chrisvoncsefalvay/vaers-outcomes huggingface dataset:
panic attack; like she couldn't breathe; hyperventilating; feeling crappy; headache; sick to stomach; diarrhea; couldn't sleep; red, burning, itchy, swollen, welt running down her left and right leg and at the back of her legs; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), INSOMNIA (couldn't sleep), PANIC ATTACK (panic attack), DYSPNOEA (like she couldn't breathe) and HYPERVENTILATION (hyperventilating) in a 67-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.     The patient's past medical history included Spinal cord injury (Patient had spinal cord injury due  to tumor she had 24 years ago and she often got 400units of Botox injected into her spine to stop muscle spasm..) since an unknown date, Hip fracture (patient had Hip fracture about 15 years ago.) since an unknown date and Spinal cord operation (Patient had two surgery done on her spinal code and last one was done in 2014, hence she tends to have neurological pain all the time.) since an unknown date. Concurrent medical conditions included Neurological disorder NOS (Neurological pain.). Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX) for Muscle spasm, IMMUNOGLOBULIN HUMAN NORMAL (IVIGLOB-EX) for Spinal cord injury.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DIARRHOEA (diarrhea), INSOMNIA (couldn't sleep) and URTICARIA (red, burning, itchy, swollen, welt running down her left and right leg and at the back of her legs). On an unknown date, the patient experienced PANIC ATTACK (panic attack), DYSPNOEA (like she couldn't breathe), HYPERVENTILATION (hyperventilating), FEELING ABNORMAL (feeling crappy), HEADACHE (headache) and NAUSEA (sick to stomach). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), INSOMNIA (couldn't sleep), PANIC ATTACK (panic attack), DYSPNOEA (like she couldn't breathe), HYPERVENTILATION (hyperventilating), FEELING ABNORMAL (feeling crappy), URTICARIA (red, burning, itchy, swollen, welt running down her left and right leg and at the back of her legs), HEADACHE (headache) and NAUSEA (sick to stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient gets IVIG once a month.  Patient received botox  up and down paraspinous muscle from  neck to sacrum  by HCP .  Treatment includes Benadryl but patient had diarrhea in the night and couldn't sleep throughout the night.   Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: Significant FollowUp appended New events are added.
Prolonged, severe left shoulder and upper arm pain.  Has not  been able to return to work since symptoms began.
I was diagnosed 35 years ago with herpes simplex virus. I had very few outbreaks, maybe one a year. Since the vaccine I have had constant prodome symptoms.
itching rash, some raised, possible;lymphadenopathy began 2MAR98 (has lump @ back of neck on hair line)
A non-serious report of expired dose of vaccine administered has been received from a consumer concerning an eight-year-old female. Neither medical history no concomitant medications were provided. The patient received FluMist on 08-Jan-2008. The FluMist that was administered on 08-Jan-2008 had an expiration date of 27-Dec-2007. No adverse events were reported. The event was considered resolved. The patient did not experience a rechallenge while receiving the suspect product. This reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
A spontaneous report has been received from a Health Professional concerning a, patient of unknown gender, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal), 0.2 millilitres. FLUMIST Quadrivalent (Intranasal) started on 25-Mar-2016. It was reported the patient received FLUMIST that expired on 25-Mar-2016 on 26-Mar-2016. The outcome of the event of received expired FLUMIST was unknown. The reporter's description of the event(s) was as follows: None reported. The report was considered to be non-serious.
This initial spontaneous case received on 25-Oct-2017, reported by other health professional and concerns a 3 year-old male child. Patient's medical history and concomitant medications were not reported. On 24-Oct-2017, the patient received FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: not reported, batch number: 1721301, expiry date: Jun-2018). The patient did not experienced any further adverse reactions after receiving the vaccine. The outcome of the events was not reported. The reporter assessed this case as non-serious. Non-significant case correction received on 25-Oct-2017: The narrative was corrected.
Irregular menstrual periods for the first time in her life experienced the month after she received her vaccine. Biopsy of the endometrium demonstrated endometrial hyperplasia without atypia.
This spontaneous report was received from a nurse regarding multiple unspecified patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, unspecified multiple patients were vaccinated with improperly stored M-M-R II lot# M015931, expiry date: 30-MAR-2018 for prophylaxis (dosing details not reported). No adverse effects were reported. Temperature was 68F, time frame was 1 hour, no previous excursion and no data logger involvement. No product quality complaint was involved. This is one of the three linked reports. 1612USA010737 (Same Reporter Link) and 1612USA009515 (Same Reporter Link). Additional information has been requested.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On unknown dates, the patients were probably received doses of improperly stored VARIVAX (lot #L048462l; expiry date: 02-DEC-2017 (route: subcutaneous) (incorrect product storage). The vaccine was stored at a temperature of -13.7 degrees C for 48 hours. There was no previous temperature excursion. Data logger was involved. No adverse effect reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
really bad headache; This is a spontaneous report from a contactable consumer (patient herself).  A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, lot number: EL8982 , expiry date: May2021), via an unknown route in the right arm on 21Jan2021 at 11:45 hrs as a single dose for COVID-19 vaccination. Patient's 4 weeks prior vaccination was none. The patient's medical history included allergy and headaches. The patient's concomitant medications included Benadryl for allergy and Excedrin for headache. On 28Jan2021, the patient woke up with a really bad headache. The patient was wondering whether the vaccine triggered the headache as she does get headaches before. She wanted to know if it is vaccine-related so that she could know how to take care of it. The patient didnot visit any emergency room or physician office due to the event. The outcome of the event was unknown.  Follow-up (28Jan2021): This is a follow-up spontaneous report from a contactable Consumer included: Patient demographics (weight and height added, Therapy start date, time, lot number and expiry date, medical history, concomitant medications added, event onset date added.  Follow-up attempts are completed. No further information is expected.
pt recv vax & mom reported 2 days later pt devel flu-like sx that lasted 3-5 days then resolved
acute cardiovascular event; pleurisy; viral respiratory infection; This spontaneous report was received from a lawyer referring to a patient of unknown age and gender.   The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. In or around 12-DEC-2017, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (lot number and expiration date were not reported). Shortly after receiving zoster vaccine live(ZOSTAVAX) vaccine, Plaintiff suffered an acute cardiovascular event, which was associated with a viral respiratory infection and pleurisy.  As a direct and proximate result, Plaintiff's symptoms have resulted in physical limitations, mental and emotional distress due to resulting physical limitations and seriousness of his condition, severe and permanent personal injuries. Further, as a tragic consequence the Plaintiff suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  Upon internal review acute cardiovascular event was considered a medically significant event.
Pt started with fever, chills and rash and soreness on the arm where he got the FLUZONE and PNEUMOVAX shot. Pt saw MD for it and MD having ptt watch the area if redness is spreading or not. Pt will follow up w/MD.
PE seen today with (R) thigh redness approximately 3 inches x 3 inches, hot and tender that gradually increase size and pain. Cellulitis secondary immunization tx cephalexin 250/5ml 10 ml bid x 10 days #QS no RF.
got her 2nd dose while she was covid positive (test positive the day after 2nd dose); got her 2nd dose while she was covid positive (test positive the day after 2nd dose); This is a spontaneous report from a contactable consumer (patient's child). This consumer reported similar events for two patient. This is the second of two reports. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient unknowingly got her 2nd dose while she was covid positive (test positive the day after 2nd dose) on an unspecified date. Reporter stated that the patient "was fine". Outcome of the events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021130210 same reporter and drug, different patient
Initially there was a fever of 101.5 few hours after shot was administered. Severe shooting pains in muscles that lasted for 3 days. Ever since the shot i have had involuntary muscle movement (sharp pain in legs and twitching) and tremors with extreme fatigue.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Additional Details: Patient stated her throat felt tight. pulse ox was 99, bp 105/80 Patient was with husband, checked for sign of swollen lips and tongue. I did not see any. asked husband to confirm. Husband confirmed patient looked normal with no swelling. Sat with patient and administered benadryl. gave patient water. Talked with patient and discovered issue was most likely anxiety related. sat with pt for 30 min. Followed up with patient on 05/22/2021. Patient totally normal, no illness and no reactions.
chest pain in the right upper chest that felt pressure-like without radiation. Was persistent through the night at around a pain of 5/10. This started 2 days after COVID-19 vaccine booster.  Patient had elevated troponin and anterior and inferior ST segment elevations on EKG. He was admitted to the hospital for treatment of COVID-19 vaccine associated myocarditis
Patient received 1st dose of Twinrix on 4-November-2022 and 2nd dose of Twinrix on 4-January 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 57-year-old female patient who received HAB (Twinrix adult) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX ADULT).   On 04-JAN-2023, the patient received the 2nd dose of Twinrix adult. On 04-JAN-2023, an unknown time after receiving Twinrix adult, the patient experienced drug dose administration interval too long (Verbatim: Patient received 1st dose of Twinrix on 4-November-2022 and 2nd dose of Twinrix on 4-January 2023). The outcome of the drug dose administration interval too long 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: 09-MAY-2023 The patient received the first dose of Twinrix on 4-November-2022 and the second dose of Twinrix on 4-January 2023.  The pharmacist wanted to know how to proceed for the third dose. The reporter consented to follow up. The patient received 2nd dose of Twinrix adult, later than the recommended interval, which led to drug dose administration interval too long.
PATIENT UNDER AGE FOR APPROVED VACCINE. DENIES ANY SYMPTOMS AT THIS TIME. SPOKE WITH GUARDIAN . SHE WAS INFORMED AND V/U OF WHAT HAPPEN. GUARDIAN HAD NO QUESTIONS AND WAS OK WITH INCIDENT. INCIDENT REPORT FILED WITH .
Swollen lymph node in armpit of insertion site arm, increased to size of golf ball. Lasted x48 hours.
the pain is protruding to the shoulder going up the neck; armpit started hurting on the arm that was injected; injection area hurts/ its a little tender still; it's going up to her shoulders, like a burning pain; This is a spontaneous report from a contactable consumer or other non hcp. A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm on 04May2021 (at the age of 49-years-old) as dose 2, single for covid-19 immunisation. The patient family medical history included, diabetes mellitus from an unknown date and unknown if ongoing and thyroid disorder from an unknown date and unknown if ongoing. The concomitant medications included zinc (ZINC) taken for an unspecified indication, start and stop date were not reported and ascorbic acid (VIT C) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 13Apr2021 (at the age of 49-years-old) as dose 1, single for covid-19 immunisation with the reaction of pain. The patient did not receive any other medications within two weeks of Covid-19 vaccine. There were no prior vaccinations within 4 weeks of Covid-19 vaccine. On 06May2021 19:00, the patient armpit started hurting on the arm that was injected an on the same day, the patient also experienced, injection area hurts/ its a little tender still, it's going up to her shoulders, like a burning pain. On 07May2021, the pain was protruding to the shoulder going up the neck. The outcome of the events armpit started hurting on the arm that was injected was not recovered, injection area hurts/ its a little tender still was recovering and the outcome of events it's going up to her shoulders, like a burning pain and, the pain is protruding to the shoulder going up the neck was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 17Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid-19", start date: Nov2020 (unspecified if ongoing), notes: Covid-19 positive 3 times (Nov2020, Dec2021, Jun2022). The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2020) Positive, notes: Covid-19 positive 3 times (Nov2020, Dec2021, Jun2022); (Dec2021) Positive, notes: Covid-19 positive 3 times (Nov2020, Dec2021, Jun2022); (Jun2022) Positive, notes: Covid-19 positive 3 times (Nov2020, Dec2021, Jun2022). Therapeutic measures were taken as a result of covid-19 which include Paxlovid from 01Jun2022 to 05Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The day I received the flu shot I started to feel tired and got a headache. The next day I took Advil for the headache. The next two days I felt  fine. However day four I woke up with a severe sore throat/burning, with many more symptoms and side effects until today. I came down with flu like symptoms and other side effects such as follows: fever, vomiting, headache, chills, body aches, tired, weakness, numb hands and face, dizzy, congestion, runny nose, sneezing, chest pain, heavier period, delirious, and nauseous.
This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 76-year-old female patient who received SHINGRIX (batch number 353S5, expiry date 29th May 2021) for prophylaxis. On 8th April 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 8th April 2019, less than a day after receiving SHINGRIX, the patient experienced blister, pruritus and rash. On an unknown date, the outcome of the blister, pruritus and rash were not recovered/not resolved. It was unknown if the reporter considered the blister, pruritus and rash to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX on left deltoid. The patient experienced bumps, blisters, and itching on her right wrist (opposite arm of the injection site). On 9th April 2019, the patient experienced bumps on her back. In outcome of the events bumps, blisters, and itching were not recovered/not resolved, however in source document the outcome of this events was reported as recovering/resolving.
Swelling in lymph node and pain in left chest. Thought it was a heart attack , went to urgent care and then on to ER.  Nothing showed up as it being a heart attack.
low grade fever, muscle soreness, muscle spasms, nausea, headache, lethargy, sleepiness, dizziness
Severe headache  Blurry vision Joint pain  Nausea  Vomiting Chest tightness Left arm tightness  Lower back pain  Congestion  No energy  Could not get out of bed
Patient presented to the ED after experiencing shortness of breath on exertion.  Patient was found to have BNP of 3163 and chest x ray showed bilateral pleural effusions.  Echocardiography showed left ejection fraction of 10%.  Cardiac catheterization showed nonischemic cardiomyopathy and moderate pulmontary hypertension.  Patient was fitted for life vest and started on bumex, dapagliflozin, losartan and metoprolol. Patient underwent cardiac MRI which showed dilated cardiomyopathy.
On 10/13/14 9 am received flu shot. By noon experiencing scratchy throat, red eyes, fatigue. By 5 pm in evening felt face and lips swollen eyes puffy. This morning still with sore throat, face and lips swollen.
patient said that he felt faint after receiving the scheduled  vaccine. Staff reported that he became pale, stiffened his arm for approx 20-30 seconds. Patient did not lose consciousness. No C/O nausea, no vomiting. He was able to maintain communication with staff during the episode. Vital signs obtained, BP 112/72, R-16, HR within normal limits. Patient was alert and oriented x3 and washed his face with a cool towel. No injuries reported. Nursing staff remained with patient until he was fully recovered. Patient stated that he has fainted or become sick in the past after having blood drawn, and with the administration of vaccines.
It?s been over a week and I still have a red circle and swelling from where the shot was given. The itchy part of it finally went away.
We administed Fluzone High Dose Lot U4491AA exp 3/13. Patient called me at 5pm and had very labored breathing and said it started about 3pm and kept getting worse.  Also had redness all along chest.  She said she was fatigued (and sounded like it) just talking to me.  I recommend she go to urgent care for follow up.
I had just returned from a trip out of town in airports etc.. I began to take Covid tests but I began symptoms at night and had  a fever the next morning or had a fever my girlfriend had symptoms and tested positive with for the flu on09FEB20223 I went to the clinic and came back positive for the flu and was prescribed cough syrup plus rest and fluids by the 19FEB2023 the flu had run its course.
c/o h/a, abdo cramps, nausea, vertigo, fever & shakes; pt reported to hosp ER & was given Periactin by ER MD;
Information has been received on 08-JUL-2016 from a registered nurse referring to a 61 year old female patient with allergy to iodine  crystals and nuts. On 24-JUN-2016 the patient was vaccinated with VAQTA lot # L009445,expiration 01-JUN-2017 intramuscular in the left deltoid for travel. Other suspect therapies included DIPTHERIA TOXOID (+) PERTUSSIS ACELLULAR VACCINE (unspecified) (+) TE). Lot # 7RJ98 expiration 18-NOV-2018, intramuscular in the right deltoid administered on 24-JUN-2016. Concomitant therapies included VIVOTIF BERNA, Alprazolam, which was ordered on 20-JUN-2016 and unspecified as to which date it was administered, bupropion hydrochloride, estradiol, trazodone hydrochloride and vitamin D (unspecified). The patient reported that initially her arm (not specified which arm) did not hurt but progressively became more painful until she was not able to use her arm. The nurse reported the patient stated that her arm kept her up night after night but seemed to be improving on an unspecified date. On 04-JUL-2016 the patient sought treatment at an unspecified walk in clinic and was prescribed NAPROSYN 500 mg as needed to arm pain by an unknown healthcare provider. This is one of two reports by the same reporter. Additional information has been requested.
Child presented with varicella illness to office on 03/23/2005. No fever known but some itching.