chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Kidney failure; She said that she can barely get around now.; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient received first dose of BNT162B2 for Covid-19 Immunization in Mar2021. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced kidney failure (medically significant and life-threatening). The doctor called the patient and told her she cannot have a kidney transplant and that she is not eligible for dialysis either. She only has 5-15 percent function left in her kidneys, all because she took the shots. She would never have taken it. She can't get any medical help. The patient reported that she can barely get around now. They told her she maybe has 6 months to live. The patient underwent lab tests and procedures which included renal function test: failure on 2021 She only has 5-15 percent function left in her kidneys. The outcome of the events was unknown.   Information on the Batch/lot number has been requested.
I had breast cancer in 2003 and had to have a left breast removed and half of the lymph nodes were removed. Due to the surgery I developed lymphedema and i have to wear a compression sleeve and glove seven days a week.  A few minutes after the injection i was reading the reaction list and caught that it might cause lymph nodes to swell and about the time i was reading it i felt pressure in left arm i looked at it my arm and hand swelled  to the point my hand and fingers turned blue i started to massage my arm and called the nurse she told to keep massaging after 30 minutes sitting there the arm was still swelled the nurse released me and told me if it got worse go to the emergency room. I came home kept massaging and elevated my arm about the time i went to bed around 9:00pm the swelling came down. The arm was normal when i woke up
Narrative:  60yo with HIV infection had been hospitalized since 08/2021 and not doing well. Was transfered to long-term community care rehab (nursing home) facility around 11/1/2021 based on social worker notes (exact date of transfer not specified). Pt died at facility on 11/10/21. Pt had received covid vaccines on 2/18/21 & 3/29/21. death is not related to covid vaccines.
Phone call from patient's mom. Pt had seizure at home. 911 called and to ER.
On 9/29/11 around 1:30 pm pt got seasonal flu. Around 9 pm the same day pt. began vomiting, had severe pain, both, fever of 100; jerking of limbs, terrible headache. Flu like symptoms.
Vomiting, Headache, Stomach Cramps and Weakness all lasting three days.
I experienced trouble with breathing, back aches, knee aches and a lump in my thigh.
Patient received the Moderna COVID-19 vaccine on 3/25/21 and 4/22/21, so was fully vaccinated when they tested positive for COVID-19 on 8/24/21.
Belly pain; Restless arm syndrome; Fatigue; Fever /Chills; Diarrhea, 5-6 times per day; Little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea, 5-6 times per day), PAIN IN EXTREMITY (Little sore arm), ABDOMINAL PAIN (Belly pain), RESTLESS ARM SYNDROME (Restless arm syndrome) and PYREXIA (Fever /Chills) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included High cholesterol (High cholesterol) in 2000. Concomitant products included TAMSULOSIN for Benign prostatic hyperplasia, PRAVASTATIN, MORNIFLUMATE (FLOMAX [MORNIFLUMATE]), TRAMADOL, VITAMIN C [ASCORBIC ACID], VITAMINS NOS (MULTIPLE VITAMIN) and GLUCOSAMINE HCL for an unknown indication.    On 04-Feb-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DIARRHOEA (Diarrhea, 5-6 times per day), PAIN IN EXTREMITY (Little sore arm) and PYREXIA (Fever /Chills). On an unknown date, the patient experienced ABDOMINAL PAIN (Belly pain), RESTLESS ARM SYNDROME (Restless arm syndrome) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) ongoing from 14-Mar-2021 for Diarrhea, at an unspecified dose and frequency. On 07-Feb-2021, PYREXIA (Fever /Chills) had resolved. On 12-Feb-2021, PAIN IN EXTREMITY (Little sore arm) had resolved. On 15-May-2021, DIARRHOEA (Diarrhea, 5-6 times per day) had resolved with sequelae. At the time of the report, ABDOMINAL PAIN (Belly pain) outcome was unknown, RESTLESS ARM SYNDROME (Restless arm syndrome) had not resolved and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There were not changes in patient diet or everyday activities Patient had no history of COVID-19   This case was linked to MOD-2021-044568 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up received on07MAY2021, updated reporter details, patient demographics, past medical history, additional concomitant medications Vitamin C, Multiple vitamins, Tamsulosin and additional event Fever. On 14-Jul-2021: Significant follow-up received on 14-jul-2021, updated concomitant drug details and outcome of events
He died on the 11May; I would say may be a week or two later his dementia got a lot worse; Acute renal failure; He started developing twitches, big twitches; He started acting strange; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: FJ6369), in arm for covid-19 immunisation. The patient's relevant medical history included: "He had an underlying neurologic disease that's called Cadasil" (unspecified if ongoing), notes: he had an underlying neurologic disease that's called Cadasil. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 Immunization; Bnt162b2 (Dose 2, single), for COVID-19 Immunization; Bnt162b2 (Dose 3 (Booster), single), for COVID-19 Immunization. The following information was reported: ACUTE KIDNEY INJURY (medically significant) with onset 05Feb2021, outcome "unknown", described as "Acute renal failure"; ABNORMAL BEHAVIOUR (non-serious) with onset 05Feb2021, outcome "unknown", described as "He started acting strange"; MUSCLE TWITCHING (non-serious) with onset 05Feb2021, outcome "unknown", described as "He started developing twitches, big twitches"; DEMENTIA (medically significant) with onset 05Feb2021, outcome "unknown", described as "I would say may be a week or two later his dementia got a lot worse"; DEATH (death) with onset 11May2022, outcome "fatal", described as "He died on the 11May". The events "i would say may be a week or two later his dementia got a lot worse", "acute renal failure", "he started developing twitches, big twitches" and "he started acting strange" required emergency room visit. The patient underwent the following laboratory tests and procedures: Lab Work: Unknown results, notes: Doctor stated, He had a lot of it at the hospital. Therapeutic measures were not taken as a result of dementia, acute kidney injury, muscle twitching, abnormal behaviour. The patient date of death was 11May2022. The reported cause of death was unknown. No autopsy was performed.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events death, dementia, acute kidney injury and the use of suspect product BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: He died on the 11May
blacking out but not passing out constantly whenever walking. this lasted for about an hour, then just felt light headed for 5-6 hours followed by a headache that went away eventually after Advil. The blacking out phase was scary though, as I wasn't able to do much without having to sit or lay down on the floor wherever I was.
This Non valid spontaneous report was received from a registered nurse and refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On dates on or after 21-SEP-2017, the patients were vaccinated with improperly stored dose of LIQUID PEDVAXHIB for prophylaxis, lot# N000238 with expiration date of 25-OCT-2019, lot# N003701 with expiration date of 01-NOV-2019, lot# N008079 with expiration date of 02-DEC-2019, lot# N012920 with expiration date of 07-FEB-2020 (strength, dose, route and frequency were not reported); or with improperly stored dose of RECOMBIVAX HB for prophylaxis, lot# N020613 with expiration date of 05-MAY-2020, lot# N002202 with expiration date of 04-NOV-2019, lot# N011851 with expiration date of 19-DEC-2019; or with improperly stored dose of ROTATEQ orally, for prophylaxis, lot# N000175 with expiration date of 20-SEP-2018, lot# N005618 with expiration date of 04-OCT-2018, lot# N005078 with expiration date of 22-NOV-2018; or with improperly stored dose of VAQTA for prophylaxis, reported lot# M019924 with expiration date of 02-SEP-2018, lot# N008823 with expiration date of 26-MAY-2018. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32°F (degrees Fahrenheit) to 35°F for 40 minutes; No previous temperature excursion was done. The call was because of a "data logger". This is a non-valid case due to lack of patient identifier. Follow up information was received from the registered nurse 30-APR-2018. The nurse stated the temperature excursion was stable and they had two refrigerators that held the related vaccines. The nurse was not able to provide patients' names or initials, or ages, but was able to provide number of patients, gender information, and vaccination dates. This report referred to a male patient vaccinated with improperly stored RECOMBIVAX HB(lot# N011851 with expiration date 19-DEC-2019 ) on 28-SEP-2017. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This is one of several reports received from the same reporter(link reports: 1710USA004069, 1805USA001661, 1805USA004617, 1805USA004618, 1805USA004590, 1805USA004591, 1805USA004593,  1805USA004674, 1805USA004675, 1805USA004676, 1805USA004677, 1805USA004678, 1805USA004679, 1805USA004680, 1805USA004681, 1805USA004682, 1805USA004683, 1805USA004967, 1805USA004968, 1805USA004969, 1805USA004970, 1805USA004971, 1805USA004972, 1805USA004973, 1805USA004974, 1805USA004975, 1805USA004976, 1805USA004977, 1805USA004978, 1805USA004979, 1805USA004980, 1805USA004981, 1805USA004982).
First dose / on October 22 2020 / did not received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 22nd October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: No patient's identifiers provided. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No lot number and expiration date provided for 1st dose. No adverse event was reported. The reporter consented to follow up.
Hospitalized with chest tightness, dyspnea, fatigue, PE, Covid-19 pneumonia and probable prolonged COPD exacerbation.
I received the Moderna vaccine 01-14-21 at approximately 930am. It hurt more than seemed reasonable to get the shot, almost like a jarring pain. The pain did not subside, and by 11am, I could not move my arm at all. By 4pm, I was in an unreasonable amount of pain from my shoulder to my hand, and this lasted the rest of the day and the next two days, which I would equate to an 8 out of 10 or similar to an abscessed tooth. The injection site was just below my right shoulder, which may have been too high and caused an injection site type injury/reaction. I now have most range of motion and strength but any movement and effort results in a repeating popping sensation in the muscle. In reading about this, and if the sensation does not go away within the week, I plan to seek medical attention.  Separately, related to the vaccine itself, the evening of the 14th, I experienced approximately six hours of chills, hot flashes, headache, nausea, and trying not to pass out. I reported this to the CDC per the paperwork your team provided. Please let me know if you need any other information from me.
See attached notes from mother. *Pt was not seen @ time of advent. Mom reported SE on return visit on 9/8/10. I took my son to his 6 month check-up on 6-9-2010. About 30 min before his appt I gave him a .8 ml dose of infant TYLENOL. After his appt. he fell asleep in the car. When we got home about 2 hours later he just didn't seem like himself. I gave him a 1.25ml dose of infant ADVIL. Over the next few days he just didn't act like himself. He wouldn't smile, laugh or really acknowledge anyone. He was very zombie like. During this time his eating & sleeping habits stayed the same. This lasted about 3 days after his appt. then he just seemed to "wake-up".
pt recv vax 10DEC96 & beginning 10DEC96 pt slept for 2 days & exp a h/a, gen malaise & aching in joints;
Within 24 hours neck pain, within 48 hours fever with sharp pains in back of head, headache, within 72 hours fever worsen, dizziness, weakness, leg felt like jello, heart racing, within 96 hours all same symptoms just worsen, plus light sensitivity, and could feel legs but wasn't able to walk for few moments almost fell down the stairs, fever, neck, headache extreme, and etc.
Received 2nd vaccine on 2/5/21 and on 2/6/21 started having a headache. Experienced tingling and pinprick sensation over her entire body. Went to ER on 2/8/21.
15 years old received vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 years old received vaccine) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021 at 2:02 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 years old received vaccine). On 24-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 years old received vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient at the time of receiving the first dose of Moderna Vaccine was 15 year old and it was noticed only when the patient appeared for second dose. No adverse reaction was reported per patient's parent statement and said that the patient was fine.  No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-239381 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow up information was received on 25-Jun-2021. Updated patient demographics. Updated the action taken to no change from unknown. Updated the description of the event in the i-narrative.
chest pain; pulse started racing; dizzy and light headed; significant allergic reaction to the vaccine/Respiratory tract oedema /Flushing/urticaria/swollen tongue/Pharyngeal swelling/Dizziness; mental fog; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 12Apr2021 14:45 (Batch/Lot Number: Er8737) as 2nd dose, single for covid-19 immunisation. The first dose was received on 22Mar2021 14:45 (lot number: En6208) on the left arm. Medical history included polycystic ovaries, thyroid and serious food allergies. Concomitant medications included levothyroxine sodium (TIROSINT) taken for an unspecified indication, start and stop date were not reported. Approximately 10 minutes after shot on 22Apr2021 15:00 (2nd dose only) patient was flushed, pulse started racing, and hives appeared all over her chest. Over the next hour hives worsened, heart rate stayed fast, had swelling in tongue and throat, and became dizzy and light headed. Patient's husband wanted to take her to ER, but patient was stupidly resistant. She took a large dose of Benadryl. As the swelling in her airway lessened and the mental fog passed it became more obvious that patient had been having a significant allergic reaction to the vaccine. She was instructed to wait at the pharmacy she received the shot at for only 5 minutes because she had not had an adverse reaction to the 1st dose. She was alone when the reaction began. Patient took a 2nd dose of Benedryl before bed. The next day on 23Apr2021, chest pain began again and patient did go to the ER. The doctor believed symptoms on day 1 were an allergic reaction to vaccine and on day 2 were a strong immune response to the vaccine. They did an EKG and monitored the patient. She reported she was okay at the time of report. Patient received treatment for the events. Outcome was recovered. Patient was not diagnosed with COVID prior to vaccination and had not been tested post-vaccination  Information on the lot/batch number has been requested.
Patient complained of difficulty swallowing after vaccination. Patient denied difficulty breathing; SOB, hives, lightheadedness. Pt refused EPIPEN injection. Pt received 2 pills of diphenhydramine 25 mg. I called 911 and she went to hospital. Patient was conscious. Patient was able to speak, walk, and be alert until ambulance arrived. Patient stated that she's never gotten any reactions from previous flu shots.
This is an initial spontaneous report from a contactable consumer (case was not medically confirmed). The consumer reported that a 3-month-old, female, daughter, received a dose of PREVNAR 13, solution for injection in pre-filled syringe on an unspecified date in 2010 as immunization. No relevant medical history or concomitant medications were reported. The patient experienced  bronchitis infection on an unspecified day in Dec2010. The patient also experienced coughing and inflammation on an unspecified date post-vaccination. Relevant laboratory data was unknown. Treatment included SINGULAIR for inflammation, BENADRYL for allergy, albuterol for bronchitis infection and also she was on a nebulizer as a therapeutic measure for the bronchitis infection. The patient recovered from the bronchitis infection but the coughing and inflammation were not recovered at the time of report.
On 11/6/98, the pt experienced hypersensitivity Vasculitis. The pt had presented to physician with myalgia, arthralgia, swelling in her joints, and local reaction.
administration of vaccine in patients from the vial which had surpassed its 'Beyond Use Date' (BUD);Doses were still frozen but temperature in the cooler during transportation was 36.98 degree F./Administered a vial 1 day beyond use date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of vaccine in patients from the vial which had surpassed its 'Beyond Use Date' (BUD);Doses were still frozen but temperature in the cooler during transportation was 36.98 degree F./Administered a vial 1 day beyond use date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of vaccine in patients from the vial which had surpassed its 'Beyond Use Date' (BUD);Doses were still frozen but temperature in the cooler during transportation was 36.98 degree F./Administered a vial 1 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration of vaccine in patients from the vial which had surpassed its 'Beyond Use Date' (BUD);Doses were still frozen but temperature in the cooler during transportation was 36.98 degree F./Administered a vial 1 day beyond use date) outcome was unknown.        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.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: FU received
Administered 1 mL instead of a 0.5 mL; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Administered 1 mL instead of a 0.5 mL) 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 ACCIDENTAL OVERDOSE (Administered 1 mL instead of a 0.5 mL). At the time of the report, ACCIDENTAL OVERDOSE (Administered 1 mL instead of a 0.5 mL) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.
Flu shot given  too soon - 1 mo. after last one - did not need  booster dose
Per Emergency room report, "Rash right 6th cranial nerve dermatone pattern from neck down to the distal arm. Lower anterior neck excoriation and hi8ve-like lesions presumed from scratching.
pt recv vax 30SEP96 & 2OCT96 reports to clinic w/redness, swelling under rt arm & tenderness;local cellulitis tx w/ATB & ibuprofen;
Symptoms started 2 days after getting the vaccines with diarrhea, upset stomach. Next day he developed blisters in the left hand. Two of the blisters popped and are now open sores.
At firs did not feel anything. But slowly my left side throat start coughing lots of thick saliva and than cough come out now and than.  Than body pain not much. I took rest and had healty diet But back of my head when i try to cough hurts.  On 22nd i felt little ok but head pain did not go way. Today morning i went for grocery i fealt little shaky and feaveris. On top i feel so so weak till now. Most impotently my libido or testosterone level went down very noticeabley which is no joke.   But day i went to get vaccine i was super healty and strong.