chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine may have been administered post excursion with no reported adverse event; Initial information received on 20-May-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a patient of unknown age and gender to whom  vaccine may have been administered post excursion with no reported adverse event, while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  It  was reported that there was a temperature excursion on unopened IPOL due to refrigerator malfunction (not human error). The time of excursion was 38 hours and 15 minutes and the temperature for excursion was -1.1 C.  On an unknown date, the patient received an unknown  dose of suspect IPV (VERO) (lot : V1A121M ; expiry date: not reported) for prophylactic vaccination.  It was stated that  vaccines may have been administered post excursion with no reported adverse event (Product temperature excursion issue) (onset date: unknown) (latency: same day)  following the administration of IPV (VERO).  Action taken: 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.
Started with palpitations, racing heart beat, sweats, feeling faint, near syncope. Diagnosed with SVTs. Aortic tachycardia. Now having to take beta blockers. Never had issues prior to vaccine.
Patient received ZOSTAVAX immunization, she had a local reaction of enlarged redden area, feverish, hard raised at injection site.
Administered expired booster dose to patient. Moderna Vial expired on 7/06/22 and administered dose on 7/13/22.
Shingles; Rash is still red and raw; The blisters are gone; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2022, the patient received the 1st dose of Shingrix. In April 2022, less than 3 months after receiving Shingrix, the patient experienced shingles, red rash and blister. On an unknown date, the outcome of the shingles and red rash were not recovered/not resolved and the outcome of the blister was recovered/resolved.   It was unknown if the reporter considered the shingles, red rash and blister to be related to Shingrix.     Additional Information: GSK receipt date: 11-May-2022 Reporter's comment: Pharmacist called to receive guidance because a patient had her Shingrix dose but a month ago she developed shingles. The patient also had rash was still red and raw and blisters were gone. Did not consent to follow-up.
patient has had irregular menses, hot Flashes, night sweats and heavy painful periods and now is not having cycles at all started August 2021 right axillary lymphadenopathy. started August 2021 increased frequency and severity of migraines
Within 5 minutes I had a headache. I woke at 12:00 PM with chills and body aches and extreme fatigue. At 9:00 AM on 10/17/17 the symptoms were gone.
shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 09-SEP-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Patient received both IMZ in the same arm. After administration of Twinrx that patient stated her arm felt numb from her finger tips through her shoulder. I offered her an ice pack which she accepted. Monitored her for 20 minutes (policy is 30 minutes but patient did not want to stay because she was feeling better/loosened her wrist brace which happened to also be on the left arm). I called her to follow up 4-6 hours later (7:30pm) to see how she was doing. She said she was doing much better and thanked me for calling.
possible fixed type skin reaction on ulnar surface of left wrist; recurring rash, 5x5cm, started in Jan p/ 1st Anthrax vax
7/18/21 3 pm Seizure  7/18/21 Elevated AST and ALT
Pt had developed warm rash at injection site getting better but red and itchy. Pt is taking TYLENOL and BENADRYL.
Noted today are very erythematous and swollen, left deltoid with no direct tenderness full ROM advised to take Benadryl.
Blisters and rash from shoulders all the way down to my back to coccyx bone all the way around my waist. Rash on right lower leg. And swelling in feet. Went to urgent care. Then went to hospital urgent care.
Tingling of left arm from shoulder to fingertips. BP 142/79 (pulse 100), 99% O2 sat.
Severe body aches, severe nausea, chills, extreme fatigue, fever from 99-101. Symptoms started around 6pm on 4/27 and lasted until  4/30 around 12pm. Treated at home with little relief from over-the-counter pain killers. I would describe it as the sickest I have ever been. Symptoms progressively got better but were very bad on 4/28 and 4/29. Went away very quickly on 4/30.
Large area of erythema, warmth-measures 8by7.5 cm today.
Despite previous varicella vaccination, our patient developed disseminated infection consistent with chickenpox; Despite previous varicella vaccination, our patient developed disseminated infection consistent with chickenpox; This literature marketed report as received from the authors of a published literature article, titled as stated above, refers to a 9-year-old female patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.   On an unknown date, the patient was fully vaccinated with varicella virus vaccine live (oka/merck) (manufacturer unknown) injection (dose, route of administration, vaccination site, lot # and expiry date were not specified) for prophylaxis.   On an unknown date, she was transferred from an outside hospital for worsening cellulitis of her right upper extremity. Two weeks prior to admission she was treated with 10 days of oral clindamycin for cellulitis of her face, chest, and right arm with clinical improvement. Four days after resolution of the cellulitis she developed a new pruritic papule on her right arm. Her sister had several similar lesions which resolved within 48 hours. The patient developed progressive erythema of her right antecubital fossa with evolution to a large, serum crusted plaque. Pruritic vesicles developed on her face, abdomen, and legs. She was transferred to the author's hospital for worsening cellulitis and was started on intravenous vancomycin while wound cultures were pending. Though she experienced moderate improvement in the right arm plaque after several days of vancomycin, she developed progressive vesicles, facial swelling, eye pain, and severe pruritus. Varicella infection was confirmed by direct fluorescence antibody testing. The bacterial culture grew methicillin sensitive Staphylococcus aureus. She was discharged home with oral acyclovir and cephalexin. Despite previous varicella vaccination, the patient developed disseminated infection consistent with chickenpox, which was complicated by a superimposed bacterial infection.  The outcome of the events was not reported. The author considered the events to be related to varicella virus vaccine live (oka/merck) (manufacturer unknown).  Upon internal review, the event of disseminated infection consistent with chickenpox was determined to be medically significant.   A copy of the published article is attached as further documentation of the patient's experience.  Literature report:
whole body felt sore and exhausted; whole body felt sore and exhausted; bad cold/flu; bad cold/flu; little chest pain; minor fever; blood pressure dropped; dizziness; backpain; left arm felt sore; sleepy/light drowsiness; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on the left arm on 11Feb2021 15:30 at a single dose (at the age of 30-years-old) for COVID-19 immunization. Medical history included >13 years ago: diagnosed TB with no symptom, completed TB treatment 1 year-plan and has issue no since then; >16 years ago: Hepatitis-b positive but received treatment and cleared out on diagnostics afterward. The patient was not pregnant. Concomitant medications were not reported. The patient had no COVID prior to vaccination. The patient has no known allergies. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) on 21Jan2021 at 13:15 on the left arm at a single dose (at the age of 30-years-old) for COVID-19 immunization. After about 4.5h post-vaccination (20:00), her left arm felt sore and within the next 3h, she felt sleepy and experienced random light drowsiness. She woke up around 06:30 the next day (12Feb2021) only felt continued sore arm. However, at 08:30 to 09:30, her whole body felt sore and exhausted, especially back pain, as if she having a bad cold/flu. She also felt a little chest pain, had a minor fever and went sleeping from 12:00, woke up around 18:00-19:00. The whole body ache was almost gone but her back was still in pain and her blood pressure dropped with random dizziness when she was walking or standing up. The next morning (13Feb2021), the back pain was gone and she felt it back to normal except for a little random dizziness in movement. She did not take any medication to alleviate the adverse effects during the timeline. The patient was not COVID tested post vaccination. The patient recovered from back pain in 13Feb2021, the patient recovered from the remaining events in Feb2021.
Pt got shot at pharmacy Sunday - about 4 hrs later started with wheezing, cough & resp difficulty. Seen at an urgent care - pt given nebulizer treatment & steroid injection. Told she had abnormal CXR w/ "fluids in her lungs".
No reported adverse event or symptoms, two doses of influenza quad administered in error. Both administered in the right deltoid.
PT REPORTS NUMBNESS AND ITCHING TO THE VACCINATION SITE. SHEE WAS ABLE TO MOVE HER ARM AND FINGER WITHOUTH DIFICULTIES. ICE PACK PLACED ON THE SITE. PT WAS FINE HALF HOUR LATER AND WAS ABLE TO DRIVE HOME
Information has been received from a school nurse concerning a child who on an unspecified date as a baby/toddler was vaccinated with a 0.5 ml dose of Varivax. Subsequently the patient developed a "less severe" case of chickenpox (also reported as small rashes of chickenpox). There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Patient returned to Immunization clinic after going to the lab complaining of fore arm redness, pain, and itching in the same arm a TDap was given. The arm was inspected, no swelling was noted but it appeared slightly more red than the unaffected arm. She stated it was slightly itchy, and somewhat painful. The site of the injection had no symptoms. I contacted my officer in charge, a physician, and he stated it did not sound like an adverse event but to continue with a VAERS report. I noitified the patient of these procedures and instructed her to return if she felt any difficulty breathing, if she noticed the pain/redness spreading, or felt itching anywhere else in her body. The patient verbalized her understanding of these instructions.
"She said on 12/30/16-she started having pain, in right arm, then she started having swelling, redness, and burning pain, after that, and swelling, pain, and redness got worse."
went to sleep and woke up with slight breathing problems.She adjusted sleeping position went back to sleep and the same occurred again. She awoke with breathing problems.; After adjusting the sleeping position again, the patient woke up with a closed throat and no air at all; Breathing returned after a few seconds, Patient stayed awake, and about ten mins later, throat closed and breathing stopped briefly again.; adjusting the sleeping position again, the patient woke up  with a closed throat and no air; She had some redness on the chest; swollen throat; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: 195518-06399, Pfizer NTEC), via an unspecified route of administration, administered in right arm on 19Mar2021 14:15 (at the age of 54-year-old, non-pregnant) as dose 1, single for COVID-19 immunization. Medical history included rheumatoid arthritis. The had not allergies to medications, food, or other products but had allergic reactions to vaccines prior. Concomitant medications included prednisone 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-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that nine hours after the vaccine patient went to sleep and woke up with slight breathing problems. She adjusted sleeping position went back to sleep and the same occurred again. She awoke with breathing problems. After adjusting the sleeping position again, the patient woke up with a closed throat and no air at all. Breathing returned after a few seconds, Patient stayed awake, and about ten mins later, throat closed and breathing stopped briefly again. The patient went to the local emergency room at the hospital where they examined her. She had some redness on the chest, a slightly swollen throat and in order to reduce the swelling and to stop the breathing issues, the doctor administered Benedryl by injection and some steroids. The patient relaxed and returned to normal sleep within a short period of time- 30 minutes. The patient was fine today (as reported). The clinical outcome for the events was recovered on an unspecified date.
Itching, blotches, redness and severe pain immediately after vaccination. Fever 102 degrees - told by dr arm was infected.
Received both doses and was under 50 y/o; Received both doses and was under 50 y/o; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 48-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 26th March 2019, the patient received the 2nd dose of Shingrix. On 24th December 2018, the patient received the 1st dose of Shingrix. On 24th December 2018, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On 26th March 2019, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate age at vaccine administration were unknown.  Additional details were reported as follows: A nurse reported that a 48 year old patient received the 1st dose and the 2nd dose of Shingrix which led to inappropriate age at vaccine administration.   The patient was wondering if 3rd dose was needed since she was under 50 years of age at time of vaccination. The reporter consented to follow up. The HCP did not want to provide the patient's DOB but did consent to follow up.
injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; feeling unwell; dizziness; weakness; This is a spontaneous report from a contactable consumer (patient).   A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot Number: EM9809),  via an unspecified route of administration, administered in right arm on 07Mar2021 11:30 (at the age of 63-years-old) as dose 1, single for covid-19 immunization.  Medical history included type 2 diabetes mellitus. Concomitant medication(s) included exenatide (BYDUREON); metformin (METFORMIN); canagliflozin hemihydrate, metformin hydrochloride (INVOKANA DUO) ;lisinopril (LISINOPRIL) and atorvastatin (LIPITOR [ATORVASTATIN]).  The patient previously took vicodin and experienced allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. The patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell, dizziness and weakness on 07Mar2021 16:00 . No treatment was taken for the events. The outcome of the events was recovered.  No follow up attempts are needed, no further information is expected.  .
Sore arm, stiff neck, headache and fatigue.  Headache and fatigue lasted for 2-3 days.
itching in hands, fingers, eyes .   Took 5mg of benedryl.    Still some discomfort next morning.   BP  OK.
Gave shot sat at office 15 mins, 1 hour after shot throat became scratchy the swelling up stopped got Benadryl started to feel better then 2 hours later started to swell up again took another dose of Benadryl called Dr. wanted me to go to hospital I couldn't asked what is stronger then Benadryl she said to take another Zyrtec can take up to 4 day if needed if effects me worse or breathing no choice hospital call 911 hives on neck and chest, became itchy all over even with all this allergy medicine.
Pt felt pain in lt arm, started feeling dizzy, felt warm, clammy &  vision got blurry; tx 02 nasal cannula, DPH; BP checks every 5 min;
Pt. developed fever, after administration w/persistence and then a macular rash from head down, no defervescence. Possible viral exanthem. BENADRYL given with no improvement of rash. Pt. also had purulent nasal discharge. No fever or URI at the time of administration of vaccine.
3 days of 104 fever, 6 months of body aches & inflimation that won't go away even with a modified diet, exercise, physical therapy & anti-inflamatory medication
rash above waist; itching above waist; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. On 26th January 2021, between 4 and 6 months after receiving Shingrix, the patient experienced rash and pruritus. On 26th January 2022, the outcome of the rash and pruritus were recovered/resolved.   It was unknown if the reporter considered the rash and pruritus to be related to Shingrix.     Linked case(s) involving the same patient:  US2022016246  Additional details were reported as follows: The age at vaccination was not reported. The patient received a 2 doses of Shingrix on August 2020 and experienced  rash and itching above waist from 26th January 2021 to 26th January 2022. The patient received 2nd dose on February 2021. The doctor suggested her to get an additional shot. The reporter confirmed with HCP that patient had not yet been administered a 3rd dose of Shingrix, till the time of reporting.  The reporter consent to follow up was denied.
pt recvd vax & subsequently devel appendicitis; addtl details are being requested;
VACCINE GIVEN SUBCUTANEOUS AND NOT INTRAMUSCULAR; OFF LABEL USE; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: amputee. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, subcutaneous, batch number: Unknown) dose was not reported, administered on 08-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-OCT-2021, the patient experienced vaccine given subcutaneous and not intramuscular. On 08-OCT-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine given subcutaneous and not intramuscular and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211018542.
8/13 PM: L sided back, abd stiffness; R neck spasm/torsion, SOB, pain; T100, hydrates, uses TYLENOL. 8/17/18 Seen in office: VSS, neck tension L to R, Labs ordered. Cyclobenzaprine ordered. 8/20 labs rec. Advised to see neurologist for cervical symptoms.
This is an instance of breakthrough COVID-19 disease after which death occurred. The individual was vaccinated with the Moderna product on 02/15/2021 and 03/13/2021. They tested positive for COVID-19 on 01/27/2022. At the time of the positive test, they had been hospitalized for approx 2 months for renal failure (not related to COVID-19).  Upon testing positive for COVID-19, they were transferred to a different hospital. The individual experienced complications of worsening renal failure and bleeding into the retroperitoneum. They were transitioned to comfort care only and died on 02/05/2022.
I suffered from dizziness and disorientation while driving for 2 to 3 weeks after each vaccine; inability to control my body temperature started three months after 2nd vaccine; neuropathy of hands and feet started three months after 2nd vaccine and persists today.  I have undergone nerve conduction studies, MRI of the brain with and w/o contrast which were normal; and am currently awaiting results of biopsy?s of the nerves in my leg.
I was diagnosed with Myocarditis on November 19th 2021, approximately 10 months after receiving the second dose of moderna COVID19 vaccine. Symptoms included chest pain, shortness of breath and difficulty performing daily activities. I was advised by my cardiologist to refrain from receiving the COVID19 Booster. Also, due to the nature of my job as a Firefighter/Paramedic, I've been unable to return to my normal work since it began per the doctor's instructions to avoid physical activity for a minimum of 12 weeks.
Fever, severe headache, chills, joint and muscle pain, fatigue, nasal congestion, fatigue, pain at left thigh injection site. All on 01/29/2021 around 8pm.  Tylenol taken and every 8 hours after. The left thigh is red, hot, and indurated 3 inches by 4 inches.