chrisvoncsefalvay/vaers-outcomes huggingface dataset:
APDT given 11/05/2004 LD Inflammation from shoulder to elbow Followup 02/09/07: Left deltoid swelling from elbow to shoulder, 11/06/04. Seen by MD, who advised motrin and ice.
The patient called at 5:15pm on 01/27/2014 about a possible reaction to the Zostavax vaccination she received on 01/25/2014. She stated that the area was red and raised.  We recommended that she contact her doctor to have it evaluated.  We called notified the Dr and she had already called the Dr and set up an appointment to have it evaluated.
I started with dizziness, arm pain, nausea, fever, fatigue, bone pain, muscle pain, severe headache.
Information has been received from a physician concerning a 16 year old female with no allergies and a family history of endometriosis but she tested negative at the beginning of this year, who on 15-DEC-2006 was vaccinated with the first dose of GARDASIL (lot # 655165/1425F) 0.5ml injection.  On 20-FEB-2007, the patient was vaccinated with the second dose of GARDASIL (lot # 655165/1425F).  On 11-MAR-2008 the patient experienced abdominal pain.  On 30-OCT-2008, the patient was vaccinated with the third dose of GARDASIL (lot # 659435/1265U).  Concomitant therapy included ORTHO-NOVUM.  On 13-OCT-2008 the patient experienced enflamed lymph nodes in the groin.  The patient's present status was not recovered.  The patient sought unspecified medical attention.  No lab diagnostics studies performed.  Additional information has been requested.
Patient became dizzy and started sweating. He was given some water and took a small sip. He then started nodding in and out of consciousness and stating that he did not know where he was and that he just needed to rest and lie down. He repeatedly attempted to stand but was kept sitting. During this, myself and his girlfriend kept trying to engage him in conversation and keep him awake. Shortly after the EMTs came and attempted to talk to him. Blood Pressure and temperature were taken (I am not aware of the readings) and he eventually agreed to go to a hospital. He was taken out of the building on a stretcher.
Presented to the emergency room via EMS from a group home with complaints mental status change. Admitted for appendicitis and COVID-19 infection; Tx w/remdesivir & zinc; did not require O2. Discharged by to group home where pt is resident.
12/11/07 w/in 5 min after injection (R) leg had redness size of quarter then blotchy macular rash all over body at 9:15am Benadryl was given. Child responded.
Client Stated redness from left deltoid to wrist, warm to touch, warm sensation all over, and nausea symptoms happened within 4 hours of shot after client went back to work. client toke Benadryl PO and had someone call us with information on reaction. Spoke with client and had her come into the clinic. The L arm was warm and pink from the shoulder to above the wrist.
Pt began c/o facial numbness and difficulty swallowing.  Pt sent to ER immediately.  Symptoms began to wane on own in ER, and no epinephrine was administered.  Pt was d/c'd from ER within 30 mins without requiring treatment.
Local reaction DPT site.  Red, swollen and indurated 5 inch diameter.  No ill.  Will follow up.
Liver injury following SARS-CoV-2 vaccination; This is a literature report.  A 46 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "NAFLD" (ongoing); "ERCP with new severe sclerosing cholangitis" (ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "drug-induced liver injury", notes: two years earlier. The following information was reported: LIVER INJURY (medically significant), outcome "recovering", described as "Liver injury following SARS-CoV-2 vaccination". The patient underwent the following laboratory tests and procedures: alanine aminotransferase: 594 IU/l; blood alkaline phosphatase: 197 IU/l; blood bilirubin: 3.9 mg/dl; endoscopic retrograde cholangiopancreatography: diagnosed with "new" sclerosing, notes: cholangitis; inflammation scan: positive; international normalised ratio: 1.3; laboratory test: negative; focal portal and peri portal; magnetic resonance cholangiopancreatography: showed subtle non-diagnostic biliary findings,, notes: raising the possibility of undiagnosed primary sclerosing cholangitis; smooth muscle antibody: 1:40; viral test: negative, notes: ERCP with new severe sclerosing cholangitis. Therapeutic measures were taken as a result of liver injury.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the currently available information the possibility of causal association between the event liver injury and the suspect drug BNT162B2  cannot be ruled out. The case will be reassessed once new information is available. 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.,Linked Report(s) : US-PFIZER INC-202101846551 Same article/drug/event and different Patient;US-PFIZER INC-202101846555 Same article/drug/event and different patient;US-PFIZER INC-202101846552 Same article/drug/event and different patient.;US-PFIZER INC-202101846560 Same article/drug/event and different patient.;US-PFIZER INC-202101846553 Same article/drug/event and different patient.;US-PFIZER INC-202101846554 Same article/drug/event and different patient.;US-PFIZER INC-202101846556 Same article/drug/event and different patient.;US-PFIZER INC-202101846561 Same article/drug/event and different patient.;US-PFIZER INC-202101846558 Same article/drug/event and different patient.
left wrist hurt, became swollen and warm; severe pain in his left wrist - feels a lot like a gout flare up; severe pain in his left arm - feels a lot like a gout flare up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe pain in his left arm - feels a lot like a gout flare up), PERIPHERAL SWELLING (left wrist hurt, became swollen and warm) and ARTHRALGIA (severe pain in his left wrist - feels a lot like a gout flare up) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event .     On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (severe pain in his left arm - feels a lot like a gout flare up) and ARTHRALGIA (severe pain in his left wrist - feels a lot like a gout flare up). On 04-Feb-2021, the patient experienced PERIPHERAL SWELLING (left wrist hurt, became swollen and warm). At the time of the report, PAIN IN EXTREMITY (severe pain in his left arm - feels a lot like a gout flare up), PERIPHERAL SWELLING (left wrist hurt, became swollen and warm) and ARTHRALGIA (severe pain in his left wrist - feels a lot like a gout flare up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Headache behind my eyesTiredness; Headache behind my eyesTiredness; This is a spontaneous report from a contactable healthcare professional.  A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 12:00 at single dose for covid-19 immunisation.  Medical history included gastrooesophageal reflux disease and known allergies: Penicillin.  Concomitant medication included omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and oxymetazoline hydrochloride (CLARITIN ALLERGIC).  The patient has known allergies: Codeine.  The patient stated, "headache behind my eyes tiredness", on 04Jan2021 12:15, The outcome of the events was recovering.   Information lot/batch number has been requested.
This spontaneous report was received from a medical assistant concerning to multiple patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medication, were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB Lot# M032148, expiration date: 18-APR-2019 for prophylaxis, which had a temperature excursion 32°F for 45 days. No previous temperature excursion were reported. The reporter stated that the temperature excursion was detected by a data logger. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA009044: US-009507513-1702USA009042: US-009507513-1702USA006132: US-009507513-1702USA009040: US-009507513-1702USA009041:
"A few hours" after vaccination, pt developed whole body shaking. This progressed to also included weakness, HA, poor sleep, dizziness. Possible tactile temp. Reaction lasted 48-72 hours. Before shakiness resolved it appeared to persist mainly in (B) hands.
1/15/21-had back pain starting 0600 . 1/16/21-hand pain, joints and fingers were stiff and painful. 1/17/21- fingers painful, joints, wrists painful, forearms hurt, elbows and knees hurt. Could not bend fingers into fist. Thumbs felt broken. 1/18/21-pain continued in all areas as explained on 1/17/21. 1/19/21- pain continued but lessened. no back pain.
patient had sensation of her tongue going numb shortly after the vaccine.  She also complained of being lightheaded.   She recovered within 20 minutes.
fever, diarrhea, crying (insolable), stopped eating typical foods she liked, needed to be in constant motion (baby jumper)to be happy, didn't want to be held, no eye contact, how she played changed (stacking objects only play), stopped making any sound at all  6/17/09 PCP records - DOS 11/18/00 to 5/27/02   Assessment: Eczematous dermatitis Records indicate healthy newborn. At about 1 year of age child presented with a rash. Dermatology consult - Eczematous dermatitis.\ksk
Redness, swelling, hot to touch 4in by 3 in, itchy at injection site going on day 9 and getting bigger   Hives to face 3 hours after injection
Eyes crusting shut,mild headache,strong fatigue,balance and walking stability issues,tinnitus and tinnitus increasing where other side effects are decreasing. Hissing sound in both ears becoming louder each month.
severe aching; exhaustion/Fatigue; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (severe aching), FATIGUE (exhaustion/Fatigue) and FATIGUE (Exhaustion) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced MYALGIA (severe aching), FATIGUE (exhaustion/Fatigue) and FATIGUE (Exhaustion). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at a dose of 1 dosage form. On 29-Jan-2021, MYALGIA (severe aching), FATIGUE (exhaustion/Fatigue) and FATIGUE (Exhaustion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.      Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: Reporter first name and email address updated.
she had a broken rib after her first dose of the vaccine; This is a spontaneous report from a Pfizer-sponsored program  from a contactable consumer (patient). A female patient of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Feb2021 as SINGLE DOSE for covid-19 immunisation, Lot Number: unknown. Medical history and concomitant medications were not provided. Patient asked if it was better to reschedule her second dose of the Covid-19 vaccine scheduled on 12Mar2021 since she had a broken rib on unknown date in 2021, after her first dose of the vaccine on 21Feb2021, and currently taking a pain medication ibuprofen (ADVIL), she wanted to know if the second dose of the vaccine will cause her any much pain given her situation. Outcome of the event was unknown. Information about Lot/Batch has been requested.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old Child patient and unknown gender. On 18-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Pain and swelling in L armpit to the size of an egg.  It started the day after receiving the vaccine and didn't reduce in size or pain for 3 weeks.  The pain eventually subsided.  The lymph node is still somewhat enlarged several months later.
After getting the second dose, three days later every time she takes progesterone she experiences shortness of breath; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization, and progesterone, via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient had her first covid vaccine (BNT162B2) last 18Dec2020 and had no reaction to the first dose. After getting the second dose, three days later every time she takes progesterone she experiences shortness of breath from an unspecified date. The patient was asking what she can do about it and also asked if the vaccine can wear off even though the immunity from the covid vaccine won't take effect as she needs to take her progesterone (as reported). The action taken in response to the event for progesterone was unknown. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Patient was vaccinated in a LTCF and requested her second dose. of Moderna.  The facility had mischarted the patient's record and it turn out the patient received a 3rd dose. This was noticed upon return to the pharmacy to process the Vars
Information has been received from a registered nurse (school nurse), via a company representative, concerning a 7th grade female student, who was vaccinated, IM (date not specified), with the first dose of Gardasil. The next day ("within 24 hours"), the student developed a fever, headache and dizziness, and had to stay home from school. The school nurse reported that the following day, the "symptoms went away" and the the student returned to school. The patient sought unspecified medical attention. Additional information has been requested.
Soreness and redness in arm, 8 hours later while asleep awoke to shivering, shaking and extreme cold. Added blankets, and was worried about seizures. Took tylenol and the shaking stopped.  Woke up next morning to temp of 101.4. Had muscle aches, headache and fatigue and continue fever. Took tylenol to control fever. This continue for at least 30 hours. Contacted by doctor and was advised to come to office if symptoms continued or worsened or seek urgent care if symptoms worsened. Unable to get out of bed for 2 days.
Severe migraines and even with blood pressure medication blood pressure thru the roof.  168/110 6 days and still a migraine with eye pain And blood pressure will not come down  average blood pressure is 149/100, also my neck is stiff
10 days after i received the 2nd Moderna Covid 19 shot I started to hear ringing in both ears (tinnitus).  Also hearing in both ears affected.
Fever 104, 10 hrs post immun & achiness red, swollen, aching arm lt arm;
This case was reported by a nurse and described the occurrence of rash in a 52 yr old female pt who received hep B vaccine recombinant (Engerix B). The pt's past medical history included allergy to penicillin. Concurrent medications included Prilosec. On 14Jan04, the pt received the first dose of Engerix B vaccine (lot ENG5520A2) in his left arm. One day later, on 15Jan04, the pt experienced a small rash on his thigh. The event unresolved.
She developed a fever almost immediately, she began acting aggressive and combative, the next day the rash began on her face then spread to her chest and hands and feet. She would not eat. She cried, and then stopped talking.
Information has been received from a consumer concerning her 21 year old daughter with no previous medical history reported who on 06-APR-2007 was vaccinated with the first dose of GARDASIL. On 07-JUN-2007, the patient was vaccinated with the second dose of GARDASIL and on 10-OCT-2007 with the third dose of GARDASIL. Concomitant therapy included birth control (unspecified). She had her papanicolaou test on 20-OCT-2007 and on 21-MAY-2008 and both came back ASCUS, and her last papanicolaou test on 03-DEC-2008 came back normal. In December 2007 and April 2008, the patient experienced yeast infections. In November 2008, the patient experienced swollen gland in her groin. Subsequently, the patient recovered. The patient sought unspecified medical attention. This is one of several reports provided by the same source. Additional information has been requested.
This spontaneous report as received from a 61 years old male patient regarding himself. The patient current conditions included glaucoma. No concomitant medications were taken by the patient. There was no drug reactions or allergies reported. The patient's medical history included shingles on approximately June 2010 (reported as about 2 and a half years ago). After experiencing pain involved with shingles, the patient was vaccinated with ZOSTAVAX (lot number, expiry date, route and dose were not reported) on December 2010 (reported as 2 years ago). No concomitant medications were reported. The patient reported that he still had some numbness and tingling sensation on the left side of his face. He occasionally gets some blisters on the inside of his lips. The numbness, tingling and blisters had never gone away completely from the initial case of shingles which occurred about 2 and a half years ago (June 20100. But they did get a little worse approximately on an unknown date in December 2011 (reported as about one year) after getting the vaccine. The patient sought medical attention (saw the health care professional) and was treated with cremes (unspecified for rash). The outcome of numbness and tingling on the left side of his face and blisters on the inside of his lips was reported as not recovered. Additional information has been requested.
pt had sore arm for a couple of days then 5 days after injection her arm became red, swollen, warm to touch.
Numb toes left and right foot.  Severe lower back, pelvic region, constant leg pain.
This literature marketed report was received from the authors of the published article. A 4-year-old boy presented with a 1-month history of three soft, pruritic, subcutaneous, 1-cm mobile nodules on the anterior left and right thighs with overlying hypopigmentation, excoriated dermatitis, and moderate xerosis. The patient had a history of persistent cervical lymphadenopathy of the right anterior and lateral neck, eczema on the flanks and upper buttock, and keratosis pilaris on the posterior bilateral arms. Viral studies were unremarkable except for detectible immunoglobulin G antibodies to EpsteinBarr virus indicating a previous infection. The patient's family first observed the nodules after he had received a hepatitis A vaccine (manufacturer unknown) in the left thigh 1 month before. The patient received six vaccinations: three doses of the diphtheria, tetanus, pertussis, polio vaccine  Haemophilus influenzae type b conjugate vaccine and three doses of the pneumococcal vaccine. There was no record of where on the patient these vaccines were administered. His scheduled vaccination program was continued after he and his family moved. A punch biopsy of a nodule on the left anterior thigh was performed for histopathologic examination. A punch biopsy specimen demonstrated lobular panniculitis with a dense infiltrate composed of lymphocytes, histiocytes, plasma cells, numerous eosinophils, and clusters of dendritic Langerhans cells. Stains for microorganisms were unrevealing. The patient underwent patch testing and at 96 hours had a 2+ positive reaction to 2.0% aluminum chloride hexahydrate. In the months after, the patient developed diffuse hypopigmented patches on his trunk and overlying the thigh nodules. The patient was diagnosed with aluminum hypersensitivity. The outcome of events was unknown. The authors considered the events to be related to aluminium salts used as adjuvants in vaccines, including hepatitis A vaccine (manufacturer unknown).
Pfizer-BioNTech COVID-19 Vaccine EUA I was vaccinated yesterday and woke up with morning with tinnitus in both ears, although it appears to be worse in the left ear than the right. I also think I've got a bit a hearing loss, but that may just be the interference of the high pitched tone. Everything sounds a bit muffled today, though, as well.
In late November 2015 she developed a UTI.  After treatment from antibiotics follow up urine tests indicated large amounts of blood and protein in urine. We were referred to urology in January 2016 and finally nephrology by May 2016.
developed a cluster type headache that lasted all night/severe cluster headache; developed pinpoint itching all over her body/mild itching today 'like when a nerve lights up'; she felt her left outer ear was burning until around 22:00 at night; This is a spontaneous report from a contactable consumer (patient).  A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. EL0142 and expiry date:Mar2021) , via an unspecified route of administration on 13Jan2021 16:15 at a single dose in left arm for covid-19 immunization.  There were no medical history and concomitant medications reported. She states that she had the first dose of the vaccine on Wed 13Jan2021 at 16:15 together with her husband, right after receiving the dose on left arm she felt her left outer ear was burning until around 22:00 at night and was milder the next day. She states that last night 14Jan2021 around 20:00, she developed a cluster type headache that lasted all night, she took ibuprofen (ADVIL) and around 22:00 the same night she developed pinpoint itching all over her body. She reported she still has some mild itching today 'like when a nerve lights up' and still has a 'little bit of a headache.' She wants to know if these were common side effects. The outcome of the event burning sensation recovered on 14Jan2021, while cluster headache and itching were recovering.
Received two doses of Covid 19 Pfizer and now has a pulmonary embolism . No previous history or pulmonary embolism