chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received flu vaccine 9/3/20 in left arm from medical center.  Patient reports normal pain associated with vaccine initially for 1-2 days, then laid on his harm and pain increased. Pain reduced to mild pain for a while, but pain increased around 9/23/20. 9/29 & 9/30  patient experienced increased pain, rates pain 6/10. Pt reports he feels the pain at the joint. No redness or pain in the area. Pain has improved a little bit as of 9/30, as he reports taking ibuprofen. No weakness in the left arm or hand, but notices some pain if he's doing certain movements.  No hx of recent shoulder injuries, pt did say he had some shoulder issues >15 years ago. Came in to Health Clinic on 9/30/20 to be assessed by health provider. X-ray ordered, PT started.
client called 5/11/04  Td site pain, nausea, body aches, chills. Treat s/s - tylenol, cold or warm compress for comfort. 5/18/04 - client had 2 more days of above symptoms plus fever and back ache. Has now recovered completley.
Question 5:  Moderna monovalent booster administered prior to receiving information to stop giving as boosters.  Client contacted and no adverse signs/ symptoms have occurred as of this time.
Hypereosinophilia (31%) asymptomatic; This is a spontaneous report from a contactable physician (patient herself). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date not reported), via an unspecified route of administration in the left arm on 17Dec2020 16:30 at a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus and penicillin allergies. The patient was not pregnant. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced hypereosinophilia (31%) asymptomatic on an unspecified date. It was unknown if treatment was given as a result of the event. Clinical outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Beginning Nov 5, patient's COPD and Congestive heart failure kicked in full force. It had been managed and maintained for years with medication. He was in and out of the hospital/ER 10 times in the next 12 weeks with excessive fluid build up that the medications could no longer manage. He died Jan 31, 2022 at home.
Information has been received from a consumer concerning her 5 year old daughter with a history of an allergic reaction to antibiotics (not penicillin) who was vaccianted on an unspecified date with a dose of Varivax (Oka/Merck). There was no concomitant medication. Subsequently, on 27-JUN-2006 the patient began to break out in a rash. She presented to the Physician's office on 28-Jun-2006 with approximately 30-50 lesions and was diagnosed with chicken pox. The physician prescribed BENADRYL as needed for itching. No fever was noted. At the time of the report the patient had not recovered. There was no product quality complaint involved. The patient's sister (WAES#0607USA00907) developed a rash of approximately 6-10 lesions following vaccination with Varivax (Oka/Merck). Additional information has been requested.
in the evening he was freezing to death; started shaking so hard, almost uncontrollably; Sweating; Had issues after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (in the evening he was freezing to death), TREMOR (started shaking so hard, almost uncontrollably), HYPERHIDROSIS (Sweating) and VACCINATION COMPLICATION (Had issues after receiving the vaccine) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (in the evening he was freezing to death), TREMOR (started shaking so hard, almost uncontrollably), HYPERHIDROSIS (Sweating) and VACCINATION COMPLICATION (Had issues after receiving the vaccine). At the time of the report, FEELING COLD (in the evening he was freezing to death), TREMOR (started shaking so hard, almost uncontrollably), HYPERHIDROSIS (Sweating) and VACCINATION COMPLICATION (Had issues after receiving the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.4 (High) 101.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not reported. Treatment medications was not reported.  Patient stated he Had issues after receiving the vaccine   This case was linked to MOD-2021-229842 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Significant Follow-up received on 28-Jul-2021, added Date of Birth, contact information and event
2 days post/vax, couldn't lift arm to brush teeth. Within 1 wk, had difficulty lifting both arms. Recurring every 2-3 days. Tylenol or Advil to relieve pain. Pt referred to Dr. Pt was given "cortisone" shot & told to come back if not better
Nausea, diarrhea, headache, fever for about 24 hours. Went away next day.
THE VERY NEXT DAY FELT LIKE A ZOMBIE COULD HARDLY MOVE, THEN WENT ONTO TO START ITCHING, NOT AT THE INJECTION SITE BUT INTERNALLY, ALMOST A WEEK WENT BY AND I KEPT HAVING TO TAKE BENEDRYL. I LEFT WORK EARLY ON MONDAY DUT TO HAVE STOMACH CRAMPS AND SEVERE DIAREHA THIS WAS ALMOST 72 HOURS POST INJECTION. FOR THE NEXT FEW DAYS STILL FELT TIRED AND TOO WEAK TO WALK!
Both hands became dry and red with itching about 7 months after receiving vaccine. Reoccurs sporadically; symptoms subside with topical cortisone. Break out occurred the following Jan. on abdomen and under right arm.
MA stated that a 75 year old patient inadvertently received Pediarix instead of Tdap; MA stated that a 75 year old patient inadvertently received Pediarix instead of Tdap; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 75-year-old patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced inappropriate age at vaccine administration (Verbatim: MA stated that a 75 year old patient inadvertently received Pediarix instead of Tdap) and wrong vaccine administered (Verbatim: MA stated that a 75 year old patient inadvertently received Pediarix instead of Tdap).  The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-OCT-2023 Medical Assistant (MA) stated that a 75 year old patient inadvertently received Pediarix instead of Tdap. Caller declined to provide additional information, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter did not consent to follow-up.
Outbreak of vaginal, vulvar, and perianal condylmoatous like lesions starting approximately 24 hours after 2nd Moderna vaccine dose.
Information has been received from a consumer and a school nurse concerning 41 child patients who in approximately 1995 were each vaccinated with a dose of varicella virus vaccine live. In approximately 2003, the patients developed mild cases of chickenpox. Most of the children were in the first grade and had been vaccinated at their private pediatrician's offices in the area. The reporter noted that her elementary school was the only one out of six in the area that has experienced a chickenpox outbreak. The reporter notified the elementary school parents of the outbreak. Follow-up information from the nurse indicated that 13 of the reported 41 patients were not previously vaccinated with a dose of varicella virus vaccine live and all of the cases of chickenpox have recovered. One of the previously vaccinated patients was a 7 year old patient (Grade 03 1B) who on 03 Aug 1998 was vaccinated with a dose of varicella virus vaccine live. On 26-Feb-2003, the patient developed chickenpox. The previously vaccinated patients included two siblings in elementary school who were vaccinated by the same pediatrician and subsequently developed mild outbreaks of chickenpox. The other patients that developed chickenpox post vaccination with varicella virus vaccine live were also identified (WAES #0305USA00974, 0306USA00276, 0306USA00277, 0309USA01822 and 0309USA01824 through 0309USA01846). Additional information is not expected.
This was second round of vaccine. Initially developed chills and shivering that lasted through the night. Following day had moderate diffuse arthralgia, myalgia and fatigue. Also had mild headache and nausea. These symptoms lasted most of the day. Second night had sweats most of the night.  Second day felt back to normal other than soreness at injection site.
FRIDAY 4/2, NAUSEA 3 HOURS AFTER INJECTION;  SHALLOW COUGH, FEVER/CHILLS, EXTREME BODY ACHES WITHIN 10 HOURS; SATURDAY 4/3, BY FOLLOWING MORNING - SEVERE CHEST/UPPER BACK PAIN,   SUNDAY 4/4, SYMPTOMS WORSENED TO EXTREME CHEST/UPPER BACK PAIN, RAPID HEART BEAT, DIFFICULTY BREATHING DEEPLY; TAKEN TO URGENT CARE; URGENT CARE DOES A TEST, SENDS PT TO ER IMMEDIATELY; HOSPITAL RUNS TESTS; CALLS IN CARDIAC SPECIALIST WHO ADMITS PT TO HOSPITAL. HOSPITAL STAY OF 3 DAYS;  DIAGNOSED WITH MYOCARDITIS AND PERICARDITIS DUE TO VACCINE.  STARTED DAILY HEART MEDS AT HOSPITAL, CONTINUED MEDS TO PRESENT DATE
Redness and itching on the patients armpit, back, neck, and lips. Reported tingling lips, vertigo, fluctuating blood pressure, weakness, and sinus congestion. Patient took Tylenol and Benadryl and improved over the next few days.
c/o temp 100.6, chills, sore throat, & muscle aches 12 hours after receiving vaccine. Symptoms resolved in 48 hours
Shingles trigeminal rash, itch, pain rx famciclovir 500mg 3x 7 days Bacitracin oinment 500mg eyes.
COUGH; LOSS OF TASTE; SOME BREATHING ISSUES; LOSS OF SMELL; JOINT PAIN; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced cough, loss of taste, some breathing issues, loss of smell, joint pain, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cough, fever, loss of taste, joint pain, some breathing issues and loss of smell was not reported. This report was non-serious.
Vomiting, diarrhea, fever, stopped eating or drinking, dehydration;
Swelling of glands below shoulder, swelling going up my neck into my jaw, tingling in my face on the left side. Doctor started me on a prednisone treatment.
post vaccine - c/o sharp pain in head Tues and now "feels like crmps in head" and still had pain in LA radiates to back. denies hx of heart disease or HTN, denies DM, "low white cells per family hx".  CG excluded, declined to be tested or MD eval. Advised G to f/u with MDfor symptoms and eval, and to F/U with CL regarding pay
colds; sneezing; loss in her taste and smell for a short period of time; loss in her taste and smell for a short period of time; began to feel unwell; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient) via Pfizer sponsored program. A female patient of unspecified age (Unknown pregnancy) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch no/ Lot Number: unknown; expiration date: unknown) via an unspecified route of administration on 20Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch no/ Lot Number: unknown; expiration date: unknown), via an unspecified route of administration on 27Feb2021 as dose 1, single for COVID-19 immunization. On 24Mar2021, patient reported began to feel unwell. On 26Mar2021 patient began experiencing a loss in her taste and smell for a short period of time. Then, patient also reported having colds and sneezing on 27Mar2021. Outcome of the events began to feel unwell, colds and sneezing was unknown and loss in her taste and smell for a short period of time was recovered on an unknown date in Mar2021  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
I have had tinnitus for years but it has never really bothered me or affected my day to day life.  The day after receiving the Moderna vaccine my tinnitus  was significantly worse (louder and more high-pitched) and I am now aware of it constantly. It has continued at the same increased level to this day. I?m sure I?ll manage but I wanted to let you know it was a notable and unpleasant difference pre and post shot. My first three shots were all Pfizer.
Progressively worsening shoulder pain (lower deltoid) radiating out to shoulder blade and down to wrist.  Lateral elevation limited, use limited. I got a shot in the other arm last year and the same thing happened.  I thought it was bursitis. Lasted about 8 months.
This spontaneous report as received from a physician via company representatives and from a support services director, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 19-APR-2016, the patient was vaccinated with a dose of improperly stored VAQTA "10Pk 50 U/1ml SD Llok w Caps Adult" with lot number L031196 and expiration date of 15-FEB-2017 (dose, route of administration and anatomical location were unknown), which was stored at the lowest recorded temperature of 32 (0 Celsius degrees) for 232 hours, at the lowest recorded temperature of 34 (1.111111111 Celsius degrees) for 96 hours, at the lowest recorded temperature of 30 (-1.111111111 Celsius degrees) for 136 hours, at the lowest recorded temperature of 33 (0.555555556 Celsius degrees) for 104 hours, at the lowest recorded temperature of 31 (-0.555555556 Celsius degrees) for 224 hours and at the lowest recorded temperature of 29 (-1.666666667 Celsius degrees) for 72 hours. The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Swollen ankle; Could not walk; Excruciating pain; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swollen ankle), GAIT INABILITY (Could not walk) and PAIN (Excruciating pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder, Drug allergy (Biaxin, morphine, codeine), Ovarian cancer since October 2018 and Dyspepsia. Concomitant products included IBEROGAST for Dyspepsia, PROBIOTICS NOS for Probiotic therapy, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, VITAMIN D3, MAGNESIUM CITRATE and PLANTAGO OVATA SEED HUSK (PSYLLIUM HUSKS) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced JOINT SWELLING (Swollen ankle), GAIT INABILITY (Could not walk) and PAIN (Excruciating pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (Swollen ankle), GAIT INABILITY (Could not walk) and PAIN (Excruciating pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided by the reporter.   This case was linked to MOD-2021-053345 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow-up contains non-significant information. On 04-May-2021: Follow-up contains additional information: Updated patient demographic details, medical history, concomitant medication On 24-Jun-2021: Follow-up contains Non-significant information.
Information has been received from a healthcare worker concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (strength, dose and frequency were unknown; subcutaneous, lot # L039092, expiration date 06-OCT-2017; lot # L048462, expiration date 02-DEC-2017; lot # M004329, expiration date 26-JAN-2018 and lot # L017142, expiration date 13-MAY-2017). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous prospective pregnancy report as received from registered nurse refers to a 20 year old female patient. Patient medical history was not reported. On 04-AUG-2014 the patient who was 34 weeks pregnant was inadvertently vaccinated with GARDASIL (strength, dose number, frequency, route, lot number and expiry date unknown) instead of BOOSTRIX. No concomitant medications were reported. The patient became pregnant with last menstrual period (LMP) of 09-DEC-2013 and estimated delivery date (EDD) of 15-SEP-2014. Patients date of conception was on 23-DEC-2013. Initial exposure of GARDASIL was at 34 week(s). The pregnancy outcome was outcome pending. No adverse effect was reported. The outcome of 34 weeks pregnant, was inadvertently administered a dose of GARDASIL instead of BOOSTRIX and no adverse effect was unknown. No further information was provided.  Additional information has been requested.
onset of diffuse erythema & urticaria w/in 30 mins of DTAP & HIB vax; rx Epi & DPH;
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Between 14-SEP-2018 and 17-SEP-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # R006752, expiration date 06-MAR-2020 for prophylaxis. Sterile diluent (manufacturer unknown) was stored properly. The vaccine underwent a temperature excursion of -9 to 8 degrees Celsius for 21 hours and 35 minutes. There was no previous temperature excursion. The digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA011766.
A non-serious, spontaneous report of positive flu test, sore throat, fever, and vomiting has been received from a registered nurse concerning a 13-year-old female subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 01-Sep-2009. On 02-Sep-2009, the patient experienced a sore throat and on 04-Sep-2009 was feeling horrible and tested positive for the flu, had a fever of 102.1 and vomiting. At the time of the report, the events were ongoing.
Patient had a fever of 105.0 rectally, as well as coughing, sneezing and decreased appetite.
had Shingrix vaccine about two years ago,I did not get the second injection; This case was reported by a consumer via (Shingrix) interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient asked, should he/she start the two injection vaccine again.
entire upper arm became red, warm, swollen and itchy a few hours following vaccination.  Patient came in next day to pharmacy where she received vaccine, pharmacist advised patient to use cold compress and bendaryl otc.  I faxed her primary Doctor, and referred patient to her PCP.  Upon follow up call by pharmacist next day patient said arm was improving and less red and less swollen.
No adverse event.  Wrong vaccination administered.  Menactra was given 05/21/14, had been previously given 03/27/13.
3-11-21 @ 9:30am -Nausea 3-12-21 @ 7:30am- Woke with nausea, headache, joint aches, extremely sore arm, low grade fever and tinnitus in left ear 3-12-21 @ 1:00pm- Hearing impairment in the left ear and tinnitus in both ears.   3-14-21 @ 7:30am- Woke with only sore arm, tinnitus in both ears and hearing impairment in both as well. 3-22-21 @ 10:00am- Still have hearing impairment and tinnitus in both ears. Slight improvement in hearing but tinnitus is worsening.
fever beginning 9 days after vaccination, lasting 2 days, max of 101.8 deg F tympanic;  moderate rash covering face, trunk, arms, and legs beginning day 10 and lasting 4 days; treated w/Motrin for fever and discomfort; we did take photos of the rash for documentation
He developed a slight fever for a day I gave him Tylenol.  He developed a cough, sore throat and sneezing.  He tested positive on 6/7 and we visited the doctor the same day and they gave him cough medicine.
supraclavicular puffiness soon after 1st dose, then increased lymphadenopathy on L side after 2nd dose
RN noted unable to obtain more than 3 complete doses of vaccine from vial.  Later, possible that less than recommended diluent added to vial.    Patient infromed of possible increased concentration and possible increased side effects.  Information regarding patient education came from Pfizer and CDC'd "Interim Clinical Considerations for use of mRNA COVID-19 vaccines.  Patient did report experiecing increased expected side effects for up to 10 days.  Patient provided RX for nausea.
pt recv vax 28APR97 & devel urticaria 29APR97
Redness at vaccination site, increasing in size to 2.3cm x 4.8cm.
Pt expressed no pain at time of vaccine. Direct soreness at injection site (but no redness or swelling) which pt says never went away and got worse over next weeks to include neck and right upper arm. Now with electric shock type pain of both upper arms with extreme abduction L>R. Also with bladder incontinence and involuntary upper body tremors-rarely .  Referred by PCP to Urology to Neurology to rule out neurological issues. Pain is only with movement upper arms. All symptoms began same time.