chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RECEIVED BOTH MODERNA COVID-19 VACCINES ON 01/19/21 & 02/16/21 (NO LOT#, ROUTE, OR LOCATION PROVIDED IN EPIC CHARTING). 02/18/21 CALL TO CARDIOLOGIST TO REPORT CHEST PAIN RADIATING TO LEFT ARM THAT HAD BEEN GOING ON X2 HOURS. HE ALSO DESCRIBED HIGH BLOOD PRESSURE AND THAT HE HAD RECEIVED HIS 2ND COVID VACCINE 2 DAYS PRIOR. CARDIOLOGIST RECOMMENDED HE GO TO ER FOR CONTINUED PAIN.  PATIENT REPORTED PAIN HAD ENDED.  02/19/21 REPORTED TO ER WITH CHEST PAIN  AND ELEVATED BLOOD PRESSURE. DIAGNOSED WITH CHEST PAIN, UNSPECIFIED TYPE AND HYPERTENSION NOT AT GOAL..  02/19/21 ADMITTED INPATIENT TO HOSPITAL..
pt recvd vax;pt devel erythematous,hot area at inject site, resolved in 2 days;
Fever; A spontaneous report was received from a consumer (patient's wife), concerning a 72-year old, male patient who received Moderna's COVID-19 vaccine and experienced fever.    The patient's medical history was not provided. Concomitant medications reported included rosuvastatin, fenofibrate, metoprolol, clopidogrel, ezetimibe, acetylsalicylic acid, colecalciferol, ubidecarenone, and ascorbic acid/vitamin B complex.   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (batch 025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient began to run a fever after vaccination. The patient was treated with Advil (Ibuprofen). On 05 Jan 2021, the patient had experienced the fever again.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event of fever was not resolved.; 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.
Information has been received from a licensed visiting nurse concerning a 24 month old female (weight 25#, height 33") medical history and drug reactions/allergies reported as none (previously not reported) who on 08-MAY-2006 was vaccinated with Vaqta (lot #652508/1194R). Concomitant medication included albuterol sulfate (previously not reported). On 09-MAY-2006, the patient experienced right side facial edema and right upper eyelid drainage (previously reported as swelling in her face). On 16-MAY-2006, the patient recovered from the right side facial edema and right upper eyelid drainage (previously reported as the patient's swelling in her face persisted). The physician considered the events to be non-serious and not related to therapy with Vaqta. The patient sought unspecified medical attention. No product quality complaint was involved. Additional information is not expected.
After administration it was discovered that vaccine dose administered was from a vial opened 5 days prior & not disposed of appropriately. It was left in a bag & un-refrigerated. There was no adverse event on the part of the patient.
Information has been received from a licensed visiting nurse concerning a 60 year old male with hyperlipidemia and hypertension and no drug allergies who on 11-SEP-2007 was vaccinated SC with a 0.5 ml one time dose ZOSTAVAX (lot# 657765/0585U) in the right deltoid. Concomitant drug therapy included atenolol 50 mg once daily, naproxen 500 mg twice daily and simvastatin 80mg at bedtime. On 04-OCT-2007 the patient developed a mild case of shingles. The patient sought medical attention via physician's office. No labs or diagnostic studies were performed. The outcome was unknown. The patient was treated with VALTREX 1 g 3 times daily for 7 days. There was no product quality complaint. Additional information has been requested.
25 year-old male who had a witnessed fainting episode, leaned on left side, with arm twitching approximately 10 minutes post 2nd dose of covid moderna covid vaccine. LOC approximately 15 seconds. Covid Observer RN called 911. Pt regained consciousness, able to state name and simple "yes and no" questions. Pt does not recall events prior to passing out; he is pale, cool and diaphoretic to touch. Initial BP 70/40, HR 32, unable to obtain Spo2 on RA due to cool extremities. Pt refused to be placed on supine position, states "I feel better sitting up." Then pt c/o chest tightness and profusely sweating, NRB mask placed. Covid Observer RN stayed with pt until 911 EMS crew arrived. Pt was taken via gurney to ED.
12 hours after my 2nd vaccination I experienced a severe asthma attack. The spasms lasted 36 hours. After that and still on-going, throat seems closed and scratchy, kind of like strep.
Have been experiencing fatigue few weeks; Along with what would probably be called brain fog; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Jun2021 18:00 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "CFS" (unspecified if ongoing), notes: Verbatim:CFS; "ME" (unspecified if ongoing), notes: Verbatim:ME; "Fibro" (unspecified if ongoing), notes: Verbatim:Fibro; "Sensitivities not allergies" (unspecified if ongoing). Concomitant medication(s) included: MAGNESIUM; POTASSIUM; MULTI; SELENIUM; VIT B COMPLEX. The following information was reported: FATIGUE (non-serious) with onset Jun2021, outcome "not recovered", described as "Have been experiencing fatigue few weeks"; FEELING ABNORMAL (non-serious) with onset Jun2021, outcome "not recovered", described as "Along with what would probably be called brain fog". Therapeutic measures were not taken as a result of fatigue, feeling abnormal.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Device Date provided as 18Sep2021.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
COVID Vaccine  2/81/21 and 1/28/21  PFIZER  Admitted wo ICU with COVID infection 8/29/21
A report was received from a health care professional on 20 October 2003 concerning an unspecified number of vaccinees less than 4 years of age who received Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees received Fluvirin. The reporter was not aware of any of adverse symptoms occurring at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 10 November 2003: A follow up report was received from a health care professional indicating that a 2 year old male vaccinee received Fluvirin on 7 October 2003. Cross reference with PJP200300839.
Redness at the site of injection. Hard nodule underneath the skin, at the site of the injection. Both symptoms were about the size of a dime.
3RD DOSE PFIZER COVID VACCINE GIVEN 05/13/2022, FP4554; Pt admitted to hospital from rehab on 9/7/22 with necrotizing fasciitis of left hip and COVID PNA; pt had a positive COVID test; taken to OR multiple times for I & D; condition worsened requiring intubation; multi-organ and renal failure; septic shock; arrhythmias; transitioned to comfort care and pt passed away in the hospital
VACCINE EXPOSED TO TEMP OUTSIDE OF REC STORAGE RANGE. UNKNOWN VIABILITY/POTENCY PER MANUFACTURER
Information has been received from a physician concerning a female who was vaccinated IM with Gardasil. Subsequently the patient experienced chest pain and shortness of breath. The patient sought medical attention at the emergency room. Additional information has been requested.
I was in such pain my left arm started swelling & it was very painful. It lasted for about 5 days, Dr. told me if it gets worse to go to ER.
102 Fever, inactive  high heart rate 144, loss of appetite, weight loss, Injection site pain
Patient contracted COVID after being fully vaccinated.  No booster. No symptoms of COVID - Incidental finding for another visit.
This case was reported by a healthcare professional and described the occurrence of an allergic reaction in a subject of unspecified age and gender who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On 10 October 2007 the subject received unspecified dose of Flulaval at 0.5 ml.  On 10 October 2007, at an unspecified time after vaccination with Flulaval, the subject experienced a severe allergic reaction.  At the time of reporting the outcome of the event was unspecified.  No further details were reported.
SEIZURE:   patient had a seizure within 1 minute of receiving the vaccine- both I, her mother, and the pharmacist observed.  Healthy individual with only one prior seizure.  Seizure lasted 1-2 minutes.  Body stiffened,  moaning, eyes wide open.  Was weak for 15-20 minutes afterward.
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 13-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 05-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059).  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: T013204; expirationdate: 03-DEC-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; Sender's Comments:  US-009507513-2102USA004059:
Patient said arm got swollen and started itching; went to ER and got steroid injection.
pt brought to ED with c/o chest pain; states has had SOB, productive cough x 1 wk; found to be positive for COVID; O2 supplementation; EKG showed inferior STEMI; prepped for cath lab; 2 stents placed; admitted to ICU; continued to have chest pain despite additional O2; code blue called later and pt developed a pulseless VT then VF; ROSC was never achieved with continued CPR; pt passed away in the hospital
Vaccine administered on 1/14/02 at MD office (varicella & MMR) 10 days after immunization presented to our office with body wide rash, low grade fever and respiratory symptoms. Dr was out of office-unable to obtain info. on lot # of vaccine(s).
Redness, swelling and heat on arm Pneumovax was administered. Redness and swelling lasted approximately 4 days. Treatment recommended oral Benadryl and ice packs on swollen area. Pt called Dr. was told allergic reaction-did not seek additional care.
I have neuropathy symptoms, sore joints and muscles believed due to Tacrolimus. I see a neurologist later this month. Following the first Covid vaccine, these symptoms increased. I was unsure whether this increase was due to the vaccine. However, following the second vaccine, my symptoms increased again and are substantially more severe than they were prior to the vaccine. I am also having increased pain in the area of my liver following both doses.
Patient was given his 3rd dose, booster Covid vaccine shot outside the 12 hour room temperature window. The vial was opened on 8/30/21 and he was given the vaccine the following day on 8/31/21 at 10am.
About 12 hours after vaccine, I had high fever of 102, severe body aches, severe chills, minimal nausea, even with two extra strength tylenols.  I went to the restroom around 5 am and had lightheadedness and FAINTED.  My husband helped me up and helped me to bed.  I was still mildly lightheaded for about 30 minutes.  I took two extra strength tylenols and two Advils.  My fever broke about 30 minutes later.  I slept.  Then about 2 pm had fever and aches again, but took two Advils and fever broke.
Booster; The patient got COVID (Coronavirus Disease) booster and got sicker; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ENBREL. Vaccination history included: Covid-19 vaccine (Dose 1 Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose 2 Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; ILLNESS (non-serious), outcome "unknown", described as "The patient got COVID (Coronavirus Disease) booster and got sicker". Therapeutic measures were not taken as a result of illness.  Additional information: Feeling really bad/ not feeling well/ got sicker than a dog. The patient thought that booster was less medicine and it would not be horrible but it was not like that. The patient was feeling really bad and not feeling well. The reporter declined consent for follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Expired ADACEL was given to patient. No reaction. CDC was contacted - they said to re-administer. Patient wants to wait. Expired 1-18-2014.
At 1207, resident was noted having facial twitching and seizures and crackles , Vitals: BP 199/95, O2 Sats 89% on RA, PR 88, Temp 97.3, RR was hardly counted because of body movement. Blood sugar was 172 mg/dL. Hooked on O2 at 4L per NC. Informed MD and ordered to send to ER. Family - were updated. Ambulance was called. Family clarified resident's status is DNR. Report was given to ER nurse. Updated ER that INR today is 5.5 and MD ordered to HOLD Coumadin till 02-11-21.
This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 35-year-old, adult, male patient. The patient had no relevant medical history and did not take any concomitant medications at the time of vaccination. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 1.5 ml instead of 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252235, expiry date: 30-Jun-2019]. At the time of this report, no adverse events were reported. This case 201804690 was linked to the source case 201804657 due to the same reporter.
High fever, severe body aches and headache, severe nausea, extreme pain at the injection site - began about 7 hours after injection and lasted for about eight hours; symptoms remained longer but not as severe
several patients were left with pencil-lead type tattooing at the vaccine administration site; little gray spot on infants after a vaccination; This non-serious case was reported by a nurse and described the occurrence of injection site reaction in an unspecified number of patients who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis and MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Pediarix, Infanrix and Priorix. On an unknown date, an unknown time after receiving Pediarix, Infanrix and Priorix, the patient experienced injection site reaction (Verbatim: several patients were left with pencil-lead type tattooing at the vaccine administration site) and skin discoloration (Verbatim: little gray spot on infants after a vaccination). The outcome of the injection site reaction and skin discoloration were not reported.   It was unknown if the reporter considered the injection site reaction and skin discoloration to be related to Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Priorix and Priorix Pre-Filled Syringe Device.  It was unknown if the company considered the injection site reaction and skin discoloration to be related to Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Priorix and Priorix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt Date: 06-JUL-2023 The reporter stated that not sure, if you recalled but when they first switched to GlaxoSmithKline vaccines, they observed that several patients were left with pencil-lead type tattooing at the vaccine administration site(s).  They documented these in our records as well as reporting them and filled out forms for each patient who experienced the tattooing. They had a patient who had again ended up with tattooing after subsequent vaccine administrations and was asking what the company had determined regarding this outcome. They were quite upset.  The reporter wanted to know if there was any update information regarding this issue and similar outcomes at other facilities. The aggregate results/investigation outcomes from the company and any information you may have would be helpful. The reporter stated that having an issue with GlaxoSmithKline vaccines leaving a little gray spot on infants after a vaccination.  They had turned in the adverse event forms on the cases that it had happened with. The clinics were looking for answers as to be this a side effect, was this harmful, how did they get rid of the spot etc.  The reporter did have a picture of one of the spots from one of our shots.  It was mostly happening with Pediarix but more recently, it had also happened with other vaccines from the GlaxoSmithKline portfolio.  Most of the information was below but he/she did have additional information as well.
Pediatric dose given instead of adult dose - no adverse reactions to vaccine.  Discussing with parents to bring patient back in to receive adult dose.
Information has been received from a company representative who reported that a male patient with multiple sclerosis (age unknown) developed shingles within one month after he received ZOSTAVAX (dates, dose not reported). No further information was provided. Additional information has been requested.
Moderate fatigue (greater than 36 hours); Muscle aches on left side of neck; Migraine-like headache (great than 36 hours); This is a spontaneous report from a contactable pharmacist. A 47-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE); Lot/batch no: EN6208) via unspecified route of administration in the left arm, as a single dose on 14Mar2021 at 15:15 (at the age of 47-years-old) for COVID-19 immunisation. The patients medical history included migraines, depression and anxiety. The patient was allergic to erythromycin. Concomitant medications included Prozac, Claritin, Alprazolam and glucosamine taken within two weeks of vaccination for unknown indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. On 14Mar2021, the patient developed migraine-like headache (greater than 36 hours), muscle aches on left side of neck (injection in left arm) and moderate fatigue (greater than 36 hours). The patient received Motrin as treatment for the adverse events. The clinical outcome of the events migraine-like headache, muscle aches on left side of neck and fatigue was resolving at the time of report. Action taken with BNT162B2 was not applicable No follow-up attempts are needed. No further information is expected.
First started getting chills at 9 PM on the day I received the vaccine. I was running a low grade fever as well. The next morning I was feeling muscle soreness/aches, neck pain, head pain, and my left lymph node under my armpit was swollen. The following day I had a headache and the swollen lymph node persisted. The following day, only the swollen lymph node persisted. It is currently 5 days since my vaccination and the only remaining symptom is my swollen lymph node, although the swelling has decreased each day slowly. I did not take any medication to alleviate the symptoms.
The pt developed swelling on the right leg Prevnar and Hib injection site within 24 hrs. Thickening of SC tisse has remained for two months.
cough that will not go away and is aggravating; feeling miserable; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough that will not go away and is aggravating) and FEELING ABNORMAL (feeling miserable) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced COUGH (cough that will not go away and is aggravating) and FEELING ABNORMAL (feeling miserable). At the time of the report, COUGH (cough that will not go away and is aggravating) and FEELING ABNORMAL (feeling miserable) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-090264, US-MODERNATX, INC.-MOD-2021-090279 (E2B Linked Report). This case was linked to MOD-2021-090392 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090264:Husband Dose 1 case US-MODERNATX, INC.-MOD-2021-090279:Husband dose 2 case
Patient had warm, red rash that started morning of 11/7/19 and continued to get worse into that evening, also had low fever. Patient went to urgent care the next day (11/8/19) and was prescribed cephalexin for cellulitis.
FEVER; CHILLS; MUSCLE ACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertensive. The patient received covid-19 vaccine ad26.cov2.s (suspension for infusion, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced muscle ache. Laboratory data included: Body temperature (NR: not provided) 102 F, 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, and muscle ache. This report was non-serious.
Nausea; vomiting; diarrea - for approx. 6 hours
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 14-OCT-2014 (reported as "yesterday") the patient was vaccinated with a dose of PNEUMOVAX23 (lot #, expiry date, dose, frequency and route unspecified) then it was found out the client had the PNEUMOVAX23 vaccine last year (2013). On 15-2014 (at the time of the report) the patient was experiencing nausea and upset stomach. The outcome of nausea and upset stomach was reported as not recovered/not resolved. No PQC involved. Additional information is not expected as we could not contact the reporter.