chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report received from a 34 year old African American, not Hispanic or Latino female patient. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A expiry: unknown) dose was not reported, administered, 1 total, to left deltoid on 17-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-AUG-2021, 5-10 minutes after receiving the injection patient fainted and was rushed to the ER (Emergency room) by paramedics. Laboratory data included: Blood test (NR: not provided) normal, EKG (Electrocardiogram) (NR: not provided) normal, and Urine analysis (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted on 17-AUG-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210900241-COVID-19 VACCINE AD26.COV2.S-Fainted. 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).
Extreme chills; Disorientation; Nausea; Poor balance; Intense cold body temperature; Diarrhea; Vertigo; Sick; Confusion; Painful neck pain.
PT RECEIVED VACCINE,  AFTER WHICH PT FELL TO FLOOR, BECAME CATATONIC, TWITCH... PT REMAINED ON FLOOR FOR APPROXIATLEY 20 MINUTES,  WAS OFFERED MEDICAL ATTENTION, BUT REFUSED...PT EVENTIALLY STOOD UP, AND LET WITH CARETAKER. (PARENT)
At least one episode of vomiting per hour since patient received 2nd dose of unknown covid vaccine.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 29-OCT-2014, the patient was inoculated with ZOSTAVAX at a family practice office, as recommended for routine adult health maintenance and for the prevention of shingles (Dose, route of administration, lot # and expiration date were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 04-NOV-2016, the patient was treated (by an unspecified health care professional) at a family practice office for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, a chronic condition of nerve pain and permanent damage secondary to shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Causality assessment was related. The event of Persistent strain of Herpes Zoster/treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, a chronic condition of nerve pain and permanent damage secondary to shingles was considered to be disabling. Additional information has been requested.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment given to patients.
Relevent test: covid test; 03Jan2022; positive; Relevent test: covid test; 03Jan2022; positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: EN6205), in arm and on 15Apr2021 as dose 2, single (Lot number: EW0169), in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 03Jan2022, outcome "unknown", VACCINATION FAILURE (medically significant), with onset 03Jan2022, outcome "unknown" and all described as "Relevent test: covid test; 03Jan2022; positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Sep2021) Negative; (09Nov2021) Negative; (03Jan2022) Positive.  Batch and lot tested and found within specifications checked. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer bioNTech COVID-19 vaccine lot EW0169 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EW0169, fill lot EP8700, and the formulated drug product lot EP8602. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer bioNTech COVID-19 injectable lot EN6205 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6205, fill lot EN5337, and the formulated drug product lot EN5326. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200013081 same reporter/patient, dose number, different event
Twelve days after receiving the second dose of Moderna, I started feeling an itching sensation in my left inner ankle around 7pm Monday night. By 6:00am the next morning (Tuesday, May 11), the itching became intense and had spread to both ankles and both legs below the knee. Numerous raised red bumps developed along the inside of both legs below the knee as well the ankles. They looked very similar to mosquito bites or bedbug bites but both of those possibilities has been ruled out through process of elimination. The itching became very intense and almost unbearable. The bumps became swollen. Most about 1/4" in diameter to as large as 1/2" in diameter. They are bright  red with  white halos. A very intense continuous burning itching sensation continued through the day, that night, and the next morning. Today (Wednesday, May 13) the itching seems to be subsiding.
Mild headaches; Night sweat; Nose running; I didn't have appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old patient received bnt162b2 (BNT162B2), administration date 05Apr2021 (Lot number: EN6205) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sinus Trouble" (unspecified if ongoing), notes: sinus trouble from past 4-5 years; "Cholesterol" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN taken for blood cholesterol abnormal; AMLODIPINE taken for blood pressure abnormal. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Mild headaches"; NIGHT SWEATS (non-serious), outcome "unknown", described as "Night sweat"; RHINORRHOEA (non-serious), outcome "unknown", described as "Nose running"; DECREASED APPETITE (non-serious), outcome "unknown", described as "I didn't have appetite".  Additional Information: Patient has taken first dose around 5Apr2021 and second shot on 28Apr2021.she is having little mild headaches and sweat at night but then she do have kind of trouble and stuff. she have been taking little over counter medication and one time I was sick and prescribed medication. So, she is feeling okay, but last night I had little mild headache and my nose running but she have been dealing with sinus trouble from past 4-5 years. So, she is asking that is the symptom of the virus or not.Patient stated before virus came she was getting little mild headaches and her doctor told her that sometime when sinus trouble they have little mild headaches and before the virus came, I did have that at night when air conditioner is on. Patient stated after About 2 days ago and she is feeling fine but they she didn't have appetite.  No follow-up attempts are possible. No further information is expected.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Additional Details: patient states her tongue and throat feel tingly similar to when she has reactions to peanuts, she states no difficulty breathing at this time.
"slightly elevated" blood sugar; low potassium; elevated blood pressure; Massive headache; shortness of breath; heart palpitations; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (Massive headache), PAIN IN EXTREMITY (Sore arm), DYSPNOEA (shortness of breath), PALPITATIONS (heart palpitations) and BLOOD GLUCOSE INCREASED ("slightly elevated" blood sugar) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 27-Mar-2021, the patient experienced HEADACHE (Massive headache), DYSPNOEA (shortness of breath) and PALPITATIONS (heart palpitations). On 28-Mar-2021, the patient experienced BLOOD GLUCOSE INCREASED ("slightly elevated" blood sugar), HYPOKALAEMIC SYNDROME (low potassium) and BLOOD PRESSURE INCREASED (elevated blood pressure). On 02-Apr-2021, BLOOD PRESSURE INCREASED (elevated blood pressure) had resolved. At the time of the report, HEADACHE (Massive headache), PAIN IN EXTREMITY (Sore arm), DYSPNOEA (shortness of breath), PALPITATIONS (heart palpitations), BLOOD GLUCOSE INCREASED ("slightly elevated" blood sugar) and HYPOKALAEMIC SYNDROME (low potassium) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 120/80 mmHg (normal) 120/80.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reports being "rushed to the ER" on 28  Mar 2021 due to her symptoms. Patient reports ER stay was less than 24 hours.  Concomitant product use was not provided by the reporter.  Treatment information was provided as Potassium tablets, Hydration fluids, BP monitoring twice daily for 7 days.
Information has been received from a health professional concerning a male patient who 09/21/00 was vaccinated with a dose of MMRII. Concomitant vaccination the same day included a dose of hemophilus b conjugate vaccine, poliovirus vaccine and diptheria toxoid (-) pertussis vaccine (t) tetanus toxoid. On 03/12/01, the patient developed a rash and was seen by his primary care physician and was diagnosed with "pityriasis rosea". The rash persisted and on 03/29/01 he was taken to the emergency room and "measles was suspect" but was not confirmed. No blood work was done and the patient was treated with acetaminophen (Tylenol) and diphenhydramine hydrochloride (Benadryl). It was reported that the patient did not experience a fever associated with this rash. On 03/30/01, that patient was taken to an emergency room and diagnosed with an "ectopic rash". On 04/05/01, the patient's mother reported to the department of Health that the patient had been diagnosed with "actopic dermatitis" by primary care physician. The  patient's mother reported that the patient's rash was not related to therapy with MMRII. Additional information has been requested.
STIFF NECK; HEADACHES; NUMBNESS IN ARM; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, and other pre-existing medical conditions included: The patient had no current medical conditions, and was taking no medications besides allergy medications. The patient experienced drug allergy when treated with acetylsalicylic acid for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 15-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-SEP-2021, the patient experienced stiff neck. On 15-SEP-2021, the patient experienced headaches. On 15-SEP-2021, the patient experienced numbness in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches, numbness in arm, and stiff neck. This report was non-serious.
sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore injection site arm). At the time of the report, VACCINATION SITE PAIN (sore injection site arm) outcome was unknown.            No concomitant medications reported.  No treatment information was provided.
This case was reported by a consumer via call center representative and described the occurrence of rash in a 77-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of stomatitis (also experienced blistering of mouth after 1st dose received on 3rd October 2018, refer case US2019032482). Concurrent medical conditions included sores mouth and blistering of mouth. On 3rd December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In January 2019, less than a year after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: In January 2019, the patient started experiencing a rash on legs and arms. The reporter did not consent to follow up.
Periorbital swelling and blotchy rash on his face.  No treatment given, was seen in the office at 1600 and the periorbital swelling had decreased but was still present.  Diagnosed with mild angioedema.
Pt complained of swelling, redness and warmth on left upper arm from injection sites to elbows after getting Pneumonia and FLUVIRIN  vaccination the next day. Pt went to ER and got antibotic treatment.
About 15-30 mins after injection, hives, rash, itchiness. I was given 25mg of Benadryl. Symptoms resolved.
Tinnitus level 8/10. Bad swelling / inflammation. Brain fog. Diarrhea. Ear pain. Treated with large doses of Antronex with recommendation from Chiropractor.  Antronex helped reduce swelling. Treated sinuses with Xlear nasal spray. Helped reduce swelling. Tinnitus still at level 4/10 after 9 days.
Headaches same night and the next day I had spotting and cramping and it was before the time I had my cycle two weeks early. Was in the bed for the whole and the pain went away after a couple of days.
3 hrs after injection, my left arm became very sore. I was unable to lift my above mid-chest. Felt as though there was a cord in my upper arm between shoulder and elbow and it was being pulled tighter and tighter. Had lack of strength - unable to use arm when driving my SUV.
The patient is now looking for information on how to reschedule her second Moderna Covid-19 vaccination shot.; migrain; sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migrain), VACCINATION SITE PAIN (sore right injection site arm) and PRODUCT DOSE OMISSION ISSUE (The patient is now looking for information on how to reschedule her second Moderna Covid-19 vaccination shot.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore right injection site arm). On 23-Apr-2021, the patient experienced MIGRAINE (migrain). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (The patient is now looking for information on how to reschedule her second Moderna Covid-19 vaccination shot.). At the time of the report, MIGRAINE (migrain), VACCINATION SITE PAIN (sore right injection site arm) and PRODUCT DOSE OMISSION ISSUE (The patient is now looking for information on how to reschedule her second Moderna Covid-19 vaccination shot.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.    This case was linked to MOD-2021-101890 (Patient Link).
felt very tired & had fever 101 x2 days following shot-was given APAP;3rd day lt arm swollen & warm to touch from shoulder to elbow-rash noted from mid-humerus to elbow;advised f/u w/allergist
I did not have an adverse reaction to the vaccine. I had been on a river cruise and started to feel bad after returning. I tested positive with a home test for COVID-19 on 06/11/2022. I started having a slight sore throat and a runny nose. I started having trouble with hearing loss in my right ear and sometime later it went to my left ear. I contacted my doctor, but it was not recommended to take PAXLOVID. I continue to have brain fog, nasal congestion and loss of hearing in both ears.
on day of vax exp aching down arm, through elbow & n to thumb;24hr later discomfort had localized to mostly near site of inj;pt contacted 26 days p/vax report tenderness remains @ site & exp aching in the arm;
Injection site swelling with severe pain. Injection given at around 2pm on the 25th, symptoms started around 6pm the same day. Localized swelling and severe pain greatly limiting range of motion in left upper arm and shoulder. Took two (2) 200mg gelcaps of Ibuprofen at around 6:30pm with no relief. Pain, redued range of motion continued into the 26th, Contacted insurance nurse line for advice at around 5:44pm on the 26th. Advise to see doctor online. Doctor examined via video call and advise alternating Tylenol and Advil throughout the next 3-5 days, warm compresses and range of motion exercises to reduce swelling. Was advised to seek further in-person care if symptoms did not improve or get worse after 5 days.
stage 2 diabetes; stage 3 kidney failure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot unknown), for covid-19 immunisation; Bnt162b2 (Dose 2, Lot unknown), for covid-19 immunisation. The following information was reported: DIABETES MELLITUS (medically significant), outcome "unknown", described as "stage 2 diabetes"; RENAL FAILURE (medically significant), outcome "unknown", described as "stage 3 kidney failure". The lot number for bnt162b2 was not provided and will be requested during follow up.  Amendment: This follow-up report is being submitted to update historical vaccine information and to allow appropriate reporting to health authorities.
Approximately 6 hours post injection (p.i.) a 2.5 inch circular area of erythema appeared around the injection site. Intensely pruritic, but painful.
Approximately 4 days after my 1st dose I experienced the following symptoms: arm swelling (Injection site and arm), hand swelling (left hand) and it felt like the left side of my throat started to swell as well as the left side of my mouth and all the blood vessels on my right hand broke. I took Benadryl for treatment, but it did not help improve my situation, so I went to the Emergency Room and was given a liquid dose of Benadryl. While the ER doctor said it was not due to my shot and insisted that it was an allergic reaction to popcorn my primary care said it was due to the shot.
Mother states hive like reaction at site of vaccination "since vaccinated" (left thigh only) On 1/31/17 baby had fever of 103 and 2 30 second seizures. Seen in ER, sepsis work up done. Rocephin given in ER. Azithromycin x 5 days. No further fevers or seizures.
body aches and pains all over; This is a spontaneous report from a non-contactable consumer(patient). A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 05Feb2021 08:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included hypotension, known allergies: latex and penicillin. The patient was not pregnant. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 22Jan2021 08:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. There was no other vaccine in four weeks. Other medications in two weeks reported as birth control. With second shot, the patient experienced body aches and pains all over starting around 10 pm day of vaccine. Adverse event start date was 05Feb2021 10:00 PM. No treatment received for the events. The outcome of the events was recovering. The patient had no covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. Information about Lot/Batch cannot be obtained. No further information is expected.
Became dizzy immediately,.  Severe weakness and fatigue with nausea persisted for about three weeks.  Weakness and fatigue are still resolving.  It's the same reaction as to the fir vaccination, only more severe and longer lasting.