chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE information; temperature excursion; Information has been received from an administrator referring to a 12 months old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 19-MAR-2021, the patient was administered improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # was reported as S028915, expiration date was reported as 16-SEP-2021, strength, dose, frequency and route unknown, therapy type: rHA) for prophylaxis (incorrect product storage). No adverse effects were reported.  The stored temperature was 1.48 degree Celsius. The time frame was 0.35 hours on 01-MAR-2021. There was no previous temperature excursion. The temperature excursion was detected by a data logger.  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2105USA004751:
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s(dose number in series 1) (suspension for injection, route of admin not reported, batch number: 042AZ1A, expiry: unknown) dose was not reported, 1 total, administered on 10-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  On 31-DEC-2021,the patient had scratchy throat, coughing, headache and body aches (suspected covid-19 infection) and suspected clinical vaccination failure. On 01-JAN-2022, the patient tested positive for COVID-19. Laboratory data included: COVID-19 virus test (home kit test) (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition).  This report was associated with product quality complaint.; Sender's Comments: V0: 20220105390-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Pt recvd 3 doses of Engerix-B & 5AUG92 HBSAB titer was neg;
Pt woke up at 3am the next morning with a headache and left red eye consistent with viral conjunctivitis on exam.
Severe headache (worst of my life) immediately following the shot, lasted for  24 hours
I95.9 HYPOTENSION 5/15/2023 ACUTE & CHRONIC RESPIRATORY FAILURE WITH HYPOXIA
Today was my second injection; the first injection was on 6/28/2017. The first injection (upper left arm) my arm was sore for several days and a noticeable lump was present for nearly a month.   Today I have experienced nausea and a headache from late afternoon into the evening.
Adverse Event: Facial edema and lip swelling.  Treatment: Benadryl 50mg by mouth (Steroids on hold if Benadryl works)
Bloating; Lack of bowel movement; Abdominal discomfort; Achy; Developed a sense of "itch" under right (vaccinated) armpit/axilla; Tired; Nauseous; This is a spontaneous report from a contactable consumer, reporting for herself. A 61-year-old female patient received the third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number FF8841) via an unspecified route of administration in right arm on 25Oct2021 14:00 (at the age of 61-year-old) at single dose for COVID-19 immunisation. The patient was not pregnant and not pregnant at the time of vaccination. Relevant medical history included BRCA1 gene mutation. The patient previously received the first dose of Moderna COVID vaccine (Lot number 039K20A) via an unspecified route of administration in left arm on 27Dec2020 10:00AM and second dose of Moderna COVID vaccine (Lot number 028L20A) via an unspecified route of administration in right arm on 25Jan2021 10:00AM, both taken for COVID-19 immunisation. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Concomitant medications included colecalciferol (VIT D), melatonin, cyanocobalamin (VIT B12) and magnesium. On 25Oct2021, after the booster dose, the patient had a few days when she felt horrible (tired, achy, nauseous). She also developed a sense of "itch" under right (vaccinated) armpit/axilla and abdominal discomfort. On day 3, she noticed bloating and lack of bowel movement since vaccination. Bloating, abdominal discomfort and lack of bowel function with bouts of nausea have continued. The patient went to urgent care, her PCP and a GI specialist. Events required Emergency Room visit and Physician office visit. Treatment was received: x-ray, prescription for Trulance, Zofran and Compazine. The events were not resolved at the time of report.
Developed small petechiae on face, around eyes and along neck, no other symptoms, no pruritis, or swelling of tongue or lips. Otherwise child was in usual state of health.
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with PROQUAD (dosing details were not reported) (lot # M004889, with expiry date of 25-JUL-2017) which was improperly stored at 7 F for a time frame of 3 hours and 49 minutes, which was having a previous temperature excursion of 28 F for 4.5 hr. The call was made due to data logger (therapy type: digital data logger). No adverse effects were reported. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
PATIENT EXPERIENCED A HIGH FEVER(.105F) AND EXPERIENCED A SEIZURE. HE WAS TRANSPORTED TO THE ER FOR OBSERVATION. UPON DISCHARGE PATIENT WAS INTRUCTED TO FOLLOW UP WITH NEUROLOGY
The symptoms I was experiencing were pain in my side. And then I became really ill and it happened very rapidly - I had an infection. Felt great one minute and then the I started feeling like hell. I tried to throw up and couldn't. Called the ambulance and they came and got me. Got to the hospital - they said I was septic. I needed immediate admission. I was in the hospital for a few days. Since then I have been problem with my anemia. My kidney is not functioning correctly - have seen specialists for that. I had already appts with the urologist for it to have the kidney stone removed - it hadn't been treated as an emergency when it should have been treated as such and removed in time so that's why I got the septic infection. Since then the kidney isn't producing what it needs to produce - for the bone marrow to produce blood cells - it's not putting out enough hormone to produce the blood cells so I have been anemic for a few months now. I have been seeing an oncologist and so she knew right away what was going on with that - I can't have an injection of the hormone so they are ordering a colonoscopy to see if there is cancer somewhere else. To see if there are other reasons why the issue is not resolving. I am better than I was but I still have problems with the kidney.  Note: flu vaccine -I had it two weeks ago; I had the COVID booster vaccine: this last Thursday, 10/7/2021.
Pt. called 9-21 said her R arm was swollen from shoulder to elbow. Red and warm to touch. Asked Pt to call PCP and see what he said. Pt called MD - MD said OK - to use TYLENOL and cold compress for pain.
Nurse accidentally administered the monovalent booster instead of Bivalent  Booster. No adverse event reported by patient
Patient drinking beer prior to vaccination earlier in the day.  Didn't eat.  Felt dizzy with headache and noticed slurred speech.  No other symptoms.  Monitored and felt better < 20 minutes.  Ambulating independently and had a ride home, able to leave after monitoring.
headache; blurred, slow response vision; blurred, slow response vision; tiredness; prickly/achy pain; fever; sweats; chills; swollen glands; shortness of breath; sore arm; nausea; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Left on 02Nov2021 09:15 (Lot Number: 30155BA; Expiration Date: 07Nov2021) as DOSE 2, SINGLE for COVID-19 immunisation at the age of 41 years old. Medical history included ongoing Birth control. Concomitant medication(s) included ethinylestradiol, ferrous fumarate, norethisterone acetate (LARIN 24 FE) taken for birth control from 1997 and ongoing.  The patient previously received first dose of BNT162B2 intramuscular in left shoulder on 12Oct2021 12:30 (Lot number: 30145BA, Exp: 30Nov2021) for COVID-19 immunisation at the age of 41 years old, and experienced almost immediate headache with blurred, slow response vision, tiredness, Prickly/achy pain moving throughout body that started hour 10 - 40 hs along with fever, sweats, chills, swollen gland. Shortness of breath. 1st dose gave a severe cough last until 2nd.  The patient experienced almost immediate headache with blurred, slow response vision. Then experienced tiredness, Prickly/achy pain moving throughout body that started hour 10 - 40 hs, along with fever, sweats, chills, swollen gland. Left shortness of breath. Additional symptoms: Sore arm for days, nausea. Both doses out of work for days and upon return, unable to work at 100%. Events onset date was reported on 02Nov2021 09:30, treatment received included oral Ibuprofen. Outcome of events was unknown. Seriousness criteria: Persistent /significant disability/ incapacity.   Follow-up attempts are completed. No further information is expected.
She got a fever the evening of the immunizations admitted abdominal pain. As of 4/7/09, she had had the fever 6 days.
This case was reported by a physician via sales representative and described the occurrence of rotavirus infection in an unknown number of subject of unspecified age and gender who was vaccinated with ROTARIX (lyophilized formulation, GlaxoSmithKline). On an unspecified date (s) the subjects received 1st dose and 2nd dose of ROTARIX lyophilized formulation (oral). At an unspecified time after vaccination with ROTARIX lyophilized formulation the subjects experienced rotavirus infection and vaccination failure. The reporter stated that "6 to 12 patients were given the ROTARIX vaccine and experienced lack of efficacy and were having break through cases." No additional information was available at the time of reporting. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events were unspecified. Follow up was received from a nurse on 7 October 2013. The nurse stated that her practice needs additional subject details to identify the subject. No details were made available to GSK therefore no additional details provided.
unusual side effect after my 1st dose; and I am scared to get 2nd.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (unusual side effect after my 1st dose) and ANXIETY (and I am scared to get 2nd.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (unusual side effect after my 1st dose) and ANXIETY (and I am scared to get 2nd.). At the time of the report, VACCINATION COMPLICATION (unusual side effect after my 1st dose) and ANXIETY (and I am scared to get 2nd.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were provided.
I was visiting some family. On 12/31/2022 I was having a runny  nose, Migraine, some diarrhea and I was tested and I was told I positive with COVID.  I was told to get retested 10 days later after the first test.
Patient inadvertently received  vaccine after published  expiration date. Moderna Company analyzed vaccine and advised lot 007B21A maintained activity needed to protect against covid 19 date vaccine was administered. Also patient did not call in to complain of adverse event.  This is administrative error without adverse event.
Itching burning at injection site, late developing acute redness, swelling increasing in size comparable to a golf ball under the skin. Pain at injection site, headache, malaise.
About 5-10 minutes after receiving the vaccine experienced spontaneously elevated heart rate and lightheartedness while sitting in a chair in the observation room. After a few minutes pulse returned to normal and lightheartedness abated.  At no point did I experience shortness of breath, no facial or airway edema. Just a brief period of tachycardia and feeling of impending doom.
Fever, vomiting,  diarrhea, insomnia, sore painful muscles ,chills, headache
the consumer received two Flu vaccines in the same flu season, No AE; Initial information received on 20-Feb-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 65 years old female patient for whom it was reported that the the consumer received two flu vaccines in the same flu season (extra dose administered) while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient had received a regular flu vaccine in Oct-2019.  The patient's past medical history, medical treatment(s) and family history were not provided.   On 19-Feb-2020, the patient received a dose of 0.5 ml of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ307AA, exp date: 29-Jun-2020 via unknown route in unknown administration site (right side). It was a case of actual medication error due to extra dose administered.   The patient wanted the flu shot and a different shot. The patient wanted the shingles and pneumonia shot. Caller stated that the patient turned 65 in December and got the regular flu shot back in October. Caller stated that the patient received Fluzone High Dose today.  No adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Received 2nd vaccine in morning at 10am, that night at Midnight started a fever. Fever of 102.2.   Fever lasted for 24 hours.  Muscle aches and pains, joint pain, lower back pain right side, headache.  Fever broke after 24 hours.  Some continued weakness for a couple days.  Then back to mostly normal.  10 days later, mild fever returned in the evening of 2/9, and 2/10, temp of 101.  These second rounds of fever went away during the day.  And temp was between 99.8 and 101.2. My question is:  Is it normal to get a mild fever 10 days after 2nd vaccine shot?
Felt hot, flushed, tingling. Then mouth and throat started to burn. Throat felt like closing. Difficult to swallow water. Able to take Benadryl liquid within 5 minutes of reaction starting and drink water (4 bottles of 16 ounces). 15 minutes later felt returning to normal status. No epinephrine used.
Injection site hard lump and very red and raised. Said some pain in arm as well. I told he cold compress and normal pain reliever also hydrocortisone if needed. Go to dr if gets worse or not better. She said she didnt notice anything until Thursday had injection on Tuesday.
Multiple Seizures unable to breathe still continuing at times still taking normal seizure meds along with Ativan  when needed
This case was reported by a nurse via call center representative and described the occurrence of injection site redness in a female patient who received FLULAVAL QUADRIVALENT (batch number C92E7, expiry date June 2016). On 10th December 2015, the patient received FLULAVAL QUADRIVALENT .5 ml. On 10th December 2015, less than a day after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site redness, injection site pain and injection site warmth. On an unknown date, the outcome of the injection site redness, injection site pain and injection site warmth were unknown. It was unknown if the reporter considered the injection site redness, injection site pain and injection site warmth to be related to FLULAVAL QUADRIVALENT. Additional details were received as follows: The reporter would like to know whether the patient should be concerned about receiving Flu vaccines in future. The reporter did not have the date of birth of the patient.
Pt recv vax on 4/8/99; on 4/9/99 pt exp sore fingers, neck, vax site, feverish feet, migraine; tx=Indocin
Sudden loss of vision in right eye due to a central retinal vein occlusion (CRVO).  Treating with regular (notionally every 6 weeks) injections of Eylea (aflibercept) to reduce swelling.  No cure for CRVO.  Treatment is expected to be life-long.
RESIDENT RECEIVED PFIZER BOOSTER. SHE HAD PREVIOUSLY HAD MODERNA FIRST AND SECOND DOSES. NO ADVERSE REACTIONS AT THIS TIME. OBSERVATION AND 72 HOUR MONITORING AS WELL AS PHYSICIAN NOTIFICATION.
Pt received vaccine 23 Nov 09. Pt's mother reported she noticed redness and swelling in the evening of the 24th. Pt's mother called ER and was told to bring pt in the following morning. Pt's mother brought pt into imm. clinic the afternoon of the 25th, pt had redness and swelling on RT thigh. Pt was alert and happy.
experiencing rednessat the injection site; experiencing swelling at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site redness in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th August 2022, the patient received the 1st dose of Shingrix (intramuscular). In August 2022, less than a week after receiving Shingrix, the patient experienced injection site redness and injection site swelling. On an unknown date, the outcome of the injection site redness and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site redness and injection site swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-AUG-2022 Reporter's Comments: The pharmacist reported that a patient had experienced redness and swelling at the injection site (left arm) after receiving the Shingrix. The reporter gave Consented to follow up.
Lightheaded, sick to stomach. Later on the day had chills, fever, cold sweats, vomiting, diarrhea, hard time breathing. Was to sick to go to work.
above temperature excursion, the highest being 52F; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, Engerix B, Infanrix, Infanrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Havrix, Kinrix, Kinrix Pre-Filled Syringe Device and Boostrix. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device, Engerix B, Infanrix, Infanrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Havrix, Kinrix, Kinrix Pre-Filled Syringe Device and Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The nurse reported that the patients had received doses of Bexsero, Engerix B, Infanrix, Pediarix, Havrix, Kinrix and Boostrix after temperature excursion, which led to incorrect storage of drug. The nurse reported that above temperature excursion, with the highest being 52F for a total of an undetermined length of time starting from 22th November 2021. The nurse did not have exact excursion information and was unsure if vaccinations were far enough out of range to qualify. The nurse was referred to CDC regarding revaccination, if required after she completed more research on total time of excursion. The health care professional wished to remain anonymous. The reporter did not consent to follow-up.
tingling LUE, LLE, Left face and left side of tongue/cheek Narrative: condition C called
Severe cramps in left thigh; unable to walk or stand normally; pain restricts bending of leg and interferes with walking and climbing stairs. Problem continues on current date.
Extreme body aches, nausea, headache, trouble walking and speaking, severe kidney/lower back pain
sore arm; feeling hot and cold; stomach pain; fatigue; rash; headache; upset stomach; feeling horrible/feel like run over by a truck; This is a spontaneous report received from a contactable consumer (patient herself). A 53 (unit: unspecified) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. Medical history included compromised immune system, due to the stress; she has history of PCOS and IBS. The patient historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization and experienced the rash after the dose. The patient's concomitant medications were not reported. Consumer received her second dose of the Pfizer covid vaccine yesterday. She stated that she regards it, she was feeling horrible, has sore arm, feel like run over by a truck, feeling hot and cold, stomach pain. She stated that she was going to get the autoimmune disease from this vaccine in 5 years, consumer questioned was she going to die, vaccine is misleading and should not be given. She feels like she has full blown covid. she also experienced fatigue, rash, headache and upset stomach. Consumer wanted to know if that vaccine would give her autoimmune disease. Consumer questioned and wanted to know if she could get covid from the vaccine. On an unspecified date, the patient experienced sore arm, feeling hot and cold, stomach pain, fatigue, rash, headache, upset stomach, feeling horrible/ feel like run over by a truck. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient developed swelling, tenderness to touch, redness at site of PNEUMOVAX injection on left upper arm. as well as flu-like syndrome.