chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Smallpox; hit the head; Eye swelling; This serious case was reported by a consumer via interactive digital media and described the occurrence of smallpox in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included smallpox.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced smallpox (Verbatim: Smallpox) (serious criteria GSK medically significant), head injury (Verbatim: hit the head) and eye swelling (Verbatim: Eye swelling).The outcome of the smallpox was not resolved and the outcome of the head injury and eye swelling were not reported.   It was unknown if the reporter considered the smallpox, head injury and eye swelling to be related to Shingles vaccine.     It was unknown if the company considered the smallpox, head injury and eye swelling to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported by a patient via (social media) interactive digital media. The reporter stated that whoever had smallpox as a child could get it again after 50 but he/she believed it and they gave him/her the shingles vaccine almost 4 years ago and he/she still had problems.  They injected the virus, he/she hit his/her head, one eye swollen shut, he/she went to A and E (emergency department) twice.  The reporter further stated that it did more harm to the body than good.  The patient met so many elderly people and no one got it.
Pain at injection site, started evening of injection (L) deltoid. Pain increases and decreases depending on the day. Pain radiates down upper arm. Pain makes it difficult to sleep on left side, waking me up at night. There is now decreased range of motion and weakness to (L) arm. Tried ibuprofen with minimal results, tried ice and heat.
Specific events unknown to this nurse. Child death was reported from local office with request for records from last 12 months including immunization records. Vaccines were given 6 days prior to death.
I woke up on 11/19/2022 with a sore throat after a hike I took a COVID-19 test on that day and  it was negative. I was very fatigued and the next day I had congestion as well.  I tested on Monday 11/21/2022 and it was positive. I have now or at the time of reporting lost both taste and smell.  I have a  persistent cough but I am now beginning to finally feel better.
Pt would like to remain anonymous as the reporter so that the doctor doesn't know she filed the complaint. Pt complains of soreness at injection sites however had serious pain on left arm, it was also hot, discomfort such that couldn't sleep at night or move left arm at all by next day. Blisters at injection site also appeared and extended through the back of the neck. Had a horrendous case of flu next day with headache, nausea, chills, coughing. No medication taken. Evening of 2nd day bad case of flu starting to recover, symptoms subsiding. Left arm muscles are paralyzed and right arm just sore. Monday hand and arm numb, unable to close fingers. The blisters are now on abdomen, upper breast, shoulder neck and more are appearing. Blisters ooze liquid.
Itching and Having Welts; Itching and Having Welts; Initial Report Received on 08-Jun-2022  A registered nurse reported that male patient (age, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced itching and welts all over his body afterwards.  No medical history at the time of vaccination was reported.   Concomitant medications at the time of vaccination were reported as unknown.  On an unspecified date, the patient received a dose of HEPLISAV-B (Lot # 935848, expiration date 02-Dec-2022, serial # 758765222631, NDC #, route, and injection site unknown).   On 06-Jun-2022, the patient complained of itching and having welts all over his body "after receiving vaccination".   No additional information was provided.  Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
3 days after shot she began having eye rolling and weird jerking movements in arms and face. Called DR several times to report this and they were not concerned at 1st. finally got appt to be seen exactly 1 week after shots were recvd and they made appt for EEG. 4 EEG's later and she is develop behind to a 1 month old per Dr and PT/OT. She may not be able to see/hear. She suffers from Infantile spasms/static encephalopathy and progressive myclonic epilepsy.  02/19/2007 MR received from PCP for office visits beginning on 11/06/2006 (date of vax.) to 01/30/2007. HPI: 1 week following vax. infant presented to PCP with parental c/o increasing frequency of eye movements.  Infant also has startle-like movements associated with the episodes PE: WNL. Assessment: ? seizures.  EEG to be obtained. Several more office visits for increasing frequency of seizures.  Seizures are focal, motor manifestations. Diagnosed with infantile spasms.  Pt did have a very short episode of upper extremity jerking during 12/09/2006 office visit. Assessment: Seizures/Other convulsions, non-febrile.  Infantile Spasms without mention of intractable epilepsy.  Treated with Topamax and ACTH.  02/26/2007 MR received from evaluating hospital for an admission to further work up child's infantile spasms. Admission PE showed a very chubby irritable child with slightly low tone in the musculoskeletal area.  Inconsistant tracking.  Can hold head when pulled up but cannot sit unsupported.  Does not reach for objects.  Axial hypotonia.  No attempt to roll over.  Otherwise WNL. Assessment:  Child appears to have a progressive encephalopathy in association with the onset of infantile spasms. Genetics and Metabolism Consult: Loss of developmental milestones now with developmental delay and seizure-like activity.  03/26/2007 DC Summary received from hospital stay. DC DX: Infantile Spasms.  Developmental Regression of milestones/delay. Developmentally delayed to a 2 month old still has abnormal EEG with Sz.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative 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 not reported, batch number: unknown) dose, start therapy date were not reported, frequency 1 total for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had suspected clinical vaccination failure, and experienced suspected covid-19 infection (loss of senses of taste, and loss of senses of smell). Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210666990-Covid-19 vaccine ad26.cov2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Red spots under skin, (arms) a week later, slight burning feeling. Sometimes tinglingly. Better after cortisone cream but some symptoms persist.
Lower back pain, fever (101.4), joint pain (17 OCT - 18 OCT 2021) - Tylenol extra-strength given, and a heating pad. Lower back pain (19 OCT 2021) - Tylenol extra-strength and a heating pad. Chest pain (9 AM 20 OCT 2021) - Ibuprofen taken (pain did not go away) Chest pain & lightheadedness (6 PM 20 OCT 2021) - Went to urgent care and the ER. Chest pain (10 PM 21 OCT 2021) - Ibuprofen taken. Chest pain (10:30AM 22 OCT 2021) - Went to cardiologist.
Fever -  First 72 hrs Vomiting - between 48 - 72 hrs Diarrhea - between 48 - 72 hrs AFIB - between 48 - 72 hrs Tachycardia - 72 hrs - 96 hrs
Patient presented to the emergency department with pleuritic chest pain.  Troponin I was elevated 0.44 (normal range 0.000-0.059).  Laboratory abnormality was consistent with possible myocardial injury.  EKG did not show any evidence of myocardial infarction.  Patient underwent myocardial perfusion imaging that showed no evidence of ischemia.  Troponin decreased to 0.31.  Patient remained stable.  He was discharged with recommendation for NSAIDs and colchicine for treatment of possible myocarditis/pericarditis.
Information has been received on 14-MAY-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 01-JUN-2016, the patient was treated by a physician at a hospital for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 25-SEP-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J00456 and expiry date: 15-DEC-2014) which was improperly  stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several repots from the same reporter. Additional information has been requested.
After my second doseWaited my 15 minutes but when I was in the car leaving so maybe 10 minutes later had a strange sensation come over my head and especially my mouth  Now 6 months later I always feel like I have either just eaten a mint or something very spicy . Tongue always feels this way  Sometimes my lips feel numb and sometimes my gums feel strange  This has not gotten any worse or any better
lt arm swollen deltoid to below elbow;local rxn;early cellulitis;tx w/ATB & atarax;
Stiffness in leg, red swollen bump at site of injection, fever, rash dx of Juvenile Idiopathic Arthritis (polyarticular).
Severe headache first. Then chills, fever and leg twitches starting 12 hours later in the middle of the night. Lasted 2 days. During this time also developed a red rash. Photos available. The rash was on the upper arms, neck, chest.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 19 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-dgree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (not adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly).
woke up overnight feeling extremely nauseated. She was on the toilet holding the trash can and gagging and thinks she remembers putting the trashcan down but then passed out. Her husband found her on the bathroom floor with her jaw clenched. She says the nausea was so intense it felt like alcohol poisoning when she was younger. She did not go to ER.  She felt weak and tired for the next several days.
2/19/21  12:30 AM- slight headache, followed by chills and body ache-especially lower bac. Last until about 4 PM 2/19/21 2/19/21  2:00 AM - discomfort chest/heart- Thought maybe I should mention it to doc if continued. Lasted 20 min.  max. 2/19/21  12:30 AM-lower abdominal discomfort, bowel movement did not relieve discomfort - intermittent for several days until  2/23/21. Did not interfere with activities. Since symptoms were mild, I "toughed" it out. No medication
Received 1st. Pfizer vaccine shot at 10:00 am Thursday 2/10/2021 At approximatly 6:00 pm same day I started to have severe  pain in my side shortness of breath and could not lie down to go to sleep. Had to go to bed sitting up with three pillows on my back. The next morning went to doctor who ordered blood test and chest X-Ray. Chest X-Ray indicated Pulmonary Embolism. Doctor started me on Eliquis blood thinner to hopefully desolve the blood clot on my lung. Doctor suggested I report Pulmonary Embolism occuring same day as my first vaccine shot. Do not know if shot caused Pulmonary Embolism or just a coinsidence. In addition doctor found blood in my urine and a CT of Bladder has been ordered
patient was given the Pentacel vaccine without mixing the powder so the patient only was given the liquid portion, no AE; Initial information received on 24-Jun-2020 regarding an unsolicited valid non-serious case received from a Nurse.  This case is linked to case 2020SA165276 (same reporter).  This case involves a four month old male patient who received a 0.5 ml second dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot Diluent: U6615AA, Powder: UJ196AB, expiry date 02-Mar-2021) via an intramuscular route in the left thigh for prophylactic vaccination on 16-Jun-2020, without mixing the powder so the patient only was given the liquid portion (product preparation issue).  The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  Concomitant vaccinations included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) for prophylactic vaccination.  It was an actual medication error case due to inappropriate reconstitution technique.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
After a week or 10 days, a large knot appeared on arm with a red mark with fever in it.  It now looks like a bruise.
Patient had his CoVID vaccine today and his mother stated that he doesn't like needles. Immunization was given in his right deltoid. He walked to registration with his mother and then crumpled to the floor. RN was called to reception and he was sitting in a chair where he was found to be diaphoretic and pale by RN. RN and MA placed him in a wheelchair and brought him back to exam room 2 where he was able to lie on the exam table with his legs elevated on pillows. RN fanned him until MA brought a portable fan. Mom was at the bedside. Patient had a cool, wet cloth applied to his forehead by MA and was comfortable.   He was able to take a few sips of cold water without issue. He reported feeling better.   Orthostatic VS taken - was able to see patient and agreed. RN assisted him to his car without incident.
stopped getting the flu shot years ago and have not had the flu since; Initial information was received on 03-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves adult patient (unknown gender and unknown age) who experienced "I stopped getting the flu shot years ago and have not had the flu since" (influenza), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications 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 developed non-serious event I stopped getting the flu shot years ago and have not had the flu since (influenza) (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 for the event.  It was reported "I stopped getting the flu shot years ago and have not had the flu since keep your shots. Probably half of your covid cases were the flu".  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX (lot# and route unknown) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2010, a healthcare provider at a pharmacy administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
redness at injection site; swelling at injection site; tenderness at injection site; itch at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site tenderness and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site tenderness and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site tenderness and injection site itching to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received Shingrix, 3 days ago of the reporting date. Till the time of reporting, the patient was experiencing redness, swelling, tenderness and itch at the shot site.  The patient asked about treatment of these symptoms specially itching.
This spontaneous report as received from a 57 year old female healthcare worker regarding herself with high blood pressure, prednisone allergy, shellfish allergy and unspecified thyroid disorder. On an unknown date in 2000 the patient received a first dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) vaccine (lot number and expiry date not reported) (dosing regimen and frequency unknown). ON an unknown date in 2005 (also reported as about 5 years later) the patient received a second dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) vaccine. Concomitant medications  included unspecified blood pressure medications and unspecified thyroid medication (manufacturer unknown). ON an unknown date approximately in November 2012 (also reproted as about a year ago) the patient developed bronchitis which lasted for about 4 months. On an unknown date a chest X-ray and a pulmonary function test were performed which showed that her lungs were fine. On an unknown date approximately in March 2013 (also reported as lasted for about 4 months) the bronchitis cleared up without treatment. It was reported that the patient sought medical attention and   went to physician's office. ON an unknown date in 2013 the patient received a third dose of an unspecified pneumococcal vaccine, polyvalent (23-valent) on an unspecified date after the bronchitis resolved. The healthcare worker reported that the third dose of the unspecified pneumococcal vaccine was administered by an unspecified physician. The outcome of bronchitis was reported as recovered. The relatedness of the event bronchitis to the therapy with pneumococcal vaccine, polyvalent (23-valent) was unknown. Additional information has been requested.