997 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 08-MAR-2007 the patient developed 30-40 pox all over. The patient sought unspecified medical attention. On 15-MAY-2007, the patient recovered. There was no product quality complaint. No further information is available.
This is a spontaneous report from a contactable pediatrician. A 4-month-old male patient received PREVNAR (lot number G6330; expiration date 01Sep2014), ACTHIB (lot number UH857AA; expiration date 07Nov2014); DAPTACEL (lot number C4454BA, expiration date 05Dec2015), and ROTATEQ (lot number 0283AE; expiration date 24Oct2013) orally; all on 23Aug2013 at the standard dose (as reported) for immunization. The patient had no medical history and was not taking concomitant medications. On 23Aug2013, the patient experienced swelling in the right leg and the right leg became blue after administering the aforementioned vaccines. Therapeutic measures were taken as a result of the events and included treatment with pseudoephedrine; dose and frequency were unknown. The clinical outcome of the events, swelling in the right leg and the right leg became blue, were unknown. Follow-up (13DEC2013): Follow-up attempts completed. No further information expected.
headache; constant smell of gasoline; nauseous; constant smell of gasoline; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 (Lot number: ER8736) at the age of 42 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number=8732, Vaccine location=Left arm), administration date: 01Apr2021, when the patient was 42 years old, for COVID-19 immunization, reaction(s): "One day after I got my first vaccine, I started to have a constant smell of gasoline.". The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "headache"; PAROSMIA (non-serious), SYMPTOM RECURRENCE (non-serious) all with onset 2021, outcome "not recovered" and all described as "constant smell of gasoline"; NAUSEA (non-serious) with onset 2021, outcome "not recovered", described as "nauseous". Therapeutic measures were not taken as a result of parosmia, symptom recurrence.  Additional information: Patient had no known allergies. Case was not serious. Patient received no other medications in two weeks. No other vaccine in four weeks. Reporter stated that One day after she got her first vaccine, she started to have a constant smell of gasoline. It lasted for a few days and they went away. Adverse event start date was on 02Apr2021. After her second vaccine, the same thing occurred. Since then she had the smell return every few weeks and last for a couple of days. She would like to know how to stop this smell as it made her feel nauseous and gave her a headache and kept coming back. No covid prior vaccination and not tested covid post vaccination.  No follow-up attempts are possible. No further information is expected.
5pm: quick hot sensation with associated increased HR, hot sensation went away after a few seconds and HR returned to normal shortly after  5:15 pm: slight tingling in tongue, lasted only a few seconds and then went away no other side effect since, except for a slightly sore injection site.
Red rash at injection site, somewhat itchy, not painful or swollen. Began 3 days after injection
patient reports numbness and tingling in elbow beginning 1 day after vaccination. this tingling then extended into fingers/finger joints. patient reports this feeling lasting between 24 and 36 hours. resolved after sleep.
Patient states to feeling nauseated and had tingling in the arm and hand. Patient was sent to the ED to rule out TIA but left before being evaluated. Patient states symptoms have resolved and did not want to be seen by ED physician. Patient was educated on returning back to ED with any new concerns.
100 degree fever overnight after dose 1; sore arm at injection; This is a spontaneous report from a non-contactable consumer (patient). A 67-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration in right arm on 13Feb2021 12:00 (at the age of 67-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 13Feb2021, the patient experienced sore arm at injection and 100 degree fever overnight after dose 1. The outcome of the events was recovered.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
It was reported that a pt (7 of 13) received a Fluzone SV '00-'01 vaccination on 17 Oct 2000. Reportedly sometime after the vaccination the pt developed a local reaction. No specifics were provided. Further information is requested.
This spontaneous report was received from an approximately 76 year old male retired pharmacist reporting on himself. The patient had no pertinent medical history and no known drug reactions or allergies. In approximately 2007, reported as "nine years ago", the pharmacist was vaccinated with a dose of ZOSTAVAX, 19400 PFU, 0.65 ml, subcutaneous (lot number and expiration date were not provided). There was no concomitant medication. Also in approximately 2007, reported as "nine years ago", the pharmacist experienced herpes zoster following the administration of ZOSTAVAX. The pharmacist also experienced itching on his right shoulder that went halfway up his back. The physician prescribed prednisone (manufacturer unknown) as treatment. There were no laboratory diagnostics studies performed. On an unknown date, the pharmacist recovered. The pharmacist did not assess the relationship of the event To ZOSTAVAX. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (exact dose, route of administration, lot # and expiry date were not reported). The dose was exposed to the temperature between 47 and 77 degrees Fahrenheit for 9 minutes. Previous temperature excursions included exposure to the temperature between 47 and 77 degrees Fahrenheit for 40 hours and 22 minutes. The highest temperature the dose ever reached during those two excursions was reported as 49.6 degrees Fahrenheit. Digital data logger was involved. The reporter noticed the excursions on 14-APR-2017 (reported as "today"). No adverse symptoms were reported. Additional information has been requested.
On January 4 at 2:00 pm I suddenly started to bleed from the nose from the left nostril and then from both. The event lasted more than 35 minutes so I had to go to the ER. The diagnosis was Epistaxis. I was discharged because at the time of the medical evaluation I removed a large clot from my mouth and the bleeding stopped.  Appointment with primary physician for diagnosis and appointment with ENT was ordered. On January 5 at 4:15 am I had another episode of nasal bleeding lasting 25 min. After removing a clot through the mouth, the bleeding stopped. At 4:00 pm I presented Epistaxis again so I had to return to the Emergency Room. I was reevaluated and the instruction was to visit the ENT and Afrin prescription for three days and Claritin D q 12 hrs PRN. From January 6 to 9, I began to eliminate a serous-bloody vaginal discharge. That began with the elimination of a clot and progressively diminished day by day.  January 11, 2021, the ENT evaluated me and indicated that it did not observe polyps or anatomical problems. I had not previously prolonged nosebleeds. Previously two minor episodes happened to me, a year ago that resolved in less than 7 minutes. I didn't have a cold or any other symptoms.  I want to raise the flag because it was a strange event that occurred after the vaccination and that I had not experienced before in that way.My next dose is January 29, 2021. I am awaiting clot test results
This happened 4 days after the vaccine. I just took Tylenol since they told us it was best to take instead of Advil. It was such a weird feeling because it was in my arm, between my bicep and forearm, not the joint or elbow, just the bone area, general weakness, like a dull pain in my arm, it was not a muscle thing, it was a strange sensation for a couple days, I was afraid I was gonna drop the dishes because it was so weak. Then it went away, but it keeps happening randomly. I have it off and on. It was pretty persistent in the beginning. I mentioned the situation to my doctor and did not prescribed anything, I just asked if she had heard about this symptoms and she said no.
She was OK the first day, next day she develops rash/redness on the arm of shots and pain all over, third day she was better with some rash / redness.
No adverse event; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On 15-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-620042 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Follow-up document contains updated co-suspect dose description.
inj site pain and redness Day 1-2 inj site pain and redness; Day 8-10 inj site pain and redness
Presented to ER 11/28/02 with febrile seizure (temp 103.7). Discharged 11/29/02 et readmitted same day with 2nd seizure et had 3rd seizure post admittance (temp 104). Onset low grade fever 11/25/02.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.  On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB for prophylaxis (dose, route, lot #, and expiration date were not reported). It was stated that the vaccine was exposed to a temperature between 32 and 35 Fahrenheit degrees (°F) with a time frame of 9 minutes. It was stated that the temperature excursion was noticed due to a data logger. No previous excursions were reported. No adverse effects were reported.  A product quality complaint was not involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA001583: US-009507513-1705USA001584: US-009507513-1705USA001585:
Extreme pain at injection site.  My arm felt as though crushed by a vise with an ice pick jabbing into it.
Fever of approximately 102F (oral temp) and chills starting 6hrs post-vaccine and resolving 12 hours post-vaccine Body aches and headache starting 6hrs post-vaccine and resolving 24 hrs post-vaccine Fatigue starting 6hrs post-vaccine and resolving 28hrs post-vaccine 100mg Tylenol administered approximately 12hrs post-vaccine, and 18hrs post-vaccine to mitigate body aches and headache
I had  mild arm pain at the injection site on 2/6, the day of the vaccination (similar to that with the flu shot) which subsided within 24 hours. Then  12 days later upon awakening in the morning my arm was very itchy and slightly painful. Upon visual inspection it was swollen and red. The are of inflammation and redness was about 3.5" in diameter. It was fairly annoying for a couple of days as it was irritated by clothing touching it but I was able to complete all my usual activities. It took about a week to completely return to normal.
Moderna COVID-19 Vaccine  Vaccine Lot Number: 027C21A dose #1 Pt reports tingling in left arm and hand where she had the shot. vitals assessed and noted. was told to monitor. PMS intact in all extr. stroke neg. no transport needed. will go home with husband and monitor. discussed HTN. food: healthy choice at 2pm. @14:22  negative. 14:05 150/89 p91 98% RA R 20
I woke up and felt dizzy and nauseated. I went to the doctor and was diagnosed with vertigo. I am not going to physical therapy every day and have a check up soon. My doctor prescribed me DRAMAMINE 3 times per day.
After leaving facility pt. advised she became nervous and took her nebulized albuterol, then she began to shake. She was returned to the facility.
Vaccines administered 12/9/02. Patient developed swelling and redness within 48 hours. On exam patient had 12.5cmx9.5cm of erythema and induration of right anterior thigh. Given Keflex. Patient recovered completely.
This spontaneous report was received from a registered nurse and refers to a 12 month old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received on 18-AUG-2016. On 12-OCT-2016, the patient was vaccinated with an improperly stored PROQUAD, lot # M019233 with expiration date of 17-OCT-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 15 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA013888:
This case was reported by a consumer (subject's parent) and described the occurrence of red bump at injection site in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included jaundice at birth. Concurrent vaccination included HIB;manufacturer unspecified; unknown; unknown given on 20 September 2013; live attenuated human rotavirus vaccine ;manufacturer unspecified; unknown given on 20 September 2013; Pneumococcal vaccine (Non-GSK); Other manufacturer; unknown; unknown given on 20 September 2013. On 20 September 2013 the subject received unspecified dose of PEDIARIX (unknown, right thigh/hip). On 20 September 2013, within hours of vaccination with PEDIARIX, the subject experienced red lump at injection site and constipation off and on. The mother reported the subject received PEDIARIX on 20 September 2013. He developed a bump the size of a quarter on the same day on his leg, the bump was red for a couple of days. The bump has reduced in size and it is now the size of pea. The mother also reported that the subject had bowel problems after the vaccination. The bowel problems were further described as he would be constipated for a few days and then would go back to using the bathroom normally, this cycle continued for two to three weeks after the shot. The mother reported that the physician told her that the bump was normal and not to massage the bump. The physician also told her to give her son prune juice for the constipation. The immunization series with PEDIARIX was not delayed or discontinued. At the time of reporting the constipation resolved and red bump at injection site was improved.
dizziness; Migraine; ears clogged; twich in the arm; uncontrolable shaking same day; saw things moving around; chills; headache; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), MIGRAINE (Migraine), EAR DISCOMFORT (ears clogged), MUSCLE TWITCHING (twich in the arm) and TREMOR (uncontrolable shaking same day) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced DIZZINESS (dizziness), MIGRAINE (Migraine), EAR DISCOMFORT (ears clogged), MUSCLE TWITCHING (twich in the arm), VERTIGO (saw things moving around), CHILLS (chills), HEADACHE (headache) and MYALGIA (arm pain). 30-Apr-2021, the patient experienced TREMOR (uncontrolable shaking same day). At the time of the report, DIZZINESS (dizziness), MIGRAINE (Migraine), EAR DISCOMFORT (ears clogged), MUSCLE TWITCHING (twich in the arm), TREMOR (uncontrolable shaking same day), VERTIGO (saw things moving around), CHILLS (chills), HEADACHE (headache) and MYALGIA (arm pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, SARS-CoV-2 test: positive (Positive) positive. On 18-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative. On 30-Apr-2021, Heart rate: 140 (abnormal) 140 beats per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant and Treatment medicines were reported
(L) upper arm, red, itchy, edematous. Dx ICD - 682.9 cellulitis and abscess. Rx KEFLEX 500mg bid x 10 days.
tingling & numbness to lt pinky & 1/2 aspect lt ring finer w/occasional;pain & burning radiating from inj site to finger as noted;
Horrible soreness over entire body, although mostly the upper body/head/neck/back/arms, slight fever (99.6),  general malaise due to feeling so sore, chills were minimal. This was the worst I have felt in what feels like I can remember. I don?t get sick often and this was awful.
Patient received less than half the dose; the needle and syringe detached; A spontaneous report  received from a physician concerning a patient of unknown age and gender, who received dose of Moderna COVID-19 vaccine and think they received half the dose (incorrect dose administered) and the needle and syringe detached (device connection issue).   The patient's medical history was not included. Patient's concomitant was not included.    On unknown date, the patient received their unknown of two planned doses of mRNA-1273 unknown arm (Batch #: unkown) intramuscularly for prophylaxis of COVID-19 infection.   Physician stated that the needle and syringe detached, and they think the patient received less than half the dose.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the events was resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered and device connection issue for mRNA-1273 (lot # unknown) with no associated AEs reported.
Information has been received from a health professional concerning a school age male pt who was vaccinated with a dose of varicella virus vaccine live. In approx March 2006 the pt developed a mild case of breakthrough varicella with less than 50 lesions. Unspecified medical attention was sought. Subsequently, the pt recovered. There was no product quality complaint involved. Additional information has been requested.
PERIPHERAL NEUROPATHY 1/17/2023 DYSPHAGIA PERIPHERAL NEUROPATHY 1/17/2023 ATRIAL FLUTTER, CHRONIC PERIPHERAL NEUROPATHY 1/17/2023 SEPTIC SHOCK PERIPHERAL NEUROPATHY 1/17/2023 ATRIAL FLUTTER, CHRONIC
Seizure; A Spontaneous report was received from a consumer concerning a 85-year-old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed seizure.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, the patient received their second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 23 Feb 2021, two hours prior to the onset of the event seizure, the patient received their second of two planned doses of mRNA-1273 (Lot 030M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 23 Feb 2021, 2 hours post vaccination the patient developed medically significant event of seizure. Treatment for the event included lorazepam.    Action taken with mRNA-1273 in response to the event was not applicable.   The outcome of the event seizure was not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
A health professional report has been received. The report concerning the 6th patient of 42 patients born on 25-Jan-1999, Male consumer, who had been receiving Nasal FLUMIST. FLUMIST (INTRANASAL) started on 17-Jan-2014. No adverse experiences have been reported. The patient was inadvertently EXPIRED FLUMIST QUADRIVALENT GIVEN. The outcome of the event of GAVE EXPIRED FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Fever - 48 hours Headache  -48 hours Bodyache - 48 hours Nausea - 24 hours Chills - 24 hours sore arm - 48 hours