chrisvoncsefalvay/vaers-outcomes huggingface dataset:
has been extremely lethargic; received a dose of ACTHIB on 23AUG2021 that had expired 2 weeks ago; Initial information regarding an unsolicited valid non-serious case was received from the consumer/non-healthcare professional via l Medical Information  (Reference number- 00736418) and transmitted on 23-Aug-2021 in the   This case involves a two-year-old male patient who had been extremely lethargic (lethargy) after receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history included Heart transplant.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE 13V for prophylactic vaccination.  On 23-Aug-2021, the patient received a second dose (0.5 ml) of suspect HIB (PRP/T) VACCINE (lot number and expiry date: not reported) via unknown route in the thigh (not specified) for prophylactic vaccination.  It was case of actual medication error as an expired dose of ACT-HIB was administered to the patient (expired vaccine used) (latency: same day).  It was reported, "Caller states she was told by doctor's office that her son, who is a heart transplant recipient, received a dose of ACTHIB on 23AUG2021 that had expired 2 weeks ago"  On 23-AUG-2021 the patient developed a non-serious event "has been extremely lethargic" (lethargy) on the same day, following the administration of HIB (PRP/T) VACCINE.  It was reported, "Caller states that she was told that the doctor's office would follow up with her after contacting the manufacturer but she has not heard back from them yet. Caller asked about how to proceed after receiving the expired dose and if there was any information on adverse reactions that she should look out for. Caller states that her son has been extremely lethargic since receiving the expired ACTHIB. Caller asked about whether or not the doctor's office was negligent and how she should proceed. "  No laboratory data was reported.  At the time of this report, the event lethargy was not recovered. The outcome of the event expired product used 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 Directive 2001/83/EC and Module VI of the regulatory authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Headache; Body aches; chills; This is a spontaneous report from a contactable consumer. A 15-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via intramuscular route of administration in the left arm on 16Jun2021 at 09:15 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. Patient had nut allergy to hazelnuts, pistachios and cashews.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via intramuscular route of administration in the left arm on 26May2021 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. Patient did not had any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Jun2021 at 22:00, the patient experienced body aches, chills and headache. The patient did not receive any treatment for the reported events. 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 not been tested for COVID-19. The clinical outcome of the events of body aches, chills and headache was recovered on an unknown date in Jun2021.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender who on 02-JUL-2015 was vaccinated with a dose of ZOSTAVAX, dose of 0.65 ml, subcutaneous. On 02-JUL-2015 (reported as "almost immediately"), the patient experienced a raised bump at the injection site. On 06-JUL-2015, the patient experienced symptoms of cerebral palsy, including paralysis of the facial and eye muscles. At the time of this report, the outcome of cerebral palsy and injection site mass was unknown. The reporting pharmacist did not assess the relatedness between the events and the therapy with ZOSTAVAX. It was also stated that the patient had seen a physician who believed these symptoms could be due to ZOSTAVAX. Upon internal review the event of cerebral palsy was considered to be medically significant. Additional information has been requested.
on bed all day; could not move; it was so painful; his body was just like "owww",felt like a caterpillar machine ran over him; left hand felt like it was going to fall out from the pain; Joints in pain; Whole body was aching; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (on bed all day), MOBILITY DECREASED (could not move), PAIN (it was so painful), FEELING ABNORMAL (his body was just like "owww",felt like a caterpillar machine ran over him) and PAIN IN EXTREMITY (left hand felt like it was going to fall out from the pain) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 031M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced BEDRIDDEN (on bed all day), MOBILITY DECREASED (could not move), PAIN (it was so painful), FEELING ABNORMAL (his body was just like "owww",felt like a caterpillar machine ran over him), PAIN IN EXTREMITY (left hand felt like it was going to fall out from the pain), ARTHRALGIA (Joints in pain) and MYALGIA (Whole body was aching). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. In November 2021, BEDRIDDEN (on bed all day), MOBILITY DECREASED (could not move), PAIN (it was so painful), FEELING ABNORMAL (his body was just like "owww",felt like a caterpillar machine ran over him), PAIN IN EXTREMITY (left hand felt like it was going to fall out from the pain), ARTHRALGIA (Joints in pain) and MYALGIA (Whole body was aching) had resolved.            No Concomitant medication were reported.   This case was linked to MOD-2021-377214, MOD-2021-377282 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Events (Bedridden, Mobility decreased, Pain in extremity, Arthralgia) added. On 10-Nov-2021: Events (Feeling abnormal) (Pain) added. Events outcome were updated. On 10-Nov-2021: Follow-up contains No New Information
8/1/2013: Broke out with vesicles, no viral s/s. 8/4/2013: Went to ER told vaccine induced rash. 8/5/2013: Went to Employee Health at other job IgG & IgM drawn. Still with vesicles. 8/7/2013: Went to Employee Health. Still with some open vesicles. Sent home. 8/9/2013:  No  open vesicles, all leisions crusted, no other s/s. Cleared to work.
approx 12 hrs p/vax awakened w/uncontrolable shaking, chills, & what pt believed to be fever; when got up later had malaise & myalgias; following day sx were gone;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Lymphoma" (unspecified if ongoing); "Drug Allergy; Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client described "red and itchy area about 6 inches long" in fatty part of arm. Denies having any pustules or vesicular lesions.
Evolving rash/hives over the body with shortness of breath and airway swelling. Intervention with IV Steroids. Prolonged course requiring steroids subsequent. PE steroid induced thyroid swelling thyroidectomy. Adrenal suppression.
Nausea, hives of mouth and eye and headache. Treated with Benadryl.
sore arm for a couple of hours; Nosebleed; This is a spontaneous report from a 71 years old contactable consumer (patient) reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Feb2021 (lot number EL9269), at 71 years old, as the second single dose, for COVID-19 immunization. No other vaccine was administered on the same date or within 4 weeks. Medical history included ongoing hereditary hemorrhagic telangiectasia (this was a life-long condition, she was born with it, her father also had it). The patient previously received the first dose of BNT162B2 vaccine on 15Jan2021 (lot number EL8982) experiencing epistaxis, sore arm, headache and blood pressure was 60/32. Concomitant medications included tamoxifen ongoing for about 4 years, at 20 mg twice a day for nosebleed suppression and an unspecified thyroid pill. On an unspecified date in Feb2021, 2-3 days after the second dose, the patient experienced epistaxis and on 05Feb2021 she experienced sore arm (no big deal). The nosebleed occurred after the second vaccination was a bad nosebleed, but she was able to stop it. The patient received also a third dose of vaccine on 19Aug2021. After each vaccine dose the patient experienced a nosebleed a couple of days after and sore arm for a couple of hours. She got nosebleeds periodically anyway. She had a history of hereditary hemorrhagic telangiectasia (HHT) and she stated that it caused nosebleed because the blood vessels in the nose were deformed so they break and bled. Nosebleed required ER visit and physician office visit. Nosebleed resolved on an unspecified date in Feb2021. Sore arm resolved on 05Feb2021. She denied any labs, testing, or treatments relevant to events. She had an appointment with her hematologist and they will check her hemoglobin.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101098025 Same patient, different vaccine dose, similar events;US-PFIZER INC-202101100937 Same patient, different vaccine dose, similar events
Prolonged and heavier menses: My menstrual cycle started June 4, 2021. Normally, it is of light flow and lasts almost seven days or less. This time my flow was moderate  progressing to heavy compared to my normal flow and it lasted 11 days. This had never happened to me. I did not have any additional stressors, life changing events or health issues that would affect my cycle. I don?t use any form of oral contraceptives. I did experience a headache for two days mid cycle but it?s not uncommon for me to have a headache sometimes during menses. I took Advil 200mg for it one time.
Developed inconsolable crying 24 hours, post vax. Seen next morning with hydrocele and ecchymosis on right scrotum. Hydrocele not noted on ER exam on 5/5/00 observed in hospital. Four days, post vax, baby was better. Subsequently, given HIB, Hep-B, IPV and DT, 1 week apart, one at a time, without any problems. Parents feel pertussis component was the cause.
Vaccine was administrated after the beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administrated after the beyond use date after the thaw process) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administrated after the beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administrated after the beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.  The patient did not report any adverse reactions after the administration of vaccine.  Vaccine number 1 NDC code was reported as 80777-0273-99.
This is a spontaneous report from a contactable consumer (patient). A 39-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EL9262), via an unspecified route of administration, administered in arm right on 26 Jan 2021,15:00 at single for COVID-19 immunization (at the age of 39 years). Medical history included known allergies of Pollen, cats. The patient's concomitant medications were not reported. No covid prior to vaccination and no covid tested post vaccination. On 26Jan2021, the patient had severe swelling of arm, fever, headaches and flu like symptoms. No treatment given for all events. Outcome for all events was not recovered. No follow up attempts are possible. No further information is expected.
4 hours after shots, he was found to have a swollen face, SOB, sore throat and fainted; patient got Benadryl and Albuterol; went to ER and given ?prednisone and evaluated; he had difficulty swallowing for 2 days and is gradually feeling better; taking Famotidine, too.
Patient received PFIZER SARS-COV-2 TRIS-SUCROSE/COMIRNATY, when they should have received the Bivalent as a booster dose.  No adverse reaction noted.
About  three hours after  receiving vaccine, starting having twitching and tingling all over, went away  after two hours, then it returned a week later and it has lasted up until today    5/11/2021.
20 days between 1st and 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (20 days between 1st and 2nd dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Contrast media allergy.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (20 days between 1st and 2nd dose). On 23-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (20 days between 1st and 2nd dose) had resolved.      Patient was not taking any daily medication but used to take tummy medicine but stopped it.   This case was linked to MOD-2021-370468 (Patient Link).
FACE FLUSH, SWELLING OF FACE, HIVES ENTIRE BODY. LUNGS CLEAR IN ALL LOBES, DENIES DIFFICULTY IN SWALLOWING.
Legs became extremely swellen with fluid. Was diagnosed with severe Adema in my legs. I tried several home remedies before contacting after approximately. 3 wks. Of no relief and the issue getting worse.
Developed skin issue.  Practitioner initially stated it was scabies.  Was seen by dermatologist and had skin biopsy.  Received diagnosis of Bullous Pemphigoid and stated it was related to vaccine.
On 1/29/16 patient came to Employee Health. Reported that "day after injection c/o of episode of dizziness and nausea, and threw up." C/o itching. RUA, red and swollen. Ice applied to injection site. CLARITIN and TYLENOL give Xl. Hydrocortisone cream even applied to site. Instructed to follow up with her Primary Care Physician it needed.
Patient received 1st Covid vaccine on 01/30/2021. Per our record of the assessment form and information system record, the patient received Pfizer (Lot # EL9261) on 01/30/2021. On 03/01/2021, the patient was scheduled for his 2nd dose and received the Moderna vaccine (Lot# 024M20A). The patient's assessment form that he signed and our information system record indicate that he did receive Moderna on 03/01/21. The patient was notified on 03/02/2021 around 9:45AM of incident. The patient stated that his vaccine card had listed Moderna as 1st dose on 01/30/21. The patient was notified that he received the Pfizer vaccine on 01/30/2021 and the Moderna vaccine on 03/01/2021. The patient was informed that the card was mislabeled and he may return to clinic for updated vaccine card for his record. The patient stated he corrected it on his current card. I also discussed with patient that both vaccines serve as the Covid vaccine and both of the doses he received will still be counted as his Covid vaccination status. The patient verbalized understanding
swollen lymph node on left collar bone.; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8727) via an unspecified route of administration in the left arm on 28Mar2021 at 15:45 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any medication within two weeks of 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no allergies to medications, food, or other products. On 01Apr2021 at 08:00, the patient experienced swollen lymph node on her left collar bone. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event swollen lymph node on left collar bone was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Patient  inadvertently received vaccine after published expiration date. Moderna analyzed vaccine and advised lot 007B21A maintained activity necessary to protect against  covid 19 on date vaccine was administered.  Also patient did not call in to complain of  adverse eveent.
Tired; Nauseated/feeling some nauseas; Fever of 102; This spontaneous case from the United States was received on 12-Oct-2022 from other non-healthcare professional (consumer) via Communications (reference number: SEQW22-04395) and concerned a 45-year-old, male patient.  The patient's had no relevant medical history and was not taking concomitant medications.   On 11-Oct-2022, the patient was vaccinated with influenza vaccine (brand not specified; dose, route of administration, anatomical location, and indication: not reported). The batch number was not reported.  On the same date, in the evening after receiving influenza vaccine, the patient was nauseated/feeling some nausea and was tired. The patient woke up that evening with a fever of 102. The patient took Motrin (ibuprofen) to alleviate the symptoms.   At the time of initial reporting on 12-Oct-2022, the patient had not recovered from the events.   The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 45-year-old patient was administered with influenza vaccine. On the same date, in the evening after receiving influenza vaccine, the patient developed nausea, fever and fatigue. The patient took Motrin (ibuprofen) to alleviate the symptoms. At the time of initial reporting on 12-Oct-2022, the patient had not recovered from the events. Causal role of the suspect vaccine is assessed as possibly related, due to plausible chronology and no alternative aetiology provided.; Sender's Comments: A 45-year-old patient was administered with influenza vaccine. On the same date, in the evening after receiving influenza vaccine, the patient developed nausea, fever and fatigue. The patient took Motrin (ibuprofen) to alleviate the symptoms. At the time of initial reporting on 12-Oct-2022, the patient had not recovered from the events. Causal role of the suspect vaccine is assessed as possibly related, due to plausible chronology and no alternative aetiology provided.
Fever, chills, coughing, and disorientation that lasted for 6 hours
Extreme pain to arm Swollen at vaccine spot Pain radiates to neck and shoulder blade Cannot lay on arm Began  22 days after vaccine
At site of injection, .8 days after the vaccine was given, I experienced a rash and itching. It has now lasted 30 hours.  It's not severe, but enough to interrupt sleep.
Nurse administered undiluted dose of Pfizer for ages 5-11, dose #1 to patient. Guardian informed of error post vaccination via phone call. Guardian states all patients were feeling "fine" at time of phone call. Guardian advised to monitor injection sites for adverse reaction, and call clinic back if any adverse effects occur. Nurse addressed all questions and concerns. Dr.  and supervisors aware.
arm very sore for 2 days then started swelling (almost as elbow) also hard & red & warm;skin over this area is rough;most of soreness subsided now but still very swollen;
pt recvd vax; low grade fever for 2 days (9nov-10nov);no fever 11nov;more fussy,softer stools then focal sz while at er;intubated; sz cont despite antiepileptic drugs for 4 days;
I received the second dose of the Moderna COVID Vaccine 3 FEB 21. Within 2-3 hours I was incredibly tired. I was hit with intense nausea and vomiting that has been persistent since the night of 3 FEB. I can?t keep much down. 4 Feb I had a fever of 102.3 starting around 4am, I brought it down with a 600 Mg dose of Ibuprofen but it came back off and on throughout the day alongside sweats and chills. All of my lymph nodes were swollen and my entire body hurt. I was unable to sleep last night 4feb/5feb due to muscle pain.  As of today I feel a little better and am without a fever, but I am still incredibly nauseous and have developed a sore throat.
Started with rash on trunk, groin, hairline.  Spreading and now has approximately 25-30 papules.  To give BENADRYL and use Calamine lotion.