chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body aches; Large welt on L. arm size of softball; arm weakness; pain behind eyes; dizzy/lightheaded; weak; diarrhea; shooting pain down arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Sep2021 11:30 (Lot number: FF8839) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Thyroid cancer" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; CYTOMEL; CETIRIZINE; ALBUTEROL SULFATE. Past drug history included: Gabapentin, reaction(s): "Allergies: Gabapentin", notes: known allergies: gabapentin; Nsaids, reaction(s): "Allergies: NSAIDS", notes: known allergies: NSAIDS. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/lot number: EW0191, Anatomical Location: Arm Left), administration date: 27Aug2021, when the patient was 42 years old, for Covid-19 Immunization. The following information was reported: PAIN (non-serious) with onset 22Sep2021 22:00, outcome "not recovered", described as "body aches"; MASS (non-serious) with onset 22Sep2021 22:00, outcome "not recovered", described as "Large welt on L. arm size of softball"; MUSCULAR WEAKNESS (non-serious) with onset 22Sep2021 22:00, outcome "not recovered", described as "arm weakness"; EYE PAIN (non-serious) with onset 22Sep2021 22:00, outcome "not recovered", described as "pain behind eyes"; DIZZINESS (non-serious) with onset 22Sep2021 22:00, outcome "not recovered", described as "dizzy/lightheaded"; ASTHENIA (non-serious) with onset 22Sep2021 22:00, outcome "not recovered", described as "weak"; DIARRHOEA (non-serious) with onset 22Sep2021 22:00, outcome "not recovered", described as "diarrhea"; PAIN IN EXTREMITY (non-serious) with onset 22Sep2021 22:00, outcome "not recovered", described as "shooting pain down arm". The events "body aches", "large welt on l. arm size of softball", "arm weakness", "pain behind eyes", "dizzy/lightheaded", "weak", "diarrhea" and "shooting pain down arm" 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 pain, mass, muscular weakness, eye pain, dizziness, asthenia, diarrhoea, pain in extremity.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Doctor's office/urgent care. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19.   Follow-up attempts are completed. No further information is expected.
Very irregular menstral cycle. Typically I have very regular heavy cycles with severe pms. Since vaccine was administered, cycle has been very light no pms and very irregular with 2 cycles a month.
Got the shingles from the shingles shot/ Suspected vaccination failure; Got the shingles from the shingles shot.....; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The age group was not reported, however it was captured as an adult as per vaccine indication. The patient stated he/she got the shingles from the shingles shot. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
sore arm after the first dose of the Pfizer covid 19 vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 68 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm after the first dose of the Pfizer covid 19 vaccine.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
TC on 4/28 by patient to Public Health Nurse, of raised area 1 inch in diameter and tender to touch at site of injection, also tired and slightly nauseated.  Instructed to do warm compresses and Ibuprofen.  TC on 4/29 to patient and she states raised area smaller and no longer tender, much improved.
Her lungs are not 100%; Dizziness; Weakness; Nausea; In bad shape; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 3 patients. This is 1 of 3 reports. A 71-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 03Feb2021 15:00 (Batch/Lot Number: EL9762) as single dose for COVID-19 immunisation. Medical history included high blood pressure, High cholesterol (Blood cholesterol increased), Asthma, Triglycerides high (Blood triglycerides increased), Problems with her stomach, Has shoulder problems and needs surgery on both shoulders. Concomitant medication(s) included salbutamol sulfate (ALBUTEROL); alendronate sodium; amlodipine; calcium, colecalciferol (CALCIUM PLUS D3); fish oil; hydrochlorothiazide; meloxicam; metoprolol; omeprazole; fish oil (OMEGA 3); simvastatin; budesonide, formoterol fumarate (SIMBICORT TURBUHALER); colecalciferol (VITAMIN D); Senofidrate 106 mg, all taken for an unspecified indication, start and stop date were not reported. Three days ago, on 03Feb2021, the patient got first COVID-19 Vaccine at 3PM (15.00). Waited 15 minutes and then 15 more minutes in her car. Had no problem at all. Had a good night's sleep. Last day (04Feb2021), around 9, the patient had dizziness, weakness, and nausea all day long. She was in bad shape. As of today (05Feb2021), she felt much better. Her health was in bad shape. Her lungs were not 100%. She was afraid now to get the second dose. Second dose was in 24 days. Later, clarified her next appointment was on 24Feb2021 at 08:30, not 24 days. She did not want to take second dosage. She wanted her appointment changed and a stamp on her patient card saying she did not want second COVID-19 Vaccine. Advised caller to follow up with vaccination facility. She was afraid. Lot of comments about the COVID-19 Vaccine. Friends comment stating feeling sick, fever, in bad shape. Seen on TV that people die after first COVID-19 Vaccine. Some facility where old people only get first vaccine. Have to get second COVID-19 Vaccine and a lot of people have died but doesn't know how many. Looked on Google and the history of the COVID-19 vaccine. Looked at how many people have died and what happened to them (No further details provided). Read every day about COVID. She wanted to know how long does it take for the COVID-19 Vaccine to help. Outcome of the event lungs were not 100% was unknown and other events was recovering.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
elevated resting heart rate of 150 beats per minute; shaking/trembling; Dizziness; Large round red spot at the injection site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (elevated resting heart rate of 150 beats per minute), TREMOR (shaking/trembling), DIZZINESS (Dizziness) and VACCINATION SITE ERYTHEMA (Large round red spot at the injection site) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Acid reflux (oesophageal) and Sinus infection. Concomitant products included CETIRIZINE and VITAMINS NOS for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Large round red spot at the injection site). On 23-Jan-2021, the patient experienced HEART RATE INCREASED (elevated resting heart rate of 150 beats per minute), TREMOR (shaking/trembling) and DIZZINESS (Dizziness). At the time of the report, HEART RATE INCREASED (elevated resting heart rate of 150 beats per minute), TREMOR (shaking/trembling) and DIZZINESS (Dizziness) outcome was unknown and VACCINATION SITE ERYTHEMA (Large round red spot at the injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, Blood glucose: normal (normal) Normal. On 23-Jan-2021, Blood lactic acid: normal (normal) Normal. On 23-Jan-2021, Heart rate: high (High) 150 beats per minute. On 23-Jan-2021, Pregnancy: negative (Negative) Negative. On 23-Jan-2021, White blood cell count: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 23 Jan 2021, patient was treated with prednisone and Pepcid. On 26Jan 2021, the injection site was looking like ringworm - lighter in the middle, darker on the outside but huge.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2021: NNI
The day after flu vaccine, IM, experienced redness to area 4 cm, warm, tingling in arm and fingers, and achy feeling to arm vaccine administered in.
Will call back later this week with lot number. Two days later my body started tingling, I ended up leaving work early. I called the doctor who said and take some Benadryl and rest it off. I was nausea all weekend and slept most of the weekend. I went to work on Monday and worked through Thursday. Friday 1/22/2021 afternoon my body began tingling again, I became so weak that I couldn't walk. I had to leave work early and they made my husband come pick up because the staff at my job did not think I was safe to drive. I was nauseous again. I had major diarrhea and vomiting about a week after receiving the vaccine. This lasted around 3 days. I finally went into the ER on 1/24/2021. They treated me Magnesium and Potassium and 2 bags of IV fluid and said I was dehydrated and sent me home.  I went from the ER and I could not sleep that night, the ER gave me so much Zofran it was just to much. I still continued to throw up at home. Went back to ER this time  in  on 1/25/2021 around 5AM I was losing feeling in my fingers and toes, they were completely numb. I was also still vomiting. They said I my electrolytes were still out of balance and gave more nausea medicine, medicine to help with the cramping and more IV fluids.  I was sent home later that afternoon. I went to work on the 26th, I felt slow to react, trouble concentrating, very lethargic, and off balance. I was still nauseous but it was getting better with medicine. My eyes yellows turn straight yellow, I thought I had jaundice.  I was able to work all day. I left work and when I pulled into driveway at home 7:01 PM and EMS was in front of my house 7:14  PM.  I went inside and went to bathroom and my husband found me and I was having a full blown seizure, foaming at the mouth. EMS took my to  ER and I was treated for a seizure and an elbow injury and went home. I have seen the neurologist and my physician since being discharged. They did more blood work. I have been having high blood pressure since then. I am trying to get an MRI scheduled that my neurologist ordered. They started Keppra 500 MG to control the seizures. I have been taking Tizanadine for muscle spams from the elbow injury when I feel during the seizure.   I did have an MRI 6 months ago.
Severe pain and stiffness, difficulty raising arm, starting about one hour after injection, for 5-6 days.  Moderate pain and stiffness, limited use of arm, continue to date.  Treatment:50 mg Meloxicam daily from 10/15/2021 to date, Voltaren Gel   Severe throat and esophageal pain. shortness of breath. lasting about am hour on 10/17/2021
Only one week after Moderna booster (3rd shot) began developing hives and rash that spread across entire body.  Had a much more mild reaction localized to injection arm only one week after the 1st shot (also Moderna).  No rash on 2nd shot.  This 3rd shot has produced hives across entire body one week later (nothing during the intervening days though).
Extreme chest pain (first 3 hours), arm pain (both arms, 24 hours) nausea (24 hours+), alternating chills and sweating, (36 hours, no temperature taken). Extreme lack of energy, sleepyness (36 hours)  Everything started about the same time, very suddenly.
Kindergarten immunizations were given on 2/27/2008. The next day mom called, "patient" upper left arm was red swollen and tender, on 2/29 it had decreased and everyday after it improved.
At first began to hives, which I am still having problems with. Around the same time developed hoarseness, and high blood pressure (149-178), dizziness, swelling, and weakness. A month after began to have earaches, and headaches.
Patient recevied 0.5ml instead of 0.25ml dose.  No adverse affects per patient.
Information has been received from a 22 year old female with no pertinent medical history or drug reactions/allergies who in August 2008, was vaccinated orally with her first dose of GARDASIL. In January 2009 she completed her GARDASIL series. "Back in March or April 2009", she started to experience hair loss. The patient saw the physician for help. At the time of reporting, the patient's hair loss persisted. Additional information has been requested.
Spontaneous itchy rashes all over body including face, feet, palm of hands, and neck. Topical corticosteroids provide short and temporary relief as well as antihistamines.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 30th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, pain, headache, sleepiness, activities of daily living impaired and feeling bad. On an unknown date, the outcome of the fever, pain, headache, sleepiness, activities of daily living impaired and feeling bad were recovered/resolved. It was unknown if the reporter considered the fever, pain, headache, sleepiness, activities of daily living impaired and feeling bad to be related to SHINGRIX. Additional details were received as follows: The patient reported that she was flattened for 3 weeks after vaccination with SHINGRIX. The patient stated that she had all the side effects then add 3 to 4 more. Side effects mentioned specifically were low grade fever, aches, headaches, being in bed and being prevented from doing things. The patient had to cancel several activities because she felt so bad. The reporter consented to follow up.
Received both shots and has covid; lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Received both shots and has covid) and DRUG INEFFECTIVE (lack of drug effect) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) for COVID-19 vaccination.     No medical history were reported.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN) for an unknown indication.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jul-2021, the patient experienced COVID-19 (Received both shots and has covid) and DRUG INEFFECTIVE (lack of drug effect). On 30-Jul-2021, DRUG INEFFECTIVE (lack of drug effect) had resolved. At the time of the report, COVID-19 (Received both shots and has covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, COVID-19: positive (Positive) positive.         No treatment medication were reported This case concerns a 62-year-old male patient with no previous relevant medical history, who experienced the non serious unexpected event of COVID-19 after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). Additionally, Drug Ineffective was captured. The event occurred approximately 5 months and 24 days after the second dose of Spikevax. Clinical course included oropharyngeal pain and fatigue. The rechallenge is not applicable, since the only reported event if COVID-19. The benefit-risk relationship of Spikevax vaccine is not affected by this report   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow-up received :Lab data added. Event outcome updated unknown.; Sender's Comments: This case concerns a 62-year-old male patient with no previous relevant medical history, who experienced the non serious unexpected event of COVID-19 after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). Additionally, Drug Ineffective was captured. The event occurred approximately 5 months and 24 days after the second dose of Spikevax. Clinical course included oropharyngeal pain and fatigue. The rechallenge is not applicable, since the only reported event if COVID-19. The benefit-risk relationship of Spikevax vaccine is not affected by this report
Janssen covid vaccination - red, swollen at site, headache, fever, chills, fatigue, body aches
pulmonary embolism; shortness of breath; A Spontaneous report was received from physician concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had pulmonary embolism and shortness of breath.  The patient's medical history was not reported, and concomitant medication included Albuterol, Lipitor, Flonase, Synthroid, loratadine, metoprolol and Torsemide.  On 24 Feb 2021, 1 day prior to the onset of the event, the patient received their first dose mRNA-1273 (Lot number: unknown, Expiration date: not provided) via intramuscular route for prophylaxis of COVID-19 infection.   On 27 Feb 2021, after administration of vaccine patient experienced shortness of breath.  On an unknown date patient experienced pulmonary embolism and was admitted for three days.   She was given Heparin and Coumadin. She was admitted for three days and was sent home with a prescription for Lovenox and Warfarin.  Action taken with the mRNA-1273 in response to the events was not provided.   The outcome were recovered for events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
An initial report was received in the USA from a health care professional on 7/19/05. An 18 year old male patient experienced a fever of 103 degrees F, sore throat, nasal congestion and headache four days post vaccination after he had received a SC injection of Menactra, lot number U1641AA in the left arm and an IM injection of tetanus diphtheria, lot number TD131 in the left deltoid. The patient was prescribed Motrin and Tylenol and his fever was decreased to 101 degrees F. A CBC was done on 7/15/05 but results were not provided. The Menactra vaccine was administered incorrectly as SC instead of the IM route. It is unknown if the patient has recovered. Follow-up information received on 30-August-2005. This patient was 17 year old at the time of vaccination an the manufacturer for the tetanus diphtheria product is the Massachusetts Department of Health. The results of the CBC were provided - within normal limits. The patient did not have any significant medical history, was not on any medications and did not have any illness at the time of vaccination. The patient recovered from the adverse events.
CEREBRAL PARSY AS PER PATIENT AND MD DIGNOSIS...TREMORS AND WEAK MUSCLE ,STIFFNESS
Hives; This is a spontaneous report from a contactable other health professional. A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899, Expiry Date: Mar2021, NDC number: 5926710001), via an unspecified route of administration on 30Dec2020 08:11 at a single dose in right bicep (right arm) for COVID-19 immunisation. Medical history included urinary tract infection from 21Dec2020 to Dec2020 which was resolved and fine after the antibiotic, ongoing eczema (had this condition basically her entire life), ongoing sensitive skin (always had pretty sensitive skin). Concomitant medication not reported. The patient previously took nitrofurantoin (MACROBID [NITROFURANTOIN]) from 24Dec2020 to 28Dec2020. The patient experienced hives on 01Jan2021 09:00 (also reported as "got it last Wednesday morning and broke out in hives the next day"). Patient stated, "I have a question to you. I got the Covid Vaccine, the Pfizer Vaccine on Wednesday morning like around 8 o' clock and this morning I woke up and I broke out hives. I didn't know if in two days, I just want to report my symptoms just to make sure everything is okay." The hives were bad on Friday and took Benadryl and Cortisone cream and it is better now. The hives are not worse; not as bad as it was on the first day. She took about 5 Benadryl throughout the first day: 01Jan2021. Over the last few days she has continued to get small breakouts of hives on pretty much every single spot on her body except for her face; the hives seem to kind of take turns in different areas of the body but have not gone away. She has used Hydrocortisone, lotion and Benadryl for the hives. The outcome of the event was recovering. She is both a sonogram technologist as well as the patient. She asked if she should or should not receive the second dose of Pfizer COVID- 19 Vaccine in response to the hives. She is supposed to get second dose on 19Jan2021; unknown if she will or will not change dose scheduling in response to event at this time.
Severe nausea and stomach pain beginning a few hours (3:00PM) after the injection, with ongoing moderate symptoms as of 9/25/2020.
Fever/chills, nausea, and headache started about 1.5 hours after vaccine administration. Pt presented back to clinic 2.5 hours after vaccine administration. Highest temperature in clinic was 103.1 F. 400 mg of ibuprofen given, water and patient observed for 1 hour. Temperature decreased to 101.9 prior to pt leaving clinic. Pt reports continued fever and chills 24 hours after vaccine administration but is responding to Tylenol and ibuprofen.