chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu symptoms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of flu symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   The patient's past medical history included shingles (had 20 years ago prior to the reporting.).   On an unknown date, the patient received Shingles vaccine and PNEUMONIA VACCINE. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced flu symptoms (Verbatim: Flu symptoms). The outcome of the flu symptoms was resolved (duration 1 day).   It was unknown if the reporter considered the flu symptoms to be related to Shingles vaccine.     It was unknown if the company considered the flu symptoms to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 31-MAR-2023 This case was reported by patient via interactive digital media. The reporter reported that he or she received Shingles vaccine and Pneumonia vaccine at the same time. The reporter reported that he or she experienced flu symptoms for one day and there was nothing horrible. The reporter stated that the shingles are much worse than the vaccine. It was unknown if the reporter considered the flu symptoms to be related to Pneumonia vaccine. The follow-up could not be possible as the as no contact details were available.
Inflammation at injection site; body ache; fatigue; fever; This spontaneous case was reported by a health care professional and describes the occurrence of INJECTION SITE INFLAMMATION (Inflammation at injection site), MYALGIA (body ache), FATIGUE (fatigue) and PYREXIA (fever) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced INJECTION SITE INFLAMMATION (Inflammation at injection site), MYALGIA (body ache), FATIGUE (fatigue) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, INJECTION SITE INFLAMMATION (Inflammation at injection site), MYALGIA (body ache), FATIGUE (fatigue) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No laboratory data was provided. Treatment included paracetamol.
suspected vaccination failure; had them; This case was reported by a consumer viainteractive digital media and described the occurrence of suspected vaccination failure in a male 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 provided as follows: The case was reported by the patient's wife. The age at vaccination was not reported. The patient received Shingles vaccine years ago from the date of reporting. Last fall from the date of reporting, after receiving Shingles vaccine, the patient got shingles. The reporter stated that, she was really skeptical of all jabs now and asked what they were mixing in with innocent sounding ones. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation for shingles were not provided.
Within about 10 min of vaccination,  patient reported feeling shaky, weak, nauseas, and was reported to be pale. His heart rate was 120. His blood glucose was 64.  Patient was admitted to the hospital for IV fluids with dextrose.
This spontaneous report was received from a licensed vocational nurse and refers to a 5 year old male patient. No information regarding the patient's medical history and concomitant medications was reported. On 11-SEP-2015 at 09_58 am, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) lot # K009891, expiration date 11-JAN-2016, subcutaneous in the right thigh (strength and dose were not provided). Concomitant vaccination included the first dose of KINRIX lot # reported as S4L2R, intramuscular in the left thigh. There was no illness at the time of vaccination. No adverse effects were reported. The patient was vaccinated at public health clinic/hospital and the vaccine was purchased with public funds. This is one of the several reports received from the same source. Additional information is not expected as all correspondence was received.
After patient  got vaccine  a few minutes later he fainted while sitting in chair and fell to the floor. He came back quickly. He stated he started to fill hot before he fainted. He said he was now  cold. Pt also said he was nauseated and felt clammy. WE eventually moved him to vaccination area to take blood pressure. While taking Blood pressure , he fainted again and was having seizure like symptoms(flailing arms, fit kicking and his head falling back) 911 was called.He came back quickly.  He was monitored at scene  by EMT. His blood glucose was 115 and initially they were only able to get systolic of 75. They removed him from pharmacy on stretcher and monitored him outside. His blood pressure was fine and they released him. He came back to the pharmacy and was fine
Redness around injection site, fever, chills, body ache, blistering around injection site.
Left facial weakness started 1 week after receiving Gardasil and Menactra. Started with sense of fullness on left side of face with left retroauricular pain and abnormal taste - seen with doctor ER. Treatment Acyclovir 200mg qd x 10 days and Prednisone 40mg qd x 2 weeks tape left eye shut q bedtime.  9/10/07 Received ER medical records of 7/25/07 from hospital which reveals patient experienced left sided headache, weakness, numbness, tingling & left facial droop upon awakening on 7/25/07.  Had left tongue numbness w/altered taste x 4 days prior.  Exam revealed prominent tearing of left eye, left facial weakness, weak left side smile & inability to completely close left eye or to wrinkle left forehead.  Tx w/eye patch, steroids & anti virals.  D/C to home from ER to f/u w/neurologist. FINAL DX: Left sided Bell's palsy. 9/18/07 Received vax record which confirms as reported & neuro note of 8/6/07. S/S had markedly improved but w/ mod left facial weakness.  Neuro DX: Post vaccinal idiopathic left sided Bell's palsy.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 01-JUL-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # M001200, dose, route of administration and expiration date was not reported). This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a physician via a company representative referring to a 17 year old female patient with anxiety, hyperandrogenism, Hashimoto's disease and penicillin allergy. The patient's medical history included ovarian cyst. The patient was not pregnant. On 11-APR-2016 the patient was vaccinated with the first dose of GARDASIL 9 (1 shot, intramuscular, lot# and expiration date unknown). Concomitant medication was not reported. On 13-APR-2016, 2 days after vaccination the patient experienced fatigue, headaches, shortness of breath and sore throat. The patient spoke with her pediatrician who recommended her to rest and increase her fluid intake. On unknown dates in 2016 the patient recovered from the events. Additional information has been requested.
Initial unsolicited report received from a non-health care professional on 16 June 2017. This case involves a 25-year-old female patient who was vaccinated with a dose of INFLUENZA VACCINE (Seasonal FLU SHOT) (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on 23 August of an unspecified year. Patient's medical history and concomitant medications were not reported. On an unknown date, 10 days following the vaccination, the patient had started experiencing neurological symptoms like not being able to eat without passing out, unable to walk without twisting and jerking movements of uncontrollable muscle contractions. It was reported that the symptoms "disappear" when she ran, she was able to speak normally and she was able to walk backwards normally. On an unknown date, doctors had diagnosed her with a rare neurological disorder - dystonia which was triggered after receiving the Flu shot. Laboratory investigations and corrective treatment were not reported. The patient was not recovered from events. This case was considered as serious by the reporter due to seriousness criteria persistent or significant disability or incapacity. List of documents held by sender: none.; Sender's Comments: Sanofi company comment dated 23-May-2017: Patient was vaccinated with FLU SHOT. Patient also experienced dystonia and associated symptoms which are unlisted with Influenza vaccine (unknown manufacturer) . The time to onset is compatible with the role of vaccine. Additional information regarding results of investigations (infectious work-up and cerebral work-up as EEG, MRI) ruling out alternative etiology, any seizure disorder, trauma, any infection needed for complete assessment of the case.
8 days after receive injection I developed a large lump under the skin in the upper left arm. On day 9, I developed a 3 inch diameter red and hot ring around injection site.
Patient developed a ~3.5 cm erythematous petichiae at the left antecubital fossa approximately 5 minutes after receiving the Pfizer vaccine. Pt admitted to itching; denied tongue swelling, sensation of throat closing, lip swelling.  Mom was advised to apply OTC Benadryl cream to area & monitor.  Mom advised if tongue/lip swelling, throat closing presents to take patient to ED.  Mom expressed understanding of above.  Patient was monitored for additional 10 minutes without other adverse event.
Patient confirmed that the tingling stared after the first dose and was able to do things; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Patient confirmed that the tingling stared after the first dose and was able to do things) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.  In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Patient confirmed that the tingling stared after the first dose and was able to do things). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Tingling, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Patient confirmed that the tingling stared after the first dose and was able to do things) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2021-305223.
Patient came in and said the area got larger each day (the red). It also got warm when I see her and about 4 inches long.
Pt.'s Husband stopped by to report that after pt.'s most recent flu shot. She experienced severe shoulder pain near the injection site. Pt. followed up with her doctor who diagnosed the issue to likely be from injection technique issues causing bursitis.
Temporary burning/itching at injection site; Temporary burning/itching at injection site; Headache; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Mar2021 at 13:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any vaccines within four weeks prior to vaccination. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), buspirone (MANUFACTURER UNKNOWN), escitalopram (MANUFACTURER UNKNOWN), naltrexone (MANUFACTURER UNKNOWN) and I (unspecified); all taken for unspecified indications from unknown dates and unknown if ongoing. On 10Mar2021 at 13:45, the patient experienced temporary burning/itching at injection site, headache and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events temporary burning/itching at injection site, headache and fatigue was resolving at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 10/13, one day after vaccination, developed cold symptoms. On 10/14, one time a day she would experience a cold sweat and a shooting pain from her shoulders down her back.  She described as a shock.  It causes her to tense up. It only lasts a few seconds and then subsides.
Patient was given 0.25mcg of Moderna Bivalent Booster not 0.5mcg. Wrong dose given.
PER PATIENT SHE WAS DIAGNOSED WITH GUILLAIN-BARRE SYNDROME. SHE HAD PAIN IN THE NECK, HEAD, BACK AND LEGS AND SHE WENT TO THE EMERGENCY ON 1/29/21. SHE WAS SENT BACK WITH THE MEDICATION. BUT THAT DIDN'T HELP SO SHE WENT AGAIN AND AFTER HER 3RD VISIT SHE GOT ADMITTED, AND TESTS WERE PERFORMED AND FINALLY A NEUROLOGIST DIAGNOSED HER WITH GUILLAIN-BARRE SYNDROME. sHE WAS HOSPITALISED FOR 2 WEEKS AND THEN PLACED IN REHAB AND PHYSIOTHERAPY. SHE IS FEELING OKAY NOW AND FINALLY DECIDED TO LET US KNOW ABOUT THIS. SHE THINKS VACCINE CAUSED HER ALL THE PAIN.
Insidious onset of debilitating lower extremity pain.  It has worsened over months to the point that medical assessments have been made without a definitive diagnosis found
"Pain in left arm/shoulder since receiving flu shot in left upper arm. Pain increases with some activities such as putting on bra or t-shirts, and hanging up clothes".
"Feel a little funny' "Had reaction first injection" seen by EMS @facility and released. Husband will drive her home. Patient felt better after 5 minutes with EMS Pt. released. Recorded by RN.
Moderate headache became a severe headache then moderate again and light. I mostly felt it on the back left side of my head. When it was severe, it felt like a sharp pain that made me wince. I took Tylenol once or twice a day and it helped. The headache was very intermittent - sometimes it was every few minutes, hours, and sometimes it was a few times within the same minute.
Caller stated he has had two positive tests for covid since 17Jan2022/  had the primary series of the Pfizer covid 19 vaccine on 18Jan2021 and 8Feb2021 and the booster 26Sep2021; Caller stated he has had two positive tests for covid since 17Jan2022/  had the primary series of the Pfizer covid 19 vaccine on 18Jan2021 and 8Feb2021 and the booster 26Sep2021; 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 69 year-old male patient received bnt162b2 (BNT162B2), administration date 26Sep2021 (Batch/Lot number: unknown) at the age of 68 years as dose 3 (booster), single, administration date 08Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date 18Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Verbatim: Hepatitis C" (unspecified if ongoing), notes: Verbatim: Hepatitis C, due to drinking during his younger years. The patient's concomitant medications were not reported. Vaccination history included: Flu shot (Caller also said he had the flu shot and the shingles shot.), for Immunization; Shingles shot (Caller also said he had the flu shot and the shingles shot.), for Immunization; Pneumonia shot (he completed getting the pneumonia shot), for Immunization. The following information was reported: VACCINATION FAILURE (medically significant) with onset 17Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 17Jan2022, outcome "not recovered" and all described as "Caller stated he has had two positive tests for covid since 17Jan2022/  had the primary series of the Pfizer covid 19 vaccine on 18Jan2021 and 8Feb2021 and the booster 26Sep2021". The event "caller stated he has had two positive tests for covid since 17jan2022/  had the primary series of the pfizer covid 19 vaccine on 18jan2021 and 8feb2021 and the booster 26sep2021" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Jan2022) positive, notes: the test was done on 17Jan2022 and the results came back on 19Jan2022; (26Jan2022) positive. Therapeutic measures were taken as a result of covid-19. The lot number for bnt162b2 was not provided and will be requested during follow up.
Expected symptoms - started about 12 hours after injection. Slight headache, slight body aches, slight fever 99, all gone within 12 hours.  Unexpected side effect: started 30 hours after injection. Severe ringing in both ears. Has continued for the past 6 months. (Since 5-9-21) On a scale of 1-12 ringing was 10-12.... 24 hours a day 7 days a week for the 6 weeks.  Then went down to 8-10, 24 hours a day 7 days a week. I've had no relief for almost 6 months, it is unbearable.  Ears are still ringing as of this day. (10-23-21)  It has ruined the quality of my life. From what I understand it may never go away. Don't know how I'm going to live with this. I have also lost my high pitch hearing from the vaccine.
I am magnetic at the site of injections; Objects sticking to me like scissors, butter knife, toe nail clippers, staples, coins, keys, and anything that is mostly stainless steel.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (I am magnetic at the site of injections) and STICKY SKIN (Objects sticking to me like scissors, butter knife, toe nail clippers, staples, coins, keys, and anything that is mostly stainless steel.) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stomach ulcer.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (I am magnetic at the site of injections) and STICKY SKIN (Objects sticking to me like scissors, butter knife, toe nail clippers, staples, coins, keys, and anything that is mostly stainless steel.). At the time of the report, VACCINATION SITE REACTION (I am magnetic at the site of injections) and STICKY SKIN (Objects sticking to me like scissors, butter knife, toe nail clippers, staples, coins, keys, and anything that is mostly stainless steel.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-194156 (Patient Link).
At 26 hrs. post injection:  At site - 2" x 1" red streak, hard lump same size, low grade fever, headache, light headedness - dizzy, low blood pressure with high heart rate. Began to take Benedryl  at 6 hour intervals and use ice pak at site.     Next day same symptoms - same treatment. On 3rd day, streak reduced to 1.5" x  3/4" same hard lump underneath, a pink area surrounding  streak about the size of small peach came up  - Still lightheaded-dizzy - no fever by 4th day. By 6th day, streak brown/black with brown surrounding area, still hard area.
Patient notice swelling in the wrist along with pain on arm of injection. Took Tylenol for 2 days and problems remained. Patient visited the doctor and doctor explain lymphoids were inflamed. and
Fever, body ache, arm sore 5-7 days took Motrin for ache. Cough at night x = 1 week.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 26-SEP-2014, the patient was vaccinated with PNEUMOVAX 23 lot # J004080, expiry date: 22-AUG-2014, intramuscular. No concomitant medication reported. On 26-SEP-2014, the patient was inadvertently administered a dose of PNEUMOVAX 23 which expired on 22-AUG-2014. No adverse effects reported. The outcome of she inadvertently administered a dose of PNEUMOVAX 23 which expired on 22-AUG-2014 and no adverse effects reported is unknown. There was no product quality complain involved. Additional information has been requested.
Within 24 hours of immunization, sharp pain and tenderness developed in left shoulder below where immunization was plaed; no fevers, feels well otherwise, no shortness of breath. Area 20x20cm tender to palpation around left arm; FROM at elbow and shoulder and no streaking notes; no nodes