chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to pharmacy to receive COVID booster. Pt met criteria of age >65 years and 6 months after 2nd dose of original COVID vaccine series. However, vaccinator failed to identify patient originally received Moderna on 02/19/21 and 03/19/21. The patient should not have received a Pfizer booster. The patient did not report any side effects after receiving the vaccine.
PATIENT DESCRIBED HAVING ALL REGULAR EFFECTS OF THE SHINGRIX SUCH AS SORE ARM BUT ALSO FEELING AN INTENSE TINGLING ALL OVER HER BODY THAT MADE HER VERY UNCOMFORTABLE AND GREW TO A LEVEL OF PAIN AND DISCOMFORT. PATIENT DID SAY THAT THE TINGLING HAD LESSENED. HOWEVER, SHE STILL SLIGHTLY HAD TINGLING TODAY, 4 DAYS AFTER ADMINISTRATION. HOWEVER, IT WAS NO LONGER PAINFUL.
This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act refers to a 13 year old male patient. The patient's past drugs included albuterol, cefdinir, guaifenesin/codeine, ZITHROMAX. The patient's historical conditions included rash and mild intermittent asthma. The patient's concurrent conditions included mild dry cough with a cold this week, mild intermittent asthma (triggered by viral illnesses) and cough with exercise. On 16-NOV-2016, the patient was vaccinated with GARDASIL 9 (lot# M009116), (route: intramuscular) in the left arm. On 16-NOV-2016, numbness and tingling in bilateral hands and legs/feet, headache, muscle weakness, vomiting and lightheadedness. Drug screen, urinalysis, CMP and CBC labs done at the hospital. The outcome of the events was reported as recovered. The causality of the events was unknown. Additional information is not expected because no further information could be obtained from the regulatory authority.
Patient had discomfort at injection site and went to urgent care where it was determined patient had infection. Treated with antibiotics. Site was red when presented to the pharmacist.
R supraclavicular 4-5 cm tender lymph node surrounded by 1-2 cm tender nodes. R Inferclavicular nodes also swollen/tender but more precisely defined. All with overlying erythema with connecting lines between nodes. Several anterior axillary nodes enlarged but not tender. On neck nodes are not enlarged but neck is sl tender esp ant cervical clavicle. Afebrile.
Narrative: Fully vaccinated presents to hospital found to be COVID positive upon admission. Presents with dyspnea and weakness. No hx of prior COVID infection.
Vaqta Hep A and Fluzone flu vaccine were administered and patient began to break out in hives starting around the Fluzone injection site. Urticaria scattered to legs, arms and chest.
injection site feeling tingly inside; having a reaction to the vaccine; Left arm being itchy; scratch on left arm; Left arm warm to the touch; redness distal to the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (injection site feeling tingly inside), ADVERSE REACTION (having a reaction to the vaccine), PRURITUS (Left arm being itchy), SCRATCH (scratch on left arm) and VACCINATION SITE WARMTH (Left arm warm to the touch) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PARAESTHESIA (injection site feeling tingly inside), ADVERSE REACTION (having a reaction to the vaccine), PRURITUS (Left arm being itchy), SCRATCH (scratch on left arm), VACCINATION SITE WARMTH (Left arm warm to the touch) and VACCINATION SITE ERYTHEMA (redness distal to the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (injection site feeling tingly inside), ADVERSE REACTION (having a reaction to the vaccine), PRURITUS (Left arm being itchy), SCRATCH (scratch on left arm), VACCINATION SITE WARMTH (Left arm warm to the touch) and VACCINATION SITE ERYTHEMA (redness distal to the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications Injectable Allergy medication Treatment medications ice, Benadryl
3 days p/immun, mom reported that pt had an inject site rxn which included redness over the entire thigh; tx APAP & ice packs;
COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID ) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced COVID-19 (COVID ). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID ) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive. On 10-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive. On 13-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; Product storage error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT STORAGE ERROR (Product storage error).    This case contains information for the 42nd out of 77 adult patients described by the reporter. No concomitant information was reported. It was reported that, approximately 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Pt fainted 2.5 days after AVA#1. Pt fainted after voiding. Pt had consumed 3 jumbo margaritas earlier in the evening. At the time of syncope pt denied chest pain, SOB, diaphoresis, straining to void. Denied hx of CVD, hypertension, previous episodes of fainting.  Pt cleared for second AVA. Instructed to return if further episodes of fainting after AVA.
joint problems; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of joint disorder in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced joint disorder (Verbatim: joint problems). The outcome of the joint disorder was not reported.   It was unknown if the reporter considered the joint disorder to be related to Shingles vaccine.     It was unknown if the company considered the joint disorder to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-Mar-2023. The patient reported this case via interactive digital media. The patient got the first jab and immediately started having a series of joint problems and then he/she found out that the shingles rate was higher among people who had both shingles jabs. Not sure what's in those shots, but it did not seem helpful.  Practice healthy skepticism. The reporter said like many others, his/her problems began when he/she got the shingles vaccine. His/her joint problems started with the shingles vaccine.  The reporter guessed that Pfizer, any disease that had to be pushed as hard as they were pushing shingles probably had a vaccine behind it that had to be sold.; Sender's Comments:  US-GSK-US2023AMR067477:same reporter
48 hours after immunization developed a few hives at injection site- both sides mostly on left. Next day progressed to head to toe hives per mom. Next day  Dx erythema multiforme minor. Patient recovered over next few days.
Erythematous skin at injection site area at left thigh 2cm in diameter and no tenderness and no swelling
Lack Of Apeptite; Hot Flash; Severe Diarrhea; Fever; Chill; Extreme Exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8732) via an unspecified route of administration in the left arm on 30Mar2021 at 17:15 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 31Mar2021 at 16:30 the patient experienced lack of appetite, hot flash, severe diarrhea, fever, chill and had extreme exhaustion. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event lack of appetite, hot flash, severe diarrhea, fever, chill and extreme exhaustion were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
According to the patient this report may have been submitted by MD seen at time of adverse event. It was reported that the client began to develop itchiness after the immunization was given. Soon after numbness began to develop in the left shoulder and continued down the arm.  Client reports that the numbness was on the left side down to his waist. Client reported having been seen at another facility where he was diagnosed with transverse myelitis and given IV Solumedrol during hospital stay. Client reports having improved with only numbness in the left fingertips as of today. Client states he was sent home with a prescription for steroids PO. Follow-up scheduled.
This spontaneous case reported by a consumer, describes the occurrence of hyperhidrosis (feet sweating), paresthesia (hands are tingling/tingling; also went from shoulders down to hand), feeling hot (hot hands) and pain (feels like a sting down entire arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 021B21A and 030A21A) for COVID-19 immunization. Concurrent medical conditions included blood pressure, high cholesterol, diabetes, heart disorder and iodine allergy. On Mar 11, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 8, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 9, 2021, patient experienced hyperhidrosis (feet sweating), paresthesia (hands are tingling/tingling; also went from shoulders down to hand), feeling hot (hot hands) and pain (feels like a sting down entire arm). At the time of the report, hyperhidrosis (feet sweating), paresthesia (hands are tingling/tingling; also went from shoulders down to hand), feeling hot (hot hands) and pain (feels like a sting down entire arm) resolved. Reporter did not allow further contact. Most recent follow-up information incorporated: On May 19, 2021: Follow-up received on May 19, 2021 contained information regarding outcome of the events.
localized hives at injection site, appeared at 24 hours post vaccination. worsening at 48h.  treated for allergic rxn with decadron, benadryl, ranitidine
No additonal AE's and no PQC's were; A nurse stated that an improperly stored dose of PROQUAD was administered to a patient.  No additonal AE's and no PQC's were reported.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-MAY-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, use as directed to prevent measles, mumps, rubella and varicella infection, lot #U015480, expiration date: reported as 13-NOV-2023 but auto-populated as 13-NOV-2022 (site and route of administration were not provided) (product storage issue). No additional adverse events were reported.
I am experiencing extremely heavy longer periods (cycle menstruation) with violent painful cramps that I have never had prior to the vaccinations. It is atrocious!!! I am using two boxes of 36 or more count due to the vaccines that I never had experience prior to the vaccinations. Also, my right arm was swollen for three weeks after the second dose was adminstered. The site is still sore and wasn't until the vaccinations. I am  having horrendous hiccups almost every day ever since I have been vaccinated and had not been prior to the vaccines.
Severe head ache woke up around 2:30, memory lapse of when I had shots and son in college, had nausea and vomiting, sensitivity to light. Has migraines usually several months apart, has been several months since last one. 4:30pm much better with hang over feeling earlier but much improved.
VAQTA was given to a 4 month old patient; This spontaneous report was received from a nurse referring to a 4 month old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 01-SEP-2020, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) 0.5 ml, lot # T014835, expiration date on 17-JUL-2021, for prophylaxis (route  and freuqencywas not provided) (Inappropriate age at vaccine administration). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014835; expirationdate: 17-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On an unknown dates in approximately 2015 (since the initial temperature excursion was reported on 14-MAY-2015), the patients were vaccinated with 30 doses of VARIVAX (Merck) subcutaneous injection, 0.5 ml, lot # K020757, expiration date 31-OCT-2016 (strength was not reported) which were improperly stored and exposed to a temperature excursion. No information on patients concomitant medication was provided. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of the two reprots from the same reporter. Additional information has been requested.
stop taking flu shots because I got the flu; Initial information was received on 03-Dec-2020 regarding an unsolicited valid non-serious case received from via social media from a consumer.  This case involves adult patient who stop taking flu shots because got the flu (Influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient stop taking flu shots because got the flu (Influenza), Unknown latency, following the administration of INFLUENZA VACCINE.  Final diagnosis was Influenza.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  There will be no information on the batch number for this case.
fever (102F); terrible chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever (102F)) and CHILLS (terrible chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.  On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 04-Feb-2021, the patient experienced PYREXIA (fever (102F)) and CHILLS (terrible chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever (102F)) and CHILLS (terrible chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature increased: 102 (High) Patient had 102F fever..   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.
patient reported increasing swelling, soreness, redness, and heat at injection site. Pt sought treatment at local Urgent Care. Patient received rx for Sulfamethoxazole/Trimethoprim 400/80 BID x10 days
Pt developed rash/blister on her 24 hours after receiving FLUARIX.
Temperature 14°F up to 46°F (-10°C up to 8°C) 40 F for 120 hours / Time frame 120 hours; No additional AE; patient administered PROQUAD instead of MMRII.; patient administered PROQUAD instead of MMRII.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 25-APR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot #W004694 has been verified to be a valid lot, expiration date 08-AUG-2023, (strength, dose, route of administration and anatomical location were not provided) administered for prophylaxis, instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong product administered) (interchange of vaccine product). No additional adverse event were reported (no adverse event). For measles, mumps, rubella and varicella (oka-merck) virus vaccine live  (recombinant human albumin) (PROQUAD) temperature excursion was from 14 to 46 Fahrenheit (also reported as -10 centigrade up to 8 centigrade), in addition the temperature was measured as 40 F for 120 hours (product storage error).; Sender's Comments:  US-009507513-2204USA009535:
Red splotchy face and upper body, progressed from small to covering whole upper body/face/ears/arms within 8hours of shot. Swollen face included eyes. Non stop crying and lethargy after 8hours.
Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 08-APR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
BODY ACHES; CHILLS; HEAD ACHE; FEVER; NAUSEA; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hay fever, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced head ache. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from nausea, body aches, head ache, and chills. This report was non-serious.
SWELLING; SORE, AND PAINFUL SYMPTOMS DID NOT GO AWAY, but, CONTINUED AND GOT WORSE; ROTATOR CUFF - RIGHT ARM - UPPER/SHOULDER - EXTREMELY PAINFUL/HAD P.T.
Low grade fever (100.4 F when first noticed) that developed the night of the injection at around 9 pm. Full body aches and a headache also developed. The following morning at 6 am took Tylenol and rested until fever went away.
Vaccine  administration error.  Patient was mistakenly given the  MenCYW only. With out the  Men A Lyophilized.
COVID vaccine breakthrough case. Moderna 1/29/21 007M20A, 2/26/21 010A21A, 11/4/21 034F21A and 10/24/22 027E22A
I started to feel anxious and I was having headaches about four and a half months after the vaccine. I have never had any high blood pressure before. I have never had any problems with anxiety before either. My blood pressure was 145/95 average but it was fluctuating. My doctor prescribed some medication and it helped my blood pressure but not the anxiety. I am still having problems with anxiety at the moment.
After 1St vaccine.  Chest pains, difficulty breathing, like breathing through a straw.  Saw cardiologist doctor,  and was seen at ER. Sent home with Aspirin and colchicine scripts. To this day still having severe chest Pain and difficulty breathing.
About 1/2 hour after shot given she felt dizzy and had a headache and got dry heaves with lots of abdominal pain and then she got diarrhea about 2 hours later. Continued with dry heaves. Went home, missed 1 1/2 days of work. Also had some lower back pain day of the shot.