chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Employee presented to COVID Clinic for Moderna COVID 19 vaccination 1st dose. Given to right arm. Left clinic after waiting 15 minute observation time. She returned to work and returned about 45 minutes reporting she was having difficulty taking deep breaths, numbness to bilateral extremities, abdominal discomfort and lightheaded, NO rash or hives noted. VSS stable A&O, Within a few minutes employee started vomiting, shaking, and C/O of severe abdominal discomfort, Epinephrine injection 0.5mg given to left arm. Employee transported to ED.
This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 29th March 2018, the patient received the 1st dose of SHINGRIX. On 30th March 2018, 1 days after receiving SHINGRIX, the patient experienced general body pain, feeling abnormal and headache. On an unknown date, the outcome of the general body pain, feeling abnormal and headache were recovered/resolved. It was unknown if the reporter considered the general body pain, feeling abnormal and headache to be related to SHINGRIX. Additional details were provided as follows: Next day after vaccination around noon (at 12:00 hours), the patient experienced body aches, a headache and feeling out of sorts. The symptoms were resolved after a day.
I'm breaking out in hives and welts since August 29, 2021. I went to allergist on September 16 and was told to take zyrtec. Once I stopped zyrtec after 2 weeks the hives came back and I continue to have them. I had my doctor change my birth control because I thought it could be the cause of the hives and I still continue to have hives and welts. I'm on IVF treatment but the treatment started in October.
Small bumps, all ov3er forearms , stomach, upper thighs, mild on calves.   Narrative:
The pt experienced left arm swelling, redness, and pain the day following the vax. This lasted for 4 days.
Information has been received on 16-JAN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 24-MAY-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous, 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 herpes zoster. On or about 18-JUL-2017, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or 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.
A report received from a health professional on 04/09/01 concerning a 7 year old, male patient who experienced flu-like symptoms, severe nausea, vomiting, and lethargy one day after receiving the Fluvirin vaccine, IM on 03/01/01, which led to hospitalization. The patient has a relevant medical history of sickle cell disease. The patient received a dose of Prevnar concomitantly. On 03/02/01, the patient experienced a syndrome of events including flu-like symptoms, sever nausea, vomiting, and lethargy for the duration of one week. The patient was not fully ambulatory and required inpatient hospitalization. The reporter was unsure of the duration of hospitalization. The patient was eventually discharged without further complications. After this adverse experience the physician noticed that his current stock of Fluvirin vaccines had partially crystallized. The reporter noted that the storage temp was 33 degrees F, below the recommended 36-46 degrees F for this product. It was recommended that the remainder of the physician's stock be discarded. There was insufficient info to determine the causality assessment of the reporter.
No other AE ocurred; The patient is 28 years old and recieved PROQUAD by mistake on 07-JAN-2022; The patient is 28 years old and recieved PROQUAD by mistake on 07-JAN-2022; This spontaneous report was received from a medical assistant regarding a 28 year-old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, concomitants, drug reactions, and allergies were not provided.   On 07-JAN-2022, a 28 year-old patient received a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) one dose, lot number T028300, expiration date: 16-FEB-2022 (route of administration was not provided) for prophylaxis (wrong product administered) (product administered to patient of inappropriate age). The reported expressed that the patient was scheduled to received the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), and varicella virus vaccine live (Oka/Merck) (manufacturer unknown) vaccines separately (vaccines were not administered), and it was confirmed that no other adverse event occurred.
3" diameter red area w/lump @ inj site rt arm;pt saw Md 23OCT98;was given ATB d/t hx of mastectomy;
I received a red rash that was on both of my arms three spots: wrist, forearm and armpit area and the base of my neck.   It does not itch or bother me.
fever; nausea; sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shoulder soreness (soreness in shoulder in 2000 due to phenergan injection), swollen joints (shoulder swelling in 2000 due to phenergan injection) and nerve damage (Nerve damage in shoulder in 2000 due to phenergan injection, that has resolved.). Previously administered products included phenergan injection. Concurrent medical conditions included allergy (in 2000 the patient had an allergic reaction to a phenergan injection). Concomitant products included ascorbic acid (Vitamin C) and zinc.   On 1st August 2019, the patient received the 1st dose of Shingrix. On 1st August 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 2nd August 2019, the patient experienced fever and nausea. On an unknown date, the outcome of the pain in arm, fever and nausea were recovered/resolved.   It was unknown if the reporter considered the pain in arm, fever and nausea to be related to Shingrix.  Additional details were provided as follows: The patient received vitamin c, zinc and echincea as a concomitant medication. After vaccination with 1st dose of Shingrix, the patient experienced sore arm on the same day and lasted for 2 to 3 days. The patient experienced fever and nausea on next day of vaccination. The reporter consented to follow up. This case has been linked with case US2020AMR015497 and US2020AMR015496, reported by same reporter.
7/6/07 3-4 hr after Rotateq developed "blood and curdling" screams and abdominal gas and farting. Dev. melena 7/30 with mucus -> resolved after 24-48 hr.
Vaccine was administered after beyond use date and CDC expiry date; Vaccine administered to patients past 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patients past 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine was administered after beyond use date and CDC expiry date) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patients past 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was administered after beyond use date and CDC expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patients past 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine was administered after beyond use date and CDC expiry date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported.  The vial was stored in standard freezer for the lot 031B21A with 2 degrees F high -1 degrees Flow on 31-Mar-2021.  The BUD date and CDC expiry date was reported as 22-Sep-2021.   No Treatment medication reported.  This case contains information for the 32 of 45 patients described by the reporter.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2008, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date late in 2008, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Choroid plexus cyst; Placenta cyst; Placenta cyst; Foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 31-Oct-2019, concerning a foetus subject. The subject's mother was 30-year-old pregnant female of body weight: 125 Ibs, height: 64 in and body mass index (BMI) 21.5 enrolled in a prospective observational safety study.  The mother's historical medical condition included ventricular septal defect.   The mother's concomitant medication included prenatal vitamins (unspecified vitamins and minerals) for an unknown indication.   The subject's mother had no previous pregnancies. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). The subject's mother had no history of offspring with MCM. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy. The mother's last menstrual period (LMP) date was 12-May-2019. Estimated delivery date (EDD) was reported as 16-Feb-2020 and corrected estimated delivery date (CEDD) was 23-Feb-2020. The type of pregnancy was singleton.   On 13-Aug-2019, the subject's mother underwent MaterniT21 test and there were no MCMs noted.  On 07-Oct-2018, at approximately 21 weeks of gestation, the subject's mother was administered Afluria QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived, batch number: P100112488, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunisation.  On the same day, the subject's mother underwent targeted ultrasound and choroid plexus cyst and placenta cyst were noted.  At the time of initial reporting, the outcome of the events of choroid plexus cyst and placenta cyst was not reported.  This case is linked to case 201905846 (corresponding mother case).  The case was assessed as serious and the reporter did not provide causality assessment to Afluria QIV.  Company comment: Causal involvement of Afluria cannot be excluded in reported events of choroid plexus cyst and placenta cyst, therefore these events were assessed as possibly related to the suspect vaccine (defaulting to the related Company causality). Foetal exposure to vaccine is unrelated to the suspect vaccine per company's guidelines.; Sender's Comments: Causal involvement of Afluria cannot be excluded in reported events of choroid plexus cyst and placenta cyst, therefore these events were assessed as possibly related to the suspect vaccine (defaulting to the related Company causality). Foetal exposure to vaccine is unrelated to the suspect vaccine per company's guidelines.
Approximate 2 - 3 hours after receiving immunizations for deployment, pt experienced onset of abdominal pain, nausea, chills and headache.
Injection site  is 3? round, red, feels warm to the touch, itches.  This started about a week after the injection when I went swimming  I?ve taken Benadryl and  rubbed Benadryl cream on the area
Shingles; This case was reported by a nurse via sales rep and described the occurrence of shingles in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2019, the patient received the 1st dose of Shingrix. On 27th July 2019, 4 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The reporter reported that, after vaccination the patient had shingles, and this was the 2nd patient in their practice with same story. Thie case has been linked with case US2019AMR167063, reported by same reporter
A consumer report has been received. The report concerns about 2 patients of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The reporter stated they had a power outage on 25Sep12. Their power outage lasted for one hour and six minutes, their storage unit reached 50 degrees F. The customer had administered one dose on 26-Sep-12 and one dose on 28-Sep-12. The outcome eof the event of COLD CHAIN BREAK is unknown. The report was considered to be non-serious.
Quite ill for 24 hours; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (Quite ill for 24 hours) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Quite ill for 24 hours). At the time of the report, ILLNESS (Quite ill for 24 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-599494, US-MODERNATX, INC.-MOD-2021-599535 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-599494:cross link (Reporter's Daughter case) US-MODERNATX, INC.-MOD-2021-599535:MOD-2021-599535 (Same reporter)
Information unavailable. Patient died at home. Covid 19 listed as a cause of death on death certificate.
Boy friend got his dose 2 weeks after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Boy friend got his dose 2 weeks after the first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Boy friend got his dose 2 weeks after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Boy friend got his dose 2 weeks after the first dose) had resolved.            Concomitant medications were not reported by the reporter. Treatment details was not reported by the reporter.; Sender's Comments: This report refers to a case of an inappropriate schedule of 2nd dose vaccination of mRNA -1273 (unknown lot number) with no  AEs reported.
This is a 67y.o. female who follows Dr She presents with Cough and hx COVID with DIB. She was also noted to have low sodium on labs -she was seen by nephro - she got IVF and then tolvaptan - sodium improved - she has no symptoms but was monitored This was prob some SIADH, with a component of mild volume depletion - she may have had a component of dec osmoles from dec intake She will continue some fluid restriction and follow with nephro, getting labs in a week or so -her COVID remained stable - she did not require any adjunctive treatment except supportive care and albuterol -possible COPD - she was given albuterol inhaler and was advised to follow with pulmonary - with her smoking history and the hyponatremia, lung cancer screening imaging will be considered
My left arm is so sore. The place in my arm where I was given the shot feels like fire. I have a bump where the shot was given. It feels like the pain is extending. I had a different physical feeling after the shot like not feeling well. I will contact my doctor today.
Pt. had one episode of streak of blood in stool on 4/27/22 with increased fussiness.
developed symptoms including sneeze, cough, stuff nose 11/8/2021 and tested positive for covid
Patient received the 2nd Pfizer dose of COVID vaccine after only 14 days.  Error was made and patient was instructed to return after only 14 days versus 21 days as indicated.  Patient contacted and informed.  No adverse outcomes to report.  Per manufacturer's guidelines, no further dosing necessary.
6 x 7 cm square area on right thigh 1 day after DTAP and IPV. Urticaria, treated with cool compresses and Benadryl
Patient reports redness around and down from injection site to elbow, extreme soreness and "not feeling well"
Headache, joint pain, back pain, sharp stomach pain, chills, cold extremities, fatigue, sleepy, can?t open eyes, Cnt fully taste food.  Nauseated.  All night 2/17/21 and took two Tylenol symptoms decreased for two hours.  Came back.  All day 2/18.   Cancelled work yesterday and today.
with pain down arm and in shoulder; pain down arm / ache arm / almost as painful without a breakout on her skin; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (in left arm 6 months ago). Previously administered products included Cold sore (One cold sore in life).   On an unknown date, the patient received Shingrix. In July 2020, less than 2 weeks after receiving Shingrix, the patient experienced shoulder pain and pain in arm. The patient was treated with non-drug therapy (Cold Compresses). On an unknown date, the outcome of the shoulder pain and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the shoulder pain and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had only having one cold sore ever in life. The patient reported having shingles in her left arm 6 months ago and that the pain she was experiencing now was almost as painful without a breakout on her skin. Two weeks ago, the patient received Shingrix and still suffering with pain down arm and in shoulder where Shingrix was administered. The pain described as shooting but mostly an ache. The patient reported using cold compresses and pain medication.
Death E87.1 - Chronic hyponatremia N17.9 - AKI (acute kidney injury) (CMS/HCC) J18.9 - Pneumonia of right lower lobe due to infectious organism
Patient had the flu shot on 8-16. She felt sick on 8-19. Her symptoms include low grade fever, body ache, cough & congestion. She missed a couple of days of work.
Constant pain in the left arm, told to put ice on it and take tylonol/advil. Pain continued and spread to other parts of the arm-shot site, underside of arm, shoulder area, restriction of motion-painful to lift arm away from the body, above the head and behind the back, and difficulty sleeping,  holding purse, lifting anything, Saw PCP who referred me to Physical Therapy which I am currently doing 2x per week and continuing to take Advil and ice area
RINGING IN THE EAR; DIZZINESS; CONGESTION; This spontaneous report received from a patient concerned a 40 year old male. The patient's weight was 245 pounds, and height was 183 centimeters. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient have no history of drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced ringing in the ear. On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ringing in the ear, and dizziness, and the outcome of congestion was not reported. This report was non-serious.
When we go after the first vaccine I had a red spot on my arm and it itched for about a day. The second vaccine about 12 hours after I had chills headache fever of 101. And also bodyaches it lasted for about 24 hours. The next day I just had no energy. The third day I was fine