chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the pain in injection site radiated to the lateral border of her axilla, she describes this pain as a shooting and nagging pain on her axilla border.; Slight headache; being weak and having no energy; warmth around the axilla border and armpit; All pain are on the left side; is 42 years old and states that her doctor recommended she get the Shingrix vaccine; is 42 years old and states that her doctor recommended she get the Shingrix vaccine; pain around injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 42-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 23rd July 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, off label use and inappropriate age at vaccine administration. On 24th July 2020, the patient experienced axillary pain, headache, weakness, feeling of warmth and pain localized. On an unknown date, the outcome of the injection site pain, axillary pain, headache, weakness and feeling of warmth were not recovered/not resolved and the outcome of the pain localized, off label use and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the injection site pain, axillary pain, headache, weakness, feeling of warmth and pain localized to be related to Shingrix.  Additional details were reported as follows: The patient received her first Shingrix dose in her left upper arm and she experienced pain around injection site on same day after receiving vaccine. On 24th July 2020 she woke up with the pain in injection site radiated to the lateral border of her axilla, she describes that pain as a shooting and nagging pain on her axilla border. She also reports some warmth around the axilla border and armpit. All pain was on the left side. She also reports a slight headache, being weak and having no energy.  The reporter consented to follow up. The patient was 42 years old and her doctor recommended she get the Shingrix vaccine because of concerns for her immune system because she takes biologics drugs and her roommate had shingles a week ago which led to drug use for unapproved indication and inappropriate age at vaccine administration.
Her son was given the bivalent booster although his primary series was Moderna and it was not recommended; Her son was given the bivalent booster although his primary series was Moderna and it was not recommended; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID: The reporter is the parent.  A 3-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Jan2023 as dose 3 (maroon cap), single (Lot number: GK1667) at the age of 3 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergy" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC ALLERGY taken for seasonal allergy. Vaccination history included: Moderna coviD-19 vaccine (Dose 1, single), administration date: 01Jul2022, when the patient was 3-year-old, for COVID-19 immunization; Moderna coviD-19 vaccine (Dose 2, single), administration date: 23Aug2022, when the patient was 3-year-old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 06Jan2023, outcome "unknown" and all described as "Her son was given the bivalent booster although his primary series was Moderna, and it was not recommended".  Additional information: It was reported that the mother of the patient did the Inquiry that her son was given the bivalent booster although his primary series was Moderna, and it was not recommended, and she wanted to get information about it. Reporter mentioned she knows this was not recommended and that this was a mistake, and she was concerned about the safety. Reporter asked if there was anything she needs to look out for as far a safety, also mentioned that the dose was administered on 06Jan2023. The primary series with Moderna's vaccine were administered on 01Jul2022 and 23Aug2022. Reporter was uncertain about the formulation of the vaccine her son received. Th vaccine was given to the patient in left arm. Specific Relevant Test: For Thromboembolic events with Thrombocytopenia: N/A. Emergency room: No, Physician's office: No.  No follow-up attempts are possible. No further information is expected.
Patient received the vaccination and was sitting in counseling room when he passed out. Called for Assistance 88 and 911 EMT. BP 100/60, EKG WNL; Patient states he had worked out, had protein drinks, was dehydrated and anxious about getting the vaccination. Recommended patient go to urgent care to get rehydrated and take care of nausea.
This spontaneous report was received from a registered nurse and refers to a 12 month old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 20-OCT-2016, the patient was vaccinated with an improperly stored PROQUAD lot # M022402 with expiration date of 01-NOV-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 23 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA013888:
At 1443 EMT observed client leaning forward in chair and approached for further assessment. Client mentioned feeling dizzy. PHN arrived at 1445 and observed client sitting upright in chair, alert and oriented x4. PHN asked EM to bring anti-gravity chair. Client able to transfer to anti-gravity on her own. First vitals by EMT at 1445: blood pressure 148/86, pulse 92, oxygen sat 100%. Grandmother present with client. Client reported feeling dizzy and nauseous. Client denied headache, blurry vision, shortness of breath. PHN observed hives on neck, bilateral arms, chest and upper left back. PHN offered Benadryl, Grandmother accepted and stated she would go get Father who was outside. Father denied client having allergies, no pertinent medical history or current medications. At 1448 PHN administered 1ml/50mg Benadryl IM on right deltoid after checking dosage table and verifying weight with client. PHN called 911 at 1449.  At 1452 client reported new onset of tingling on both hands. Client appeared pale and diaphoretic. Vitals at 1452 by EMT: blood pressure 150/90, pulse 108, oxygen sat 100%. Hives on bilateral arms improving, hives on upper left back resolved. Flushing of face and ears. 1456 PHN and EMT observe edema of lower lip. PHN on phone with 911 operator asked client if she was having trouble swallowing. Client unable to fully describe, drowsy, but was speaking in full coherent sentences. At 1456 pulse 95, oxygen sat 100%. Paramedics arrived at 1458 and assumed care.  Client transported to
headache, fever, body aches, nausea, chills, muscle. Vaccine was administered at 8:30 am and symptoms ocurred at 10:30 pm
I felt exhausted, and had body aches all over. For the next 3 days I was mainly in bed sleeping.
Developed Shingles ( Herpes Simplex) om neck in an area that has had repeated outbreaks.   Didn't connect the dots to COVID shot until I read about the connection between MRNA shots and herpes simplex outbreaks.
I had a normal menstrual cycle in August after the shot, as far as getting it on time. It was a bit lighter than usual.   Then two weeks later, on the date. My ovulation should have started, I got my period again. I remember cramping the day before,  but figured it was because I was going to ovulate.   It?s now been a week, and I?m still bleeding. It?s not heavy, but it?s definitely there.   I have had the paraguard IUD since January 2021, and my period has been like clock work. I have never experienced breakthrough bleeding, or an additional menstrual cycle any other month since having it in.
I woke up with a significant sore throat on 12/13/2022. I tested negative for COVID-19 that day. I had a very fitful night of sleep that night with lots of body aches. When I woke up the next morning on 12/14/2022, I had a fever of around 100 degrees, and I tested positive for COVID-19. I had minimal coughing and very little postnasal drip. I had a virtual visit with my doctor on 12/14/2002. She reviewed my symptoms and decided to prescribe me Paxlovid. On Thursday morning, my oxygen saturation dropped at 91% and I was running a fever of 100.7 even while on 1 gram of Tylenol, so I began taking the Paxlovid on 12/15/2022. I finished my prescription on 12/19/2022. By 12/18/2022, I was feeling a little fatigued, but otherwise normal. I had Tessalon pearls from a previous illness, I took two on Friday, and again on Saturday. I tested negative for COVID-19 yesterday and confirmed with an additional negative result this morning.
This spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with a dose of PNEUMOVAX 23 injection, lot number L037554; expiration date 25-DEC-2017 or lot number N001007; expiration date 19-SEP-2018 (strength, dose and route of administration were not reported) for prophylaxis. The temperature of excursion with the PNEUMOVAX 23 was between 47 to 77 Fahrenheit degrees during 5 hours. Previous temperature excursion was between 47 to 77 Fahrenheit degrees during 6 hours. The temperature of excursion was detected by a data logger. No adverse effects reported. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1707USA006407: US-009507513-1707USA006397.
On day to the left arm had some redness at the injection site and was sore.  This was listed as unknown possible side effect. On the days following a became increasingly red and itchy.  I took Benadryl to help resolve the itching.  Redness and itching continued and then on Sunday 12/27/20 The site became increasingly read painful to touch  and warm to touch.  On Monday morning I contacted my immediate supervisor advised her that I was having something outside of what I believed to be a ?normal? reaction or side effect.  I went to urgent care to see occupational health.  I was given prescriptions for keflex and naproxen for cellulitis.  My arm is extremely painful to touch.  I was advised if the area worsens or spreads to see the ER because I may need IV antibiotics.
I received my first dose on March 31, 2021 and my second dose on 4/21/21.  I started experiencing chest pain upon exertion on July 12th, 2021.  Heart scans indicate no blockages noted, so the cause of the heart / chest pain is unknown, however the only new variable in my health is this vaccine.  Root cause of pain still being determined.
angioedema; nonurticarial rash; This literature-study case was reported in a literature article and describes the occurrence of ANGIOEDEMA (angioedema) in a 28-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.   LITERATURE REFERENCE: Graded administration of second dose of Moderna and Pfizer-BioNTech COVID-19 mRNAvaccines in patients with hypersensitivity to first dose. Open Forum Infect Dis. 2021;8(12)     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 ANGIOEDEMA (angioedema) (seriousness criterion medically significant) and RASH (nonurticarial rash). At the time of the report, ANGIOEDEMA (angioedema) and RASH (nonurticarial rash) 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 considered ANGIOEDEMA (angioedema) and RASH (nonurticarial rash) to be related.    Patient experienced hypersensitivity reactions to the first dose Company Comment This case concerns a 28-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of angioedema. The event occurred on an unknown number of days after the first dose of mRNA-1273. The rechallenge was unknown since no information regarding the second dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-409757, MOD-2021-409798, MOD-2021-409799, MOD-2021-409803, MOD-2021-409801, MOD-2021-409802, MOD-2021-409800, MOD-2021-411105, MOD-2021-411106, MOD-2021-411107 (Patient Link).; Sender's Comments: This case concerns a 28-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of angioedema. The event occurred on an unknown number of days after the first dose of mRNA-1273. The rechallenge was unknown since no information regarding the second dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sudden intense itching on back of left leg, right at/below back of knee. It felt hot and it swelled. Next morning it was pink and still itched but not as bad. I took pictures.  The following evening I also took pictures. By then it was a dark red, looked like a bruise and followed the shape of my vein.
The patient presented to outpatient clinic earlier today with complaints of what sounds like pleuritic-type chest pain.  Described it as a pressure like an elephant was sitting on his chest.  Worse with lying flat.  He did get his second COVID vaccine on Friday and Saturday.  He began to have symptoms of fever, body aches, and chest pain.  High sensitive troponin is elevated.  Point of care troponin is 4.  EKG shows subtle inferolateral ST elevations.  There is also PR depression noted.  He will be taken to the cath lab urgently for evaluation to rule out ST elevation myocardial infarction, but likely all vaccine associated myopericarditis. Hospitalized 1 day and discharged home with Ibuprofen x 1 week and colchicine x 3 months.
a little tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (a little tiredness) in a 120-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced FATIGUE (a little tiredness). On 10-Feb-2021, FATIGUE (a little tiredness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Upon in internal review on 21 May 2021, the age was corrected to an unknown age.   This case was linked to MOD-2021-075139 (Patient Link).
This spontaneous report was received from a pharmacist via Poison & Drug Center (PDC) regarding a 60 year old female patient. The patient's pertinent medical conditions and concomitant medications were reported as unknown. On 09-DEC-2017, the patient was vaccinated with ZOSTAVAX lot # M032141, 1 syringe once, subcutaneous (strength was reported as unknown), expiry date: 02-OCT-2017 for prophylaxis (experienced expired product administered). It was reported that, the patient did not experience any adverse events. There was no relevant lab data. This is one of the two reports from same reporter.
12/25/2020 - left lower vision loss,  felt very dizzy, severe headache, severity waxed and waned until presented to eye doctor on 1/5/2021, did visual field testing, recommended PCP for potential stroke, saw PCP on 10/5/2021 and MRI completed and showed recent stroke
Pin and needles in feet, then burning sensation in soles of both feet, then burning sensation moved into both legs, then into portions of torso, and right arm.
Phantom smells, I kept smelling Eucalytus and mint when there wasn't any.; This is a spontaneous report received from a contactable consumer.   A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported), via an unspecified route of administration at the right arm on an unspecified date of Feb2021 at single dose for COVID-19 immunization at Health Clinic. The patient had no other medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not take other vaccine within 4 weeks. On an unspecified date on Feb-2021, the patient had phantom smells and kept smelling Eucalyptus and mint when there wasn't any. It was reported no other family members smelled it. Event was not treated. The patient had no COVID prior vaccination nor tested post vaccination. Outcome of event was reported as recovered on an unspecified date.  Information on the lot/batch number has been requested.
Information has been received from a pharmacist concerning a 62 year old female who on 23-APR-2012 was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot # not reported) in the left posterior shoulder. The patient called the pharmacy in the morning on 25-APR-2012 and reported that she noticed on 24-APR-2012 (last night) she had an area around her injection site that was warm and red and approximately 2 inches by 2 inches. No fever or rash was presently reported. No treatment was given for adverse event. Varicella Zoster Virus Identification Program (VZVIP) was offered to the physician, but he denied. At the time of reporting, the patient was not recovered. Follow up information received from the pharmacist who stated that the patient developed an injection site reaction that was tender, red and the size of the quarter on an unspecified date. The pharmacist stated that the injection site reaction resolved within 4 to 5 days. The patient sought medical attention. Additional information has been requested.
fever and severe body aches and chills , body aches pfizer - no problems / first vaccine no problem- sore arm only
Itchy  around upper arms (2) lower stomach and back--within 5-6 days. Followed by more locally areas followed by small pimple like pustules, very itchy over the following week. (Now in the 14th day) Have covered the areas (Small) with calydril lotion and getting good relief-called the Clinic and talked to a Nurse who said to stay away from children and this will pass. Said I have a small case of the "Chicken pox"
Pt. received vaccine on Wednesday 1-27-2021, felt itchy on Friday 1-29-2021, broke out all over on Saturday with hives and no other apparent reason.  Pt. used benadryl cream and bathed in alcohol that helped slow it down for a little while. recommended Medrol dose pack and keep allegra 180 mg 24 hour antihistamine on standby, may add pepcid. Informed pt. may be up to 14 days for it to go away.
PT presented on 7/15/16 with fever, lethargy, nausea, and rash at injections site.
Headache - Induration at site of injection 5cm X 2cm - Erythema, tissue edema total area 10 cm X 10 cm at injection site.
Left shoulder, injection pain, deep muscle pain, sore on it causes pain level pain = 7) No help with meds. No change since initial complaint. Got pain that same day of injection.
Receiving a dose from a vial that was opened more than 12hs before vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving a dose from a vial that was opened more than 12hs before vaccination) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving a dose from a vial that was opened more than 12hs before vaccination). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Receiving a dose from a vial that was opened more than 12hs before vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Receiving a dose from a vial that was opened more than 12hs before vaccination) to be not applicable.    No treatment medications were provided. Concomitant medications were reported as unknown.
Injection site itching; Suspected COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (Suspected COVID-19) and INJECTION SITE PRURITUS (Injection site itching) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE RHEUMATOID ARTHRITIS).   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. In 2021, the patient experienced SUSPECTED COVID-19 (Suspected COVID-19). On an unknown date, the patient experienced INJECTION SITE PRURITUS (Injection site itching). In 2021, SUSPECTED COVID-19 (Suspected COVID-19) had resolved. At the time of the report, INJECTION SITE PRURITUS (Injection site itching) had resolved.            No concomitant medications were reported.   On an unknown date, the patient experienced itchy at injection site. In 2021,the patient experienced covid-19 symptoms. In 2021, the covid-19 symptoms resolved. On an unknown date, itchy at injection site resolved. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment medication was provided.  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.
Numbness, tingling in ball of right foot. Dr sent me to Orthopedics, treatment was steroid shot and insertion of insole in right shoe. Numbness and tingling is persistent to this day.
Large local rxn to elbow with erythema and swelling left arm. Tx with Motrin and Benadryl. Refer to Allergist.
12:15pm Post vaccination reports feelings of "hoarseness, itchy throat, tingly tongue; medical monitoring x 30 min, HR 60 RR 12 All symptoms resolve with no additional complaints or new symptoms; released from facility to home
Diffuse hives. 10/27/09 ED records records received service date 10/25/09. Assessment: Allergic reaction to H1N1 Vaccine. Patient presents with generalized, diffuse, itching rash. Mild headache. Urticaria.