chrisvoncsefalvay/vaers-outcomes huggingface dataset:
menactra was administered to a patient of age 4 month with no adverse event; Initial information was received on 20-Apr-2023 regarding an unsolicited valid non-serious case from a physician.  This case involves a meningococcal a-c-y-w135 (d conj) vaccine [Menactra] was administered to 4 months old male patient with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (Pentacel) for Prophylactic vaccination (Immunisation) and Rotovax.   On 19-Apr-2023, the patient of age 4 months received a dose of 0.5 ml total suspect of meningococcal A-C-Y-W135 (D CONJ) vaccine Solution for injection (lot number: U7596AB, expiration date: 14-Mar-2025) via intramuscular route in the thigh nos for immunizations (immunisation) with no adverse event (product administered to patient of inappropriate age) (latency: same day).  No lab data reported.  Action taken: not applicable.  Outcome was Unknown for the event menactra was administered to a patient of age 4 month with no adverse event.  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.
nausea; Vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NAUSEA (nausea) and VOMITING (Vomiting) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM (REMODULIN  IV) for Pulmonary arterial hypertension.    The patient's past medical history included Pulmonary arterial hypertension (Primary pulmonary arterial hypertension). Concomitant products included MACITENTAN (OPSUMIT) for an unknown indication.   On 10-Mar-2017, the patient started TREPROSTINIL SODIUM (REMODULIN IV) (unknown route) 5 mg/dl. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced NAUSEA (nausea) (seriousness criterion hospitalization) and VOMITING (Vomiting) (seriousness criterion hospitalization). The patient was hospitalized on 21-Mar-2021 due to NAUSEA and VOMITING. At the time of the report, NAUSEA (nausea) and VOMITING (Vomiting) outcome was unknown.            The treatment medication was unknown.  Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.  Concomitant use of IV treprostinil may have been contributory.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.  Concomitant use of IV treprostinil may have been contributory.
51 yo F with PMHx of asthma, no h/o intubation, pre-DM, known severe allergic reaction to eggs, presenting from upstairs vaccination center for tingling sensation of the lips, itching hives, and heaviness sensation few mins after vaccination.
Pt arrived at observation area. at around 8:45 am.  At 08:53, the patient stated 'I feel dizzy" Patient lower extremities elevated on a chair. V/S obtained BP 152/88, P-61,  SaO2 100%. Pt denied anu other concerns but stated B/P usually 120/70.. POC glucose obtained by EMT. Result 103. Apple juise and Graham crackers given to patient. Pt. stated she has eaten this am but was thirsty. 0905- Pt remains stable with c/o dizziness at same level. VS 151/86, P-60 Sats 100%. Pt. given small bottle of water. Pt. stated she had been under moderate stress due to a recent release from employer. She denied any chronic conditions other than HTN.  09:20- Pt. states she is 'still dizzy' this is what happened last time" EMY and writer continue to monitor Monitoring patient at present.. VS improving. Pt states level of dizziness unchanged. BLE remain elevated on chair. Stated she 'felt a headache coming on'. VS 140/81, P-62, Sats 100%  09:46- Recheck of vital signs- 145/87, P-61, Sats 100% Pt stats she is starting to 'feel better' juice pak, small bottle of water and  @) graham crackers consumed.  10:00- Pt has felt 'well' and wants to leaved. VS stable. B/P 147/68, P-61, Sats 100%. Writer walked with pt. to elevator. Tolerated well. Denies any issue of dizziness.. Pt. discharge to home. All questions answered. Impression- vertigo and elevated blood pressure related  to anxiety. Pt advised to follow up with her MD. Also advised to call 911 if symptoms return. Pt verbalized understanding of all information.
Painful arm from Shoulder to Wrist. Body ache from head to toe. Heavy Chills with spikes of high Temperature.
temperature excursion involving ACTHIB, were administered twice post excursion, The condition was 31.5F for 1 hour and 58 minutes due to a refrigerator malfunction with no reported adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old female patient who had temperature excursion involving HIB (PRP/T) VACCINE [ACT-HIB], were administered twice post excursion, the condition was 31.5f for 1 hour and 58 minutes due to a refrigerator malfunction with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.  On 06-Jul-2022, the patient received a 0.5ml 1X(once) dose of suspect HIB (PRP/T) VACCINE (strength, formulation was unknown, lot UJ604AAA and expiry date: 29-Oct-2022) via intramuscular route in the left thigh for Immunization.  On 06-Jul-2022 the patient developed a non-serious event of temperature excursion involving acthib, were administered twice post excursion, the condition was 31.5f for 1 hour and 58 minutes due to a refrigerator malfunction (not human error) with no reported adverse event (poor quality product administered) (Latency: same day) following the administration of HIB (PRP/T) VACCINE.  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  Outcome: 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.
NUMBNESS AND TINGLING IN THE LIPS, HANDS AND HEADACHE WEAKNESS IN LOWER EXTREMITIES
Info has been received from a health professional concerning a 10 year old male with no medical history and no allergies who on 5/21/97 was vaccinated with a 1st 0.5ml dose of varicella virus vaccine live. Concomitant medication included a 5th dose of DTAP. On 11/18/05, the pt started with an itchy rash. He was seen in the office on 11/20/05 with 10 lesions, some vesicles and papules and some scabbed over. The pt was afebrile. He was treated with Benadryl and calamine lotion. Subsequently, the pt recovered. No product quality complaint was involved. Follow-up info indicated that the pt was seen in the office with chicken pox on 11/20/05, after having an itchy rash for 2 days duration, since 11/18/05. The pt had scattered papules, many scabbed and some near vesicles. There were about 40 lesions. It was noted that 3 classmates had chicken pox. The pt was sent home with recommendation for symptomatic treatment and isolation for the duration of the rash. The pt recovered on 11/26/05. The pt's sibling had chicken pox after vaccination with varicella virus vaccine live. Additional info is not expected.
Information has been received from a licensed practical nurse concerning a 32 year old female whon on 6/5/02 was vaccinated with her second dose of hep B vaccine recombinant. On 6/5/02 the pt received the vaccine intradermaly into the left forearm developing a 4mm wheal at injection site that has not resolved. Unspecified medical attention was sought. Additional info has been requested.
19 minutes post-vaccination, C/O tingling of tongue and roof of mouth; no dyspnea; BP 120/80, pulse 104 resp-18 O2 sat= 98%; gave Benedryl po 50 mg and juice; continued to observe until 2pm at which times s/s subsided; vitals signs remained stable; discharged in the care of her mother.
pt recvd flu vax on 24SEP93 & felt extremely tired for 2 days;
Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that vaccine administered to total of 24 patients including 15 males and 9 females, mostly for booster shots. No side effects was reported No concomitant medication was reported. No treatment medication was reported.
12/31/2016 initial tingling in feet. 1/1/2017 unable to walk steady, used a cane, went to emergency room at hospital. Sent home. 1/4/2017 saw Dr. at Clinic, walking with a cane. Appointments made for future dates, sent home. 1/4/2017 wife drove me to another Hospital. Emergency room did spinal tap, results showed GBS, checked into hospital and treated for GBS with IVIG, five daily treatments of IVIG.
Patient called Pharmacy stating he had a swollen lip. I informed patient to take some benadryl and recommended he proceed to the ER due to lip swelling which could be a  sign of a severe allergic reaction.
nausea; dose of MMR ll  was administered via the intramuscular route versus fue subcutaneous route; The patient received her first dose of MMR ll; This spontaneous report was received from a pharmacist and refers to a 21-year-old, non-pregnant female patient. She had no known allergies. No information regarding her pertinent medical history, drug reactions or concomitant therapies was provided.  On 08-JUL-2020, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) intramuscularly, lot # S018594, expiration date: 17-JUN-2021 (exact dose and injection site were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK) intramuscularly, lot # S029574, expiration date: 29-MAY-2022 (exact dose, indication and injection site were not provided). On the same date, she experienced nausea. The patient did not seek medical attention and there were no lab diagnostic studies performed. No treatment was given for the adverse event. The outcome of nausea was unknown.  The relatedness between the event of nausea and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) and sterile diluent (MERCK) was not provided
had two little bumps on her collar bone; Swelling on collar bone; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 54-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0161), via an unspecified route of administration in left arm on 18Apr2021 (age at vaccination 54-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history included ongoing asthma. Concomitant medications were not reported. Had an inhaler but she was not using it because she was taking care of herself when she goes outside. No further details provided. On 19Apr2021, the patient experienced swelling and two little bumps on her left collarbone. The patient reported that she had two little bumps on her collar bone that started at 12:30 at night. Patient stated that on Sunday she had the vaccine on her left arm and two days after she has swelling and two little bumps on her left collarbone. Stated that she was scared. Stated that she did not know if the swelling was going to go or if it will be increasing. Did not know what to do. Clarified vaccine as Pfizer Covid vaccine and it was her first dose. No treatment was taken for the events. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information was expected.
I had 2 shots and still break out/ Suspected vaccination faliure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had 2 shots and still break out/ Suspected vaccination faliure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 22-JUL-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received two doses of Shingles vaccine and still experienced break out. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Patient reports intermittent fever, sweats, fatigue, insomnia, decreased appetite, nausea, and vomiting after receiving 2nd series of Shingrix on 6/22/23. Symptoms were severe enough for patient to go to Emergency Department on 6/22/23; he was discharged home later that day. Symptoms slowly improved but still persisted until last date of contact on 6/30/23.
pt recvd 3 doses of Engerix-B & less than 24 hrs p/3rd dose devel malaise, fatigue & tiredness which persist;
11:00PM very tired and fatigued day of vaccination, left eyebrow 3 large bumps, 1 bump on forehead felt like pimples resolved in the AM  arm pain to hand tongue was numb in AM and voice hoarse during the day to evening tongue numbness began to resolve and. Injection site was red and swollen welt at site where injection puncture  3-4 day rash on neck resolved later in day. All symptoms have resolved today
On March 6, I woke up feeling like I had a Charlie horse in my left calf. I tried to walk and it was sore but I felt it would go away in a day or two. By Wednesday, March 10, I called my doctor and after telling them my left calf hurt , they had me come right in. After seeing dr  I was sent to get a sonogram immediately  and was told I had a blood clot  inside my  left knee. I was sent back to Dr and was given Xerelto 15 mg twice a day for 21 days and the 20 mg once a day until gone.  Today,, it is still sore. I am asking if I should take my second shot on March 29 or not.
Slight hot flash; Back,butt and down right thigh feel like a thousand needles are pricking skin; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration on 22Feb2021 at 08:15 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation (Afibrulation), chronic obstructive pulmonary disease (COPD), chronic sinusitis and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included celecoxib (CELEBREX), salbutamol (ALBUTEROL), theophylline (MANUFACTURER UNKNOWN), estrogens conjugated/medroxyprogesterone acetateprempro (PREMPRO) and gabape (MANUFACTURER UNKNOWN); all from an unknown date and unknown if ongoing for an unknown indication. The patient previously took codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982) via an unspecified route of administration in the left arm on 01Feb2021 at 08:30 AM for COVID-19 immunisation. On 23Feb2021 at 20:00, the patient experienced a slight hot flash, then the patient's back, butt and down her right thigh felt like a thousand needles were pricking her skin which was hurt for about 5 to 10 seconds. Therapeutic measures were taken as a result of the events and included treatment with unspecified pain medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events slight hot flash and back, butt and downright thigh felt like a thousand needles pricking the skin were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
I had long COVID syndrome. I couldn't breathe properly and couldn't get enough air in my lungs. I was so winded from doing any activities in the house. I tried to exercise and I would get chest pain. When I tried to catch my breath or cough, I would cough up a watery substance. I went to the urgent care and they gave me an albuterol inhaler, cough syrup, and steroid pack.
Post vaccination, patient had a syncope episode. Patient sustained a contusion and abrasion to right side of head due to fall. No bleeding from fall. EMS was contacted to evaluate patient. No hospitalization or emergency room required. Patient released to parents.
pt recvd vax & devel ataxia; dx w/ opsoclonus; myoclonus synd;
Mother of infant reported temp. of 101.4 at 7pm Thursday 6/2/16. Her right leg felt warm, was red and swollen. She was given TYLENOL every 4h through Friday 6/3/16. Mom was instructed to take to ER.
On 04/16/2022 I had headache, congestion, brain fog, and head pressure. Then I began having muscle aches and pains. Fatigue was better than with Pfizer but still had minor fatigue. Symptoms began subsiding and by day 4 I was able to return to normal activities. On 4/21 or 4/22 began having minor respiratory issues. Tested positive for COVID-19 on 04/23. By 04/24 symptoms became severe enough that I made a telehealth appointment. The MD live provider prescribed an inhaler and a physician from my PCP's prescribed Paxlovid. Began Paxlovid on 4/26 and respiratory symptoms began improving but fatigue is still lingering. I would say that my symptoms are 80% resolved.
This case was reported by a healthcare professional and described an adult subject of unspecified gender who did not respond to immunization with Engerix B for prophylaxis. On an unspecified date before 13 November 2006 the subject received an unspecified dose of Engerix B. The healthcare professional reported that the subject received the full vaccine series. On an unspecified date on or before 13 November 2006, at an unspecified time after vaccination with Engerix B, a hepatitis B surface antibody titer indicated that the subject had no response to the vaccine.
Loss of equlibrium; Chills, shivering and shaking; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Loss of equlibrium) and CHILLS (Chills, shivering and shaking) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A. and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced BALANCE DISORDER (Loss of equlibrium) and CHILLS (Chills, shivering and shaking). At the time of the report, BALANCE DISORDER (Loss of equlibrium) and CHILLS (Chills, shivering and shaking) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  Concomitant product used was not provided by the reporter. Treatment information was not provided by the reporter.
Within 24 hrs had pain, swelling, low grade fever (99 degrees) and rash. Rash was 8X12 cm
Burning and swelling in left arm. Visible streak from injection site on upper arm to blisters on forearm. Fever, soreness in areas where the streaks were.
Phone call fr mom: pt became flaccid turned white in color w/blue lips & cool skin;
1) Fever 103 degrees (the fever got over after 1.5 days).  2)  Reduced sense of taste (over a week) 3) Tiredness ( a week) Did not take any medicine
Nose bleed the next day; Immediate pain through the hand and fingers on the arm; This is a spontaneous report received from a contactable consumer (patient).  A 37-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 21Apr2021 17:30 (Batch/Lot number was not reported), age at vaccination of 37-years-old, as single dose, for covid-19 immunisation. Medical history included corneal erosion from an unknown date and unknown if ongoing (Recurrent Corneal Erosion syndrome), food allergy from an unknown date and unknown if ongoing known (allergies to Dairy products), allergy to chemicals from an unknown date and unknown if ongoing known (allergies to MRI contrast dye). The patient was not pregnant and was not pregnant at the time of vaccination. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX) taken for an unspecified indication, start and stop date were not reported; hydroxyzine (HYDROXYZINE) taken for an unspecified indication, start and stop date were not reported; valeriana officinalis root, valeriana officinalis root extract (VALERIAN ROOT EXTRACT) taken for an unspecified indication, start and stop date were not reported. . The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took penicilline and experienced drug hypersensitivity, quinolones and experienced drug hypersensitivity, zoloft and experienced drug hypersensitivity. The patient experienced immediate pain through the hand and fingers on the arm it was administered on 24Apr2021 at 12.00 and  woke up with a nose bleed the next day on 23Apr2021. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.