chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling of the supraclavicular lymph; Redness and swelling around the injection site; swelling around the injection site; This case was reported by a physician via call center representative and described the occurrence of enlargement of lymph nodes in a 19-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA92AZ, expiry date 28th February 2022) for prophylaxis.   On 4th August 2020, the patient received the 1st dose of Bexsero. In August 2020, 1 week after receiving Bexsero, the patient experienced enlargement of lymph nodes (serious criteria clinically significant/intervention required), injection site erythema (serious criteria clinically significant/intervention required) and injection site swelling (serious criteria clinically significant/intervention required). On an unknown date, the outcome of the enlargement of lymph nodes was not recovered/not resolved and the outcome of the injection site erythema and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the enlargement of lymph nodes, injection site erythema and injection site swelling to be related to Bexsero.  Additional details were provided as follows: The patient received the first dose of 1 Bexsero. About a week later, the patient developed swelling of the supraclavicular lymph node onthe left side, which was on the injected side. Redness and swelling around the injection site were also reported.  The physician saw the patient last 12th August 2020, but it was reported the symptoms were improving (lymph node) and the arm was back to normal. An ultrasound was performed for the lymph node showed it was benign and reactive in nature. The reporter consented to follow up.
Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a three years old male patient who was vaccinated with a 0.5 ml dose of vaccine FLUBLOK QIV (lot QFAA1807 and Exp. Date 29-JUL-2019) via intramuscular route in the right deltoid on 26-Sep-2018. The patient's past medical history was not reported. No other meds or immunizations were given. At the time of the event, the patient had ongoing Food allergy (he is allergic to egg white). It was an actual medication error due to inappropriate age at vaccine administration. It was reported that, he was given this vaccine because he is allergic to egg white. No information reported whether patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Information has been received from a female pharmacist concerning herself who in approximately November 2010, reported as "within the past 3 months" was vaccinated with PNEUMOVAX 23, (route, doe and lot number was unspecified). In approximately November 2010, also reported as "within the past 3 months", the pharmacist experienced localized pain and swelling at the sight of the injection. On an unknown date, the she recovered from the symptoms. It was unknown if the pharmacist sought unspecified medical attention. This is one of two reports received from the same source. Additional information has been requested.
PATIENT RECEIVED PFIZER MONOVALENT INSTEAD OF PFIZER BIVALENT
Dizziness, stiff neck, redness and soreness at site of injection, no fever.
NO adverse event; Instead of TdaP (Boostrix) , patient was given DTaP (Infanrix). I discussed with DOH here, advised no more Tdap needed. DOH advised me to report VAERS
No additional AEs; vaccine administered after temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 13-APR-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) 0.5 mL, lot #T027935, expiration date: 18-AUG-2022, subcutaneously (SQ) for prophylaxis (strength was not provided), after temperature excursion (product storage error).  The administered dose of the vaccine experienced a temperature excursion in 47.8 degrees Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No additional adverse events (AEs).
bilateral arm neuralgia, achy bones, general malaise, flu like symptoms, only more deep set ache
COVID-19; COVID-19; Nerve pain in left arm and down to fingers for some months; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program (FACILITATED COLLECT). The reporter is the patient. Other Case identifier(s): 22K-163-4256098-00.  A 48 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Oct2021 (Batch/Lot number: unknown) at the age of 47 years as dose 2, single and intramuscular, administration date 01Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for colitis ulcerative, crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19"; NEURALGIA (non-serious), outcome "recovering", described as "Nerve pain in left arm and down to fingers for some months". The action taken for adalimumab was unknown.  The reporter's causality for the event second vaccine caused nerve pain in left arm down to fingers for some months and COVID with HUMIRA was not provided. The reporter's causality for the event second vaccine caused nerve pain in left arm down to fingers for some months and COVID with PFIZER BIONTECH COVID-19 VACCINE reported as possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of Suspected COVID-19  and Drug ineffective.
achy, swollen joints, skin rash and fatigue/diagnosed with lupus; This initial spontaneous information was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the patient suffered achy swollen joints, skin rash and fatigue. As a result of these symptoms, the patient was seen and treated by medical providers and was diagnosed with lupus and at the time of the report, was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered not recovered/not resolved. The event was considered to be related to zoster vaccine live (ZOSTAVAX).  Lupus was considered to be disabling. Upon internal review, the event of lupus was considered to be medically significant.
Fever 100.7 at highest 24 hours,  headache  27 hours, body aches 26 hours,  scratchy  throat 15 hours, fatigue  ongoing 48+ hours,  continued redness/swelling/pain at and surrounding injection site , beginning 12/21 red/burning face (sunburned  looking)
Fever X 6 days, started on 12/16/02 evening, was irritable, rash on chest and back. After the fever broke, she had decreased appetite and irritable. Pt "not the same" since the vaccine.
In January 2022 I began to notice I was unable to eat anything with tomatoes and this had never happened before. It also happens with pineapple. I was also getting symptoms of lactose intolerance. I started having horrible cramps in my legs. At first, I had them at night every day. Sometimes my arms cramp a little bit but not like my legs. I began to take extra electrolytes daily. I have not been able to see a doctor about this because I do not have health insurance.
4:00a.m. - Violent severe stomach cramps; vomiting. ~3:00pm - symptoms subsided.
Menstrual cycle that lasted for 3 months.  Severe cramping.  Very heavy bleeding and large blood clots. Depression. Anxiety, Mood-swings. Not able to sleep. Not able to perform work due to lack of concentration. Very irritable.  Developed polyps and had to have surgery to scape my uterus. Severe fatigue. Dizziness and fainting spells due to blood loss. Collapsed at my desk. Next morning woke up feeling weak and faint and I went to the ER because I did not feel normal. After uterus surgery I had a normal 3 day period with minor cramps and a day after I started bleeding that lasted 1 month. I was put on hormones to stop the bleeding and some worked while othered did not. Know, Im scheduled to have my uterus removed. Severe weakens and fatigue.
Red, "hot", itchy and swollen 4"x5" localized area x 2 days after injections. 3rd day better, decreased pain and swelling - 4th day reaction gone (Right deltoid)
Pt began experiencing pectoralis pain, pectoralis and axillary lymphadenopathy on the same side as vaccine administration.
HAD A FEVER OF 103  ON 3/5/2010 AM HAD A RASH ON TRUNK, AND NECK ON 3/6/2010 AM HAD RASH ON BUTTOCKS AND STARTING ON LEGS AND HANDS, AND ARMS
After first and second vaccine, are was very sore at injections site.  Right arm bruised after first vaccine for over a week. After first vaccine, menstrual cycle stopped. After second vaccine, starting at 12 hours after vaccine, severe chills, then fever 101.4 then  body aches then headache. 23 hours later, fever and body aches came back.
persistent strain of herpes zoster or shingles; The vaccine did not prevent shingles as intended; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not provided. On or about 31-JUL-2007, the patient was vaccinated with the zoster vaccine live (ZOSTAVAX) (strength, lot # expiration date, dosage, injection anatomical location and route of administration were not provided) at a medical center as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 09-MAY-2014, she was treated by a physician at the same medical center, for a vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed valacyclovir hydrochloride (VALTREX), triamcinolone and mupirocin for management of her painful symptoms and chronic pain. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, she had suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Therefore, the outcome for herpes zoster was not recovered, and for vaccination failure was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Shingles about 2 to 2 1/2 weeks after first injection same side on and in my buttocks. Nothing immediate other then sore arm right after.
Patient returned 4 days after yellow fever immunization. Arm is red, swollen and hot to the touch at site of injection.
EXACERBATiON OF  Tinnitus IN ears  noted after vaccine ( exact  date  not   determined )  noticed days after VACCIne
Instant, horrible Tinnitus.  Very red, thick, vein-like mark in appreance, but not a vein, down forearm down from injection site. Hot to touch.
The day after the vaccine, a lymph node under my right jaw became swollen enough to result in shooting pain. The swelling and pain gradually reduced in severity over the next several days, but the lymph node remained swollen to some degree for the next month.
insomnia, tachycardia, shortness of breath, chest tightness; lasted for 12 hours starting the evening of the day of the shot
04/16/2022 A few weeks after my vaccine. I started to notice red bumps across my body and so I called my dermatologist for care. They were itchy and very annoying. It got worse and lotion was not helping at all. It was very gradual in its buildup. After doing a biopsy, my dermatologist diagnosed me with Lichen planus. I was given a prescription for a prescription ointment, and it has helped with the redness tremendously and the areas are no longer raised.
Pt received injection 2/12/13 later on in the day developed lg local warm & tender to the touch. Next day c/o itch, rash on legs, butt, arms, ankles & feet swelling at injection site. Spread to the rest of her arm. One week later still has a rash in inner thighs, neck is sore, congested, fatigue, cough, mucous, headache, earaches, sinus pain.
Patient received 0.25ml dose of moderna. patient should have received 0.5ml because they indicated they were immunocompromised on their cdc check list.
Developed Tinnitus a few days following second shot. No other side effects at all.  Various tones and sounds throughout the day...whooshing, hissing, etc. Sometimes very loud and at other times more softly but always there. Went to an ENT specialist who found no infection, fluid or wax which could cause the problem. Hearing test showed inability to hear high pitched sounds. Continue to have Tinnitus. Must have TV or music on to drown out noise. Sleep with white sound machines.
23 yo F w/ CC: HA/Rash L arm x 5 days after HPV#3 Vaccine, H/A with going from sitting to standing or laying to Monday night low grade subjective F and L arm rash w/increased pain at injection site Color also at site, fast pounding heart rate w/ F. H/A mild to severe if stands up, sharp Continuous since onset Monday night, Dizziness like fuzzy in head. No problem with 1st 2 HPV shots. D/w pt assessment and self care medications useful for H/A and their SE including N,stomach pain and rebound H/A. Given Naproxen for HA pain.
Patient is a G2P1, received her second Pfizer vaccine on 4/16/21. She began having bleeding on 5/19/21 and had a completed AB confirmed on USG 5/20/21. She was 6 4/7 weeks at the time of her miscarriage.
My granddaughters other grandmother went bald from it; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. It was reported that, reporter granddaughters other grandmother went bald from it, and a friend whose hair fell out the back, and another friend who goes to the beauty shop, and the beautician said people are complaining left and right about their hair. The outcome of the event was unknown.  The lot number was not provided. Information on lot number has been requested during follow up.
Within 30 seconds of receiving shot my throat and lungs started closing up and restricting my breathing. Heart rate and blood pressure elevated quickly. Rash on chest and neck.   Within two-three minutes of shot I received Epi Shot and Benadryl shot. Sent to ER and received IV, steroid and Pepcid.
Fatigue, shaky, crooked, ache all over, chills. Vaccine was Sunday pm, reaction started after 4-mile walk Monday pm, missed meeting.  Took 2 Tylenol, slept.   Tues-Thurs: fatigue, chills, aches, diminished over the days.  I rested and slept. Today=Friday, declared myself cured, took shorter walk, got tired, normally don?t get tired. *Today I discovered why I felt crooked: right shoulder higher because it?s swollen, down to mid-way between elbow & wrist, down to waist, some of side of body.*   Treatment still only rest, but still I'm not so fatigued, aching easy to ignore. Never had fever (temp around 96.8 which is normal for me). I never felt too bad.  Except for overpowering fatigue, I felt like doing things.
The healthcare worker is reporting that a patient received improperly stored vaccine.; No additional AEs were reported; This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions and concomitant medications was not provided.  On unknown day, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (1 dosage form, lot #x0006983 was not valid, expiration date 07-MAR-2025 or lot #x000999, expiration date 09-JAN-2025, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Product storage error). It was unknown which of two lots was given to patient.   On unknown dates, the vaccines experienced temperature excursion of 6 degrees Fahrenheit (F) up to 14 F for 10 hours and 14 F up to 46 F for 3 hours 30 minutes. No additional adverse events (AEs) were reported (No adverse event). No further information provided. No previous temperature excursion.
Sore arm; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Sore arm) and NAUSEA (Nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD (Is on oxygen) and Neurological disorder NOS.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 01-Mar-2021, the patient experienced AXILLARY PAIN (Sore arm) and NAUSEA (Nauseous).   The patient was treated with ONDANSETRON HYDROCHLORIDE DIHYDRATE (ZOFRAN [ONDANSETRON HYDROCHLORIDE DIHYDRATE]) at an unspecified dose and frequency.   On 02-Mar-2021, AXILLARY PAIN (Sore arm) and NAUSEA (Nauseous) had resolved.      Concomitant product use was not provided by the reporter.
right basal ganglia intracerebral hemorrhage; slurred speech; vomiting; severe left lower extremity pain; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 19-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) (date not reported), the patient suffered slurred speech, vomiting and severe left lower extremity pain. The patient went unresponsive and suffered right basal ganglia intracerebral hemorrhage. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events slurred speech, vomiting, severe left lower extremity pain, right basal ganglia intracerebral hemorrhage was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the events slurred speech, vomiting, severe left lower extremity pain, right basal ganglia intracerebral hemorrhage to be disability.  Upon internal review, the event right basal ganglia intracerebral hemorrhage was determined to be medically significant.
approx 3hrs p/vax pt made gagging noises while in walker, color went pale;father performed hand sweep-gentle stimulation;pt dusky-@ arrival MD ofc smiling;color resolved w/stimulation 15mis p/onset;observed in ofc 30mins
Pt vaccinated with DTP/OPV fine for 4hrs then began screaming continuously x 2hrs, cried constantly but quite as vigorously x 4 hrs. Mom also stated she had fever, degree not documented; at f/up office visit about 9PM, baby quiet w/mom.