chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received vaccine, 15 minutes post vaccine patient alerted personnel that her left hand was itching and felt warm on the inside.  Patient refused to have EMS check her out, but she wanted to inform staff how she was feeling.  Patient was having no other symptoms.  Patient stated her hand was feeling better after approx 5 minutes.  Patient informed to report to v-safe and call 911 or go to the nearest emergency room if her symptoms worsen.  Patient verbalized understanding.
Cough beginning 01-26-21.  Cough/sore throat 01-27-21 Cough/sore throat/fever/sneezing/body aches/chills/headache/fatigue.  01-28-21. Temp of fever was 102.5. Took Aleve and Nyquil. Fever gone on morning of 01-29-21. Still feel tired, aches, congestion, headache.
Arm is magnetic/shoulder is attracting metals after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Arm is magnetic/shoulder is attracting metals after the vaccine) in a patient of an unknown age and gender 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 REACTION (Arm is magnetic/shoulder is attracting metals after the vaccine). At the time of the report, ADVERSE REACTION (Arm is magnetic/shoulder is attracting metals after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment medications was provided.
Following the first and second dose I experienced continuous extreme fatigue and brain fog, and joint aches. Following the 3rd shot (booster) that I received in December, the extreme fatigue became extreme exhaustion, worse brain fog, and constant joint aches.
arm was sore; 9APR93 out patient clinic; anaprox given-out of work x 1 wk; feels like tendonitis;
left big toe numb. progressed into right arm and wrist. Swollen tingling feeling. Spread to both legs and both arms. now spread to entire body. Spread to face. Inflammation and numbness in entire body. Experiencing fatigue and tiredness. Tightening in airway. Sore throat/scratchy. Going to neurologist
23OCT c/o arm very stiff & sore pt warm to touch; 25OCT arm red 1/2" diam swollen sores; MD felt allergic reaction to shot;
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 71-year-old female patient who received SHINGRIX for prophylaxis.  On 25th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, general body pain and headache. On an unknown date, the outcome of the influenza-like symptoms, general body pain and headache were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, general body pain and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX on right arm. The patient experienced flu-like symptoms, including body aches and headache.  These symptoms resolved within a day. There was no consent to follow up. The reporter was unable to provide additional information.
"down for a day" after the second dose; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received the second dose of BNT162B2 (TRADE NAME UNSPECIFIED; lot number unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation and experienced sore arm after dose one. The patient experienced "down for a day" after the second dose on an unspecified date. The clinical outcome of "down for a day" after the second dose was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
within a few days of the first vaccine shot I had pain and stiffness in my right hip.. over the course of a few weeks that pain and stiffness gradually went to my  other hip and then to both hamstrings, then my right knee. there was a great deal of swelling in the right knee. I also have pain and stiffness in my shoulders. I have now been diagnosed with possibly polymyalgia rheumatica. I have been on oral steroids (prednisone) since May 4. I have improved significantly but remain with some level of swelling, stiffness and pain in a all areas.
A quarter of a dime sized reddened area with moderate amt of Pain at site of injection.  Denies any fever, chills, SOB, or hives.
got the flu; Initial information was received on 14-Dec-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional.  This case involves an unknown age male patient who got the flu (influenza) after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "every time my dad got a flu shot he got the flu"  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, outcome of the event was unknown.  The reporter did not report the causality of event with suspect.  There will be no information available on the batch number for this case.
Information has been received from a RN concerning a 9 yr old female who on 02Apr01 was vaccinated with a dose of varicella virus vaccine live (lot 635185/0764K). On 01Feb06 the pt developed chickenpox characterized by itchy, crusting, pimple like blisters. Unspecified medical attention was sought. It was reported that the symptoms lasted 4 days and the pt subsequently recovered. No product quality complaint was involved. Additional information has been requested.
had shingles /after getting the shot/suspected vaccination failure; had shingles 3 times; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a 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.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had shingles 3 times after getting the Shingles shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
woke up at 2:30 am with fever.  Did not take it with thermometer but consistent with a 100.00' range no chills, sore injection site and shoulder joint in general including pec insertion.  fevevr lasted for three hours, for fever took 2 ibuprofen 200mg and woke at 7am with no fever.  Continued ibuprofen for rest of day every 4 hours, last doe at 5:30 pm.  Shoulder and injection site pain lasted 3-4 days after
FINAL DIAGNOSIS: 1. COVID-19 PNA 2. Acute Hypoxemic Respiratory Failure 3. Fall 4. Acute Sacral Fracture 5. Chronic Lumbar Compression Fx 6. Dementia 7. Hypertensive Disease with CAD 8. Headache     REASON FOR HOSPITALIZATION AND ADMITTING DIAGNOSIS:   Fall and Back Pain Fall [W19.XXXA] Hypoxia [R09.02] Closed fracture of sacrum, unspecified portion of sacrum, initial encounter [S32.10XA] COVID [U07.1]   HOSPITAL COURSE:  Patient is a 101 y.o. female who presented to Hospital 1/15/2023 with fall   1. COVID-19 pneumonia with superimposed bacterial pneumonia 1. Onset of symptoms this 1 week prior to presentation symptoms included hypoxemia and cough.  COVID test was positive on January 15, 2023.  Patient has received 3 vaccinations for COVID.  Chest x-ray demonstrated superimposed likely bacterial pneumonia.  Patient discharged on completing course of Augmentin.  Oxygen requirements 3 L nasal cannula will be discharged with arrangements for home oxygen.  ID was consulted did not recommend remdesivir or Paxlovid at this time.  2. Acute hypoxemic respiratory failure 1. Arrangements being made for discharge with oxygen at home 3. Fall, unwitnessed 1. Mechanical fall PT OT followed during hospitalization 4. Acute sacral fracture 1. Ortho reports sacral fractures nonsurgical recommended continuation of PT OT and weightbearing as tolerated 5. Chronic lumbar compression fractures 1. Symptomatic management 6. Dementia 1. Returning to memory care unit 7. Hypertensive heart disease with CAD 1. Management per PCP on discharge 8. Headache 1. CT head ruled out any acute intracranial process
left shoulder pain difficulty raising arm pain rated as 8  apply ice take tylenol and motrin which dose help for short time  pain and difficulty raising arm has not lessened in 10 days
pt recv vax 23OCT96 & 30JAN97 pt exp t99.8, cough, & nasal congestion;tx included flumadine 4FEB97 for 21 days;pt recovered;this is 1 of 28 cases;
pericarditis; headache; fever; having trouble breathing; chest pain; tingling down his arms; This is a spontaneous report from a contactable consumer. An 18-year-old male patient received second dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 04May2021 at 16:00 (Batch/Lot Number: ER8736) as 2ND DOSE, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no Covid prior to vaccination and was not tested post vaccination. The patient experienced Pericarditis, headache, fever, having trouble breathing, chest pain and tingling down his arms all on 06May2021. It was reported that the patient had all the normal reactions to a significant extent, the headache, the fever, etc. But two nights after the vaccination he was having trouble breathing, he had chest pain, and tingling down his arms. The next day, patient was taken to urgent care and was diagnosed with pericarditis. The patient underwent lab tests and procedures which included EKG (electrocardiogram): pericarditis on 06May2021 (EKG showing Pericarditis and 10 days  of medication). Therapeutic measures were taken as a result of all the events. The outcome of all the events was unknown.
PERSON WAS IN A long term care facility AT TIME OF DEATH; LITTLE RECORDS AVAILABLE. DIED ON 2/2/2022. PRIOR COVID-19 INFECTION WAS IN DECEMBER 2020.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Patient had vasovagal event after COVID vaccine. No hx of fainting in the past, but "got close" per mother. Patient fainted twice after vaccine. Was bradycardic and hypotensive, but responsive. Activated EMS to transport to ED for further evaluation since patient remained pale, diaphoretic and lethargic 30-40 minutes after vaccine. Airway remained patent. Mother agreed with plan of care for patient.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On 05-JAN-2018, the patient was vaccinated with an improperly stored and expired PROQUAD lot # M031566 with an expiration date 24-DEC-2017 for prophylaxis (dose, route of administration and anatomical location were not reported). Concomitant therapies included sterile diluent (STERILE DILUENT) which was properly stored and not expired. No adverse effect was reported. Administered dose of PROQUAD experienced the temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit for 48 hours. There was previous temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 13 hours. A digital data logger was involved.
This case was reported by a nurse and described the occurrence of hepatitis b antibody negative in a subject of unspecified age and gender who was vaccinated with Engerix-B for prophylaxis. Concurrent medical conditions included hemodialysis. On three unspecified dates on or prior to 30 August 2006, the subject received three doses of Engerix-B vaccine (40 mcg, unknown). The indicated dosing for Engerix-B in hemodialysis subjects is four doses of the vaccine, administered on a 0, 1, 2, and 6 month dosing schedule. After receiving the three doses of Engerix-B, the subject tested negative for antibody to hepatitis B. The nurse stated that she planned to administer an Engerix-B booster dose to the subject and check titer levels approximately six weeks after the booster was administered. No additional information was reported regarding this event. At the time of reporting the outcome of the event was was unspecified.
delayed type of reaction; arm was red, itchy, and bumpy.; more like a rash; bruised and red; This spontaneous case was reported by a consumer and describes the occurrence of INFUSION SITE BRUISING (bruised and red), SKIN REACTION (delayed type of reaction), VACCINATION SITE PRURITUS (arm was red, itchy, and bumpy.) and INJECTION SITE RASH (more like a rash) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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 INFUSION SITE BRUISING (bruised and red). On 30-Jan-2021, the patient experienced SKIN REACTION (delayed type of reaction), VACCINATION SITE PRURITUS (arm was red, itchy, and bumpy.) and INJECTION SITE RASH (more like a rash). At the time of the report, INFUSION SITE BRUISING (bruised and red), SKIN REACTION (delayed type of reaction), VACCINATION SITE PRURITUS (arm was red, itchy, and bumpy.) and INJECTION SITE RASH (more like a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication use was not provided by the reporter she applied Benadryl cream on the rash and it faded  significanty.   Reporter did not allow further contact
This is a spontaneous report from a contactable consumer who reported for herself. A 60-year-old female patient received pneumococcal 13-val conj vaccine, on 21Dec2016 at 0.5 ml single in right arm as prevention vaccine. Medical history included diabetes mellitus and blood pressure high. Ongoing concomitant medications included metformin for diabetes, estradiol as hormone replacement therapy and metoprolol for blood pressure high . Starting 21Dec2016 patient could not move her right arm due to it being sore. The right arm soreness went from the top of her shoulder to right before her elbow. Since 21Dec2016  she can't move her arm without it hurting, her right arm was more stiff and painful and the shot also made her tired, she slept most of the day after getting it. On 21Dec2016 she also experienced swelling and hard at the injection site on right arm. She took 2 ADVIL as treatment and wondered if she should use hot or warm compresses. It was reported a worsening of the following events: right arm sore, can't move her right arm without it hurting and right arm was more stiff and painful. Fatigue was recovering; outcome of she slept most of the day after vaccination was unknown, while the outcome of the other events was not recovered. Pfizer is the Marketing Authorization holder of pneumococcal 13-val conj vaccine in reporter's country. This may be a duplicate report in situations where another Marketing Authorization holder of pneumococcal 13-val conj vaccine has submitted the same report to the regulatory authorities.
Extreme vertigo Vomiting  Extreme migraine  Stomach pain Extreme tiredness... could not hold my head up Lasted almost 48 hours
Reaction at injection site on Right arm, red, swollen and warm to touch. Redness and swollen line of demarcation just below injection site and extends 6 inches down and around entire arm.
had covid after receiving dose 1 & 2; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had covid after receiving dose 1 & 2) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Bronchiectasis and Hypertension.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced COVID-19 (had covid after receiving dose 1 & 2). The patient was treated with MONOCLONAL ANTIBODIES, GRANULOCYTE for Bronchiectasis, at a dose of 4 shots in the stomach.. At the time of the report, COVID-19 (had covid after receiving dose 1 & 2) outcome was unknown.            Concomitant medication included  blood pressure pill and other medications patient was taking but  reporter did not knew the names of them. It was reported by the reporter that both she and her husband had COVID -19 infection in mid -Nov-2021.It was reported that patient was given monoclonal antibody infusion, 4 shots in the stomach. t was reported that patient was fully vaccinated from  moderna with dose 1 and dose 2.It was reported by the reporter that her husband did not had COVID as bad as she had.It was further stated that patient would be seeing  his family care doctor that thursday because of the booster dose. It was reported that patient was given monoclonal antibody infusion, 4 shots in the stomach as a treatment medication for underlying pulmonary issues like Bronchiectasis.  COMPANY COMMENT : This spontaneous case concerns 61 years old male patient with no relevant medical history, who experienced unexpected non serious AESI event of COVID-19, which occurred on unspecified days after second dose of mRNA-1273. It is reported that patient was given monoclonal antibody infusion as a treatment medication for underlying medical condition Bronchiectasis. Current ongoing pandemia remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow up received includes no new information.; Sender's Comments: This spontaneous case concerns 61 years old male patient with no relevant medical history, who experienced unexpected non serious AESI event of COVID-19, which occurred on unspecified days after second dose of mRNA-1273. It is reported that patient was given monoclonal antibody infusion as a treatment medication for underlying medical condition Bronchiectasis. Current ongoing pandemia remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
During Hospitalization, patient tested positive for COVID-19 post vaccination. Patient experienced shortness of breath requiring supplemental oxygen
Swelling, redness and hot to the touch. Pt given Cephalexin 250mg/5m/3m BID (q12h) X 7 days.
Within 12 hrs of PENTACEL and PCV-13 administration fever, vomiting and erythema/induration surrounding injection site. From where PENTACEL was given developed fatigue, decreased appetite.
Initial information received on 08-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA313488 (same patient and same reporter). This case involves a 9 years old male patient who was vaccinated with TENIVAC instead of ADACEL (lot number: U5882AA, expiry date: 08 March 2020) in the left arm on 01-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines given at this visit. It was also a case of actual medication error due to wrong vaccine administered. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
She woke up thinking she didn't sleep; Nausea; sore arm; was really tired; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration at the right arm on 09Jan2021 at single dose for COVID-19 immunization.  The patient had no medical history and there were no concomitant medications. The patient took the first dose of the Covid-19 vaccine and was fine. The lot for the first dose of the vaccine was EH9899. She received it on 19Dec2020 (at the age of 51 years). She took the second dose on Saturday (09Jan2021). She experienced nausea and had a sore arm on 10Jan2021. It was not death defying. She was also really tired on 10Jan2021. She was advised by her employer to report this information. She took some Tylenol and relaxed. She was no longer nauseated or tired. Her arm was not sore only tender. She woke up thinking she didn't sleep on an unspecified date. The patient added that her boss said she might have to be tested. The patient asked if that was something that she needs to do. The outcome of the events nausea and tired was recovered on 11Jan2021. The outcome of the event sore arm was recovering. And the outcome of the event "She woke up thinking she didn't sleep" was unknown.
Slight throat tightness and itchy eyes about 15 minutes after vaccination. Slight cheek warmth without rash or hives. Benadryl 50 mg PO administered with mother's consent. Symptoms did not progress and slowly resolved over a 1 hour observation time at CVC. No SOB, wheezes, tongue thickness, or hives at any time. BP, pulse, O2 sats were all normal.     Initial BP - 118/78, pulse-84, O2 sat - 99%. No orthostasis at dismissal.     Home with mother with precautionary instructions.