chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 10/05/2016 I got a flu shot. 12 hours later my left side of my face went numb & I became concerned that I may of had stroke so went to the urgent care. I was informed that I have Bell's Palsy. I was given Prednisone to treat it for 5 days. On 10/11/2016 I went to my doctor because it has not gone away & have been given more Prednisone & Valacyclovir to treat it. I was informed by my doctor to file a report since it happened 12 hours after my flu shot. I'm still waiting for pharmacy to respond since I notified them on 10/11/2016. They informed me that they didn't now how to handle the report? My condition has not changed with the current treatment.
This spontaneous report as received from a nurse refers to a 19 year old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On an unknown date, 19 year old patient was vaccinated with pediatric dose of RECOMBIVAX HB injection 2.5/0.5 (dose, frequency, lot number, expiration date and route were not reported) for prophylaxis. No adverse effects reported. No product quality complaint was involved.
First episode of non-specific dizziness on 5/25.  Dizziness, nausea started daily on 6/6/21. Progressively debilitating dizziness, brain fog, extreme fatigue limiting my daily activities and eventually leading to my cutting back on schoolwork substantially and having to return from school to my home.  Symptoms have been improving over past month, though not resolved. Now under care of neuroimmunologist at medical facility.
My arm was really sore. I had chills and night sweats throughout the night. I had fevers, chills, sweats, headache, fatigue the rest of the following day after the vaccine. I continued to have headaches for the next two nights.
Information has been received from a medical assistant who on 18-JUN-2009 got "some" ROTATEQ (Lot # 663147/1486X) on both of her hands. It was noted that she washed her hands right away. The medical assistant stated she opened the foil pouch and as she was removing the oral dosing tube it felt wet and sticky. She then realized that the inside of the pouch was wet and concluded that the tube had leaked into the package. She stated that the end of the foil pouch was not sealed. It did not look like the foil was cut or as if someone opened it; it just looked as if it had not been sealed. There was no damage noted to the tube or cap or the foil other than the open end. It was reported that this had never happened before to this office. The medical assistant also reported that her hands have felt itchy since she was exposed to ROTATEQ. The medical assistant did not think it was related to the exposure but she thought she would mention it. At the time of the report, the patient's status was unknown. Follow-up information received from a physician indicated that the vaccine was already opened and was leaking when removed from paper box. It was not administered by them to patient. The medical assistant had not sought medical attention. There were no adverse effects reported. Additional information is not expected.
Almost immediately post vax, this child developed an erythematous area covering an area of 2x3 inches. Two additional wheals developed. There was no fever and the registered nurse said it was not anaphylactoid reaction. Additional information has been requested.
This spontaneous report was received from a nurse practitioner referring to a 52-year-old male patient. The patient's historical drugs, medical history and concurrent conditions were not reported. The patient's concomitant therapies included sterile diluent (MERCK STERILE DILUENT) 0.5 ml, one time, lot# U001953, expiration date 18-JAN-2023. On 30-NOV-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 ml one time, lot# N017698, expiration date 09-JUN-2019, for prophylaxis (strength, route and frequency were not reported) (expired product administered). There was no temperature excursion. No other adverse event reported.
pain over the entire body / aches; unable to move from her bed; This case was reported by a consumer via call center representative and described the occurrence of immobile in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th August 2019, the patient received the 2nd dose of Shingrix. On 12th August 2019, less than a day after receiving Shingrix, the patient experienced generalized aching. In August 2019, the patient experienced immobile (serious criteria GSK medically significant). On an unknown date, the outcome of the immobile and generalized aching were not recovered/not resolved.   It was unknown if the reporter considered the immobile and generalized aching to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient's husband. The age at vaccination was not reported. The patient received Shingrix and was experiencing pain and aches and she was unable to move from her bed.  The pain was over her entire body. In the structural field for source document, the patient's age group was reported as infant, however in the database, it was reported as adult. The reporter consented to follow up.
pain, redness & swelling of lt arm 1 day p/vax given;began oral amoxicillin 2 days p/inj;had spread to entire lt arm;30MAR-1APR hosp-adm to hosp for IV ATB followed by oral dicloxicillin;staph bursitis & cellulitis distal to inj
Patient received immunizations at 3:50PM, to check on infant at 4:05pm parents noted rash on abdomen, trunk, neck, both cheeks, jaw line.  Patient was given 0.2 ml of Benadryl 50mg/iml vial intramuscular in left deltoid.  Checked on patient 10 minutes later rash was fading time 4:30pm.  At 4:30pm rash was gone.  Patient received other the counter Motrin prior to  immunization.
Headache, Myalgia, Arthralgia, NauseaVomiting, Fatigue, pain/swelling of injection site Narrative:  Swelling/pain/tenderness at injection site starting 6-7 hours after vaccination, continuing for 3-4 days. Headache, body aches, nausea and fatigue starting 24 hours after vaccination (all continued for 3-4 days). At time of report (8 days post vaccination), still complains of headache and fatigue.
DIFFICULTY WITH THE RIGHT SIDE OF NECK; RIGHT SIDE MUSCLE ATROPHY DOESN'T REALLY SHOW, EXCEPT FOR BUTTOCKS; HURTS DOWN THROUGH SHOULDER BLADE; LIMBS FELT HEAVY; MUSCLES AND BRAIN ON STRIKE, BRAIN HAD A HARD TIME COMING UP; MAJOR MUSCLE  FATIGUE/ DIFFICULT DEALING WITH THE MUSCLE FATIGUE; TWINGES; ABLE TO SPEAK MORE CLEARLY, MORE MOBILITY IN LEGS AND ARMS, LESS PAIN IN THE RIGHT SIDE OF THE BODY MORE ANKLE MOVEMENT AND READ JUST JOINTS; CHILLS; WOKE UP WITH SLIGHT HEADACHE; ACHY MUSCLE; TIRED; FEVER; RIGHT ARM NUMB; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included hemorrhagic stroke associated with pain, and concurrent conditions included seizures, felt like a chain mail sock on up to thigh, arm was standstill, and felt like arm had more soft tissue (padding) than muscle. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced right arm numb. On 15-MAY-2021, the subject experienced chills. On 15-MAY-2021, the subject experienced woke up with slight headache. On 15-MAY-2021, the subject experienced achy muscle. On 15-MAY-2021, the subject experienced tired. On 15-MAY-2021, the subject experienced fever. On 18-MAY-2021, the subject experienced able to speak more clearly, more mobility in legs and arms, less pain in the right side of the body more ankle movement and read just joints. On 25-MAY-2021, the subject experienced twinges. On 26-MAY-2021, the subject experienced limbs felt heavy. On 26-MAY-2021, the subject experienced muscles and brain on strike, brain had a hard time coming up. On 26-MAY-2021, the subject experienced major muscle fatigue/ difficult dealing with the muscle fatigue. On 17-JUN-2021, the subject experienced difficulty with the right side of neck. On 17-JUN-2021, the subject experienced right side muscle atrophy doesn't really show, except for buttocks. On 17-JUN-2021, the subject experienced hurts down through shoulder blade. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, achy muscle, and fever on 15-MAY-2021, and woke up with slight headache, had not recovered from major muscle fatigue/ difficult dealing with the muscle fatigue, and the outcome of able to speak more clearly, more mobility in legs and arms, less pain in the right side of the body more ankle movement and read just joints, right arm numb, tired, twinges, difficulty with the right side of neck, hurts down through shoulder blade, right side muscle atrophy doesn't really show, except for buttocks, limbs felt heavy and muscles and brain on strike, brain had a hard time coming up was not reported. This report was non-serious.
Information has been received from a physician concerning an 8 week old female who on 18 Dec 2006 was vaccinated with Rotateq (Lot# 654970/0777F). Concomitant vaccinations received on 18 Dec 2006 included Comvax, Prevnar, poliovirus vaccine and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 18 Dec 2006, the patient vomited several times after receiving Rotateq. The patient sought unspecified medical attention. Subsequently, the patient recovered from vomiting. The patient's guardian decided not to continued the series of Rotateq series in the future. Additional information has been requested.
I received my first Moderna booster for COVID-19 on 10/17/2021. I had a known exposure to COVID-19 on 10/9/2022. I then self-isolated immediately afterwards, and I then began to have a sore throat on 10/11/2022. I used a nasal swab test that day, and it yielded a negative result. I then took a swab of my throat and got a positive result. On 10/12/2022, I took more nasal swabs, which then yielded a positive result. Over the next 6 days, my symptoms developed from a severe sore throat to coughing and sinus congestion. I then began to test negative on home antigen tests on day 7 and continued to test negative until day 10, which was the last day of the isolation. We then tested again on day 11 and got a negative result. On 10/14/2022, I received a monoclonal antibody  treatment, which I believe improved the symptoms pretty quickly. On 10/17/2022, I took a Mucinex tablet every 12 hours (2 in total), because I was very congested. I don't know if they helped, since I was still pretty congested afterwards.
This spontaneous report was received from a female patient of unknown age reporting on herself. The patient's concurrent conditions included familial risk factor. The patient did not have medical history. The patient did not take concomitant medications. On unspecified date in 2007 (reported as: "about 10 years ago"), the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (strength, dose number, route of administration, lot number and expiration date were not provided) for herpes zoster. The reporter stated that "she gets shingles every year" (In 2007) since receiving ZOSTAVAX, it was stated that she "gets shingles roughly around every November" (last episode was In November 2016); additionally, the patient presented "a small rash in the same spot, on her upper hip" (unspecified right or left hip). The patient "self-medicates" (unspecified treatment). At the time of the report, the patient recovered on unspecified date in November 2016 from the herpes zoster. The reporter did not assess the relatedness between herpes zoster and ZOSTAVAX.
Began running a fever, chiils, headache,  temp reached 104 degrees the day after the injection.  Went to ER  to be seen.  Several tests run all negative Discharged same evening advised to take Tylenol and reaction should be gone within 24 hours.  Arm began to swell in the area of the injection site and that continues 2 days after the injection.  Arm at injection site is warm to the touch.
Some discomfort in breathing for a very short period .  Itchy red Rash on back of thighs and buttocks, scalp beginning Sat, the next day after vaccine.  I am not certain if the rash is hives from vaccine or possibly from gardening and a reaction to a plant I might have gotten on my skin while gardening Sat morning.
Sneezing multiple times in quick succession; Runny nose; This is a spontaneous report from a contactable consumer (mother) reported for her son. A 17-years-old male patient received BNT162B2 (Formulation: Solution for injection, Lot Number: EW0161, Expiry Date was not reported) via an unspecified route of administration in Arm Right on 20Apr2021, Tuesday (age at vaccination 17 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were none. History of all previous immunizations with the Pfizer vaccine considered as suspect was none. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Apr2021 the patient experienced sneezing multiple times in quick succession and runny nose. Mother was calling to report her son symptoms that he has been experiencing since he got the COVID Vaccine on Tuesday, 20Apr2021. She Stated, sneezing was started within an hour of the injection. Her son sneezes multiple times in quick succession which did not seem to be as bad today as it was yesterday and Tuesday. Runny nose was also started on the day of the injection which was ongoing at about the same pace. The patient did not require a visit to Emergency Room as well as Physician Office. The outcome of the event sneezing multiple times in quick succession was recovering while the event runny nose was not recovered.  No follow-up attempts are possible. No further information is expected.
redness,hot to the touch Dr from a walk in health prescribed doxy 100mg 1 bid
Low grade fever x 2 - 3? days. Mom did not check to confirm. Parent and caregiver noticed behavioral changes - hateful lashing out and hitting others. Child attends home daycare no problems before reports mom.
a moderna shot was mistakenly administered in place of a PPSV23 shot; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (a moderna shot was mistakenly administered in place of a PPSV23 shot) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-May-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced EXTRA DOSE ADMINISTERED (a moderna shot was mistakenly administered in place of a PPSV23 shot). At the time of the report, EXTRA DOSE ADMINISTERED (a moderna shot was mistakenly administered in place of a PPSV23 shot) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication was provided.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient reported lightheadedness/dizziness immediately after receiving pfizer COVID vaccine. He proceeded to lie down and blood pressure was taken. BP was 90/60 mmHg. Patient was able to sit up after receiving water and sat in a chair within 10 minutes. Blood pressure was rechecked and  was 98/68 mmHg. Patient felt normal after 30 minutes and left the pharmacy.
pt c/o pain, swelling, redness & rash @ inj site approx 24hr p/vax;swelling inc p/48hr of inj;site red, swollen & is producing heat;inj site erythema, >5cm or subcutaneous nodules or pruritus @ site;
Flu like chills, low body temperatures(96.4 to 98.4), unremitting swelling of under-arm lymph nodes,  achy chest, diaphragm,  loss of appetite, night sweats, lassitude.
Moderna COVID-19 Vaccine EUA Local allergic reaction at injection site:  Redness, swelling, hot, itching Began 2 days after injection, got better, then worse again 1 week later.
Had vaccination series and shingles/suspected vaccination failure; Shingles every 6 months; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Had vaccination series and shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles every 6 months). The outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 13-Mar-2023 The patient stated that he had the shingrix vaccination  series approximately 2 years ago and he had confirmed cases of shingles approximately every 6  months since receiving the vaccination series (no further information was known). The patient did not have an appointed primary care physician, he was assigned a different primary care physician with each visit. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The reporter consented to follow-up.
This spontaneous report was received from a medical assistant concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, unspecified patients were vaccinated with improperly stored doses of COMVAX (dose, route, Lot No. and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
fever of 101.4 and myalgias; fever of 101.4 and myalgias; This is a spontaneous report from a contactable nurse. This 24-Year-old female nurse reported for herself that:  A 24-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) intramuscular at single dose at left arm on 22Dec2020 for Covid-19 immunisation, administered at hospital.  Medical history included anxiety, depression, attention deficit hyperactivity disorder (ADHD), had experienced Covid prior vaccination. She was not pregnant at time of vaccination. The patient's concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced fever of 101.4 and myalgias on 22Dec2020. The patient underwent lab tests and procedures which included body temperature: 101.4 on 10Jan2004 fever of 101.4. No treatment received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of event was recovered.  Information on Lot/batch number has been requested.
pt recvd vax;later in the day, pt devel erythematous, hot area w/ induration at inject site which resolved w/in 5 days;
first dose hit her the same way the first dose did in neck and shoulders/felt the stiffness and pain in left side of neck and arm and shoulder blade first; first dose hit her the same way the first dose did in neck and shoulders/felt the stiffness and pain in left side of neck and arm and shoulder blade first; first dose hit her the same way the first dose did in neck and shoulders/felt the stiffness and pain in left side of neck and arm and shoulder blade first; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17Mar2021 (Lot number: ER2613) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (ongoing). There were no concomitant medications. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), NECK PAIN (non-serious), ARTHRALGIA (non-serious) all with onset Mar2021, outcome "recovered" (2021) and all described as "first dose hit her the same way the first dose did in neck and shoulders/felt the stiffness and pain in left side of neck and arm and shoulder blade first".  Additional information included: It was stated that the first dose hit the patient the same way the first dose did in neck and shoulders which lasted 10 days with the first shot, did not have the dried tissues and cramps at that time.   No follow-up attempts are possible. No further information is expected.
From initial information received on 23Jun05 from the pt's parent regarding an adverse event occurring, it was reported that a two month old male pt received his first dose of Daptacel, lot number C21DBAA; a dose of Ipol, lot number X1240; a dose a Comvax, lot number 0807P; and a dose of Prevnar, lot number A67184F, admin on 04Jan05. The routes and sites of admin were not reported. Three to four hours later, the pt developed persistent crying and arching of the back. Reportedly, he did have a temp prior to vaccination. The pt's recovery status was reported as not recovered. This pt was diagnosed with sensory problems following subsequent immunization with Daptacel on 23Feb05. This information has been captured in case 200501213. Follow up - From initial information received on 23/Jun/2005 from the patient's parent regarding an adverse event occurring, it was reported that a two-month-old male patient received his first dose of DAPTACEL, lot number C21DBAA (not a valid lot number); a dose of IPOL, lot number X1240; a dose a COMVAX, lot number 0807P; and a dose of PREVNAR, manufacturer Ederle), lot number A67184F, administered on 04/Jan/2005. The modes and site of administration were not reported. Three to four hours later, the patient developed persistent crying and itching of the back. Reportedly, he did have a temperature prior to vaccination. The patient's recovery status was reported as not recovered. This patient was diagnosed with memory problems following subsequent immunization with DAPTACEL on 23/Feb/2005. This information has been captured in case 2005-01213. On 19/Aug/2005, Pediatricians office called and confirmed the patient's mother never reported the events to the office. Correct lot number for DAPTACEL received on 04/Jan/2004 was C021033AA. The office will request additional information. Follow-up information received on 01/Sep/2005 confirmed no illness or use of other medications at the time of vaccination. There was no history of fever and no fever was noted on 04/Jun/2005. No adverse events were reported to the pediatrician's office post vaccination. The "memory problems" are not noted in the physician's chart. The patient is no longer cared for by the physician's office and the last note for this patient was on 21/Feb/2005. No further information is expected.
Pain, swelling, redness at injection site. area firm and warm to touch. Patient states that the pain radiated into her neck and under her arm.