chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. During 2015 (specific date not provided), the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended. On or about May 2016, the patient was treated at a hospital/clinic and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
At time of injection pt c/o tip of tongue tingling, BP 109/52, no other s/s at 0800. At 1910 pt went to ER with c/o HA, tightness in chest - tip of tongue tingling. Rx administered TYLENOL 1550mg PO, prednisone 60 mg PO & BENADRYL 50 mg PO then discharged to home.
Patient was admitted due to lower extremity weakness and redness with pain. Patient was diagnosed with right lower extremity DVT by his oncologist. During this hospitalization initially required heparin drip, then was placed on Eliquis. He tested positive to COVID-19 infection he remained asymptomatic on room air. He didn't require any steroids or oxygen use.
Weakness in legs and feeling of warm that started from the injection site and spread across the body couple of minutes after the injection. Lasted for about 15 min. Once I went outside in the cool air, it started to get better. I was able to leave about 20 minutes after the vaccination. I was already feeling a little weird in the morning due to the start of menstruation.
No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 03-APR-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # S006050, has been verified to be a valid lot number; expiration date 12-DEC-2020) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703:
51 y/o F BIBA for throat swelling sensation after receiving COVID-19 vaccine today. After the injection, pt proceeded to wait for 15 minutes for observation. She felt well initially, but while walking back to her car, she developed a ?lump? in the throat with a scratchy sensation. She returned to the clinic where she was given 1x 0.3mg Epinephrine and 2x 25mg Benadryl. In the ED, she feels much improved. She denies any angioedema, CP, palpitations, rash, n/v/d. No PMHx. Medications reviewed. NKDA.
Rash; Welts; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received the first dose of bnt162b2 (lot: EX9231), via an unspecified route of administration in left arm on 23Dec2020 08:30 at single dose for covid-19 immunization. Medical history included allergic to Sulfate, diabetes, blood pressure, cholesterol, "helps regulate heart", thyroid, stomach. Concomitant medication included ongoing atorvastatin for Cholesterol, acetylsalicylic acid (BAYER ASPIRIN) as blood thinner, cyanocobalamin for Vitamin Supplementation, dofetilide to help regulate heart, glipizide for Diabetes, iron as Supplementation Therapy, ongoing insulin glargine (LANTUS) for Diabetes, ongoing levothyroxine for thyroid, lisinopril for Blood pressure, magnesium for Supplementation therapy, metformin for Diabetes, metoprolol for Blood pressure, insulin aspart (NOVOLOG) for Diabetes, ongoing omeprazole for stomach, dabigatran etexilate mesilate (PRADAXA) as blood thinner, colecalciferol (VITAMIN D3) for Vitamin Supplementation. The patient previously took amiodarone, carafate, nexium [esomeprazole magnesium] and all experienced allergic. After the first vaccine, 9 days later (01Jan2021) he broke out in a rash. He states a lot of them are pretty good size welts. He did call the health department and they said it was just a rash, they didn't act like they were really concerned about it. Patient confirmed he noticed the rash 9 days after the first vaccine. He received his shot on a Wednesday (23Dec2020) and the Friday of the next week (01Jan2021), he noticed the rash. Patient confirmed the rash is still ongoing. He stated it seems like the rash is getting better but then he breaks back out in welts, the welts are the size of a quarter or so. The events did not require a visit to Emergency Room/Physician Office. The patient received the second dose of bnt162b2 (lot: EL8982), via an unspecified route of administration in left arm on 13Jan2021 11:00 at single dose for covid-19 immunization. The outcome of the event rash was recovering, the event welts was unknown.
Cellulitis of left upper extremity  baseball size red area that is swollen around injection site started the evening of 2/2/21. Patient was seen in the primary care office today 2/4/21 and given a script for CEPHALEXIN 500 MG  2 BID for 10 days.
Information has been received from a 75 year old female with hyperlipidemia, osteoporosis, insomnia, chronic sinusitis, anxiety and depression and a history of hysterectomy, lumpectomy, lymphadenectomy, breast cancer with some lymph nodes removed from that left arm, radiotherapy and breast lump and no allergies who on 06-JUN-2008 at 11:00 AM was vaccinated subcutaneously in her right arm with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included ZOLOFT, RESTORIL, and alprazolam. The patient reported that about 21 years ago she had a lumpectomy done on her left breast where they had removed all of her lymph nodes. On 11-JUN-2008 the patient's left hand, finger and palm was swollen to the point where she can not tighten her hand. The patient had a sort of stiff feeling in the left arm. The patient also reported that at the injection site it was black and blue with a red ring around it, itchy and there was a lump underneath the skin, and underneath her right arm the patient was having a weird sensation feeling that the patient had not had before. The patient reported that as of 12-JUN-2008 her hand was still swollen, she still had the injection site reactions and the sensation under her arm, but she had spoken to her physician and would be seeing him at the office on 13-JUN-2008. Review of system indicated that the patient's weight was stable and her appetite was good, no chest pain or palpitations and no dyspnea, cough or sputum. Physical examination indicated: Blood pressure 116/80; Pulse 78; Respirations 14 and Temperature 98.6 degrees Fahrenheit. The patient was well developed, well nourished and in no acute distress. The patient's left arm did have lymphedema, from the elbow down it was obvious. Palpation of the axilla did not reveal any lymphadenopathy. There was no edema in the right arm. The left arm had full rang of motion. No product quality complaint was involved. Additional information is not expected.
Pt called office with sore throat, cough, wheezing s/p vaccines. Instructed to return to office for evaluation. Rx: MEDROL Pak and ZANTAC. Pt treated with IM DECADRON, Albuterol nebulizer. 9/17/15 MD F/U improving.
potentially late for the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix  (received first dose on an unknown date ).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: 2-Nov-2022 Reporter's comment: The pharmacist stated a patient was potentially late for the second dose of the Twinrix series. The reporter did not consent to follow up and stated she was unsure whether she could provide additional information, so she did not provide further details. Did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Twinrix, which led to incomplete course of vaccination.
The mother of the pt told the reporter that 16 days post vax the pt experienced red and hot face and a rash that spread from the face to chest, legs and arms. The reporter thought that the symptoms lasted for approximately 24 hours. The most recent information reports the condition of the pt is resolved.
Information has been received from a registered nurse concerning an approximately 80 or 90 year old immunocompromised female who was in the same room where the other residents of the retirement community were vaccinated with a dose of Zostavax (Oka/Merck). It was reported that the patient had spouses or contact (s) who lived in the independent residences within the community and who were vaccinated with a dose of Zostavax (MSD). The patient was not vaccinated with the vaccine. On 10-OCT-2007 the patient developed shingles. At the time of report the patient had not recovered. The patient's experience was considered to be an other important medical event and disabling by the reporter. Additional information has been requested. This is one of several reports received from the same source.
Vaccinated 7/16, 7/17 developed mild chest pain, fever and body aches. 7/19 developed dizziness in addition to previously reported symptoms. 7/20  developed right leg numbness and reported symptoms to this clinic. Was escorted to ED
Administration of expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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 details were provided as follows: The age at vaccination was not reported. On 1st February 2022, the patient received Bexsero which was already expired on 31st January 2022, which led to expired vaccine used. The reporter asked if they had any information on extended expiry dates or recommendations for the next steps. This report was received afterhours via web. No additional information was provided in web. The reporter consented to follow-up.
11/6/21 presents to EC ED "with concerns about covid.  Patient began experiencing cough and shortness of breath 3 days prior after contact with COVID+ individual.  Patient tested positive 2 days prior to presentation." PMHx "polycystic kidney disease, deceased donor renal transplant on CellCept".
Despite receiving varivax child has confirmed varicella with fever, malaise, and classic rash. Both brothers vaccinated at different times and with different lots have breakthrough varicella.
Information has been received from a physician concerning a 40 year old female nurse who on 23-MAY-2007 was got Rotateq in her eye. On "22-MAY-2007" the patient had redness of the conjuctiva of one eye that had contact with Rotateq. At the time of the report the patient had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Redness at site of injection-drifting down arm to below crook of elbow on medial aspect. Swelling accompanied redness, no temperature AM of 10/04. Right deltoid (pneumococcal) problem site.
Pt presents with increased redness and warmth to injection site on right thigh with swelling noted. Dx: cellulitis. Tx: Keflex 250/5m 1/2 tsp TID for 7 days, Ibuprofen PRN.
Information has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent conditions and medical history were not provided. On 02-MAR-2015 the patient was vaccinated with GARDASIL (lot # K006191, expiration date 02-FEB-2017, dose, dose# and route not provided) after it was improperly stored (incorrect product storage). No adverse effects reported. The outcome of the events was not provided. This is one of several reports received from the same source. Additional information has been requested.
A 30 year old male, who denies any previous medical conditions, received the 1st dose of Anthrax vaccine on 27 September 1999. No other vaccines were given on this date. The patient was taking no concomitant medications at the time of the event. The patient denies any illnesses at the time of the vaccination and did not report any reactions to previous vaccinations. The patient stated that sicne the date of the first vaccination, he has been full of rage, anger, and unable to concentrate and sleep. He also has other psychological effects, but denies hospitalization or temperature, redness or pain at the injection site. At the time of this report, the patient had not fully recovered.
Pneumonia three times; Reaction to Pfizer shot/rash looked like shingles with sores from injection site up from arm to neck; Reaction to Pfizer shot/rash looked like shingles with sores from injection site up from arm to neck; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4360554-00 (Company).  A 72-year-old female patient received BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), from 01Apr2013 (Batch/Lot number: unknown) to 2020, subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMONIA (medically significant), outcome "recovered", described as "Pneumonia three times"; VACCINATION SITE RASH (non-serious), VACCINATION SITE ULCER (non-serious), outcome "not recovered" and all described as "Reaction to Pfizer shot/rash looked like shingles with sores from injection site up from arm to neck". The action taken for adalimumab was dosage permanently withdrawn in 2020.  Clinical course:  The reporter's assessment of the causal relationship of Humira for the event Pneumonia recurrent  (Pneumonia) was reported as Reasonable possibility, Vaccination site rash was reported as no reasonable possibility and Vaccination site ulcer was not reported.  The reporter's assessment of the causal relationship of Pfizer BioNTech  COVID-19 vaccine (Tozinameran) for the event Pneumonia recurrent  was not reported, Vaccination site rash and Vaccination site ulcer was reported as possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. 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.
Narrative:  Patient reports stiffness in arm on injection site. Symptom resolved today.   Other Relevant Hx:  Symptoms:  & stiffness in arm Treatment:
Patient had just been evaluated by FNP, and was diagnosed with a URI.  Patient was given an influenza injection approximately at 2:30 pm by myself. Shortly after, around 3:00 pm, the patient's father was being evaluated by another provider, who observed patient experience a seizure in the exam room.  Note: Patient in clinic w/ father (who was being seen as patient). Patient had just been evaluated by another provider in this clinic and given flu shot approx 30-45 minutes before seizure.No hx seizures per father. Child was happy/playful in exam room, suddenly fell onto floor hitting head w/ seizure. Father states he noticed that patient first stiffened before fall. I did not witness this, but first saw her on floor, seizure activity. Stiffened body posturing w/ dilated pupils, gray coloring, unable to open mouth, no response. Heart rate remained regular, breath sounds apparent. Immediately provided safe care, airway and called 911. Pediatrician called to exam room. After approx 1 minute, patient aroused, crying, recognizing father. No incontinence. O2 sats monitored during seizure and post-seizure, reamined over 95%. Temp 97.1. Transported to ER per ambulance.
11yr old male was administered adult pfizer vaccine (30mcg dose) instead of the pediatric pfizer vaccine (10mcg dose). It was caught immediately after administering. Regional Medical Director was contacted for advisement. Error was disclosed to the patient's mother. Patient was monitored for twice the standard 15 minute observation period. Patient did not manifest any adverse symptoms. Mother was advised to continue to monitor child at home and seek immediate medical attention should any worrisome post-vaccination symptoms manifest.
Patient requested Pneumovax23 and accidentally received Flublok vaccine. Patient previsouly received Fluad Quad vaccine on 9/29/20 so this was her second flu vaccine for 2020/2021 season. Patient called the following day stating she felt ill after receiving a second flu vaccine, including chills/fatigue. Patient's doctor was contacted and made aware of the situation.
07/23/2009 MODERATE Other.  FATIGUE RASH STARTING ON L EAR.  CONTINUING TO BE ON FACE AND MIDSECTION SAW PHYSICIAN ON 7/28.  (L) side of body only.
Had after frist two vaccinations ipilepsy attack each which lasted over 1/2 hour. After 3rd vaccination had very short epliepsy attack and had two more long attacked 1/2-1 1/2 hours yesterday and today (at early morning hours)
Case number PHEH2014US011628 is an initial spontaneous report  from a physician received on 06 Jun 2014 with a follow up information received from a physician on 17 Jul 2014. This report refers to a 12 year old male patient. His medical history included Hodgkin's Lymphoma in remission and his concomitant medication included PERIACTIN for appetite stimulation at a dose of 5 ml thrice daily via oral route since 22 Aug 2012. On 05 Jul 2014 at 11 am, the patient received intramuscularly lyophilized Men A powder vial of MENVEO (batch number: M13017) mixed with a BOOSTRIX (other manufacturer, batch number unknown) vial. Later on the same day the patient received the MenCYW 135 liquid component of MENVEO alone. No adverse event was reported following these medication errors. Follow up information received from a physician on 17 Jul 2014: Updated patient demographics (height and weight), medical history, concomitant medication and cosuspect vaccine.
This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received PREVNAR 13, Solution for injection in pre-filled syringe via an unspecified route of administration on 06Feb2019 at single dose for immunisation. Medical history included coeliac disease. The patient's concomitant medications were reported as none. The patient experienced headaches in Feb2019 for 5 days following the vaccination. On 22Feb2019, the patient had ear ache in left ear and was then hospitalized on 24Feb2019. He was diagnosed with bilateral bel palsy. Diagnosing Neurologist indicated this could be due to inflammation of C7 nerve following vaccination. The outcome of events was unknown. Information on the batch number has been requested.
10/01/2022, about 8:00PM ET, I started coughing, throat tickled, had chills, could not get warm, I was achy. I took a COVID-19 test and I was positive. I was positive for almost 4 weeks. I was prescribed antibiotics and prednisone. Even after I tested negative, there was some weakness muscular-wise. I am still trying to get my strength back. I think I have recovered now.
This spontaneous report was received from a pharmacy technician, referring to a 67 year old male patient. The patient had no pertinent medical history or drug reactions/allergies to be reported. On 08-JUN-2016, the patient was vaccinated with 0.65 ml of ZOSTAVAX lot # L046897, expiration date 23-FEB-2017, subcutaneous (dose number not reported). The patient was on unspecified concomitant medications. On 22-JUN-2016, the patient went into the pharmacy and reported that he had been experienced generalized muscle aches and joint pain, as well as headaches since an unspecified date of June 2106, after receiving the vaccine. No treatment was given for the events. No laboratories were performed. At the time of the report, the patient had not recovered from the events. The relatedness between generalized muscle aches, joint pain and headaches and ZOSTAVAX was unknown. Additional information has been requested.
Second Dose Three Months After First; Initial Report Received on 15-Sep-2022  A registered pharmacist reported that a 40-year-old male patient (race and ethnicity unknown) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization in Jun 2022 and then received the second dose three months later.  Medical history was not reported and concomitant medication at the time of vaccination included omeprazole. Allergies was reported as unknown.   On 08-Jun-2022, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, injection site, and route of administration not reported).   On 15-Sep-2022, 100 days after receiving the first dose HELPLISAV-B injection, the patient received the second dose of HEPLISAV-B (Lot # 937234, expiration date 12-Sep-2023, NDC # 43528-003-05) intramuscularly in the right deltoid. The patient did not experience any adverse reactions.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: :  The company assessed the event as non-serious.