chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 3 (booster), single (Lot number: GH9703) at the age of 66 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "aplastic anemia" (unspecified if ongoing); "celiac disease" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: COVID-19 (non-serious) with onset 21Sep2022 at 12:00, outcome "recovering", described as "COVID 19". Therapeutic measures were taken as a result of covid-19.  Additional information: Patient received other medication in 2 weeks. On 21 Sep2022, patient was having bad cough and sore throat. Patient received Paxlovid from 22Sep2022 to 27Sep2022 for the treatment of Covid-19 and received benzononate as treatment.
Child given PENTACEL in (L) leg at end of morning (12 noon) - crying, inconsolable, (L) thigh swollen from hip to knee. Marking erythema. Rechecked her in office 430pm. Rechecked next AM (1/7/12) erythema, swelling & crying resolved.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 29-MAR-2014 the patient was vaccinated with an improperly stored dose of VAQTA 50unit/ml (lot # J001396, expiration date 02-AUG-2015, dose and route unknown). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 248 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 408 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
pt was given vaccine on the afternoon of 01-29-2021. Pt was administered the moderna covid-19 shot into the deltoid muscle of this pt. Pt was observed and left pharmacy. on 2-6, pts daughter calls pharmacy, and says the night of 1-29, after recieveing the vaccine, her mother had a hemmorhagic stroke and passed away
p/vax 12OCT95 pt began to feel bad;had nausea on 13OCT could barely move arm, arm was swollen & had induration; devel body aches, h/a & vomiting; seen in ofc 16OCT95;doing better but still had induration @ inj site
ACHY HIPS/ACHY KNEES; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced achy hips/achy knees, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea and achy hips/achy knees was not reported. This report was non-serious.
Early June 2008, noticed large ecchymoses on left flank. On June 10, a CBC showed platelets to be 36, 000 (normal 140, 000 -250,000). Saw hematologist at hospital. Test (incl. Bone marrow biopsy) Diagnosed ITP (Idiopathic thrombocytopenic purpura). Attempts to treat with WINRHO. High-dose Betamethasone and IG.G all failed. Started on study for N-Plate (AMGEN) platelets have now risen to 330, 000. Routine colonoscopy (3-24-08) with removal of 4 benign polyps (No complications). ZOSTAVAX administered 3-11-2008. Early June 2008 - 2 large ecchymoses of left flank . Subsequent Dx of ITP (see page 1/2)  6/24/09 Hematology/Oncology consult received DOS 6/12/08 to 4/16/09. Includes ER visit for 8/22/08. Assessment: Idiopathic thrombocytopenic purpura. Patient presented with concerns of increased bruisability. Later ER visit: Nausea and vomiting. Pancreatitis.
Covid-19 Treatment; Covid-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Batch/Lot number: unknown), on 02Apr2021 as dose 2, single (Batch/Lot number: unknown), on 20Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 30Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Crohn(s) Disease (mild)" (unspecified if ongoing); "Low HDL" (unspecified if ongoing). Concomitant medication(s) included: EDARBYCLOR; CRESTOR; REPATHA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: Multiple negative RATs; Positive, notes: On day 11, mild Covid symptoms (sneezing, congestion) returned. RAT showed distinct positive; Positive, notes: Continue to be positive and symptomatic on day 12. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course-Facility where the most recent COVID-19 vaccine was administered was Other. The patient receive any other vaccines within 4 weeks prior to the COVID vaccine. There was list of other medications the patient received within 2 weeks of vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
8/2/03 Pt complained of arm itching at 1:00 PM. Later that evening Mom noticed his right arm was red and hot to the touch. Went to ER that night. Arm measured 15 x 8". Recommended for Tylenol, Benadryl and cold compress.
This spontaneous report as received from nurse refers to unspecified number of patients of unknown age. The patients medical history was not reported. On an unknown date in 2014 the unspecified number of patients were vaccinated with LIQUID PEDVAXHIB. concomitant medications were not reported. It was reported that the LIQUID PEDVAXHIB vaccine was exposed to 11 degree celsius (C) for 84.5 hours, and then for -2.5C for 47 hours in January 2014. These doses of LIQUID PEDVAXHIB are administered consistently throughout the period of January 2014 to May 2014. No adverse effect were reported. The outcome of administered vaccine exposed to 11C for 84.5 hours and then for -2.5c for 47 hours and no adverse effects was unknown. This case was linked to 1406USA000152, 1406USA000392, 1406USA000394 and 1406USA000395 (same reporter link). Additional information has been requested.
fever of 102.5, migraine, chills, body aches and exhaustion (slept for almost 2 days (Wednesday and Thursday 4/6 & 4/8) I felt fine on Friday
10cm induration at immunization site (DTAP) within 24 hours, post vax.
DOUBLE VISION; SHORT TERM MEMORY LOSS; LACK OF ATTENTION; COGNITIVE DEFICIENCIES; HEADACHE; POSSIBLE INFARCTION DUE TO RECENT EVENT; This spontaneous report received from a health care professional concerned a 67 year old white and not Hispanic or Latino male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 14-MAR-2021, the patient experienced headache and dizziness. On 15-MAR-2021, patient had experienced double vision, trouble reading, lack of attention, short term memory loss and cognitive deficiency. One or two days later, (possibly on 16-MAR-2021), the patient visited emergency room and his computerized axial tomography (CAT) scan was normal. In MAR-2021 (a week after), the patient's symptoms got worsened and he consulted primary care physician. The patient underwent magnetic resonance imaging (MRI) scan which showed possible infarction due to recent event. It was reported that, the patient was yet to visit cardiologist and neurologist for follow up on the MRI scan.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 18-MAR-2021, had not recovered from double vision, short term memory loss, lack of attention, and cognitive deficiencies, and the outcome of possible infarction due to recent event was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210427306-covid-19 vaccine ad26.cov2.s-possible infarction due to recent event. 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).
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 06-AUG-2018, the patient was vaccinated with an unspecified dose of improperly stored PROQUAD recombinant human albumin (rHA), lot number R006217, expiration date 28-AUG-2019, route of administration was not reported) for prophylaxis. It was reported that sterile diluent (lot number and expiration date were not provided) used for reconstitution of the vaccine was not improperly stored. The vaccine was stored in temperature range between 15 and 46 Fahrenheit degrees for 3 hours 30 minutes (date unspecified). Previous temperature excursion was recorded in temperature range of 15 to 46 Fahrenheit degrees for 1 hour 30 minutes (date unspecified). A Digital Data Logger was involved. No adverse effects were reported. This is one of 2 reports received from the same reporter. Sender's Comments: US-009507513-1808USA003281.
Fever, 102 x 48 hours, malaise body aches, dizzy. Local induration where shot given L upper arm. Had pulmonary edema - 1 day before shot.
Fever 100.8, cold symptoms and worsening cough. Cough severe enough to wake from sleep. Intensifying cough episodes.
It was reported that a 26 month old male received vaccines on 11/1/99. On 11/2/99, he experienced "localized erythema and mild induration at injection site of 5cm X 6cm". The pt has recovered. On 11/17/99, document reviewed, no additional information at this time.
In late Oct or Nov I felt lump under right toes left. Pin and needles in feet. Lower legs weak couldn't walk as far w/o rest. Painful "shocking" hand shakes, coffee cup got too heavy to lift with right hand. Burned hand on broiler. Paralysis started 2-28-16.
felt like was going to pass out; became very cold; she didnt eat today; This is a spontaneous report from a contactable consume reported for a female friend from a mass vaccination event. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date, as unknown single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient felt like she was going to pass out and became very cold on an unspecified date, after the vaccination at a mass vaccination event. She had to lay down after 10 minutes and EMTs were called and was not sure of result or any other information except she did not eat for the day. The outcome of the events was unknown at the time of this report.  Information on the batch/lot number has been requested.
Shot was given at 2:30pm, I went to a high intensity interval class at 4:30 pm. At the end of the class at ~5:30pm I started feeling chest tightness and acute pain. This continued for approximately 10-15 minutes until I got home and chewed 3 aspirins and laid down. The tightness then subsided and did not return.
1) Arm felt tight around shot injection site for one Day. Muscle slightly painful Nothing unusual 2) Sat AM I woke up in AM. so dizzy that I fell back in bed when I tried to get up. Rested & tried again. Could not walk without help of furniture & walls! I was flat on my back the first Day & got up a few times only I was flat on my back most of 2nd Day - got up some. I could get up and site up for half of 3rd day - got up more felt almost back to normal 4th Day, but could not exercise at all. Since I started feeling better beginning in afternoon of second day, I did not contact my doctor until Monday, since she would have not been available. I contacted & talked with my dr's assistant on Monday. She talked with Doctor, who asked if my reaction might have been a coincidence. The only time I have had dizziness was different brand name for my high blood pressure medication. I have not changed or increased any medication, however, recently. My main question to my doctor was and is still on my mind: Should I get the 2nd shot of this medication? What could happen to me then?
This spontaneous report was received from a Medical Assistant regarding unknown number of patients and age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with unknown number of doses of GARDASIL 9 (lot # L036301 with expiry date 20-DEC-2016, lot# L038503 with expiry date 18-DEC-2017 and dosing details not known) that improperly stored. The administered doses experienced a temperature excursion of 32.1 F(Fahrenheit) for 5 hours 10 minutes. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the two reports received from the same reporter. Additional information is not expected as the reporter denied consent to be contacted for further information.
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a adult patient who received Shingrix for prophylaxis. On 19th August 2018, the patient received the 1st dose of Shingrix. In August 2018, less than a day after receiving Shingrix, the patient experienced injection site swelling and injection site erythema. On 20th August 2018, the patient experienced petechial rash. On an unknown date, the outcome of the injection site swelling, injection site erythema and petechial rash were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema and petechial rash to be related to Shingrix. Additional details reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. No effects, the patient experienced other than mild swelling and faint redness at injection site. The day of reporting, the patient developed a petechial rash on the injection arm, that began at the level of the injection site and on the day of reporting (throughout the day) had spread to patients forearm. There were no other side effects. The patient asked did this require treatment.
patient received their booster vaccine earlier than protocol currently recommends. No concerns from patient or parent noted following vaccine, no adverse effects noted during 30 minute post-vaccine observation.
Headache, Redness in the injection site, fever, chest pain, Tachycardia, weakness, fatigue, muscle pain
Redness and warmth to injection site.  Only painful when pressed on.  Fever of 101.3 noted at that time.  Some diarrhea.
Mother of above phoned clinic stating that child was experiencing the "shakes," rapid pulse, "funny breathing" and c/o tingling all over. Encouraged mother of client at that time to phone physician ASAP to have child evaluated.
No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 33-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 939902) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Oct-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date).    No concomitant information was reported. BUD reported as 02Sep2021. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live follow-up Appended.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Within an hour I started feeling a little dizzy.  At around 5:30 PM I was extremely nauseated and even threw up a little.  I had fever and chills.  Next day still really nauseated.  Nausea lasted about four days.  Tired feeling for about 4 days. I'm still having days in which I get a nauseated wave hit me.
Breakthrough case admission after 2 vaccines Pfizer 3/5/21 lot# En6206;  Pfizer 3/2621 lot# ER2613
This patient got a Tetanus shot on 12/20/00, she developed a generalized hive like rash.
The following day after receiving first dose of Covid vaccine, there was swelling at the area of injection. During the swelling, the muscle remained firm and painful to touch. Although the swelling finally went away, several months later (last week) I had the same issue. But this time the pain was more intense and affected my mobility, like using my right arm to reach behind me was very painful.
Vaccine was expired at time of administration.  It was past the 10 weeks in the refrigerator.  We are calling patient to notify them and advise revaccination.
some itching at the injection site; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (some itching at the injection site) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005c21a and 022L0N/D) for COVID-19 vaccination.     The patient's past medical history included Itching.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (some itching at the injection site). On 06-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, VACCINATION SITE PRURITUS (some itching at the injection site) had resolved. Unknown          No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-023895 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Itching added to med history, Event outcome updated
Initial information received on 19-Mar-2019 regarding an unsolicited valid non-serious case received from a physician. This case is linked to case 2019SA077334 (same reporter). This case involves a 11 years old male patient received a first 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6217AA and Exp. Date 21-Mar-2021) via unknown route in the right deltoid on 18-Mar-2019 at around 4:00 pm, that may have been frozen. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MENINGOCOCCAL VACCINE for Immunisation. It was an actual medication error case due to Incorrect product storage. No adverse reactions reported. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. List of documents held by sender: none.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; manufacturer unknown.), for Covid-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "Sore arm", "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm". Additional information: Patient was taking blood pressure medication. Patient always went with Pfizer for the Covid virus and never had any side effects. She just had a sore arm from the needle when being injected that goes away in 3 days, had this after all the injections. Patient stated It was right upper arm where she was given the needle.  It was the same like when she gets the flu shot where she has a sore arm for a few days, later clarified that the consumer was not administered the flu shot. Patient got the new vaccine on 16Oct2023, and it was the four-booster shot that she got from Pfizer.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300332493 same patient/event, different vaccine doses;
Breakthrough COVID hospitalization in fully vaccinated patient; Patient was transferred to hospital on 2/3/22.