chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash all over body and rash keeps growing; Initial information received on 15-Apr-2022 regarding an unsolicited valid non-serious case received from a patient via phone.  This case involves a female patient who experienced, "rash all over body and rash keeps growing" while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.    On an unknown date, the patient received a dose of suspect Influenza Vaccine at (unknown formulation, strength, dose, route, frequency, batch number and expiry date) produced by unknown manufacturer in unknown administration site for prophylactic vaccination [immunization].  On an unknown date, the patient reported a non-serious event, "rash all over body and rash keeps growing" (rash) (unknown latency) following the administration of Influenza Vaccine.  It was reported by the patient that, "she is calling to report an adverse event with the flu product. Caller states the clinic convinced her to get the flu vaccine. She has a rash all over her body and she got the flu vaccine in December and the rash keeps growing. Caller did not know which flu vaccine she received an will call back with the flu product and lot and expiration information. Reporter relationship : Self".  Action taken with Influenza Vaccine was not applicable.   At time of reporting, the outcome was Unknown for the event, "rash all over body and rash keeps growing".
Patient received vaccines at 15:00 in clinic, presented to ER at approximately 19:00 complaining of rash on torso, face/eyes swollen, no respiratory distress- 08/18/08.
For 3 days: Chills, fever (1st 48 hours) Aches & pains head, back, chest, arms, stomach, hips (1st 48 hours) Sore throat  & pain in sinuses, neck, ears, teeth, jaws, (starting second 24 hours for 36 hours) Nausea (1st 24 hours) Pain at injection site (1st 72 hours)
Right after getting vaccine she get metallic test in mouth which goes away after 36 to 48 hours; soreness of left arm; A spontaneous report was received from a consumer concerning a 49-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a metallic taste in mouth and soreness of left arm.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31-Dec-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 31- Dec 2020, after receiving the vaccine, the patient reported getting a metallic taste in her mouth and had soreness of left arm. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, developed a metallic taste in mouth, was considered resolved on 02-Jan-2021. The outcome of the event, soreness of left arm, was considered unknown.; Reporter's Comments: Based on the information provided, a temporal association between the reported events and administration of mRNA-1273 vaccine, and excluding any other etiology, a causal association cannot be excluded.
This spontaneous report as received from a healthcare worker refers to unspecified patients. Patients medical history and current condition was not reported. Since an unknown date the patients were vaccinated with improperly stored ROTATEQ oral liquid (unknown dose and frequency) (Lot number and expiry date not reported) and sterile diluents. No adverse effects reported. The outcome of the event was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.
Erythematous circular area around site of injection on (L) deltoid. This rash showed the day after shot was given. No fevers.
Diarrhea/My stools have gradually returned to normal although I still have occasional intermittent bouts of  diarrhea; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Diarrhea/My stools have gradually returned to normal although I still have occasional intermittent bouts of  diarrhea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Pyloric stenosis (Pyloric stenosis). Concurrent medical conditions included Arthritis (Arthritis), Osteopenia (Osteopenia) since 06-Jan-2015, Drug allergy (Innovar) and Allergy to antibiotic (Tetracycline). Concomitant products included CURCUMIN for Herbal supplement, PROBIOTIC [BIFIDOBACTERIUM BIFIDUM;BIFIDOBACTERIUM LACTIS;BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS] for Nutritional supplementation, ALENDRONATE SODIUM (FOSAMAX) from 06-Jan-2020 to an unknown date for Osteopenia, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for Pyloric stenosis, TOCOPHEROL (VITAMIN E [TOCOPHEROL]) for Vitamin E supplementation, MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE] for Vitamin supplementation, UBIDECARENONE (COQ 10) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced DIARRHOEA (Diarrhea/My stools have gradually returned to normal although I still have occasional intermittent bouts of  diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) on 16-Feb-2021 for Diarrhea, at an unspecified dose and frequency. On 16-May-2021, DIARRHOEA (Diarrhea/My stools have gradually returned to normal although I still have occasional intermittent bouts of  diarrhea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient reported that she tried brat diet but symptoms not relived and also tried protein max ensure which seemed to curb diarrhea somewhat at first but then subsequently seemed to be not effective. Avoided fiber rich foods which didn't gave any effect. Patient consumed fruits and vegetables for general health Other concomitant product included Omega EFA which is used for general health.   This case was linked to MOD-2021-106486 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: significant  follow up received on 26 May 2021, Updated patient demographics, medical history, added concomitant medications and treatment, event outcome updated On 23-Jul-2021: Non significant follow up received on 23-jul-2021.
Severe anemia,  low hemoglobin, low body temp, weakness, confusion, shakiness, all blood levels abnormal. Meningitis due to varicella zoster virus. Died on June 13 2021
Booster; Her arthritis was acting up again; This is a spontaneous report from a contactable consumer or other non hcp (patient's husband) via medical information team. A 74-year-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported), via an unspecified route of administration on an unspecified date in Sep2021 as dose 3 (BOOSTER), single for COVID-19 immunization. The patient medical history included arthritis. The patient concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported), via an unspecified route of administration on an unspecified date in Mar2021 as dose 1, single for COVID-19 immunization. Also, patient has received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported), via an unspecified route of administration on an unspecified date in Mar2021 as dose 2, single for COVID-19 immunization. Reporter stated, my wife received the booster dose of the Pfizer covid vaccine yesterday around noon. Reporter wanted to know if she can have ibuprofen. She received her 2 earlier doses in Mar2021. Patient arthritis was acting up again on an unspecified date in 2021. If today is 28 hours later, can she take ibuprofen. On an unspecified date in Sep2021, the patient received booster. The clinical outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.  Follow-up (10Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
The evening of 3/27/2021 noticed rash at injection site approximately 1.5 inch diameter with uneven edges and redness. A couple days prior I noticed slight swelling but that is not as noticeable anymore. There is no pain, itching, or other noticeable irritation other than the rash.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Healthcare facility consulted with the regulatory authority and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare facility is working with the regulatory authority on a compliance improvement plan and has been reinstated vaccination privileges.
Child inadvertently given improperly prepared Pfizer vaccine.  Adult Pfizer vial was mixed as Ped Pfizer (using 1.3 ml diluent) and 0.2 ml dose administered to child age 5-11 year old.  Error discovered after child left clinic.  Steps taken immediately to correct the problem and prevent it from happening again.  Parent notified of error and to watch for side effects.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot #, dose and route were not provided). The vaccine also underwent previous temperature excursion, but no details were provided. Digital data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA000892:
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patient (age and gender not reported) who was vaccinated with the vaccine FLUZONE QUADRIVALENT via intravenous route on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate route of vaccination because the patient was administered via intravenous route instead of intramuscular route. It was unknown if any adverse event was occurred or not following the vaccination. 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 Directive 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. Documents held by sender: none.
She received her first dose on 09Mar2021 and tested positive for Covid on 29Mar2021.; She received her first dose on 09Mar2021 and tested positive for Covid on 29Mar2021.; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EJ1686), at same age, intramuscular administered in arm left on 09Mar2021 as single dose for covid-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient experienced she received her first dose on 09Mar2021 and tested positive (sars-cov-2 test positive) for covid on 29Mar2021 (drug ineffective) (medically significant) on 29Mar2021. Patient stated that she had symptoms starting Saturday, Saturday the 27Mar2021. And she tested positive Monday 29Mar2021. Patient did not receive the treatment for COVID. The outcome of the event was unknown.  Follow-up (02Apr2021): New information reported via a contactable consumer (patient) includes: patient details, medical history details, suspect medicine details, and event details.
Staff member made a scheduled visit to pt. Rt upper arm red and swollen, temp 99.7. Swelling and redness under arm pit radiating to left chest. Chest area was reported. Visited Dr and received Decadron, Dr told her to never take the pneumonia shot again.
Patient reported feeling "nauseous" about 5 minutes after having received vaccine. Patient had an episode of syncope in the restroom. Assisted patient to sitting position was A&O x4, no signs of active bleeding or cuts.  O2 saturation was 99% with HR of 83. Patient was able to swallow and answer basic commands.
Right arm swollen from shoulder to fingers after the dose of trihibit (hot and tender). Applied ice, elevation Motrin.
Shivering w/slight fever, joint aches, fatigue all began approx. 12 hours after injection and lasted approx. 30 hours. Pain at injection site began 12 hours after injection and is still present but diminishing.
Information has been received from a physician concerning a 14 year old male who on 19-NOV-1996 and 01-MAY-2000 was vaccinated with the first and second dose of MMR II respectively (route, site, and lot number not reported). On 11-NOV-2009, the patient experienced mumps (the date diagnosed was reported as 03-JAN-2009). The patient was afebrile and had right parotitis. The outcome for mumps was not reported. Follow-up information was received which reported that on 10-JAN-2010 (previously reported on 11-NOV-2009), the 14 year old (also reported as 13 year old) patient experienced mumps. The patient was diagnosed on 11-JAN-2010. The patient had left side parotitis (previously reported as right side) and was afebrile. The first blood work was done on 11-JAN-2010, which revealed that IgM <1:10, IgG 7.62, serum amylase 105. This is one of several reports from the same source. No further information is available.
Varivax given 08/15/1996. Varicella diagnosed 12/20/2001.
Moderna Vaccine had side effects; Herniated disc; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Moderna Vaccine had side effects) and INTERVERTEBRAL DISC PROTRUSION (Herniated disc) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.    The patient's past medical history included Hip replacement in 2012. Concurrent medical conditions included Psoriasis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) (1 in 1 Once). On an unknown date, the patient experienced IMMUNISATION REACTION (Moderna Vaccine had side effects) and INTERVERTEBRAL DISC PROTRUSION (Herniated disc). At the time of the report, IMMUNISATION REACTION (Moderna Vaccine had side effects) and INTERVERTEBRAL DISC PROTRUSION (Herniated disc) outcome was unknown.            No concomitant medications were reported No treatment medications were reported Patient still had psoriasis scarring after taking Skyrizi.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient stated Skyrizi was a miracle drug, he was always so embarrassed of being covered 95 percent still had some scaring and had herniated disc and other health Issues. He had Side effects he said it Knocked him down. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
At the site of shot, red, warm, hard, raised, very sore, hard to sleep.
This spontaneous report has been received from a pharmacist and referred to a patient of an unknown age and gender. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. On 07-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX23 (strength, dose, frequency, route of administration, and lot number were not reported, the expiration date of the vaccine was June 2018) for prophylaxis. Then, on an unknown date in May 2107, the patient experienced arm swelling and tenderness. The patient called the pharmacy for information regarding these events, however, did not seek medical attention.  At the time of this report, the outcome of the arm swelling and tenderness was unknown. The causality assessment between arm swelling and tenderness with PNEUMOVAX23 was not reported. This is one of two reports from the same reporter. Additional information has been requested.
I have been having trouble breathing since I had the vaccine done. I get really bad chest pains just from laying down and it is a daily struggle to do everyday things like walking because I get short of breath really easily after I had the vaccine done. It has been 3 and a half months now and I am still struggling trying to recover.  My treatment right now is that my pulmonologist put me on Symbicort to see if it could give me a little bit of relief and I am still being seen by the cardiologist as well, and I am also using my rescue inhaler Albuterol HFA more often than before. I am taking Singulair and I was also put on a heart monitor for 2 days to check my heart rhythm to see if that has anything to do with the chest pains I have been feeling
9:38 am -8-10 minutes after vaccine injection patient felt nausea and dry heaving 9:42 am - patient evaluated by by EMS BP 142/100 Pulse 120 9:48 am patient transported to ER.
Information has been received from a father concerning his 12 year old son with no medical history or allergies who in 1995 was vaccinated with a dose of Varivax. There was no concomitant therapy. The father reported that on 18 Mar 2006, his son developed a breakthrough rash characterized by about 50 lesions with associated pain at each lesion site. The father noted that the most painful lesions had the largest surface area. The patient was taken to the Emergency Room, but was not admitted. No laboratory/diagnostic tests were performed. It was also noted that the scabbing began "almost immediately." At the time of this report, the patient's breakthrough rash persisted. Additional information has been requested.
Patient stated she has felt faint when receiving certain vaccines in the past.  Patient stayed at the pharmacy after receiving her first dose of Shingrix today for monitoring.  Shortly after receiving the vaccination she stated she felt overheated and after about 20 minutes she laid down on the bench due to feeling dizzy.  Temperature was normal with infrared thermometer to forehead and initial blood pressure (BP) reading was 106/80, patient stated she felt hot and sweaty.  A cool, wet compress was applied to the back of her neck and changed frequently and the patient sipped on ice water.  After about 10 minutes her BP was 107/81 and temperature was normal.  She did not feel sweaty any longer but still felt dizzy.  Patient felt like sitting up after another 10 minutes and drank some more ice water, BP was 112/81, she still felt a dizzy but not as much.  Upon recheck of BP of 112/81 she decided to walk, using a shopping cart for support and a staff member nearby, to the restroom.  Upon successful return she felt much better and a neighbor came to bring her home.
The patient received the monovalent instead of the bivalent.  The patient has not reported any side effects as of the time of this reporting
localized itching around vaccination site; inability to lift arm "more than half way up"; swollen arm; red arm; itchy arm; circular rash on arm "the size of a 50 cent piece"; sore  painful tender arm; knot formation post vaccination; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (inability to lift arm "more than half way up"), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red arm), PRURITUS (itchy arm) and RASH (circular rash on arm "the size of a 50 cent piece") in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMIN [VITAMINS NOS], BIOTIN, VITAMIN D [VITAMIN D NOS], VITAMIN B12 [VITAMIN B12 NOS], DULOXETINE HYDROCHLORIDE (CYMBALTA), OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]), TIZANIDINE, OLODATEROL HYDROCHLORIDE, TIOTROPIUM BROMIDE MONOHYDRATE (STIOLTO RESPIMAT) and GUAIFENESIN (MUCINEX) for an unknown indication.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced LIMB DISCOMFORT (inability to lift arm "more than half way up"), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red arm), PRURITUS (itchy arm), RASH (circular rash on arm "the size of a 50 cent piece"), MYALGIA (sore  painful tender arm) and VACCINATION SITE INDURATION (knot formation post vaccination). On 20-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (localized itching around vaccination site). At the time of the report, LIMB DISCOMFORT (inability to lift arm "more than half way up"), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red arm), PRURITUS (itchy arm), RASH (circular rash on arm "the size of a 50 cent piece"), MYALGIA (sore  painful tender arm), VACCINATION SITE INDURATION (knot formation post vaccination) and VACCINATION SITE PRURITUS (localized itching around vaccination site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Hospitalized 9/28/22-10/4/22 decreased appetite, loss of taste and smell,  weakness, fatigue, fall, debility, hypoxia, altered mental status, cough, PNA, fluid overload,
Hissing popping crickets loud muffled  sounds and ringing in my left ear.  Vertigo confusion head spinning  hearing words but not being able to understand them.  Hearing sounds but can?t tell where they are coming from feeling extremely disoriented.