chrisvoncsefalvay/vaers-outcomes huggingface dataset:
has not yet received the second dose of Shingrix; rashes on their cheeks, neck, and anterior chest; This case was reported by a physician via call center representative and described the occurrence of rash in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 453LA, expiry date 18th February 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 31st October 2019, less than a month after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rash. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the rash was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose. The patient received Shingrix and experienced rashes on their cheeks, neck, and anterior chest.  Reaction occurred within a few days of getting the shot, which was given back in October 2019 and rashes had since resolved.  The patient has not yet received the second dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Pregnant at the time of vaccination: Yes; She is pregnant at time of vaccination; She is pregnant at time of vaccination; first, covid 19; first, covid 19; This is a spontaneous report from a non-contactable consumer A 33-year-old pregnant female patient received bnt162b2 (BNT162B2; Solution for injection) via an unspecified route of administration on 31Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had last menstrual on 31Jan2021. She is pregnant at time of vaccination while taking bnt162b2. On an unknown date in 2021, patient had first, covid 19. The mother was due to deliver on 07Nov2021. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. There was no treatment for the event covid 19. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
About a week after booster, I experienced itchy hives. They appear all over the body and spread if I itch. They are worse at night and are hot to the touch. They are red and sometimes raised.
hearing loss; other zoster-related conditions; other zoster-related conditions; 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 19-MAY-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration 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 physician for hearing loss and other zoster-related conditions. 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 hearing loss and other zoster-related conditions was not recovered. The causality assessment was considered as related by the lawyer.  Upon internal review, hearing loss was determined to be medically significant.
Right arm red, swollen, itchy, warm to touch x 5 days. Mother had done BENADRYL. States BENADRYL helps.
10 minutes after receiving vaccine, patient had throbbing pain in arms, legs and buttocks, lasted about 5 minutes then stopped.
Mom reported on 3/5/03 that child had a welt on right deltoid. No other Sx's. Mom then told RN that the last DTaP had caused a welt that lasted few days. Mom was instructed to apply compresses, massage that area and give Tylenol. Mom called back later to report area streak going around the arm. No other Sx's.
when they were drawing the needle back out of her arm there was unusual amount of blood that came out; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs), by a contactable pharmacist.   A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at 0.3 mL, single on 22Dec2020 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced that when they were drawing the needle back out of her arm there was unusual amount of blood that came out on 22Dec2020 with outcome of unknown. We don't know if we needed to re-dose or revaccinate her since it was unusual amount that came out.  Information on the Lot/Batch number has been requested.
swelling in the eye; swelling in the head; pain in the arm; it was like very hot; head started itching a lot; Felt like balls, hives in the head; appeared like a little balloon on the eyelids; both eyes had swollen eyelids; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (swelling in the eye), SWELLING (swelling in the head), PAIN IN EXTREMITY (pain in the arm), FEELING HOT (it was like very hot) and PRURITUS (head started itching a lot) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced EYE SWELLING (swelling in the eye), SWELLING (swelling in the head), PAIN IN EXTREMITY (pain in the arm), FEELING HOT (it was like very hot), PRURITUS (head started itching a lot), URTICARIA (Felt like balls, hives in the head), SWELLING OF EYELID (appeared like a little balloon on the eyelids) and BLEPHARITIS (both eyes had swollen eyelids). The patient was treated with IBUPROFEN at a dose of 1 dosage form and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 1 dosage form. On 22-Apr-2021, SWELLING (swelling in the head), PRURITUS (head started itching a lot) and URTICARIA (Felt like balls, hives in the head) had resolved. At the time of the report, EYE SWELLING (swelling in the eye), PAIN IN EXTREMITY (pain in the arm), FEELING HOT (it was like very hot), SWELLING OF EYELID (appeared like a little balloon on the eyelids) and BLEPHARITIS (both eyes had swollen eyelids) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
93 yo male presented to the ED with the complaint of fatigue and weakness.  His wife was diagnosed with covid on 4/24 and he developed symptoms on 4/25.  At that time he was evaluated and discharged home from the ED.  His CXR shows right basilar atelectasis vs infiltrate.  His inflammatory markers were not significantly elevated.  He was admitted for therapy evaluation and monitoring.  The ED provider did prescribe him paxlovid which the family picked up and brought in for us to start.  The following day he was seen by PT and OT.  They feel he may return home with home therapy.  He is feeling better and is in agreement.  His vitals have been stable and he has not developed hypoxia.  He will discharge home today in improved and stable condition.
Began having nausea, body aches and pains and the chills around 10am 1/19. Was unable to eat anything without emesis for 36 hours.
After the second dose of Pfizer vaccine, the patient describes gradual onset of shortness of breath with exertion ultimately culminating in acute shortness of breath, chest tightness and nausea that resulted in hospital admission.  She underwent a heart cath after having positive troponins, heart cath was described as normal and then had CTPA that was positive for pulmonary embolism.
Information has been received from a physician concerning an 84 year old female who in 2007 was vaccinated with a dose of ZOSTAVAX.  On 11-FEB-2008 the patient developed a severe case of shingles on thoracic area that traveled around her back.  Visual diagnosis was done.  Unspecified medical attention was sought.  At the time of report the patient had not recovered.  A product quality complaint was not involved.  Additional information has been requested. Follow up information has been received from a physician concerning an 82 year old female with penicillina and TAMIFLU allergies who on 12-JUN-2007 was vaccinated intramuscularly with ZOSTAVAX (Oka/Merck). There was no illness at the time of vaccination. On 6 FEB 2008 the patient dveleoped a rash. On 11-FEB-2008 the patient was seen in the office at which time there was a rash present in the middle o f the back and left breast area, accompanied by pain in back. On  FEB 2008 the patient was see again in the office, at which time the skin had sacrred/scabbed with no open lesions. At the time of reporting the patient was recovered. No diagnostic or lab testing was performed. Additional information is not expected.
Severe pain in both hips, upper right thigh, and lower back; virtually constant. Treatment was the use of OTC Tylenol Arthritis Extended Release 650mgs, (2) three times a day. After approx 12 weeks pains abated except for lower back pain which is consistent with the chronic pain I experience. There are infrequent but occasional recurrences of acute hip oain.
Started with pain at injection site, continued to hot and cold flashes and severe mental fogginess. Had to go home from work the following afternoon. Did not feel able to perform metal or physical tasks until about 40 hours after the dose.
This spontaneous report was received from a Licensed Vocational Nurse and refers to an unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with an improperly stored doses of M-M-R II (unknown albumin status) lot # L023386 with an expiration date: 25-JUN-2017 and lot # L041457 with an expiration date 22-OCT-2017 (dose, frequency and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report has been received from a registered nurse referring to a currently 3 years old male patient. Concomitant medication included sterile diluent( MERCK STERILE DILUENT). The patient's concurrent conditions, medical history, and historical drugs were not reported. On an unspecified date in 2016, the patient was inadvertently vaccinated an expired dose of M-M-R II (dose, route, lot number and expiration date were not reported) for prophylaxis. On 09-AUG-2018, the patient returned to be revaccinated with another dose of M-M-R II (rHA), "subcutaneous in the right arm", lot# N013866, expiration date 04-MAY-2019. The Nurse reported "because the patient did not want to receive the dose, he was squirming during administration, and some of the dose sprayed out of the syringe, and he did not receive the full dose (accidental underdose). No adverse effects reported. This is one of three reports received from the same source.; Sender's Comments: US-009507513-1808USA004703: US-009507513-1808USA004943:
The patient has a history of Parkinson's. He was seen in the ED on 6/5/23 after increasing cough, lethargy, weakness, and fever of 101 at home for the past few days. A COVID PCR test performed in the ED resulted positive. Ultimately, the patient was admitted 6/5/23 - 6/13/23. Discharge diagnosis include sepsis secondary to acute bacterial superimposed pneumonia and acute hypoxemic respiratory failure secondary to COVID-19 pneumonitis, among other diagnoses. During admission, he was started on dexamethasone and did require several liters of nasal cannula which was eventually weaned to room air. Of note, the patient has received the primary COVID-19 vaccine series and three boosters.
Patient was unable to move arm for nearly 2 days due to significant pain and muscle weakness. On exam 10/17/18, 7 x 8 x 9 cm erythematous raised swollen rhomboidal area spreading distally and medially to injection site which was slightly indurated but not firm/hard.
hepatitis B nonresponder;   This literature report has been received from authors of a published article, titled as above, regarding an adult patient. The medical history, current conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with initial series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 69 (unit not provided). And the patient was vaccinated with the second series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 71 (unit not provided) on an unknown date. Total number of standard hepatitis B vaccine (recombinant) doses were 6. The patient did not respond to two complete standard hepatitis B vaccine (recombinant) vaccine series and was termed as nonresponder (Vaccination failure). The outcome of vaccination failure was unknown.  The causality between vaccination failure and hepatitis B vaccine (recombinant) was related.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2207USA004701:
Pain immediately after the shot and continuing, with shaking, moaning, fever (101), and vomiting starting around 3:15 PM. I had given her Motrin around 12:30 pm for the pain, and dosed her again around 4:30 after she had vomited three times. She then retched and dry heaved without producing any vomit.
Sore throat; Severe body rash; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-May-2021 and was forwarded to Moderna on 04-May-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and RASH (Severe body rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and RASH (Severe body rash). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and RASH (Severe body rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was also given steroids
pt presented to clinic on 29APr99 w/rash had fever & vomiting x 2 days;dx response to chickenpox vaccine;
I have severe menstrual cramps and my period started today. But I have a Mirena IUD, and I haven't had my period in several years. I'm not sure if I should go to the doctor over it. The cramps are worse than I remember them being years ago.
Pr. received vaccine at noon on 8/14/17. About 4 pm pt complained of pain on right arm increased achiness. On 8/15/17 erythema around injection site approximately 180 mm. Patient can barely lift arm 10/10 on pain scale. Low grade fever 99 F nausea; abdominal cramps. Physician ordered 60 mg of Prednisone x1 dose. Pt's condition improved by 8/16/17.
received Bexsero instead of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received Men B NVS (Bexsero) (batch number 5AR2D, expiry date 31-DEC-2025) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: received Bexsero instead of Menveo).The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-SEP-2023 The reporter called to ask for information regarding a patient who received Bexsero instead of Menveo, which led to wrong vaccine administered. The healthcare professional asked how to proceed with this patient. The reporter did not provide the date of administration. The reporter consented to follow up.
Hospitalized (10.14-10.17);  COVID-19 positive (10.14.21);  Fully vaccinated  Discharge Provider: Doctor Primary Care Provider at Discharge: Doctor Admission Date: 10/14/2021 Discharge Date: 10/17/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Pneumonia due to COVID-19 virus  COVID-19 HOSPITAL COURSE: Patient is an 85-year-old female who presented to the emergency department on 10/14/2021 with chief complaint of fatigue, weakness and a cough.  In the emergency department, patient was initially hypotensive.  Lab work was obtained which revealed AKI.  Patient was positive for COVID-19.  Chest x-ray revealed streaky bilateral opacities most suggestive of infection in the left lower lobe with additional chronic atelectasis and scarring.  Patient did desaturate with ambulation on room air.  She was admitted to the Internal Medicine Service.  She was started on Decadron.  She was given gentle IV hydration with improvement in her acute kidney injury.  Patient improved during her stay.  PT/OT evaluated the patient recommended home with assist.  Patient was recommended follow-up primary care physician.  She was discharged home in stable condition.
This case was reported by a physician via call center representative and described the occurrence of blister in a 67-year-old female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced blister and back pain. On an unknown date, the outcome of the blister and back pain were not recovered/not resolved. It was unknown if the reporter considered the blister and back pain to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) reported that the patient received dose of SHINGRIX 1 week before the date of reporting but did not have exact date. The patient experienced 6 to 8 blisters in the right lower abdominal area spreading towards the back. The patient was also having pain in this same area. The symptoms had not resolved at the time of reporting. The patient came to the doctor's office because of this issue. No additional information was provided.
Per patient email: After my injection site fully erupted, I began to have bouts of fever, severe cramping, fatigue, headache, tightness in chest, etc, and these continued to worsen/persist. Yesterday, I displayed symptoms of vertigo, loss of vision, hearing loss, and near unconsciousness. I was admitted to the Medical Center where I was treated and tested. After several hours, it was determined that I had succumbed to acute renal failure. After stabilization, I was referred to a kidney specialist, with whom I have yet to see. Most of my symptoms were alleviated, but I'm still enduring extreme pain in the kidneys, fatigue, sleeplessness (due to extreme pain), and loss of appetite.
This spontaneous report has been received from a medical assistant referring to a unspecified patient of unknown age and gender. Information regarding pertinent medical history, drug reactions, allergies, concurrent conditions and concomitant therapies was not provided. On 01-FEB-2017,  the patient was vaccinated with an improperly stored dose of ZOSTAVAX, lot number reported as M037013 with expiration date of 22-NOV-2017 (strength, dose, frequency, and route of administration were not provided) for prophylaxis. The reporter stated that the administered dose experienced a temperature excursion of >14°F but <46°F (>-10° Celsius (C) but <8° Celsius (C)  and the time frame was 166 hours, also she stated that previous temperature excursion was not involved, this information was no registered in a digital data logger. No adverse effect was reported nor product quality complaint was involved. Additional information has been requested.
unable to communicate; was given a Moderna Vaccine yesterday and a Pfizer Vaccine today; was given a Moderna Vaccine yesterday and a Pfizer Vaccine today; was given a Moderna Vaccine yesterday and a Pfizer Vaccine today; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received bnt162b2 (Formulation: Solution for injection; (Batch/Lot number was not reported), dose 1 via an un-specified route of administration on 18May2021 as dose 1, single for covid-19 immunisation (at the age of 74-year-old); covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), via an unspecified route of administration from 17May2021 (Batch/Lot number was not reported) to 17May2021, at dose 2, single for covid-19 immunisation (at the age of 74-year-old). Medical history included ongoing dementia. The patient's concomitant medications were not reported. The patient was given a Moderna Vaccine yesterday and a Pfizer Vaccine today. She advised that a family member took her today and she was given the Pfizer vaccine, unaware that the aunt was given the Moderna Vaccine yesterday, as she is also unable to communicate. I advised her to contact the location that provided her the vaccines and to also contact her aunts doctor and or local hospital for medical advice. The locations were closed, and the local hospital couldn't provide her with advice. She complained about the Medical Vaccination Tracking System that contains the vaccination records for everyone as she stated it was the systems mistake for her aunt being vaccinated twice with two different vaccines. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt dx'd with Varicella. Rx: Acyclovir 200/5 1 tsp Q6 hours x 5 days.