chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen feet; Left/right leg numbness; Tingling and numbness sensations on the legs remain and come and go throughout the day and night; Fever and exhaustion were present the day and the day after of the second dose of the vaccine; Fever and exhaustion were present the day and the day after of the second dose of the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 27Apr2021 at 08:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 06Apr2021 at 08:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 27Apr2021, the patient experienced fever and exhaustion present on the day and the day after of the second dose of the vaccine. On 01May2021 at 16:00, the patient experienced swollen feet, left/right leg numbness and tingling, feeling of having tight socks on the legs. These symptoms began on the 4 days after the second dose of the vaccine. Tingling and numbness sensations on the legs remained and come and go throughout the day and night. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures on an unknown date, which included COVID-19 test (nasal swab) and the results were negative. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of events fever, exhaustion, swollen feet, left/right leg numbness/ feeling of having tight socks on the legs and tingling was not resolved at the time of this report.
Large, hard, red knot in loose flesh under arm directly below where shot was given. Larger than golf ball. Hurt and itched slightly. Used ice - 3 days. Reduced but still noticeable week later.
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. Information on the patient's past medical history, other concurrent condition, drug reactions or allergies and concomitant medications were not reported. On 29-MAR-2019, the patient was vaccinated with PROQUAD one dose with lot # N022972 and expiry date 19-FEB-2019 (strength, frequency and route of administration were not provided) for prophylaxis (expired product administered). No adverse effect reported.
Lower right upper buttocks pain; dull pain in my back located on the right side by my upper buttock and waist; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL PAIN (Lower right upper buttocks pain) and BACK PAIN (dull pain in my back located on the right side by my upper buttock and waist) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma since 1979, Drug allergy (sulfa drugs) and Drug allergy (some antibiotics). Concomitant products included SALMETEROL XINAFOATE (SEREVENT) from 1979 to an unknown date and CICLESONIDE (ALVESCO) from 1979 to an unknown date for Asthma.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced MUSCULOSKELETAL PAIN (Lower right upper buttocks pain). In May 2021, the patient experienced BACK PAIN (dull pain in my back located on the right side by my upper buttock and waist). At the time of the report, MUSCULOSKELETAL PAIN (Lower right upper buttocks pain) and BACK PAIN (dull pain in my back located on the right side by my upper buttock and waist) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was provided by the reporter.   This case was linked to MOD-2021-333574 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Follow-up information received on 30-SEP-2021 included no new information. On 01-Oct-2021: Follow information received on 01-OCT-2021 Patient demographics, medical history, concomitant medications and vaccination facility information was updated.
Red firm bump the size of a quarter immediately after. Couple days later it was just a bruise. Redness and firmness started to come back. By day 7 post shot 1, Full COVID arm. Red, firm, slightly itchy. No pain.
Vaccination Site pain; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Vaccination Site pain) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination Site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination Site pain) was resolving. Possible      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE PAIN (Vaccination Site pain) to be possibly related.    Action taken with mRNA-1273 in response to the event was not applicable. No concomitant medication was reported. Treatment medication was not provided by the reporter.
Arm where injection stated to be painful and swelled. Within 8 hrs I stated to experience a fever body aches head and neck pain chills nausea. I contacted a nurse the next morning and asked her if I should go to the emergency room. She said they would only give me ibuprofen and send me home. She also told me the symptoms would subside in 24 to 48 hours. it has been 72 hours and I am still sick from the flu vaccine. I dont know if I should go to the emergency room.
12 plus hours vertigo  Severe shaking 2 hours  Tinnitus  Ear fullness
Eczema; Skin infection; Little, flat, round, very, very itchy circles that started on her legs, but traveled up her body; This spontaneous case was reported by a patient and describes the occurrence of RASH PRURITIC (Little, flat, round, very, very itchy circles that started on her legs, but traveled up her body), SKIN INFECTION (Skin infection) and ECZEMA (Eczema) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 10A21A) for COVID-19 vaccination.     The patient's past medical history included Keratosis (Patient stated that she had keratosis in the past and she used "used spray" on it and it will go away.).   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH PRURITIC (Little, flat, round, very, very itchy circles that started on her legs, but traveled up her body). On 07-Apr-2021, the patient experienced SKIN INFECTION (Skin infection). On 04-May-2021, the patient experienced ECZEMA (Eczema). The patient was treated with HYDROCORTISONE (topical) on 20-Apr-2021 for Skin infection, at an unspecified dose and frequency and TRIAMCINOLONE on 04-May-2021 for Eczema, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Little, flat, round, very, very itchy circles that started on her legs, but traveled up her body), SKIN INFECTION (Skin infection) and ECZEMA (Eczema) outcome was unknown.            No concomitant medicines were reported   Reporter did not allow further contact
patient was inadvertently administered expired doses of ADACEL/no AE; Initial information regarding an unsolicited valid non-serious case was received from Nurse via Medical Information (Reference number- 00737625) and transmitted to Sanofi on 24-Aug-2021.  This case involves a 11-year-old male patient who vaccinated with a 0.5mL (once) dose of an expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (suspension for injection) inadvertently [lot U6321AA and expiry date 07-Jun-2021] via intramuscular route in the right deltoid on 11-Jun-2021 for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) [MENACTRA] and HPV VACCINE [HPV VACCINE] for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt. received vaccine at 0745 and returned at 0935 with hives located on her back. Pt was examined by Dr. and given oral BENADRYL and an EPIPEN to take home. Pt followed up next day w/ doctor and was fine.
Redness & itching below injection site. Cold compress & hydrocortisone cream used.
Vaginal bleeding and genital herpes outbreak within 24hrs of receiving first dose of vaccine. Bleeding for 6 days straight even though previous menses ended two days before receiving the shot. It was a normal period prior to that.
Uncomfortable pain in arm started a week after dose. Fatigued, pain in head but not quite a headache, swollen lymph node under arm
This spontaneous report was received from a nurse practitioner via a company representative and refers to a female patient of age between 60 and 64. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. In September 2017, 7 to 10 days prior to the report, the patient was vaccinated with a dose of ZOSTAVAX (route of administration, lot number and expiration date were not reported). 4 days after the vaccination, in September 2017, the patient visited the physician's office with soreness, swelling and pain at the injection site. There was no treatment given for the events. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not reported.
Patient received IM hepatitis B vaccine on 10/27/2005. Hives developed 27th worse on 28th, 29th and 30th. Came to ER on 10/29/2005 and received IV meds back on 10/30/2005 with worsening of symptoms. Face, lips swollen hives over entire body scattered and complaint of shortness of breath. 2/6/06 ER medical records received from hospital which stated patient experienced urticaria, swelling of lips/throat, SOB. Dx erthema multiforme & allergic reaction.  PMH: allergy to PCN./ss
Nausea, vomiting following self administration of oral typhoid/VIVOTIF. pill #3 Lot # 3003104. Crucell.  Discontinued after emesis contained.
Patient passed out after vaccination. She fell and hit her head on a padded chair, so there was no evident injury. No symptoms other than the "dizziness" she described immediately to falling down. She was alert immediately afterward.
Neck ache; Headache; Muscle ache; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), NECK PAIN (Neck ache), HEADACHE (Headache) and MYALGIA (Muscle ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), NECK PAIN (Neck ache), HEADACHE (Headache) and MYALGIA (Muscle ache). At the time of the report, DIARRHOEA (Diarrhea), NECK PAIN (Neck ache), HEADACHE (Headache) and MYALGIA (Muscle ache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow up received on 28 Apr 2021:  Second dose was reported and Event outcome updated.
Pt presented to hospital post mechanical fall, status post surgery. pt tested for covid for fervers but other wise asymptomatic. once stable pt d/c to snf.
Developed pain at site of injection after receiving injection in L deltoid. Progressed to continual L shoulder pain with decreased range of motion.
patient get dose that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a male patient who received HAV (Havrix pediatric) (batch number yr532, expiry date 9th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th September 2022, the patient received the 2nd dose of Havrix pediatric and Havrix Pre-Filled Syringe Device. On 14th September 2022, unknown after receiving Havrix pediatric and Havrix 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: 14-Sept-2022 Reporter's comment: The office manager had a question around Havrix Pediatric vaccine.  The reporter  had a pediatric patient get the booster dose of Havrix pediatric dose on day of reporting and after noticed that the product had expired on 9th September 2022. Agency inquiry was did they need to call the patient back in to redo the booster dose and how long do they need to wait if so. Patient's date of birth and initials unavailable at this time. The reporter will be out of the office from tomorrow until next Tuesday.  The reporter consented to follow-up via email. Additional supportive information: The patient had received an expired dose of Havrix pediatric vaccine, which led to expired vaccine used.
Vaccine given Jan 5, 2010; patient called 1/27/2010 to say painful, but no swelling or redness. Advised by RN to use ice pack. Came to 3/2/2010 appt still experiencing pain, limited abduction of left shoulder. Tender to palpation. Treated with SEPTRA for possible abscess.
Soreness at injection site, muscle pain, fatigue, headache, weakness & diarrhea started on 10/10/2023 and continue to current date 10/12/23
1 week following  my injection I developed redness, extreme itching, swelling , and warmth  at the injection site in my left upper arm. Symptoms resolved in 48 hours; I took Benadryl and applied Hydrocortisone cream to the site.
THYROIDITIS; This spontaneous report received from a patient 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 was not reported, administered on 02-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced thyroiditis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from thyroiditis. This report was non-serious.; Sender's Comments: V0.Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Received HPV vaccine on 8/13/18. Develop headache on 9/16/18, fever on 9/17/18, vaginal ulcers on 9/19/18. Seen on 9/18/18 - diagnosed with pneumonia by chest x-ray - started Augmentin. Seen on 9/19/18 for vaginal ulcers. Admitted to the hospital 9/21/18 - 9/23/18 for pneumonia and vaginal ulcers, and poor PO intake. She was diagnosed with mycoplasma pneumonia and Lipschutz ulcers. Had follow up on 9/26/18 - all symptoms were improving. Also complained of right shoulder pain during the illness. (Vaccine given in left shoulder and pneumonia was in left upper lung.)
Patient reported feeling weak a few hours after shot. He had local skin reaction at the injection site which included redness and swelling. Patient stated on 4/6/19 he lost use of his limbs from the waist down. On 4/6/19 he was admitted to the hospital for two days.
Sinus pressure; Bronchitis; Sinus infection; Allergies; COVID-19; COVID-19; Booster dose: Aug2021; soreness; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date Aug2021 (Batch/Lot number: unknown) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) at citrate free for psoriasis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 2nd, Route: Intramuscular), administration date: 23Apr2021, when the patient was 57 years old, for Covid-19 immunization, reaction(s): "Bronchitis", "Soreness"; Bnt162b2 (Dose: 1st, Route: Intramuscular), administration date: 31Mar2021, when the patient was 57 years old, for Covid-19 immunization, reaction(s): "Bronchitis", "Soreness". The following information was reported: COVID-19 (medically significant) with onset 16Aug2021, outcome "recovered" (2021), DRUG INEFFECTIVE (medically significant) with onset 16Aug2021, outcome "unknown" and all described as "COVID-19"; IMMUNISATION (non-serious) with onset Aug2021, outcome "unknown", described as "Booster dose: Aug2021"; PARANASAL SINUS DISCOMFORT (non-serious), outcome "recovered", described as "Sinus pressure"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "soreness"; BRONCHITIS (non-serious), outcome "not recovered", described as "Bronchitis"; SINUSITIS (non-serious), outcome "recovered", described as "Sinus infection"; HYPERSENSITIVITY (non-serious), outcome "recovered", described as "Allergies". The action taken for adalimumab was dosage not changed.  Additional Information: The reporter's causality for BNT162B2 was reported as For the event(s) Sinus pressure :Not Reported; Pain (Pain) Probable; Bronchitis (Bronchitis)Not Reported; COVID-19 (COVID-19) ): Not Reported; Sinus infection (Sinusitis): ): Not Reported; Allergy (Hypersensitivity) ): Not Reported.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the Limited information in the case report and a plausible temporal relationship, a possible causal relationship between the reported events Drug Ineffective, COVID 19, Booster,Paranasal sinus discomfort, pain, Bronchitis, Sinusitis,Hypersensitivity and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : 21K-163-4141765-00
Moderna COVID?19 Vaccine EUA Severe, migraine like headache Body aches Low-grade fever (<100) Extremely swollen left armpit lymph node that was accompanied with a burning/stabbing sensation and tingly fingers in left hand
Left arm swelled, hot to the touch, deep red color, hurt to touch it, or to move it welts Diagnosis: Cellulitis due to reaction to shot Medication: Cephalexin 500mg 40 capsules (10 days - 4 per day) Both the pharmacist + Urgent Care provider said I had an extreme reaction to the shot
Severe headaches; This case was reported by a other health professional via sales rep and described the occurrence of headache in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra) for prophylaxis.   On an unknown date, the patient received Fluarix Tetra. On an unknown date, unknown after receiving Fluarix Tetra, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Fluarix Tetra.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Fluarix Tetra vaccine and had severe headaches after receiving the vaccine. No further information was available. The reporter did not consent to follow up.
Immediately felt heart tightness/warmth; completely resolved the following morning Delayed- itching (full body); Began after 15-20min lasted the remainder of the day and nearly completely resolved the following morning.  Delayed Hives (to neck/face above neck); resolved the following morning Delayed injection site soreness; Began 4-5hrs after the injection worsened, extremely tender to touch Following morning the injection site is slightly raised, red to pink, warm to touch, swollen 2-2.5cm in circumference around the injection site, some itching remains. General fatigue 4-5hrs following the injection. Resolved the following morning
Patient seen in clinic 8/17/17 by provider. Left arm, deltoid arm, had a circular ring of erythema, no TTP, no excessive warmth noted. Patient reports it is not painful, just itchy, AOX3, NAD, VSS, afebrile. BENADRYL Rx sent, area marked to monitor, picture taken for chart, advised MOC to monitor and rtc is s/s persist/worsen, ER precautions given.
1 degree fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (1 degree fever) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included AFib (2yrs ago.) in 2019. Concurrent medical conditions included Cancer (Has no lymph nodes in right arm due to having cancer.). Concomitant products included APIXABAN (ELIQUIS), DILTIAZEM and LEVOTHYROXINE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (1 degree fever). At the time of the report, PYREXIA (1 degree fever) outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2021-370407, MOD-2021-370846 (Patient Link).