chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Well visit 10-19-09, chest clear. Received H1N1 vaccine. By supper time, wheeze and resp distress. Fever by next a.m., Several meds given. In office: pulse ox 85%, admitted to PICU.  11/19/09:  ED and hospital received for date of service 10/19 and 10/23/09. Dx:  Pneumonia, asthma, hypoxia.  Assessment:  Presented with 2 day hx. of SOB, oxygen sats. 85%, respiratory distress, non-productive cough, wheezes, rhinorrhea, tachycardia, tachypnea,  decreased breath sounds, crackles, increased WOB,  vomited x 3, moderate retractions, and fever of 101 degrees. Treated with IV fluids, Antibiotics, nebulizer therapy, oxygen therapy, Tamiflu, admitted to PICU. Discharged in improved condition.
Initial misuse report received from a healthcare professional on 27 JUNE 2013. It was reported that a 16-month-old patient was administered ADACEL instead of DAPTACEL. No adverse event was reported. Documents held by sender: none
FATIGUE AND DYSPNEA ON EXERTION EVER SINCE GETTING COVID VACCINE
I had 2nd Pfizer vaccine in my left arm at 3pm 04/28/2021 and 1130 AM 4/29/2021 was expecting severe cramping and gastrointestinal pains  I started vomiting and continued for 36 hours.  I had fever chills  severe fatigue.   I was throwing up bile.  I couldn?t eat or really do anything for 4 days.  On ?Monday May 3rd those symptoms subsided but I then experienced a bad sinus infection along w high fatigue but unable to get real sleep just rest.  I also felt like my head is cloudy.
+25 hours: severe nausea, moderate diarrhea, moderate chills, no fever.
Tested positive for Covid 19 on 09/20/2021 - mild congestion for 3 days
Pt developed palpitations 3.5 hrs after dose (along w/nausea, malaise, fatigue). She did not require ED or office eval, just monitored on her own. Then 3/13 pt had a presyncopal episode w/profound weakness sensation, flushing and nausea
Pt was initially cleared for no reaction after 15 minutes of monitoring, however, once she left our office and drove down the street, she has numbness, tingling and swelling in the left side of her face. she drove right back. declined chest pain, sob, throat swelling. pt vitals were stable, and after another 15 minutes of monitoring her symptoms started resolving
I tested positive for COVID-19 on Fri (09Sep2022); This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I tested positive for COVID-19 on Fri (09Sep2022)) in a male patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Sep-2022, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Sep-2022, the patient experienced COVID-19 (I tested positive for COVID-19 on Fri (09Sep2022)). At the time of the report, COVID-19 (I tested positive for COVID-19 on Fri (09Sep2022)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2022, SARS-CoV-2 test: (Positive) Tested positive for Covid-19.     The action taken with mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       Company comment: This is a spontaneous case concerning a male patient of unknown age with no reported medical history, who experienced the non-serious unexpected event of COVID-19, the next following day after receiving booster dose with mRNA-1273.222 BIVALENT vaccine.  SARS-CoV-2 test was performed with positive result. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  No concomitant medications was reported. No treatment drug details was reported. Sender's Comments: Company comment: This is a spontaneous case concerning a male patient of unknown age with no reported medical history, who experienced the non-serious unexpected event of COVID-19, the next following day after receiving booster dose with mRNA-1273.222 BIVALENT vaccine.  SARS-CoV-2 test was performed with positive result. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No concomitant medication was reported.  No treatment medication was reported.  This case was related to patient number 69 out of 190 patients   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment details provided. No concomitant medications provided.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant  medication were reported.   No treatment drug were reported.  The vaccines was stored in freezer, they take out one to two vials and place in fridge each day as needed.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  Concurrent medical conditions included dialysis.  Subjects had previously received Recombivax and did not respond to therapy.  On an unspecified date the subject received unspecified dose of Engerix B (unknown).  At an unspecified time after vaccination with Engerix B, the subject did not respond to therapy as laboratory results did not show anti-hepatitis B antibodies.  At the time of reporting the outcome of the event was unspecified.  The nurse reported that this occurred in a total of eight patients.  GSK case numbers are A0638778A and A638780A through A0638786A.
Lung cancer; A spontaneous report was received from a consumer concerning her mother, a female patient, who was diagnosed with lung cancer/lung neoplasm malignant.  The patient's medical history was not provided by the reporter. Concomitant product use was not provided by the reporter.  On unknown date , the patient received their first of their two planned doses of mRNA-1273 (Lot number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On an unspecified date, post-vaccination, the patient was diagnosed with lung cancer. Treatment  information was not provided.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event, lung cancer, was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Patient came in to store on 3/5/19 letting us know her arm had swollen up, was red, hot and had gone to the ER for treatment. She said it started about 2 days after receiving the first dose of SHINGRIX.
This spontaneous report as received from a pharmacy technician refers to a 4 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 13-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1802USA001558:
Body Ache - Base of Neck, Shoulders, Back, Thighs, Arms,
Redness that is spreading, itchiness, swelling lump at injection site; itchiness, swelling lump at injection site; swelling lump at injection site; swelling lump at injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: EW0168), dose 1 via an unspecified route of administration, administered in arm left on 17Sep2021 12:00 (at the age of 40-year-old) as dose 1, single for COVID-19 immunization. Medical history included Sulfa allergies. The patient's concomitant medications were not reported. The patient previously took doxycycline and experienced allergies and dichloralphenazone;isometheptene;paracetamol (MIDRIN) and experienced allergies. 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. Since the vaccination, the patient has not been tested for COVID-19. On 18Sep2021 at 15:00, the patient experienced redness that is spreading, itchiness, swelling lump at injection site. Therapeutic measures were taken as a result of the reported events which included Benadryl. The outcome of the events was not recovered.
At the time of vaccination the arm was free of any scabs/sores/abrasions, etc.  After the vaccination, patient came in and showed me his arm.  The injection site had a local scab at the injection site.   Additionally, what likely was the site of the FIRST Shingrix injection was also scabbed.  The area was about the size of a quarter, local, circular shape.
Initial report received from healthcare professional on 11 September 2014. A 66-year-old male patient, whose concomitant medications were not reported, had received a dose of FLUZONE HD (batch number: U5017AA, intramuscular in left deltoid) having expiry date: 3 April 2015 on 11 September 2014. It was noted that, the patient had no known allergies but has hypertension and glaucoma. As per reporter, the patient had no acute illness at the time of vaccination. It was reported that on 11 September 2014, on the same day after receiving FLUZONE HD vaccine, the patient experienced tingling in the face. The patient's corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none. Follow-up information received from the healthcare professional on 20 Oct 2014. Received no additional information.
Patient had been in the clinic room for about 10 - 15 minutes after he received the RabAvert vaccination.  He was fine in the clinic room, no symptoms reported.  He walked out of the building with his parents.  Once outside he complained of tingling in his throat and mouth.  He continued out to his parents car.  His symptoms worsened with continued tingling in throat and mouth, nausea, and chest pain.  His parents drove to outside the health department's door and his father came to get me.  911 was called as I went out to the car.  When I arrived to the car, he was lying on his right side on the back seat of the car.  His blood pressure was 110/66 and his pulse was 104.  He was diaphoretic and complained of chest pain and nausea.  He vomited.  He said he was afraid.  The ambulance arrived and took him to the ED.  In the ambulance, he was treated with benedryl 50 mg IVP. At the ED, he was found to have a rash on neck, trunk,and hands.  BP 138/68, pulse 89, respirations 16.  Treated in ED with solumedrol 50 mg IVP X1 and Pepcid 20 mg IV.  He was sent home with prednisone 2 pills daily X 4 days, then 1 pill daily X 3 days, Benedryl 25 mg q 6 hrs for 4-5 days, and pepcid 20 mg q 12 hours prn for hives not controlled by benedryl.  History of 5 doses Rabies post-exposure vaccination in 1993 with Imovax.  No reactions to any of those vaccinations.
Like mild flu symptoms; Sore left arm; Low fever 99F; Chills; Achiness; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Like mild flu symptoms), VACCINATION SITE PAIN (Sore left arm), PYREXIA (Low fever 99F), CHILLS (Chills) and MYALGIA (Achiness) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2020, the patient experienced INFLUENZA LIKE ILLNESS (Like mild flu symptoms), VACCINATION SITE PAIN (Sore left arm), PYREXIA (Low fever 99F), CHILLS (Chills) and MYALGIA (Achiness). On 31-Dec-2020, INFLUENZA LIKE ILLNESS (Like mild flu symptoms), VACCINATION SITE PAIN (Sore left arm), PYREXIA (Low fever 99F), CHILLS (Chills) and MYALGIA (Achiness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, Body temperature: 99 (Low) 99 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-410982, MOD-2021-410984 (Patient Link).
felt like he got wallaped in the left injection site arm with both Moderna Covid-19 vaccines.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (felt like he got wallaped in the left injection site arm with both Moderna Covid-19 vaccines.) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced VACCINATION SITE REACTION (felt like he got wallaped in the left injection site arm with both Moderna Covid-19 vaccines.). At the time of the report, VACCINATION SITE REACTION (felt like he got wallaped in the left injection site arm with both Moderna Covid-19 vaccines.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were provided by the reporter.   This case was linked to MOD-2021-361616 (Patient Link).
Arm hurts at injection site. It has been three weeks and still having problem with range of motion.
Extensive swelling of vaccinated limb/swelling; Arm redness, large red area; Itching, itchiness; puffy skin; Arm Heat; Temp 99.3 degrees; This case was reported by a consumer and described the occurrence of extensive swelling of vaccinated limb in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included paracetamol (Tylenol).   On 11th January 2023, the patient received the 1st dose of Shingrix. On 11th January 2023, less than a day after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, erythema of extremities, pruritus and puffy skin. In January 2023, the patient experienced extremities hot feeling of and body temperature increased. On an unknown date, the outcome of the extensive swelling of vaccinated limb, erythema of extremities, pruritus and puffy skin were not recovered/not resolved and the outcome of the extremities hot feeling of and body temperature increased were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema of extremities, pruritus, extremities hot feeling of, body temperature increased and puffy skin to be related to Shingrix.  Additional Information: GSK Receipt Date: 16-JAN-2023 Reporter's Comment: The case was reported by the patient. The reporter stated that it had been 4 days.  Her arm had large red area with itchiness and heat (Just to temperature 99.3 degrees F). The patient also experienced puffy skin.  The arm redness, swelling, puffy skin and itching and the symptoms were not treated. Permission to contact the reporter. Additional Supportive Information: Fever was not captured as event because it was not cleared if patient experienced it or not. Additional Supportive Information: The case US2023005866 was found to be duplicate of case US2023006720. Hence case US2023006720 would be deleted and all the information of this case would be added in case US2023005866 which was the case of record for this patient.
This literature report has been received from the authors of a published article. In this case series, the authors described seven immunized healthy children without a history of primary varicella who presented with herpes zoster that correlated with the vaccination site of live attenuated varicella-zoster vaccine. These cases highlight the varied clinical presentations and diagnostic and therapeutic considerations for herpes zoster in healthy children. Seven vaccinated healthy children without underlying immunodeficiency presented with herpes zoster in the limb that correlated with the vaccination site. Their clinical histories are summarized. Each patient underwent varicella zoster vaccination at 12 to 14 months of age. The pediatrician's office confirmed the site of vaccination in six patients and the parents in the seventh. Median age at presentation was 3 years (range 1.5-6 years). There were no precipitating factors elicited by history in five patients; one patient developed the rash at the site of recent influenza vaccination and one patient developed the rash after surgery. The morphology of the lesions included erythematous papules, pseudovesicles, pustules, and plaques, with associated pain in two patients and pruritus in three. Systemic symptoms ranged from none to low-grade fevers, upper respiratory symptoms, and joint pain. Clinical and laboratory findings, specifically positive direct fluorescent antibody (DFA) testing, were consistent with herpes zoster in four cases; because of distinct similarities in the clinical examination, DFA testing was not conducted in the other three cases. Acyclovir was prescribed for five patients but deferred in two because of the mild or late presentation. The evaluating physician's differential diagnosis in the seven cases included viral exanthem, eczema herpeticum, atopic dermatitis, contact dermatitis, microcystic lymphatic malformation, herpes simplex infection, and herpes zoster infection. In one patient with knee pain, there was initial concern for septic hip, but inflammatory markers were not elevated, joint effusion was not seen on ultrasound, and the rash and knee pain self-resolved after several days. This report refers to a 2 year old female patient without a history of primary varicella. On an unknown date, the patient was vaccinated with varicella-zoster vaccine (code as "varicella virus vaccine live (Oka/Merck) (manufacturer unknown), Zoster Vaccine Live (manufacturer unknown) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (manufacturer unknown)") (dose and route unknown, right arm) for prophylaxis. On an unknown date (reported as 12 months later), the patient experienced herpes zoster in right arm (in C6 dermatomal distribution) with symptoms of fever and itchy lesions. The direct fluorescent antibody (DFA) testing was positive. The patient received acyclovir treatment for the event for 10 days. The outcome of the event was recovered without complications. The reporter considered the event of herpes zoster was related to the suspected therapies. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1802USA003640:
Patient c/o headache, dizziness and feeling shaky. States that she was feeling anxious prior to receiving vaccine. Patient appears well, in NAD. Had patient lie down for 15 minutes. Vital signs noted; wnl. After 15 minutes had her sit up and drink juice and eat crackers. Waited ten more minutes. Patient states that she feels fine and appears well. Had patient stand and ambulate in the observation room. Denies symptoms at this time. Discharged from clinic.
Pt was administered Pfizer COVID vaccine for 12+ instead of Pfizer 5-11 for booster dose. The vial was diluted with 1.3 mL of normal saline. Pt's family was notified and no side effects have occurred.
My period was 5 days early. I'm always regular at 28 days and this time was only 23 days.
Sore arm/neck, fever for approx. 36 hours up to 102.3 F, headache, body aches, chills - symptoms ended after 36 hours
Body aches, chills, headache, diarrhea. All started at 8:30pm on April 26, 2021. The body aches and headaches continued to the next morning