chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ED Note: 84-year-old male with past medical history of multiple myeloma, CKD, squamous cell carcinoma of the lung (diagnosed in 2008 status post left upper lobectomy), clear cell carcinoma of the kidney (diagnosed in 2009 status post left nephrectomy),  and anemia presented to the emergency room complaint of shortness of breath.  He states his symptoms began 1 week ago.  He states initially started off as a cough which was mostly dry, occasionally productive with clear sputum.  He states he then began to experience some shortness of breath which she described as trouble catching his breath, and states worse with exertion.  He states last week he was having some chills and myalgias.  He went to the drugstore on Wednesday, 9/1/2021, and tested positive for Covid.  He denies any trauma, injury or fall.  Denies any fevers, headache, vision changes, eye pain, neck pain, back pain, chest pain, palpitations, lightheadedness, dizziness, syncope, hemoptysis, abdominal pain, nausea, vomiting, diarrhea, dysuria, hematuria, extremity numbness or tingling, or focal weakness.
1- Pfizer vaccine on 4-14-21 @10am monitored family clinic. 2-Thursday 4-15-21 Acute febrile events at 1pm temp 40 degree C. Altered mental status, went to ER.  work up included CSF-NL, D/C's on 4-18-21
Patient was given Oral Typhoid started his first dose on April 23rd, second dose on April 25th, and third dose on April 27th. Shortly after taking his third dose of ORAL TYPHOID he developed a raise rash on his extremities and chest. His face was slightly flushed. Treated with 3 days of Prednisone.
has lump in arm starting day after vaccination and continued for about a week post vaccination. Was tender when applied pressure to spot. No redness
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 10Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: "GERD" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ammonia, reaction(s): "Known Allergies: Ammonia when inhaled", notes: ammonia when inhaled. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml).    No concomitant medications were provided. No treatment medication was provided. This case contains information for the 4th of 17 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-707980 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707980:Case for patient 1
Shortly after patient received vaccine, she became pale, said she felt dizzy and nauseous.  She requested an ice pack while sitting down.  After 5-10 minutes she was feeling better and looked less pale.  She then left office.
Faint metallic bitter sensation on the back of palette/tongue/sinus area; This is a spontaneous report from a non-contactable consumer, the patient. A 54-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep6955) via an unspecified route of administration on an unknown date in Apr2021 (at age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included hyperthyroidism, hyperpigmentation skin, penicillin allergy and yeast infections. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Apr2021, immediately after being injected, the patient felt a faint metallic bitter sensation on the back of the palette/tongue/sinus area. Although it was not an adverse reaction, it had been 25 hours after it began at the time of reporting and nothing had alleviated the sensation. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event of metallic taste was not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Hospitalization/death due to COVID-19 Reported per Pfizer COVID-19 Vaccine EUA
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 as dose 5 (booster), single (Lot number: GJ6665) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High; SARS-CoV-2 test: Positive, notes: positive test days after feeling better; negative, notes: Increase in Covid symptoms and positive test days after feeling better and testing nearly negative. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
12 hours after shot started chills, body aches, severe headache. 24 hours after shot, same conditions, with nausea. 48 hours after shot same conditions, with vomitting.  Unable to eat or drink and would just throw it up. 72 hours, severe headache, extreme light and sound sensitivity, nausea. 96 hours finally starting to feel better.  Mild symptoms, such as slight headache, weakness.
Following immun last yr, 74 yo consumer became disoriented as to place. This remained for 3 days. Had rec'd the vax six yrs consecutively w/o a problem.
pt felt lightheaded & hot w/in 5 mins of receiving vax;  also pale; VS 810AM BP 68/40 P88; 812AM BP 90/60 P80; 814AM BP 94/60 P72;
I started feeling heart palpitations 3 days after my second shot. Yesterday, I took my blood pressure at home and it was 177/91.
Per patient, he had to go to hospital emergency room and was given iv fluids because there was sodium lost. He also stated that he was there for about 3 days.
elevated SGPT level after having two hepatitis B vaccine.  no symptoms. labs drawn for other reasons
Hives on face, legs, feet, and hands. 3 days later, hives are still appearing periodically throughout the day.
Patient received Moderna vaccine 10/01/2021 as the 3rd dose. the first two doses where Pfizer.
I was given the shingle vaccine on the 16 of April and my niece came down with chicken pox that same week and was hospitalized. My niece is 54 years old and has Down Syndrome she has a weak immune system I had no idea she was in danger of getting the disease just thought you should know.
a little bit of pain; she has her arm in which she received the vaccine warm to the touch; he has her arm in which she received the vaccine red; she has her arm in which she received the vaccine tender; she has her arm in which she received the vaccine swollen; a little bit of pain; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of PAIN (a little bit of pain), VACCINATION SITE WARMTH (she has her arm in which she received the vaccine warm to the touch), INJECTION SITE ERYTHEMA (he has her arm in which she received the vaccine red), INJECTION SITE PAIN (she has her arm in which she received the vaccine tender) and VACCINATION SITE SWELLING (she has her arm in which she received the vaccine swollen) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041CZ010D) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arthritis since an unknown date. Concurrent medical conditions included Seasonal allergy (Patient is taking allergy medicine  for seasonal allergies.). Concomitant products included NAPROXEN for Arthritis.   On 05-Feb-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) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced the first episode of PAIN (a little bit of pain), VACCINATION SITE WARMTH (she has her arm in which she received the vaccine warm to the touch), INJECTION SITE ERYTHEMA (he has her arm in which she received the vaccine red), INJECTION SITE PAIN (she has her arm in which she received the vaccine tender), VACCINATION SITE SWELLING (she has her arm in which she received the vaccine swollen) and the second episode of PAIN (a little bit of pain). At the time of the report, VACCINATION SITE WARMTH (she has her arm in which she received the vaccine warm to the touch), INJECTION SITE ERYTHEMA (he has her arm in which she received the vaccine red), INJECTION SITE PAIN (she has her arm in which she received the vaccine tender), VACCINATION SITE SWELLING (she has her arm in which she received the vaccine swollen) and the last episode of PAIN (a little bit of pain) outcome was unknown.            No treatment information provided.
hives at night under his arm pits/ on legs; This case was reported by a consumer via call center representative and described the occurrence of hives in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (received 1st dose on 13th Juanuary 2020, refer case US2020121792).   On 22nd June 2020, the patient received the 2nd dose of Shingrix. On 29th June 2020, 7 days after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional information was provided as follows: The patient developed hives at night under his arm pits and on his upper legs. The reporter stated the hives disappear in the morning but come back at night and this was still happening at the time of reporting and asked if this was normal side effect. The reporter did not consent to follow up. Caller refused to give the HCP's contact information. She stated she would call herself.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020121792:same patient
Patient fell in the parking lot when we left the docors office. She became flushed and purple and fainted and shaking. She was drug back into the clinic by Me, her mother. Ambulance came and took her to hospital for monitoring.  Patient has extremely healthy  diet and fitness habits and ha a full breakfast and plenty water pror to vaccine.
a 5 years old female received a 0.5 ml dose of Fluzone Quadrivalent vaccine in her inner thigh instead of the deltoid muscle/No AE; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a five years old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] in her inner thigh instead of the deltoid muscle lot number and expiry date not reported via unknown route on 16-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) on 16-Oct-2019.  It was an actual medication error due to vaccine administered at inappropriate site.  There were no side effects reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive  and Module VI of the  Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
-04/13/20- Mood swings (Crying on-and-off, depressed mood) -04/12/20- Fatigue and soreness in arm
Pt recv vax on 12/22/98; on 12/27/98 pt exp muscular weakness, loss of muscle tone & mass, fatigue
Fainted; This is a spontaneous report from a contactable consumer (patient). A 13-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 13-years-old via an unspecified route of administration, administered in arm right on 22May2021 10:30 (Batch/Lot Number: EW0185) as 1st dose, single dose for covid-19 immunisation. Medical history included seasonal allergy and known allergies: lactose intolerance from an unknown date and unknown if ongoing. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and ascorbic acid (VITAMIN C); both taken for an unspecified indication, start and stop date were not reported. The patient fainted within 5 minutes of receiving Pfizer Covid-19 vaccine on 22May2021 10:45 (as reported). The patient recovered from the event on an unspecified date.
her tongue was going numb/mouth was going numb; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE SINGLE for covid-19 immunisation. Medical history included hypersensitivity. Concomitant medication included diphenhydramine hcl (DIPHENHYDRAMINE HCL) taken for an unspecified indication, start and stop date were not reported. It was reported that a few minutes after taking the vaccine her tongue was going numb. Today it's still the same but also her mouth was going numb. The outcome of the event was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Vomiting; Chills; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of   in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Dialysis (Patient has to regularly do dialysis.). Concurrent medical conditions included Blood pressure, High cholesterol and Potassium high.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol increased: High. On an unknown date, Blood potassium: High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications for blood pressure, high cholesterol and high potassium was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689916 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow up received, updated Case narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689916:Master case MOD-2022-689916
Low grade fever of 100 occurred at 3:00 pm on 4/11/16. Child went to sleep fine.  Next morning no fever (4/12/16) however by 3:00 pm low grade fever once again.  Went to bed at 8 pm and woke at 11 pm with a temp of 105.  Administered infant Motrin, temp went to normal after an hour but went back up to 105 in three hours.  Day 3, 4/13/16, temp of 103 sustained throughout the day.  No rash yet.
Received the Pfizer vaccine; she may have tested positive for Covid; Received the Pfizer vaccine; she may have tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 48-year-old female patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EP6955, Expiration Date: 30Jun2021), in left arm, on 14Apr2021 as dose 2, single (Lot number: EP6955, Expiration Date: 30Jun2021), in left arm and on 08Dec2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing). Concomitant medication(s) included: NORTRIPTYLINE taken for migraine. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Received the Pfizer vaccine; she may have tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she may have tested positive for Covid.  Investigation result received on 31May2022. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EP6955 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EP6955, fill lot EP6954, and the formulated drug product lot EP6953. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
In 2012 patient experience spotty hair loss almost immediately after vaccines.  End of August/first of September patient's hair began to fall out again - he presented with alopecia areata By October the hair loss has worsened.  Since this is patient's second reaction after some form of Tdap I wanted to report. The hair loss may be due to vitamin deficiency, but time relationship to vaccines is questionable.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were inadvertently vaccinated with improperly stored doses of GARDASIL 9 (dose and route were not reported, lot # L016428, expiry date 27-JUL-2017). Concomitant medications were not reported. No adverse reactions were reported. This is one of several reports received from the same reporter. Additional information has been requested.
No adverse events were reported.  Reporting for vaccine administration error.  Vial was not left out of refrigerator for 30 minutes before diluting and administering.
This spontaneous report as received from a other health professional refers to a patient of unknown age with prophylaxis. On an unknown date the patient was vaccinated with VARIVAX lot # N002204 for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT). On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX.; Sender's Comments: US-009507513-1707USA011165: