chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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-163-4296882-00 (RA). A 57 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown (booster), single for Covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First Dose, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Second Dose, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovered", described as "moderate to severe rheumatoid arthritis flare up". The action taken for adalimumab was unknown. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of moderate to severe rheumatoid arthritis flare up was not provided. The reporter's assessment of the causal relationship of the event moderate to severe rheumatoid arthritis flare up with the suspect product bnt162b2 was Possible at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Clinical course: Solicited report by a consumer of an adult female with an event of non-serious moderate to severe rheumatoid arthritis flare up with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced moderate to severe rheumatoid arthritis flare up. On an unknown date, moderate to severe rheumatoid arthritis flare up resolved. Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event. 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.
Nausea, back pain, joint pain, muscle pain, headache, numbness and tingling of hands, and fatigue.
I had ongoing menstrual bleeding which went on for 3 months straight. I had a biopsy and an ultrasound to check for other causes. progesterone to reduce the bleeding. The progesterone did help to resolve the issue.
Spreading erythema, warmth, swelling near site of injection consistent with cellulitis vs. adverse reaction.
Moderna Covid-19 vaccine (EUA) -- My shot was thursday 4/15 and on Friday 4/16  I woke up with fever of 101.  I Felt tired and weak.   A little dizzy too.  I had muscle pain in my legs.  -- i was so tired couldn't get off of couch.  Fever only went down to 100 with Tylenol and then went back up.  I felt like a truck hit me my head was killing with pain.  I had neck pain also.   It kinda felt like I got the flu.  I also had a  upset stomach.  I also have a red rash on my left arm a little down from the injection site.  The rash itches and it is inflamed.   The rash is still there  3 days later.  I am still fatigue 3 days later, when I bend down i feel like pressure runs to my head.  On Saturday 4/17 afternoon my fever went down normal but still very tired.  My reaction was very, very uncomfortable.  I was in a lot of pain especially with the headache.  I am very reluctant to ever get any more.
hair loss; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "hair loss".  Additional information: Caller was considering to get the Pfizer-BioNTech COVID-19 Vaccine, bivalent booster, but she was concerned because recently, she has had hair loss. Caller also has had the Pfizer vaccine (primary vaccination and booster doses) and she was wondering if there could be a correlation between the vaccine and her hair loss or it's just simply age-related. She received the last dose of the vaccine about 3 or 4 months ago.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
light headedness; chills; drowsiness; fatigue; lethargy; headache; body ache; Muscular pain in arm that received vaccine for 48 hours; Headache after 12 hours; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021273425 (Pfizer).  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Feb2021 02:30 (Lot number: EN6200) as dose 1, single and administered in arm left, administration date 09Mar2021 02:30 (Lot number: EN6200) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (Dose number: 1, Time: 02:30AM, Anatomical site of injection: Left arm, Batch/Lot number: EN6200), administration date: 16Feb2021, when the patient was 42 years old, for COVID-19 immunization. The following information was reported: MYALGIA (non-serious) with onset 17Feb2021 03:00, outcome "recovered" (2021), described as "Muscular pain in arm that received vaccine for 48 hours"; HEADACHE (non-serious) with onset 17Feb2021 03:00, outcome "recovered" (2021), described as "Headache after 12 hours"; DIZZINESS (non-serious) with onset 10Mar2021 09:00, outcome "recovered with sequelae" (2021), described as "light headedness"; CHILLS (non-serious) with onset 10Mar2021 09:00, outcome "recovered with sequelae" (2021), described as "chills"; SOMNOLENCE (non-serious) with onset 10Mar2021 09:00, outcome "recovered with sequelae" (2021), described as "drowsiness"; FATIGUE (non-serious) with onset 10Mar2021 09:00, outcome "recovered with sequelae" (2021), described as "fatigue"; LETHARGY (non-serious) with onset 10Mar2021 09:00, outcome "recovered with sequelae" (2021), described as "lethargy"; HEADACHE (non-serious) with onset 10Mar2021 09:00, outcome "recovered with sequelae" (2021), described as "headache"; PAIN (non-serious) with onset 10Mar2021 09:00, outcome "recovered with sequelae" (2021), described as "body ache". Therapeutic measures were not taken as a result of myalgia, headache, dizziness, chills, somnolence, fatigue, lethargy, headache, pain.  No follow-up attempts are possible. No further information is expected.
4/23/2021  3 days after getting vaccine, Menstrual cycle started early morning, after NOT having a period since JULY 7, 2020. Very heavy bleeding.  5/8/2021 Big Toe on right foot feels numb, asleep  5/15/2021 Left hand, index finger  started feeling numb. Still having issues with both toe and finger.
Pt has rash but no puffy blisters on base of spine went down right side of leg of soles of feet. Pt reports no pain and isn't sure if he had chicken pox in the past. Pt was itchy in evening after receiving vaccine & rash appeared large in arm, following vaccination.
Vasovagal syncope within 1 minute of vaccine administration.  Recovered within 1 minute.
I was given my second shot yesterday and at first I had a mild headache and then it got worse and I was very tired. My arm was sore and I could not lift it. Waking up this morning and my chest hurts and is getting tight. I have a bad headache. And I am very irritable. My arm at the injection site still hurts a bit.
Redness, swelling, possible infection. MD prescribed KEFLEX 500 ml.
had some burning before; showed small kidney stones; maybe had a UTI going on; lower back pain; was not able to get up from the bed or the chair; maybe back kidney pain; This case was reported by a consumer via call center representative and described the occurrence of renal stone in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included tamsulosin hydrochloride (Tamsulosin), lidocaine hydrochloride (Lidocaine), tramadol and diclofenac (Diclofenac Topical Gel).   On 14th January 2021, the patient received the 1st dose of Shingrix. On 15th January 2021, 1 days after receiving Shingrix, the patient experienced renal stone (serious criteria GSK medically significant), urinary tract infection, low back pain, mobility decreased and renal pain. On an unknown date, the patient experienced burning sensation. On an unknown date, the outcome of the renal stone, urinary tract infection, low back pain, mobility decreased, renal pain and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the renal stone, urinary tract infection, low back pain, mobility decreased, renal pain and burning sensation to be related to Shingrix.  Additional details were reported as follows: The reporter was patient's daughter. The patient next day of vaccination started to be had lower back pain. The patient was not able to get up from the bed or the chair. The reporter stated that the patient might be had a UTI (urinary tract infection) going on that we were not aware of or might be back kidney pain and the patient had some burning before, but it was not confirmed. X-Ray or MRI (magnetic resonance imaging) showed small kidney stones. The reporter stated that events had still not resolved. The reporter did not consent to follow up with him/her via email as well as with healthcare professional.
1/5/09 received DTAP, IPV, MMR,Volvox and flu 1/6/09 T100.3 1/7/09 0 fever 1/8/09 fever to  104 lasting 3 day associated with headache 1/11/09 blotchy pink rash on trunk last < 2 yo 1/12/09 Barely visible residual rash and febrile.
For 12 days: all symptoms were extreme: dizziness, nausea, light sensitivity, motion sickness, constipation, difficulty lying down to sleep, inability to look at screens
BREAKTHROUGH COVID: FULLY VACCINATED AND BOOSTED. 97-year-old male with past medical history of , presenting to ED with worsening weakness. COVID-19 positive w/o signs of severe features. Pt was found by himself alert and oriented x 2. He reports he was brought to the hospital because he fell and had trouble standing up. Spoke over the phone with daughter who provided most of the history. She reports she recently tested positive for COVID-19,  until last night where the worsening confusion and weakness were evident. Patient had two unwitnessed falls in the last 24hrs. Has not had fever but has been c/o chills. PT TREATED COVID INFECTION WITH Paxlovid 150 mg-100 mg (300 mg-100 mg Dose) oral tablet. Mild runny nose and dry cough noticed. Denies any other complaint such as headache, chest pain, SOB, abd pain, vomiting or diarrhea. Acute encephalopathy superimposed on baseline dementia, POA, likely releated to COVID infection
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "He provided that his primary care provider is also sick". Additional information: Reporter's primary care provider was through the (State withheld). Declined to provide mailing address, phone number and email. Reporter provided that his primary care provider was also sick. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
She reported feeling like her throat was closing and was also experiencing lightheadedness, apprehension, and numbness/tingling in her left hand. Her vital signs were monitored every 5 minutes for 20 minutes, and she was given 20 mL (50 mg) of liquid Diphenhydramine. Her signs and symptoms subsided, and she was ambulatory and stable with no distress at dismissal from clinic.
Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: blurry vision-Medium, Systemic: Visual Changes/Disturbances-Medium
HEADACHES, POOR VISION, JOINT PAINS UPPER AND LOWER PART OF BODY, BACK PAINS, EXCESSIVE THIRST DURING THE MORNING THROAT PAINS.
COVID arm.  On the eighth day, my arm swelled up and I had a large red rash which caused itching.  It's been approximately 2 days and the rash is almost gone, but still itching somewhat.  My arm is still swollen.
post menopausal bleeding. Very scant intermittant since 04/08/2021
Swollen; Painful; Arm was a bit tender; Itches real bad; Redness; Rash more developed on vaccination arm; Feels like its burning; Could feel a rash on her arm; Rash; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen), PAIN IN EXTREMITY (Painful), TENDERNESS (Arm was a bit tender), PRURITUS (Itches real bad) and ERYTHEMA (Redness) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Cholesterol. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache). On 30-Mar-2021, the patient experienced RASH (Rash). On 01-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen), PAIN IN EXTREMITY (Painful), TENDERNESS (Arm was a bit tender), PRURITUS (Itches real bad), ERYTHEMA (Redness), VACCINATION SITE RASH (Rash more developed on vaccination arm), VACCINATION SITE PAIN (Feels like its burning) and RASH (Could feel a rash on her arm). At the time of the report, PERIPHERAL SWELLING (Swollen), PAIN IN EXTREMITY (Painful), TENDERNESS (Arm was a bit tender), PRURITUS (Itches real bad), ERYTHEMA (Redness), RASH (Rash), VACCINATION SITE RASH (Rash more developed on vaccination arm), VACCINATION SITE PAIN (Feels like its burning), RASH (Could feel a rash on her arm) and HEADACHE (Headache) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant product included blood pressure and cholesterol medication. Treatment information was not provided.
Severe irritability, breathing with audible stridor, croup like symptoms, positive lethargy. IN the ER, received Decadron injection, Epinephrine, Albuterol treatment and then transferred to ICU. No new terms in Discharge Summary rec'd 12/08/2005/sr
Information has been received from a consumer referring to his spouse, a 76 year old female patient with heart rate irregular, coagulation time shortened and arthritis. In June 2016 the patient had a severe case of pneumonia that led to a prolonged hospital stay, heart failure, stroke and a compromised immune system, in which case, the physician recommended PNEUMOVAX 23 once she recovered. The patient had no drug reactions or allergies. Concomitant medication included heart regulator medication, blood thinner medication, vitamins and arthritis medication. On 02-NOV-2016 the patient was vaccinated with PNEUMOVAX 23 (lot #, expiration date and dose were unknown, intramuscular). On 03-NOV-2016, the patient experienced extreme fatigue, swollen, injection site pain, labored breathing and extreme dizziness which led to her falling. It was reported that therapy was not discontinued. The patient did not seek medical attention. No lab diagnostics studies were performed and no treatment was given for the events. At the time of reporting, the patient had not recovered from the events. Causality was not reported. Additional information has been requested.
Received COVID Vaccine Dose #1 Friday morning around 8am. Pain at injection site was manageable. Friday evening I began to feel achy. Went to bed and woke up around 1am Saturday with a fever (101.5), muscle aches and chills. I also had a headache but headaches are more common for me so may or may not have been related to the vaccine.   Fever subsided with ibuprofen. Continued to take ibuprofen every 6 hrs throughout the day on Saturday. By Sunday, I felt fine.    FYI I did have COVID back in December.
the eyes are changing sometimes to like a cat eye; This spontaneous case was reported by a patient and describes the occurrence of EYE DISORDER (the eyes are changing sometimes to like a cat eye) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE DISORDER (the eyes are changing sometimes to like a cat eye). At the time of the report, EYE DISORDER (the eyes are changing sometimes to like a cat eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
While vaccinating at an offsite clinic at Middle School, Staff administered a Hep B vaccine to the patient instead of the scheduled TDAP.
headache; dizziness; fever; This case was reported by a consumer via call center representative and described the occurrence of headache in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 1st May 2019, the patient received the 1st dose of Bexsero. On 2nd May 2019, 1 days after receiving Bexsero, the patient experienced headache, dizziness and fever. On an unknown date, the outcome of the headache, dizziness and fever were unknown.   It was unknown if the reporter considered the headache, dizziness and fever to be related to Bexsero.  Additional details were provided as follows: The reporter was the patient's mother. The reporter declined to provide the patient's demographic details. After vaccination with Bexsero, the patient had mild headache and mild fever with dizziness. The reporter did not consent to follow up.
57 yo presents with symptoms after receiving a pneumococcal vaccine. Patient reports developing hives and blotchiness to skin, dyspnea which resolved, and myalgias. Patient was given BENADRYL and MEDROL pak.
I had no immediate side effects initially other than soreness in left arm for about 4 days.  I woke up on 4/1, (9 days after shot) with a large red circle around injection site that was extremely sore, itchy and hot to touch, felt hard bump on skin.   I believe this to be what is being called Corona Arm based on information i received from the pharmacist where I had vaccine.  She advised to take Benedryl for itching and tylenol for pain.
Significant flu-like symptoms with severe fatigue, lower extremity myalgias, rigors, chills, brain fog, decreased appetite.
Fever of 102; extremely painful arm; arm swollen and red; severe headache (note: this was a pneumonia shot, not a flu shot).
Initial misuse information was received from a health care professional on 19 Sep 2013. Cases were received on 21 March 2014 at GPV. A patient whose demographic details, medical history and concomitant medication were not reported received a dose of FLUZONE HD on an unspecified date (route, site, dose and batch number not reported). It was reported that on an unspecified date patient received incorrect route of vaccination. Laboratory investigation were not reported. No adverse event was reported. List of documents held by sender: none
I'm 57 years old, received an initial dose of Bexsero; This case was reported by a consumer via interactive digital media and described the occurrence of inappropriate age at vaccine administration in a 57-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient was 57 years old and received an initial dose of Bexsero asked when he/she get a second dose. Additional supportive information: The Bexsero was received at the age of 57, which led to Inappropriate age at vaccine administration. Follow-up would not possible as no contact details were available.
1-11-12 Pt calls approx 300pm talks to nurse who gave HPV#1 2nd MENVEO vaccine on 1-10-12 at approx 230pm - pt says at 730pm 1-10-12 she c/o headache, lost appetite fever 101, trouble sleeping and chest pains - says fever down to 99 1-11-12 but still having chest pain - nurse told her to have family take her to local ER - pt also has asthma tried to call pt 1-12-12 wrong phone no in chart.
Fever, chills, shaking, pain, joint and body pain, rapid pulse, sweating, nausea, very painful arm , headache, dizzy, brain fog, chronic fatigue
Patient complains of chronic itching around the left shoulder where she received the shingrix vaccine since september, when she received the vaccination.
REDNESS AROUND THE AREA WHERE SHOT WAS GIVEN. PATIENT COMPLAINED OF ITCHINESS.
Fever, loss of appetite, irritability starting at 2 AM on 01/22/19.
Approx 5 to 10 minutes p/DTP/OPV pt fainted, became cyanotic & had shallow resp; hospitalized 24 hrs; tx included IV fluids; pt recovered w/ no residual sequelae;
After receiving both injections, I left  pharmacy area of store and walked to bathroom. Began feeling tickle in lungs and began coughing. Increased as I was using the bathroom facility. Face felt very hot. Looked in mirror and face was extremely red. Returned to pharmacy. Sat down. Felt pressure in chest, loud ringing in ears, heart racing. Began to have very severe back spasms, beginning at lumbar and radiating  into thoracic area. Had approximately 6-10 spasms. Then all symptoms slowly ended, although my hands were shaking uncontrollably for several more minutes. Entire event lasted approx. 10-15 minutes.
Circular rash @ 2cm diameter on anterolateral right thigh with small scab. Initially pimple like but clear per family. History of fever and fussiness. No other lesions or symptoms.
CONSTANT PAIN IN LEFT HAND (SOME DAYS HARD TO MAKE A FIST)  AND LEFT FOOT. NO PAIN BEFORE  THE COVID VACCINE.