chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On Saturday morning I woke up with a headache and swollen lymph nodes in my neck/collarbone area. As the day progressed, I began to have pain in my joints and muscles. I felt very tired all day as well. I also experienced skin sensitivity which basically just made my skin hurt if anything/one touched me. Sunday my headache persisted, still had pain at injection site and felt warm to the touch. Swollen lymph nodes also still there and fatigue. Monday morning symptoms of headache, injection site pain and warmth and swollen lymph nodes still felt.  Taking Tylenol to help with headache, warm compresses to help swollen lymph nodes and ice pack for injection site pain.
Breakthrough case of COVID/ Symptoms were mild moderate headache, mild cough, nasal congestion/runny nose; Breakthrough case of COVID/ Symptoms were mild moderate headache, mild cough, nasal congestion/runny nose; 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 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), on 25Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 05Nov2021 as dose 3 (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Breakthrough case of COVID/ Symptoms were mild moderate headache, mild cough, nasal congestion/runny nose". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Breakthrough case of COVID. Clinical course: Breakthrough case of COVID after receiving the primary series of the vaccine and a booster dose. Booster dose was administered on 05Nov2021, and primary series completed on 25Mar2021. Symptoms were mild moderate headache, mild cough, nasal congestion/runny nose.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Dose 1 1/30/2021 Moderna lot # 029K20A patient dies of pneumonia, not a covid related death
Allergic type reaction, arm swelling shoulder to elbow, painful, patient went to ER received IV and PO antibiotics and BENADRYL.
PATIENT MOVED WHILE PROVIDING IMMUNIZATION RESULTING IN VACCINE GIVEN HIGHER UP IN DELTOID THAN RECOMMENDED. PATIENT REPORTED HER ARM FEELING SORE IMMEDIATELY AFTER. NO OTHER ADVERSE EFFECTS REPORTED. RECOMMENDED OTC PAIN RELIEF AND SYMPTOMS SHOULD SELF RESOLVE IN A COUPLE OF DAYS. DISCUSSED SIRVA ALTHOUGH UNLIKELY TO OCCUR.
3 WEEKS POST VACCINE AND ARM MUSCLE/SHOULDER HAS PRETTY SEVERE PAIN.  IT HURTS TO RAISE MY ARM ABOVE MY HEAD, SHAMPOO/BRUSH MY HAIR, ETC....
Patient presented on 11-5-21, 3 days post injection, to report large swelling, redness to injection site, hard lump at injection site, warmness to touch, and slight bruising distal to injection site. Patient reported cough occuring the evening of vacination and sore throat.
The patient experienced no symptoms; An improperly stored dose of GARDASIL 9 was administered to the patient; This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapies were not reported.    On 15-MAY-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscularly, lot # R028656, experitation date 27-JUL-2021 (dose was not reported) for prophylaxis. The vaccine was exposed to 27 Fahrenheit degrees for 3 hours. There was not previous temperature excursion. The call was made due to "data logger". The patient experienced no symptoms. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R028656; expirationdate: 27-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Information has been received from a physician concerning a 10 year old patient who "at a younger age" was vaccinated with a dose of Varivax. Subsequently the patient developed full blown varicella, it was reported that the patient had no fever but did have some scarring. Subsequently, the patient recovered. Additional information has been requested.
Information has been received from a physician concerning an 8 year old female with no known allergies who on 08/08/1996 was vaccinated with a first dose of varicella virus vaccine live SC in the left arm. There was no illness at the time of vaccination. On 02/11/2002, the pt's mother contacted the physician's office and stated that the pt had a mild case of chicken pox. There was no relevant diagnostic tests and lab data. Subsequently, the pt recovered. No additional info is expected.
Heart issues and Problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 21 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "Heart issues and Problems". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: My son received your vaccine, the second of his shots coming in Jul2021.Not long after that he has been having heart issues and Problems. He was a perfectly healthy 21-year-old man. He is going under some testing now but he is sure that your vaccine is causing all of this. This letter is to put you on notice of a lawsuit against you should anything happen to him or he has long term effects from your vaccine  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
PT COMPLAINED THEY FELT VERY DIZZY AND SICK TO THEIR STOMACH WHEN THEY WENT TO BED THE NIGHT THEY RECEIVED THEIR FLU SHOT.  HE SAID THE SYMPTOMS LASTED ABOUT 48 HOURS.
I received Moderna vaccine. The first shot on 2/25/21 010A21A on right arm. The second shot on 3/25/21 016B21A on left arm. I have enlarged breasts. They have gone from a size B to a size D.  I recently got a mammogram and ultrasound on July 30th and the results came back as no sign of breast cancer. I didn't know that larger breasts were an adverse reaction until I recently did a Google search recently. They are also hurting a lot and have been hurting for months which is why I went for a mammogram.
3:30 - stiffness in neck, left side, just below jawline 5:30 - sharp internal pain while on light walk, left/center chest (patient practices intense cardiovascular exercise several times weekly)  8:30pm - urgent care diagnosed with anaphylaxis. Prescribed prednisone and Zyrtec. Neck symptoms decreased, chest pain continues 08/06/2021 4:00pm - Urgent Care #2 - EKG, diagnosed with pericarditis, prescribed ibuprofen and Colchicine Symptoms decreased slowly over the next 48hrs.
a 36 hour excruciating migraine headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly female patient received BNT162b2 (BNT162B2), as dose 1, 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: MIGRAINE (non-serious), outcome "unknown", described as "a 36 hour excruciating migraine headache".  Additional information: It was reported that each time, after receiving both primary series doses of the COVID-19 Vaccine, as well as their first booster shot (monovalent) the patient reported having "a 36 hour excruciating migraine headache.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300205271 same patient and event, different dose;US-PFIZER INC-202300205272 same patient and event, different dose;
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOTENSION 8/31/2022 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Fever 102 F,  headache (predicted), muscle ache (expected) but 2 days post-injection started to develop small red spots on hands and feet. Some filled with water and burst, turning into larger red , flat spots. Itchy and somewhat painful. Several on fingertips. Nurse at urgent care said it was not shingles since appearance was bilateral. She said she had never seen similar response. I am not allergic to eggs. Had first dose of SHINGRIX about 2 weeks prior to flu vac. I have photos if desired. I still have remaniants of the bumps but they appear to be healing. Treated them with corticosteroids cream OTC, Bender il and liquid bandaid to protect site.
Blood pressure went way up and has been that way for seven weeks My doctor increased the dose of my blood pressure medication twice and also started me on a second one
Pain at injection site during shot. Soreness for 48 hours. Headache, chills, body aches - onset at 7 hours after and continued until next morning. Headache persisted until 24 hours from injection. Also experienced gastrointestinal discomfort and diarrhea until 48 hours.
Information has been received from an office manager (also reported as a nurse) concerning a 15 year old female with no medical history or allergies, who on 21-JUN-2007 was vaccinated intramuscularly with a first 0.5mL dose of Gardasil (Lot #357736/0389U). Concomitant vaccinations on 21-JUN-2007 included Menactra and Tdap 10/08/07 This is in follow-up to report(s) previously submitted on 7/16/2007. Initial and follow up information has been received from an office manager (also reported as a nurse) concerning a 15 year old female with no allergies and anxiety, who on 21-JUN-2007 at 18:30 was vaccinated intramuscularly in the right arm with a first 0.5mL dose of GARDASIL (Lot #357736/0389U). Concomitant vaccinations on 21-JUN-2007 at 18:30 included MENACTRA (Lot# U2338AA) and ADACEL (Lot# C2720AA) in the left and right arm, respectively. Subsequently, at 18:30 the patient became lightheaded and passed out (previously reported as the patient fainted) after receiving the three shots that "she did not want". The patient collapsed and fell although she did not lose consciousness. The patient did come to right away. Treatment consisted of a cold cloth to her forehead and after eating and drinking sips of cold soda pop, the patient felt better. No lab diagnostic studies were performed. It was noted that the patient was "very anxious" about the shots. On 21-JUN-2007 the patient recovered. No product quality complaint was involved. Additional information is not expected.
The night of vaccination patient reported pain/tenderness in the arm/shoulder that received the vaccine. Upon arrival to the pharmacy the next day (today) I inspected the patient's arm and saw no signs of redness/inflammation. Her arm was painful to move and needed help to show it to me. Advised to rest arm and ice. Also, stated she could take an OTC anti-inflammatory to help control pain.
Patient received first dose of Moderna on 4/8.  He reports a history of passing out with procedures that require needles.   Patient reported he was feeling OK when he entered the observation area. 4:40 he waved his hand and reported his ears were ringing and that feeling like he "was going to pass out".   Patient then placed his chin to his chest and became slow to respond and diaphoretic.  Staff called for assistance and patient was lowered to the floor.   VS...BP 110/70  Pulse 60  Resp 12.  4:50  Patient reported feeling better.  Assisted to a sitting position and offered a juice box.  VS...BP 160/72  Pulse 72  Resp 16.   4:50  Patient reports he is feeling fine.  No further symptoms.  Was released and reported walking around for a few minutes prior to driving home. 4/13  Call placed for follow up.  Patient reports no further symptoms.  Was informed of there being a cot available when he comes in for his second vaccine and that he should ask for it if it is not offered.  Appreciated us checking in with him.  Denies any questions or concerns at this time.
Moderna COVID-19 Vaccine EUA Low grade fever (99.0-100.9) Tightness of chest Soreness in chest Fatigue Soreness in injection site
Information has been received from a physician concerning a 16 year old female with concomitant medications and pertinent medical history reported as unspecified, who on 24-MAY-2007 was vaccinated with her first dose of GARDASIL vaccine (yeast) (Lot # not reported). On 25-MAY-2007, the patient felt weak, dizzy and fainted, and sought unspecified medical attention. The patient recovered completely a short time later (date unspecified). No product quality complaint was involved. Additional information is not expected.
Initial report was received on 03 September 2013 from a health care professional. An unknown infant (end of pregnancy reported as 30 September 2012) had received during mother's pregnancy, Tdap (manufacturer, lot number, route and date of administration not reported) and Influenza vaccine (manufacturer, lot number, route and date of administration not reported) and an unspecified amount of time later was found to have a birth outcome of other: lack of respiratory effort. The mother had a history of depression and concomitant medication was reported as CYMBALTA. No further information was available at the time of the report. This case is linked to mother case 2012-08664. Documents held by sender: none.
Arm developed swelling, redness, pain, hot to touch w/in 12 hrs of injection, trouble lifting left arm, chills
Pt's representative (spouse) came to pharmacy and reported discoloration on the palm of patient's hand. Only one hand is affected. She described it as dark purple discoloration covering the entire palm. She said it looks as if it was "bruised," but there is no pain when pressure is put on the area. No other sensation such as itching. Just dark disoloration.
patient received the vaccine at 12:00 pm on 01/06/2021 at the hospital. after 6 hours and at around 6;00 pm patient noticed that he has difficulty hearing in general, but didn't give it much attention since he was doubting the fact he couldn't hear. next day he noticed that all voices coming from the right side is completely dimmed. till he used his phone for a phone call he realized he couldnt hear form his right ear at all. he found out he does hear normally from his left ear. today is day 3 from receiving the vaccine, and the symptoms has not resolved. with complete hearing loss form his right ear. no improvement since the incident. no treatment or medical intervention has yet occured prior to this report.
Missed and then late menstrual period, heavy menstruation, longer then normal cycle, hot flashes for first time
This spontaneous report was received from a nurse practitioner (also reporter as nurse prescriber) via a field representative, concerning a 72 years-old male patient. The patient's concurrent conditions included diabetes (unspecified). His medical history, concomitant medications, drug reactions or allergies were unknown by the reporter. On 13-DEC-2013, the patient was vaccinated with ZOSTAVAX lot # J008528 and expiration date on 19-OCT-2014 (strength, route of administration or anatomical location were not provided); one dose was administered for prevention of shingles. On an unspecified date in the fall of 2016, the patient developed shingles. Therefore, he sought medical attention and received an unspecified treatment for the event. It was unknown if laboratory diagnostics studies were performed. The outcome of the event shingles was unknown. The relatedness between the event shingles and the vaccine was not reported. No product quality complaint (PQC) was involved. Additional information is not expected as there was no consent to contact the reporter.
Guillen Barre; Guillen Barre; Sep2022 diagnosed with CIDP chronic form of Guillen Barre; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There was no known allergies. Concomitant medication(s) included: OZEMPIC. Vaccination history included: BNT162b2 (Dose 2, single, Batch/Lot No: EL9267, location of injection: Arm Left), administration date: 03Feb2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "Guillen Barre"; BNT162b2 (Dose 1, single, Batch/Lot No: EL8982,  location of injection: Arm Left), administration date: 22Jan2021, when the patient was 70-year-old, for COVID-19 Immunization. The following information was reported: GUILLAIN-BARRE SYNDROME (caused and prolonged hospitalization, disability, life threatening), DISEASE RECURRENCE (caused and prolonged hospitalization, disability, life threatening) all with onset Jun2022, outcome "not recovered" and all described as "Guillen Barre"; CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (caused and prolonged hospitalization, disability, life threatening) with onset 2022, outcome "not recovered", described as "Sep2022 diagnosed with CIDP chronic form of Guillen Barre". The patient was hospitalized and prolonged hospitalization for guillain-barre syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, disease recurrence (start date: Aug2022). The events "guillen barre" and "sep2022 diagnosed with cidp chronic form of guillen barre" required emergency room visit.  Therapeutic measures were taken as a result of guillain-barre syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, disease recurrence. The patient was hospitalized for Guillen Barre in Aug2022, and was hospitalized again for Guillen Barre in Sep2022 diagnosed with CIDP (Chronic inflammatory demyelinating polyneuropathy) form of Guillen Barre. It was also reported vaccine received during existing hospitalization. The patient received treatment intravenous immunoglobulin for the events.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 62-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 09Apr2021 at 14:00 as dose 2, single (Lot number: EW0153Q), in left arm, on 09Oct2021 at 13:00 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 18Mar2022 at 10:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 62 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: FENOFIBRATE, start date: 16Apr2022, stop date: 03May2022; HYDROCHLOROTHIAZIDE, start date: 16Apr2022, stop date: 03May2022; LOSARTIN, start date: 16Apr2022, stop date: 03May2022. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: tested negative 4 consecutive days; (unspecified date) Positive, notes: COVID-19 Treatment; (02May2022) Positive, notes: then tested positive again two days in a row. Therapeutic measures were taken as a result of Covid-19. Clinical course: Patient had no known allergies. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Tired, fatigue, stomach ache, nausea begain 5/28/10 (last dose of oral Typhoid taken on 5/23/10). Fever up to 103.8.  Denies vomiting, nor diarrhea.
10 days after varicella vaccines, developed rash on extremities. Macular papular in nature. Extremities lasted 2 weeks and slowly low grade fever required CBC and electrolytes as not feeding resolved in 3 weeks.
12-36 Hours After: Extreme Fatigue, Alternating Chills and Sweats 36-60 Hours After: Headache, Muscle Pain Throughout Body, Vomiting, Diarrhea 72 Hours After: Migraine
7 day after the shot on 8/30/2021, my husband developed fever, chills and loss of cognitive functions. He didn't know his name, day, month and could hardly answer yes and no questions without struggling. He was admitted to the hospital and had CT scan, MRIs, blood work, lumbar puncture, eeg. All tests have come back normal. Awaiting to see the lab tests to see if its viral encephalitis from the herpes virus since he developed a cold sore at the time of the fever. He was treated 7/31 with antiviral medication every 8 hours intravenously and has recovered to almost 100% by 8/3/2021.
Very sore; Bones hurt; Blurry vision; Couldn't speak clearly; Blood sugar was 160.; Blood pressure was 140/96; Felt a rush of heat from the area of vaccination to chest neck and head.; Hard time breathing; Disoriented; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Apr2021 at 15:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient was not aware of any allergies. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 15:00, the patient experienced immediately after the shot, felt a rush of heat from the area of vaccination left arm to chest, neck and head. Had a hard time breathing, got disoriented, couldn't clearly express what she was feeling, couldn't speak clearly. checked blood pressure and it was 140/96 and blood sugar was 160. Patient reported that she was not diabetic, got lost in a familiar territory and had to use a GPS, to get home. On 13Apr2021, the patient experienced very sore, bones hurt and had blurry vision, and continued having high blood pressure and high blood sugar. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with losartan and metformin. On 12Apr2021, the patient underwent Blood pressure and the result was 140/96 (UNSPECIFIED UNITS). On 12Apr2021, the patient underwent Blood sugar and the result was 160 (UNSPECIFIED UNITS). The clinical outcome of the events a rush of heat from the area of vaccination left arm to chest, neck and head, hard time breathing, got disoriented, couldn't clearly express what she was feeling, couldn't speak clearly. checked blood pressure and it was 140/96 and blood sugar was 160. very sore, bones hurt and had blurry vision, and continued having high blood pressure and high blood sugar was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Narrative: Patient had 2 Covid vaccines and following the second shot, she developed hives. Initially they were on her arm in which she got the vaccine, but then she had itching both arms, her scalp, and trunk