chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.
He received his second Covid Vaccination and had the same reactions as the first time:  fever and feeling like he was having a heart attack.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On 12-AUG-2015, the patient was vaccinated with VARIVAX (Merck), expired on 24-JUL-2015, (dose, frequency and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No additional information was provided. Additional information has been requested.
pt recvd flu vax & pt exp pain inthe arm of inject, h/a & malaise;
10 MINUTES POST VACCINATION PATIENT BECAME DIAPHORETIC, RAPID BREATHING, TACHCARDIA, PROGRESSED TO NUMBNESS AND TINGLING IN DISTAL EXTREMITIES. EVALUATED IN THE HOSPITAL ED FOR OBSERVATION
This spontaneous report as received from a healthcare worker refers to a male patient of unknown age. No medical history or concomitant conditions were reported. On 07-OCT-2015, the patient was vaccinated with a second dose of improperly stored oral, ROTATEQ, administered orally (dose unspecified), with lot # L004466 and expiry date 02-AUG-2016. No concomitant therapies were reported. No adverse effects were reported. Additional information has been requested.
Information has been received from a physician concerning a patient who was vaccinated with varicella virus vaccine live (Oka/Merck). After getting the second dose of the vaccine, the patient developed a red swollen arm. Unspecified medical attention was sought. As of 31-MAY-2007 the outcome was unknown. This is one of several reports received from the same source. Additional information is expected.
I lost my sense of smell and taste entirely. Now it comes and goes but everything smells rancid and horrible
Breakthrough Covid Infection. Symptoms _ Fever, Cough, Headaches, Congestion, Fatigue. Treated with Paxlovid-5 days.  Symptoms gradually moderated.
This spontaneous report as received from a female consumer of unknown age refers to herself. The patient's concurrent conditions, concomitant medication and medical history were not reported. On 25-NOV-2013, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported). On 15-SEP-2017, she was vaccinated with another dose of ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported). The patient was vaccinated twice with the same vaccine. No adverse effects were reported. No product quality complaint was involved. The reporter's physician stated that the patient did not receive either of these vaccines at their office.
Information has been received from a physician concerning a patient who was vaccinated with 0.5 ml dose of PNEUMOVAX.  Subsequently the patient developed rash from elbow to shoulder on the arm that received the injection.  No lot number was provided.  The patient had sought unknown medical attention.  At the time of report the patient's status was unknown.  This is one of several reports from the same source.  On 15-SEP-2009 all telephone attempts to obtain follow-up information have been unsuccessful.  Additional information has been requested.
This spontaneous report as received from a nurse refers to unspecified patients of unknown age. On an unknown date, unspecified numbers of patients were with LIQUID PEDVAXHIB (dose, frequency, route of administration and indication were not provided). LIQUID PEDVAXHIB was exposed to 8.8C for 10 days, and then administered to unspecified number of patients on unspecified dates. No concomitants were reported. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. No further information provided. This report is linked to 1405USA013338 and 1405USA013916 by the same reporter link. Additional information has been requested.
Primary first dose of Pfizer Covid-19 vaccine for age 5years-11years old was administered after expiration.
Vaccine administered to upper L arm on 7-16-09 area 7" X 5".  Became hot, dark red, swollen with 1 pustule in center.  Pain level 7 by evening of 7-17 with deep itching.  Area has faded by 7/25 except for original site.
Fever of 100+, extreme fatigue, body aches and cough.  Lasted until about 8:00 AM on 11/02/2009.
flu like symptoms; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) in a 50-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) was not applicable no concomitant product information was reported. no treatment information was reported   This case was linked to MOD-2021-09261 (Patient Link).   Reporter did not allow further contact
RECEIVED VACCINE, STARTED SWEATING, BECAME DIZZY, PALE, LEANED BACK IN CHAIR WITH ASSIST, AND LOST CONSCIOUSNESS FOR ABOUT 45 SECONDS. REGAINED CONSCIOUSNESS, ASSISTED TO WHEELCHAIR AND BROUGHT TO OBS. PLACED IN TRENDELENBERG ON STRETCHER. COLOR RETURNED, FELT BETTER VSS, STATES HR LOW AT BASELINE, SAT UP, GIVEN SNACK/WATER. SYMPTOMS RESOLVED AND ESCORTED TO EXIT WITH NO ISSUES AT 1100. 1035 INTIAL BP 125/68 HR 50 RR 18 SATS 98% ON RA (STATES HR USUALLY THIS LOW) 1055 SITTING UP BP 121/79 HR 62 RR 18 SATS 99% RA 1058 STANDING BP 142/76 HR 51 RR 18 SATS 99%
dizzy/feel faint; perspiring; like blood not getting to my head; had to get on hands and knees, crawl; felt like my heart may be racing 10 min after vaccine/heart felt off beat and like blood not getting to my head/heart rate was 142; felt like my heart may be racing 10 min after vaccine/heart felt off beat and like blood not getting to my head/heart rate was 142; arm sore day #1 and #2- not unexpected; This is a spontaneous report from a contactable Physician(patient). A 48-year-old female patient received first dose (BNT162B2, lot number EK5730) , intramuscular at Arm Right on 18Dec2020 14:15 at the 48-year-old at single dose for COVID-19 immunization.  The medical history included elevated blood pressure , allergic to sulfa, hypertension and Covid. The concomitant products included alprazolam, diphenhydramine hydrochloride (BENADRYL), spironolactone, metoprolol for hypertension, colecalciferol (VITAMIN D 3).  The patient previously took nubaine and experienced drug allergy. The patient also happened to be a physician in private practice and received the vaccine at her local hospital. The patient had hypertension which was under excellent control on metoprolol 25 mg. She took it as prescribed every day surrounding the vaccine. On day #1 at the vaccine she felt like her heart may be racing 10 min after vaccine was about 80 on 18Dec2020 14:25. nothing serious. The patient experienced arm sore day #1 and #2 and not unexpected. On about 7 pm the day after the vaccine 19Dec2020 she was tachy at rate of about 105. She took her metoprolol heart rate never came down. At about 9:30 pm on 19Dec2020 when her rate should have been about70- she got up from couch after falling asleep. Upon standing felt like she was very dizzy. Walked upstairs, started to feel faint, perspiring, heart felt off beat and like blood not getting to my head. She had to get on hands and knees, crawl and heart rate was 142 and sustained for almost a minute. It took over an hour for it to come back to 86 and stayed there all night. There was not treatment to all of the adverse events. The outcome of the events was Recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the palpitations, tachycardia and other reported events due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided. No treatment medications was provided.
Pt developed loss of consciousness within a minute of vaccine administered. Resulted in fall from exam table, hit head and had lacerations.
This spontaneous report was received regarding a 86-year-old male patient was received from his wife. The patient had no pertinent medical history. The patient has drug allergies with penicillin and aspirin. On an unknown date in 2007, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiration date and route not reported). Concomitant medications included SYNTHROID, ALLEGRA and PLAVIX. On an known date in March 2011, the patient contracted shingles over his eye after receiving ZOSTAVAX. On an unknown date in 2012, the patient received an additional dose of ZOSTAVAX, (lot number, expiration date and route not reported). The reporter stated that the patient has had allergic reactions to several unspecified treatments he had received. There were no laboratory diagnostics performed. At the time of this report the patient had not recovered from the event. The patient had sought medical attention for this adverse experience on numerous unspecified dates. Additional information has been requested.
I have had the "normal" reactions such as; sore arm, ear and throat pain, headache, fatigue, and body aches. I have also noticed my neck hurting and this am I notice a knot like form on my left clavicle bone that was not there prior to the the vaccine. I have not had any treatment for this.
Can't eat anything but Jell-O; Stomach pain; Headache; Convulsing vomiting; stomach was having trouble like nausea; fever; lost about 10 pounds; Stomach was having trouble like nausea; Lost about 10 pounds; Fever; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Lost about 10 pounds), DECREASED APPETITE (Can't eat anything but Jell-O), ABDOMINAL PAIN UPPER (Stomach pain), WEIGHT DECREASED (lost about 10 pounds) and PYREXIA (Fever) in an 84-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.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced WEIGHT DECREASED (Lost about 10 pounds) and PYREXIA (Fever). On 26-Jan-2021, the patient experienced NAUSEA (Stomach was having trouble like nausea). On 07-Jul-2021, the patient experienced WEIGHT DECREASED (lost about 10 pounds) and PYREXIA (fever). On an unknown date, the patient experienced DECREASED APPETITE (Can't eat anything but Jell-O), ABDOMINAL PAIN UPPER (Stomach pain), HEADACHE (Headache), VOMITING (Convulsing vomiting) and NAUSEA (stomach was having trouble like nausea). The patient was treated with ONDANSETRON for Nausea, at a dose of 1 dosage form. On 28-Jan-2021, PYREXIA (Fever) had resolved. At the time of the report, WEIGHT DECREASED (Lost about 10 pounds), WEIGHT DECREASED (lost about 10 pounds), PYREXIA (fever) and NAUSEA (stomach was having trouble like nausea) outcome was unknown and DECREASED APPETITE (Can't eat anything but Jell-O), ABDOMINAL PAIN UPPER (Stomach pain), NAUSEA (Stomach was having trouble like nausea), HEADACHE (Headache) and VOMITING (Convulsing vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Added information about that after discharging from hospital patient experienced with same events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Chills, Headache, Soreness, Nausea, Swollen Lymph Nodes
Patient was given a Pfizer vaccine. Approximately 10 mins after receiving same her mother reported that patient was having chest. Brought into observation Rm and closely monitored & within normal limits. 14:44 BP 106/69 HR 83 R 14 O2 Sat 96% Pain 7/10 14:54 B/P 113/71 HR 71 R 14 Pain 1/10
Information has been received from a physician who is the parent of a 12 month old male patient who on 06/26/200 was vaccinated subcutaneously with a 0.5ml dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  There was no concomitant medication.  Within 3 months of receiving measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live, in approximately September 2000, the patient developed significant speech delays.  Unspecified medical attention was sought.  There was no product quality complaint involved.  Additional information has been requested.
Fever of 101.9 on 10/24/99. 10/26 broke out only on legs with red bumpy rash.
SHINGLES. Starting on or about 5.2.21, shooting pain in knees, followed by odd sensations to touch. RICE'd & used roll on pain relievers. Waking up every two hours in pain. Pain moved to back a couple of days later. 5.8.21 quit using roll on because rash developed on left leg. Monday 5.10.21 rash is worse and went to Resurgens for knees and overall pain. Dr. thought shingles so went directly to Primary Care. Got positive diagnosis of Shingles, antivirals and pain meds. On or about Wednesday 5.12 ear pain and odd hearing sensations started. Went back to PCP - ear infection. Got antibiotics.
Fully vaccinated individual became symptomatic for COVID-19 on 8/10/2021 and tested positive on 8/11/2021.
Pt recvd vax 23SEP92 & p/pt left clinic 12noon, t101 then p/APAP temp down nl; slept all evening until 6PM back to bed @ 9PM-3AM pt awoke mom 29SEP having convuls called 911 (temp was not taken @ home); t104 @ hosp;
Pt. began itching around 9:20 am, Benadryl PO 50 mg given, around 9:25 am pt. states she feels her throat begin to close up. 9:27 am Epinephrine .50mg given IM , and then at 9:32 second dose of Epinephrine given.  Ambulance arrived at 9:35 am. Pt. transferred to Hospital.
J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 7/28/2021 PNEUMONIA J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 10/12/2021 PNEUMONIA J96.22 ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 9/10/2021 PNEUMONIA R09.02 HYPOXEMIA 10/12/2021 PNEUMONIA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 7/28/2021 GALLBLADDER MASS J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 10/12/2021 GALLBLADDER MASS J96.22 ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 9/10/2021 GALLBLADDER MASS R09.02 HYPOXEMIA 10/12/2021 GALLBLADDER MASS
Patient experienced sharp pains, down left arm throat was feeling a little swollen, fingers numb, Was advised to go to urgent care immediately. 1:00pm
Patient states, "My arm hurt for around 4 to 5 days, down to my fingertips and felt like arthritis in my arm/hand. My skin near the injection site became itchy and developed a pink patch that was slightly raised 2 inches across."
Administered after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified numbers of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, HAV (Havrix) for prophylaxis, Herpes zoster (Shingrix) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patients received Bexsero, Twinrix, Boostrix, Havrix, Shingrix and Engerix B. On an unknown date, an unknown time after receiving Bexsero, Twinrix, Boostrix, Havrix, Shingrix and Engerix B, the patient experienced incorrect storage of drug (Verbatim: Administered after temperature excursion). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 29-MAR-2023 The clinic supervisor stated Bexsero, Twinrix, Boostrix, Havrix, Shingrix, and Engerix-B vaccines went out of recommended temperature range for 12 days (288 hours) to a maximum temperature of 60 degrees Fahrenheit.   She stated some of the vaccines were administered following this excursion, though she did not had any details on which vaccines, dates of administration, lot numbers, or patient information available at the time of reporting. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patients received Bexsero, Twinrix, Boostrix, Havrix, Shingrix, and Engerix-B vaccines, which were stored at inappropriate temperature, which led to incorrect storage of drug.
Patient had come to office to get her booster shot.  She had received 2 previous doses of Pfizer covid vaccine on dates 8/27/2021 and 9/17/2021.  She received the booster dose before the 6 month period.
Patient received 1st dose of COVID 19 vaccine. Pt. reported some dizziness and denied having eaten anything prior to vaccination so pt was moved to cardiac chair. Approx 5 minutes after vaccination RN observed pt's eyes fluttering shut and unresponsive. Pt was unresponsive to verbal commands and sternal rub. Vitals were obtained and within normal limits, code blue called in hospital and pt transferred to ED via ambulance at approx 1325
This spontaneous report as received from an office manager and a medical assistant refers to a 5 years old female patient. The patient was vaccinated SQ with, 0.5 PROQUAD (Lot number 665512/0144Z is not a valid number for PROQUAD, expired in 27-APR-2012) on 19-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. There was no adverse effect reported. Additional information has been requested.
I am breaking out with an allergic rash from vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient received bnt162b2 (BNT162B2), administered in arm right (Lot number: FF2589) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DERMATITIS ALLERGIC (non-serious), outcome "unknown", described as "I am breaking out with an allergic rash from vaccine".  Additional Information: It was reported that COVID-19 Vaccine is a Pfizer product and Dates for event I am breaking out with an allergic rash from vaccine was Unspecified to Unspecified. Other Products reported as Yes and dates for Concomitant Products Vitamins are unspecified. Investigation assessments not reported. Consumer stated, "I guess, I am calling, I am not sure. I was given a state number to call and they give me a Pfizer. Basically like I am breaking out with an allergic rash from vaccine." Consumer stated, "I am about to take Benadryl but I have not yet." Consumer also stated, "Can I get a confirmation number or anything to show that I have filed a report".  No follow-up attempts are possible. No further information is expected.
Administered dose to 17 years old 2 male patients; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered dose to 17 years old 2 male patients) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered dose to 17 years old 2 male patients). On 16-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered dose to 17 years old 2 male patients) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment was reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Followup email received on 04-JUN-2021 contains no new information; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old male) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Inflammation, rash the size of a baseball (now a lump the size of a golf ball), itchiness, immobility of arm, nausea, headaches, constant stabbing pains all within 12-24 hours.
I have chronic tension headaches and yesterday my headache wouldn't go away even with over the counter medication. I felt overall achy but still able to get up and do what I needed to do. Once I went to bed though, I woke up around 2:00a sweating, achy, and with a fever. I couldn't fall back asleep very easily and once I woke up around 7:00a I confirmed I had a fever. I am currently still bedridden with a fever, complete body aches, and slight feelings of nausea. As of right now it is 8:56a 04/06/21 and the symptoms haven't gotten any better. I haven't taken any medication since 04/05/21 at 6:15p ish, which was to treat my headache from yesterday.