chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm that received the vaccination became red, itchy and swollen on the injection site; Arm that received the vaccination became red, itchy and swollen on the injection site; Arm that received the vaccination became red, itchy and swollen on the injection site; This is a spontaneous report from a contactable consumer (patient).    A 47-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, via an unspecified route of administration, administered in arm, on 18Feb2021, as single dose, for COVID-19 immunisation. The patient medical history was and concomitant medications were not reported. The patient stated that the arm that received the vaccination became red, itchy and swollen on the injection site. Due to the events, the patient went to the doctor and was given a steroid cream and diphenhydramine (BENADRYL).  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Throat swelling, difficulty swallowing, Intense pain at injection site, nausea, fatigue
Information has been received from a physician concerning a 4 year old patient, who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (dose, route and Lot # not reported). The physician reported that the patient developed a small, local bubbling at the injection site after administration of VARIVAX (Merck). At the time of the report, the outcome of the patient was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Immediately following vaccination and continuing for the last 2 weeks - chills, muscle aches, chest pain, fatigue, nausea
Patient has had a 2 day history of left sided chest pain, chest tightness, shortness of breath, dizziness, nausea and tightness in the left shoulder.
FAINTED; LOSS OF CONSCIOUSNESS; CRASHED VEHICLE; This spontaneous report received from a patient concerned an adult (In between 18 to 65 years) male. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient fainted while driving on the interstate after  vaccination. He crashed his vehicle (road traffic accident) and experienced loss of consciousness, Currently under the care of a neurologist. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fainted, loss of consciousness and crashed vehicle was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210436363.; Sender's Comments: -20210436318-Covid-19 vaccine ad26.cov2.s-Fainted, Loss of consciousness. 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).
Severe weakness, severe pain, difficulty breathing. Pain meds, heart meds, aspirin, TYLENOL. Could not walk without assistance.
Numbness and pins and needles sensation in legs that progressed upward. Guillain-Barré syndrome diagnosed and plasmapheresis received.
Patient received vaccine around 745 am on 4/22/21.  He did not have any side effects or concerns until 4/23/21 at approximately 9:30 am when he had what Mom describes as a grand mal seizure while at school.  Patient was reportedly sitting in his chair at school.  He stretched his arms above his head then fell onto the floor with full body convulsions for just under 1 minute.  Patient vomited about 20 minutes later.  Our office was informed by mother around 10:30 am.  Patient at home and sleeping.  Advised Mom to take patient to local ED for further evaluation and monitoring.
Patient is a 28 year old female who presents for administration of a single dose of J&J COVID19 vaccine in the left deltoid.  While administering the vaccine, the vaccine leaked out at the luer lock and onto the patient and onto the clinician's glove.  The provider stated that >50% of the vaccine leaked out of the syringe and did not actually enter the patient.  Clinician immediately consulted with the pharmacist to determine the next steps.   Pharmacist confirmed that because the clinician felt that <50% of the vaccine was actually administered to the patient that the clinician may administer a new dose in the opposite (right) arm of the patient.  Explained the situation to the patient and the patient was amenable to receiving the new dose of vaccine.  Patient did not experience any adverse events following the vaccine and discharged without complaint or complication.
pt devel an inj site rxn, characterized by induration & redness, following inj;pt has recovered;
Initial information received on 12-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional on 12-Mar-2019. This case is linked to case 2019SA072764. This case involves a female patient (nurse) who received a tetanus shot and it hurt and pain, while she received vaccine TETANUS TOXOID. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route. On an unknown date, the patient developed a non-serious received a tetanus shot and it hurt following the administration of TETANUS TOXOID. On an unknown date, the patient developed a non-serious pain following the administration of TETANUS TOXOID. No lab test reported. Final diagnosis was pain and received a tetanus shot and it hurt. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovered / Resolved on an unknown date for received a tetanus shot and it hurt and as Recovered / Resolved on an unknown date for pain.
COVID-19; Gastric disorder; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and GASTRIC DISORDER (Gastric disorder) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   In 2022, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19) and GASTRIC DISORDER (Gastric disorder). At the time of the report, COVID-19 (COVID-19) was resolving and GASTRIC DISORDER (Gastric disorder) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication were reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trail.  The daily dose of moderna vaccine was reported as 1 in 1 once. It was reported that patient experienced non serious COVID-19 and stomach issues with RINVOQ(UPADACITINIB). The action taken and dechallenge were UNK and not applicable for the event COVID-19 and drug discontinued and UNK for the event gastric disorder with respect to drug RINVOQ. It was reported that the reporter's causality for the events COVID-19 and gastric disorder with RINVOQ(UPADACITINIB) was no reasonable possibility.  No treatment medication were reported.  Company comment: This is a spontaneous case concerning an adult female patient with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (COVID-19) which occurred on unspecified day after receiving a dose of mRNA-1273 vaccine (dose number not specified). It was reported that patient experienced non serious COVID-19 and stomach issues with co-suspect RINVOQ(UPADACITINIB) non-company product for Rheumatoid arthritis which is concomitant medication. Patient was not hospitalized and no treatment details was  provided. Ongoing Covid 19 pandemia and co-suspect RINVOQ could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This is a spontaneous case concerning an adult female patient with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (COVID-19) which occurred on unspecified day after receiving a dose of mRNA-1273 vaccine (dose number not specified). It was reported that patient experienced non serious COVID-19 and stomach issues with co-suspect RINVOQ(UPADACITINIB) non-company product for Rheumatoid arthritis which is concomitant medication. Patient was not hospitalized and no treatment details was  provided. Ongoing Covid 19 pandemia and co-suspect RINVOQ could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Dad reported pts arm had some reddness and pt was reporting arm discomfort. Pt had mild localized eccymosis. We gave 12.5mg benadryl PO and applied ice pack to arm. Redness did not progress and pt did not have any other symptoms develop. Dad took pt home after being educated on follow up treatment and what else to watch for.
Headache, Myalgia, Fever, Fatigeu, chills Narrative:
Information has been received on 07-Oct-2003 from an elementary school licensed practical nurse concerning a 7 year old who on 07-Oct-1996 was vaccinated with varicella virus vaccine live (site unknown). Subsequently, "within the last month," the patient developed chicken pox. The patient sought unspecified medical attention. It was also reported that five other children also developed chicken pox (WAES #0310USA01244 through WAES #0310USA01246, WAES #0310USA01248 and WAES #0310USA01249). Additional information has been requested.
This is a spontaneous report from a contactable consumer (patient). A 23-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 23, via an unspecified route of administration, in the left arm, on Apr 23, 2021, at 18:30, single dose, for COVID-19 immunisation. Medical history included painful bladder syndrome, allergy to some molds and COVID-19. Prior to vaccination, patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. On unknown date in Apr 2021, patient had an extreme sore throat, shortness of breath and tight chest. She felt like she was breathing through a straw the two days after the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The outcome of  extreme sore throat, shortness of breath and tight chest: not recovered at the time of this report. No follow-up attempts required. Information about batch/lot number cannot be obtained. No further information expected.
Information has been received from a nurse practitioner concerning a 34 year old, unemployed, female patient with depression and a history of hepatitis C, with no illnesses at time of vaccination, who on 10-JUL-2008, was vaccinated with a first dose of RECOMBIVAX HB, (lot # 660951/0399X) intramuscularly to the right deltoid.  On 31-JUL-2008, the patient experienced body swelling, joint pain, malaise and weight fluctuations.  The patient had gained 12 pounds since her last visit.  Unspecified medical attention was sought.  The nurse practitioner reported that weight fluctuated by 10 pounds.  At the time of this report, it was unknown if the patient had recovered.  No product quality complaint was involved.  On 26-AUG-2008, the patient was vaccinated with the second dose of RECOMBIVAX HB, lot # 653363/1283F) intramuscularly to the right deltoid.  Additional information had been requested.
little congestion; body ache so bad; chills; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (little congestion), PAIN (body ache so bad), CHILLS (chills) and HEADACHE (severe headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Migraine.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced NASAL CONGESTION (little congestion), PAIN (body ache so bad), CHILLS (chills) and HEADACHE (severe headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. On 06-Feb-2021, NASAL CONGESTION (little congestion), PAIN (body ache so bad), CHILLS (chills) and HEADACHE (severe headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 101 (High) 101°F fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15 july 2021.Patient contact details were updated.
Hives, full body red itchy rash that required ED visit, physicians office visit and medications, started 3 days s/p vaccine continued up until at least 4/22/2021
severe body aches, body really hurt; Felt like I had been hit by a truck; Low grade fever; headache; felt foggy; slept most of the day; tired; bruise on arm where the shot was given; lost sense of taste; loss of smell; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 30Mar2021 at 09:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient included COVID-19 for 3 months, but symptoms started around 23Dec2020. The concomitant medications of the patient included Hormone Patch (estrogen), vitamin D calcium supp within two weeks of vaccination. The patient had possibly penicillin allergy and was allergenic to some products like lotions with aloe and PABA. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 03:00 the patient awakened with severe body aches, felt like hit by a truck, low grade fever and felt like the start of a headache. The patient taken Thereflu and went back to sleep. Again, awakened at 7 in morning, felt the same and taken aspirin. The patient didn't really get better through the day, felt foggy, body really hurt, headache never materialized, slept most of the day. On the next day the patient had still some body aches but not as bad, tired and kind of foggy and big bruise on arm where the vaccine was given. On 23Dec2020, the patient underwent COVID-19 test and the result was negative and lost sense of taste and smell about 2 weeks later. On 20Feb2021, the patient underwent COVID-19 antibodies test and the result was positive. The clinical outcomes of the events severe body aches, felt like hit by a truck, low grade fever, headache, felt foggy, body really hurt, slept, tired, bruise on arm and lost sense of taste and smell was recovering.   No follow-up attempts are needed. No further information is expected.
After the first and second shot, my platelets decreased significantly one week after. My doctors were aware and both decided that the covid vax was still more beneficial for me than worrying about low platelets which were easier to treat. I was being monitored due to aplastic anemia. Treated with platelets after both shots. Platelets went up to 150 for months, then the booster was recommended. Had that in October, platelets normal till 12/10/21 and they dropped to 16. Treated with platelet infusion.
I tested positive for COVID-19, Delta Variant, on August 31, 2021.   Treatment: I received  a monoclonal antibody infusion on 9/2/2021. Symptoms: loss of smell & taste, fever, severe headaches, body aches, bradycardia, congestion, cough, tight chest, fatigue Time: VERY unwell at least until September 14, 2021. Began severe chest tightness, more frequent cough September 14, and it CONTINUES today.
Allergic reaction to Flu vac 1-14-07. Extreme pain to operate muscles. Two visits to clinic. (See attached diary of events and treatment, enclosed for details).
Patient developed left-sided chest pain with radiation into throat/neck with some shortness of breath while pedal biking. Patient took (3) 81 mg aspirin at 7 pm and went to ER with dizziness and above symptoms which were improved by the time he presented to ER. ER workup found elevated troponin, received nitroglycerin and heparin IV drip, Cardiology consut for NSTEMI, underwent radial coronary angiogram on 9/18 with minimal core disease found. Found to have hypertension and nonsustained ventricular tachycardia during angiogram. Seen and examined by Cardiac. Cardiac MRI done on 9/19 showing non-specific findings suggesting infarct versus non-ischemic cardiomyopathy or possibly myocarditis. Discharged with diagnosis of NSTEMI likely due to MINOCA (mycardial infarction with nonobstructive coronary arteries) due to cardiac MRI showing inflammation over bottom of heart versus all over as would be suspected with myocarditis as well as troponin that quickly escalated in the ER versus a gradual slow increase as would be expected with myocarditis. Patient had Cardiology f/u on 9/27/21 and is scheduled for additional Cardiology f/u in 1 month with echo. Per Cardiology patient is to hold second dose of Moderna until Cardiology performs additional testing and research on risks vs benefits.
No additional AE reported; dose of VAQTA that was inadvertently administered after labeled expiry date; This spontaneous report was received from a certified medical assistant and refers to a 18-monht-old male patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 13-JAN-2021, the patient was inadvertently vaccinated with expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) 25unites/0.5 ml, 1 injection, lot # S032359 was confirmed to be valid, expiration date 11-JAN-2021 (route and site of administration were not provided) for prophylaxis. No additional adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032359; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: SHOT given on 03.08.21 rash developed 03.10.21 on arms.  on 03.11.21 progressed to legs, and chest 03.12.21 pt states itching worse, states she feels a little bit of labored breathing. advised to go to md, er, now. offered to call ambulance pt states not necessarey. advised her not to get 2nd shot unless it is in hospital setting and physician authorized. stressed she must go to md now
Pain, swelling, bruising on arm at site of vaccine administration. Pt. also developed rash around neck & across chest.
Fever, chills, joint pain, muscle pain, nausea, headache, diarrhea
6/13 P.M. Fever 99-101 began. 6/14 Headache/Neck pain began. 6/19 Hives on legs moving up back to arms and abdomen. Seen by Dr. (PCP). Rx Benadryl and Tylenol. Taking oatmeal baths. 6/20 Whelps are worse. Mother called Health Clinic. Mother advised to notify client's PCP if symptoms become worse.
Patient described significant swelling of arm over widespread area after receiving Pneumovax vaccine. He also said redness spread down his arm.  He did not seek any treatment and said reaction does not hurt and is dissipating.
Neck pain; all over body inflammation; Shoulder Pain; Pain in the legs muscles/the pain is similar to Polymyalgia Rheumatica that she had a few years ago; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain), INFLAMMATION (all over body inflammation), ARTHRALGIA (Shoulder Pain), MYALGIA (Pain in the legs muscles/the pain is similar to Polymyalgia Rheumatica that she had a few years ago) and HEADACHE (Headaches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Polymyalgia rheumatica (Recurrence after 7 Years of having disease under control) since 02-Jan-2012. Concurrent medical conditions included Drug allergy (Sulfa Drugs), Glaucoma since 15-May-1990, Hypothyroidism since 01-Jun-1965 and Seasonal allergy (allergies). Concomitant products included CETIRIZINE HYDROCHLORIDE (CETRIZINE) from 15-Feb-2010 to an unknown date for Allergy, LATANOPROST (LATANOPROST-OPTIC) from 15-May-1990 to an unknown date for Glaucoma, LEVOTHYROXINE from 01-Jun-1965 to an unknown date for Hypothyroidism, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), FISH OIL from 10-Feb-1995 to an unknown date and VITAMIN D NOS from 01-May-2002 to an unknown date for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced NECK PAIN (Neck pain), INFLAMMATION (all over body inflammation), ARTHRALGIA (Shoulder Pain), MYALGIA (Pain in the legs muscles/the pain is similar to Polymyalgia Rheumatica that she had a few years ago) and HEADACHE (Headaches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form; IBUPROFEN at a dose of UNK dosage form and PREDNISONE on 04-Apr-2021 for Pain, at a dose of 5 mg twice a day. On 25-May-2021, NECK PAIN (Neck pain), INFLAMMATION (all over body inflammation), ARTHRALGIA (Shoulder Pain), MYALGIA (Pain in the legs muscles/the pain is similar to Polymyalgia Rheumatica that she had a few years ago) and HEADACHE (Headaches) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Significant follow-up, New event updated- all over body inflammation, all events outcome updated to Recovered/Resolved and concomitant drugs added. On 06-Jul-2021: ADR: FU 3 and FU 4 - no new information.
No adverse event. Child reported having period on Dec. 15, 2013. Admits to sexually active but using protection. Pregnancy test completed and came back positive for pregnancy on 01/06/2013.