chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; Moderna bivalent vaccine was administered as Dose1; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna bivalent vaccine was administered as Dose1) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 27-Jun-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Moderna bivalent vaccine was administered as Dose1). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna bivalent vaccine was administered as Dose1) and NO ADVERSE EVENT (no adverse event) 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 (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Moderna bivalent vaccine was administered as Dose1).    No concomitant medications were reported.  Patient didn't report any adverse events. No treatment drug information was provided.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732160:same reporter
Fainting/feeling hot. Placed patient on floor, resp, pulse were normal limits. Pt recovered quickly, keep lying down for 15 minutes. No adverse affects noted.
SEVERE RIGHT SHOULDER PAIN AND LIMITED RANGE OF MOTION LASTING OVER 1 MONTH.
vasovagal pre syncope, no loss of consciousness. Light headedness and nausea 1 minute after vaccine upon standing. HR 52, no loss of consciousness. all symptoms resolved with 15minutes. disposition: home
hardening of injection site with redness and itchiness. This started 8 days after the vaccine was taken.
Herpes Zoster Ophthalmicus; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 06-DEC-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date (reported as shortly after received zoster vaccine live (ZOSTAVAX) vaccine), the patient suffered blurry vision, floaters, and was diagnosed with herpes zoster ophthalmicus. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations did not present prior to used vaccine. The patient also experiences mental and emotional distress due to resulted physical limitations and seriousness of his condition. The patient sustained severe and permanent personal injuries (disability). Further, as a tragic consequence, and suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient had suffered and incurred damages, included medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of ophthalmic herpes zoster was not recovered. The reporter considered ophthalmic herpes zoster to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, ophthalmic herpes zoster was considered to be a medically significant event.
This spontaneous report was received from a registered nurse concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On approximately 22-JAN-2017 (reported as "between 22-JAN-2017 and 20-FEB-2017"), the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # M020100, expiration date 07-MAR-2019) (lot # M001811, expiration date: 04-NOV-2018) (lot # L042835, expiration date: 19-AUG-2018) for prophylaxis (dose number, route and anatomical location of administration were unknown). The temperature excursion reported was: refrigerator: 49.8 Fahrenheit for 2 hours 30 minutes; freezer: 30.3 Fahrenheit for 4 hours. The previous temperature excursion reported was: refrigerator: 49.6 Fahrenheit for 31 minutes; freezer: 11.2 Fahrenheit for 48 minutes. Digital data logger was 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-009507513-1702USA009652: US-009507513-1702USA009654: US-009507513-1702USA009133:
Fever of 103.5 that wouldn?t come down with Tylenol . This lasted about 24 hours. Continued elevated temperature for another 24 hours after that (99.7). Pain, swelling and redness at injection site for 5 days. Today is day 5 and the pain is minimal now but was moderate to severe for 3-4 days.  Extreme fatigue for the first 24-36 hours starting the following day after vaccination.  Moderate to severe headache for about 3 days following vaccination.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 31-JAN-2017, the patient was vaccinated with improperly stored doses of ROTATEQ lot# M031650, expiration date 16-MAR-2018 orally; (dose was not reported) and PEDVAXHIB lot# M034187, expiration date 17-MAY-2019 (dose and route of administration were not reported). There was no adverse effect reported. No product quality complaint was involved. Administered doses of vaccines experienced the temperature excursion with temperature above 8 degrees Celsius and below 25 degrees Celsius for 1 hour and 11 minutes. Data logger was involved. There was no previous temperature excursion. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000223.
02/11/2021 - Stomach upset, a change to my sense of taste in that many foods taste different than  before, some common foods now taste bad to the point of being unable to eat it anymore including some favorites, this has not returned to normal yet. 02/22/2021 Woke up to the pain of broken ribs on  right side, a pinched nerve running down right arm, shortness of breath to the point that a  moderate breath hurt. These symptoms began to subside the next day lasting four and a half days except shortness of breath that lingered for two weeks and still is not fully restored. As you can see  by the dates these reactions happened at two different dates.
Fever and chills.  Nausea and vomiting Body aches Lethargic   Redness and swelling in arm, hard to move.
Vasovagal syncope, code blue called, patient regained consciousness and did not require further treatment.  Patient did not visit ED.  Patient did report after vasovagal episode that they typically respond like this after administration.
Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Unexpected Vaginal Bleeding-Medium
Experienced a delayed reaction to vaccine that occurred at 11 p. m.  Administration was at 8:23 a. m. earlier in the day.  Symptoms began as build up of mucous in back of throat and reflux. Very early the next morning symptoms progressed to near inability to swallow,    Took 50 mg of Benadryl which gave a bit of relief.  Very hard to drink the water and get it down with the two pills.  The symptoms included swollen lips and inside of the mouth swelling.  Went to the emergency room at the Clinic  at 7:30 a. m.   I was given 60 mg of Prednisone, Pepsid to coat the stomach re the steroids. Was sent home with prescription for epi pen, medrol dose pack, Pepsid and Zyrtec.  Symptoms improved except for swelling of lips.  However, on 3/11/21, despite taking the medication, the symptoms worsened in terms of renewed lip swell as well as new symptoms of facial flushing and chest flushing.  Symptoms then abated with medication.  On 3/13/21, symptoms flared again with renewed lip swelling, inside and outside check swelling and outside face and chest flushing.  They they abated again with medication.  On 3/14/21, lip swelling renewed as a symptom.  To date, my lips do not feel right but tingly and bloated and irritated.  Saw an allergist this morning who thinks I am allergic to polyglycol a preservative in the vaccine.
About 6 hrs after shot was administered, there was a large softball size swelling around the injection site which was hot to touch and hard. As of today, it is still swollen and started to decrease swelling by 10% when BENADRYL taken W/I last 12 hrs.
skin is discolored; skin is red; rash about 2-3 inches at injection site; itching; burning; arm was slightly sore; didnt feel real good; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm was slightly sore), FEELING ABNORMAL (didnt feel real good), PRURITUS (itching), INJECTION SITE DISCOLOURATION (skin is discolored) and ERYTHEMA (skin is red) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (she had covid back in October and received convalescent plasma. She had antibodies for covid in December.) in October 2020. Concomitant products included VITAMIN C [ASCORBIC ACID], ZINC, VITAMIN D NOS, UBIDECARENONE (COQ10 [UBIDECARENONE]), AZILSARTAN MEDOXOMIL, CHLORTALIDONE (EDARBYCLOR), METFORMIN, ROSUVASTATIN CALCIUM (CRESTOR), VITAMIN B12 [VITAMIN B12 NOS], VITAMIN B6, FOLIC ACID (FOLATE) and TAGETES SPP. (LUTEIN [TAGETES SPP.]) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was slightly sore), FEELING ABNORMAL (didnt feel real good) and FATIGUE (fatigue). On 20-Feb-2021, the patient experienced PRURITUS (itching), INJECTION SITE RASH (rash about 2-3 inches at injection site) and INJECTION SITE PAIN (burning). On 03-Mar-2021, the patient experienced INJECTION SITE DISCOLOURATION (skin is discolored) and ERYTHEMA (skin is red). On 27-Feb-2021, INJECTION SITE RASH (rash about 2-3 inches at injection site) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was slightly sore), FEELING ABNORMAL (didnt feel real good), PRURITUS (itching), INJECTION SITE DISCOLOURATION (skin is discolored), ERYTHEMA (skin is red), FATIGUE (fatigue) and INJECTION SITE PAIN (burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
cellulitis @ site of vax, rt distal upper arm, outer aspect;t103, red, hot, tender lesion 7cm diameter w/3cm center deeper red & indurated;also has concurrent mild URI;
Raised erythematous rash through out bilat UE, torso, back, bilat thighs. Pt given Benadryl which improved sx x 1d. Pt now on Benadryl and Prednisone taper.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 14-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
COVID 19 Vaccine, Pfizer BioNTech is administered after its useful life. Shelf Life Date 11/17/2021 7:00 am.
The patient received his first dose of the Moderna COVID Vaccine in clinic on 07/21/2021. It was after he was discharged that it was realized the dose that was given to him was from a vial that has beyond use date (vial was opened 07/20/2021 10:46 AM)   Patient was contacted multiple times but no reponse, messages left on pt's voicemail to contact clinic.
first dose > 35 days ago; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago). On 17-Apr-2021, PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago) had resolved.        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 relevant concomitant medication was reported. The treatment information was not provided.
swelling of throat feeling, throbbing lips, tongue, gums, and mucus membranes of the nose. I took a dose of Benadryl when it started (about 40 minutes after getting the vaccine) and I took another dose of Benadryl before going to bed that night. I had slightly swollen eyes and lips the next morning, and it subsided thereafter. Question: Can I get the second vaccine? Is there any special protocol I should follow?
It makes most people sick; I know people that has gotten worse than me, the side effects of this drug are terrible.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (It makes most people sick) and VACCINATION COMPLICATION (I know people that has gotten worse than me, the side effects of this drug are terrible.) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (It makes most people sick) and VACCINATION COMPLICATION (I know people that has gotten worse than me, the side effects of this drug are terrible.). At the time of the report, ILLNESS (It makes most people sick) and VACCINATION COMPLICATION (I know people that has gotten worse than me, the side effects of this drug are terrible.) 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 medication was provided.  No treatment medication was provided.
mother noticed pt c/o of itching everywhere, then at 6pm he began to have facial swelling and headache
Headache, NauseaVomiting, Sore throat,fatigue Narrative:
Pt was given MMR #2, DTap #5, IPV #4 on 7/31/06 pt had high fever one day after.
I woke up in a cold sweat in the middle of the night. I was dehydrated, I had a headache, and I nearly threw up. We later confirmed that I have a fever of 101. I've been very lethargic, as well.
Flu like symptoms, fever, diarrhea (4 times home, 2 times work)
Two days after vaccinated,  injection site became red, swollen, and slightly itchy.  Looked like a large welt. It is getting better today, 1/3/2021.
Pain at injection site; Body aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included eczema and arthritis.   On 20th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 9 months after receiving Shingrix, the patient experienced injection site pain and general body pain. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the general body pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain and general body pain to be related to Shingrix.  Additional details were provided as follow: The case was reported by the patient herself. The patient received Shingrix in the left arm. The patient reported body aches and pain at injection site which lasted a day and then resolved.  The reporter consented to follow up. For tolerance in 2nd dose refer case US2021014428.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021014428:Same reporter
Noted swelling on right side of upper lip several hours after Flumist. Gave Benadryl and popsicles. No fever or complaints of pain.
That evening I developed body aches that reminded me of COVID. I developed a fever and bad fatigue. I didn't seek treatment and I was warned about symptoms, so I just took Tylenol.
2nd dose pfizer vaccine was given to patient on 07/06/2021. We found out on 07/09/2021 vaccine was stored outside the recommended 31 day expiration window. We reached out to pt on 07/10/21 to get the 1st dose again. Patient will return to the pharmacy to repeat dose on 07/14/21.
R arm heaviness, pain in R arm and R foot blistering at site. Lips turned blue and had HA.
Reporting administration error as per immunization system. We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only include manufactuarer dates on the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from them.  No adverse reaction reported from the patietn at the time of the vaccination and no adverse reaction reported since given vaccine.
My left arm and shoulder are in constant pain.  I have loss of range of motion and use.  I have sleep loss from the shoulder and arm pain.   SIRVA
HCP reported patient received first dose on 29Jan2021 and did not get second dose yet.; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (HCP reported patient received first dose on 29Jan2021 and did not get second dose yet.) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (HCP reported patient received first dose on 29Jan2021 and did not get second dose yet.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (HCP reported patient received first dose on 29Jan2021 and did not get second dose yet.) 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 medication was reported. No treatment medication was reported.
I had extremely bad sore throat, coughing, I took a home COVID-19 test, it came back negative. I took a second test on the first of April, it came back positive, I called my doctor. I had a telehealth visit, I was prescribed, Paxlovid and a cough medication. I started to feel better, but the cough lingered until Saturday April 8, 2023. I went running today, I didn't have any trouble breathing at all.
Received Tdap vaccine 5/2/07 IM into (L) arm. Woke on 5/22/07 with hives on back, chest, stomach and thigh. Resolved with Benadryl ->evaluated in office after developed hives under her eye. No fever or s/s illness. Possible reaction to Tdap. No resp distress or swelling anywhere
dizziness; Weakness; Difficult staying awake; Unable to talk; Chills; Joint pain; This is a spontaneous report from a contactable consumer (patient) to a Pfizer-sponsored Program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient wanted to report side effects after her first dose of covid-19 vaccine and stated that on an unknown date she experienced dizziness, weakness, difficult staying awake, chills, joint pain, and unable to talk. She was concerned about getting her second shot of covid-19 vaccine. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a adult patient who received SHINGRIX for prophylaxis. On 25th February 2019 08:30, the patient received SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced injection site itching, injection site rash, injection site swelling, injection site pain and fever. On an unknown date, the patient experienced injection site warmth. On an unknown date, the outcome of the injection site itching, injection site rash, injection site swelling, injection site pain, injection site warmth and fever were unknown. It was unknown if the reporter considered the injection site itching, injection site rash, injection site swelling, injection site pain, injection site warmth and fever to be related to SHINGRIX. Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient had small itchy rash, swelling, warmth, pain and a low fever of 99.0 about 2 inches in diameter around the injection site. The patient had send message to physician and was waiting to hear from them.
Allergic reaction: itching hands, feet, extreme rash, difficulty swallowing, fatigue. Benadryl for a week, Epi pens on hand
Pt developed rash on abdomen on 2-24-12. On 2-25-12 rash was described as red blotchy and was worse over body mostly on face and trunk. Temp was 98.1 no fever and no signs of itching. Pt finished AMOXIL 1 week prior to rash for B/L otitis media (prescribed on 2/9/12).