chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COPD; Trouble breathing; shuffling instead of walking; depressed; losing weight; confused; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) in an 82-year-old male patient 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.   In February 2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced CONFUSIONAL STATE (confused). On an unknown date, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) (seriousness criterion hospitalization), DYSPNOEA (Trouble breathing), GAIT DISTURBANCE (shuffling instead of walking), DEPRESSION (depressed) and WEIGHT DECREASED (losing weight). At the time of the report, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) and DYSPNOEA (Trouble breathing) was resolving and CONFUSIONAL STATE (confused), GAIT DISTURBANCE (shuffling instead of walking), DEPRESSION (depressed) and WEIGHT DECREASED (losing weight) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jul-2021, Blood test: normal (normal) normal.         No concomitant medication reported.  Daughter of patient called to report that he had his second dose of the Moderna vaccine in late Feb. At the end of May he started acting confused almost like an Alzheimer's patient. He was sharp as a tack, cutting his own lawn, and working out at the gym. He is now a completely different person he has trouble breathing, shuffles instead of walking, losing weight, and very depressed. Approximately 28Jul 2021 he had perfectly normal bloodwork. Two weeks ago his breathing was so bad he went to the emergency room and was admitted to the hospital. The diagnosis was out of control COPD, they stabilized it and sent him home.  She did not have vaccine information or the exact number of days and dates of hospitalization.   No treatment was provided.  Based on the 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. COPD does not happen overnight. It is a chronic disease developing through the years. Unlikely, that the events are related to the vaccine. Further information is expected.; Sender's Comments: Based on the 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. COPD does not happen overnight. It is a chronic disease developing through the years.  Unlikely, that the events are related to the vaccine. Further information is expected.
This study case was received from the investigator in a trial on 28 October 2011. A 44 year-old female subject with no significant medical history was found to have encephalitis following immunization procedures 8 days after she had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 11 June 2011. She also received on 09 June 2011 an injection of TYPHIM VI (lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). The subject's ECG was not available. A Troponin I, Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
This spontaneous report has been received from a nurse refers to a patient of unknown age and gender. On unknown date in 2003 the patient was vaccinated with the first dose of VARIVAX (Merck) (Lot number, dose and frequency were unknown). The patient was late for the second dose of VARIVAX (Merck). No adverse effects were caused by the first dose of VARIVAX (Merck). At the time of reporting, the patient was on prednisone which the reporter thought it was used for asthma. The outcome of asthma was not reported. The reporting nurse questioned if the second dose of VARIVAX (Merck) could be administered due to drug interaction with prednisone. Additional information is not expected because the reporter did not want to be contacted.
Symptoms at first were soreness in the arm, later in the evening, I developed strong chills, a severe headache, neck stiffness and pain, nausea, and sweating alternating with chills. These symptoms were pretty strong, lasted through the night, and kept me awake. I felt sick enough to go to urgent care, but I was alone and did not feel up to driving myself. This lasted about 10 hours. I took 600mg of MOTRIN the next morning, and felt better. The chills and sweating stopped and the headache was much more mild by mid morning.
Elevated temp.Irritability.Swelling lt lateral thigh @ site of inject.Cough.N/V.Rash @ site of inject
Around 12:30 am on 10/24/21 I started to have very bad chills and pain in my entire left arm. Especially the joints. I started experiencing body aches as well. Around 1:30 am on 10/24/21, I started having severe chest pain. There was a stabbing sensation going in through my heart out to my shoulder blade. The pain radiated from my heart into my left collar bone, armpit, shoulder and jaw. There was a loss of grip strength in my left hand and I had a very bad headache. Around 5:30am I got very nauseous and started to vomit. Around 8:00 am I noticed swelling in my left armpit. The flu like symptoms only lasted 24 hours, but the chest pain continued. I went to ED on 10/26/21 and they said it was muscular. I went to Cardiologist on 11/1 and they said the vaccine most likely triggered my pericarditis.  I did also receive my flu vaccine on 10/23/21 (in right arm). I did not add it because I did not know which one it was.
At 9:10 PM on 5/11/21, I experienced chills that required multiple layers of heavy blankets. This lasted till about 10:20 PM on 5/11/21. I was shaking a lot. I never experienced chills that extreme before. At 10:30PM on 5/11/21, I took one Tylenol.  At about 2:00AM on 5/12/21, I woke up with heat flashes for an unknown time due to sleeping.  At 7:30AM on 5/12/21, I woke up to a heart rate of 105 beats per minute. This lasted for about six hours. I could feel my heart pounding through my chest. During this event, I also experienced shortness of breath. That lasted for about the same time. At 9:00AM on 5/12/21, I took one Tylenol. By 4:00PM on 5/12/21, I started to feel better and my heart rate got down to my normal level of 70 beats per minute while resting.
Passed away had received 2 of the vaccine shots from your company/developed Myocarditis and Pericarditis; Passed away had received 2 of the vaccine shots from your company/developed Myocarditis and Pericarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A 19-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), for COVID-19 Immunization. The following information was reported: MYOCARDITIS (death, medically significant), PERICARDITIS (death, medically significant), outcome "fatal" and all described as "Passed away had received 2 of the vaccine shots from your company/developed Myocarditis and Pericarditis". The patient date of death was 26May2023. Reported cause of death: "Passed away had received 2 of the vaccine shots from your company/developed Myocarditis and Pericarditis". It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in this case and considering a plausible drug-event temporal association, there is a reasonable possibility that the reported fatal listed events (Myocarditis and Pericarditis) are related to the suspect product BNT162b2 (COMIRNATY). However, additional information is needed to better assess this case and determine patients cause of death. This case will be reassessed upon receipt of follow-up information.; Reported Cause(s) of Death: Passed away had received 2 of the vaccine shots from your company/developed Myocarditis and Pericarditis; Passed away had received 2 of the vaccine shots from your company/developed Myocarditis and Pericarditis
Menstral cycle has changed and not been as regular as it had been prior to the vaccination. Since the vaccination, I have had muscle aches to my back, especially the lower back. To this day, symptoms have persisted. My period varries month to month since the vaccine by a few days. I was also nursing when I received the vaccine, and my milk supply drastically decreased by more than half. My biggest concern is my back pain. It is worse with increased activity and at night. I had no prior history of back aches, no changes in activity, no traumas. Changes began shortly after the vaccine.
32/89 pt failed to maintain adequate titers 27mo p/vax w/Rabies;
rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 RASH (rash). At the time of the report, RASH (rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
I received the maternal booster shot on 12/03/21 at about 1:45 PM right away I felt burning sensation from the injection shot towards my fingers however that went away within five minutes then I had a medicine taste in my mouth that went away also within five minutes.  I also have been having arm pain in the ejection shot and the pain goes down my fingers and that hasn?t stopped. So the next day 12 /4/2021 my head has been in pain swollen in the injection site and the pain has not stopped since 12/3/2021.   12/5/2021 I?ve been having pain since the morning and right now is 4:41 PM and I looked at the injection site and it?s swollen and now it has a red rash and they took a picture.
Pt recvd Hep B vax following the inject, pt devel pain, tendinitis & bursitis, requiring surgery; No further details were provided;
pt was sitting in waiting area during 15 minute waiting period after shot and says she thinks she passed out for a couple minutes. she also reports feeling sweaty and anxious but anxiety is something she has had a problem with in the past getting vaccines
Pt recv vax on 2/9/99; 1 min post vax pt exp holding breath, fainting, malaise, headache, dizzy
No Adverse event; Received 0.25 ml of bivalent dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) in a 35-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis. No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent dose).    No concomitant medications were provided. Reporter saw that the dosage was changed to 0.5 ml. For the past month, reporter had been giving 0.25 ml. 19 patients received the half doses on 15-Sep-2022, 22-Sep-2022, 29-Sep-2022 and 06-Oct-2022. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-662961, US-MODERNATX, INC.-MOD-2022-662887, US-MODERNATX, INC.-MOD-2022-662970, US-MODERNATX, INC.-MOD-2022-662974, US-MODERNATX, INC.-MOD-2022-662991, US-MODERNATX, INC.-MOD-2022-663001, US-MODERNATX, INC.-MOD-2022-663009, US-MODERNATX, INC.-MOD-2022-663012, US-MODERNATX, INC.-MOD-2022-663015, US-MODERNATX, INC.-MOD-2022-663040, US-MODERNATX, INC.-MOD-2022-663041, US-MODERNATX, INC.-MOD-2022-663044, US-MODERNATX, INC.-MOD-2022-663045, US-MODERNATX, INC.-MOD-2022-663091, US-MODERNATX, INC.-MOD-2022-663128, US-MODERNATX, INC.-MOD-2022-663137, US-MODERNATX, INC.-MOD-2022-663147 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2022-662961:Same reporter US-MODERNATX, INC.-MOD-2022-662887:Same reporter US-MODERNATX, INC.-MOD-2022-662970:Same reporter US-MODERNATX, INC.-MOD-2022-662974:Same reporter US-MODERNATX, INC.-MOD-2022-662991:Same reporter US-MODERNATX, INC.-MOD-2022-663001:Same reporter US-MODERNATX, INC.-MOD-2022-663009:Same reporter US-MODERNATX, INC.-MOD-2022-663012:Same reporter US-MODERNATX, INC.-MOD-2022-663015:Same reporter US-MODERNATX, INC.-MOD-2022-663040:Same reporter US-MODERNATX, INC.-MOD-2022-663041:Same reporter US-MODERNATX, INC.-MOD-2022-663044:Same reporter US-MODERNATX, INC.-MOD-2022-663045:Same reporter US-MODERNATX, INC.-MOD-2022-663091:Same reporter US-MODERNATX, INC.-MOD-2022-663128:Same reporter US-MODERNATX, INC.-MOD-2022-663137:Same reporter US-MODERNATX, INC.-MOD-2022-663147:Same reporter
Chronic hives to this day, no relief from antihistamines, currently taking Zyrtec 4x/day with no relief
6-8 hours following the vaccine, the patient developed a severe head ache, SOB and fatigue. Patient took an unknown OTC medication, this did not help her symptoms. Her headache receded on 04/08, and her symptoms improved, but never fully resolved (per patient's son).
Pt. received Shingrix on 5/14/19 (L) Deltoid. Pt did not feel well on 5/15/19 no specific complaint "just off a little" On 5/16/19 pt noticed a 3 mm fluid filled blister 1-1 1/2 from injection site. Does not hurt or itch
punctured ipol temperature reached: 46.6 F duration was 2 minutes with no reported adverse event; patient was given IPOL after the temperature excursion with no reported adverse event; Initial information received on 31-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA235015, 2023SA235023, 2023SA235246, 2023SA235694, 2023SA235058 and 2023SA234814.  This case involves a 11 years old male patient who was given ipol after the temperature excursion and punctured ipol temperature reached: 46.6 f duration was 2 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included varicella zoster vaccine (Varicella Vaccine) and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) for Prophylactic vaccination.  On 13-Jul-2023, 0.5 ml (dose 3) of suspect IPV (VERO), Suspension for injection lot W1A191M, expiry date: 15-Feb-2025 via intramuscular route in the right arm for Immunization (strength: unknown), patient was given ipol after the temperature excursion with no reported adverse event (poor quality product administered) (latency same day).  On an unknown date punctured ipol temperature reached: 46.6 f duration was 2 minutes with no reported adverse event (product storage error) (unknown latency).  This situation is due to human error.  Action taken: not applicable.  Outcome was Unknown for the events poor quality product administered and product storage error.   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 the guidelines. 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.
had shot still got shingles/suspected vaccination failure; shingles; sharp pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had shot still got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and pain (Verbatim: sharp pain). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the pain was not recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 25-Mar-2023 and 27-Mar-2023 The case was received from the patient via interactive digital media. The patient had the shot and still got the shingles. The patient still feels the sharp pain occasionally. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Stroke twice within 3 weeks of vaccine.  Now using a cane to walk.  Dizziness that is all the time.  Vision problems.  Now on new medications.  I was on aspirin prior to events.
This initial spontaneous case, was received from other non-health care professional on 09-Nov-2017, concerning a 39-year-old adult male patient. The patient's historical drug included FLUCELVAX, which was administered on 19-Oct-2016, (batch number: 185888, expiry date: May-2017), anti-histamine and topical cortisone cream. The patient's historical conditions included broken arm x (2) and hives on arms, hands and feet, which was started about 3 days after injection. The patient had allergic to mold, and maple pollen. cine was updated. The narrative was amended accordingly. On 29-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195219, expiry date: Apr-2018. On 03-Oct-2017, after 5 days of vaccination, the patient experienced hives, but it was not localized, and it covered 80 percent of his body. The patient was treated with BENADRYL and steroid (hydrocortisone) cream. On 07-Oct-2017, the patient completely recovered from the event. The reporter assessed the case as non-serious. Follow up received on 27-Nov-2017: Dose, route of administration, anatomical location and indication of suspect vaccine was updated. The narrative was amended accordingly.
No additional AE information provided; Patient was administered an dose of improperly stored PNEUMOVAX 23; Information has been received from a nurse and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug/reactions allergies.  On 18-SEP-2019, the patient was vaccinated with a dose of improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S004548 and expiration date of 12-AUG-2020 (route of administration and anatomical location were not reported), for prophylaxis, which was stored in the range of 47.3 Fahrenheit degrees for 20 minutes. No previous temperature excursion was reported. No additional adverse event information provided.   Digital data logger was involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Confirmed Breakthrough   COVID-19 (Moderna) 1 02/07/2021  Medical Center  Moderna 031L20A   COVID-19 (Moderna) 2 3/07/2021  Medical Center  Moderna 036A21A   COVID-19 (Moderna) 3 01/28/2022  Pharmacy  Moderna 083J21A
Severe headache and neck pain- I went to clinic  Had pain underarm - Dr. said  enlarged lymph node - sent me to get ultrasound and they also said  enlarged lymph node on side of the 2 shot.   Still had pain for about 2 months.
Patient reported symptoms of tiredness, chill, weakness and heat (like having a fever) the night after received the vaccine.. When patient went to kitchen that night, she got dizzy and fell (little bit like fainting). After the night resting, patient still feels tired the next day (11/01/2019) but started to feel better than the night before. No local injection site symptoms.  Recommended self care like Tylenol for fever, rehydration and take a lot of rest and contact PCP. Let patient know symptoms could take a few day to diminish and recommended patient to take a lot of rest and if symptoms worsen then call us back and call pcp/ER.
Patient was administered the FluBlok in error.  Should have received the Flulaval  because of his age (under 18).
Got lymp on my collar bone; Still aching a little bit; This spontaneous case was reported by a consumer and describes the occurrence of BONE SWELLING (Got lymp on my collar bone) and BONE PAIN (Still aching a little bit) 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 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BONE SWELLING (Got lymp on my collar bone) and BONE PAIN (Still aching a little bit). At the time of the report, BONE SWELLING (Got lymp on my collar bone) and BONE PAIN (Still aching a little bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
red raised area on arm about 4 x 4 inches sore to the touch, arm was itchy
Symptoms started 03/31/11 and escalated till patient saw MD on 04/01/11- MD prescribed BENADRYL- itching; swelling; red; hard like bee sting.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patient's involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 29-JUL-2013 (lot # H021608, Expiration Date: 13-AUG-2015). This is one of the report from the same source, linked reports. Additional information is not expected.