chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; heart and lung problems; lung problems; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information about the pt's medical history, concurrent conditions and concomitant medications was reported. On 29-OCT-2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) injection (dose, route of administration, vaccination site, lot # and expiry date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In May 2014, the pt was diagnosed with painful and debilitating shingles and heart and lung problems thereafter, caused by zoster vaccine live (ZOSTAVAX). As a direct and proximate result of the Company's defective zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered severe injuries and life-long disabilities not present prior to using the Company's product, which were directly caused by the zoster vaccine live (ZOSTAVAX) vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of their condition and suffered economic losses due to her inability to work. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and disfiguring personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the pt suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered.  The events of shingles, heart and lung problems were considered to be disabling.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA013316:
Nausea, arm swelling, red rash at injection site, dizziness, chills. Treated with prednisone, Benadryl.
In the middle of June I've noticed that there was a lump in the front of my neck I called my doctor and scheduled an appointment for July 07/03/2022. The same day I was referred to the endocrinologist and did an ultrasound. On  07/21/2022 my doctor reviewed the results and told me that I was diagnosed with a large thyroid condition. I have an appointment with the endocrinologist on 08/16/2022.
This spontaneous report was received from pharmacy technician regarding multiple unspecified patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On unspecified dates unspecified number of patients were vaccinated with improperly stored GARDASIL (lot # L048237; expiry date 08-MAY-2017) dosing details unknown, intramuscularly. Concomitant medications were not reported. It was reported that the vaccines administered were subjected to temperature excursion of 31 degree Celsius for a time frame of 16 hours and these vaccines were not subjected to previous temperature excursions. No adverse effects were reported. Additional information has been requested.
7.5x9.5 area of erythema, warmth and mild induration around IPV given the day before (right deltoid area).
For several days, experienced chills, headache, body aches, sweats, extreme fatigue, fever, extremely pain in hands and feet and sensitivity in lower legs. All symptoms resolved except pain in hands, feet and legs, which include continuing sensitivity, tingling, numbness, prickling, and burning sensations, as well as intermittent shooting pain in hands and feet.  Hands and feet also experience stiffness.
Information has been received from a registered nurse (RN) concerning a 20 week old male who on 07 Dec 2006, at 7 weeks old, was vaccinated with the first dose of Rotateq. On 08 Mar 2007, 13 weeks after receiving the first dose, the patient was vaccinated with the second dose of Rotateq. Unspecified medical attention was sought. Additional information has been requested.
little achy  with a sore arm/ sore and achy arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (little achy  with a sore arm/ sore and achy arm) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030C22B) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Sep-2022, the patient experienced PAIN IN EXTREMITY (little achy  with a sore arm/ sore and achy arm). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] on 27-Sep-2022 at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (little achy  with a sore arm/ sore and achy arm) outcome was unknown.            No concomitant medication was reported. Patient states that she had two primary doses and two booster doses of vaccine. It was reported that the patient felt like someone sucker punched her. The patient not had any other side effects from it, just a sore and achy arm.
Low grade fever 100.5, headache, severe body aches, redness and swelling at the site of injection.
Information recieved form a man concerning his son who in July 1999 recieved vax. Approximately 24 days post vax the pt experienced sniffling, flu like symptoms and seven marks. No further information is available.
Patient woke up at 2:00am, approximately 14 hours after dose #1. Patient states he got up and went to the bathroom, got out of the bathroom took 3-4 steps and his legs from his knees down went weak, and he went down in slow motion, could not hold himself up. He could not get back up onto his feet, so he crawled back to bed and got up into bed. Then around 5:00 got up and went to the bathroom again, and walking was hard, but he used a cane, the same thing happened again, and his legs went under him and he fell backwards and ended up on his back. He laid there for a bit and got legs straightened out and his arms had not a lot of strength from elbows down. He crawled back into bed again and about 8:00 am got up and had trouble walking and had to use a computer chair to steady himself. Then sat for a while. Had trouble getting his lower body dressed and about 10:00 am felt as if he had no strength and was going to fall again so he called his doctor. He talked to the nurse who told him to take some Tylenol and see how he was in a couple hours. He said he could get around with a walker but felt as if his legs would not hold him up. Patient states he has stiffness in his legs, but not weakness. By that night was using the walker ok, by the next morning he stated he was walking fine and did not need a cane or walker.
syncope, elevated heart rate, fever 99-102, chest pain, began overnight.  Was evaluated at Medical Center ER the following day, diagnosed with pleurisy
After 2nd dose, rapidness came with the skipped heart beats. I had skipped beats, pounding, and rapid heart rate kept getting worse. After a month, I went to the doctor because I was scared and she sent me to the heart doctor and they put a monitor on me and then put me on medication to try and control it, and then I had a Cardiac Ablation. I had the surgery at a local hospital and I had a blood clot when they did the surgery. I was having 24000 a day on PVC and now I'm having 1200 a day and still have the rapid heart rate like it was. I can't think of anything else that happened. I had a vascular check up 2 months prior to 1st dose and they found nothing abnormal.
Left arm swollen with a red rash (big red lumps) less painful today. Blisters on top and bottom of lips. Pt had fever yesterday but no fever today. On 3/7/03, spoke with pt and swelling is considerably reduced, fever is normal but still has red rash on left arm around vaccination site.
In about 24-48h post flu shot - she developed a very diffuse sort of "red man" syndrome - called to say it started on her arm at the site of the flu shot then spread to her limbs and included her face. No rash just extreme redness, everywhere! We medicated w/ benadryl + pepcid and within 12 hours she was better and had no recurrence.
Nov 07 till recent symptoms, headaches, fatigue, vomiting, dizziness, back and neck pain, weight loss, rash, nausea. Signs-jerking, dropping things confuse-seizures treatment-emergency room stay in hospital overnight. Diagnose with epilepsy, now on medication.  10/28/08 Reviewed hospital medical records of 08/18-08/19/2008. FINAL DX:juvenile myoclonic epilepsy Records reveal patient had initial convulsive seizure on 8/18/08 but had been experiencing myoclonic jerks x 2 years prior along w/brief episodes of speech loss.  11/4/08 Reviewed neurology medical records of 9/4/08. FINAL DX: seizure disorder, partial Records reveal patient had 'jerking episodes' of arms & head for approx 8 mos.  Developed generalized tonic-clonic seizure, bit tongue & was confused & disoriented afterward.  No further seizures while on medication.
14 year old patient was administered a dose of proquad; no adverse effects reported; This spontaneous report was received from a registered nurse via company representative and refers to a 14-year-old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (exact dose, route of administration, lot # and expiration date were not provided), for prophylaxis (product administered to patient of inappropriate age). No adverse effects were reported.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. A 66-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ELIQUIS, start date: 01Sep2017. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "We got shot down for a bit due to Covid". Clinical information: patient got shot down for a bit due to Covid but lets get moving forward in helping others again! Patient getting out of hospital today but still laid up at home with drainage tubes. Patient received all vaccines including the Fourth and made sure they were all the Pfizer Vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reported no to having prior history of fainting or dizziness after receiving vaccine. Vaccine was administered at approximately 9:04 am and patient's boyfriend was administered at approximately 9:08. Upon return to his seat beside her at approximately 9:10 am, he noticed she was losing color and going limp. He called for help, and I assisted. The pharmacy team sent a Code White on the radio and several members of management responded to check on the scene. We moved the patient to the floor and applied ice packs to the neck and chest and removed her face mask for better circulation. The patient was wearing a thick sweatshirt so we attempted to increase air flow around her head and neck to cool her down as she was visibly sweating. The patient never lost consciousness or breathing and her pulse was always palpable. By 9:20 am, we had moved the patient from the floor to a sitting position then to a chair and provided her with a cold bottle of water and continued one ice pack on her neck. She stayed seated until 9:40 (34 minutes after her injection). She denied the need for an ambulance transport as she had her boyfriend here who could drive her.
Drug ineffective; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma; "Known allergies: Shellfish" (unspecified if ongoing); "interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: PROBIOTICS; ZINC; NYQUIL.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt vaccinated with Pneumococcal Vaccine developed 15cm diameter raised erythemia, tenderness skin was raised 1/2 inch. Rx was noted 1 hr after injection tx the next day w/Benadryl duration of local rx was 8 days off work x1 day.
Information has been received from a pharmacist referring to a 77 year old female patient with no concurrent and historical conditions and no allergies. On 09-JUN-2015 the patient was vaccinated with ZOSTAVAX (0.65 ml, once, subcutaneous, lot# and expiration date were not reported). There were no concomitant therapies. On 15-JUN-2015, the patient experienced redness, swelling, and itching similar to a bee sting at the injection site. The patient was seen at the pharmacy. There were no lad diagnostics studies performed. No treatment ws given for the events. The outcome of the events was not recovered. Additional information has been requested.
one episode of seizure attack while sleeping; low grade fever of 100F; injection arm soreness; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (one episode of seizure attack while sleeping) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Epilepsy. Concomitant products included PHENOBARBITAL (PHENOBARBITONE COX) and LEVETIRACETAM for Seizure, ZONISAMIDE and PARACETAMOL (TYLENOL) for an unknown indication.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced VACCINATION SITE PAIN (injection arm soreness) and FATIGUE (tiredness). On 15-May-2021, the patient experienced PYREXIA (low grade fever of 100F). On 17-May-2021, the patient experienced SEIZURE (one episode of seizure attack while sleeping) (seriousness criterion medically significant). At the time of the report, SEIZURE (one episode of seizure attack while sleeping), VACCINATION SITE PAIN (injection arm soreness), FATIGUE (tiredness) and PYREXIA (low grade fever of 100F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 °F (High) 100 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment information included Tylenol.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Nausea and Vomiting---with headache. 11/16/2009 OB-GYN records, 10/22/2009 patient  with c/o's nausea/vomiting x 2 weeks, worse last 2 days. Tx: Phenergan and hydration.
Face swelling, extreme pain in jaw, muscle pain throughout, sweating/chills, headache.
Patient reports a red rash that is hot to the touch that started a little over a week after her second covid vaccine. The rash was present on her left arm and leg. Patient also reports a bug bite the same day that the rash started that may or may not be related. Patient was instructed to take Benadryl and call doctor if it does not go away/gets worse. Patient reports no pain or itching.
Immediate pain after injection , fever that night.  Pain in left shoulder still decreased range of motion, severe pain in the front of shoulder.  Seen in ER the by an ortho specialist. Given two cortisone injections (October and December) and still unable to bring arm across chest and nonstop pain.  Had an MRI in Dec 2005, showed
soreness on her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness on her arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045a21a and 030b21a) for COVID-19 vaccination.     Concomitant products included AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) and VITAMINS NOS for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness on her arm). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency and SUMATRIPTAN for Symptomatic treatment, at an unspecified dose and frequency. On 18-Mar-2021, VACCINATION SITE PAIN (soreness on her arm) had resolved. Not Provided          This case was linked to US-MODERNATX, INC.-MOD-2021-076198 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076198:For Second dose
Dec 1, received first injection, with symptoms of fever, chills, nausea, lethargic, headache, arm soreness, and body/muscle aches over the next several days.  Continued to have a migraine everyday since with varying degrees of pain. Migraines were lessened by medications and Botox injections provided by my neurologist. However, I still suffer from the migraines everyday, and worse since my 2nd COVID vaccine on January 7. The other main lingering symptom was nosebleeds and excessive sinus/nasal dryness which resulted in surgery on January 5, Nasal septal cautery and dermatoplasty to address the nosebleeds.
This spontaneous report was received from a phlebotomist, referring to a patient of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On an unknown date, the patient may had vaccinated (the reporter was not sure) with one of the improperly stored vaccines of PNEUMOVAX23 (which had the lot # L019836, expiration date  24-MAR-2017) or RECOMBIVAX HB (lot # M006708, expiration date 02-JUN-2018, lot # M018625, expiration date 11-AUG-2018) or VAQTA (lot # L015460, expiration date 20-JUL-2017) for prophylaxis (dosage information, route or anatomical site of vaccination were not informed). Information about concomitant medication was not provided. No adverse effect was reported. There was no product quality complaint involved. It was also informed that the vaccines experienced a temperature: >46°F but < 77°F. The time frame was 12 hours and 45 minutes. There was no previous temperature excursion. The call was because of a "data logger". Additional information has been requested.
Narrative: LUE swelling after PPSV 23 injection yesterday. Erythema of proximal LUE. Symptoms: Erythema Multiform.
This spontaneous report as received from a consumer via Clinic refers to a currently 68 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-NOV-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
From initial information received on 10/06/03 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a female patient (age and birth date not reported) received Fluzone SV '2003-'2004 USP, lot number U1260AA, administered intra-muscularly in the right arm on 10/03/2003. The following day the patient developed redness and edema at the injection site, as well as itching, fever, aching, nausea, and pain and swelling in her joints. The patient's recovery status was not reported. The reporter of this case is the same reporter of cases 200302253, 200302256, 200302257 and 200302258.
a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (a sore arm) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood disorder.    On 22-Feb-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 VACCINATION SITE PAIN (a sore arm). At the time of the report, VACCINATION SITE PAIN (a sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication include chemotherapy for a blood disorder. No Treatment information was reported.   This case was linked to MOD-2021-285685 (Patient Link).
Two days after immunizations, child started with staring spells followed by screaming, hair pulling and head banging. The episode was daily at first and quite severe. The episode don't occur every day now. But they can happen any time on any day. The severe episodes usually end with crying spell that last for about an hour.
Pediatric dose given on 5/29/19 in left delt, patient scheduled to come back in for adult dose on 7/3/19
After taking last booster shot on 12/23/21 about month later I started to notice 2 bald spots on my head. After a few months they grew back but 2 more large patches emerged.
Within about 3 min of shots she suddenly lost consciousness was pale, limp and unresponsive. She was being held by her 15 year old sister when she collapsed backward, head and arms dangling to the floor. She was carried to an examining table. We remained there for about an hour waiting for her to recover enough to go home. Large swelling and redness in arm for 2 weeks afterward.
Fever of over 102, uncontrollably sweating that turned into uncontrollably shaking from being cold.  Swollen throat, hardly can swallow. Headache, extreme body aches, light headed.
Developed fever 4PM evening of immun; mom gave APAP; Next night awake w/arm hurting; 14APR reddness, swelling & area hard @ inject site lt arm; Given Augmentin;
Vomited, ran a fever and chills, sweated through multiple pairs of clothes in the first 24hrs. 2nd 24hrs had sinus headache, chest pain, and nausea. 5 days later still experiencing nausea and joint pain.
Pain and stiffness in neck and shoulders, some relief with Ibuprofen Pain in right thumb , new onset, worse pain in left thumb and wrist join