chrisvoncsefalvay/vaers-outcomes huggingface dataset:
neck not sleeping well; neck not sleeping well; body pain; he can't even lift his arms up due to the pain; arthritis; severe fatigue / very fatigued / now if he walks a mile thats a long walk for him, he's very tired; achy shoulder / pain in his shoulders /muscles and joints started to ache like crazy; sleeping from 12 to 16 hours a day; had no energy; very lethargic; muscles and joints started to ache like crazy; This is a spontaneous report from a contactable consumer. This patient reported similar events for 5 patients. This is the 2nd of 5 reports.  A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 27Jan2021 (lot number: EK4176) as single dose, and second dose via an unspecified route of administration, administered in left arm on 18Feb2021 (lot number: EL3247) as single dose for COVID-19 immunisation. Medical history included open heart surgery, cholesterol, and blood pressure. Concomitant medications included arginine hydrochloride, ascorbic acid, calcium, calcium pantothenate, cyanocobalamin, ferrous fumarate, folic acid, magnesium, methionine, nicotinic acid, phosphorus, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, thiamine hydrochloride, tocopheryl acetate, triticum aestivum, zinc (MULTI VITAMIN), atorvastatin for cholesterol, amlodipine besilate (AMLODIPIN (BESILAT) DEXCEL) for blood pressure, and acetylsalicylic acid (ASPIRIN 81). Vaccine was not administered in a facility. The patient experienced he can't even lift his arms up due to the pain on an unspecified date, severe fatigue / very fatigued / now if he walks a mile that's a long walk for him, he's very tired on Apr2021, achy shoulder / pain in his shoulders /muscles and joints started to ache like crazy on Apr2021, neck not sleeping well on an unspecified date, body pain, sleeping from 12 to 16 hours a day on Apr2021, had no energy on Apr2021, very lethargic on Apr2021, arthritis on May2021. The patient underwent lab tests and procedures which included height: 183 cm on an unspecified date, X-rays (spinal x-ray): arthritis on May2021, weight: 89.81 kg on an unspecified date, X-rays (X-ray limb): arthritis on May2021. Therapeutic measures were taken as a result of arthritis. The outcome of the events fatigue and asthenia was recovering; the outcome of the events arthralgia and myalgia was not recovered; and the outcome of the other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021541547 Same reporter/drug/event, different patients
Chills; Injection site pain; flu; cold; Joint pain; Muscle stagnant; Where they gave me the shot the muscle goes jumping up and down; Not feeling well; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL9262 expiry date not reported, via an unspecified route of administration from 28Jan2021 at single dose for COVID-19 Immunization. Medical history included High blood pressure and Pre-diabetic. Concomitant medications included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) 12.5 mg, metformin (METFORMIN) 1000 mg, twice a day, lisinopril (LISINOPRIL) 20 mg at night, pravastatin (PRAVASTATIN) 20 mg, acetylsalicylic acid (BABY ASPIRIN) and atorvastatin calcium (ATROSTAT). The patient experienced joint pain, not feeling well and muscle stagnant; where they gave me the shot the muscle goes jumping up and down all on 29Jan2021 and chills, injection site pain, flu and cold all on unspecified date. Consumer stated, "I am having a joint pain and chills and not feeling well, I had it Thursday evening, I took it Thursday evening. I am not feeling well from that Friday night and last night I mean the joint pain, the muscle pain you know, it's just you have to deal with." Consumer added, "I have been taking pain medicines, Ibuprofen and Tramadol for pain and Mucinex for cold and flu." Therapeutic measures were taken as a result of joint pain, injection site pain, flu and cold. Outcome of the events was unknown.
cold sore; This is a spontaneous report from a contactable Nurse and reported for herself. A female patient of an age 55 (Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on 12Mar2021 as 1st single dose for COVID-19 immunization. Patient's medical and concomitant medication history were not reported. On 17Mar2021, five days later patient developed a cold sore which never had been before. "Patient asked, Is this a side effect of the vaccine? And patient can receive second dose of the vaccine?". The outcome of the event was unknown.   No follow up attempts are possible. Information about lot/batch number cannot be Obtained.
Sore arm started on same day as vaccines, mild left sided chest pain and mild shortness of breath that started the next day.
Information has been received from a physician concerning a 17 year old female patient who on an unspecified date was vaccinated with the third dose of GARDASIL (Lot # 666987/1016Z, expire date 22-NOV-2012), 0.5 ml, intramuscularly. Physician stated that on 08-FEB-2011 after receiving the third dose of GARDASIL, a large lump formed on patient's arm. The large lump formed on patient's arm was red and inflamed. No treatment was given to the patient. The patient did not seek medical attention. Therapy was reported as discontinued on 10-FEB-2011. At the time of the report, patient's outcome was unknown. Additional information has been requested.
pt recvd vax for prophylaxis; 3 hrs later exp hives; was not seen by MD;
Per H&P and physician notes, patient was admitted to hospital on 2/7/21 with status epilepticus from home. He had received his second dose of COVID19 vaccine on 2/6/21 per Emergency Department note. Patient was febrile on admission (40.7 Celsius) and was intubated. Patient had issues with hypotension, neurologic impairment, and metabolic issues. Received pressors, IV fluids, Keppra, IV antibiotics to cover for possible CNS infection. Lumbar puncture performed. Abnormal EEG on 2/9/21. Recurrent seizure on 2/10/21. Pt extubated on 2/12/21. Blood cultures, urine culture,  and CSF culture all no growth. Sputum culture mixed oral flora. As of 2/22/2021, patient tolerating tube feeds, shakes head yes and no responding to questions.
Had a low fever at the time of vaccination. Immediately after, fever spiked to 104 for a few days. During that time, began limping. Limped for around 3 months before being diagnosed with juvenile arthritis.
Information has been received from a doctor of pharmacy concerning a 66 year old female patient with no outbreak and was not on any antivirals with a history of cold sore presented before getting ZOSTAVAX (Merck), who on 05-JUL-2010 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot number 664673/0150Z) subcutaneously in her left arm. The doctor of pharmacy reported that in February 2011, seven months after vaccination, the patient experienced shingles on the right side of her face. The patient was treated with valacyclovir hydrochloride, 1gm, three times a day was given when was an another city. Subsequently, the patient recovered. Then it was reported that just last week, in April 2010 the patient now had shingles on the other side of her face (also reported as right side of the face). No labs diagnostics were performed. Valacyclovir hydrochloride, 1gm, three times a day was given as a treatment for the experience. The patient was seen at physician's office for the recent bout of shingles. At the time of the report, the patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Pt is epileptic & suffers from cerebral palsy; 25OCT temp to 104 triggering epileptic seizure; 26OCT of 102; mom gave seizure medication & packed pt in ice packs;
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX via intramuscular route (dose and frequency were not reported) lot # N009777 and expiration date: 04-MAR-2018. The ZOSTAVAX was reconstituted with sterile diluent (manufacturer unknown). No causality was provided by the reporter.
pt recv vax 10SEP97 & p/vax pt exp alopecia on head which has gradually worsened;
blood pressure was high; Arm was really sore; feeling sick; vomiting; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0158; Expiration date: Jul2021; NDC number: 59267-1000-02), via an unspecified route of administration in right arm on 12Apr2021 (at the age of 42-year-old) as single dose for COVID-19 immunization. Medical history of the patient included ongoing hypertension (from 2020), ongoing acid reflux (from an unspecified date), allergies (unspecified) and stomach problems. Family medical history of the patient included high blood pressure and diabetes. Concomitant medication included Diphenhydramine 25 mg once daily (started in Apr2021 and ongoing) for allergies, Womens Vaginal and Digestive Health Probiotic (started in Apr2021) for stomach problems and multivitamin one tablet once daily (started in Apr2021) to keep up with her health as patient was in her 40s. Patient previously took Amlodipine Besilate/Telmisartan (expiration date: 31Dec2022) in 2020 and stopped the medication because her blood pressure went down. Patient reported that she had not taken the amlodipine/telmisartan at all previously in 2021, but her blood pressure was high this week, so amlodipine/telmisartan was started again in in May2021. Patient previously received flu vaccine (unspecified) on an unspecified date for immunization and did not get sick. Patient stated that she does not usually get sick with vaccinations. On 12Apr2021, patient's arm was really sore, patient had to sit and wait after receiving the first dose of vaccination, and by the time she got home her arm was progressively getting sore and tender. Patient reported that her arm hurt the rest of the week into the weekend. In Apr2021 (two days later after first dose of vaccination), patient was feeling sick when she woke up and experienced a little vomiting and diarrhea. Patient was really sick for a few hours with vomiting and diarrhea. Next day, when patient woke up her stomach had settled. Reportedly, as per patient she had a small reaction to the first dose of the COVID-19 vaccine where she experienced a little vomiting and diarrhea on the third day and reported that the vomiting and diarrhea passed. Patient did not report the vomiting and diarrhea because vaccine information had said that about the third day after the vaccine, patients would get a little sick and the caller thought it was normal. Events arm was really sore, little diarrhea and vomiting resolved in Apr2021 while outcome of event feeling sick was unknown and blood pressure was high as unknown. Investigation Assessment: No  No follow-up attempts are needed. No further information is expected.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE 11/20/2022 -- RECURRENCE OF SAME SYMPTOMS
I developed Lichen Planus on the back shoulder, neck, neck and the back vaginal area. I am still under treatment.
Prolonged (4 to 6 hours) crying episode and sleeping longer than usual for nap and night -not a high-pitched or unusual cry.  No significant fever.
I overslept on the 19th and woke up w/ chest pain. I got nitroglycerin for the pain and went to the dr. They did an EKG and a chemical stress test. I had an angioplasty shortly after but they couldn't enter my right coronary artery because it was blocked. About a month later, I woke up and had severe shortness of breath and went to the ER and was in the hospital for few days and was given albuterol. A few days after leaving the hospital and experienced the shortness of breath again and had to go back to the ER. They gave me a nebulizer and more albuterol and was told that my heart was not pumping enough and providing enough o2 to my body. After an MRI, they found an aortic valve was not opening. They provided me medication to help rid my lungs and body of fluids. They just did a aortic valve replacement.
Patient  noted leg swelling  for 2 days ago, with  significant pain in her left leg and felt that she couldn't move it or walk on it due to the pain. Patient was admitted for treatment of extensive LLE DVT and hyperglycemia.  Her regimen while hospitalized included glargine 10U daily with SSI mild correctional and apixaban 10 mg bid.  Patient was discharged on 01/07/2022
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL on 08-APR-2013 (lot number: H011350; exp date: 21-FEB-2015) (dose, frequency, route and site of administration were not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
about 5 hours post vaccination, patient started experiencing fever with severe chills and shaking. she then noticed some splotchy skin on her face, neck, and chest, but there was no itching. she went to a pharmacy near her home to get some benadryl, and the pharmacy there helped her get some benadryl and tylenol and called the paramedics. she was send to the emergency room where they observed her for about 3 hours. her blood pressure was slightly elevated (167/85 per patient) when she arrived, but stabilized. she was sent home around 1:30 am on 3/13. she said the next day, she was extremely tired, but by 3/14, she was her usual active self.
Vaccine given 4/11/06 at 14:05. Onset of symptoms started 4/12am with headache, mild body aches and progressed through day. Fever 102 at 19:00. Medicated with with Advil after vaccination, then next at 07:00, then at 1900 with fever. Continues to take every 8 hours. Fever broke at 2100 on 4/12. Had joint pain with fever more in the knees. Difficulty to stand. Joint pain decreased gradually after fever broke. Has pain at site in left axilla. Has dry pustule at injection site and perimeter remains swollen and warm.
A report has been received from a Health Professional concerning several patients of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started during 2011. The patient experienced EYE TEARING. The outcome of the event of EYE TEARING is unknown. The report was considered to be non-serious by the company physician.
I had labral replacement surgery on 10/18/2022. On 10/20/2022, I began exhibiting psychotic symptoms and struggling to eat. I continued getting weaker and weaker and more psychotic. We tried changing my opiate prescription and taking me off opiates, but I did not improve. On 10/27/2022, I had a panic attack due to hallucinations and called 911. I was transported to hopsital, who then transported me to hospital liver transplant floor.  The hospital found: bilateral PE?s, right femoral DVT, shock liver, inflamed gallbladder, acute kidney injury, pneumonia, psychosis, metabolic encephalopathy, enlarged heart, PFO. I was discharged on 10/31/2022. On 11/15/2022, I had to return to my PCP for an IV due to increasing weakness and dehydration.
12 hours post vaccination began having chills then fever was 101.2 Sleepless night with intense frequent urination.  Headache, body aches and skin hurt.  Also nauseous and very fatigued.  this lasted for 12 hours. First fever broke then after 12 hours other symptoms began to subside.
Approximately 5-6 days after my second Pfizer vaccine dose, I began having paresthesias in patchy areas on the outside of my right ankle. Over the next 3-4 weeks, the paresthesias (burning,  tingling, temperature sensation) progressed to the other leg and then ascended up the legs bilaterally to the upper thigh area. I consulted my neurologist and he ordered a MRI of the cervical and thoracic spine. The day after the MRI (4/15/21), I had two seizures in the morning after being seizure free for a year. I had significant fatigue and felt very poorly. A few hours later, I had a sudden onset of severe bilateral leg weakness. Because I could not walk, EMS was called. I went to Hospital where I was admitted for leg weakness. Additional imaging was performed. I was able to walk a few steps after receiving a dose of 1g solumedrol via IV that night. My symptoms improved over the next few days with IV steroid treatment. I was discharged on 4/19/21 and was advised to follow up with outpatient neurology. My neurologist initially diagnosed acute transverse myelitis and ordered physical therapy. I continued a steroid taper for 6 days after hospital discharge. Today (4/29/21), my symptoms have improved but continue to have adverse effects. I am able to walk but tire quickly and am very fatigued. I have been unable to work since hospital discharge.
Rash on right side of neck, left arm, left Breast, all around pubic area.  Headaches, stiff neck, and occasional shortness of breath.
5/6 Admit to hosp. 5/7 Dx made GBS. Sx started on 5/3/17 with upper back pain and bilat feet and hand paresthesias and episodic bowel incontinence. By 5/5 she was having difficulty walking.
17th fever & upper arm had redness; Gave DPH & Cifzil; small tiny area; On the 19th got bigger & gave Prenazone;
Received booster dose (0.25 ml) in error/since she was immunocompromised; Did not receive 3rd primary series dose (0.5 ml)/his daughter should have received a 3rd primary series dose (0.5 ml), and then the booster dose (0.25 ml) since she was immunocompromised.; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Received booster dose (0.25 ml) in error/since she was immunocompromised) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive 3rd primary series dose (0.5 ml)/his daughter should have received a 3rd primary series dose (0.5 ml), and then the booster dose (0.25 ml) since she was immunocompromised.) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 045A21A and 044B21A) for COVID-19 vaccination.     Concurrent medical conditions included Down's syndrome (since from birth), Immunocompromised (since from birth) and Airway obstruction NOS (since from birth).   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (Received booster dose (0.25 ml) in error/since she was immunocompromised) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive 3rd primary series dose (0.5 ml)/his daughter should have received a 3rd primary series dose (0.5 ml), and then the booster dose (0.25 ml) since she was immunocompromised.). At the time of the report, ACCIDENTAL UNDERDOSE (Received booster dose (0.25 ml) in error/since she was immunocompromised) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive 3rd primary series dose (0.5 ml)/his daughter should have received a 3rd primary series dose (0.5 ml), and then the booster dose (0.25 ml) since she was immunocompromised.) outcome was unknown.      No concomitant medications were reported.  It was reported that no AE cause patient to seek medical care.  No treatment medications were reported.
nausea; This spontaneous report was received from a medical assistant refers to a male patient of 15-16 year old. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route, lot and expiry date unknown) for prophylaxis. On an unknown date in July 2019 (about a month ago), when the patient was about 17-18 years old, he returned to finish the last dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the series. On the same day after the injection, the patient had one episode of nausea (apparently he suffers from nausea with anything that involves needles). The patient was kept under observation for 30 minutes and had blood pressure rechecked which was normal. The patient received treatment. The outcome of the event nausea was recovered after 30 minutes on the same day. The patient had left with no side effects. Causality assessment was not provided
At 1650 on 9-3-10 was given TDAP (BOOSTRIX), MENACTRA & varicella vaccinations. At approx 1715 developed hives, shortness of breath, itchy eyes, throat swelling, vomiting seen in urgent care. SOLU-MEDROL 125mg IM BENADRYL 25 mg p.o. Ibuprofen 200 mg p.o.
Narrative:  He relates having developed abdominal cramping about 30 minutes after the initial vaccination, which lasted for 2 hours prior to resolving. He did not experience other common adverse effects - other than some tenderness to the injection site - including nausea, vomiting, and diarrhea. He was able to tolerate oral intake. No therapies were tried or applied.
Right arm pain, swelling and redness.   Also with fever, shortness of breath.      Went to ER, diagnosed with pneumonia and treated with outpatient antibiotics.  Arm and respiratory symptoms resolved over next 2-3 days.
Information has been received from a health professional, for GARDASIL, a Pregnancy Registry product, concerning an approximately 23 year old patient who on an unspecified date, was vaccinated with a dose of GARDASIL. Subsequently the patient was pregnant. At the time of reporting, the outcome was unknown. It is unknown if the patient sought medical attention. Follow up information was received from the health professional which reported that on 16-SEP-2009, the 23 year old female patient was vaccinated with a dose of GARDASIL (lot # 663453/0249Y). On the same day, she had a negative pregnancy test. Subsequently the patient was pregnant, with last menstrual period (LMP) 22-SEP-2009, estimated delivery date (EDD) 30-JUN-2010. The patient visited the physician. Follow-up information was received from the health professional concerning a patient with anaemia and depression who on 16-SEP-2009 was vaccinated with the first dose of GARDASIL. Concomitant therapy included prenatal vitamins and NIFEREX-150. On 01-DEC-2009, the patient's ultrasound test revealed viable intrauterine pregnancy (IUP). On 21-DEC-2009, the patient's Maternal Serum Alpha-Fetoprotein Screening (MSAFP) test showed normal. On 06-JAN-2010, another ultrasound test revealed normal. It was reported that the patient had no previous pregnancies. Follow up information has been received from a registered nurse who reported that the patient had depression which was treated with ZOLOFT sporadically prior to pregnancy but the patient did not take it during the pregnancy. She also smoked during 2007 to 2010. Other concomitant medications used during pregnancy also included: KEFLEX, MACROBID, PREFERA OB and FERRI. On 09-NOV-2009 the patient developed urinary tract infection. In November 2009, the patient experienced anemia. On 20-APR-2010 (also reported on 28-APR-2010) the patient developed intrauterine growth restriction (IUGR). On 29-MAY-2010, the patient delivered a normal male baby with no congenital anomalies. There were no other complications or abnormalities. The baby's experience has been captured in WAES # 1001USA00985B1. This is an amended report, the AE term of foetal growth restriction was moved to 1001USA00985B1, and the concomitant therapies and narrative were updated. Additional information is not expected.