chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the vial was initially stored in the refrigerator 22-May-2023 and admininstered on 21-Jun-2023; No adverse event; 1 Patient received as a fifth dose an expired dose of the Moderna COVID19 vaccine bivalent; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 Patient received as a fifth dose an expired dose of the Moderna COVID19 vaccine bivalent), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 22-May-2023 and admininstered on 21-Jun-2023) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jun-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (1 Patient received as a fifth dose an expired dose of the Moderna COVID19 vaccine bivalent). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 22-May-2023 and admininstered on 21-Jun-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 Patient received as a fifth dose an expired dose of the Moderna COVID19 vaccine bivalent), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 22-May-2023 and admininstered on 21-Jun-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (1 Patient received as a fifth dose an expired dose of the Moderna COVID19 vaccine bivalent) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 22-May-2023 and admininstered on 21-Jun-2023).    No concomitant medication was reported. Dose administered after 30-day Use By Date or after manufacturer. Vial size was reported as  2.5ml . Vial did not undergo any temperature excursions. Treatment information was not provided.
From probably 9pm till 8am I was freezing cold with crawling skin and flu-like symptoms. I wasn?t tired though, just so freezing cold and sore all over. I couldn?t sleep because the discomfort was so bad. I was probably 70 degrees in my house and I was in fleece pajamas and had 3 blankets and was still freezing all night. No fever though, oddly.
Initial information received on 27-Aug-2018 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case was linked with the case 2018SA242242 (Siblings/ Same reporter). This case involves a patient (gender and age unknown) who was vaccinated with a 0.5 ml dose of DAPTACEL (lot C5202BA and expiry date: 16-May-2019) via intramuscular route in the right thigh. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient's concomitant medications included PREVENAR 13. It was a case of actual medication error due to Inappropriate schedule of vaccine administered because DAPTACEL given too early. It was unknown if any adverse reaction was occurred or not following the vaccination. 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. List of documents held by the sender: None.
Muscle ache and pains. Slight fever, nausea, vomiting. Headache weakness. Pink eye. Runny nose, severe coughing.
Loss of balance when standing or walking. Started 11-2-2018 day after vaccination. I still have loss of balance but not as bad as 11-2-18 or 11-3-18.
17-year-old patient administered his first Moderna vaccine dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient administered his first Moderna vaccine dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient administered his first Moderna vaccine dose). On 22-Jan-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient administered his first Moderna vaccine dose) had resolved.        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.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (lot number unknown) with no associated AEs reported.
This is a spontaneous report from a contactable consumer. This male consumer reported on behalf of his 12 month old son who received PREVNAR13 0.5 ml single dose intramuscular injection at 17:30 on right arm on 04Jun2012. Relevant medical history was none. Relevant concomitant medication was none. Vaccine given on the same day included two other unspecified vaccine on left arm. Vaccines taken within the last four weeks were none. Illness at the time of vaccination was none. On 05Jun2012, he experienced red spot at the site of administration which was hard to touch. Relevant lab data was none. At the time of the report he had not recovered from the event. The contactable physician stated that the patient provided information regarding reported adverse event. The contactable physician also stated that cannot confirm the occurrence of the events reported by the patient. Follow-up (25Jun2012): New information received from a contactable physician includes: the physician did not confirm the occurrence of the events. Follow-up (02Jul2012): This follow-up report is being submitted to amend previously reported information. The case was not medically confirmed. Follow-up (12JUL2012) Follow-up attempts completed. No further information expected.
Information has been received from a nurse practitioner concerning a 15 month old male who was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot # not provided). Subsequently, the patient experienced rash. Subsequently, the patient recovered.
Pfizer vaccine was given in error as the second dose instead of Moderna. Patient was contacted and has no complaints of any adverse events yet.
Patient's arm was slightly swollen and red. Had some pain and heat radiating from site. Explained to patient that these reactions where a normal reactions to the vaccine. Advise patient to apply an ice pack to the site every 15 mins, take tylenol for the pain and fever, and benadryl for swelling and allergic reaction. After I comfort her and advised her on what to do, she was at ease. I assure her that she was not having any analphylactic reactions. However, I told her if her condition gets worst, she needs to be seen immediately, such as chest tightness or shortness of breath.
c/o dizziness, nausea and shaking.  BP elevated and tachycardic.  Blood glucose 110. Started to resolve and then felt worse again.  Transported by POV with husband driving to Er.  Refused 911.
Left deltoid red, swollen, and hard to the touch.  Measures ~40mm in diameter.  Center of swelling is scabbed w/ lesion ~ 2mm in diameter.  Client reports swelling was much worse.  Reports no treatment.
Breakthrough case admission after 2 vaccines ; Pfizer 10/11/21 lot# FE3590;  Pfizer 10/31/21 lot# FH8020
will be having a Wet or Dry macular degeneration procedure; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sponsored Program.  A female patient of an unspecified age received bnt162b2 (BNT162B2) at single dose on 22Feb2021 for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 03Feb2021 for Covid-19 immunisation.  The patient experienced macular degeneration on an unknown date and she will be having a wet or dry macular degeneration procedure on 23Feb2021 with outcome of unknown. Patient was kind of worried because they're asking her questions about if she took vaccination these past few weeks before going to hospital.   Information on Lot/Batch number has been requested.
Fever (103.8); headache; sore arm at injection site; lethargy; muscle aches; malaise; swollen lymph node- size of golf ball under left arm (injection arm); This is a spontaneous report from a contactable consumer or other non hcp. A 71-years-old patient of an unspecified gender received bnt162b2 (PFIZERBIONTECH, Formulation: solution for injection, Batch/Lot Number: EM9810) via intramuscular route of administration, administered in Arm Left on 08Feb2021 at 12:00 (at the age of 71-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history included influenza from 2017 to an unknown date Pertinent detail: Fever, Flu symptoms, urinary retention from 2019 to an unknown date Pertinent details: Resolved at ER. Concomitant medication(s) included omeprazole, 40 mg, oral taken for reflux gastritis from 06Mar2021 and ongoing, Tamsulosin 4 mg, oral taken for urinary retention from 06Mar2021 and ongoing. The patient previously received first dose of COMIRNATY (Lot Number: EJ1686) via an intramuscular, Anatomical site of injection was left arm on 18Jan2021 at 08:00 am for COVID-19 immunisation. On 08Feb2021 at 8PM the patient experienced Seriously high fever (103.8) with splitting headache, Sore arm at injection site, muscle aches, lethargy and Malaise. Swollen lymph node - size of golf ball-under left arm (injection arm). The patient underwent lab tests and procedures which included body temperature: 103.8 fahrenheit on Feb2021, prostatic specific antigen was negative on 2019 PSA+ Follow up- benign, urine analysis was negative on 2019 (Normal). Treatment received for the events fever and pain relief rest, Miss work. The outcome of the events was reported as recovered.  No follow-up attempts are possible. No further information is expected.
VACCINE WAS NOT EFFECTIVE AT ALL; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. Initial information was processed along with the additional information received on 28-MAR-2022: The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced that the vaccine was not effective at all. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine was not effective at all was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000223705.; Sender's Comments: V0: 20220354677-COVID-19 VACCINE AD26.COV2.S-vaccine was not effective at all. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Pt in ER c/o difficulty breathing, onset one day prior.  Tested positive for Covid a few days prior to ER visit.
Day 1 evening - dizziness, headache, mild body aches, insomnia Day 2 - major headache, severe body aches not helped by ibu/tylenol, insomnia, fever 100.8, nausea - missed work Day 3 - slightly better - headache, body aches, nausea, fever 100.3- 100.6, missed work
just got over a 12 day flu bout; Initial information received on 21-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves Adult and unknown gender patient who just got over a 12 day flu bout while receiving vaccine Influenza Vaccine.  It was unknown if the patient had any medical history, concomitant disease or risk factor. Past medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number, expiry date, dose, strength, form, route, site was unknown) for Prophylactic vaccination.  On an unknown date the patient just got over a 12 day flu bout (influenza) (unknown latency) following the administration of Influenza Vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.   At time of reporting, the outcome was Unknown for the event.
pt became extremely lethargic 3 days p/vax;no other sx;pt was seen again in MD office on 5MAR96;
pt recv vax 16DEC96 & swelling & pain in lt ankle;initially felt to have fracture on x-ray but no fracture found on MRI;ankle aspirate w/negative cult;elevated ESR of 56;poss arteritis secondary to vax;
24 hours after flu shot, pt experienced headache, fever/chills dry heaves, had no desire to eat or drink. Went on for four days. One week after symptoms stopped, pt contacted pharmacy.
erythema to left tricep area started day after varivax vaccine administered on 7/20/09.  Bactrim prescribed x10days.
Patient awoke early AM of 7-12-07 with pleuritic chest pain left anterio-lateral chest area, increased with deep breath. No dyspnea or cough, left friction rub heard in the area in office today. 8/20/07-office note received for DOS 7/12/07-C/O pain around rib cage. Pleuritic left and lateral chest pain onset during night after NCV vaccine. Treated with NSAID.  We have no records of this for that pt.
No Adverse Event; 5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30DEC2022 beyond MFG Expiration Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30DEC2022 beyond MFG Expiration Date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30DEC2022 beyond MFG Expiration Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30DEC2022 beyond MFG Expiration Date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided    For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30DEC2022 beyond MFG Expiration Date).    No concomitant medication information provided. Vial size was 2.5 ml. Date the vial was initially stored in the refrigerator was 30-Dec-2022.  The vial did not undergo any temperature excursions. No treatment information provided. This case contains information for the 3rd of 5 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-694396 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-694396:MASTER CASE
Flu shot given approx 9:30 on 10/27/2005. Client reports 24 hours later that at 17:00 on 10/27/2005 she began itching and noticed hives on her scalp, face, neck, chest. At the time it was reported head and neck rash had resolved, but hives had developed on lower half of body. Client took Benadryl. Reported was concurrently taking erythromycin and almost complete.
Sensitive skin:  Feeling of sunburn without redness. Pain / discomfort upon contact. Area:  Middle of back, side body, front of torso.
Severe swelling at the location of vaccine and surrounding area, redness, itchiness, hot to the touch, hard to the touch, pain, slight fever, drowsiness, slight sore throat and headache.
At approx 30 minutes after I received the vaccine, my tongue felt coated and I tasted metallic taste.  Lips started tingling, and felt swollen.  My ears and throat were itchy.  At approx 60 minutes after I received the vaccine I started coughing
Information has been received from a PA concerning a 40 year old female who on 03/26/04 at 15:30 was vaccinated IM with a first dose of pneumococcal 23v polysaccharide vaccine (Lot # 647271/1138N). Subsequently the pt developed a large local reaction. The reporter indicated that the reaction was not serious and that she did not know the recovery status.  Follow up information indicated that on 03/27/04, approximately 18 hours after vaccination, the pt complained of a large local reaction 3x2 inches with erythema and wheal. It continued for the next several days. The outcome was reported as recovered on 04/01/04.  The reporter also indicated that another pt developed an adverse experience after vaccination with pneumococcal 23v polysaccharide vaccine (WAES # 0402USA01911).  No further information is expected.
Patient accidentally received an expired dose of DAPTACEL with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional (health care professional and nurse) via medical information (Reference number- 00693201).  This case involves a five-year-old patient (gender unspecified) who accidentally received an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  List of concomitants was reported as no other vaccines.  On 21-Jun-2021, the patient received a 0.5 mL fifth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [Injection, frequency: once, strength: standard, lot C5624AA, expiry date: 10-Jun-2021] via an intramuscular route at the left thigh for prophylactic vaccination (expired product administered). (Latency: on the same day)  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  It was reported that "nurse states that on 21-Jun-2021, a five-year-old child received a DAPTACEL vaccine that had expired on 10-Jun-2021 and HCP (Healthcare Professional) wanted to know when the consumer can be re-vaccinated with DAPTACEL that is not expired".  It was also reported that treatment- 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. 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.
About 4 hours after injection, pain at injection site started. 5 hours after injection, fatigue, body aches, and fever and chills occurred. Symptoms subsided for several hours until night time. Severe nausea occurred sometime around 1:30 am, a little 12 hours after injection. Vomiting happened at 5am. The entire next day after injection I experienced nausea, fatigue, sore throat, headache and fever.
chills; severe shortness of breath; rapid heartbeat; Headache; Fatigue; This is a spontaneous report from a contactable consumer (patient) reported for himself that a 66-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1283) via intramuscular at right arm on 11Jan2021 14:00 at single dose for COVID-19 immunisation. Medical history reported as none. There were no concomitant medications. The patient previously received first dose of BNT162B2 on an unspecified date for COVID-19 immunisation and experienced sinus infection from 24Dec2020 and recovered on 31Dec2020, he went through antibiotics for a week for the sinus infection which was completed by the second dose. Patient works in a hospital laboratory. He wanted to report a reaction/side effect for Pfizer COVID 19 vaccine. Stated this was his second dose. The reaction started 12 hours post vaccination of chills that went overnight (12Jan2021). Stated that it was followed by severe shortness of breath at about 4 to 5 AM and rapid heartbeat. He was advised to get tested and was negative (undated). He also had headache and fatigue, all on 12Jan2021. Stated that he had gotten his second dose at 14:00 on 11Jan2021.  Stated that he never experienced anything like on 12Jan2021 that he was literally frantic. Outcome of fatigue was recovered on 13Jan2021, outcome of other events recovered on 12Jan2021.
infection; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (infection) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced INFECTION (infection). At the time of the report, INFECTION (infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. The patient started taking antibiotics for an infection on 22-JAN-2021. She stopped taking them that very same day because she read that it might affect the effectivity of the vaccine. In Follow up patient stated that her husband had similar reaction but did not know about whether husband report it or not.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow up received 9/JUN/2021 included No new significant Information
Dose 1: slurring speech, confusion, sweating, rapid heart beat, chest pain   Dose 2: Mydriasis in both eyes, rapid heart beat, oxygen sat lower than my normal, cold hands and feet, under eye swelling
Presented on 1/7/99 with vesicular lesions on lower back x 5.  Suspect early varicella - had the vaccine 6-17-97.