chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 10:09 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 10:09 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 20.84.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
they described it as a nasal swab and that test came back positive; they described it as a nasal swab and that test came back positive; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer reported similar events for 2 patients. This is 2nd of 2 reports. This consumer reported for a female patient (wife) of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 26Jan2021, they did 2 test, they did a rapid test which both of them came negative. And then they did what they call a 2 day test, could get the results back within a 2 days that was, they described it as a nasal swab and that test came back positive for both of them. The outcome of the events was unknown.  Information of lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021123696 same report/drug/event, different patient.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. No concurrent condition, medical history or concomitant therapy was provided. On 28-JAN-2016, the patient was vaccinated with improperly stored VARIVAX (Merck) (lot # L025209 and expiration date: 07-JUL-2017, dose and route not reported), after a reported temperature excursion of 13.7 Fahrenheit (F) for 1 hour and 51 minutes. The previous temperature excursion was reported as 13.5 F for 57 hours and 27 minutes, 14.8 F for 20 hours and 33 minutes, and cumulative excursion was reported as 13.7 F for 61 hours and 3 minutes, 14.8 F for 20 hours and 33 minutes. The temperature had been back in range. No adverse effects were reported. All telephone attempts to obtain follow up information had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested.
9hr p/vax pt had inc apnea, bradycardia & oxygen desaturation;tx w/supportive therapy;
Four days after immunization patient presented to the pharmacy with a swollen injection site reaction on the back of her arm. There were also skin blisters at the injection site. Patient went to the ER where they determined it was an allergic RXN to the vaccine. She was told to cover blisters with a BANDAID and follow up w/her PCP.
Had four shots and still got it/Suspected vaccination failure; Still got it in eye; Severe pain; Had four shots; in bed for 1 month; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis, Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 4th dose of Shingles vaccine, the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), bedridden, pain and extra dose administered. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster and extra dose administered were unknown and the outcome of the bedridden was recovered/resolved and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, bedridden and pain to be related to Shingles vaccine, Shingles vaccine, Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 4-Dec-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had four shots and still got them in left eye. The was in bed for 1 month and still had severe pain. The reporter denied for the follow-up. Additional supportive information: The patient received four shots of Shingrix, which led extra dose administered. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Patient has developed shingles. She stated that a person who she was in close contact had the shingles already before she received the vaccination.
First dose my left eye swelled and was itchy. Had a hard time catching my breath. Took over the counter allergy medication (Zyrtec, Allegra, Benedryl) Second dose had a rash that came up within hours on my left leg. Took allergy medicine again. Next day left eye swollen. Took allergy medicine. I had exhaustion the day after and for the following 4 days. Had rash come up on right leg and on torso.
9/17/2020 Developed systemic rash, red papule covering trunk, legs, arms. It appeared approximately 12 hours after receiving vaccine.  Patient took 50mg of Benadryl oral the evening and used 1% cortisone cream topically.
Patient reports having an adrenal crisis consisting of N/V/V, chills and confusion.
Received second dose of Moderna vaccine afternoon of Feb 25, 2021.  (had no significant reaction to first dose 4 weeks earlier).  Patient is handicapped with severe Lupus neuropathy but lives alone.  Around 1 AM of Feb 27 fell when arising from chair.  Called 911 but refused EMT suggestion to go to ER.  At 8 AM her daytime aide found her on floor, confused.  Called 911 and EMTs took her to ER where she was admitted to hospital with BP 84/40, Temp 103.1.  Dx dehydration vs infection.  Responded to IV fluids.  After 3 days in hospital was discharged to facility for rehab.  Doing well and plan is for discharge to home on Marc 19, 2021.
difficulty walking; vertigo; dizziness; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "difficulty walking"; VERTIGO (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown".  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300287162 same reporter/drug/event, different patients;US-PFIZER INC-202300285647 same reporter/drug/event, different patients;
No additional adverse events reported; The patient was administered with improperly stored vaccine; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Information about the patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies was not reported.   On 15-DEC-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (lot# T033815, expiration date 05-OCT-2022; strength, dose and route were not reported) for prophylaxis (product storage error).  The administered vaccine experienced a temperature excursion in 49.6 Fahrenheit degrees (F) for 35 hours 9 minutes. The previous temperature excursions included 32.9 F for 53 hours 16 minutes, 49.1 F for 5 hours 9 minutes, and 56.3 F for 14 hours 7 minutes. No additional adverse events reported.   This is one of multiple cases received from the same reporter.; Sender's Comments:  US-009507513-2202USA003592: US-009507513-2203USA003310: US-009507513-2203USA003311: US-009507513-2203USA003312: US-009507513-2203USA003313: US-009507513-2203USA003314: US-009507513-2203USA003316: US-009507513-2203USA003317: US-009507513-2203USA003318: US-009507513-2203USA003319: US-009507513-2203USA003320: US-009507513-2203USA003321: US-009507513-2203USA003322: US-009507513-2203USA003323: US-009507513-2203USA003324: US-009507513-2203USA003325: US-009507513-2203USA003326: US-009507513-2203USA003327: US-009507513-2203USA003328: US-009507513-2203USA003329: US-009507513-2203USA003330: US-009507513-2203USA003331: US-009507513-2203USA003332: US-009507513-2203USA003333: US-009507513-2203USA003334: US-009507513-2203USA003335:
Per patient, Janssen vaccine received 2 days prior to presenting to the ER on 5/11/2021 for 1 day of SOB and CP.  This was diagnosed as pulmonary embolism at the ER.
Narrative: HPI: Patient presented to the ED on 12/7/2021 with a chief complaint of weakness. Son stated Patient fell at home earlier that day. Son also reported decreased appetite and fever at home. In triage, Patient was afebrile and hemodynamically stable. SpO2 was 93% on Room Air. Labs in ED revealed leukocytosis with left shift (WBC 14.39, bands 5), elevated BUN (34mg/dL), depressed serum bicarb (CO2 20.4mmol/L, AG 18.4), hypophosphatemia (Mg 2.3mg/dL), elevated T. bili (2.4mg/dL), normal transaminases, elevated CRP (19.65), positive d-dimer (3.5), positive lactate (4.2), and elevated ferritin (886.1). UA was suggestive of UTI. COVID-19 test was POSITIVE. ABG on room air revealed hypoxic respiratory failure (pH 7.5, pCO2 27 , pO2 37). Blood and urine cultures were obtained. CXR revealed interval bilateral interstitial infiltrates. Patient was given acetaminophen 1000mg IV x 1, ceftriaxone 1g IV x 1, and 1L NS in the ED. He was admitted to ICU fur further care. Update of Present Illness: 12/13/2021 - Patient was placed on HFNC on admission. Dexamethasone and remdesivir were initiated upon admission to the ICU. Ceftriaxone was continue. Azithromycin and linezolid were initiated. Tocilizumab was given. Linezolid was discontinued on 12/8/2021. Respiratory status declined. Patient was transitioned to BIPAP on 12/10/2021 and ultimately was intubated that AM. Patient develop hypotension post-intubation and pressors were initiated. This AM, Patient remains sedated and intubated. Norepinephrine continues. 12/20/2021 - Patient remains sedated and intubated this AM. FiO2 and PEEP requirements decreased over the weekend. Patient developed leukocytosis on 12/19/2021. Patient was pan-cultured. Piperacillin/tazobactam and vancomycin. Norepinephrine was resumed last night at low dose. 12/21/2021 - Low dose norepinephrine continues. Sputum growing a mold and a yeast on preliminary report. 12/22/2021 - Voriconazole was initiated yesterday due to sputum culture. No acute events noted overnight. Norepinephrine requirements have slightly increased over the past 24 hours. Ventilator settings stable over the past 24 hours. 12/23/2021 - CT angiogram obtained this AM and was positive for PE. CT head was negative for acute intracranial findings. Patient develop atrial fibrillation with RVR and hypotension this afternoon. Amiodarone protocol initiated. Art line placed. Digoxin given. 12/27/2021 - Micafungin was initiated on 12/24/2021. Repeat sputum culture from 12/23 is also growing an unidentified fungus. Micafungin was discontinued and amphotericin B was initiated on 12/25/2021. Vasopressin initiated on 12/25/2021. Patient remains vasopressor dependent this AM. PEEP and FiO2 requirements are high. Patient is in NSR this AM. Patient's family came in for visit and elected to withdraw care. Patient died shortly after terminal extubation.
Slight headache 12 hrs after shot, fever/flu like symptoms  started 30 hrs after shot.
student requesting Adacel inadvertently received Tenivac, patient received 1st dose of Tenivac on 07/08/2019 and 2nd on 09/20/2019/ No AE; student requesting Adacel inadvertently received Tenivac/ No AE; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 21 years old female patient who inadvertently received 0.5 mL dose vaccines DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] on 08-Jul-2019 and 20-Sep-2019 (lot U6101AA, expiry date-23-10-2020 via intramuscular route in the left deltoid) instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  no other vaccines received.   It was a case of actual medication error due to wrong vaccine administered and inappropriate schedule of vaccine administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sore arm at the time of shot and for 8 days after. Within 10 min of receiving the shot, I had a slight metallic taste in my mouth. I had my second dose on 3/31/2021. My first menstrual cycle after the second dose began on 4/27/2021. I experienced painful cramping in my lower back about 1 week prior to my cycle starting and heavy bleeding and more painful than normal cramping on the day that I started my menstrual cycle.
Patient has been irritable nightly - not eating well, not sleeping well.  On 10/27/16 at 6:30pm she got out of her bath and became extremely upset, screamed words in random order, contorted her body, arching her back, and was inconsolable, crying, screaming, and non-interactive for 25 minutes.
Extreme chills for first couple of hours, body aches, headache, and after I went to bed, high fever of 101.3 until the fever broke.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter's husband. The age at vaccination was not reported. The patient was breaking out with shingles every 4 to 5 weeks and had this for two years. The patient had all the shots nothing helped with pain. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, laboratory test confirming shingles and time to onset for shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
pt recv vax 19MAR96 & 23MAR96 pt exp resp sx & a low grade fever;pt seen @ clinic 27MAR96;exam revealed macular rash on trunk;28MAR96 rash spread to face & progressed to papules & vesicles;dx chickenpox & tx w/med;
Vaccine at 1600hrs on 1/4/2021. Had hives, itching, arm soreness, chills, and body aches, at 1800hrs 1/4/2021. Could not sleep all night. Took Clear fast acting allergy relief 30ml next morning (1/5/2021). Hives and itching started on left wrist then right wrist. It then progressed to all over her body. She says it is like when she has a reaction to PCN.
When the needle was withdrawn from the arm,  a substantial amount of vaccine sprayed out of the needle/syringe.  The concern was if enough vaccine was administered to complete the covid vaccination series.  No adverse affects were noted at the time.  A vanishpoint retractable needle/syringe combination was used.  3ml 23G 1 "
Boostrix instead of Infanrix; Boostrix to a 15 month old; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number G7749, expiry date 3rd November 2024) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments: MA reported that she administered a dose of Boostrix to a 15-month-old patient inadvertently.  Patient was supposed to get his 4th dose of Infanrix. The consented to follow up via HCP email. Additional Supportive Information: the 15 month old patient received Bosstrix instead of 4th dose of Infanrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
This is a 42 year-old who received her annual influenza vaccination on 01/09/04. She had been in her usual health prior to receipt of the vaccination. She states that she received the vaccination and waited approximately 10 minutes in the Immunization Department.  She returned to her workspace and in route she relates feeling flush, dizzy and having tightness in her throat. Within minutes, the symptoms seemed to be subsiding; however she suddenly experienced a worsening of symptoms. She states that she felt like she was going to "pass out" and had difficulty breathing. Co-workers came to assist her and stated that the client's face was "lobster red".  She did not seek additional medical care, except from her fellow co-workers. She states all the symptoms seemed to subside with relaxation and deep breathing, lasting a total of about 45 minutes. Approximately 36 hours after the initial onset, the client developed cutaneous symptoms. She relates developing a large "burning" whelp and rash at the injection site. This subsided without intervention. Additionally, the client relates that she has developed multiple allergies in the last 6 months. She had an Allergy and Immunology work-up approximately 4 years ago. She states at that time she was only allergic to one type of pine tree. Medical record states anaphylaxis.
0.5mL dose administered to patient as booster dose instead of 0.25mL; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (0.5mL dose administered to patient as booster dose instead of 0.25mL) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 15-Dec-2021, the patient experienced ACCIDENTAL OVERDOSE (0.5mL dose administered to patient as booster dose instead of 0.25mL). On 15-Dec-2021, ACCIDENTAL OVERDOSE (0.5mL dose administered to patient as booster dose instead of 0.25mL) 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 information was provided The pharmacist stated that the patient was fine after the dose was administered. Patient received total of 1.5mL of moderna vaccine for all 3 doses combined.
I woke patient at 7:00 am and he had a mild headache and moderate mid to left sternal pain that was 5 out of 10 on his pain scale. He has a high tolerance to pain. No shortness of Breath or palpitations.  No increase pain with inspiration.