chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DID NOT HAVE MENSTRUAL CYCLE FOR A PERIOD OF 6 MONTHS; DIZZINESS; FEVER; DIARRHEA; SWOLLEN LYMPH NODES; WEAKNESS; EXTREME HEADACHE; This spontaneous report received from a parent 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced did not have menstrual cycle for a period of 6 months, dizziness, fever, diarrhea, swollen lymph nodes, weakness, and extreme headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) between 10 and 103.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, fever, diarrhea, swollen lymph nodes, weakness, and extreme headache, and the outcome of did not have menstrual cycle for a period of 6 months was not reported. This report was non-serious. This case, from the same reporter is linked to 20211235952.
Patient was laying down to receive vaccine and became clammy, sweaty and dizzy after administration. Patient was given water and verbal support. Patient was released symptom free @1130.
Patient presented for administration of his first Janssen and Janssen vaccine. After receiving his vaccine, he was sitting in his wheelchair in the waiting area when he started seizing. It is not clear how long after vaccine administration he started seizing. The patient?s mother, informed me that he has chronic recurrent seizures. She reported that he usually experiences about 10 seizures per day. She reported that he had been seizing for more than 4 minutes when she called me to provide help.  I attempted to take his blood pressure without success due to seizure activity. I noticed that he was receiving oxygen though a nasal cannula, so I noted his oxygen saturation, which was 100% at the time of seizure. I called for the rapid response team, who transferred him to the ER for evaluation.
Standard inflammatory reaction at site was covering entire triceps area. This lead to compression of elbow and elbow pain, numbness of hand and significant loss of grip strength in the immunized arm.
This spontaneous report was received from a pharmacist, concerning an approximately 67 year old female patient. The patient's medical history included cancer but she was completely in remission at the time of this report. The patient did not have concomitant medications, drug reactions or allergies were unknown by the reporter. On 07-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 with lot # N022704 and expiration date on 27-FEB-2019 (strength was not reported), one injection shot was administered once for prevention of pneumococcal disease; but her arm swelled up overnight. The reporter stated that the swelling resembled Cellulitis, but was not Cellulitis". The patient was told to see her doctor it was unknown if she has made contact with her physician. No treatment was given for the event and no laboratory diagnostics studies were performed. No product quality complaint (PQC) was involved. At the time of this report, the patient had not recovered from the swollen arm. The causal relationship between the swollen arm and PNEUMOVAX 23 was not provided.
Information has been received from a office manager in a doctor's office concerning a 15 year old female patient who on 15-AUG-2007 was vaccinated IM into left deltoid with a dose of GARDASIL vaccine (yeast) lot #658222/0927U. The reporter reported that the patient received the injection and developed several hours later on the same day a temperature of 101 F to 102F. The fever took 2 to 3 days to pass. The patient also experienced abdominal pain and was lethargic. The patient saw her primary physician. The outcome was unknown. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 11:30 as dose 5 (booster), single (Lot number: 59267-0304-02) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Known allergies: Sulfa Drugs" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: MELOXICAM, start date: Oct2022, stop date: Nov2022; CYCLOBENZAPRINE, start date: Oct2022, stop date: Nov2022; ATOVAQUONE/PROGUANIL MYLAN, start date: 17Oct2022, stop date: 02Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive test four days after completing Paxlovid series. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received medication in 2weeks. Patient received the treatment of Paxlovid.
p/vax pt devel constipation, irritability;pt was eval by GI MD who ordered upper GI w/small bowel follow through;pt sx resolved w/passing of barium;
1st day: fatigue, intermittent joint pain/urticaria. 2nd day: generalized rash, pruritus - have taken benadryl
Information has been received from a physician's nurse concerning a 2 year old male who's 2 month old brother was vaccinated with an oral dose of rotavirus on 02-MAR-2007. One week later, on 09-MAR-2007, the 2 year old experienced developed vomiting and diarrhea. It was reported that the patient's mother believed that the patient had rotavirus. It was noted that the patient was not immunocompromised. The patient's mother said that the "stools smelled like rotavirus." The physician did not diagnose the patient with rotavirus since he was not brought into the office until three days after the symptoms had started. No product quality complaint was involved. No other information was provided. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 4/13/2007.  Information has been received from a physician's nurse concerning a 23 month old male who's 2 month old brother was vaccinated with an oral first dose of ROTATEQ (Lot# 655867/1111F) on 02-MAR-2007.  One week later, on 09-MAR-2007, the 2 year old experienced developed vomiting and diarrhea.  It was reported that the patient's mother believed that the patient had rotavirus.  It was noted that the patient was not immunocompromised.  The patient's mother said that the "stools smelled like rotavirus."  The physician did not diagnose the patient with rotavirus since he was not brought into the office until three days after the symptoms had started.  There were no laboratory or diagnostic tests performed.  No product quality complaint was involved.  No other information was provided.  Follow-up information indicated that the patient had rotavirus, five times, starting seven days after the patient's sibling received ROTATEQ.  It was reported that the patient recovered.  Additional information is not expected.
Child contracted chicken pox from vaccination.  Pox located all over various parts of the childs body to include trunk, legs, and face.
Headache, moderate pain at injection site. Following 3 days:  spotting (period not due for 2 wks), nausea, loss of appetite, sleepiness, lack of energy. Today: spotting for 3 months in between periods.  This NEVER occurred prior to the vaccination.
Patient get really sick; Initial information was received on 15-Dec-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (Patient).  This case involves patient [age and gender unspecified] who got really sick (illness), while patient received vaccine INFLUENZA VACCINE [Flu shot].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got really sick (illness) (non-serious) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
I am an HIV+ patient that has had an undetectable viral load for over 20 years - in bloodwork that was 4/14 they are showing my HIV status as detectable; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 at 13:00 as dose 1, single (Lot number: EN6198), in left arm, on 30Mar2021 at 13:00 as dose 2, single (Lot number: ER2613), in left arm and on 22Aug2021 at 13:00 as dose 3 (booster), single (Lot number: FD8448) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillan Allergy" (unspecified if ongoing), notes: known allergies: Penicillan Allergy. Concomitant medication(s) included: VALACYCLOVIR [VALACICLOVIR]; BIKTARVY; TRAZODONE; SERTRALINE. Past drug history included: Z-pack, reaction(s): "known allergies: Z-Pack", notes: known allergies: Z-Pack. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 14Apr2022 at 13:00, outcome "unknown", described as "I am an HIV+ patient that has had an undetectable viral load for over 20 years - in bloodwork that was 4/14 they are showing my HIV status as detectable". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of therapeutic response unexpected.  Additional information: Did the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19.
12/20/21 presents to ED for "fatigue and weakness". PMHx of "atrial fibrillation, hypertension, type 2 diabetes and coronary artery disease"
Onset new dermatitis to abdomen and upper thighs  day 17 after receipt characterized by erythematous, macular papular non priuritic lesions.  No vesicles, or systemic symptoms such as fever, malaise or decreased responsiveness. Normal activity, eating, drinking, peeing and otherwise well..
The patient has been admitted due to an apparently acute-onset anoxic brain injury and unresponsive event two days after receiving the Varivax and Havrix vaccines, with leading diagnoses of inborn error of metabolism vs. myocarditis. The night prior to the event she seemed well, and she slept in her parents bed overnight, awakening multiple times for her bottle and behaving normally. The following morning the patient was found unresponsive in the parents' bed. Initial evaluation showed diffuse hypoxic-ichemic brain injury on CT head, EEG with diffuse slowing, hypoglycemia, leukocytosis, myocardial dysfunction on echocardiogram, and hypotension requiring pressors. She was intubated and admitted to the PICU. Started on empiric antibiotics, though LP could not be obtained. Blood viral and bacterial testing was negative. MRI shows small multifocal infarcts. She is now extubated and improving, with underlying etiology unclear
Erythema and swelling at R deltoid noted 11/4/2020 with spreading to the morning of 11/5/2020
Patient felt some numbness in throat post vaccination. Drank water and rested, feeling resolved.
Took the vaccination on Sunday woke up Monday morning with flu like symptoms and a fever of 101, woke up today Tuesday feeling fine until this afternoon with a sudden severe migraine with both eyes going blurry and feeling really weak.
R shoulder muscles frozen, unable to rotate R shoulder, to reach or to lift. All ribs and intercostals spasming, painful. Rigors and shaking chills without increased temp
lower stomach pain; lower intestinal pain; a slight headache; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on the right arm on 27Feb2021 at 11:30 (Lot Number: 6203) at the age of 74-year-old as single dose for COVID-19 immunization. Medical history included iliac artery blockage, partial arterial blockages and excess salt, salt craving, high cholesterol, blood pressure, diabetes 2, diverticulitis and chronic obstructive pulmonary disease (COPD), all from an unknown duration. The patient not had any known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included clopidogrel (manufacturer unknown), Irbesartan (manufacturer unknown), hydrochlorothiazide (manufacturer unknown), metformin (manufacturer unknown), fluvastatin (manufacturer unknown), ezetimibe (manufacturer unknown), Tamsulosin (manufacturer unknown), ibuprofen (manufacturer unknown), acetylsalicylic acid (ASPIRIN BAYER), vitamin d nos (manufacturer unknown) and fluticasone (manufacturer unknown), all were taken for an unknown indication and within two weeks of the vaccination. On 27Feb2021 probably around 11:30, after the first shot on the ride home, the patient developed a slight headache, that disappeared the next day. The patient was not sure when but prior to the second shot, in Mar2021, the patient experienced lower stomach and lower intestinal pain for about 2 days, and then it disappeared. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The outcome of headache was recovered on 28Feb2021. The outcome of Pain stomach was recovered in 2021. The outcome of Lower abdominal pain was recovered in 2021.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a pharmacist referring to a 61 year old patient of unknown gender. There were no concomitant medications, concurrent conditions and medical history reported. In September 2015 (reported as "between 10-SEP-2015 and 18-SEP-2015"), the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose, frequency and route of vaccination were not reported, lot # L011533 with expiration date: 03-JUL-2016). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
no additional adverse event; one ROTATEQ was already open at both ends, neither hash mark was used, residue was leaking out on my hands; one ROTATEQ was already open at both ends, neither hash mark was used, residue was leaking out on my hands; one ROTATEQ was already open at both ends, neither hash mark was used, residue was leaking out on my hands; This spontaneous report was received from a nurse, who was reporting on herself. The patient's age, medical history, concurrent conditions and concomitant medications were not reported.  On 05-JUN-2020, the nurse was opening the 25 doses container of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1660942, expiration date: 06-FEB-2021 and noticed that one rotavirus vaccine, live, oral, pentavalent (ROTATEQ) foil sleeve was already opened at both ends. The residue was leaking out on her hands. The oral dosing vial was closed and intact inside of the foil sleeve. Only one for all 25 vials was defective. No additional adverse event reported.
Information has been received from a physician concerning a 65 year old male who in August 2008 was vaccinated with ZOSTAVAX.  Concomitant therapy included PROTONIX, lovastatin (manufacturer not reported), CELEXA, metoprolol and aspirin.  On 03-SEP-2008, approximately 2 weeks after vaccination, the patient developed arthritis in one hand.  The patient then developed general fatigue and neck and scalp pain.  The arthritis from the one hand then moved to the other hand.  The patient visited the physician's office.  Laboratory tests performed included complete blood count (normal), calcium/magnesium/phosphorus (normal), sedimentation rate 59, C-reactive protein 200, antinuclear antibody positive, and rheumatoid factor negative.  The reporting physician felt the patient developed symptoms of polymyalgia and or temporal arthritis.  As of the reporting date, the events were ongoing.  The physician considered the events to be disabling and immediately life-threatening.  Additional information has been requested.
I came home around 5:30pm after receiving the injection at 3PM and felt very drowsy.  I was drowsy and my head felt really heavy on my shoulders.  After another hour at 6:30 pm, I felt a strong headache coming on. Throughout the evening I was drowsy and went to bed early.  In the middle of night, I woke twice due to headaches.  This morning 1/8/2020, my headaches continued even after I took 1000mg of acetaminophen at 11:00am.  That was my first dose of any type of pain medication.  I thought the side effects would go away therefore I delayed taking any pain medication.  I usually do not have headaches and healthy.   My arm is very sore at the injection site as compared to when I received the flu shot in November.   It is almost 2:30pm almost 24 hrs from the injection and my headache continues.
This spontaneous report as received from a medical assistant refers to a 9 week old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 16-NOV-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # R007988, expiry date: 16-OCT-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009325: Original Case: 1902USA009323; US-009507513-1902USA009323: Original Case: 1902USA009323.
This spontaneous report as received from a nurse via company representative refers to a patient of unknown age and gender. The patient pertinent medical history and drug reactions or allergies were not provided. On an unknown date, the patient was inadvertently administered VARIVAX (Merck) (route, lot # and expiration date were not provided) when the patient was prescribed ZOSTAVAX. No adverse events were reported. It was unknown if the patient sought medical attention. At the time of the report, the patient status was unknown. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to an unknown number of patients of an unknown age and gender. The patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unspecified dates in April 2016, (reported as since 16-APR-2016), the patients might had been vaccinated with improperly stored ROTATEQ (lot # L029618, expiration date: 20-MAY-2017; dose was not provided) orally. The vaccine was exposed to temperature of 6 degrees Fahrenheit for 7 hours. No previous temperature excursion was reported. No adverse effects were reported. There was no product quality complaint. This is one of several reports received from the same reporter. Additional information has been requested.
Left shoulder where the injection was made was extremely painful at time of injection. Pain went away the next day; however, it came back the next week and as of 10/26/2015 is still painful. Worse in the mornings. I have never had a reaction before. Seemed like the injection was done very high up on the shoulder and the injection itself took longer then usual.
suspected vaccination failure; shingles; hurting; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient had shingles for nearly four months. At the time of reporting, it was still hurting. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Headache flushing & chills Narrative:  Per nursing report: "2nd Moderna vaccine on 1-27-21. States Thursday [1/28] c/o felt extremely tired with headache, hot sensation and chills. States took off on Friday because felt the same way. States at work and feeling better today."
patient experienced hives; Initial information regarding an unsolicited valid non-serious case was received from a healthcare professional on 25-Oct-2019.  This case involves an unknown age female patient who experienced hives(Urticaria), while she received vaccine influenza quadrivalent recombinant vaccine [Flublok Qiv].  The patient s past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications and concurrent conditions were unknown.   On an unknown date, the patient administerd influenza quadrivalent recombinant vaccine of an unknown dosage(Batch No: Unknown, Expiration date : Unknown) via unknown route for an unknown indication.  On an unknown date, (latency period: Unknown) after administering influenza quadrivalent recombinant vaccine, it was reported that the patient experienced hives(Urticaria).  Final diagnosis was hives.  Action taken was not applicable.  It was not reported whether corrective treatment was received.  Outcome of the event hives was unknown.  Batch number has been requested.  No further information was reported.
On 08/06/2001 received pneumovax injection. On 08/07/2001, pt complained that his arm was swollen, tongue thick and eyes slow to focus. BP dropped briefly, no treatment except warm compresses to the arm.
Fever of 105, swelling in entire arm, wrist and finger, bodily pain , all culminating in hospitalization