chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Big and itchy at injection site; Redness at the injection site; Swelling at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Big and itchy at injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unkwown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Big and itchy at injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Redness, Swelling and Itching, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Big and itchy at injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) outcome was unknown.        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.   No concomitant medication provided.
Pt recv vax on 11/12/98; within hr post vax pt exp fussiness
This spontaneous report as received from a pharmacist refers to a 62 years old female patient with no pertinent medical history and no drug reactions or allergies. The reporter stated that she held a ZOSTAVAX clinic, on 02-MAY-2014, patient was administered with ZOSTAVAX lot number K000456, expiration date-15-DEC-2014, dose single dose, route SQ. On an unknown date in May 2014, the patient developed redness, swelling and induration at injection site. The pharmacist stated she became aware of the adverse events the patient was experiencing on the weekend (03-MAY-2014 and 04-MAY-2014). The vaccine clinic took place at a high school. Vaccine recipient was teacher. The pharmacist spoke to the school nurse on Monday 05-MAY-2014. The school nurse shared with the pharmacist that the adverse experiences, the teacher was experiencing, was resolving. There was no hospitalization. No specific treatments mentioned. The pharmacist shared the initials, gender and age of each ZOSTAVAX vaccine recipient. All vaccine recipients were women. The pharmacist learned from school nurse that one of the patient experiences of redness spread to over 5 inches from injection site, the pharmacist unable to identify which patient. Patient sought medical attention (called pharmacy). The patient did not receive treatment for the adverse event. There was no lab diagnosis or studies performed. The outcome of redness, swelling and induration at injection site was recovering. No product quality complaint was involved. This is one of 9 reports from the same source. Additional information has been requested.
INDIVIDUAL RECEIVED VACCINE STORED PAST THE BEYOND USE DATE (FOR REFRIGERATION) AND THE ADDITIONAL 14 DAY STABILITY DATE (OFF LABEL).  INDIVIDUAL TO BE REVACCINATED.
Hot , red swelling  of arm going up neck , ear, face lasted about 10 hours
Moderna vaccine given to a 16 year old male. Did not discover age until after vaccine given.
Information has been received from a female patient who a "couple of years ago", was vaccinated with a dose of PNEUMOVAX 23. On an unknown date the patient experienced neck pain. The patient's final outcome was not reported. This is one of two reports received concerning the same patient. No further information is available.
Client was seen at pediatric center 3/18/03. We did not see pt and are unable to describe adverse events.
HAD COVID ONCE; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced had covid once. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had covid once was not reported. This report was non-serious. The report was associated with product quality complaint number: 90000217487. This case, from the same reporter is linked to 20220234028.
pt. c/o light headache, dizziness, body weakness after pfizer vaccination.  BP 159/98 ; p-82- Sat 97%
loss of appetite; blood pressure was high; experienced symptoms of COVID-19; achy hurting body; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (experienced symptoms of COVID-19), MYALGIA (achy hurting body), FATIGUE (fatigue), DECREASED APPETITE (loss of appetite) and HYPERTENSION (blood pressure was high) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included METFORMIN for Diabetes mellitus.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced COVID-19 (experienced symptoms of COVID-19), MYALGIA (achy hurting body), FATIGUE (fatigue) and HYPERTENSION (blood pressure was high). On an unknown date, the patient experienced DECREASED APPETITE (loss of appetite). On 29-Jan-2021, COVID-19 (experienced symptoms of COVID-19), MYALGIA (achy hurting body), FATIGUE (fatigue) and DECREASED APPETITE (loss of appetite) had resolved. At the time of the report, HYPERTENSION (blood pressure was high) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Tylenol
This case reported by a pharmacist and described the occurrence of shingles in a 50 year old female subject who was vaccinated with influenza virus vaccine for prophylaxis. On 10/20/05 the subject received a dose of Fluarix. The pharmacist reported that the suject received influenza virus vaccine, "in the past without incident." At an unspecified time following the administration of Fluarix, on 10/20/05, the subject "did not feel well." The subject was seen at a physician's office on 10/21/05 and was diagnosed with shingles. The subject was treated with anti-viral medication. The events had improved as of the time of initial reporting. 10/05 the pharmacist considered the events to possibly be related to vaccination with fluarix. On follow up received 11/22/05, the pharmacist reported the events had resolved with treatment unspecified anti-viral medication. The pharacist considered the events to be unrelated to vaccination with Fluarix.
dose has expired on February 8th 2022; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 52-year-old female patient who received HAB (Twinrix adult) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th March 2022, the patient received Twinrix adult and Twinrix Pre-Filled Syringe Device. On 25th March 2022, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-Mar-2022 Reporter's Comments: The reporter stated that on 25th March 2022, the patient received a dose of Twinrix that had already expired on 8th February 2022. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow-up. Additional Supportive Information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Information has been received from a physician concerning a 22 year old female with no pertinent medical history who on 21-AUG-2007 was vaccinated with a 0.5 ml first dose of Gardasil.  Concomitant therapy included YASMIN.  On 22-AUG-2007 the patient developed an itchy rash all over her body.  The patient was taking BENADRYL for relief of symptoms.  The patient was going to visit the physician on 22-AUG-2007 at 2:00 pm.  At the time of the report the patient was recovering.  Additional information has been requested.
Developed swollen painful lymph node in left clavicle area/neck. Determined by doctor to be due to vaccine 8 days prior.
Redness, swelling, hot to touch per mom on day 1. On 04/05/12 at MD's office significant swelling noted from mid thigh to knee joint. Redness and warmth resolved.
This spontaneous report as received from a Licensed Practical Nurse refers to a 9 month old patient. On an unknown date the patient was vaccinated with received the third dose of PEDVAXHIB (lot#, expiry date, dose, frequency unspecified) at 9 month of age rather than at recommended 12-15 month of age. No adverse effects reported. No PQC involved. Additional information has been requested.
Arm soreness that lead into not being able to lift arm past 90 degrees, pain in upper arm area, that gradually got worse over time, pain at night while waking from sleep. Pain during certain movements of arm extension. I have gone to 3 providers for this. First told nothing was wrong to use heat pad and take ibuprofen which did not solve the problem. I am now seeing an acupuncturist, osteopathic doctor who has helped but I still cannot move my arm in full range of motion. She said I have frozen shoulder. I am also seeing a primary care provider for this.
The individual donated plasma and then proceeded to receive the Twinrix vaccine after which he felt "lightheaded" and lost consciousness for < 10 seconds.  The individual recovered quickly and was released to home.
1st and 2nd doses two weeks apart; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 75BA4, expiry date 5th February 2023) for prophylaxis.   Concomitant products included ZOSTER VACCINE RECOMBINANT, ADJUVANTED (NON-LIVE) (SHINGRIX).   On 4th October 2021, the patient received the 2nd dose of Shingrix. On 4th October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were reported as follows: This case was reported by the nurse. The nurse reported that the patient was administered his 1st and 2nd doses of Shingrix two weeks apart, which led to drug dose administration interval too short. The nurse consented to follow- up.
Spouse reported that patient had been feeling achy, tired and fevered most of day and had spent day in bed.  When he got up, he fainted face down on bed.  EMT arrived and rolled him over.  Oxygen level was at 88, fever of 99.9.  Since a diabetic, finger stick done (171) Patient given oxygen and IV fluids before transport and he started to feel better.  Transported to Hospital - unknown if admitted.
1/12 - localized reaction, red with hard center, then in eve - nausea and fever. By 1/13 area increased and redness to axillary area fever cont., nausea and body aches. Local health department suggests to be evaluated. Has apt to see PCP 1/13/16.
Patient called 11/11/2022 complaining of arm pain and shortness of breath. Advised patient to go to the ER since she did not have a primary care physician to call.
genital warts; the nurse was not sure which vaccine the patient had received; the nurse was not sure which vaccine the patient had received; This spontaneous report as received from a nurse via company representative and refers to a 22-year-old female patient. The patient's pertinent medical history, concomitant therapies, drug reactions and allergies were not provided.  Approximately in 2012 (the patient's vaccination age was reported as 15 years), the patient was vaccinated with a first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection or hpv rl1 16 18 vlp vaccine (baculovirus) (CERVARIX) (for both lot #, expiration date and anatomical location were not provided), both for prophylaxis (the nurse was not sure which vaccine the patient had received). On an unknown date in 2012, she received second and third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot #, expiration date and anatomical location were not provided) for prophylaxis. On an unknown date in April 2019 (reported as last week), the patient experienced  genital warts.  The outcome of reported event was not recovered.  The causality assessment was not provided.
Extreme body aches, chills, fever of 100.2, headache, fatigue, weakness, and extreme nausea
Facial numbness / paralysis, mostly in the left side of my face. I?m not able to independently close my right eye but most of the numbness is in the left side of my face and mouth.
stomach has been in knots.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach has been in knots.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach has been in knots.). At the time of the report, ABDOMINAL DISCOMFORT (stomach has been in knots.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Med Info Agent: Staff Patient stomach has been in knots since he got his 1st shot.  Treatment medicines were not reported.
11 years old Patient came accompanied by mother to receive Pediatrics Pfizer Bivalent booster, patient was given 12+ years Pfizer Bivalent booster. Vaccinating nurse adminsted Pfizer adult dose 12 years and above, med error was not caught until after patient had already left. Allergist notified and manager notified. Patient was mother was called and mother stated patient is okay and will monitor her for any reactions. Patient's mother stated no SOB, or any other respiratory issues, patient was educated that if any SOB or respiratory issues to go to nearest ED. Patient mother stated " I will continue to watch her"
patient reports cellulitis needing treatment with an antibiotic after receiving a Moderna Booster dose 0.25ml
Became diabetic, and had heart issues. Diagnosis is DKA. I have never been a diabetic before.
Mother reports that she notice a rash this am 12/14/2023 after her bath.  It is erythemic confluent wheals on her right lower extremity and one erythemic wheal on her left lower extremity
Headache, Myalgia, Fever, Fever, Chills, Body aches, Dizzy, Fatigue, HA, Sore arm Narrative:  Other Relevant History:
Pt had tachycardia with a heart rate in the 160's after receiving the vaccine. She also had chest pain. EMS was called and took the patient to the emergency department for evaluation.
Patient received first dose on 3/22/2021 and second dose on 4/7/2021. The earliest the patient should have received the second dose is 5/5/2021. Pt. had no adverse reactions/outcomes/symptoms as a result of receiving the shot.
Started feeling very tired and achy at first at about 1530, then head felt cloudy, dizzy, very weak, like I could pass out at about 1700-1900. At 2000-2100, I tried to sleep, but kept waking feeling restless and muscles were twitchy. Started having involuntary movements (dystonia) of my arm and face, facial grimacing, then my head and upper shoulders, legs. Went to ER, where I was given Ativan for possible seizures. Then husband took me to our hospital for further evaluation. MRI and CT scans were done of my head, which were normal. Neurologist requested EEG which I don't know results of. I am to follow-up with Neurologist on 12/16/11. I continue to have slight dystonia and muscle weakness, tiredness. I called health care provider who gave the vaccine to repost the issue.
cannot talk; Amyotrophic lateral sclerosis; Has deteriorated significantly; tingling in her feet and hands; numbness in her feet and hands; Difficuty walking; She couldn't open jars; voice was weak; This spontaneous case was reported by a consumer and describes the occurrence of AMYOTROPHIC LATERAL SCLEROSIS (Amyotrophic lateral sclerosis) in a female patient of an unknown age 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 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced DYSPHONIA (voice was weak). On 20-Mar-2021, the patient experienced MUSCULAR WEAKNESS (She couldn't open jars). In April 2021, the patient experienced PARAESTHESIA (tingling in her feet and hands), HYPOAESTHESIA (numbness in her feet and hands) and GAIT DISTURBANCE (Difficuty walking). In July 2021, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (Has deteriorated significantly). In August 2021, the patient experienced AMYOTROPHIC LATERAL SCLEROSIS (Amyotrophic lateral sclerosis) (seriousness criterion medically significant). On an unknown date, the patient experienced APHASIA (cannot talk). The patient was treated with EDARAVONE (RADICAVA) for ALS, at an unspecified dose and frequency. At the time of the report, AMYOTROPHIC LATERAL SCLEROSIS (Amyotrophic lateral sclerosis), MUSCULAR WEAKNESS (She couldn't open jars), PARAESTHESIA (tingling in her feet and hands), HYPOAESTHESIA (numbness in her feet and hands), GAIT DISTURBANCE (Difficuty walking), GENERAL PHYSICAL HEALTH DETERIORATION (Has deteriorated significantly), APHASIA (cannot talk) and DYSPHONIA (voice was weak) outcome was unknown.            Concomitant medications was not reported. Treatment history was not reported.  The reporter's causality assessment for the events AMYOTROPHIC LATERAL SCLEROSIS, DYSPHONIA, MUSCULAR WEAKNESS, APHASIA, HYPOAESTHESIA, GAIT DISTURBANCE, GENERAL PHYSICAL HEALTH DETERIORATION and PARAESTHESIA in relation to Edaravone  therapy was not related.  Company Comment: This is a case of Amyotrophic Lateral Sclerosis 6 moths after receiving the second dose of the product in a woman of unknown age. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-293348 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This is a case of Amyotrophic Lateral Sclerosis 6 moths after receiving the second dose of the product in a woman of unknown age. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
chills; Tremors/Spasms starting 13 hours after vaccination; Tremors/Spasms starting 13 hours after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Oct2021 11:45 (Lot number: FF2593) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chemical Sensitivity" (unspecified if ongoing), notes: other medical history: Chemical Sensitivity. Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0161, Location of injection: Arm Left), administration date: 20Apr2021, when the patient was 64 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8733, Location of injection: Arm Left), administration date: 28Mar2021, when the patient was 64 years old, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 26Oct2021 01:15, outcome "not recovered", described as "chills"; TREMOR (non-serious), MUSCLE SPASMS (non-serious) all with onset 26Oct2021 01:15, outcome "not recovered" and all described as "Tremors/Spasms starting 13 hours after vaccination". Therapeutic measures were not taken as a result of chills, tremor, muscle spasms.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient has no covid prior vaccination. Patient was not tested covid post vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
slight fever 98.4 degrees F; tired; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (slight fever 98.4 degrees F), FATIGUE (tired) and FATIGUE (fatigue) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M2EA and 012AQ1A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Sinusitis.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PYREXIA (slight fever 98.4 degrees F), FATIGUE (tired) and FATIGUE (fatigue). At the time of the report, PYREXIA (slight fever 98.4 degrees F), FATIGUE (tired) and FATIGUE (fatigue) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.4 98.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-224949 (Patient Link).
Initial report received from a nurse on 22 November 2013. A 75 year old male patient received FLUZONE HD (lot # and expiration date unknown) intramuscular in right deltoid on 01-Oct-2013. The patient reported that since that day he has had pain in the arm where he received the vaccine. His pain started that day and increased day by day for 3 days. He stated that it was now 7 weeks later and the pain continues. He was unable to exercise or swim as he used to. The event was ongoing at the time of this report. Medical history includes hypertension. List of documents held by sender: none
erythematous  warm to touch no drainage Linear vesicular Left groin groin area has a papular lesion with localized erythema no drainage from the tick bite