chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A mother reported, via a company representative, that her 18 month old daughter received a 2nd dose of Prevnar vaccine (date unknown). The child has a past history of pneumonia, ear infection, bronchospasm and cough following her 1st dose of Prevnar vaccine in 11/00. See case ID HQ3082310JUL2001. One day later, the child developed fever and swelling. Three days later, the child developed wheezing and was taken to the ER. At the ER, she developed labored breathing, appealed pale and was dx'd with bronchiolitis. The child received "breathing" and steroid treatments and was discharged to home with an inhaler. This case was considered serious since bronchiolitis was considered to be "Medically Important" in this case. No additional information was available as of the date of this report. F/U information received 7/30/01; Prevnar and Hib-Titer vaccines received on 4/25/01. Concomitant medication included amoxicillin clavulanate (Augmentin). Lab data includes CXR that revealed no active lung disease. The child recovered. Follow-up info received on 7/27/01, stated that child had several ER visits (unidentified) following Prevnar immunization. Additional information received 9/7/01. Four days, post vax of 2nd Prevnar immunization, child started vomiting. She vomited 5 times before being seen in the ER. In 7/01, the child was given a dx of asthma.
This spontaneous report as received from a certified medical assistant, refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB lot# L006545, expiration date: 27-NOV-2017 (dose and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: Gh9702) at the age of 57 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: Er8727), in left arm, on 16Apr2021 as dose 2, single (Lot number: Er8735), in left arm, on 25Oct2021 as dose 3 (booster), single (Lot number: Eno173), in left arm and on 22Apr2022 as dose 4 (booster), single (Lot number: Fka894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Grass allergy" (unspecified if ongoing); "Trees allergy" (unspecified if ongoing); "Cats allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid for COVID-19 from 03Sep2023 to 07Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300303795 Same patient/different product, different dose/event;US-PFIZER INC-2021549691 Same patient/same product, different dose/event;US-PFIZER INC-2021550466 Same patient/same product, different dose/event;
Initially stored in the refrigerator on 13Jun2022 and administration of vaccine on 16Jul2022, 23Jul2022, 24Jul2022; 12 People were vaccinated with the Moderna Covid 19 vaccine past its beyond use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 People were vaccinated with the Moderna Covid 19 vaccine past its beyond use by date) and PRODUCT STORAGE ERROR (Initially stored in the refrigerator on 13Jun2022 and administration of vaccine on 16Jul2022, 23Jul2022, 24Jul2022) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In July 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 People were vaccinated with the Moderna Covid 19 vaccine past its beyond use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Initially stored in the refrigerator on 13Jun2022 and administration of vaccine on 16Jul2022, 23Jul2022, 24Jul2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (12 People were vaccinated with the Moderna Covid 19 vaccine past its beyond use by date) and PRODUCT STORAGE ERROR (Initially stored in the refrigerator on 13Jun2022 and administration of vaccine on 16Jul2022, 23Jul2022, 24Jul2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The number of doses/vials reported were 3 vials and 12 doses. The vial was initially stored in the refrigerator on 13-Jun-2022. The dates of administration and number patients were reported as on 16-Jul-2022 3 patients, on 23-Jul-2022 5 patients and on 24-Jul-2022 4 patients. All the vials were moved to fridge on the same day on 13-Jun-2022. The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.  This case contains the information of the eighth of 12 patient who received the vaccine on Jul-2022 as described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2022-615215 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2022: Follow Up received contains reporter details and updated narrative.; Sender's Comments:  MODERNATX, INC.-MOD-2022-615215:Master Case
other serious neurological problems; herpes zoster; post herpetic neuralgia; hearing problems; Information has been received regarding a case in litigation from a lawyer and the pt on 14-DEC-2020, referring to a currently 73 year old pt of unknown gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 27-FEB-2012, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot# and route unknown) for long-term prevention of shingles and zoster-related conditions. The pt suffered the following injuries as a result of the zoster vaccine live (ZOSTAVAX) vaccine: herpes zoster, postherpetic neuralgia, hearing problems and other serious neurological problems. The outcome of herpes zoster, postherpetic neuralgia, hearing problems and other serious neurological problems was unknown. The causality assessment between herpes zoster, postherpetic neuralgia, hearing problems and other serious neurological problems with zoster vaccine live (ZOSTAVAX) was reported as related.
PATIENT SELF-MEDICATED WITH TYLENOL(1000MG) AND BENADRYL(50MG) AT 0906 PRIOR TO RECEIVING COVID-19 VACCINE. PATIENTED PRESENTED WITH SYMPTOMS OF MILD THROAT SWELLING AND  PINS AND NEEDLES SENSATION(PARESTHESIA) IN EXTREMITIES BILATERALLY. VITAL SIGNS WERE TAKEN AT 0944, 0947 AND 1014 AM. DOCTOR CALLED AT 1020 AM; DOCTOR SAW PATIENT AT 1028 AM. PATIENT DISCHARGED FROM COVID-19 VACCINE SITE AT 1048 AM. VITAL SIGNS;  @0944 B/P: 154/103      HR: 68   R/R: 20   SPO2: 100%   TEMP. 98.4  F ORALLY @0947 B/P: 142/93 @1014 AM B/P: 125/84   HR: 66    R/R: 16   SPO2: 100%     TEMP.: 97.8 F ORALLY
"Covid Arm".  Bright red mark on left arm at injection site.  Large bump underneath mark.  Very sore to the touch.  Also night sweats. Started day after vaccine and went away 2 days later.  Returned 1 week later with same symptoms. Mark finally went away 2 days after that.
Weakness in upper left arm noticed within 1 hour of injection. Weakness remains. Soreness at the injection site lasting 4 days. Soreness in the muscle where the injection was given lasting 4 days.
Child diagnosed positive pertussis by PCR on 11-23-12. Treated with Z-pack.
Pt recvd 3 doses of engerix-B & it was determined that pt did not seroconvert; 4th & 5th doses of Engerix-B were administered;
Chemical taste in the back of throat taste of vaccine; This is a spontaneous report received from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration on the left arm on 18Mar2021 at 15:45 (at the age of 32-year-old), as single dose for COVID-19 immunisation. Medical history included celiac. The patient has allergic to latex. Concomitant medication included tramadol (MANUFACTURER UNKNWON) and multivitamin ritual (MANUFACTURER UNKNOWN) from an unknown date and for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via an unspecified route of administration on the left arm on 22Feb2021 at 15:00, as single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not tested positive for COVID-19. On 18Mar2021 at 16:00 (for 2 hours after second dose), the patient experienced chemical taste in the back of throat taste of vaccine. On the following day, the patient had the same feeling which went away quickly. The patient described the event as it was similar to when she swallows a pill and it gets stuck or had not enough water. The patient did not receive any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event chemical taste was resolved on 19Mar2021.   No follow-up attempts possible. No further information expected.
R arm edema 5inch X 7 inch, eyes swollen shortness of breath, rapid pulse and chest pain.
This spontaneous report was received from a 69 year old female patient consumer referring to herself. The patient's current conditions included: bipolar disorder, additionally the patient's concomitant therapy included an unknown number of medications for treatment of bipolar disorder. The patient's allergies and drug reactions included: alfentanil (manufacturer unknown), codeine (manufacturer unknown) and Penicillin (manufacturer unknown). On unknown date in November 2017, the patient started therapy with BELSOMRA oral, tablet (dose, frequency, lot number and expiration date were not reported) for insomnia. On 27-NOV-2017 the patient fell down, went to the emergency room and sought medical attention. The patient was diagnosed with pneumonia and subsequently she was admitted to a medical center. She was discharge on 30-NOV-2017. The patient was treated with ZITHROMAX and MUCINEX. Therapy with BELSOMRA was continued. The outcome of pneumonia and fall was reported as not recovered. The reporter did not assess the causal relationship between therapy with BELSOMRA and the aforementioned events. Upon internal review the event of pneumonia was considered to be medically significant event. Follow-up information has been received from a consumer on 08-DEC-2017. The patient's allergies and drug reactions included: fentanyl, NEURONTIN and ampicillin. On an unspecified date, the patient received a second unspecified "pneumonia shot" Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (formulation,strength, dose, frequency, route, indication, lot# and expiration date were not provided). Also, on an unspecified date, the patient was vaccinated with PREVNAR for sleep (formulation, strength, dose, frequency, route, lot# and expiration date were not provided). The causality between the events and Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) was not provided. The reporter considered the pneumonia as disabling.
headache and fatigue for 24 hours; headache and fatigue for 24 hours; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 immunisation. The following information was reported: HEADACHE (non-serious), FATIGUE (non-serious), outcome "recovered" and all described as "headache and fatigue for 24 hours".  Additional Information:Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Off label dosing frequency; Diagnosed with COVID; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Diagnosed with COVID) and OFF LABEL USE (Off label dosing frequency) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010N20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced COVID-19 (Diagnosed with COVID). On an unknown date, the patient experienced OFF LABEL USE (Off label dosing frequency). At the time of the report, COVID-19 (Diagnosed with COVID) and OFF LABEL USE (Off label dosing frequency) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, SARS-CoV-2 antibody test: positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications include medications for anxiety and peptic ulcer disease.  Treatment medication include monoclonal antibodies   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Follow up received on 6-Apr-2021 added hcp details, concomitant medication, treatment details
Information has been received from a physician concerning her daughter with a history of migraine in past who on an unspecified date was vaccinated with GARDASIL vaccine (yeast). There was no concomitant medication. The physician's daughter said GARDASIL vaccine (yeast) aggravated her migraine condition. Subsequently, "within a day or two after receiving vaccination", the patient recovered from aggravated her migraine condition. The patient sought unspecified medical attention. Additional information has been requested.
In the early afternoon hours I was doing a physical count of Moderna compared to how many administered doses. I discovered we had one extra dose of Moderna on the table. I then accounted for the doses of Pfizer in the building compared to the doses recorded as given and discovered we were missing one dose. I went back through the system and reviewed the records of the seven Moderna patients we had seen that day. One patient was noted as given Pfizer that was scheduled to receive Moderna. I notified my supervisor of the finding.
Fussy, low fever, pain when moving or touching his leg, hard lump at injecton site accompanied by redness around area.
had fever that got to 104.9; severe headache; chills; extreme shaking; eyeballs hurt; This is a spontaneous report from a contactable consumer reported for himself. A 72-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6205; Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 09Mar2021 12:00 (at the age of 72-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included cardiac arrest, have pacemaker, neuropathy, covid-19 from an unknown date and unknown if ongoing. Concomitant medication(s) included apixaban (ELIQUIS); pregabalin (LYRICA); duloxetine (DULOXETINE); atenolol (ATENOLOL); spironolactone (SPIRONOLACTONE) taken for an unspecified indication, start and stop date were not reported. The patient previously took meloxicam (MELOXICAM) and Vicodin (VICODIN) and experienced known allergies. No other vaccine in four weeks. Had COVID prior vaccination and COVID was not tested post vaccination. The patient experienced had fever that got to 104.9, severe headache, chills, extreme shaking, eyeballs hurt on 10Mar2021 16:00. Over 24 hours later, had fever that got to 104.9, severe headache, chills, extreme shaking. Got fever down to 103 after few hours, then hours later to 99.8. (3:30 am). This morning 99.1 then back up now to 100.4. Headache but not so severe and eyeballs hurt. No treatment was received. Clinical outcome of events was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from the Vaccine Coordinator referring to a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 14-SEP-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.
Body aches and headache starting the evening of receiving vaccination Continued body aches and headache next day 2 days after, feeling of being "run-down" and generally tired.
Admitted on 7-24-2022 for covid symptoms and sepsis.  Patient stated that he had flu like symptoms.
I woke up at 11:30PM violently shaking and immediately began vomitting. I vomitted on and off for several hours, and the violent shaking continued as well. I was weak and tired. I did not seek treatment. I took Tylenol for muscle pain, joint pain, and fever. I did not feel better until the morning of Sunday May 30.
Little bruised dots on both thighs; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Little bruised dots on both thighs), HEADACHE (Headache) and FATIGUE (Tired) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONTUSION (Little bruised dots on both thighs), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, CONTUSION (Little bruised dots on both thighs), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Patient hospitalized for cesarean section within 6 weeks of receiving COVID vaccination. Per notes both mom and baby were healthy at that time.
products been administered post excursion with no reported adverse event; Initial information received on 08-Nov-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 48 years old female patient who has been administered Influenza Quadrival A-B Multidose vaccine Preserved [fluzone] post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect Influenza Quadrival A-B Multidose vaccine preserved Suspension for injection of lot U8041DA and expiry: 28-Jun-2024 via unknown route in unknown administration site for immunization; post excursion with no reported adverse event (poor quality product administered) (latency: same day).  No lab data was reported.  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 Good Pharmacovigilance 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.; Sender's Comments:  US-SA-2023SA353747:01836277 US-SA-2023SA353755:01835076, 01836277, 01836324 US-SA-2023SA351631:01835076
patient received the vaccine at around 930am on 11/21/2020.  Patient came back to the pharmacy at around 230pm on the same day 11/21/2020.  The patient mentioned to me that she could not raise her left arm at all, where the vaccine was given.
The patient presented to medical Clinic with mother stating she would like for patient to receive an influenza vaccination as well as a Covid-19 booster vaccination. Myself, a nurse practitioner, brought the mother and patient back to the clinic room and verified name, date of birth, and intended vaccinations requested. Patient and mother verified all information. I accidently mixed up the patient's birthdate due to reading numbers incorrectly and thought patient was 12+ years old. Because of this, the patient accidently received the Covid-19 booster intended for age 12+ instead of the appropriate dose intended for an 11 year old patient. I was unaware of the mistake until I was recently contacted by my manager on 11/14/23 after the mistake was discovered.  I have attempted to contact patient's mother via telephone with no answer. safe voicemail was left by myself asking to return call to clinic at earliest convenience with a brief reason for call explained. Clinic telephone number provided. At the current time of submitting this form, I have not yet made contact with patient's mother to explain what happened and see if any adverse reactions have occurred.
Pt became unresponsive after leaving health department according to his mother. She brought him back and he was very lethargic. The physician evaluated him and within 10 minutes he was fully responsive.
left arm is sore to the touch; left arm is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left arm is sore to the touch) and VACCINATION SITE ERYTHEMA (left arm is red) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069H21A, 023M20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE PAIN (left arm is sore to the touch) and VACCINATION SITE ERYTHEMA (left arm is red). At the time of the report, VACCINATION SITE PAIN (left arm is sore to the touch) and VACCINATION SITE ERYTHEMA (left arm is red) outcome was unknown.            No concomitant drug details were reported. No treatment details were reported.
I noticed hearing problems compounded with ringing in my left ear. I decided to see my primary care physician who referred me to the audiologist, for MRI and ENT evaluations.