chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SORENESS AND PAIN AT INJECTION SITE (LEFT ARM) AND ALSO LEFT BREAST (PAIN SCORE OF 8/10), FEELING FATIGUE, TIRED AND COLD. PATIENT ADMINISTERED ACETAMINOPHEN 500MG  2 TABLETS TO ALLEVIATE THE PAIN, SYMPTOMS STARTED 6 HOURS AFTER THIS BOOSTER SHINGRIX VACCINE INJECTION WAS ADMINISTERED.   PATIENT REPORTED THAT SHE EXPERIENCED THE SAME SYMPTOMS WITH FIRST SHINGRIX DOSE 2 MONTHS AGO, HOWEVER IT WAS WAY LESS PAINFUL AND MORE TOLERABLE THAN THE SECOND TIME.  PATIENT CONTACTED PHARMACY AND PRIMARY CARE PROVIDER, WAS ADVISED TO TAKE OTC PAIN RELIEVERS, DRINK FLUIDS AND REST IN BED UNTILL ALL THE SYMPTOMES HAVE DECLINED.
Chills, fever - 101.3, nausea, headache, swelling at injection site that has continued to spread
Moderna vaccine was administered outside of our facility - reported by patient. NO LOT NUMBER WERE SUPPLIED  I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 6/2/2021 HTN (HYPERTENSION) I82.409 ACUTE DVT, UNSPECIFIED VEIN 6/8/2021 HTN (HYPERTENSION) I95.9 HYPOTENSION 5/17/2021 HTN (HYPERTENSION) I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 6/2/2021 SEVERE ALCOHOL USE DISORDER I82.409 ACUTE DVT, UNSPECIFIED VEIN 6/8/2021 SEVERE ALCOHOL USE DISORDER I95.9 HYPOTENSION 5/17/2021 SEVERE ALCOHOL USE DISORDER I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 6/2/2021 OLIGURIA I82.409 ACUTE DVT, UNSPECIFIED VEIN 6/8/2021 OLIGURIA I95.9 HYPOTENSION 5/17/2021 OLIGURIA I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 6/2/2021 LEUKOCYTOSIS I82.409 ACUTE DVT, UNSPECIFIED VEIN 6/8/2021 LEUKOCYTOSIS I95.9 HYPOTENSION 5/17/2021 LEUKOCYTOSIS
9/3/21 vaccine received.  9/27/21 pt developed a CP, went to ED 9/28/21.  Pt says she was told she had pericarditis.  Pt was treated with Ibuprofen,  Pt states she is improving as of today 10/1/21.
Information has been received from a registered pharmacist concerning a male patient who on an unspecified date was vaccinated with a dose of RECOMBIVAX HB (Lot# not reported) (manufacturer unknown). It was reported that following vaccination on an unspecified date, the patient developed a rash that persisted for six months. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. Follow up information has been received from the pharmacist who stated that the patient was interested in getting the PNEUMOVAX 23 vaccine, but wanted to make sure it did not contain any methylparabens due to a previous reaction to the RECOMBIVAX HB (manufacturer unknown). Patient indicated that he got a rash. No further information is expected.
My menstrual cycle even through the IUD began to get heavier. My active cycle started to become longer. I started to have 21 active bleeding days a month. The days between active bleeding days decreased to 3-7 days in between. I was having abnormal period pain and ovulation pain. It was severe and through my lower back. I started having night sweats and hot flashes and hyperpigmentation through my facial skin. I also had trouble sleeping. I went to have my hormone levels checked and when I was referred to the OBGYN, they confirmed that I was into perimenopause at 37 years old. I have no family history with this health issue and women in my family usually experience menopause around 45-50 years old. Our resolution for a while was to add a 2nd form of birth control for a while. We decided to take me off the pill and IUD.  We had surgery to remove the fallopian tubes and uterine ablation. I was also experiencing nearly daily migraines through all of this. I'm unsure if it was related to this event, but that's what prompted me to go to the doctor for all of it. I am just one month post surgery and have no experienced a period yet. I'm unsure if this is relation to the vaccine or if this was just a coincidence in timing.
patient was administered an expired daptacel vaccine, with no reported adverse event; Initial information received on 21-Apr-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 1 years old female patient who was administered an expired daptacel vaccine, diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Prophylactic vaccination.  On 20-Apr-2023, the patient received suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection, dose number 4 at dose of 0.5 ml (lot C5828AA, Expiry date: 30-Mar-2023) via intramuscular route in Right thigh for prophylactic vaccination (immunization).  On 20-Apr-2023, patient was administered an expired daptacel vaccine(expired product administered) (same day latency) with no reported adverse event  Action taken was not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Nausea; Chills; Body aches; Fever; Headache; pregnant and last menstrual date 19May2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Sep2021 13:00 (Batch/Lot number: unknown) at the age of 38 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing). Date of last menstrual period: 19May2021. The patient was 19 weeks pregnant at the time of exposure to bnt162b2. The patient was 19 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 22Feb2022. There were no concomitant medications. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 29Sep2021 13:00, outcome "unknown", described as "pregnant and last menstrual date 19May2021"; NAUSEA (non-serious) with onset 29Sep2021 23:00, outcome "recovering", described as "Nausea"; CHILLS (non-serious) with onset 29Sep2021 23:00, outcome "recovering", described as "Chills"; PAIN (non-serious) with onset 29Sep2021 23:00, outcome "recovering", described as "Body aches"; PYREXIA (non-serious) with onset 29Sep2021 23:00, outcome "recovering", described as "Fever"; HEADACHE (non-serious) with onset 29Sep2021 23:00, outcome "recovering", described as "Headache". Therapeutic measures were not taken as a result of nausea, chills, pain, pyrexia, headache.  Additional information: 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. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Striations from shot site, Right swollen lymph node to right axillary, fever of 101 F for 7 days.
Information has been received from a physician concerning a cluster of six of seven patients who did not develop sufficient titer after vaccinations with RECOMBIVAX HB. On 23-NOV-2010, 5 patients were vaccinated with a dose of RECOMBIVAX HB (lot number: 666029/1456Y), thimerosal free (dose and site of administration not reported) and 2 patients were vaccinated with a dose of RECOMBIVAX HB (lot number: 666806/0732Z), thimerosal free (dose and site of administration not reported). On 22-DEC-2010, all 7 patients were vaccinated with a dose of RECOMBIVAX HB (lot number: 666805/0657Z), thimerosal free (dose and site of administration not reported). On 25-MAY-2011, 1 patient was vaccinated with a dose of RECOMBIVAX HB (lot number: 666809/1631Z), thimerosal free (dose and site of administration not reported). Titers drawn in June 2011 showed that six of seven total patients did not developed sufficient titers. The titers were repeated in July 2011 at a second laboratory. The patients did not seek medical attention. At the time of the report, the patients' outcomes were unknown. Follow up information has been received from the physician who stated that on 23-NOV-2010, on 22-DEC-2010 and on 01-JUN-2011 one of the patients involved was vaccinated with the first, second and third doses respectively of RECOMBIVAX HB thimerosal free (dose and site of administration not reported) (lot numbers: 666806/0732Z, expiring 10-NOV-2010; 666805/0657Z, expiring 09-NOV-2012 and 666809/1631Z, expiring 12-NOV-2012, respectively). The physician reported that on unspecified dates, two titer test were performed (both results: NR). Follow up information was received from the physician who reported that his office does not treat any pediatric patients, the office only treats adults. The physician reported that the office purchased the pediatric vials (0.5 ml vial dose) "which are cheaper" and dispensed two vials to each patient to provide an adult dose. Related WAES#s include: 1107USA03575, 1108USA01425, 1108USA01426, 1108USA10427, 1108USA01429. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot numbers 666806/0732Z and 666805/0657Z in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Moderna is not FDA approved for 18 age and under. Patient is 12 year-old and received the Moderna vaccine.
PT presented with severe bruising on left arm from the injection point to mid arm, wrapping partially around front of arm. Nurse evaluated arm.  No swelling, no harness.  Equal in size compared to right arm.  Bruising was yellowed, with some mild purple (more fresh) bruising on inner portion of arm.  Nurse asked patient if he was currently taking any "blood thinners" patient stated, "no", but on lated evaluation remembered he takes ASA 81mg. Patient c/o pain in left arm, but now only related to bruising.  Patient stated no other injury had occurred to arm. Nurse informed patient to return on Friday (2 days later) to ensure bruising was not worsening, or to report to ED if pain/bruising worsens.   Patient evaluated arm as well and concurred with nurse.  Patient in no immediate harm.
pfizer vaccine was in fridge beyond 30 days at time of administration. pharmacist did not know of this until after administration. discussed with pt. pt stated body aches, tired. advised repeating vaccination.
It was reported the occurrence of a "woozy" feeling in a pt who was inadvertently vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix) for prophylaxis. The pt had no relevant medical history, concurrent conditions, or concurrent medications. He experienced no adverse events following previous injection of Twinrix, which is not recommended for immunizing individuals less than 18 yrs old. On the same date, he also rec'd an injection of tetanus toxoid (manufacturer unknown). At an unspecified time post immunization, the day of the immunization, the pt experienced a "woozy" feeling. The reporter considered the event to be possibly related to Twinrix administration. The outcome of the even was unknown.
Multiple severe abdominal blood clots of the Portal Vein, Splenic Vein, Superior Mesenteric Vein I presented to Hospital with severe abdominal pain on Nov 5, 2021.  I was hospitalized for a week on a heparin drip.  Concern for bowel ischemia secondary to clots.  Released on Nov 12, 2021 with a Rx for Eliquis 50mg BID. Significant abdominal  pain continues through today 03/16/2022.  CAT scan on Feb 01, 2022 showed chronic thrombosis and significant varices throughout the stomach and abdominal veins.  My GI doctor, recommended a vascular surgeon consult.  I am scheduled to see Dr, March 17, 2022.  He is an Interventional Radiologist.
Received vaccines 8/1 at 11:27 am; fever of 103.9 degrees at 10 pm with 1 episode nausea and vomiting; temp 104 degrees at 1 am 8/2. Pt received 160 mg APAP and 150 mg ibuprofen. Symptoms resolved by 8/3.
4-5 days p/shot h/a, stomachache, swollen knees, hives, t101; ?brown spider virus;
Baby experienced fevers for 2 days before waking up on day 3 covered in a full head to toe body rash with little spread out bumps all over body. Ped said it is a reaction to the MMR vaccine she was given 12 days prior.
Moderate muscle/Joint aches lasted approximately 24 hours. Treated with NSAIDs.
Fevers; Headaches; Arm lifting up for no reason Pain; Loss of appetite; Loss of control to talk or move; Loss of control to talk or move; Loss of speech; Confused; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A 21-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (hospitalization), outcome "unknown", described as "Fevers"; HEADACHE (hospitalization), outcome "unknown", described as "Headaches"; PAIN IN EXTREMITY (hospitalization), outcome "unknown", described as "Arm lifting up for no reason Pain"; DECREASED APPETITE (hospitalization), outcome "unknown", described as "Loss of appetite"; LOGORRHOEA (hospitalization), MOVEMENT DISORDER (hospitalization), outcome "unknown" and all described as "Loss of control to talk or move"; APHASIA (hospitalization), outcome "unknown", described as "Loss of speech"; CONFUSIONAL STATE (hospitalization), outcome "unknown", described as "Confused". The patient underwent the following laboratory tests and procedures: fevers: 100-103, notes: 100-103 every other day.  Clinical course: Patient took your pfizer shot last year, and now our little girl was in need of medical attention, Symptoms: Headaches Sizers Arm lifting up for no reason Pain Loss of appetite Loss of control to talk or move Loss of speech Confused Fevers from 100-103 every other day Plus many more. Taken to hospital every week on file.  The information on the batch/lot number for [BNT162B2 NOS] has been requested and will be submitted if and when received.
Within 30 seconds of vaccine, patient began vomiting continuously and felt like her throat was closing. She was given IM epinephrine in the clinic and transported to the ED. By ED arrival, she stated her throat no longer felt tight. In the ED, was given 25mg IV benadryl, 20mg IV famotidine, 125mg IV methylprednisolone and 1L of saline.  She was monitored prior to discharge.
Arm soreness, headache, severe body aches, severe joint pain, tremors, fever 103.1 F, body felt cold, cold sweats.
Varicella Encephalitis; shingles, included any an all of its sequelae/ as well as other severe and personal injuries; shingles, included any an all of its sequelae; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a 70-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or about 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported) (it was reported the patient was 60 year old at time of vaccine, conflicted information). On 25-DEC-2015, as a result of zoster vaccine live (ZOSTAVAX) administration, foregoing act and omissions, the patient was caused to suffered serious and dangerous side effects included: varicella encephalitis and shingles, included any and all of its sequelae, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, included diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of vaccination, the patient had been caused to suffered severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. Negligence was the proximate caused of injuries, harm and economic loss which the patient suffered and/or would continue to suffer. As a result of the foregoing acts and omissions the patient required and/or would require more health care and services and did incur medical, health, incidental and related expenses. The patient was informed and believed and further alleged that the patient would in the future be required to obtained further and/or hospital care, attention and services. The outcome of herpes zoster meningoencephalitis, shingles and ill-defined disorder were not recovered. The reporter considered herpes zoster meningoencephalitis, shingles and ill-defined disorder to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, herpes zoster meningoencephalitis was determined to be medically significant events. Herpes zoster meningoencephalitis, shingles and ill-defined disorder were considered to be disable events.
approx 12 days p/ vax pt devel varicella-like rash w/approx 250 vesicles lasting 1 wk;reporting MD felt rash was not r/t vax;
Patient received Pfizer Covid shot. Staff from the front saw the patient seated on the floor in the grocery aisle. Staff came to the pharmacy where I went over to see what happened. She was with her mother and they stated she passed out. She stated she did not hit her head, she was responsive and seated. I offered to call EMS and patient and mother declined the offer. We brought a chair over to her to sit. She stated she had not eaten or had anything to drink and she said it was probably due to that. I offered her water and she said she already had Gatorade to drink and her mother was getting her something to eat. They thanked me for checking on her and remained in the aisle seated.
EXTREME FATIGUE, PROTEIN IN URINE, LEFT LEG SWOLLEN AND BLOOD CLOT BEHIND PACEMAKER.
It was reported that a pt (5 of 7) rec'd a TD adult vaccination, date not specified. Reportedly sometime after the vaccination the pt developed flu-like symptoms and a local reaction, red swollen arm. Further information is requested.
Patient complained of bilateral arm itching about 14 minutes after vaccine. No respiratory distress noted. No rash noted. O2 sats were 98% on RA throughout event. She was given Benadryl 25 mg PO liquid. Instructed to call 911 if she has further distress at home.
Palpitations in the evening after the shot. High HR the next day. Resting HR of 110 bpm. HR of 130-150 with normal walking.
Myalgia, Fever, Arm pain; Chills; Temperature; Headache
complete insomnia I can go 3 days without sleep and try all kinds of medication and nothing works, sinus problems worse then before and headaches and sore body.  right now the sides of my face feels swollen and my lymph nodes are swollen
Approximately 4x5cm swelling with redness noted L deltoid area is warm to touch. Gave ALeve 200mg to take bid.
On 1/13, my right underarm/gland started to ache.  On 1/14, I woke up and my gland/underarm was noticably swollen and sore.  After 6 hours, it is still swollen and sore and now the left underarm is starting to become mildly sore.  I do not have any other COVID symptoms: no fever, taste is normal, no cough, no respiratory nor GI symptoms.
Second monovalent dose was given per patient's information given, but patient had neglected to tell nursing staff he had already had received a second monovalent injection. So wrong dose and given too early. Should have been a bivalent given in two months.
Pinpoint, red, flat lesions noted on face, neck,shoulder and chest.  Noted by parent soon after shots administered and she returned to office within 2 hours of shots where child seen by ARNP. No fever, not itchy, don't blanch, child appears to have no other changes. Advised monitoring, Ibuprofen, see MD if worsening of symptoms.
Headache, weakness, nausea, vomiting, weight loss, dehydration, low blood sugars
sore armpit that started on evening of 2nd vaccination and still hurts today 1 day later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 43 year-old male patient received bnt162b2 (BNT162B2), administration date 24Mar2021 10:00 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1), when the patient was 43 years old, for COVID-19 Immunization. The following information was reported: AXILLARY PAIN (non-serious) with onset 24Mar2021 19:00, outcome "not recovered", described as "sore armpit that started on evening of 2nd vaccination and still hurts today 1 day later". It was unknown if therapeutic measures were taken as a result of axillary pain.  Additional information: Serious: No, Seriousness criteria-Results in death: No, Seriousness criteria-Life threatening: No, Seriousness criteria-Caused/prolonged hospitalization: No, Seriousness criteria-Disabling/Incapacitating: No, Seriousness criteria-Congenital anomaly/birth defect: No. It was unknown whether patient receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was Unknown. Prior to vaccination, was the patient diagnosed with COVID-19 was unknown. Since the vaccination, has the patient been tested for COVID-19 was unknown. Allergies to medications, food, or other products was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
severe chest pain; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 16-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EW0179, expiration date unknown) via an unspecified route of administration in the arm left on 28May2021 at 11:45 AM at age of 16-year-old at single dose for COVID-19 immunization. Patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EW0171, expiration date unknown) via an unspecified route of administration in the left arm on 07May2021 at 02:30 PM at age of 16-year-old for COVID-19 immunisation. Patient had no known allergies. Medical history and concomitant medications were not reported. On the night of day 1 into day 2 following the second vaccine, patient woke up with severe chest pain and shortness of breath that lingered for hours after onset. Events onset date was reported as 30May2021 at 02:00 AM. Events didn't result in emergency room visit or physician office visit. Outcome of the events was recovering. No treatment received for the events. Patient had no COVID-19 prior vaccination. COVID-19 was not tested post vaccination.  Follow up needed, further information has been requested.