chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 12:00, I began to have a bad head itch. Rash appeared around the front rim of hairline. Sunday, face was flushed with small bumps and neck was hives. The hives itched. Monday, called MD. Rash had moved to trunk and back. The old hives on face and neck began to widen and turn dark red and began to move to my lips and ears. Tuesday, limbs were covered with itching and unable to sleep at night. Wednesday, blood evaluated. Thursday, had chills, fatigue, itching all over body, nervousness and irritability. Friday, doctor's office. Treated with antibiotic (Prednisone, anti-histamine and creams for external and internal use for itching. Saturday, had high blood pressure, heart rate and temperature of 101.7F. Went to ER and admitted into the hospital and is still being treated.
This medically confirmed spontaneous report (initial receipt: 21-NOV-2012) concerns a 68-year-old female patient. Concomitant medications included folinic acid, methotrexate, indapamide, trazodone, SUBOXONE, hydrocodone, prednisone, simvastatin, gabapentin, omeprazole, lisinopril, tolterodine, metronidazole and metoprolol. On 09-Nov-2012 the patient received AFLURIA (batch number: 06549221A) injection at a dose of 0.5 mL intramuscularly. On 20-Nov-2012, 12 days after vaccination, the patient was admitted to hospital for kidney failure.
On 1/14/21 I took ibuprofen at 400.      By 9am I was starting to feel achy and had chills.      The symptoms progressed throughout the day. I felt feverish and the symptoms worsened. Chills, flush, all over body aches including headache.      I went to buy some ibuprofen since I forgot to bring any with me.  I felt better after I took the medicine.
This case was reported by a consumer via call center representative and described the occurrence of pain in a adult female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced pain, feeling unwell, swelling arm and skin warm. On an unknown date, the outcome of the pain, feeling unwell, swelling arm and skin warm were recovered/resolved. It was unknown if the reporter considered the pain, feeling unwell, swelling arm and skin warm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient had the injection at around 5 PM and did not notice anything that evening or the next day but on the second day her arm became swollen, bumpy and hot to the touch. The patient did not feel well for a few days. All symptoms were resolved within seven days. The patient did not want to provide personal information. An event was reported as whelp, clarification has been requested for the same.
Redness at injcetion site; Swelling at injection site; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site), VACCINATION SITE ERYTHEMA (Redness at injcetion site) and VACCINATION SITE SWELLING (Swelling at injection site) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included Thyroiditis, unspecified and Hypertension.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). On 10-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injcetion site) and VACCINATION SITE SWELLING (Swelling at injection site).   On 03-Feb-2021, VACCINATION SITE PAIN (Pain at injection site) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injcetion site) and VACCINATION SITE SWELLING (Swelling at injection site) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: NNI
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 15Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 64 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "MGUS" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Antigen home test 6 days after a negative antigen home test; Positive, notes: Antigen home test my antigen home test was positive 6 days after a negative antigen home test; Positive, notes: along with being positive; Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. I experienced all of the side effects of Paxlovid: diarrhea; "Paxlovid mouth" - extremely foul taste for the duration of the 5 day course; but most importantly, "Paxlovid Rebound" - my antigen home test was positive 6 days after a negative antigen home test. I had been in quarantine for 8 days at the time of the negative test. I still have nasal congestion and a cough, along with being positive.
This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A female patient of an unspecified age, race and ethnicity received (TRUMENBA (lot. s26962) on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medication were unknown. On an unspecified date, the patient experienced fever, chest tingling, pain/soreness, headache, and fatigue. Clinical outcome was unknown at time of this report. No follow-up attempts possible. No further information expected.
mild redness and soreness at injection site; soreness at injection site; This case was reported by a nurse and described the occurrence of injection site erythema in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingrix.  Additional details were reported as follows: The patient was an operating room nurse and she called to report the event. The patient received Shingrix and developed mild redness and soreness at injection site. The patient also received 2nd dose of Shingrix and experienced adverse events, for tolerance refer linked case US2020250693.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020250693:2nd dose, same reporter
Menstrual cycle has become irregular: No longer regular, fluctuates, extremely painful, debilitating, excessive unusual bleeding and clotting.
Patient admitted because of intentional acetaminophen ingestion (today patient states she ingested ibuprofen) as a suicide attempt. Current severe episode of major depressive disorder without psychotic features without prior episode. Behvioral health admission and treatment. Hospital admission within 6 weeks of receiving the COVID vaccine.
36 hours of muscle, joint, lymph node pain, as well as a low headache.  Continued headache every day since vaccine. Today is day day 22 s/p 2nd vaccine.  Over the past 5 days, headache has turned into a migraine with nausea, vomiting, and diarrhea. Given covid test yesterday at urgent care and medication for migraine. Unfortunately the  headache has returned.
Local and systemic reaction to flu vaccine. Developed headache within one hour, Lt. arm pain with bruising across most of upper Lt. arm. Dark circle at injection site with dry peeling skin.
Patient went to hospital (911) call within 3 hours after shot. Patient vomited violently, severe abdominal pain, headache, nausea, loss of appetite, rashes on chest, couldn't breathe, fever, paleness, dizzy, severe allergic reaction to shot.  9/25/09 Medical records received for service date 8/24/09: Seen in ER for N/V dizziness, abdominal pain, fatigue.  D/C DX: N/V, post vaccination, abd pain.  ICD-9 Codes: 789.03, 250.01, 999.5.
This spontaneous report as received from a physician refers to a 65 years old female patient.  The patient's medical history included bullous pemphigoid and the patient had chickenpox as a child. The patient was vaccinated with ZOSTAVAX (route, dose and lot # were unspecified by reporter) on 12-OCT-2012. No other co-suspects were reported. Concomitant medications included CELLCEPT 500mg twice daily and prednisone 5mg every other morning. On 13-OCT-2012 (the next day) the patient had a headache and "then the next day", on 14-OCT-2012, had pain in the right face near the ear. The patient then developed a lesion on the upper lip and the physician saw the patient today(on 16-OCT-2012) and it was a clear vesicle on the upper lip. Physician had cultures sent out today(on 16-OCT-2012) to verify whether this vesicle was herpes simplex. Treatment of VALTREX and ADVIL or MOTRIN were given for pain. The outcome of the events were reported as not recovered/not resolved. The patient sought medical attention via visiting office. Additional information has been requested.
There was no adverse reaction. Patient received first moderna shot march 27. The mother gave wrong birthday by mistake so patient was given  the first moderna shot. Only later when about to give 2nd moderna shot it was understood the patient was only 16 years old . the mother said she had told us she got her sons birthday confused with her daughter.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Hypotension-Medium
Headache, swelling, soreness day of shot lasting for about 4 days.  ~ Covid arm 3/28 lasting for about 10 days ~ Red, burning, chaffing, bumpy lips with bright red reaction under nose 4/4  ~ Heart racing, palpitations, increased heart rate, irregular heart rate  ~ high cholesterol
Patient claimed she had the reaction on 7/1/17, redness, swollen, warm, bumps - she took 2 BENADRYL and used icepacks then it's gone on 7/5/17 (pt. consulted MD, not hospitalized).
Flushing/sweating, dizziness, vision; BP 102/41; HR 63, RR 18, SpO2 100%, T 97.5
blood pressure; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and BLOOD PRESSURE MEASUREMENT (blood pressure) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A219 and 15M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE for Blood pressure high.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced BLOOD PRESSURE MEASUREMENT (blood pressure). On 12-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, BLOOD PRESSURE MEASUREMENT (blood pressure) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Blood pressure measurement: 144/?, 140/? (High) 144/?, 140/?. On 18-Apr-2021, Blood pressure measurement: 145/85 (High) 145/85. On 19-Apr-2021, Blood pressure measurement: 123/77, 128/69 (High) 123/77, 128/69.         No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-080489 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Added additional event; Sender's Comments:  MOD-2021-080489:Dose-1
About 1 week after vaccination, intermittent migraine/headaches started, with sharp pain right behind the eyes and some sensitivity to light. The headache worsens with activity and is also worse at night. The headaches increased in severity throughout last week and peaked last night 11/20. OTC painkillers don?t do much but provide some relief before bed. Additionally I noticed decreased appetite at first, but it has lessened over time.  At the same time as covid vaccine (booster) I also got the flu vaccine.
Pt reported site of injection right deltoid is hot to touch and redness.  Site measured 7cm x 3 cm. Nurse taught on otc medications and ice pt declined. Nurse encouraged pt to follow up MD for evaluation.
I started to develop a pain in my upper right quadrant.  It started as dull, then became stronger and more sharp. It hurt so much to take a breath.  I thought it might be gas so I was hoping it would get better when I laid down, but that didn't change it at all.  It was extremely painful.  I wasn't sure if I should go to the ER.  It started to subside around 11:30-12:00pm, and I was able to fall asleep.  When I woke up the next day it was completely gone.  I never felt a pain in that spot before or after that evening.  It might have been in my gallbladder area?  I have two small polyps in my gall bladder that I monitor every few years, but have never felt any discomfort in that area before or after that night.
This case was reported by a healthcare professional, via a sales representative, and described the occurrence of not responding to therapy in an adult male subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  The subject's medical history included human immunodeficiency virus.  On an unspecified date the subject received 3rd dose (20 mcg, unknown), 2nd dose (dose unspecified) and 1st dose of Engerix B (dose unspecified).  At an unspecified time after vaccination with three doses of Engerix B, the subject experienced not responding to therapy.  At the time of reporting the outcome of the event was unspecified.
received an expired Shingrix; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 44-year-old female patient who received Herpes zoster (Shingrix) (batch number LN399, expiry date 9th October 2022) for prophylaxis.   On 16th November 2022, the patient received the 2nd dose of Shingrix. On 16th November 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 17-Nov-2022. Reporter's Comment: The patient received an expired Shingrix second dose by error. The reporter did not consent to follow-up. Additional Supportive Information: The patient received an expired Shingrix second dose by error which leads to expire vaccine used.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Nov2022 as dose 4 (booster), single (Lot number: GJ6739) at the age of 14 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 17May2021 as dose 1, single (Lot number: EW0179), on 21Jun2021 as dose 2, single (Lot number: EW0191) and on 31May2022 as dose 3 (booster), single (Lot number: FM7553) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had no known allergies. Patient received Paxlovid treatment from 29Aug2023 to 03Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300295414 same patient, different drug and different AE.;
10 am received H1N1 20 minutes later in clinic stated she felt itchy throat dry added HR 66 O2 Sat 97. Dr. assessed no egg allergy. IM 50 mg BENADRYL. 10:30 continue to evaluate. 11 am pt. stated feeling better. 11:15 given ride to unit.
Pt developed severe swelling of right arm and chest about 24 hours post vaccine. Erythema worsened over 48-72 hrs. Pt seen today with resolution of erythema and swelling.
This case was reported by a consumer via call center representative and described the occurrence of tremor in a 80-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included Influenza vaccine Quadrivalent (2018-2019 season) for prophylaxis. On 5th September 2018, the patient received the 1st dose of SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. On 6th September 2018, 1 days after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced tremor. On 7th September 2018, the patient experienced sleepiness. On an unknown date, the outcome of the tremor and sleepiness were recovered/resolved. The reporter considered the tremor and sleepiness to be related to SHINGRIX. It was unknown if the reporter considered the tremor and sleepiness to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The patient experienced events the following night of having the vaccine, when he was severely shaking for about 45 minutes and he could notstop. Then 2 days after the injection, he was also sleeping most of the day. The reporter said the patient received flu vaccine the same day on 5th September 2018, when he received SHINGRIX vaccine. This case has been linked with case US2018180204 reported by the same reporter.
Dizziness about 3-4hrs after injection Heart rate between 114-138 about 6hrs after injection to 4/5 Fainting about 14-16hrs after injection Extreme SOB and palpitations upon exertion about 6hrs after injection to present
Immunization given on 9/3/02. Mother called on 9/5/02 states notice leg was slightly swollen with a local reaction. Pt denies any pain or discomfort. Pt inst to apply Benadryl cream to area.
I was find all day with no symptoms.  My normal diet and normal activities that day.  Retired around 9 p.m.  Awoke at 1:00 a.m. in a cold clammy sweat, warm all over.  Did not take my temperature.  Got up to go to the bathroom and felt very weak all over, nearly passed out.  Called to my husband to help me.  He helped me get to the sofa in the living room.  I felt very nauseous and nervous. At first I thought I was coming down with the flu.  My mouth was extremely dry.  After about 5 hours, I fell asleep.  I awoke at 8 a.m. and felt somewhat better.  In another hour or so, I was basically back to normal.  It was a terrible experience.  I felt that I was going to die.  I would like to add additional information if it makes a difference.  My appointment was for 10 a.m.  When I arrived, there was a long line outside and the facility administering the Covid-19 vaccine was closed.  We were told that there was a power outage and the vials had to placed back into the freezer.  Once the power was back on, they started to defrost the vials and it was going to take an hour.  In about an hour, the line of people were allowed into the facility and administered the vaccine.    I am now scared to get the second vaccine, which is due to be administered on April 6.   Thank you.
Feeling sick; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 008B21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced MALAISE (Feeling sick) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 29-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. On 31-May-2021, MALAISE (Feeling sick) had resolved.            No Concomitant medication was reported.     No treatment medications were reported.    This case was linked to MOD-2021-405546 (Patient Link).
Patients husband came in stating his wife had developed a itchy, red rash concentrated in her neck area. She came in I examined it, suggested she apply topical products, etc. Stated if she did get worse to contact PCP. PCP was contacted. No treatment necessary.
The pt experienced swollen feet, hands, fatigue, aches, headache, fever, joint pain, memory loss. The pt states he has been sick since 8/98. Treated with Doxycillian, Vioxx, and Tylenol. Follow up information received 04/25/2003 states: Eyesight failing, hearing loss, memory loss increased, low grade fever daily, face numbness, rash, arthritis progressed, blank staring daily. Depression. Short patience. Constant head sweats.
Narrative:  Daughter stated that pt had a "stroke" on March 15th. She stated that he has been in local hospitals and rehab. She stated he cannot speak and has other symptoms also. She stated "he has lots of those symptoms." She did state he has not had a seizure or had spots under his skin that she is aware of but is on blood thinners.
Patient experienced injection site pain immediately after the vaccine. She noted that 30 minutes after the vaccine she started noticing the area became warm and red. She stated this was expected as she had been counseled on it. The next day she started noticing tingling and numbing in the last three fingers of the immunized arm, which recurred 5-6 times throughout the day. The redness and warmth persisted. The patient also experienced flu-like sx 24-hours post the immunization (headache, fever, fatigue), which she reports lasted for 1-2 days. The redness and numbness persisted for 4 days following the immunization, but are noted to have improved as time passes. The patient has not noted a similar reaction in the past. She stated that the injection site pain had occurred for 1-2 days after receiving Tdap, but never with other immunizations.
This spontaneous report was received from a pharmacist concerning an adult female patient of an unknown age. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly, lot number reported as M002583, and expiration date 27-NOV-2017 (dose was not reported) for prophylaxis, after her 26th birthday. Lot number M002583 is an invalid lot number for GARDASIL 9. Additional information has been requested.