chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Product Complaint; Large golf ball sized whelp at site; Erythema streak across chest and up neck; Feeling "drunk, like a weird state of awareness."; This case was reported by a pharmacist via call center representative and described the occurrence of injection site urticaria in a adult patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number T9N35, expiry date 30th June 2020) for prophylaxis. This case was associated with a product complaint.   On 3rd October 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On 3rd October 2019, less than an hour after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site urticaria, erythema and feeling drunk. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site urticaria, erythema, feeling drunk and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the injection site urticaria, erythema and feeling drunk to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient demographic details were not provided. The age at vaccination was not reported. The pharmacy manager stated that, within minutes after vaccination, the patient experienced large golf ball sized whelp at site, erythema streak across chest and up neck and felt drunk like a weird state of awareness. The reporter stated that all 9 employees received dose from same batch number and was warm transferred to the Glaxosmithkline response center for documentation of potential product complaint. The pharmacy manager did not have any patient-specific details available at the time of this call, but stated safety could follow up. The reporter consented to follow up. This case was 4 of 9 linked cases reported by same reporter.
IM injection given in left thigh due to patient having bilateral Eversense glucose monitors embedded in upper arms
First dose given at 17 years of age; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose given at 17 years of age) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for Asthma.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose given at 17 years of age). On 13-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose given at 17 years of age) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications provided
Tdap x 2 2/5/14 and 2/20/14. None noted or known reaction.
Client admitted to the hospital on 7/27/2021 with Covid pneumonia, SOB, tachypnea, congestion and probable sepsis. Submitter does not have access to information on hospital course our outcomes. Please contact the hospital directly for follow up information.
first dose from a Moderna Covid-19 vaccine vial on August 4, 2021. The vial was first punctured on August 3, 2021. The punctured vial was kept in the refrigerator up until the doses were administered. The vial was not exposed to room temperature for greater than 24 hours. The vial was punctured greater than 12 hours before being administered to patient. patient reports no issues with vaccine injection site
Localized rash below injection site; Rash under site of injection; This spontaneous case was reported by a physician and describes the occurrence of RASH (Localized rash below injection site) and INJECTION SITE RASH (Rash under site of injection) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced INJECTION SITE RASH (Rash under site of injection). On 22-Jan-2021, the patient experienced RASH (Localized rash below injection site). The patient was treated with HYDROCORTISONE for Rash, at an unspecified dose and frequency. On 23-Jan-2021, INJECTION SITE RASH (Rash under site of injection) had resolved. On 24-Jan-2021, RASH (Localized rash below injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.       Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2021: Added event. Updated Address, age, route of administration, anatomical location. Added patient demographics.
Body aches and pain; swollen, painful lymph nodes. Left breast and left arm pit severe. Cardiac dysrhythmia, bounding pulse. (Dx: frequent PAC's and PVC's. Now taking Metoprolol succ ER 12.5 mg daily). Scar from surgery 3-8-2021 swollen, reddened, painful, burning, itching.(ongoing). Healing of surgery site WNL prior to COVID-19 vaccine.
An hour after getting the shot my upper back was very painful. Could not put any pressure on it while sitting. That lasted about an hour and that pain gradually went away.  Around 6pm I started to itch all over my body.  At first it was just mild but as the night went on it got more severe. The itching was from my scalp all the way to my feet. The itching did not diminish in intensity until Saturday but I still having itching one week later. The doctor I saw on Tuesday said that there was nothing medically that could be done. I bought anti itch spray and I am also taking allergy pills a day to combat the itchiness.
Information has been received from a registered nurse for the pregnancy registry for GARDASIL concerning a baby.  The baby's 15 year old mother with asthma who on 20-FEB-2009 was received her first dose of GARDASIL, 0.5ml, intramuscularly (Lot # 661764/0650X), and the second dose on 22-APR-2009 (Lot # 661766/0652X).  Subsequently, the baby's mother was pregnant with the last menstrual period date of 22-FEB-2009 and the estimated delivery date of 29-NOV-2009.  The mother experienced preeclampsia.  Growth abnormality was revealed on ultrasound.  The mother was induced at "37 weeks and 5 days" on 13-NOV-2009 delivered an abnormal infant with no congenital anomaly and with low birth weight, 2338 gm.  Additional information has been received from the registered nurse, OB coordinator in a medicine practice.  The nurse reported the patient's ultra sound revealed intrauterine growth restriction (IUGR).  The patient had mild pre-eclampsia.  The patient was induced and delivered the infant.  The infant had a low birth weight.  The baby was normal with no problems other than a low birth weight.  The baby was being followed by another nurse practitioner who practiced in the same medicine office.  Follow-up information has been received from the registered nurse who reported a healthy baby girl was delivered, weighing 5 pounds and 2 ounces with no problem.  At the time of report, the baby was with no known medical problems.  The mother's experience had been captured in WAES # 0904USA04206.  Additional information is not expected.
METALLIC TASTE IN MOUTH; Itching of ears and face; INJECTION SITE PAIN; TIREDNESS; HEADACHE; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in left arm on 24Mar2021 at 12:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus and chronic pain. The patient had no allergies to medications, food or other products. The patient received other medications (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 24Mar2021 at 12:30, the patient experienced metallic taste in mouth, itching of ears and face, injection site pain, tiredness and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the events. The clinical outcome of the events metallic taste in mouth, itching of ears and face, injection site pain, tiredness and headache were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 16-FEB-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 756 hours with the lowest recorded temperature of -3 Fahrenheit degree. The total cumulative excursion time of the second time was 336 hours with the highest recorded temperature of 59 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Severe vertigo upon wakening; Dizziness/ lightheadedness; nausea; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 24Mar2021 at 18:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. The patient had no allergies to medications, food, or other products.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient previously the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 03Mar2021 at 17:15 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Concomitant medications included lisinopril dihydrate(LISINOPRIL) and vitamin D nos (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 at 06:30, approximately 36 hours after second vaccination, the patient experienced severe vertigo upon wakening. On 26Mar2021, the patient experienced dizziness/ lightheadedness and nausea. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event of severe vertigo upon wakening was recovered on 26Mar2021( lasting for 1-2 hours). The clinical outcome of the events of dizziness/ light-headedness and nausea were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Fever T101 degrees and vomiting developed approximately 12 hours after DTaP and IPV were given. Also associated with diarrhea. Sxs have continued for 6 days.
Initial report received from a consumer who is a also a patient on 05 June 2012. A 61-year-old female patient, with no significant medical history, had received an intramuscular dose of ADACEL in left arm on 01 June 2012 (lot number: unknown). On 01 June 2012 the patient presented soreness at the injection site, On 04 June 2012 it was reported that the patient's fingers on left hand were moving on their own with tremors and it continued throughout the night and next day some of her fingers moved on their own. The corrective treatments and laboratory investigations were not reported. The patient's outcome was not recovered. Documents held by sender: none. Follow up information received on 10 September 2012: The patient had last shot of tetanus vaccine 20 years back. The patient had never received Shingles vaccine. It was unknown if patient had a serious allergy. The patient was not pregnant during the time of report and had no seizure or a brain disorder. The patient had no serious reactions with any previous vaccination. Upon internal review on 21 August 2012, the case 2012-06054 was identified as a duplicate. This case 2012-05828 is considered as the reference case.
Within 24 hours of administration of vaccines, patient with mild swelling and redness of  right thigh and refusal to bear weight.  Improvement of  symptoms 48 hours after time of injection.  Patient reassessed on 12/08, noted to have  decreased range of motion of right leg with respect to hip internal / external rotation.
Mother states about a half hour after vaccination or returning home, patient was experiencing vomiting and diarrhea. Mother was going to monitor patient, watch for fever, and follow up with physician
Pt got vaccine had sore arm, next day all over joint pain was concerned on 12/16/2020 that joint pain was still there + very bad + occuring in all joints. He stated he called his dr. was told to take motrin
Dizziness and weakness. Difficulty in describing the dizziness. Stated weakness felt like body weighed alot. brought to immediate care for further care. Patient states he is a diabetic and hasnt eaten. initial sugar 200. Due to the severe dizziness and weakness the ICC doctor advised 911 to ER for further care.
Angina at rest; Chest pain; Dyspnea, unspecified type; NSTEMI (non-ST elevated myocardial infarction); SOB (shortness of breath)
The patient received an expired dose of the Moderna COVID-19 Vaccine as a booster dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received an expired dose of the Moderna COVID-19 Vaccine as a booster dose.) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A, 030L20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021 at 9:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received an expired dose of the Moderna COVID-19 Vaccine as a booster dose.). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (The patient received an expired dose of the Moderna COVID-19 Vaccine as a booster dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.  The vial was initially stored in the refrigerator on 22Oct2021
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unknown date, the patient was vaccinated with ZOSTAVAX, subcutaneous (lot number and expiration date not reported)for prophylaxis. The pharmacist reported that the patient received only "about half of a dose" of ZOSTAVAX, because the syringe leaked at the place where the needle is connected to the syringe (manufacturer unknown). No adverse event. Additional information has been requested.
The patient received a Dtap in the left arm, and about 36-48 hours later, had onset of induration, swelling, warmth, and erythema, resembling cellulitis.  The area was 4 x 5 inches.  There was also a 1.5 inch round area of vesicle/blisters inside the red area, but NOT immediately around the injection site.  She was started on Bactrim for presumed cellulitis.
This spontaneous report as received from a Doctor of pharmacy concerning a 76 years old female patient who many years ago was vaccinated with a first dose of 0.5 ml PNEUMOVAX 23, IM, left arm (Lot # not provided) and in 2008 was vaccinated with a 0.5ml dose of PNEUMOVAX 23, IM, left arm (lot # H018440, Exp 29-MAR-2014). No other co-suspects were reported. No concomitant medications were reported. No adverse effects afterwards. Additional information is not expected.
Patient came for her Moderna COVID-19 booster vaccine and was given vaccine that has been on room temp for 53-hours. Patient denies of any adverse effects at this time.
Sore Throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-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-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat). At the time of the report, OROPHARYNGEAL PAIN (Sore Throat) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.
Baby became lethargic evening of morning vaccines. Became so altered in neurological status; referred to neurology to help evaluate. At about 8 Monday after 2 weeks, began to be more alert and active. Baby slept up to 20 hours 1 day. Discharge Summary received on 1/25/2005 states pt experience tongue quivering & hands trembling and tiredness. The discharge diagnosis was the pre-existing condition of hypoplasia of inferior vermis of the cerebellum. Dandy-Walker syndrome was diagnosed in utero and hypoplasia of inferior vermis of the cerebellum shortly after birth.
Lg induration covering upper rt arm hot to touch, painful, w/ some itching. No fever present.
Localized redness, swelling, warm to touch, mild itching of left deltoid.
The patient blacked out briefly after receiving the vaccination. She came to within minutes not realizing she blacked out. We gave the patient some water to hydrate her and had her seated for 15 minutes afterwards while monitoring her.
Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included SIMVASTATIN, SERTRALINE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) outcome was unknown.            No Treatment medication was reported. Patient concomitant also included Rheumatoid arthritis weekly shots. Patient thinks they may have gotten another full dose instead of the booster half dose and will confirm with vaccination provider.   This case was linked to MOD-2021-374592 (Patient Link).   Reporter did not allow further contact
pt received Men B # 2 in clinic 14:53, went home  to nap , woke sweating, tired, chest discomfort ,SOB and fever pt requested inhaler , which mom states not used for a long time  he spoke to Healthline and directed to ED
12/3/13 1530 intradermal vaccine 1700 burning itching begins 2000 viewed arm huge bullseye indurated wheal took 25 mg BENADRYL 600 mg MOTRIN, ice pack went to sleep. 12/4/13 0800 condition worsened red area spread 1430 employee health at hospital. 12/4/13 1430 employer stated severe local reaction, recommended ice, MOTRIN, antihistamines, visit MD if worsens 2000 onset of flushing, chills, temp normal. 12/5/13 0800 deep muscle pain radiating down arm and across chest, flushing, itching, burning, pain at site, induration reduced somewhat. 12/5/13 0830 visited provider given 60 mg prednisone and 5 days at 40 mg a day, advised to continue antihistamines and MOTRIN daily. 12/5/13 1300 visited pharmacy to inform of reaction and file report.
This spontaneous report was received from a pharmacist via company representative, regarding a patient of unknown age and gender. Information on the concurrent conditions and medical history of the patient were not reported. On 17-MAR-2106 (a week ago), the patient was vaccinated with ZOSTAVAX Vial 19400 PFU (lot, expiry date, route and anatomical location were not specified). Concomitant medications were not reported. On an unknown date, patient was being prescribed prednisone for an unspecified reason (adverse event). The reporter did not know why the patient was going to receive prednisone. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
Prolonged itching (more than 2 weeks); hard red lump under injection site; skin discoloration at injection site
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 25-MAR-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (expiration date not provided) lot # K004930, 0.5 ml, intramuscular. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Routine mammogram on April 13, 2021 indicated a cyst in my left breast.
This patient developed intussusception irreducible by air enema requiring  ex-lap with ileocecetomy 5 days after Rotavirus vaccine administration. Pathology was negative for a lead point.
Arm extremely sore and hard by injection site 3days long All joints stiff and sore-day after Tiredness-day after Nausea(no vomiting)-day after
I received the vaccine on 2/9 and started having an adverse reaction. Chills, extreme fatigue, muscle and body aches, bone and jaw pain, no appetite, nausea and diarrhea?all starting on the same day and rather severe by the next day.
pt recv vax 23JUN97 & 11JUL97 pt exp draining pustule @ site of inj lt arm;12JUL97 pt exp papulovesicular lesions on head & face;no fever or other sx were noted;
Started 9 hours later with 101 temp, vomiting, chills, aches. Next morning, vertigo. Doctor called in medicine. Missed whole week of work.