chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Took the flu vaccine two years ago and had the flu twice/ Suspected vaccination failure; Had the flu twice / Thought I was going to die; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 75-year-old patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis.   The patient's past medical history included shingles (experienced when patient was younger).   On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, less than 2 years after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced vaccination failure (serious criteria GSK medically significant and life threatening) and influenza (serious criteria life threatening). On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent 2018-2019 season.  Additional details were reported as follows: The case was reported by patient him/herself on interactive digital media. The age at vaccination was not reported. The patient received flu vaccine two years ago and had the flu twice and the patient thought he/she was going to die, it was so bad. Patient stated that no more vaccines for him/herself no matter what anyone says, did not matter what you had (flu, cold, allergies, pneumonia, etc.) they probably would say it's the Covid virus, he/she had not lived all this time with no common sense. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. For tolerance of shingles vaccine refer case US2020AMR231599.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR231599:same reporter
This spontaneous report as received from a registered nurse refers to an multiple patients of unknown age and gender. There was no information about the patients, concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M011832 (expiry date: 25-JAN-2018), M031802 (expiry date: 09-NOV-2017), M019691 (expiry date: 02-NOV-2017), M004885 (expiry date: 23-OCT-2017), orally (dose was not reported). There was no adverse effect reported. Administered doses of vaccines underwent the temperature excursion of 0-2 degrees Celsius for 3 hours, which was detected by a data logger. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA014419.
Child with fussiness, fever and erythema on left leg. Instructed to seek Urgent Care. No erythema seen, no intervention given. Follow up appointment-child doing well.
Patient developed large area of redness and warmth on left arm/deltoid area and kept spreading the next day.
01/21/2022, In the evening, I had a big lymph node in my armpit the size of a plum, that lasted almost a week.  It was hurting all the way to my breast. I had more and more of those lymph nodes appear on my breasts.  I had trouble with my period.  It went away for a while.  In March, I started having pain around my eye. I went to the eye doctor, who told me my eyes were fine.  I went to see an Ear Nose Throat Doctor, who said I did not have an infection.  I had pain all over my head.  I had a sensation that someone was pouring burning water all over my head.  They did an MRI, Blood Tests, founds nothing. I saw Neurologist, Rheumatologist, two family doctors.  Sometimes I cannot move my body.  I have had vision problems, my eyes were blurry. I could feel my blood, it felt like something was crawling through my legs.  I could see the blood. My hands were turning blue, purple and white.  My breasts were so painful. I did a Mammogram in December and another on January 5.  It is a thick tissue, an abnormality. I had stomach pain, nausea, and I still deal with that. Burning sensations are now gone. I also had a rash on my legs.
soreness in neck; hands and feet were on fire/burning sensation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Oct2021 (Lot number: FF2588, Expiration Date: Dec2021) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "car accident", start date: Dec2020 (unspecified if ongoing), notes: she had a car accident 9.5 months ago in Dec2020; "carpal tunnel" (unspecified if ongoing), notes: She had carpal tunnel in both hands due to the accident; "swelling" (unspecified if ongoing), notes: She had swelling previously. The patient's concomitant medications were not reported. The following information was reported: BURNING SENSATION (non-serious) with onset 06Oct2021 22:30, outcome "not recovered", described as "hands and feet were on fire/burning sensation"; NECK PAIN (non-serious) with onset 08Oct2021, outcome "recovering", described as "soreness in neck".  Additional information: She did not initially have any reaction like within a couple minutes or hours after the vaccine. It wasn't until later that evening she started to experience reactions. The injection site was on left arm. Towards the evening she started to have side effects. Her hands and feet were on fire and it hasn't stopped. That was the first day. The second day she had the same symptoms, but then had issue where her neck was very sore. The burning sensation continued through the night. Initially she didn't have the soreness of the neck.  Time the vaccination was given between 6:00PM and 6:30PM. No any AEs prior vaccinations (within 4 weeks) and following prior vaccinations.  No follow-up attempts are possible. No further information is expected.
Slept for 17 hours; Arm hurt; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jan-2021 and was forwarded to Moderna on 29-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt) and SOMNOLENCE (Slept for 17 hours) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0137K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced PAIN IN EXTREMITY (Arm hurt). On 02-Jan-2021, the patient experienced SOMNOLENCE (Slept for 17 hours). On 31-Dec-2020, PAIN IN EXTREMITY (Arm hurt) had resolved. On 03-Jan-2021, SOMNOLENCE (Slept for 17 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
pt recv vax;  devel erythematous petechial pruritic pattern on lt dorsal forearm which spread to involve several of fingernails; it was unclear to the reporter whether pt's exp were related to vax;
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: During administration of first covid pfizer vaccine patient was fine. Shortly after administration while patient was sitting the required 15 minutes he fainted and was unresponsive for a few seconds.  He felt cold and clammy to touch and patient's blood pressure was 115/75.  Once patient came to and felt well enough to walk we took him to minute clinic to lay down.  Paramedics were contacted and assessed patient before he left 30 minutes after administration of first dose.
This spontaneous report was received from a health care worker refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, lot # and route of administration were not reported). The reported stated that the patient received 3 doses of PREVNAR and then 1 dose of PNEUMOVAX 23, instead of a 4th dose of PREVNAR, by mistake. No adverse effects reported. Additional information has been requested.
Within 24 hours of vax, on 12/8/00 he developed severe redness and swelling at the Infanrix injection site. He also developed severe swelling of his right thigh, the swelling was almost circumferential. His thigh was not tender. He was treated with diphenhydramine (Benadryl) and ibuprofen (Motrin). He recovered 12/12/00. The reporter considered the thigh swelling to be related to the vax administration.
dizziness; heavy headedness; Weakness; 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 male patient received bnt162b2 (BNT162B2), administration date 21Apr2021 (Batch/Lot number: unknown) 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:1), for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 01May2021, outcome "not recovered", described as "dizziness"; HEADACHE (non-serious) with onset 01May2021, outcome "not recovered", described as "heavy headedness"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Weakness". The events "dizziness" and "heavy headedness" were evaluated at the physician office visit. Therapeutic measures were taken as a result of dizziness.  Additional information: Patient is calling about the Pfizer BioNTech Covid-19 Vaccine. Patient states that he got his second dose on 21Apr2021 after that day everything was back to normal after 3 or 4 days. No further information provided. He states that on Saturday 01May2021 he started to dizziness on and off, on and off and it is still continuing onto today. He states that he has went to doctor, and they gave him tablets for dizziness, he has been using them since yesterday. Patient wants to know how long the dizziness and heavy headedness takes to go away. He states that his head was spinning, and he had weakness. He clarifies his head is heavy and it is dizziness, spinning, all things related to his head.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received through a pregnancy registry from two licensed practical nurses concerning a 21 year old female with asthma and type II diabetes mellitus who on 23-MAR-2007 was vaccinated with the first dose of Gardasil (lot #655618/0186U).  On 18-APR-2007 the patient had a positive pregnancy test.  The patient was vaccinated with the second dose on 23-MAY-2007 Gardasil (lot #657617/0384U).  (It was also reported that this was the patients first dose).  Concomitant therapy included prenatal vitamins (unspecified) and folic acid.  Subsequently, on 23-MAY-2007 within one hour of the vaccine, the patient experienced dizziness, nausea and vomiting.  The patient was prescribed promethazine hydrochloride (PHENERGAN) and symptoms are resolving.  Patient had prenatal blood work and abdominal ultrasound, results not reported.  The patient is pregnant with twins.  The last menstrual period was 26-FEB-2007 with estimated delivery date is 03-DEC-2007.  (The last menstrual period was also reported as 03-MAR-2007).  Additional information has been requested.
she feels so rotten; Been sick since Saturday, 12Jun2021; The only thing improved is headache has let up some; can't eat; can barely drink anything. Everything that comes into the caller, comes right back out.; This is a spontaneous report from a contactable consumer (Patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8735 and Expiration date: unknown), via an unspecified route of administration, administered in right arm on 11Jun2021 (Friday) before noon (at the age of 56-years-old) as single dose for COVID-19 immunization. Medical history was reported as no, and patient stated diabetes runs in the family. The patient's concomitant medications were not reported. Patient did not receive any additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the vaccination and any other products. On Saturday night, 12Jun2021 (next day of vaccination), patient noticed that she was sick and had headache, and stated that the only thing improved was the headache had let up some. On the same day, patient cannot eat, can barely drink anything, stated that everything that comes into the patient, comes right back out. The Patient stated she did go to the doctor and was tested for Covid. The patient thought she may have Covid from the actual first dose Pfizer Covid 19 Vaccine, however, she was tested Negative for Covid as well as for Flu. The patient asked why she feels so rotten on an unspecified date. The patient underwent lab tests and procedures which included Flu: Negative and SARS-CoV-19 Test: Negative on an unspecified date. There was no investigation assessment and no relevant tests. The patient stated that, everyone else says they just have sore bones, but however she declined to report for said persons and states, no, this is not the caller's place. The patient just decided it was time to get vaccine and was really regretting it right now. The outcome of events headache was recovering, sickness was not recovered, and unknown for other events.
Immediate pain in upper left arm that quickly spread and lasted many days. Within 6 hours aches, chills, fever, headache, fatigue. The latter symptoms lasted a solid three days. The arm pain continues today, though it has abated greatly in the last day or so. I was unable to exercise or even really leave the house for those three days. I now have a head cold. I am hoping this vaccine will not trigger a Hashimoto's flare up.
Vomiting x 2 approx 6-8 hours after receiving vaccines. Running 101 degree fever although parent states has given fever reducer. Next morning no nausea or vomiting still have low grade temp but feeling much better.
Inconsolable fussiness x 6 hours, fever 40 C (rectal) lasting 10 hours+ (not resolved at discharge).
This spontaneous report was received from a licensed vocational nurse  and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with   an improperly stored dose of ZOSTAVAX (lot # L013546 with expiration date 17-JUL-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified patients were vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions mentioned above that the VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow-up information which has been unsuccessful) has been received from nurse concerning VARIVAX temperature excursion and one patient of unspecified age gender who was vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided)(lot# J012384, exp date: 31-OCT-2015) that reached 18.5 F  for 10 hours and 44 minutes. This is one several reports received from the same source. Additional information has been requested.
Patient received the vaccine in the morning and that evening (time unknown) she had numbness and tingling in her feet and legs. Several doctor visits later on 8/6/15 she was diagnosed with multiple sclerosis.
Patient has experienced a red quarter sized rash at the site of injection on 8/3/21 and has now expanded up her arm towards her next and is itchy.  No fever or infection lines. Patient's lymph nodes under that same right arm are inflamed and a little painful.  Otherwise, patient feels fine.
I was vaccinated at 27 weeks pregnant. I could not fully lift my arm again for 15 months because there was severe pain when I tried to lift my arm above my head. There is still pain in my arm three years later. My unborn child did not move for three weeks after I was vaccinated. He is now 2.5 years old and he is developmentally delayed and showing signs of autism.
Discomfort from under left arm towards her left breast; Slight fatigue; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Discomfort from under left arm towards her left breast) and FATIGUE (Slight fatigue) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Cancer. No concomitant medication 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 FATIGUE (Slight fatigue). On 15-Feb-2021, the patient experienced AXILLARY PAIN (Discomfort from under left arm towards her left breast). At the time of the report, AXILLARY PAIN (Discomfort from under left arm towards her left breast) and FATIGUE (Slight fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Feeling Very Weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feeling Very Weak) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced ASTHENIA (Feeling Very Weak). At the time of the report, ASTHENIA (Feeling Very Weak) outcome was unknown. Not Provided          Concomitant medications were not provided by the reporter Treatment information includes Fluids and Tylenol   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: No specific follow-up information recorded.
Patient had onset of 102-105 deg fever with lethargy at 11PM after vaccine, Tylenol did not bring fever down and did not improve patient affect, at 11AM started having myoclonic seizures (muscle twitches every 30-60 seconds that lasted for 1-2 sec at a time for 7 hours). Patient getting Tylenol every 4 hours with no change at 5 pm on 10/09/15 patient started getting Motrin. At 6pm patient had end of myoclonic seizures. Fever remained but at 101 and patient began speaking again. Patient recieved Motrin and Tylenol throughout night of 10/9/15 and maintained a fever and was fussy but no further neurological signs. At 8 am on 10/10/15 patient had no further fever and was back to himself. Medicine stopped.
sore arm; bladder problem; temperature; fatigue; flu; loss of appetite; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), BLADDER DISORDER (bladder problem), PYREXIA (temperature), FATIGUE (fatigue) and INFLUENZA (flu) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), BLADDER DISORDER (bladder problem), PYREXIA (temperature), FATIGUE (fatigue), INFLUENZA (flu) and DECREASED APPETITE (loss of appetite). At the time of the report, PAIN IN EXTREMITY (sore arm), BLADDER DISORDER (bladder problem), PYREXIA (temperature), FATIGUE (fatigue), INFLUENZA (flu) and DECREASED APPETITE (loss of appetite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment included Tylenol. Concomitant medications were not provided.
AT TIME OF INJECTION, PATIENT FELT LIGHT HEADED, DIZZY, TUNNEL VISION, NAUSE (HAD SOME VOMITING), CLEARED UP WITHIN 5 MINUTES, FELT BETTER WHEN DRANK GATORADE
This case was reported by a healthcare professional to a sales representative and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On an unspecified date in 2006, on or before 03 October 2006, on or before 03 October 2006 less than one year after vaccination with Fluarix, the subject experienced injection site swelling "the subject experienced injection site swelling " the size of a baseball". At the time of initial reporting, 03 October 2006, the event was worse. The healthcare professional considered the event was probably related to vaccination with Fluarix. This is in follow-up to report(s) previously submitted on 12/08/2006. Follow-up received on 16 April 2007 via a healthcare professional. She reported that the 29 year old female subject was vaccinated with FLUARIX on 28 September 2006. Two hours after the vaccination, the subject experienced a raised, red rash on arms, chest and top of her feet. The rash was hot and itchy. She was diagnosed with a photosensitive rash. She was seen on 01 October 2006 and 02 October 2006 in occupational medicine at the hospital. She was treated with ATARX, hydrocortisone cream and methylprednisone. The reporter noted that the events were improved on 10October2006 and she considered that the events were related to the use of FLUARIX.
Swelling redness tenderness heat - 3 inches diameter.  Started on day 6, with mild pain at site and grew
first dose on May 2019, did not remember if he received the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in May 2019).   On an unknown date, the patient received 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: 11-MAY-2022 Reporters comment: The patient self-reported the case. The patient was not immunocompromised. After receiving 1st dose of Shingrix, the patient did not remember if he received the 2nd dose. He was looking information about taking a third Shingrix dose. Permission for follow-up was not asked as well as no other information because member of public was looking only for an answer. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. This case had been linked with case US2022076981, reported by the same reporter for the patient's wife.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022076981:same reporter