chrisvoncsefalvay/vaers-outcomes huggingface dataset:
80 year old male patient administered expired dose of Fluzone High Dose, with no reported adverse event; Initial information received on 08-Sep-2021 regarding an unsolicited valid non-serious case from a physician via other health professional via Medical Information (Reference number- 00759809).  This case involves 80-year-old male patient who was vaccinated with the expired dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 07-Sep-2021, the patient received a 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ567AA and expiry date: 30-Jun-2021) (Frequency: Once) via intramuscular route in the right deltoid for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  It was reported "they administered expired FLUZONE HIGH DOSE to a patient. what are the proper steps for the patient after this situation?"  At time of reporting, no adverse event was 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 the 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.
2 1/2 hrs high pitched cry 4hrs p/last shots & marked swelling @ DTP site;
12/26/21: patient started having COVID symptoms 12/29/21: present to the ED with nausea, vomiting, body aches, fatigue, cough and test positive for symptomatic COVID-19  Her hospitalization has been complicated by management of chronic hypoxic respiratory failure and hepatic encephalopathy. Significant events during hospitalization include a rapid response called at 2:10 AM on 1/2/2022 for acute changes in mental status. A second rapid response was called on 1/4/2022 for altered mental status and large hematoma along the left flank. Unfortunately, the patient continued to decline until requiring vasopressor support for septic shock. Therefore, she was admitted to the ICU for critical care management on 1/4/2022, as well. A few hours later, a third rapid response was called for unresponsiveness. Due to concern for airway protection the patient was intubated at that time. Discussion between staff and family continued throughout the day regarding Goals of Care and the patient's poor prognosis. After significant thought, the patient's family decided to withdraw care. The patient was pronounced on 1/4/2022 @ 1412 hours with the family at the bedside.
Information has been received from a physician concerning a 24 year old female who was vaccinated with Gardasil vaccine. The patient had an abnormal PAP after she was given the Gardasil vaccine. No other information was reported. Additional information has been requested.
No additional AE reported.; expired dose of ROTATEQ administered to a patient; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 28-APR-2021, the patient was vaccinated with an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 1 dose (exact dose was not reported), orally, lot # 1660946 was confirmed to be valid, expiration date 10-APR-2021 for prophylaxis. No additional adverse event was reported.
vision went blurry; Dizzy/Light-headed; weird sensations in different parts of her head; hands and legs went weak; vision was so bad.; left eye twitching; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, solution for injection, lot number: EW0176) via unknown route of administration on 30Apr2021 at dose 1 single in deltoid left (left shoulder as reported) for COVID-19 immunisation. Medical history included lyme disease (since she was young, weakened immune system), bartonella (since she was young, weakened immune system), anaemia (several years), vitamin D low (several years), interstitial cystitis (10 years) all are ongoing. Concomitant medications were not reported. Then 1-2 min after her vision went blurry. She was dizzy, and light-headed. She felt weird in different parts of her head. She was like having weird sensations in different parts of her head. One second it would be in her forehead and then in the back of her head. It was weird. That occurred on 30Apr2021 but went away that same day. Her hands and legs went weak. That happened on 30Apr2021, just that day and she recovered. All the side effects subsided after several hours except for the blurred vision. Her vision was still blurry. Her left eye was also twitching which has started since the vaccine in 2021. She didn't have eye twitching before, but she thinks that was less frequent now. She went to the Ophthalmologist, and he did an eye exam with unknown results. That was 3 weeks ago in 2021. Her last eye exam was 8 years ago with unknown results. But he said that her vision change since that exam was extremely significant. It was now illegal for her to drive her vision was so bad in 2021. Her doctor was not sure what happened either. Her doctor was now referring her to a Neuro-ophthalmologist.  She has been taking Vitamins to try to help. She has been taking Vitamin D3 and iron. She does have chronic Lyme disease and Bartonella because of that she does have a weakened immune system. She has had both of those since she was little. She was a lot better now. She was not as sick anymore from those. She was not going to get the second dose. She was wondering if she can reverse the blurry vision. she asked her doctor about the Lyme disease, and her vision change. The doctor said she needed to report this to Pfizer. If it was because of the Lyme disease it would have happened before the vaccine. The outcome of event vision blurred was not recovered, vision abnormal was unknown, eyelid twitching was recovering and remaining were recovered on 30Apr2021.   Information on the batch number has been requested.
Child was given only the diluent component of vaccine. Vaccine was not reconstituted prior to administration. Child has not suffered any adverse reaction at this time. Parent being contacted to bring child in for re-administration of vaccine.
after lunch he vomitted; stool is very liquid like; felt a little sick to his stomach; feel nauseous; This is a spontaneous report from a contactable consumer reporting for a 79-years-old male patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number and Expiration date was unknown) via an unspecified route of administration in right arm on 04Mar2021 at 17:15 as 1 ST DOSE, single for COVID-19 immunization. The patient medical history included cholestrol, blood pressure, light asthma, stroke in 2014 and allergies with bactrum, tapes and hydrocodone. The patient previously took bactrum t and hydrocodone and experienced   drug hypersensitivity. It was reported that the patient did not take any vaccine in four weeks, he did not have covid prior vaccination and did not get tested for covid post vaccination. The concomitant medications included lansoprazole 30mg twice a day, clopidogrel 75 mg, lisinopril 20mg, metoprolol tartrate 50mg, evolocumab (Repatha)140mg injection pen, colecalciferol (Vitamin D) 1000 iu twice a day, fiber, cyanocobalamin (Vitamin B12), fluticasone furoate, vilanterol trifenatate (Breo ellipta) inhaler, fexofenadine hydrochloride (Allegra) and macrogol 3350 (Miralax) all taken for unknown indication, start date and ongoing status unknown. Approximately 1 to 2 hours after the shot on 04Mar2021, he felt a little sick to his stomach, during the night he felt bad but did ok. On the next day on 05Mar2021 he ate breakfast felt ok and after lunch he vomited and his stool was very liquid like. On an unknown date in Mar2021, he continued to feel nauseous. No fever just feels nauseous still on Saturday, after he eats he then has to vomit. Stool and vomit all have the same look. He was not keeping any food down but was drinking a lot of water. Just taking a lite diet, broth, toast, crackers, etc. Patient did not received treatment for the events. The outcome of events was recovering.  No follow-up attempts were possible; information about lot/batch number cannot be requested.
Nausea; light headed; redness and pain at the site of varicella administration; swelling initially but has now decreased per MD given antibiotic, prednisone and rx for the nausea.
Positive for large (15cm) in diameter redness, with some swelling & tenderness in the middle (3 cm diameter) on left anterior thigh with needle puncture spot in center. Treatment - Ibuprofen prn, cool compresses, BENADRYL 25-50mg every 4-6 hour prn - observation.
upper left arm, around injection site is bruised. bruised down left arm and into the inner-brachial area
Patient was very fatigued and arm hurt a little bit. Patient did not get sick other than that patient went to school today.
I experienced a seizure.  A family member told me I was "out" for 1 or 2 minutes, got very stiff,  breathed very heavy then seemed as though I stopped breathing, involuntarily urinated.  When I came to, my speech was slurred for a few minutes and my blood pressure was very low.  The EMT's arrived, took my blood pressure, reported it was 85 / 58.  After a few minutes, drinking some fluids, I began to feel more normal.  I declined to go with the EMT's.  That afternoon, I was extremely tired and slept most of the afternoon.
BRUISES ON LOWER LEFT ARM OR TINY BLOOD SPOTS UNDER SKIN  AND EASY BRUISING; EXTREMELY TIRED (COMPARED THIS LEVEL OF TIREDNESS TO BEING PREGNANT); This spontaneous report received from a patient concerned an 85 year old female. The patient's weight was 160 pounds, and height was 61 inches. The patient's past medical history included: stents, and concurrent conditions included: non smoker, and alcohol use, and other pre-existing medical conditions included: patient felt tired prior to receiving the vaccine, The patient had no known drug allergies and and no history of drug abuse or illicit dug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. Concomitant medications included cyanocobalamin for tiredness.  On an unspecified date, the patient experienced bruises on lower left arm or tiny blood spots under skin and easy bruising, and extremely tired (compared this level of tiredness to being pregnant). The action taken with covid-19 vaccine was not applicable. The outcome of the extremely tired (compared this level of tiredness to being pregnant) and bruises on lower left arm or tiny blood spots under skin and easy bruising was not reported. This report was non-serious. This case, from the same reporter is linked to 20210908782.
Customer reports giving 0.1 ml PNEUMOVAX 23 intraderamally in error.; Customer reports giving 0.1 ml PNEUMOVAX 23 intraderamlly in error.; redness; itching; This spontaneous report has been received from a registered nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.        On 03-NOV-2020, the patient was vaccinated in error with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23),  0.1 milliliter, intradermally for prophylaxis (Lot # and expiration date were not reported).         The patient did not have any adverse events and  no additional information was provided.  This is a non-valid case due to lack of patient's identifiers.   Follow-up information was received on 15-DEC-2020 from the vaccine provider.  The 27-year-old (also reported as 38-year-old) female patient had no illness at the time of vaccination or pre-existing physician-diagnosed allergies, birth defects, or medical conditions. The temperature excursion of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not recorded by a data logger. She experienced itching and redness on an unspecified date in 2020. At the time of this report, the patient was recovered from the events.   The causality between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported.   This case was previously considered non-valid due to lack of patient's identifiers, but upon receipt of follow-up it was determined that the case is now valid.
Shingles; Pain/hurt that bad/still it hurt worse than childbirth; Rash; Got shingles shot but got shingles/ suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shingles shot but got shingles/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) (serious criteria hospitalization), pain (Verbatim: Pain/hurt that bad/still it hurt worse than childbirth) (serious criteria hospitalization) and rash (Verbatim: Rash) (serious criteria hospitalization). The outcome of the vaccination failure was unknown and the outcome of the shingles and rash were not reported and the outcome of the pain was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and rash to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain and rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by a patient via  interactive digital media. The patient reported that he or she received Shingles vaccine and experienced shingles on his or her right side of lower back.. The patient was in pain all over and stated that he or she never had hurt that bad. The patient stated that he or she went to the hospital two times and three times to his or her physician. The patient reported that someone thought that to look to see if it was a rash and check for shingles and after 2 weeks they know that it was shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
mild transient rash with some welts, but mostly redness and itching located on right foot and ankle. Took diphenhydramine 50 mg po x 1 dose and used hydrocortisone cream x 1 application.  Rash resolved in that location, but came up on both thighs just above the knee cap on both legs on Sunday.  Repeated diphenhydramine 50 mg po x 1 and used hydrocortisone 1% cream x 1 application.  Both events resolved within 2 hours, with no further issues.  This could be unrelated since it was 4 days out, but I wanted to report it for consideration.
got COVID 1 week ago; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (got COVID 1 week ago) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 004F21A, 013620A and 039K20-2A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2023, the patient experienced COVID-19 (got COVID 1 week ago). The patient was treated with MOLNUPIRAVIR (LAGEVRIO) in January 2023 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (got COVID 1 week ago) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2023, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported.  It was reported that, Patient started with nasal congestion about 1 week ago and COVID-19 home test was positive. Patient called the doctor and doctor kept patient on Lagevrio now patient was on 5th day of the medicine.   This case was linked to MODERNATX, INC.-MOD-2023-696187 (Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-696187:Same Reporter (Husband case)
Felt flushed, warm sensation throughout body especially in upper thighs and face. Described feeling tongue tingling and swelling - but no physical signs of swelling or erythema on actual physical exam. This began 30 minutes after vaccine given. She was monitored for a total of 45 minutes and given 50 mg of Benadryl. She felt better after 45 minutes and described no difficulty breathing, walking, no dizziness or other concerning symptoms.
Pt. stated she had sandy, watery eyes about 4 hrs following vaccine followed by her eyes being swollen shut the morning after. Did clear up later the following day approximately 24 hours after vaccine.
Pain under the shoulder, the back and under the chest area,Pain from under right shoulder blade wrapping around; Pain under the shoulder, the back and under the chest area,right chest area.; Pain under the shoulder, the back and under the chest area; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Pain under the shoulder, the back and under the chest area,Pain from under right shoulder blade wrapping around), CHEST PAIN (Pain under the shoulder, the back and under the chest area,right chest area.) and ARTHRALGIA (Pain under the shoulder, the back and under the chest area) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Previously administered products included for Flu: Flu shot (likely more than 1 month prior). Concurrent medical conditions included Blood pressure high (within past 2 years) and High cholesterol (within past 2 years). Concomitant products included ATORVASTATIN for Coronary artery disease, VALSARTAN and HCTZ for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Pain under the shoulder, the back and under the chest area,Pain from under right shoulder blade wrapping around), CHEST PAIN (Pain under the shoulder, the back and under the chest area,right chest area.) and ARTHRALGIA (Pain under the shoulder, the back and under the chest area). At the time of the report, BACK PAIN (Pain under the shoulder, the back and under the chest area,Pain from under right shoulder blade wrapping around), CHEST PAIN (Pain under the shoulder, the back and under the chest area,right chest area.) and ARTHRALGIA (Pain under the shoulder, the back and under the chest area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient received 2nd dose on 17Feb2021 having lot no: 004M20A  Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.    This case was linked to MOD-2021-369179 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Follow-up received. Medical history, concomitant medication and patient race added.
This spontaneous report was received from a registered nurse concerning an unspecified number of patients. The patient's historical conditions, concurrent conditions, concomitant therapies, historical drugs or allergies were not reported. On an unspecified date, the patients were vaccinated with an unspecified number of doses of PROQUAD subcutaneously, reported lot number R011217, expiry date 15-OCT-2019, reported lot number R011802, expiry date 21-OCT-2019, (laterality, strength, dose and frequency were not reported) and VARIVAX reported lot number R009411, expiry date 29-MAR-2020, reported lot number R003300, expiry date 01-FEB-2020, reported lot number N035940, expiry date 18-DEC-2019 and reported lot number N034551, expiry date 05-DEC-2019 (laterality, strength, dose, route and frequency were not reported) both vaccines for prophylaxis, following a temperature excursion. The administered doses of the vaccines experienced a temperature excursion of 6°F to 14°F (-14°C to -10°C) for 14 hours 30 minutes and of 15°F to 46°F (-9°C to 8°C) (-6.1°C) for 20 minutes, as recorded by a data logger. No previous temperature excursion was reported. As of 09-NOV-2018, all telephone attempts to obtain follow up information had been unsuccessful. Follow up information was received from a registered nurse on 08-JAN-2019. This spontaneous report refers to a 12 month old male patient. The patient did not have any pre-existing physician-diagnosed allergy, birth defects, medical conditions or illness at time of vaccination. On 14-SEP-2018, the patient was vaccinated with the first dose of VARIVAX lot # R009820, expiration date: 03-APR-2020, subcutaneously (SC) in the left thigh (LT); first dose of M-M-R II lot # N026828, expiration date: 27-APR-2019, SC. in the right thigh (RT); first dose of VAQTA lot # R006210 , expiration date: 22-APR-2019, intramuscularly (IM), RT; fourth dose of PREVNAR 13 lot # W11304 (expiration date not provided), IM, LT; and FLUBLOK lot # NT6242MA (expiration date not provided), IM, RT. All the vaccines were administered for prophylaxis and purchased with private funds. The administered doses of the vaccines experienced a freezer temperature excursion (not specified) as recorded from a digital data logger which occurred at the time of storage in clinical practice. None adverse effects were reported. Also, the patient received an unspecified treatment for the experience. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA002757: US-009507513-1901USA002758: US-009507513-1901USA002759: US-009507513-1901USA002760: US-009507513-1901USA002761: US-009507513-1901USA002762: US-009507513-1901USA002763: US-009507513-1901USA002764: US-009507513-1901USA002765: US-009507513-1901USA002756: US-009507513-1901USA002755: US-009507513-1901USA002753: US-009507513-1901USA002754.
Patient received her nasal Flumist on 12/7/15 at our flu clinic. She returned for her 5 year check-up on 12/16/15 and was given her MMR and Varicella.
08/06/2021- I experienced an intense joint pain episode. The second vaccine I was fatigued, horrible joint pain, respiratory issues, 1 urgent care visit. I had difficulty swallowing. I had a lot of mucus. I have a strange coating on my tongue that the doctor said is probably thrush. Last night 08/25/2021 I noticed a rash on my torso and back more on my left side than my right side.
Same symptoms I had with the virus.  Fever, chills, fatigue, nausea, pain at injection site.
EE states day after vaccine had tingling in Rt arm/hand /feet. Spread to rt foot/lower leg. Left side still tingling