chrisvoncsefalvay/vaers-outcomes huggingface dataset:
illness/very ill; could not move; This case was reported by a consumer via media and described the occurrence of unwell in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received the 1st dose of Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced unwell and mobility decreased. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the unwell and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the unwell and mobility decreased to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported, but the patient received Flu vaccine as a child. The patient was very ill after receiving Flu vaccine the first time and patient had it attacked immune system so bad that the patient could not move. A year on after receiving Flu vaccine, at the time of reporting the patient was still not 100 percent better even after receiving a long course of steroids. The patient requested not to spout the opinions to people who knew for a dammed fact that it was caused by the Flu vaccine as they were different.  It was reported that the patient would never receive the Flu vaccine again and the patient was certainly not an anti anti vaxxer.
One day post receiving flu vaccine noticed ear ache/pressure bilateral that progressed to pain behind rt ear on 10/23/02. Started having numbness to rt side of face. Was dx with Bell's palsy.
Breakthrough COVID-19 case. Admitted 8/29/2021. Patient presented with chills, abdominal pain, nausea and vomiting. Discharge data 9/2/2021. Breakthrough COVID-19 case.
Patient describes excessive fatigue, malaise, and nausea/ vomiting went to emergency room on 11-11-2010 and was treated for dehydration.
Tested positive for covid on January 16, 2021. Death 2/9/2021
Patient described fatigue and dizziness at 6:00 PM. Chills and cold sweats, rigors, headache, and nausea decreased appetite 8:00 PM and continued until 11:00 AM the next day.
Inflamed injection site; Rash at injection site; Unable to lay on injection arm; Really sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (Inflamed injection site), LIMB DISCOMFORT (Unable to lay on injection arm), PAIN IN EXTREMITY (Really sore arm) and VACCINATION SITE RASH (Rash at injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced LIMB DISCOMFORT (Unable to lay on injection arm) and PAIN IN EXTREMITY (Really sore arm). On 20-Mar-2021, the patient experienced VACCINATION SITE INFLAMMATION (Inflamed injection site) and VACCINATION SITE RASH (Rash at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INFLAMMATION (Inflamed injection site), LIMB DISCOMFORT (Unable to lay on injection arm), PAIN IN EXTREMITY (Really sore arm) and VACCINATION SITE RASH (Rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
Administration site was sore and somewhat red after injection.     Redness a couple of days after the shot, then again noticed redness on 1/19/2021.  Dr. assessed the area on 1/20/21 at facility site where received vaccine and was assessed again at facility site of administration on 1/21/2021.  The area of redness is not as red as yesterday.   Area is continuing to be observed by the patient.
Information has been received from a physician concerning a 20 year old female who on 15-OCT-2008 was vaccinated with the second dose of GARDASIL vaccine, IM "single dose vial". The patient experienced nausea almost immediately after receiving her second dose of GARDASIL vaccine sometime around 15-OCT-2008. Physician reported that the patient's nausea "got progressively" for a couple of weeks after which it started to diminish. The patient sought medical attention. The pregnancy test was negative. Additional information has been requested.
Running a temperature; My temperature is still 99.9; I have been feeling like I got Covid all over again; This is a spontaneous report from a contactable consumer(patient). A 76-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot/batch no: EN6206) via unspecified route, as a 1st dose, single dose on 08Mar2021 for COVID-19 immunization (at the age of 76-years). Medical history included blood pressure measurement, Type 2 Diabetic and covid-19 infection from an unknown date. Concomitant medication included insulin glargine (LANTUS) taken for an unspecified indication, start and stop date were not reported. Patient stated that she received her first dose of vaccine on Monday (08Mar2021) at noon and she felt fine. But by Tuesday morning, she was running a temperature and she had been feeling like she got Covid all over again, the whole time because she had it in November. That morning, her temperature was still 99.9. Patient wanted to know if she was contagious to somebody, she meant, she was trying to get the shot to take care of that but here felt like she got it again. The patient underwent lab tests and procedures which included body temperature: still 99.9 on an unspecified date. The clinical outcome of the events was unknown.
Herpes zoster ophthalmicus; Shingles; Information has been received from a lawyer regarding a patient (pt) of unknown age and gender. Information about concurrent condition, history condition and concomitant medication was not reported. In or around 26-DEC-2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, dose number, route, anatomical location, lot# and expiration date unknown) for its intended purpose: the prevention of shingles. Shortly after receiving zoster vaccine live (ZOSTAVAX) (date not reported), pt suffered severe side effects including shingles rash and was diagnosed with shingles and Herpes Zoster Ophtalmicus. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations not present prior to using the vaccine. Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Pt had incurred and would continue to incur medical expenses and other economic harm as a direct result of use of zoster vaccine live (ZOSTAVAX).  Upon internal review, Herpes Zoster Ophtalmicus was considered to be a medically significant event.
This case was reported by a consumer via call center representative and described the occurrence of shivering in a 61-year-old female patient who received SHINGRIX (batch number B327C, expiry date 4th July 2020) for prophylaxis. On 4th June 2018 14:37, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 5th June 2018, 1 days after receiving SHINGRIX, the patient experienced fever and fatigue. On 5th June 2018 15:00, the patient experienced nausea and headache. In June 2018, the patient experienced pain in arm. In June 2018, the patient experienced shivering. The patient was treated with TYLENOL. On 5th June 2018 20:00, the outcome of the headache was recovered/resolved. On 6th June 2018, the outcome of the fever, nausea and fatigue were recovered/resolved. On an unknown date, the outcome of the shivering and pain in arm were recovered/resolved. The reporter considered the shivering, fever, nausea, headache, pain in arm and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient woke up at 1:00 am the next morning shivering (latency 10 hours and 23 minutes) and barely able to get out of bed. She did take some TYLENOL and the shivering subsided after 20 minutes and was gone when she woke up that morning. She had fever on and off during the day on 5th June 2018 but only measured her temperature later in the day when it registered 100 degrees F. She felt it was higher earlier in the day. She had a bit of nausea and developed a headache around 3:00 pm on 5th June 2018 that lasted about 5 hours (latency 1 day and 23 minutes). She said she thought her arm may have hurt (latency less than a week) but it was so secondary to all other events she could not remember. She went to sleep that night and when she awoke of June 6, all symptoms were resolved. The patient usually had a strong reaction to medication as she was only 110 pounds. The patient did say her doctor was unaware she received the vaccine.
Having some side effects from the second dose; I have given it a week and a half almost and I am getting a little weary about it; The initial case was missing the following minimum criteria: [AE for BNT162B2]. Upon receipt of follow-up information of 05Oct2021, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Lot number: FF2587) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, Lot FC3183 (manufacturer unknown)), for covid-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Having some side effects from the second dose; I have given it a week and a half almost and I am getting a little weary about it".  Additional information: It was stated that, patient was calling because she had been having some side effects from the second dose (clarification unknown) and she thought it would go away but it was not going away. Consumer stated, well, she was really concerned about what it was doing to her body (further clarification was unknown).  Follow-up attempts completed. No further information expected.
Pt. called our clinic at 1320 on 8/11/21 to report a reaction to the vaccine. Pt received Janssen COVID-19 Vaccine on 8/9/21 and in the evening of 8/10/2021 he stated that he developed HIVES on his back. He denies any SOB or Swelling and states that they Itch. He took a Benedryl at noon on 8/11/21 and states that at 1320, the Hives are still present, but the itching is going away. Advised patient to register for V-Safe again and report the side effect, and told him that I would be filing a VEARS report as well. Asked patient if he would like to be seen by a provider here at the clinic and he stated he did not at this time, but would call us if he changed his mind.
Found deceased collapsed over edge of overflowing bath tub with head and upper torso submerged.  Autopsy revealed signs of drowning and severe heart disease (hypertensive and coronary heart disease and cardiac amyloidosis).  There was no evidence of anaphylaxis or myocarditis. Cause of death = Drowning Contributory causes = Hypertensive and coronary heart disease; Cardiac amyloidosis
Initial report received on 14 September 2011 from another manufacturer (reference number 1-4467474454) who received the original report via their National Service Center from a health care professional. This is a case of misuse where the wrong dose of IPOL was administered (1.0 mL administered instead of 0.5 mL). A 12-year-old female patient developed a dose of IPOL (lot number not reported) on an unspecified date and instead of the patient receiving 0.5 mL administered intramuscularly, the patient received 1 mL administered intramuscularly. No adverse effects were reported. No further information was provided. Documents held by sender: None.
All dairy products have a strong odor too them, lackluster and taste spoiled.  Member had this reaction after first dose and states second dose made it worse.  Member did also have covid positive in January.
This spontaneous report was received from a pharmacist referring to a non-pregnant female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 22-MAY-2017, the patient was inadvertently administered intramuscularly rather than subcutaneously with a dose of ZOSTAVAX lot # M040144, with expiration date 26-DEC-2017, for vaccination (dose was not reported). The patient stated that the ZOSTAVAX "stung just a little bit" upon administration (injection site pruritus). No treatment was provided for the adverse event. At the time of reporting the outcome of the event was unknown. A product quality complaint was not involved. The causality assessment between the adverse event and ZOSTAVAX was not provided. Additional information has been requested.
[Janssen Covid Vaccine] use for COVID-19 under Emergency Use Authorization (EUA): Patient received the janssen vaccine on 11/24/2021. Patient presented with covid-19 pneumonia on 1/16/2021 - less than 60 days after the vaccine which signifies therapy failure.
Headache, Myalgia, Fever, Diarrhea, upset stomach, chills, fever, body ache, headache, fatigue Narrative: Employee stayed at home and treated with OTC meds.
Hives, fever, chills, body aches, swollen neck glands Hives lasted for 4 days would lesson after Benadryl, then came back on March 10th.
Arm was red and swollen with a loss in range of motion. (left arm) Patient had mild fever.
Patient c/o redness, swelling, hardness above, pain and warmth on right arm at site of injection of Pediarix vaccine.
pt developed a rash with swelling  at injection site on 4/2/21, but hives continue to pop up in different places on her arm with burning and stinging periodically on arm, back, chest and neck
lightheadedness, fatigue, fever and pain & stiffness in the arm were the vaccine was administered. These symptoms lingered into the next day causing me to stay home from work the following day.
Mom came into office and reported that they were at the park and the babysitter saw the baby have shaking movements of the body for approximately 1 minute. Temperature was 100.5 rectal. Mother and brother both with history of seizures.
anaphylactic reaction - angioedema of tongue and pruritis of face. treated with epi, Benadryl, pepcid, steroids.
Severe migraines within 24 hours of vaccine. Took ibuprofen and migraine went away about 6 hours later. Headaches persist, much like a head cold.
arm a little sore... when stressed in a specific way; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm a little sore... when stressed in a specific way) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm a little sore... when stressed in a specific way). On 15-Feb-2021, PAIN IN EXTREMITY (arm a little sore.. when stressed in a specific way) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
Severe swelling and reddening of entire arm, from shoulder to wrist, that lasted 72 hours. High fever.
1st dose in March 2022, 2nd dose not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in March 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 10-Feb-2023 Reporter's Comments: The consumer did not remember the exact date of her 1st dose of Shingrix or where the injection was administered.  The consumer reported that she did not receive her 2nd dose of Shingrix yet and it has been almost a year since the first dose.  The reporter consented to follow-up.  Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporting system provided corresponded to the first dose of Shingrix as the second dose was not administered yet.
Symptoms:  I  started running a fever - 100.4 degree F- around 11:00pm, accompanied by severe body aches and headache.  The fever lasted for about 12 hours- then was just low grade 99.8 ( my normal temperature ranges between 96.8 and 97.6).  Muscle aches and headache persisted until the morning of March 27th. Treatment:  I pushed fluids, took Ibuprofen 400 mg every 6 hours, and stayed in bed (I was scheduled to work at the Hospital (I am a RN and work on the Family Birthing Center at our local hospital), but called off work). All symptoms are listed as side effects.
Inappropriate schedule of vaccine administered; This spontaneous report was received from a lawyer referring to a 67 years old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.   The patient was vaccinated with pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) via intramuscular in left arm on 16-OCT-2014 to 07-OCT-2015 (strength, dose, lot# and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). The patient was vaccinated with tetanus toxoid vaccine in 2015 and influenza virus whole virion 3v vaccine inactivated (FLUZONE) in left arm on 14-SEP-2018.   This case was split from a legal case regarding the same patient.; Sender's Comments:  US-009507513-2101USA004646:
8 hours after dose symptoms began, all severe. Muscular and joint aches and pains, nausea, chills, abdominal discomfort, difficulty swallowing, excruciating headache.  Began to improve about 36 hours after dose.  However,  still experiencing muscular and joint pain, abdominal discomfort and headache although now  moderate,  not severe.
hot to the touch; numbness in fingers; tingling in her fingers; her arm pit hurts; arm got swollen at the injection site; lymph nodes are swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING HOT (hot to the touch), HYPOAESTHESIA (numbness in fingers), PARAESTHESIA (tingling in her fingers), AXILLARY PAIN (her arm pit hurts) and INJECTION SITE SWELLING (arm got swollen at the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced FEELING HOT (hot to the touch), HYPOAESTHESIA (numbness in fingers), PARAESTHESIA (tingling in her fingers), AXILLARY PAIN (her arm pit hurts), INJECTION SITE SWELLING (arm got swollen at the injection site) and LYMPHADENOPATHY (lymph nodes are swollen). At the time of the report, FEELING HOT (hot to the touch), HYPOAESTHESIA (numbness in fingers), PARAESTHESIA (tingling in her fingers), AXILLARY PAIN (her arm pit hurts), INJECTION SITE SWELLING (arm got swollen at the injection site) and LYMPHADENOPATHY (lymph nodes are swollen) outcome was unknown.            Action taken in response to mRNA-1273 was considered to be not applicable.  The patient arm got swollen at the injection site, hot to the touch, and ever since had numbness and tingling in fingers. Concomitant medications were not provided. Treatment information was not provided.
Received Varivax booster on 9/19/07, on 9/20/07 patient's arm around injection site was red, itchy, and warm to touch (large area). Patient evaluated in office.
This spontaneous report as received from a health care professional refers to an unspecified number of patients who were vaccinated on unknown dates with unspecified doses of MMR II that were improperly stored. No adverse effects reported. No further information provided. Additional information has been requested.
COVID AFTER RECEIVING THE JANSSEN COVID 19 VACCINE; This spontaneous report received from a patient concerned a 40 year old male. 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 not reported, batch number: 204521A expiry: UNKNOWN) dose was not reported, administered on 10-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JAN-2022, the patient experienced covid after receiving the Janssen Covid 19 vaccine. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid after receiving the Janssen Covid 19 vaccine was not reported. This report was non-serious.
Woke up on 8/1/14 with sore throat soon after I developed fever, chills, achiness, extreme fatigue and loss of appetite. Sought treatment at urgent care, was put on antibiotics, cough medicine and inhaler and advised not to work. 8/13/14 follow up with regular physician. Blood work and check x-rays taken. bacterial pneumonia revealed in a cat scan w/contrast. Dr recommended a pulmonary consultation. This will take place 10/1/14.