chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 02-AUG-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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.
Hospital Course and Significant Findings: Patient is a 79 year old male with a history of dementia, NPH who lives alone with part time caregiver who presented with fall and inability to get up.  Daughter called emergency number.  In the ER patient found to have UTI and COVID.  For his UTI he was treated with cipro with improvement in WBC and no fever.  Urine culture grew Enterococcus.  In terms of his COVID, he was not hypoxic so received no decadron.  He did receive Remdesivir while in the hospital.  He will go home on COVID isolation through 12/26/22.
On 12/07/2017, after receiving the MMR, I began to develop cough, sore throat and sinus drainage that worsened over the next several days. On 12/12/2017, I went to my primary care provider for complaints of severe nonproductive cough, sore throat, elevated temperature, and sinus drainage. I was given oral antibiotics, cough medications, and nasal spray.
Sore arm at injection site; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (02Apr2021), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 75 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Feb2021 10:00 (Lot number: EL9265) at the age of 75 years as dose 2, single for covid-19 immunisation. Family history included: "Diabetes" (ongoing), notes: more than 10 years, both parents had diabetes. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus (ongoing); LEVEMIR taken for diabetes mellitus (ongoing); JANUVIA taken for diabetes mellitus (ongoing); RAMIPRIL taken for diabetes mellitus (ongoing). Vaccination history included: Bnt162b2 (1st dose, lot EL1283, administered intramuscularly on left arm at 10:00), administration date: 14Jan2021, when the patient was 78 years old, for Covid-19 immunisation, reaction(s): "Sore arm at injection site". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 11Feb2021 10:30, outcome "recovered" (12Feb2021 04:30), described as "Sore arm at injection site". Therapeutic measures were not taken as a result of vaccination site pain.  No follow-up attempts are possible. No further information is expected.
Immune system is low; Muscle twitches in arms and leg; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED IMMUNE RESPONSIVENESS (Immune system is low) and MUSCLE TWITCHING (Muscle twitches in arms and leg) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 006B21A) for COVID-19 vaccination.     The patient's past medical history included Hysterectomy since an unknown date. Concurrent medical conditions included Insomnia, Menopausal and Hypertension. Concomitant products included ESTRADIOL (ESTROGEN) for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DECREASED IMMUNE RESPONSIVENESS (Immune system is low) and MUSCLE TWITCHING (Muscle twitches in arms and leg). At the time of the report, DECREASED IMMUNE RESPONSIVENESS (Immune system is low) and MUSCLE TWITCHING (Muscle twitches in arms and leg) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood triglycerides: high (High) High.         Concomitant medication include PTSD, insomnia and  blood pressure medication.  Treatment information was not provided.
fever, chills, chest pain/dizziness for 4 days starting 48 hours after vaccine - dizziness - SOB since
excruciating pain in the left arm; arm numb; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 4G5HX, expiry date unknown) for prophylaxis.   On 8th March 2019, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm and numbness of upper extremities. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the numbness of upper extremities was unknown.   It was unknown if the reporter considered the pain in arm and numbness of upper extremities to be related to Shingrix.  Additional details were reported as follows: The patient experienced excruciating pain in the left arm and finally subsided at the time of reporting, two months later completely numbness there. The reporter agreed to follow up with GlaxoSmithKline.
On Oct 29 patient received the Pfizer Covid-19 booster. On Nov 5 she developed mild abdominal pain without other symptoms or comoplaints. On Nov 11 patient developed herpes zoster of the left inferior thorax
This spontaneous report as received from a healthcare worker, refers to an unspecified number of patients of unknown age and gender. On unspecified dates since 02-JAN-2015, the patients were administered an unspecified number of improperly stored doses of ROTATEQ orally (dose and lot numbers were not reported). This is one of several reports received from the same source. Additional information has been requested.
After waiting 15 mins  I developed a dry throat and walked to my car (8-10 mins later). Began to develop difficulty swallowing by the time I reached my car.  Waited a few minutes and it did not abate and continued worsen,. Went to hospital's ER and was seen by Dr. At that time, my voice had become coarse and gravely. Was given oral steroid and a Benadryl.  Symptoms lessened a bit and were gone after about 2 hours. While at first I thought my breathing wasn't affected, after symptoms cleared, I realized that my breathing was easier. Symptoms did not reoccur.
PNEUMOVAX 23 administered on 11/21/16. Patient returned to pharmacy on 12/1/16 and said she contracted an infection in her arm due to the vaccine and had to received antibiotics from the emergency room.
Patient said he felt light-headed after his shot. He was advised to continue sitting in the vaccine area. Since he was feeling light-headed, the immunizing pharmacist told me to get the blood pressure cuff. When I got back, the patient passed out. The pharmacist and I moved the chair from underneath him and he gently put him on the floor. He quickly woke up and the pharmacist began to ask him questions such as his name and where he was to make sure he was ok. He was able to answer those questions fine and we placed him in a chair so he can rest. When he was in the chair, he began to pass out again. He quickly woke up again but wasn't feeling good. The pharmacist checked his blood pressure and it was low. His temperature was at 93F. The pharmacist continued to stay with him and he made sure that someone else was able to come and pick him up. Once he felt ok, he had the patient go sit in the post-vaccination waiting area until he had his ride pick him up.
Sore arm after injection. I could bearly move it. Fever chills, weakness headache and body pains for 24 hours. I did not seek treatment but I will be letting  my OBGYN know at the next appointment.
Patient experimented skin hyperpigmentation on vaccine site right after it was administered and the skin still did not return to normal color since.
Patient received vaccination on 2/13/2021 around 15:44 CST. Patient called 2/26/21 and reported that after receiving the vaccine she experienced an itchy rash all over her back from her neck to her waist the next day which took 3 days to fully clear up. The patient reported using a cream (unknown) on the rash to help it resolve.
expired Moderna vaccine administered past 12 hours puncture time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator: 4APR2022. Date(s) and time(S) vial was first punctured: 4APR2022 at 1:55 PM. Vial did not undergo any temperature excursions. It was reported that 7 doses of the Moderna COVID-19 vaccine were administered to patients more than 12 hours after the vial was first punctured. HCP stated that she would like to get information on stability of the Moderna vaccine that was administered to patients past 12 hours puncture time. No treatment information was provided by the reporter. No concomitant medications were provided by the reporter.
Breakthrough case admission after 4 vaccines Moderna 4/3/21 Lot# 026B21A;  Moderna 5/1/21 Lot# 017C21A;  Moderna 11/18/21 Lot# 077C21B;  Moderna 5/27/22 Lot# 056M21A
Tingling on both fingers. NO SOB, In no acute distress. No rashes in body.
This was patients 4th Moderna IMZ, 1st Bivalent Patient either hurt herself standing up from IMZ chair or had adverse reaction. Within 5 minutes of receiving vaccination she reported pain in spine, hips and legs. Pain started when standing up but became severe a few minutes later. We called 911 and when EMT arrived pain had subsided some.
Soreness; redness; hard lump; swelling; nausea; ringing in the ears.
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 73-year-old female patient who received Influenza vaccine Quadrivalent. In September 2014, the patient received Influenza vaccine Quadrivalent. In September 2014, an unknown time after receiving Influenza vaccine Quadrivalent, the patient experienced fatigue and fever. In November 2014, the patient experienced swine influenza and unwell. In September 2014, the outcome of the fatigue and fever were recovered/resolved. On an unknown date, the outcome of the swine influenza and unwell were recovered/resolved. Additional information received: Consumer reported having the 4 dose in September, and felt fatigued and feverish for ten days. Then, got the swine flu in November and was desperately ill for over one month. Consumer had 73 y/o and wondered if this illness would be her last.
Woke up with fatigue. Throughout the day it progressed to muscle aches and headache. Was gone by next morning
Moderna COVID-19 Vaccine EUA Fever, Headache, Chills, body convulsions, delirium, confusion, severe fatigue, dyspnea on exertion.  Symptoms persisted for about 30 hours.  Following recovery of acute symptoms, persistent chest pain is present and is worsened with exertion.  Mild soreness is present at the injection site over 1 week later, but is mild and has no significant erythema indicative of allergic response.
This spontaneous report was received from a health professional refers to a patient of unknown demographics. On 23-MAR-2015 the patient was inadvertently administered with improperly stored M-M-R II (lot # J014873, expiry date: 21-NOV-2015), .5 ml, subcutaneous. No adverse effects were reported. Outcome of the event was unknown. Reporting health professional considered the event to be not related to M-M-R II. Additional information has been requested.
PATIENT EXPERIENCED EXTREME HEADACHE, MUSCLE ACHES,FEVER, WHICH LASTED 2 DAYS AND VERY RED, SORE UPPER ARM WHERE VACCINE WAS GIVEN. SHE FELT BETTER AS OF 9/18/17 BUT HER ARM WAS STILL RED IN A LARGE AREA OF HER DELTOID.
17 year old patient received Moderna covid vaccine which is only approved for 18 year olds and above. Patient experienced no adverse effects.
Patient became pale, loss consciousness. Arms became tense with one extended and one flexed. Patient did not respond to painful stimuli. Awoke at 0955. Paitent pale, diaphoretic, Vital signs at 0956 were 132/84 Pulse 72, SpO2 98% RA. Denied pain, c/o nausea. Patient sat up and becaume more pale and diaphoretic, vitals remained stable. Patient had not eaten or drank any fluids since 2000 the night before.
Developed blisters and sores outside of the vagina. Not sure if it triggered the HPV I had as a teenager.
is requesting a third dose now; is requesting a third dose now.; No additional AEs or PQC reported; patient has received PNEUMOVAX 23 in October 2011 and again in September 2014; This spontaneous report was received from a pharmacy intern and refers to a 71-year-old patient of an unknown gender. Medical history included stem cell transplant in April 2011. There was no information about the patient's concurrent conditions and conomitant medications provided.  In October 2011, the patient received first dose of Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (exact dose, route of administration, lot number and expiration date were not provided) (inappropriate schedule of product administration).  In September 2014, the patient received second dose of Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) (exact dose, route of administration, lot number and expiration date were not provided) (inappropriate schedule of product administration).  The patient was requesting now a third dose of Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) (inappropriate schedule of product administration; circumstance or information capable of leading to medication error). No additional adverse events were reported.
Pt started with a low grade fever and headache, pain on injection site. Rash started on 5/19/17 on both arms, legs, chest area(s), and stomach area(s), not itchy, but photosensitive. Pt described the rash as red bumps but not itchy. Pt called 5/19 to inform about the adverse reaction. Pt has taken ZYRTEC for rash. Pt said the fever was gone in 1 day but the rash lingered. Pt was instructed to take BENADRYL for rash for a couple of days for rash, if not improved, then pt can go see dr. No other neurological reactions were reported.
ADPT, IPV given. 30 minutes later child developed full blown anaphylaxis. With respiratory distress. Epipen given and transported to hospital.
Tinnitus, high pitch constant tone primary in left ear at onset. Symptoms have progressed to both ears.
Pt recvd vax 21AUG92; recvd 2nd HIB 23JUN92 & on 26JUN seen in ER for vomiting, extreme fussiness & rigidness in back; dx of Haemophilus meningitis made by LP; serotype unk;
one syringe is broken; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 28Feb2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: GM9409, Expiration Date: Mar2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "one syringe is broken". Additional information: Caller stated that she was calling about the Pfizer Product:  Prevnar 20 (NDC number: 00052000-10). They have a box containing a broken syringe.  The container had not yet been opened.  Caller stated that there were 10 syringes in a box, there was containers in the box each containing 5 syringes. The container with the broken syringe in it was still sealed and unopened. Caller stated that no patients had received the affected medication. Caller stated that the affected syringe was available to be sent to Pfizer for evaluation if it was requested.  Caller stated that they were not going to open the container that the affected syringe was in, so all 5 syringes in that container were available if needed.  Follow-up attempts are completed. No further information is expected.
Information has been received from a 61 year old female consumer with hypertension and no drug reactions or allergies who on 29-SEP-2007 was vaccinated with 0.65 ml Zostavax (Oka/Merck).  Concomitant therapy included PREMARIN and "Catarix".  On 30-SEP-2007 the patient reported developing back pain and "found out that she developed PHN after the Zostavax (Oka/Merck)".  Unspecified medical attention was sought.  There was no product quality complaint.  There were no lab diagnostic studies performed.  At the time of reporting the patient had not yet recovered.  Additional information ahs been requested.
Redness, puffy, and warm to the touch in the shot location. Three inch diameter in size.
Within 7 days, freckles (purpura) below eyes on cheeks. 10 days, freckles/purpura spread all over body, bruising on legs and arms; nosebleed not clotting. ITP Low platelet counts since vaccine. Hemo low; RBC low, WBC high, bleeding, mood swings. 5/27/04 still to today.  Nurse follow up on 09/21/04 states: "No new information."
hand gets / numb; shooting pains radiate from injection site, from the muscle / through the neck; shooting pains radiate from injection site, from the muscle / to the left side of my head; cannot move shoulder back at all. Cannot bend shoulder backward and has limited mobility.; severe pain at arm of injection, left arm, deltoid / Pain radiates to the scapula and forehand / Cannot sleep on that arm; shooting pains radiate from injection site, from the muscle, up the shoulder/The trigeminal radiation of pain at times; Worst pain at the injection site; severe tendonitis; muscle pains; hand gets cold; This case was reported by a physician and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number N42DE, expiry date 4th June 2022) for prophylaxis.   On 12th September 2020, the patient received the 1st dose of Shingrix. On 13th September 2020, 1 days after receiving Shingrix, the patient experienced injection site pain, tendonitis, muscle pain, cold hands, joint range of motion decreased, pain in arm and shoulder pain. On an unknown date, the patient experienced numbness in hand, neck pain and headache. On an unknown date, the outcome of the injection site pain, numbness in hand, shoulder pain, neck pain and headache were unknown and the outcome of the tendonitis, muscle pain, cold hands, joint range of motion decreased and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, tendonitis, muscle pain, cold hands, numbness in hand, joint range of motion decreased, pain in arm, shoulder pain, neck pain and headache to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received 1st dose of Shingrix in left arm deltoid and experiencing severe pain at arm of injection. The patient had been experiencing severe tendonitis and muscle pains and they were not easing up.  The pain radiates to the scapula and forehand. Worst pain at the injection site. Sometimes the patient hand gets cold and numb and could not move shoulder back at all.  The patient cannot bend shoulder backward and had limited mobility.  The patient could not sleep on that arm and sometimes shooting pains radiate from injection site, from the muscle, up the shoulder and through the neck and sometimes to the left side of head. The trigeminal radiation of pain at times, sometimes very disabling like shoulder was going to be ripped apart. The reporter consented to follow up.  The email could not be obtained since reporter mentioned that had many emails and did not remember passwords, maybe would contact a family member. For tolerances of 2nd dose, refer case US2021AMR070411.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR070411:same reporter
Possible transverse myelitis with numbness and tingling of bilateral upper and lower extremities approximately 1 wk after receiving vaccine
Within 24 hours of vaccination,patient developed full body rash that mimics chicken pox. Patient complained of itching but no other symptoms.
Patient received additional dose of original series in place of updated, bivalent, vaccination.  Patient contacted and informed. Patient reports no side effects.
A report has been received from a Health Professional concerning a 31 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The patient experienced smell of MSG in FLUMIST causes patient to feel sick due to MSG allergy, she perceives the odor and develops the allergic reaction, feeling sick and severe headache. The outcome of the event of smell of MSG in FLUMIST causes patient to feel sick due to MSG allergy, she perceives the odor and develops the allergic reaction, feeling sick and headache is unknown. The report was considered to be non-serious.
Raised red rash under affected arm 48 hours later x 3 days; noticed indentation in armpit 96 hours later; atrophy left deltoid muscle 1 week later.
Pt. states her eyes turned red the same day as the vaccination and he vision turned dark around the edges and she became congested. She states she has now had a sinus infection for 4 months and her vision is still dark around the edges. She states she went to the ER that day and they gave her antibiotics and pain meds and ran an  Follow-uo - Pt did not know the time therefore I left it blank.
Pt was admitted for acute, severe exacerbation of her Hidradenitis suppurativa, tested positive on 01/27/2022 patient does not present with any symptoms and this is not considered a breakthrough case.
01/12/23 presents to ED for "breathing problem". PMHx of "COPD, chronic hypoxic respiratory failure on 3L NC QHS, Atrial fibrillation with hx pacemaker not on AC, CKD stage 3a, HTN, AAA, OSA, HTN"
I had a sore throat, runny nose with a headache. A slight fever with minor coughing.
Pain rated 10/10 that evening and presented to urgent care. Difficulty lifting arm. Update on 11-22-16 with no pain, but it aches still. Able to lift arm more, but not full range.