chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever of 107.2°F; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of HYPERPYREXIA (fever of 107.2°F) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included INFLIXIMAB (REMICADE) for Rheumatoid arthritis, ATORVASTATIN, LISINOPRIL, FUROSEMIDE (LASIX [FUROSEMIDE]), GLYCERYL TRINITRATE (NITROSTAT), BISOPROLOL, GABAPENTIN, SULFASALAZINE, DICLOFENAC DIETHYLAMINE (VOLTAREN [DICLOFENAC DIETHYLAMINE]), TIZANIDINE HYDROCHLORIDE (ZANAFLEX), METHOTREXATE, CICLOSPORIN (RESTASIS), SUCRALFATE, CARBAMAZEPINE, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), FOLIC ACID, SALBUTAMOL (VENTOLINE [SALBUTAMOL]), FLUOXETINE HYDROCHLORIDE (PROZAC), TRAZODONE, HYDROXYZINE, PANTOPRAZOLE, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), FERROUS SULFATE, MECLIZINE [MECLOZINE] and VALPROATE SEMISODIUM (DEPAKOTE) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced HYPERPYREXIA (fever of 107.2°F) (seriousness criterion medically significant) and PAIN IN EXTREMITY (arm hurt). At the time of the report, HYPERPYREXIA (fever of 107.2°F) was resolving and PAIN IN EXTREMITY (arm hurt) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included acetaminophen. The patient also used cold bath and Ice.  Company comment:Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, excluding other etiologies causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-077761 (E2B Linked Report).; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, excluding other etiologies causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-077761:Mother
pt tested pos for COVID 19 on 9/23/21. pt reported to ED on 10/03/21 with SOB, cough and ab pain, admitted for hypoxia secondary to COVID pneumonia pt given oxygen, remdesivir and dexamethasone 10/07/21 pt discharged on oxygen at night
Chest pain; Bruises; Neck pain; Shortness of breath; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient).   A 33-Year-old female (non-pregnant) patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Batch no: not reported/ Lot number: Ewo183) via unspecified route of administration on 14May2021 09:00 AM (at the age of 33-years-old) in Arm Left as dose 1, single for covid-19 immunization. Medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 15May2021, patient experienced with chest pain, bruises, neck pain, shortness of breath. No Hospitalization required for the events caused. Seriousness reported as no. No treatment received for the events caused. Outcome of the events was unknown.    Follow-up attempts are completed. No further information is expected.
After patient got shot was in waiting area for about 12 minutes and patient go up and passed out. EMS was called but patient was conscious before EMS got there patient  was examined. His vitals were good and  blood sugar was elevated. patient said he had not eaten and also had not taken his metformin for the day. patient was okay and will follow up with his PCP
Soreness and some pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness and some pain at the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness and some pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness and some pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Breakthrough case admission after 2 vaccines Moderna 3/13/21 Lot# 038A21A;  Moderna 4/10/21 Lot# 040B21A
Mother complained of child crying about 3 hours after shots given. Had temperature of 103F that night, was irritable from 6/21/01 to 6/26/01. No fever since 6/21/01. She did not consult with physician yet but encouraged mother to do so.
patient received the first dose of the Pfizer vaccine on 10Feb2021 and today, 02Mar2021, return and mistakenly received a dose of the Moderna vaccine; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received the first dose of the Pfizer vaccine on 10Feb2021 and today, 02Mar2021, return and mistakenly received a dose of the Moderna vaccine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.). Previously administered products included for an unreported indication: COVID-19 VACCINE (Patient received their 1st dose from Pfizer on 10th feb 2021) on 10-Feb-2021.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced WRONG PRODUCT ADMINISTERED (patient received the first dose of the Pfizer vaccine on 10Feb2021 and today, 02Mar2021, return and mistakenly received a dose of the Moderna vaccine). On 02-Mar-2021, WRONG PRODUCT ADMINISTERED (patient received the first dose of the Pfizer vaccine on 10Feb2021 and today, 02Mar2021, return and mistakenly received a dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Reporter's Comments: This report refers to a case of wrong vaccine administered for mRNA-1273, lot # 030M20Awith no associated AEs.
Burning sensation across whole outer front quadrant of right thigh from hip joint to knee. 5 days earlier I had strained my back but it wasn't bad. 2 days earlier I woke up at night and had pain between spine and right pelvic crest that was so severe I thought I would pass out. My physician asked if I had a new rash. I didn't. She ordered an MRI. I saw an orthopedic spinal specialist and PT. Both said my back strain location, X-rays, and MRI could not explain my leg pain.
This spontaneous report was received from a pharmacist referring to a male patient of unknown age. Information of concurrent condition, pertinent medical history, concomitant medication and drug reactions/allergies was unknown. On around 11-DEC-2018, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, lot # and expiration date were unknown) intramuscularly for prophylaxis (reported as patient was due for it). On an unknown date in December 2018, the patient developed "fluid in his bicep". The outcome of the event was unknown. The patient contacted pharmacy on an unknown date. It was unknown if patient was given treatment or performed lab diagnostics/studies. The causality between PNEUMOVAX 23 and the event was not provided.
The vaccine given to the patient experienced a temperature excursion at 48.4 degrees Fahrenheit on 5/10/21 at 7:05am. Due to this excursion the vaccine was expired at the time of administration. Patient reported no adverse effects as of the time this form was being filled out
phone call from mom states child has been crying cont since recv vax;pt devel swelling of face, hands & legs;
First two Moderna shots had been in right arm, with only temporary side effects that resolved within several days. The problem was with the booster, which I received in my left arm. Within several hours of receiving the shot, I developed joint pain in my left hand, primarily in the fingers, which lasted for a few days. The pain was worse in the little finger. Once the pain subsided, I noticed that the joint at the end of the little finger, the one near the nail, had changed shape and was still painful. The bone had thickened, sticking up and also out to the sides. I could no longer straighten the finger fully, and any pressure onto the joint area was painful. This has continued. The bone deformity appears to be permanent, and in fact has been getting a bit more pronounced with time, along with the pain. My primary care physician, when I told him about this at my next checkup earlier this month (March 15, 2022)  advised me that he had not heard of any such side-effects from any of the COVID vaccines, and advised me to report this to the CDC. The only suggestion he had, which would not be to resolve the issue but to try to prevent the joint from deforming further, was to exercise the left hand using a squeeze ball.
Vasculitis with positive testing for antineutrophil cytoplasmic antibody- Patient has been on prednisone 60 mg once daily for the past 3 days.Solu-Medrol induction 500 mg daily x3 days were given during this admission. Plan to go Rituximab on outpatient basis. S/p left CT-guided kidney biopsy on 10/12/2021. Patient was started on tapering dose of prednisone post discharge. She was started on bactrim for pcp prophylaxis. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
2 weeks after receiving the vaccine the inside of mouth (both cheeks and upper and lower lip areas) became numb and possibly swollen. After a couple of days my mouth improved. My mouth was almost well by Feb16. On Feb 10 I received the Moderna covid boster vaccine.  On Feb 17 my mouth again became numb and swollen. As of this date 2/22/2021 my mouth is again improving and is nearly well. I visited my Primary Care Doctor on Feb 19, 2021. We decided to wait and see if this gets better on its own. If not I will see an Ear, Nose, and Throat Specialist.
Rash 4 -5 days after RSV vaccine. Itchy, red, urticarial-appearing. Improved in past couple of days, not as itchy or red, with cortisone. No face/neck lesions, facial/lip swelling, or respiratory issues.
Information has been received from a physician concerning a 11 year old female who in approximately January or February 2008, was vaccinated with the first dose of GARDASIL. The patient recently (approximately April 2008) came in for her second dose of GARDASIL. The patient experienced excruciating pain at the injection site after the first dose of the vaccine. The patient outcome was recovered. The duration of the pain was not provided. It is unknown whether medical attention was sought. Additional information has been requested.
Light chest pain /chest pain; Pins and needles in my hands; This spontaneous case was reported by a pharmacist and describes the occurrence of CHEST PAIN (Light chest pain /chest pain) and PARAESTHESIA (Pins and needles in my hands) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced CHEST PAIN (Light chest pain /chest pain) and PARAESTHESIA (Pins and needles in my hands). At the time of the report, CHEST PAIN (Light chest pain /chest pain) and PARAESTHESIA (Pins and needles in my hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.
Patient received dose 2 of Moderna on 4/9/21. On 4/10/21 notice bruise in left underarm. Bruise had started to resolve by the time patient contacted pharmacy on 4/13/21. Bruise was approximately 1&1/2 inch in diameter.
received doses from the same lot number #015h22a administered after 30-day Use By Date; The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received doses from the same lot number #015h22a administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date) 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. 015h22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received doses from the same lot number #015h22a administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received doses from the same lot number #015h22a administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (received doses from the same lot number #015h22a administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date).    No concomitant product reported by reporter. Vial was initially stored into refrigerator on 01-Nov-2022 and was administered after 30 days use by date on 17-Dec-2022, 19-Dec-2022, 20-Dec-2022, 20-Dec-2022, 23-Dec-2022 and 24-Dec-2022. Vial size was 2.5ml. Vial did not underwent any temperature excursion issue. No treatment medication reported by reporter.    This case was linked to MODERNATX, INC.-MOD-2022-692559 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-692559:master case
Redness at injection site - warm, itchy, swollen Red patch got bigger over 24 hours Took Benadryl prior to doc appt Doctor prescribed benadryl around the clock and keflex
Patient was given vaccine that was expired and past usable time window. Vaccine was reconstituted on 7/15/21 at 12:00PM, and vaccine was administered around 5:00PM on 7/16/21.
24 hr delayed localized reaction - itching, heat & redness at injection site. Minor headache. Visited MD. BENADRYL & APAP administered.
Severe left shoulder pain, through collarbone and neck. Could not move arm, lift or drive, without pain.  Did not seek any professional diagnosis. Received some massage over the past few months, and I continue to exercise. Shoulder slowly got better, currently I have full range of motion and strength, but there is still intermittent sharp pain in shoulder, neck, and collarbone that I did not have previously.  (I received the second done with much less pain and recovered quicker than the first dose, and still have lingering pain from the first dose.)
Pt received the covid-19 vaccine from Pfizer and started to experience symptoms 6 days later. Symptoms includes hives, low appetite, wheezing, coughing, and fatigue.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. In 2017 (reported as "on or after 05-JUL-2017"), the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # M040423 with expiration date 03-JUL-2019; an improperly stored dose of ROTATEQ per oral, lot # M044396 with expiration date 19-JUN-2018; or an improperly stored dose of VAQTA lot # N005274 with expiration date 03-APR-2018, for prophylaxis (dose and route of administration were not reported). It was stated that the vaccine was exposed to a temperature of 32 to 35 Fahrenheit degrees with a time frame of 1 hour. No previous temperature excursion was reported. The reporter did not know which vaccine was administered to the patient. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1710USA015406: US-009507513-1711USA008229: US-009507513-1711USA008230: US-009507513-1711USA008231: US-009507513-1711USA008232: US-009507513-1711USA008234:
Pt recv vax on 11/13/98; on 11/15/98 pt exp headache, fever, chills, abnormal spinal fluid; dx=aseptic meningitis
I began to feel a little dizzy on 03-25.   This light lack of equilibrium steadily grew for the next couple days. I found my limbs had apparently began to lose strength.  breathing became difficult  as if I could only take 1/4 breaths unless I actively forced myself to inhale deeply.  I developed sleep apnea about this time.  Driving became difficult. I was walking and driving as if I was drunk.  When walking, it felt as if I was on a swaying ship. Driving felt like my workvan was in a constant crosswind that I wanted to correct from.  At this point, I stopped driving.  That was on 03-25.  On 03-26 I suddenly developed up-beat nystagmus in my vision that continues to this day, making me functionally blind.  I visited multiple urgent care facilities.  Received full panel blood work, urine tests and a MRI. All tests came out completely normal.   Doctors are baffled. I was given Valium to help with my eyes and that does help a little.  However I'm still unable to see adequately to function without assistance.
Fever - 99 t0 101, Still persists on this reporting date, fever decreases temporarily after taking my routine pain medication of Hydrocodone 10-325 up to 6 tabs daily.
Spinal stenosis/l5 was pushing on vertebrae/whenever do housework in lot of pain; Spinal stenosis/l5 was pushing on vertebrae/whenever do housework in lot of pain; welts on left arm; Urinary tract infection; soreness on left arm; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), LUMBAR SPINAL STENOSIS (Spinal stenosis/l5 was pushing on vertebrae/whenever do housework in lot of pain), INTERVERTEBRAL DISC DISORDER (Spinal stenosis/l5 was pushing on vertebrae/whenever do housework in lot of pain), URTICARIA (welts on left arm) and URINARY TRACT INFECTION (Urinary tract infection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included SULFASALAZINE, FISH OIL, LACOSAMIDE (VIMPAT), FOLIC ACID, METHOTREXATE, VITAMIN D NOS, OMEPRAZOLE, PRAVASTATIN SODIUM, FUROSEMIDE, OXYBUTYNIN, CHLORIDE, OXYCODONE HCL, PHENAZOPYRIDINE HCL, CIPROFLOXACIN HCL, IBUPROFEN, METHYLPREDNISOLONE and LISINOPRIL for an unknown indication.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 19-Dec-2020, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced LUMBAR SPINAL STENOSIS (Spinal stenosis/l5 was pushing on vertebrae/whenever do housework in lot of pain), INTERVERTEBRAL DISC DISORDER (Spinal stenosis/l5 was pushing on vertebrae/whenever do housework in lot of pain), URTICARIA (welts on left arm), URINARY TRACT INFECTION (Urinary tract infection) and PAIN IN EXTREMITY (soreness on left arm). On 30-Dec-2020, COVID-19 (COVID-19) had resolved. At the time of the report, LUMBAR SPINAL STENOSIS (Spinal stenosis/l5 was pushing on vertebrae/whenever do housework in lot of pain) and INTERVERTEBRAL DISC DISORDER (Spinal stenosis/l5 was pushing on vertebrae/whenever do housework in lot of pain) had not resolved, URTICARIA (welts on left arm) and PAIN IN EXTREMITY (soreness on left arm) was resolving and URINARY TRACT INFECTION (Urinary tract infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   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
Severe Pain in the left shoulder the morning following vaccination accompanied by loss of range of motion and strength.  I have been treating it with Advil/Ibuprofen since.  It has improved over the last 3 weeks but still interfering with normal everyday activities and pain still there but less severe.  I have not sought medical treatment yet as it has improved slowly over the course of time.  I still have pain with small things like folding laundry or reaching above shoulder level to get a dish from the cabinet or clothes out of the closet and range of motion is still affected but has improved since first week following shot.  The first few days I could hardly lift my arm past elbow height and just the weight of my arm hurt my shoulder.
1ST DAY- WELPS ON STOMACH, noticed in the evening. Days went by.   Then noticed on left front on stomach, a ONE-INCH AREA with BUMPS.  ROUGH BUMPS. CLEANED WITH ALCOHOL.  DAYS LATER AGAIN CLEANED AND SCRATCHED at it hard to remove bumps.   SCRATCHED TILL TOPS came off.  ALCOHOL.  SCABBED OVER and  STILL GOT SCABS.
pt recv vax 23OCT95 & devel a severe inj site rxn characterized by pain & inflammation;pt has recovered;this is one of six patients from this site who exp the above rxn;