chrisvoncsefalvay/vaers-outcomes huggingface dataset:
doses were administered post excursion; had a temperature excursion. 9 doses were administered post excursion; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses were administered post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (had a temperature excursion. 9 doses were administered post excursion) and NO ADVERSE EVENT (no adverse event) in a 3-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses were administered post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (had a temperature excursion. 9 doses were administered post excursion) and NO ADVERSE EVENT (no adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses were administered post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (had a temperature excursion. 9 doses were administered post excursion) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (doses were administered post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (had a temperature excursion. 9 doses were administered post excursion).    Concomitant products were not reported.  It was reported that 9 doses were administrated post temperature excursion. The storage condition at the time of excursion was reported as frozen. The vial belongs to one of the following batch numbers AR9236B: Exp: 22Aug2023, AS1903B: Exp: 14Jun2023, AS7170B: Exp: 09Jun2023 and 216K22A. The maximum or minimum temperature reached was -2 to -18 C. The excursion duration was reported as 2 hours.   Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2023: Live Follow up Significant Information received Event added, Narrative Updated.
This spontaneous report as received from a nurse refers to an 6 months 1 day old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. 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 is not expected, no contact details were provided.
Hives; Rash; Welts; Itching/very bad itching and scratching; Very bad itching and scratching; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), RASH (Rash), URTICARIA (Welts), PRURITUS (Itching/very bad itching and scratching) and SCRATCH (Very bad itching and scratching) in a 66-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 016B22A) for COVID-19 prophylaxis.    Co-suspect product included non-company product CETIRIZINE HYDROCHLORIDE (ZYRTECNO) for an unknown indication.    Concomitant products included ACICLOVIR (ACYCLOVIR DENK), ESCITALOPRAM and ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS) for an unknown indication.   On 25-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular use) 1 dosage form. On an unknown date, the patient started CETIRIZINE HYDROCHLORIDE (ZYRTECNO) (unknown route) at an unspecified dose. On an unknown date, the patient experienced URTICARIA (Hives), RASH (Rash), URTICARIA (Welts), PRURITUS (Itching/very bad itching and scratching) and SCRATCH (Very bad itching and scratching). At the time of the report, URTICARIA (Hives), RASH (Rash), URTICARIA (Welts) and PRURITUS (Itching/very bad itching and scratching) had not resolved, and SCRATCH (Very bad itching and scratching) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular use) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular use), the reporter did not provide any causality assessments.   The patient did not experience any additional symptoms/events. It was reported that patient visited urgent Care first time and received a steroid shot. There were no lab data/results available. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2023: Live significant follow-up received: New event was added.
PT WAS GIVEN THE LOWER DOSE MODERNA BIVALENT 10 MCG INSTEAD OF 25 MCG. NO ADVERSE VACCINE REACTIONS
This case was reported by a physician via call center representative and described the occurrence of injection site joint pain in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, 30 days after receiving SHINGRIX, the patient experienced injection site joint pain. On an unknown date, the outcome of the injection site joint pain was not recovered/not resolved. It was unknown if the reporter considered the injection site joint pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that the patient was vaccinated 2-3 months before the reporting date. Approximately 1 month after vaccination, the patient experienced unresolved pain at the injection site/shoulder. The healthcare professional was unable to provide dates for vaccination but was okay with a follow up and will research. She was not the healthcare professional that gave injection.
Migraines, swollen lymph nodes, aphasia, feet and toes turned purple for approx two hours
Information has been received from a nurse concerning a 57 year old female patient who on 24-SEP-2010, was intramuscularly vaccinated in her left arm with a 0.5 mL dose of PNEUMOVAX 23 (LOT# 663888/0627Y). On 24-SEP-2010, approximately four or five hours after vaccination, the patient experienced severe pain in her left arm, from shoulder to her finger and finger of the left hand became swollen. The patient went to the emergency room and was hospitalized. At the time of the report, the patient was recovering. Severe pain in her left arm, from shoulder to her finger and finger of the left hand became swollen were considered an other important medical event by the nurse. Additional information has been requested. The patient was hospitalized.
Parts of my face feel tingly and a little numb.  The area around my mouth and top of my check on left side. This started about 20 minutes after shot and has not gone away. It?s been about 5 hours now.
Shots were given around noon, and patient woke up later that night shaking. He described it as similar to a tremor. The shaking was not related to chills or a fever. He also had trouble with his balance, but did not fall. He said the shaking episode lasted around 30 minutes. He then went back to sleep. He felt mostly better the following normal but still had a small amount of trouble with his balance. He also had a headache. He said he continued to improve over the course of the day.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a adult female patient who received SHINGRIX. On 1st May 2018, the patient received SHINGRIX. In May 2018, 5 days after receiving SHINGRIX, the patient experienced muscle pain and shooting pain. On an unknown date, the outcome of the muscle pain and shooting pain were unknown. The reporter considered the muscle pain and shooting pain to be possibly related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine last week before the date of reporting and she developed severe muscle pain and shooting pain. The reporter commended that she could not hear and that she would call back, she then disconnected the call.
After a week, pt, reported severe itching, to where she bruised her skin, reddish-purple from elbow to shoulder. Stated it was hard at injection site, and very warm to touch. This was due to PREVNAR - upper left arm affected.
Pt is 21 y/o male, Received AVA (3 right) and primary smallpox vaccine (left) on 10/10/06. Denies significant local reaction at anthrax vaccine site. Smallpox vaccine site with some redness and pruritis, but no streaking or lymphangitis. No tender nodes in left axilla. Has been covering SPV site with dressing and following guidelines regarding site care and hand washing etc. SPV site assessed as take and undergoing normal progression. NO unusual or prolonged systemic symptoms following vaccine receipt, but did experience 2 day history of generalized body aches around post vaccine days 8 and 9. New onset of pruritic lesions around post vaccine day 10 (Oct 20th). Described appearance of about 10 red, slightly raised, pruritic lesions on both arms. By the following day, had generalized rash on arms, trunk, back and legs. Seen in ER on 10/21 and treated with Benadryl. Denies change in character of lesions other than lesions becoming confluent. Came in for follow up evaluation in Dermatology on 10/23 and had punch biopsy done. Continues to experience significant pruritis despite treatment with Benadryl. Denies previous history of any vaccine adverse events. Denies any recent symptoms of viral type illness or infections. No exposure to skin irritants, not using new soap, not new detergents, not new lotions and not recently changed cleansing agents. Allergies: no allergy to foods and no known drug allergies. past medical history denies history of chronic illnesses. Specifically denies history of allergies (aeroallergens), asthma, and eczema. No history of hospitalizations. No surgeries. Previously well, not feeling tired or poorly, no fever, and no chills, no headaches. No mouth sores, no lip sores and no sores on the tongue, Pruritus localized to a skin rash or sores. No blisters. Generalized lesions excluding the palms and soles. No tingling and no burning sensation. Lesions macule, papule, pruritus
Patient was given shingrix on her left arm. She felt the vaccine entering her arm. Said that she did not like that feeling or sensation but does not mind the needles at all. I told her what the side effect and what to expect of the shingrix vaccine. We exchanged seat and I gave her flu vaccine on the right arm. As soon as I was gave her the flu vaccine, she said she was not feeling right and she felt dizzy and seeing white spot, she felt like fainting. I help to her to support her. She also said she felt hot and I started fanning her. I was trying to hold to her and hug to support her. She rolled her head and she slightly tug her head on the wall and fainted for her seconds and became conscious when she hit her head slightly on the wall. I stabilized her a bit . I went to get her cold water while I asked her 15 year old daughter to watched her. She drunk the cold water and said she felt a little better. No fainting spell but she still felt rubbery. I asked her to stay for a while and observed her. She did not have any hives or allergic reaction. She said she also have stomach upset. Her older daughter came after 30-45 minutes and brought her home. Around 5pm I called patient at home and said she felt better but still is cold and wearing sweater and has blanket on. Slight headache  but not from bumping her head.  for follow up and observation and told her to inform her pcp on Monday as well.
purpuric rash;pain, swelling involving @ site;entire UE on side of inj;also pain & swelling reportedly on LE on same side;sx lasting 10 days;
Dizziness; Nausea; This is a spontaneous report from a contactable pharmacist. A 16-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via intramuscular route of administration in the left arm on 14Apr2021 (at the age of 16-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not take any concomitant medications. On 14Apr2021 the patient experienced nausea and dizziness following the 15 minutes observation period and was advised to sit. The patient denied any shortness of breath and did not eat anything that morning. The vital signs were all within normal limits. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events and included juice and crackers. The patient reported improvement after hydration and snacks.  The clinical outcome of the event nausea and dizziness were resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Felt a boom in his chest; pacemaker adverse event; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Felt a boom in his chest) and COMPLICATION ASSOCIATED WITH DEVICE (pacemaker adverse event) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pacemaker insertion (cardiac).    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 CHEST PAIN (Felt a boom in his chest) and COMPLICATION ASSOCIATED WITH DEVICE (pacemaker adverse event). At the time of the report, CHEST PAIN (Felt a boom in his chest) and COMPLICATION ASSOCIATED WITH DEVICE (pacemaker adverse event) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Concomitant medications were not reported. Treatment information were not provided.   This case was linked to MOD-2021-059062 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: New event pacemaker adverse event was added
At around 0100 I began developing body aches, severe headache, chills,  and joint pain. I also developed a mild fever of 101.3. I took Tylenol, took a warm bath with epsom salt and began feeling better around 0500-0700. I then slept 9hrs. Woke up ran some errands went home and was extremely tired. I then napped for 5hrs. After that I felt a lot better. I did have a pretty sore arm for several days but it was tolerable.  The more concerning adverse effect I experienced from Moderna was after my first dose on 2/12/21, my period following  that dose which was to be 02/23/22  was essential non-existent. I then had pregnancy tests done to confirm I was not pregnant.  My period has since seemingly returned to normal.
This non-serious spontaneous case, initially received from a pharmacist on 27-Mar-2018, concerning a 28-year-old, adult male patient. On 27-Mar-2018, the patient (under age of 65 year) was inadvertently administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number, expiry date: not reported) instead of FLUCELVAX QIV. It was reported that, no adverse event was experienced by the patient. The reporter assessed the case as non-serious.
Tinnitus (ringing in ears) began within 1 hour of vaccination and has continued unabated ever since.  Never had these symptoms prior to injection, nor any other hearing issues.
I just do not feel good; Dizzy; Heartburn; I have like things in my stomach; My sugar was high for some reason; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Apr2023 as dose number unknown (booster), single (Lot number: GL0087, Expiration Date: 31Aug2023) at the age of 59 years, in left arm for covid-19 immunisation; dulaglutide (TRULICITY), (Batch/Lot number: unknown); metformin (METFORMIN), (Batch/Lot number: unknown); simvastatin (SIMVASTATIN), (Batch/Lot number: unknown); lisinopril (LISINOPRIL), (Batch/Lot number: unknown) at 40 mg for diabetes mellitus. The patient's relevant medical history included: "diabetic" (unspecified if ongoing), notes: Other medical condition: Consumer stated, "No, I just got, I am diabetic.". The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I just do not feel good"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; DYSPEPSIA (non-serious), outcome "unknown", described as "Heartburn"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "I have like things in my stomach"; BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "My sugar was high for some reason". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for dulaglutide, metformin, simvastatin and lisinopril was unknown. Therapeutic measures were not taken as a result of malaise, dizziness, dyspepsia, abdominal discomfort, blood glucose increased.  Additional information: All the medications (Metformin, Simvastatin, Lisinopril, Trulicity) are outdated so they gave patient too many at a time, they gave me too much medicine at a time. Patient had a Covid vaccine initially and tonight he just do not felt good and had like things in his stomach and he was trying to, and he had real bad heartburn and everything else and he do not know what is causing it, might be its part of that and he felt little dizzy. Consumer stated his weight was 5'9, 189 pounds somewhere around that. Last time he checked it, he did not know if its right or not. Patient usually took a Metformin and Simvastatin and he was taking Trulicity but had not taken it yet because he got to get checked again for, get blood work because they got to see if they want him to still take it or not, and he was taking Lisinopril. Patient took one Trulicity but it said some of them, his sugar was high for some reason he do not know why but it was. Patient told that he needed some medicine, told the doctor he needed some more but they did not give him anymore yet, he did not want to go back, he was suppose to go back. All these (Metformin, Simvastatin, Lisinopril, Trulicity) are outdated, they got outdated before he could use it.
PATIENT WAS GIVEN HER FIRST PFIZER COVID VACCINE AT 12:38 PM. SHE WAS VERY EMOTIONAL AT THAT TIME AND STATES NOT ABOUT THE VACCINE ALTHOUGH SHE SAID SHE WAS NERVOUS. SHE WAS CRYING AND ASKED ABOUT IF I KNEW OF A GOOD COUNSELOR. I TOLDER HER A PLACE AND SHE SAID SHE ALREADY HAD AN APPT SCHEDULED WITH THEM. SHE TALKED HOW SHE JUST RECENTLY WAS DIAGNOSED WITH ANXIETY AND PUT ON BUSPIRONE ABOUT A MONTH AGO BUT SHE NEED THE THERAPY SIDE OF IT ALSO.  I TOLD PATIENT AFTER THE VACCINE SHOT TO WAIT IN THE CLINIC FOR 15 MINUTES IN CASE OF AN ALLERGIC REACTION. 6 MIN LATER I AM CALLED OUT IN STORE CLINIC WHERE SHE HAD PASSED OUT. WE GOT HER BACK TO THE EXAM ROOM AND GOT HER SOME WATER AND CALLED 911 BECAUSE WHEN SHE WOKE UP SHE SAID SHE BUMPED HER HEAD ON SOMETHING. SHE SAID THAT SHE WENT TO GET SOME GROCERIES AND THAT WHILE IN THE CHECKOUT LINE SHE FELT FAINT AND TRIED TO MAKE IT BACK TO THE CLINIC AND PASSED OUT.  EMS ARRIVED AT 1250 FOR EVALUATION AND AT 1:02 PM SHE WAS TAKEN BY EMS TO HOSPITAL
(11/28/2021) At morning had tightness in my chest that seemed like pneumonia. Went to a clinic that wouldn't treat me. Then went to the hospital and was seen by a NP and was issued Prednisone and Azithromycin. As of today, 12/7, I am at the tail end of this issue and on the road to recovery.
Patient has abnormal swelling and redness at the injection sight today 06/1/2019  4 days post injection  is hot red and swollen. Advised pt to make an appointment with primary care provider.  No outcome at this time. She said small amount of swelling started on day one had has gotten worse the last few days  it is painful red and swollen.
Patient received DTaP left arm 08/19/2002. On 08/20/2002 pt seen in office with erythema, swelling of arm. Treated with Keflox.
pt recvd vax 3SEP93 & w/in 15 mins of vax pt exp a local react @ the inject site manifested by redness, swelling, & soreness; w/in 24 hrs pt exp flu-like sx of sweating, arthralgias, myalgias, chills, aches, & pains; There was no fever;
Nauseous; Stayed in bed as head was hurting; He felt really sick; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 15Mar2021 (Lot Number: EN6206), as single dose, for COVID-19 immunisation. Medical history included hypertension, blood cholesterol and spinal fusion surgery. Concomitant medications included losartan (unknown manufacturer), rosuvastatin (unknown manufacturer) and oxycodone (unknown manufacturer) for spinal fusion surgery (taking from last decade, as needed). The patient experienced nauseous (nausea) (non-serious) in Mar2021 with outcome of recovering, stayed in bed as head was hurting (headache) (non-serious) in Mar2021 with outcome of recovering, he felt really sick (illness) (non-serious) in Mar2021 with outcome of recovering.    No follow-up attempts are needed. No further information is expected.
Patient was to get her 3rd  Moderna dose .-  not Moderna Booster dose. I gave  2.5ml and then realized she was to get 5 ml.  I gave her the additional  2.5ml dose in opposite arm 60 min apart.  so she received total dose of 5ml. on 11/8/2021 at 1pm and 2pm respectively
Site swelled excessively described as half size of golf ball. Red- itched and burned. Site was left deltoid.
This spontaneous report as received from a patient's grandmother refers to a 4 year old male patient with no allergies, drug reactions or pertinent medical history. On 11-MAR-2010 (reported as two years ago) the patient was vaccinated with VARIVAX (Merck) (dose 1, 0.5 ml, subcutaneous, lot number not reported). No concomitant medications. On 07-MAY-2013, the patient was diagnosed with shingles. The patient sought medical attention by an office visit and was treated immediately with unspecified medications and lesions were resolving. Additional information is not expected.
Swelling to left deltoid at injection site encircles entire upper arm. Mom described as red, hot touch, and hard. Area the size of baseball.
Dizziness; Pots; Paresthesias; PM Hx JRA.