chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He has a 100.0 fever; Cough; Little bit of congestion in his chest; Body ache; Sore shoulder; Joint pain; Muscle pain; This is a spontaneous report from a contactable consumer.  A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1685), intramuscular on 21Dec2020  as single dose for covid-19 immunization.  There was no medical history and no concomitant medications.  The patient experienced body ache on 27Dec2020 with outcome of unknown; sore shoulder on 27Dec2020 with outcome of unknown; joint pain on 27Dec2020 with outcome of unknown; muscle pain on 27Dec2020 with outcome of unknown; he has a 100.0 fever on 28Dec2020 with outcome of unknown; cough on 28Dec2020 with outcome of unknown; little bit of congestion in his chest on 28Dec2020 with outcome of unknown.  The patient underwent lab tests and procedures which included fever at 98.9 on 27Dec2020, and 100.0 on 28Dec2020, weight: 315 on an unspecified date.  Details were as follows: patient has been experiencing side effects. Per the reporter (wife to patient), he got a little under the weather, body ached kind of like sore shoulder, like joint pain, muscle pain. He did not have a headache. First he had a  fever at 98.9, it was okay but this morning as he woke up, it was 100.0 fever. When he woke up,  he felt better because he rested, but he woke up with a cough and a little bit of congestion in his chest. Therapeutic measures were taken as a result of  the events, and included acetaminophen (TYLENOL). The outcome of the events was unknown.
Headaches; Shortness of breath; Cough; Muscle aches; Drowsiness; Sinus pain; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 11Apr2021 at 08:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Concomitant medications included levonorgestrel (KYLEENA IUD) from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 14Mar2021 at 08:45 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Apr2021 at 13:00, the patient experienced headaches, shortness of breath, cough, muscle aches, drowsiness and sinus pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of headaches, shortness of breath, cough, muscle aches, drowsiness and sinus pain were recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Approximately 7 days after vaccinations, my baby developed a fever. The fever was treated for two days at home, but seemed to reappear. On 9/22 he wakened with huge welts all over his body. Initally on the left arm then on the legs. I was alarmed by this and called the nurse advice line and was advised to take him to immediate care. I was told he had developed an ear infection and had an allergic reaction "to something". The welts/hives reappeared again that evening (9/22), the next morning (9/23), and the day after (9/24. Each time only lasting between 1 1/2 - 2 hours each course. The physician prescribed antibiotics and benadryl.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for protein calories malnutrition, cortical myoclonus, fatty liver, Alzheimer dementia, HTN, hyperlipidemia, ckd stage 2. PT was on end of life palliative care at time of death and NPO. Pt deceased 4/29/21 at age 73 years of age.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Medium, Systemic: severe headache that woke her up from sleep, pt has taken apap 500mg, advised patient to report the event also and to contact her md if the symptoms get worse or severe-Severe, Systemic: Headache-Severe, Systemic: Nausea-Medium, Systemic: Neurological Disorder (diagnosed by MD)-Medium
received a third dose; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st and 2nd dose received in 2019).   On 13th October 2022, the patient received the 3rd dose of Shingrix. On 13th October 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.       Additional Information: GSK Receipt Date: 31-Oct-2022 Reporter's comment: The nurse was in a clinic and the patient inadvertently received a third dose of Shingrix.  The patient was not immunocompromised.  The nurse inquired via chat, but the patient chat ended by user before providing consent for follow up. Additional supportive information: The patient inadvertently received a third dose of Shingrix, which led to extra dose administered.
arm soreness from 12/31/20 to  1/5/21. fatigue 12/31/20 to  1/4/21.
Hospital admission on 03/22/2021, dx COVID+  with acute respiratory failure, acute embolism and thrombosis of unspecified deep veins of unspecified lower extremity.
After receiving his vaccines today, pt was fussy and developed deviation of both eyes to the right along with lip-smacking, before falling over.  Episode lasted about 30 seconds and recurred 5 or 6 more times.  Between episodes pt seemed tired and less interactive.  Episodes continued at ED and were refractory to first dose of Ativan 1 mg.  Received another 2 mg Ativan and 200 mg Cerebryx which pt did respond to.
I contracted Covid-19 SARs 2 and became ill on June 1, 2022
Initial dull abdominal pain with chills 2 days later followed by tinnitus, body aches, nasal drip, dizziness, and weakness. There wasn't a fever or sharp abdominal pain in the exact location of the appendix, so a doctor's visit was delayed but adverse conditions continued. Went to the ER on 7/6/2021 and was admitted to hospital. 2 days of antibiotic treatments did not stop white blood cell count elevation, so surgery was performed on 7/9/2021. The final pathologic diagnosis is as follows and the recovery has been nominal.  Terminal iluem, cecum, and ascending colon, extended ileocecectomy:  1) Severe acute appendicitis with perforation containing marked transmural acute and chronic inflammation with abscess formation, necrosis and acute serositis extending into the surrounding pericolonic soft tissues 2) Viable shaved proximal and distal shaved mucosal margins 3) Six reactive pericolonic lymph nodes, negative for malignancy (0/6) 4) No evidence of dysplasia or malignancy
PATIENT MENTIONED FEELING TIGHTNESS IN THE BODY. PATIENT FELT THAT THE MEDICATION WAS "STUCK IN THE STOMACH". PATIENT WAS MONITORED DIRECTLY BY THE PHARMACIST FOR SIGNS AND SYMPTOMS. PT WAS OFFERED TO HAVE THE 911  CALLED BUT PATIENT REFUSED. PT WAS MONITORED UNTIL SHE FELT STABLE ENOUGH TO LEAVE.
rash @ inj site approx 3" diameter which devel on afternoon of 14MAY97;raised & red, felt warm to touch, afeb;
Her arm feels sore after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Her arm feels sore after vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple myeloma.    On 09-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Sep-2021, the patient experienced MYALGIA (Her arm feels sore after vaccination). At the time of the report, MYALGIA (Her arm feels sore after vaccination) outcome was unknown.            Concomitant medication was not provided. no treatment medication was provided. patients sated that she was wanted to know if she could take Tylenol or apply heat to the site of the injection.
Shingles on face (around eye). Visit to ophthamologist scheduled. Valacyclovir and prednisone prescribed. Symptoms: rash on forehead and above/next to eye, burning/stinging, itchy eye (right side).
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were unknown. It was unknown if the reporter considered the fever and chills to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient's age group was taken based on the product indication as no other patient details were provided. The healthcare professional stated that the patient experienced fever and chills with dose 1 of Shingrix. The healthcare professional heard this information about a patient's experience from a healthcare professional outside of her facility. The healthcare professional did not had any patient information or vaccine information regarding this adverse event. The healthcare professional heard it second hand, and had no access to the patient or the vaccine. For tolerance to 2nd dose refer linked case US2018GSK169159, for same patient.
Patient lip swell up after receving the vaccination. Patient treated, Left aginst medical advice.
Information has been received from a physician concerning an approximately 4 year old male patient (now 6 years old) who in approximately August 2005, at the age of 15 months old, was vaccinated with the first dose of VARIVAX (Merck) (lot number 651043/0215R). In approximately May 2008, at the age of 4 year old, the patient was vaccinated with the second dose of VARIVAX (Merck) (lot number 658935/1349U). After receiving VARIVAX (Merck), the patient presented with pustules on his arms, legs, and trunk. Patient was seen by the physician for this symptom on 13-SEP-2010 and at this time the pustules had started to crust over. At the time of report the patient's status was unknown. Follow-up information has been received from the physician concerning the patient, a 4 year old male child (now 6 years old, last year height around 46 inches). The physician reported that the patient was "well child" when "given at 4 and half years" with the second dose of VARIVAX (Merck) (lot number 658935/1349U), subcutaneously in the right thigh on 14-AUG-2008 (previously reported as approximately May 2008). On 10-SEP-2010 the patient was seen in ER with pustules on his arms, legs, and trunk. Diagnosis was chicken pox. No lab test was performed. The patient was put on CEFZIL. On 13-SEP-2010, the patient was seen in office. Physician confirmed diagnosis. There were many crusted lesions on arms and thighs. No new ones and no signs of infection. The patient was still on CEFZIL. He was out of school for 7 days. The patient recovered from the event within 2 weeks. No further information is available.
10/25/2003 @ 20:00: Chills, body aches; 10/26/2003 @ 11:00: Hives (palms of hands, torso, thighs)
(L) leg swollen hip to knee. Non stop crying x 2 hrs. TYLENOL given.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: ENTIRE BODY ITCHED AND HAD HIVES-Severe, Additional Details: PATIENT CAME TO PHARMACY ABOUT 15 MINUTES AFTER INJECTION COMPLAINING OF ENTIRE BODY ITCHING.  I GAVE 50MG OF BENADRYL AND SHE SAT FOR ABOUT ANOTHER 15 MINUTES WITH NO RELIEF.  I TALKED WITH  CLINIC NURSE SHE CAME OVER AND LOOKED AT PATEINT AND DETERMINED WE SHOULD CALL AN AMBULANCE.  THEY LOOKED HER OVER IN THE STORE AND SHE WALKED OUT THE DOOR WITH THEM. DON'T KNOW IF SHE WENT WITH THEM OR NOT.  I TRIED TO CALL PATIENT TO GET UPDATE BUT NO ANSWER
Chest pain, shortness of breath, pain in the left arm, joints , head and neck. She also had itching all over, as well as a sore throat. She did not go to the ER. She treated symptoms with Tylenol.  Symptoms were intermittent and lasted 2 weeks
BODY SORENESS; INTENSE HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body soreness, and intense headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the intense headache and body soreness was not reported. This report was non-serious.
Covid arm; horrible rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm) and RASH (horrible rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 VACCINATION SITE REACTION (Covid arm) and RASH (horrible rash). At the time of the report, VACCINATION SITE REACTION (Covid arm) and RASH (horrible rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Nausea, dizzy, feel heating all body , heart beat fast for1-2 min then back to normal and fast heart beat again in 5 minutes for 1-2 minutes. It happened for 20 min then stop, only mild dizziness and nausea still come sometimes for a few hour. It feels better after after drink cold water and resting.
arm was pretty sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles, feeling abnormal (feeling like someone held something over a flame and stuck it to patient back), pain and crying.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: arm was pretty sore). The outcome of the pain in arm was resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-JUL-2023. This case was reported by a patient via interactive digital media. The patient had them once it felt like someone held something over a flame and stuck it to patient back. The patient could handle guite a bit of pain, but the shingles had patient crying in agony, never hurt that bad before but never again.  The patient got the two vaccines. The patient arm was pretty sore for a couple of days but it was worth it to prevent getting shingles again. The follow-up could not be possible as no contact details were available.
Headache, muscle ache, back ache, nausea, vomiting, fatigue, fever, chills
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. No information has been reported regarding the patient's medical history, current conditions and concomitant medications. On an unknown date in 2016 (also reported as starting on or after 24-MAR-2016) unspecified patients were vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # L045713 with expiry date 14-JAN-2017 and lot # L029618 with expiry date of 20-MAY-2017). VAQTA vaccine was stored at a temperature of 34 F (Fahrenheit) for a time frame of 20 minutes. There was no previous temperature excursions reported. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reported received from the same reporter. Additional information has been requested.
1/2/13 Received Adacel, Tdap vaccine that morning, went home and slept about 4 hours. 1/5/13 patient woke up feeling like every joint was hurting. 1/9/13 patient began having difficulty walking from painful joints. 1/11/13 patient went to Dr, he prescribed Prednisone, and it made patient feel better. 1/16/13 took last dose of Prednisone and by that evening his pain had returned to his joints. 1/21/13 patient went back to Dr where he drew lab for Arthritis, which was negative, and told patient that something in the Tdap vaccine connected with something in the patients body and has attacked all his joints. 1/23/13 patients wife called to report this incident and ask for direction.
This literature marketed report as received from the authors in a published article refers to 12 patients of unknown age and gender. The aim was to determine current hepatitis A (HAV) and hepatitis B (HBV) immunity rates for patients on the liver transplant list at a tertiary care center and any associations with unsuccessful vaccinations. A retrospective chart review was performed of adult patients listed for liver transplantation at a single transplant center as of June 2014. Data collected included demographics, etiology of cirrhosis, HAV/HBV immune status and vaccination history. To determine immune status, the authors looked at the presence of serological markers (HBsAg, anti-HBc, anti-HBs, IgG-anti-HAV). Statistical analysis was performed using the student t-test and the Chi-square test to detect any association between immune status and unsuccessful vaccination with patients' demographic data and etiology of cirrhosis. Results: A total of 184 patients (73 females, 111 males) were on the liver transplant list as of June 2014. Mean age was 58. Etiology varied with 35% due to hepatitis C and 18% due to alcohol. 119 (66%) patients were immune to HAV. Of this, 15 (13%) had been previously vaccinated with the remaining 104 (87%) developing immunity through prior infection. 48 (27%) patients demonstrated immunity to HBV. Of these, 17 (36%) had evidence of previously cleared infection and the remaining 31 (67%) were vaccinated with Hepatitis B Vaccine (Recombinant) (manufacturer unknown) (dose, route of administration and lot number not reported). 12 patients vaccinated for HBV either never acquired immunity or lost protective antibody over time. There was no statistically significant association between etiology of liver disease and unsuccessful vaccination for HAV (0.500) and HBV (0.517). There was no significant association between HAV immune status and age (0.898), sex (0.918) and etiology of liver disease (0.506). There was also no significant correlation between HBV immune status and age (0.071), sex (0.686) and etiology of liver disease (0.052). Conclusion: The presence of protective antibody for HAV and HBV among patients on the liver transplant waiting list was low, particularly for HBV. This is despite current AASLD recommendations for vaccination of nonimmune patients in the pre-transplant setting. We next hope to identify potential barriers to vaccination and improve immunity rates prior to transplant. The outcome of unsuccessful vaccination was unknown. Unsuccessful vaccination was considered related to Hepatitis B Vaccine (Recombinant) (manufacturer unknown). Additional information has been requested.
MODERNA COVID-19 VACCINE EUA  I had several side effects after the second shot, but the ringing of the left ear continues ( it is very loud - right along with headaches) My right ear is starting to bother me also, but as of today (May 12th 2021) is not as bad
Chest pain and left arm pain w/ dull ache secondary to exertion/driving. Weakness, numbness in hands and feet with chills, increased chest pain, tingling, pins and needles, dull aches in extremities that comes and goes. Fatigue and chest/arm pain with increased exertion.   Booster was received in combination with TDAP, and annual flu shot. I was exposed unknowingly to COVID following the shot within the next week at work.   I started taking aspirin due to chest/left arm pain 12/6. This did not relieve symptoms, and I visited the ER on 12/11 and 12/12 due to extreme chills, light headedness, numbness in hands and feet, and chest/left arm pain. I was discharged both nights and told nothing was wrong. The first night I was told it could be mild pericarditis due to a viral infection, but that the ECG did not support that diagnosis. Vitals were fine, but the second night I was given a liquid IV steroid, and it was the only thing that had worked to reduce symptoms.   I was referred to cardiology and a 3rd EKG revealed no problems. PA-C prescribed methyprednisolone 6 day course which alieviated symptoms but did not resolve entirely. I am still experiencing pain, fatigue with exertion, and neuropathy/pain in extremities with chest/arm pain with exertion.
This spontaneous report was received from an office manager and refers to a 4 year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 26-OCT-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.