chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had a menstrual flow on 12/30/2020 and 12/31/2020 that was heavier than I?ve ever experienced. This was particularly abnormal because I had already had my period from 12/08/2020 through 12/18/2020. The length of which isn?t abnormal because they are usually long but light, due to utilizing my birth control to have only a single period every three months. Then, it seemingly disappeared until 01/06/2021 and 01/07/2021 when I experienced some spotting, but then on 01/08/2021 I had a normal amount of flow for a regular period that appeared to stop before I woke up on 01/10/2021. As of today 02/13/2021 I have yet to experience more bleeding.
Either that evening or the next evening she developed an itchy, rash across her back; her body felt like it was on fire; Initial information was received on 02-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a 37-year-old female patient who had developed an itchy rash across her back (rash pruritic) and her body felt like it was on fire (feeling hot), after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.    On 30-Jan-2019, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious itchy rash across her back (rash pruritic) and her body felt like it was on fire (feeling hot) (Either that evening or the next evening) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported "The caller is requesting the ingredients for FLIBLOK of the 2019/2020 flu season. She said that she had a reaction to it. The caller stated that she received Flublock Quad on 1/30/2019. Either that evening or the next evening she developed an itchy, rash across her back and her body felt like it was on fire. Those symptoms resolved in less than a day. The rash was not treated. She does not have a Lot # or exp date for the product. She would like to obtain a flu vaccination this flu season and would like the ingredients."  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the patient was recovered from both the events.
Outcome: unexpected/unexplained death Had first dose Moderna Vaccine 3/31/21. She described body aches and mild fever ? ?like I had COVID again for a day? ? lasting about 36 hours, and then felt fine.  Had dose # 2 Moderna vaccine about 6:50 PM at Community vaccination site. She was driver, received left deltoid injection from Doctor. During observation period reported no symptoms, was happy and talkative with family and staff.  Family reports later that evening she did not feel well ? ?just not hungry? and wanting to lie down. Slept well, then woke up feeling better except for left arm achiness at injection site. Did not report redness, rash, or any difficulty breathing. Was talkative, walking around, took a shower, and was planning to drive to the grocery store later that day.  Mid morning ? maybe beginning about 11 AM, family said she went in and out of bathroom several times. She told them she had vomited three times and was feeling shaky. Her oral temperature was 101.3.   About 1:30 PM, she was in her room and called out for her mother. When family went into the room, she was shaking ?like she was having a seizure? and then her eyes rolled back and she fell to her side and stopped breathing. Family called 911 and started CPR. CPR was continued by EMT?s once they arrived, but they were not able to resuscitate her.
rapid heartbeat; fever; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (rapid heartbeat) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced PYREXIA (fever). On 07-Feb-2021 at 3:00 AM, the patient experienced PALPITATIONS (rapid heartbeat). At the time of the report, PALPITATIONS (rapid heartbeat) and PYREXIA (fever) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/3/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/3/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA
About 5 minutes after injection, patient complained of itching in throat and began coughing. No rash or reaction was visible at injection site. Patient used an albuterol nebulizer to help with breathing until EMS arrived. Patient was also given 50mg diphenhydramine po while waiting for EMS as she did not want Epinephrine injection.
Dry throat, deep cough, headache, dizziness, swelling above left eye lid, pain at application site, loss of appetite, hot and cold flashes.
Client came in to receive a second dose of Covid vaccine. The first dose was received at Medical Center on 4/22/21. They are no longer administering the vaccine so she was instructed to come receive her second dose. During both screening and vaccine administration it wasn't  noticed that it two days too early to receive it so the dose was given.
Pain in liver area; fatigue; Arm pain; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 10:00 as dose 4 (booster), single (Lot number: GH9702) at the age of 62 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: METOPROLOL; LOSARTAN; AMLODIPINE; PANTOPRAZOLE. Vaccination history included: BNT162b2 (Dose 1, Single, Batch/Lot No: EP6955), administration date: 18Mar2021, when the patient was 60-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, Single, Batch/Lot No: ER8731), administration date: 15Apr2021, when the patient was 60-year-old, for Covid-19 immunization; BNT162b2 (Dose 3, Single, Batch/Lot No: FE3594), administration date: 16Dec2021, when the patient was 61-year-old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 22Sep2022, outcome "unknown", described as "Arm pain"; HEPATIC PAIN (non-serious) with onset 22Sep2022, outcome "unknown", described as "Pain in liver area"; FATIGUE (non-serious) with onset 22Sep2022, outcome "unknown". Therapeutic measures were not taken as a result of hepatic pain, fatigue, pain in extremity.  Additional information: Facility type of vaccine was reported as Pharmacy or Drug Store. Patient did not received any other medication within four weeks. Other medications in two weeks included: Metoprolol, Losartan, Amlodapine, Pantoprazole, Si. Patient did not had Covid-19 prior to vaccination. Patient did not tested for Covid-19 since vaccination. Patient does not have any known allergy. Treatment was not received.  Follow-up attempts are completed. No further information is expected.
sore arm; chills; nausea; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in an 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in arm, chills, nausea and diarrhea. On an unknown date, the outcome of the pain in arm, chills, nausea and diarrhea were unknown.   It was unknown if the reporter considered the pain in arm, chills, nausea and diarrhea to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The patient experienced sore arm, chills, nausea and diarrhea after receiving the Shingrix vaccine. The patient provided the consent to follow up.
started out with severe headaches , then started getting out of breathe,  which became really intense , admitted to emergency on 5/13/21  released 5/21/21 with mini heart attack and multiple blood clots in the lungs.  No blood clots in the legs  which would have been from the estrogen pill. Oncologist stated that the clots form in the legs if from the estrogen pill, this formed in both lungs. Been on the tamoxopine for over a year and no side effects at all. Headaches and breathing issues all started after the vaccine
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.  No Medical History information was reported.On 04-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients). On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) had resolved.For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Concomitant medication of the patient was not reported. No treatment information was provided by the reporter.It was reported that that some patients who received the expired vaccine had reported flu-like symptoms after receiving the vaccination.It was reported that some individuals received a primary dose of the Pfizer vaccine and then received a second primary dose of the Moderna vaccine but for whom it was reported, was not provided by the reporter. Vial was initially stored in the refrigerator on 01-Dec-2021. Vial did not undergo any temperature excursions.This case was linked to MOD-2022-449812 (Patient Link).Most recent FOLLOW-UP information incorporated above includes:On 31-Jan-2022: Reporter information, suspect product information (batch number, expiration dates and route of administration) and event description was updated.
Patient reported getting pfizer at a different pharmacy, did not have card, after administration system revealed the first dose was moderna.
22-year-old female got the meds are not covert 19 vaccine dose 1 and immediately after the vaccine she started to experience systemic hives that responded to Benadryl.  She also noted at the same time she was having a scratchy throat but no facial swelling or anaphylaxis.  She went to the ER sent home after being hemodynamically stable and monitored for a couple of hours.  She was sent  with prednisone, Benadryl, Pepcid and Claritin.
Approx. 1 1/2" x 2 1/2" hard, swollen left deltoid area; below injection site approx 2cm x 2xm reddened area. Mom gave child Tylenol; refferal to pres for follow up.
By 9:30 that night I started shaking uncontrollably - like my entire body clenched and wouldn?t let go.  I have never reacted like that before.  That lasted about 4 hours, but my body didn?t recover for months.  I developed SIRVA from the injection going in too deep, which cause excruciating pain and loss of motion.  Finally, after escalating pain, I figured out what SIRVA was and went to my doctor, who prescribed physical therapy because I lost about 60-70% functionality of my left arm.  Finally, my body started to stabilize 4 months later.
Pt received FLUZONE Intradermal on 1/27/13 w/ history of sensitivity to eggs (she can have some eggs, but if eating too many, some itching). She reported having headache, one episode of diarrhea & vomiting on 1/28/13, but she felt better on 1/29/13. She did have some redness and raised skin at injection site & she treated w/ hydrocortisone, it went away.
throat closing; severe shortness of breath; body shakes; chest kind of clamping in my chest; This is a spontaneous report received from a contactable consumer (patient). A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 10Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced throat closing, severe shortness of breath, body shakes, chest kind of clamping in chest 9 days after first dose in Apr2021 with outcome of unknown. The events were reported as non-serious.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
My arm was barely sore; This is a spontaneous report received from a contactable consumer (patient). A 63- year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EW0169 and expiration date was not reported) via an unspecified route of administration (Anatomical location: Arm) on 16Apr2021 as a single dose for COVID-19 immunisation. Medical history included Crohns disease. Concomitant medications were not reported. Historical vaccine included patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: ER8733 and expiration date was not reported) via an unspecified route of administration as a single dose for COVID-19 immunisation. On an unspecified date in Apr2021, (after second dose), patient experienced arm was barely sore.  The Outcome for the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021490065 same reporter/drug, different patients/AE;US-PFIZER INC-2021490064 same reporter/drug, different patients/AE
On 3/4/02, child received DTaP in RA along with IPV and MMR in LA. On 3/5/02, mother returned to clinic with child c/p red firm area approximately 22 mm. child febrile Cool compresses and Tylenol have been given. Child continue with daily activities as usual.
Intermittent stabbing, burning pain in right breast. Began on outside, nearest to arm and spread to top center of right breast. Lasted for about a day and a half. Had a brief reoccurrence on 4 th day post vaccination, but then went away.  Sort of reminded me of shingles pain (had shingles on same side about 4 years ago).
Extreme pain in upper left arm, could not move or lift arm without extraordinary pain.  Lasted for two weeks.  An itchy lump at sight has come and gone since injection.
On Sunday morning i woke up to my left arm being swollen, red, hot to the touch. Over the course of the next few days the swollen part got bigger to the size of a baseball Tuesday I called my doctor and they wanted me to get seen right away at the ER. They did an ultrasound  right away and they ruled out a blood clot and an abscess. They figured it would just be an infection. They put me on an antibiotic for 7 days up to 4x a day. Today 4/21 I took my last dose of the 7 days. Called my doctor and they are starting me on another 5 days of antibiotic to get rid of this infection in my arm. It is now down to a quarter size or a little bigger. Hoping that in the next 5 days it will be completely gone. I don't have the redness and heat anymore just a smallish lump.
Had a fever under 100F for 3 days; rapid pulse that lasted for 1.5 days; hives for which took Claritin and it went away after about 4 hours; weakness for 4 days and jaw soreness that lasted 2 days.
sensitivity to light, nausea, migraine (5 days), lightheadedness  overall lasted for approximately 15 days with various symptoms
three days after vaccine, severe chills, no temp above 99.9, body aches, headaches.  Took tylenol and/or aleeve
3RD DOSE PFIZER COVID VACCINE GIVEN 9/28/21, #30145BA 4TH DOSE PFIZER COVID VACCINE GIVEN 7/23/22, #FP7135 pt brought from SNF by EMS due to altered mental status, unconscious, respiratory distress; pt positive for COVID; papers sent with EMS to hospital stating pt is DNR, comfort measures only; pt passed away in the ED.
Fever (up to 100.5),; Chills; Muscle Aches; Fatigue; Headache; Swelling in left arm; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 07Apr2021 at 08:45 AM (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The medical history of the patient included none. The concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6206) via an unspecified route of administration in the left arm on 17Mar2021 at 08:30 AM as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 07Apr2021, on the same day of second dose of vaccination at 20:00 the patient experienced Fever (up to 100.5), chills, muscle aches, fatigue, headache and swelling in left arm. No therapeutic measures were taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events Fever (up to 100.5), chills, muscle aches, fatigue, headache and swelling in left arm was resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
One week after the shot, I started having heart palpitations. Still continues. After the second shot it increases in frequency.
Pain in left tricep 1 hour following shot-over the course of 12 hours increasing severe muscle aches in joints, back, feet, shoulders, head,chest pains.  Severe shortness of breath for 2 days, coughing, wheezing, chills, fever (highest 101.4), sweats, insominia, dry heaves, extreme thirst, loss of appetite, fatigue.  a 8"x11" hot, red, swollen, very painful left arm just above and including the left elbow area-injection area was hot but not red or swollen.  Went to urgent care and the dr. prescribed dexadron, medrol dose pak, and keflex for 10 days in addition to wearing a sling.
VARIVAX given at another office: #1 - VARIVAX 2/4/2009. #2 - VARIVAX 6/12/12. 8/20/18 seen with singles in urgent care clinic. ACUTE HPI: R upper back and R side around to the breastbone with rash, red based blistering lesions, went to outside clinic and Dx shingles, started on 500 mg valcyclovir yesterday three times a day. Outside clinic recommended here for "verification" of Dx. Started last week with aching pain in the back and blistering started on Thursday. Not described as burning. No fevers. Mom reports pt. has had vaccines for VZV but no acutal disease.
Narrative: Transported patient to the emergency department via wheelchair for high bp, dry mouth, swelling sensation on right deltoid (covid vaccine site), and light headedness after receiving 2nd covid booster (Pfizer). Charge nurse and nurse manager made aware. Transported patient in stable condition. Not in any type of distress. Report given to RN at 1018am. NO further questions/ concerns at this moment.
Rash on the back of left calf below the knee.  Small bumps, general redness of area.   Area affected 2" by 4".  No tx.
Myalgia & NauseaVomiting Narrative:  . I received the vaccine on 01/19 and I was able to work on 01/20.  By the end of the shift I began feeling nauseous and a bit clammy, but was able to  work through it. Over the next few hours that night the symptoms just became worse and worse. I had this awful tension headache in my jaw and behind my right eye. I had, and still have this aching in my bilateral flank as well as this overall general aching. My stomach was in knots and I was in the restroom multiple times.
PATIENT WOKE UP AT 11:00AM ON 10/3/2020 AND FATHER NOTICE PATIENTS EYES WERE BOTH SWOLLEN, RED AND ITCHING.  AFTER LOOKING OVER THE PATIENT'S BODY THE FATHER NOTICED THE PATIENT HAD A RASH AND RED SPLOTCHES ALL ROUND THE NECK AND SOME ON THE FACE AND BEHIND BOTH EARS.  THE PATIENT TOOK ONE 25MG TABLET OF DIPHENHYDRAMINE AT 12:00PM.  THE MOTHER CALLED THE PATIENT'S PEDIATRICIAN AROUND 11:30AM ON 10/3/2020 AND LEFT A MESSAGE WITH THE ANSWERING SERVICE.
Booster; Booster; Multi organ failure; Liver; Renal; Pancreatitis; A-fib; Feeling pretty crappy like he had the flu or virus; This is a spontaneous report from a contactable physician reporting for himself. A 62-years-old male patient received bnt162b2 (BNT162B2), dose 3 (booster) intramuscular, administered in arm on 10Sep2021 (Batch/Lot Number: FC3183) as a single dose for COVID-19 immunisation. The first dose of the Pfizer COVID Vaccine was given on 05Jan2021, with Lot EL0142 expiration Mar2021. The 2nd dose was given on 26Jan2021 with Lot EL9262, expiration May2021. Prior vaccinations (within 4 weeks) prior to the first administration date of the COVID vaccine was none. Medical history included hypertension from an unknown date and unknown if ongoing, blood cholesterol from an unknown date and unknown if ongoing, iodine allergy from an unknown date and unknown if ongoing allergy to iodine diagnosed 10-15 years ago, rubber sensitivity from an unknown date and unknown if ongoing allergy to latex diagnosed 10-15 years ago. There were no concomitant medications. On an unspecified date in 2021, the patient experienced multi-organ failure, feeling pretty crappy like he had the flu or virus, liver (hepatic failure), renal (renal failure), pancreatitis, a-fib (atrial fibrillation), and hemodialysis. The patient was hospitalized for a-fib, multi organ failure, liver (hepatic failure) renal (renal failure), and pancreatitis (pancreatitis) from 04Oct2021 to 19Oct2021. The physician described the clinical course of the events as follows: He had booster shot and about 3 weeks later started feeling pretty crappy like he had the flu or virus.  He went to the doctor who sent him to the ER and he ended up in multi organ failure including: renal, liver, pancreatitis, A-fib and hemodialysis for about a week and a half. His Creat, Bili, and Lipase is still high, but trending better.  He is not on dialysis anymore. The patient underwent lab tests and procedures which included blood bilirubin: 14 on 04Oct2021, blood creatinine: 8's on 04Oct2021, blood urea: 80's on 04Oct2021, lipase: 900 on 04Oct2021. The patient received hemodialysis as treatment for renal failure. The outcome of the events was unknown.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product 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.