chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was given PNEUMOVAX23 that was recalled; Incorrect Product Storage; This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications and drug allergies/reactions were not reported.  On 16-OCT-2020, the patient was vaccinated with recalled dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 0.5 milliliter (lot # S036495, expiry date 13-SEP-2021), for prophylaxis.  On 16-OCT-2020, 1 day after onset of therapy the patient experienced recalled product administered and product storage error.    The outcome of recalled product administered and product storage error is unknown.   It was also reported that the aforementioned vaccine was incorrectly stored (temperature excursion details were not reported) and administered to the patient before being recalled. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Information has been received from a certified medical assistant concerning a 25 year old female patient with no drug allergies or allergies who on 03-AUG-2011, was vaccinated with the first dose of GARDASIL (route, dose and lot number not reported). On 21-SEP-2011, the patient had a seizure. On approximately 30-NOV-2011 (date reported as 31-NOV-2011), was vaccinated with the second dose of GARDASIL (route, dose and lot number not reported). There were no concomitant medications. On 05-DEC-2011, the patient had another seizure. The healthcare worker reported that the patient visited the physician because of an abnormal PAP smear (date of abnormal PAP smear unspecified also reported as medical history). Healthcare worker stated that patient reported she was on KEPPRA for seizures. The patient sought medical attention. No laboratories were performed. At the time of the report the outcome of the patient was unknown. Upon internal review, the seizures were determined to be an other important medical event. Additional information has been requested.
Headache & Muscle aches day 1  Fever, Chills, Muscle Aches, Fatigue day 2 Headache day 3
Information has been received from a consumer, who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot # not provided). The consumer mentioned she received PNEUMOVAX 23 and got reactions. The consumer was told she had mild valve damage to her heart. In the past years during regular checkups was told she had no heart murmur. The consumer before she received PNEUMOVAX 23 was told she had no heart murmur. At the time of the report, the patient's outcome was unknown. No further information is available.
Shot 1 - arm pain at injection site/Shot 2 - arm pain at injection site; moderate headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 13:30 (Lot number: ER8729) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine. Vaccination history included: Bnt162b2 (Product:COVID 19, Lot number: ER8732, Lot unknown:False, Administration date:24Mar2021, Administration time:04:45 PM, Vaccine location: Left arm, Dose number:1, Shot 1 - arm pain at injection site), administration date: 24Mar2021, when the patient was 55 years old, for COVID-19 Immunisation, reaction(s): "Shot 1 - arm pain at injection site". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 15Apr2021 15:00, outcome "not recovered", described as "Shot 1 - arm pain at injection site/Shot 2 - arm pain at injection site"; HEADACHE (non-serious) with onset 15Apr2021 15:00, outcome "not recovered", described as "moderate headache". Therapeutic measures were not taken as a result of vaccination site pain, headache.   Additional information: Facility type vaccine was School or Student Health Clinic. There was Report about COVID vaccine. There was no other vaccine in four weeks. Reporter was not COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a licensed practical nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 31-JAN-2017, the patient was vaccinated with an expired dose of VAQTA, injection (unspecified strength, dose and frequency) (Lot number: L027735; expiration date: 12-JAN-2017) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
After Injection, he had a very brisk local site reaction that caused redness and pain.  The redness got better, but the pain progressed and began to radiate down the arm to the  elbow.  The pain is deep and aching.  it has persisted for a month.  It is just now beginning to slowly resolve.
Patient states that she received the injection on 3/25 and on 3/26 she began with a full body itch and has continued daily and still strong.  She said that is feels like itching underneath her skin and her MD stated she had a rash on her back
urgent continuous diarrhea, abdominal cramps, weight loss (5 lbs) in 3 days, dehydration, low blood pressure. clear liquid diet, blood pressure medications adjustment
pt recvd vax 01MAR95 & had tremors (eyes were closed) lasted about 1 min; woke w/face flushed was tired; slept about 4 hrs;  hx of szs beginning last yr
I went to Pharmacy and had 4th Shot. I waited my 15 minutes and went home after that. Once I got home I started feeling bad I felt I had to much caffeine. The next day at dinner time and I was eating I started itching and I started hyperventilating and went to Urgent care and was not able to be treated they sent me to ER where they gave me medication and I was there for about 20mins where the Itchy subside. I am still taking medication and will follow up with my doctor.
11dec89 pt vax hepta B apprx. 14 1/2 hrs after pt ex. mild wheezing and dyspnea.  pt recovered.
Patient stated the vaccine hurt at the time of administration and was sore from that point on. Pt states she had pain at the site and entire upper arm area that was limiting movement. She went to her Dr. on 10/12 to seek treatment. Patient states she still has some pain in the upper arm today, 10/29.
Received vaccine 11/19/09 at 1pm. Approx 11:30pm woke from sleep with coughing, sounds like barking. Airway is raspy during inspiration and expiration. Given 5mg claritin and 1 1/2 tsp children's Ibuprofen, continues to have bouts cough until 3:30 ant. periods of apnea when seizure lasted 5 seconds. Continues now tih wet cough.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). At the time of vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the patient's healthcare provider that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. Alternatively, in 2014, the patient's healthcare providers included but not limited to a pharmacist, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis that it did not carry any significant risks of adverse effects. On an unknown date, reported as subsequent to the vaccination, the patient was treated for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffered ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was not recovered. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Employee reported fever of 101.4, arm swelling/redness/itchiness, vomiting  and diarrhea starting on 10/14/21.
Patient had muscle aches so badly she couldn't get out of bed for an entire day. She said she had a fever but she didn't take her temperature.  She said she was short of breath. She said this after the 2nd dose was already given.
her heartbeat was pounding in her ears and it was faster than normal: Second dose; itching on her arm, it was hot and hard: Second dose; itching on her arm, it was hot and hard: Second dose; itching on her arm, it was hot and hard: Second dose; This is a spontaneous report from a contactable consumer (patient).  A 67-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution of injection, Batch/Lot Number: EW0169), via an unspecified route administered in right arm on 04May2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included, follicular lymphoma from Nov2010, she has to get Rituxan infusions for it. Rituxan infusions. After the first dose that the she received, she got really cold and chilled and her teeth were chattering. From there on she has had to get a steroid and a Benadryl infusion prior. Then the she has to stay there for 6 hours getting the slow drip of the Rituxan, Asthma, blood pressure abnormal, anxiety, anaphylactic reaction, rubber sensitivity and drug hypersensitivity (reaction to all penicillins and aspirin) all from an unknown date and unknown if ongoing. Concomitant medication included amlodipine 10mg once daily by mouth, taken for blood pressure abnormal, alprazolam 0.5 mg 3-4 times a day as needed, taken for anxiety, start and stop dates were not reported. The patient previously took BNT162B2 (BNT162B2, Solution of injection Batch/lot number: EW0151) via an unspecified route on right arm on 08Apr2021 as dose 1, single for covid-19 immunisation and experienced injection site pain. Past drugs include Rituxan infusions for follicular lymphoma, steroids and aspirin. The caller stated that, she had the second vaccine on a Tuesday, 04May2021, and seemed fine and had the reaction on the following Thursday, 06May2021, and Friday, 07May2021, it was a delayed reaction. The patient woke up on 06May2021, after taking Benadryl and she noticed that her heartbeat was pounding in her ears and it was faster than normal. The patient took some more Benadryl and went back to sleep. The patient was itching on her arm, it was hot and hard, when she woke up so she took Benadryl and went back to sleep. This went away after taking some Benadryl. These events started Thursday morning, 06May2021, and happened again on Friday morning, 07May2021, then that was it, she can't tell when it exactly stopped. The patient has been fine since and hasn't had to take Benadryl. The patient didn't feel like she was in danger or anything, she was concerned about her fast heart rate. The patient thinks this was an allergic reaction. The patient underwent lab tests and procedures which included heart rate increased: heartbeat was pounding in her ears and it was fast on an unknown date heartbeat was pounding in her ears and it was faster than normal. Therapeutic measures taken as result of the events includes Benedryl. The outcome of the events was recovered on an unspecified date in 2021.   No follow-up attempts are possible; No further information is expected.
This case was reported by a physician and described the occurrence of arm pain in a 41-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included genital herpes, hemorrhoids and hypothyroidism. Concurrent medications included Acyclovir, ALESSE and SYNTHROID. On 6 January 2011 the subject received 1st dose of BOOSTRIX (.5 ml, unknown, left arm). On either 7 or 8 January 2011, one or two days after vaccination with BOOSTRIX, the subject experienced arm pain and "not regained full use of the arm". The physician reported that the subject received a BOOSTRIX injection on 06 January 2011. Approximately one or two days later, the subject reported arm pain and sought medical attention from her primary care physician. The physician reported that subject "has not regained full use of the arm". The physician considered the events were disabling. At the time of reporting the arm pain and inability to use arm were unresolved. The physician considered the events were possibly related to vaccination with BOOSTRIX.
approximately 2-3 minutes after receiving the vaccine, patient became pale and complained of blurry vision.  His skin was also cool and moist.  Patient stated that he had not eaten lunch.  He was given a piece of candy and some water and cool compresses applied to head.  Within a few minutes, he was fully recovered.  He remained in the physician office for 30 minutes to monitor his condition.  No further symptoms exhibited.
Patient presented to the ED on 3/29/2021 "for evaluation of right groin, right flank pain and gross hematuria." Patient presented to the ED on 4/4/2021 for UTI. Patient presented to the ED on 4/19/2021 for dependent edema. Patient presented to the ED and was subsequently hospitalized for alcoholic intoxication. Patient had second vaccination on 4/26/2021. Patient presented to the ED and was subsequently hospitalized on 5/19/2021 for atrial fibrillation. These visits are within 6 weeks of receiving COVID vaccination.
This  75 year old male received the Covid shot on 3/25/21    and went to the ED on 4/7/21     and was admitted  on  4/7/21   with  the diagnoses listed below. U07.1 - COVID-19 J12.82 - Pneumonia due to Coronavirus disease 2019
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 02-JAN-2020, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
I was not able to move leg  and pain was so strong difficult to bear. It happens 4 hours after the vaccine. My daughter estimated that  it last about 5 minutes since she started hearing my cry ( she is my next door neighbor) When the paramedics came the pain was gone,  they checked my vitals and recommended me to hydrate.
Red patchy rash about 4 inches by 3 inches below Anthrax injection site.  Warm to touch,  Swelling and pain.  No streaking noted, Denies other symptoms.
Double vision, hearing changes ("tinty sound - helium like speech), decreased hearing ability, increased sense of smell, photosensitivity, severe headache, elevated blood pressure (systolic) (180-200/90). Hospitalized - 11/15/13. Treated for dehydration. Pain down spine. Released from hospital 11/18/13.
Severe headache; Muscle & joint pain; Muscle & joint pain; This is a spontaneous report from a contactable 64-year-old female consumer reported for herself that:  A 64-year-old female patient received BNT162B2 (COMIRNAT, solution for Injection, Batch/Lot number: Unknown), via Intramuscular route of administration administered at right arm as single dose on 25Jan2021 11:30 for COVID-19 immunization. The patient was allergies to penicillin, sulfa and codine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history included fibromyalgia, migraines, bipolar disorder, kidney disease and depression sinusitis. Patient has not had symptoms associated with COVID-19. Concomitant medications included Exceeding migraine (ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL), Azelastine HCI and Flucticasone. On 25Jan2021 at 12:15 the patient experienced severe headache, muscle & joint pain lasted 3 days after the vaccination. The events were assessed as non-serious. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19.  On an unspecified date, the outcome of the events were recovering.   Follow-up attempts have been completed and no further information is expected.
This spontaneous report as received from a healthcare professional concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with one dose of VARIVAX (Merck) (dose, strength, lot number and expiration date were not reported) subcutaneous route. Co-suspect and concomitant therapies were not reported. The healthcare worker reports that an improperly stored VARIVAX (Merck), were administered on 05-MAY-2014. The reporter stated that the VARIVAX (Merck) was exposed to a temperature of 6.4F for 2 hours on 05-MAY-2014. No adverse effect reported. Additional information has been requested. This case is one (1) of ten (10) reports from the same reporter. (MARRS 1405USA011237, 1405USA013601, 1405USA013602, 1405USA013603, 1405USA013604, 1405USA013605, 1405USA013606, 1405USA013607, 1405USA013608 and 1405USA013609).
1 week post-vaccine, my deltoid (injection site) became swollen, severely erythematous and very itchy  with a single wheel/welt over the injection site. Lasted approximately 36-48 hours, then swelling, erythema, and itchiness began dissipating .
Bulging fontanel:  First noticed 6/24/06 approximately 8:00 AM.  Bulging gone 6/25/06 AM.  No treatment.  High Fever:  101.7 temporal artery method first noted 6/24/06 approximately 2:00 AM.  Fever gone by 8:00 PM 6/24/06.  Four doses of infants Tylenol given approximately 5 hours apart.
A red patch/rash about 2 inches in diameter was slightly noticeable on my arm on the morning of Jan. 26. The rash was red and slightly raised by the end of day Jan 27th.  Rash still present but a little less red. Not itchy or painful.
Generalized fatigue and hypotension at home. The patient states her blood pressure has been running 80s/50s. She denies any fevers or chills. The patient does have a history of ovarian cancer. She has erythema noted to the right upper arm. Her inital vital signs show the patient is tachycardic, hypotensive and increased respiration. Sepsis protocol was initated. The patient is given ROCEPHIN and vancomycin in the ED. Her vital signs improved after fluids.
This case was reported in a literature article and described the occurrence of multifocal choroiditis of eye in a 33-year-old male subject who was vaccinated with Typhoid vaccine (manufacturer unspecified), yellow fever vaccine (non-GSK) and hepatitis A vaccine inactivated for travel. Historic vaccination included 1st dose of hepatitis A vaccine inactivated (manufacturer unspecified, unknown route and injection site) given 12 years prior. The subject had no history of autoimmune disease or recent viral illness and had no family history of autoimmune disease. Before vaccination, the subject was healthy. On an unspecified date, the subject received 1st dose of typhoid vaccine (unknown route and injection site, batch number not provided), 1st dose of yellow fever vaccine (unknown route and injection site, batch number not provided) and 2nd dose of hepatitis A vaccine (unknown route and injection site, batch number not provided). 3 weeks after vaccination with hepatitis A vaccine, typhoid vaccine and yellow fever vaccine, the subject experienced intermittent floaters and flashing lights in right eye. On examination, visual acuity was 20/20 in both eyes. Pupil responses, visual fields to confrontation, and intraocular pressures (14 mmHg) were normal bilaterally. Slit lamp examination revealed 1+ anterior vitreous inflammation bilaterally. Fundus examination of the right eye revealed a few scattered peripheral nonpigmented chorioretinal lesions. The macula and optic nerve appeared normal, and the left fundus was unremarkable. Fluorescein angiography of the right eye demonstrated scattered peripheral hyperfluorescent lesions correlating with those seen in the fundus, and there was no evidence of disc leakage. A comprehensive review of systems was negative for fever, rash, oral ulcers, arthralgias, headache, or vertigo. The patient was diagnosed as having acute multifocal choroiditis and was observed. This case was assessed as medically serious by GSK. After 2 weeks, the subject continued to describe occasional floaters. His ocular examination revealed continued low grade anterior vitreous inflammation and the peripheral retinal lesions began to demonstrate early hyperpigmentation. Because of the non-progressive examination findings and given the excellent visual acuity, it was decided to continue close observation. After 8 weeks, the subject's symptoms had self-resolved, the vitreous was clear of cellular inflammation, and the fundus revealed punched out areas of retinal pigment epithelium atrophy. Although this case did not prove causation and the relationship remained presumptive, it did suggest that some vaccinations could act as a trigger for immunologic initiation that could subsequently lead to the development of non-infectious uveitis.
Patient has complained of a raised, warm to the touch, red inflamed skin a couple inches below the vaccine and spreading at least 6 inches.
Within minutes of injection had pain at site, had increasing difficulty lifting arm over head that progressed for about 2 weeks but is now resolving somewhat.  Saw doctor who stated must be bad reaction to shot but take medicine for pain as needed or Motrin.  12/02/2005 follow up call states is improving.
About 2-3 days after recieving the vaccine, my upper lip got swollen and red. This side effect was easily treated with OTC anthistamines. I also developed a twitch in both eyes, which took a couple of weeks to wear off on its own.
Fever, Childs, Muscle and joint paint, diarrhea, headache, severe pain at the injection site
Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium