chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: At approximately 3:15 pm on  March 6, 2021  I was sitting on the couch and all of a sudden felt like something happened in my head and I was going cross eyed and double vision/impaired vision and thought I was going to black out, but after a minute started to get better. After which i felt i had to be very careful walking around like something was going to happen again in my head.. and I felt like i was groggy or in the fog for about 3 or 4 hours following the incident.  I was sure I had experienced a TIA because I never had anything like that happen in my life.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Biopsy skin abnormal, C-reactive protein increased, Chills, Fatigue, Gait disturbance
Clinical narrative: Persistent Fever & Chills starting 1/26/22, treated with alternating Ibuprofen and Tylenol Petechiae rash in bilateral lower extremities and edema and pain  making walking difficult. Severe fatigue, malaise Treated with high dose steroid and tapered off, and Naproxen
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test normal, Malaise, Oedema peripheral, Pain in extremity, Petechiae
Clinical narrative: Persistent Fever & Chills starting 1/26/22, treated with alternating Ibuprofen and Tylenol Petechiae rash in bilateral lower extremities and edema and pain  making walking difficult. Severe fatigue, malaise Treated with high dose steroid and tapered off, and Naproxen
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Rash, Red blood cell sedimentation rate increased
Clinical narrative: Persistent Fever & Chills starting 1/26/22, treated with alternating Ibuprofen and Tylenol Petechiae rash in bilateral lower extremities and edema and pain  making walking difficult. Severe fatigue, malaise Treated with high dose steroid and tapered off, and Naproxen
Age: 12.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Product administered to patient of inappropriate age, Product administration error
Clinical narrative: Pt. Received Pfizer 5 yrs - 11 yrs in error recently turned 12 years and had received previous age group. Parents informed.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site infection, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented to the pharmacy on 1/24/2023. The injection site was red (size of an orange), warm to touch, and slightly swollen. I advised her to see her provider. She then returned and informed us she had an infection at the injection site.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Burning at time of injection.  Redness, swelling and fever night of injection. Following morning hardness at injection, swelling and redness spreading. Back pain and heaviness of arm and swelling in lymph node under arm on side of injection. Serious fatigue.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Limb discomfort, Lymphadenopathy, Pyrexia
Clinical narrative: Burning at time of injection.  Redness, swelling and fever night of injection. Following morning hardness at injection, swelling and redness spreading. Back pain and heaviness of arm and swelling in lymph node under arm on side of injection. Serious fatigue.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Condition aggravated, Hallucination, Loss of consciousness, Magnetic resonance imaging
Clinical narrative: Migraine medication stopped working and no other medications, injections or infusions have worked. Migraine now presents with hallucinations of all 5 senses, paranoia, neuropathy in arms/legs, episodic fevers and loss of consciousness; among other symptoms.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Neuropathy peripheral, Paranoia, Pyrexia, Scan with contrast
Clinical narrative: Migraine medication stopped working and no other medications, injections or infusions have worked. Migraine now presents with hallucinations of all 5 senses, paranoia, neuropathy in arms/legs, episodic fevers and loss of consciousness; among other symptoms.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Migraine medication stopped working and no other medications, injections or infusions have worked. Migraine now presents with hallucinations of all 5 senses, paranoia, neuropathy in arms/legs, episodic fevers and loss of consciousness; among other symptoms.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal discomfort
Clinical narrative: Reports some discomfort in r shoulder with rom from 100-180 degree rom. Denies limitations in rom to r upper extremity or r shoulder. Denies instability to r shoulder. Offered visit and declines this option.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Electrocardiogram normal, Electroencephalogram normal, Eye movement disorder, Generalised tonic-clonic seizure
Clinical narrative: An unprovoked, generalized tonic-clonic (convulsions, stiffness in neck and body, eyes rolling back in the head, unresponsive, interrupted and inefficient breathing) seizure lasting less than 2 minutes occurred around 9:00 PM CT.  A postictal period of unconsciousness for approximately 20 minutes, then an irritable state of confusion for approximately an hour followed.  Pt was taken to a local Clinic where an EEG and EKG were performed and showed no significant findings. A follow-up visit was scheduled and pt. was released. Pt has continued to have multiple unprovoked seizures and is now on medication to control them. A sedated MRI was also performed in October of 2022 with no significant findings.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Irritability, Loss of consciousness, Magnetic resonance imaging normal, Musculoskeletal stiffness, Postictal state
Clinical narrative: An unprovoked, generalized tonic-clonic (convulsions, stiffness in neck and body, eyes rolling back in the head, unresponsive, interrupted and inefficient breathing) seizure lasting less than 2 minutes occurred around 9:00 PM CT.  A postictal period of unconsciousness for approximately 20 minutes, then an irritable state of confusion for approximately an hour followed.  Pt was taken to a local Clinic where an EEG and EKG were performed and showed no significant findings. A follow-up visit was scheduled and pt. was released. Pt has continued to have multiple unprovoked seizures and is now on medication to control them. A sedated MRI was also performed in October of 2022 with no significant findings.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Respiration abnormal, Seizure, Unresponsive to stimuli
Clinical narrative: An unprovoked, generalized tonic-clonic (convulsions, stiffness in neck and body, eyes rolling back in the head, unresponsive, interrupted and inefficient breathing) seizure lasting less than 2 minutes occurred around 9:00 PM CT.  A postictal period of unconsciousness for approximately 20 minutes, then an irritable state of confusion for approximately an hour followed.  Pt was taken to a local Clinic where an EEG and EKG were performed and showed no significant findings. A follow-up visit was scheduled and pt. was released. Pt has continued to have multiple unprovoked seizures and is now on medication to control them. A sedated MRI was also performed in October of 2022 with no significant findings.
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: patient had received same vaccine on 09/29/22 and was not due for vaccine. Dose given on 1/21/23 was unnecessary.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Hypersomnia, Immediate post-injection reaction
Clinical narrative: Adverse effects included: light-headiness right after receiving shot. Sore arm - even as of 2/1/2021, have redness below the injection site and feels a little warn. Mild fever and chills, Headache, I slept almost continuously for 24+ hours except to wake up to go to bathroom periodically. Afterwards, I would go right back to sleep.  I haven't called or sought any medical advice (pharmacy suggested I call Vaers phone #).. I am concerned about taking the 2nd shot (2/6/21).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity, Pyrexia
Clinical narrative: Adverse effects included: light-headiness right after receiving shot. Sore arm - even as of 2/1/2021, have redness below the injection site and feels a little warn. Mild fever and chills, Headache, I slept almost continuously for 24+ hours except to wake up to go to bathroom periodically. Afterwards, I would go right back to sleep.  I haven't called or sought any medical advice (pharmacy suggested I call Vaers phone #).. I am concerned about taking the 2nd shot (2/6/21).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Eye pruritus, Fatigue, Lymphadenopathy
Clinical narrative: hive/welt under right eye 100.5 temperature headache rashes/hives swollen lymph nodes left side of neck and under left arm unrelenting chills nausea itchy eyes fatigue
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Rash, Urticaria
Clinical narrative: hive/welt under right eye 100.5 temperature headache rashes/hives swollen lymph nodes left side of neck and under left arm unrelenting chills nausea itchy eyes fatigue
Age: 28.0
Sex: M
Vaccine: HPV9, SMALLMNK
Symptoms: Chest discomfort, Fatigue, Lip swelling, Rash, Respiratory tract congestion
Clinical narrative: Patient called PA and told her he woke up at 0900 and he had lip swelling, a rash all over his trunk, some throat congestion, and pressure to his chest. Patient had taken some Benadryl prior to calling into our clinic. PA advised patient to go to ER to be seen.  Patient was seen and treated in the Emergency Dept at Hospital at 1057 and given IV Methylprednisone 125mg, Diphenhydramine 25mg PO, and femotidine 20 mg IV. 11:10AM pt c/o fatigue, post vaccine O: BP 220/110 P 90 regular RR 12 O2 100% no allergies no significant PMH 11:20AM BP 190/92 EMT - called ER MD pt instructed to go to urgent care or ER with family. 11:30AM signed AMA and left clinic
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Heart rate irregular
Clinical narrative: THE ABOVE PATIENT C/O FEELING DIZZY S/P #2 COVID VACCINE. 15 MINUTES LATER C/O FEELING DIZZY BP 144/98, P/23. P.O 99%, HYDRATION WAS OFFERED WITH REST THE PATIENT IMPROVED CONTINUED ON BACK  3/30/21 1PM Continued from front: Hx HYPERTESION      OPEN HEART/LUNG/VALVE SURGERY      HIGH CHOLESTEROL.  NO ALLERGIES    MEDICATIONS          COUMADIN          ASA          GABAPENTIN          AMIORDONE          ATROVASTIN THE PATIENT WAS INSTRUCTED TO FOLLOW UP WITH PCP - FOR ABNORMAL RAPID HEART BEAT
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: No adverse events
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Hypertension
Clinical narrative: high blood pressure that causeda stroke
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Nurse administered COVID 19 vaccine (Moderna) to 17 y/o. This was discoved afer time of service clients mother was contacted 3/30/21, notified. Clients mother states client had no known reactions or side effects except a sore arm
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Gave Moderna 0.5cc  -3/30/21 I spoke with clients gaurdian, she reports patient only had a sore arm.  3/17/21 called Gaurdian No Answer. Left message 3/18/21 called Gaurdian, No Answer. Left message
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Case 0.5 cc Moderna IM - Not recommended until age 18 - 3/30/21 I spoke with patient's gaurdian. She reports today had a sore arm.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood urine present, Bone pain, Fatigue, Headache
Clinical narrative: I got the vaccination at 12.15pm (03/28/2021) and after couple of hours, I developed headaches. I felt tired and went to bed early but I woke up at 2am (03/29/2021) with bone, muscle, and joint aches. I had chills, I couldn't sleep all night due to the pain especially in my legs (mainly bones). I used an electric blanket in the morning, which helped me with the pain a little bit. Around noon (03/29/2021), I had some blood when I peed. Then, in the evening, my kidneys started aching. I thought this was all related to urinary system, but today (03/30/2021) when I had a rush of blood coming from vagina, I think this vaccination might be causing vaginal bleeding too. I have Mirena IUD, and I don't have periods at all.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Renal pain, Sleep disorder, Vaginal haemorrhage
Clinical narrative: I got the vaccination at 12.15pm (03/28/2021) and after couple of hours, I developed headaches. I felt tired and went to bed early but I woke up at 2am (03/29/2021) with bone, muscle, and joint aches. I had chills, I couldn't sleep all night due to the pain especially in my legs (mainly bones). I used an electric blanket in the morning, which helped me with the pain a little bit. Around noon (03/29/2021), I had some blood when I peed. Then, in the evening, my kidneys started aching. I thought this was all related to urinary system, but today (03/30/2021) when I had a rush of blood coming from vagina, I think this vaccination might be causing vaginal bleeding too. I have Mirena IUD, and I don't have periods at all.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Skin discolouration, Skin lesion, Syncope, Urticaria
Clinical narrative: Dad reports sycope with vaceine administration.   lesions around ankles. Developed 1 small hive on L ankle over the next week more lesions appeared around ankles. Lesions began to widen and dusky purplish center appeared. Monitor and return if sx worsen.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash vesicular
Clinical narrative: - rash with blisters on bilateral arms & face - vaccine administered at Hospital.
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; 17 patients were administered EXPIRED doses of the Moderna COVID-19 vaccine bivalent as booster doses.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (17 patients were administered EXPIRED doses of the Moderna COVID-19 vaccine bivalent as booster doses.) 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. 059F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2023, 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 17-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (17 patients were administered EXPIRED doses of the Moderna COVID-19 vaccine bivalent as booster doses.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (17 patients were administered EXPIRED doses of the Moderna COVID-19 vaccine bivalent as booster doses.) 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 (17 patients were administered EXPIRED doses of the Moderna COVID-19 vaccine bivalent as booster doses.).    Concomitant and treatment medications were not reported.  17 patients were administered expired doses of the Moderna COVID-19 vaccine bivalent as booster doses.  This case included information for patient 16 out of 17.   This case was linked to US-MODERNATX, INC.-MOD-2023-698998 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2023: Live follow up received on 19-Jan-2023, no new information was received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698998:
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; 17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day 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. 059F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2023, 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 17-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day 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 (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day 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 (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date).    This case contains information for the 2  of 17 adult patients described by the reporter.  No concomitant and treatment medications were reported.  17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date.   This case was linked to US-MODERNATX, INC.-MOD-2023-698998 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2023: Live Non Significant Follow up received, no new information were added; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698998:(Master case)
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; 17 patients were administered *EXPIRED* doses of the Moderna COVID-19 vaccine bivalent as booster doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (17 patients were administered *EXPIRED* doses of the Moderna COVID-19 vaccine bivalent as booster doses) 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. 059F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2023, 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 17-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (17 patients were administered *EXPIRED* doses of the Moderna COVID-19 vaccine bivalent as booster doses). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (17 patients were administered *EXPIRED* doses of the Moderna COVID-19 vaccine bivalent as booster doses) 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 (17 patients were administered *EXPIRED* doses of the Moderna COVID-19 vaccine bivalent as booster doses).    No concomitant medications were reported. No treatment information was provided. This case contains information of 13th patient out of 17 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-698998 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2023: Live Non Significant FU; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698998:
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day 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. 059F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2023, 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 17-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day 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 (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day 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 (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date).    This case was reported for patient 10 out of 17 patients. Concomitant and treatment medications were not provided. 17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date.    This case was linked to US-MODERNATX, INC.-MOD-2023-698998 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2023: Live non significant follow up received and contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698998:master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; 17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day 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. 059F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2023, 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 17-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day 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 (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day 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 (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date).    This case belonged to adult patient 14 out of 17 patients described by the reporter.  Concomitant and treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-698998 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2023: Live follow up received on 19-Jan-2023 and contains non-significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698998:master case
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; 17 patients were administered EXPIRED doses of the Moderna COVID-19 vaccine bivalent as booster doses.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (17 patients were administered EXPIRED doses of the Moderna COVID-19 vaccine bivalent as booster doses.) 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. 059F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2023, 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 17-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (17 patients were administered EXPIRED doses of the Moderna COVID-19 vaccine bivalent as booster doses.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (17 patients were administered EXPIRED doses of the Moderna COVID-19 vaccine bivalent as booster doses.) 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 (17 patients were administered EXPIRED doses of the Moderna COVID-19 vaccine bivalent as booster doses.).    This case contains information for the 3 of 17 adult patients described by the reporter.  No concomitant and treatment medications were reported.  17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date.   This case was linked to US-MODERNATX, INC.-MOD-2023-698998 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2023: Live non-significant follow up received by safety on 19-Jan-2023: No new information received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698998:master case
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Exposure during pregnancy, Foetal growth restriction, Induced labour, SARS-CoV-2 test positive
Clinical narrative: 01/06/22 presents to birth center Triage for "IOL for FGR""38W0d". PMHx of  "seizure disorder on Keppra" "positive chlamydia in pregnancy" "Anemia during pregnancy"
Sex: F
Vaccine: COVID19
Symptoms: Fear
Clinical narrative: I am so scared that I got the vaccine that I don't know what else to do; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Dec2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Single), administration date: Aug2021, for Covid-19 Immunization. The following information was reported: FEAR (non-serious), outcome "unknown", described as "I am so scared that I got the vaccine that I don't know what else to do".  Additional information: Caller stated, to have so much anxiety on about the Pfizer COVID vaccine, got it a year ago in Aug2021 and waited until Dec2021 to get the second dose. She 100 percent wished to didn't get it because she had more anxiety because she got the vaccine. Her family believed that the vaccine was there to kill people. She was so scared that she got the vaccine that didn't know what else to do.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 11:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 64 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Mar2021 at 13:00 as dose 1, single (Lot number: EP6955), in left arm, on 14Apr2021 at 13:00 as dose 2, single (Lot number: EW0164), in left arm, on 05Dec2021 at 11:00 as dose 3 (booster), single (Lot number: 330308D), in left arm and on 10Apr2022 at 11:00 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "A-fib" (unspecified if ongoing), notes: Controlled by medication and cardiac ablation; "cardiac ablation" (unspecified if ongoing). Concomitant medication(s) included: MULTAQ, start date: 01Aug2010; ELIQUIS, start date: 01Aug2010. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received PF-07321332, ritonavir (PAXLOVID), from 12Jan2023 (Lot number: Unknown) to 16Jan2023 for covid-19 treatment.
Age: 45.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Amnesia, Computerised tomogram normal, Drug screen negative, Echocardiogram normal, Electroencephalogram
Clinical narrative: She got her vaccine, her arm was sore, tender initially.  On Tuesday she went to work as usual and attended her gym class and from that point getting to the gym she remembers that vaguely but from that moment on she did not remember that work out or the entire night.  She had made a serious of phone calls to her family.  Her sister was informed to pick her up who picked her up from the gym as she could not remember anything, did not remember her day, how she got there, or some events.  She was brought home and was taken to the hospital as she lives a block from the gym, she was sitting under a light post, and does not remember any of these events.  She was checked into the hospital and an MRI/CT scan, EEG, EKG and a echo of her heart were done.  The doctors indicated that she possibly had transient global amnesia.  Then the doctors did not find anything.  She was given Tylenol through the night, an IV, some potassium.  They released her to do FU with her PCP and neurologist to see what happened.  She did not have any seizures . She saw her PCP on Monday for a FU and since then she has continued to have headaches, and kind of fogginess every day.  It is getting better, but she is keeping a journal.  Her family is watching over her, not able to go back to work or drive.  She does have a neurologist appointment on 2/6/23 and to FU with her PCP for lab work results.  They said that she had a TIA as she has a lot of fatigue and slow to remember things.  At the same time it is taking her a long time to focus, feels that she has to refocus again.  The headaches do come and go and has interactions she has more headaches and/or pressure.   Her PCP believes it is due to the vaccine.  She is very consistent with her FU's and the only thing that changed was that she had the vaccine and may have had a mini-stroke due to the vaccine and the symptoms that she continues to have.    She does not remember anything from Tuesday at work, was told that she did go through the work out, and did everything per this person, and has no recollection to that.  She does not remember communicating with her son and where she was as she did not remember where she was or where she parked.   She is wondering why she continues to have the headaches as all the testing was negative and is eager to find out what is wrong so that this doesn't happen again and to be able to get back to work and to being herself again.
Age: 45.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Laboratory test normal, Magnetic resonance imaging normal
Clinical narrative: She got her vaccine, her arm was sore, tender initially.  On Tuesday she went to work as usual and attended her gym class and from that point getting to the gym she remembers that vaguely but from that moment on she did not remember that work out or the entire night.  She had made a serious of phone calls to her family.  Her sister was informed to pick her up who picked her up from the gym as she could not remember anything, did not remember her day, how she got there, or some events.  She was brought home and was taken to the hospital as she lives a block from the gym, she was sitting under a light post, and does not remember any of these events.  She was checked into the hospital and an MRI/CT scan, EEG, EKG and a echo of her heart were done.  The doctors indicated that she possibly had transient global amnesia.  Then the doctors did not find anything.  She was given Tylenol through the night, an IV, some potassium.  They released her to do FU with her PCP and neurologist to see what happened.  She did not have any seizures . She saw her PCP on Monday for a FU and since then she has continued to have headaches, and kind of fogginess every day.  It is getting better, but she is keeping a journal.  Her family is watching over her, not able to go back to work or drive.  She does have a neurologist appointment on 2/6/23 and to FU with her PCP for lab work results.  They said that she had a TIA as she has a lot of fatigue and slow to remember things.  At the same time it is taking her a long time to focus, feels that she has to refocus again.  The headaches do come and go and has interactions she has more headaches and/or pressure.   Her PCP believes it is due to the vaccine.  She is very consistent with her FU's and the only thing that changed was that she had the vaccine and may have had a mini-stroke due to the vaccine and the symptoms that she continues to have.    She does not remember anything from Tuesday at work, was told that she did go through the work out, and did everything per this person, and has no recollection to that.  She does not remember communicating with her son and where she was as she did not remember where she was or where she parked.   She is wondering why she continues to have the headaches as all the testing was negative and is eager to find out what is wrong so that this doesn't happen again and to be able to get back to work and to being herself again.
Age: 45.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Computerised tomogram normal, Echocardiogram normal, Electrocardiogram normal, Electroencephalogram normal, Fatigue
Clinical narrative: She got her vaccine, her arm was sore, tender initially.  On Tuesday she went to work as usual and attended her gym class and from that point getting to the gym she remembers that vaguely but from that moment on she did not remember that work out or the entire night.  She had made a serious of phone calls to her family.  Her sister was informed to pick her up who picked her up from the gym as she could not remember anything, did not remember her day, how she got there, or some events.  She was brought home and was taken to the hospital as she lives a block from the gym, she was sitting under a light post, and does not remember any of these events.  She was checked into the hospital and an MRI/CT scan, EEG, EKG and a echo of her heart were done.  The doctors indicated that she possibly had transient global amnesia.  Then the doctors did not find anything.  She was given Tylenol through the night, an IV, some potassium.  They released her to do FU with her PCP and neurologist to see what happened.  She did not have any seizures . She saw her PCP on Monday for a FU and since then she has continued to have headaches, and kind of fogginess every day.  It is getting better, but she is keeping a journal.  Her family is watching over her, not able to go back to work or drive.  She does have a neurologist appointment on 2/6/23 and to FU with her PCP for lab work results.  They said that she had a TIA as she has a lot of fatigue and slow to remember things.  At the same time it is taking her a long time to focus, feels that she has to refocus again.  The headaches do come and go and has interactions she has more headaches and/or pressure.   Her PCP believes it is due to the vaccine.  She is very consistent with her FU's and the only thing that changed was that she had the vaccine and may have had a mini-stroke due to the vaccine and the symptoms that she continues to have.    She does not remember anything from Tuesday at work, was told that she did go through the work out, and did everything per this person, and has no recollection to that.  She does not remember communicating with her son and where she was as she did not remember where she was or where she parked.   She is wondering why she continues to have the headaches as all the testing was negative and is eager to find out what is wrong so that this doesn't happen again and to be able to get back to work and to being herself again.
Age: 45.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Feeling abnormal, Head discomfort, Headache, Impaired driving ability, Impaired work ability
Clinical narrative: She got her vaccine, her arm was sore, tender initially.  On Tuesday she went to work as usual and attended her gym class and from that point getting to the gym she remembers that vaguely but from that moment on she did not remember that work out or the entire night.  She had made a serious of phone calls to her family.  Her sister was informed to pick her up who picked her up from the gym as she could not remember anything, did not remember her day, how she got there, or some events.  She was brought home and was taken to the hospital as she lives a block from the gym, she was sitting under a light post, and does not remember any of these events.  She was checked into the hospital and an MRI/CT scan, EEG, EKG and a echo of her heart were done.  The doctors indicated that she possibly had transient global amnesia.  Then the doctors did not find anything.  She was given Tylenol through the night, an IV, some potassium.  They released her to do FU with her PCP and neurologist to see what happened.  She did not have any seizures . She saw her PCP on Monday for a FU and since then she has continued to have headaches, and kind of fogginess every day.  It is getting better, but she is keeping a journal.  Her family is watching over her, not able to go back to work or drive.  She does have a neurologist appointment on 2/6/23 and to FU with her PCP for lab work results.  They said that she had a TIA as she has a lot of fatigue and slow to remember things.  At the same time it is taking her a long time to focus, feels that she has to refocus again.  The headaches do come and go and has interactions she has more headaches and/or pressure.   Her PCP believes it is due to the vaccine.  She is very consistent with her FU's and the only thing that changed was that she had the vaccine and may have had a mini-stroke due to the vaccine and the symptoms that she continues to have.    She does not remember anything from Tuesday at work, was told that she did go through the work out, and did everything per this person, and has no recollection to that.  She does not remember communicating with her son and where she was as she did not remember where she was or where she parked.   She is wondering why she continues to have the headaches as all the testing was negative and is eager to find out what is wrong so that this doesn't happen again and to be able to get back to work and to being herself again.
Age: 45.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Magnetic resonance imaging normal, Memory impairment, Mineral supplementation, Pain in extremity, Tenderness
Clinical narrative: She got her vaccine, her arm was sore, tender initially.  On Tuesday she went to work as usual and attended her gym class and from that point getting to the gym she remembers that vaguely but from that moment on she did not remember that work out or the entire night.  She had made a serious of phone calls to her family.  Her sister was informed to pick her up who picked her up from the gym as she could not remember anything, did not remember her day, how she got there, or some events.  She was brought home and was taken to the hospital as she lives a block from the gym, she was sitting under a light post, and does not remember any of these events.  She was checked into the hospital and an MRI/CT scan, EEG, EKG and a echo of her heart were done.  The doctors indicated that she possibly had transient global amnesia.  Then the doctors did not find anything.  She was given Tylenol through the night, an IV, some potassium.  They released her to do FU with her PCP and neurologist to see what happened.  She did not have any seizures . She saw her PCP on Monday for a FU and since then she has continued to have headaches, and kind of fogginess every day.  It is getting better, but she is keeping a journal.  Her family is watching over her, not able to go back to work or drive.  She does have a neurologist appointment on 2/6/23 and to FU with her PCP for lab work results.  They said that she had a TIA as she has a lot of fatigue and slow to remember things.  At the same time it is taking her a long time to focus, feels that she has to refocus again.  The headaches do come and go and has interactions she has more headaches and/or pressure.   Her PCP believes it is due to the vaccine.  She is very consistent with her FU's and the only thing that changed was that she had the vaccine and may have had a mini-stroke due to the vaccine and the symptoms that she continues to have.    She does not remember anything from Tuesday at work, was told that she did go through the work out, and did everything per this person, and has no recollection to that.  She does not remember communicating with her son and where she was as she did not remember where she was or where she parked.   She is wondering why she continues to have the headaches as all the testing was negative and is eager to find out what is wrong so that this doesn't happen again and to be able to get back to work and to being herself again.
Age: 45.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Transient ischaemic attack
Clinical narrative: She got her vaccine, her arm was sore, tender initially.  On Tuesday she went to work as usual and attended her gym class and from that point getting to the gym she remembers that vaguely but from that moment on she did not remember that work out or the entire night.  She had made a serious of phone calls to her family.  Her sister was informed to pick her up who picked her up from the gym as she could not remember anything, did not remember her day, how she got there, or some events.  She was brought home and was taken to the hospital as she lives a block from the gym, she was sitting under a light post, and does not remember any of these events.  She was checked into the hospital and an MRI/CT scan, EEG, EKG and a echo of her heart were done.  The doctors indicated that she possibly had transient global amnesia.  Then the doctors did not find anything.  She was given Tylenol through the night, an IV, some potassium.  They released her to do FU with her PCP and neurologist to see what happened.  She did not have any seizures . She saw her PCP on Monday for a FU and since then she has continued to have headaches, and kind of fogginess every day.  It is getting better, but she is keeping a journal.  Her family is watching over her, not able to go back to work or drive.  She does have a neurologist appointment on 2/6/23 and to FU with her PCP for lab work results.  They said that she had a TIA as she has a lot of fatigue and slow to remember things.  At the same time it is taking her a long time to focus, feels that she has to refocus again.  The headaches do come and go and has interactions she has more headaches and/or pressure.   Her PCP believes it is due to the vaccine.  She is very consistent with her FU's and the only thing that changed was that she had the vaccine and may have had a mini-stroke due to the vaccine and the symptoms that she continues to have.    She does not remember anything from Tuesday at work, was told that she did go through the work out, and did everything per this person, and has no recollection to that.  She does not remember communicating with her son and where she was as she did not remember where she was or where she parked.   She is wondering why she continues to have the headaches as all the testing was negative and is eager to find out what is wrong so that this doesn't happen again and to be able to get back to work and to being herself again.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral thrombosis, Memory impairment
Clinical narrative: cerebral blood clot; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 48-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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 (Primary Immunization series completed; unknown manufacturer), for COVID-19 Immunization. The following information was reported: CEREBRAL THROMBOSIS (medically significant), 3 months after the suspect product(s) administration, outcome "unknown", described as "cerebral blood clot". The event "cerebral blood clot" required physician office visit.  Additional information: The reporter said that the patient developed a cerebral blood clot three months after the Pfizer Covid Booster. Reporter said that the team of cardiologists and neurologists narrowed down the cause of the blood clot to the mRNA vaccine. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.