chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient called on 7-4-15, said they had apparent itching and swelling at site of shot. Patient came in on 7-15-15. Area looked red at and around site of injection and felt warm. Referred to her physician.
bilateral lower extremity weakness following 2nd dose leading to a fall. Hospitalized same day and found to have right bundle branch block on EKG.
12/30/20 Vaccine given, 1/5/21 developed hives at approximately 10:30 pm.  Had eaten shrimp around 6 pm.  1/6/21 - 1/11/21 continued to have Hives.  1/6/21 received Sol u medrol injection 125 mg.  1/7/21 started Prednisone x 5 days.  1/7/21 had allergy panel blood draw for shellfish & eggs - all negative.  1/9/21 low grade temp of 99 F.  Took benedryl from  1/5/21 to present.
Pink rash an inch below injection site on left arm the size of a dollar coin. Warm to the touch, slight pain, a little itchiness.
Nothing bad.  Minor body aches, most pain was in my lower back.  Took Advil and Aleve.  The meds keep the body aches tolerable.
his temperature goes up and down from his normal temp of 97.6 up to 99.5; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 23Feb2021 as dose 1, single for COVID-19 immunization. Medical history of the patient included Guillain-Barre syndrome in 1975 and was completely paralyzed, hospitalized, flu. Concomitant medications were not reported. Patient read an article which suggested the vaccine can trigger an auto-immune response if you have a history of Guillain-Barre syndrome. Reportedly, patient had history of Guillain-Barre syndrome. He didn't get it from the vaccine. He just got it from the flu. Patient was hospitalized for 6 months and put on a ventilator for 2 months. It was shown one dose is 70% effective. Patient would just get one dose. Patient have asked doctor's and pharmacist if eligible to receive the second. They referred patient to call Pfizer." Patient asked if he was eligible to receive the vaccine. On an unspecified date after first dose of vaccination, patient had noticed that his temperature goes up and down from his normal temp of 97.6 up to 99.5 but stated that his immune response could be triggering temperature. Patient asked if there was any contraindication to using Norco, Lortab or Mobic when getting the covid vaccine. Patient had his first Pfizer shot 3 days ago [date unspecified] and he has done a lot of research but can't find anything other than don't take Tylenol or medicine like that because it can affect the efficacy. He asked if there was any more information and how much does it affect the immune response? Patient only takes those medicines as needed and will likely not take it to prevent any kind of decreased effectiveness. Patient asked "when does the vaccine start protecting me? How does the vaccine work? Is antibody testing helpful to determine immunity?" Outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Had seizures, 1st at age of 3 and 2nd at age of 4 1/2. Vaccine given at 1 year of age. Dx'd with Post-infectious demyelination.
Erythema and mild edema at site of injection and extending lateral and inferiorly across soft tissue of right thigh 2 injection in right thigh reaction only at site of lower injection.
This spontaneous report was received from a consumer (the patient's parent) and refers to a female patient of unknown age. Her current conditions, medical history and concomitant therapies were not provided. On an unknown, date the patient was vaccinated with a dose of expired vaccination of VARIVAX injection, subcutaneously (dose, lot# and expiration date were not provided) for prevention of varicella.
*Delayed neck rash - started about 3 weeks after vaccination, lasted approximately 2-3 months *Severe low back pain - started approximately 3-4 months  after vaccination *Microscopic blood in urine and bladder - started approximately 3-4 months  after vaccination
Tightening in the chest; Feeling dizzy; Thought she was going to pass out, faint; Thought she was going to pass out, faint; Not breathing real well; Sick; Needed magnifier to read small writing on card; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6204; Expiration date were not reported) on 24Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included low blood pressure; and used to pass out. The patient had unspecified concomitant medications ("fewer pills"). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6206; Expiration date was not reported) on 03Mar2021 for COVID-19 immunization. On 24Mar2021, the patient thought she was going to pass out and faint; was not breathing real well; and was sick. On 29Mar2021, the patient had tightening in the chest; and was feeling dizzy. In Mar2021, the patient needed a magnifier to read small writing on card. It was unknown if the patient had received treatment for the events. The outcome of the events was recovering for 'thought she was going to pass out and faint', 'tightening in the chest' and 'feeling dizzy'; was recovered in Mar2021 for 'not breathing real well'; and was unknown for 'sick' and 'needed magnifier to read small writing on card'.  Follow-up action is needed. Further information is requested.
expired product was administered to a patient with no reported adverse event; Initial information received on 08-May-2023  regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 6 months old female patient who was administered expired vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] 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 rotavirus vaccine; hepatitis B vaccine; pneumococcal vaccine conj 7V (CRM197) (Prevnar); and influenza vaccine for Immunisation.  On 08-May-2023, the patient received an expired 0.5 mL (dose number: 3) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine, suspension for injection (batch number: UJ662AAA; Expiry date: 04-May-2023) via intramuscular route in the right thigh for immunization with no reported adverse event (expired product administered) (same day latency). The reporter was not aware of any adverse reactions post administration.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired product was administered to a patient with no reported adverse event.  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.
Warm to touch at injection site; Felt like didnt enjoy living in my skin; Itchy at injection site; Chills; Tired; Injection site is very very red; Sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch at injection site), FEELING ABNORMAL (Felt like didnt enjoy living in my skin), VACCINATION SITE PRURITUS (Itchy at injection site), CHILLS (Chills) and FATIGUE (Tired) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included POTASSIUM for an unknown indication.    On 24-Jan-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 VACCINATION SITE WARMTH (Warm to touch at injection site), FEELING ABNORMAL (Felt like didnt enjoy living in my skin), VACCINATION SITE PRURITUS (Itchy at injection site), CHILLS (Chills), FATIGUE (Tired), VACCINATION SITE ERYTHEMA (Injection site is very very red) and VACCINATION SITE PAIN (Sore at injection site). At the time of the report, VACCINATION SITE WARMTH (Warm to touch at injection site), FEELING ABNORMAL (Felt like didnt enjoy living in my skin), VACCINATION SITE PRURITUS (Itchy at injection site), CHILLS (Chills), FATIGUE (Tired), VACCINATION SITE ERYTHEMA (Injection site is very very red) and VACCINATION SITE PAIN (Sore at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up received on 16 APR 2021and does not contain any new information
Information has been received from a medical assistant referring to a 6 months old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 07-JUL-2017, the patient was vaccinated with the third dose of ROTATEQ (lot # M002254, expiration date 15-NOV-2017) (oral, dose was not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature excursion between 46.8 degrees Fahrenheit (F) on 13-JUN-2017, which lasted for a 18 hours. There was 59F previous temperature excursion for 4 hours. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA010591: US-009507513-1708USA005381: US-009507513-1709USA012722: US-009507513-1709USA012723: US-009507513-1709USA012724: US-009507513-1709USA012725: US-009507513-1709USA012726: US-009507513-1709USA012727: US-009507513-1709USA012728: US-009507513-1709USA012729: US-009507513-1709USA012730: US-009507513-1709USA012731: US-009507513-1709USA012732: US-009507513-1709USA012733: US-009507513-1709USA010537: US-009507513-1709USA012776: US-009507513-1709USA012774.
102F; This is a spontaneous report from a contactable consumer (parent). A 17-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 08Sep2021 (at the age of 17-years) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single for covid-19 immunisation. On an unspecified date of Sep2021, the patient experienced 102F fever. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
About 2 months after receiving vaccine I tested positive for COVID-19. Had contact with positive grandchild. Tested positive shortly after contact. Called PCP and they prescribed Paxlovid. Compared symptoms to severe cold.
4/24 Pneumovax vaccine given. 4/25 Patient developed swelling, redness, and pain in 3 x 5 area of left deltoid (arm) where vaccine given. Temp 102 degrees F. 4/26 Seen in clinic: u/s, needle aspirate done. Most likely hematoma, but cover for cellulitis. Clindamycin x 5 days, ibuprofen, hot packs, diphenhydramine as needed.
The patient stated he experienced severe shaking and chills that worsened over time starting at around 8-9pm the night of 9/24 after receiving the Fluzone High Dose Vaccine. It progressed and eventually he was experiencing chest tightness and went to the emergency room for medical treatment around 10pm. He was admitted for 1 day there and released after that.
This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 20-DEC-2012 (today) was vaccinated with a dose of GARDASIL (dose, route and lot # not reported) that was exposed to 30 degrees F. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Patient's outcome was unknown. The relatedness between the event and GARDASIL was unknown. Additional information has been requested.
stractty  throat and itchy eyes for 12 hrs and sore arm for 48 hours.  Pregnant on Jul and in August no fetal heart beat at late august and no symptoms  DNC on 3 sep2021
Patient called the morning of August 22 stating that on  the evening that she had her immunizations she developed a fever and chills. She also stated there was warmth and  redness around the injection site. She stated subsequently that the redness began to progress. She said the area is warm to touch as well.  I advised her to be seen by a physician  as the redness and warmth  instead of receding  was now spreading down to her elbow. I was concerned that she may have developed cellulitis.
Right hand hand was red; Right hand swelling; 4 days after my bivalent booster dose my right hand started to hurt; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Right hand hand was red), PERIPHERAL SWELLING (Right hand swelling) and PAIN IN EXTREMITY (4 days after my bivalent booster dose my right hand started to hurt) in an 84-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis.     Concomitant products included DILTIAZEM for an unknown indication.    On 19-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Sep-2022, the patient experienced ERYTHEMA (Right hand hand was red), PERIPHERAL SWELLING (Right hand swelling) and PAIN IN EXTREMITY (4 days after my bivalent booster dose my right hand started to hurt). The patient was treated with DICLOFENAC DIETHYLAMINE (VOLTAREN [DICLOFENAC DIETHYLAMINE]) for Pain in hand, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Right hand hand was red), PERIPHERAL SWELLING (Right hand swelling) and PAIN IN EXTREMITY (4 days after my bivalent booster dose my right hand started to hurt) was resolving.            Patient had 1st Dose of Moderna COVID-19 vaccine on 02-Jan-2021 with Lot number 011L20A. Patient had 2nd Dose of Moderna COVID-19 vaccine on 29-Jan-2021 with Lot number 029K20A. Patient had 1st Booster Dose on 07-Aug-2021 with Lot number 042B21-2A. Patient had 2nd Booster Dose on 04-APR-2021 with Lot number of 042S21. Patient placed treatment medication on the hand and that reduced the pain. After application of treatment medication on right hand, Patient felt a lot better (ninety percent better). Patient hand swelling and redness in hand was not all gone, but it was much better now. Patient stated that the redness in hand was fading.   This case was linked to MOD-2021-214543 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Sep-2022: Live follow up was received on 26-Sep-2022. I-Narrative Supplement was updated.
Felt off Throughout day; Chills; Fever 102; Muscle aches; Pregnancy; Nausea; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MALAISE (Felt off Throughout day), NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever 102) and MYALGIA (Muscle aches) in a 34-year-old female patient (gravida 4, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20 and 025I20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Spontaneous abortion in 2017, Full term baby on 12-May-2018, Spontaneous abortion in 2020, Alcohol use (Occasional,Before Pregnancy) and Smoker (1 pack/day). Concurrent medical conditions included Drug allergy (Migraine), Peanut allergy (Migraine) and Asthma.   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 29-Dec-2020 and the estimated date of delivery was 12-Oct-2021. On 20-Jan-2021, the patient experienced NAUSEA (Nausea) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). On 21-Jan-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever 102) and MYALGIA (Muscle aches). On an unknown date, the patient experienced MALAISE (Felt off Throughout day). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  On 20-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. On 24-Jan-2021, NAUSEA (Nausea) had resolved. On 25-Jan-2021, CHILLS (Chills), PYREXIA (Fever 102) and MYALGIA (Muscle aches) had resolved. At the time of the report, MALAISE (Felt off Throughout day) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Body temperature: 102 (High) 102. On an unknown date, Blood test: normal (normal) WNL. On an unknown date, Scan: normal (normal) WNL. On an unknown date, Ultrasound scan: normal (normal) WNL.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's day of conception was 20-Jan-2021. Patient's Positive Pregnancy is 23 Mar 2021 Concomitant products includes Rainbow light prenatal(Oral),ongoing Treatment information was not provided.   This case was linked to MOD-2021-109802 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Additional information received contains non significant information On 28-Jul-2021: Medical History includes 3 previous pregnancies, Alcohol use, Allergies includes Imitrex,peanuts, Nicotine use. Lab data includes Ultrasound, Blood Work, Anatomy Scan. Concomitant products were added. Felt throughout the day was added.
Have taken shingle shot it is after six months do I need to start all over?; This case was reported by a consumer via Shingrix GSK and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 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 case was reported by patient himself/herself. The age at vaccination was not reported. The patient received 2nd dose of shingrix vaccine after six months,which led to lengthening of the schedule. The patient asked did he/she need to restart the schedule.
You can get deathly sick from the flu shot; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 05-DEC-2020.  This case involves a patient of unknown age and gender who reported  you can get deathly sick from the flu shot (Illness), while he/she received vaccine Influenza Vaccine.   The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient reported that one can get deathly sick from the flu shot (Illness). Call it what you like. The patient liked to die and was disappointed for a few days when the patient didnt. One can't sell that bologna to the patient.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.  The reporter assessed the causal relationship with suspect vaccine as related.
Patient is a 88 y.o. male who presents with weakness.  Tested positive for covid at home, presented to ER because he has become so weak that his son in law had to pick him up from his bed because he couldn't get up.  Patient with history of atrial fibrillation (on warfarin), pacemaker placement, chronic systolic heart failure, OSA on CPAP, prostate cancer, QT prolongation, type 2 diabetes, CKD stage 3 and thrombocytopenia who was admitted on 6/12/2022 with weakness and diarrhea due to COVID-19.
No report of patient experiencing symptoms from improperly stored and administered MMR II / No additional AE; Medical assistant calling to report adverse event with improperly stored and administered vaccine, MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 13-JUL-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliter, two dose series, administered as prophylaxis (lot number, expiration date, and route of administration were not provided) (Product storage error). No report of patient experiencing symptoms or adverse event from improperly stored and administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).
Was 42 days too long/needed to get the second shot; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Was 42 days too long/needed to get the second shot) 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.    In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Was 42 days too long/needed to get the second shot). In 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Was 42 days too long/needed to get the second shot) had resolved.            No concomitant medications were provided. Treatment information was not provided.
Syncopal episode with myoclonic activity x2. First 15 seconds after 2nd shot given, lasting 10 seconds. Second 5 minutes later, lasting 10 seconds.
Severe deltoid muscle pain, requiring an emergency room visit and pain meds (Morphine, Hydrocodone).
102.5 fever for greater than 12 hours// lump at injection site itching of whole arm //. Migraine  lasting more than 48  hours. Rapid heart beat
Bruised arm for a few days where the injections was. Middle finger on same arm went numb in a few hours after the injection.
Patient was given a high dose flu shot and should have received a regular flu shot as patient is only 64.
I experienced a Central Retina Artery Occlusion (CRAO) shortly after the 2nd booster was administered. I have lost the site in my right eye. Per Ophthalmologist, I will no regain my sight.
Knots under right arm and under both collarbones. Started on right side the next day and went to the left side 2-3 days later.
patient received first dose on 06/8/21 and second dose on 6/22/2021
Painful welt around injection site.  Swollen, red, and hot. Sore to touch. Size of a lemon.