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. On an unknown date in 2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) from a physician, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date later in 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, 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. Additional information has been requested.
PT COMPLAINED OF PAiN IMMEDIATELY AFTER INJECTION OF HPV. MORE THAN THE OTHER VACCINES. 5-31-2020 @ 3pm. REDNESS, TENDERNESS, SWELLING AND WARMESS NOTED AROUND INJECTION SITE.
Client states she started feeling bad, vomiting, dizzy, night sweats, uncoordinated. Doctor prescribed prednisone.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Information has been received from a consumer who has received the information from the internet. The information in the internet was received by the consumer and by the consumer's mother. A 15 year old female patient was vaccinated with 3 doses of GARDASIL at the age of 15. The patient was slowly dying. At the time of reporting, the outcome was unknown. The reporter felt that dying was related to therapy with GARDASIL. Dying was considered to be immediately life-threatening. Additional information has been requested.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was unknown. Since 15-MAR-2015 doses of PROQUAD (Merck)(lot # K022447 with expiration date of 13-MAY-2016; strength, dosage, frequency and route unspecified), which were exposed to temperatures outside of the recommended range, had been administered to the patients. The reporter was not aware of any adverse experiences. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccines given at 1230. Med Asst reported that left arm became red immediately after IPV administration. At 1250, patient c/o rash, itching, throat felt tight. Administered benadryl and epipen at 1306 and transported to ER via ambulance.
Patient hospitalized 9/6/21 for pneumonia and tested positive for COVID same day.
Pt had localized reaction to left arm pneumococcal vaccine (PPV) - secondary cellulitis - tx at ER 9/13/14.
Patient got a PNEUMOVAX 23 and a shingles vaccine on 5/21/2016. Both given in the left arm. About 2 days later patient reported appox 6" circle rash on inside R elbow.
left ear became "clogged" a feeling of "water in the ear" cant hear and a slight ringing in ear. This has never happened to me before.
I?m 65 years old and took 2nd Moderna vaccination on 3/16: ? Had severe dizziness the next day. Fell onto bed after trying to get up ? Have been dizzy for the last 15 days. ? Constant phases of lightheadedness
Patient received Td vaccine L deltoid 04/29/05 at 8:05 AM.  04/30/08 pt. had fever 101 degrees at 5pm took aspirin.  05/01/08 arm red & swollen  from armpit to midsection of arm with "knot" below armpit.  Treated by Priv. Dr. 05/02/08.
Patient admitted straight from GI lab status post colonoscopy with finding of large obstructive, hemorrhagic, friable (malignant appearing) mass. Patient tested positive on 2/3 prior to rehab placement.
got the shingles shot but still got them / suspected vaccination failure; got them; 8 days to get a decent night´s sleep; took 8 days to feel better; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, sleep disturbance and feeling abnormal. On an unknown date, the outcome of the vaccination failure, shingles, sleep disturbance and feeling abnormal were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, sleep disturbance and feeling abnormal to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got the shingles shot but still got them on back. It tooks 8 days for patient to feel better and get a decent night's sleep. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Pt. reported difficult breathing and injection site swelling 24 hours post injection. Sought medical care for adv rxn and treated for cellulitis.
Day 5 and day 6 following vaccination I had continuous muscle twitches in my upper left arm. The spasms could be felt externally and we're in various muscles of the upper arm, mostly around my deltoid and also my scapula. I had some twitches in the first few days following vaccination but day 5 and 6 they were almost continuous (maybe 10-20 second intervals at longest).
Pt recvd 1st dose of Engerix-B & that evening exp nausea & malaise; The next morning was OK but felt tired; has resolved; tx none;
Cough, congestion, lethargy, rhonchi in bilateral lower lobes, decreased appetite, showing signs of weakness Guaifenesin-DM, Lactobacillus, Duonebs, Cefpodoxime, Rocephin
Patient presented through drive-in tent vaccination on 10/26/21. During her screening, her first two doses were Moderna. At 13:05 she received her third dose and chose to receive Pfizer. At 13:35 her 30 minutes monitoring period was up and she was complaining of lower lip swelling. On exam patient had significant angioedema of her lower lip. No difficult breathing; however, was sent to ED.
fluid-like lump the size of a turkey egg under the vaccinated arm, fever, pain over body  (body aches), headache, rapid heart rate, high blood pressure (both numbers), chills, nausea, pain at injection site
7 year old female patient was administered DAPTACEL, they are aware that the cut-off is 6 years old with no adverse event; Initial information was received on 26-Oct-2020 regarding an unsolicited valid non-serious case from a non-healthcare professional.  This case involves a 7-year-old female patient was administered diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel], they are aware that the cut-off was 6 years old (off label use) on 26-Oct-2020. (formulation, dosing frequency and strength were unknown) (lot number: C5643BA and expiry date: 17-JUL-2021) at 0.5 ml via intramuscular route in the left deltoid site for prophylactic vaccination.  Medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included polio vaccine inact 3v (vero) (Ipol).  This was an actual off label use case due to inappropriate schedule of vaccine administered (latency unknown).  At the time of reporting, no adverse event was reported.  No further relevant information was reported.
Date the vial was initially stored in the refrigerator on 30Jun2022, Date of administration of vaccine on 01-Aug-2022; No Adverse reaction; used Moderna Covid-19 vaccine last week beyond its use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (used Moderna Covid-19 vaccine last week beyond its use by date.), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 30Jun2022, Date of administration of vaccine on 01-Aug-2022) and NO ADVERSE EVENT (No Adverse reaction) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 prophylaxis. No Medical History information was reported. On 01-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (used Moderna Covid-19 vaccine last week beyond its use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 30Jun2022, Date of administration of vaccine on 01-Aug-2022) and NO ADVERSE EVENT (No Adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (used Moderna Covid-19 vaccine last week beyond its use by date.), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 30Jun2022, Date of administration of vaccine on 01-Aug-2022) and NO ADVERSE EVENT (No Adverse reaction) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse reaction) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (used Moderna Covid-19 vaccine last week beyond its use by date.) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 30Jun2022, Date of administration of vaccine on 01-Aug-2022). No concomitant medication was reported. Medical history related to mentioned AE and both Acute and Chronic illnesses at the time of vaccination reported as unknown. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine reported as unknown.  Patient's COVID + test or diagnosis was reported as unknown. Patient was administered with second booster dose. Date the vial was initially stored in the refrigerator on 30-Jun-2022. The vial did not undergo any temperature excursions. No treatment information was reported.
Pt reported that about 10 minutes after receiving vaccine, she became lightheaded and sat down. 15 minutes later improved but feels tired and left arm tingling.
10 minutes after injection patient was sitting in chair became diaphoretic and unconscious. Patient heart rate dropped to 51. After 2 minutes patient was aroused to consciousness and moved to a lying position. Patient began to shake and complain of crushing left shoulder and chest pain.
Syncope, fainted for 10 seconds. Patient became pale with rapid breathing then head bobbed back. Patient woke up and was given smelling salts.
Covid-19 positive; he started feeling ill; Started feeling ill as if stomach flue; Diarrhea; fatigue; body ache; This spontaneous case was reported by a consumer and describes the occurrence of GASTROENTERITIS VIRAL, DIARRHOEA, FATIGUE, MYALGIA, and COVID-19 in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced GASTROENTERITIS VIRAL, DIARRHOEA, FATIGUE, MYALGIA, and ILLNESS. On 23-Apr-2021, the patient experienced COVID-19 (Covid-19 positive). At the time of the report, GASTROENTERITIS VIRAL, DIARRHOEA, FATIGUE, MYALGIA, COVID-19 (positive), and ILLNESS outcome was unknown. Not Provided.     DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, SARS-CoV-2 test: Positive Covid Test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No concomitant medication reported. No treatment medication reported.   Most recent FOLLOW-UP information incorporated above included, on 27-May-2021: Follow up report received on 27-MAY-2021 contains No New Information.
Administered Flumist to a 70 year old, who is above the recommended age range.
My arm was instantly sore, and it has been since injection. I?ve got a fever, chills, and difficulty sleeping.
I received my second dose of the Pfizer vaccine on April 18th and that day seemed to go well with only a sore arm. When I woke up the next day on April 19 my day started with horrible joint aches. I couldn't even grab my coffee cup without pain. As the day progressed I had fever and chills for less than 12 hours, but the joint pain lingered. When I woke up April 20 I still had joint pain especially in my right arm. This pain in the right elbow has continued since and increasing in pain and discomfort. It's a burden on my daily activity especially since my right arm is my dominate arm/hand.
nigh time developed fever 101F; sore arm at injection site; next day feel tired; This is a spontaneous report from a contactable consumer or other non HCP (Patient, self-reporting). A 58-year-old male patient received unspecified dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EL3247 and expiration dates were not reported), via an unspecified route of administration in left arm on 09Feb2021 at 09:30 AM (age at vaccination 58-year-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. The patient did not receive any other vaccine in four weeks. On 09Feb2021 at 19:00 after vaccination patient experienced by night time developed fever 101F, sore arm at injection site, next day feel tired and fever subsided after taking 400 mg Tylenol. The did not visited the emergency room or physician office visit. The patient did not receive treatment for the adverse events except fever. No COVID prior to vaccination and not tested COVID post vaccination. The patient underwent lab test and procedure which include body temperature: 101F. The outcome of the patients event was recovering at the of report.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
45 yo M had syncopal episode after getting vaccine. Has hx of vasovagal syncope, usually with medical procedure or blood draws. Passed out for about 40 seconds, witnessed by son who was in the car. On my evaluation, symptoms had resolved,pt was asymptomatic, vitals unremarkable.  Given juice, and observed in car. Subsequently discharged home.
Redness and swelling at injection site and warm. Flu-like symptoms. Patient went to urgent care and told to watch for 48 hours and return if no better. She was better, but MD said it was an allergic rxn.
12/20: 10 mins after the injection my arm started hurting so I was moving it around and suddenly a felt a tickle in my throat, swallowed and felt like I swallowed the wrong way and was coughing to the point of feeling like I was going to vomit. Per everyone around I was bright red and I looked weird. The ER nurse said my heart rate was 125 and my systolic BP was elevated at 130s (normally in the 110s). After sitting for 45 mins heart rate was back to 60s. Still felt like I was in a fog but felt ok. Once I walked to my car I felt alot of nausea again and was on and off the rest of the day.  In the middle of the night I woke up short of breath laying on my back had to lay on my side.  12/21. I was moving pavers and got short of breath. Checked my heart rate and it was 100. O2 sat was 99%. If I sat and didn't move I was fine as soon as I started moving it started again. Also felt nauseating all day. I was having a hard time concentrating and my husband was getting frustrated that I wasn't understanding what he was saying. My left arm hurt really bad all day  12/22 By the afternoon felt more normal except my arm still hurting really bad.  12/26 was shoveling dirty and suddenly my arm where I got the injection started hurts and I got very nauseated again.  On 12/29 the cdc called me because I did the vsafe program. They were wondering if I was actually going to get the second vaccination because they said my reaction is a severe reaction.  12/30 my arm started itching had chills and temp right after  1/1 rapid test was negative for covid  1/2 pcr was negative
Itching after 2nd COVID injection, ongoing since injection, no change with 75 mg PO Benadryl, patient works at assisted living facility- vaccination occurred at her place of employment
Had a positive COVID-19 diagnosis; Had a positive COVID-19 diagnosis; This is a spontaneous report from a contactable pharmacist (patient's wife). A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 07May2021 (Batch/Lot Number: EW0176) as dose 2, single and on 16Apr2021 (Batch/Lot Number: EW0169) as dose 1, single; both via an unspecified route of administration vaccinated at the age of 37-years-old for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 30Oct2021, the patient had a positive COVID-19 diagnosis. The patient took two capsules of Decol in the morning and two capsules of Nicol at the night as treatment for the event. Outcome of events was unknown.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Vaccination failure and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
patient has had no adverse reactions or side effects; PROQUAD was given to a patient along with VARIVAX instead of MMR-II; 15 month old patient received an extra dose of Varicella; This spontaneous report was received from an operations manager for physician's office concerning to a 15-month-old male patient.  The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. Concomitant medications included Merck sterile diluent.   On 21-APR-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (dosage regimen, lot #, expiry date, anatomical location and route of administration were not provided) administered as prophylaxis along with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) injection, 0.5 milliliter x 1dose, lot #W039843, expiration date: 12-JUN-2024, product  quantity: 1, administered subcutaneously as prophylaxis (anatomical location was not provided), instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong product administered). Therefore, the patient received an extra dose of varicella vaccine (extra dose administered).  Reporter also stated that the patient has had no adverse reactions or side effects (no adverse event).
FEVER, SWOLLEN GLANDS, RASH, DIARRHEA, VOMITING, BLOCKAGE IN INTESTINES.
Pt. presented with a macular rash from head to toe x 1 day. Rash itches. Patient given cetirizine 5mg/5ml 1/2 tsp QHS.
Developed chills, low BP, low 02 after Pfizer COVID vaccine. Did not receive vaccination at clinic. Per patient report.
I had a pain in my skeleton, my neck, my jaw, shoulders, and wrist hurt. It felt more skeletal than anything. They provided my Tylenol. I took Advil and the prescription ibuprofen I was given. I spoke to the doctor on the phone, on the 27th of October. I had an appointment with the endocrinologist on 28th. He asks that I don't take the new drug to avoid any complication from Vescepa.
Fever of 103 for 12 hours,  migraine headache for 2 days, mild headache on day 3 and 4, extreme fatigue 3 days, sore arm for 2 days
No additional AE was reported; temperature excursion for VARIVAX; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 19-OCT-2021, the patient was vaccinated with improper stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T024287,expiration date 15-JUL-2022, 0.5 milliliter, route and strength were not provided) for prophylaxis (product storage error). The vaccine administered experienced temperature excursion of 8 Degree Celsius for 1 hour 47 minutes. There was no previous temperature excursion. No additional adverse event was reported.  Follow up information has been received from vaccine coordinator on 26-OCT-2021.  Information has been received regarding a 20-month-old female patient who weights 6lb 12Oz at the time of birth. She had 2 sisters.   On 19-OCT-2021, she was vaccinated with an improperly stored first dose of varicella virus vaccine live (oka/merck) (VARIVAX) administered subcutaneously (SQ) through right arm; with the first dose of diphtheria vaccine toxoid (+) hepatitis B vaccine rhbsag (yeast) (+) hib vaccine conj (menigococcal protein) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (VAXELIS) (dosage regimen not provided), lot# U7124AA, expiration date 13-JUL-2024 administered intramuscularly (IM) through left thigh; with the first dose of hepatitis A vaccine (dosage regimen not provided), lot# 2JD3Y, expiration date 04-DEC-2022, IM through left thigh; and with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-R II) (dosage regimen not provided), lot# S039316, expiration date 04-DEC-2021, SQ through left arm. All vaccines were storage in clinical practice administered as prophylaxis. On that day, second dose of pneumococcal vaccine conj 13v (CRM197) (PREVENAR 13) (dosage regimen was not provided) lot# DL2971, expiration date 30-NOV-2022, IM through right thigh for prophylaxis. It was reported that the operator was trained, and the vaccine was used according to the instruction's leaflet; however, the vaccine was not available for return because was used.  On that day, the clinic lost power and the vaccine was administered to the patient before being cleared by manufacturer for use. On 20-OCT-2021, the manufacturer was contacted and were cleared all affected vaccines for use. The patient involved had not reported any adverse reactions to immunization. All staff clinic was aware to have vaccines cleared by manufacturer after a temperature excursion. The temperature excursion occurred as a result of a reading from the digital data logger.
Breakthrough case admission after 2 vaccines pfizer 6/17/21 Lot# Ew0168;  Pfizer 7/20/21 Lot# Ew0198
developed fever and headache 2 days after injection of Rabies pre-exposure. Diagnosed with adverse effect of vaccine. Out of work for 1 day.