chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sixth nerve eye palsy; Double vision; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VITH NERVE PARALYSIS (Sixth nerve eye palsy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  The patient's past medical history included Cataract operation (Consumer had a cataract surgery about 6 years ago.) in 2015. Concurrent medical conditions included Diabetes and Blood pressure.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced VITH NERVE PARALYSIS (Sixth nerve eye palsy) (seriousness criterion medically significant) and DIPLOPIA (Double vision). At the time of the report, VITH NERVE PARALYSIS (Sixth nerve eye palsy) and DIPLOPIA (Double vision) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) Consumer stated her A1C stays below7.. On an unknown date, Magnetic resonance imaging: abnormal (abnormal) Consumer was scheduled for MRI to rule out for brain tumor. Consumer was diagnosed with sixth nerve eye palsy.         Consumer was call to report possible adverse events and with a MI inquiry.  Consumer stated she experienced adverse event after 1st dose of the vaccine but still got her 2nd dose. Consumer stated her adverse event is still ongoing and has not subsided. On 03Mar2021 consumer experienced double vision while driving. Consumer contacted her HCP who scheduled MRI and additional eyes tests. Consumer's HCP suggested that the condition may be caused by diabetes and give it time to selfheal. Consumer stated that she was healthy prior to vaccination.  Consumer was not prescribed medication(s) for the condition.   Consumer does not take any medicaion except for blood pressure and diabetes. Treatment information was not provided.  Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient's med hx of HTN and DM are confounding factors that may play a possible contributory role.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient's med hx of HTN and DM are confounding factors that may play a possible contributory role.
Fever, chills, diaphoresis, body aches, head/neck pain, lymph node swelling/tenderness in left armpit (received vaccine in L arm), numbness/tingling/pins/needles sensation throughout entire body.
Blurred/double vision, swollen hand itch red rash on same side as injection( left arm)
This spontaneous prospective pregnancy report was received from a registered nurse and refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 17-FEB-2016, the patient was inadvertently vaccinated with GARDASIL 9 (dose, route of administration, lot number and expiry date were not reported). Concomitant therapy was not reported. At the time of vaccination, the patient was unaware of her pregnancy, but the patient was about 4 to 5 weeks gestation (last menstrual period (LMP); 13-JAN-2016 and estimated date of delivery (EDD): 19-OCT-2016). Pregnancy was discovered via unspecified method, an unspecified amount of time after receiving GARDASIL 9 (on an unknown date in 2016). No adverse effect was reported. The patient's outcome was not reported. Additional information has been requested.
Thrombosis of femoro-popliteal bypass graft -  presented to the clinic for vascular follow-up and was found to have occlusion of his of his femoral popliteal graft.  He was admitted.  Interventional radiology consulted and he underwent a series of right lower extremity angiograms with catheter thrombolysis as described above in procedures.  See procedure notes for details.  IV heparin was transitioned to Eliquis and aspirin.  He received a transfusion of 1 unit of packed red blood cells for hemoglobin of 7.2.  He was seen in consultation by podiatry for consideration of right transmetatarsal amputation due to ischemic changes to the right distal foot.  He was taken to the operating room by podiatry on January 3, 2022 for right transmetatarsal amputation.  Hyperbaric medicine consulted and he underwent hyperbaric oxygen therapy. Discharged home. Hospital admission within 6 weeks of receiving the COVID vaccine.
received expired Engerix-B; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 55-year-old male patient who received HBV (Engerix B adult) (batch number 54A32, expiry date 12th November 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd November 2021, the patient received the 1st dose of Engerix B adult 1 ml and Engerix B Pre-Filled Syringe Device. On 22nd November 2021, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were provided as follows: The patient received expired dose of Engerix B adult, which led to expired vaccine used. The reporter was transferred to Medical Information for further guidance. This case was linked with case US2021243048, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021243048:Same reporter
Saw doctor on January 11, 2021 for raised skin on arm where vaccine was injected, looks like hives, still not feeling well, joint pain localized on left side of upper body. Started Prednisone prescription.
vaccine was stored and administered on 17-May-2022 and found out that the vaccine had been expired for 2 weeks; Patient received vaccine that had been expired for 2 weeks; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that had been expired for 2 weeks) and PRODUCT STORAGE ERROR (vaccine was stored and administered on 17-May-2022 and found out that the vaccine had been expired for 2 weeks) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A and 076C21A) for COVID-19 vaccination.     No known allergies were reported.  Previously administered products included for Product used for unknown indication: Johnson & Johnson COVID-19 Vaccine (Lot no-1805031 and First dose.) on 10-Mar-2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson COVID-19 Vaccine.   On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that had been expired for 2 weeks). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine was stored and administered on 17-May-2022 and found out that the vaccine had been expired for 2 weeks). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that had been expired for 2 weeks) and PRODUCT STORAGE ERROR (vaccine was stored and administered on 17-May-2022 and found out that the vaccine had been expired for 2 weeks) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that Moderna Covid 19 vaccine was administered on 17-May-2022 and found out that the vaccine had been expired for 2 weeks. The reporter explains that since the expiration date was not written on the vial, they did not notice it had already expired. On 17-May-2022, the vial was stored in fridge.  The vial did not undergo any temperature excursions.  Reporter stated that none of them had reported side effects.  No treatment information was reported.
TOOK UNREFRIGERATED DOSES; A spontaneous case report was received from a physician on 10-Feb-2019 for four consumers.  Based on the information obtained from the physician, four individual case safety reports PVX201902-000103 (PVX2019-369; physician), PVX201902-000104 (PVX2019-371, male consumer), PVX201902-000105 (PVX2019-372, female 1) and PVX201902-000106 (PVX2019-373, female 2) were created and cross-linked in the database.  This case report describes a 63-year-old adult male consumer who "took unrefrigerated doses". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer took all the unrefrigerated doses of Vivotif. The doses were taken on 30-Jan-2019, 01-Feb-2019, 03-Feb-2019, and 05-Feb-2019 respectively.  The action taken with Vivotif with respect to event "took unrefrigerated doses" was not applicable.  The clinical outcome of the event "took unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable. US-PaxVax Berna GmbH-PVX201902-000104: US-PaxVax Berna GmbH-PVX201902-000105: US-PaxVax Berna GmbH-PVX201902-000106:
Swollen face and throat. Rashes and blisters on hands, face, & feet that were extremely painful and itchy. Difficult and painful breathing. Went to ER 3 times within a week same doctor at 2 visits misdiagnosed me. I was not treated for actual symptoms until 3rd ER visit with a different doctor who gave steroids which started to help the breathing finally. It took a long time, over a month for blisters and rashes to go away. I still continue to this day  get these same rashes  which are itchy and painful.
Patient was due to 12mo/epsdt and was due for routine vaccines of MMR, Varicella, Hep A, Hib, Prevnar 13, and Influenza. When patient received vaccination, vaccine MMRV was given instead of MMR causing patient to get double vaccinated for Varicella. When adverse event was acknowledged the proper steps of reporting began.
Information has been received from a physician concerning a 41 year old female patient who on approximately 01-MAY-2010 was vaccinated with a first dose of VARIVAX (Merck) (Lot # not provided). It was reported that the patient experienced multiple symptoms since receiving VARIVAX (Merck). The adverse event began as low back pain and 1 week later she developed right scapula radiculitis. She also developed a fever of 101F that lasted 1 or 2 days. She also had pharyngitis. She was admitted to the hospital and then discharged on antibiotics. After discharge she developed pleuritic chest pain and was admitted to another hospital. She also had slightly elevated liver enzymes. At the time of this report, the patient had not recovered. The adverse events were considered to be other important medical events by the physician. Additional information has been requested.
He felt dizzy twice; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (He felt dizzy twice) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced DIZZINESS (He felt dizzy twice). At the time of the report, DIZZINESS (He felt dizzy twice) outcome was unknown.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Pt cried unconsoleably x 1 1/2 hrs; no seizures or fever;
This spontaneous report was received from a registered nurse referring to a 15 year-old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided.    On 13-DEC-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # N004799, expiration date on 15-NOV-2019 or lot #N021475, expiration date on 21-JAN-2020, for prophylaxis (strength and route were not reported). The vaccine was stored at a temperature of 50°F for a time frame of 2 hours. No adverse effects neither previous temperature excursions for the improperly stored vaccine were reported. The call was because of a data logger. This case was one of several reports received from the same reporter. Sender's Comments: US-009507513-1801USA002510: US-009507513-1801USA002511: US-009507513-1801USA002512: US-009507513-1712USA010085: US-009507513-1801USA002515: US-009507513-1801USA002516: US-009507513-1801USA002517: US-009507513-1801USA002518: US-009507513-1801USA002519: US-009507513-1801USA002520: US-009507513-1801USA002521: US-009507513-1801USA002522: US-009507513-1801USA002509: US-009507513-1801USA002508: US-009507513-1801USA002514:
2.5mL dose of booster shot was administered; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (2.5mL dose of booster shot was administered) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (2.5mL dose of booster shot was administered). On 09-Nov-2021, ACCIDENTAL OVERDOSE (2.5mL dose of booster shot was administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. On 09-Nov-2021 during administration of booster Moderna shot, Patient was  administered with 2.5mL instead of 0.25mL dose.No concomitant medication  were reported.No Treatment information was provided.
temporary tachycardia; This is a spontaneous report from a contactable physician. This physician reported similar events for 3 patients. This is 1st of 3 reports.   A patient of unspecified age and gender received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose in Dec2019 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced temporary tachycardia after receiving the vaccine in Dec2019 with outcome of recovered.   The reporter monitored the patient using a pulse ox with a heart monitor. Let the patient drink water. She has monitored the patient for about 30 minutes and tachycardia has resolved in 30 to 40 minutes. The reporter was a bit concerned about what to expect and how to prepare for the patient's 2nd dose of the vaccine.  The information on the Lot / Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520695 same reporter/event/product, different patient;US-PFIZER INC-2020517983 same reporter/event/product, different patient
On 16JUN91 pt devel fever, rash x 4 days, fussy; 30JUN91 feet hurting & swollen; 1JUL91 dx OM & measles given Metrodiazole w/Codeine/Eryzole; 3JUL91 t99.8 A, very flushed w/diffuse rash, T. M's red, throat red, chest clear;
Narrative: COVID infection following COVID vaccine series 02/19, Pfizer, dose #1 03/12, Pfizer, dose #2 06/09 COVID swab, result: not detected 08/06 pt cc: chills, cough, fatigue, fever, headache, loss of taste or smell, rhinorrhea, sore throat exposure: unknown 08/09 COVID swab, result: detected 08/10-08/16 pt symptoms continue 08/17 clinically resolved
shingles; This is a spontaneous report from a contactable consumer (patient).   A 59-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 19Feb2021 14:30, at the age of 59-years-old, (Lot Number: EL9269) as SINGLE DOSE for covid-19 immunisation.  Medical history included Hodgkin Lymphoma diagnosed in Feb2017; had chemotherapy until a cell transfer on 15Oct2018. The patient did not have COVID-19 prior vaccination.  The patient was not pregnant at the time of vaccination. Concomitant medication included cyanocobalamin (B12-VITAMIIN) taken for an unspecified indication, start and stop date were not reported.  The patient previously took Benadryl and experienced allergies.  On 21Feb2021, the patient was diagnosed with shingles and received Acyclovir 800 mg, 4 times per day as a treatment. The event involved physician office visit. The patient has not been tested for COVID-19 post vaccination. The patient stated she still have some remaining signs of the shingles. The outcome of the event was recovering.
Vx nearly killed me; This serious case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had a bad case of shingles).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced near death experience (Verbatim: Vx nearly killed me) (serious criteria GSK medically significant and life threatening). The outcome of the near death experience was not reported.   The reporter considered the near death experience to be related to Shingles vaccine.   The company considered the near death experience to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient took the shingles vaccine later to prevent another breakout of shingles.  The reporter stated that the shingles vaccine nearly killed him/her so it was need to know there were risks. The follow up would not possible as no contact details were available.
first injection was just perfect, little bit of a sore arm and that was all; This is a spontaneous report from a contactable Nurse(patient). An 85-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247, expiration date unknown) intramuscular, administered in Arm Left on an unspecified date as 1st dose, single for covid-19 immunisation. Medical history included hypertension, atrial fibrillation. Investigation assessment was done. Concomitant medications included apixaban (ELIQUIS) taken for atrial fibrillation; furosemide; losartan; propranolol; alprazolam. On an unknown date patient experienced little bit of a sore arm and that was all. On an unknown date patient took second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiration date unknown) intramuscular, administered in Arm Left for covid-19 immunisation. Retired Nurse stated, my first injection was just perfect, and the patient experienced, little bit of a sore arm and that was all. The injection that patient got a week ago, for the second injection I was okay until the next day, and then I got my mouth got a lot of blisters inside my mouth and I was just miserable. I wasn't able to eat for three days. It was difficult, and I just wanted to know if you had anyone else that had that kind of symptoms, I sure had troubles with that. Expiration date did not see anywhere here. I was so sick, yesterday at clinic and my biggest problem was my mouth was full of sores they did took blood work and they said it was okay. My blood pressure was of some concern. Treatment they gave me four different things, they gave me it's called Ondanse, Lidocaine for the pain, it's Valacyclovir and I didn't take it. it's was an antibiotic; it's Clindamycin I didn't take it because my daughter who was in medical field thinks it probably a viral infection not bacterial. The outcome of event pain in arm was unknown. Follow-up (11May2021): Follow-up attempts completed. No further information expected.
PATIENT CAME TO GET FLU SHOT AND INSTEAD GOT Covid19(pfizer) . PATIENT CLAIMS TO EXPERIENCES DIFFICULTY IN BREATHING , BODY ACHES , NAUSEA , FEVER FOR 2 DAYS
Patient received vaccine that experienced a temperature excursion. Vaccine kept in the refrigerator for more than 30 days. No adverse reaction reported after 1st vaccination.
Became extremely tired. A couple of hours later I began with extreme chills, aches, fever and headache.   I was able to get the fever down alternating between ibuprofen and acetaminophen, but continued with the headache. Fever last around 18 hours and headache lasted around 24 -36 hours.
Information has been received from a physician's assistant concerning her relative, a female who on an unspecified date was vaccinated with GARDASIL. It was reported that the patient thought she developed GUILLAN-BARRE after receiving GARDASIL. The patient sought unspecified medical attention. Upon internal review GUILLAN-BARRE was considered to be an other important medical event. Additional information has been requested.
10/30: Pt seen by MD: left thigh hard, tender red lump around 2cm x 1.5cm, painful to touch. Advised hot soaks to leg vaccine site. Questionably infected. 10/31: Doctor spoke to mom. Still hard, red, tender. Advised to continue hot soaks and to recheck, would consider oral prescription (not yet). 11/5: mom called: still has lump, advised lump could stay x several months.
Trouble breathing; Chest pain; Pain; Achiness; Left shoulder swollen - Lymphedema; Really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Trouble breathing), CHEST PAIN (Chest pain), PAIN (Pain), PAIN (Achiness) and LYMPHOEDEMA (Left shoulder swollen - Lymphedema) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced DYSPNOEA (Trouble breathing), CHEST PAIN (Chest pain), PAIN (Pain), PAIN (Achiness), LYMPHOEDEMA (Left shoulder swollen - Lymphedema) and HEADACHE (Really bad headache). On 06-Apr-2021, DYSPNOEA (Trouble breathing), CHEST PAIN (Chest pain), PAIN (Pain), PAIN (Achiness), LYMPHOEDEMA (Left shoulder swollen - Lymphedema) and HEADACHE (Really bad headache) had resolved.            Relevant concomitant medications were not reported. Treatment information was included paracetamol. Action taken with mRNA-1273 in response to the event was not applicable. Patient had been to emergency.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow-up received on 19 MAY 2021 and does not contain any new information.