chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, Impaired work ability, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: I received my first Pfizer COVID-19 booster on 11/26/2021. On 4/30/2022, I woke up with a sore throat. I found out that some people I had socialized with recently had tested positive for COVID-19, so I decided to test myself. I took a home antigen test, and it was positive. I was out of work for a week, and by the time 5/4/2022 rolled around, I was pretty much back to normal. For the most part, my illness was very mild. I started off with a scratchy throat, which went away. I then had sinus congestion and runny nose, but I don't remember sneezing.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sinus congestion, Throat irritation
Clinical narrative: I received my first Pfizer COVID-19 booster on 11/26/2021. On 4/30/2022, I woke up with a sore throat. I found out that some people I had socialized with recently had tested positive for COVID-19, so I decided to test myself. I took a home antigen test, and it was positive. I was out of work for a week, and by the time 5/4/2022 rolled around, I was pretty much back to normal. For the most part, my illness was very mild. I started off with a scratchy throat, which went away. I then had sinus congestion and runny nose, but I don't remember sneezing.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Allergy to chemicals, Blood test, COVID-19, Dermatitis contact, Eczema
Clinical narrative: Mild rash on legs and arms became extreme after testing positive for Covid on July 17, 2022.  The rash spread to my neck and face.  After seeing three dermatologists and an allergist I was diagnosed with Eczema and contact dermatitis.  I had never experienced this type of rash everything changed after I got covid.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash, SARS-CoV-2 test positive, Skin test positive
Clinical narrative: Mild rash on legs and arms became extreme after testing positive for Covid on July 17, 2022.  The rash spread to my neck and face.  After seeing three dermatologists and an allergist I was diagnosed with Eczema and contact dermatitis.  I had never experienced this type of rash everything changed after I got covid.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest discomfort, Chest pain, Condition aggravated, Dizziness, Dyspnoea
Clinical narrative: I had previously received the original 2 vaccinations from Moderna, and the first Moderna booster a year before this Pfizer bivalent booster (my side effects from the Moderna booster were similar and much worse but I didn't think to report it last year). After 2 hours the normal aching in arm, pain at injection site, tiredness began. By 12 hours after, skin sensitivity, whole body aches, labored breathing, and extreme fatigue began. By 27 hours after my booster shot, pain in and around my lungs/chest, trouble closing my fist, and dizziness began. By 42 hours after, muscle pain /body aches & skin sensitivity mostly stopped, dizziness became only occasional, fatigue decreased. I couldn't take a deep breath but breathing didn't feel heavy or labored. Sharp pain at injection site remained, but was not worse and didn?t include redness or swelling. All side effects subsided on day 5, but from day 6 on I've had bouts of dizziness, nausea, and soreness/tightness in my chest/lungs whenever I don't get enough sleep, or when I over exert myself (it seems I get tuckered out very easily now, so this happens either daily or about every other day). It's been a little over 2 weeks since my shot. I only got 5 hours of sleep today, and that was enough to trigger chest/lung pain and difficulty breathing today.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Injection site pain, Migraine, Mobility decreased, Myalgia
Clinical narrative: I had previously received the original 2 vaccinations from Moderna, and the first Moderna booster a year before this Pfizer bivalent booster (my side effects from the Moderna booster were similar and much worse but I didn't think to report it last year). After 2 hours the normal aching in arm, pain at injection site, tiredness began. By 12 hours after, skin sensitivity, whole body aches, labored breathing, and extreme fatigue began. By 27 hours after my booster shot, pain in and around my lungs/chest, trouble closing my fist, and dizziness began. By 42 hours after, muscle pain /body aches & skin sensitivity mostly stopped, dizziness became only occasional, fatigue decreased. I couldn't take a deep breath but breathing didn't feel heavy or labored. Sharp pain at injection site remained, but was not worse and didn?t include redness or swelling. All side effects subsided on day 5, but from day 6 on I've had bouts of dizziness, nausea, and soreness/tightness in my chest/lungs whenever I don't get enough sleep, or when I over exert myself (it seems I get tuckered out very easily now, so this happens either daily or about every other day). It's been a little over 2 weeks since my shot. I only got 5 hours of sleep today, and that was enough to trigger chest/lung pain and difficulty breathing today.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Pain, Pain in extremity, Pulmonary pain, Sensitive skin
Clinical narrative: I had previously received the original 2 vaccinations from Moderna, and the first Moderna booster a year before this Pfizer bivalent booster (my side effects from the Moderna booster were similar and much worse but I didn't think to report it last year). After 2 hours the normal aching in arm, pain at injection site, tiredness began. By 12 hours after, skin sensitivity, whole body aches, labored breathing, and extreme fatigue began. By 27 hours after my booster shot, pain in and around my lungs/chest, trouble closing my fist, and dizziness began. By 42 hours after, muscle pain /body aches & skin sensitivity mostly stopped, dizziness became only occasional, fatigue decreased. I couldn't take a deep breath but breathing didn't feel heavy or labored. Sharp pain at injection site remained, but was not worse and didn?t include redness or swelling. All side effects subsided on day 5, but from day 6 on I've had bouts of dizziness, nausea, and soreness/tightness in my chest/lungs whenever I don't get enough sleep, or when I over exert myself (it seems I get tuckered out very easily now, so this happens either daily or about every other day). It's been a little over 2 weeks since my shot. I only got 5 hours of sleep today, and that was enough to trigger chest/lung pain and difficulty breathing today.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abortion spontaneous, Exposure during pregnancy, Hypertension, Peripheral swelling, Pre-eclampsia
Clinical narrative: I was pregnant and my estimated date of delivery was April 24, 2023. I was seeing a high-risk gynecologist.  My blood pressure was high, and I had swelling in fingers and toes.  I had an ultrasound when the baby was 16 weeks and there was no heartbeat.  The baby had died the previous week.  I was then diagnosed with a rare pre-eclampsia.  The baby's weight at the time of miscarriage was 324 grams.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Malaise, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I woke up and had a bit of a temperature like maybe 99 or 100 degrees. I had congestion.  I didn't feel very well so I took an at home COVID-19 test and it was positive.  Basically the symptoms were very mild for about two days.  I received a prescription from my doctor for Paxlovid.  All in all to me it was very mild and nothing major.  I received the prescription that morning and took for the duration.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal hernia, Breast pain, Dyspnoea, Pain, Periorbital swelling
Clinical narrative: Body ache, pain on breasts, puffy eyes, sensitive skin, vaginal irritation, tachycardia, shortness of breath. Patient also reported a resurgence in a stomach hernia.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Sensitive skin, Tachycardia, Vulvovaginal discomfort
Clinical narrative: Body ache, pain on breasts, puffy eyes, sensitive skin, vaginal irritation, tachycardia, shortness of breath. Patient also reported a resurgence in a stomach hernia.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Incorrect product formulation administered
Clinical narrative: PATIENT WAS SUPPOSED TO GET PFIZER BIVALENT BOOSTER, INSTEAD SHE WAS GIVEN A REGULAR PFIZER DOSE (PRIMARY SERIES).  PATIENT STATED NO ADVERSE EFFECTS, SHE WAS TIRED FROM THE SHOT AND WAS SLEEPING WHEN CONTACTED ABOUT THE INCIDENT.
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: Patient felt light headed , just sat down for 10 minutes
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blindness, Laboratory test normal, Optic ischaemic neuropathy
Clinical narrative: Had a stroke in my right eye causing blindness!!! No problems before having these series of shots!!! Stroke was on May 29, 2021
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was given expired lot 051b22a exp 11/21/22. no adverse reaction after administration. patient was instructed to start series over in a few weeks.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Very sore at injection site, with large 3 to 4 inch red swollen area, that is hot and discolored.  I am also having trouble sleeping and my joints are sore.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Insomnia
Clinical narrative: Very sore at injection site, with large 3 to 4 inch red swollen area, that is hot and discolored.  I am also having trouble sleeping and my joints are sore.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Condition aggravated
Clinical narrative: Acute and Chronic knee and ankle pain.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Echocardiogram, Electrocardiogram T wave inversion, Electrocardiogram abnormal, Positron emission tomogram
Clinical narrative: Inverted T wave on EKG
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Echocardiogram, Electromyogram, Hypoaesthesia, Magnetic resonance imaging, Metabolic function test
Clinical narrative: Right arm weakness, PVCs, numbness
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscular weakness, Ventricular extrasystoles
Clinical narrative: Right arm weakness, PVCs, numbness
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: I initially had an upper sore arm at injections site the day following the vaccination. It went away and on January 4, 2023 , over 3 months later, I have been having a very upper sore arm at the injection site and my arm hurts to raise it. Also , when I push on the injections site , it is sore. I was just wondering if this is normal? There is no visible signs of bruising or anything like that, just muscle pain in upper arm and the injection site.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood elastase decreased, Pancreatic failure
Clinical narrative: Exocrine Pancreatic Insufficiency likely auto-immune, occurred following Covid RNA shots.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Herpes zoster oticus
Clinical narrative: Ramsey-Hunt Syndrome
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait inability, Peripheral swelling
Clinical narrative: I'VE HAD BACK TROUBLE-BUT 2-1-21 MY LEGS SWELLED. TWICE AS BIG-THE VACCINE SEEMED TO SETTLE IN MY BACK - THE 2ND SHOT MADE WORSE @ THIS TIME I CAN'T WALK!!
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: The wrong Moderna dose was given to the pt. The pt needed the bi-valent and the Moderna booster pediactric dose was given instead.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: my middle ear was acutely affected; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Series of primary immunization completed. Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 3), for Covid-19 immunization; Covid-19 vaccine (DOSE 4), for Covid-19 immunization. The following information was reported: MIDDLE EAR DISORDER (non-serious), outcome "unknown", described as "my middle ear was acutely affected". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient experienced the so-called "Paxlovid rebound" 5 days after he finished. He was not Admitted in hospital due to the event. This waste first time he had covid symptoms and tested positive everything he knew to do to help get over a viral infection, he did it. Added acupuncture as one middle ear was acutely affected. He had all 5 Pfizer shots for covid. The 5 th Was 5-6 weeks before he got sick from covid.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Middle ear disorder, SARS-CoV-2 test
Clinical narrative: my middle ear was acutely affected; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Series of primary immunization completed. Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 3), for Covid-19 immunization; Covid-19 vaccine (DOSE 4), for Covid-19 immunization. The following information was reported: MIDDLE EAR DISORDER (non-serious), outcome "unknown", described as "my middle ear was acutely affected". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient experienced the so-called "Paxlovid rebound" 5 days after he finished. He was not Admitted in hospital due to the event. This waste first time he had covid symptoms and tested positive everything he knew to do to help get over a viral infection, he did it. Added acupuncture as one middle ear was acutely affected. He had all 5 Pfizer shots for covid. The 5 th Was 5-6 weeks before he got sick from covid.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Death
Clinical narrative: Death
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: There was no adverse event, patient was vaccinated with a vaccine and as per Moderna no need for re-vaccination since vaccine it maintained its stability.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: There was no adverse event.  Patient was vaccinated with a BUD vaccine, as per moderna no need for re-vaccination since vaccine still maintained its stability.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: There was no adverse event, patient was vaccinated with a BUD vaccine. As per moderna no need for re-vaccination since vaccine it maintained its stability.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: There was no adverse event patient was vaccinated with a BUD vaccine as per moderna no need to re-vaccinate
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: There was no adverse event, patient got vaccinated with a BUD vaccine as per manufacturer moderna no need for re-vaccination since vaccine it maintained its stability.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: There was no adverse event.  Patient got vaccinated with a BUD vaccine, as per manufacturer moderna no need for re-vaccination since vaccine maintained its stability.
Age: 8.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Polymerase chain reaction, Transient ischaemic attack
Clinical narrative: Three left hemiplegia Transient ischmic attacks  (12/17/22; 12/20/22;12/23/22) + Brain MRI (12/23/22): several small acute infarcts , measuring less than 1 cm, in the left posterior cerebellum. additional punctate acute infarct in the left occipital lobe subcortical white matter.   Above mentioned vaccination dates: 11/18/2021; 12/15/2021; 9/16/2022; 12/15/2022. In addition, he experienced an acute Covid infection (PCR proven) on 4/20/2022.   Patient admitted for 2 days in our PICU. Neurological exam WNL. Treated with Tab Aspirin 81 mg daily, discharged.
Age: 8.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Activated partial thromboplastin time normal, Angiogram cerebral normal, Blood fibrinogen normal, C-reactive protein normal, COVID-19
Clinical narrative: Three left hemiplegia Transient ischmic attacks  (12/17/22; 12/20/22;12/23/22) + Brain MRI (12/23/22): several small acute infarcts , measuring less than 1 cm, in the left posterior cerebellum. additional punctate acute infarct in the left occipital lobe subcortical white matter.   Above mentioned vaccination dates: 11/18/2021; 12/15/2021; 9/16/2022; 12/15/2022. In addition, he experienced an acute Covid infection (PCR proven) on 4/20/2022.   Patient admitted for 2 days in our PICU. Neurological exam WNL. Treated with Tab Aspirin 81 mg daily, discharged.
Age: 8.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Cerebral infarction, Computerised tomogram head normal, Fibrin D dimer normal, Hemiplegia, Intensive care
Clinical narrative: Three left hemiplegia Transient ischmic attacks  (12/17/22; 12/20/22;12/23/22) + Brain MRI (12/23/22): several small acute infarcts , measuring less than 1 cm, in the left posterior cerebellum. additional punctate acute infarct in the left occipital lobe subcortical white matter.   Above mentioned vaccination dates: 11/18/2021; 12/15/2021; 9/16/2022; 12/15/2022. In addition, he experienced an acute Covid infection (PCR proven) on 4/20/2022.   Patient admitted for 2 days in our PICU. Neurological exam WNL. Treated with Tab Aspirin 81 mg daily, discharged.
Age: 8.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: International normalised ratio normal, Laboratory test normal, Magnetic resonance imaging head abnormal, Neurological examination normal, Platelet count normal
Clinical narrative: Three left hemiplegia Transient ischmic attacks  (12/17/22; 12/20/22;12/23/22) + Brain MRI (12/23/22): several small acute infarcts , measuring less than 1 cm, in the left posterior cerebellum. additional punctate acute infarct in the left occipital lobe subcortical white matter.   Above mentioned vaccination dates: 11/18/2021; 12/15/2021; 9/16/2022; 12/15/2022. In addition, he experienced an acute Covid infection (PCR proven) on 4/20/2022.   Patient admitted for 2 days in our PICU. Neurological exam WNL. Treated with Tab Aspirin 81 mg daily, discharged.
Age: 8.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Protein S normal, Prothrombin time normal, SARS-CoV-2 test positive, Transient ischaemic attack, White matter lesion
Clinical narrative: Three left hemiplegia Transient ischmic attacks  (12/17/22; 12/20/22;12/23/22) + Brain MRI (12/23/22): several small acute infarcts , measuring less than 1 cm, in the left posterior cerebellum. additional punctate acute infarct in the left occipital lobe subcortical white matter.   Above mentioned vaccination dates: 11/18/2021; 12/15/2021; 9/16/2022; 12/15/2022. In addition, he experienced an acute Covid infection (PCR proven) on 4/20/2022.   Patient admitted for 2 days in our PICU. Neurological exam WNL. Treated with Tab Aspirin 81 mg daily, discharged.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Pain in extremity, Syncope
Clinical narrative: faint along; abnormally sore arm; This spontaneous report was received from a Pfizer Inc, regarding a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant therapies, previous drug reactions, or allergies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (doses, frequencies, vaccination schemes, anatomical locations, lot number or expiration dates were not provided) for prophylaxis.  On an unknown date, the patient stated that when she got the polio vaccine, she had not side effects, but, when she got the second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) faint along with having an abnormally sore arm. The covid vaccine (manufacturer unknown) made her have brain fog like her first pregnancy, along with being completely down/ill for one week, and a horribly sore arm/hand for nearly a year. She was not of age to receive varicella zoster vaccine rge (cho) (SHINGRIX), but she had heard countless stories from that age group of how they were ill for some time and completely down for two days. The outcome of the events syncope and pain in extremity was not provided.  The causality assessment between the events syncope and pain in extremity with the suspect vaccines was not reported.   Upon internal review, the event syncope was determined to be medically significant.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; the patient had already received the Moderna Bivalent on 26Sep2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (the patient had already received the Moderna Bivalent on 26Sep2022) and NO ADVERSE EVENT (No adverse event) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     No describe relevant medical history and conditions, allergy, concomitant diseases and risk factor. No history of Covid-19 diagnosis. No known allergies.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine on 12-Jan-2021, Moderna COVID-19 Vaccine on 10-Feb-2021, Moderna COVID-19 Vaccine on 01-Nov-2021 and Moderna COVID-19 Vaccine on 27-Apr-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.   On 26-Sep-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 12-Jan-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2023, the patient experienced EXTRA DOSE ADMINISTERED (the patient had already received the Moderna Bivalent on 26Sep2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (the patient had already received the Moderna Bivalent on 26Sep2022) 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 assessment was provided for EXTRA DOSE ADMINISTERED (the patient had already received the Moderna Bivalent on 26Sep2022).    No concomitant medication was provided by reporter.  The nurse was report that they administered the Bivalent today, 12Jan2023, to a patient, who didn't have their vaccine card with them. Their protocol was to update their state's website after vaccination, so they were unaware until that time that the patient had already received the Moderna Bivalent on 26Sep2022.   No treatment medication was provided by reporter.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received Moderna bivalent booster dose that had undergone a temperature excursion.; Patient received Moderna bivalent booster dose that had undergone a temperature excursion.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent booster dose that had undergone a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster dose that had undergone a temperature excursion.) 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. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent booster dose that had undergone a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster dose that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent booster dose that had undergone a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster dose that had undergone a temperature excursion.) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent booster dose that had undergone a temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster dose that had undergone a temperature excursion.).    No concomitant medications were reported.  The case was reported for 53rd out of 77 adult patients who had received the vaccine as reported by the reporter.  It was reported that the vaccine was administered approximately to 77 patients before it was known if the vaccine was ok to use after the excursion.  No treatment medications were reported.   This case was linked to MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-696122:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received a vaccine 12 hour beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine 12 hour beyond use 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. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-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) .5 milliliter. On 23-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine 12 hour beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine 12 hour beyond use date) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine 12 hour beyond use date).    Concomitant medication was not reported. It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment drug was not reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; product storage error; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) 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. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT STORAGE ERROR (product storage error).    This case contains information for the 73th patient out of 77 patients described by the reporter. No concomitant medication information provided. It was reported that 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion. No treatment information provided.   This case was linked to MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-696122:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) 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. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion).    Concomitant product use was not provided by the reporter.  On an unknown date, the patient received Moderna bivalent booster dose that had undergone a temperature excursion. The dose was administered before it was known if the vaccine was ok.  Treatment information was not provided.  This case contains information for 74th of 77 adult patients described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-696122: Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) 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. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.).    This case was for 76 patient out of 77 patients reported.  No concomitant medication information provided.  It was reported that 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion.  No treatment information provided.   This case was linked to MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-696122: Master case
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Menstruation irregular, Thyroid function test
Clinical narrative: irregularity as missed periods entirely, they didn't come.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 42-year-old female patient received BNT162b2 (BNT162B2), on 16Feb2021 at 07:45 as dose 2, single (Lot number: EN5318, Expiration Date: 31May2021) at the age of 41 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, NDC: Unknown , LOT: EL1283, EXP: 30Apr2021, Dose and Route: Unknown , Time: in the morning, guessing between 8:00AM-8:30AM), administration date: 26Jan2021, when the patient was 41-year-old, for COVID-19 Immunization, reaction(s): "menstrual cycle irregularities after receiving the COVID-19 vaccine and the booster".  The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "not recovered", described as "irregularity as missed periods entirely, they didn't come.". The event "irregularity as missed periods entirely, they didn't come." required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of menstruation irregular.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Menstruation irregular, Thyroid function test
Clinical narrative: irregularity as missed periods entirely, they didn't come.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 42-year-old female patient received BNT162b2 (BNT162B2), on 10Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Manufacturer: Pfizer, LOT: EL1283, EXP: 30Apr2021, Dose and Route: Unknown , Time: in the morning, guessing between 8:00AM-8:30AM), administration date: 26Jan2021, when the patient was 41-year-old, for COVID-19 Immunization, reaction(s): "Menstrual irregularity"; BNT162b2 (DOSE 2, SINGLE, Manufacturer: Pfizer, LOT: EN5318, EXP: 31May2021, Dose and Route: Unknown, Time: 7:45 AM), administration date: 16Feb2021, when the patient was 41-year-old, for COVID-19 immunization, reaction(s): "Menstrual irregularity".  The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "not recovered", described as "irregularity as missed periods entirely, they didn't come.". The event "irregularity as missed periods entirely, they didn't come." required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of menstruation irregular.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ischaemic stroke, Wrong product administered
Clinical narrative: Wrong vaccine administered; Ischemic stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years intramuscular, in right arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 25Oct2022, outcome "unknown", described as "Wrong vaccine administered"; ISCHAEMIC STROKE (hospitalization, disability, medically significant, life threatening) with onset 19Nov2022 at 15:00, outcome "recovering", described as "Ischemic stroke". The patient was hospitalized for ischaemic stroke (hospitalization duration: 4 day(s)). The event "ischemic stroke" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of ischaemic stroke. Clinical Course: The event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. AE treatment: Rehabilitation. No covid prior vaccination. Not tested for Covid post vaccination. No known allergies.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Seizure
Clinical narrative: Seizure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Dec2022 at 16:30 as dose 4 (booster), single (Lot number: G33274) at the age of 48 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior vaccination and had not been diagnosed with COVID-19 prior vaccination. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTUERER UNKNOWN), for Covid-19 immunization. The following information was reported: SEIZURE (hospitalization, medically significant, life threatening) with onset 02Jan2023, outcome "unknown". The patient was hospitalized for seizure (hospitalization duration: 2 day(s)). The event "seizure" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jan2023) Negative, notes: Covid test post vaccination: Nasal Swab. Therapeutic measures were taken as a result of seizure.
Age: 74.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Interchange of vaccine products, Pemphigoid, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; Horrible case of bulbous pemphigoid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 at 10:00 as dose 4 (booster), single (Lot number: Gh97036) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Peritoneal dialysis" (unspecified if ongoing). The patient has no known drug allergies. The patient had not been diagnosed with COVID-19 prior vaccination. Concomitant medication(s) included: INFLUENZA taken for immunisation, on 04Oct2022 as dose 1, single; ATORVASTATIN; AMLODIPINE; LISINOPRIL; HYDRALAZINE. Vaccination history included: moderna (DOSE 1, Administration time: 11:00 AM, Lot number: 026D21A, Vaccine location: Right arm), administration date: 21Oct2021, when the patient was 73-year-old, for COVID-19 immunization; moderna (DOSE 2, Administration time: 10:00 AM, Vaccine location: Right arm), administration date: 03Nov2021, when the patient was 73-year-old, for COVID-19 immunization; moderna (DOSE 3 (BOOSTER), Administration time: 11:00 AM, Lot number: 059M21A, Vaccine location: Right arm), administration date: 04May2022, when the patient was 74-year-old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (hospitalization, life threatening) with onset 19Oct2022 at 10:00, outcome "recovering"; PEMPHIGOID (hospitalization, medically significant, life threatening) with onset 28Oct2022, outcome "recovering", described as "Horrible case of bulbous pemphigoid". The patient was hospitalized for pemphigoid (hospitalization duration: 2 day(s)). The event "horrible case of bulbous pemphigoid" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Nov2022) Negative. Therapeutic measures were taken as a result of pemphigoid which included steroids bi iv.