chrisvoncsefalvay/vaers-outcomes huggingface dataset:
INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; This spontaneous report received from a consumer concerned a 16 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced inappropriate age at vaccine administration, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate age at vaccine administration and off label use was not reported. This report was non-serious.
Rash since yesterday. Has had fever past 2 days; night sweats. No N/V/D. No other symptoms. Pruritis.
After receiving the vaccine the patient complained of not being able to move her arms. She said it felt like "brakes" were in her shoulders.
Pt c/o numbness & tingling to left arm, neck & head, HA & blurred vision.  That progressed to not being able to see out of left eye.  Pt had eye exam 11/24/09, uses corrective contacts.  12/09/09 Progress notes for DOS 11/24/09. Pt c/o numbness, tingling of L side, HA, temporal pain, blurry vision and loss of vision in L eye. On examination: drainage from L eye, L sclera & conjuctiva erythematous, purulent drainage, Visual field: deficit in L eye, cranial N I-VII intact, strength equal in U and L extremities. tx: antibiotics. dx: L eye conjuctivitis. Pt to follow up with ophthalmologist.
arm soreness, RT side of head towards back  at curve and top of head soft spot area cold heavy sensation
Itching of bottom and toes on both feet on 1st night; sore arm plus temperature of 102 on 2nd day; sore arm with bump, red circle and heat, plus temperature up to 101.5, 3rd day; sore are with bump, large red circle (over 4 inches) and heat.
Gets real shaky once in a while; Wanted to sit around and do nothing all day - not like me; Vomiting; Achy all over; chills; left shoulder hurt again,sore shoulder - left; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Gets real shaky once in a while), VACCINATION COMPLICATION (Wanted to sit around and do nothing all day - not like me), VOMITING (Vomiting), MYALGIA (Achy all over) and CHILLS (chills) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A. and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced VOMITING (Vomiting), CHILLS (chills) and ARTHRALGIA (left shoulder hurt again,sore shoulder - left). 17-Mar-2021, the patient experienced MYALGIA (Achy all over). On 18-Mar-2021, the patient experienced VACCINATION COMPLICATION (Wanted to sit around and do nothing all day - not like me). On an unknown date, the patient experienced TREMOR (Gets real shaky once in a while). The patient was treated with ONDANSETRON HCL for Vomiting, at a dose of 4 mg. At the time of the report, TREMOR (Gets real shaky once in a while) outcome was unknown and VACCINATION COMPLICATION (Wanted to sit around and do nothing all day - not like me), VOMITING (Vomiting), MYALGIA (Achy all over), CHILLS (chills) and ARTHRALGIA (left shoulder hurt again,sore shoulder - left) had resolved.            No relevant concomitant medications reported.     This case was linked to MOD-2021-249622, MOD-2021-249622 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow up information included no new information.
As pt's PCP office, we became aware that pt was admitted to hospital on 5/3/21 with dx of pulmonary embolism. Per admission note, pt reporting increased shortness of breath x 4 days prior to his admission date. Also noted to have received J&J vaccine on 4/29/21. Pt still currently admitted to the hospital and undergoing treatment for PE.
pt started w/erythematous maculopapular rash on face, back, chest, abd 7 days post vax;illness also includes fever to 104.3;no URI sx;pt also has infected pharynx w/koplik spots on buccal mucosa;tx supportive measures-APAP & DPH;
broke out into hives on left side of face, neck and ears; neck stiffness; swollen glands; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (broke out into hives on left side of face, neck and ears), MUSCULOSKELETAL STIFFNESS (neck stiffness) and LYMPHADENOPATHY (swollen glands) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Allergic dermatitis, Allergic conjunctivitis and Bell's palsy (Weakness on right side of face) on 28-Nov-2016. Previously administered products included for Product used for unknown indication: Cymbalta. Past adverse reactions to the above products included Allergy with Cymbalta. Family history included Stroke and TIA. Concurrent medical conditions included Hypertension since 2000, Diabetes since 2005, Fibromyalgia since 2008, Latex allergy, Shellfish allergy and Allergy to molds. Concomitant products included CETIRIZINE HYDROCHLORIDE (CETRIZINE) from 24-Mar-2020 to an unknown date for Allergy, SALBUTAMOL SULFATE (VENTOLIN HFA) from 24-Mar-2020 to an unknown date for Cough, METFORMIN for Diabetes, GABAPENTIN for Fibromyalgia, LEVOCETIRIZINE DIHYDROCHLORIDE from 24-Apr-2020 to an unknown date and FLUTICASONE PROPIONATE from 24-Apr-2020 to an unknown date for Hypersensitivity, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL + HIDROCLOROTIAZIDA) and METOPROLOL TARTRATE for Hypertension, NAPROXEN from 17-Jan-2019 to an unknown date for Pain, DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) and IBUPROFEN from 20-Jan-2018 to an unknown date for an unknown indication.    On 04-Jan-2021 at 2:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021 at 11:00 PM, the patient experienced URTICARIA (broke out into hives on left side of face, neck and ears), MUSCULOSKELETAL STIFFNESS (neck stiffness) and LYMPHADENOPATHY (swollen glands). The patient was treated with METHYLPREDNISOLONE ACETATE at a dose of 40 milligram; CETIRIZINE HYDROCHLORIDE at an unspecified dose and frequency; DIPHENHYDRAMINE at an unspecified dose and frequency and METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) at an unspecified dose and frequency. On 05-Feb-2021, URTICARIA (broke out into hives on left side of face, neck and ears), MUSCULOSKELETAL STIFFNESS (neck stiffness) and LYMPHADENOPATHY (swollen glands) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: Reporter Last name changed.
1 week after receiving vaccines, diagnosed with gingivostomatitis. BMX mouthwash prescribed.
On 10/13/2016, patient called the pharmacy around 8:30pm, 10/13/2016, and described symptoms of swelling on upper left arm and pain (near injection site). No itching, fever, chills, or redness reported. Pharmacist called patient today around 3pm to follow-up and patient stated that around 3am she awoke to being in pain in her left arm and was sleeping on it. She then applied ice and took 1 tablet of Advil. She woke up at 5:30am and reported to her volunteer activity today. She stated that she took 1 tablet of Tylenol during the day. Today, patient reported no malaise, chills, fever, redness, and noted decreased swelling and pain. Pharmacist spoke with patient today and will follow up with Primary Care Doctor, and patient on Monday to check on patient.
Patient called to complain of an increased heart rate (180) BP of 142/100 hot flashes and headache for 4-5 days.  She has gone to the ER for this.  They gave her some things to try and will have a follow up tomorrow.
No additional adverse events; a patient was administered an improperly stored VARIVAX; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 21-JUL-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot#S036635 and expiration date 14-NOV-2021) (exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis. Properly stored sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) was used to reconstitute improperly stored vaccine. The temperatures to which the vaccine was exposed was from -14 degrees of Celsius (C) to -10C (-11.1C) and the time frame was reported as 2 hours, from -9 C to 8 C (2.2 C) and the time frame was reported as 9 hours and 30 minutes, from 14 C to -10 C (-9.8C) for 2 hours and 30 minutes, from -9 C to 8 C (0.4 C) for 3 hours. The vaccine underwent previous temperature excursion of temperature from -9 C to 8 C (-6.1C) for 8 hours. A digital data logger was involved. No adverse events were reported.
Child c/o pimple size bumps with no head, no redness, no fever, but itched. Bumps were on arm, site of injection, down to elbow.
Beginning  approximately 20 hours after injection, the patient developed urticaria from her forehead to toes, sparing only palms and soles of feet. She is started on a Medrol dose pack today.  Taking Zyrtec 10 mg daily (hold Claritin while on Zyrtec) and Benadryl  25 MG every 8 hours as needed for itching.
Patient experienced numbness and tingling down left arm, from injection site to fingers. No swelling or redness at injection site. Patient has tried heating pad, MOTRIN, and cold pack with no change.
pt. has Shingles, diagnosed by MD on 8/12/19 - severe case
No additional AE. No PQC.; Caller reporting a vaccine was administered after a temperature excursion.; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient"s medical history, current conditions, drug reaction or allergies and concomitant medications were not reported.  On 09-AUG-2022, the patient was vaccinated with an improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliters (ml) as prophylaxis (lot number: U039723, which was determined to be valid, with an expiration date on 15-DEC-2023) (route and anatomical location of administration were not reported) (Product storage error). Details regarding temperature excursion were not provided. No additional adverse event was reported.
Forget 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 17-OCT-2022 Reporter's comment: The pharmacist had inquired about the Shingrix and had asked that for how long before they could start the series over if they had forgotten the second dose. The inquiry came through chat, which was ended by the user before collecting any other details available. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which had led to incomplete course of vaccination.
Pt experienced Z dizziness and syncope in office after vaccination. Occurred at approx 7:45 pm, held pt due to elevated BP until 9:00 pm. No treatment necessary, record BP for 10 days and report to us.
12-28-01 10 am 2 hours post injection-swelling and itching occurred. 6 pm Hives developed around injection site Upon awakening next day lips swollen. Hives and itching-lasted x 3 days. Consulted MD by phone. Left arm
By the end of the day, I had a large red, itchy, hot, welt at the injection site, about 3 inches in diameter. The following day I developed a fever, which, at its height was 100.3 degrees F taken orally. The fever lasted about 24 hours. Additionally, I had headaches similar to those of a sinus infection. For 8 days, the headaches continued AND the welt grew larger, eventually flattening, but encircling my arm completely, before dissipating 10 days later. The area is still itchy however.
Patient had 2 negative covid test, per her work requirements within 24 hours of her moderna vaccine, Patient received 1st dose of moderna vaccine on 1/21/22 am. Within 1 hour of vaccine patient developed severe dizziness, near syncope, shortness of breath, palpitations, chest pain, vomiting and severe lower extremity weakness. Patient waited couple hours in hopes symptoms would improve. Symptoms became so severe within  4 hours patient had to go to the emergency room. There she was noted to have tachycardia and hypotensive. She also was found to be COVID + via PCR test. Lab workup was otherwise unremarkable .
Pt complained of Shortness of breath and chest tightness that started just a few minutes after vaccine administration. Pt has history of asthma. Exam done within normal limits. Pt given 2 puffs of albuterol. Symptoms remain mild after 45 min of observation. Pt discharged home with precautions.
Initial unsolicited report received from a nurse on 04 August 2016. This case involves a 17-year-old female patient who was vaccinated with a second dose of MENACTRA (batch number: U5244AA, expiry date 01 May 2017, dose, route of administration were not reported) in right deltoid on 02 August 2016. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as no known allergies and none. Concomitant medications were reported as none. On 02 August 2016, same day following the vaccination, in the evening patient developed hives starting at the injection site and progressing to full body hives and experienced tongue swelling. It was reported that patient was taken to emergency department. Patient required emergency room or doctor visit. Lab data was reported as none. Patient received corrective treatment with Intravenous Benadryl and Medrol. On unspecified date, patient recovered from events. List of documents held by sender: none.
Developed COVID 19 on 3/8/21  after being dually vaccinated.
no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-JAN-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R013858, expiry date 12-JUN-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Patient received immunization and went to sit-down in post-immunization area. Their eyes rolled back and they started shaking. The episode lasted less than 1 minute. After this, patient was alert and oriented. Upon speaking with the patient they stated that they have this same reaction every time they give blood. They did not disclose this during the patient question or the pre-immunization interview with RPh. Patient felt hot and clammy, so we got patient an ice pack and advised they stay seated. We took patient's blood pressure and heart rate, both were normal. After monitoring patient a while longer patient stated they felt okay to leave.
No adverse effect; The patient received the first dose of GARDASIL 9 on an unspecified date in February 2018 and the second dose on 13-AUG-2019; This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On an unspecified date in February 2018, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # N022584, expiration date: 15-JUN-2020; and on 13-AUG-2019, with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  lot # R009615, expiration date: 07-DEC-2020 (route of administration and anatomical location were not provided for any dose) as prophylaxis (inappropriate schedule of product administration). No adverse effects were reported.
Patient was administered Ped dose of Pfizer COVID vaccine, which is outside the EUA indication for this vaccine. No adverse reactions were reported by patient or family.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # M031651, expiration date: 30-MAR-2018, dose, frequency and route were unknown) for prophylaxis(incorrect product storage). The ROTATEQ was exposed to 31 Fahrenheit degree or colder for a time frame of 13 hours. Data logger was involved. No adverse effects reported.
Patient is a 59 yo M with pmh of HTN, OSA, BPH, alcohol abuse, herpes genitalis who presented to the ED today for generalized body rash and lip swelling. Pt received pneumococcal vaccine and Tdap vaccines on 3/22/2017. Noted (R) arm pain yesterday and since this morning acute onset of worsening lip swelling and a circumoral pruritic disseminated body rash. Denies any stridor or shortness of breath. Pt also had presyncopal episode lasting about 5-10 seconds while his vitals were being taken at the ED triage. Symptoms: 1. Anaphylaxis, 2. Angioedema, 3. Skin Rash, 4. Hypotension. Treatment Drugs Used: 1. Epinephrine, 2. Methylprednisolone, 3. Ranitidine.
Patient reports  itchy skin and tingling in right arm. Pt was observed for 40minutes and provided oxygen at 2Liters for 30minutes. Pt was provided information sheet and precautions if symptoms  continued. Pt states she had a Doctors' appointment later in the day and  will report the incident to her Doctor.
Fever of 102 for 6 days straight had to give motrin/ tylonol every 6 hours and only brought it down 1 degree. Very weary during that time. When her fever was 102 she would tense up and start almost convulsing like, as well as just unexpectedly fall asleep in my arms. It's now been almost two days without fever and she has a bad rash on stomach and back.
Dizziness Muscle pain Weakness Tierdness A monthly cycle of 13 days, Menstruation preceded by 11 days
Patient reports cold sweat, aching around injection site, occurring 4-6 hrs after vaccination.  Patient reports passing out that night after getting up from bed.  Patient did not feel 100% for 24-48 hr after vaccination.  Patient was seen at Pharmacy Care on 10/1/2012 at which time he appeared to be back to his baseline and reported no further adverse effects.
they accidentally administered a patient with an expired dose of the Moderna Covid 19 vaccine.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they accidentally administered a patient with an expired dose of the Moderna Covid 19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS1417B) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (they accidentally administered a patient with an expired dose of the Moderna Covid 19 vaccine.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they accidentally administered a patient with an expired dose of the Moderna Covid 19 vaccine.) 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 EXPIRED PRODUCT ADMINISTERED (they accidentally administered a patient with an expired dose of the Moderna Covid 19 vaccine.).    No concomitant medication were reported. No treatment information was provided by the reporter.
Site of injection 7-8 cm erythema and induration and significant axillary tenderness, neck pain.
COVID vaccine received a dose from punctured vial after 12 hour timeframe; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (COVID vaccine received a dose from punctured vial after 12 hour timeframe) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (COVID vaccine received a dose from punctured vial after 12 hour timeframe). On 12-Mar-2021, EXPIRED PRODUCT ADMINISTERED (COVID vaccine received a dose from punctured vial after 12 hour timeframe) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-208074, MOD-2021-258552, MOD-2021-258572, MOD-2021-258587, MOD-2021-258599, MOD-2021-258615, MOD-2021-258632, MOD-2021-258644, MOD-2021-258660, MOD-2021-258672, MOD-2021-258682, MOD-2021-258689, MOD-2021-258691, MOD-2021-258697, MOD-2021-258699, MOD-2021-258700, MOD-2021-258702, MOD-2021-258703, MOD-2021-258704, MOD-2021-258706, MOD-2021-207548 (Patient Link).
Awoke gasping for air, lasted for about 45 min. Took Benedryl and it helped.  Didn't have full lung function most of the day but it got better next day.  Extreme soreness at times in left arm.
Bruise; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruise) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced CONTUSION (Bruise). At the time of the report, CONTUSION (Bruise) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Patient had Vaccinations at 8 am with no symptoms or complaints denied any allergy except benadryl.At 1053am patient came back to clinic complaining of chest pain, no SoB,not radiating Patient was put on 15 litres of 02 via nonrebreather and ems was called.Vital Signs were 124/88  pulse 65 respirations were 18 patient was alert and oriented