chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Unsure which version of Hib was given. Did receive Pediarix, Hiv PCV and Rotavirus vaccines. Later in the evening had an episode of appearing pale, eyes roled back into head, took about 25 minutes to return to baseline. Was admitted to hospital for EEG, observation overnight.
36 hours after I received the vaccine, I had PVC's, premature ventricle contractions, and it lasted for about an hour and a half. I was feeling very exhausted and went to bed. Five days after receiving the vaccine I got shingles. I couldn't move for 4 days without excruciating pain. I was acute outbreak for 4 days and had lingering pain for three weeks. I felt fatigued, malaise and I had a fever when it first started. I went to my PCP and she verified that it was quite likely that the vaccine activated the herpes virus. She gave me a prescription for a high dose antiviral medication for when I took my second vaccine. She told me to avoid caffeine and alcohol before, during and after receiving the vaccination. She wanted me to stay away from anything that could increase heart palpitations. Today, I am feeling fine. I received the vaccine at the pharmacy and they were terrible. There was no waiting area and they did not increase their staff to cover the participants that wanted to get vaccinated.
Woke to pool of blood from blood blister on scrotum. Bleeding stop with direct pressure. NEVER had blood blisters, especially on my scrotum. Remembered that Nurse questioned me about "blood thinning medication". I said "No, just a baby aspirin (81mg)", she gave me a questioning look and vaccinated me. I have stopped the baby aspirin and the blood blisters are fading slowly.
Received vaccine at 11 am 9/23/2013 at 3 pm started to feel cold at 5 pm temperature reach to 103 F felt chill, headache called Med Ctr was instructed to take TYLENOL.
pt recvd vax 26SEP95 & 5OCT95 pt exp atypical rash,not like chickenpox;had 6 to 8 lesions on arms 1 to 2 lesions on legs;vesicles were thick;pt was also cranky;no further details were provided;
Initial and follow-up information has been received from a registered nurse for the Pregnancy Registry of GARDASIL concerning a 21 year old female with no pertinent medical history or drug reactions or allergies who on 21-FEB-2007 was vaccinated with GARDASIL, lot# 653736/0014U (first dose). Concomitant therapy included YASMIN. As of 02-APR-2007 the patient was pregnant (LMP = 28-FEB-2007, estimated delivery date = 05-DEC-2007). There were no adverse experiences related to this event. The patient sought unspecified medical attention (not further specified). Follow-up information indicated that the patient terminated the pregnancy at less than 12 weeks. Upon internal review the elective termination was considered to be an other important medical event. Additional information is not expected.
Patient recieved Flu mist instead of Influenza shot, due to his age, it is CDC recommended over the age of 50 recieves flu shot. patient is 50 yrs and 3 mo.
general malaise; sore arm; This spontaneous case was reported by a physician and describes the occurrence of MALAISE (general malaise) and PAIN IN EXTREMITY (sore arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced MALAISE (general malaise) and PAIN IN EXTREMITY (sore arm). At the time of the report, MALAISE (general malaise) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter.   This case was linked to MOD-2021-385128, MOD-2021-385158 (Patient Link).
Large red swelling below injection site, sore arm lymph nodes both arms, headache, fatigue, chills, stomach cramps, vomiting
Arm is still sore two weeks after shot.    I had all the signs of Covid a week after the shot.  Taste is still off.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination. No Medical History information was reported. On 27-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 12:30 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 77.22. Concomitant products were not provided. On 31-Mar-2021, Excursion time was 09 AM and 10 AM, temperature was 35, total doses given for the day was 195, condition of vaccine prior to administration was not frozen, vaccine was   moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 20 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Itchy hands, blotches spreading from hands to trunk. Hands burning, developed slight tightness in chest.
Pneumovax admin 7/8/04 on 7/9/04 developed s/s 1 day after injection following redness right arm injection site with pain and swelling. Dx: Cellulitis Tx: Cleocin 300mg, 1 cap q 8 hours x 7 days.
When I first got the shot I got a tad lightheaded. After sitting I was fine,  I went home and had bad chest pain it was light and got worse over the next few days.  I went to a Dr about a week after due to chest pain.  I was told it may be pericarditis/ pleurisy and was given steroid and amoxcillin. For 7 days I took these and Symptoms were worse, I have burning chest pain that has developed more.  My heart and blood spike for just standing up and feel like I'm going to pass out everytime.  My bpm and BP are reading high at times fluctuating randomly.
Cellulitis with redness and inflammation.  Patient received an Rx for prednisone and cephalexin
Information has been received from a physician concerning a 10 year old male who on 06Jul99 was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that the pt had a serious breakthrough of varicella. The pt was seen at the office on 08Mar2004 and had many lesions on the face, trunk and extremities. The pt was treated with diphenhydramine hydrochloride (Benadryl) and ibuprofen (Advil). It was noted that the physician already reported the event to the health dept. A product quality complaint was not involved. Additional information has been requested. This is in follow up to report previously submitted on 5/14/2004 information has been received from a physician concerning a 10 year old male who on 07/08/1999 was vaccinated in the right arm with a dose of varicella virus vaccine live (lot # 629615/0310J). Concomitant vaccinations on the same day included a second dose in the left arm of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 627426/0540J), a fifth dose in the right arm of diphtheria toxoid (-) pertussis vaccine (unspecified) (-) tetanus toxoid (lot 464-301), and a fourth oral dose of poliovirus vaccine inactivated (unspecified) (lot 0800X). The reporter indicated that the patient had a serious break through of varicella. The patient was seen at the office on 03/08/2004 and had many lesions on the face, trunk and extremities. The patient was treated with diphenhydramine hydrochloride (Benadryl) and ibuprofen (Advil). It was noted that the physician already reported the event to the health department. A product quality complaint was not involved. Follow up information was received from a woman in the physicians office who indicated that the patient was diagnosed with varicella on 3/1/2004. Subsequently, the patient recovered. No further information is expected.
It was determined that the recipient was administered too much Pfizer vaccine in error.  Upon the discovery, the recipient was notified and given care instructions by the school's physician.  Upon follow-up the next day by the nurse, recipient complained of nausea, headaches and being tired. Continious monitoring and follow-up will be made on the recipient's condition and care.
This is a spontaneous report from a contactable pharmacist.  A 84-year-old female patient of unspecified ethnicity started to receive PREVNAR; (lot number N16561, expiration date 30Sep2017), intramuscularly, in an unspecified deltoid, on 11Oct2016, at 0.5 ml, as single dose for immunization.  Medical history was reported as none.  Concomitant medications included: OMNISEPT, 300 mg two times a day, lidocaine 5% ointment (TRADE NAME UNSPECIFED), once a day, hydrocodone bitartrate, NORCO, every four hour as needed, PYRIDIUM, 200 mg, three times as day and RAPAFLO, 8 mg, once a day.  On 11Oct2016, the patient experienced sore neck, muscle pain in left quadriceps and could not walk.  The action taken with pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) was not applicable. No treatment was received for the reported events.  The patient was recovering from sore neck, muscle pain in left quadriceps and could not walk at the time of reporting on 19Oct2016.  No causality was reported.
Severe headache, fatigue, difficulty staying awake. Treated with fluids, Advil, and sleep.
T100 9FEB92, loss of appetite, achy legs c/o h/a; 12FEB92 now feeling well, no h/a or achiness noted;
Completed the Shingrix series yes still got Shingles/ Suspected vaccination failure; Completed the Shingrix series yes still got Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by the sister of the patient. The age at vaccination was not reported. The reporter stated that the patient completed the Shingrix series yes and still got shingles. The reporter had the minimal information. The reporter did not consent to follow up. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
VOMITING AND DIARRHEA. VISISTED ER ON 1/29/21. CAME BACK TO ASSISTED LIVING FACILITY, THEN WENT BACK OUT TO HOSPITAL AND WAS ADMITTED ON 1/31/21
Felt hot, heart racing. BP 139/98, HR108, RR16. 20 minutes later, patient recovered with BP 131/81, HR74, RR16. Given water
No symptoms or adverse reactions. Patient given wrong age appropriate vaccine. Patient received 6month to 4 year vaccine and should have receive 5-12 year old vaccine.
Left arm cellulitis ~3 days after vaccine.  Treatment with Amoxicillin, Benadryl/Motrin.
I received the shot at 11:30, 11:40 tongue started to feel swollen, shortly after lips were tingling, sought medic, was observed for a few minutes then troat started closing and symptoms of bad asthma attack was offered an epi-pen but chose to use my flyp nebulizer with albuterol and was transported to ER. Face started itching(minor). Was able to breathe normally after several minutes in the ER bp was elevated to 144/93 was keep until about 1:20 given prescriptions for  Hydrxyzine pamoate 25 mg, famodine 20 mg, prednisone 20 mg and sent home
This spontaneous report as received from a health worker on 03-NOV-2014 refers to a patient of unknown age and gender. On 30-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J008802, expiration date: 19-OCT-2014, strength, dose and route were unknown). The ZOSTAVAX did not have any previous temperature excursions. The ZOSTAVAX was supported with post-expiry data. No adverse symptoms reported. Additional information has been requested.
Pt received dose #1 of Moderna on 1/20/2021 at clinic. On 1/24/2021, developed self reported fatigue and sleep disturbances with pruritis. Sought no medical care. Routine labs were obtained on 2/23 which demonstrated new-onset transaminitis and hyperferritinemia (ALT 2366, AST 1260, alk phos 362, ferritin 32,000) and was admitted to hospital for evaluation. No etiology for acute liver failure identified, including comprehensive evaluation for viral hepatitis and other common causes of hepatitis common after transplant. Concern raised for hemophagocytic lymphohistiocytosis (HLH) due to extreme hyperferritinemia, although bone marrow biopsy negative. Ultimately transferred to another hospital for further care at patient's request. No specific treatment was given and transaminitis ultimately resolved. Soluble IL-2 receptor (CD25) level checked on 3/2, at time of admission, markedly elevated at 2338.6, consistent with diagnosis of HLH. Pt discharged on 3/5. Ultimately readmitted on 3/9 and found to have rapidly progressive Legionella pneumonia and died on 3/16. Two events felt to be unrelated and pneumonia not felt to be cause of HLH due to patient's status at time of initial admission.
Symptoms were noticed about noon 3/14 with an on again off again fever peaking at 100 with on again off again sore throat.  Just one day of a headache.  With a very bad cough that did not allow participant to lay flat, this lasted 3 days.  Fatigue was considerable.  Tested positive with an At Home COVID-19 Test.  Did not consult with doctor, just treated symptomatically.   Fatigue lingers to time of reporting but is much diminished with a very minor cough.
Headache; chills; fever; nausea; This is a spontaneous report from a Pfizer-sponsored program COVAX US support via a contactable consumer reported for a patient (reporter's granddaughter). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 24Apr2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache, chills, fever and nausea after the first dose of the COVID vaccine. The reporter was wondering what the patient could take to treat the symptoms. The outcome of the events was unknown.  No follow up attempts are needed. No further information is expected.
This spontaneous report was received from a Registered Nurse via a company representative referring to a 15 month old female patient. The patient's concurrent conditions included hypertrophic cardiomyopathy. There was no concomitant medications reported. On 14-JUN-2018, the patient was vaccinated with VAQTA 25/0.5 (dose, route, lot number and expiration date were not reported) for prophylaxis. Other suspect therapies administered on that same date included VARIVAX (dose, route, lot number and expiration date were not reported) and another unspecified vaccine, both administered for prophylaxis. On 15-JUN-2018, the patient was lethargic and was taken to the office, later she was taken to the hospital and was admitted. The nurse reported that patient died next day (16-JUN-2018). It was also informed that an autopsy was done, but the results were not available at the reporting time. The nurse reported that patient was a twin and that the other unspecified 15 month old twin also received the same vaccinations (no further information was provided). The causality assessment between the events and the suspect therapies was not provided. The event lethargy was considered as disability and life threatening as serious criteria by the reporter.; Reported Cause(s) of Death: death.
Within 10 min of injection i went to the 15 min waiting area and began to have a racing heart, feeling of impending doom, timgling in my mouth and throat, dizziness, shaking, sweating. They came in waves or rushes for the next hour. Doctor said i look like im getting oxygen and confirmed i had a racing heart. I took lorazepam to calm myself down and doctors concluded it was a panic attack although i know this was something i had never experienced before.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 at 09:00 as dose 1, single (Lot number: EN6198), in left arm, on 26Mar2021 at 09:00 as dose 2, single (Lot number: ER8732), in left arm, on 01Oct2021 at 09:00 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 26May2022 at 10:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 67 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid).
This child had a Hepatitis B injection #2, 01/23/01. After school symptoms of an achy stomach, temp of 99.0 at 3:30 PM, and 102.7 at 4:50 PM. No pain or redness at the injection site. No problem with first Hepatitis B shot. The patient was seen in the doctors office the next day 01/24/01, it is believed that he has the flu, the Hep B shot from the day before causing the reaction is totally coincidental.
Patient presented to the hospital with atrial flutter, COPD exacerbation within 6 weeks of receiving covid vaccination.
On 9/17/99, the pt experienced injection site reactions described as hard, red, painful, larger area under the injection site.
Patient is a 9yo adopted male without significant past medical history. His two adoptive mother's are now separated and he spends time between both homes. Patient had suspected COVID 19 infection in November 2020 (not lab confirmed but symptomatic). He has not had clinically apparent COVID 19 infection in 2021 to mother's knowledge, but did have exposure to neighbor with symptoms consistent with COVID 19 (though their testing was reportedly negative) around the end of November 2021.   Patient was vaccinated with his first dose of Pfizer-BioNTech COVID-19 vaccine on 12/17/21. Starting 12/20/21 he began to experience lethargy, abdominal pain, some emesis, diarrhea, subjective fever (no temp taken), malaise, decreased oral intake. He was under care at one parent's home. He was seen by PCP who recommended supportive care measure for suspected viral illness. On 12/24 he returned to the care of his other parent's home. He was then taken to the hospital for evaluation and found to have work up consistent with MIS-C.
big red 3 inch diameter welt at injection site hurts, itches; big red 3 inch diameter welt at injection site hurts, itches; I felt terribly sick; Feels like having a bad cold; third dose was given on 19OCT2021 with expiration of 13OCT2021; Have a sore arm; nauseated; big red 3 inch diameter welt at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I felt terribly sick), NASOPHARYNGITIS (Feels like having a bad cold), PAIN IN EXTREMITY (Have a sore arm), VACCINATION SITE PAIN (big red 3 inch diameter welt at injection site hurts, itches) and VACCINATION SITE PRURITUS (big red 3 inch diameter welt at injection site hurts, itches) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 011M20A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced PAIN IN EXTREMITY (Have a sore arm), NAUSEA (nauseated) and VACCINATION SITE URTICARIA (big red 3 inch diameter welt at injection site). On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (third dose was given on 19OCT2021 with expiration of 13OCT2021). On an unknown date, the patient experienced ILLNESS (I felt terribly sick), NASOPHARYNGITIS (Feels like having a bad cold), VACCINATION SITE PAIN (big red 3 inch diameter welt at injection site hurts, itches) and VACCINATION SITE PRURITUS (big red 3 inch diameter welt at injection site hurts, itches). The patient was treated with CHLORPHENAMINE MALEATE, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (MUCINEX COLD & FLU) at an unspecified dose and frequency and ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) at an unspecified dose and frequency. On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (third dose was given on 19OCT2021 with expiration of 13OCT2021) had resolved. At the time of the report, ILLNESS (I felt terribly sick), NASOPHARYNGITIS (Feels like having a bad cold), VACCINATION SITE PAIN (big red 3 inch diameter welt at injection site hurts, itches) and VACCINATION SITE PRURITUS (big red 3 inch diameter welt at injection site hurts, itches) outcome was unknown and PAIN IN EXTREMITY (Have a sore arm), NAUSEA (nauseated) and VACCINATION SITE URTICARIA (big red 3 inch diameter welt at injection site) was resolving.            No concomitant medication was reported.