chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sneezing a lot/ sneezed a lot throughout the night; next day felt like he had a cold; ears congested in the morning; COVID-19; lack off drug effect; he reports minor aches, very minor aches; fever of 101.6; smell and taste faint; smell and taste faint; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (sneezing a lot/ sneezed a lot throughout the night), FEELING COLD (next day felt like he had a cold), EAR CONGESTION (ears congested in the morning), COVID-19 (COVID-19) and ANOSMIA (smell and taste faint) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-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 SNEEZING (sneezing a lot/ sneezed a lot throughout the night), FEELING COLD (next day felt like he had a cold), EAR CONGESTION (ears congested in the morning), COVID-19 (COVID-19), ANOSMIA (smell and taste faint), AGEUSIA (smell and taste faint), DRUG INEFFECTIVE (lack off drug effect), MYALGIA (he reports minor aches, very minor aches) and PYREXIA (fever of 101.6). The patient was treated with ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, SNEEZING (sneezing a lot/ sneezed a lot throughout the night), FEELING COLD (next day felt like he had a cold), EAR CONGESTION (ears congested in the morning), COVID-19 (COVID-19) and DRUG INEFFECTIVE (lack off drug effect) outcome was unknown and ANOSMIA (smell and taste faint), AGEUSIA (smell and taste faint), MYALGIA (he reports minor aches, very minor aches) and PYREXIA (fever of 101.6) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.6 (High) fever of 101.6. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Viral load: high (High) High.         Concomitant medication was not provided.  He had a little bit of dark, yellow mucous. He reports oxygen was normal.; Sender's Comments: This case concerns a 25-years-old, male patient with a past medical history of covid-19 in Oct2020, who experienced the unexpected event of Covid-19 (second time) and drug ineffective was considered as an additional event. Other associated non-serious events are captured in the narrative.  The events occurred after the second dose of mRNA-1273, Moderna COVID-19 Vaccine. Events were considered non-serious as per the reporter. The rechallenge was considered not applicable. The reporter did not provide a causality assessment. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.
hx of ESRD s/p kidney transplant, CAD s/p CABG; to hosp with hypoxemia; positive for COVID; transferred to ICU; on supplemental O2, HFNC and eventually intubated; started on remdesivir, dexamethasone; suffered cardiac arrest due to tachyarrhythmia; progressive renal failure; septic shock; worsening O2 requirements; suffered a MI with cardiogenic shock; pt died in the hosp
Tingling and numb face and lips mostly on right side of face, right ear pain, right jaw pain, right side headache, sore arm at site, nausea, dizziness, lethargic
Patient passed out and was pale.  Breathing and blood pressure was stable and normal.  Patient called his physician after becoming conscious again and his physician thinks it is due to patients lack of eating recently along with his still getting over the complications from his surgery 3 months ago.  Physician does not think it's due to the vaccine. An employee drove patient home.  Called patient throughout the day to check on him.
This case was reported by a healthcare professional and described the occurrence of incorrect route of drug administration in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent vaccination included Salmonella typhi Vi capsular polysaccharide vaccine given on an unspecified date. There were no concurrent medications. On 2 November 2008, between 09:00 and 16:00, the subject received a dose of FLULAVAL 0.5 ml, subcutaneously. This was the incorrect route of drug administration. FLULAVAL should have been administered intramuscularly. Within 12 to 24 following injection of FLULAVAL, the subject experienced injection site pain, redness and swelling. At the time of reporting, the events were improved. In the reporter's opinion, the events were probably related to treatment with FLULAVAL. The reported stated that approximately 200 adults were vaccinated with FLULAVAL via deep subcutaneous injection during a flu clinic. Out of these 200 plus subjects, four females reported local reactions of pain, redness and swelling within 12 to 24 hours of vaccination. One of these subjects was seen by the on-site physician who diagnosed it as a secondary infection and treated with antibiotics and TYLENOL. It was reported that the adverse events were improving, but unknown if they resolved. Linked cases include: A0759176A, A0759183A, A0759189A, and A759190A.
Narrative:  63y.o. MALE with a h/o CAD s/p CABG 2014, COPD not on home O2, Mechanical Mitral valve replacement (hx of noncompliance with AC),Hfpef (EF 50% 2016),treated Hep C s/p harvoni tx, HTN presented to ER on 5/20/21 for shortness of air for the past 3 weeks. Patient was recently discharged from medical center 4/1/21 for copd exacerbation, pneumonia sent home on oral antibiotics. Pt with -Subtheruaputic INR POA: -Mechanical mitral valve, non adherent with AC POA: Started on Heparin gtt here, will resume warfarin after eval by pulm and pharm to follow. Heart cath performed on 5/24/21. Pt agitated and left AMA on 5/24/21. Notes in CPRS not able to reach pt by phone on 5/25/21 for post AMA followup. Per CPRS note pt deceased on 6/3/21 reported to medical center from community hospital where pt died. Pt had presented to this community ER on 6/3/21 with ST ELEVATED MYOCARDIAL INFARCTION diagnosis. Likely death not related to covid vaccinations given on 5/7/21 & 4/7/21.
I have been feeling itchy at the injection site; My menstrual cycle was off this month. I was three weeks late; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 07Apr2021 at 08:45 (at age of 45 years old, no pregnant at time of vaccination, Lot Number: EP7533) as a single dose for covid-19 immunization. Medical history included cholesterol high. No allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not had been tested for COVID-19. Concomitant medication included fenofibrate. The patient had been feeling itchy at the injection site on 08Apr2021. It comes and goes and was not that serious. Also she think it was worth mentioning that her menstrual cycle was off this month in Apr2021. She was three weeks late. No treatment received for the events. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Syncope episode ~20 min after vaccine given-while pt in parking lot-fell to ground -> carried back to office VSS-got rest, elevate legs, fluids.
EXPIRED DOSE ADMINISTERED; OFF LABEL USE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-SEP-2021, the patient experienced expired dose administered. On 22-SEP-2021, the patient experienced off label use. The action taken with covid-19 vaccine  was not applicable. The outcome of the off label use and expired dose administered was not reported. This report was non-serious.
Not feeling well; Lethargy; Injection site pain; Muscle aches; Tiredness; Low grade fever; 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 MALAISE (Not feeling well), LETHARGY (Lethargy), INJECTION SITE PAIN (Injection site pain), MYALGIA (Muscle aches) and FATIGUE (Tiredness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (Not feeling well), LETHARGY (Lethargy), INJECTION SITE PAIN (Injection site pain), MYALGIA (Muscle aches), FATIGUE (Tiredness) and PYREXIA (Low grade fever). At the time of the report, MALAISE (Not feeling well), LETHARGY (Lethargy), INJECTION SITE PAIN (Injection site pain), MYALGIA (Muscle aches), FATIGUE (Tiredness) and PYREXIA (Low grade fever) outcome was unknown. Not Provided          No concomitant product use was provided by the reporter.  No treatment medication was provided.   The patient submitted AE via a chat online stating that had second covid vaccine last night and woke up not feeling well.     Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: XML File attached on 25-May-2021 and contains non significant information.
I broke out in large hives all over my body. At first there was also low grade fever and extreme lethargy. It has now continued on for over 2 months with hives daily moving to different parts of my body continually. Sometimes they are on face and neck.
Post first vax, 5-7 days later, reportedly, he developed a raised red, itchy rash at the injection site. He was treated with Benadryl and cortisone cream at the reaction site and it disappeared in 2-3 days. The most recent information reports the condition as resolved.
Pt recv vax on 10/19/98; on 10/20/98 pt exp chills &fever, vax site redness & edema (13 x 16 cm), chest tightness & fever
Extreme soreness, stiffness in right side of body, hip, leg.  Same side of injection.  Pain relented slightly after a few days, has now returned, making walking or lying difficult.
Urticaria, induration, erythema. Tx'd with Benadryl 25mg from 11/6/99 to 11/9/99, resolved.
mild periorbital edema w/o apparent urticaria;no stridor but scattered wheeze;given EPI & DPH;loss of wheeze & pruritus;
HPI: Pt reports pain and redness to the upper L arm. Pt was seen 2 days ago for well visit where he received the TRUMENBA vaccine in the left deltoid. This was his 2nd dose of TRUMENBA - he had no adverse reaction to the first dose. PE: 0.9cm x 0.7cm erythematous macular patch on the left deltoid, warm to touch, small area of induration at superior pole. L shoulder abduction strength 4+/5 and symmetric.
Patient received both pneumovax 23 and fluzone hd on 9/26 in left arm, one inch for each other. patient came in on 9/28 stating that her left are was swollen and hot. When looking at her arm, most of her upper bicep was red. She stated that it did not hurt. She stated that she was taking an NSAIDs to help with swelling and had applied cold compress. I instructed her to contact pcp asap and then to let us know the result of the conversation and to go seek medical treatment if get worse.
Patient reported increased swelling, itching, and irritation at site of injection. Patient went to her PCP 3 days after injection and received a prescription for a steroid type cream.
couldn't remember passcode for the phone or her address; feeling heavy; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration first dose on 10Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that after receiving her Covid19 vaccine on Sunday 10Jan2021, reports feeling "heavy", chills, and a headache on Sunday 10Jan2021. On 11Jan2021 Monday afternoon she reports that she "couldn't remember the 4-digit passcode to my phone" or her address, but that her memory came back "in a second". The event couldn't remember passcode for the phone or her address was reported as recovered and unknown for the other events.   Information on the Lot/Batch number has been requested
No additional adverse event; Pharmacist inadvertently administered a PNEUMOVAX 23 to a patient several months after its expiration date; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapy were not reported.     On 12-OCT-2021, the patient was inadvertently vaccinated with an expire dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S029542, expiration date 10-JUN-2021 (dose and route were not reported) for prophylaxis (expired product administered).  No additional adverse event details or product quality complaint were reported.
After first dose: arm (shot site) pain, fever, fatigue, worsened heart palpitation and irregular heart beats; After second dose: temporary - arm (shot site) pain, fever, fatigue,                                             extended adverse events: severe headache, nausea, worsened heart palpitation and irregular heart beats; short of breath, dizziness, joint and muscle pain, numbness on one side of the body
INCORRECT DILUTION, THE DOSE (0.2 ML) WAS GIVEN BEFORE DILUTING THE ORIGINAL VIAL
2 days after injection patient complained of severe diffuse myalgias and (L) arm pain - no rash, no shortness of breath refused to take symptomatic treatment. Now (4 days after injection) arm sore, 2cm erythema myalgia resolved. improving
Headache, fever (as high as 102.2), shivers, extreme muscle aches, 36  hours,  Pharmacy recommended Tylenol.  Injection site developed hand-sized welt (still there Saturday night (80 hours later).
after the 4th dose I had rash on different parts of my body like wheels with excessive itching.  I went to the urgent care for  a severe chest pain. They  gave  me some kind of drink for the pain and they also did an endoscopy to rule out where the pain is coming from.  I know for fact that I  had Gerd.  After 3-4 days I went back to the urgent care for the second time  for the chest pain again. They thought I was having heart attack  so, they called the ambulance and took me to the hospital. I stayed in the hospital for  1 over night.   They prescribed me Pantoprazole  which I am still taking as of now.
Formed a hard raised area 2x1 inch / swelling from 1/19/2021-01/29/2021; no itchingo r irritation
spotting; headaches; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (spotting) and HEADACHE (headaches) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced VAGINAL HAEMORRHAGE (spotting) and HEADACHE (headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, VAGINAL HAEMORRHAGE (spotting) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included paracetamol and ibuprofen.
2 days post vaccination, patient noticed her arm at injection site was red and slightly swollen. It also felt warm to the touch
Child vomited X 4 on 7/18/01-Brought to PCP's office on 7/19. Had a hypotonic response while waiting to see PCP. Transported to hospital and diagnosed with arachnoid cyst.
Information has been received from a nurse referring to a patient of unknown age and gender. No pertinent or historical conditions were reported. On 27-JUL-2015, the patient was inadvertently administered a dose of ROTATEQ orally (strength and dose unknown, lot # J011340, expiration date 15-MAY-2015). No adverse effects were reported. Additional information has been requested.
Couldn't sleep; Massive headache; Felt like a "truck ran over me"; terrible reaction; Violent shaking; This case was reported by a consumer and described the occurrence of insomnia in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th September 2019, the patient received the 2nd dose of Shingrix. On 30th September 2019, less than a day after receiving Shingrix, the patient experienced tremor and adverse reaction. On an unknown date, the patient experienced insomnia, headache and feeling abnormal. On an unknown date, the outcome of the insomnia, headache, feeling abnormal and adverse reaction were unknown and the outcome of the tremor was recovered/resolved.   It was unknown if the reporter considered the insomnia, tremor, headache, feeling abnormal and adverse reaction to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The reporter was informed of a reaction by a neighbor.  The day before the reporting date, the patient received Shingrix. The patient had terrible reaction. From 9:30 pm to 3:00 am, the patient was violent shaking. Less than a week after receiving Shingrix, the patient could not sleep, massive headache and felt like a truck ran over her.
Expired vaccine used; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Product storage error) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Product storage error). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Follow-up received Non-significant.
Broke out into shingles; This case was reported by a physician via call center representative and described the occurrence of shingles in a adult 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 week 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 age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix last week on unspecified date and broke out into shingles. The health care professional declined to provide patient or vaccination information.
Itching so badly; Pain under my armpits; Headache; Cold; This is a spontaneous report from a contactable consumer. This 92-year-old female consumer (patient) reported that.  A 92-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9267), dose 1 via an unspecified route of administration on 15Feb2021 as (At the age of 92-years) dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced itching so badly, pain under my armpits, headache, and cold on an unspecified date. It was reported that patient had number of reactions of Pfizer vaccine which she took on 15Feb2021 at the town hall community center. It was the Pfizer Vaccine, it was a first vaccine, the first shot. Patient had several reactions to the vaccine, patient had to go to the emergency room twice in County on Saturday and on Sunday. It was reported that patient was good for the first couple of days and by late Thursday she started with several reactions. Patient went to the emergency room and they gave intravenous of steroid and Benadryl because she was itching so badly. she couldn't stand it. It was reported that patient did not hospitalized, they were thinking about it, but they said no, they gave (incomplete sentence). It was reported that patient have to go back again next day on Sunday because it came back (Clarification unknown). It's not something she supposed to have handy, it's intravenous and she have to go back on Sunday afternoon to the same hospital. Patient had pain under his armpits, she has severe itch, she has headache, she was cold, is he have everything and just got feeling better maybe this past Wednesday. she doesn't know about the second vaccine. What should I do?" Consumer was provided with the number of Pfizer Medical Information Department. It was reported that patient really afraid to take the second shot after all the reactions she had from the first one. Therapeutic measures were taken for the events. The outcome of events was recovering.    No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 75 year old female with hypertension, hypercholoesterolaemia, sinus bradycardia, osteoporosis, hand osteoarthritis, gastroesophageal reflux disease, hiatus hernia, penicillin allergy and sulfa allergy and a history of colonoscopy electrocardiogram, stress cardiolite, dual energy x-ray absorptiometry (DEXA scan) who on 29-JAN-2007 was vaccinated subcutaneously in the left arm with the first dose of ZOSTAVAX (lot # 652907/1411F). Concomitant therapy included DYAZIDE, CELEXA, ACTONEL, VIACTIV SOFT CALCIUM CHEWS, multivitamin and flaxseed. On 27-JAN-2008, the patient had painful rash under her right arm. On 01-FEB-2008 the patient was diagnosed with shingles. There were mild to moderate vesiculopustular grouped lesions to the right axilla and upper back following a dermatomal pattern. The patient started valacyclovir hydrochloride tablet and calamine lotion to help dry up the lesions. Subsequently the patient recovered from shingles.