chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Occasionally, at the injection site my arm feels  slightly itchy; nausea; aching; Occasionally, at the injection site my arm feels sore; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Occasionally, at the injection site my arm feels  slightly itchy), NAUSEA (nausea), MYALGIA (aching) and VACCINATION SITE PAIN (Occasionally, at the injection site my arm feels sore) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Occasionally, at the injection site my arm feels  slightly itchy), NAUSEA (nausea), MYALGIA (aching) and VACCINATION SITE PAIN (Occasionally, at the injection site my arm feels sore). At the time of the report, VACCINATION SITE PRURITUS (Occasionally, at the injection site my arm feels  slightly itchy), NAUSEA (nausea), MYALGIA (aching) and VACCINATION SITE PAIN (Occasionally, at the injection site my arm feels sore) outcome was unknown.            Treatment information was not provided. List of concomitant medication were not given.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Non-significant Follow-up
Severe Migraines; Dizziness; Fatigue; Nausea; Chills; Severe Sweating; Shortness of breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) physician received via COVID-19 Adverse Event Self-Reporting. The reporter is the patient. A 30-year-old adult female patient (not pregnant) received bnt162b2 (BNT162B2, product=COVID 19, brand: Pfizer, brand unknown: False), administered in arm right, administration date 23Jun2021 (Lot number: EW0185, lot unknown: False) at the age of 30 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Facility type Vaccine was unknown. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was none Known allergies. Concomitant medication(s) included in two weeks: sertraline (ZOLOFT); bupropion (WELLBUTRIN). The following information was reported: MIGRAINE (disability) with onset Jul2021, outcome "not recovered", described as "Severe Migraines"; DIZZINESS (disability) with onset Jul2021, outcome "not recovered", described as "Dizziness"; FATIGUE (disability) with onset Jul2021, outcome "not recovered", described as "Fatigue"; NAUSEA (disability) with onset Jul2021, outcome "not recovered", described as "Nausea"; CHILLS (disability) with onset Jul2021, outcome "not recovered", described as "Chills"; HYPERHIDROSIS (disability) with onset Jul2021, outcome "not recovered", described as "Severe Sweating"; DYSPNOEA (disability) with onset Jul2021, outcome "not recovered", described as "Shortness of breath". The events "severe migraines", "dizziness", "fatigue", "nausea", "chills", "severe sweating" and "shortness of breath" were evaluated at the physician office visit and emergency room visit. Adverse event:  Severe Migraines. Dizziness. Fatigue. Nausea. Chills and Severe Sweating. Shortness of breath after normal activities. Has not stopped since Jul2021. Ae resulted in: [Disability or permanent damage]. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. It was unknown if therapeutic measures were taken as a result of migraine, dizziness, fatigue, nausea, chills, hyperhidrosis, dyspnoea.  Follow-up attempts are completed. No further information is expected.
intentional dose omission; Tested positive for COVID after first vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID after first vaccine) and INTENTIONAL DOSE OMISSION (intentional dose omission) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL SUCCINATE (TOPROL XL), ALPRAZOLAM (AZOR [ALPRAZOLAM]), ATORVASTATIN CALCIUM (LIPITOR), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), LORAZEPAM (ATIVAN), ALLOPURINOL, ACETYLSALICYLIC ACID (ASPIRIN 81) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID after first vaccine). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (intentional dose omission). The patient was treated with Immunotherapy (BAMLAN monoclonal antibodies) for SARS-CoV-2 test positive. At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID after first vaccine) outcome was unknown and INTENTIONAL DOSE OMISSION (intentional dose omission) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, COVID-19: positive (Positive) positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date.       On 09-Jan-2021, the patient went to the hospital and received an antibody infusion and came home the same day after the treatment. Patient was instructed to wait 90 days and start the vaccination series all over again. Patient said the doctor told them their first dose must be repeated.   This case was linked to US-MODERNATX, INC.-MOD-2021-083092, US-MODERNATX, INC.-MOD-2021-083133, US-MODERNATX, INC.-MOD-2021-083104 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: Treatment information was added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083092:2nd dose US-MODERNATX, INC.-MOD-2021-083104:Wife's 1st dose US-MODERNATX, INC.-MOD-2021-083133:Wife's 2nd dose
Significant chills; Pain; This case was reported by a other health professional via sales rep and described the occurrence of chills in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills and pain. On an unknown date, the outcome of the chills and pain were unknown.   It was unknown if the reporter considered the chills and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patients had been reporting significant chills with the 2nd dose of Shingrix.  The reporter wanted to know if this has been an observed pattern and if pre-medication with an NSAID or acetaminophen for pain relief was advised.  Upon additional inquiry, no further details were shared.
Experienced, throat itchiness, skin rash and hives 12 hours after vaccine was administered. Rash and hives persisted on the 4th day contacted a physician and was prescribed prednisone and Benadryl.
Information provided by patient as follows.  My date of 1st dose Moderna vaccine was 1/28/21. My initial reaction was only sore arm, headache and fatigue for about 4 days. Several days later, on 2/6, I developed a fever, bodyaches, chills, extreme fatigue, and mild headache.   On 2/7, my symptoms nearly resolved with only fatigue.  The afternoon of 2/8, my symptoms of fever, fatigue, body aches returned. Resolving again on 2/9 morning and returning by afternoon and evening.   On 2/10 morning, I was tested for COVID19 and Influenza. Results were both negative. Symptoms from above all returned again by afternoon/evening and are still persistent (minus fever/chills/body ache) as of 2/11/21.   Is it possible this could be a vaccine reaction several days after 1st dose? No family members are experiencing symptoms of other illness.
Narrative:  87yo male pt with CURRENT PROBLEM LIST: Atrial Flutter (ICD-9-CM 427.32) Hypertrophy (Benign) of Prostate without Urinary obstruction and other lower Uri (ICD-9-CM 600.00) Chronic atrial fibrillation (SCT 4267490Proteinuria (ICD-9-CM 791.0) Gout (ICD-9-CM 274.9) Transient Ischemic Attack (ICD-9-CM 435.9) Benign essential hypertension (SCT 12010PEPTIC ULCER NOS (ICD-9-CM 533.90) Hyperlipidemia (SCT 55822004) OSTEOARTHROSIS-MULT SITE (ICD-9-CM 715.89) Other and unspecified alcohol dependence Complaining of erectile dysfunction Pt died of unknown causes on 12/11/2021. Pt had covid vaccines on 1/15/21 & 2/12/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
Swelling at site of injection, swelling of hands and redness. Rash developed on arms legs and cheeks. Some tightness in throat and difficulty swallowing (resolved by am) treated with BENADRYL.
Sore bruised arm after 1st dose; Sore bruised arm after 1st dose; Arm with raised places after 1st dose; became fatigued; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Sore bruised arm after 1st dose), VACCINATION SITE PAIN (Sore bruised arm after 1st dose), LIMB DISCOMFORT (Arm with raised places after 1st dose) and FATIGUE (became fatigued) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CLOPIDOGREL BESYLATE (CLOPIDOGREL +PHARM), AMLODIPINE, LEVOTHYROXINE, OMEPRAZOLE and OXYBUTYNIN for an unknown indication, EZETIMIBE (ZETIA).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE BRUISING (Sore bruised arm after 1st dose), VACCINATION SITE PAIN (Sore bruised arm after 1st dose), LIMB DISCOMFORT (Arm with raised places after 1st dose) and FATIGUE (became fatigued). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE BRUISING (Sore bruised arm after 1st dose), VACCINATION SITE PAIN (Sore bruised arm after 1st dose), LIMB DISCOMFORT (Arm with raised places after 1st dose) and FATIGUE (became fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
headache; body aches; feeling bad; sick; he thought he was going to pass out at work; fever of 105.2F; This is a spontaneous report from a contactable consumer (mother). A 16-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 31Mar2021 12:00 (at 16-years-old) as single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The caller is calling about her 16 year old son. She just left the doctor with her son who received his first Covid 19 vaccine. She would like to report an adverse event. Her son has had a fever of 105.2F (07Apr2021). The doctor just did blood tests, a rapid test for Covid that was negative, they tested him for strep throat that was negative and he doesn't have an ear infection. He's been running a fever over 105F for the past 2 days (07Apr2021). The caller wanted to rule out that nothing else is going on. They have called the Medical Director of (name)  and he didn't know what was going on with her son. If this fever continues she'll be calling Pfizer back. She is waiting on the results of his blood tests like his mononucleosis test pending and other viral and bacterial tests (unknown result). Her son started feeling bad about 4-5 days (unspecified date) after he received the Covid 19 vaccine. The last 2 days he's had a very high fever. He has a headache and body aches (unspecified date). He had a Covid 19 test not long before he received the Covid 19 vaccine and it was negative. She thought her son might have the Covid 19 virus but he had the rapid Covid 19 rapid test (09Apr2021) and it was negative. The caller does not know what is going on with her son. She took her son to a clinic because he was sick and because his fevers are too high. She also called the state but they told her that fevers are normal with the Covid 19 vaccine but if it persists after today, 09Apr2021, she needs to seek medical attention. It was further reported that earlier in the week her son told her he thought he was going to pass out at work (unspecified date). He told her he thought he had a fever but she checked it with a forehead thermometer and it didn't show a fever. Then on Wednesday, 07Apr2021, her son woke up around 4:30AM and had a fever of 105.2F with an oral thermometer. He woke Thursday, 08Apr2021 and this morning, Friday 09Apr2021 with a fever. His mother can control the fever during the day with Ibuprofen but he's spiking these fevers in the middle of the night. She knows fevers spike at night but she can't come with any other reason why this is happening. The patient lab tests and procedures also included CBC: pending, mononucleosis: pending, and rapid strep test: Negative; all from 09Apr2021. The outcome of events fever of 105.2f, headache, and body aches was not recovered; while for other events was unknown.    Information on the lot/batch number has been requested.
2 Months old  Male who was brought in by parents presenting with fever that began earlier today.  Maximum temperature recorded was 100.3 °F.  Per parents, patient had received his first months immunizations yesterday, 3 injections and 1 oral.  Mother also reports that the patient unable to extend bilateral lower extremities.  Symptoms viewed as moderate by parents. Better with nothing, worse with nothing.  No history of other contacts with same symptoms. No travel overseas.  Vaginal delivery at 38 weeks and patient was in the NICU due to jaundice and difficulty breathing.
Arm with edema; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A 65-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown). The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OEDEMA PERIPHERAL (non-serious), outcome "recovered", described as "Arm with edema". Therapeutic measures were not taken as a result of oedema peripheral.  Additional information: Edema Day after given PCV 13 which lasted for about a week. Patient did not take any medication but put cold packs on her arm with edema. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax & 5hr post vax exp nausea, vomiting & chills which were sometimes severe;temp taken 10 hr post vax was 101;pt devel swelling & welt-like rash extending to lt should;APAP given;
This spontaneous report was received from a registered nurse concerning an adult patient of unknown age and gender. Pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. This is a non-valid case due to lack of patient identifiers. On unknown dates (reported as since an unspecified amount of time), the patient has been vaccinated with two combine pediatric doses of RECOMBIVAX HB injection for prophylaxis (strength, route, dosage schedule, anatomical location, lot # and expiry date were not provided). No adverse effects were reported.
Received IPV, MMR, HEP B, VARICELLA 10-12 hours later developed swollen upper lip, no shortness of breath, difficulty breathing, when to ER.
hives and sore throat the day after receiving COVID19 Vaccine; hives and sore throat the day after receiving COVID19 Vaccine; This is a spontaneous report from a contactable Nurse. A 46-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0140, Expiry Date: 31Mar2021), intramuscular (injection left deltoid) on 18Dec2020 (around 1621) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient has no prior vaccinations. The patient experienced hives/ She had body hives all over and sore throat the day after receiving COVID19 vaccine on 19Dec2020, within 24 hours. The patient took BENADRYL and was fine. Reporter was not sure if the patient would receive the second dose. The adverse event did not require a visit to the emergency room nor physician office. Outcome of the event was recovered on 19Dec2020.
A BOUT OF ANAEMIA; This spontaneous report received from a patient concerned a male of unspecified age. 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 was not reported, 1 total, administered on 13-MAR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 25-JUN-2021, the patient experienced a bout of anaemia, and was hospitalized on 25-JUN-2021 for 5 days and was discharged on 29-JUN-2021. On 01-OCT-2021, Laboratory data included: Laboratory test (NR: not provided) Normal, and RBC count (NR: not provided) 13 points. On 15-OCT-2021, Laboratory data included: Laboratory test (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bout of anaemia on 01-OCT-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211133607-Covid-19 vaccine ad26.cov2.s-A bout of anaemia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Baseball sized raised red area at injection site- tender and warm to touch: Looks like giant hive.
Nonpruritic, nonpainful outbreak of tiny pustules across shoulders and upper back, one day after receiving MENACTRA in left deltoid.
patient reports nausea, dizziness and feeling hot;  placed supine and observed    BP 152/92   HR  72  sat 96%    Observed 30 mins  repeat BP 150/82  HR 74  Sat 97% and denies further complaints
Patient developed dizziness, lightheadedness, ~30 minutes after vaccine administration, which persisted despite conservative treatment for possible vasovagal episode.
she experienced flu-like symptoms; fever/low grade fever; chills; feeling unwell; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient) via Pfizer-sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not reported) via an unspecified route of administration on 29Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that she received her 1st dose on 29Mar2021, then on the 31Mar2021 she experienced flu-like symptoms like fever, chills, and feeling unwell. All adverse effects that patient felt were already gone. She only now had low grade fever. Caller asked how long it would last. Caller 2nd dose was on 19Apr2021. The outcome of the event fever/ low grade fever was not recovered, and the other events was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's son. The age at vaccination was not reported, but it could be 71 or 72 years. The patient experienced shingles within 24 hours after receiving Shingrix. Diagnosis was provided by the patient's doctor and no contact details was provided. No start date of shingles was provided. The reporter consented to follow up.
No prior injury to sight.  Gradual pain and swelling on right calf.  Tender, hot and puffy.
This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13May2022 at 11:45 as dose 1, single (Lot number: 59267-1025-01) at the age of 47 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "If COVID prior vaccination: Yes" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. Concomitant medication(s) included: ADVIL [IBUPROFEN]. The following information was reported: PAIN (non-serious) with onset 14May2022 at 18:00, outcome "not recovered", described as "Soreness and swelling under left armpit"; SWELLING (non-serious) with onset 14May2022 at 18:00, outcome "not recovered", described as "swelling under left armpit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, swelling. Additional information: Patient did not received any other vaccine in four weeks. Patient did not have any known allergies.
pt recvd vax 13oct94; seen on 29oct94 & 31-oct-94 when admitted w/ thrombocytopenic purpura; platelet count 16,000, rose to 164,000 after IV gamma globulin;
Generalized achiness, fatigue low grade fever 100 - 100.8 x 48 hours stiff neck headache symptoms are still ongoing
Patient had become pale, unconscious with some involuntary muscle jerking movements shortly after receiving Tdap. Was placed in supine position with legs elevated. Became conscious in approx 1-2 min. Cool pack to neck. Vital signs monitored @ 2:45 pm BP 140/72 P60 with mucus membranes pink moist. Reported by patient that he had not eaten this day Gave sips of Soda Pop. @ 2:55 pm 112/62 P60 R14.  @3:10 pm BP 110/70 P64 R12. Sat upright and then slowly stood - walking out of facility.