chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired PENTACEL was accidentally given to a 10 month old male patient/ No adverse reactions have been reported; Initial information regarding an unsolicited valid non-serious case received from a Nurse via Agency (Reference number- 00661536) and transmitted to Sanofi on 29-Jun-2021.  This case involves a 10-month-old male patient who was accidentally vaccinated with expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and HEPATITIS B VACCINE for prophylactic vaccination.  On 28-Jun-2021, the patient received third dose in series of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (0.5ml standard, lot U6841AA and expiry date: 22-Jun-2021) once via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency was on same day) (expired product administered).  At the time of reporting, no adverse reactions had been reported.  The nurse stated that vaccine was later noted to have expired and asked if it is a valid dose.  Treatment reported as dose will be repeated.  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.  Follow up information regarding an unsolicited valid non-serious case received from a Nurse via Agency (Reference number- 00661594) and transmitted to Sanofi on 29-Jun-2021.   Suspect vaccine coding, vaccination details including batch number and expiry date and concomitant medication was added and accordingly narrative was updated.
pt stated that both arms and legs started tingling and aching.  She stated she would would drop anything she tried to pick up or hold.  Pt states her hands are still weak uncontrollable but no longer tingling and her legs are still aching but no longer tingling.  Pt has not contacted her PCP at this time.
pt recvd vax 26JUl94 @ 4PM; pt broke out w/whelps 27JUL94 @ 530PM, mom called & was told to bring pt to office; pt had whelps on both upper legs, & buttocks; pt was running & playing in clinic; 28JUL94 8AM pt had no more whelps
Had a bulge at the injection site; had a strong pain in the arm of the injection , lasted for 2 or 3 days.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Had a bulge at the injection site) and VACCINATION SITE PAIN (had a strong pain in the arm of the injection , lasted for 2 or 3 days.) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Had a bulge at the injection site) and VACCINATION SITE PAIN (had a strong pain in the arm of the injection , lasted for 2 or 3 days.). At the time of the report, VACCINATION SITE SWELLING (Had a bulge at the injection site) and VACCINATION SITE PAIN (had a strong pain in the arm of the injection , lasted for 2 or 3 days.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication were provided
Patient reports to pharmacy on June 29th 2021 that he had pain and inflammation in both arms after both covid vaccines.  He switched vaccine administration sites but still had pain/burning after both vaccines.  He told the technician that he has myocarditis from the covid vaccine and that he saw a cardiologist.
Began having severe joint pain in fingers, shoulders and knees, making it difficult to walk and hold items in my hands or work.  Very similar to initial episode of Lyme Disease in 2009.  Slight rash noted on left arm, barely able to lift arm overhead due to pain and muscle aches, slight headache, nauseated, lack of appetite, armpits had stinging sensation and felt swollen, skin hypersensitive to touch.  I felt very energetically heavy and every step took great effort for walking. Saw my acupuncturist who gave me a detoxification treatment.  After the session I felt lighter and more energized, my left arm did not hurt and I could lift it overhead with ease. My armpits were no longer swollen and the rash was less noticeable. I felt energized. but went home and slept for several hours and drank extra water. Later that evening my appetite returned. The next day I felt much better and only minor discomfort. The ache in my joints is very mild and no longer inhibits cooking and cleaning and other household tasks.  Typing on the computer is no longer painful.  When I was at the acupuncturist for treatment, the first thing she did was to begin working on my right lower leg and ankle, and asked how my left arm where the vaccine booster was.  It felt significantly better and the pain was almost completely gone within 2 minutes of placing the needles.  She also did blood letting on my ears for toxicity and then aruicular seed beads for home use to continue to activate the ear acupressure points. My liver meridian points were extremely tender which she attributed to the need for my body to detox from the effects of the booster.   I feel almost back to normal 2 days after the acupuncture treatment.  The online surveys that you have patients fill out should include any integrative health treatments and medications patients use following the vaccine. I used OTC Advil for the first 2 days after the vaccine, then acupuncture.  i also used Arnica gel (homeopathy treatment) for swelling and pain around the site of the booster to take away the redness and burning sensation the first few hours after the booster. Complementary and Integrative Medicine treatments make a positive impact on my health and well-being.
Patient came in to get the 2nd dose of shingles vaccine. Upon registering the patient, we noticed that we gave the Varivax vaccine instead of shingles. No adverse reaction reported.
Information has been received from a medical assistant (MA), concerning a 28 year old female patient who on 23-JUL-2007 was vaccinated SC in the left arm, with a dose of PNEUMOVAX 23 (Lot #657039/0698U). On 23-JUL-2007, following the vaccination. The patient experienced extreme tenderness and arm pain, and redness at the injection site. At the time of this report, the patient had recovered from the events. The patient sought unspecified medical attention. The MA reported that of the 6 vaccinations with PNEUMOVAX 23 administered from Lot #657039/0698U, (3 male and 3 female patients with an age range from 28-61 years) 3 additional patients experienced similar symptoms involving pain, warmth, swelling, redness at the injection site, difficulty with arm movement, and fatigue (WAES 0707USA04971, 0708USA04275), 1 patient developed cellulitis (WAES #0707USA04634), and 1 patient experienced a "minimal reaction" (WAES 0708USA00702). The records of testing prior to release of the lot in question, have been rechecked and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research, and was released. Additional information is not expected.
pt recvd several doses of vax & exp unspecified reacts p/all of the doses; No further details were provided;
suspected vaccination failure; got the flu; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient's demographic details were not provided. The patient received dose of flu vaccine and experienced influenza. This case was considered as a suspected vaccination failure case as the time to onset for influenza were unknown.
Clinical Summary Patient is a 94 y.o. female with a history of CHF, recent dx of COVID on 9/26/22 who presented to RMH 10/15/2022 with dyspnea, nausea, and acute hypoxic respiratory failure.    1. Hypoxic Respiratory failure: With recent COVID infection and sats 85% on RA consistently at SNF.  CTPA negative for PE, is showing atelectasis and residual findings from recent infection. Continue aggressive IS. No fever/ sputum production to indicate PNA, but monitor. Procalcitonin 0.09. TTE unremarkable. Resolved after admission and satting >91 on RA. 2. COVID-19: Date of onset- 9/26/22 with positive test and slight fever, aches at the time which improved. Received paxlovid therapy at facility. She had completed isolation at SNF. Had 3 days remdesivir and 5 days steroids completed here.  3. Afib: Continued BB and Eliquis 4. HFpEF: Echo 10/20/22 with EF 53% with mild aortic valve regurgitation without significant change from prior studies 5. Moderate malnutrition: GI removed PEG tube on 10/18/22 after discussion with family 6. Meningioma, likely schwannoma: seen on CT imaging. Discusses with Daughter without further workup needs at this time 7. Asymptomatic bacteruria: Given Keflex for 5 days 8. Blurry Vision: intermittent, probably related to macular degeneration. Outpatient ophthalmologist to follow
needed a Boostrixbooster due to a cat bite; 81 YO given Infanrix; Patient given Infanrix instead of Adacel; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 81-year-old female patient who received DTPa (Infanrix) (batch number Y4259, expiry date 3rd March 2024) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis and DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included Boostrix. Concurrent medical conditions included animal bite.   On 13th September 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, the patient received Boostrix. On 13th September 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device and not applicable after receiving Boostrix, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the patient experienced off label use. On an unknown date, the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and off label use were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-SEP-2022 Reporter's Comments: The case was reported by nurse. Nurse stated 81 year old patient was inadvertently given Infanrix instead of Adacel yesterday (from the day of reporting). As of the time of this call the patient had not reported any reactions. Nurse noted the patient last received Boostrix in 2019 but needed a booster dose due to being bitten by a cat. Additional supportive information: Patient was inadvertently given Infanrix instead of Adacel, which led to wrong vaccine administered and inappropriate age at vaccination administration. The patient needed a booster dose due to being bitten by a cat, which led to off label use. Reporter consented to follow up. No further details were provided.
Liver issue; Periods have gotten really bad; Periods have gotten heavier/feel the blood flowing out/Periods have gotten longer/Clots (in the flow); Gets weak (from blood loss); Feelings of hot then cold; Her arm hurt, but not as bad as with the first shot; A little achy; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LIVER INJURY (Liver issue) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Morbid obesity, Blood pressure high, Asthma, Immunocompromised (Immunocompromised secondary) and Sciatica (Patient received cortisone shots for her back pain.). Concomitant products included LOSARTAN and METOPROLOL SUCCINATE (TOPROL) for an unknown indication, HYDROCHLOROTHIAZIDE.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Feelings of hot then cold), PAIN IN EXTREMITY (Her arm hurt, but not as bad as with the first shot), PAIN (A little achy) and CHILLS (Chills). In March 2021, the patient experienced MENSTRUAL DISORDER (Periods have gotten really bad), HEAVY MENSTRUAL BLEEDING (Periods have gotten heavier/feel the blood flowing out/Periods have gotten longer/Clots (in the flow)) and ASTHENIA (Gets weak (from blood loss)). In August 2021, the patient experienced LIVER INJURY (Liver issue) (seriousness criterion medically significant). On 18-Feb-2021, PAIN (A little achy) and CHILLS (Chills) had resolved. At the time of the report, MENSTRUAL DISORDER (Periods have gotten really bad), FEELING OF BODY TEMPERATURE CHANGE (Feelings of hot then cold), HEAVY MENSTRUAL BLEEDING (Periods have gotten heavier/feel the blood flowing out/Periods have gotten longer/Clots (in the flow)), ASTHENIA (Gets weak (from blood loss)), LIVER INJURY (Liver issue) and PAIN IN EXTREMITY (Her arm hurt, but not as bad as with the first shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Liver function test: abnormal (abnormal) Liver issue/Patient had a liver panel drawn and  one of the liver enzymes was elevated..         Patient took water pill (sounds like hydrochlorothiazide) and allergy pills as a concomitant product.  She reiterated several times her periods had been completely normal, occurring on a 28 day cycle, until she received the vaccine. She had one child and had  no  fertility issues.   This case was linked to MOD-2021-305798 (Patient Link).
Following the injection patient got pale and diaphoretic in his chair.  He was assisted to the ground by the staff and a loss of consciousness of about 15 seconds.  patient was transported to the observation area via a stretcher.  Upon, arrival he is alert and oriented and pale initial BP 107/70 HR 75 and oxygen sat 100% room air.  he was elevated slightly and given cold water and an apple juice.  sitting his BP 105/69 HR 77 and oxygen sat 100% on room air.   1330 patient was sitting on the edge of the stretcher and feeling better.  BP 114/75 HR 72 oxygen sat 100% patient was able to be released and he was taken to south entrance via wheelchair
the day p/vax had vomiting & diarrhea, lower abdo cramping & dizziness;
? PT suffered syncopal event immediately following Vax admin (Jansen).   ? Was lowered to floor, legs elevated.   ? Nurse/ Vaccinator provided immediate emergency care while Safety Officer was alerted.   ? PT regained consciousness and transported to screened Observation area.   ? PT hx syncope.  ? Reported lightheadedness, feverish in head, nausea.   ? EMS responded.  ? vitals: laying @1912 BP 119/77, P 52, SPO2 97; Standing @1918 BP 106/70, P 50, R 100.   ? PT recovered at scene, declined transport, left ambulatory AOx4.
This spontaneous report as received from a pharmacist refers to a 78 year old female patient. No concurrent conditions, medical history and concomitant medications were reported.  The temperature excursion occurred on 26-SEP-2016; the vaccine was exposed to a maximum temperature of 11.6 F for 7 hours and 30 minutes, and a maximum temperature of 6.2 F for 20 minutes. On 28-SEP-2016, the patient was vaccinated with improperly stored ZOSTAVAX lot # M020902,expiry date:18-JUL-2017 (dosing details was not reported) subcutaneously for prophylaxis. No adverse event was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1609USA012216:
asking if okay to take aspirin for pain after first dose; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 17Mar2021, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pollen allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 17Mar2021, outcome "unknown", described as "asking if okay to take aspirin for pain after first dose". Therapeutic measures were taken as a result of pain.  Additional Information: The patient has allergies and was wondering if taking "allergy" and aspirin medication would be safe. The reporter then clarified allergy was pollen and aspirin for pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt started c/o itching and hives 11/17/09 at approx 7:30pm. Pt treated with BENADRYL and topical hydrocortisone. Symptoms persisted bilaterally on arms through 11/18/09 and was seen in our office on 11/19/09 with SINGULAIR. PREDNISONE, CLARITIN and ZANTAC.
Initial stomach ache, headache for 5 days, mild stuffiness, intermittent diarrhea, depressive thoughts.
Rash on left deltoid (had hep A #1 on 4/29/05), itchy, warm at touch, red and raised. Spreading. Felt warm and flushed today.
Moderna COVID-19 Vaccine EUA after I received the vaccination everything was fine but later when I was laying in bed I felt a nodule just below the left elbow on the same arm of the injection, I couldn't remember if I had banged my elbow on something so I read the side effects and swollen glands is one of them so I called and left a message and now I am reporting it, I will wait to see what the status of its size is tomorrow before proceeding...
Injection given at app 0930 this date.  Redness & swelling at injection site noted app 1130. Measures 4"x5" at 1300.
Elevated heart rate, seen at hospital, EKG done, shows afib (has history), states vaccine reaction.
Experiencing neurological adverse events after receiving the booster dose; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 immunization. The following information was reported: NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "Experiencing neurological adverse events after receiving the booster dose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After seven days, I had an itchy arm. I scratched it and it swelled up a lot. The injection site is red, puffy, itchy, tender, very hard. It looks much like "COVID arm". The reaction is large 6-7 inches in length.  I applied a bug bite gel. I took ratinidine and then later benedryl. I iced it off and on. After waking up swelling is still present but not as severe. Itchy feel has subsided.
Right arm swollen at shoulder and upper arm. Full ROM at all joints; not tender, minimal erythema.
prolonged crying & irritability-poor sleeping; fever to 103; started less than 24 hrs p/vax; cont > 48 hrs then resolved;
Experienced dizziness that lasted several weeks. This dizziness lasted most of each day.  Took about 8 weeks to subside. Then, started to have tinnitus in both ears for about a month, and now this has started to subside. Primary care doctor did basic lab workup and everything was normal. Went to ENT doctor and was given steroids, however elected not to take them. ENG showed horizontal nystagmus to both right and left side. Was told usually this sort of thing happens due to inflammation and is usually post-viral. However, there is a slight possibility it could be due to anything that causes inflammation (aka the vaccine).
3/12/21-HEADACHE BEGAN; 3/15/2021- FACIAL WEAKNESS; 3/16/2021- ER VISIT TO HOSPITAL; 3/18/2021- OV TO DR.
Covid monitoring documentation. PT admitted 12/15/21 documented to have positive covid. PT received Moderna 3/24/21 Lot 044A21A for dose 1. Dose 2 was Moderna given on 5/5/21 Lot 017B21A.
Vial was initially stored in the refrigerator on 17 Feb 2022 and administerd on 08 Apr 2022 (BUD 30 days); 21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 17 Feb 2022 and administerd on 08 Apr 2022 (BUD 30 days)) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 17 Feb 2022 and administerd on 08 Apr 2022 (BUD 30 days)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 17 Feb 2022 and administerd on 08 Apr 2022 (BUD 30 days)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Expiry date of vaccine: 01 Apr 2022. Date the vial was initially stored in refrigerator is 17Feb2022, 10:00am. The vial didn't undergone any temperature excursions. No Concomitant Medications were provided by the Reporter. No Treatment Medications were provided by the Reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow up received contains non significant information.