chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced joint pain, joint swelling, fatigue, visual problem, eye pain, eye twitching, cognitive impairment, memory loss, decreased activity level, rheumatological symptoms, neurological impairment and autoimmune disease. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 15 October 2008 via an interview conducted by a lawyer with the subject. The subject received LYMERIX on 29 June 1999, 02 August 1999, and in May 2000. On 02 August 1999 he developed knee pain. In September 1999 he developed "mental fog". In the fall of 1999 he developed restless leg syndrome. In October 1999 or November 1999 he experienced compartment syndrome. Treatment included ibuprofen, "Icy-Hot", and VIOXX. He underwent an emergency fasciectomy on an unspecified date. The events were unresolved at the time of this report. This case was assessed to be medically serious by GSK based upon follow up information.
Narrative: Breakthrough covid-19 infection: Admitted with acute chronic hypoxic respiratory failure COVID-19 pneumonia
The patient was administered an expired vaccination. The vaccine expired March 06, 2020 and was given on 06/02/2020. The patient had no adverse effects to the vaccine at the time or following the injection.
Fainted and fell of chair-Partially broke fall-Kept lying down for 10 min Given something to eat Small bump on head Ice applied
Patient arrived with Father in our drive up vaccine line.  Father stated that he had brought the patient in for a shot.  I asked for the COVID card, he did not have one.  I looked and our RX system and concluded by that information that they were in need of a 2nd Moderna dose.  There was a unfilled order for Moderna on the patient's profile and there was only 1 dose recorded.  I made up the dose, handed the father a white COVID card and gave the vaccine.  I cannot recall if I stated what vaccine I was giving, but it is something I routinely do.  Later a nurse called to question what vaccine we had given the patient that morning.  Upon review we found that the patient had gotten their 2nd dose of Moderna on the Monday before 12/5/2022.  This dose was recorded in our daily record but was not entered into system or processed in our RX system.  That is a failure in our protocol and is ultimately what led to this error.  We are investigating how we had a breakdown procedure so that we may make changes to mitigate this error in the future.    I spoke with the mother and informed her of the potential side effects and risk to getting a 3rd dose.  Doctor was also made aware of the error.  Mother will inform us of any negative side effects.
5/28/21 PMH HTN, HLD, BPH, prostate cancer with bone mets undergoing chemo presented to ER with concern for developing sepsis/shock
Metal taste in my mouth; maternal exposure during pregnancy, first trimester; This is a spontaneous report from a contactable consumer (patient). This consumer or other non hcp reported information for mother. This is a maternal report.  A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration, administered in left arm on 15Apr2021 09:45 (at the age of 39-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Patient had no known allergies to medications, food or other products. Concomitant medication included prenatal supplements for unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The last menstrual period was on 26Feb2021. On 15Apr2021 at 21:00, the patient experienced metallic taste in mouth. Since the patient had received the vaccine during pregnancy there was maternal exposure during pregnancy, first trimester. Patient was 7 weeks pregnant at the onset of the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Patient was due to deliver on 03Dec2021. The clinical outcome of the event metallic taste was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Approximately 3 weeks after my 4th dose I contracted COVID and experienced the following symptoms: Headache, Sore throat, Muscle aches, Fatigue, Dry cough, and a rash (Redness without itching). I did not take anything for treatment until I had an online chat with a PA after I tested Positive for COVID using a home kit test. I was prescribed with PAXLOVID for 5 days and have been taking for 2 days and so far I have been feeling a bit better.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 03-SEP-2013 the patient was vaccinated with a dose of ROTATEQ (Lot number 1808AA, Expiration date: 29-AUG-2013) (dose and route not reported) which expired on 29-AUG-2013. No adverse effects were reported. Additional information has been requested.
Day after injection redness,warmth, painful to touch at injection side. Next day gone. One week from the day I received the vaccination Red and warmth at injection site and sore under left armpit same side injection given on.
Noticed sharp joint pains in my hands and left greater toe.  9-12-2011 - right index finger and large joint, edematous & tender. Progressively got worse. Lab work done on 9/14 (CBC, CRP, uric acid & RA were all negative). Was started on prednisone.  9/16/2011 - synovial fluid aspirated, was cloudy, cultures were negative. Received IV Vancomycin & Rocephin twice daily for 4 days. Then oral antibiotics prescribed for 11 days - Clindamycin 450 mg three times daily. Finger/joint still slightly swollen and remains tender along the flexor tendon area of hand.
I started sneezing and coughing all night this a week before I went to urgent care as it was not getting better. I went on 14MAR2023 and went back on 16MAR2023 as I was not getting better, both times I was tested for COVID-19 and the tests were negative. On 16MAR2023 a nasal swab it determined I had Pneumonia and an non specified cough. I saw my Pulmonologist on 17MAR2023 he ordered a prescription of cough syrup and a regiment of prednisone.
4 yo booster given on 4-1-14. Left thigh became markedly red and swollen. Pt seen in Urgent Care 4-2-14 and in our office 4-3-14 = improving on BENADRYL. DTaP and Polio given in left thigh.
Generalized Vaccinia (mild); limited to both distal arms, both thighs and right hand. No oral lesions. Immunization site healing well, no involvement.
Stroke like symptom- babble; could not form words to communicate to wife or EMT; 24 hrs before he didn't feel well nothing in particular-no headache, no stomach issue, no fever, no tremors or motor skill issues.; This is a spontaneous report received from a contactable consumer (patient). An 86-year- old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 18Feb2021 as a single dose and first dose on 28Jan2021 as a single dose and both the doses (at the age of 86-years-old) for COVID-19 immunisation. The patient medical history included Prior stroke, Kidney disease and inactive pituitary gland. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received concomitant medication within two weeks of vaccination (names not specified). The patient did not receive any vaccine within 4 weeks prior to the vaccine. On 09Mar2021, the patient had stroke like symptom- babble, could not form words to communicate to wife or EMT and he didn't feel well on an unknown date in Mar2021 (24 hrs before) (as reported). It was reported that patient had no headache, no stomach issue, no fever, no tremors or motor skill issues. The patient visited emergency room and was hospitalised on an unknown date in Mar2021 for the events Stroke like symptom- babble, could not form words to communicate to wife or EMT for 2 days. Therapeutic measures were taken as a result of events stroke like symptom- babble, could not form words to communicate to wife or EMT. The patient had undergone laboratory test and procedures on an unknown date in Mar2021 includes EKG, heart CT, monitored blood, a full MRI (next morning) and the results were not reported. The outcome of the events Stroke like symptom- babble, could not form words to communicate to wife or EMT was recovered on an unknown date in Mar2021 while for another event was unknown.  Information about batch number and lot number is requested.
Within in an hour of my vaccination I experienced neck and shoulder pain on my left side. During the the next several days I took Tylenol and Motrin to help ease the pain however by the 8th day the pain became unbearable I reached out to my PCP.
Patient complained of facial flushing, tingling lips, and his throat feeling like it was tightening.  Nurse administered 25mg IM Benadryl per clinic protocol. The reaction resolved after administration of IM Benadryl.
Developed a severe sore throat and productive cough began on 6/24/2022, Initially treated with amoxicillin for 10 days, but three days into this the throat swab for suspected strep infection came back negative.  I was not comfortable quitting the antibiotics mid-coursse, so I finished the 10 days.  PCP believed I was suffering from Thrush and treated me with NYSTATIN, which I did until the bottle was empty on 7/18/2022; on which day I woke up with general body aches, productive cough, and a very mild fever 99,3 (normal for me is 97.7).
Hypertension; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and HYPERTENSION (Hypertension) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.  Concurrent medical conditions included Non-smoker and Abstains from alcohol. Concomitant products included ESOMEPRAZOLE MAGNESIUM TRIHYDRATE (NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]) for Gastroesophageal reflux disease, LEFLUNOMIDE and PREDNISONE for Rheumatoid arthritis.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) (40 mg,1 in 2 wk). On 06-Jan-2022, the patient experienced COVID-19 (COVID-19). On 28-Jan-2022, the patient experienced HYPERTENSION (Hypertension). The patient was treated with LOSARTAN at an unspecified dose and frequency; GUAIFENESIN (MUCINEX) at an unspecified dose and frequency; DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (TUSSIN DM) at an unspecified dose and frequency and HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE & HCTZ) at an unspecified dose and frequency. In January 2022, COVID-19 (COVID-19) had resolved. At the time of the report, HYPERTENSION (Hypertension) had not resolved.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2022, Viral test: Positive. On 26-Jan-2022, Viral test: Negative. On an unknown date, Blood pressure measurement: Blood pressure raised to 173/72.         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   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded  No known allergies  The reporter's causality for the event(s) of COVID-19 and HYPERTENSION with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility.
Intermittent rapid/irregular heartbeat when at rest. Began 12/28 and has intensified slightly since 1/1. Had a similar but stronger reaction to the second vaccine shot (Pfizer, received 2/16/21) that eventually resolved on its own.
11 year old patient was given flublok meant for ages >18. Patients guardian was immediately notified of the error and was told to monitor their child for any signs and symptoms of adverse reactions. If any occurred patient was told to go to the emergency room.
nausea, abdominal distention, irregular bowel movements, a feeling of fullness even after eating very little, severe weight loss; autoimmune attack which damages the vagus nerve,; damages the vagus nerve; felt at an all-time low in terms of mental and physical health. He was in the worst shape of his life both physically and mentally.; felt at an all-time low in terms of mental and physical health. He was in the worst shape of his life both physically and mentally.; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt.) of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. It was reported that prior to receiving the vaccine the pt. was in the best shape of his life in terms of physical health and ability.  On 04-JUN-2020, the pt. was vaccinated with a first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for preventing cancer (dose, route of administration, lot number and expiration date were not reported).   Following his quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection, on an unspecified date, the pt. began suffering from nausea, abdominal distention, irregular bowel movements, a feeling of fullness even after eating very little, severe weight loss, and an inability to engage in normal physical activities. He received a colonoscopy which was negative for colitis was diagnosed with gastroparesis (paralysis of the stomach) (Impaired gastric emptying), which is a neurological disorder affecting the vagus nerve (vagus nerve disorder) interfering with the digestive process.  As a result of his post- human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, pt. had been unable to pursue his dream   He was devastated. To this day, pt. felt at an all-time low in terms of mental (Feeling abnormal) and physical health (General physical health deterioration). He was in the worst shape of his life both physically and mentally.  As a further proximate result, the pt had suffered and would continue to suffer significant medical expenses, including but not limited to costs for hospitalization (unknown date), physician care, monitoring, treatment, medications and supplies and suffered ongoing injuries, pain and other damages.  The outcome of all events was not reported. The causality between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was related.  Upon internal review, impaired gastric emptying and autoimmune disorder were considered to be medically significant.  The events were considered to be disabling by the reporter.
General feeling of tiredness / sickness / weakness for 3 days.  Swelling in the left arm , swelling in left lymph node under the armpit, multiple red raised lumps on left arm from injection site down to the elbow with significant swelling and tightness with pain.
Headache 14 hours Fever 36 hours Rash on injection arm 5 days Swollen lymph node injection side 7 days but decreasing daily
Patient received dose of Moderna vaccine post excursion; Patient received dose of Moderna vaccine post excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received dose of Moderna vaccine post excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received dose of Moderna vaccine post excursion).    No Concomitant products reported.  It was reported that patient received the dose of Moderna vaccine post excursion.  No treatment products reported.  This case contains information for the 14th of 19 patients reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-706941, US-MODERNATX, INC.-MOD-2023-706966 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706941: US-MODERNATX, INC.-MOD-2023-706966:
presenting to the emergency department for evaluation of weakness, confusion, decreased appetite, cough and shortness of breath for the last 5 days
Patient states swelling of left hand and cannot feel thumb and palm. Started the next day and is present currently.
Radiating pain down arm; achy and painful x 4 weeks; cannot raise arm over head.
The patient developed an acute right posterior frontal stroke with weakness, dysarthria and hemineglect at 1015pm on 1/26. He had received the Moderna vaccine second dose on 1/25. He received tPA and is now in the ICU for monitoring. Also found to have atrial fibrillation on EKG which seems to be a new finding.
No additional information; Expired dose of PROQUAD was administered; This spontaneous report was received from nurse referring to a patient of unknown age. The patient's current condition, pertinent medical history, concomitant medications and drug reactions or allergies were not reported.  On 18-FEB-2022, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) (lot # T028296 and expiration date reported as 16-FEB-2022), 0.5 milliliter for prophylaxis (expired product administered). Vaccine had not experienced any temperature excursion. No additional information (No adverse event). No product quality complaint reported.
Severe Chest pain  and pressure for about 20 minutes , breathing was normal but unable to move.
A rash that is crusty in nature at the injection site. It has been there for almost 9 months.
Information has been received on 01-MAR-2018 regarding a case in litigation from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route during 2008, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of shingles. On or about 01-MAR-2016, the patient was treated at a medical center for blistering vesicular outbreaks that were diagnosed as severe shingles. As a direct and proximate result of these malfunctions, 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.
4/7/2021-Very sore injection site. 4/8/2021-Repeated rapid trips for bowel movements in AM then hot flashes/fever in PM. 4/9/2021-Mild irritability after work feeling rushed. Trip out of state she vented a lot of stress related events unusually. 4/10/2021-Unusual heightened smelling and cleaning tendency followed by emotional mood swing later at night. She felt like a migraine was coming on. 4/11/2021-She barely slept and cleaned all night then read self-care books outside on porch.  Excessively packed the car to head home then repacked in an unusual manner and mood.  Took a Ketorolac (Tordol) to try to ease migraine she felt was coming on. Refused to let husband drive home because of drinking a beer. Made it home
Passed out. Became Diaphatetic was unconscious for 1 minute also salvia coming out of his mouth. outcome resolved  MD & paranoid
Dont have much time on this, keeps expiring. Started feeling headache, weakness in legs in April, May started having tingline in feet, and then Very bad pain in feet, then in June Knees started hurting too. thought it could be disease I saw on tv I cant pronounce, Geare Briaone? Went to ER April 29 2021 and again in June, emitted at hospital in June 25 I think for 3 days, they thank could be my Arthritis, I now think maybe the Johnson and Johnson some how speed up my Psoriatic/ Rheumatoid Arthritis, because I couldn't hardly walk in June and July, had to buy a cane, never in 10 years had I had so much pain in feet and knees.  I t is a little better, still hurts terriably when I first get up and try to walk. At work it takes a while to get moving, but toleratable if I keep moving,I just deal wit pain.
Pt lethargic and sleepy most of day and night, left thigh swollen, red and lumpy at injection site.
Two ladies (a grandmother and her granddaughter) came to the drop-off window and stated they wanted a flu shot.  The technician gave both of them paperwork to fill out.  The first person to turn in her paperwork was the granddaughter.  I prepared her IMZ and was going to go and administer it, but the grandmother turned her paperwork in as well.  I thought I would go out at the same time and give them each an IMZ while I was out there.  I prepared one Fluzone Quad and one Fluzone HD.  When I went to give the granddaughter her IMZ, I used the handheld to verify her name and DOB and correctly verified the NDC on the syringe that I was going to use for her.  Instead of putting it on the table, I put her IMZ in the tote where the Fluzone HD for the grandmother was.  When I picked up the syringe and administered it, I noticed that I had injected the Fluzone HD instead of the Fluzone Quad.  Otherwise no adverse event.  Incorrect vaccine administered.