chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I broke out in a rash; it's very sore; This is spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162b2 (PFIZER-COVID-19 VACCINE), via an unspecified route of administration on 23Mar2021 (Lot Number: ER2613) as single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had Covid Pfizer shot on 23rd of March and about the 27Mar2021 the patient broke out in a rash and patient just wanted to know what can be done to relieve it. Patient thought maybe it was patient's medications (unspecified medication) so called pharmacist and she said no sometime people have rash associated with it because before patient had the Pfizer patient's medicine was fine, Ionly take 2. Patient didn't had no problems when had it. First of all would like to know if people who got this that happened to them and then wanted to know what can be done to relieve it because it's very sore. Event outcome was unknown.  No follow-up attempts are needed. No further information is expected.
This is a spontaneous report from a contactable consumer (patient).  A 56-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left on 25Feb2021 13:00 (Batch/Lot number was not reported) as single dose at the age of 56-year-old for COVID-19 immunisation, administered at hospital.  Medical history included known allergies to nut, ongoing hospitalisation Vaccine received during existing Hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) at 112mcg, and isosorbide mononitrate (ISOSORBIDE MONONITRATE) at 60mg, both taken for an unspecified indication, start and stop date were not reported.  The patient had not received other vaccines within 4 weeks prior to BNT162B2. The patient experienced tightens of chest, difficult breathing, light headed, pulmonary embolism on 26Feb2021. The outcome of events was not recovered. The patient was hospitalized for events in 2021 for 21 days. Seriousness criteria for the evens were Life threatening and prolonged hospitalization.  The patient underwent lab tests and procedures which included Sars-cov-2 test (nasal swab): negative in Sep2020. Therapeutic measures were taken as a result of tightens of events.  Information on the lot/batch number has been requested.
This spontaneous report as received from a pharmacist refers to a 62 year old male patient with no pertinent medical history and no drug reactions/allergies. On 02-SEP-2014 the patient was vaccinated with a dose of 0.65 ml of ZOSTAVAX (lot # K000996, expiration date 13-MAR-2015), subcutaneous. Concomitant therapies included VIAGRA and alprazolam. On 08-SEP-2014, the patient experienced a rash with raised areas, "like blisters" around the eyes, nose and on the cheeks after receiving ZOSTAVAX. Patient has not had any pain or itching. No lab diagnostics studies performed. The patient sought medical attention via saw pharmacist. No treatment was given. The outcome of a rash with raised areas, "like blisters" around the eyes, nose and on the cheeks was unknown. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 16-FEB-2016, the patient was vaccinated with incorrectly stored doses of PROQUAD (Merck) (dose, frequency, therapy type, route of administration and indication were not reported, lot # L041626 with expiration date 20-APR-2017). No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected, because the reporter did not wish to be contacted.
have cellulitis in the face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CELLULITIS (medically significant), outcome "unknown", described as "have cellulitis in the face". The patient underwent the following laboratory tests and procedures: blood test: unknown results; investigation: unknown results; negative test results.  Clinical course: Find damages photos. Apparently the patient now had cellulitis in the face which obviously had been totally neglected for a while. He insisted on getting all his blood work. Clinic with tests for pulmonary embolism dvt scrotum rash etc. He needed a correct diagnosis now as this had been nightmare. He sent a letter of intent to sue and to follow will be court summons and claims. He needed to get correct medical attention and damages due to direct intent to injure and connected injuries. He had negative test results but needed to correctly diagnose the skin damage done by the experiment vaccine. Totally and abject unfair and bodily harm.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient lost consciousness within 15 minutes after vaccine administration. Patient was transitioned to supine position and quickly recovered
Within an hour or 2 of receiving the vaccine she started not feeling well in general, like she was coming down with something. She also started feeling pain in her shoulder, up to the neck and down the arm to the elbow. As the day progressed the pain became worse and she couldn't move her arm at all. This lasted for 2 days. The reaction started to subside by 3/26/15 and she could move her arm a little, but still does not have full ROM. Spoke to patient on 3/27/15. She continued to have low energy through 3/26 but feels better today. The arm is still tender to touch, but she has full ROM and her energy is better.
This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history was not reported. The reporter informed that an unspecified dates since 22-MAY-2014, the patients received GARDASIL, (lot # H020901, expiration date 05-JUL-2015 and lot# J006236; expiration date: 25-FEB-2016) via intramuscular, dosage and strength were not reported. Concomitant therapy was not reported. The reporter stated that from 22-MAY-2014 until 27-MAY-2014 the GARDASIL were improperly stored at 66 F (the total duration of exposure was 5 days). No known adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse concerning a 13 months old patient of unknown gender. There was no information about the patient's medical history, concurrent conditions and concomitant therapies. On 12-JAN-2017, the patient was vaccinated with improperly stored dose of VARIVAX from lot number M028551 with expiration date of 07-JUN-2018 (strength, anatomical location and route of administration were not provided) for prophylaxis. The administered dose with lot number M028551 was exposed to a temperature higher than -10°C but lower than 8°C for 9.7 hours measured with digital data logger. The lot also had previous temperature excursion higher than -10°C but lower than 8°C for 20 hours 16 minutes and -2.8°C for 1 hour 32 minutes. The nurse reported that a possible cause for the temperature excursions was the action of the auto defrost cycle of the refrigerator. They had ordered a commercial unit to eliminate this issue. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA009503: US-009507513-1701USA009504:
Sore arm; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter reported that patient experienced a sore arm for about a week after receiving the 1st dose of Shingrix. No further information was available.
Symptoms: Joint pain, multiple joints, muscle pain, paresthesia, tingling in lower extremities. Service member would like to report a vaccine related side effect-reports polyarthralgia, polymyalgia, and neuropathy in lower extremities following receipt of her 3rd anthrax vaccine. Received anthrax (3) in left arm over triceps on 3/7/03. Had a moderate local reaction with swelling and redness from near shoulder to just above elbow with myalgias described as dull, aching type pain affecting all joints and major muscle groups. Describes muscle pain as "tightness fatigued, like after major muscle use", but with minimal muscle exertion (example: after climbing 1 flight of stairs, leg muscles feel like she has pushed herself running several miles). Also reports muscles sometimes "tremble" which is self limited and last <1 minute. Usually wakes up with morning joint stiffness that last 2-3 hours; stiffness becomes more severe after sitting during a 45 minute drive, especially pain in sacral area. At end of day, "everything hurts". Stretching and heat help with pain. Also, if on her feet for extended periods, finds standing with a wide-based stance helps. Takes Motrin 800mg bid on daily basis, which helps make pain tolerable. Has taken Percocet for more severe pain, especially at the end of the day. Denies swelling, redness or increased warmth over joints. She thought the pain was related to 40 pound weight gain. Some improvement with weight loss accomplished through increased exercise (walking); when she stopped walking, her left SI joint became extremely painful and there was evidence of inflammation of SI joint around that time per CT. Has been evaluated by Rheumatology, with no definitive diagnosis. She denies history of trauma or injuries. No decreased strength. Positive family history of RA. Noted onset of bilateral lower leg, ankle and feet tingling. Paresthesias have gradually worsened. Neurology exam diagnosed as peripheral neuropathy, but not able to attribute to DM or other etiology. No stumbling or altered gait.
Fever; Chills; Aches; Fatigue; Nausea; Itchy and painful at injection site; Painful at injection site; Rash at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 13Apr2021 at 12:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included mental illness, fibromyalgia and allergies to cats and dogs. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient received unspecified medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 12:15, the patient experienced fever, chills, aches, fatigue, nausea, itchy and painful at injection site and rash at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, aches, fatigue, nausea, itchy and painful at injection site and rash at injection site was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
hiccups  11/12/22------8-9 pm 11/13/22------1201 am-1 am.     330am-430 am.    1230 pm. 115 pm.    325pm-4pm.  510 pm- - on going as of 605pm
"COVID arm'  About a week after the immunization, I developed a palm-sized red area under the site of the injection.  At first, it was hard and itchy.  Later, it softened.
22JUL94 730PM pt spiked fever then sz to ER: blood cultures done then sent home; 23JUL94 seen @ hosp fever all day;
I felt bad for a few days, which I expected and believe is normal.    Symptoms the day after 1/26/22 were headache, body aches, sore arm, and chills.  What I'm concerned about is the ongoing HEADACHE that I'm experiencing.  It is one week today since vaccine and I've had a headache every day since the vaccination.  Bright lights make it worse.  Medication, ibuprofen is not helpful.  Last night, 1/31/22 my vision was also blurry.   Headaches are rare for me.
Moderna Bivalent vaccine in refrigerator had a beyond use date of 5/18/2023. Vaccine vial was retrieved from the refrigerator and administered on 5/19/2023. Moderna healthcare team determined the vaccine maintained activity to protect against Covid-19.
Information has been received from a physician concerning a 5 year old patient who on 3/19/2001 was vaccinated with a dose of varicella virus vaccine live (lot 635607/1153K). On 5/30/2005 the patient developed a rash. On 5/31/2005 the physician diagnosed the patient with breakthrough varicella with 50-249 lesions. The patient had a fever of 100.3 that lasted 1 day. There were no complications. The patients diagnosis was not confirmed by the lab. The patient had no prior history of chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No medical history provided. On an unknown date the patient was vaccinated with PNEUMOVAX 23. No concomitant medications were reported. The pharmacist was informed by the patient that she had an allergic reaction PNEUMOVAX 23 on an unknown date. The allergic reaction was described as a local skin reaction at the injection site that was swollen. The outcome was reported as recovered. The patient sought medical attention by contacting the pharmacist and physician. Additional information has been requested.
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 23-JUL-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB "10Pk 10mcg/1mL SD LLok Cap AD", lot # L001441 with expiration date 17-AUG-2017 (route of administration and anatomical location were not reported). There were no concomitant therapies and adverse effects reported. No product quality complain was involved. On an unspecified date, the RECOMBIVAX HB had four temperature excursion of 32 F (0 Celsius Degrees) for 152 hours, 31 F (-0.5 Celsius Degrees) for 40 hours, 33 F (0.5 Celsius Degrees) for 40 hours and 34 F (1.1 Celsius Degrees) for 88 hours, respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and type of excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
Pt was given Pfizer vaccine as the second vaccine in the series when pt had Moderna as 1st vaccine in the series.  Pt had no adverse reaction to the vaccine today.
GI Bleed; Blood count dropped; A spontaneous report was received from a consumer, who was also a female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced a GI Bleed and her blood count dropped.   The patient's medical history included high blood pressure, obesity and type 2 diabetes.  Products known to have been used by the patient, within two weeks prior to the event, were Metformin and Lisinopril.   The patient received their first of two planned doses of mRNA-1273 (LOT 041L20A) on 02-Feb-2021, approximately six days prior to the onset of event, intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 08-Feb-2021, patient reported having gone to the ER and was subsequently admitted to the hospital with a GI bleed.  She reported that she received 10 units of blood during her hospitalization. She received 10 units of blood over the days she was in hospital, from 02-08-2021, up until 02-16-2021. Patient asks is it safe for her to get the second vaccine? She never had a GI bleed like that before. Her blood count dropped. She was discharged on 16-Feb-2021. Patient expressed concerns about receiving the second dose of mRNA-1273.   No relevant laboratory details were included.  Action taken with the drug in response to the event, GI bleed, was not reported.  The outcome of the event, GI bleed, was considered recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events of GI bleed and blood count dropped, a causal relationship cannot be excluded. Patient's significant medical history included high blood pressure.
Initial information received on 29-Aug-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown demographic patient who received a of vaccine IPOL which got expired due to temperature excursion. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On an unknown date, the patient received a dose of suspect IPV (VERO) lot number not reported via unknown route. It was a case of actual medication error due to incorrect product storage. It was unknown any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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. List of documents held by sender: none.
Arm is extremely sore and my whole body is very achy and sore.  Almost passed out and had tingling all over and almost threw up. Significant headache.
The arm that I received the vaccine in (Right Arm) Has been falling asleep if I hold it still, in as little as 10 minutes.  This hasn?t been too big of an issue while awake, But in my sleep last night I woke up around eight times with my arm completely dead limp and getting no blood circulation.  I had to move it around with my left hand for a while to force blood circulation before I could move my right arm again. I would then do little blood circulating exercises with my right hand and arm until it felt normal again, Then I would go back to sleep. I was sleeping on the opposite side (on left arm or back) So there was nothing else that could?ve been cutting off circulation. This is not something that?s normal for me. I spoke to a nurse at the site that administered the dose, and she advised me to call back and get an appointment with a nurse if the problem continues in my sleep tonight.
administered the 2nd dose of GARDASIL 9 26 days ofter the first dose; no adverse event; This spontaneous report was received from a physician referring to a 20 year old patient of unknown gender.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 1 for prophylaxis and then, 26 days later, received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported)  (inappropriate schedule of product administration).  No adverse events were reported.
This is a 38 year-old who presents for evaluation prior adverse event to receipt of his first two anthrax vaccinations. The client relates that he received his 1st anthrax vaccination on or about 01/16/2003. Within a day or two of receiving the vaccination, the client developed a "white pimply, itchy" rash behind his left knee. Since he has a known history of eczema, the client treated it initially as he would his eczema. He applied Eucerin cream and later was provided with hydrocortisone cream. He relates that the area seemed to clear up, but remained itchy.  Approximately 2 weeks after receiving the first anthrax vaccination, the client received his second vaccination per the accepted schedule. Later the same day he was deployed. He developed a "white pimply, itchy" rash in his groin and scrotal area approximately 3 days following receipt of the 2nd vaccination. He was initially treated for tinea corpus (jock itch), but this did nothing to cure the problem. He reported back to medical on 16 February 2003 with complaints of a 5-day episode of left testicular pain and swelling. He relates that his pain on standing was 8-10/10 and while sitting was 5-6/10. It was determined that he did not have tinea corpus and he was admitted to the hospital for further evaluation and treatment. He underwent a diagnostic ultrasound that demonstrated left testicle intact without masses, epididymal cyst with fluid and scrotal wall edema. His WBC count was 10.8, with the remainder of the complete blood count within normal limits. His urinalysis was also within normal limits.  On 19 February, the client underwent incision and drainage of penile base, left hemi-scrotal secondary to abscess formation. He was treated with multiple antibiotics, both for anaerobic and aerobic organisms. He progressed satisfactorily and on 26 Feb 2003, he was medivaced to another hospital. Sometime thereafter, the date is not listed in the chart, the client was returned to continue convalescence.  Nurse follow up on 08/31/04 states: "Confirmed scrotal abscess; fever; rash."
SUPERIOR CEREBELLAR ARTERY SYNDROME ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY HYPOTENSION
Rectal fever 101.7; uncontrolled by Tylenol and Motrin.  Refusal to eat.  Unconsolable crying and deep cough.  Immunosuppression due to existing illness. Given IV fluids, oxygen, Xopenex, and Pulmicort. Information from discharge summary states dehydration, thrush, hypoxia.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II, lot number L019989, expiration date: 01-JUN-2017, lot number L024268, expiration date: 01-JUL-2017 and lot number M001200, expiration date: 28-AUG-2016, (dose, route of administration and injection site were not reported). There were no concomitant medications reported. It was stated that the vaccines underwent a temperature excursion of 54.9 degrees Fahrenheit for 2 hours and 40 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.