chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pinkish area where the shot was given, hot, itchy; Pinkish area where the shot was given, hot, itchy; Pinkish area where the shot was given, hot, itchy; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pinkish area where the shot was given, hot, itchy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 16 Jan 2021, 9 days prior to the onset of the events pinkish area where the shot was given, hot, itchy, the patient received dose of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 24 Jan 2021, the patient started getting a pinkish area where the shot was given. It was hot and itchy.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events pinkish area where the shot was given, hot, itchy were not reported.
Oth complications following immunization, NEC, init on 2017-10-02.
10 minutes after injection started having metallic taste, pressure to the left back tongue, left arm heaviness and fatigue Narrative:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Sep2022 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid, 02Jan2023 to 06Jan2023).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had a difficult time swallowing, and breathing, I awakened one morning after about 2 weeks and my left eye was red. The symptoms lasted for about 6 months.
This spontaneous report was received from a healthcare worker referring to a 4 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 15-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Headache Muscle pain After 36 hours had sever nausea. Mild fever  Took Tylenol to relieve headache and Advil four hours later to reduce fever.
I got a metallic taste in my mouth, had severe acid reflux and indigestion, it messed up my menstrual cycle
This employee reported being in good health prior to receipt of AVA vaccine on 2/16/2009. Day 1 after vaccination she stated she just didn't feel well and had a sore arm to vaccine site. She reported she was nervous, scared and crying as this was her first trip. Day 2 she left the country. Once there she noted bilateral ankle swelling, had a nonproductive cough, fever, felt dizzy and nauseous. Her recall of exact events was vague prompting a comprehensive medical record review. Regarding her current complaints, her records document medical care x 7 from 3/2/2009 to 4/23/2009 with recurrent complaints of chills-fevers (101.8F), frontal headache, bilateral earache, sore throat, swollen neck glands and a cough with purulent green sputum, nausea and vomiting. She was diagnosed with upper respiratory infection, viral syndrome, and common cold. Treatment included use of Z-PAK, Amoxicillin, MUCINEX-D, TYLENOL, ULTRAM, ADVIL, FIORICET and ZOFRAN. On 3/31/2009 she was treated with IV ZOFRAN and 2000 cc NS for dehydration secondary to vomiting x5 in 24 hours (temp 99-101 F and no labs or diagnostic studies identified). Meanwhile between sick calls, she was able to perform required duties without restrictions. She stated it took about 3-4 months for above symptoms to resolve. However she continued to require AMBIEN for insomnia (treated x 3 between May-July 2009). Other treatment in late 2009 included treatment for spider bite (8/2009) and essential hypertension (10/2009). In February 2010 while on R and R, she reported she "felt down" - lack of energy, tired and was found to have a low platelet count (70,000). She reported further examination was reported to be normal and she returned. Follow up for low platelets was found on 7/30/2010 listing the following labs: WBC 11.1; RBC 4.52, Hgb 12.6, Hct 39.6, MCH 27.8, MCHC 31.8, Platelets 70, LY% 23, LY# 2.5. She reported to this provider a history of easy bruising, but no fatigue, menorrhagia, or family history of blood dyscrasias. She was diagnosed with asymptomatic thrombocytopenia and candidiasis vaginal. She reported she would follow up with provider in 3 weeks. (No medical records available to this provider). She advised she is seeing an Oncologist. The only records received from this facility were on 9/4/13 visit where MD listed her ITP cause as "unclear with negative work up for hepatitis C, HIV, H. Pylori, and ANA. His note discussed a review of a few reported cases of ITP with MMR vaccine but none for AVA". He lists her diagnoses on 9/4/2013 as thrombocytopenia, immune medicated; musculoskeletal pain, iron deficiency, mild hypertension and depression. Recommendations included discussion on use of prednisone, IVIG, N-plate injections, RITUXAN and splenectomy; psych evaluation and starting antidepressants and anxiolytic drugs.
Rash and itchiness radiating from about 1 inch below injection site. Did not start until 8 days after injection.  At this time, rash is about 2.5 inches in diameter.
Case number PHEH2014US019884, is an initial spontaneous report from a health care professional received on 01 Oct 201. This report refers to a 54-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN, (batch number: 1413101) intramuscularly on 29 Sep 2014. It was reported that the patient received FLUVIRIN that was at room temperature for 48 hours. No adverse reaction reported following the maladministration (incorrect storage of drug).
Spontaneous hives (urticaria) Cannot figure out trigger Never had them before now. Began 12/17/22, almost daily since
severe reaction that culminated in transverse myelitis; This case was reported by a consumer via call center representative and described the occurrence of myelitis transverse in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced myelitis transverse (serious criteria GSK medically significant). On an unknown date, the outcome of the myelitis transverse was recovered/resolved.   It was unknown if the reporter considered the myelitis transverse to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the dose approximately 2 years ago from the date of reporting.  The reporter reported a severe reaction that culminated in transverse myelitis.  The reporter stated that a detailed account had been reported via a vaccine website and by their neurologist. The reporter did not consent to follow-up.
patient received a 0.25ml bivalent booster dose instead of a 0.5ml Moderna bivalent booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (patient received a 0.25ml bivalent booster dose instead of a 0.5ml Moderna bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 49-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Dec-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 08-Dec-2022, the patient experienced ACCIDENTAL UNDERDOSE (patient received a 0.25ml bivalent booster dose instead of a 0.5ml Moderna bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (patient received a 0.25ml bivalent booster dose instead of a 0.5ml Moderna bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (patient received a 0.25ml bivalent booster dose instead of a 0.5ml Moderna bivalent booster).    No concomitant medication information was provided.  The patient received her first Moderna additional booster dose on 08-Dec-2022  The patient received the vaccine in her right arm deltoid muscle, the patient reports no other adverse reactions.  The patient received her first dose of the Moderna Covid-19 vaccine on 27-Apr-202, lot number 045B21A expiration date is not known. It is not known which arm the patient received the vaccine in. There are no known adverse reactions.   The patient received her second Moderna Primary Series vaccine on 25-May-2021, lot number 033B21A expiration date is not known. Injection site arm is not known. There are no known adverse reactions.  No treatment medication were provided.
Information has been received from a physician concerning a female who on an unspecified date, was vaccinated with three doses of GARDASIL (lot # not reported). After receiving her third dose, the patient experienced a reaction to the vaccine. She felt strange, numb all over and generally felt unwell. The symptoms lasted for around 24 hours. Subsequently, the patient recovered from felt strange, numb all over and generally felt unwell. The patient did not seek medical attention. In follow-up, the physician indicated that the patient had not been there in quite a while and that he was working on it. He had no information at this time. This is one of several reports received from the same source. Additional information is not expected.
delayed-type hypersensitivity reaction at the site of injection; A spontaneous report was received from consumer concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  Vaccination site hyper sensitivity/Delayed type hypersensitivity reaction at the site injection.  The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies were provided. The reported stated that the patient was physically and mentally healthy before vaccination.   On unknown date, prior to the onset of the events, the patient received their first planned dose of mRNA-1273 (Lot number: unknown)  via unknown route  at unknown location for prophylaxis of COVID-19 infection.   On 21 Jan 2021 caller had  provided with a delayed type hypersensitivity reaction at the site of the injection to the Moderna vaccine. On a unknown date patient experienced with the event Delayed type hypersensitivity reaction at the site injection to the Moderna vaccine. Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the event Delayed type hypersensitivity reaction at the site injection was considered unknown.; Sender's Comments: Based on the 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.
cant eat anything; Aching in legs; Lack of appetite; Nauseous; intermittent achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Aching in legs), DECREASED APPETITE (Lack of appetite), FEEDING DISORDER (cant eat anything), MYALGIA (intermittent achy) and NAUSEA (Nauseous) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 027A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for Hypertension.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced MYALGIA (intermittent achy). On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Aching in legs), DECREASED APPETITE (Lack of appetite) and NAUSEA (Nauseous). On an unknown date, the patient experienced FEEDING DISORDER (cant eat anything). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Aching in legs), DECREASED APPETITE (Lack of appetite), FEEDING DISORDER (cant eat anything), MYALGIA (intermittent achy) and NAUSEA (Nauseous) had not resolved.            The consumer is taking Tylenol, ibuprofen, OTC cold and flu to try to alleviate the symptoms.   This case was linked to US-MODERNATX, INC.-MOD-2021-080199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080199:1st dose events
Patient administered Bexsero (meningitis serogroup B) instead of Menactra (meningitis ACYW). No further adverse effects were reported by patient's mother. No medical follow-up was required.
Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapy or medical history provided. On 09-MAY-2016, the patient was vaccinated with one dose of improperly stored PROQUAD (Merck), Lot # L041627 with expiration date of 20-APR-2017 (dose and route of administration were not reported), which was under -10 Celsius degrees for 12 hours and -14 Celsius degrees for 3 hours. There was also a previous temperature excursion of cumulative total 58 hours, 48 minutes, all in unlimited range). The cumulative temperature excursion was reported as -10 Celsius degrees for total 73 hours, 48 minutes, all in unlimited range. The temperature excursions were detected by a data logger. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported. It was reported that patient took Booster dose. The Lot 012H21B vials were placed in refrigerator on 6-Dec-2021. The vaccine was used past 30-day use by date.
2 weeks later became cyclically dizzy like a migraine with aura  relatively fine in the morning, but by afternoon incredibly dizzy bedridden for several days
Information has been received from a certified medical assistant concerning an approximately 37 year old female who was vaccinated as a child with a dose of MMR II. Subsequently the patient was tested for immunity to measles, mumps and rubella recently for entry to nursing school. The patient tested positive for measles immunity, but was negative for mumps and indeterminate for rubella immunity. The office did not have the patient childhood vaccination record. Unspecified medical attention was sought. Additional information has been requested.
At noon on 10/12 she began experiencing chills, fevers, severe body aches and pains, generalized malaise, localized reddness, swelling and itching at the site. Also reports she had itching/burning eyes. Presents at Public Health office 10/15 with swelling and reddness in left upper arm and continues to be tired and achey, feels 'clammy and drug out' yet 10/16/07.
heart palpitations, racing heart, forceful intrinsic cardiac beating continuously (> 21 days), worse at night. metoprolol 12.5 PRN - improvement avoiding caffeine or stimulants - small improvement. Mostly exacerbated symptoms   Nothing has relieved these forceful beats. Since all was negative - 2nd dose given (10/11) and worsened symptoms. Improved slightly over time, but remains.
There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on 09/17/2021.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on 09/17/2021.) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Mixed hyperlipidemia, Type 2 diabetes mellitus, Obesity and Drug allergy (allergy to codeine). Concomitant products included LISINOPRIL, METFORMIN, ACETYLSALICYLIC ACID (ASPIRINE), SIMVASTATIN and INSULIN DETEMIR (LEVEMIR) for an unknown indication.    On 17-Sep-2021 at 4:34 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on 09/17/2021.). On 17-Sep-2021, EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on 09/17/2021.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on 09/17/2021.) to be not related.    There was no adverse reaction. Patient height reported as 65 inches.   No treatment medications were provided.
Notified that patient received the MONOVALENT version of the Pfizer COVID-19 booster vaccine rather than the intended BIVALENT version of the Pfizer COVID-19 booster vaccine on 09/16/2022.
Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry; No adverse event; Moderna Bivalent vaccines that were put it in the fridge, was administered to patients 1 month beyond Use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccines that were put it in the fridge, was administered to patients 1 month beyond Use by date), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry) and NO ADVERSE EVENT (No adverse event) in a 55-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7172B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccines that were put it in the fridge, was administered to patients 1 month beyond Use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccines that were put it in the fridge, was administered to patients 1 month beyond Use by date), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccines that were put it in the fridge, was administered to patients 1 month beyond Use by date) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry).    Concomitant medication details not reported by the reporter. Vial was initially stored in refrigerator on 11-JAN-2023. Vial did not undergo any temperature excursion. Treatment details was not reported by the reporter.
Panic attack: dizziness, disorientation, tingling and numbness in both arms and hands, muscle stiffness in both hands, near fainting, white lips. Episode lasted 5-10 minutes.
feeling tired; headache; product preparation issue; inappropriate dose of vaccine administered; This case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 7PS9E, expiry date 10th September 2021) for prophylaxis.   On 14th May 2019, the patient received Shingrix. On 14th May 2019, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter gathered patient's information. The healthcare professional reconstituted Shingrix with sterile diluent instead of supplied diluent and maladminister to a patient, this led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered  The reporter asked information to proceed with series and about details to look for with patient.   Follow up report received from pharmacist on 10th July 2019: Batch number was updated. On 14th May 2019, the patient received 1st dose of Shingrix. It was reported that the Shingrix was accidentally mixed and administered with the Merck diluent intended for Zostavax and MMR, NDC 00006-4309-0D. It was not the Shingrix approved diluent. It was erroneous administration. Less than a year after vaccination, the patient felt a little tired and headache which could be related or unrelated to the error or the fact that the patient received 3 other vaccines that day. On an unknown date, the outcome of the tiredness, headache were unknown. It was unknown if the reporter considered the tiredness and headache to be related to Shingrix. This was medication error with adverse event. The VAERS details were updated.   Upon instream quality review for the month July 2019, following correction was performed on 9th October 2019: Classification from exclude from general tab was removed.
Body chills and sweats, extreme fatigue, unable to focus or concentrate, extremely sore arm, runny nose and some congestion.
PATIENT EXPERIENCED SEVERE PAIN THROUGHT ENTIRE BODY. PATIENT STATES IT FELT LIKE KNIVES WERE BEING STABBED INTO THEIR LEGS. PATIENT WAS VERY SORE FOR THE FOLLOWING 24 HOURS.