chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Near syncope following vaccination followed by 2 days of HA, elevated HR and blurry vision. March 8th, symptoms worsened. Went to ED and was told she had a fib. 3/25- reported to clinic for continued fevers, blurry vision, poor appetite, HA, dizziness, body aches and increased HR. Returned to clinic on 3/29, 4/8 and 4/15 with a similar constellation of symptoms. 5/11- seen in the ED for migraine. 5/12- Seen again in the clinic with autoimmune panel run. Seen again on 5/17 in the clinic and in the ED on 5/30 for ongoing tachycardia and dizziness that worsens throughout the day. Additional neuro and cardiology work ups requested.
Full body soreness, worse in major joints (hips, back, shoulders); About 24 hrs after injection, FREEZING and couldn't warm up then had problems breathing, had to take inhaler and use CPAP to catch breath but, pulse ox was OK.  Got Covid arm. Major symptoms gone , still have Covid arm
Horrible rash on bottom (48 hours after vaccination), diarrhea (24 hours after vaccination), sleeplessness ( 12 hours after vaccination)  low grade temp (12 hours after vaccination)
Muscle and joint aches, fatigue, headache, nausea began the day after vaccine administration. Nausea and headache had resolved by Friday, December 11. Muscle/joint aches and fatigue have persisted and I am still experiencing them at this time of reporting.
SOB, wheezing, increased heart rate, epinephrine 0.3mL given IM, O2 administered face via face mask.
pt recv vax 27JUL97 & on 3AUG97 pt exp itchy, maculopapular rash all over body;pt was treated w/atarax & lotrisone for the rash;the rash has not resolved & appear to have worsened 6AUG97;
This spontaneous report as received from a registered nurse refers to an unspecified patients of unknown age and unknown gender. The patients pertinent medical history was not reported. On an unknown date the patients were vaccinated with a supported dose of ZOSTAVAX (dose, route and lot number was unknown). No adverse effect was reported. No product quality complaint (PQC) was reported. This case is one of the several cases linked with the same reporter link. Additional information has been requested.
Fever 103 degrees for 3 days. Then began to have a chronic cough. Cough has lasted over 2 months and still currently have it.
Patient reported pain when moving arm and swollen from shoulder to elbow. Patient called Dr's office and was told to ice and heat and continue to take Ibuprofen.
Heavy clotted periods lasted about 4 months; pain in breasts and pain in arm/shoulder still persistent 7 months after vaccination; pain in breasts and pain in arm/shoulder still persistent 7 months after vaccination; pain in breasts and pain in arm/shoulder still persistent 7 months after vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 10:30 (Lot number: EW0173) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0158, Location of injection: Arm Right), administration date: 08Apr2021, when the patient was 39 years old, for Covid-19 immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 01May2021, outcome "not recovered", described as "Heavy clotted periods lasted about 4 months"; BREAST PAIN (non-serious), PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 01May2021, outcome "not recovered" and all described as "pain in breasts and pain in arm/shoulder still persistent 7 months after vaccination". The events "heavy clotted periods lasted about 4 months", "pain in breasts and pain in arm/shoulder still persistent 7 months after vaccination", "pain in breasts and pain in arm/shoulder still persistent 7 months after vaccination" and "pain in breasts and pain in arm/shoulder still persistent 7 months after vaccination" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heavy menstrual bleeding, breast pain, pain in extremity, arthralgia.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. Patient not had covid prior to the vaccination and had no known allergies.  No follow-up attempts are possible. No further information is expected.
received the first dose of Engerix-B on 13/SEP/2020 / the second on 31/JAN/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 21-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 13th September 2020).   On 31st January 2021, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 31st January 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, 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 details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Engerix B, later than the recommended interval, which led to lengthening of vaccination schedule. The patient wanted to receive the third dose on 26th April 2021 however the patient did not receive dose three at the moment of the reporting. The reporter consented to follow up.
Right thigh soft tissue swelling, erythema, induration in an area of about 10-12cm around administration site with smaller area of darker erythema and vesicle formation (about 3cm), fever to 105 reported by mother of child. Resolved now.
10/13/08 Pt sates noticed pain and redness at ZOSTAVAX site 2 days after it was administered. Site assessed - at injection site there is erythema 12 cm x 9 cm with ecchymosis to approx 50%. Warm to touch. Not worsening
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 11-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route of administration were not specified; lot # L035686 and expiration date on 16-FEB-2017) that "might" have been improperly stored (it was unknown if the vaccines underwent a temperature excursion). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received MMR, varicella & PREVNAR 13 vaccines on 8/17/2012. Parent noted local reaction "rash" 8/18/2012. Patient seen in office 8/19/2012 - left thigh at injection site red, firm, slightly tender. No fluctuance, blanches well. About 3 cm in diameter. Treatment: MOTRIN, BENADRYL, cool compresses per dr.
Fatigue, Fever, Chills.  Tylenol 500 mg every 6 hrs x 4 doses
Later that evening I developed noticeable ringing in my ears, quite loud.  I have waited until now to report hoping somehow it would resolve.  I did report to my MD as I am aware a certain amount can be attributed to age related hearing loss.  However this was like someone turned a switch on to intense ringing.
Diarrhea; Fever of 101 F; Lightheadedness; Migraine; Back Pain; Arm Pain; Chills; Whole body weakness; Legs are weak cannot stand up; A spontaneous report was received from a consumer concerning a 34 year old male patient,  who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple events of arm pain, migraine, diarrhea, fever of 101F, chills, back pain, whole body weakness, lightheadedness and leg weakness that he feels he cannot stand up.  The patient's medical history was not provided. No concomitant medications were reported.  On 30 Dec 2020, the patient received his first of two planned doses of mRNA-1273 (Lot number unknown).   On 31 Dec 2020, the patient experienced arm pain, migraine, diarrhea, fever of 101F, chills, back pain, whole body weakness, lightheadedness and leg weakness that he  feels he cannot stand up. The treatment information included paracetamol and excedrin.  The Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the events, arm pain, migraine, diarrhea, fever of 101F, chills, back pain, whole body weakness, lightheadedness and legs are weak he feels he cannot stand up was considered as not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Near-syncope 3 days after vaccination prompted ER eval.  Subsequent onset of chronic headaches, palpitations (with confirmed PACs and PVCs on Holter), and diarrhea with unintended 20 lb weight loss.  Work-up is ongoing, but this far unrevealing for specific etiology now >3 months after vaccination.
redness at injection site; itchiness at injection site; injection site was also hard; injection site was hot; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness at injection site), INJECTION SITE PRURITUS (itchiness at injection site), INJECTION SITE INDURATION (injection site was also hard) and INJECTION SITE WARMTH (injection site was hot) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (redness at injection site), INJECTION SITE PRURITUS (itchiness at injection site), INJECTION SITE INDURATION (injection site was also hard) and INJECTION SITE WARMTH (injection site was hot). At the time of the report, INJECTION SITE ERYTHEMA (redness at injection site), INJECTION SITE PRURITUS (itchiness at injection site), INJECTION SITE INDURATION (injection site was also hard) and INJECTION SITE WARMTH (injection site was hot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was given Keflex, Benadryl, Pepcid by the doctor .   No concomitant medication was provided.
June 20th Red rash all over over my body. June 21st woke up with ptosis of the eye and muscle weakness and blurry vision. It continued to get worse until a doctor diagnosed me with Myasthenia Gravis and started me on medicine. 6 months later I underwent a Thymectomy and IVIG to try to go into remission. It has only been 3 weeks since surgery and no change yet.
On the evening of 12/26 I slipped into my comfy shoes I noticed my right foot at swollen to about 3x the size out of nowhere. The next morning my entire leg was hot and swollen. I went to the ER and they said it was probably cellulitis. It spread to the other foot and both my legs got hot and I am just not finishing my course of doxycycline for that. My heartrate was 140 according to my smart watch and I started having an anxiety attack, and they administered some medication at that time. January 1st I started having symptoms that I thought was cat allergies. I went to doctor's office on January 3rd and took a COVID-19 test that was positive. By January 4th I had lost my taste and smell. I still have some deep congestion that I am using MUCINEX double layer tablets and DAYQUIL and NYQUIL. I took another home test last night and the line was still faintly pink positive.
A report has been received from Regulatory Authority via consumer concerning a 79 year old male patient, height: 182.0 centimeters; weight: 76.2 kilograms. Concomitant medications included aspirin, atenolol and statin. The patient's concomitant diseases were not reported. During Oct-2013 the patient started to receiving parenteral influenza virus vaccine. The patient experienced pain and weakness in right arm, weakness of arms which started during Oct-2013. Slowly getting worse over the last 18 months. The injection caused muscle damage which started during  Oct-2013 by being incorrectly administered. The patient was referred to clinic at hospital. He had 7 x-rays over a 6 month period. Was also referred to physiotherapy, but this was ineffective. He still had to attend hospital again. At the time of reporting, the event of pain and weakness in right arm, weakness of arms and muscle damage was ongoing and the outcome of the event of wrong injection technique was unknown. All the events were considered as serious with the serious criteria of important medical event by company physician.
4 hr p/flu shot, presented @ MD w/profound rigor, vasoconstriction, & barely able to get around; acutely ill & conjunctivitis; direct admit fr ofc to hosp; admitted for rigor, t102 unk origin; blood culture drawn, UA cult of eye;
Dizziness fatigue, neck pain Narrative: Employee in vaccine clinic observation area when she developed dizziness, fatigue and neck ache shortly after her injection. She walked out under her own power in stable condition.
pt had the Moderna bivalant booster and was given 0.25ml instead of the full 0.5ml
Heaviness in my chest, racing heart, back and shoulder pain, fatigue, and nausea.
Redness, swelling, itching, and pain, at injection site, areas of redness 35mm.
My arm had a 3" X 2" swollen area around area where follow-up shot was given. It was warm and hurt to touch and it lasted for several days.
COVID 19 Treatment; COVID 19 Treatment; Off label use; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 12Feb2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 05Mar2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 01Sep2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Apr2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prostate cancer remission" (unspecified if ongoing), notes: Prostate cancer remission; "heart valve replacement" (unspecified if ongoing); "aorta repair" (unspecified if ongoing), notes: aorta repair; "Vaccine dose number=3, 2,1 Pfizer, Vaccine dose number=4 Moderna" (unspecified if ongoing), notes: Vaccine dose number=3, 2,1 Pfizer, Vaccine dose number=4 Moderna. There were no concomitant medications. The following information was reported: IMMUNISATION (medically significant) with onset 11Apr2022 at 13:00, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 11Apr2022 at 13:00, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course information: It was reported that the patient had no known allergies and the patient was not taking any other medications in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Arm swelling. Headache -light headed feeling. Slight irritated throat - made me cough a bit. Red blotches starting coming on body and haven't stopped to date!! My body is being covered! Got very sick by 8-17-17 -> pneumonia was sick for months and lungs still not 100%. Was in hospital and on antibiotics and steroids for a very long time.
Employee stated he had urgent need to use the restroom. Stated he had 2 episodes of diarrhea. Employee informed possible allergic reaction. Was questioned if body had any itching stated none. S/S employee had was redness not at vaccine site bilateral ears and stomach discomfort no urge to vomit and loose stool X2 within the last 30 minutes.
First vaccination: Sore lest arm for 3 days .    Second Vaccination:  12 Hours following vaccination, Chills, low grade fever and head ache lasting approx 24hrs.
Fatigue after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue after the first dose) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced FATIGUE (Fatigue after the first dose). At the time of the report, FATIGUE (Fatigue after the first dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were provided.  No treatment information were provided.   This case was linked to MOD-2021-406418 (Patient Link).
Patient got sick from Covid Vaccine Pfizer Feb2021 her lungs filled with fluid did not get 2nd dose; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got sick from Covid Vaccine Pfizer Feb2021 her lungs filled with fluid did not get 2nd dose (as reported) with outcome of unknown.   Information on the lot/batch number has been requested.
A spontaneous report was received from a consumer concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events delayed minor rash/vaccination site rash.  The patient's medical history was not provided. relevant concomitant products usage were not reported by the reporter.  On 17 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 024M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 3 Mar 2021, the patient experienced the event,  delayed minor rash.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event,  delayed minor rash was unknown.
Body rash. Itchy, red and swollen on both arms, both shoulders, neck and face. It's almost 3 weeks and the rash is still going, and repeatelt at the same place.  I visited my PCP doctor 3 day ago, and doctor gave me "Triamcinone Acetonide 0.1%".  I also got fever, headaic and tirenese for couple days afer second shot.
mild tinnitus in my ears; uncomfortable spike waking up; left ear had A pressure feeling; could not hear out of this ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Apr2021 16:00 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: LIPO FLAVONOID PLUS. The following information was reported: TINNITUS (non-serious) with onset 11Apr2021 04:00, outcome "recovering", described as "mild tinnitus in my ears"; DISCOMFORT (non-serious) with onset 11Apr2021 04:00, outcome "recovering", described as "uncomfortable spike waking up"; EAR DISCOMFORT (non-serious) with onset 11Apr2021 04:00, outcome "recovering", described as "left ear had A pressure feeling"; HYPOACUSIS (non-serious) with onset 11Apr2021 04:00, outcome "recovering", described as "could not hear out of this ear". Therapeutic measures were not taken as a result of tinnitus, discomfort, ear discomfort, hypoacusis.  Additional information: Patient did not receive other vaccine in four weeks. No covid prior vaccination. Covid test was not taken post vaccination. The patient had no known allergies. Patient haven't had a spike or any problems in two years. Eight days after receiving the vaccine patient had a very uncomfortable spike waking up in the morning which eventually faded, several days later my left ear had A pressure feeling which made it feel like patient could not hear out of this ear. Eventually faded after several days and again had another spike of tinnitus in his left ear. Patient saw several forums online with people that had the exact same symptoms at almost the exact same start time after their first dose of the Pfizer vaccine. Because of this patient was not going to get the second dose out of fear of worsening his condition.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021452611 Same reporter/drug/event, different patient.
The flu shot was very painful in my right upper arm. The pain went away but then a few hours later my upper arm really started to hurt. There was no sign of swelling or redness yet intense pain deep in  my arm muscles. It has been 18 days of constant pain and no ALEVE or Ibuprofen has made any difference in the pain level. I try to keep moving it as I am afraid I will get a frozen shoulder from under-using it. I did mention it to my regular Dr. when I visited him the next day but I assumed the pain would get better but it has not. I think I have to go to a physical therapist for treatment as it is effecting my ability to use that arm well.
2nd dose of vaccine recieved 3 days after end of expected monthly period (8-14th of 5/2021).  12 hours after 2nd dose of Phizer (5/17/2021), flu-like symptoms of muscle aches and fever, lethargy, as with first dose. sympoms duration of almost exactly 24 hours from first onset. Then, 8 days after vaccine (5-25-21), 2nd period within 30 days begins after hours of major pains throughout pelvic girdle and legs, with ache reducing with onset of bleeding. light period persists until 5/30/2021, until sharp abdominal pains, then bleeding stops. Sharp abdominal pains resume 6/1/21, accompanied by tenderness of breast tissue, persists for 3 days. Period returns for the 3rd time in 30 days 6/7/2021.