chrisvoncsefalvay/vaers-outcomes huggingface dataset:
only the diluent administered not mixed; only the diluent administered not mixed; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster Shingrix for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional information was provided as follows: The age at vaccination was not reported. The reporter stated that the patient received adjuvant only and not the active component of Shingrix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The mistake was realized, and the correct formulation was re administered on the same day. The reporter did not consent to follow up. This case is linked to case US2021AMR189269 reported by the same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR189269:Same reporter
Patient's left arm was red that wrapped around the arm and was warm to the touch. Injection site was hard. Received vaccine on 11/16/11 and reported the event on 11/18/11. Redness had reduced by then.
Narrative: COVID infection following COVID vaccine series 08/11 Janssen, dose #1 12/20 SARS-COV-2 Variant Sequencing: pending 12/20 COVID swab result: detected 08/15 pt cc: chills, cough, diarrhea, fatigue, fever, headache, loss of taste or smell, nausea, sore throat, vomiting exposure: unknown
Heavy menses for 9 days and counting.  Never experienced more than 6 days in my entire life.
This spontaneous report was received from a registered pharmacist refers to a 65 years old male patient with no pertinent medical history and no drug reactions or allergies who on 23-AUG-2012, was vaccinated subcutaneously with a dose of ZOSTAVAX (lot number 0364AE, Exp. Date: 16-MAR-2013). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on 23-AUG-2012, the patient bled a little at the injection site during the administration of ZOSTAVAX. It was stated that the patient also received less than the recommended dose of ZOSTAVAX because some of the solution leaked out between the syringe and the needle. No treatment was given for the experience. No lab diagnostic studies were performed. The patient recovered on 23-AUG-2012. The patient sought medical attention by seeing the pharmacist. The relatedness for patient bled a little at the injection site during the administration of ZOSTAVAX was unknown for ZOSTAVAX. Additional information has been requested.
Patient reported that she had "completely lost range of motion" after receiving her COVID booster. Patient stated "she knew something was wrong right away, the shot was too high and too far back and it really hurt going in." Employee who administered vaccine said the patient reported no issues/discomfort during her 15 minute monitoring period. Became aware of issue on 10/20/2022 when patient called pharmacy to report.  (Patient did report she had received flu vaccine is past 4 weeks but was not given at our facility so I do not know vaccine information.)
Red raised areas on upper chest, bilateral arms, face. Itchy scalp. Will continue BENADRYL. Pt was seen in clinic for this concern. Follow-up with-in 2 weeks if symptoms continue.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 07-JUL-2009, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance 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 condition of herpes zoster. In 2016, the patient was treated for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the 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.
Hive like rash appeared first on left leg then on right leg within 5 minutes of giving immunizations, mom advised to go home and give some Benadryl-by later that evening, rash had all but disappeared.
No additional AEs were reported; The healthcare worker reported that a patient received improperly stored vaccine (storage temperature: 11.3 C); This spontaneous report as received from an other health professional refers to a 4-month-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.     On 29-AUG-2022, the patient was vaccinated with one dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot# W002562 (was verified to be valid), expiration date: 12-OCT-2023 or lot# w004504, expiration date: 16-JUN-2023, administered orally (exact dose was not reported) for prophylaxis. Administered dose of vaccine has been stored in the temperature of 11.3 degrees Celsius for 34 minutes (LLT: Product storage error temperature too high). There were no previous temperature excursions reported. No adverse event was reported.
Patient reports getting a fever blister the day after receiving the vaccine. Patient states that this does not bother him and he did not seek medical attention.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. It was reported that on an unspecified date, several months ago, the patient received their first dose of GARDASIL (Lot # not reported) (dose and route not reported). Concomitant therapy was not reported. On 08-AUG-2013 the patient went the office and would like to receive the second dose of GARDASIL. No adverse effect reported. Additional information has been requested.
to ED c/o cough, + pneumonia, TX: toci, decadron, req vasopressors for hypotension, CRRT, develops afib, cardiac arrest on 10/26, made DNR 10/27, pt expired 10/28
Day of shot:  Arm was sore and started itching in the evening.   Day 2-5:  Arm was sore. (Mostly on day two.)  Arm had around 2-inch local reaction at injection site.  Red, hot to touch, itchy, hard. Day 6-7:  Arm was lightly itchy.  Redness went away. Day 8:  Arm began to itch fairly consistently late in evening. Day 9: Arm was increasingly itchy through out the day.  In the morning had around a 2-inch red spot. Size of the redness increased througout the day, became redder, hot to touch, hard, itchy. Day 10:  Approximately 1/2 of upper arm (between shoulder and elbow area around 6 or 7 inches by 4 or 5 inches) red, swollen, hard to touch, hot, itchy. Day 11: Reaction began to fade.   Day 12-13:  Arm is still read at injection site.  Bottom area of the large reaction area is also still red and itchy. Day 14- 15 (today):  Arm is still read at injection site.  Bottom area of the large reaction area is also still itchy and appears to be redder than it was.  Redness at the bottom of the reaction area seems to be slowly spreading back up towards initial injection site.
FF2593 Vial specified that expiration date was 11/2021. The pharmacy notified team that vial was expired 11/24/21. The vaccine was administered 11/29/21.
The patient presented to Doctor on 10/16/2020 at 4:20 PM, Patient stated that she started to get achiness the evening of the vaccination, and then next day she noticed redness around the injection site moving down her arm with swelling.  The patient is to follow up with her PCP as scheduled, and if the condition worsens the patient should receive another evaluation at the emergency room immediately or contact the primary medical clinic to discuss further concerns.  The patient is diagnosed with cellulitis. The patient should take Cipro 500 mg oral tablets as 1 tablet by mouth every 12 hours for 7 days, and should apply topical hydrocortisone to the site of inflammation twice daily.
11/11/08 PM developed swelling and tenderness below left breast in a 4-5" bend from mid chest ground left side to mid back. went to good 5 am . No symptoms at injection site. Improved ZANTAVAC, surgeon diagnosed Shingles treatment 11/13/08, she developed rash and blisters on front of trunk and on back. 11/17/2008 filled prescriptions for PREDNISONE 20mg and FAMATEVIX? 500mg  from local dermatologist.
I experienced inflammation, feet swelling in my feet, headache, fatigue, 8 hours after the vaccine was administered and lasted for 3 to 5 days. I contracted COVID 19 11/26/2021 with symptoms of sore throat, congestion, cough, fever of 102.6 on 12/2/21, insomnia, myalgia and joint aches, fatigue, chills, loss of taste and smell, chest pain/tightness, shortness of breath and my symptoms did not improve for 3 weeks. I was prescribed steroids, and an inhaler. I am still experiencing lingering symptoms of loss of taste and smell, fatigue, cough, and insomnia.
no adverse event; one dose of VARIVAX and one dose of MMR II that experienced a temperature excursion was administered to a single patient; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapy were not reported.      On 25-AUG-2022, the patient was vaccinated with improperly store doses of varicella virus vaccine live (oka/merck)(VARIVAX) lot # U024765, expiration date 10-AUG-2023 and a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), lot # T034388, expiration date 08-OCT-2023 (dose and route were not reported) for prophylaxis (product storage error).  Concomitant therapies included sterile diluent. The vaccines were exposed to 10.1 Celsius for 1 hour and 30 minutes and to -11.5 Celsius for 4 hours and 30 minutes. There was no previous temperature excursion.  There was no additional adverse event and nor product quality complain reported.
Headaches; nausea; muscle cramps; Date of start of drug: 09Feb2021, dose number: 01/09Feb2021, dose number: 02; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; HYDROCHLOROTHIAZIDE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 09Feb2021, for COVID-19 immunisation, reaction(s): "headache", "nausea", "muscle cramps". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 2021, outcome "unknown", described as "Date of start of drug: 09Feb2021, dose number: 01/09Feb2021, dose number: 02"; HEADACHE (non-serious) with onset 01Jul2021, outcome "not recovered", described as "Headaches"; NAUSEA (non-serious) with onset 01Jul2021, outcome "not recovered", described as "nausea"; MUSCLE SPASMS (non-serious) with onset 01Jul2021, outcome "not recovered", described as "muscle cramps". The events "headaches", "nausea" and "muscle cramps" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, nausea, muscle spasms. Additional information: Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications within 2 weeks of vaccination was Lisinopril 2.5mg, Hydrochlorothiazide 25 mg. Treatment received for the adverse events was doppler ultrasound and Zofran medication. Prior to vaccination, the patient was not diagnosed with COVID19. Since the vaccination, the patient had been tested for COVID-19. Hospitalization Prolonged: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Insomnia; headache; fatigue; pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in the left arm, on 06Feb2021 at 17:45, at single dose, for COVID-19 immunisation. Medical history included asthma. Patient did not experience COVID-19 prior to vaccination. Concomitant medications included ethinylestradiol, norgestimate (SPRINTEC) and loratadine (CLARITINE ALLERGY). The patient experienced insomnia (non-serious) on 06Feb2021 at 20:00 with outcome of recovering, headache (non-serious) on 06Feb2021 at 20:00 with outcome of recovering, fatigue (non-serious) on 06Feb2021 at 20:00 with outcome of recovering, pain at injection site (non-serious) on 06Feb2021 at 20:00 with outcome of recovering. No therapeutic measures were taken as a result of the events. Patient did not tested for COVID-19 post vaccination.  The information on the lot/batch number has been requested.
Patient presented with  a rash to bilateral under arms, groin and back that was pruritic and maculopapular in nature which started approximately 24 hours after the injection, but was seen in approximately 48 hours after the injection with no improvement or worsening symptos
Patient had left sided facial tingling and then facial weakness and drooping which lasted about an hour.  It didn't affect speech but did affect the smile and was obvious to coworkers.  After the first and second one, she had tingling but never drooped.  The tingling always started within 30 minutes of the vaccine.
PRODUCT GIVEN PAST STABILITY DATA/DOSE ADMINISTERED FROM PUNCTURED VIAL; MEDICATION ERROR; PUNCTURED VIAL PLACED IN FRIDGE; This spontaneous report received from a physician concerned a 4 decade old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced punctured vial placed in fridge. On 17-MAY-2021, the subject experienced product given past stability data/dose administered from punctured vial. On 17-MAY-2021, the subject experienced medication error. The action taken with covid-19 vaccine  was not applicable. The outcome of the product given past stability data/dose administered from punctured vial, punctured vial placed in fridge and medication error was not reported. This report was non-serious.
- pt states she got her 2nd dose of bexero 2 d ago.  At the time of the shot she got some tingling down her arm that resolved and then shoulder started hurting that night and is not getting better.  Hurts to move the shoulder/arm.  No help with tylenol or motrin.  Ice and heat help some but only while actually being on her skin.  No known fever at home, did have low grade here.  No other sx.
Severe headaches, black spots in vision, constipation, severe abdominal pain, rash on face, severe anxiety, rashes, extra salivation, nausea, chest pain, sore throat, diarrea, fatigue, extra persperation.  All started around 9/24/2016 after several doctor appointments and er visits no conclustions came for a reason to the above symptoms for over a year.  One of our ER visits for extreme abdominal pain came back with a Dermoid Cyst in her left ovary that was removed surgically in 5/2018.
Pulmonary embolism; Initial information was received on 01-Oct-2021 regarding an unsolicited valid serious case received from a consumer/non-health care professional via Social Media.  This case involves a female patient of unknown age who experienced pulmonary embolism, after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious pulmonary embolism (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and lead to death.  It was unknown if the patient experienced any additional symptoms/events.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment for the event.  It was unknown if an autopsy was done and the cause of death was reported as Pulmonary embolism.  Information on the batch number was requested for this case.; Sender's Comments: This poorly documented social media case concerns a female patient (age unknown) who died due to pulmonary embolism after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). It was unknown if an autopsy was done. Further information regarding patient's past medical condition, previous vaccination tolerance, autopsy data and other laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: Pulmonary embolism
WOKE UP AT 1230AM AND FELT AS THOUGH MY THROAT WAS SWELLING UP. BOTHS ARMS SWOLLEN. WENT RIGHT TO LOCAL ER.
This spontaneous report as received from a nurse refers to a 21 months 26 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Very sleepy, feeling faint to almost passing out, severe abdomen pain, feeling like she couldn't breathe, after 2 sleep study tests she's been diagnosed with Narcolepsy, IBS. I couldn't get NO ONE TO LISTEN TO ME!! SHES 25 and it took YEARS for a doctor to listen.  I asked him to test her for HEAVY METALS but he said he hasn't ever done one of those test before and DIDN'T DO IT!! THIS VACCINE IS THE CAUSE OF MY DAUGHTERS HEALTH ISSUES!
felt across her chest a lot of pressure; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient felt across her chest a lot of pressure. Patient thought that it was just a heart burn but then confirmed that it's not. Patient wanted to know if this was a side effect because she is having second thoughts to take the second dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
The day after the vaccine was given patient reports that he was sore and swollen at vaccine injection site. He also developed a headache later that day. He reports being able to use arm normally but it is still very sore.  It was hot to the touch but is better now. He overall feels weak and tired and plans to see his PCP
1-2 days after 2 month old immunizations, patient had an episode of turning blue. required stimulation to return to normal. had increasing frequency and severity of events. Peds ICU admission. Reflux, seizure; no clear etiology. Now transferred to hosptial for further evaluation. Per 60 day follow up, pt still on seizure medicine but remains seizure free. The discharge summaries received on 4/5/04 state apnea. He has had events at times that are possible subtle seizures as we have tried to take him off his seizure medication. Seems to be developing well.
Patient had a syncope event post vaccination, was caught by nurse before hitting floor. 911 was called and was assessed by the paramedics and the patient and was cleared to go home. Additional set of vitals -done and were WNL and patient was finally released and sent home. No further action taken
T104, diarrhea, loss of appetite @ office visit 11AUG92 230PM t103.4 R; nl PE; t101.6 @ 435PM;
No additional AEs were reported; received improperly stored vaccines; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.  On 29-MAR-2022, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, lot #U026664, expiration date: 24-FEB-2023 or lot# 1741817, expiration date: 30-JUL-2022 (the nurse did not know which specific lot of vaccines were administered to specific patients) (strength and exact route of administration were not provided) for prophylaxis (product storage error). The vaccines had been improperly stored in the temperature of 34.3 Fahrenheit degrees (F) for 55 minutes with no previous temperature excursion. It was unknown if digital data logger was involved. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA001816: US-009507513-2204USA001821: US-009507513-2204USA001821: US-009507513-2204USA001621: US-009507513-2204USA001657: US-009507513-2204USA001730: US-009507513-2204USA001839: US-009507513-2204USA001848: US-009507513-2204USA001926: US-009507513-2204USA001952: US-009507513-2204USA001980: US-009507513-2204USA001994: US-009507513-2204USA001998: US-009507513-2204USA002003: US-009507513-2204USA002007: US-009507513-2204USA002009: US-009507513-2204USA002052: US-009507513-2204USA002055: US-009507513-2204USA002072: US-009507513-2204USA002073: US-009507513-2204USA002074: US-009507513-2204USA002075:
Pt. became white and weak - stated "I think" the eyes rolled back in head and pt fell limp to floor. Pt. then became rigid and stiff and arms drew up to chest. Lasted app. 1 minute. Pt. then started swinging BUE and opened eyes and appeared to be in confused state.
Cellulitis of upper right arm at injection site.  Infection/abscess of lymph node in right arm pit.