chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had 2 shots and have shingles/Suspected Vaccination Failure; have shingles; severe pain, pain is terrible; 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: had 2 shots and have shingles/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: have shingles) and pain (Verbatim: severe pain, pain is terrible). The patient was treated with analgesic, nos (Pain Medication). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 22-MAR-2023 This case was reported by a patient via interactive digital media The patient had two shingles shots for shingles and he/she had shingles now and severe pain on his/her right side. The pain medicine did not help it had been 3 weeks and pain was terrible. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
This is a spontaneous report from a contactable physician, reporting on his son.  An 18-year-old male patient received the first dose of TRUMENBA, via an unspecified route of administration in the arm on an unknown date in Jun2016 at a single dose for immunization. Medical history was not reported.  There were no concomitant medications.  The patient previously took ZITHROMAX and experienced drug hypersensitivity.  On an unknown date in Jun2016, the same day as the vaccination, the patient experienced fever of 103.5 degrees Fahrenheit and swelling at injection site. The events did require a visit to the physician office; however, there was no visit to the emergency room or hospitalization required.  The clinical outcome of the events, fever of 103.5 degrees Fahrenheit and swelling at injection site, was recovered on an unknown date in Jun2016 after a duration of 2-3 days.
Patient is a 66 y.o. female patient local DO with history of migraines and environmental allergens presented with fever    Covid-19 Virus Infection Multifocal pneumonia Acute respiratory failure with hypoxia On arrival, SPO2 88% on RA Date of onset of symptoms: 12/9/2022 (approximately 1 wk before testing) Symptoms present on admission: Fever, shortness of breath, drenching sweats Date of covid positive test: 12/16/2022 Vaccination status: vaccinated Imaging: CT pulmonary arteries - diffuse airspace disease throughout all lobes; extensive hilar and mediastinal lymphadenopathy; CXR - Bilateral pulmonary opacities suggesting edema or pneumonia. Small left basilar effusion is not excluded.  Oxygen requirements on admission: 2L Current oxygen requirements: Oxygen saturation 93% on 2 L nasal cannula Medical therapy: outpatient Rx Paxlovid therapy pack x 5 days started 12/16/2022 and only completed 3 days due to migraine development  Anticipated special isolation end date: 12/26/2022  The patient was treated with steroids and incentive spirometry.  She gradually improved with treatment. Patient's oxygen levels improved and she tolerated room air by the time of discharge. Patient was discharged in stable condition.   Hypokalemia Potassium replacement   Hyperglycemia, likely reactive Initial glucose 125 A1c 5.4 8/2022 Continue to monitor and treat as needed   History of migraine headaches Patient reports triggered easily with many common medications
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare providers recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2014, a physician administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 2016, the patient was treated by a healthcare provider for shingles.  The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
After receiving his 1st dose of Pfizer Vaccine. Our pt was waiting in the observation area when he slumped to the ground. He was unresponsive for about 20 seconds. When he came to he was awake and oriented. He reported that he has a history of seizures. He is not on medication and has not had a seizure in 9 years. 911 was called and the paramedics took the pt to the hospital for further evaluation.
12 HOURS AFTER INJECTION-FATIGUE, TROUBLE SLEEPING 31 HOURS AFTER INJECTION-THROAT PAIN, PAIN RADIATING DOWN TO BOTTOM OF STERNUM, LEFT ARM PAIN (INJECTION SITE RIGHT ARM WITH NO PAIN, REDNESS, OR SWELLING) 38 HOURS AFTER INJECTION-UPSET STOMACH, NAUSEA AND VOMITING OVERNIGHT 48 HOURS AFTER INJECTION-CHEST (ESOPHAGUS) PAIN, SHORTNESS OF BREATH, DIZZINESS, AND LEFT ARM PAIN CONTINUES
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19 ) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 026L21B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 ). At the time of the report, COVID-19 (COVID-19 ) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication and treatment medication were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-746929 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746929:Case for SPIKEVAX 2023-2024 PFS
Itchy rash/small bumps at the site of the injection.   Appeared approximately 1 week after initial vaccine injection.
No adverse event; Varivax administered to a patient during a temperature excursion; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T021821, expiration date 25-JUN-2022, 0.5 milliliter, for prophylaxis.     On 22-FEB-2021, the reporter noticed the excursion.    Temperature -7.4 C Time frame 3 hours and 54 minutes Previous temperature excursion? No Was call because of a "data logger"? (YIN) Y
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 77 year-old male patient received bnt162b2 (BNT162B2), administration date 06Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date 07Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date 17Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), PAIN (non-serious), MUSCLE TWITCHING (non-serious), outcome "unknown" and all described as "I received my 3 covid vaccine shots 1st 17Feb2021 2nd 07Mar2021 3rd 06Oct2021 and just this month started experiencing ALS symptoms(aching & stiffness in my legs - random body twitching at night)".  Additional information:I received my 3 covid vaccine shots 1st 17Feb2021 2nd 07Mar2021 3rd 06Oct2021 and just this month started experiencing ALS symptoms (aching & stiffness in my legs - random body twitching at night)   The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient was accidentally given 2 Menactra vaccines. One in L and one in R deltoid. Call to Agency spoke with epidemiologist and Poison control .  discussed double dose with toxicologist and recommended to monitor and treat the symptoms .     fever/ headache or redness on the side of injection.  Was advised by Agency and Poison control that there's no potential harm for accidental double dose, parent was present when vaccine was administered and was made aware immediately of error.  Provider Dr. explained patient might get a fever which is one of the symptoms after being vaccinated ,  Mother was understanding and will monitor Patient and treat her with Tylenol if she develops fever. She was encouraged to call our office with any questions or concerns . Guradian was informed this incident was going to be reported.
Chills, sweats, and fever by 1:00 am the following day; getting worse at approx. 03:30 am. Headaches and body ache lasted several days after.
Started itching around 12:00pm and then laid down for naptime. After nap, he continued to itch. Small red dots started & hives were on stomach & back area by 3:30pm. Immediately called doctor's office & administered 1 tsp Benadryl.  After having Benadryl in his system for about 20 minutes, redness started to fade & whelps were subsiding. Once 4 hours would pass (when Benadryl was wearing off) hives would begin. Using Benadryl creme on areas also.  This process continued on 10/10/13 & on 10/11/13.  At 4pm on 10/11/13, he started to run a low fever with hives starting on his arms, feet & neck area (some areas exist on stomach).
Fever 102.2 sore arm shot at 11:20, achy body, fever at 12:30, vomiting and nausea at 4:45 and beyond. Went to ER. Gave nausea drug.
Swelling of Left arm/ (L) chest wall, Erythema, Itching.
Patient with hives and no anaphylaxis Benadryl 50 mg IM given with resolution of symptoms
3/18 Chills and slight temperature.  Sore arm 3/19 Injection site warm and red 3/20 arm still warm, but less than previous day slightly ref
S: RRT initiated 1/14/2021 in Room 432 (Vaccine Monitoring Room) for lip itching, throat tightness, and coughing after receiving her 1st dose of Moderna Vaccine. A: Upon arrival, patient is A&Ox4, pt stated " she had an anaphylactic rxn to CT IV contrast before". Airway intact, RR 20s unlabored. O2 sat 100% on RA. No s/s of difficulty breathing, stridor, rashes, or swelling. BP 139/82. HR 70s. Afebrile.  R: Transported to ED for further evaluation and management.
Patient developed redness, itching, and swelling from elbow to top of upper arm. Patient still had symptoms 4 days after the vaccine but was improving.
received 2 adjuvants components in her left arm without active component; received 2 adjuvants components in her left arm without active component; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 07-JUL-2023, the patient received Shingrix (left arm). On 07-JUL-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: received 2 adjuvants components in her left arm without active component) and inappropriate dose of vaccine administered (Verbatim: received 2 adjuvants components in her left arm without active component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 10-Jul-2023 According to the pharmacist, the patient was doing fine. No lot was provided. Transferred to medical information for further assistance. The reporter consented to follow-up. The patient received 2 adjuvants components in her left arm without active component, due to a inappropriate reconstitution technique, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
At 2:45 pm, patient woke up from her nap and vomited all over her crib, more than we have ever seen, and were astonished that she was capable of producing than much vomit. Over the next 5 hours, she vomited 7 more times. After two hours of vomiting, I called Advice line. They advised us to bring her to the emergency room, since she was at risk for becoming dehydrated and we didn?t know what was causing the vomit. Since she had received the flu vaccine that morning, I imagined there could be a correlation.
Starting one day following her Pfizer COVID-19 booster shot the patient began to have daily right temporal headaches. They have occurred almost every day since receiving the vaccine, at various times of day. Pain starts over her right eye and then extends onto her right temple and scalp. Pain is throbbing and hot. Sometimes takes Advil for pain or tries to rest. Last for variable amounts of time.  Pain is sometimes so severe that she cries. She has a past history of very occasional headaches but these seem very different.
Within 1 month after receiving vaccination progressive clumsiness noted with complaints of leg pain with inability to run without falling.  Eventually, lost ability to run and only able to participate in some aspects of gym classes.  Alternate written assignments had to be done.  On April 9,2008 had severe pain to left leg while in bed.  While stepping up onto school bus, passed out.  Complained of dizziness at that time.  pain progressed to right leg that day with tingling and numbness.  Taken to ED, CT scan of head and labs done.  Referred to neurologist.  Many blood tests performed, EMG, nerve conduction studies, MRI's. May 1, 2008 reported right leg pain worsening and now present in right hip and waist.  Referred to neurologist due to progressive weakness and right leg lag.  Adaptations have had to be made at school through the 504B plan to accomodate for her disabilities.  Stairs are very challenging.  Swallowing difficulties started within last 3 months.  Now seeing neurologist, rheumatologist, endocrinologist to find cause of proximal weakness. Lots of autoimmune studies have been done and repeated.  No answer to this problem for a child who was in perfect health prior to this vaccination.  Bills are immensely expensive and continue.
Arm pain after 12 hours, unable to lift arm.  Fatigue and mild body aches 12-24 hours after vaccine.  24-36 hours after vaccine fever of 101, extreme body aches, chills and headache with nausea.
Six patients received expired Moderna vaccine booster shots after 30-day Use By Date / after manufacturer date of expiry.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Six patients received expired Moderna vaccine booster shots after 30-day Use By Date / after manufacturer date of expiry.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Six patients received expired Moderna vaccine booster shots after 30-day Use By Date / after manufacturer date of expiry.). On 27-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Six patients received expired Moderna vaccine booster shots after 30-day Use By Date / after manufacturer date of expiry.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided. Nurse reported that six patients received expired Moderna vaccine booster shots on 27-Dec-2021 after 30-day Use By Date / after manufacturer date of expiry. Number of doses/vials was 1 vial /10 dose.   This case was linked to MOD-2021-429306 (Patient Link).
Slept for 12-15 hours; Odd taste in mouth; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept for 12-15 hours), TASTE DISORDER (Odd taste in mouth), CHILLS (Chills) and PYREXIA (Fever) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002H21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient stated that he had COVID before and has not fully recovered after). Concomitant products included APIXABAN (ELIQUIS), AMLODIPINE, ACETYLSALICYLIC ACID (ASPIN), FLECAINIDE, ATORVASTATIN, LEVOTHYROXINE and EZETIMIBE for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced SOMNOLENCE (Slept for 12-15 hours), TASTE DISORDER (Odd taste in mouth), CHILLS (Chills) and PYREXIA (Fever). On 05-Mar-2021, PYREXIA (Fever) had resolved. On 06-Mar-2021, SOMNOLENCE (Slept for 12-15 hours), TASTE DISORDER (Odd taste in mouth) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up  received and contains no new information
The next morning, I had a very large rectangular, raised patch of skin (approximately 4" long x 3" wide) on my injected arm, it was very hot to the touch but the worst issue was needle-like pain radiating UP from the skin which hurt quite a lot.  This remained for 4-5 days then the pain subsided and the rash/swelling disappeared after a week.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 22-MAR-2010, as prescribed by a physician and administered at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-APR-2014, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed valacyclovir for management of the persistent and painful symptoms. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
Sinus pressure runny nose fever and cough but started in July not close to date of vaccine
I felt dizzy about 25 minutes after it was given. I went back to work for a couple of hours, but noticed my face and chest were red. I took Benadryl when I got home (about 3 hours after the shot) and slept for a few hours. I had a headache when I woke up, and my arm really hurt. I took it easy all weekend with Benadryl. I took hydroxyzine at night, and went into work on Monday. I continued with Benadryl until I felt my throat close when I got home ( I couldn?t take Benadryl at work due to lethargy). When I felt my throat closing, I called EMS.
Acid reflux (esophageal); Pain/Aches; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux (esophageal)) and PAIN (Pain/Aches) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux (esophageal)) and PAIN (Pain/Aches). At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux (esophageal)) and PAIN (Pain/Aches) was resolving.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received booster dose COVID-19 Vaccine manufactured by Moderna. Primary reporter contact for lot number information was unsuccessful.  The reporter's causality for the events of gastroesophageal reflux disease and pain with HUMIRA (ADALIMUMAB) was no reasonable possibility.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
aura (like having a seizure) on the left arm and left leg; This spontaneous case was reported by a consumer and describes the occurrence of AURA (aura (like having a seizure) on the left arm and left leg) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced AURA (aura (like having a seizure) on the left arm and left leg). At the time of the report, AURA (aura (like having a seizure) on the left arm and left leg) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medications were reported.