chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she stated that se has a sore arm (pain at the injection site); she is experiencing body aches; sort of back pain; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administration date 24Aug2021 (Batch/Lot number: unknown) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: Jun2020 (unspecified if ongoing), notes: Caller also mentioned she had COVID-19 infection last year, in June. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "she stated that se has a sore arm (pain at the injection site)"; PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "she is experiencing body aches"; BACK PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "sort of back pain"; PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "unknown", described as "sore arm". Therapeutic measures were taken as a result of vaccination site pain, pain, back pain, pain in extremity. Additional information: stated that she had a sore arm (pain at the injection site) and requested information on the use of ibuprofen for the treatment of her symptoms following vaccination with the Pfizer COVID-19 vaccine first dose received yesterday 24Aug2021. stated last night she took one Tylenol PM 500mg and today ibuprofen 800mg because she had body aches sort of back pain, and a sore arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chest pain, hives, edema face, angioedema right leg and throat swelling. Epipen 2 times, dexamathasone, Benadryl given. Transported via ambulance to hospital. This is in follow-up to report(s) previously submitted on 5/19/2006. Information has been received from a health professional concerning a 19 month old male who was vaccinated with a subcutaneous second dose in the right thigh of MMR II (Lot# 649230/0027R0. Concomitant vaccine administered on the same day included a first intramuscular dose in the left thigh of HAVRIX (Lot# AHAVB032AA). Subsequently the patient experienced an anaphylactic reaction from the vaccine. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information from a health professional indicated that on 17-AUG-2005, shortly after vaccination, the patient developed respiratory difficulty and small hives. Also he developed flushing of the skin. Oximetry at that point was 90% and he was having mild respiratory distress. He was given BENADRYL, 1 tsp, oral administration, plus and EPI-PEN, 0.15 mg, intramuscular. The patient responded clinically with increased oxygenation, ease of breathing and the redness decreased. The patient did develop some swelling around his eyes at that point. After about 30-minutes the patient returned to having respiratory distress. The patient was given a second shot of epinephrine plus dexamethasone, 8 mg, oral administration. The assessment was respiratory difficulty. The patient was sent to a medical center. It was noted that the patient was stable at the time of discharge. Follow-up information from a health professional indicated that the patient has recovered and was fine. No other information was provided. Anaphylactic reaction to vaccine was considered to be an other important medical event. Additional information is not expected.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm started to ache and went right across to the other arm), NECK PAIN (neck hurt and he could not turn it), PERIPHERAL SWELLING (Both arms swelled up and were itchy and tingly), ARTHRALGIA (excruciating pain through his shoulders and arms and could not even make a fist, pain spread to his knees. They felt weak, shoulder pain) and PRURITUS (Itchy) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee replacement. Concomitant products included VALSARTAN, LOVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMIN 15.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (left arm started to ache and went right across to the other arm), NECK PAIN (neck hurt and he could not turn it), PERIPHERAL SWELLING (Both arms swelled up and were itchy and tingly), ARTHRALGIA (excruciating pain through his shoulders and arms and could not even make a fist, pain spread to his knees. They felt weak, shoulder pain), PRURITUS (Itchy) and PARAESTHESIA (tingly). On 09-Feb-2021, the patient experienced MUSCULAR WEAKNESS (barley able to lift up his arms, lost all strength in his hands). On 07-Feb-2021, PAIN IN EXTREMITY (left arm started to ache and went right across to the other arm), NECK PAIN (neck hurt and he could not turn it), PERIPHERAL SWELLING (Both arms swelled up and were itchy and tingly), ARTHRALGIA (excruciating pain through his shoulders and arms and could not even make a fist, pain spread to his knees. They felt weak, shoulder pain), PRURITUS (Itchy) and PARAESTHESIA (tingly) had resolved. At the time of the report, MUSCULAR WEAKNESS (barley able to lift up his arms, lost all strength in his hands) 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.   Treatment included prednisone, Benadryl, immodine.   This case was linked to US-MODERNATX, INC.-MOD-2021-015074 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-015074:
extremely tired that had to lift the eyelid to see the hour; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extremely tired that had to lift the eyelid to see the hour) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007821A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (extremely tired that had to lift the eyelid to see the hour). At the time of the report, FATIGUE (extremely tired that had to lift the eyelid to see the hour) outcome was unknown.        This case was linked to MOD-2021-043382 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant follow up accepted on 27-May-2021
His heart is beating too fast/a rapid heartbeat; Chills; Fever; He has been feeling like very very different; He feels like his muscles is not, he feels like he is not himself; He cannot sleep with his heart like that; This is a spontaneous report received from a contactable consumer (Patient mother). A 21-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0181) via an unspecified route of administration in left arm on 07Jun2021 (at the age of 21-years-old) as dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were No. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0174), via an unspecified route of administration on 07May2021 as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccine prior to COVID-19 vaccine. The patient mother reported that the patient got his second shot like almost month and half ago but since then from an unspecified date, he has been feeling like very, very different like his heart is beating too fast and he feels like his muscles is not, he feels like he was not himself, and a week later he started with symptoms of chills, fever and a rapid heartbeat, like he can't control it. Patient mother took him to the hospital, but they found nothing, he was hospitalized for a few days from an unspecified date, but they found nothing. He was healthy before, so patient mother knew that this was related to the vaccine. Patient mother stated that he can't sleep with his heart like that, and she was very worried and was just calling to know what she can do or what's happened with him or she don't know because she already took him to the hospital, they kept him to the hospital till 8 and they couldn't find nothing, so she was like worried, and it was desperate already. The reporter seriousness was assessed as serious (hospitalization). The patient underwent lab tests that included a lot of checkup of the health, and everything says normal range on an unspecified date. When asked about treatment, the patient mother replied as, "No they didn't give nothing". The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
A non-serious spontaneous report of received expired FLUMIST was received from a health professional concerning a seven-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 20-Nov-2011. The patient received the expired FLUMIST on 29-Nov-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. The reporter stated that the patient did not experience any late occurring adverse events.
Symptoms happened 4 hours after shot, throat closing, eye secretion, swollen eyes and bloodshot. Low blood pressure in hospital.
Information has been received from a physician's assistant concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. It was reported that the patient received her first dose of GARDASIL 9 on an unknown date in 2016 from an unknown doctor's office (lot number, expiration date, and route of administration not provided). The patient received her second dose of GARDASIL 9 on 28-MAR-2017 (lot number, expiration date, and route of administration not provided). No adverse effects reported. No additional information was provided. Additional information has been requested.
Temp 101 degrees and broke out with a rash on his back and chest - little pinkish red spots as if he were bitten by bugs.
Approximately six hours after Pfizer booster shot, got severe headache and body aches and pains along with a low-grade fever.  Took two extra strength Tylenol, drank lots of water, stayed in bed two days.  Extremely tired and next day same symptoms but not as severe.  Today, Dec. 10, I am up and about but feel a bit light-headed.   Interestingly, I had this same reaction after my second dose of Pfizer.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On 30-DEC-2015 the patient was vaccinated an expired dose of ZOSTAVAX (Lot # K012921, expiration date 29-NOV-2015) dose, route and anatomical location were not provided. No concomitant medication was reported. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Day 1: Very mild headache, slight soreness at injection sight - began upon waking and lasted until 3pm that day Day 4: began at 10:30 pm - Chills, Body Aches, Severe Headache, Sweating - ended around 3am
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium
Patient presented to office for catch up immunizations. Patient was administered DTap/IPV (Kinrix) combination immunization in office. Kinrix has not been studied in children under the age of 4. Patient has not developed any adverse reactions as of today's date, 11/18/2021. Appropriate dose would have been to administer DTap and IPV separately.
Onset of 4 in. x 3 in. diameter red indurated itchy area around vaccine site in right arm at ~ 12 noon on 10/1/19 then by 10/1/19 9pm whole back of upper right arm red, swollen and itchy.  On 10/2/19 morning redness had extended to below right elbow and at 3pm on 10/2/19 patient went to Urgent Care as she was leaving on vacation the next day.  Urgent Care provided Prednisone tapering dose pack for the next week & Clindamycin antibiotic just in case became infected while on vacation (patient did not use);  patient used OTC Benadryl spray to help with itching. 10/3/19 redness & induration much less and by 10/7/19 all symptoms resolved and no sequellae.
Symptoms began with arm tenderness approx 6 hours after vaccine administration. Went to bed and was awakened from sleep with shortness of breath significantly worse than usual. Could not stabilize and EMS was called. I was transported to the hospital and admitted for  Dose at 9:30am; arm pain at 6pm; to bed
HEALTH CARE PROFESSIONAL ACCIDENTALLY GAVE 0.3 ML INSTEAD OF 0.5 ML; HEALTH CARE PROFESSIONAL ACCIDENTALLY GAVE 0.3 ML DOSE TAKEN FROM A JANSSEN VIAL INSTEAD OF A PFIZER VIAL.; This spontaneous report received from a pharmacist concerned a 49 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient was previously treated with tozinameran for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A expiry: 08-SEP-2022) dose was not reported, administered on 25-APR-2022 for prophylactic vaccination. Age at time of vaccination 49 years old. No concomitant medications were reported. On 25-APR-2022, the patient experienced health care professional accidentally gave 0.3 ml instead of 0.5 ml, and health care professional accidentally gave 0.3 ml dose taken from a janssen vial instead of a pfizer vial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the health care professional accidentally gave 0.3 ml instead of 0.5 ml and health care professional accidentally gave 0.3 ml dose taken from a janssen vial instead of a pfizer vial. was not reported. This report was non-serious.
none COVID 19 VACCINE EXPIRED 11/22/2022 GIVEN 12/1/2022
The pt developed pneumococcal bacteremia on 3/31/02 despite receiving appropriate, recommended doses of Prevnar vaccine. Is this a vaccine failure?
Pain in the lymph node on the same side as her injection site; Pain in the breast on the same side as her injection site; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Pain in the breast on the same side as her injection site) and LYMPH NODE PAIN (Pain in the lymph node on the same side as her injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. n/A) for COVID-19 vaccination.     Concurrent medical conditions included Graves' disease (Graves with thyroid Noduales) since 1999 and Varicose veins since 2019. Concomitant products included COLECALCIFEROL (VIT D [COLECALCIFEROL]), VITAMINS NOS (MULTI-VIT), FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 04-Feb-2021 at 3:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced BREAST PAIN (Pain in the breast on the same side as her injection site). On 05-Mar-2021, the patient experienced LYMPH NODE PAIN (Pain in the lymph node on the same side as her injection site). On 13-Feb-2021, BREAST PAIN (Pain in the breast on the same side as her injection site) had resolved. On 10-Apr-2021, LYMPH NODE PAIN (Pain in the lymph node on the same side as her injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided.   This case was linked to MOD-2021-265852 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow-up received and included updated contact information. On 27-May-2021: Follow-up received and contains no new information. On 23-Jul-2021: Follow-up received and included updated event dates, outcome, vaccination information, medical history and concomitant medications.
Patient had an anaphylactic  reaction to half-dose of the PFizer vaccine within 15 minutes of administration requiring Benadryl 50mg , Epinephrine 0.3mg, and solumedrol 125mg to be given in-facility. Patient then required transfer to another acute-care hospital for a 5 admission and administration of monoclonal antibodies.
Redness and swelling at injection site and along right upper arm. Pain and warmth noted by patient.
Patient arrives 12/11/07 s/p flu shot at Heritage.  11/7/07 patient reported bruising at site since 11/9/07 x 2 weeks with return ecchymosis with INR drawn on 12/5/07.  X-ray: negative foreign body, negative fx, negative bursitis.  Labs: CBC nl except hot 35.1 (Sl down), INR 2.4/Plat 252.
VACCINE WAS STORED IN FREEZER LONGER THAN MANUFACTURER RECOMMENDED, CAUSING IT ADMINISTRATION TO BE BEYOND THE USE DATE.
Patient was due for booster dose 0.25 mL but 3rd dose 0.5mL was given . No adverse reaction
Patient is complaining of severe pain to the deltoid/upper left arm that started the day after receiving the shot. Patient has sharp painful attacks. Patient having trouble moving arm. She seems very distressed. It has been 3 weeks after shot.
Pt recvd vax 10AUG92 & on 11AUG92 devel generalized rash; seen by MD & treated w/Hismanal & DPH; pt later recovered; No further details were provided;
80-year-old female presents emergency department no acute distress by EMS from home.  She got up to go the bathroom today and fell off the toilet and was not able to get up for an hour.  She crawled to her phone to call 911.  She takes no blood thinners and did not hit her head.  She does not report any injuries just weakness.  She does have a history of Parkinson's as well as CHF TIA blood clots pacemaker anxiety depression A. fib coronary artery disease GI bleed.  She arrived with a 102 fever.  She denies any recent illnesses but states she felt cold yesterday.  No dysuria.  No upper respiratory infection symptoms such as runny nose cough or sore throat.  No sick contacts that she knows about.  No chest pain difficulty breathing or abdominal pain. Associated Symptoms: chills, fall, weakness
Symptoms recur + test 25Aug; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 19Dec2020 at 09:00 as dose 1, single (Lot number: EH9899), in left arm and on 09Jan2021 at 08:00 as dose 2, single (Lot number: EL1284) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: 01Oct2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Aug2022, outcome "unknown" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 25Aug2022, outcome "unknown", described as "Symptoms recur + test 25Aug". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Aug2022) Positive; (24Aug2022) Negative; (25Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: If vaccine received was Yes. Other medication in 2 weeks was Yes. Known allergies was None. Antiviral details: Product=COVID 19 Treatment, brand=Paxlovid. Treatment start date=17Aug2022. Treatment stop date=21Aug2022. Indication=Treatment of COVID-19. Administrator route=Oral. Adverse event Paxlovid rebound + test 17Aug, -test 24Aug, Symptoms recur + test 25Aug.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided and known drug safety profile, the causality between the suspect drug BNT162B2 in the occurrence of the event  Vaccination failure, covid-19, Disease recurrence  cannot be excluded.
Case number PHEH2044US003618, is an initial spontaneous report from a pharmacist received on 21 FEB 2014 and a follow up report received from the pharmacist on 18 MAR 2014. This report refers to a 17-year-old male patient. The patient's medical history and concomitant medications were not reported. The patient had no known drug allergies. This patient under the age of 18 years was vaccinated with 0.5 ml of FLUCELVAX (batch number: unknown) intramuscularly in the right deltoid on 20 JAN 2014. No adverse event was reported following the medication error. No further information was provided.  Follow up report received from the pharmacist on 18 MAR 2014. Information related to patient's medical history and vaccination site were updated.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 18  MAR 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
I contracted a community grade pneumonia and had to be hospitalized the next day after taking the first vaccine; This is a spontaneous report from a contactable consumer (patient).    A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 18Jun2021 15:00 (Lot Number: EWO181) as single dose (at 41 years old) for COVID-19 immunisation.  Medical history included hernia repair. Concomitant medications included ibuprofen  and multivitamins, both taken for an unspecified indication, start and stop date were not reported.  The patient stated that "on 19Jun2021 15:00 I contracted a community grade pneumonia and had to be hospitalized the next day after taking the first vaccine (hospitalization) with outcome of recovering.  The patient underwent lab tests and procedures which included sars-cov-2 test: negative  on 19Jun2021. Therapeutic measures were taken as a result of the event included antibiotics and painkillers. She received the second dose of BNT162B2 (Lot number FA6780), in the left arm on 18Jun2021 (as reported).
On day 5 of high fever, extreme joint pains, nausea, headache, chills, fatigue and shortness of breath with exercise- reported to CDC daily