chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use) and NO ADVERSE EVENT (No adverse event) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use).    No concomitant medications were reported.  Pharmacist reported that they have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 days beyond use date.  The lot number for the monovalent vaccines with their corresponding BUD dates were 027C21A (BUD - 21-May-2021), 053C21A (BUD - 01-Jul-2021), 939902 (BUD - 02-Sep-2021), 011F21A (BUD - 04-Nov-2021), 012H21B (BUD - 23-Dec-2021), 056M21A (BUD - 12-May-2022), 082B22A (BUD - 08-Sep-2022).   The lot numbers for the bivalent vaccines with their corresponding BUD dates and the interval period of administration. 052D22A (BUD - 17-Nov-2022), dates of administration 18-Nov-2022 to 28-Nov-2022, 023H22A, (BUD - 15-Dec-2022), dates of administration 16-Dec-2022 to 20-Dec-2022.  It was reported lot 042J21A should have been reported with a BUD of 17-Feb-2022.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: The live significant follow-up contains narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Tested positive for covid-19; Tested positive for covid-19; Male patient received Pfizer/BioNTech booster in Dec2021; Sore throat; Cough; Chills; Fever; Fell ill; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist).  An adult male patient received bnt162b2 (BNT162B2), administration date Dec2021 (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: Covid-19 vaccine (Dose Number: 1, MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "Covid-19", "Vaccination failure"; Covid-19 vaccine (Dose Number: 2, MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "Covid-19", "Vaccination failure". The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Dec2021, outcome "unknown", COVID-19 (medically significant) with onset Dec2021, outcome "recovered" (Dec2021) and all described as "Tested positive for covid-19"; IMMUNISATION (medically significant) with onset Dec2021, outcome "unknown", described as "Male patient received Pfizer/BioNTech booster in Dec2021"; OROPHARYNGEAL PAIN (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "Sore throat"; COUGH (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "Cough"; CHILLS (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "Chills"; PYREXIA (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "Fever"; MALAISE (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "Fell ill". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive, notes: if Covid tested post vaccination: Yes. It was unknown if therapeutic measures were taken as a result of covid-19, oropharyngeal pain, cough, chills, pyrexia, malaise.  Clinical course: Male patient received Pfizer/BioNTech booster in Dec2021. He attended a work Christmas party and fell ill (sore throat, cough, chills, fever) the next couple days. He tested positive for Covid-19. He has recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
With the 1st dose of Moderna I had a fever, chills, muscle aches,  pain, nausea, vomiting, fatigue, headaches, redness and swelling. All of the side effects cleared up except the fatigue and headaches. The headaches were manageable with Excedrin and ibuprofen. The headaches have not gone away, and with the 2nd dose of the Moderna vaccine the headaches have turned into migraines and I?ve become dizzy and shaky with the 2nd dose of the Moderna vaccine. I?m still very fatigued and the dr. Noted my blood pressure was abnormally high for me from my past visits.
VACCINE EXPOSED TO TEMPERATURE OUTSIDE OF RECOMMENDED STORAGE RANGE.  UNKNOWN POTENCY OR VIABILITY PER MANUFACTURER.
could not get up; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and ILLNESS (could not get up) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included INSULIN HUMAN INJECTION, ISOPHANE (HUMULIN N), INSULIN HUMAN (HUMULIN R), CARVEDILOL, HYDRALAZINE, Slomag, IRON, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) and FISH OIL for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PYREXIA (Fever). On 01-Apr-2021, the patient experienced ILLNESS (could not get up). At the time of the report, PYREXIA (Fever) and ILLNESS (could not get up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Became lethargic, sweaty, almost fainted but father carried her to a chair.
@ 10:10 patient reports feeling nauseated, she reports that it lasted for 10 minutes. She was monitored for 30 minutes and was asked to return to clinic if any changes occur.
Pt experienced weakness progressing almost to the point of paralysis in vaccination arm. Pt is also taking chemotherapy (IMFINZI) and had an infusion about 1 week prior to vaccination in the same arm. Patient is somewhat better today.
Was vaccinated at approx 4pm on 1/16/20.  Woke up at 2am on 1/17/20 with headache.  Went to work but developed nausea and a sore arm. Symptoms became worse by mid-day with flu like symptoms and she left work early and went to bed. 1/17-1/20 stayed in bed, took motrin and slept. 1/21 Went back to work, arm continued to hurt with pain shooting up into her shoulder, neck and ear. Also, noted skin was blotchy.  Went to clinic who refered to PCP.  PCP gave Keflex for possible cellulitis and questioned injection site. (rash often seen above and below the injection site). PCP said she should still get #2. 1/23/20 followed up with patient and symptoms were improving. Systemic symptoms had resolved and local reaction was getting a little bit better each day.
the pain with the feet; arm started hurting badly after 3 hours/Consistent stabbing arm pain; Cant lift arm; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (Cant lift arm), PAIN IN EXTREMITY (the pain with the feet) and MYALGIA (arm started hurting badly after 3 hours/Consistent stabbing arm pain) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced MOBILITY DECREASED (Cant lift arm) and MYALGIA (arm started hurting badly after 3 hours/Consistent stabbing arm pain). On an unknown date, the patient experienced PAIN IN EXTREMITY (the pain with the feet). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at a dose of 1 dosage form. At the time of the report, MOBILITY DECREASED (Cant lift arm), PAIN IN EXTREMITY (the pain with the feet) and MYALGIA (arm started hurting badly after 3 hours/Consistent stabbing arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: No New Information
2 Injections (DTAP and Hep A) given right upper thigh 12/09/2002. Pt developed erythematous and bluish rash and swelling approx. 3 x 5 inch area. Seen in clinic 12/12/2002. No fever, started Benadryl and ice. Decreased symptoms 12/13/2002.
doses administered past the published expiry date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.
This spontaneous report as received from a licensed practitioner nurse regarding 1 patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored ZOSTAVAX lot # L037791/expiration date - 30-DEC-2016. No adverse event was reported. No concomitant medication was reported. Excursion temperature was 10.5 F and timeframe was 4 hours and 45 minutes. There was no prior temperature excursion. Call was because of the data logger. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Menactra was given subcutaneously instead of Intramuscularly/no AE; Initial information regarding an unsolicited valid non-serious case was received on 10-Nov-2020 from an other health care professional via The Agency (Reference number- 00353139) and transmitted to Sanofi on 10-Nov-2020.  This case involves a 16-year-old male patient who was vaccinated with first dose 0.5 mL (once) MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] via subcutaneously instead of intramuscularly (batch number U6596AA and expiry date 24-May-2021) at left deltoid on 09-Nov-2020 at 16:48 for prophylactic vaccination (Incorrect route of product administration).  Concomitant medications included HEPATITIS A VACCINE INACT (HAVRIX) at left deltoid as prophylactic vaccination.  Medical history, medical treatment, vaccination and family history were not provided.  It was a case of actual medication error due to inappropriate route of vaccination (latency was on same day).  At the time of report, patient had not experienced any adverse events.  This suspected adverse reaction report was 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 was 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 had contributed to or is to be held liable for the occurrence of this medication error.
Started with tics of sounding out "s" and "t" sounds at the end of words, progressing to stutterting at the end of words (eg. "Mommy, y, my, my...", "Right there, there, there...") by the next afternoon.  Still stuttering and having the "s" and "t" tics now, regularly throughout the day.
Arm soreness Arm swelling Headache Right side neck pain Bumps on both cheeks (face)
Moderna vaccine expired on 9/04/2021 and was administered to individual on 9/07/2021.  During fifteen therapeutic observation period patient did not report any adverse signs and/or symptoms after administration of vaccine.
Pt. was given Zoster vaccine on 7/2013 - she developed Ocular herpes zoster on 1/27/14 - she saw eye Dr and family practice numerous times. She required multiple medications to treat this. Pt. wanted someone to know there was a vaccine failure.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 as dose 5 (booster), single (Lot number: EJ2524) at the age of 62 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "lung cancer" (unspecified if ongoing), notes: lung cancer surgery with chemo 4 years ago; "Lung cancer surgery" (unspecified if ongoing), notes: lung cancer surgery with chemo 4 years ago; "chemo" (unspecified if ongoing), notes: lung cancer surgery with chemo 4 years ago. Concomitant medication(s) included: LEVOTHYROXINE, start date: 12Apr2021.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Arm sore and trouble moving, later redness, feverish, and very painful even to the touch, felt sick.  The sickness last one full day.  Redness, feverish, painful lasted about 3 days, 15th - 18th, after that started improving, very itchy and still painful to the touch.  About 11 days after vaccination, the limited movement changed and I started get severe pain when I moved my arm from the shoulder down through my arm into my hand. This was a pain that felt like a rubber band was snapping apart.  In a few days the pain changed again.  I could move my shoulder fairly well, but the pain in my forearm hurt when I moved it with a burning, painful sensation.  Sometimes it feel like something squiggly inside my forearm.  I have developed a numbness in my forearm, but still get the burning, painful, and squiggly feelings when I move certain ways.  I have not gone to the Doctor as I am hoping this will pass.  Just a note, there was a blood pool under the skin a little bigger than a quarter from one of the injections.  If it doesn't improve I will going to a doctor.
Pain to left arm continued for 3 wks after injection. Full range of motion, no swelling to site.
2/24  tired couldn't stay awake, body ached.  It felt like when I had covid.  Sstarted at 1:30 by 6:30 was sound asleep, 9:30 woke up to ok two Alieve, 12 woke up sweating but felt fine.    2/25 feeling better, body ached  and still does a little    injection site red  hive like spot the size of a half dollar and is sore to touch
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) lasted 24-48 hours.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were provided. No treatment medication details were provided.   This case was linked to MOD-2021-113578 (Patient Link).
Severe pain at the left shoulder radiating to left deltoid, associated with tingling and sharp pains to the left forearm and hand. There is less strength.
patient was given expired PENTACEL with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician, other health care professional and consumer/non-health care professional via Medical Information (Reference number- 00580819) and transmitted to Sanofi on 13-Aug-2021.  This case is linked to case 2021SA270589 (same reporter).  This case involved 6-month-old male patient was given expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (expired product administered)  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); (HEPATITIS B VACCINE) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination.  On 12-Aug-2021, the patient received third 0.5ml (total) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot: UJ343ABA and expiry date: 22-Jun-2021) (Form: Solution for injection) (Frequency=once) (Strength: standard) via intramuscular route in the left thigh for prophylactic vaccination (expired product administered)  This case was an actual medication error due to expired vaccine used (latency: same day)  At the time of reporting, no adverse event  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 the 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.
cluster of papules developed at Proquad injection site, after dose and itching at area.
Breakthrough case admission after 3 vaccines Moderna 2/6/21 Lot# 031L20A Moderna 3/6/21 Lot# 032M20A;  Moderna 10/26/21 Lot# 033C21A
March 3 onward, sore arm at injection site March 10-16   Headaches, fatigue, severe stomach cramps March 12-16  Covid arm red, swollen, rock hard, very painful
Headache, fever (101.4) x 2 days, insomnia 1 night, Lymph node pain and swelling under arm, 4 days, softball size red area with heat and swelling at injection site 5 days. Had dizziness when turning over in bed on night 4. It has eased up but is still present off and on during the day, especially when I look down. Otherwise I am back to normal.
In June of 1999 pt received third dose of varicella virus vaccine live. Pt laboratory evaluation revealed delayed IgG response after two previous doses. The serum antibody test repeated on 09/21/1999 after third dose of the vaccine indicated immunity 1.17 EIA value.
Case number PHEH2014US021010, is a combined initial and follow up spontaneous report received from a nurse on 16 Oct 2014 and on 20 Oct 2014. This report refers to an adult female patient. Her medical history and concomitant medication was not reported. She was vaccinated with seasonal influenza vaccine (batch number: unknown) on an unknown date. On an unknown date post vaccination she was hospitalized due to egg allergy. This did not happen this year, but sometime in the past. Outcome of the event and causality assessment was not reported. No further information was provided.
My back aches, arthritis in my hands flared, I have a headache, I am nauseous, I feel a general malaise, I'm having chills, but do not have a fever.
This case was reported by a consumer via interactive digital 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), 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 self-reported this case. The age at vaccination was not reported. The patient got the shingle shot and still got shingles. It was very painful. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
dizziness BP: 80/40 P- 62 o2-99%  pt. is adviced to drink water. transfer patient to gurney feet side elevated.  BP: 100/58 Pulse 64 Patient feels better and resolved the symptoms. after 15 mins. BP:106/60 Advised patients father to consult with primary physician before 2nd dose.  Patient left for home with parents after observation.