chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hives on 12th dayand 15th day after vaccine; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (hives on 12th dayand 15th day after vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced URTICARIA (hives on 12th dayand 15th day after vaccine). At the time of the report, URTICARIA (hives on 12th dayand 15th day after vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information provided.    Reporter did not allow further contact
Large hives appeared on his face, mostly on the left side. I took him back to dr that day. I was told although there was no other hypothesis, that it could not be vaccines. I asked about information about others having similar reactions and was told I can't believe anything I find on the internet. I was told to keep giving him Zyrtec and applying ice when the hives appear. They kept showing up once per day on both sides of face and under his chin, for about 5-6 days. I asked for a medical vaccine waiver for school and the dr said I wouldn't get one. That he would never attribute this to the vaccine. That his reaction was  an 'enigma'... I provided several photographs of his face swollen up with the hives.
Due to a pharmacy substitution client received Infanrix Dtap vaccination rather than Adacel Tdap vaccination, University Drug Information Center indicated that the pediatric Infanrix version contains the same amounts of tetanus and pertussis and an increased amount of the diphtheria component. The patient should be adequately immunized. They may, however, be at an increased risk of adverse reactions due to the elevated diphtheria component. The agency was contacted per doctor name reported and they concurred with this information. The patient was contacted per the University and did not experience any serious adverse reactions. Follow-up corrective actions are being taken at the University
Reports redness, arm pain to and around insertion site, diarrhea, body aches, fever (low grade) that started about 3 hours after receiving vaccine.   diarrhea has been improving.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   69-year-old male patient received BNT162b2 (BNT162B2), on 03Nov2021 as dose 3 (booster), single (Lot number: FF2S90) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05Feb2021 as dose 1, single (Lot number: 028L20A), in left arm and on 06Mar2021 as dose 2, single (Lot number: 027A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: High cholesterol, controlled with statin; "Interchange of vaccines" (unspecified if ongoing). No known allergies. There were no concomitant medications. No other medication in 2 weeks.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Antiviral details included product: COVID 19 treatment, brand: Paxlovid, treatment start date: 24Apr2022, treatment stop date: 28Apr2022, indication: treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
Received PNEUMOVAX 23 in left arm at 3:00 P. 9.24.10. Injection site inflamed.
Information has been received from a consumer concerning her husband, a 71 year old male patient with dementia and no allergies, with a pertinent medical history of open heart surgery and knee replacement who on 29-DEC-2010 was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) (Lot# 669187/1543Z, Exp date 06-FEB-2012), "in the arm". Concomitant therapy included albuterol sulfate, PREVACID, lisinopril-HCTZ, cyproheptadine hydrochloride (MSD), NIASPAN, TOPROL XL TABLETS, LIPITOR, aspirin, NAMENDA, ARICEPT, VENTOLIN HFA, albuterol sulfate inhaler, SYMBICORT and oxygen. The consumer stated that her husband "three weeks ago" on approximately 13-JAN-2011 experienced headaches "a dull pain in his head" and vision problems. The nurse that administered ZOSTAVAX (Merck) mentioned that the consumer's husband could experience certain side-effects 45 days after receiving the vaccines. It was no treatment given for the events. The patient was checked for vision problems (No results reported). At the time of the report the patient had not recovered. Follow up information has been received from the consumer who reported that on 17-APR-2011 her husband developed a case of shingles. The patient had blisters, burning, itching and pain on his right side. They had not yet contacted their physician but would do so. At the time of reporting the patient's status was unknown. Additional information has been requested.
Psoriatic arthritis; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis) in a 64-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic ).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis) (seriousness criterion medically significant) and FATIGUE (Fatigue). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medication provided. No treatment information mentioned. Causality for Skyrizi(risankizumab): the reporter's causality for the event(s) of psoriatic arthritis and second dose of Moderna vaccination caused fatigue 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  Company comment:  This spontaneous case concerns a 64-year-old female patient with relevant medical history of Chronic plaque psoriasis, who experienced the unexpected, serious  (medically significant) event of Psoriatic arthropathy (Psoriatic arthritis)  on an unknown date in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as event onset date was not provided. Patient was treated with Risankizumab.  Patient received a 2-dose primary series of mRNA-1273 vaccine given 29 days apart.  The relevant medical history of Chronic plaque psoriasis remains a confounder as 1 in 3 people will likely develop psoriatic arthritis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 64-year-old female patient with relevant medical history of Chronic plaque psoriasis, who experienced the unexpected, serious  (medically significant) event of Psoriatic arthropathy (Psoriatic arthritis)  on an unknown date in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as event onset date was not provided. Patient was treated with Risankizumab.  Patient received a 2-dose primary series of mRNA-1273 vaccine given 29 days apart.  The relevant medical history of Chronic plaque psoriasis remains a confounder as 1 in 3 people will likely develop psoriatic arthritis.   The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Red raised rash at injection site & on front of torso & upper thighs. No SOB. No medical attention required.
Fainted and lost consciousness, came back quickly (30 seconds) but did not remember anything. Was taken S/V, blood sugar test (DXT). All normal values
She said she had severe headache, severe dry/sore throat and could not swallow, chills and profuse sweating, nausea, diarrhea, red/raised warm skin, streaked below injection site
1 day after HPV - Sharp pain in head lasted a few seconds, achy, low grade temp.
Patient woke up with fluid filled raised area on her left arm where she received her immunization. She complains of persistent pain in that area. It hasn't gotten any worse since the onset, but it hasn't gone away either. Went to the doctor several days later and given antibiotic KEFLEX 10 days, but condition did not improve.
COVID arm: itching and splotchy red  began 7 days post vaccine, redness got larger and covered whole top of arm on day 8. Made a large red ring (5? diameter) on day 9.    Normal sore muscles for a few days following vaccine.
This spontaneous report was received from a 58-year-old female consumer with asthma, blood pressure abnormal and drug reactions or allergy to penicillin. The patient's medical history included thyroidectomy. On 18-MAR-2016, the patient was vaccinated with a dose of ZOSTAVAX in the right arm (dose, route of administration and lot number not reported). Concomitant therapies included SINGULAIR, PROTONIX, LEVOTHROID, vitamins and blood pressure medicines. The reporter stated that on 19-MAR-2016, she developed a red, itchy, swollen and hot spot on the right arm near the injection site. On 20-MAR-2016, the spot on the arm quadruped in size and was bigger than a 50 cent piece. The redness on the arm, which was light red and dark red in color, was spreading all around. The patient had a big knot on the right arm. The area was really hot to the touch and itching. The patient was taking BENADRYL but it was not working. The patient went to the pharmacy. The outcome of the event was reported as not recovered/not resolved. The relationship between vaccination with ZOSTAVAX and the events was not provided. Additional information has been requested.
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 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Oct2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "controlled high BP" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was unknown that Other medication in 2weeks. Anti viral details product=COVID 19; Treatment start date was 27Apr2022, Treatment stop date was 02May2022, Lot number was FY5656.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
2nd Flu shot given. 8 days after shot a red pustule and abscess developed. Patient had sores in other spots before shot given.  Treated as MRSA boils.
Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine product; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8730), in right arm, on 29Apr2021 as dose 2, single (Lot number: EW0167) and on 23Apr2022 as dose 4 (booster), single (Lot number: FK9893), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Nov2021 as dose 3 (booster), single (Lot number: CVX207) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Nov2021, outcome "unknown", described as "Interchange of vaccine product"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: known allergies: No; other medication in 2weeks: Yes; Patient was received paxlovid treatment from 30Aug2022 to 03Sep2022 for treatment of covid-19. Adverse event: I am Reporting rebound COVID symptoms after showing significant improvement from Paxlovid treatment. Four days After completing the 5 day regimen, I began experiencing new/worsening symptoms such as new sinus congestion, aggravated asthma and worsening cough with wheezing and continued fatigue. Required a trip to the ER for assessment of possible pulmonary embolism (ruled out with testing). Prescribed course of prednisone and released. Husband who also took Paxlovid fully recovered.
PATIENT HAS DEVELOPED A RASH IN THE SAME LOCATION OF A PREVIOUS SHINGLES OUTBREAK 3 YEARS AGO
PFIZER-BIONTECH COVID-19 VACCINE EUA:  PATIENT PASSED AWAY AT MEDICAL CENTER ON SEPT 26,2021 FROM COMPLICATIONS OF COVID-19.  SHE WAS FULLY VACCINATED WITH PFIZER COVID-19 VACCINE.  1ST DOSE ON 12/31/20 AND 2ND DOSE ON 1/19/21.
Pt experienced flushed face and temperature of 103. Pt also experienced swelling of left leg and redness at injection site. Pt acted like the leg was painful.  Pt also had severe diarrhea, decreased appetite and vomiting. Pt was treated with Benadryl.
Patient received a vaccine dose which was under-diluted, vial prepared with 0.8ml rather than 1.8ml diluent.   The patient was informed that she may experience a local or systemic adverse event.   And the team followed up with patient via a phone call on 9/16 and patient reported that she was doing good.   She stated that she has had a little arm soreness and was a little nauseous after the shot (she did not eat anything prior to receiving the shot).    She was given instructions to call if she experiences any abnormal reactions.
Patient was given Moderna at age 16. Moderna is not approved for patients under 18 years of age.
5th dtap and 4th IPV dose, erythema and induration at site of injection originally about 3 cm in size at onset.
Expired Bexsero administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABXC06AA, expiry date 31-MAR-2023) for prophylaxis.   On 17-APR-2023, the patient received the 2nd dose of Bexsero. On 17-APR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Bexsero administered). The outcome of the expired vaccine used was 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: 18-APR-2023 The nurse reported that an expired dose of Bexsero was accidentally given and wished to know what information was available.  The reporter gave information about the vaccine and patient. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up. The patient received a Bexsero vaccine which was already expired, which led to expired vaccine used.
Clotting event; Fibrin D dimer high; chest pains; Little injection site soreness; This is a spontaneous report from a contactable consumer reporting for himself. A male patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer -BioNTech), via an unspecified route of administration in the arm, on 22Dec2020, at single dose, for COVID-19 immunisation. Medical history was none. Concomitant medications were not reported. The patient experienced fibrin d dimer high in Jan2021 with outcome of unknown, clotting event on 03Jan2021 with outcome of unknown, chest pains on 03Jan2021 with outcome of unknown, little injection site soreness on 22Dec2020 with outcome of unknown. The events fibrin D dimer high and clotting event caused patient's hospitalization in Jan2021. The patient underwent lab tests and procedures which included fibrin d dimer: high in Jan2021. The patient was vaccinated on 22Dec2020 close to the evening and had a normal response with a little soreness in the arm at the injection site. Then on 03Jan2021, he reported to be having chest pains that he never had before and went to the emergency department (ED) due to a clotting event. Upon blood work, they discovered that his D-dimer was elevated and was really high for his age. He mentioned that he had no history and no issues with this whatsoever before. He received the 2nd dose on 11Jan2021.   The information on the lot/batch number has been requested.
Fever (102.8), myalgias; headache; nausea; vomiting, sx lasted about 6-8 hours after immunizations.
hives; weakness; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), ASTHENIA (weakness), PYREXIA (fever) and CHILLS (chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028120a) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives), ASTHENIA (weakness), PYREXIA (fever) and CHILLS (chills). At the time of the report, URTICARIA (hives), ASTHENIA (weakness), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Severe urticaria reaction with angioedema of lips. 5-10 minutes after vaccines, redness. Treated with Epipen 0.3mg 1:1000, IM, was given.
throat tightness; Vaccine Related Anxiety (include misc mental health); hypoglycemia; hypotension; generalized rash; This is a spontaneous report from a non-contactable other HCP. A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6203) via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient medical history included elevated blood pressure (BP) from an unknown date and unknown if ongoing. The concomitant drug was not reported. The patient experienced throat tightness, vaccine related anxiety (include misc mental health), hypoglycemia, hypotension and generalized rash on an unspecified date. It was reported that, during the patient's 30-minute waiting period after the injection, the patient began to experience throat tightness. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, light-headedness, dizziness, facial swelling, lip swelling and tongue swelling. The patient discharge stable to go home and follow up with PCP. Differential diagnosis: Vaccine related anxiety (include misc mental health) and systemic reaction (hypoglycemia, hypotension, generalized rash). Hypertension (HTN) More likely anxiety related in her reaction today. No progression of her symptoms of throat tightness. She reports it was resolving. Time of observation was 30 minutes. She feels comfortable going home. She was aware of what to monitor for. In regard to BP she stated that she was off her medications for a while and working on diet. She was stable without (w/o) cp, shortness of breath (sob), jaw pain, neu. Treatment included: antihistamines and water Pepcid and Zyrtec. The follow up response to treatment was good. The patient underwent lab tests and procedures which included blood pressure measurement: elevated on unspecified date. Therapeutic measures were taken as a result of throat tightness. The outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
02DEC22 @ 1330 RECEIVED TYPHOID VACCINE AND @1332 BEGAN TO HAVE ITCHINESS THROUGHOUT BODY.  AT THAT POINT SHE ALSO HAD DIFFICULTY BREATHING AND WAS GIVEN EPIPEN 0.3 MG AS WELL AS BENADRYL 50 MG IM.  AT ABOUT 1350 PT WAS GIVEN PREDNISONE 20 MG 3 TABS NOW.
5APR99 cried self to sleep @ noc;6APR99 crying & inconsolable since 10Am-3PM; 60day f/u -screaming syndrome (6hrs)
I had a break through COVID-19 Infection, even though I had all three vaccine shots. Required negative test to re-enter country. Negative test out of country, positive test when we arrived in the country. I had other plans during the holiday but sheltered in place. I went to bed for 3 days, not really fatigued. I took Nyquil. No muscle fatigue or phlegm or coughing, just mild fatigue. My wife brought my meals and I isolated.
Severe pain in left shoulder increased everyday horrible pain in mobility cant sleep went to chiropractor, had heat and TINS, then emergency room had shoulder injection and Tramadol neither  Stopped the pain then went to Orthopedist xrays and ultrasound; who recommended physical therapy I cant afford therapy so exercise with rubber straps but no help still unbearable pain with any arm movement. Constant pain and lack of use for two months and 3 days so far.
This spontaneous report as received from a physician refers to a 12 year old female patient. On 05-AUG-2013 the patient was vaccinated with the fifth dose of GARDASIL (lot # and expiration date unspecified) injection (dose, route and anatomical location unspecified) for prophylaxis. The physician reported that patient received 5 doses of GARDASIL. The patient received the first dose on 22-NOV-2011, the second dose on 13-JUL-2012, the third dose on 15-JAN-2013, the fourth dose on 23-JUL-2013 and the fifth dose on 05-AUG-2013 (dose, route and anatomical location unspecified for all). No adverse effect reported. The physician reported that the patient was a foster child and then adopted, the patient's initials changed, so he did not realize the patient was in the registry twice, so the patient received 5 doses of GARDASIL all together. The patient's outcome was unknown. Additional information has been requested.
p/vax pt exp shaking while trying to fall asleep; from moms description sounded like infantile spasm
Having a very high heartrate; This case was reported by a consumer via call center representative and described the occurrence of heart rate high in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced heart rate high. On an unknown date, the outcome of the heart rate high was unknown.   It was unknown if the reporter considered the heart rate high to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The age at vaccination was not reported. The reporter declined to provide any demographics. The patient had very high heartrate, after receiving second dose of Shingrix a year ago from the reporting date. The reporter did not consent to follow-up.