chrisvoncsefalvay/vaers-outcomes huggingface dataset:
One family member who is dying today after being taken off the ventilator. The dying family member was vaccinated with the Pfizer vaccine; This is a spontaneous report from a Pfizer sponsored program CEP 159558.. A non-contactable consumer reported that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported.  Reporter was concerned about taking the vaccine, she has a few family members who took the vaccine and got sick afterwards and has one family member who is dying today after being taken off the ventilator. The dying family member was vaccinated with the Pfizer vaccine. Read beginning of ISI. Reporter disconnected, had to take a call from family member about dying family member. Will fax AE to report family members sick and family member dying after vaccine. Event onset date was 22Sep2021. It was not reported if Autopsy Done. The outcome of the event was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: One family member who is dying today after being taken off the ventilator. The dying family member was vaccinated with the Pfizer vaccine
Chills; Fever; This is a spontaneous report from a contactable consumer (patient). This consumer similar events for two patient (for himself and wife). This case is for himself. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported) via an unspecified route of administration on 13Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced chills and fever. Reporter stated, I just have some questions about side effects of your Covid vaccine about the side effects. Reporter wife and reporter received Pfizer vaccine and I know that some of the side effects are chills and fever. Reporter wife started experiencing chills and fever like 4 days after the vaccine and it's been gone after like 4 or 5 days and patient just wanted to know if it's something reported to you. The doctor is saying don't worry about it just treat the fever, you are fine, and I just like fine I don't think doctor is someone who knows about this vaccine. The outcome of the events was unknown.  No follow-up attempts are possible. Information about Lot/Batch number cannot be requested. No further information is expected.; Sender's Comments: Linked Report(s) :-PFIZER INC-2021326447 same reporter/drug/event, different patient
Pt. developed rash, nausea, chills, fever, inflammation around injection site 24 hr. after receiving ZOSTAVAX.
9/26/21: Patient arrived at the ER due to complaints of sore throat, cough, HA, myalgias, and urinary frequency x 09/22/2021. Pt tested positive on 09/23/2021 and is vaccinated against COVID.
Appendicitis; fearful of getting the booster shot; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (Appendicitis) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 008B21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 17-Aug-2021, the patient experienced APPENDICITIS (Appendicitis) (seriousness criteria hospitalization prolonged and medically significant). On an unknown date, the patient experienced FEAR (fearful of getting the booster shot). The patient was hospitalized from 17-Aug-2021 to 21-Aug-2021 due to APPENDICITIS. The patient was treated with Surgery (Had surgery on 19-Aug-2021 to have appendix removed) for Appendicitis. On 25-Mar-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. At the time of the report, APPENDICITIS (Appendicitis) had resolved and FEAR (fearful of getting the booster shot) outcome was unknown.            No Concomitant medication provided. No treatment medication reported.  Company Comment: This case concerns a 75-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected event of appendicitis. The event occurred 4 months and 25 days after the second dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since the event happened after the second dose. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.   This case was linked to MOD-2021-374276 (Patient Link).; Sender's Comments: This case concerns a 75-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected event of appendicitis. The event occurred 4 months and 25 days after the second dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since the event happened after the second dose. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.
6 hours after vaccine, developed rash around waist line, next morning woke up to itchy rash on back of head and neck, took Claritin. Next day, developing more small rashes, called Kaiser and was told to take Benadryl. Next morning woke up with more hives and had to go to ER because throat felt like it was closing. Given epipen, prednisone, prevacid . Sent home and symptoms worsened again so gave herself epipen before heading back to the ER.
had tinnitus in both ears; ringing in ears; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "Adhesives" (unspecified if ongoing), notes: Known allergies: Adhesives. The patient's concomitant medications were not reported. Past drug history included: Lidocaine cream, reaction(s): "Allergies: lidocaine cream", notes: known allergies: Lidocaine cream. Vaccination history included: BNT162b2 (Dose number: 2, Lot number: ER8731, Dose administration time=10:00AM, vaccine location=Left arm, brand: Pfizer), administration date: 08Apr2021, when the patient was 61-year-old, for Covid-19 Immunization; BNT162b2 (Dose number:1, Lot number: ER2613, Dose administration time= 12:00PM , vaccine location=Left arm, brand: Pfizer), administration date: 18Mar2021, when the patient was 61-year-old, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 12Oct2021 at 13:00, outcome "not recovered", described as "had tinnitus in both ears"; TINNITUS (non-serious) with onset 12Oct2021 at 13:00, outcome "not recovered", described as "ringing in ears". The events "had tinnitus in both ears" and "ringing in ears" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus, tinnitus.  Additional information:  Following the booster vaccination (3rd shot) I have had tinnitus in both ears. At the time I did not associate this issue with the vaccination as it was not listed as a possible adverse side effect. He tinnitus continued to persist. I visited my family physician in Jan when the ringing in ears had not stopped. I had a hearing screen performed by an audiologist in late Feb2022. Hearing screen showed no issues. There was no infection. My family physician has me scheduled for a visit with an ENT but I can't get in until Jun. The tinnitus is high pitched and borderline between uncomfortable and painful. I recently read an article and saw a news report indicating rare complaints of tinnitus and realized my tinnitus corresponded exactly with receiving the Pfizer booster shot. Patient has no covid prior vaccination and patient has covid tested post vaccination.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 26-year-old male. Neither medical history nor concomitant medications were reported. On an unspecified date in Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
Infant became listless, skin was pale, would refuse to eat.  On 9/11/14 developed fever, diarrhea, started having seizures.  Doctor gave Ativan (anti-seizure medicine), then infant stopped breathing, had to be revived.  Infant stopped breathing a number of times between 11pm and 3am.  Infant was intubated and transferred to ICU where infant was on oxygen support, blood pressure support.  Infant continued to have seizures for 24-48 hours after transfer to the hospital.  Infant also had a blood by-product transfusion as it was found her blood clot factors were low.  Once infant was stable, MRI scan was done, and brain injury as a result of "illness" was found.  Doctors ran all sorts of tests but could not find the cause of the injury/illness or explanation for injury/illness or seizures.  Infant has since recovered, but is on anti-seizure medication and will be monitored by PT/OT and neurologist to assess development as a result of the brain injury.
This spontaneous report as received from a Medical assistant refers to a patient of unknown age and gender. No concurrent conditions or medical history were described. On 30-JUL-2015, the patient was vaccinated with an improperly stored PROQUAD (Merck) (lot # K004860, expiration date 04-OCT-2015), (Dose, route and frequency were not described). No adverse effect was reported. No Product Quality Issue was described. Additional information has been requested.
This spontaneous report was received from a registered nurse referring to a 1 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 16-AUG-2017, the patient, at the age of 1 year old, received a dose of PNEUMOVAX23 lot # M037533, for prophylaxis (strength, route and expiration date were not reported). No adverse effects were reported.
11mins post vaccination, pt had a syncopal episode.  Pt reports that her vision blacked out and she had a "panic attack" Initial Vitals: BP 85/58, HR 64, RR 18, O2 Sat 98%.  Pt was given H2O and crackers.  Pt had not eaten before dose.  Pt recovered quickly.  No further difficulties, pt states she feels ok to go home. @14:09 pt to car via w/c.  Boyfriend waiting to drive home.  Recommended pt eat and drink adequately before next dose.  Pt stable and released from the vaccination site.
Muscle pain, fatigue, loss of appetite, nausea; between 11am-5pm  Treated with Acetaminophen, 1000 mg
This spontaneous report was received from a physician referring to 13-month-old male patient. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 30-MAY-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005274 and expiration date 03-APR-2018; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 25-APR-2017 until 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 54F for the period of up to 70 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA007325.
PATIENT RECIEVED MODERNA FOR SECOND DOSE, FIGURED OUT AFTERWARDS THAT PATIENT GOT PFIZER FOR 1ST SHOT
Presented with syncope, CXR with bilat infiltrates, + covid; also CHF and afib; Tx- Vit C, Vit D3, Decadron, lovenox, zinc; O2 @ 2 LPM, then down to room air by dc
mild flu-like symptoms; Mouth sores/ulcers; Mouth sores/ulcers; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection) intramuscularly on 03Feb2021 07:15 AM in left arm as dose 2 single for COVID-19 immunization at Hospital. Medical history and Concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE) intramuscularly in left arm on 13Jan2021 08:00 AM (at age of 32-year-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. It was reported that patient experienced mild flu-like symptoms, mouth sores/ulcers on 04Feb2021. No treatment received for the adverse events. The outcome of events was unknown.   Information on the lot/batch number has been requested.
33 weeks gestation.  sudden onset of upper abdominal pain, constant with palpable tenderness over b/l CVA, lower abdomen and upper abdomen.   urine and labs normal.  vitals normal, afebrile.  sent to L and D to monitor.  good fetal activity and cervix closed.  sx gradually decreased and was able to go home but today 1/11 still with diffuse tenderness, worse with activity and some braxton hix contractions.
Presumed myocarditis following the second dose of COVID-19 mRNA vaccine; Myocardial infarction; This is a literature report.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1; manufacturer unknown), for Covid-19 immunisation. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "Presumed myocarditis following the second dose of COVID-19 mRNA vaccine"; MYOCARDIAL INFARCTION (medically significant), outcome "unknown". Per previous case-report about vaccine-related cardiac complication, one patient experienced myocardial infarction with mRNA vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.    The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Extreme fussiness. He was screaming & crying & inconsolable for hours before finally falling asleep only to wake up every 20 to 30 minutes to start again. This went on for a week. I eliminated dairy from my diet after him all of a sudden having an issue with it after his 1 month vaccine. Breast milk seems to be the only thing he can digest ok. I've  tried several foods & his gut just can't handle them. He has seemed to be ok with sweet potatoes finally at 6 months. His digestive system seems to have been damaged by the vaccines.
Infant received 2 doses of Hepatitis B vaccine (Recombivax HB) in the hospital.
Developed lower lip swelling and tingling, later noted both lips and tongue felt swollen.  Mild itching of both eyes with drainage.  Symptoms improved after taking Zyrtec 10 mg.   Reports had also eate Indian food prior to receiving the vaccine, had never eaten Indian food in the past.  (Ist Influenza vaccine, Ist time eating Indian food).
Tinnitus.  Approximately 9 days after my first vaccine shot, both of my ears developed a constant ringing sound that continues as I report this today.   I have never had this issue before.  I am an extremely healthy individual.  I exercise vigorously.  I do not take any medication.  This vaccine caused Tinnitus and has been a big problem for me over the last several weeks including problems with sleeping and the mental/psychological aspect of dealing with the constant ringing 24 hours a day.
c/o nausea, h/a, arm pain, chest pain several hr p/vax;BP 104/80 pulse regular 80;pt had not eaten all day & class was being observed by principal;
lt upper arm devel a lump the size of a tennis ball, sore, swollen & sl pink;also neck is some, stiff & achy like flu;sx began 24hr p/vax;lump began to go down by 3 days & sl pink;
Patient appeared to faint. She said everything became black and then she came to. She apparently passed out but recovered extremely quickly. This occurred within 5 minutes of receiving the immunization. We provided her orange juice and observed her for another 20 minutes.
pfizer vaccine ( for patient 12 and over ) was given to patient under the age minimum, called father of the patient and he states pt isnt having any symptoms
After the first 10 minutes, vision blurry and anxious,  felt like she was going to pass out.  Pt unaware if she lost consciousness. then had emesis.  Appears pale and dry in oral mucosa.  1910.  Now with complaints of stomach cramps.  Drinking water.  Emergency team called and patient refused transport to ER.
A non-serious spontaneous report of 15-month-old received FLUMIST has been received from a health professional concerning a 15-month-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 24-Aug-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event was considered resolved. There were no late occurring adverse events. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
No additional adverse effect reported; Caller reported that a PROQUAD lot that underwent a temperature excursion was administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 17-AUG-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection as prophylaxis (lot number T037954 which has been verified to be valid, expiration date reported and validated as 09-MAY-2022) (dose, frequency, route of administration, and anatomical site of injection were not reported). The administered dose of the vaccine was stored at a temperature of -10 degrees Celsius (C) to 8 C (-5C), during a time frame of 0 hours 15 minutes and 0 seconds (product storage error). There was no previous temperature excursion. No additional adverse effects were reported in the patient.   This is one of two reports received from the same reporter.
BLOOD CLOTS; This spontaneous report received from a consumer via a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, start therapy date was not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots and had surgery to remove blood clots. It was reported as "Horrible company! My family member just got its COVID vaccine and just had surgery to remove blood clots". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221059477-Blood clots. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Child broke out with facial hives the same evening the vaccines were administered. According to the ED report the reaction was mild and could have been a result of an allergic reaction to his vaccinations. Child was given a prescription for Prednisolone 4 mg PO Q 8 hr for 2 days.
Pt complained of HA ~ 20 min after shot. I took her BP and it was elevated. She also told me that the Dr recently increased her BP med recently and she forgot to take. I took her BP several times over the next 30 min and it seems to decrease 159/100 was her last reading. -later that night she still said it was elevated.
Chills for 2-3 hours of duration following 5 hours after vaccination, nausea, The following morning: 10/10 non-radiating chest pain of pleuritic feeling, tingling in limbs, syncope, SOB Tachycardia(108 bpm)
Live virus vaccine (MMR and Varicella) was given by mistake to a pregnant woman.
Patient 1st dose was Pfizer-COVID 19 and for second dose, Moderna COVID-19 was inadvertently administered by the nurse.
Mom reports hives at injection site, diaper area, foot.  Still with hives 5 days later.
Inner body inflammation flare up and terrible body pains - the worst is my opposite shoulder and neck from where I got the vaccine has been very sore and I have trouble sleeping or getting things done from the pain of the flare up. I?ve been taking NSAIDs to help with the inflammation and pain and soaking in salt baths but it is mildly helpful. I felt this pain about 5 minutes after the vaccine and it has not gone away since. I saw my primary care doctor and she recommended I report this as an adverse event.
fever 102 7-10 days on & off-very fussy; no relief w/APAP; MD will give Acell DTP @ 18 months;
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious.