chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2nd day after administration of zostavax patient stated she had redness at injection site about the size of a quarter, 3rd day after injection, site is red, puritic and size of an egg per patient. NP had patient begin taking benedryl p.o per package directions for the next few days and apply ice to site x 15 min every 1-2 hours while awake.
This spontaneous report as received from a pharmacist via a field representative refers to a female patient of unknown age. The patient's pertinent medical history included fibromyalgia. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, strength, dose and route not reported). The patient developed "flu-like" symptoms "within 24 hours". The reporter stated that the patient saw her unspecified primary care provider on an unspecified date but no treatment was given. At the time of reporting, the patient "still feeling under the weather". Additional information has been requested.
Short period fever, headache, sinus followed by 2-3 weeks light-headedness and increased energy. Since then pressure on head beginning with back of head area with headaches. Headaches more frequent in beginning, tapered off. Head pressure continues 5 months out now from 2nd dose.
p/ a known exposure to natural chicken pox pt devel 38 lesions of breakthrough chicken pox;pt devel a severe h/a, nuchal rigidity, & fever;dx w/aseptic meningitis & hosp;CSF cult negative for bacteria & virus;
Heavy period. In every period I have experienced before this dose,  changing my tampon every 3-4 hours was sufficient. For this period, I changed my tampon every hour and it was still overflowing. I started my period the day I got the vaccine. The day after receiving the vaccine, I experienced the heavy period.  Additionally, my period cycle was consistently 28-29 days before my first dose in March 2021. Since then, my period cycle has ranged from 20-30 days and is generally unpredictable.
Patient had injection site pain, sore scratchy throat, red, watery eyes. Symptoms occurred 3-4 hrs post inj. Treated with BENADRYL & TYLENOL. Felt better by evening.
Adverse Event NOS; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Adverse Event NOS) in a female patient of an unknown age 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 ADVERSE EVENT (Adverse Event NOS). At the time of the report, ADVERSE EVENT (Adverse Event NOS) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.
At approximately 2:30 pm on 2/4/21, I developed a headache and arm pain. The headache remained of constant intensity until it resolved late in the evening on 2/5/21. It was located toward the front of my head and felt like dull sinus pressure. The arm pain started out light and intensified throughout the evening, with the height of the pain occurring late in the evening of 2/4. The pain radiated to my shoulder and lower neck, depending on it's positioning. It was difficult to sleep the night of 2/4. This pain eventually resolved completely on the morning of 2/8. During the afternoon of 2/5, I noticed a red, raised, slightly itchy "rash" on my  arm about 2 inches below the injection site. It was painful also. The morning of 2/6, I noticed another small patch below it and by the evening of 2/7 I also had a small patch on my hand. All areas have resolved as of 2/10/21.
pt stated that starting about 1:30 after getting the vax she had nausea and severe pain in the right arm which kept increasing in pain until she was unable to move her arm.  That night her arm was in the 9-10 range for pain.  She hasn't been able to sleep due to the pain.  The next day she took Tylenol but did not help with pain. She had a strange taste in her mouth and also loss of appetite.  On 3/6/2021  she started getting a back ache.  She tried taking Ibuprofen which helped some with swelling in her arm but not the pain.  On 3/7/2021 she started getting a headache, brain fog and saying her words backwards.  She is very upset with the lack of warning that she was given at the time of the getting the first dose of the vax about being in this type of pain afterwards.  She said she was not prepared for this.  She has to have help doing everything and lives alone. Today the arm pain seems to slightly be improving but her back is still hurting.  Pt contacted her PCP.  They only instructed her to take Tylenol and not to ice it.  She contacted the Public Health Dept they told her to take Ibuprofen and to ice it.  She is getting conflicting information and doesn't know how to treat it.
Migraine with auras (no previous hx of auras), currently for 2 days and ongoing. OTC meds and rizatriptan having no effect
pt recvd vax;woke up crying; very bad cough; inc T; lethargic;to er;
Redness, itching, swelling, hot to the touch at injection site 4days in a row, fever 102degrees F on 2nd day with chills and tingly/prickly feeling all over, weakness/dizziness
Pt c/o of L arm pain and numbness that started a few minutes after vaccine was administered. Vitals signs stable; 114/70, pulse 66, RR 16, O2 sat 98% RA. Pt transferred to Adult family medicine.
Site: Pain at Injection Site-Medium, Additional Details: patient called back about a week later stating that her arm was still hurting from the shot.  she said that her dr instructed her to call
Talking incoherently "Vaccines work, GMO's are safe, everything is a chemical."
NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 11-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea. This report was non-serious. This case, from the same reporter is linked to 20210519757.
2nd day after immunization, fever began, 3rd day after immunization- non-stop crying for several hours
Bruising over arms and legs; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced bruising over arms and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruising over arms and legs. This report was non-serious. This case, from the same reporter is linked to 20210630100.
Patient presents with redness around the injection site, approximately 3' x 3', not raised or warm.
I received my second Moderna dose and approximately 1 minute later I was extremely nauseous and felt like vomiting. I was kept for an hour by the nurses for observation on 3/13/21. I had fever, nausea, vomiting, fatigue, chills, exhaustion, restlessness for 50 hours.  Skip ahead to 3/26/21, approximately two weeks after my shot...I began getting many symptoms. My symptoms were: decreased appetite, nausea, vomiting, nasuea was worse at night, bloating, distended stomach, increase in urination, abdominal cramping, increased sense of smell, my menstual cycle was 7 days early, acid reflux, heartburn, GERD, extreme fatigue and tiredness, migraines, and an increase in regular headaches, constipation. These symptoms lasted until 5/16/21.
Began feeling hot and cold/feverish with full body chills 11:30pm 1/21, continued to 1/22 hot and cold with chills.
Information has been received from a nurse concerning a patient who was vaccinated with a first dose of Gardasil vaccine. Subsequently the patient experienced syncope. Subsequently, the patient recovered. On an unspecified date the patient was vaccinated with the second dose of Gardasil vaccine. Subsequently the patient experienced syncope. At the time of the report the patient's outcome was unknown. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to a an approximately 20 unspecified patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # N022978, expiry date 12-SEP-2018 (dose, route of administration were dot reported) for prophylaxis. The doses of vaccine were stored in unspecified out of range temperature in an unspecified time frame. Previous temperature excursions were detected over 30 days. Digital data logger was involved. No adverse effects were reported. Additional information was received from the medical assistant on 19-JAN-2018. Identifiers for some of the patients were provided. The following temperature excursions were reported for the lot number N022978 of VARIVAX: Temperature excursions between 6°F to 14°F (-14°C to -10°C) on 23-NOV-2017 (3 hours),  26-NOV-2017 (3 hours), 28-NOV-2017 (3.5 hours), 01-DEC-2017 (3 hours), 04-DEC-2017 (3 hours), 07-DEC-2017 (2 hours), 10-DEC-2017 (2 hours), 13-DEC-2017 (2 hours), 16-DEC-2017 (2 hours) and on 18-DEC-2017 (1 hour);  and between 15°F to 46°F (-9°C to 8°C) on 24-NOV-2017 (4 hours),  25-NOV-2017 (3 hours), 27-NOV-2017 (4 hours), 29-NOV-2017 (3 hours), 30-NOV-2017 (3.5 hours), 02-DEC-2017 (3 hours), 03-DEC-2017 (3.5 hours), 05-DEC-2017 (3 hours), 06-DEC-2017 (2.5 hours), 08-DEC-2017 (2.5 hours), 09-DEC-2017 (2.5 hours), 11-DEC-2017 (2 hours), 12-DEC-2017 (2 hours), 14-DEC-2017 (1.5 hour), 15-DEC-2017 (2 hours), and on 17-DEC-2017 (2.5 hours). The vaccines underwent a total of 69 hours of temperature exposure. Additionally, the reporter stated that one of the patients was vaccinated on 08-JAN-2018. This is one of several cases reported by the same reporter.; Sender's Comments: US-009507513-1801USA006569:
Pt c/o arm lump, reddness at site about palm of hand, itchiness, and numbness at injection site.
Arm pain on Day 1. Difficult to lift even light objects, painful to the touch. Applied ice and took a pain reliever. Red blotchy rash on chest and cheeks that subsided after 1-2 hours. Arm only slightly sore by Day 2. On day 2 fatigue and dizziness in the morning. Headache, body aches, and advanced fatigue by afternoon. Day 3 all symptoms subsided.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "adhd" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE; CYMBALTA. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), 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: Positive; Negative, notes: Tested negative then positive; Positive, notes: Tested negative then positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks product Lamotrigine 300, other medication in 2 weeks product Cymbalta 20. Adverse event Paxlovid rebound a day or two after 5 day course completed. Tested negative then positive, symptoms, different than original.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mild case of COVID Sept 2021 - cough, congestion - up to 72 hours; Mild case of COVID Sept 2021 - cough, congestion - up to 72 hours; Mild case of COVID Sept 2021 - cough, congestion - up to 72 hours; This is a spontaneous report from 2 contactable consumers or other non-healthcare professionals. A 25-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955), intramuscular, administered in arm right on 06Apr2021 12:30 (at the age of 25-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was none. Historical vaccine included bnt162b2 dose 1 intramuscular, administered in arm right on 26Mar2021 12:30 (Batch/Lot Number: EP6955) for covid -19 immunization. There were no concomitant medications. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 01Sep2021, the patient experienced mild case of covid sept 2021 - cough, congestion - up to 72 hours. Since the vaccination, the patient has been tested for COVID-19. On 13Sep2021, the patient underwent lab tests and procedures which included sars-cov-2 test: negative with nasal swab. On an unspecified date in Sep2021. The outcome of the events was recovered on an unspecified date in Sep2021.   Follow-up attempts are completed. No further information is expected.
Nausea and Headache 1.5-2 hours administration; Nausea and Headache 1.5-2 hours administration; This is a spontaneous report from a contactable other healthcare professional (HCP) reported for herself. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 22Dec2020 11:30 at single dose for covid-19 immunization. Vaccine location was Left arm and it was the first dose. The COVID-19 vaccine was administered at Nursing Home/Senior Living Facility. Medical history included hypertension (HTN), bipolar disorder, Known allergies included PCN and cefixime (BIOXIN). Concomitant medications included metoprolol, celecoxib (CELEXA), and Multivitamin one a day. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea and headache 1.5-2 hours administration on 22Dec2020 13:00. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was unknown.
p/vax pt develT102.8 & then temp 105;cont w/motrin MD appt 6/9/99;poss fever is likely secondary to Rabies vax;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Heparin, reaction(s): "Known allergies: Heparin". 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: (2023) Positive, notes: Rebound. Covid came back one week after I'd tested negative; (2023) Negative, notes: Rebound. Covid came back one week after I'd tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
5 or 6 bumps on the child, puffy injection site.  Showed up about 21 days after the vaccine.
This spontaneous report as received from a registered pharmacist who reported that expired diluents (lot# 0762Z, exp January 2012) may had been used to reconstitute some doses of (Merck) VARIVAX (lot# 669346/0030AA, exp 18-DEC-2012) and ZOSTAVAX (lot # 0421E is an invalid lot number for ZOSTAVAX. Some of doses may had been administered to patients. Specific number of patients were unknown. Additional information has been requested.
Vaccines received 5/30/07 mom noted decreased in patient activity approximately 1700 on 5/30/07. Patient felt hot and wobbly. States stepping on "tippy toes" with "light shakes" on 5/30/07 and 5/31/07 (AM).  Decrease activity, decrease appetite. Right deltoid seem bruise. Right deltoid erythema ring around injection site.
Information has been received from a registered nurse concerning an adult patient who on 24-MAR-2009 was inadvertently vaccinated with VARIVAX (Merck) (lot # not reported).  The patient was intended to receive ZOSTAVAX (Merck).  The reporting nurse confirmed this was human error and not product confusion.  No problems reported.  It was unspecified if the patient sought medical attention.  Follow-up information was received from a registered nurse who confirmed that the 68 year old male patient did not experienced any adverse events.  There were no relevant diagnostic tests performed, no treatment was required and there was no illness at the time of vaccination.  The patient did not seek medical attention.  No further information is available.
2 days after, my skin on stomach felt tender but there was nothing there. On day four I had re bumps on left side of my stomach and back I was diagnosed with shingles  The next few days it worsened, and I was in agony for 11 days and nights.
The day after receiving immunization arm was swollen and red and warm to touch. Pt did not run a fever, was advised to use ice for swelling. Mom took her to the dr 2 days later. No change in treatment but requested VAERS
Immediate body aches, low grade fever, arm pain, extreme fatigue.  Could not sleep, nightmares all night. Second day:  Body aches all over had to take 12 Ibuprofen just to get through the day.  My whole right side hurt not just the arm.  Ringing in my ears, exhausted fatigued feeling Third day: Body aches and fatigue.  I am having trouble sleeping and still having nightmares Fourth day and following:  continued ringing in my ears that comes and goes, but I have it everyday.  Still having trouble sleeping and nightmares since I got the shot.
Employee developed extreme fatigue 3 hours after vaccine administration.  Went home, fell asleep.  Woke about midnight with redness, swelling to cheeks and eyes; also a generalized itch.  Took Benadryl which helped.  Pt has multiple food allergies and sensitivities to medications.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 24Mar2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 66 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "DM" (unspecified if ongoing), notes: Other medical history: DM; "RA" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing), notes: Known allergies: Shellfish; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. Past drug history included: Cipro for Known allergies: Cipro.  The following information was reported: DRUG INEFFECTIVE (medically significant), 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: Positive, notes: COVID rebound symptoms and testing positive (Ag test) after full course of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not take other medication in 2weeks. Patient received COVID 19 Treatment from 18May2022 to23May2022.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on the information given in narrative, the causal relationship between the reported events drug ineffective, COVID 19 and the suspect drug BNT162B2 cannot be excluded.
headache; nauseas; A spontaneous report was received from a consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache and nausea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011J20A) via unknown route for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced headache and felt nauseas.  Treatment details was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
Severe arm pain that traveled down to my fingers and up to my spine. Causing numbness, and pain that had me thrashing day and nigh. No amount of Motrin or changing my position offered relief. This morning, day five is the first feeling of relief after the worst night of pain. All five nights, extreme sleeplessness. I still have pain, but it has abated some.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 13-JUL-2016 the patient was inadvertently vaccinated with ROTATEQ (lot # L000433, expiry date: 09-JUL-2016) orally (expired vaccine used). This was supported as per memo. No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
Patient given Pfizer vaccine for 2nd dose in series rather than Moderna.  Moderna was administered 1st dose
Information has been received from a 20 year old female patient with no pertinent medical history and no drug reactions/allergies who on 13-JUL-2009 was vaccinated with the first dose of GARDASIL (lot # unknown), in her right arm. Concomitant therapy included ORTHO TRI CYCLEN. The patient reported that since she was vaccinated, she had had severe shooting pain the the injection area and the shoulder. She stated that the pain on the injection site was getting worse. She also stated she cannot lift her arm. Lab diagnostic studies were not performed. At the time of the report, the patient had not recovered and she had not contacted her physician yet about her AE. Additional information is not expected.