chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm became hot and itchy, hard egg-size lump.   Swollen and very tender lymph nodes in area of left armpit and above left collarbone.
Patient received first dose of COVID vaccine on 2/23/2021. Presented to clinic for 2nd dose on 3/16/21. Reported that she had swelling on the left side of her neck x3 days after first dose and also had fatigue. Reports s/s resolved after 3 days. Did not seek medical care. Clinic staff contacted medical advisor to discuss before giving 2nd dose. MD recommended to vaccinate with 2nd dose. Patient agreeable. Received 2nd dose without incident.
This non-serious initial spontaneous case was received on 14-Sep-2017, from other health professional (nurse), concerning a 69-year-old, elderly, female patient. The historical condition of the patient included polio at the age of 2. The current conditions included fibromyalgia, asthma, sleep disorder, thyroid disease, depression to fibromyalgia since unspecified dates. The concomitant medications included,  AMBIEN, ALLEGRA, Piroxicam, CYTOMEL, BUTRIN, ALBUTEROL when needed, SINGULAIR for unknown indications. On 14-Sep-2017, the patient (nurse) had administered FLUCELVAX QIV (batch number 195128, expiry date: Apr-2018, dose, route of administration, anatomical location: not reported). It was reported that, the patient withdrew 6 full doses of injections successfully. Upon the withdrawal of the seventh dose, the vaccine leaked around the metal collar and the patient was exposed to the vaccine. It was reported that, vaccine started to leak out of the metal stopper upon administration of the product. Reporter stated that, the package was in good condition and there was no damage in the carton and leaflet or PIL was wet or appeared as water damaged. It was reported that, the leaking was coming around the stopper and the needle used was 23 gauges and 1 inch. The syringe was set to 1/2 cc and injected that air into the vial. The PTC reference number was 1024513. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch, or any other FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper. The most likely root cause can be attributed to improper handling by the user. The patient had washed her hand after the exposure. The outcome of the event was not reported. The reporter assessed the event as non-serious. The causality between the vaccine and the event was not reported. Follow up report received from QA investigation on 31-Oct-2017: Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured incompliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process or relating to the vial or stopper components, and no trends were identified for the batch, or any other FLUCELVAX batches form the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper. The most likely root cause can be attributed to improper handling by the user.
C/O onset of redness and coldness in both hands, right greater than left. The right hand had some numbness, tingling, weak grip and swelling s/p vaccination on left arm within 3 days. She has no prior history of similar symptoms. Treated with Nifedipine a  Narrative: C/O onset of redness and coldness in both hands, right greater than left. The right hand had some numbness, tingling, weak grip and swelling s/p vaccination on left arm within 3 days. She has no prior history of similar symptoms. Treated with Nifedipine and medrol dose pack at urgent care. Reports h/o COVID infection in 11/2020.
Patient received positive COVID-19 test result on 03/15/2021 with secondary pneumonia diagnosis
Site: Pain at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Additional Details: Patient experience Syncope
6 days later he was tested positive; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported that a male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 26Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient had his first dose of the covid vaccine last 26th of February. 6 days later he was tested positive. He was asking if he would be continuing his second dose of the vaccine on 19th of March after being tested positive. Outcome of the event was unknow.  Information on the lot/batch number has been requested.
SEVERE LUPUS FATIGUE, ACHES, PAINS, FEVER, EXHAUSTION, NECESSITATING THE LONG-TERM USE OF PREDNISONE. SYMPTOMATIC FLARE X  5 MONTHS SO FAR.
Guillain-Barré syndrome. Neurologic symptoms developed 2/21/04. Headache for 2 wks prior to 2/24/04. Thigh pain L 2 wks prior to 2/24/04. Recovery is in progress. Admitted 2/25/04 with progressive neurologic changes; tests c/w GBS. Nurse follow up on 05/18/04: urinary incontinence, weakness lower extremities, hypertension, hoarse voice, fluid retention.
Narrative:  COVID infection following COVID vaccine series 05/21, MODERNA, dose #1 06/18, MODERNA, dose #2 12/20 HUMAN RHINOVIRUS/ENTEROVIRUS: DETECTED 12/20 SARS-COV-2 Variant Sequencing: pending 12/27 COVID swab, result: detected 12/17 pt cc: cough, diarrhea, fatigue, headache, rhinorrhea, sore throat exposure: unknown
lymphoma; Ill; This case was reported by a consumer via call center representative and described the occurrence of lymphoma in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced lymphoma (serious criteria GSK medically significant) and unwell. On an unknown date, the outcome of the lymphoma and unwell were unknown.   It was unknown if the reporter considered the lymphoma and unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in spring 2018. The patient became ill with lymphoma and could not get the 2nd dose of Shingrix within 6 months.  The patient asked if the patient could could start all over again and get two new doses of Shingrix or only the one which the patient had not received till the time of reporting. At the time of reporting the patient was in remission and was doing well.
Puffy eyes, swollen glands in throat, lump where inject was. Body has spasm on right side and sharp pains.
Site: Redness at Injection Site-Mild, Systemic: Left ankle swelling, mild-Mild, Additional Details: Told patient to lift left ankle above heart level. Stayed for about 30 minutes. Provided patient education to decrease swelling. Patient bought Ibuprofen and Benadryl. Took 50 mg of Benadryl and 400 mg of Ibuprofen in the store. Warned patient about potential side effects of drowsiness of driving and she said she was fine due to her height and weight. Told patient to get in contact with her healthcare provider.
I woke up in the middle of the night with severe cramps and pain  in the stomach, I was up all night long. I had diareha that following day and really had digestive issues the whole time and I still have them after almost 2 weeks. My husband has the same thing. Our stools are darker than normal. Feels like had an colonoscopy done, and my stomach is full of gas. Did only a call with my doctors nurse. No virtual/actual visit at this time
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. On 06-FEB-2011, 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 2013, the patient was treated by a healthcare provider 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.
Info has been received from a health professional concerning 1 year old female with Von Willebrand and a reaction to ibuprofen who on 8/22/96 was vaccinated, SC with a 0.5mL, dose of varicella virus vaccine live (lot 609287/0393B). There was no concomitant medication. On 12/29/05, the pt broke out in a rash "all over, head to toe". The rash "looked like pustules with fluid in them, just like chickenpox rash, about 100 lesions". The pt had a fever to 101F, earache and sore throat. Unspecified medical attention was sought. The physician ordered Benadryl and Tylenol. The pt was not hospitalized and was recovering. No lab tests were performed. There was no product quality complaint involved. Additional info has been requested.
Acute onset of swelling of tongue 0 full sensation in throat, 0 resp distress; Onset w/in 10-15min p/shot; Relieved p/SQ Epinephrine 0.3 x 2 10min apart;
Started vomiting at 5 o?clock morning after the shot. Went to ER at 3 o?clock in the afternoon, was administered IV and vomiting was stopped about 4 o?clock in the afternoon. Severe diarrhea, intense headache. Was given nausea medicine and medicine to stop diarrhea, medicine for headache. Was sent home with prescriptions for nausea, diarrhea.
ANKYLOSING SPONDYLITIS KICKED UP SOME DUE TO TRAVELING; BODY ACHE; ANKLE  SWELLING COMES AND GOES; HANDS/LEFT KNEE ARTHRITIS; HEADACHE; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4327158-00.  A 62 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) as citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), outcome "not recovered", described as "ANKYLOSING SPONDYLITIS KICKED UP SOME DUE TO TRAVELING"; PAIN (non-serious), outcome "recovered", described as "BODY ACHE"; JOINT SWELLING (non-serious), outcome "not recovered", described as "ANKLE SWELLING COMES AND GOES"; ARTHRITIS (non-serious), outcome "not recovered", described as "HANDS/LEFT KNEE ARTHRITIS"; HEADACHE (non-serious), outcome "recovered", described as "HEADACHE". The action taken for adalimumab was unknown. The reporter considered "body ache" and "headache" related to bnt162b2.  Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of Ankylosing Spondylitis Kicked Up Some Due to Traveling, Ankle Swelling Comes and Goes, Hands/Left Knee Arthritis, Headache and Body Ache with Humira (Adalimumab) was no reasonable possibility.  Causality for Pfizer BioNTech Covid-19 Vaccine (Tozinameran) (Tozinameran): The reporter's assessment of the causal relationship of the reported events Ankylosing Spondylitis Kicked Up Some Due to Traveling, Ankle Swelling Comes and Goes, Hands/Left Knee Arthritis, Headache and Body Ache with the suspect product(s) bnt162b2 was no reasonable possibility provided at the time of this report. Since determination has been received, the case is managed based on the company causality assessment as related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  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
A case was received from a consumer's daughter on 13 June 2007. A 79-year-old female patient with medical history of bat exposure, increased cholesterol, hypothyroidism, high blood pressure, and heart disease, had received in initial injection of rabies vaccine, tetanus vaccine and RIG (rabies immunoglobulin) on 05 November 2006. "The post exposure series was completed on 08 December 2006", and on 15 December 2006 the patient "had stomach problems" and was seen in the emergency department. On 15 January 2007 the patient was admitted to the hospital "for five or six days" (reason for this admission was not provided). In March of 2007 she was admitted to the hospital with pneumonia. On 01 May 2007 she developed a sinus infection. Concomitant medications included Lotensin, Zocor, Tricor, Levothyroid, Prilosec, Clonopin, and antibiotics. The events were reported as not yet resolved. A Corrective version was created using the original receipt date in order to change the rabies immunoglobulin from Immunoglobulin Equine Antirabies to Immunoglobulin Human Antirabies. No additional medically significant information has been added
Pt admitted to hospital with 3 week history of bleeding from mouth, nose, ears and insulin injection sites.  INR found to be 5.0 with Plt count of <5.  Medications prior to admission included aspirin, clopidogrel, and warfarin.  Pt stated he had influenza vaccine 3 weeks prior to admission. 5/21/08-records received for DOS 12/7-12/12/07-DC DX: Idiopathic thrombocytopenic purpura. Coumadin coagulopathy. Presented to ED with bruises on skin and bumps at the insulin injection site 3 days prior to presentation. Bleeding from gums, ears and nose for 3 days. Abdominal soreness for 2-3 months.
This spontaneous report was received from a certified medical assistant (healthcare worker) refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 18-JAN-2016, the patient was vaccinated with an improperly stored VAQTA lot # L023232, 25-FEB-2017. This is one of the several reports received from the same reporter. Additional information has been requested.
itchy rash on Right side back/chest area; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th July 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th July 2021, 4 days after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was not recovered/not resolved.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional detail were provided are as follows: The case was reported by reporter for herself. The patient received dose of Shingrix in left arm and developed an itchy rash on right side back /chest area. Education provided per Shingrix frequently ask questions (FAQ) and PI. The patient was referred to Health care professional. MI department phone number was provided. The reporter did not consented to follow up.
intermittent chest pain and some SOB, pain under left arm after 2nd dose of covid vaccine
Patient had fever exceeding 104 F for following three days along with severe shoulder/arm pain. Fever dissipated after three to four days. However, severe shoulder/arm pain and stiffness persisted for weeks. After seeing family physician for continued shoulder/arm pain and stiffness, patient was referred to Orthopedic for evaluation on May 28, 2021. An X-Ray was performed at the 5/28/2021 Orthopedic visit. Doctor ordered an MRI on June 13, 2021. At follow up appointment on June 22, 2021 Doctor stated that he recommended surgery to address "frozen shoulder" indicating pain in left shoulder/arm due to COVID vaccine. Surgery is scheduled for July 15, 2021.
Headache; Nausea; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 10Apr2021 at 13:00 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Medical history included thyroid disorder. The patient did not have any allergies to medications, food or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 23:45, the patient experienced headache, nausea and tiredness. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events headache, nausea and tiredness were not resolved at the time of reporting.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
1. About 3 hours after the injection, pain at the injection site. 2. About 10 hours after the injection, experience headache, chills, fevers,  nausea, extreme exhaust, and unable to move the arm of injection. 3.  All symptoms resolved 48 hours after the injection.
2 hrs afterwards I set out for my walk, after 20 steps I experienced sharp pain  deep in my right groin?making it difficult to walk, pain remained for the evening and at my shower that night I noticed the top half of my right leg was swollen down to the knee. The pain was a bit better the following morning so I saw my gp who recommended an ultrasound to rule out a blood clot.
Pt received Moderna booster on 11.2.21. On 11.3.21 pt's spouse called the clinic reported in that he had a swollen red left foot. Pt was seen later in the day for this issue with +1-2 pitting edema to the left foot/ankle. The ankle was erythematous and mildly warm to the touch. Pt reported that palpation of the area was moderately uncomfortable. Pedal pulses were strong. Pt has never had anything like this occur prior to this, or with previous vaccinations for COVID 19.  No hx of cellulitis, gout, or DVT.  Differential diagnosis: cellulitis, gout, very low potential for DVT based on exam.  Labs drawn to r/o infection versus gout. Pt treated conservatively with OTC NSAIDs and instructed to ice, elevate, and call back for any progression of this condition and scheduled to FU with clinic in 2 days.
Went to ER 4/30/11 with hives, was tx with prednisone and BENADRYL, seen back in office 5/3/11 still having random hives advised to complete meds. Back to ER 5/5/11 with more hives and fever tx with prednisone, BENADRYL, TYLENOL. Seen 5/7/11 for follow up and advised to cont meds & follow up if worsens or persists.
exp flu-like sx p/vax; weakness, dizziness, abdo pain x 1 day; abdo cramping, fever (low grade), chills; states lasted 1-2 wks; pt states reflux problem & something on the liver still c/o weakness, fatigue & bloating of abdo, lost 20 lbs;
65 yr old male with hx of Diabetes, HLP, reports right arm/hand pain and weakness for about 15 days. He was evaluated by primary MD, and had mRI brain which was negative, and he was prescribed Neurontin, also seen neurology. he has increasing weakness where he can not extent right hand fingers getting worse so i advised him to go to er. He denies any falls, or any trauma. he also has tremor in both hand which is new.
5 little pricks (like in Acupuncture); Panicked; Palpitations/ heart palpitations; Tenderness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (5 little pricks (like in Acupuncture)), PANIC REACTION (Panicked), PALPITATIONS (Palpitations/ heart palpitations) and VACCINATION SITE PAIN (Tenderness on the injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (5 little pricks (like in Acupuncture)). an unknown date, the patient experienced PANIC REACTION (Panicked) and VACCINATION SITE PAIN (Tenderness on the injection site). an unknown date, the patient experienced PALPITATIONS (Palpitations/ heart palpitations). At the time of the report, PARAESTHESIA (5 little pricks (like in Acupuncture)), PANIC REACTION (Panicked) and VACCINATION SITE PAIN (Tenderness on the injection site) outcome was unknown and PALPITATIONS (Palpitations/ heart palpitations) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that the patient never tested positive for COVID-19 and did not have any acute illness at the time of vaccination and up to 1 month before. Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Significant Follow up information received included information about concurrent condition, concomitant medication, outcome of the event (palpitation), patient demographics and narrative was updated.