chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sleepy and tired; itching on the upper middle back, legs, foot, and in arms too; foot getting numb when she is trying to sleep or when she wake ups; eye and nose teary; shingles seems to be activated; sleepy and tired; right knee started getting sharp pain, middle and behind the knee, couldn'nt weight on it, hard time getting off the bed; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy and tired), PRURITUS (itching on the upper middle back, legs, foot, and in arms too), HYPOAESTHESIA (foot getting numb when she is trying to sleep or when she wake ups), LACRIMATION INCREASED (eye and nose teary) and HERPES ZOSTER (shingles seems to be activated) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Shingles (had shingles 20 years ago, it seems to have been activated (after mRNA-1273 administration)), Arthritis, Pinched nerve, Environmental allergy and Allergy to animals. Concomitant products included RIVAROXABAN.    On 03-Mar-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 SOMNOLENCE (sleepy and tired), PRURITUS (itching on the upper middle back, legs, foot, and in arms too), HYPOAESTHESIA (foot getting numb when she is trying to sleep or when she wake ups), LACRIMATION INCREASED (eye and nose teary), HERPES ZOSTER (shingles seems to be activated), FATIGUE (sleepy and tired) and ARTHRALGIA (right knee started getting sharp pain, middle and behind the knee, couldn'nt weight on it, hard time getting off the bed). The patient was treated with Physical therapy (She went to physical therapy and had acupuncture.) for Arthralgia. At the time of the report, SOMNOLENCE (sleepy and tired), PRURITUS (itching on the upper middle back, legs, foot, and in arms too), HYPOAESTHESIA (foot getting numb when she is trying to sleep or when she wake ups), LACRIMATION INCREASED (eye and nose teary), HERPES ZOSTER (shingles seems to be activated), FATIGUE (sleepy and tired) and ARTHRALGIA (right knee started getting sharp pain, middle and behind the knee, couldn'nt weight on it, hard time getting off the bed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the events included physical therapy and acupuncture, Benadryl for her nose, Tylenol, and pain medication for the knee.  On 08-Mar-2021 the patient talked to a neurologist who gave her a prescription for Valtrex. She took 1 tablet the next day and 2 tablets the day after. It looked like her symptoms went away but then they returned.
Initially, red, swelling, slight itch started day of injection. Swelling went away in  7 days. Used ice.  10th day upper arm red,very itchy. Took Benadryl. Lasted about 12 days.
Developed a relapse of nephrotic syndrome (proteinuria) after being in remission since late May.  Was treated with cyclophosphamide spring 2021 x 12 weeks.  Weaned off high dose steroids late May 2021.  Off all medications for nephrotic syndrome late May and in remission until 12/15/21, when developed trace proteinuria.  On 12/17/21: 2+ proteinuria, then 12/21/21 had 3+ proteinuria.  Started prednisolone 51 mg po every morning on 12/22/21 for relapse.  Onset periorbital edema 12/18/21.  No viral illness symptoms earlier in month to suggest viral trigger for relapse.  Suspect 2nd COVID vaccine was trigger for this relapse, in discussion with pediatric nephrologist.  Plan is for high dose prednisolone until UA negative or trace proteinuria x 3 days, then will decrease prednisolone dose to 36 mg every other day x 4 weeks, then stop prednisolone.
About 12 hours after the vaccination the patient woke up with Flu like symptoms and a high fever. When the patient measured the fever later in the day he states it was higher than 103 F. The fever continued until about 12 noon on Friday. when the patient measured his temperature on Friday morning it was just over 100 F. The patient treated his symptoms with 650mg of TYLENOL taken at 3 separate times on Thursday. He has reported no further symptoms.
Pt having fever, chest pain, and palpitations two days after 2nd Pfizer covid-19 dose.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 20-DEC-2016, the patient was vaccinated with an expired dose of VAQTA lot # L030442 with expiry date 19-DEC-2016 (dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. The dose had never been improperly stored. Product quality complaint (PQC) was not involved. Additional information has been requested.
Within 12 hours of vaccine I started to have intense anxiety symptoms.  The anxiety lasted for approximately 36 hours.  I felt like I just drank six Red Bulls.  The second night I questioned if I should be go the ER.
This spontaneous report as received from a 63 year old female nurse, who was also the patient, via company representative. Medical history, concurrent conditions and concomitant medications were not provided. In approximately 2010 (about 5 years ago), the patient was vaccinated with ZOSTAVAX (dose, frequency, and route of administration were not provided), for prevention of shingles. On 09-MAY-2015 (currently), the patient had an active case of shingles. No treatment was given for the adverse event. Patient sought medical attention (office visit on unspecified date). The outcome of shingles was not recovered. Causality was not provided. No product quality (PQC) was involved. No further adverse event information was provided. Additional information has been requested.
Client received Flucelvax Lot 283849 exp. 06-30-2021 on 9-29-2020 per protocol. I received a call from client at 8:30 am on 09-30-2020 stating that her arm was swollen and "heavy" She reported to me that her arm itched on the way home after taking the vaccine and she didn't think much of it because she had always taken flu vaccine without problems. She reported that once home her arm began to turn red and swell below the injection site and her inner arm. She reported taking Tylenol and using cold compresses but that it isn't getting any better. Client arrived at the health department for evaluation of her arm. Erythema and slight swelling noted 2 inches below injection sight extending to inner arm down to elbow. No redness or swelling noted on back of arm. Client reports some slight itching but reports she does not like to take Benadryl because of how it makes her feel.  Client was encouraged to follow up with her PCP for further evaluation and possible treatment of redness and swelling. Client reported she would call as soon as she leaves health department.  Received a call from client 10-01-2020 at 8:00 a.m. stating that she went to clinic on 9-30-2020 and doctor feels like symptoms were likely related to the flu vaccine. Reports the doctor is still trying to decide if she should take future doses of flu. Reports she was prescribed steroid injection, antibiotic and took Benadryl last night along with some anti itch cream and has improvement this morning in both swelling and redness.
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: After the injection I noticed a swelling and a little red on the injection site.  After monitoring her pt stated that she has some tingling on her right thumb and monitored by  NP for about 40min to an hour and felt ok and went home and an hr later called for follow up and she was 100% better. she was given water while here. rph  spoke to her family member while she was here. and I called her about 8:39pm and spoke with her and she said she is doing ok.
This spontaneous report as received from a pharmacist concerning a 64 year old female patient. The patient's drug reactions/allergies included PHENERGAN allergy, DEMEROL allergy, iodine allergy and sulfa (exact allergic reactions to all of these were unspecified). On 28-SEP-2013, the patient was vaccinated with PNEUMOVAX23 lot # J004332 (expiration date 26-SEP-20014) 0.5 ml, intramuscular. Concomitant therapies included FLUVIRIN given on the same day as PNEUMOVAX23 (which arm was unspecified). On 28-SEP-2013, the pharmacist reported that after the patient was administered PNEUMOVAX23, the patient developed redness and swelling at the injection site, and the patient's entire arm where she had PNEUMOVAX23 administered to was now red and swollen. On an unspecified date, the patient sought medical attention, the patient contacted the pharmacist. There was no treatment given for the adverse events. There were no labs diagnostics studies performed to the patient. At time of report, the patient had not recovered of the events. Additional information has been requested.
Headache, muscle aches, irritable, disturbed sleep, fatigue, sore arm.
Pt recvd vax 20AUG91 @130PM; 4PM listless, jerking movements of arms, eyes rolled back, gray color; On exam t103.9 AX, was alert on exam; APAP given & observation; Pt seen by MD 5PM;
Information has been received from a nurse referring to unknown number of patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally (lot # L008574, expiration date 22-NOV-2016; K023157, expiration date 23-JUL-2016; strength and dose unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a published article, title as stated above. This literature case was initially reported on 29-MAR-2010. This article concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean age of patients was 29 years). The patients received a RECOMBIVAX HB, manufacturer, batch number, route and site not reported, on unreported dates. This report concerns patient #12 of 32, a 16 year old female. On an unreported date between 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccination in 15 patients, after the second vaccination in three patients and after the third vaccination in three patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second doses of vaccine. One patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. A 16 year old female on an unspecified date was vaccinated with the second dose of RECOMBIVAX HB (lot number, route and site not reported). There was no concomitant medication. One day after vaccination, the patient developed uveitis. At the time of the report, the patient's outcome was not reported. The patient also experienced symptoms of arthritis. The authors stated the RECOMBIVAX HB may have a possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential pathogenic mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. Additional information has been requested. The article also discussed the experience of an additional 31 patients while on therapy with RECOMBIVAX HB (WAES #1004USA01716, WAES # 1004USA02327 to WAES # 1004USA02336, WAES # 1004USA02338 to WAES # 1004USA02357).
Atrial Fibrillation beginning at about 12:35pm on 10/9/22 with heart rate of 155 bpm (preceded earlier in day by a 10-15 minute period of many PVC's, then occasional PVC's over several hours).  Went to ER, arriving at about 1pm. Treatment: At ER, 2 attempts at electrical cardioversion (unsuccessful), followed by admission to hospital and overnight IV administration of Amiodarone which resolved the issue.  Also given Eliquis.  Discharged on 10/10/22.  Continuing daily oral Eliquis and Amiodarone for 30 days
bluish area to Lt inner aspect of thigh. Redness to lt inner aspect of thigh. Less than 1" apart.
5in x 7.5in area of erythema and warmth over (R) deltoid. (site of injection). No induration.
Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021; Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 9:29 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 9:29 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported age 60.61.  No concomitant medication was reported by reporter.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. Vial was moved to fridge on 30-Mar-2021 and moved to clinic on 03-Apr-2021. Vial was punctured right before administration. Vial best before use date was 29-Apr-2021. Vial was undergone temperature excursion at 09:00 AM with 34 degree Fahrenheit. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment medication was reported by reporter.   This case was linked to MOD-2022-566976 (Patient Link).
Temp of 104F; Taken to MD; Dx viral synd; sz on 28APR90; past hx of rash;
Increased apneas - severity and frequency - led to rule out sepsis and antibiotics.  Occurred 24 hours after immunizations.  See attached notes.  Was near time of discharge.  3/21/08 Reviewed hospital medical records of 01/04/2008-2/22/2008. FINAL DX: resolved distress of prematurity; apnea of prematurity requiring caffeine; anemia of prematurity on iron. Medical records reveal patient experienced multiple complications of prematurity.  Initially received TPN & gradually transitioned to oral feeds.  D/C weight 1915 gms.  Developed sepsis & received IV antibiotics.  Possible ROP to f/u at d/c.  Transferred to neonatal unit more convenient for parents when stablized.                      4/11/08 Reviewed hospital medical records for 2/22-3/27/2008. FINAL DX: preemie as noted in prior records, anemia, apnea, GERD, ROP, RSV Records reveal increased severity & frequency of apnea;increased CRP w/n 24 hrs of immunizations & likely due to immunizations in preemies at 2 mo shots. Experienced several apnea spells s/p immunizations, last one 3/20.  Progressed well overall & D/C home on RA, d/c weight 3240 gms, only med iron, taking nipple feeds well on reflux precautions.
Approx. 30-40 min after H1N1 vaccine admin. intranasal, child developed flat rash on front and back of trunk. C/O of itching. NKA, no new foods or cleaning products used in home.
severe reaction; chills; high fever; shaking, trembling; body aches; headache; rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (severe reaction), CHILLS (chills), PYREXIA (high fever), TREMOR (shaking, trembling) and MYALGIA (body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (severe reaction), CHILLS (chills), PYREXIA (high fever), TREMOR (shaking, trembling), MYALGIA (body aches), HEADACHE (headache) and RASH PRURITIC (rash). At the time of the report, VACCINATION COMPLICATION (severe reaction), CHILLS (chills), PYREXIA (high fever), TREMOR (shaking, trembling), MYALGIA (body aches), HEADACHE (headache) and RASH PRURITIC (rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2021: Adverse events information was added.
On 05/21/2003 muscle of left arm was hot and sore and hurt really bad. Also hurt to move shoulder the next am after injection. Neck hurt 05/28/2003 p/c stated arm was much better- no pain now.
Case number PJHEH2014US019839, is an initial spontaneous report from a nurse received on 03 OCT 2014. This report refers to a 7 years old female patient. Past medical history and concomitant medications were not reported. She was inadvertently vaccinated with FLUCELVAX 2014/2015 (batch number: 017011A) at a dose of 0.5 ml intramuscularly on 01 OCT 2014. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).
FEVER; HEADACHE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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. Company is unable to perform follow-up to confirm batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and headache was not reported. This report was non-serious.
Injection site soreness only first 24hrs.; fatigue; chills; fever of 99.8 F; body aches; headache; vomiting; Diarrhea; This is a spontaneous report from a contactable other health professional (patient). A 44-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 22Dec2020 14:00 at single dose at right arm for COVID-19 immunization. Medical history included Asthma, no Allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included budesonide, formoterol fumarate (SYMBICORT), omeprazole. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that injection site soreness only first 24hrs. At 30 hrs, fatigue, chills, fever of 99.8 Fahrenheit (F), body aches, headache, vomiting and diarrhea. These lasted for 24hrs. Diarrhea persisted for 48 hrs. To the best of his knowledge he had not ever been exposed to Covid. The events onset date reported as 23Dec2020 23:00 (pending clarification). Treatment received for the adverse event reported as "Called nurse line". The events were non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was unknown.
4/6/23 I did not feel well. I was taken to the emergency room and had a CT. I was diagnosed with a 6.7-centimeter aortic aneurysm and descending dissection. I had an aneurysm repair on 4/10/23. I was in the hospital until 4/20/23. When I was discharged, I was sent home with nurses and had physical therapy. I was not started on any new medication.
Hot off and on; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hot off and on) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 29-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 an unknown date, the patient experienced FEELING HOT (Hot off and on). At the time of the report, FEELING HOT (Hot off and on) outcome was unknown.            No treatment information was provided.  No relevant concomitant medications were reported.  Patient reported feeling hot off and on afterwards.   This case was linked to MOD-2021-333376 (Patient Link).
4 hrs after flu shot, felt burning in (R) ear, (R) side of neck and chest.
This spontaneous report was received from a registered nurse and refers to a 10-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-DEC-2018, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB thimerosal-free, lot # R001530, expiration date 07-NOV-2020 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (It was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.