chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Loss of consciousness; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A2 and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant) and MYALGIA (Muscle pain). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness) and MYALGIA (Muscle pain) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable  No relevant concomitant medications were reported  No treatment information was provided.  Based on current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-125319 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: follow-up received on 23-Jun-2021 contains non significant information; Sender's Comments: Based on current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
pt recv vax 24JAN96 & 25JAN96 pt devel a low grade fever of less than 100;pt self treated w/APAP & recovered in less than an hr
Diagnosed with Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with Covid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COVID-19 on 29-Dec-2020.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced COVID-19 (Diagnosed with Covid). At the time of the report, COVID-19 (Diagnosed with Covid) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.   Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Mental fatigue; Sensitive on arm due to covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL FATIGUE (Mental fatigue) and VACCINATION SITE HYPERSENSITIVITY (Sensitive on arm due to covid vaccine) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-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 ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MENTAL FATIGUE (Mental fatigue) and VACCINATION SITE HYPERSENSITIVITY (Sensitive on arm due to covid vaccine). At the time of the report, MENTAL FATIGUE (Mental fatigue) had not resolved and VACCINATION SITE HYPERSENSITIVITY (Sensitive on arm due to covid vaccine) had resolved.            No Concomitant medications were reported. No treatment medications were reported.  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.
Sharp, repeated headache; muscle pain; tiredness that evening and next day. Also upset stomach next day. Emailed doctor, took TYLENOL. Felt better 48 hours later.
Pneumococcal Conjugate 13-Valent - PREVNAR 13 shot side affects: Constant gurgling stomach, gas, blackish green stools, raucous smell, 17 days and counting. Tried PEPTO-BISMOL, symptoms still with me. Have MS, weakness, numbness and spasticity in legs constant and greatly increased. Still waiting for symptoms to pass.
Itching all over continuing for a week; Greatly increased tinnitis; This is a spontaneous report received from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 14:30 as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included vitamins (MANUFACTURER UNKNOWN), estrogen;progesterone;testosterone (MANUFACTURER UNKNOWN) and LIZEN all for an unknown indication from unknown dates. The patient was allergic to medications, food, or other products (unspecified). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 13Mar2021 at 09:00 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. On 06Apr2021 at 12:00, the patient experienced itching all over continuing for a week and increased tinnitus greatly. It was reported that the patient did not receive any treatment for the reported events. The adverse events result in a visit to the doctors or other healthcare professional office/clinic visit. The clinical outcome of itching and tinnitus was not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This case was reported by a consumer via call center representative and described the occurrence of rash in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 27th February 2019, the patient received SHINGRIX (intramuscular). On 9th March 2019, 10 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The case was reported by patient. The patient got SHINGRIX and she developed a rash around her eyes, on both sides of her face. It looks like mosquito bites, but it was not itching or burning. The patient gave consent to follow up, she had given permission to contact her primary care physician (PCP) and provided contact details for the same.
Minor Soreness in arm day of. Next day had red rash occur on upper arms shoulders down back to lower back and on front torso chest and under breasts. Part of the rash was raised. This was side affect with second shot as well all 3 vaccines were Moderna.
Large red rash around injection site. It is raised and warm to the touch and itchy. It's about 6 inches diameter, and the area is painful to touch. First noticed it early morning of 4/7/21
.Patient was initially presented on 1/9/2022 with a chief complaint of worsening shortness of breath and a fall.  Patient was diagnosed to have COVID-19 infection 6 days ago.  He was on 90% on home BiPAP upon EMS arrival.  Patient also appeared to be more confused and had generalized weakness per MMR.  Patient also have a history of chronic respiratory failure and is on 4 L of oxygen at baseline.  Patient was started on doxycycline 2 days ago by his PCP.  Upon evaluation in the ED, BP 116/76, heart rate 140, febrile at 100.4 and rectal temperature is 103 Fand  SpO2 100% on BiPAP.  Patient reportedly had respiratory distress with the using accessory muscles and high-pitched wheeze, left side more than right coarse breath sounds bilaterally.  Patient was unable to speak in sentences per ED physician.  EKG reported sinus tachycardia lab work abnormal for mildly elevated creatinine 1.1, CRP 4.39, procalcitonin 0.23, D-dimer elevated at 1408. Chest x-ray did not report any significant abnormalities.    Patient was subsequently admitted for further evaluation and treatment under Hospital Medicine to moderate care with pulmonary service on consult.  Patient received IV Bumex for coarse bilateral breath sounds as he received significant amount of IV fluid in the ECC prior to arrival to floor.  Patient was placed on HF N/C of 50 L and 30% and BiPAP as needed.  Patient is evaluated by Pulmonary service and recommended to continue Remdesivir and Decadron. Patient developed significant shortness of breath when he was moved from the bed to the chair.  Patient also have cognitive impairment and confusion could be due to delirium in the setting of COVID-19 infection.  Patient subsequently improved with oxygenation and is at baseline oxygen at 4 liter/minute via nasal cannula and a web setting is baseline as well.  Pulmonary service recommended patient can be discharged from their point of view on 1/13/22 Per Family request he stayed additional 1/15/22 until able to ambulate.
Chest pain; Weakness; High heart rate/beating; Light muscle ache; Severe headache/Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), ASTHENIA (Weakness), HEART RATE INCREASED (High heart rate/beating), MYALGIA (Light muscle ache) and HEADACHE (Severe headache/Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0503C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jul-2021, the patient experienced CHEST PAIN (Chest pain), ASTHENIA (Weakness), HEART RATE INCREASED (High heart rate/beating), MYALGIA (Light muscle ache) and HEADACHE (Severe headache/Headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 08-Jul-2021, CHEST PAIN (Chest pain), ASTHENIA (Weakness), HEART RATE INCREASED (High heart rate/beating), MYALGIA (Light muscle ache) and HEADACHE (Severe headache/Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jul-2021, Blood pressure measurement: 118/100 (High) Very high blood pressure. On 07-Jul-2021, Heart rate: 120 (High) High heart rate.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
moderna vaccine for pregnant mothers; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (moderna vaccine for pregnant mothers) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (moderna vaccine for pregnant mothers). At the time of the report, EXPOSURE DURING PREGNANCY (moderna vaccine for pregnant mothers) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown Treatment information was unknown  This is a Spontaneous case concerning a female patient of unknown age that reports the probable maternal exposure during or before pregnancy with unknown medical history. The exposure occurred in relation to a dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: Upon internal review on 17-Nov-2021, Gender captured, pregnancy type, Birth type and Fetal outcome updated; Sender's Comments: This is a Spontaneous case concerning a female patient of unknown age that reports the probable maternal exposure during or before pregnancy with unknown medical history. The exposure occurred in relation to a dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
This spontaneous report was received on 08-MAY-2017 from a licensed practical nurse and refers to a 4 month infant (gender not reported). There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 20-SEP-2016 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. The administered dose of ROTATEQ experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1608USA012794: US-009507513-1608USA012908: US-009507513-1705USA004977: US-009507513-1705USA004978: US-009507513-1705USA004979: US-009507513-1705USA004980: US-009507513-1705USA004981: US-009507513-1705USA004894: US-009507513-1705USA004895: US-009507513-1705USA004996: US-009507513-1705USA004997: US-009507513-1705USA004998: US-009507513-1705USA004999: US-009507513-1705USA004893: US-009507513-1705USA004892: US-009507513-1705USA004891: US-009507513-1705USA004890: US-009507513-1705USA004889: US-009507513-1705USA004888: US-009507513-1705USA004887: US-009507513-1608USA012916: US-009507513-1705USA004982: US-009507513-1705USA004983: US-009507513-1705USA004984: US-009507513-1705USA004985: US-009507513-1705USA004942: US-009507513-1705USA004944: US-009507513-1705USA004945: US-009507513-1705USA004947: US-009507513-1705USA004948: US-009507513-1705USA004949: US-009507513-1705USA004950: US-009507513-1705USA004951: US-009507513-1705USA004952: US-009507513-1705USA004953: US-009507513-1705USA004954: US-009507513-1705USA004955: US-009507513-1705USA004956: US-009507513-1705USA004957: US-009507513-1705USA004958: US-009507513-1705USA004959: US-009507513-1705USA004960: US-009507513-1705USA004961: US-009507513-1705USA004962: US-009507513-1705USA004963: US-009507513-1705USA004964: US-009507513-1705USA004965: US-009507513-1705USA004966: US-009507513-1705USA004967: US-009507513-1705USA004969: US-009507513-1705USA004970: US-009507513-1705USA004975: US-009507513-1705USA004971: US-009507513-1705USA004972: US-009507513-1705USA004973: US-009507513-1705USA004974: US-009507513-1705USA005007: US-009507513-1705USA005006: US-009507513-1705USA005005: US-009507513-1705USA005004: US-009507513-1705USA004943:
This spontaneous report as received from a nurse refers to 3 or 4 unspecified patients of unknown age. No information about medical history concurrent conditions and concomitant medications was reported. On an unknown date about 3 or 4 patients received their second dose of GARDASIL, 0.5 ml, route intramuscular, within the past six months, off-schedule from their first dose of GARDASIL and no adverse effects reported. The outcome of event reported is unknown. No product quality complaint was involved. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; COVID-19 VACCINE, unknown manufacturer administered as dose 1, 2, 3, and 4; BNT162B2 as dose 5 (booster); This is a spontaneous report received from a non-contactable reporter (Nurse). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18May2022 as dose 5 (booster), single (Lot number: FM0173) at the age of 61 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "bronchiectasis" (unspecified if ongoing); "erosive arthritis" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing); "known allergies: Penicillin (pcn)" (unspecified if ongoing). Concomitant medication (in 2 weeks) included: SPIRONOLACTONE, start date: Jan2018. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18May2022, outcome "unknown", described as "COVID-19 VACCINE, unknown manufacturer administered as dose 1, 2, 3, and 4; BNT162B2 as dose 5 (booster)"; DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: patient was asymptomatic and tested negative after full course Paxlovid; Negative, notes: continued to test negative on day 6; Negative, notes: continued to test negative on day 7; Negative, notes: continued to test negative on day 8; Positive, notes: cough and sore throat returned day 9 and also tested positive day 9; Positive, notes: treatment of COVID-19. Therapeutic measures were taken as a result of covid-19.  Additional information: COVID-19 treatment included Paxlovid, brand: Pfizer (Lot number: GE6376), administered orally from 28Jul2022 to 01Aug2022. The patient was asymptomatic and tested negative after full course Paxlovid. The patient continued to test negative on days 6, 7, 8. Cough and sore throat returned on day 9 and also tested positive on day 9.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between LOE events and suspect drug BNT162B2 cannot be excluded.
Siezures, eyelids swallen, could not see without experiencing headaches, feels ill when she wakes every morning.  Very rarely does she feel well anymore, has been running a low grade temp off and on since the shot was administered and eyelids still puff up with headaches. 10/24/08-records received for DOS 10/1/08-2nd Gardasil vaccine received, vasovagal episode no post-ictal sequelae. Similar reaction to 1st Gardasil vaccine. Office visit 10/7/08-C/O eyelid edematous. Well until 3 days prior. Painful to move eye. Runny nose, headache, malaise. Day after vaccination returned to normal. Assessment: periorbital edema.
On 10/10/22, pt. developed acute ITP with platelet count <2,000. She has been treated with IVIG x2 on 10/10/22 and 10/20/22 and high dose steroids started on 10/19/22 with recurrent thrombocytopenia after weaning steroids as of 12/2/22.
lips/mouth swelling; lips/mouth swelling; tingling sensation in throat and on tongue; tingling sensation in throat and on tongue; This is a spontaneous report from a contactable other healthcare professional (HCP, also the patient).  A 28-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at right arm on 17Dec2020 10:45 at single dose for COVID-19 immunization. The patient's medical history included asthma, hashimoto's thyroiditis, depression, anxiety, seasonal allergies, known allergies: latex, banana. Concomitant medication included levothyroxine, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR), bupropion hydrochloride (WELLBUTRIN XL), escitalopram oxalate (LEXAPRO), trazodone, alprazolam (XANAX), fexofenadine hydrochloride (ALLEGRA), salbutamol (ALBUTEROL) (as needed), cyanocobalamin (VITAMIN B12), colecalciferol (VITAMIN D), zinc, all reported as other medications in two weeks. No other vaccine in four weeks. The patient previously took codeine and experienced drug alergy (known allergies). The facility type of vaccine was hospital. No COVID prior vaccination and no COVID tested post vacccination. The patient was not pregnant at the time of vaccination. On 17Dec2020 11:00, the patient experienced "lips/mouth swelling tingling sensation in throat and on tongue". Therapeutic measures were taken as a result of "lips/mouth swelling tingling sensation in throat and on tongue" included over the counter (OTC) Benadryl. The outcome of the event "lips/mouth swelling tingling sensation in throat and on tongue" was recovered (assumed in Dec2020).  Information about lot/batch number has been requested.
Mom came into office to report client would not eat dinner after the shot and was hysterical and was consolable. He was quite during daycare throughout the day and "just not himself". Mom was not able to get child to take TYLENOL but she was worried that he was hurting all over.
mild injection site soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 10:15 (Lot number: EL3247) at the age of 59 years as 2nd dose, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Codeine sensitive, reaction(s): "Known allergies". Vaccination history included: Covid-19 vaccine (product: COVID 19, brand: Pfizer,, lot number: EL3247,, lot unknown: False,, administration date: 22Feb2021,, administration time: 01:15 PM, vaccine location: Left arm, dose number: 1), administration date: 22Feb2021, when the patient was 59 years old, at workplace clinic for COVID-19 immunisation.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 15Mar2021 15:00, outcome "recovering", described as "mild injection site soreness". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Patient had no COVID prior vaccination. Patient was not tested covid post vaccination.   No follow-up attempts are possible. No further information is expected.
16 days p/vax devel blisters on face, trunk & legs-total of 15 lesions;appear typical for chickenpox;
I contracted COVID-19 on 05/30/2022 with symptoms of congestion, fatigue, cough, diarrhea, slight nausea, abdominal pain, loss of appetite, myalgia, and I am having trouble concentrating. I was prescribed PAXLOVID on 06/02/2022, and began taking it on 06/03/2022. My symptoms have begun to improve, and congestion has resolved, but I am still quite fatigued.