chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Uncomfortable tingling in calf and ankle of left leg for 2 days; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Aug2021 13:00 (Batch/Lot number: unknown) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN. The following information was reported: PARAESTHESIA (non-serious) with onset 02Aug2021, outcome "recovered" (04Aug2021), described as "Uncomfortable tingling in calf and ankle of left leg for 2 days". Therapeutic measures were not taken as a result of paraesthesia.  Additional information: Lot number unknown reason reported as unable to locate or read the details. Facility type vaccine reported as pharmacy or drug Store. The patient was not received other vaccine in four weeks. The patient received other medication in two weeks was Rosuvastatin. The adverse event was not resulted in emergency room or physician office visit. Prior vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID-19. The patient had no known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient felt dizzy and stomach upset in 8 to 10 minutes after vaccination. Patient's mother helped her to lie down on back on floor safely as she was vomiting.  EMS summoned right away. Patient was conscious. EMS came on 11 minutes , checked patient vitals. Patient was feeling well and family decided to go home and follow up with PCP.
Vaccine was picked up on 12/07/2021 to be stored in fridge and used by 01/07/2022. Patient received this dose one day past the vaccine usage date. Patient reported no known symptoms.
LESS THAN 5 MINUTES AFTER RECIEVING THEIR VACCINATION, THE CLIENT WAS FOUND LAYING DOWN ON A ROW OF CHAIRS IN THE OBSERVATION AREA. CLIENT REPORTS HAVING FELT WARM, FLUSHED, AND LIGHT HEADED. CLIENT REMAINED LAYING DOWN FOR SEVERAL MINUTES (AROUND 30 MINUTES). CLIENT WAS GIVEN WATER AND CLIENT'S FATHER GAVE HER STARBURSTS TO HELP, AS THE CLIENT STILL FELT LIGHTHEADED. CLIENT DENIES THIS EVENT HAPPENING BEFORE AND REPORTS HAVING HAD FOOD FOR LUNCH. CLIENT WAS ABLE TO WALK OUT OF THE ROOM ON HER OWN AFTER EATING STARBURSTS. NO OTHER CONCERNS PRESENTED.
By the late afternoon/early evening  I had developed a rash that covered my body from the bottom of my feet to the top of my head.  The rash was clearly visible but not bumpy.  It was extremely itchy.   I took Benadryl and soaked in an Epsom Salt bath several times that night as I was unable to sleep due to the intense itching.  The next morning (Saturday) I called my doctor and was prescribed a steroid to combat the itching  but was told not to take it until Monday so as not to interfer with the antibodies my body was obviously producing in response to the vaccine.  I was also instructed to start taking  one Zyrtec tablet each morning and two Benadryl tablets each night.  On Monday morning (01/25/2021) I began taking Methylprednisolone (4mg Dospak 21s) which relieved the itching.  At this time the rash is greatly reduced and the itching has almost stopped.  I will continue the meds until the  dosage is completed.
8/25/2023 - 8/31/2023 (6 days) Date of Admission: 8/25/2023  Discharge Date: 8/31/2023 Discharge Disposition: Skilled Nursing Facility (SNF) with Certification in Anticipation of Skilled Care COVID infection No signs or symptoms suggestive of upper or lower respiratory tract infection Afebrile, hemodynamically stable and maintaining saturation room air Monitor vital signs and symptoms trend Continue supportive care  PMHx: obesity, chronic systolic CHF (EF 40-45%).  Presented to ED due to bilateral lower extremity swelling.   6/14/2021 Moderna US 039B21A 5/17/2021 Moderna US 039B21A
very large red area, about 2&1/2" x 2&1/2" in size; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (very large red area, about 2&1/2" x 2&1/2" in size) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not available) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE RASH (very large red area, about 2&1/2" x 2&1/2" in size). At the time of the report, INJECTION SITE RASH (very large red area, about 2&1/2" x 2&1/2" in size) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This case concerns a 23-year-old male, with medical history of sulfa allergy, who experienced a NS expected event of injection site rash.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Hives and tightness of throat about 4 hours after vaccination with FLUZONE HD and ZOSTAVAX. Hives occurred on the same arm as flu shot.
Lichenoid Dermatitis/Lichen Planus spreading over torso and extremities; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 21Apr2021 (Lot number: EP7533) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8734), administration date: 02Apr2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: LICHENOID KERATOSIS (non-serious) with onset Nov2021, outcome "not recovered", described as "Lichenoid Dermatitis/Lichen Planus spreading over torso and extremities". The event "lichenoid dermatitis/lichen planus spreading over torso and extremities" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lichenoid keratosis.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse event did not require a visit to Doctor or other healthcare professional office/clinic visit. The treatment received for the adverse event included Steroid cream and antihistamine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has been tested for COVID-19. No Known allergies. The patient also received BNT162B2 (Lot number: FH8027) on 16Feb2022 as dose 3, (booster) single for covid-19 immunisation.  No follow-up attempts are possible. No further information is expected.
I woke up the morning following my first dose of the COVID 19 vaccine feeling very lethargic, tremulous and achy. I felt like my heart rate has been rapid all day and my rate of breathing has been slightly increased. The pain in my left arm, where I was given the injection is very sore to the point where it is difficult to lift or to touch. I was too weak to attempt to go to follow up with medical professionals today and opted to wait to see if symptoms resolved.
Child complained of soreness in the right leg. Parent stated that the child could not walk or stand.
Initial report received from a physician on 03 Dec 2010: This patient vaccinated with FLUVIRIN (batch number unspecified) intramuscularly in Oct 2010 (date unspecified). In Nov 2010 (date unspecified), the patient developed Coomb's positive hemolytic anemia. The outcome of the event was reported as condition unchanged (persistent).
Swelling around the collar bone; bad headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling around the collar bone), HEADACHE (bad headache) and NAUSEA (Nausea) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced HEADACHE (bad headache) and NAUSEA (Nausea). On 16-Mar-2021, the patient experienced SWELLING (Swelling around the collar bone). On 14-Mar-2021, HEADACHE (bad headache) and NAUSEA (Nausea) had resolved. At the time of the report, SWELLING (Swelling around the collar bone) outcome was unknown.            No relevant concomitant medications were reported.  Treatment information was not provided.
Redness swelling tenderness site of injection. Felt feverish (she'd id not v temp) lasted 3 days.
101 Y year old female with PMH significant for hypertension, CKD, hyperlipidemia, COVID + on 7/8/21 (reportedly got 2 doses of vaccine, though only have 1 documented in EMR) who presents with COVID pneumonia. ý Pt went to out of town for July 4th weekend. COVID + on 7/8/21. Housemate noticed pt seemed sicker upon returning with more fatigue, sleeping more, sinus congestion, intermittent cough. Denies any fevers, chills, chest pain, sob, abd pain, n/v/d, dysuria, loss of smell/taste. States that she got both her vaccine shots outside of clinic (Pfizer), but can't remember the date. Pt admitted on 7/10/21. Pt was found to be hypoxic and was treated with decadron. She was not a candidate for remdesivir due to low GFR. She was given lasix to alleviate leg swelling which improved. On date of discharge patient is afebrile and no longer requiring supplemental O2. She is to remain isolated until 7/20/2021
Fever chills, pain in left arm, lymph node swelling in left arm Narrative:
Pain at the injection site/arm pain; Fever; Jitteriness/Jittery; Body aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th April 2021, the patient received the 2nd dose of Shingrix. In April 2021, less than a week after receiving Shingrix, the patient experienced injection site pain, fever, jitteriness and general body pain. On an unknown date, the outcome of the injection site pain, fever, jitteriness and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever, jitteriness and general body pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported but it could be 55 or 56 years old. The patient received Shingrix and was experiencing pain at the injection site (arm pain), fever, jitteriness and body aches. All symptoms were ongoing at the time of reporting. The reporter did not consent to follow-up and declined to provide date of birth.
Moderate Headache started 11/28 @ 0600 Severe headache/Shaking/chills/fever (102) started 11/28 @ 12 noon Vomiting started 11/28 at 13:55
experienced tightness in the throat  for about 10 seconds within 1 minute after administration; experienced dizziness for about 10 seconds within 1 minute after administration.; This spontaneous case was reported by an other and describes the occurrence of   in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
extreme dizziness, felt like going down; fever of 102 F; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (extreme dizziness, felt like going down) and PYREXIA (fever of 102 F) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M21A) for COVID-19 vaccination.  The patient's past medical history included Ex-smoker. Concurrent medical conditions included Allergy to antibiotic (severe allergy to amoxicillin 12 months ago). Concomitant products included ASCORBIC ACID (VITAMIN-C) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced DIZZINESS (extreme dizziness, felt like going down) and PYREXIA (fever of 102 F). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (extreme dizziness, felt like going down) and PYREXIA (fever of 102 F) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 102 f (High) 102 F, high.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  This case was linked to MOD-2022-452561, MOD-2022-452562 (Patient Link).
Atrium flutter  Blurry right eye  Shortness of breath  July 4 2021 onset. Still in vestigating. Ruled out stroke, glaucoma, no retina damage. At ER on 5th
Patient inadvertently received a vaccine dose when records indicate they did not need any. No reactions at time of injection.
IRRITATION SAME NIGHT OF INJECTION. REDNESS AND SWELLING AT INJECTION SITE. NO FEVER, CHILLS.
Eight days post vaccine, itchy, red, hot, swollen arm at vaccine site, felt sluggish, an ankles and knees aching, resolved in 36 hours
Information has been received from a registered nurse concerning a male who in 1997 was vaccinated with varicella vaccine. On 05/16/2001, the pt had "tubes" placed in his ears. On 05/30/2001, a younger sibling ws vaccinated with varicella vaccine. On 06/14/2001, the pt developed a chicken pox like rash on his face only, especially around his nose and eyes. Unspecified medical attention was sought. Additional info has been requested.
Got the shot called Recombinant Zoster vaccine (Zostavax?) on 11 July 2019.  Two weeks later I developed myalgia along my spine, beginning in the lower back and progressing to the neck and front and back shoulder area.  It was severe enough to interfere with my normal activities which include swimming and walking.  After a month I went to my health care provider who took me off atorvastatin as this can either cause or aggravate myalgia.  The myalgia disappated but continued for 2 months before finally disappearing.  I am pretty sure the shingles shot caused the myalgia as I have spoken to 2 other people who had the same reaction, although theirs occurred more immediately after the shot and continued for a much shorter period of time.  I have suggested they file their own reports.
Vaccine leaked from the arm while administering; Vaccine leaked from the arm while administering; Vaccine leaked from the arm while administering; The pharmacist doesn't know if the leak was from the hub area of the syringe or the arm after the needle was withdrawn; This spontaneous case was received on 30-Sep-2020 from a pharmacist via agency (reference number SEQW20-02648) and concerned a patient of unknown age and gender.  The patient's medical history and concomitant medications were not reported.  On an unknown date, while administering the Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; route of administration, dose, anatomical location and indication: not reported) some of a vaccine leaked from the arm (explicitly coded as 'Accidental exposure to product' and 'Incomplete dose administered'). The pharmacist doesn't know if the leak was from the hub area of the syringe or the arm after the needle was withdrawn (explicitly coded as 'Syringe leak'). The batch number was not reported.  The reporter assessed the case as non-serious.  Company comment: A patient was administered incomplete dose of Fluad Quadrivalent. Reportedly, some of a vaccine leaked from the arm. The pharmacist didn't know if the leak was from the hub area of the syringe or the arm after the needle was withdrawn. Vaccination site extravasation is assessed as not related to the vaccine substance. Syringe issue, incorrect dose administered and accidental exposure to product are assessed as not related, per company's conventions.; Sender's Comments: A patient was administered incomplete dose of Fluad Quadrivalent. Reportedly, some of a vaccine leaked from the arm. The pharmacist didn't know if the leak was from the hub area of the syringe or the arm after the needle was withdrawn. Vaccination site extravasation is assessed as not related to the vaccine substance. Syringe issue, incorrect dose administered and accidental exposure to product are assessed as not related, per company's conventions.
7 Months Pregnant; Initial Report Received on 04-Aug2022  A registered nurse  reported that a 39 year-old female patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while 7-months pregnant.  No medical history was reported. Concomitant medications and allergies were unknown.  The patient's last menstrual period (LMP), estimated date of delivery (EDD), pregnancy history, and pregnancy risk factors were not reported.    On 05-Jul-2022, the patient received a dose of HEPLISAV-B (Lot # 937233, expiration date 11-Mar-2023, NDC # 43528-003-01; route not reported) in the left arm. The patient had no adverse reactions.   No other information provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
2 doses administered more than 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 doses administered more than 12 hours post puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 001M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 doses administered more than 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 doses administered more than 12 hours post puncture) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.   Additional information reported regarding date when vial was initially stored in the refrigerator was 11 Apr 2022. 2 doses from 1 vial was administered past 12 hours post puncture. On 12 Apr 2022 at 10:40 AM the vial was first punctured. From first puncture on 12 Apr 2022 at 10:40 AM till the last dose was administered on 13Apr2022 5:45 PM the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F):
2 weeks after the shot I started experiencing hives, but not on the vaccine spot but on the whole body, showlders inside knees back of neck and back of hips. ichy hives daily but it did not escalate to anaphilactic level, I took Allegra anti histamine 3 times on first days when it felt a bit itchy on my throath.  I decided to stop taking allegra as it effects were not immediate and the hives go down on their own. But symptoms persist for 16 days now.
In bed not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (In bed not feeling well) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced MALAISE (In bed not feeling well). At the time of the report, MALAISE (In bed not feeling well) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
hives and itching including eyes, tongue, face; rapid heart rate; additional Benadryl and Pepcid given 2 hours after injection/3 hours after pre-dosing; minor petechiae, fatigue, headache, lymph node swelling on same side as injection site.  Dizziness increased began about 7 days after injection and lasted about 6 weeks.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical histories, concomitant medications and drug reactions or allergies reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of VAQTA (lot# M003011, expiration date 15-NOV-2017, dose, anatomical location and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt experienced headache, dizziness, feeling hot, weakness without documented fever approximately 12 hrs after receiving the vaccine.
Severe pain in the joint of the arm that the shot was given and in the shoulder/Throbbing in the shoulder; Pinky finger was red and swollen; Pinky finger was red and swollen /Finger is swollen down to the knuckle; Very uncomfortable; Reluctant to use that arm because it is painful; This is a spontaneous report from a contactable consumer reporting for her husband.   A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3246, expiry date unknown) via an unspecified route of administration on 26Jan2021 at single dose into his arm (shoulder) for COVID-19 immunization.  Medical history included wheelchair user, nephrectomy on an unspecified date, previous immunotherapy (unspecified medication, first dose in Dec2019, second dose in Mar2020) and side effects (Bullous pemphigoid, it's blistering of the skin) from the immunotherapy. The patient had a test for kidney function in Jan2021, results not reported. The patient received the vaccine on 26Jan2021 and he experienced severe pain in the joint of the arm that the shot was given, in his shoulder and his pinky finger was red and swollen and that finger was swollen down to the knuckle. He was very uncomfortable and he said it was throbbing in the shoulder and he was reluctant to use that arm because it was painful. The event onset date was 29Jan2021. The patient was given paracetamol (TYLENOL) as treatment. The result of the events was unknown.