chrisvoncsefalvay/vaers-outcomes huggingface dataset:
given a 0.25mL dose of the bivalent vaccine; given a 0.25mL dose of the bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (given a 0.25mL dose of the bivalent vaccine) and NO ADVERSE EVENT (given a 0.25mL dose of the bivalent vaccine) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 14-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (given a 0.25mL dose of the bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (given a 0.25mL dose of the bivalent vaccine). At the time of the report, ACCIDENTAL UNDERDOSE (given a 0.25mL dose of the bivalent vaccine) and NO ADVERSE EVENT (given a 0.25mL dose of the bivalent vaccine) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (given a 0.25mL dose of the bivalent vaccine) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (given a 0.25mL dose of the bivalent vaccine).    The concomitant and treatment medication was not reported. On 14-Oct-2022, the four people over the age of 18 were given 0.25 ml dose of the bivalent vaccine by intramuscular injection. The patient had no reported symptoms, no additional doses, medications and treatments.
An extremely sore area on right arm. Unable to lift above should height. Has persisted since inoculation on 2/25/2021
DRY HEAVING; NAUSEA; HIGH FEVER; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies and had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced flu like symptoms. On 19-MAY-2021, the subject experienced high fever. Laboratory data included: Blood glucose (NR: not provided) Not Reported, and Body temperature (NR: not provided) up to 101.9. Treatment medications included: paracetamol. On 20-MAY-2021, the subject experienced dry heaving. On 20-MAY-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) up to 102.9. Treatment medications included: prochlorperazine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flu like symptoms, dry heaving, and nausea, and had not recovered from high fever. This report was non-serious.
I have a lot of swelling in my left breast. It started 3 days after the shot. It is very sore. I went to my doctor and she said it's in the lymph nodes. She said if it didn't go away in 3 weeks we would schedule a mammogram.
About 10 minutes after injection - extreme sedation, flushing, hives and itching on right side of chest, and continuous cough.  Was administered one dose of epi-pen injection, steroid injection, and oral benedryl by doctor on site.  20 minutes later flushing, headache, and extreme nausea.  Was given second dose of epi-pen and sent to the hospital in an ambulance for monitoring.
Ringing in ears really increased, on 1st july 2021 loud noise like crickets; Aches all over; Chills; fever; Immense soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Immense soreness of arm), TINNITUS (Ringing in ears really increased, on 1st july 2021 loud noise like crickets), PAIN (Aches all over), CHILLS (Chills) and PYREXIA (fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Immense soreness of arm), PAIN (Aches all over), CHILLS (Chills) and PYREXIA (fever). On 03-Apr-2021, the patient experienced TINNITUS (Ringing in ears really increased, on 1st july 2021 loud noise like crickets). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 03-Apr-2021, PAIN IN EXTREMITY (Immense soreness of arm), PAIN (Aches all over), CHILLS (Chills) and PYREXIA (fever) had resolved. At the time of the report, TINNITUS (Ringing in ears really increased, on 1st july 2021 loud noise like crickets) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient's ear continued to have loud noise like crickets. Concomitant medications are not provided.   This case was linked to MOD-2021-097829 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: The follow up does not contain any new information On 01-Jun-2021: Added updated information upon the event( that ringing of ears is still continuing very annoying).
None at the time . Started $/19/2021.  Had hospitalization. Wore Holter monitor before that which showed altered beats. Had stress test in hospital and saw my own cardiologist which said heart was normal but said I do have irregular beats during episodes.
Extreme fatigue and headache starting the day after vaccination and persisting through patient's appointment May 4, 2021
5mins p/vax lips began to swell & throat began to hurt;upon returning home, mom gave APAP immed;fever devel & entire face, including nose swelled up;c/o h/a, stiff neck, fatigue, irritability;mom called ER pt seen by MD;t102-103;swollen arm
Pfizer on 2/25 and 3/25. Positive on 9/24
Arm was sore; Runny nose; Running a temperature; arm is sore/site is sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), RHINORRHOEA (Runny nose), PYREXIA (Running a temperature) and VACCINATION SITE PAIN (arm is sore/site is sore) in a 59-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in May 2022. Previously administered products included for Drug use for unknown indication: Pfizer on 12-Mar-2021, Pfizer on 09-Apr-2021 and Pfizer on 26-Oct-2021. Past adverse reactions to the above products included No adverse reaction with Pfizer, Pfizer and Pfizer.    On 12-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced PAIN IN EXTREMITY (Arm was sore), RHINORRHOEA (Runny nose), PYREXIA (Running a temperature) and VACCINATION SITE PAIN (arm is sore/site is sore). At the time of the report, PAIN IN EXTREMITY (Arm was sore), RHINORRHOEA (Runny nose), PYREXIA (Running a temperature) and VACCINATION SITE PAIN (arm is sore/site is sore) outcome was unknown. No concomitant medications were reported. No treatment information was reported.
Approx 2 weeks after, Severe dizziness, mental fog, massive panic attacks, heart palpitations, nausea.  High epinephrine levels seen in clinical testing. Brain MRI, Heart workup, Bloodwork all within normal levels, except epinephrine levels.
Headache, Body Aches, Cold Chills, injection spot pain, red in color, warm to the touch
Noticed problems, more than expected, on right arm. Stiffness and inability to move - like paralysis - on shoulder joint. Had enough pain to call nurse on hotline for pain. Recommended ADVIL and TYLENOL. The medicine helped a little but got worse. Even though was taking ADVIL every 4-6 hours still getting up at night. Has problems moving arm; can't lift it on its own higher than the chest. Called doctor the next day who recommended to continue to take ADVIL. It doesn't seem to be getting better. Pain is going down arm; pain in joint is steady but down arm is intermittent. Pain level is at 4/10 with ADVIL.
Patient received Day 14 HDCV 1cc IM to RT deltoid 8/31/09. Area became red and itchy. Seen by PA at the facility on 9/3/09 for evaluation and diagnosed with local vaccine reaction.
dry scales to my back "scratch- like" periodically! / skin scales / S/ effect. I experienced; dry scales to my back "scratch- like" periodically!; dry scales to my back "scratch- like" periodically!; This case was reported by a consumer via interactive digital media and described the occurrence of scales in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced scales, dry skin and scratch. On an unknown date, the outcome of the scales, dry skin and scratch were unknown.   It was unknown if the reporter considered the scales, dry skin and scratch to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. Age at vaccination was not reported. The age group was selected as an adult. Patient experienced dry scales to back "scratch- like" periodically. No pain was reported. Reporter did not consented to follow up.
Dizziness/ syncopal  event with loss of consciousness  and urinary tract infection on 5/5/2021
On day 9 post vaccine, 3 inches X4.5 Inches oval shaped pink, flat rash, itchy at injection site.  Took Benadryl one 25 mg tab x1.  By 1/26/21 rash area gone.
On  3-11-2021, I had has a hot bath at some point - MAYbe about 5PM?     About 11:10 PM ,climbing stairs (7 steps) to bed, I was scratching  the area (2"X4").  In bathroom saw that red area and freaked out,. washed up,  NOTED that the area had calmed down + skin looked pitted the headed to bed + slept after reading a n hour or so.  As I type this 12:30 in public library I see red skin in area (Unlike measles) with darker measle-like dots.
Patient received Vaxelis at 4 month wellness visit/ Patient developed fever and seemed little "off or sluggish" after the vaccination; Patient received Vaxelis at 4 month wellness visit/ Patient developed fever and seemed little "off or sluggish" after the vaccination; This non-serious spontaneous safety report was received by a partner on 25-May-2022 and forwarded on 27-May-2022, from a physician.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "the patient developed fever and the patient seemed little "off or sluggish" after the vaccination".   Further information is expected.  NON-SIGNIFICANT Follow-up information, with reference number 02174082, was received by a partner on 06-JUN-2022 and forwarded on 07-JUN-2022, from a physician. The case is maintain as non-serious.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "the patient developed fever and the patient seemed little "off or sluggish" after the vaccination".  No further information is expected as all the follow-up attempts have been completed and the physician could not identify the patient.
This spontaneous report as received from a nurse, refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored RECOMBIVAX HB injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No symptoms were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received an expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 0034C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, OXYBUTYNIN and OMEPRAZOLE for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine). On 21-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment reported.   This case was linked to MOD-2021-408490, MOD-2021-408558, MOD-2021-408490, MOD-2021-408585, MOD-2021-408476, MOD-2021-408547 (Patient Link).
Headache, Myalgia, Fever, NauseaVomiting,  fatigue  Narrative:  Employee reported chills, headache, myalgia,  fatigue, nausea resulting in unable to work 2/16 and 2/17/2021.   Other Relevant History:
After first shot, felt weak, tired, overall under the weather on the day after shot (3/27/2021). Then about 3 days after vaccine (3/29/2021) got red rash with bumps on my face/cheeks.  Redness lasted 3-4 days, and bumps were white spots.
Information has been received from a pharmacist concerning a 76 year old female who on 12-FEB-2008 was vaccinated with ZOSTAVAX (Merck). Subsequently the patient got shingles. It was unknown if the patient sought medical attention. At the time of report, the patient was recovered. Follow-up information was received from the 76 year old female retired consumer with no pre-existing allergies, birth defects or medical conditions who on 12-FEB-2008 was vaccinated with a dose of ZOSTAVAX on her "right side" (dose, route and lot # not provided). There was no illness at time of vaccination. On 25-APR-2012, the patient developed rash in right temple area and into her head, stinging, burning and feeling of something crawling on her face and her hair in her head. The patient also experienced pain in temple and in her head. The rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. She was treated with prednisolone 10 mg and valacyclovir 1 mg. On an unknown date, direct fluorescent antibody was positive; specimen was not collected for PCR and no photos were taken. On an unknown date, the patient recovered from shingles. Additional information is not expected.
Extreme chills - needed heating pad, 2 socks, 2 pants, 4 tops, 2 blankets and a warm body next to me 102 fever fatigue Fever and chills lasted approximately 24 hours and fatigue total 36 hours Felt like every lymphatic in my body was doing fireworks at the same time.  Venous/lymphatic congestion throughout the body.
Left arm pit swelling and pain along with soreness at injection site.; Left arm pit swelling and pain along with soreness at injection site.; Left arm pit swelling and pain along with soreness at injection site.; dizzy; weak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Oct2021 09:15 (Batch/Lot number: unknown) at the age of 49 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), PAIN IN EXTREMITY (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 24Oct2021 02:00, outcome "not recovered" and all described as "Left arm pit swelling and pain along with soreness at injection site."; DIZZINESS (non-serious) with onset 24Oct2021, outcome "not recovered", described as "dizzy"; ASTHENIA (non-serious) with onset 24Oct2021, outcome "not recovered", described as "weak". Therapeutic measures were not taken as a result of lymphadenopathy, pain in extremity, vaccination site pain, dizziness, asthenia.  Additional information: Lot was unknown because it was downstairs in her purse and she was in her bed. Facility where the most recent COVID-19 vaccine was administered was at Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no COVID prior vaccination. Patient did not test for COVID post vaccination. No other medical history. There were no known allergies. Device Date was 24Oct2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up attempts completed. No further information is expected.
Extreme pain, loss of ROM in left arm/shoulder,loss of strength in left arm, radiating pain to neck & fingers. Tx. ASA & heating pad
SWELLING OF ARM TO ELBOW- TREATED WITH ICE AND BENADRYL
Red rash all over body 4JAN92; MD notified by phone advised to not take any more HIB vax; sleep disturbance consisted of awakening approx 5x during the noc; pt slept w/o problem in moms arms; given DPH;
Noticable pain and swelling at injection sight. Used warm compress. Headache. Untreated because I can't take pain relievers. Mild dizziness upon standing.
7 days post-injection a rash developed at the injection site which worsened overnight. Day 8 post-injection the injection site is red swollen, warm,  sore, and itchy with a red circle about 3 inches in diameter. The right arm's elbow and wrist are also sore.
This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 11-FEB-2016, the patient was vaccinated with an improperly stored (Temperature: 32F - Time frame: 5 minutes) dose of RECOMBIVAX HB lot# K009953 and expiration date: 03-APR-2016, (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
plaque like rash 2-3 cm below injection site that appeared on 1/18/21.  warm to touch
Information has been received from a physician regarding a 22 year old female who on 07-JUL-2006 was vaccinated with her first dose of varicella virus vaccine live (Oka/Merck). A second dose of varicella virus vaccine live (Oka/Merck) was administered on 04-AUG-2006. Concomitant therapy included Ortho Tri-Cyclen. The physician reported that the patient experienced a lack of efficacy. On 03-OCT-2007, the patient had a negative antibody test. The patient's VZV antibody level was found to be seronegative. The patient has no pertinent medical history, and no drug allergies. The patient did seek unspecified medical treatment, however, she did not have to be hospitalized, it was not life threatening nor a significant disability. The physician did not have the lot numbers because the patient was vaccinated a a hospital. At the time of the report, the patient still had not recovered. Additional information is not expected.
side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (side effects) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.; Reporter's Comments: vvdvbdbdbdjbfbbfn f jgkkl./
From initial information received on 01/11/2005 from a pharmacist regarding an adverse event occurring in the USA, it was reported that a 25 year old female patient received a dose of TD ADS Adult, lot number U1280AA, administered intramuscularly in the left deltoid on 01/09/2005.  Two days later, the patient developed a local reaction of redness and soreness at the site of injection.  Reportedly, the patient experienced the soreness on movement.  It is unknown whether the patient recovered from these events.
sore arm.; This is a spontaneous report from a contactable consumer (patient).  An elderly male patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (around 2013-2014) (Batch/Lot number was not reported) as dose number unknown, single for an immunization.  Medical history included Low thyroid and possible atrial fibrillation. Concomitant medications included levothyroxine (LEVOTHYROXINE); ascorbic acid, biotin, boron, calcium, chromium, copper, folic acid, ginseng nos, iodine, magnesium, manganese, menadione, molybdenum, nicotinic acid, pantothenic acid, phosphorus, potassium, potassium chloride, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon, thiamine, tocopherol, vitamin b12 nos, vitamin d nos, xantofyl, zinc (MATURE MULTIVITAMINS); ascorbic acid, rosa canina fruit (VITAMIN C & ROSEHIP); chondroitin sulfate sodium, glucosamine hydrochloride (GLUCOSAMINE/CHONDROITIN); vitamin d3 (VITAMIN D3); and acetylsalicylic acid (ASPIRIN (E.C.)) all taken for an unspecified indications and therapy dates. The patient previously received his tetanus and diphtheria booster in 2007 at the age of 63-years-old that caused a sore arm.  Then, he had shingles vaccine in 2012 at the age of 68-years-old and also caused a sore arm. The patient then had his pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) also reported as PREVNAR-23 vaccine in 2013 or 2014 and caused a sore arm. Outcome of the event was unknown.   No follow-up attempts are needed, information about lot/batch number cannot be obtained.
A non-serious spontaneous report of administration of expired FLUMIST was received from a physician concerning a four-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 13-Dec-2011, the patient received expired FLUMIST. The product expired on 20-Nov-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.