chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to an unknown number of unspecified patients (information about the patients' gender and age was not reported). Information regarding the patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On unknown dates in 2016 (reported as starting in February 2016), the patients were vaccinated with improperly stored GARDASIL 9 (lot# reported as L037554, expiration date 25-DEC-2017; lot # L016429, expiration date 09-AUG-2017; doses and routes of administration were not reported). The vaccines were stored at 51 degrees Fahrenheit for a time frame of 126 hours and 34.4 degrees Fahrenheit for a time frame of 19.94 days. There was no previous temperature excursion. No adverse effect was reported. Product quality complaint was not filed. This is one of several reports received from the same reporter. Additional information has been requested.
Post vax the patient developed very swollen eyelids. The patient was treated with Benadryl and a cool compress and sent home.
Information has been received from a physician concerning a 13 year old female with no pertinent medical history who on 18-APR-2011 was vaccinated with the first dose of GARDASIL (lot # not reported). There was no concomitant medication. On 18-APR-2011 the patient experienced headache that lasted for multiple days. The outcome of headache was unknown. The patient sought unspecified medical attention. The patient was initiated a migraine protocol with unspecified medications. Additional information has been requested.
Little knot about an inch above collar bone; the knot was a little bit sore yesterday; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 09:00 (Lot number: EP6955) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (ongoing), notes: Verbatim: Blood pressure, Diagnosed 4 years ago. Concomitant medication(s) included: TRIAMTERENE & HCTZ taken for blood pressure measurement (ongoing). Vaccination history included: Bnt162b2 (Dose number - 01, Anatomical location: Left arm, Lot number: EV6205, Route: Injection), administration date: 17Mar2021, when the patient was 44 years old, for COVID-19 Immunization. The following information was reported: NODULE (non-serious) with onset 08Apr2021, outcome "not recovered", described as "Little knot about an inch above collar bone"; NODULE (non-serious) with onset 08Apr2021, outcome "recovered", described as "the knot was a little bit sore yesterday".  No follow-up attempts are possible. No further information is expected.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Treatment details was not reported by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
Engerix-B vaccines to a 14 year old female; Engerix-B vaccines to a 14 year old female; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 14-year-old female patient who received HBV (Engerix B adult) (batch number AC397, expiry date 08-AUG-2023) for prophylaxis.   On 17-JUL-2023, the patient received the 1st dose of Engerix B adult. On 17-JUL-2023, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: Engerix-B vaccines to a 14 year old female) and inappropriate age at vaccine administration (Verbatim: Engerix-B vaccines to a 14 year old female). The outcome of the overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 18-JUL-2023 The reporter reported that the medical assistant administered adult dose of Engerix-B vaccine to the 14 years old patient. The vaccine administration facility was the same as primary reporter. This case had been linked with US2023099074 by same reporter for different patient. The Adolescent patient was administered a adult dose of Engerix B, which led to overdose and inappropriate age at vaccine administration. The reporter did consent to follow up.
9/23 (liver) Dizziness (very quickly); headache; flu type aches; lower chest soreness with breathing, causing cough; very sore, swollen glands under left arm for 4-6 days. Symptoms gradually went away within a week.
Pt vaccinated with DTP/OPV developed hypotensive/hyporesponsive reaction; would not breathe unless stimulated. Taken & admitted to Hosp. Seen by neurologist. Treated as if he was septic.
Case number PHEH2015US009759 is an initial spontaneous report from a pharmacist received on 18 May 2015. This report refers to a 61-year-old male patient who was inadvertently vaccinated with MENVEO (batch number: X13014) intramuscularly on 02 Feb 2014. No adverse event reported following this medication error (off label use).
No adverse event; more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day 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 (more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date).    Concomitant medications were not reported.   Treatment medications were not reported.   This case was linked to MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live Follow up received contains no new information; Sender's Comments:  MODERNATX, INC.-MOD-2023-704416:Master case
Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Patient had No Known Drug Allergies.  The patient's past medical history included Stent placement. Concurrent medical conditions included Hypertension, Diabetes mellitus and Peripheral vascular disease. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), LISINOPRIL, ACETAMINOPHEN, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET) and MEMANTINE for an unknown indication.    On 06-Apr-2022 at 9:13 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021 at 9:13 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The expiration date was reported as 25 Mar 2022. It was reported that patients that received a vaccine past the 30 day storage on the refrigerator. It was reported that the vial did not undergo any temperature excursions. No treatment medications were provided.
Within 24 hours of influenza virus vaccine, developed ataxia and slurred speech - progressive over 72 hours. Admitted 9 days local hospital and transferred to another hospital for 3 additional days. Numerous nl ct and MRI, head, numerous labs and procedures to include LP - grossly normal - improving with outpatient speech and physical therapy.
Starting 2 days after the vaccine dose, I had severe fatigue that went on to last at least 7 days. Then, it slowly faded. About the same onset of time, I had sort of weakness. I couldn't even stand up for very long periods of time. Holding my arms up to wash my hair, my arms would get really fatigued. I would describe it as a muscle fatigue. I had zero strength. Going up my floor of stairs in my house, I would get really tired. It was kind of all over in all muscle groups but more noticeable in my shoulders and thighs, large muscle groups that I wouldn't expect a lot of fatigue from. It's a remarkable change for me because I run and hike around 40 miles per week. So, not even being able to hold my arms up to wash my hair is extremely unusual.
Rash with hives: Ears, mouth, groin, buttocks, lips, breasts.  Itching with discomfort. Not resolved despite taking over the counter Anti-histamines. Vaccines received on 2/17. Rash/hives continues. PCP aware.
12/28/20 12:49 COVID-19 (SARS CoV-2, RNA Molecular Amplification). Collected: 12/27/20 12:17 | Final result | Specimen: Swab from Nasopharynx. COVID-19 SARS-CoV-2 Overall Result Detected Critical.
severe body pain, pain; Can hardly move comfortably; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain (first dose was received on an unknown date, refer case US2022AMR155372).   On 24th October 2022, the patient received the 2nd dose of Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced general body pain and mobility decreased. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the general body pain and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the general body pain and mobility decreased to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR155372   Additional Information: GSK Receipt Date: 26-Oct-2022 Reporter's Comment: Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received second dose of shingles vaccine this past Monday morning. This dose his/her body had more severe body aches and pain. The patient could hardly move around comfortably. Additional Supportive Information: The follow up would not possible, as no contact, details were available.; Sender's Comments:  US-GSK-US2022AMR155372:Same reporter
Patient developed paresthesia of the left arm; Patient developed paresthesia of the left arm and left side of face.; This is a spontaneous report received from a contactable healthcare professional, the physician. A 28-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left deltoid on 26Mar2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included herniated disc of lumbosacral spine. It was unknown if the patient had any allergies to food, medications, or other products. It was unknown if the patient received any medication within two weeks prior to the COVID-19 vaccine. It was unknown if the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient had not been tested for COVID-19. On 28Mar2021, the patient experienced paraesthesia of the left arm and left side of face and neg (negative) weakness was reported. The adverse events resulted in a visit to the doctor's or other healthcare professional office/clinic visit. The clinical outcome of the events paraesthesia of the left arm, left side of face was not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.
The left arm was reported sore soon after the injection.  It continued to be sore and noticed redness about 12:00pm on the following day.
Injection site pain - left shoulder; Injection site pain - left shoulder; The patient received third/booster dose of BNT162b2; This is a spontaneous report from a non-contactable consumer, the patient. A 55-year-old male patient received third booster dose of BNT162b2 (COMIRNATY; FF8841) via an unspecified route of administration in the left arm on 01Nov2021 at 14:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 21Jan2021 (at the age of 54-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 11Feb2021 (at the age of 54-years-old); as single dose for COVID-19 immunisation. On 01Nov2021 at 19:00, the patient experienced injection site pain-left shoulder. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with acetaminophen (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of events injection site pain-left shoulder were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
1st dose 2019, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 11th March 2019, received 1st dose with batch number 43Y5R, expiry date: 08th February 2024.). Concurrent medical conditions included bone marrow transplant (In April 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, 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: 04-Jan-2023. Reporter's Comment: The patient got first dose of Shingrix in 2019 and had not had a second dose administered. The reporter did not consent to follow-up. Additional Supportive Information: Patient did not receive 2nd dose of Shingrix till the time of reporting which led to incomplete course of vaccination.
Pfizer COVID-19 Vaccine: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/1/2021, 3/30/2021 and 8/24/2021. Presented to ED 1/14/2022 with complaints of shortness of breath, cough, and fever of 7 days duration. Admitted to MICU for acute hypoxemic respiratory failure due to Covid PNA. Started on remdesivir and decadron and given 1 dose Toci per ID recommendations. Intubated 1/19/21. Developed septic shock requiring levophed to maintain blood pressure. Increased to 3 pressors 1/22. Code status changed to DNR/COT 1/22/22. Required a 4th pressor 1/23/22.  Expired on 1/23/2022.
I awoke with severe body aches, including headache, low grade fever and general "malaise" or fatigue that lasted throughout the day.  I felt almost completely normal the next day.
Painful to touch or move, Swelling and Redness 3 3/4 x 4 in in arm MENACTRA vaccine was given.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: patient experienced tingling and nausea with headaches after the vaccine. Patient was told to lie down for a few minutes trhen had patient sit up and given water. After about 20 minutes patient was able to stand an walk around on her own. She expressed that she still felt some tingling still. Will call later to follow up. Will also have 1 more follow up call tomorrow
Garbled Speech lasting 20 seconds/Disassociation/Dizziness; Believed to be TIA;Every possible test was administered to determine source; ALL TESTS RETURNED NORMAL RESULTS; Dizziness/Disassociation/Balance Issue persists on and off; TREATMENT RECOMMENDED: One 325 mg aspirin daily
Client has not had any prior vaccines and coming in for as many as possible. Client was on 10/15/18 (Monday) and received an influenza vaccine along with 4 other shots. On 10/16/18 Client and parent returned to the clinic to receive more vaccines. Both parent and client was asked if he had received the flu shot the day before. Both said no. RN did not see the influenza vaccine on client's record from the day before so administered the vaccine again along with 4 more vaccines. Parent was called and informed of the second flu injection.
The next day after my second dose, I woke up at 6:00 am to start work (working from Home) and I realized I was feeling feverish. I put on the heater but it did not help, I decided to call my boss at work to report sick and that was when I noticed I could not put words together. I was stuttering and shivering and my words were incoherent so my boss told me to either take Tylenol and go to bed or call 911.  I took Tylenol PM and covered myself and went to sleep. I woke up at 4:20 pm and noticed I felt better and even sweating. I put off the heater and everything seemed fine.  Then when I went to bed that night, I realized I was having shortness of breath and palpitations, I could hear my heartbeat in my chest. I propped up pillows and went to sleep feeling very uncomfortable.  The next day it continued but I thought it will pass just like what happed the previous day. This continued on and off for some time but I still hoped it will pass until I decided to let my primary care physician know. She did an EKG and confirmed something was not right and referred me to a Cardiologist whom I'm yet to see.
Pt. developed hives approx. 2 hrs after receiving vaccine. Tried BENADRYL - no improvement. Went to Urgent Care on 6/7/17. Treated with Prednisone. Follow up at Clinic on 6/12/17. Hives resolving.
Patient died at medical center from Covid 19. Dose 1 given 2/25/2021 Lot #EN6198 Pfizer
This initial spontaneous case was received on 25-Oct-2017, reported by other non-health professional, concerning a female patient of unspecified age. The patient's historical drug included Influenza vaccine. The patient's historical conditions included pain, redness and blisters at the injection site. The patient did not receive any concomitant medications. On 25-Oct-2017, the patient was administered with INN Flu Vaccine (dose, route of administration, anatomical location, expiry date, batch number, manufacture and trade name: not reported). On the same day, after administration of vaccine, the patient had a "skin reaction" redness and pain at the injection site. The outcome of the events was not yet recovered. The reporter assessed the events as non-serious.
The dose administered past the 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The dose administered past the 30 day use by date) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The dose administered past the 30 day use by date). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (The dose administered past the 30 day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-354306, MOD-2021-354515 (Patient Link).
1mo p/vax pt started up w/small vesicles & pustules-dx as varicella;