chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Numbness in the arm where injection was given; Soreness; 6 months pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of INJECTION SITE HYPOAESTHESIA (Numbness in the arm where injection was given), PAIN (Soreness) and EXPOSURE DURING PREGNANCY (6 months pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced INJECTION SITE HYPOAESTHESIA (Numbness in the arm where injection was given), PAIN (Soreness) and EXPOSURE DURING PREGNANCY (6 months pregnant). At the time of the report, INJECTION SITE HYPOAESTHESIA (Numbness in the arm where injection was given), PAIN (Soreness) and EXPOSURE DURING PREGNANCY (6 months pregnant) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
3 hrs post vax pt devel t105 R which persisted 72 hrs & did not respond to APAP; pt devel a persistent non productive cough 14APR92 which contiues @ this report date 16APR92; LMD was seen x 2 w/lab work done;
Left side of my face became numb, eye itching in the back of my eye balls that lasted for weeks, strong headaches that lasted for  3 days and then a milder version that lasted for months after the injection.  When getting the shot, I felt a bad pain that travelled through my left arm all the way to my wrist. It felt like a nerve had been hit. Heaviness and pressure that lasted while the shot was being administered. I am terrified of getting another J&J booster shot.
Fever, headache, and myalgia presented about 12 hours after recieving the vaccination and required hospitalization 8 days later from 10/10/12-10/16/12.
FLARE UP; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (FLARE UP) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    The patient's past medical history included Plaque psoriasis (Improved) in 2020. Concurrent medical conditions included Psoriatic arthritis.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2022, received third 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) UNK (Solution for injection in pre-filled pen). On an unknown date, the patient experienced CONDITION AGGRAVATED (FLARE UP). At the time of the report, CONDITION AGGRAVATED (FLARE UP) outcome was unknown.            No concomitant medications was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Formulation for suspect Humira given as Solution for injection in pre-filled pen Causality for HUMIRA(adalimumab): The reporter causality for the events of PLAQUE PSORIASIS and FLARE UP was not provided. No treatment drug details was reported.
Extreme pain at time of vaccine. 10x worse at least to any other flu shot I've ever gotten. Since then, without ceasing: extreme and crippling pain in shoulder/upper arm especially when moved certain ways; can barely do so at times and have loss of mobility, and stiffness (for over 3 wks now).
Black out/couldn't remember anything for days; A spontaneous report was received from a consumer who was also a 68-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced a black out and couldn't remember anything for days/amnesia.  The patient's medical history included allergies to industrial chemicals, glaucoma, and diabetes. Concomitant product use was not provided by the reporter.  On 23 Jan 2021, approximately one day prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot# 013L20A) intramuscularly for prohylaxis of COVID-19 infection.  On 24 Jan 2021, the patient reportedly experienced a black out and was unable to remember anything for days. In the early morning hours on 29 Jan 2021, the patient's memory returned but he was reportedly still unable to remember "silly" things such as how to go to a restaurant. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The events of black out and inability to remember anything for days were considered resolved on 28 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Patient presented to the pharmacy today in regards to a reaction on her left arm from the P23 immunization she received on 2-21-19. Her arm was red, swollen and painful below the injection site. She went to Urgent Care who indicated it was not infected, but was having a bad reaction to the immunization. She was given a prescription for a steroid to take for 4 days to help calm down the reaction.
patient called 1/16/2021 said she is still having pain at injection site( from date 11/20/20) and when she sleeps on  her left arm the pain intensifies or unable to move arm without pain . She also feels a small nodule further down away from site . She is taking Tylenol and applying icey hot for relief. She will contact her doctor on Monday . No other side effects, no skin discoloration.
Within minutes of receiving flu shot developed itching feet, watery eyes runny nose, chills, sore sinuses. C/O burning sensation & muscle soreness. Nausea & vomiting 48 hrs later. At OV 10/17/11 noted to have flushed, warm face, mild erythema of oropharynx 98 degree temp. Tx with prednisone 10 mg 6 day dose pack. Full recovery.
Syncope PCP evaluated fluids and food. Patient did not eat for 5 hours.
First, a very large rash all over my body (diagnosed by doctor on 12/17/2021). Later diagnosed with dermatographic urticaria on 1/18/2022. The urticaria is still ongoing and causing me considerable discomfort. It has substantially degraded my quality of life. There does not seem to be any perceivable improvement. It has caused me significant anxiety and some digestive problems too.  It is unclear if the digestive problems are related to the anxiety or the reaction to the vaccine.
Diagnosed with GBS / Hospitalized her for 5 nights to undergo testing/ Gullian-Barre Syndrome; Tingling in her arms and legs / Hospitalized her for 5 nights to undergo testing; legs were weak / Hospitalized her for 5 nights to undergo testing; fell down / Hospitalized her for 5 nights to undergo testing; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE MODERNA for prophylaxis and COVID-19 VACCINE MODERNA for prophylaxis.   On 1st December 2020, the patient received Shingrix. On 15th January 2021, the patient received the 1st dose of COVID-19 VACCINE MODERNA .05 ml. On 12th February 2021, the patient received the 2nd dose of COVID-19 VACCINE MODERNA .05 ml. On 1st March 2021, 90 days after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), tingling of extremity (serious criteria hospitalization), lower extremities weakness of (serious criteria hospitalization) and fall (serious criteria hospitalization). On an unknown date, the outcome of the guillain barre syndrome and tingling of extremity were recovering/resolving and the outcome of the lower extremities weakness of and fall were recovered/resolved.   It was unknown if the reporter considered the guillain barre syndrome, tingling of extremity, lower extremities weakness of and fall to be related to Shingrix.  Additional details were provided as follows: The patient experienced tingling in her arms and legs.  The patient went to the physician's office on 1st March 2021 and her legs were weak and she fell down.  The patient went to the emergency room, and the neurologist on duty hospitalized her for 5 nights to undergo testing. The patient had a brain scan which was negative, lumbar puncture which was negative and X-Rays were negative.  The patient then underwent an electroencephalogram and was diagnosed with guillain barre syndrome. Her symptoms at time of reporting were slightly improved.  On 1st March 2021, 45 days after receiving 1st dose and 17 days after receiving 2nd dose of Covid-19 vaccine Moderna, the patient experienced guillain barre syndrome, tingling of extremity, lower extremities weakness of and fall. It was unknown if the reporter considered the guillain barre syndrome, tingling of extremity, lower extremities weakness of and fall to be related to Covid-19 vaccine Moderna and Covid-19 vaccine Moderna. The emergency room visit was required. The reporter did not consent to follow-up.
urticarial rash involving 4 extremities & trunk w/mild angioedema of hands & feet;no resp sx;
aches in my legs; sick; swelling in the arm; I wasn't feeling good; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 26Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient took first shot (Pfizer's COVIDA vaccine) on 26Mar2021 and she got sick after that. She was wondering if it was ok to get the second shot on the 16Apr2021. She had swelling in the arm, she wasn't feeling good. It wasn't a fever, it was aches in her legs. She was feeling fine now. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Initial report received on 16 October 2006 from a health care professional. A 51-year-old female patient had received an intramuscular, left deltoid injection of Fluzone, lot number U2194AA, on 12 October 2006. Two days later, the patient experienced swelling, redness, itching, and warmth to touch at the injection site. The event did not require medical examination. At the time of this report, the patient had not recovered.
2nd dose of influenza admin. 4 days early.  Appt not listed as 2nd dose.  Parent never stated this was 2nd dose.
About 24 hours after receiving the vaccination, my heart was beating out of rhythm and had pain, I have an ICD to keep my heart in rhythm. I didnt sleep for almost 6 days. I could feel when my heart went back into a normal rhythm, It was very painful. My heart is very sensitive. It took about 3 weeks to recover.
Headache that lasted 18 hours. Treated with Toradol 60mg IM. Headache subsided 1 hour later.  Deep muscle leg pain that lasted 3-4 hours. Treated with 50mg Tramadol PO and CBD muscle rub. Pain subsided on its own around the 4 hour mark.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 03/24/21,pfizer,Lot#ER8727 2nd dose: EW0150 ,04/14/21, Pfizer,Lot#  Diagnosed covid positive:07/19/21 symptoms began:07/16/21 Exposure: Community exposure Symptoms:Fatigue, loss of smell/taste,headache.
7 day after PREVNAR - red and bumpy-no blisters 2 inches, lasted about 4 days =, no other symptoms. Left arm.
No adverse effect reported; patient received first dose of improperly stored PNEUMOVAX 23; This spontaneous report was received from a medical assistant referring to a 66 year old female patient. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.   On 30-MAY-2019, the patient was vaccinated with a first dose of improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vial lot # R031812 with expiration date on 26-SEP-2020, by intramuscular route (strength, dose, and anatomical location were not reported) indicated for prophylaxis.         It was unknow if there was a previous temperature excursion. A data logger was not involved.  No adverse effect was reported.
COLD/FREEZING FOR 2 DAYS. 3RD & 4TH NIGHTS, SWEATS & CHILLS ALL NIGHT, LOW GRADE FEVER 99.5, 3RD DAY RASPY THROAT, HEAD CONGESTION, SLIGHT HEADACHE. LOSS OF APPETITE.
Local rxn, arm was hot, red, inflamed, swelled to size of softball at ZOSTAVAX injection site.
DIARRHEA; This spontaneous case (PVX2019-1339) report was received from a consumer on 24-May-2019. It describes a 53-year-old adult male consumer who had diarrhea, after the administration of oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took three doses of Vivotif on 18-May-2019, 20-May-2019, and 22-May-2019, respectively. After taking the second dose, he had only one bout of diarrhea on 20-May-2019. He did not take any treatment for it. He did not take any contaminated and unhygienic food or water intake before the bout of diarrhea.  Concomitant medications included tamsulosin (0.4 mg; once a day) and epleronone (25 mg; once a day).   Action taken with Vivotif was dosage maintained.  The consumer had recovered from the event on 20-May-2019.  Company's Comment: In this case, it was reported that the consumer had diarrhea, after the administration of oral Vivotif . There seems to be a temporal association between the intake of the vaccine and the event. Also, diarrhoea is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had diarrhea, after the administration of oral Vivotif . There seems to be a temporal association between the intake of the vaccine and the event. Also, diarrhoea is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.
Approximately 24 hours later, began to violently tremble/shake, became freezing cold (despite 80 degree inside temperature; 105 outside), extremely fatigued, spiked a fever (100.3 F before departing for ER). Due to patient's age, history of multiple pneumonias, etc., we checked in at local Emergency Room. ER ordered tests (blood, urine, chest x-ray, etc.) which ruled out pneumonia, and concluded this was a vaccine reaction. Injection site sore, quite red, and swollen.
watery drainage; increased tearing; dry eyes; itchy eyes; irritated eyes; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 57-year-old female patient received BNT162b2 (BNT162B2), in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid", start date: 2005 (ongoing); "Menopause", start date: 12Feb2019 (ongoing); "Migraine HA's", start date: 2005 (ongoing); "hormone disbalance" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID oral taken for hypothyroidism, start date: 13Dec2016 (ongoing); ARMOUR THYROID oral taken for hypothyroidism, start date: Aug2005; ESTRADIOL topical taken for menopause, start date: 12Feb2019 (ongoing); TESTOSTERONE topical taken for hormone level abnormal, start date: 12Feb2019 (ongoing); PROGESTERONE oral taken for hormone level abnormal, start date: 12Feb2019 (ongoing). Vaccination history included: BNT162b2 (Dose: 1st, Date: 13Apr2021, Route of Administration: Intramuscular, Batch/Lot Number: Not Available / Provided at Time of Report Completion), administration date: 13Apr2021, when the patient was 55-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 2nd, Date: 04May2021, Route of Administration: Intramuscular, Batch/Lot Number: Not Available / Provided at Time of Report Completion), administration date: 04May2021, when the patient was 55-year-old, for COVID-19 Immunization, reaction(s): "dry eyes", "itchy eyes", "irritated eyes", "tearing eyes", "watery drainage". The following information was reported: DRY EYE (non-serious) with onset 2022, outcome "unknown", described as "dry eyes"; LACRIMATION INCREASED (non-serious) with onset 2022, outcome "unknown", described as "increased tearing"; EYE IRRITATION (non-serious) with onset 2022, outcome "unknown", described as "irritated eyes"; EYE PRURITUS (non-serious) with onset 2022, outcome "unknown", described as "itchy eyes"; LACRIMATION INCREASED (non-serious) with onset 2022, outcome "unknown", described as "watery drainage".  Additional information: Prior Vaccinations (within 4 weeks) was none. The patient experiences dry, itchy plus irritated eyes associated tearing and watery drainage. Relevant tests were none.   The patient considered the Pfizer product had a causal effect to the adverse event.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I experienced severe pain to the upper arm where the injection was administered  and not being able to lift upper  arm at all with the exception of only being able to move arm from elbow down to hand for 2 days. I treated myself at home with Ibuprofen and ice packs at home due to being a licensed nurse.
Rec'd SHINGRIX and PNEUMOVAX 23 on 7/16. A few hours later, developed bilateral arm pain at site of injections. Pain overnight so couldn't sleep on either side/arm. Awoke 7/17 with increased pain and barely able to move arm(s). Also felt fatigued. By afternoon on 7/17 had shaking chills, nausea, headache, fever, weakness, unsteadiness, and severe right arm pain. Was taken to ER found to have a fever of 102. Heart rate 130. WBC count of 22,000. Both arms found to be very warm and tender. R arm swollen and hot. No redness. Treated with intravenous fluids, lab work including blood cultures, pain medication, fever medication, IV steroids and IV antibiotics. No source of infection identified. Was admitted to hospital.
2 hours post vaccination, my right hand and right foot started to feel the feeling you get before pins and needles and did not go away. This morning I woke up and have weakness in my right hand and right foot.
Consumer is beyond 42 days for second dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Consumer is beyond 42 days for second dose.) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Consumer is beyond 42 days for second dose.). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Consumer is beyond 42 days for second dose.) 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 did not provide any causality assessments.
Arm cramping below the elbow of the injected arm. And Headache.; Headache; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration on 05Mar2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On 05Mar2021, the patient experienced arm cramping below the elbow of the injected arm and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm cramping below the elbow of the injected arm and headache was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021 at 11:54 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021 at 11:54 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 19.15.  Concomitant products were not provided.  On 29-Apr-2021, excursion time was 10 AM, temperature was 33, total doses given for the day was 201, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 29-Apr-2021. 5 vials were sent to clinic. Vaccine BUD date was 19-May-2021.  On 29-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 36, 10 AM: 33, 11 AM: 44, 12 PM: 45, 1PM: 45, 2 PM: 44, 3 PM: 45 and 4 PM: 44.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Large, red, hot injection site. Body aches, fever, chills, muscle pain, headache, vomiting, rash on neck and chest.
- Injection site soreness: developed the day after injection and largely resolved after about 24-36 hours. - Headache: minor tension headache developed about 48 hours after injection and lasted a little over a day. - Sore throat: mild; developed about 48 hours after injection and continues to persist about 2 days later.