chrisvoncsefalvay/vaers-outcomes huggingface dataset:
suspected vaccination failure; Have had shingles twice since then; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving 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.  Additional details were reported as follows: The age at vaccination was not reported. The patient received shingles vaccine and experienced shingles twice since then. This case was considered as suspected vaccination failure since the details regarding time to onset, completion of primary vaccination  schedule and laboratory confirmation of shingles was not provided.
This spontaneous report as received from a other health professional (reported as immunization coordinator) refers to 2 patients of unknown age and gender. No information about medical history, concurrent conditions were reported. On an unknown date the patients were vaccinated with VARIVAX (Merck) (dose strength, route not reported) that was stored improperly (Incorrect product storage). No adverse effects reported (No adverse event). No concomitant therapy was reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Information has been received from a nurse referring to multiple unknown patients of unknown age and gender. Information about pertinent medical history and drug allergies was not provided. On multiple unspecified dates, multiple unknown patients were administered improperly stored RECOMBIVAX HB (lot#/ expire date: L048848/09-AUG-2018, lot#/ expire date: M032649/11-NOV-2018, dose and frequency were unknown) for prophylaxis. The temperature of storage for RECOMBIVAX HB was 22 Celsius for 5 minutes. This alarm happened while plugging in the Data logger. No adverse effects reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA004318: US-009507513-1612USA004317: US-009507513-1612USA003676: US-009507513-1612USA004316.
Pt recv vax on 10/20/98; 1/2 hr later pt exp erythema, redness to vax site & fever x 8-10 day; tx=Benadryl & cold compress
a couple of hours after the shot, I started to get dizzy, stomach a little off.  a headache started.  with in 3 hours from the vaccination time, I had bad-not severe headache pain on the left side of my head.  throat/neck gland swelled.  heart was racing.  the pain went from my vaccination site up my shoulder blade to the back of my neck and up into the left side of my head.  once I laid down the heart racing slowed down.  I was able to fall asleep and slept for 3 hours.  when I awoke, I had slight headache, dizziness was gone, swelling in my neck was gone, heart rate back to normal.  I had much discomfort in my shoulder. the following day I was extremely tired.  by the end of the day I felt much better.
Had mild soreness a couple days after injection; a week later experienced a painful swollen lymph node near armpit on the arm of the injection site. On day 8 after the injection, there is a tender, warm, and slightly itchy lump at the injection site (?covid arm?)
Patient complained of bone pain at the location of the Pneumovax injection.  Patient told to come in for same day appointment.
7:00 P.M. 4/5/21 began having body aches, chills, extreme weakness 99.8 fever in morning of 4/6/21 until mid afternoon around 2:00 P.M. Slept most of the day with Tylenol and Advil administration By 7:00 P.M., body aches subsided and energy levels felt better 24 hour period of symptoms.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Sep2021 as dose 1, single (Lot number: EW0184), as dose 2, single (Lot number: FL3209 ) (Lot number also reported as FL3209 / HT326; vaccine administration date for dose 2 also reported as 06Apr2022, pending confirm), on 02Mar2022 as dose 3 (booster), single (Lot number: ENG6208) and on 13Apr2022 as dose 4 (booster), single (Lot number: ER8729) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's Disease" (unspecified if ongoing); "Stroke" (unspecified if ongoing); "Malaria" (unspecified if ongoing); "Colon removed" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 10Sep2022, stop date: 16Jan2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures paxlovid from 17Jan2023 to 21Jan2023 were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300040084 Same patient/product, different dose different event.;
This case was reported by a consumer via call center representative and described the occurrence of polymyalgia rheumatica in a 76-year-old female patient who received SHINGRIX for prophylaxis.  The patient's past medical history included polymyalgia rheumatica (had about 8 years ago before the date of reporting, it lasted about a year). In August 2018, the patient received SHINGRIX. In September 2018, 7 days after receiving SHINGRIX, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant), stiffness, shoulder pain, injection site pain, injection site rash and pain in hip. On an unknown date, the outcome of the polymyalgia rheumatica and stiffness were not recovered/not resolved and the outcome of the shoulder pain and pain in hip were unknown and the outcome of the injection site pain and injection site rash were recovered/resolved. It was unknown if the reporter considered the polymyalgia rheumatica, stiffness, shoulder pain, injection site pain, injection site rash and pain in hip to be related to SHINGRIX. Additional details were provided as follows: On 30th or 31st August, the patient received the SHINGRIX vaccine. Since patient had the vaccine, she has experienced a relapse of polymyalgia rheumatica. The patient has been experiencing stiffness and pain in  her shoulders and hip joint. The patient started having the symptoms about a week or 2 weeks since getting the vaccine. Less than a week after receiving SHINGRIX, the patient did not notice that immediately because she also experienced a sore arm and a large rash at the injection site. The rash was about 4 inches long by 2 to 3 inches wide on her arm at the site of injection. It took a while for that to go away. The patient reported this to her rheumatologist and he reported that to the the Center for disease control and prevention (CDC). The reporter consented to follow up.
Information has been received from a registered nurse concerning a physician with no pertinent medical history and no know drug allergies who on approximately 25-JUN-2008 was vaccinated with ZOSTAVAX (Oka/Merck) 0.65ml SC. In June 2008, the patient developed neuropathy within a day or 2 after vaccination. The patient's neuropathy persisted. The patient sought medical attention and the patient was the prescriber. Follow up information was received from the physician (concerning himself) with arthritis, high blood pressure, lipid abnormal and Benign prostatic hyperplasia and a history of mild herpes zoster at age 35 who developed left arm neuritis after self administering the vaccine 0.65ml in left deltoid about 5 weeks ago on approximately 16-JUN-2008. There was no illness at the time of vaccination. The patient developed pain in the left elbow and a granulomatous lesion at the injection site in the left deltoid about 3 weeks ago on approximately 2 weeks after self injection the patient experienced mild sensory discomfort. The pain was described as extending from the elbow to the wrist on the volar side and was most bothersome at the antecubital fossa not related to use. There was no motor change and the pain was not constant, there was more time without discomfort than with. The pain severity was described as a one 1 of 10 and the pain was improving without treatment. There were not relevant diagnostic tests and laboratory data. The patient felt that the symptoms were "pre zoster" type changes recognized before appearance of zoster. No other symptoms or treatment reported. Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/24/2008. Additional information is not expected.
C/o fluid filled blister 1-2cm in diameter at injection site. Instructed to cover it, and take TYLENOL/Ibuprofen if necessary.
it says it expired October 13,2021. But we administered it without knowing to our patients; fever; body aches; headaches; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (it says it expired October 13,2021. But we administered it without knowing to our patients), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headaches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (it says it expired October 13,2021. But we administered it without knowing to our patients), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headaches). At the time of the report, EXPIRED PRODUCT ADMINISTERED (it says it expired October 13,2021. But we administered it without knowing to our patients) had resolved and PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headaches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications details were reported.  The health care professional reported that, they had a stock of lot number and when they checked it was expired. The vials were Manufacturer on 23-Jun-2021 and expired on 13-Oct-2021 and they were still continuing to use those vials.   The number of doses per vials were 200-250 patients per doses. The vials stayed in the freezer since they were received on 08-Sep-2021 and they take the vials out of the freezer and move them to the fridge each day of administration. These vaccines were administered between 14-Oct-2021 to 08-Dec-2021 and they did not undergo the temperature excursion. Further health care profession reports, the patient had called in with fever, body aches, headaches and normal side effects.   Most recent FOLLOW-UP information incorporated above includes: On 13-Dec-2021: Follow-up information received includes new events added, reporter details and vaccine details were updated. On 13-Dec-2021: Follow-up information includes no new information.
given the diluent portion only from Pentacel; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a non-hcp (Office Staff).  This case involves female patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] VACCINE lot UJ098AAA via unknown route in the right thigh on 19-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  It was a case of actual medication error due to inappropriate reconstitution technique.   It was reported that patient was given only the diluent portion of Pentacel.  At a time of reporting no adverse event 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.  Documents held by sender: none.
Administered vaccine after 33 days in the refrigerator; Product storage error; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Admission Date: 6/17/2022 Discharge Date: Jun 18, 2022 PRESENTING PROBLEM: Acute hypoxic respiratory failure Acute respiratory disease due to COVID-19 virus   HOSPITAL COURSE: Patient is a 61-year-old woman with history of mild intermittent asthma who presented to the hospital with few days of more shortness of breath and cough.  She tested positive for COVID-19.  She had acute hypoxic respiratory failure and was admitted to the hospital for treatment.  She was started on Decadron and had scheduled albuterol nebulizers.  Her acute hypoxic respiratory failure resolved but she continued to have significant wheezing.  She overall felt better and wanted to be discharged.  She was discharged home with refills for her Spiriva and albuterol.  She was instructed to always use a spacer with her albuterol inhaler.  She was also prescribed 8 more days of Decadron.
Patient felt flushed and experienced palpitations. BP: 144/86, 128/78. Pulse 74, 70. Respiratory rate, 20. O2 sat 99%. Patient lay down, drank water - symptoms resolved in 15 minutes.
This spontaneous report as received from a healthcare worker refers to a adult patient of unknown age. The patient was vaccinated with the first dose of M-M-R II (dose and lot # unknown) on 19-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. The adult patient's titer for Mumps was low after receiving a first dose of M-M-R II. The titer was drawn on 05-SEP-2012. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
This case was reported by a nurse and described the occurrence of swelling of the leg of an 8-month-old male pt who received diphtheria and tetanus toxoids and acellular pertussis adsorbed hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. On unspecified dates, the pt received 2 previous doses of diphtheria and tetanus toxoids and acellular pertussis vaccine (unknown manufacturer), inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur) and combination Haemophilus influenzae type b conjugate vaccine/hepatitis B vaccine (Comvax, Merck). On 10/22/2003, the pt received his 1st dose of Pediarix which was given as the 3rd dose in the DTPa, poliomyelitis, and hepatitis B immunization series. The dose of Pediarix was administered in the left leg. One day later, on 10/23/2003, the pt experienced a rash on his leg "which covered one-fourth of his thigh," swelling of the leg, fever, vomiting and gas pains. The fever, vomiting and gas pains resolved on 10/24/2003. The leg rash and leg swelling were unresolved. The nurse considered the events were probably related to vaccination with Pediarix. The nurse considered the leg rash and leg swelling to be related to vaccination with Pediatrix and the fever, vomiting and gas pain to possibly be related to Pediarix and Prevnar.
Patient reports experiencing pain in left arm to fingers with numbness/tingling starting on the day of injection (9/28/20). Acute worsening of pain, numbness, erythema of arm, and nausea starting in the middle of the night 10/1/20-10/2/20.  Patient was seen for virtual visit on 10/2/20 and reported severe pain of entire left arm extending to hand, numbness/tingling, and nausea with any movements. During virtual visit noted slight inflammation at site but no erythema of arm/skin changes, patient tender to slight palpation (done by mother). Advised warm compresses, ibuprofen, and benadryl. .Spoke to patient 10/3/20 at 2:15pm, all symptoms improving - still with tenderness/pain, tingling, and nausea but all symptoms reported as minimal per patient.
Moderna Dose administered after 30-day Use By Date; vial undergo temperature excursions; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Dose administered after 30-day Use By Date) and PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Dec-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions). On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Dose administered after 30-day Use By Date). On 19-Jan-2022, PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions) had resolved. On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Moderna Dose administered after 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial undergo temperature excursions.  The vials were transported from one facility to another in frozen state. The 2nd facility stored them in refrigerator for 2 days from 20th December 2021 to 22nd December 2021.  Accidentally the vials got misplaced back into freezer on 22nd December 2021 even though they had assigned BUD of 30 days. HCP did not know if vials were frozen or thawed out when moved back into freezer.  The vials were assigned BUD date of 19th January 2022.   0 F was the lowest temperature that vaccine has reached when moved back to freezer.  The excursion duration was reported as 22nd December 2021 to 19th January 2022.  The vials were pulled out of the freezer on 20th January 2022 and 15 doses were administered.  The reporter asked whether they need to revaccinate the patients.  No concomitant and treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2022: Significant follow up contains updated reporter details and patient details. Case was upgraded from invalid to valid.
The vaccine did not cause covid. I had minor muscle aches and fatigue after both initial doses and the booster.  I got covid in January of 2022 and tested positive January 21, 2022 and was told to report via this system to aid in accummulating data to help others.
Fever, chills, headache, body aches, sore throat, diarrhea, top of head hurts to touch, pain in kidney, elevated HR all lasting for days
3/15/21 ER HPI - Transferred to Hospital, remains inpatient as of 3/16/21  74 y.o. male who presents with near syncopal episode.  Patient states he was getting ready for his doctor's appointment this morning and when he started walking outside he fell dizzy.Wife states that before leaving for his doctor appointment this morning the patient complained of not feeling well, was sweaty and complained of upper chest pressure radiating into both arms.  This symptoms have pretty much subsided on arrival to the emergency room. After initial dizzy episode, he almost collapsed, stood up, recovered and then felt dizzy again and was helped down by his wife and denies any injury except for some redness on his left knee.  Patient denies chest pain or palpitations.  He does not have any prior history of syncope.  He is diabetic and hypertensive.  Recently underwent bladder surgery due to cancer and now has a urostomy(ileal conduit).  This was performed by Dr., urologist  at Hospital He is on clindamycin postoperatively due to incisional infection on 03/08.    3/15/21 Hospital H&P:  The patient is a 74 y.o. male with history of bladder cancer s/p open radical cystectomy resection with ileal conduit urinary diversion, type 2 diabetes, hypertension, diabetic neuropathy and chronic back pain presented to ED at Hospital because of dizziness and weakness in addition to  chest discomfort.  He stated that he was walking in the parking lot of his doctor's office when he suddenly felt dizzy weak and started falling on the ground.  His son helped him and the ambulance was called.  He stated that he felt pressure in his chest with radiation to the shoulders.  He also felt short of breath.  Stated that the symptoms lasted for about half an hour.  He stated that he has never had any similar episodes in the past.  He is not known to have any heart or lung disease.  He was treated for bladder cancer and had open radical cystectomy with ileal conduit.  He has been diabetic for the last 16 years.  He has diabetic neuropathy.  He stated that he gets out of breath walking a notice increasing swelling in the lower extremities
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 315-DEC-2015 at 08:42, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperature were 8.6 and 7.4 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Confusion, Dizziness, fatigue, chills Narrative:  Dizzy, confused, fatigue, chills.  Other Relevant History:
Pentacel vaccine was administered; however, the vaccine was not diluted with the diluent that was in the boxed package. When pulling the vaccine to be administered, I did not realize/see that there was a specific diluent to be used with the vaccine. RN diluted the vaccine with sterile diluent instead.
Found pt lying on floor in room, c/o being thirsty & appears to be hyperventilating. c/o tightness and extremities stiffening up. .5 of epinephrine given & 911 called BP 92/50, 180/102 post epi. EMS on seen & taken to hospital at 07:40.