chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired drug used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 54-year-old female patient who received HAV (Havrix) (batch number NZ7GR, expiry date 17-JUN-2023) for prophylaxis.   On 28-JUL-2023, the patient received Havrix. On 28-JUL-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: expired drug used). The outcome of the expired vaccine used 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: 28-JUL-2023 The reporter was a medical assistant. The reporter did not consent to follow-up. The Vaccine Administration Facility was the same as Primary Reporter. The reporter stated that a patient inadvertently received an expired dose of Havrix, which led to expired vaccine used.
Slight soreness near injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Slight soreness near injection site".  Additional information: The patient received Pfizer/BioNTech COVID-19 vaccine on 27Feb2021 as dose 1, single (Lot number: EN6200) intramuscular, in upper left arm. On 21Mar2021, patient received Pfizer/BioNTech COVID-19 vaccine as dose 2, single (Lot number: EN6208) intramuscular, in upper left arm and on 27Sep2021, patient received Pfizer/BioNTech COVID-19 vaccine as dose 3 (booster), single (Lot number: FF2589). On 27Apr2022, the patient received second booster Moderna (Lot number: 065K21A). There was no negative reaction to any of the shots. Slight soreness near injection site resolved in as few hours. No relevant or specific relevant tests for thromboembolic events with thrombocytopenia were done. None of the vaccinations involved family doctor.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sudden onset of heart palpitations and tachycardia at rest. Intermittent palpitations/dyspnea of unclear etiology. Symptoms began at rest on 3/30/21. I went to the ER and had normal basic workup. I started propranolol 10mg PO BID and the symptoms have largely improved, but can recur if i miss a dose of propranolol.  It is unclear if there is a relation to the vaccine, however, knowing about 3 other people who developed palpitations after the Moderna vaccine I thought it should be reported. I am a family physician.
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: rash on back and tarso areas-Medium, Systemic: Weakness-Mild, Additional Details: pt described some pain at injection site, and rash on back and tarso areas
On Sunday, December 27, I had the injection. I was fine. Monday the 28th, I was in pain in my arm. December 29 to currently ( January 4 2021) I am sick. I believe I got it from the vaccine. I have been out of work for two weeks. I will not go get the other vaccine. I thought I was protecting myself but find out I am not. I am currently laying in bed sick as a dog. I have shortness of breath,  cough, sneezing,sore throat, and bodyaches. I am in severe pain
Initial information received on 10-Dec-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves female patient who was exposed to vaccine FLUBLOK QIV in context of administered the FLUBLOK to a pregnant patient. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route while she was pregnant. The patient outcome is reported as Not Applicable for administered the FLUBLOK to a pregnant patient. Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Got the shots / Oral shingle in my mouth and lips/Suspected vaccination failure; Shingles; Oral shingle in my mouth and lips; Nerve pain; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles in 2012).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, oral herpes and nerve pain. On an unknown date, the outcome of the vaccination failure, shingles, oral herpes and nerve pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, oral herpes and nerve pain to be related to Shingles vaccine and Shingles vaccine.  Addition details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the shingles shots couple of months before the reporting and as a side effect of the shots, the patient had oral shingles in mouth and lips and at present the patient on 2 kinds of medication to prevent the nerve pain. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
Information has been received from a medical assistant concerning a patient (age and gender not reported). In 2009, the patient received dose 1 of GARDASIL (dose, route, location and batch number were not reported). On 03-NOV-2015, the patient was vaccinated with dose 2 of GARDASIL (dose, route, location and batch number were not reported). No adverse effect reported. Additional information has been requested.
This spontaneous report as received from a licensed vocational nurse refers to an unknown number of patients of unknown age and gender. The patients medical history and concurrent conditions were not provided. On unknown dates since 23-JAN-2015, the patients were vaccinated with doses of GARDASIL (route, lot # and expiration dates were not provided). Concomitant medication information was not provided. On unknown dates since 23-JAN-2015, the patients had been administered GARDASIL which underwent supported temperature excursions. No adverse effects were reported. It was unknown if the patients sought medical attention. At the time of the report, the patient status was unknown. This is one of several reports received from the same source. Additional information has been requested.
8/6/2021 I woke up with my left eye significantly lower than my right eye, headaches, and no sense of smell. My left eye will feel fatigued by the end of the day like it has been straining. After 4 months my left eye started to improve by coming back up a little, but even now at about 5 months my pupils are not level. I had constant headaches for 3 weeks straight and then intermittent for a couple months then constant again for about 1.5 months and now the headaches are back to intermittent. I lost my sense of smell completely until a couple weeks ago I smelled shampoo and a bathroom cleanser, but that is it.
This case was reported by a other health professional via sales rep and described the occurrence of vasovagal reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vasovagal reaction. On an unknown date, the outcome of the vasovagal reaction was unknown. It was unknown if the reporter considered the vasovagal reaction to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The health care professional reported that she was copied on email notifying her of patient who had vasovagal reaction following administration of SHINGRIX. The reporter was unable to provide any information on patient, vaccine administration, vaccine lot number and expiration date or information about the event. Agency offered to complete adverse event report. The health care professional stated she did not know if adverse event report was filed but they usually file them on their own.
approx. 3/14/19 pt. complaint of burning and stabbing pain, right interior medial thigh DX: Mono-Neuropathy of anterior cutaneous branch of right femoral nerve  TX: high dose prednisone tapered over 1 month, gabapentin daily since time of DX, still taking gabapentin on 8/12/19 pt. still has episodes of moderate pain (aprox. 6 episodes per day, each lasting 2 minutes) each episode is described with burning stabbing pain
first dose on on 10-18-19 / second dose almost 24 months later; This case was reported by a consumer via Shingrix GSK and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 18th October 2019).   On 15th September 2021, the patient received the 2nd dose of Shingrix. On 15th September 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received 2nd dsoe almost 24 months later the 1st dose of Shingrix. The patient received 2nd dose later than the recommended time interval, which led to lengthening of vaccination schedule The reporter asked under this situation, did you recommend that, get a third does in 4 to 6 months.
Dose administered after exceeded storage guidelines; Dose administered after exceeded storage guidelines; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered after exceeded storage guidelines) and EXPIRED PRODUCT ADMINISTERED (Dose administered after exceeded storage guidelines) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced PRODUCT STORAGE ERROR (Dose administered after exceeded storage guidelines) and EXPIRED PRODUCT ADMINISTERED (Dose administered after exceeded storage guidelines). At the time of the report, PRODUCT STORAGE ERROR (Dose administered after exceeded storage guidelines) and EXPIRED PRODUCT ADMINISTERED (Dose administered after exceeded storage guidelines) 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 medications were provided by the reporter. No treatment details were provided by the reporter.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in an 84-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 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No Treatment given on the paitent. Reporter also stated that the vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.
COVID 19 FHP OF CASE STATED SHE DOESNT HAVE CARD, OR KNOW EXACT VACC DATE
Headache, fatigue, nausea, body aches beginning the morning following the 2nd dose and continuing for approximately 24 hours.
Admitted for suspected myocarditis. Patient received the first dose of Moderna COVID vaccine, 2 weeks later patient received the TDAP and Typhoid vaccines, then 2 weeks later on Friday 7/23 patient received second dose of the Moderna COVID vaccine - on 7/25 patient developed stabbing chest pain rated it a 7/10 on the pain scale at which point he went to his local ER and was transported to another medical facility for further evaluation and management due to concerns for myocarditis. Cardiology visualized regions of epicardial delayed gadolinium enhancement consistent with myocarditis.  Chest pain resolved with ibuprofen. Follow-up with cardiology in 2-3 weeks.
Client had burning at injection site following vaccination with COVID-19 vaccine. No itching was reported. Ice pack was applied at the site for 10 minutes following the symptom onset. Client reported symptom improvement and was able to leave under their own power.
Redness, vesicles at Varivax injection site (LA SQ)-started 12/15/06. Lasted approx 2 weeks now scared area.
arm soreness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An adult patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
HEADACHE NAUSEA VOMITING MALAISE WARMTH AND TO INJECTION SITE SWELLING
This spontaneous report as received from a 41 year old male patient, concerning himself. The patient's current conditions included allergy to pecans, walnuts, almonds, ragweed, pollen, and grass. The patient's medical history included corneal transplants and his concomitant therapies included an steroid eyedrop called fluorometholone (FML) as treatment for corneal transplants. On an unspecified date in April 2018, the patient was vaccinated with one dose of VAQTA injection (strength, anatomical location, route of administration, lot # and expiration date were not provided) as prevention of hepatitis A. On an unspecified date in 2018 (reported as A few weeks after getting the first dose of VAQTA, the patient started to get minor hives on his back, butt and legs any time after he had dairy products like Milk or Ice cream (Milk allergy, angioedema). The patient stated that that had never happened before getting the first VAQTA vaccine. On an unspecified date in October 2018, the patient received the second dose of VAQTA (strength, anatomical location, route of administration, lot # and expiration date were not provided). On an unspecified date in 2018 (reported as after getting the second dose of VAQTA, the patient started to get a major allergy after eating any dairy products, he would get nauseous and had major hives, he stated that it was very painful, his face would swell up, but not his throat. As treatment, the patient tried BENADRYL, and said that would make it better. At the time of the report, the patient has not recovered from aforementioned adverse events, he had not seek medical attention and no laboratory diagnostics or studies had been performed. The causal relationship between VAQTA and the events was not reported. He also stated that the events were a "major allergy", however, he did not consider the events to be life threatening. Upon internal review, angioedema was considered a medically significant event. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1811USA002196.
Approximately 15 minutes after vaccine injection, right upper eyelid started spasming. This has happened approximately 15-20 times every day, for the last 9 days. Never had this before.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Chills-Medium, Systemic: Fever-Medium, Systemic: chiils and tiredness-Medium, Systemic: Nausea-Medium, Additional Details: patient experienced fever, chills, nausea and tiredness.. Hives appeared on arm ( not at injection site but on elbow and other areas on arm ) 2 days after 5/29/2021, it disappered 2 days later with no medicine ingested. patient contacted md but md didn't advise to use any medication. Overall time was 4 days to recover.
Left arm was sore in the shoulder and hot at the injection site the next day. The arm became red and the heat and redness spread from the injection site around the bicep and behind the arm. The area was slightly swollen and continued to be red and hot for 6 days
A few months after my son received his Gardasil shot he started to have seizures and he has had them ever since. He has had multiple in one setting and has dislocated and even broken his shoulder from these seizures. He is a different kid now. And I fully believe they started once he got this Gardasil shot.
Vaccine supply issue; This case was reported by a pharmacist via call center representative and described the occurrence of product supply issue in a patient who received Herpes zoster (Shingrix) for an unknown indication.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, an unknown time after receiving Shingrix, the patient experienced product supply issue. The action taken with Shingrix was unknown. On an unknown date, the outcome of the product supply issue was unknown.   It was unknown if the reporter considered the product supply issue to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not applicable. A Pharmacist stated that most of the patients who received the first dose of Shingrix are now outside of the six month time-frame due to supply. The reporter consented to follow up. The reporter declined to give the number of patients at the time of the call.  No specific patient data given.
Post-vaccination, patient was waiting in pharmacy.  Husband was standing, and she was sitting.  Husband reported that patient slumped head to the side and was demonstrating syncope.  Immunizing pharmacist stabilized patient on floor pad, and she took vitals.  Patient's blood pressure and temperature were normal, and patient was alert and answering questions.  She reported that she had "tingling" in her lips and arms.  Local EMS responders arrived and transported patient for medical evaluation at local hospital.
Starting immediately after the vaccination,  I felt immediate palpitations and fluctuating HR for about 40 minutes.  It would go up then come down.  I went to my doctor and he did an EKG and that was normal.   I was instructed to continue to take my heart medication Cardizem as normally prescribed.  The symptoms lasted 1 day.
Numbness in both leg; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HYPOAESTHESIA (Numbness in both leg) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Pfizer Covid 19 vaccine. Past adverse reactions to the above products included No adverse event with Pfizer Covid 19 vaccine.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in both leg). At the time of the report, HYPOAESTHESIA (Numbness in both leg) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications was reported. No treatment medications was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
No adverse effects. A flu clinic was held at school. Mom indicated that she preferred patient be given "Live intranasal vaccine only." Mom also indicated patient has asthma on the top of form.
Warm flush feeling, feeling like floating, ears overly congested, legs feeling like rubber and floating. Came in waves for about an hour and a half. Given Benadryl. Symptoms subsided by night. next day headache body aches tired increased to svere headache, aches, dizziness, sore throat, lymph nodes swollen around neck. Day 11 saw ENT doc Dr. Given Prednisone 40mg x3 days then 20mg x2 days. most symptoms subsiding but still left with slight headache and terrible vertigo.
Lymph nodes are tender; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (Lymph nodes are tender) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced LYMPH NODE PAIN (Lymph nodes are tender). At the time of the report, LYMPH NODE PAIN (Lymph nodes are tender) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment medications included unspecified steroids and antibiotics.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.