chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Warm at the site of injection; Itching around the same area; Small rash around that same area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm at the site of injection), VACCINATION SITE PRURITUS (Itching around the same area) and VACCINATION SITE RASH (Small rash around that same area) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL and METFORMIN for an unknown indication.   On 27-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced VACCINATION SITE WARMTH (Warm at the site of injection), VACCINATION SITE PRURITUS (Itching around the same area) and VACCINATION SITE RASH (Small rash around that same area). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE WARMTH (Warm at the site of injection), VACCINATION SITE PRURITUS (Itching around the same area) and VACCINATION SITE RASH (Small rash around that same area) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  Upon internal review on 16 Jun 2021, the patient age was captured as unknown.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Event outcome updated.
1 of 3 pt who experienced an inject site rxn which included swelling 2" diameter, induration 1-2' in diameter, redness & hot to touch; Tx included heat @ the inject site & Advil or Tylenol for the pain; Pt is currently asymptomatic;
Rashes are itchy; Rashes on both arms - upper arm and forearm, in medium to large patches; Rashes are sore; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rashes are itchy), RASH (Rashes on both arms - upper arm and forearm, in medium to large patches) and RASH (Rashes are sore) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash and Rash pruritic.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced RASH PRURITIC (Rashes are itchy), RASH (Rashes on both arms - upper arm and forearm, in medium to large patches) and RASH (Rashes are sore). At the time of the report, RASH PRURITIC (Rashes are itchy), RASH (Rashes on both arms - upper arm and forearm, in medium to large patches) and RASH (Rashes are sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Significant shoulder pain - woke me through the first two nights - unable to raise arm - significantly reduced range of motion - after two days it was no longer painful but still residual for a week. Beyond a week, any extra use of that arm would trigger discomfort in the shoulder that I haven't had before. This seems to have resolved as of 6 weeks post-vaccination.
Palpitations x5 hours, fever, chills and body aches x3 days. Took ibuprofen which somewhat helped with symptoms.
Black and blue arm; Body Aches, soreness; Nausea; Fever 100 F; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Black and blue arm), PAIN (Body Aches, soreness), NAUSEA (Nausea), PYREXIA (Fever 100 F) and CHILLS (Chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced PAIN (Body Aches, soreness), NAUSEA (Nausea), PYREXIA (Fever 100 F) and CHILLS (Chills). On 03-Feb-2021, the patient experienced SKIN DISCOLOURATION (Black and blue arm). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event following immunisation, at an unspecified dose and frequency. On 01-Feb-2021, NAUSEA (Nausea) and PYREXIA (Fever 100 F) had resolved. At the time of the report, SKIN DISCOLOURATION (Black and blue arm), PAIN (Body Aches, soreness) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2021, Pyrexia: 100 Fever 100 F.         No relevant concomitant medications were reported.
expired dose of Tenivac was administered to a patient, with no reported adverse event; Initial information was received on 10-Jul-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves 9 years old female patient who reported that expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (Tenivac) was administered to a patient, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis a vaccine (hepa [hepatitis a vaccine]) for prophylactic vaccination; and polio vaccine (polio) for prophylactic vaccination.  On 10-Jul-2023, the patient received a dose of  0.5 ml of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult(Suspension for injection) (lot U7092AA, Expiry date: 24-Jun-2023) (strength was unknown) via intramuscular route in the left deltoid for Immunization.  On 10-Jul-2023 the patient administrated expired dose of tenivac was administered to a patient, with no reported adverse event (expired product administered) (latency : same day) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event expired dose of tenivac was administered to a patient, with no reported adverse event.  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 guidelines. 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.
Information has been received from an investigator and refers to a 62 year old female subject enrolled in a study. The subject's concurrent conditions included aphasia, anxiety, libido decreased, depression, cough, seasonal allergies, and urinary urgency. The subject's medical history included thyroid biopsy and colloidal cyst. Concomitant therapies included montelukast and IOPHEN C NR. On 28-AUG-2015, the subject was randomized into one of the three treatment plans with MK-8931, 12 mg, or 40 mg, or placebo tablet taken orally once a day. On the same day at 11:40, the subject started therapy with double blinded MK-8931 for Alzheimer's disease. The subject was in the main cohort of the study. ^^Other suspect therapy included Zoster Vaccine Live (manufacturer unknown) administered on 16-AUG-2016, single dose, intramuscularly.^^ The subject was given the varicella vaccination (also reported as on 15-AUG-2106). The following morning she developed a high fever, low blood pressure and muscle weakness and was brought into the hospital (information was also captured in MARRS # 1608USA015723). On 16-AUG-2016, the subject experienced shingles vaccine adverse reaction (severe) and was hospitalized on the same day. The subject was treated for fever, hypotension and generalized muscle weakness. She was tested for tick born infections and was given intravenous (IV) fluids overnight. The subject felt at baseline following one overnight in the hospital. Her vital signs were stable. On 17-AUG-2016, the subject recovered from shingles vaccine adverse reaction (severe) and was discharged on the same day with a diagnosis of fever and hypotension. She was instructed to follow up with her primary care physician (PCP) within one week of discharge. The action taken with the study therapy was reported as ^^not applicable. The last reported dose of the study therapy was administered on 24-AUG-2016. The action taken with Zoster Vaccine Live (manufacturer unknown) was reported as not applicable^^. The investigator considered shingles vaccine adverse reaction (severe) to be not related to the study therapy and not related to the study procedure. The investigator considered shingles vaccine adverse reaction (severe) to be related to ^^the Zoster Vaccine Live (manufacturer unknown)^^. Updated information received on 07-SEP-2016 from the investigator has been captured in between double caret (^^).
Consistent Hives on body for at least 6 months; Hives from increased sun exposure; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Jul2021 at 16:00 (Lot number: FA7485) at the age of 24 years as dose 1, single for COVID-19 immunisation and also received bnt162b2 (BNT162B2), administered in arm left, administration date 03Aug2021 at 16:00 (Lot number: FA7484) at the age of 24 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "None", notes: Other medical history: N/A. Concomitant medications were not reported. The following information was reported: URTICARIA (non-serious) with onset an unknown date in Jul2021, outcome "not recovered", described as "Consistent Hives on body for at least 6 months"; PHOTOSENSITIVITY REACTION (non-serious) with onset an unknown date in Jul2021, outcome "not recovered", described as "Hives from increased sun exposure". Therapeutic measures were not taken as a result of urticaria and photosensitivity reaction.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Tingling ran down on arm to fingers that lasted 2 seconds (on left injected arm); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient (not pregnant) (reported as patient's age: 47; unit: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious), outcome "recovered", described as "Tingling ran down on arm to fingers that lasted 2 seconds (on left injected arm)". Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced a mild case of chickenpox with 20 lesions. The pt also experienced croup around the same time. Pt was treated with steroids for the croup.
after receiving 2nd shot (Moderna 004C21A) described like a marble on the right side of the throat. pt states she did fine with first shot. pt states that after resting, knot was gone and she was feeling fine. pt advised for pcp follow up-HTN 15:41 155/102 p88 r14 15:42 150/103 p78 r14 15:51 154/106 p86 r14 15:53 150/103 p82 r14
HCP administered an expired Pentacel vaccine to a patient/No AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old female patient who received first 0.5 mL dose of expired vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot 5529AA, expiry date-04-Oct-2019 via unknown route in the left thigh On 07-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was a case of actual medication error due to Expired vaccine used.  There were no side effects reported related to this expired vaccine.  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 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.  Documents held by sender: none.
pt recvd vax; inconsolable crying for more than 3 hrs; rt thigh very red & very swollen; no fever;
Woke up about 4:00 am with intense headache, body aches and very sore injection site on left arm.  Have been experiencing significant joint stiffness, headache, mild chills and nausea all day (as I type this, 10.5 hours elapsed since I woke up with symptoms).
Prior to COVID about 5 or six years I had a lesion n on the right side of my tongue, that had been biopsy twice, I was Diagnosed with Biotrophic tissue Common - Non cancerous. October or November the lesion became more large and painful. It had done this previously and regressed. This time it expanded and became more painful, I visited the ENT whom did Biopsy, where I diagnosed Squamous Cell Cancer of the tongue. My concern is that you become aware of the possibility that the immunization may be exacerbating prior conditions, just as the COVID itself can.
Localized swelling, redness, pain at site of DTAP injection. Improving slightly w/BENADRYL, cool compress and Ibuprofen.
PNEUMONIA; RIGHT FEMUR FRACTURE; UNSPECIFIED INTELLECTUAL DISORDER; MAJOR DEPRESSIVE DISORDER; PARKINSON'S DISEASE; SEIZURE DISORDER; ANXIETY; HYPERTENSION; CONSTIPATION; VITAMIN D DEFICIENCY; OBSESSIVE-COMPULSIVE DISORDER; IMPAIRED WALKING/MOBILITY; DRY EYE SYNDROME; URINARY INCONTINENCE; BENIGN PROSTATIC HYPERPLASIA; OSTEOARTHRITIS; PSYCHOTIC DISORDER; This spontaneous report received from a health care professional concerned a 69 year old male of an unspecified race and ethnic origin. 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 (dose number in series 1) (suspension for injection, route of admin not reported, batch number and expiry were not reported) dose was not reported, 1 total, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 22-DEC-2021, the patient was admitted (hospitalized) to facility for nursing care due to pneumonia, right femur fracture, anxiety, hypertension (HTN), constipation, vitamin D deficiency, unspecified intellectual disorder, major depressive disorder, obsessive-compulsive disorder (OCD), Parkinson's Disease, impaired walking/mobility, seizure disorder, dry eye syndrome, urinary incontinence, benign prostatic hyperplasia (BPH), osteoarthritis, and psychotic disorder (dose number in series 1). Outbreak COVID-19 testing revealed negative tests throughout course of stay. Number of days of hospitalization was unknown. It was unknown if the patient was discharged. It was reported that, post form signed by representative and physician indicated comfort measures only. Resident was admitted with known historical administration of J and J COVID-19 vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pneumonia, right femur fracture, anxiety, hypertension, constipation, vitamin d deficiency, unspecified intellectual disorder, major depressive disorder, obsessive-compulsive disorder, Parkinson's disease, impaired walking/mobility, seizure disorder, dry eye syndrome, urinary incontinence, benign prostatic hyperplasia, osteoarthritis and psychotic disorder was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20220124404 (dose number in series 2 case). This case, from the same reporter is linked to 20220124221.; Sender's Comments: V0:20220130332-COVID-19 VACCINE AD26.COV2.S-.Pneumonia, Right femur fracture, Anxiety, Hypertension, Constipation, Vitamin d deficiency, Unspecified intellectual disorder, Major depressive disorder, Obsessive-compulsive disorder, Parkinson's disease, Impaired walking/mobility, Seizure disorder, Dry eye syndrome, Urinary incontinence, Benign prostatic hyperplasia, Osteoarthritis ,Psychotic disorder - This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Redness, swelling, down right side of bicep up to sight of injections, itchy, rash, cough, pain. 8/27/16 Follow-up, rash and pain gone now-everything is ok.
pt recv vax; devel full blown varicella rash on head & trunk;red bumps devel into papules;RN stated pt was afebrile;
leg cramp; body ache; headache; not feeling good at all; This is a spontaneous report from a non-contactable nurse (patient's colleague) via the Medical Information Team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously administered the first dose of BNT162B2 on an unspecified date, single for COVID-19 immunisation. The patient experienced leg cramp, body ache, headache, and not feeling good at all on an unspecified date after receiving the second dose. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Employee received TDAP - 2 weeks, severe arm pain.  Unable to raise arm above head.  Dresses with great difficulty getting arm in sleeve.  After 2 weeks, she called primary HCP for Rx.  Given hydrocodone.  Pain persisted for > 1 month.
PATIENT EXPERIENCED EARLY MENSTRATION ON SAME DAY AS VACCINE.  PATIENT HAD COMPLETED MENSTRATION FROM PREVIOUS CYCLE ON OR ABOUT 8/1/2022 PER CONVERSATION WITH PATIENT.  NO PAIN, CRAMPING HAVE BEEN EXPERIENCED.  PATIENT REPORTED THIS ADVERSE EVENT TODAY, WAS ADVISED TO CONTACT PRIMARY CARE AND/OR OB/GYN.
12-07-06 Woke up with a painful soar throat, very hoarse, could hardly speak, general feeling of malaise, joints achey, no energy 12-08-06 Major joint pain, fever, chills, no energy - I could not go to work 12-09-06 Major joint pain, fever, no energy, bad head cold that would not get better with the cold/sinus otc medication that I would normally use 12-10-06 Joint pain, fever, deep cough has began, head cold has lessoned, no energy 12-11-06 Joint pain, slight fever, went to work, only stayed an hour because of general malaise, joint pain, and deep, painful cough, no energy.  Coughing will not get better with otc medication.  I made an appointment to see my primary care physician.  12-12-06 missed another day of work. deep, painful cough, joint pain, general malaise,no energy, doctor diagnosis is asthmatic bronchitis and I had a fever.  I began taking antibiotic. 12-13-06 Missed another day of work.  deep, painful cough, joint pain, general malaise, no energy. 12-14-06 Missed another day or work. persistent, deep, painful cough, joint pain, no energy.
This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 07May2021 (Lot number: EW2174) at the age of 59 years as dose 2, single and administered in deltoid right, administration date 07May2021 (Lot number: EW2173) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known allergy: erythromycin"; Lisinopril, reaction(s): "Known allergy: lisinopril"; Aciphex, reaction(s): "Known allergy: aciphex"; Bactrim, reaction(s): "Known allergy: Bactrim"; Codeine, reaction(s): "Known allergy: Codeine". Vaccination history included: Bnt162b2 (Dose number:1, lot number: EW0162, vaccine location: Right arm), administration date: 16Apr2021, for COVID-19 Immunization. The following information was reported: NEUROMYOPATHY (disability, medically significant) with onset 16May2021, outcome "not recovered", described as "neuromuscular symptoms"; ALOPECIA (disability) with onset 16May2021, outcome "not recovered", described as "Hair loss"; SPEECH DISORDER (disability), MASTICATION DISORDER (disability), DYSGRAPHIA (disability) all with onset 16May2021, outcome "not recovered" and all described as "Trouble talking and chewing and handwriting"; CONSTIPATION (disability) with onset 16May2021, outcome "not recovered", described as "Constipation". The events "neuromuscular symptoms", "hair loss", "trouble talking and chewing and handwriting", "trouble talking and chewing and handwriting", "trouble talking and chewing and handwriting" and "constipation" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) unknown result, notes: AE treatment; electromyogram: (unspecified date) unknown result, notes: AE treatment; magnetic resonance imaging: (unspecified date) unknown result, notes: AE treatment; sars-cov-2 test: (21Nov2021) negative, notes: post vaccination. Therapeutic measures were taken as a result of neuromyopathy, alopecia, speech disorder, mastication disorder, dysgraphia, constipation.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug 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.