chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Experienced achey arm and swollen lymph nodes in the arm of injection site for over 48 hours after second shot. Also experienced fatigue. Took Tylenol and applied a heating pad to the underarm. It did not help with the pain in the underarm. Currently still experiencing slight pain (May 12), but it is less than on May 11.
Covid Positive; Flu like; Cold like; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like), NASOPHARYNGITIS (Cold like) and COVID-19 (Covid Positive) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like) and NASOPHARYNGITIS (Cold like). On 27-Mar-2021, the patient experienced COVID-19 (Covid Positive). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like), NASOPHARYNGITIS (Cold like) and COVID-19 (Covid Positive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported. No concomitant medication was reported
Initial and follow up information has been received from a Registered Nurse (R.N.) concerning a 17 year old female patient with cervical dysplasia, penicillin allergy and allergic reaction to erythromycin who on 12-MAR-2007 was vaccinated IM into the left arm with a first dose of Gardasil and on 18-JUN-2007, at 09:00AM she was vaccinated into the right arm with a second dose of Gardasil (lot # 655154/1210U). The nurse reported that patient developed an injection site rash after the second dose of Gardasil. The date the rash appeared was unspecified. The patient sought medical attention for the rash on 30-JUN-2007. The rash at the injection site was diagnosed as viral and not related to the injection. On 08-SEP-2007 the patient sought treatment for another condition and the physician re-evaluated the injection site rash on the right arm. The rash was described as "a hypo-pigmented area 8 centimeters in size with red papules at the periphery." The physician advised the patient not to continue with the third injection. It was reported that the patient would be evaluated on 24-SEP-2007 for the rash. At the time of this report patient had not recovered. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 10/12/2007. In follow up report the reporter reported that on 29-JUN-2007 at approximately 08:00 AM "Rash on arms, stomach, thigh, back-doesn't itch. Red, pen tip size to small pen cap. Raised, darker spot in middle of Rash spots. Arm swelling and scabbed area of inj site, area is sore." The patient recovered. Additional information has been requested.
dose administered to a patient who is breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (dose administered to a patient who is breastfeeding) in a 26-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 25-Mar-2022, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (dose administered to a patient who is breastfeeding). On 25-Mar-2022, MATERNAL EXPOSURE DURING BREAST FEEDING (dose administered to a patient who is breastfeeding) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.
Pt presented 24 hours post COVID-19 vaccine (Pfizer) with systemic rash which was pruritic. Multiple lesions on trunk, axilla, groin which appeared pus pustular seen at clinic, prescribed Zyrtec, antifungal cream and hydrocortisone cream. I discontinued the creams and placed on oral steroid burst. still no improvement.
Pt's mother called and stated pt's arm was swollen, told to bring her in to have it checked.  Pt came in and it had a 60mmx80mm reddened and raised area on right deltoid. Mother notified she can give her Zyrtec and Tylenol or Motrin and apply ice per doctor's instructions.
Chest pains ranging from mild to severe. Intermittent and unpredictable. Severe effects lasted 2-3 days but mild effects continue after several weeks. Cardiologist said likely diagnosis is pericarditis caused by COVID-19 Moderna booster (3rd shot). No history of chest or heart issue in patient or family history.
patient felt extreme fatigue and weakness -- trouble in moving and getting to bed-- layed down for 30 min and improved after 30 minutes
This case was reported in a literature article and described the occurrence of clinically isolated syndrome in a unk subject who received DTPa-HBV-IPV vaccine. On an unknown date, 90 days after receiving DTPa-HBV-IPV vaccine and Hepatitis B vaccine, the subject developed clinically isolated syndrome. Serious criteria included GSK medically significant. The outcome of clinically isolated syndrome was unknown. It was unknown if the investigator considered the clinically isolated syndrome to be related to DTPa-HBV-IPV vaccine and Hepatitis B vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of a clinically isolated syndrome in a subject of unknown age and gender who had been vaccinated with an unspecified hepatitis B-containing vaccine (manufacturer unknown). No information on the subject's medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, from 1999 onwards, the subject received a dose of either PEDIARIX (GlaxoSmithKline; dosage, administration route and site unknown; batch number not provided) or other unspecified hepatitis B-containing vaccine (manufacturer unknown; dosage, administration route and site unknown; batch number not provided). On an unknown date after 1 January 2000, 90 days after receiving the vaccine, the subject developed a clinically isolated syndrome. Treatment was unknown. The outcome of the events was unspecified at the time of reporting. The authors did not comment on any causal relationship between the vaccine and the events. The authors concluded that "Findings from the present study no long-term association of vaccines with an increased risk of multiple sclerosis and other central nervous system demyelinising diseases. In younger subjects, they observed a short-term increase in risk after vaccination of any type, which suggested that vaccines (like infections) could accelerate the transition from subclinical to overt autoimmunity in subjects with existing disease. The authors found no association between hepatitis B vaccination and an increased risk of multiple sclerosis or other central nervous system demyelinising diseases up to 3 years after vaccination. The results for human papillomavirus vaccine were inconclusive given the small number of cases and the paucity of previous studies on the topic. The findings reconciled the anecdotal clinical reports of a central nervous system demyelinising diseases onset shortly after vaccination with the larger body of epidemiologic literature showing no long-term increased risk of multiple sclerosis or other forms of central nervous system demyelinising diseases following vaccination. The findings do not warrant any change in vaccine policy". This case is 1 of the 9 valid cases reported in the same literature article (see case US2014GSK053625).
Was given Shingles vaccine at same time as flu vaccine on 9/24/13. By that evening I was already feeling sick. By the morning I was throwing up & had a fever up to 104, blurry vision, weakness & couldn't get up. One week later started getting fire & pain sensation in both legs. To date I still suffer from the pain & fire in my legs. It has spread to my upper body. Also suffering from memory loss. I was a very active person, enjoying time outdoors, taking long walks, enjoying my grandchildren. I was very healthy prior to having these vaccinations. I expressed to my medical provider that I 100% feel this has been caused by the Shingles vaccine. Was finally diagnosed with peripheral neuropathy. Other than a thyroid issue & high blood pressure, I had NO problems prior to having these vaccinations.
Information has been received from a physician concerning a female patient who was vaccinated with a dose of Pneumovax 23.  The patient received a dose of influenza virus vaccine (unspecified) at the same time.  Subsequently, the patient developed an injection site reaction from the vaccination with Pneumovax 23.  It was reported that the patient's arm swelled up "like a cellulitis".  She was treated with an unspecified antibiotic.  The patient's outcome was unknown.  Additional information has been requested.
Post-herpetic neuralgia flare with severe pain.  Gabapentin dose increased to twice daily, but pain is not controlled.
multiple patients received a Moderna dose from a vial that had been stored in the refrigerator for more than 30 days; multiple patients received a Moderna dose from a vial that had been stored in the refrigerator for more than 30 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (multiple patients received a Moderna dose from a vial that had been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (multiple patients received a Moderna dose from a vial that had been stored in the refrigerator for more than 30 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (multiple patients received a Moderna dose from a vial that had been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (multiple patients received a Moderna dose from a vial that had been stored in the refrigerator for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (multiple patients received a Moderna dose from a vial that had been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (multiple patients received a Moderna dose from a vial that had been stored in the refrigerator for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported Doses were administered on and after 14Sep2021   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow-up received on 03-Nov-2021 contains no new information. On 04-Nov-2021: Follow up received includes Batch number added and narrative was updated.
full dose of medquadfi has not been administered because the patient moved with no reported adverse event; Initial information received on 13-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old male patient who had not administered full dose of Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi], because the patient moved, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine, solution for injection (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient had not administered full dose of Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi], because the patient moved, with no reported adverse event (incorrect dose administered) (unknown latency) following the administration of Meningococcal A-C-Y-W135 (T Conj) Vaccine.  It was reported, "Caller stated that full dose f Medquadfi has not been administered because the patient moved. Doctor wanted to know recommendations regarding re-administration."  No lab data reported.  Action taken with MENINGOCOCCAL VACCINE was not applicable.  At time of reporting, the outcome was Unknown for the 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.
abdominal pain, hematuria, n/v x 2 weeks. Has 4 ED visits and continued pain despite negative workup.
Involuntary movement in right arm and head; Numbness and tingling with severe pain in hands feet and lower legs with joint pain; Numbness and tingling with severe pain in hands feet and lower legs with joint pain; Numbness and tingling with severe pain in hands feet and lower legs with joint pain; Numbness and tingling with severe pain in hands feet and lower legs with joint pain; Numbness and tingling with severe pain in hands feet and lower legs with joint pain; This is a spontaneous report from a contactable consumer (patient). A 13-years-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Ew0196; Expiry date was unknown), via an unspecified route of administration in the right arm on 14Jun2021 (at the age of  13-years-old) as dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. Medical history was not reported. Patient had known allergies. There were no concomitant medications. 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 vaccine within four weeks. The patient had no other medications in two weeks. Historical vaccine included first dose of BNT162B2 (Lot number: Ew0172; Expiry date was unknown), via unspecified route of administration at right arm on 22May2021 (at the age of  13-years-old) as dose 1, single for COVID-19 immunization. On 17Jun2021 at 02:00, after second vaccination, the patient experienced numbness and tingling with severe pain in hands feet and lower legs with joint pain and involuntary movement in right arm and head. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, Disability or permanent damage. Therapeutic measures were taken as a result of involuntary movement in right arm and head, numbness and tingling with severe pain in hands feet and lower legs with joint pain. Outcome of the events was not recovered at the time of report.  Follow-up attempts are completed. No further information is expected.
Somnolence and fatigue Severe joint and muscle pain lasting 12 hours Sweats and chills 100.7 fever treated with Tylenol  Severe headache  Vomiting  Headache still lasting 4 days later
Itching of his left arm; Hypersensitivity reaction; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (Itching of his left arm), HYPERSENSITIVITY (Hypersensitivity reaction) and NAUSEA (Nausea) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) 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) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PRURITUS (Itching of his left arm), HYPERSENSITIVITY (Hypersensitivity reaction) and NAUSEA (Nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) on 12-Apr-2021 at a dose of 25 mg po. At the time of the report, PRURITUS (Itching of his left arm), HYPERSENSITIVITY (Hypersensitivity reaction) and NAUSEA (Nausea) 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 medications were reported.  Treatment medication received was reported as Diphenhydramine (Benadryl)   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Reporter information, treatment medication updated.  Vaccination facility information and  event added
start feeling unwell after a few days, tested positive for COVID; start feeling unwell after a few days, tested positive for COVID; This is a spontaneous report from a contactable Nurse. A female patient of (3 decade) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, administered at an unknown anatomical location on an unknown date at a single dose for covid-19 immunisation. Medical history and concomitant medication were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) for covid-19 immunisation. On 09Apr2021, patient start feeling unwell after a few days, tested positive for COVID. After the second dose, the patient started feeling unwell after a few days, tested positive for COVID, and a week after still tested positive for COVID. Event took place after use of product. The outcome of the events was unknown.  Information on Lot and Batch number has been requested.
Information has been received from an epidemiologist with the county health department concerning a patient who was vaccinated with varicella virus vaccine live. The reporter indicated a physician stated a patient was vaccinated with varicella virus vaccine live, and now has shingles. The reporter indicated she does not have the physician name or demographics at this time, and the patient was not in the physician's office at the time of this report. The reporter indicated that she had no other information at this time. Unspecified medical attention was sought. Additional information has been requested.
chills from neck to waist; received it up on my shoulder higher than normal; A spontaneous report was received from a consumer who was also a 76-years-old, white, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and received it up on my shoulder higher than normal and experienced chills from the neck to waist.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 20 Jan 2021, six days prior to the onset of the event, the patient received their first dose of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 20 Jan 2021, the patient received his vaccine and reported that he "received it up on my shoulder higher than normal".  On 26 Jan 2021, the patient experienced chills from his neck to waist. He felt fine the next day. Treatment for the events, included 3 teapots of Earl Grey Tea, which did not help.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, received it up on my shoulder higher than normal, was not reported. The outcome of the event, chills from the neck to waist, was resolved on 27 Jan 2021.; Reporter's Comments: This case concerns a white male patient who received their first dose of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection and received shot up on shoulder higher than normal and experienced non-serious listed event of chills from the neck to waist. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event of chills, a causal relationship cannot be excluded and the event of chills is possibly related to the vaccine.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. In July 2014 the patients were vaccinated with GARDASIL (dose, route of administration and lot # were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient developed calf pain in the morning of 3/18/21, pain for 2 days and then the pain went away. Right lower leg started swelling on or around the 19th and patient went to the urgent care on the morning of 03/22/21. Patient was sent to imagining center to have venous doppler where they in turn sent her to the ER after having a positive  venous doppler study. Blood clot noted behind right knee.
sore arm; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 17Feb2021 (at the age of 74 years old) (Lot Number: EL9266; Expiration Date: 31May2021) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm. The patient received no treatment for the event. The patient informed that she was just trying to reschedule her appointment for her second dose. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
This spontaneous case was reported by a patient and describes the occurrence of CD4 LYMPHOCYTES INCREASED (After the booster, T-Cells were a little higher than the last time) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 021C21A and 016B21A) for COVID-19 prophylaxis. No Medical History information was reported. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced CD4 LYMPHOCYTES INCREASED (After the booster, T-Cells were a little higher than the last time). At the time of the report, CD4 LYMPHOCYTES INCREASED (After the booster, T-Cells were a little higher than the last time) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, CD4 lymphocytes: Had elevated T-Cells. No concomitant medications were reported. The patient was not allergic to any medications, food and other products. The patient did not received any other vaccines within 1 month prior to Moderna COVID-19 vaccine. The patient did not experienced a similar event in the past and did not felt sick. Adverse event did not cause patient to seek medical care and symptoms got worsened. The patient did not tested or diagnosed for covid-19 but tested for antibodies on 2020: results not provided. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 08-Aug-2022: Patient demographic details, suspect drug details were updated.