chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness at injection site,about 3 inches around, and not as severe in intensity.; swelling at injection site,about 3 inches around, and not as severe in intensity.; Itching at injection site,about 3 inches around, and not as severe in intensity.; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness at injection site,about 3 inches around, and not as severe in intensity.), INJECTION SITE SWELLING (swelling at injection site,about 3 inches around, and not as severe in intensity.) and INJECTION SITE PRURITUS (Itching at injection site,about 3 inches around, and not as severe in intensity.) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included SOLIFENACIN SUCCINATE (VESICARE) for an unknown indication.    On 18-Feb-2021 at 11:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (redness at injection site,about 3 inches around, and not as severe in intensity.), INJECTION SITE SWELLING (swelling at injection site,about 3 inches around, and not as severe in intensity.) and INJECTION SITE PRURITUS (Itching at injection site,about 3 inches around, and not as severe in intensity.). At the time of the report, INJECTION SITE ERYTHEMA (redness at injection site,about 3 inches around, and not as severe in intensity.), INJECTION SITE SWELLING (swelling at injection site,about 3 inches around, and not as severe in intensity.) and INJECTION SITE PRURITUS (Itching at injection site,about 3 inches around, and not as severe in intensity.) outcome was unknown. Not Provided          No treatment medications were reported.  Patient height was reported as 5'7 and weight was reported as 150.   This case was linked to MOD-2021-027223 (Patient Link).
Alopecia- hair loss; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 5-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2022 as dose 2, single (Lot number: FL0007) at the age of 5 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FL8094, Location of injection: Arm Right), administration date: 04Feb2022, when the patient was 5-year-old, for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 02May2022, outcome "not recovered", described as "Alopecia- hair loss". The event "alopecia- hair loss" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of alopecia.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not received any other medications within 2 weeks of vaccinationPrior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has been tested for COVID-19. It was reported that; patient had past drug reaction of allergy to unknown drug.  No follow-up attempts are needed. No further information is expected.
PATIENT'S MOTHER CALLED MORNING OF THE 2OTH TO SAY HER DAUGHTER BECAME ILL AFTER RECEIVING THE VACCINATION ON THE 19TH. SHE REPORTED A FEVER, CHILLS, BODY ACHES, AND SORE THROAT. MOTHER WAS GOING TO TREAT PATIENT WITH TYLENOL; PHARMACIST SUGGESTED VISITING AN URGENT CARE CLINIC TO RULE OUT AN ACTIVE INFLUENZA INFECTION BUT TO DATE THEY HAVE NOT SOUGHT ADDITIONAL MEDICAL TREAMENT.
This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 06Jul2021 as a single dose for COVID-19 immunisation. The patient's medical history was reported as none. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included multivitamin womens from an unknown date for an unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 30Jul2021, about 2 weeks after the patient had received the second dose, the patient developed a constant eye twitch on the left eye on both upper and lower eye lids, which lasted over 2 months long. On 15Oct2021, the patient underwent SARS-COV-2 test (polymerase chain reaction (PCR)) and the result was negative. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported event. Since, the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event constant eye twitch on the left eye on both upper and lower eye lids was resolved on unknown date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
4/28/2000 child fell over and was stiff thin began jerking mother called 911. Seizures lasted 4-5 minute per mom. Had bad OM.
multiple seizures; sick; pain in his legs; This is a spontaneous report from a contactable consumer.   A male patient (reporter's husband) of an unspecified age received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 on an unspecified date for COVID-19 immunization. The patient received the two shots of the COVID-19 vaccine and has been sick ever since the second dose was administered on an unspecified date. The patient also experienced multiple seizures in the evening on an unspecified date. He has also been suffering from pain in his legs which he did not encounter before the contact with the second dose of the vaccine. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Developed blood clot on left leg on 11/12/21 . Called MD and referred for Ultra Sound. Saw hematologist and all other tests. Now on Eliquis x12 months.
Patient came back after 30 minutes and complained about itching on scalp/FACE /BACK OF NECK
red almost round patch around injection site;  approximately 3 inch diameter; not itching or hurting
Injected too close to the shoulder, sore shoulder (not at injection site), felt discomfort upon administration
initial reactions for 5 days:  sore arm, tiredness, fuzzy brain, fever, gastric distress.  All of these would fluctuate in intensity and sometimes weren't noticeable at all, except the sore arm which started strong and gradually lessened and disappeared after 3 days.  The real adverse reaction I've experienced and has actually been getting worse is a racing heart.   It may have actually started in May but I simply thought I had gotten out shape.  I really noticed it going uphill.  But starting in July, especially the last two weeks, the racing from just a brisk walk on flat land.  I have to stop and rest when I haven't really exerted myself.  There's no rational explanation where this has suddenly come from, until I just googled and found that it's been a reaction for some to the vaccine.
Flu symptoms for about 36 hours: chills, body aches, headache, exhaustion. Also sore arm.
Rash & UrticariaPruritus  Narrative:  Other Relevant History:
mom reports started to get rash on Friday & had a T102;was seen by Md who didn't say anything about rash;had sore throat & swollen glands;started on Spurax; today comes to PHN office rash worse;has rash on back of neck, arms, trunk;
"Febrile" seizure T Max of 100.6 degrees F was seen in ER and f/u visit at PCP office. Potential associated viral illness. past medical HX positive for PFO.
Parents report that the infant developed poor nursing, pallor, and "puffy cheeks" 24 hours post vax. Physical exam at 10:45 on 10/19/99 was entirely normal. We could not confirm the parents observations.
Osteoporosis; This spontaneous case was reported by a consumer and describes the occurrence of OSTEOPOROSIS (Osteoporosis) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced OSTEOPOROSIS (Osteoporosis). The patient was treated with DENOSUMAB (PROLIA) at an unspecified dose and frequency. At the time of the report, OSTEOPOROSIS (Osteoporosis) had not resolved.            No concomitant medication information was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
tired; dizzy; hungover; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tired"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; HANGOVER (non-serious), outcome "unknown", described as "hungover".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021392759 Same reporter/drug/AE, different patient;US-PFIZER INC-2021407626 Same reporter/drug, different patient/AE
pain, redness and swollen left arm still 3 days post injection, Arm is hot. WHAT ARE THE POSSIBLE SIDE EFFECTS OF SHINGRIX? The most common side effects of SHINGRIX are: Day after I slept all day, felt feverish, got no relief from Tylenol, had a headache, felt same on 3rd day so took a naproxen. Felt better for a while but headache returned. Day 4 tiredness, feverish resolved but arm is still swollen, red and hot.
Narrative:  62-year-old male with PMH of AFib, weight loss, BPH, chronic back pain, GERD, metastatic carcinoid tumor, liver mass presented to the ED on 4/22/2021 with shortness of breath and productive cough that had worsened over the past several days. He had a known COVID-19 exposure within 1 week of being seen. He had received his COVID-19 vaccinations in Nov/Dec 2020, but with his worsening symptoms wanted to be evaluated. Initial workup was pertinent for COVID-19 + test and EKG demonstrating atrial fibrillation with rapid ventricular response. He was placed on diltiazem gtt with heart rates decreasing to the 70s and was admitted to the ICU. After one night in the ICU, the patient converted back into normal sinus rhythm, and was transitioned to oral diltiazem. Patient was subsequently transferred to the floor for further cares. Patient did not require supplemental oxygen throughout his hospital stay. However, due to his clinical condition being borderline high risk, the patient received antibody infusions for his COVID-19 infection.
All joints hurt for several hours, then they all stopped hurting except for both achilles tendons. 5 weeks later I sought medical attention and was put on steroids which helped, but did not completely stop the pain. I underwent 12 sessions of P.T., and it did not help. I used Rx topical creams which did not help. I then developed a mass on the outside of my left achilles tendon and had surgery on October 27, 2021 to clean it out  I will need my right achilles tendon surgery once my left side heals I have also developed tarsal tunnel syndrome in both ankles and had surgery on the left one on March 8, 2022
SkinRash  Narrative:  Employee is taking OTC antihistamine/topical corticosteroid for symptoms
Received first shot of COVID 19.  Felt fine until 4 hours after.  Migraine like symptoms with chills and shaking and nausea.  Driving home and had photophobia and aura like vision.  Took Tylenol and tried to sleep.  Woke up today and felt ok.
Heart Palpitations and several heart conditions found following the vaccination. PFO, incomplete right branch block, extra beats, thickening / lagging valves.
This spontaneous report was received from an unspecified reporter through an unknown reporter via social media and refers to an unspecified female patients reported as "girls" of unknown age. The patients' concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with a dose of GARDASIL (dose, route of administration, lot number and expiration date were not reported). There were no concomitant medications reported. The reporter stated that GARDASIL cause premature menopause in girls (dates not provided). The outcome of premature menopause was not provided. The reporter considered premature menopause to be related to GARDASIL. Additional information is not expected because the reporter contact details were not provided.
Swollen lymph nodes under left arm, injection site pain, under arm pain, fatigue, headache, slight chills,.
Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature.   On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM.  On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM.  On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Dec2021 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure (controlled)" (unspecified if ongoing), notes: High blood pressure (controlled). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The anti viral details included, product=COVID 19 Treatment, brand=Pfizer, treatment start date=22Jun2022, treatment stop date=27Jun2022, indication=Treatment of COVID-19. BNT162B2 vaccine lot unknown reason: other (Not provided to reporter). The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient was previously receive a COVID-19 Vaccine and the patient experienced fever and sinus congestion on 30Jun2022 at 08:00 PM. The outcome of fever and sinus congestion was recovering. No treatment was given for fever and sinus congestion. No known allergies were reported.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Mom wake up child on 01/21/05 and wrist felt warm. Visual inspection revealed multiple "mosquito like" bumps on arms, stomach and legs. On her buttocks was a single, large, erythematous whelp per mom. Mom states child did not have this when put to bed previous night. Also stated child look like she did when she had allergic reaction to Amoxicillin, that occurred recently. Child "fuss" and felt warm. Referred to primary care provider. Diagnosised as allergic reaction and treated with Zyrtec. On 01/24/05 per mom, skin clear and whelps gone.  Patient has allergy appointment on 02/08/05.
pt was post 5-10 minutes after vaccine. started to seize. pt came out of it within a minute. ems was notified. pt came out of it and was able to talk, drink fluids and then vomited. pt stated had recent history of passing out and seizing and went to the hospital recently. when ems arrived pt signed waiver stating that they did not want to be taken with ems and left the store with company.
Given into shoulder joint, not in muscle. Severe pain in left shoulder and unable to lift left arm or use left arm. Started less than 2 hrs after vaccine.
Rash on shoulders & chest 10 hours after vaccination. BENADRYL was taken and rash - hives gone the following day.
Pt reports within 24-48 hours noted red raised area at site of injection 3x5cm area, no pain, no fever, no pruritus.
I got the vaccine around 12:45 on a Monday - 1/4/21 4pm that day, started having a massive headache, laid in bed.   Laid in bed all day, fell asleep around 10PM. 3:30AM woke up panicking with fever, tremors, chills, myalgia and very lethargic. Got out of bed to get tylenol and was shaking.  Tuesday morning - woke up feeling the same as I did at 330 AM, plus no appetite on top of headache, chills, myalgia, lethargic and slept pretty much all day, felt fatigued. Wednesday was doing better, thought it was the end. Then suddenly about 7-8pm started having chills and shivering.  I would say Thursday night is when I actually felt better and by Friday morning I was good with just residual ?brain fog/feeling dazed?
Janssen COVID-19 Vaccine EUA  Flu like symptoms: no sleep from low grade fever, bone and joint pain, nausea and headache  - lasted 24 hours
PATIENT SAID SHE HAD DIARRHEA, FEVER AND MYALGIA A DAY AFTER THE VACCINATION. Patient reported about diarrhea 10/5/18.
The vial was initially on 07-Sep-2022 and administered on 11-Oct-2022; No adverse event; Received the Moderna Covid 19 vaccine after the 30-day use by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine after the 30-day use by date.), PRODUCT STORAGE ERROR (The vial was initially on 07-Sep-2022 and administered on 11-Oct-2022) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     The patient had no allergy.     On 11-Oct-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine after the 30-day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially on 07-Sep-2022 and administered on 11-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine after the 30-day use by date.), PRODUCT STORAGE ERROR (The vial was initially on 07-Sep-2022 and administered on 11-Oct-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine after the 30-day use by date.) and PRODUCT STORAGE ERROR (The vial was initially on 07-Sep-2022 and administered on 11-Oct-2022).    No concomitant medications were reported.  The monovalent vaccine was initially stored on 07-Sep-2022. The vial size was 2.5 ml. The vial did not underwent any temperature excursions.   No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-657740 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657740:Same Reporter
Chills; Sleepy; Terrible Fatigue; Could not get out of bed; Headache; Not feel good at all; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Terrible Fatigue), ASTHENIA (Could not get out of bed), HEADACHE (Headache), MALAISE (Not feel good at all) and CHILLS (Chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced FATIGUE (Terrible Fatigue), ASTHENIA (Could not get out of bed), HEADACHE (Headache) and MALAISE (Not feel good at all). On 10-Feb-2021, the patient experienced CHILLS (Chills) and SOMNOLENCE (Sleepy). At the time of the report, FATIGUE (Terrible Fatigue), ASTHENIA (Could not get out of bed), HEADACHE (Headache), MALAISE (Not feel good at all), CHILLS (Chills) and SOMNOLENCE (Sleepy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.