chrisvoncsefalvay/vaers-outcomes huggingface dataset:
An expired dose of RECOMBIVAX HB was administered; No adverse event; This spontaneous report as received from a Nurse referrin to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, pertinent medical history and concomitant medications was not provided.  On 02-NOV-202, the patient was vaccinated with an expired dose of Hepatitis B vaccine (recombinant)(RECOMBIVAX HB) (Lot # S022584, expiration date 31-OCT-2021) dosage, route of administration and anatomical location were not provided used to prevent hepatitis B.  No additional Adverse events and no product quality complaints (PQCs) were reported.  This is one of two reports from the same reporter. ; Sender's Comments:  US-009507513-2111USA000981:
This is a spontaneous report obtained from a non-contactable physician. This physician reported similar events for three patients.  This is the second of three reports. A patient of unspecified age, gender and race received on an unknown date PREVNAR 13 at 0.5 ml single dose, for immunization. Medical history and concomitant medications were not provided. On an unspecified date the patient experienced large local pain, swelling locally and hard time raising the hand over the head. Clinical outcome of the events was unknown at time of this report. No follow-up attempts possible. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2016483131 same reporter/drug/AE, different patient.;US-PFIZER INC-2016482854 same reporter/drug/AE, different patient.
Patient received a pneumonia vaccination and several hours later after her lunch reported upset stomach, general itching with some welts (no respiratory issues).  She stated she didn't know if the reaction was to the immunization or something she ate at lunch time.  Patient took benadryl and applied cold compresses and reported she was improving and doing better.  Pharmacist instructed patient to go to the emergency room if her symptoms should return.
One week after administering vaccine patient calls complaining for severe muscle pain. Since then patient has seeked 3 medical opinions, an MRI and Tramadol 50mg for pain.
Experience body ache; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Experience body ache), NAUSEA (Nausea) and PYREXIA (Fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included THYROID (ARMOUR THYROID), CIMETIDINE, SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM), OXYBUTYNIN, PHENTERMINE, TOPIRAMATE, HYDROXYZINE, PREDNISONE, SPIRONOLACTONE, ESZOPICLONE (LUNESTA), LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), FLUTICASONE and METHENAMINE for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Experience body ache), NAUSEA (Nausea) and PYREXIA (Fever). The patient was treated with SUMATRIPTAN (IMITREX [SUMATRIPTAN]) at an unspecified dose and frequency. At the time of the report, MYALGIA (Experience body ache), NAUSEA (Nausea) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-309664 (Patient Link).
shingles; Information has been received from a lawyer and a male patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a health care provider at a physician office for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
I started to get a tooth ache which started around June 15th or 18th (in a tooth already root canaled) and it grew into a strong infection and they drilled the root canal. Infection did not go away. I was treated with 3 different antibiotics. And just started the 3rd on on Saturday the 17th.
Information has been received from a health professional concerning a 4 year old male child with hemoglobin c trait who on 13-NOV-2003, at 13:40, was vaccinated subcutaneously into the left thigh with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 644796/0336N). Concomitant therapy that same day included a fourth dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PCV7) (Lot # 492849) administered intramuscularly into the right thigh. There was no illness at the time of vaccination. On 01-AUG-2007 the patient developed bumps on his face and mouth. On 13-Aug-2007 the patient was seen in office. The patient presented with over 50 lesions on body, erythematous papules with overlying vesicles. The patient was afebrile and symptomatic. There were no lab diagnostic tests performed. There were no reported adverse events following prior vaccinations. At the time of reporting the patient was considered recovered, but the recovery was noted to be ongoing. No product quality complaint was involved. No further information is available.
Severe headache, body aches (ankles and wrists), neck ache across shoulders and base of neck, lethargy
Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) 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 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain). At the time of the report, PAIN (Pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient took Steroid as treatment medication to treat pain. No concomitant medication were reported
Patient reports a generalized feeling of being unwell, similar to flu like symptoms. Has fever, chills, nausea, severe HA, and arthralgia.
Redness and swelling at injection site, continued for 2 days until patient presented to ED with complaint of malaise, fever, and chills. Patient reports induration has decreased but redness has increased. He is being admitted to the hospital and treated for presumed cellulitis.
Site: Bruising at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild
Information has been received from a licensed practical nurse concerning a 49 years old female with asthma and colitis who on 01-Apr-2009 was vaccinated with a 0.5ml dose of PNEUMOVAX 23 via intramuscular administered at the left deltoid. Concomitant therapy included ADVAIR. There as no history drug reactions and allergies. On 02-Apr-2009, one day after receiving PNEUMOVAX 23 vaccine, the patient developed pain at the injection site of left upper arm. The patient was examined in the office on 22-Apr-2009 and was found to have pain on movement of the left arm but no edema, no swelling and no redness at the injection site. The patient was recommended to take Ibuprofen. The patient returned to the office on 29-May-2009 stating that the pain had persisted and radiated up to the left shoulder. The examination on revealed that the patient had full range of motion of the left arm but movement caused discomfort. An X-ray of the left arm was performed on 29-May-2009, and the result was negative. At time of reporting, the patient did not recover. Additional information has been requested.
Fever 101.2 for several hours, Tylenol to reduce. Slight fever for 6 hours Mild rash over entire body. Oral Benadryl and topical spray. Rash still present
extreme thirst; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (extreme thirst) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX from July 2020 to October 2020.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-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 THIRST (extreme thirst). At the time of the report, THIRST (extreme thirst) outcome was unknown.            It was stated that before the 2nd dose he drank about 5 glasses of water before going to the vaccination facility.  He began feeling thirsty again while waiting the 15 minutes, drank 8 ounces of water that he brought with him, then drank 32 ounces he had in the car on the way home, then drank more water once he got home.    The concomitant medication was centrum.  The treatment information was not reported.   This case was linked to MOD-2021-282241 (Patient Link).
MIGRAINES; MUSCLE ACHES; This spontaneous report received from a patient concerned a female of unspecified age. 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 not reported, batch number: Unknown) 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 subject experienced migraines, and muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraines and muscle aches was not reported. This report was non-serious. This case, from the same reporter is linked to 20210644749.
This is a spontaneous report received from a contactable reporter (consumer or other non HCP) from product quality group. The reporter is the patient. A 39-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 09Oct2021 at 12:00 as dose 3, single (batch/lot number: FF2590) for Covid-19 immunization; COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (batch/lot number: unknown) and as dose 2, single (batch/lot number: unknown) for Covid-19 immunization. The patient's relevant medical history included: "ulcerative colitis" (unspecified if ongoing), notes: on biologics for treatment. Concomitant medications included: STELARA, start date: 09Oct2021 at 12:00. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 treatment". Therapeutic measures were taken as a result of drug ineffective, suspected Covid-19 which included Paxlovid from 16May2022 to 20May2022.
Post vax, the pt developed swelling and redness on left thigh. 4 inches with warmth and slight pain.
This spontaneous report was received from a certified medical assistant, referring to an unspecified number of patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified date, the patients were administered doses of improperly stored (Oka/Merck) VARIVAX (lot # L048465, expiration date 02-DEC-2017; lot # M009765, expiration date 23-FEB-2018); which were exposed to temperature of 11F for 30 minutes. There was not previous temperature excursion and the call was because of a data logger. No adverse effect were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Within 2 hours of PNEUOMVAX injection in right upper arm client couldn't raise her arm due to pain. Within 4 hours she was experiencing chills (took temp - 97 degrees). Went to primary care MD within 7 hours injection & was told that reaction was more severe (by MD per client) as she'd had them close together (1st PNEMUOVAX vac was 10 1/2 yrs ago). MD prescribed a 5 day course of Prednisone medication. Also ice to area. As of 11/22/10 5pm still has arm pain but can move arm in full range of motion. PHN advised another follow-up visit to MD if continues to have (R) arm pain.
This spontaneous report as received from a physician, who learned of the events from one of her patients, via a company representative refers to a female high school student patient (the physician patient's family friend) of unknown age. The patient's pertinent medical history, drug reactions or allergies were not reported. On an unspecified date, the patient was administered an unspecified dose of GARDASIL injection or GARDASIL 9 injection by an unspecified health care provider in the same town (dose in series, route of administration, lot # and expiration date were not reported). It could not be confirmed which of these vaccines the patient was administered. Concomitant medications were not reported. On an unknown date over a year ago and an unspecified time after vaccination, the patient was diagnosed with a neurological disorder. It could not be confirmed if the patient was diagnosed with encephalopathy or encephalitis. The patient also experienced symptoms of on-going fainting spells and seizures. The patient was taken to another city for unspecified treatment from an unspecified specialist for her condition. The outcome of the event was not recovered/not resolved at the time of reporting. The relatedness between the event and GARDASIL or GARDASIL 9 was not reported. Upon internal review, the event of encephalopathy or encephalitis was determined to be medically significant. Additional information has been requested.
Half of left arm hurts and it radiates to the left armpit/chest. Chest is also a little swollen
Unfortunately, it had been administered to 1 patient on 22May2023. no adverse event; This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Unfortunately it had been administered to 1 patient on 22May2023.) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Unfortunately it had been administered to 1 patient on 22May2023.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Unfortunately it had been administered to 1 patient on 22May2023.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Unfortunately it had been administered to 1 patient on 22May2023.).    No concomitant medication details was reported. No treatment medication details was reported.
Family member developed shingles a week after 2nd dose of Covid vaccine.; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received the second dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2), on an unspecified date (Batch/Lot number was not reported) for COVID-19 immunization. The reporter stated that a family member developed shingles a week after 2nd dose of Covid vaccine. They are calling to see if this has been reported before. Outcome of the event was unknown.   Information on lot number/batch number has been requested.
pt recvd vax 29MAR91 & 2 days later had a fever 103-104, appeared pale-washed out, & irritable; hospitalized; bacterail cultures all neg; pt has been hospitalized several times in the past few months; rash consistent w/roseola
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Mild, Additional Details: Pt fainted about 8 minutes after vaccine. He had been given cold water and candy.  Blood pressure was normal, but he was sweating and continued dizzy. He admitted to vaping earlier. He wanted us to call 911. 911 said he was hyperventilating and said it was from anxiety. He was checked out and fine. Called him later and he was fine.
Back pain worsened with fatigue, slight cough, nausea, loss of taste and headache.
Swelling and pain in the armpit of the left arm of the injection sight.; Swelling and pain in the armpit of the left arm of the injection sight.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 27Apr2021 at 09:15 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications included lansoprazole DR (MANUFACTURER UNKNOWN) 30 mg and lisinopril-hydrochorthiazide (Lisinopril HCTZ) 20-12.5 mg, both for an unknown indication and since an unknown date. The patient previously 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 06Apr2021 at 10:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021 at 11:00, the patient experienced swelling and pain in the armpit of the left arm of the vaccination site. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events swollen lymph node and armpit pain was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Amended dose description auto-populated for Concomitant drug.
Within 2 weeks after receiving the first dose, I started seeing signs of erectile disfunction. Unable to keep an erection during sex and premature ejaculation. This is an ongoing event, this has not resolved itself.
Vaccines were stored after CDC expiry date; Vaccine administered to patients past 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patients past 30-day use by date) and PRODUCT STORAGE ERROR (Vaccines were stored after CDC expiry date) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patients past 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored after CDC expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patients past 30-day use by date) and PRODUCT STORAGE ERROR (Vaccines were stored after CDC expiry date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  CDC expiry date was reported as 02-Apr-2022 for Lot-068H21A.   Date Stored in Standard Freezer for the lot 068H21A was 2 degrees F high, -1 degrees F low on 01-Apr-2022.  No treatment medication was reported.  This case contains information for the 19 of 45 patients described by the reporter.
after the second dose she developed severe left forearm pain that was principally from the elbow to the wrist. The pain worsened after the booster dose and never really subsided after the second dose. She is in chronic pain in the left lower arm. She reports some pain in the right, but nothing like the left. Initially after each subsequent dose she got a very red hot deltoid and had significant adenopathy that took weeks to resolve.
Swelling, redness, large round hive/welt one day after injection. Surrounding injection site. Increased in size after 2 days to 3x3 inches. Very sore, red, swollen.
I really think this was a result of my anxiety regarding  needles rather than from the actual vaccine.  I have had fainting spells after blood draws.  After about 5 or 10 minutes from receiving the shot I started feeling warm and nauseous.  The on site nurse came over and I did vomit.  I felt better almost instantly.  She was wonderful, but had me stay in the supervision area for an additional 20 minutes to make sure I didn't have any more nausea or other symptoms.