chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; Have shingles again now!; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got shingles in 2015).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. After receiving 2 series Shingles shot in 2020, the patient got shingles again. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation were not provided.
the Bivalent vaccine was inadvertently given as dose #2 in the series instead of the original Pfizer vaccine
I was positive for COVID-19 on 01JAN2023, I couldn't breathe I had a horrible cough and couldn't think straight. I slept a lot, I didn't have a fever and tired. I contacted my doctor and her prescribed me PAXLOVID. I started feeling better 5 days after but then I started feeling bad and it was recurring for 2 weeks.
Client verbalized mild lightheadedness after receiving the vaccine.  Full assessment done by onsite Paramedics.  Client was observed for additional 15 min. and released to go home at 8:49 am accompanied by spouse.
Per mother on 07/28/2001 the patient experienced facial swelling in front of and under his ears to his upper neck and going to his eyes. The patient was seen in the ER. The swelling lasted 1-2 days.
PAIN LEFT AND RIGHT SHOULDER,  WRIST AND RIGHT HIP RIGHT HIP STOPED AFTER ABOUT TWO WEEKS WRIST PAIN DECREASED AFTER TWO MONTHS NOW MINOR LEFT SHOULDER DECREASED PAIN AFTER 4 MONTHS RIGHT SHOULDER HAS NOT DECREASED AS OF TODAY
We inadvertently administered the Moderna COVID vaccine to a patient that is 17 years old. The patient did not have an adverse reaction to the vaccine.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-SEP-2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 14-MAY-2015, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Redness at injection site, spreading to back in the next few days. Patient reports itching, redness and warmth of rash.
Information has been received from a physician concerning a 12 week old male infant with no prior medical history, no predisposing conditions and no noted congenital malformations of the intestine who on 23-OCT-2009 was vaccinated with the first dose of ROTATEQ. On the morning of 23-NOV-2009 the baby was brought to the physician's office because he had been vomiting. The baby weighed 15 lbs 4 ounces upon examination. There was no abdominal distention noted and bowel sounds were present. On 25-NoV-2009 the baby's mother called the office to report that he was still vomiting. The physician recommended that the patient be taken to the emergency room for evaluation. The baby's weight had gone down to 15 lbs 0.5 ounces. He was admitted to a hospital for observation and further testing. The baby had developed bloody stools in addition to the vomiting; an x-ray diagnosed the intussusception on 26-NOV-2009. The baby was transferred to another hospital due to the availability of a pediatric surgeon. On 27-NOV-2009 an air enema was performed, which successfully reduced the intussusception with no further surgical intervention needed. On 01-DEC-2009 the patient was seen in the office for a follow-up visit one day after his discharge from the hospital. His examination was normal and the physician noted that he had fully recovered. The physician was unsure if he was going to continue with ROTATEQ series. No further information is available.
Described as "COVID toes" a little over a week from the first dose of Pfizer COVID vaccine, the three small toes on my left foot started to itch like I had gotten a mosquito bite in between my toes. Within 12 hours, the itching got much worse and my three toes started to swell. The itch was bad enough that I couldn't sleep, but I wouldn't say there was much pain. I noticed a cut in between a couple of my toes and a small blister. I thought it was Athlete's foot until a colleague told me about COVID toes. I've been taking Benadyrl and using athlete's foot products (Lotrimin) that have been helping with the itch. Going on day 5 with some reduction in swelling.
Pain and soreness immediately after receiving the shot, was advised that should expect pain for 2-3 days. Pain got worse overnight and became severe and lasted at a high intensity over approximately the next 3 weeks. I told my doctor who has since left that she should let patient know that she was "full of it" RE: "the pain only lasting 2-3 days" because of how much pain I had been in. After about a month I started to block out the pain but it got progressively worse by Feb 21 when it gave way while trying to rest on it with very sharp pain. To summarize briefly, I then thought an MRI would help determine if it was from the flu shot. This was denied both from my doctors request and specialist but was later approved and a frozen shoulder was confirmed.
This spontaneous report was received from a registered nurse regarding an unspecified number of "older adolescent" patients of unspecified gender. On an unknown date the patients were vaccinated with the first dose of GARDASIL (lot numbers and expiration dates not reported) (dose and route not reported) for prophylaxis. The nurse reported that these patients had been off schedule with receiving their second doses of GARDASIL. The nurse reported the patients received their first doses of GARDASIL on unspecified dates and have returned to the office at various times on unspecified dates to receive their second doses after the second dose was due to be given. The reporter mentioned that the time between the first and second doses had often been a year and did not specify how many patients were involved. The nurse also stated some of these patients may had only received a two dose series of GARDASIL and did not receive all three doses. No adverse symptoms were reported. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a 5 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 06-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # reported as M010476 with expiration date of 01-SEP-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 9 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA014053.
On November 14, 2021 we were taking a walk around our neighborhood at around 6:00 PM and after about 1/4 of a mile the patient started having trouble breathing. We stopped for a short time to rest and the breathing did not get any better. The patient started to get very nervous so we returned to the house.  Once inside she tried sitting for a few minutes and she then showed symptoms of anxiety and indicated that she was scared so I (spouse) got her into the car and headed for the Hospital (about 20 minutes away).  Upon arrival at the hospital they immediately admitted her to the Emergency room where they performed many tests and put her on medications to get her stabilized after about 2 hours and many test. She was doing much better and was breathing without mask assistance.  She stayed in the hospital for a total of 3 days.  Scheduled follow-up with cardiologist. She is now on Entresto and Metoprolol Succinate ER.  Her cardiologist has indicated that her heart muscles are stronger now and are improving.  They found no blockages and no damage as a result of the episode.  I can provide medical records from the hospital stay if necessary.
reoccurring pneumonia; congestive heart failure; herpes zoster dermatitis of the eyelid; Information has been received regarding a case in litigation from a lawyer and referred to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 15-NOV-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered reoccurring pneumonia resulting in multiple hospitalizations. The patient was diagnosed with pneumonia and congestive heart failure. The patient additionally suffered from and was diagnosed with herpes zoster dermatitis of the eyelid. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered as not recovered. The causality assessment between all the events and zoster vaccine live (ZOSTAVAX) was considered as related by the lawyer.    Upon internal review, pneumonia, congestive heart failure and herpes zoster dermatitis of the eyelid were determined to be medically significant. The lawyer considered all the events to be disability.
No additional AE reported; an expired ROTATEQ was administered; This spontaneous report was received from a pediatrician, referring to a patient of unknown age and unknown gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 27-AUG-2021, the patient was vaccinated with expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1691140, expiration date 10-JUL-2021; dose and strength were not provided) orally for prophylaxis (expired product administered). The vaccine had no temperature excursions. No additional adverse event reported.  This is one of two reports received from the same source.; Sender's Comments:  US-009507513-2109USA000873:
Information has been received from a registered nurse concerning an 8 year old male with allergy to animal dander and no medical history who on 18-DEC-2001 was subcutaneously vaccinated with the first 0.5ml dose of VARIVAX (Merck) (lot# 638249/0426L). On 23-JUL-2009 the patient received the second 0.5ml dose of VARIVAX (Merck) (lot# 663762/0344Y) subcutaneously. There was no concomitant medication. On 23-JUL-2009 the patient experienced an allergic reaction 5 minutes after vaccination. He started sneezing a lot and his one lip became swollen on the way home from the physician's office. The area around the injection site became red and swollen. He also experienced pain in his chest, sore throat, shortness of breath, and coughing. He was examined in the ER room and diagnosed with allergic reaction to vaccine. He was treated with liquid BENADRYL. He was not admitted. No lab diagnostics studies were performed. Subsequently, the patient recovered from allergic reaction to vaccine. Additional information has been requested.
Diarrhea, vomiting; Emergency room visit for 10 hours. IV ,  CT scan, X-ray , lab work; Admission to hospital for 2 days.
Patient developed pleuritic left sided chest pain worse with laying back and better with leaning forward.  Patient diagnosed with pleurisy.
No adverse event; a patient was administered a properly stored but expired dose of VAQTA.; Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's concomitant medication, concurrent condition, pertinent medical history and drug reactions/allergies were unknown.  On 28-OCT-2019, the patient was vaccinated with a properly stored but expired dose of hepatitis A vaccine, inactivated (VAQTA) (lot#: R018775, expiration date: 09-AUG-2019, dose, frequency and strength were unknown) for prophylaxis. There was no adverse event.
Rec'd. varicella on 5-9-17 at 11:23. Noticed next AM after removing BAND-AID. Red swollen, hot to touch. Measures 30 x 34 cm. Called Dr. at 9:35 Recommendations: warm moist compressed, MOTRIN or ibuprofen - pain, BENADRYL or ZYRTEC, monitor diameter and report.
Swollen red arm, eye swelled shut, severe headache, legs move involuntary, could not move or communicate for two days.
Ringing in left ear every I'm talk to, or talk myself, or touch part of my ear
experienced swelling of the face and eyes on 24Dec2020. The swelling has progressed since 24Dec2020.; experienced swelling of the face and eyes on 24Dec2020. The swelling has progressed since 24Dec2020.; This is a spontaneous report from a contactable nurse. A 39-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EJ1685, expiry date not reported), via an unspecified route of administration on the left arm at a single dose on 21Dec2020 14:30 for COVID-19 immunization. Medical history was not reported. Concomitant medications included multivitamins (unspecified). The patient experienced swelling of the face and eyes on 24Dec2020 at 22:00. The swelling has progressed since 24Dec2020. No therapeutic measure was taken as a result of the event. Clinical outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Pt recvd vax 21SEP93 itching sensation started @ 10PM, 21SEP93; pt woke up @ 2AM, 22SEP93 w/hives & severe itching; seen by MD;
Patient started to have increased blood pressure and heart rate in the evening of the vaccination, with blood pressure 156/89 and heart rate 85 when her usual BP is 130 and HR 70. Patient went to ER and got many tests (according to patient) and beta blocker at ER. Patient also received a prescription for metoprolol tartrate 25mg to take 2 times a day for 14 days. Patient was told by ER MD that the cause is unknown but vaccination cannot be ruled out. Patient was also told by ER MD that all the labs and tests are normal and follow up with cardiologist if she does not get better.
I first felt very fatigued that was the only symptom I could detect waking up. I felt generally sick and onset headache hours after. I could tell I was coming down with something. I had chills and shortness of breath throughout the day. Every hour things got progressively worse. I went to urgent care and was prescribed PAXLOVID. I also had a fever of 100.4 degrees. It sustained all day Tuesday and took PAXLOVID that night. That next morning my symptoms started to subside. I tested positive for at least two weeks. I think I was going through a rebound of COVID-19. I just started not having a headache for two weeks. My neck is hurting and tight, it's at the base of my skull. I have to stretch every day. Four to five days after having COVID-19, I dealt with light sinus inflammation and nose pain.
Initial report was received from a health care professional on 22 October 2012. An 87-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE High-Dose, lot number U4496AA, on 01 October 2012 and the same day her arm was sore and red. The patient was seen by the physician on 03 October 2012 and noted a 1/2 cm area of redness, no fluctuation, mild erythema that was "similar to a first degree burn". Treatment included cephalexin 500 mg. The patient had no illness at the time of vaccination and an allergy to sulfa. The patient's outcome was unknown. Documents held by sender: None.
Pt not sure when vax was administered either in November 2016 or March 2017. 2 days later after vax, chest congestion began and it still have it. Went to doctor on 3/23/17. Pt prescribed multiple medications but only fill Furosemide 20mg. because legs swollen from knees to ankles and feet. Considering stopping water pills because they are not doing anything. Today feels worse, weaker, tired. Was hospitalized in January doesn't know if related since doesn't remember vax date.
Information has been received from the authors of the above entitle published literature article concerning a 16 year old female patient who was vaccinated with a dose of GARDASIL.  It was reported that the patient felt dizzy and had pallor within five minutes of receiving an GARDASIL vaccination.  While being escorted back to an examination room, she fainted, but the physician caught her as she fell.  She was observed for thirty minutes in the clinic and recovered completely.  Additional information is not expected.
Severe muscle pain, loss of use of upper arm, inability to complete normal tasks, disability continues, sought medical care in December. Rotator cuff tendonosis and biceptical tendonitis. 4 week of therapy ahead.
administered Adacel that were exposed to temperature excursions and not acceptable for use/no AE; Initial information received on 06-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA157616.  This case involves a 12 years old male patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and reported that administered Adacel that were exposed to temperature excursions and not acceptable for use/no AE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HUMAN PAPILLOMA VACCINE (HUMAN PAPILLOMA VACCINE); and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA).  On 28-May-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot C5585AA and expiry date: 06-Mar-2019 via intramuscular route in the right deltoid.  It was a case of actual medication error due to incorrect product storage.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.  List of documents held by sender: none.
SHE KNOWS THAT THE J AND J/JANSSEN COVID 19 VACCINE IS ASSOCIATED WITH BLOOD CLOTS; This spontaneous report received from a consumer concerned multiple patients of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total for COVID-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the multiple patient's (that consumer knows) experienced blood clots which were associated with J and J/janssen covid 19 vaccine. The consumer also questioned about how many were caused by a COVID infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of she knows that the j and j/janssen covid 19 vaccine is associated with blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220824464-covid-19 vaccine ad26.cov2.s-  She knows that the j and j/janssen covid 19 vaccine is associated with blood clots. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
This spontaneous case, initially received on 28-Sep-2016, was reported by a health professional and concerns a 33-year-old female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA from 27-SEP-2016 to 27-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular. Batch number: WT55407. Site: Left deltoid. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown day in Sep-2016 following vaccination, the patient experienced an AFLURIA injection site reaction of a whelp that measures 60 mm by 50 mm. The reaction is red, warm, and raised. The injection site is on left deltoid. Ice was recommended. Outcome for all events: not reported. Reporter comments: The reporter considered all events as non-serious.