chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At 11:00 am noted Redness,burning at right arm anterior upper chest and neck and posterior neck. Petechial rash to right inner arm. Papular rash to outer upper arm and lower inner arm. BENADRYL 25mg oral given and Prednisone 60mg oral given. At Noon redness subsiding and patient states burning was not present. Patient was instructed to give BENADRYL this afternoon and every 6 hours as needed until redness and rash are gone and call the office in the am to report how child is doing. Take to ED or call 911 if needed before then.
C/o rash, stiffness after receiving INH ON 2/13/2014, ll leg weakness.
SORE INJECTION SITE FOR 5 DAYS AFTER. 10 HRS AFTER INJECTION STARTED TO EXPERIENCE FEVER, CHILLS, HEADACHE AND BODY ACHE.  FEVER AND CHILLS LASTED 15 HOURS AFTER START.  BODY ACHES LASTED 48 HOURS AFTER INIAL SIGNS.  HEADACHES CONTINUED DAILY FOR A WEEK, LESSENING IN STRENGTH, FOLLOWING INITIAL ONSET.
Pt receive HPV vaccine fainted, skin sweaty and clammy, BP dropped, and also pulse. B/P checked along with pulse.
Patient received vaccine at 16:05 and at approximately 16:15, the patient reported blurred vision in her right eye.
Full body ache, headache with sensitivity to light and noise, temperature of up to 101.7. Treated with Advil Or Tylenol  Happened 8 hours after dose. Broke at 8 am that next morning. Came back at 8pm that evening as well (24hrs post initial symptoms)
1305: vaccine administered 1312: Client reports facial numbness, feeling faint, short episode of shortness of breath x 1 min that resolved already, O2: 97%, P: 74 1315: Given life savers candy, BP 142/82 LA, Temp 98.1, Lungs CTAB 1317: States that he is no longer feeling faint but still has lip numbness, capri sun given 1325: Client states he is feeling better 1335: Client feels ok to drive. Released from clinic
Temperature excursion occurred and vaccine was deemed unsupported by manufacturer and should not have been administered.
Symptoms:  inflammation of the arm (extending from just below the shoulder to the middle of the forearm).  The arm is hot and swollen, appearing similar to simptoms of cellulitis.  No fever was present.  Patient received vaccination on 09/11/2003.  Symptoms were seen on 09/12/2003.  The physician was called 09/12/2003.  Patient saw physician on 09/13/2003 at approximately 10:30.  Treatment (Duricef) on 09/13/2003.
Sweating, intentional breathing, both hands, pins and needles, felt light-headed and hot.  All symptoms lasted only a few minutes (less than 5).
Incidental blood test on 4/2/21 showed  slightly low platelet count:  166 (nl 182-369) First time this has appeared.  Is it incidental Thrombocytopenia?  Or is it a result of the vaccine.? It should be reported either way according to your guidelines.  It will be monitored by primary physician, Facility and I have been advised to watch for bleeding or easy bruising.
Headache; slightly elevated temperature, nausea, diarrhea; tired - extremely; sunburn like rash on my face; felt really sick - this lasted about 12 hours.   On  April 15th - I was having pain in my left chest would I would inhale - I thought it was either lung or muscular but since it I have heart history I went to get it checked. It was muscular - it moved up from my chest to shoulder the next day and then went away after about a week. I was icing it and massaging it and taking muscle relaxers.  I had a routine visit with cardiologist yesterday. My blood pressure has been elevated lately and so they have added another blood pressure medicine for me to start - I just picked it up and will start tomorrow - Losartan  - 25 mg (and I am already on Metoprolol) and I'm taking an antibiotic for a procedure I had done on Friday
This spontaneous report as received from a healthcare worker refers to a 12 month old patient of unknown age and gender. On 11-AUG-2014 the patient was vaccinated with a dose of ZOSTAVAX instead of a first dose of VARIVAX (dosage, route and lot# not reported). No adverse symptoms reported. The outcome of event was unknown. Additional information has been requested.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 09-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L012482, expiration date: 10-APR-2017) (Incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Got the shot and got shingles/Suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, 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 Shingles vaccine.     Additional Information: GSK receipt date: 01-Oct-2022 Reporter's comment: The case was received from the patient's buddy via interactive digital media. The patient got the shot and got shingles. The reporter's elderly dad had them for third time in 2019 and reporter treated him with 6 essential oil blend which for him was amazing. The reporter's dad was not getting the shots. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
GIVEN 5 MODERNA VACCINE INJECTIONS THAT EXPIRED ON 8/8/21; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (GIVEN 5 MODERNA VACCINE INJECTIONS THAT EXPIRED ON 8/8/21) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (GIVEN 5 MODERNA VACCINE INJECTIONS THAT EXPIRED ON 8/8/21). At the time of the report, EXPIRED PRODUCT ADMINISTERED (GIVEN 5 MODERNA VACCINE INJECTIONS THAT EXPIRED ON 8/8/21) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (GIVEN 5 MODERNA VACCINE INJECTIONS THAT EXPIRED ON 8/8/21) to be not applicable.    No concomitant and treatment medications provided by reporter.
Fever; Chills; Aching left leg; Left leg tender; Left leg / red / Leg is still /pink; Left leg / swollen / Still swollen / foot; Still swollen ankle; Leg is peeling; Leg is / still warm to touch; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2021, the patient received the 2nd dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced fever, chills, leg pain, tenderness, redness of legs, swelling of legs, ankle swelling, skin peeling and skin warm. On an unknown date, the outcome of the fever, chills, leg pain, tenderness, redness of legs, swelling of legs, ankle swelling, skin peeling and skin warm were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, leg pain, tenderness, redness of legs, swelling of legs, ankle swelling, skin peeling and skin warm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. Two weeks after second shot the patient experienced fever, chills, aching left leg tender, red and swollen. After four weeks the patient had still swollen ankle and foot leg was peeling and still warm to touch and pink.
body aches; dizziness; fever; Initial information received on 26-Aug-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2020SA229965, 2020SA230493 and 2020SA231710 (same reporter).  This case involves an unknown demographic patient (age reported as between 20-30 year) who experienced dizziness, fever (pyrexia) and body aches (pain), while received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment, past vaccination, family history and concomitant medication were not provided.  On an unknown date, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (dosage form: pre-filled syringes) (lot UJ432AB and expiry date: 30-Jun-2021) via an intramuscular route in the deltoid for prophylactic vaccination.  On an unknown date, the patient developed a non-serious dizziness, fever (pyrexia) and body aches (pain) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data was not reported.  It was not reported if the patient received any corrective treatment.  At the time of this report, event outcome was not reported (unknown).
Headache/Sharp stabbing pains in head as well as muscles; cough; cold chills; hot flashes; fever; muscle and joint pain/Sharp stabbing pains in head as well as muscles; muscle and joint pain; fatigue; Loss of appetite; Brain fog; Some sinus pressure; flushed cheeks; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EL9265) via an unspecified route of administration on 04Feb2021 at 08:30 (at the age of 36-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was reported as none. It was reported that the patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (other medications in two weeks) included ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), zinc and multivitamin, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: 9L3246) via an unspecified route of administration on 07Jan2021 at 18:45 (at the age of 36-years-old) as a single dose in the left arm for COVID-19 immunization. On 04Feb2021 at 20:30 the patient experienced headache, cough, cold chills, hot flashes, fever, muscle and joint pain, sharp stabbing pains in head as well as muscles, fatigue, loss of appetite, brain fog, some sinus pressure and flushed cheeks. The patient did not require treatment for the events. The clinical outcome of the events headache, cough, cold chills, hot flashes, fever, muscle and joint pain, sharp stabbing pains in head as well as muscles, fatigue, loss of appetite, brain fog, some sinus pressure and flushed cheeks were recovering/resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Lupus Symptoms starting on 4/8: Joint pain, stiffness, muscle pain, Raynaud?s syndrome Joint Pain/Stiffness in fingers, wrists, knees, ankles; pronounced stiffness in fingers and wrists Treatment: Started with Advil, Doctor recommends Hydroxychloroquine
she develops high temperature; This is a spontaneous report received from a Pfizer sponsored program COVAX US Support. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on 09Mar2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had a knee surgery last Wednesday (31Mar2021) and developed high temperature on an unspecified date. The outcome of the event was unknown. The patient was due for her second dose on 09Apr2021.    No follow-up attempts are needed. No further information is expected.
It is suspected that the vaccine also reactivated a preexisting Hep C infection; In early september, I developed systemic lymphadenopathy and lymphedema; In early september, I developed systemic lymphadenopathy and lymphedema; chronic active Epstein-Barr viral infection incited by the second vaccine dose; fatigue; low RBC; low lymphocyte counts; This is a spontaneous report from a contactable pharmacist (patient). A 51-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 28Apr2021 (Lot Number: EW0169) as dose 2, single at the age of 51-years-old for covid-19 immunization. Medical history included asthma. Known allergies: penicillin (PCN), sulfa. No covid prior vaccination. The patient received other medications in two weeks (unspecified). The patient previously took bnt162b2 (Lot Number: ER8729) in arm left on 07Apr2021 for covid-19 immunisation. No other vaccine in four weeks.  The patient developed crushing fatigue following second vaccine dose. Blood tests yielded several abnormalities, including low RBC and lymphocyte counts. By early Aug2021, the blood tests normalized, and the fatigue mostly resolved. In early Sep2021, the patient developed systemic lymphadenopathy and lymphedema. These progressed rapidly, leading him to go to the ER on 16Sep2021. Subsequently, the patient saw multiple specialists and had a plethora of tests performed, including 3 biopsies, multiple CT scans, multiple ultrasounds, and innumerable blood tests. The final diagnosis from his hematologist at hospital was chronic active Epstein-Barr viral infection incited by the second vaccine dose. In addition, an antibody test for hepatitis C came back positive with a quantitative PCR test revealing a low viral load. A repeat viral load test was negative, suggesting the patient cleared the virus. It is suspected that the vaccine also reactivated a preexisting Hep C infection. Adverse events start date was reported as Apr2021. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received treatment for the events (also reported AE treatment included multiple testing procedures). No covid tested post vaccination. Outcome of the events was recovering.; Sender's Comments: The event of Hepatitis C Relapse, fatigue, red blood cell count decreased, lymphocyte count decreased, lymphadenopathy, lymphedema, Epstein-Barr virus infection, is assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Flue like symptoms. Severe headache and body ache. Fever two degrees above normal temp.
Client developed fever of 100, vomiting and red spots on chest (Size of a fist)the evening of immunizations. Rash disappered by the next morning, however still vomiting and lethargic. Left arm is sore but moving.Parent states client has history of hives after using certain soaps or having a fever, but never the size of a fist. Referred to primary physician.
Severe chest pains, ER visit following. No definitive cause determined. Possibly heartburn.  Condition started after first shot and has continued ever since.  Now on daily prescription heartburn medicine to control this new condition.
Adverse reaction noted 9-26-10, 200 pm. Redness, pain and warmth at injection site. Redness 4cc in diameter. Some numbness from shoulder to hand of (R) arm. 9-27-10 Arm numb from shoulder to elbow, redness decreasing, less discomfort today.
My arm and underarm are killing me; My arm and underarm are killing me; I also have a fever; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Apr2021 at 16:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and unknown if ongoing. On 27Apr2021 at 02:00, the patient's arm and underarm were killing. The patient also had a fever. 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 patient arm and underarm were killing and fever was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
3 1/2 hours after flu vaccine, developed itchy throat, trouble swallowing "feels like a golf ball in throat" went to medical facility and treated for a reaction.
COLD, FLU, ALLERGY.  10/9/06 Received medical records from MC which reveal patient experienced a fall 3/03 with resultant knee and low back pain.  PMR eval 6/03 dx: knee sprain & low back pain muscle spasm.  Referred to PT, given HEP & meds & sent for x-rays.  Patient seen 7/03 for left arm pain s/p anthrax vax.  Neurosurg eval 6/05 for LBP revealed no neuro deficit.  MRI of c-spine done 5/05 revealed exagerated lordosis of c-spine with no cord compromise. Neurosurg eval 8/05 revealed dx: lumbar & cervical spondylosis. Psychiatry exam 1/06 revealed patient had been referred by outpatient med clinic psychiatrist where he had been treated for approx 6-7 mos.  He was to be eval for day hospital eval for major depressive disorder since returned from overseas; patient on multiple psych med at that time. Other medical history includes cervical & lumbar spondylosis, glaucoma, GERD, PUD (large gastric ulcer dx 3/05), H. pylori infection, hypertriglyceridemia  & idiopathic neuropathy (dx by outside source).  Noted to be using cane for ambulation at that time & it was felt that chronic back pain was a major contributor to his depression. D/C from psych day program 2/06 to continue outpatient treatment & meds.  In 3/07 was reeval by PMR for neck & back pain, peripheral neuropathy & carpal tunnel syndrome. LS MRI done 2/06 revealed disk herniation L4-L5, disk bulge at L5-S1 with loss of LS lordosis; MRI of c-spine done same time revealed no herniation but disk bulge at C5-6 & C6-7.  Both areas with DDD, facet arthrosis & spurring.  Referred for interventional pain clinic eval & additional PT.  Interventional pain recommended right sacroiliac joint injection under fluoroscopy.  PCP eval 8/06 revealed additional dx: adb obesity, insulin resistance & low HDL, most likely metabolic syndrome, & HTN.  Cardiac w/u ordered which was WNL.  EMG/NCS done to r/o bilateral carpal tunnel was WNL 9/06.
At 12:20 p.m, patient began to experience dizziness and the eyes began to roll back into the head. Initial blood pressure reading was 80/160 with a heart rate of 60 and an O2 saturation of 100%. This patient has a history with passing out with shots. Patient was given juice and multiple blood pressure screenings were recorded with results being 100/80, 112/78 and 104/75. At 1300, patient's heart rate was 68 bpm while sitting. Once the patient stood, blood pressure went to 90/60 and heart rate went up to 115 bpm. Patient was pale. Over next 15 minutes blood pressure and heart rate were routinely taken until patient felt better. Patient entered the vehicle safely and left with parents at 1:15
Pt recvd 1st dose Recomb on 9JAN91 & on 11FEB91 pt exp arthritic pain in rt arm & shoulder; pts pain was not attributable to vax w/Hep B vax;
Soreness in left arm, then on day four, noticed lg. red patch on arm and felt warm and itchy. Not at spots, injection. As of 11/20/11 everything is all better.
The patient came to the pharmacy to get his "second shot" and informed the pharmacy he needed to pfizer vaccine. The information on his card was verified over the phone. He received a dose of the pfizer vaccine, only to realize 9 days later that his first dose was actually the moderna vaccine.  The patient reported having a sore arm and fatigue.
The shot was given at 1:40pm. At 11:30 pm I woke with uncontrollable shivering while feeling very cold. I had a fever. I went back to sleep after about 45 minutes of shivering. The following day, I had a fever between 99-100 all day. I alternated between feeling too hot and feeling too cold. I was very tired and took several naps. I did not feel hungry all day. Two days after receiving the vaccine, I still felt very tired but no longer had a fever. I still had a depressed appetite on the second day.
Information has been received from a physician concerning a 4-week-old patient who was vaccinated with a dose of hepatitis A virus vaccine inactivated instead of a dose of hepatitis B vaccine, recomb (MSD). No adverse event was reported. No further information was given. There was no product quality complaint. Additional information has been requested.
A 64 year old male patient was treated with 2 full courses of OncoTICE (12 total treatments) in 1998 and subsequently received maintenance doses every  months for an unknown amount of time. Reportedly the patient received a total of 36 instillations. He was experiencing back problems and was seen by a physical therapist but his back problems remained. At his spine as well as deterioration of the spine was detected. A culture and sensitivity test of bone material of the spine showed colonization of Mycobacterium bovis. He was diagnosed with bone TB of spine in April 2003. At an unreported date the infected bone was removed from the spine and plates and rods were inserted in his SSPINE.
Stomach problems; Felt like they had the flu; Sore Arms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach problems), INFLUENZA (Felt like they had the flu) and MYALGIA (Sore Arms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Stomach problems), INFLUENZA (Felt like they had the flu) and MYALGIA (Sore Arms). At the time of the report, ABDOMINAL DISCOMFORT (Stomach problems), INFLUENZA (Felt like they had the flu) and MYALGIA (Sore Arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.