chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. Information regarding the patient's past medical history, concurrent conditions, or concomitant medication was not provided. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 06-SEP-2013, as recommended for routine adult health maintenance for the prevention of shingles. It was reported that the ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 08-JUL-2015, the patient was treated for a painful rash that was diagnosed as shingles. While shingles is a chronic and incurable condition, the patient has been prescribed valcyclovir to manage his symptoms. 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.
No reaction to first vaccine. Night after second vaccine, woke up with hands locked together, fatigue, headache and body aches. Patient states he had to have his fingers pulled apart. Each day since, he has continued with hands "locking". Patient states he has been using a stress ball to help relax the muscles in both hands. Patient is concerned since the problem is not only happening at night, but also during the times he is walking, "my hands clinch up."
I started hem morning from my nose for over a hour and my blood wouldn?t clot. My nose was profusely bleeding while it was constantly running down my throat and bleeding out my right eye.
Normal arm soreness for approximately 24 hours. Then, eight (8) days after injection, a large red area developed around the injection site. Area was hot and itchy with minor soreness.  Symptoms are still present, but have subsided after two days.
Information was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 03-JUN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L045953 (dose, route and expiration date not reported). Concomitant therapy was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Soreness in arm, day 3-4 was extremely fatigued, I could not get up off the couch. Then I developed a runny nose and sore throat. I went and got tested for COVID and it was negative.
I had the regular symptoms (fever of 104, shaking, chills, headache) 6 hours after the shot. What is my new concern is leg weakness and pins and needle feeling in my legs that started a few days after the vaccine. My legs still feel weak and I have occasional pins and needles and muscle cramps all through my legs, but especially my left.
severe nerve pain; feeling under the weather; cause some spillage; This case was reported by a nurse via sales rep and described the occurrence of nerve pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nerve pain, malaise and accidental underdose. On an unknown date, the outcome of the nerve pain was recovered/resolved and the outcome of the malaise and accidental underdose were unknown.   It was unknown if the reporter considered the nerve pain and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose and a half of product this happened 8 weeks ago, and was patients first dose. The patient was receiving first dose of shingrix, when due to error, caused some spillage. The patient was immediately on same arm gave an additional dose of shingrix, full dose.  The patinet then suffered severe nerve pain for a couple of days following immunization, as well as feeling under the weather. The follow up consent was granted.
No adverse effects; patient received an expired dose of VARIVAX; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.         On 29-APR-2019, the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) (expired product administered) lot # N012619 and expiration date 21-APR-2019, subcutaneous for prophylaxis (dosage schedule, anatomical location were not reported). No adverse effects were reported in the patient.     The outcome of expired product administered and no adverse event were unknown.
LINGERING FATIGUE, CHEST TIGHTNESS, UPPER BACK PAIN, NAUSEA, DIARRHEA, HEADACHE
Pt had body aches, then back from shoulder blades to waist broke out in hives. Mom applied ice. Called Dr's Office.  Ice and ibuprofen given throughout day as needed. Hives eventually decreased, left w rash, that too had faded by night time.
Patient presented to Medical Center on 01/31/2022 with severe fatigue, worsening of his nonproductive cough and SOB.  CXR showed multifocal PNA.  He was given a dose of vancomycin, cefepime, IV steroids and fluids, and supplemental oxygen.  Patient was admitted to hospital for treatment of acute hypoxic respiratory failure and sepsis secondary to Covid-19 PNA.  He was placed on dexamethasone, but remdesivir was not administered d/t kidney function.  Empiric treatment for bacterial coinfection with ceftriaxone an azithromycin was started.  Started on bicarbonate drip for metabolic acidosis.  On 02/04/2022 he began requiring high glow nasal cannula.  He was then transferred to CCU.   He required intubation and  intermittent HD.  On 02/23/2022 comfort care measures initiated and patient expired.
An investigator reported that an unidentified child received Prevnar and Hep B vaccines on 08/09/2001, as part of the GMA/Local study. Post immunization, the child developed a fever that was rated grade 3. A fever of grade 3 measures greater than or equal to 103 deg. F. but less than or equal to 105 deg. F. According to the protocol, grade 3 adverse reactions require a clinic visit within 48 hrs of the event. This case was considered serious since fever (grade 3) was considered medically important for this event. The investigator assessed the relationship between fever and Prevnar as "possibly related."
Large localized reaction on her right thigh where administered. One red blotch on forearm and one red splotch on each hand/fingers.
Extreme fatigue lasting more than 1 week, headache for several days, back pain, abdominal pain, joint pain so bad it was hard to get dressed, urinary tract infection (about 36 hours later)
Sore throat; Sweating; Felt sick; Head rash; Headache; Swelling lymph node; Chills; Fatigue; Throw up; Foggy brain; Felt sick; Bad headache; Chills; Fever; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggy brain), the first episode of ILLNESS (Felt sick), OROPHARYNGEAL PAIN (Sore throat), HYPERHIDROSIS (Sweating) and the second episode of ILLNESS (Felt sick) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2020.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced FEELING ABNORMAL (Foggy brain), the first episode of ILLNESS (Felt sick), HEADACHE (Bad headache), the first episode of CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea), the first episode of FATIGUE (Fatigue) and VOMITING (Throw up). On 07-May-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), HYPERHIDROSIS (Sweating), the second episode of ILLNESS (Felt sick), RASH (Head rash), HEADACHE (Headache), LYMPHADENOPATHY (Swelling lymph node), the second episode of CHILLS (Chills) and the second episode of FATIGUE (Fatigue). On 28-Apr-2021, FEELING ABNORMAL (Foggy brain), HEADACHE (Bad headache), PYREXIA (Fever), NAUSEA (Nausea) and VOMITING (Throw up) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), HYPERHIDROSIS (Sweating), the last episode of ILLNESS (Felt sick), RASH (Head rash), HEADACHE (Headache), LYMPHADENOPATHY (Swelling lymph node), the last episode of CHILLS (Chills) and the last episode of FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use of birth control pills was reported  Treatment using advil(Ibuprofen) was reported
pt recv 1st vax;exp noc sweats,weight loss,d,loss of appetite;lasted 6wk;anti HBs =15;later part of november sx recurred & lasted approx 2-3 wk;work up neg;pt felt exp due to vax but MD felt exp not related;pt refused addtl doses;
This spontaneous report as received from a registered nurse via GlaxoSmithKline, refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored (Merck) VARIVAX dose and route were not reported (lot# K005428, exp.date: 15-APR-2016; lot# reported as K011800, exp.date: 21-AUG-2016; lot# reported as K021836, exp.date: 10-NOV-2016). No adverse events were reported. This is one of two reports received from the same source. Additional information has been requested.
Site: Itching at Injection Site-Severe, Systemic: Anaphylaxis-Medium, Systemic: Rash (other than injection site)-Medium
Severe shakes, fever, sore throat, severe muscle aches, severe headache, night sweats, chills
patient gave an expired dose of IPOL with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician and other health care professional via Medical Information (Reference number- 00725597) and transmitted to Sanofi on 16-Aug-2021.  This case involved 7-year-old female patient gave an expired dose of IPV (VERO) [IPOL] (expired product administered)  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) and MMR VARICELLA COMBINATION for prophylactic vaccination.  On 02-Aug-2021, the patient received fourth 0.5ml dose of suspect IPV (VERO) (lot: R1D97 and expiry date: 17-Jul-2021) (Frequency=once) (Strength=standard) via intramuscular route in the left thigh for prophylactic vaccination (expired product administered)  This case was an actual medication error due to expired vaccine used (latency: same day)  At the time of reporting, no adverse event  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Had major nausea beginning 4 days after vaccination.  Then was tested positive for COVID 12 Days after Vaccination on 02/02/2020.  Confirmed with Rapid test, Confirmed with PCR Test.  Patient was 1 of 4 in a small group of elderly relatives who got vaccinated that day.  2 individuals received Moderna, 2 received Pfizer vaccine. His wife then also tested positive for COVID 1 week later. The Moderna Couple never tested positive for COVID. ( 3 Tests over 2 weeks.  )  All 4 had practiced strong COVID preventative measures and did not ever let their guard down.  Face Mask, Constant Hand Sanitizing, Washing, No Crowds. He started to worsen and was given Bamlanivimab infusion on 02/08/2020 which had an immediate positive affect.  By end of 02/12/2020 he appears to have almost completely recovered.
severe swelling in her eyes; severe rash all over her face; This is a spontaneous report from a contactable other health professional (patient). A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 06Jan2021 (at 22-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that on 06Jan2021 (reported as 2 hours after administration) she experienced severe swelling in her eyes, and a severe rash all over her face. Her mother called in right after it happened and when it was time to get her second shot, she was advised not to get her second shot. She held off, but now her work was requiring her to get the second shot and booster later. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Full loss of peripheral vision left eye-narrow band can see high tips of fingers and bottom of hand a little before the full palm; 24 Hours after injection, dark spots in peripheral vision left eye; This is a spontaneous report from a contactable consumer reporting for himself. A 51-Year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: en6207 and expiry date was not reported), via intramuscular route of administration, in Arm left, on 25Mar2021 at 10:30 AM (at the age of 51 years), as a single dose for covid-19 immunization. The patient medical history was reported as none and concomitant medications received within 2 weeks of vaccination included Aspirin day of injection. The most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no Allergies to medications, food, or other products. On 26Mar2021 at 08:00 am, the patient experienced peripheral vision defective and spots before eyes. It was reported, on 26Mar2021 at 08:00 AM, 24 Hours after injection, dark spots in peripheral vision left eye. As of today, 29Mar2021-full loss of peripheral vision left eye-Narrow band can see high tips of fingers and bottom of hand a little before the full palm. There was no treatment received for adverse events. Outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Pt vaccinated with DT 48 hrs post DT developed severe pain, redness, edema at site of injection dx of sterile abscess - tx Amoxicillin.
expired dose was administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-IPV (Kinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th February 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 9th February 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. An expired dose of Kinrix was administered to the patient, which led to expired vaccine used. The reporter did not have the patient's demographics to provide. The reporter consented to follow up.
During first 15 minutes after dose began to feel sensation in jaw on the same side as injection (left). After left site, felt sensation from elbow into pinky and ring finger like a tingling. This persisted on and off throughout the following days up to and including today (4/6/21).  The sensation has been at times worse. The feeling in face/jaw has been like novocaine wearing off after having dental work. The sensation in arm has gone up to underarm  and down along leg into toes. This sensation could be described as feeling like these areas are "waking up after falling asleep"/a tingling sensation/mild numbness, though I have never lost ability move these areas and can still feel them. Pain in my hip and elbow has developed on that side (left) . So far, only very temporary similar sensation in right foot on outside of the foot. On 3/18/21 (8th day after injection) I developed a large (as big as my hand with fingers spread out) red, warm, hard  area at and around the injection site. I saw pictures of this on the internet and mine looked very typical to that. This lasted about 5 days. A couple of those days, my left breast felt bruised. On the 13th day after the injection, I had a fever, chills and slept most of the day. Fever and chills only lasted that one day.  My greatest concern is about the numbness/tingling because it has persisted and not subsided. Here I am a month after the first dose and I tire easily. I think the tiredness may be stemming from the persistent numbness/tingling sensations. I
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 21-OCT-2015 22:15, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 8.5 and -2.7 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
09/29/04 Acute episode of dizziness, paresthesias all 4 extremities, blurred vision, short attention span, extreme weakness. 9/30/04 saw neurologist, lethargic, dizzy, weak grasps, blurred vision. Took Advil and Allegra 12/1/04 MRI follow up 12/10/04. Saw neurologist, MRI negative (no contrast used). Much improved, occasional weakness and dizziness.
Dizziness Reported feeling "tingley", throat/tongue "feel thick" no obvious respiratory distress, no rash Narrative:  Pt received dose #1 of Moderna vaccine at 1253. At 1317 she reported feeling light-headed followed by "throat and tongue feeling think", SHe had no obvious respiratory distress, SOP2 remained 96%-98% on room air. BP 144/80, HR 71, resp rate 20 and non-labored. She was given 25mg benadryl PO at 1321 and repeated at 1327. No further worsening of complaints. SHe reported "feeling better" at 1350. She was monitored for a total of 45 minutes after reporting symptoms.
This spontaneous report as received from a nurse, via company representative, refers to her 15 year old son with hay fever. The patient's medical history included neonatal seizures after birth which stopped after unspecified time. On 05-FEB-2015, he was vaccinated with the third dose of HPV vaccine (manufacturer unknown) (dose, route and lot number were not reported) (dates of the first and the second dose were not provided). Concomitant therapies included AUGMENTIN for sinus infections. On 09-FEB-2015, the patient experienced grand mal seizure which lasted approximately 5-6 minutes. After the seizure, on the same day, he experienced forgetfulness. The patient had magnetic resonance imaging (MRI), electrocardiography (ECG), urine analysis, drug analysis and other unspecified laboratory work done, results were not provided. He sought medical attention at the emergency room (ER). The outcome of grand mal seizure was unknown. The outcome of forgetfulness was reported as not recovered ("was still persisting"). Relatedness between the therapy and the events was not provided. Upon internal review, grand mal seizure was considered to be medically significant. Additional information is not expected because the reporter did not wish to be contacted.
10/04/2012 Swelling and redness in left arm (vaccine area). 10/06/2012 Patient was in hospital and received antibiotics and cortisone. 10/14/2012 Patient inform she was hospitalized because of numbness in arms and legs and she can't walk. 10/16/2012 Patient notify she was diagnosed with Guillain-Barre Syndrome.
Itching from my head to my torso; rash on my wrists; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 at 16:30 as dose 5 (booster), single (Lot number: 5H 9702) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; ATORVASTATIN. Past drug history included: Betadine, reaction(s): "Known allergies: betadine"; Iodine, reaction(s): "Known allergies: iodine". Vaccination history included: BNT162b2 (Dose 4 (Booster), single, Batch/Lot No: FK 9894, Location of injection: Arm Left, Vaccine Administration Time: 12:45 PM), administration date: 06May2022, when the patient was 69-year-old, for Covid-19 Immunization; moderna (Dose 3 (Booster), single, Batch/Lot No: OSIE 21A, Location of injection: Arm Left), administration date: 28Oct2021, when the patient was 69-year-old, for Covid-19 Immunization, reaction(s): "Itching from my head to my torso"; moderna (Dose 3 (Booster), single, Batch/Lot No: OSIE 21A, Location of injection: Arm Left), administration date: 28Oct2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "rash on my wrists"; moderna (Dose 3 (Booster), single, Batch/Lot No: OSIE 21A, Location of injection: Arm Left), administration date: 28Oct2021, when the patient was 69-year-old, for COVID-19 Immunization, reaction(s): "pinpoint numbness on lip"; moderna (Dose 1, single, Batch/Lot No: 032L20a, Location of injection: Arm Left), administration date: 24Jan2021, when the patient was 68-year-old, for covid-19 immunization; Moderna (Dose 2, single, Batch/Lot No: 023m20a, Location of injection: Arm Left), for COVID-19 Immunization. The following information was reported: PRURITUS (non-serious) with onset 29Sep2022 at 01:30, outcome "recovered", described as "Itching from my head to my torso"; RASH (non-serious) with onset 29Sep2022 at 01:30, outcome "recovered", described as "rash on my wrists". Therapeutic measures were not taken as a result of pruritus, rash.  Additional information: Patient stated that, I received the shot at 4:30 in the afternoon. Went to bed around 10. Woke up at 1:30 am, itching. Itching from my head to my torso. Got up to go to bathroom to see if I had a rash but the light was bad. I did see a rash on my wrists where the itching was worst. Itching lasted an hour. I did not take Benadryl as I wanted to see how long it lasted. Curiously, I had same reaction to Moderna dose 3 shot. Itching lasted 3 hours then I took Benadryl, also had pinpoint numbness on lip with Moderna dose 3. So I thought I was allergic to something in the Covid shots. Patient had known allergies to latex. Patient did not receive any other vaccines within 4 weeks. Other medical history was reported as healthy. Prior to vaccination the patient did not diagnosed with COVID-19. Since the vaccination the patient did not tested for COVID-19.