chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DEATH; HEART HAD STOPPED ONLY FOR 4 HOURS AFTER SHE HAD GONE TO BED; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: colon cancer surgery. The surgery was performed to remove the cancerous tumor from her colon. The patient received Covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose was not reported, with frequency time 1 total, administered on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 12-JUL-2021, her heart had stopped only for 4 hours after she had gone to bed. On 23-JUL-2021, four months after the vaccination the patient died. The cause of death was unknown. An autopsy was performed on an unspecified date. It is reported that the pathologist who had performed the autopsy was deliberately holding back the toxicology results which could prove the cause of death. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. Patient died due to unknown cause of death. The patient died on 23-JUL-2021, and had recovered from heart had stopped only for 4 hours after she had gone to bed. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20211220645-COVID-19 VACCINE AD26.COV2.S- Death, heart had stopped only for 4 hours. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
16 yo given Moderna first dose instead of Pfizer first dose. Family counciled by physician.
pt recv vax 17NOV97 & pt devel 15 skin lesions, 4 ! the site of inj;
administered vaccine to a 17 years old; A spontaneous report was received from a rep concerning a 17-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced inappropriate age at vaccine administration.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Batch 025J20-2A) and was administered vaccine to a 17 year old. The patient did not experience any symptoms. No treatment information was provided.   Action taken with mRNA-1273 in was not reported.  The outcome of the event, inappropriate age at vaccine administration, was resolved on 30 Dec 2020.; Reporter's Comments: This case concerns a 17-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 025J20-2A), reporting Product administered to patient of inappropriate age without any associated adverse events.
got dose1 / 3 yrs ago, got 2nd dose today on 6/16/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 52B24, expiry date 23rd August 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 years ago, batch number-T24P9, expiry date-23rd August 2021).   On 16th June 2021, the patient received the 2nd dose of Shingrix. On 16th June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received 2nd dose longer than the recommended interval, which led to lengthening of vaccination schedule. The pharmacist inquired that they had to restart the series or give another dose. The reporter consented to follow up.
headache; extreme fatigue; sore arm the first 24 hours; vomiting and could not keep even water down; diarrhea; 101 fever; full body chills; dizziness; dehydration; I have no appetite; This is a spontaneous report from a non-contactable consumer (Patient). A 32-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EW0167) via an unspecified route of administration, administered in left arm on 29Apr2021 at 04:45 PM as dose 2, single for COVID-19 immunization (at age of 32 years) at pharmacy or drug store. The patient medical history had included sulfa allergy. Concomitant medications included etonogestrel (NEXPLANON), spironolactone (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN), citalopram (MANUFACTURER UNKNOWN). The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EP7533) via an unspecified route of administration into left arm on 01Apr2021 at 04:00 PM (at age of 32 years) as dose 1, single for COVID-19 immunization and experienced sore arm, headache, fatigue, full week of head cold (sneezing, runny nose, congestion). On 30Apr2021 at 07:00 PM, the patient experienced headache, extreme fatigue and sore arm the first 24 hours. Right at the 48 hour mark - vomiting and could not keep even water down, diarrhea, 101 fever, full body chills. 65 hours in then, dizziness, headache, and fatigue likely due to dehydration as she had no appetite. The patient did not receive any treatment for the AE. The clinical outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
The night of the shot client's hand hurt/ached and she could not sleep. She used hot and cold water on it with no relief. Starting out the following day, she reports her hand was not better, but was a little better later in the day. Periodically, the joints in her hand ache at about a 5 on a scale of 0-10. This is something that never happened before and it hurts worse in the morning if it is going to hurt.
No adverse event Patient was given booster dose (0.2 ml) instead of the primary dose of 0.25 ml. Child was underdosed. Child will receive a bivalent primary dose (0.25 ml) 8 weeks after the 4/27 dose. No further booster.
Very sore upper arm since the day of the injection.  Arm has gotten progressively worse.  It feels like a toothache all the time.  I can't sleep on my left side.  It's getting harder to lift anything or to reach up  and to move it normally.  (I am also left-handed, which makes it worse).  I have been taking physical therapy with a "hand and upper body" specialist/ therapist for several months now.
"No energy" persists; Severe fatigue; No energy; "Loss of 6 pounds"; Vomiting for 2 days; Severe shaking for 18 hours; Disoriented; Diarrhea for 2 days; High pulse (90's); Sweating; A spontaneous report was received from a consumer concerning a 81-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events severe shaking for 18 hours, disoriented, vomiting for 2 days, diarrhea for 2 days, high pulse (90's), sweating, severe fatigue, no energy, loss of 6 pounds, no energy persists.  The patient's medical history was not provided. Concomitant medications reported were Vitamin B3, Calcium, Magnesium for unknown indication.  On 13 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 024M20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 14 Feb 2021, the patient experienced the events severe shaking for 18 hours, disoriented, vomiting for 2 days, diarrhea for 2 days, high pulse (90's), sweating. On 16 Feb 2021, the patient experienced the events severe fatigue, no energy, loss of 6 pounds. On 25 Feb 2021, the patient experienced the event no energy persists.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, severe shaking for 18 hours, disoriented, vomiting for 2 days, diarrhea for 2 days, high pulse (90's), sweating, severe fatigue, no energy, loss of 6 pounds, no energy persists was unknown.
Needle  was loose at the hub. When injected the needle, most of the dose spilled on the patient's skin.  Wasted that dose and administered another dose in the opposite arm.
For some reason I had two eruptions on my left arm and the top of my right hand. They looked like chicken pox eruptions. They blistered and broke. I put on Betadine (iodine) which did nothing. The area became inflamed. I used an anti-biotic cream which appeared to make them worse. They began to weep. I have now left them to dry out. I have never had anything like this before and am assuming it was a side effect of the Shingrix vaccination. I felt I should inform someone of this reaction.
1st dose: crippling fatigue 24 hours after receiving the vaccine. Pain and tenderness that lasted for 3-4 days 2nd dose: Headache and severe pain at the injection site, slight swelling at injected site, severe tenderness at the injection site and shoulder (all within 24 hours of receiving the dose. Body aches everywhere and flu-like symptoms
Mom states child started complaining of his legs hurting.  Mom states child's feet are starting to turn out, and that he is being seen by an orthopedic specialist.  States he also complains of stomach pains.  Had diarrhea "for awhile", but now stays constipated.  Is scheduled for abdominal ultrasound and CR Small bowel follow-through on Monday, 10/18.  He has been seen by numerous doctors at various facilities.
Fever 102, persistant crying, screaming & fever for 4 days. Called Dr office & was told this was normal & not to worry. Changed DRs & was told that this was a reaction & charged to DTP shot. I didn't know about this form until last mo.
Information has been received from a physician concerning a 2 month old female with no pertinent medical history and no known drug reactions/allergies who on 13-SEP-2007 was vaccinated with first 2 ml oral dose of Rotateq (Lot # 657291/0669U). Concomitant therapy that day included PEDIARIX (Lot # AC21B124BA), PEDVAXHIB (Lot # 656521/0436U) and PREVNAR (Lot # B26510F108). Subsequently within a few days of vaccination, the patient experienced diarrhea for about 10 days. The patient's diarrhea persisted. On 21-SEP-2007, the patient was seen in the office for diarrhea and diaper rash. The patient required no treatment and continued with routine feedings (Isomil formula). No stool cultures were done. The physician noted that no lab test were needed at this time. The outcome was not provided. There was no product quality complaint involved. Additional information has been requested.
Moderna COVID- 19 Vaccine EUA: patient reports heachache, neck pain, and dizziness since vaccination six days ago. Also reports chills and myalgias starting the day after vaccination- those symptoms resolved. Headache with without aura and pain is near frontal sinus and temples and is improving with acetaminophen. Patient able to manage symptoms at home.
PATIENT PASSED OUT AFTER RECEIVING SHOT, BECAME LUCID AND THE PROCEEDED TO HAVE A SMALL SEIZURE
Achy; nauseous; pretty itchy; the injection site is swollen; warm; tender to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm), TENDERNESS (tender to touch), PAIN (Achy), INJECTION SITE PRURITUS (pretty itchy) and VACCINATION SITE SWELLING (the injection site is swollen) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm), TENDERNESS (tender to touch), INJECTION SITE PRURITUS (pretty itchy) and VACCINATION SITE SWELLING (the injection site is swollen). On 06-Feb-2021, the patient experienced PAIN (Achy) and NAUSEA (nauseous). At the time of the report, VACCINATION SITE WARMTH (warm), TENDERNESS (tender to touch) and INJECTION SITE PRURITUS (pretty itchy) outcome was unknown and PAIN (Achy), VACCINATION SITE SWELLING (the injection site is swollen) and NAUSEA (nauseous) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication and treatment provided
she was hospitalized with pulmonary embolism and they also found blood clots in her spleen (she had both venous and arterial clots).; she was hospitalized with pulmonary embolism and they also found blood clots in her spleen (she had both venous and arterial clots).; she was hospitalized with pulmonary embolism and they also found blood clots in her spleen (she had both venous and arterial clots).; This is a spontaneous report from a contactable Nurse. A 72-year-old female patient (Reporter's mother, not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included hypertension (HTN), hyperlipidemia and high cholesterol. The patient's concomitant medications were not reported. No other vaccine in four weeks. 2 weeks after the immunization, 06Feb2021 the patient was hospitalized with pulmonary embolism and they also found blood clots in her spleen (she had both venous and arterial clots). Follow up with hematologist after discharge, MD reported unable to determine cause of clots. AE resulted in Emergency room/department or urgent care, Hospitalization. The patient hospitalized for three days. The patient received treatment blood thinners. The patient tested Covid post vaccination on 06Feb2021 with negative result. The outcome was Recovered with Sequel.   Information on the lot/batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the reported events cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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 RAs, Ethics Committees, and Investigators, as appropriate.
arm got sore the next day; Extreme fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 56-years-old female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 11Mar2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization (at the age of 56-years-old). Medical history included type 2 diabetes mellitus and overweight (she's a high risk) and pneumonia (she was hospitalized in Jan2020 with double pneumonia) all from an unknown date and unknown if ongoing. The patient also stated that she qualified to receive the Covid 19 vaccine because she was a high risk due to type 2 diabetes and overweight. She has also had multiple rounds of pneumonia in the past. She actually thought she had the Covid 19 virus in Jan2020. She was hospitalized in Jan2020 with double pneumonia. The emergency room doctor told her that her lungs sounded like a washing machine. The chest x-ray did not show the pneumonia, so she had to have a CT scan of her chest. She was at a New Year's Eve party with about 40 people and all 40 people got sick. She's the only one who had to be hospitalized. All 40 people had various symptoms. She wasn't coughing anything up and she thinks she had more Covid 19 virus symptoms. Hospitals weren't testing for Covid 19 at that time. The Covid 19 antibody test was available in May2020 so she had that done and it showed negative Covid 19 antibodies. She doesn't think those early antibody tests were accurate. Concomitant medication(s) included dulaglutide (TRULICITY) and metformin taken for diabetes mellitus, atorvastatin taken to guard her heart, acetylsalicylic acid (BABY ASPIRIN) and dapagliflozin propanediol monohydrate (FARXIGA) both were taken for an unspecified indication, start and stop date were not reported for all. The patient previously received flu shot at least 6 years ago at a CVS pharmacy in Virginia for flu prophylaxis and stated that the flu vaccine bubbled up under her skin. She called the pharmacist at the and he told her she may have had a subcutaneous injection. She thinks one of the flu vaccines was subcutaneous and one was intramuscular. It was reported that after receiving first dose of vaccine the patient experienced extreme fatigue on 11Mar2021 and had arm got sore the next day on 12Mar2021. The outcome of the events was unknown.   No Follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a medical assistant refers to a 2 month old patient. On an unknown date the patient was inadvertently vaccinated with a dose of VAQTA (Lot# and route were not reported). No adverse effect was reported. It was unknown if the patient sought medical attention. Additional information has been requested.
10/31/03: Received Flu and pneumo in afternoon and by that evening developed itchy rash on back, arms and stomach. Reports rash and itchiness have decreased but still present today 11/3/03. Reports she has not had any previous reactions to annual flu or pneumo given in 1997. Referred to PMD.
Member states of having symtoms of Fatigue, Headache,Dizziness,Low back pain,Slight fever,Numbness of the hands,Memory loss,Nausea and Diarrhea,Shortness of breath and blurred vision. Member begin to have symtoms two days after the anthrax shot. Patient received his fourth vaccination.The area of the vaccination was the size of a softball in accordance to the emergency room visit on 09 Dec 03. Member continues to have similiar symtoms after ER visit and was seen again on 15 Dec 03. Member was presribed medication again and released.
1503: Patient returns to area, mom lifts atient?s shirt to reveal hives on back and front of trunk, neck, and on upper arms. Pt also noted to be scratching. Patient AAO, respirations even/unlabored at 20/min, child is calm with no s/s of distress.   1505: area cleared, Vital signs taken, initiated close monitoring and observation for safety. 1508: Administered Benadryl 25mg chewable tablet PO 1511: Language line called, explained to mother that hives are an allergic reaction, that the children are not in immediate danger or distress, and explained the medication administered and how it should help 1517: Vital signs taken and pt reassessed. Hives still visible, but no s/s of distress or increase in severity. Close monitoring continued. 1520: Notified Dr. of situation via phone, MD orders taken: 1. Follow SDO for moderate allergic reaction 2. Continue monitoring for 30 minutes, then evaluate ensure reaction is not progressing in severity. 1524: Onsite provider NP comes to area, evaluates patient. NP reinforces that patient is experiencing a mild reaction, and that it is safe for patient to leave clinic as reaction is not progressing in severity. 1529: Patient reassessed. Fewer hives visible, and those seen are noted to be smaller and less raised. Close monitoring continued. 1537: Program manager contacted via phone and briefed on situation. 1545: Spoke with parent again via language line iinterpreter.Educated parent on hives as an allergic reaction, medication given as treatment, s/s of anaphylaxis, and instructed to seek emergency medical care if symptoms worsen. Parent verbalized understanding. 1550: Reinforced instructions to parent to seek emergency care if condition worsens. Assessment reveals hives visibly reduced, no s/s of discomfort or distress. 1551: Patient left clinic in stable condition.
started to get real jittery; was dead tired and went to bed at 6 pm and didn't get up the next day; dizzy; headaches; eyes hurt; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on 06Feb2021 (at age of 73-years-old) as dose number unknown, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 06Feb2021, the patient started to get real jittery within 15 minutes. 6 hours later, the patient was dead tired and went to bed at 6 pm and didn't get up the next day. On an unspecified date in Feb2021, the patient was dizzy, had headaches and eyes hurt, but the patient also saw the eye doctor 2 days before. The patient was still having problems with dizziness, headaches and eye pain 4 days later. The patient did not think it was related to the bnt162b2 vaccine. The patient's eye doctor told the patient to try eye drops. The nurse that gave the patient shot said there's usually no side effects for the first dose and the second dose was usually the one with side effects. The outcome of the events started to get real jittery, was dead tired and went to bed at 6 pm and didn't get up the next day was unknown. The outcome of the events dizziness, headaches, and eye pain was not recovered.  Follow-up attempts are completed. No further information is expected.
By early evening I had an extreme headache, with sharp joint pain and nausea. The next day, the headache continued and also the pain and nausea. I developed a fever that began at about 100, and climbed to 102 throughout the day. (my "normal" is low - barely 98)  The fever broke that evening, and the nausea and joint pain subsided during the next 24 hours.
Left arm-2cm area of erythema and firmness. Tender to touch. Treatment, cold compress.
My arm is swollen down to my forearm with pain in my wrist and elbow.. the Derm in my forearm has not gone away and is aggravated with a lot of usage, such as washing dishes etc.
Information has been received from a nurse referring to 2 unspecified patients of unknown gender and age. Information about concurrent condition, drug reactions/allergies and medical history was unknown. Concomitant therapies included sterile diluent (manufacturer unknown). On 07-AUG-2017, 2 unspecified patients were vaccinated with improperly stored PROQUAD (Lot# N002325, expiration date 19-JUL-2018) (strength, dose, and route unknown) for prophylaxis. The diluent (unspecified lot #'s and expiration dates) used to reconstitute the vaccine above was properly stored. The vaccine was stored at 6 to 14 degrees Fahrenheit for 15 hours and 45 minutes. There had not been a previous temperature excursion and the phone call was a result of the data logger. No adverse effects were reported. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-708USA007019: US-009507513-1709USA009152: US-009507513-1709USA009151: US-009507513-1709USA009153: US-009507513-1709USA009150: US-009507513-1709USA007605: US-009507513-1709USA007604: US-009507513-1709USA007603: US-009507513-1709USA007602: US-009507513-1709USA007601.