chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant refers to unspecified patients of unknown age and gender. There was no information on concomitant medications, medical history and concurrent conditions. On unknown dates, unknown number of patients were vaccinated with improperly stored ROTATEQ (Lot# M018957 with expiry:22-NOV-2017, Lot#M019691 with expiry:02-NOV-2017, dosing details not provided) for prophylaxis. The vaccine was stored at a temperature below 36F (2C) but above 32F (0C) (33F) for 46hours 30 min. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA001864.
Headache, Myalgia, Arthralgia & Diarrhea Narrative:  Other Relevant History:
previously healthy, admitted for left vertebral artery dissection, hypertensive emergency on 6/14/21
Laryngitis - lost voice. Tight feeling. Sore throat (burning). Missed 2 days of work (RN). No fever, no shortness of breath, no wheezing, no cough.
ON 5/5/21 A 17 Y/O MALE RECEIVED MODERNA BRAND VACCINE AT A DIFFERNT PHARMACY. PER PROTOCOL WHEN THEY CAME TO OUR LOCATION ON 8/2/21 WE FOLLOWED PROTOCOL AND GAVE MODERNA ALSO. THEY UNDERSTAND THEIR SERIES IS COMPLETE
Estimated due date: 06/02/2021 I woke up and my underwear was completely wet. Not urine. My husband is a doctor and he examined me and suggested me to go to the ER Labor and Delivery. The OB that was there examined me and said it was fine and that I might lose a little more (amminiotic fluid)  and to just observe and let them know in case I lost much more. I went to the Labor and Delivery at the hospital. Had lost s little more after that but that is it.
A report was received from a health care professional on 11/22/02, concerning a group of vaccinees less than 4 years old of unknown demography who inadvertently received Fluvirin from approximately 11/07/02 onwards. There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update (1) 12/10/02: A follow up report was received by a health professional indicating that a 21 month old male vaccinee was inadvertently administered Fluvirin intramuscularly on 11/12/02. Cross reference with: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200863, PJP200200864, PJP200200865, PJP200200866, PJP200200805, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP200200875, PJP200200876, PJP200200877.
arm soreness; lightheaded; general weakness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), DIZZINESS (lightheaded) and ASTHENIA (general weakness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), DIZZINESS (lightheaded) and ASTHENIA (general weakness). At the time of the report, PAIN IN EXTREMITY (arm soreness), DIZZINESS (lightheaded) and ASTHENIA (general weakness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported.
pain spread into to shoulder and neck; pain spread into to shoulder and neck; Constant throbbed pain at injection site; Constant throbbed pain at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jul2021 (Lot number: Ew0172) at the age of 30 years as dose 2, single for covid-19 immunisation.   Relevant medical history included: "allergies: Shellfish" (unspecified if ongoing); "allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: IRON; FLUOXETINE. Vaccination history included: Bnt162b2 (Dose 1, single, lot Number: Ew0178, Administration date and Time: 23Jul2021 04:45 PM, vaccine location: Left arm, Pain at the injection site that lasted from 23Jul2021 to 20Aug2021 .), when the patient was 30 years old, for Covid-19 Immunization, reaction(s): "Pain at the injection site".  The following information was reported: ARTHRALGIA (non-serious), NECK PAIN (non-serious) all with onset 23Jul2021 17:00, outcome "not recovered" and all described as "pain spread into to shoulder and neck"; VACCINATION SITE PAIN (non-serious), PAIN (non-serious) all with onset 23Jul2021 17:00, outcome "not recovered" and all described as "Constant throbbed pain at injection site". Therapeutic measures were not taken as a result of arthralgia, neck pain, vaccination site pain, pain.  Additional information: The patient received no other vaccine in four weeks. Patient did not have covid prior vaccination and was not tested for covid post vaccination. The device timestamp was 05Sep2021  No follow-up attempts are possible. No further information is expected.
She got Omicron; She got Omicron; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 44-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "kidney problem" (unspecified if ongoing), notes: She has kidney and heart problems; "heart problem" (unspecified if ongoing), notes: She has kidney and heart problems. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "She got Omicron". The patient underwent the following laboratory tests and procedures: Blood test: damper on her heart and kidneys, notes: Omicron put a damper on her heart and kidneys that showed up on bloodwork; COVID-19: Positive, notes: she had Omicron really bad. Clinical course: Report 3 of 3 on caller's daughter. Caller doesn't know if she is in the right spot. She got the last booster, the 2nd booster of Omicron/something and had horrible side effects. She has called on the last 3, every time she got one she called to tell us side effects. During report caller states her daughter has a lot of problems. She has kidney and heart problems, has 4 kids, has EDS and just a lot of problems. She got Omicron variety and had gotten all her shots except the 2nd booster. Omicron put a damper on her heart and kidneys that showed up on bloodwork. Doesn't have details of the vaccines. Has reported on her in the past and she is 43. Had originally called and asked why it would bother her kidneys so bad, it made her hurt more. Had the Pfizer Covid 19 vaccines but not the last one because they told her to wait. She doesn't know if it's because she got Covid. Is that true you build immunity? Her daughter said she has so much built up, she had Omicron really bad. She felt like passing out and wanted to sleep and sleep and sleep. Caller states it affected it kidneys and heart after getting Omicron. She had 3 Pfizer Covid 19 vaccines. Does have where her right leg turns purple due to her heart, and they did blood work. She went to the hospital when she had Covid and the tests found it was affecting her heart and kidneys and showed damage to both.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: A contributory role of BNT162B2 to event She got Omicron cannot be excluded based on temporal association and available information.,Linked Report(s) : US-PFIZER INC-202201246587 same patient, different vaccine dose/events;
fever & chills, aching in back, shoulders, legs, ankles & site of inject; began 11MAY93; >10 yrs since last Td;
This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine have undergone several temperature excursions and was administered to the patient), PRODUCT TEMPERATURE EXCURSION ISSUE (refrigeration excursions identified) and NO ADVERSE EVENT (No adverse event) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if patient had ever been diagnosed or tested positive for COVID-19.     On 21-Sep-2022 at 1:51 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 21-Sep-2022 at 1:51 PM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine have undergone several temperature excursions and was administered to the patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (refrigeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine have undergone several temperature excursions and was administered to the patient), PRODUCT TEMPERATURE EXCURSION ISSUE (refrigeration excursions identified) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccine have undergone several temperature excursions and was administered to the patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (refrigeration excursions identified).    No concomitant medications were reported.  Vaccination site was deltoid muscle. Dose/volume reported 0.5.    No treatment medications were reported.
got sick; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 26-Nov-2020.  This case involves a patient of unknown demographics who got sick for a week 10 years ago and never had one since (illness), while she received INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route on unknown site of administration for prophylactic vaccination.  On an unknown date, (Unknown latency) the patient reported getting sick for a week 10 years ago and never had one since (illness) (non-serious) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.   It was not reported if the patient received a corrective treatment for the event.  The patient had recovered from the event, at the time of reporting.  There will be no information available on the batch number for this case.  No further information was reported.
Extremely sore arm, swollen arm, dizzy, fatigue, headache, muscle pain
Patient said that her toes started going numb. It left like both her feet was in ice water. The pain then went to her knees. Someone had to help her get to her car, When she  got home she started having a headache and her vision got blared. The next day when she got up for church she was feeling fatigue and her had started swelling. She has been talking with a lift like her tonged is swollen.
Treated for ear infect OCT91 temp elevation continued w/no known source; blood culture 11OCT91 h. Influenzae B;
stage-3 chronic kidney disease; This is a spontaneous report from a contactable consumer, the patient. A patient of unspecified age and gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: UKNOWN) via unspecified route on 08Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) on 15Jan2021 as a single dose for COVID-19 immunization. Two days after the second dose (10Feb2021), the patient went in for routine blood test that he/she has taken every year. Patient never had a problem with kidneys before, it had always been normal, but 2 days after that vaccine, the patient had abnormal reading on kidney that put him/her in a stage-3 chronic kidney disease (10Feb2021). Then doctor sent the patient for an ultrasound (unspecified date). There was nothing wrong with kidney, not even a tiny little cyst. Patient inquired if the vaccine can possibly interfere with blood test specially kidney function. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
cranky, petechial rash, mottled appearance x 24hrs; seen in ER for tests; no tx;
02/15/2023 I started feeling unwell and noticed a rash on my left hip and my left buttock. I also noticed that I did not have any feeling in my left groin area. I carry the Zoster virus and believe that I had a Zoster flare up caused by the COVID-19 vaccine. Prescribed VALTREX; azelastine eye drops for conjunctivitis. I continue to have no feeling in my groin.
Red, sore, and itchy at injections site. There is a white bullseye area where vaccine was injected.
Patient is fully vaccinated. COVID +. Hospitalized for 18 days. 65yor presented from goup home after having respiratory sx; on presentation states sx have been present for 3 days with associated non productive cough; denies any recent exposure. CXR: Patchy multifocal bilateral pulmonary opacities consistent with atypical pneumonia such as Covid pneumonia. completed remdesivir, steroids. Pt intubated after remdesivir completed. Pt developed septic shock, circulatory shock, Acute renal failure.  Pt expired.
28FEB99 pt devel rash on face & neck;face became swollen & exudate;fever 1MAR99 (temp not taken);inj site was fine;no swelling or redness or rash;May have been exposed to poison oak;went to PMD, given pred;
Patient was given wrong vaccine. Wrong vaccine given was Kinrix.  Mother notified of this. No adverse side effect noted.
I was experiencing on and off earache pains. I was put on steroids and doctors couldn't tell me what it was. I went for a second visit.
This solicited report has been received from a 55 year old male patient enrolled in a study. The patient's concurrent condition, historical conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with dose of Pneumovax 23 (dose, route and anatomical location were not reported) for prophylaxis. On an unknown date, he had gotten sick after taking the shot. The outcome of event was unknown. Action taken with the therapy was unknown (not applicable). The causality between the event and Pneumovax 23 was not reported. Additional information is not expected as the reporter did not consent for further follow up.
The following is all per father's report to the Public Health Department. Some information verified by a Health Information Network.  On 10/7/22, child presented to a local ED with his parents reporting child had been having an intractable headache, nausea, vomiting for the past week. Onset was 9/30/22.   Per the father, a CT scan was done which was negative. Child was given pain medicine and anti-nausea meds and felt better. All blood work that was done was normal.  MD told father it was likely viral.   On 10/10/22, father took child to chiropractor for continued headache and child saw some pain relief.  Throughout the next couple of days, the child started having BUE tremors, balance issues, BLE weakness, chills and diaphoresis.   On 10/14/22, father took child to PCP office due to worsening symptoms.  PCP sent father and child to a hospital for evaluation.   Child was evaluated by ED and admitted to the hospital on 10/14/22 for a work up.  Father reports the medical team did not know what was wrong with his son but over the weekend of 10/14-10/16 , child developed bladder/bowel incontinence.  Father reported to Public Health Department that all blood work was coming back normal but they did do a MRI of head and spine on 10/16/22 which showed his body attacked itself and created an autoimmune response that caused lesion development through his spine and two lesions on his brain.  Steroids' were started and father reports they began to see improvement in his symptoms.  Father was told by the MD that he could not rule out the possibility that this inflammatory response was caused by the vaccinations received but the father felt they did.  Child was hospitalized for a week and discharged home.
Patient received vaccination, nothing abnormal.  Woke up the next morning and her arm (deltoid area) was red, warm, painful and difficult to move.  I checked on her everyday and the redness and warmth faded after 5 days, but the pain with movement is still there.
Pt recvd DTP/HIB 12AUG92 mom had given APAP prior to vax; approx 4 hrs following vax pt became listless, almost lifeless; temp elevated to 103 ax; next day extreme irritability, long periods of crying;PE revealed redness in throat & TM ears
DIZZINESS, NAUSEA AND SWOLLEN TONGUE, PASSED OUT FOLLOWED BY SUBSEQUENT SEIZURES (MULTIPLE) OVER 48 HOUR PERIOD.  HOSPITALIZED FOR 72 HOURS (3 DAYS)  12/03/09 MR and DC summary received for DOS 11/12/09. Final DX: Vasovagal syncope with increased stress and depression  Pt presented with syncope and seizure like episodes.  On examination: pseudoseizures, dehydration, and leukocytosis.
Strong Headache; Non-stop shivers; Fever; Body aches (muscular); diarrhea; dose number=3; dose number=3; This is a spontaneous report from a contactable consumer. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 29Sep2021 12:15 (at the age of 30 years) (Batch/Lot Number: EW0217) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient had no medical history. Concomitant medication included influenza vaccine inact sag 3v (FLUCELVAX) taken for immunisation from 28Sep2021 to 28Sep2021. The patient previously took BNT162B2 DOSE 1 on 20Jan2021 (lot: EL3247) and DOSE 2 on 08Feb2021 (lot: EL3247); (at the age of 29 years) via intramuscular route for COVID-19 Immunization. The patient experienced strong headache, non-stop shivers, fever, body aches (muscular) and diarrhea on 29Sep2021 21:00. Therapeutic measures were taken as a result of the events (Tylenol, Advil and Dexamethasone). The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
at the time of the injection she had leakage at the site and thinks she did not get the whole amount of the vaccination; at the time of the injection she had leakage at the site and thinks she did not get the whole amount of the vaccination; bruise on that arm where she received the COVID-19 Vaccine; This is a spontaneous report from a contactable nurse. A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 08Feb2021 (Batch/Lot Number: EM9810), at the age of 73-years-old, as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as dose 1, single for COVID-19 immunization. The patient had second dose of COVID-19 Vaccine two weeks ago today (at the time of report). The patient had no reaction to the second COVID-19 Vaccine. At the time of caller's injection, the nurse administering the COVID-19 Vaccine said "oops" or "uh oh" and stated there was leakage at the injection site. The nurse cleaned the site with alcohol and caller noticed there was no blood on the alcohol pad. She has been thinking over the past two weeks that she clearly didn't receive the whole amount of the COVID-19 Vaccine. She still has a bruise on that arm where she received the COVID-19 Vaccine. The bruise in 1.5 inches vertically and 1 inch horizontally. She wanted to know should she be concerned if she didn't get the full amount of the COVID-19 Vaccine and should she be tested for antibodies to see if she has full immunity. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Onset of severe stuttering, holding his face in his arm and using a large amount of diaphragmatic force/exertion to complete a word.  Jumping up and down during occasionally to get a word out. Frustration was evident and this has continued for the last two weeks. Usually worse during times of excitement, nervousness.  He has begun crying now during these episodes, stating "I can't talk".  No treatment has occurred yet but referral has been made by our pediatrician to speech pathologist.
Dizziness, Chills, Diarrhea Nausea Weakness, Tiredness
got the shot had shingles/suspected vaccination failure; had shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, 3 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the shot had shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 17-Mar-2023 The case was received from the patient via interactive digital media. The patient got the shot and then 3 years later had shingles. The patient mentioned that if they were any worse he/she would not made it. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.