chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Broke out with Fever blisters in mouth, throat and nose; Muscles hurt; Fever up to 104 Fahrenheit degrees.; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Broke out with Fever blisters in mouth, throat and nose), MYALGIA (Muscles hurt) and PYREXIA (Fever up to 104 Fahrenheit degrees.) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0022M21A, 039D21A, 037A21B and 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Skin disorder (Skin condition, patient was taking Dupixent as a immune suppresent for the treatment) and Seasonal allergy (Seasonal changes). Concomitant products included DUPILUMAB (DUPIXENT) for Skin disorder, MONTELUKAST and SERTRALINE for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2022, the patient experienced MYALGIA (Muscles hurt) and PYREXIA (Fever up to 104 Fahrenheit degrees.). On 11-Apr-2022, the patient experienced ORAL HERPES (Broke out with Fever blisters in mouth, throat and nose). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. On 11-Apr-2022, PYREXIA (Fever up to 104 Fahrenheit degrees.) had resolved. At the time of the report, ORAL HERPES (Broke out with Fever blisters in mouth, throat and nose) had not resolved and MYALGIA (Muscles hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2022, Body temperature: 104 fahrenheit degree (High) 104 Fahrenheit degree.         Patient took the second booster dose on 08-Apr-2022. Patient usually experience Fever blisters during Hormonal changes and wanted to know if she can take Acyclovir as a treatment. Patient did not wanted this medication to interfere with vaccine. Concomitant medication included Allergy pill for Seasonal changes.
Within 24 hours of administration of vaccine the patient experienced right arm swelling, and redness, by evening the area became worse, patient was seen at an urgent care. DX cellulitis, TX antibiotics. patient see in our office 10/26/2022, patient is improving.
Information has been received from a registered nurse concerning a 13 year old female who on 03-OCT-2006 was vaccinated with a dose of  GARDASIL.  The nurse reported that the patient had received the first and second doses of GARDASIL (the second dose was two months late)  and experienced swelling of the injection site arm. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Additional information is not expected.
Large knot on her injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Large knot on her injection site arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced VACCINATION SITE MASS (Large knot on her injection site arm). At the time of the report, VACCINATION SITE MASS (Large knot on her injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported.  The treatment information was  not provided.   This case was linked to MOD-2021-300583 (Patient Link).
Injection site has been swollen, red, and warm to touch. It's about 3inches  4 inches.; Injection site has been swollen, red, and warm to touch. It's about 3inches  4 inches.; There is a lump on the site; Injection site has been swollen, red, and warm to touch. It's about 3inches  4 inches. There is a lump on the site; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EU0181) via an unspecified route of administration on an unknown date (at the age of 33-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the injection site was swollen, red, and warm to touch. It was about 3 inches x 4 inches. There was a lump on the site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event injection site was swollen, red, and warm to touch, lump on the site was unknown at the time of report.   No follow-up attempts are possible. No further information is expected.
Rheumatoid Arthritis; sun blister due to out in sun a lot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: RO-NMA-2022-SPCOV17451.   A 67-year-old female patient received BNT162b2 (COMIRNATY), on 28Mar2021 as dose 2, single (Lot number: ET7205) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacture Unknown), for Covid-19 Immunization.   The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 29Mar2021, outcome "recovering", described as "Increased blood pressure"; HEADACHE (non-serious) with onset 29Mar2021, outcome "recovering", described as "Severe headache". Relevant laboratory tests and procedures are available in the appropriate section.   Clinical course: The patient received COVID-19 vaccine ad26 Cov2.s (Dose number in series 1) (suspension for injection intramuscular, batch number was not reported, expiry: unknown' dose was not repotted, 1 total (dose 1) (1 in 1 once) administered on 09Apr2021 for COVID-19 prophylaxis. The batch number was not repotted. The Company is unable to perform fallow-up to request batch and lot number. Age at time of vaccination 71-years-old. Concomitant medications included hydroxy chloroquine and prednisone for drug used for unknown indications. On Oct2021, the patient experienced COVID-19 virus test positive (drug Start period: 06 months) (Dose number in series1) Laboratory data included: COVID-19 test positive. On an unspecified date, the patient experienced rheumatoid arthritis and sun blister due to being Out in Sur. a lot (Dose number in series I). The patient received additional. two doses of non-company suspect vaccine of Tozinameran (Pfizer) (Dose number in series 2) (form of admin not reported, intramuscular, batch number: unknown, expiry: dose was not reported administered on 01Apr2021 (second dose) and 02May2022 (booster dose) one in 1 Once' for COVID-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with two doses of tozinameran (Pfizer vaccine) (dose number in series 2). The patient had Non-company suspect drugs included: adalimumab (Humira) (solution injection in pre-pen, citrate free, subcutaneous, batch number was not. reported, expiry: unknown) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis.   Follow-up attempts are completed. No further information is expected.
Fever, large itchy lump, very sore all over, couldn't stand for long, had to stay home from work, extreme soreness that lasted 36 hours.
Recurring spells oflightheadedness to the point of presyncope; tingling sensation in hands. Sx occurring several times per day. Cardiac testing done - normal. Referred to neurol - MRI did not show demyelination, but neurologist thought this was a neurologic response to yellow fever vaccine.
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. Patient concurrent conditions and medical history were not reported. On 26-MAR-2014 the patient was vaccinated with PNEUMOVAX lot # J014401 (Expiry: 26-NOV-2014) (also reported as lot check was requested) by intramuscular route (dose and frequency was not reported). On an unknown date in March 2014 patient experienced severe redness and swelling at the injection site where the PNEUMOVAX was injected. Patient had difficulty in lifting the arm that had received PNEUMOVAX injection. The patient visited physician (reporter also mentioned 3 patients received PNEUMOVAX from same lot# and an unspecified patient among 3 visited an unspecified emergency room). Reporter was not sure whether patient received treatment with either DECADRON or SOLU-MEDROL. The outcome of the event was reported as recovering. The reporter did not provide the causality between event and the suspect drug. Additional information has been requested. This is one of several reports from same reporter.
Mother and Father report Regress in development, loss of grasp reflex for seven days. (this has not resolved) Not interactive, poor sleep, increased irritability,  decreased appetite. All of this for 7 days. Then she was back to her normal self.
A little sore at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE PAIN (A little sore at the injection site) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation and Cardiac thrombosis. Concurrent medical conditions included Hypertension. Concomitant products included SOTALOL for Arrhythmia, VALSARTAN (DIOVAN) for Hypertension, RIVAROXABAN (XARELTO) for Thrombosis.   On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Dec-2020, the patient experienced INJECTION SITE PAIN (A little sore at the injection site). On 23-Dec-2020, INJECTION SITE PAIN (A little sore at the injection site) had resolved.        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.   Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: Medical history, concomitant medications, outcome of the event were updated.; Reporter's Comments: This case concerns a 55 year old male subject, who experienced the listed event of sore at the injection site. The event occurred  on 21 DEC 2020, 30-40 minutes after first dose of IP.  The event was considered ongoing as of 28 DEC 2020. The event was considered related to IP due to temporal association. However, it might be explained due to the way of administration. Further details are requested to the reporter.
Left deltoid red, swollen, entire muscle hot. Treated with Benadryl 1/2 tsp.now and every 6 hours and Ibuprofen 1 tsp.now and every 6 hours.
Information has been received from a physician concerning a patient who was vaccinated with a 2 ml oral dose of Rotateq. Subsequently the patient developed bloody stools. It was reported that the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Upon internal review, the patient's bloody stool was determined to be an other important medical event. Additional information has been requested.
Herpes Zoster Rash on trunk on the Right side in Dermatomal Distribution.Seen at clinic for rash and diagnosed on 07/29/09.As of 8/3/09 per telephone consult with mother,he still had the rash (7 days after onset). The rash is pruritic and he has been experiencing pain but is not taking Tylenol as recommended.The rash is reported to be drying up and has not spread elsewhere.Patient has not developed any other new symptoms.
Fever 102, shortness of breath, swollen glands, headache, sore throat, dizziness, disoriented. This happened 18 to 24 hours after injection.  Treated with prednisone and Tyleno for fever.
She developed a rash on her abdomen and leg. It was itchy she recalls but she didn't receive treatment and it resolved in about 24 hours
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 19-FEB-2014, the patient was vaccinated with a dose of ZOSTAVAX lot # J000492, expiration 19-JAN-2014, 0.65 ml once, subcutaneous for shingles prevention. The pharmacist states the date was noted to be past expiration. An unspecified staff from the office providing the vaccination reported to pharmacist on 21-FEB-2014 about expiration date. No adverse effects were reported. The patient did not seek medical attention. Additional information has been requested.
Suffering from chest pain, numbness to arm for 5 days, pt is currently still in patient.
Breast swelled up to 3 times its size; Vomiting; Diarrhea; Face was swollen; Lips tingled; Right side of face tingled/Pain in face; Panic attack; Breast swelled up to 3 times its size; This is a spontaneous report from a contactable consumer (parent) or other non-healthcare professional. A 46-years-old female patient 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 in Arm Right on an unspecified date in 2021 as dose 2, single (at age of 46-years old) for covid-19 immunization. Medical history included thyroid disorder from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for thyroid disorder from an unspecified start date and ongoing (did not know how long had taken it, about 5 years). The patient previously taken first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: unknown), via an unspecified route of administration, administered on unspecified date in right arm at 14:30-15:00 (at the age of 46 years old) as single dose for covid-19 immunization. It was reported that Investigation Assessment was No. Prior Vaccinations (within 4 weeks) was no. Family medical history relevant to adverse event was none. History of all previous immunization with the Pfizer vaccine considered as suspect was second dose. Additional vaccines administered on same date of the Pfizer suspect was none. The reporter stated that her daughter had a reaction to the Covid vaccine breast swelled up to 3 times its size, vomiting, diarrhea, face was swollen, lips tingled, right side of face tingled/ Pain in face, panic attack on 2021 and took some medicine and it finally went away. Reporter stated did not know what day her symptoms started. It happened three days after getting the vaccine and did not remember what day got the shot. Therapeutic measures were taken as a result of, panic attack. Adverse events did not require a visit to Emergency Room or Physician Office visit. Relevant tests were none. The outcome of events was recovered on unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Severe dizziness; Visual disturbances; Nauseous; Sweaty; first turned on my side, since I didn't want to rush to get up. When doing so with eyes opened, they flickered without me doing so.; Able to rise but had help walking and sitting; Vertigo; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), via an unspecified route of administration in the left arm on 11Apr2021 at 10:00 (at the age of 64-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as various. The patient had known allergies. Concomitant medications included sotalol (MANUFACTURER UNKNOWN), warfarin (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN) and magnesium (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 19Mar2021 at 11:15 (at the age of 64-years-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 30Apr2021 at 00:30, the patient awaked from sleep with severe dizziness, visual disturbances, also nauseous and sweaty, the patient first turned-on side, since didn't want to rush to get up, when doing so with eyes opened, they flickered without doing so. Finally able to rise but had help walking and sitting, the patient still experiencing dizziness/ vertigo since that evening with periodic episodes. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of severe dizziness, visual disturbances, nauseous, sweaty, eyes flickered, unable to walk and sit without help, vertigo and included treatment with meclizine (MANUFACTURER UNKNOWN) from an unknown date. The clinical outcome of the events severe dizziness, visual disturbances, nauseous, sweaty, eyes flickered without doing so, able to rise but had help walking and sitting and vertigo were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
cold sore; This case was reported by a pharmacist via call center representative and described the occurrence of cold sores in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced cold sores. On an unknown date, the outcome of the cold sores was unknown.   It was unknown if the reporter considered the cold sores to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received dose of Shingrix (dose number unknown) and shortly after developed a cold sore (timing of cold sore not known). The reporter consented to follow up.
Headaches, nodulars, fatigue, numbness and weakness in upperbody, neck and arm pain--chronic.
This spontaneous report was received from a physician via company representative and refers to a 13 year old female patient. No pertinent medical history or concurrent conditions were reported. On an unknown date in December 2015, the patient was vaccinated with the second dose of GARDASIL. On an unknown date, the patient experienced hair loss after vaccination. The outcome of hair loss was reported as not recovered. The reporter did not assess the causality of hair loss with GARDASIL. Additional information has been requested.
itching; tingling; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: E19226), via an unspecified route of administration on arm right on 14Feb2021 14:15 PM at single dose for COVID-19 immunisation. The Facility type vaccine was reported as Hospital. The patient medical history included elevated blood pressure and had known allergies to penicillin, Bactrim, shrimp. There was no Covid prior vaccination and had no Covid tested post vaccination. There was no other vaccine in four weeks. The patient Concomitant medications in two weeks included hydrochlorothiazide; fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) take n for unspecified indication from an unknown date. On 14Feb2021 03:00 PM, About 45 minutes after vaccine my arms began itching and my face was tingling. Both were mild and last about 15 - 20 min. The patient did not receive any treatment for the events. The outcome of the events was resolved on 14Feb2021 .  No follow up attempts are Possible. No further information is expected.
Hives on child?s back, arm where vaccine was injected large red whelps hot to the touch and painful
Painful prick of needle. Redness area around 3 x 4 inches, hot to the touch, sore, diminishing but still faintly present after 4 days.
This case was reported by a consumer via call center representative and described the occurrence of ringing in ears in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced ringing in ears. On an unknown date, the outcome of the ringing in ears was unknown. It was unknown if the reporter considered the ringing in ears to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient reviewed the side effects associated with SHINGRIX. The patient was trying to find out if the ringing in his ears was a potential side effect. The reporter had talked with his physician and he did not have much more information than what's on the website. This case has been linked with US2019AMR041011, reported by same reporter.
Approximately 12 hours after the injection my skin started burning.  This worsened overnight and for approximately 48 hours felt like severe full body sunburn.  I had chills on and off for two days and occasional dizziness.  I had these same reactions following the second dose; however, the reporting system was not working properly for me to report that (02/11/21 and Pfizer lot EN5318).  I treated it as a fever with Tylenol and ibuprofen.
Periorbital edema upon wakening that resolves throughout the day but reappears the next morning
Patient lost consciousness for a few seconds and was caught and led to the ground by wife. When pharmacist arrived to assist patient he was already getting up into a chair. He stated he was fine and that he felt really nervous. Patient wife stated he has fainted in past at birth of children so she was expecting this. He stated that he felt better and did not need to have us call 911. Patient was given water and monitored for 15 minutes after which he left the pharmacy
A wheal was not present after the vaccine was administered intradermally. An expert administered the second attempt, a wheal formed, and the attempt was successful.