chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse events; A medical assistant reported that an improperly stored VARIVAX vaccine was administered to a patient.; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 28-JUL-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #T041505, expiration date: 09-DEC-2022, administered as prophylaxis for varicella infection, (strength, and route of administration were not provided) (Improper storage of product in use). The reporter stated that the vaccine was stored at a temperature of -14 Celsius degrees during 37 minutes, and that there were no previous temperature excursions. No additional adverse events were reported.
Severe migraines; Hot and cold; Fell asleep on the phone; Her whole body went numb; Zombie kind of feeling; Diarrhea; Dry mouth; It feels like the flu; Wanting to throw up; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Severe migraines), FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), SLEEP DISORDER (Fell asleep on the phone), HYPOAESTHESIA (Her whole body went numb) and FEELING ABNORMAL (Zombie kind of feeling) in a 59-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 Thyroid cancer in 2017.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced MIGRAINE (Severe migraines), FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), SLEEP DISORDER (Fell asleep on the phone), HYPOAESTHESIA (Her whole body went numb), FEELING ABNORMAL (Zombie kind of feeling), DIARRHOEA (Diarrhea), DRY MOUTH (Dry mouth), INFLUENZA LIKE ILLNESS (It feels like the flu), NAUSEA (Wanting to throw up) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, MIGRAINE (Severe migraines), FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), SLEEP DISORDER (Fell asleep on the phone), HYPOAESTHESIA (Her whole body went numb), FEELING ABNORMAL (Zombie kind of feeling), DIARRHOEA (Diarrhea), DRY MOUTH (Dry mouth), INFLUENZA LIKE ILLNESS (It feels like the flu), NAUSEA (Wanting to throw up) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications used are Cancer medication.
he got his booster dose on Friday; he got his booster dose on Friday; had a bad day Saturday; This is a spontaneous report from a contactable consumer (patient) via medical information team.   A 77-year-old male patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unknown date (age at vaccination: 77 years), as a dose number unknown single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. Reporter was frustrated that Pfizer does not have specific qualitative measured numbers for antibody testing available for the clinical trial data. Reporter stated that he talked at length about the booster dose and argued that it must be approved for everyone, because the pharmacies are just making people check a box and giving it to them. He has been told the booster dose was for anyone. Reporter states that he has never seen anything published by Pfizer as to whether or not pfizer had antibodies. Somebody told reporter yesterday that there was a test from that was a titer test that showed the number of antibodies and a scale to determine that. His doctor told him there was no such test. Reporter stated that he would had assumed during trials, they must had measured efficiency and effectiveness. Reporter stated that he read that Pfizer was 43% effective against delta, and Moderna 80%; in (privacy), it was a little bit different. Further reporter stated that Pfizer determined the minimum number of antibodies needed to achieve the 94 or 96% efficacy. Reporter stated that he got his booster dose on Friday. He had a bad day Saturday, on Sunday things got better, and by Monday it was gone. Reporter later mentioned that someone he knows had their first dose of the vaccine and had no side effects other than a sore arm that she couldn't lift above her head for a day or so. Outcome of event had a bad day Saturday was recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Central retinal vein thrombosis with associated retinal hemorrhage.  Started the week after vaccination. Identified by opthalmology on 4/12/21
Client let nurse monitor know she was experiencing tingling/numbness in left arm and prickling in left hand, dry mouth, "lumpy throat".  Client seated in private room. Benadryl provided. Clinic lead notified, MD notified. BP taken x2. Client declined EMS. Client felt better post benadryl administration.
Got first dose but not the second; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (On an unknown date the patient received the 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 10-Jan-2023 Reporter's Comment: This case was received from consumer via  interactive digital media. The reporter stated that the patient got first dose but not the second and reporter said what to do. Additional supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. The follow up would not possible as no contact details were available.
pt recd 2nd dose of MMR II & was later dx w/serological confirmed mumps.
Sore arm; COVID-19; Slight fever for a couple of days; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), COVID-19 (COVID-19) and PYREXIA (Slight fever for a couple of days) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 027AC1A and 630620A) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high, Diabetes and Drug allergy (Codeine). Concomitant products included LISINOPRIL for Blood pressure management, METFORMIN for Diabetes, GABAPENTIN for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), COVID-19 (COVID-19) and PYREXIA (Slight fever for a couple of days). At the time of the report, PAIN IN EXTREMITY (Sore arm) and COVID-19 (COVID-19) outcome was unknown and PYREXIA (Slight fever for a couple of days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         Patient had no medical history relating to mentioned adverse events and both Acute and Chronic illnesses at the time of vaccination. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. On 12-Nov-2021, received third dose as booster dose of Moderna COVID-19 Vaccine. It was reported that patient had normal problems with the first three doses that she received: sore arm, slight fever for a couple of days, just normal reactions.  No treatment drug was reported.   This case was linked to MOD-2022-659170, MOD-2022-659178 (Patient Link).
Patients have been administered from vaccines that experienced a T excursion; Patients have been administered from vaccines that experienced a T excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) in a 50-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information were provided. Max Temperature reached was 64°F Excursion duration was approximately 7 hours Three was no changes in visual inspection.
Three days after the second booster. the left bicep began itching, and a 7" diameter, raised, red spot appeared. So far, it hasn't worsened.
Pt was hospitalized 10.13.14 for epistaxis. Vaccines were given on discharge. Reported 10.15.14 to PCP warm, swollen arm. PCP Dx cellulitis, noting it completely circled upper arm. Pt was started on cefdinir 300mg po bid. Complete recovery was reported. (This was right arm).
Pt reported as crying all night and did not sleep after Prevnar, very fussy for 3 days following.
Patient reports heavy menstrual cycle, bleeding 10 days straight after 2nd vaccine.  Was given birth control pills to control bleeding, labs ordered.
pt recvd vax;22jul95 devel red patches w/ white welts on chest; stomach & back; T 99.7;
Subsequent to receiving one dose of varicella virus vaccine live the pt was exposed to varicella. 1-2 weeks post exposure she developed a moderate case of breakthrough chickenpox. The pt sought unspecified medical attention. She recovered from the experience. It was reported that 2 of the pts siblings had similar experiences. No further information is available.
This spontaneous report as received from a Medical Assistant refers to an unspecified number of patients of unknown ages and genders. On unknown dates the patients were administered with ROTATEQ (lot# and dose not reported) that were stored improperly. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Chest Pains on my left side. sharp pains like I am having  a heart attack. Comes and goes.
C/O pain at site of injection, persisting symptoms 1 month  after with numbness and weakness of arm. No evidence of swelling or ecchymosis/infection.
2PM c/o ringing in ears, dizziness, & pain @ inject site; BP 124/80 pulse regular; 205PM dizziness, color good; 220PM dizziness, pale in supine position; 245PM BP 120/72, P61 MD notified;
left hand went numb,Left wrist and hand had numbness before going to sleep; This is a spontaneous report from a contactable consumer. A 82-Year-old male patient received First dose of bnt162b2 (PFIZER-BIONTECH COVID19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 15Feb2021 13:30 as single dose for covid-19 immunisation.  Medical history included diabetes, hypertension, Cured cancer, hayfever allergy. Concomitant medications included Metformin HCL, Vit D3, Vit B12. No other vaccine in four weeks. The patient reported on 16Feb2021 18:30, left hand went numb. Left wrist and hand had numbness before going to sleep on 18Feb2021. No numbness on 19th. Outcome of event was recovered on 19Feb2021.  Information of lot/batch number has been requested.
sore arm; neck sore; injection spot warm to touch; face felt flushed; headache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), NECK PAIN (neck sore), VACCINATION SITE WARMTH (injection spot warm to touch), FLUSHING (face felt flushed) and HEADACHE (headache) in a 61-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 COVID-19.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), NECK PAIN (neck sore), VACCINATION SITE WARMTH (injection spot warm to touch), FLUSHING (face felt flushed), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills). On 24-Mar-2021, PAIN IN EXTREMITY (sore arm), NECK PAIN (neck sore) and FLUSHING (face felt flushed) outcome was unknown and VACCINATION SITE WARMTH (injection spot warm to touch), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
thought this was a rash like her second one; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  An 87-year-old female patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 86 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism. Vaccination history included: BNT162b2 (1st dose Pfizer COVID-19 Vaccine, Lot number: EL9262 or GL9265), administration date: 25Jan2021, when the patient was 86-year-old, for COVID-19 immunization. The following information was reported: RASH (non-serious), outcome "unknown", described as "thought this was a rash like her second one". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: 2nd dose Pfizer COVID-19 Vaccine: Lot Number / Expiry Date: EN5318 or GN5318/ unknown.  Synthroid: She has been taking Synthroid for years and thinks 10 years. she states she has only ever taken one medication. She states she has never taken a flu shot or the any other shots that are offered at her yearly physical. prior vaccinations within 4 weeks of  first administration date of the suspect vaccine. Caller states she has never had a vaccination before except as a child whatever vaccinations were required but has received none since. No family medical history relevant to AE.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200789445 similar report from same reporter
Sick with fever first 3 days, chills (first night seemed like a convulsion could not stop shaking), aches.  Felt better after 1 week.  But on day 12 my feet swelled.  I went to a walk in and N.P. put me on Lasix and swelling left after 7 days.  Next day, 5/29/21 broke out in horrific rash, hives, welts, itching extremely bad.  I called doctor on Sun., 5/30/21 and he gave me a steroid pack for 6 days.  Welts and swelling  subsided after about  10 days but I continue to itch.  Although I do not like to take Benadryl I do P.R.N. There is no longer a rash but I continue to itch terribly almost 4 weeks later.  It comes and goes on various parts of my body at different times. There is no rhyme or reason as to why it is moving around.   It has subsided somewhat so at least it is tolerable but extremely annoying.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective included Paxlovid form 11Oct2023 to 15Oct2023   The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Extreme muscle aches, moderate body chills, skin felt really hot, fatigue. Just took some pain relievers and used ice packs for muscles. Mostly gone after 24 hrs
BLOOD CLOTS TO LUNGS; This spontaneous report received from a patient via a company representative concerned a 03 decade old female. The patient's height, weight and pre-existing medical conditions were not reported. Patient refused to report if he she had any allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, dose number in series was 01, 01 total was administered on an unspecified date in JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13-JAN-2022, the patient experienced blood clots to lungs and trouble breathing (dose number in series was 01)on the same day patient was hospitalized for 5 days and was discharged on 17-JAN-2022. Patient was being treated for blood clots (unspecified treatment) at the time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clots to lungs. This report was serious (Hospitalization Caused / Prolonged). This case is associated with product quality complaint (PQC): 90000215105. The suspected product quality complaint has been confirmed to be this record indicates a medical adverse event for the patient. There was no product quality issue described in the information reported. It was approved to void this record due to no PQC identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20220200444 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Blood clots to lungs. 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).
Information has been received from a physician concerning a 6 month old female with no pertinent medical history or drug allergies who on 30-APR-2008 was vaccinated PO with her third 2.0 ml dose of ROTATEQ.  There was no concomitant medication.  On 08-MAY-2008 in the morning the patient experienced a fever of 102F and irritability.  That same evening the child had mild diarrhea.  The physician was called for medical attention.  The fever was improving with TYLENOL.  The patient's mild diarrhea and irritability persisted.  There was no product quality complaint.  No further information is available.
got covid after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got covid after receiving the vaccine) in a female patient of an unknown age 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 COVID-19 (got covid after receiving the vaccine). At the time of the report, COVID-19 (got covid after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Gait is crippled, crippled until he takes a few steps to warm up; stiffness of the knee,he cannot bend his knee well to take a step; both of his lower extremities (below knee) has muscle pain and pain; both of his lower extremities (below knee) has muscle aches/Pain was from hamstrings to down below ankles; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Gait is crippled, crippled until he takes a few steps to warm up), JOINT STIFFNESS (stiffness of the knee,he cannot bend his knee well to take a step), PAIN IN EXTREMITY (both of his lower extremities (below knee) has muscle pain and pain) and MYALGIA (both of his lower extremities (below knee) has muscle aches/Pain was from hamstrings to down below ankles) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (on high blood pressure medication) and Blood cholesterol abnormal (on Cholesterol Medications.).    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced GAIT DISTURBANCE (Gait is crippled, crippled until he takes a few steps to warm up), JOINT STIFFNESS (stiffness of the knee,he cannot bend his knee well to take a step), PAIN IN EXTREMITY (both of his lower extremities (below knee) has muscle pain and pain) and MYALGIA (both of his lower extremities (below knee) has muscle aches/Pain was from hamstrings to down below ankles). At the time of the report, GAIT DISTURBANCE (Gait is crippled, crippled until he takes a few steps to warm up), JOINT STIFFNESS (stiffness of the knee,he cannot bend his knee well to take a step), PAIN IN EXTREMITY (both of his lower extremities (below knee) has muscle pain and pain) and MYALGIA (both of his lower extremities (below knee) has muscle aches/Pain was from hamstrings to down below ankles) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medications included unspecified medications for High blood pressure and Cholesterol.  No Treatment medications reported   This case was linked to MOD-2022-505486, MOD-2022-505549 (Patient Link).