chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable office supervisor, then from a medical assistant on behalf of a doctor's office, and from a contactable Other HCP (Supervisor). These contactable reporters reported similar events for 3 patients. This is the 3rd of 3 reports. An 85-year-old male patient received PREVNAR 13 (lot M51192, expiry date 31May2017) in left deltoid at 0.5 ml single on 16Feb2016 at 09:00. Medical history and concomitant medications were not reported. Illness at time of vaccination: none. No other vaccines given on same date along with suspect vaccine. No other vaccinations within 4 weeks prior to date of vaccination. On 17Feb2016 the patient experienced swollen arm, hot to the touch, red, hard lump and could not move left arm and on unknown date "he has still persistent pain in left arm". All the events had not yet been resolved and resulted worsened at the time of report. The patient was in the office seeing the doctor on 18Feb2016. The reporter considered the events were related to vaccination. The contactable Other HCP (Supervisor) stated that the patient provided to him/her information regarding the reported adverse events with the use of the suspect vaccine. The contactable Other HCP (Supervisor) considered there was a reasonable possibility that the event is related to suspect product. The contactable Other HCP (Supervisor) was willing to be contacted again by Pfizer on the reported adverse events. Follow-up attempts completed. No further information expected. Follow-up (14-APR-2016): Follow-up attempts are completed. No further information is expected. Follow-up (22Apr2016): Additional information received from medical assistant includes: pain in arm added as adverse event. Follow-up (13May2016): New information reported from a contactable Other HCP (Supervisor) included:  event "still has pain in arm" changed to "still has pain persistent in arm/pain left arm" serious; No other vaccines given on same date not other vaccinations within 4 weeks prior to date of vaccination; outcome of AEs swollen arm, hot to the touch and red confirmed as ongoing; reporter informed regarding the adverse events; reporter event causality assessment; reporter further contactability.
Maladministration of Havrix after the Expiration Date; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 46-year-old male patient who received HAV (Havrix) (batch number NZ7JR, expiry date 17-JUN-2023) for prophylaxis.   On 22-AUG-2023, the patient received the 2nd dose of Havrix. On 22-AUG-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Maladministration of Havrix after the Expiration Date).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date: 23-AUG-2023 Medical Assistant reported that one nurse administered Havrix after the expiration date to a patient as a second dose in the Havrix series which led to expired vaccine used. The reporter consented to follow up by email.
body discomfort; "feeling down"; Pain; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (body discomfort), DEPRESSED MOOD ("feeling down"), PAIN (Pain) and FATIGUE (tiredness) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (body discomfort), DEPRESSED MOOD ("feeling down"), PAIN (Pain) and FATIGUE (tiredness). At the time of the report, DISCOMFORT (body discomfort), DEPRESSED MOOD ("feeling down"), PAIN (Pain) and FATIGUE (tiredness) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant and treatment medication were provided.   This case was linked to MOD-2021-195316, MOD-2021-195316, MOD-2021-195316, MOD-2021-195316 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Patient's initials and gender updated.
PATIENT DENIED RECEIVING ANY OTHER PREVIOUS COVID VACCINE ON FORM. WHEN ENTERING VACCINE IN STATE SHOTS FOUND OUT THAT HE RECEIVED JANSSEN VACCINE ON 03/13/2021. WHEN CLIENT WAS ASKED WAS ASKED ABOUT THIS IS STATED THAT HE HAD RECEIVED THE JANSSEN VACCINE BUT WANTED THE PFIZER SERIES NOW BECAUSE HE DID NOT TRUST THE J&J EFFECTIVENESS ANYMORE.
Work up sweating, chilled and heavy pressure in the chest.  Initially was concerned I was having a heart event but pulse and blood pressure was normal.  After several hours the symptoms subsided.
I developed severe, high-pitched tinnitus in  both ears. For a couple of days, it was deafening. Now, it is just loud.
She got her vaccine, just had the typical pain in the arm.  Four weeks after her last vaccine her hair started falling out in hand-fulls, hand-fulls of hair falling out.  She has had alopecia but not for 10 years, but only had two little spots.   She went and saw her PCP and her dermatologist said that she should contact us as there is a relationship between the COVID vaccine and igniting complete alopecia in people.  She has alopecia Areata which has turned into the alopecia universalis where she has no hair anywhere including eyelids and eyelashes.  She did have full lab work.  She has been on steroids for 4-6 months, which are about 150 shots in her scalp, topical steroids which she rubs in twice a day, and Minoxidil.  Her dermatologist told her that there is nothing else that they can do for her.  These treatments have not improved anything, in fact it has gotten worse.    She knows that the vaccine sparked her alopecia again.  It is devastating that her hair fell out in hand-fulls until she has no hair anywhere on her body.  She felt that she was doing something better for herself getting the vaccine, but she ended up with the total alopecia.
Elevated temperature; Body aches; Chills; Strong abdominal cramps; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in right arm on 24Feb2021 at 15:00 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and allergy to antibiotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included losartan (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the right arm on 03Feb2021 at 15:00 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. On 11Mar2021 at 16:00, 2 weeks after second vaccine, the patient experienced elevated temperature, body aches, chills and strong abdominal cramps. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of elevated temperature, body aches, chills and strong abdominal cramps was recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Patient is 1 day shy of his 18th birthday and received the Moderna COVID-19 vaccine. No adverse symptoms at this time.
Within a half hour of receiving the vaccine, I experienced severe cramping in my right forearm at the elbow joint. Also some numbness in the right calf. This is in addition to the expected headache and feeling like I was run over by a truck that evening through the night. Muscle aches over my entire body.
Headache from 4/14/21 to 4/24/21, tonic-clonic seizure on 4/24/24 admitted to hospital on 4/24/24
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 10:42 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 10:42 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 25.66 years. No concomitant medications were reported. Batch number 044B21A underwent temperature excursion on 15-Apr-2021 with temperature 34 degrees Fahrenheit from 09:00 AM. The vial was initially moved to the fridge on 06-Apr-2021 and proposed beyond use date was 09-May-2021. Product moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
My son told me that his "heart hurt" and he said it was beating very fast.  He was fine the next morning.
Administered 0.5mL instead of the 0.25mL dose. Patient is not aware of the error and never reported any side effects or adverse reactions.
Patient has a rash on his left lower leg that is itchy (not painful) with pustules. I recommended that he see his doctor.
After the first shot my arm was pretty sore. That was to be expected. After the second shot my arm was VERY sore. It hurt all the way down to my wrist. I was trying not to even use it. That started about 4hrs after the vaccination. I went to sleep early(I slept about 14hrs)and I woke up feeling drained. Had no energy whatsoever, and my arm was still hurting.  Imy whole body ached and I just didn?t feel good. Around 2pm that day(the day after the second shot) I felt like I was running a small fever. I took my temp and it was 99.7. I took some ibuprofen and started feeling better. Today is the 2nd day after the shot and I feel much better. Arm is still a little tender, but I feel better everywhere else.
Pt seen on 12/1/00 with swollen, red, very tender left shoulder and fever.
chills to the point of uncontrollable shaking with no fever present; chills to the point of uncontrollable shaking with no fever present; Armpit lymph node was swollen and very painful; pain in the armpit on the side of the vaccine/ armpit lymph node was swollen and very painful/ could not lift arm without pain in lymph node located in armpit; This is a spontaneous report from a non-contactable other healthcare professional (patient) received via COVID19 Reporting. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EC9266), via an unspecified route of administration on 18Feb2021, at 12:00 (at the age of 27 years old) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Twelve hours after vaccination (on 19Feb2021), the patient began experiencing chills to the point of uncontrollable shaking, with no fever present. On 19Feb2021, she also began feeling pain in the armpit on the side of the vaccine. The armpit lymph node was swollen and very painful. She could not lift arm without pain in lymph node located in armpit. The patient was not diagnosed with COVID-19 prior to vaccination and she has not been tested for COVID-19 since the vaccination. No therapeutic measures were taken as a result of the events. The patient has not recovered from the events.   No follow-up attempts are possible. No further information is expected.
Pain at injection site; Nausea; Body aches; Fever; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 20Jul2021 at 12:15 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. The medical history was not reported. The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT), diphenhydramine hydrochloride (BENADRYL) and valproate semisodium (DEPAKOTE), all from unknown dates and for unknown indications. On 20Jul2021 at 14:00, the patient experienced pain at injection site, nausea, body aches and fever. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain at injection site, nausea, body aches and fever were resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hospital Course:  Patient is a 77 y.o. male patient of Hospital with a history of CAD s/p CABG (2008), CVA (2015), bladder cancer s/p TURBT (2021), IDDM2, and CKDIIIa. Recent hospitalization (12/1-12/9/22) for left temporal brain mass s/p resection on 12/1/22 with initial pathology concerning for glioblastoma; post-op course complicated by intraparenchymal hemorrhage and dysphagia with ultimate discharge to IPR. Patient represented to Hospital from IPR on 12/11/22 with dyspnea and known positive covid-19 test, found to be in acute hypoxemic respiratory failure secondary to sepsis from presumed pneumonia requiring MICU admission. Upon initial arrival to ICU, patient was noted to be in significant respiratory distress despite heated high flow and ultimately required intubation. Shortly thereafter, patient went into PEA arrest and CPR was initiated with achievement of ROSC within 5 minutes. Ultimately family had decided to transition care to comfort measures however before this occurred patient expired after becoming bradycardic. Time of death pronounced on 12/12/22 at 0501.   Discharge Diagnoses: Acute hypoxemic respiratory failure Septic shock COVID-19 infection  Elevated troponin AKI on CKDIIIa Acute metabolic encephalopathy Left brain mass s/p resection
Adverse Event: Patient was given 2nd dose on 4/4/2022, vaccine expiration was 4/4/2022. Team was notified about expiration on 4/11/2022. Patient has not reported any adverse symptoms or signs.
Bouts of dizziness (spinning feeling) headaches, overall feeling of nausea and restlessness.
Per patients description; - Friday; Received vaccine @ 12:30ish - Soar arm as the day continued. - Saturday; Woke up with chills, nausea, fatigue, slight dizziness, battled fevers throughout the day, shortness of breath if I walked too much. The arm was super sore and it was starting to really hurt. - Sunday; Slight fever, sweats, fatigue, upset stomach, my arm was really hurting both at the injection site and underneath in my armpit area and side boob. It was constant pain mixed with surges of throbbing. Felt like it had been stung by bees. Did not sleep much, Advil was just not cutting it. - Monday; The injection site was super red, hot to the touch, and swollen. My armpit and side boob still hurt very much. I could not touch the arm and it was hard to move it because of the pain. Still had nausea, dizziness, and fatigue.  The doctor said I had an allergic reaction, the pain in my armpit was due to very inflamed and irritated lymph nodes. Recommended Benadryl, Advil, and lots of ice both on the injection site and in my armpit. She also said I should expect the same reaction with a second dose.
Pain in arms where vaccine was administered. Headaches, dizziness and nausea. Patient has been drinking Motrin 800.
Case number PHEH2014US020949, is an initial spontaneous report received from a pharmacist on 15 OCT 2014. This report refers to a 70 year old female patient. Her medical history and concomitant medication was not reported. Pharmacist reported that she received 2 dose of FLUVIRIN 2014/2015 (batch number: unknown) on the same day. No adverse event was reported. No further information was provided.
Low grade temperature, headache, sore and achy muscles (cramps also), diarrhea,  decrease of ability to taste. Headache started soon after, temp and soreness later that day. Haven't eaten until this evening and that's when I noticed that I had a reduced sense of taste. For instance, I couldn't taste the garlic on the roast, the whole thing tasted different. I also couldn't taste the homemade applesauce. Just wondering if I should be concerned.
Resident came in for her 2nd dose booster, however later in day when doing reporting found that she had already received her 2nd booster - she forgot that she did get it.
all got the shot all got the flu 100 percent failure; Initial information regarding an unsolicited valid non-serious case received from a consumer or non-health care professional via Social Media and transmitted to Sanofi on 12-Nov-2020.  This case involves 72 patients with an unknown age who all got the INFLUENZA VACCINE all got the flu 100 percent failure (Influenza), while all patients received INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number unknown) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, all patient got the flu 100 percent failure (Influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as Unknown for Influenza.  There will be no information regarding the batch number for the case.
This spontaneous report received from a consumer via a company representative concerned a female patient of unspecified age, race, and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) (dose number in series was 1), 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the "patient got covid-19 and suspected clinical vaccination failure (dose number in series was 1) and patient received treatment medications (dates unspecified) included: ivermectin, ascorbic acid, zethrimician, colecalciferol, hydroxychloroquine and monoclonal iv (intravenous)". The action taken with covid-19 vaccine s was not applicable. The outcome of covid-19 and suspected clinical vaccination failure was not reported (dose number in series was 1). This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000208210.; Sender's Comments: V0:20211251654-covid-19 vaccine suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS 20211251654-covid-19 vaccine covid-19. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Information has been received from a nurse referring to a 13 month old male patient. The patient's medical history, concurrent condition and concomitant medication were unknown. On 19-JAN-2017, the patient was vaccinated with a dose of PROQUAD (dose, route, lot# and expiration date unknown) not VARIVAX (dose and route unknown, lot# reported as L005461, expiration date: 28-OCT-2017) in the mist of confusion for prophylaxis. No adverse effects were reported. Additional information has been requested.
Information has been received from a Registered Nurse (R.N.) concerning a 64 year old female patient, with penicillin and ALEVE allergy, hypertension and asthma, with a history of chickenpox and with none illness at time of vaccination, who on 26-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# 670382/0218AA), 0.65ml, SC in the right deltoid. Concomitant therapy included hydrochlorothiazide (manufacturer unknown), CARDURA, sertraline HCl, gabapentin and aspirin ("ASA"). It was reported that on 06-MAY-2012 the patient experienced herpes zoster. The patient had no recent exposure to chickenpox or herpes zoster. On 11-MAY-2012 she presented to office with rash on left arm for 1 week, very painful, extended from left hand to left shoulder. Physician noted as erythematous maculopapular rash in dermatome with distribution over lateral left arm from posterior shoulder to hand - C6C7 distribution, 2-3 areas with drying vesicles tendered to palpation. Pain scale was 7. Patient was treated with VALTREX. At the time of reporting the patient's status was in process of recovering. The reporter considered the herpes zoster was an other important medical event (required medical intervention). This is one of several reports received from the same source. Additional information is not expected.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOXIA 1/14/2023,  1/10/2023,  1/19/2023,  1/9/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS