chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Following day, Patient returned to my office not wanting to bear weight on the leg that had the shot given in.  Muscle very sore to palpation.  Within the next couple of days was walking just fine.
Patient reported having the following adverse events for 2 weeks after vaccine administration:  Pain in arm from shoulder to elbow Problems with moving arm Rash, swelling and itching in area  Skin peeling in area  After the reaction she spoke to her PCP over the phone, Dr. and he recommended ice at area and Acetaminophen by mouth.  Patient reported having still after the two weeks a mild pain in arm administration site and a little of itching of the arm. She came on 11/30 to report adverse event.
Extreme fatigue (unable to engage in daily activities), all-over muscle aches, chills, headache, injection site soreness
Developed chills, fever, swelling at injection site, was sick for 3 days following vaccine.
Mom noticed pt's (R) deltoid to be red, hot & swollen 8/20 at 0700 after shower. Was seen by physician & recommended BENADRYL, none was taken, resolved by 8/23/10.
Approx. 5 min after vaccination pt stated she wasn't feeling well. Her body started to shake; stiffen slightly. She fainted (just briefly then opened her eyes. She was sweating, her skin was cold and clammy, skin color was pale. I had pt lie down, gave her water to drink. Also cold wash cloth of her forhead. Doctor came in to check her. She fully recovered after approx 25 min.
pt recvd Engerix-B on 18MAY92 & 2-3 hrs later pt exp what looked like a herpetiform rash (vesicles filled w/blood);
Pt was given 3 immunizations and approx. 5 minutes later, after a small amount of water, passed out - (pt had not eaten prior to immunizations).
30-45 min after shot, sharp pain in shoulder. Pain got worse for about 1 hour. Pain would shoot down leg into toes during that time. 90 mins after that the pain went away.
broke my arm; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on unknown date at single dose for COVID-19 immunisation. Medical history was not reported. The patient was not on any concomitant medications. On 13Mar2021, she broke her arm pretty severely. Treatment for event reported as HCP who treated her arm (as reported). The patient was due for her next dose on Monday (22Mar2021). It was not known whether the patient was hospitalized for broken arm. Outcome of the event of broke arm was unknown.   Follow-up attempts are needed. Information on the lot/batch number has been requested.
pt first developed a swelling without redness, purple, that receded quickly with cold compress Pt within 5 minuted developed resp distress, sob, chest pain and crushing chest feeling along with lip tongue mouth tingling, difficulty swallowing, increasing anxiety and diaphoresis.
Patient fainted. Placed patient on floor. Emergency personal were contacted. Was brought to the emergency room and diagnosed with vasovagal syncope.
Patient received 1/2 dose Td due to local reaction in 1996. She experienced elevated temperature (100) numbness all over, worse in legs, rash evening of vaccine; presented to ER 6-10-06. No treatment; symptoms resolved.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 15:15 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism (mild)" (unspecified if ongoing), notes: hypothyroidism (mild), cll (0 stage, no treatment needed); "cll" (unspecified if ongoing), notes: hypothyroidism (mild), cll (0 stage, no treatment needed). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 01Mar2023 to 06Mar2023, day 2 of symptoms).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
7 days after MMR given, the child developed a test book case of rubella-quite extensive and nearly as bad as I would expect from a wild type infection.  No significant fever, corta, or koplicks spots developed.  Probably 200 lesions.  The mother has photo's on disk.
aches, alternate between sweats and chills between 0200 and 0600, temperature of 100.8 at 0600. Two acetaminophen taken.  Temperature 100.2 at 0700. Fluids and rest. Aches continue. Temperature 99.6 at 1000. 1 Acetaminophen taken. Temperature 99.7 at 1100. Headache started.  1 ibuprofen taken.  Fluids and rest.  Temperature 99.6 at 1230. Headache resolved. Temperature at 1310 98.2. Sweats and chills resumed. At 1440 temperature 98.6, and 1 acetaminophen taken. Sweats and chills resolved approx. 1620, but headache and body aches continued. 1 Acetaminophen taken.  Headache intensified approx. 1800. 1 Ibuprofen taken.  At 1830 headache and body aches fading.
was diagnosed with life-threatening meningitis, encephalopathy, diplopia, and suffered rhabdomyolysis and life-altering stroke, as well as permanent disabilities; was diagnosed with life-threatening meningitis, encephalopathy, diplopia, and suffered rhabdomyolysis and life-altering stroke, as well as permanent disabilities; was diagnosed with life-threatening meningitis, encephalopathy, diplopia, and suffered rhabdomyolysis and life-altering stroke, as well as permanent disabilities; was diagnosed with life-threatening meningitis, encephalopathy, diplopia, and suffered rhabdomyolysis and life-altering stroke, as well as permanent disabilities; was diagnosed with life-threatening meningitis, encephalopathy, diplopia, and suffered rhabdomyolysis and life-altering stroke, as well as permanent disabilities; Information has been received from a lawyer and the patient (pt) regarding a case in litigation involving a male patient (pt) of unknown age. No information about the pt's pertinent medical history, concomitant medications and drug reactions or allergies was provided.     On 29-SEP-2014, the pt was inoculated with a dose of zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, route, frequency, lot/batch # and expiration date were not reported).     Shortly after receiving zoster vaccine live (ZOSTAVAX), in early December 2014, the pt was diagnosed with life-threatening meningitis, encephalopathy, diplopia, and suffered rhabdomyolysis and life-altering stroke (cerebrovascular accident), as well as permanent disabilities and injuries resulting in prolonged hospitalization and acute care. After of several months of being hospitalized, the pt endured a progression of medical care including physical therapy which continued today.  As a direct and approximate result of zoster vaccine live (ZOSTAVAX), the pt suffered sustained, severe, serious, and permanent/incurable personal injuries and life-long disabilities not present prior to using zoster vaccine live (ZOSTAVAX), which were directly caused by zoster vaccine live (ZOSTAVAX). Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition and has suffered economic losses due to his inability to work, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.   The reporter considered the events to be related to zoster Vaccine Live (ZOSTAVAX).  The reporter considered all the events to be disabling, and meningitis to be life-threatening. Upon internal review, meningitis, encephalopathy, rhabdomyolysis and  stroke were considered to be medically significant events.
No additional AE details; VARIVAX and PROQUAD were inadvertently concomitantly administered to a 12 month old patient; This spontaneous report was received from a nurse referring to a 12-month-old male patient. The patient's medical history, concurrent conditions, and previous drug reactions or allergies were unknown by the reporter. Concomitant therapies included sterile diluent.   On 01-APR-2022, the patient was inadvertently concomitantly administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rha) (PROQUAD) 0.5 milliliters (mL) subcutaneously (lot number U029149 has been verified to be valid, expiration date reported and established as 16-MAR-2023), and varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliters (mL), once (route of administration was not reported; lot number U020240 has been verified to be valid, expiration date reported and established as 28-JUN-2023) (inappropriate schedule of product administration). Both vaccines were administered as prophylaxis.   No additional adverse event reported (no adverse event).
lesions on her left arm, from the shoulder to her fingers; headache; This case was reported by a consumer via call center representative and described the occurrence of skin lesion in a elderly 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, unknown after receiving Shingrix, the patient experienced skin lesion and headache. On an unknown date, the outcome of the skin lesion and headache were recovered/resolved.   It was unknown if the reporter considered the skin lesion and headache to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The case was reported by the patient herself. The patient had a severe reaction to the 1st dose of the shingrix vaccine.  After 1st doses she developed lesions on her left arm, from the shoulder to her fingers, that resolved in 2 weeks and a headache that resolved 3 days. The reporter consented to follow up. For tolerance to 2nd dose refer case US2021AMR027693.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR027693:same reporter, 2nd dose
Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves unknown age of female patient for whom something wrong with the technique when the FLUZONE HD was administered and some of the vaccine squirted out was reported, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, lot number not reported via unknown route in unknown administration site. It was reported that FLUZONE HD administered to a patient at another facility who stated there was something wrong with the technique when the FLUZONE HD was administered (wrong technique in product usage process) and some of the vaccine squirted out (underdose) unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Lab data was not reported. Final diagnosis was some of the vaccine squirted out and something wrong with the technique when the FLUZONE HD was administered. It was unknown whether patient experienced any adverse reaction after vaccination. Outcome of the event was not applicable. 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. Documents held by sender: none.
The vial was initially stored in the refrigerator on 25-Apr-2023; No adverse event; Patient came in yesterday that they gave a Moderna Bivalent to and it expired on 23May2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient came in yesterday that they gave a Moderna Bivalent to and it expired on 23May2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Apr-2023 ) and NO ADVERSE EVENT (No adverse event) in a 57-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-May-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient came in yesterday that they gave a Moderna Bivalent to and it expired on 23May2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Apr-2023 ) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient came in yesterday that they gave a Moderna Bivalent to and it expired on 23May2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Apr-2023 ) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient came in yesterday that they gave a Moderna Bivalent to and it expired on 23May2023) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Apr-2023 ).    No concomitant medications were reported.  The vial was initially stored in the refrigerator on 25-Apr-2023.  The vial did not  undergo any temperature excursions.  No treatment medications were reported.
Swelling and tenderness (not pain) in left deltoid (site of inoculation). Tenderness and swelling in armpit. Very minor redness in swollen area.
fatigue within 6-8 hours after the vaccine, chills and fever ~102 F 12-15 hours after vaccine. Lasted 24-36 hours
This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 05-FEB-2015, the patient was vaccinated with LIQUID PEDVAXHIB (lot number: K008878 with unspecified expiration date) (dose, frequency and route unspecified) for prophylaxis that had underwent temperature excursion. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with LIQUID PEDVAXHIB was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
High fever, body aches, confusion, lethargy, exhaustion (slept 36 straight hours), mild headache. This was severe for 24 hours but still existing mildly going into day 3 after vaccine
Moderna COVID?19 Vaccine EUA. First 24 hours, sore injection site and mild diarrhea. Second 24 hours, fever of 100.2, fatigue. Third 24 hours non-itchy rash at injection site. All other symptoms have subsided.
experiencing nausea (pretty intense); feels dizzy (she's getting a "spinning feeling, which comes and goes); fatigue; chills; couldn't sleep last night; bruise on her second toe; This is a spontaneous report from a contactable consumer or other non hcp. A female consumer (Patient) of 69 (unit: unknown) age received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Thursday 25Feb2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient experienced experiencing nausea (pretty intense), feels dizzy (she's getting a "spinning feeling, which comes and goes"), fatigue, chills and could not sleep last night until 05:00AM. She added that she had a bruise on her second toe, but had not dropped anything on it. The outcome of all the events was reported as unknown.   No follow-up attempts were possible; information about lot/batch number could not been obtained.
Information has been received from a physician concerning a 12 year old female who was vaccinated with a dose of Gardasil.  Concomitant therapy included two other vaccines (therapy unspecified) in the same day of vaccination.  The patient "fainted" after receiving the Gardasil.  Unspecified medical attention was sought by the patient.  The outcome was unknown.  Additional information has been requested.
COVID-19 breakthrough. I first started feeling some kind of brain fog. It was disorientation but I had to stop to gather myself together. I had a headache around my nose area that would not go away. That lasted the duration of being sick and a little bit when I went back to work. I had a really bad cough that I took some codeine medication for because it was so bad. I also had runny nose, chills, and I felt run down. I would sweat a lot and then the next minute I would be cold. I also had slight muscles aches in both my legs. I think I have recovered but I still find myself searching for words or thought, which didn't have before. My cough is pretty much gone, I still have a few episodes at night.
paraspinal myalgias, lasted approx 8-12 hours, resolved, took OTC ibuprofen.
This case was reported by a lawyer and described the occurrence of arthralgias in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). On an unspecified date after vaccination with LYMERIX, the subject experienced arthralgias, difficulty walking, hip pain, swollen joints, and rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be caused by vaccination with LYMERIX. He also has decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow-up information was received on 13 February 2009 in the form of a claimant interview. It was reported that the subject received three doses of LYMERIX with the 1st on 14 July 1999, the 2nd on 02 September 1999 and the 3rd on 13 July 2000. The subject had a past medical history of Lyme disease diagnosed in mid 1999. The subject believed these symptoms resolved following a course of antibiotics. Events experienced by the subject that he attributes to LYMERIX include hip pain and swelling with onset of September 2000 and groin pain and difficulty walking with onset in late 2001. These events were said to have resolved. Events experienced by the subject that he did not attribute to LYMERIX included stomach pain and shoulder pain. No medications were reported. Follow-up information was received on 25 March 2009 in the form of medical records. The subject was evaluated on 07 March 2002 for the purpose of an orthopaedic consultation regarding right hip symptoms. Impression was osteoarthritis of the bilateral hips, right greater than the left. X-rays obtained during the visit included AP pelvis, AP and lateral views of both the right and left hip. The right hip had advanced osteoarthritic changes. There was a significant medial osteophyte, and there was bone-on-bone contact throughout the weight bearing region. The left hip also had the beginning of arthritic change although articular cartilage space was fairly well preserved. The subject underwent right total hip arthroplasty on 11 June 2002 due to osteoarthritis of the right hip. One month post surgery, on 11 July 2002, the subject was doing well. The subject continued to do well and recover at visits dated 08 August 2002, 05 September 2002 and 13 December 2002.
Numbness in left side of face, lack of muscle control on left side of face and partial feeling in left hand and arm. Hospital visit on 10/19/2009 at hospital. Diagnosis of Bells Palsy. Prescribed steroids which caused an allergic reaction similar to thrush in mouth and throat.
Redness, warm, tenderness, swelling to left deltoid/upper arm. 1 Tramadol 50 mh p.o. 1 tablet 3 times daily prn. 2 prednisone 40 mg po x 1.
severe pain on my arm; severe pain on my arm, arm pit on my left side where I got the vaccine and it's still badly hurting me; it's very difficult to go work with this pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "severe pain on my arm"; AXILLARY PAIN (non-serious), outcome "not recovered", described as "severe pain on my arm, arm pit on my left side where I got the vaccine and it's still badly hurting me"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "not recovered", described as "it's very difficult to go work with this pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
night time sweats; headache; muscle pain; shots of pain at injection site; skin has pins and needles; muscle cramps; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night time sweats), HEADACHE (headache), MYALGIA (muscle pain), VACCINATION SITE PAIN (shots of pain at injection site) and PARAESTHESIA (skin has pins and needles) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced NIGHT SWEATS (night time sweats), HEADACHE (headache), MYALGIA (muscle pain), VACCINATION SITE PAIN (shots of pain at injection site), PARAESTHESIA (skin has pins and needles) and MUSCLE SPASMS (muscle cramps). At the time of the report, NIGHT SWEATS (night time sweats), HEADACHE (headache), MYALGIA (muscle pain), VACCINATION SITE PAIN (shots of pain at injection site), PARAESTHESIA (skin has pins and needles) and MUSCLE SPASMS (muscle cramps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.