chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris
Clinical narrative: Patient felt heart pain within hours of receiving 2nd monovalent vaccine in the primary series; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 39-year-old male patient received bnt162b2 (BNT162B2), 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: Covid 19 vaccine (Manufacturer unknown, dose 1, not bivalent), for COVID-19 immunization. The following information was reported: ANGINA PECTORIS (medically significant), outcome "recovered", described as "Patient felt heart pain within hours of receiving 2nd monovalent vaccine in the primary series". Therapeutic measures were not taken as a result of angina pectoris.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; testing positive for Covid; testing positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Sep2023, outcome "unknown" and all described as "testing positive for Covid"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was prescribed Paxlovid by her doctor yesterday after testing positive for Covid Tuesday morning. She has had "all of her boosters up until now." The first two vaccines she received were the Pfizer Covid-19 vaccines, then she received a Moderna booster, then a Pfizer booster, then a Moderna Bivalent vaccine, and was scheduled to receive the most recent Comirnaty vaccine on 08Oct, however she had to cancel her appointment.   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: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 80.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Injection site erythema, Injection site inflammation, Injection site rash, Injection site swelling
Clinical narrative: Patient came today to pharmacy and reported she experienced rashes, redness, swelling & a little inflammation on her top left arm where she got her Fluzone HD shot. and after a few days, the redness were increased in size around 5 inches, but the swelling had subsided. Pt was advised to notify her regular PCP since she mentioned she always get redness/rash whenever she gets her annual flu shots.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Chills, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: 9/19 3:30pm Severe chills/shivering for 5 hours. Took 2 advil. Sleep 8:49 hrs.   9/20 4:30pm chills/shivering for 4 hrs. Covid antigen test at pharmacy, negative. 9/21 3:30am woke up nauseous but didn?t throw up. 4:30am shivering again. Took 2 ibuprofen. 5:25pm started shivering again not as bad.  9/22 6:30 feel I?ll, headache and body aches. Bed at 8pm feeling miserable. 9/23 1:30am diarrhea and nauseous but never threw up. Diarrhea 5 more times before doctor appt. Nurse took sub for Covid PCR and flu. Dr said he wouldn?t have tested if nurse hadn?t already swabbed.  He said it?s side effects from RSV vaccine. All swabs came back negative.  Extremely tired at 5pm and no energy. 9/24 felt ok most of day.about 5pm started to feel achy, no fever but not well and no energy.  9/25 Woke with another headache. Took 2 ibuprofen and went back to bed from 7:30-9am. From 5:30-6:55pm had chills and shivering as bad as first few days. Didn?t last as long because I took 2 ibuprofen and drank hot tea.  Report says I?m being timed out!
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Headache, Immunisation reaction, Influenza virus test negative, Malaise, Nausea
Clinical narrative: 9/19 3:30pm Severe chills/shivering for 5 hours. Took 2 advil. Sleep 8:49 hrs.   9/20 4:30pm chills/shivering for 4 hrs. Covid antigen test at pharmacy, negative. 9/21 3:30am woke up nauseous but didn?t throw up. 4:30am shivering again. Took 2 ibuprofen. 5:25pm started shivering again not as bad.  9/22 6:30 feel I?ll, headache and body aches. Bed at 8pm feeling miserable. 9/23 1:30am diarrhea and nauseous but never threw up. Diarrhea 5 more times before doctor appt. Nurse took sub for Covid PCR and flu. Dr said he wouldn?t have tested if nurse hadn?t already swabbed.  He said it?s side effects from RSV vaccine. All swabs came back negative.  Extremely tired at 5pm and no energy. 9/24 felt ok most of day.about 5pm started to feel achy, no fever but not well and no energy.  9/25 Woke with another headache. Took 2 ibuprofen and went back to bed from 7:30-9am. From 5:30-6:55pm had chills and shivering as bad as first few days. Didn?t last as long because I took 2 ibuprofen and drank hot tea.  Report says I?m being timed out!
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Pain, SARS-CoV-2 test negative
Clinical narrative: 9/19 3:30pm Severe chills/shivering for 5 hours. Took 2 advil. Sleep 8:49 hrs.   9/20 4:30pm chills/shivering for 4 hrs. Covid antigen test at pharmacy, negative. 9/21 3:30am woke up nauseous but didn?t throw up. 4:30am shivering again. Took 2 ibuprofen. 5:25pm started shivering again not as bad.  9/22 6:30 feel I?ll, headache and body aches. Bed at 8pm feeling miserable. 9/23 1:30am diarrhea and nauseous but never threw up. Diarrhea 5 more times before doctor appt. Nurse took sub for Covid PCR and flu. Dr said he wouldn?t have tested if nurse hadn?t already swabbed.  He said it?s side effects from RSV vaccine. All swabs came back negative.  Extremely tired at 5pm and no energy. 9/24 felt ok most of day.about 5pm started to feel achy, no fever but not well and no energy.  9/25 Woke with another headache. Took 2 ibuprofen and went back to bed from 7:30-9am. From 5:30-6:55pm had chills and shivering as bad as first few days. Didn?t last as long because I took 2 ibuprofen and drank hot tea.  Report says I?m being timed out!
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: Cold chills, sweats & fever, ear pain, stomach pain (felt like abdominal ripping/tearing), extreme pain in entire body, worst in entire left arm (booster side), slight headache, intractable vomiting, diarrhea, dizziness, difficulty breathing, heavy menstrual bleeding off schedule (one week since last period ended)
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Feeling cold, Gaze palsy, Heavy menstrual bleeding, Hyperhidrosis
Clinical narrative: Cold chills, sweats & fever, ear pain, stomach pain (felt like abdominal ripping/tearing), extreme pain in entire body, worst in entire left arm (booster side), slight headache, intractable vomiting, diarrhea, dizziness, difficulty breathing, heavy menstrual bleeding off schedule (one week since last period ended)
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Polymenorrhoea, Pyrexia, Vomiting
Clinical narrative: Cold chills, sweats & fever, ear pain, stomach pain (felt like abdominal ripping/tearing), extreme pain in entire body, worst in entire left arm (booster side), slight headache, intractable vomiting, diarrhea, dizziness, difficulty breathing, heavy menstrual bleeding off schedule (one week since last period ended)
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Administration site erythema, Administration site reaction, Livedo reticularis
Clinical narrative: Patient had a mottled red spot with a black dot where the immunization was administered
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Bruxism, Gaze palsy, Irritability, Muscle twitching, Respiratory viral panel
Clinical narrative: Mom reports got their shots, they were fine, fussy, gave motrin 6p, he woke up fussy just bf MN, mom gave tyl, then mom heard something on monitor early AM 5:26am, looked convulsing, bilat shoulder twitching/eyes up and back, arms up/shaking, they got him out into living room, called 911, around 5min, then clinched jaw and eyes still kinda up, couple min maybe, dad thought 10min, but less than that, lots of spit in mouth.  Plan is to monitor for further symptoms and then separate the MMR and Varicella vaccines at age 4.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: SARS-CoV-2 test, Salivary hypersecretion, Tremor
Clinical narrative: Mom reports got their shots, they were fine, fussy, gave motrin 6p, he woke up fussy just bf MN, mom gave tyl, then mom heard something on monitor early AM 5:26am, looked convulsing, bilat shoulder twitching/eyes up and back, arms up/shaking, they got him out into living room, called 911, around 5min, then clinched jaw and eyes still kinda up, couple min maybe, dad thought 10min, but less than that, lots of spit in mouth.  Plan is to monitor for further symptoms and then separate the MMR and Varicella vaccines at age 4.
Age: 33.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Stomatitis
Clinical narrative: Developed an oral mucositis two days after vaccination. Resolved a few days later.
Age: 55.0
Sex: M
Vaccine: FLUA4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: FluAD was administered to a 55 y.o. patient. He was too young to receive this dose.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Feeling cold, Hyperhidrosis, Malaise, Nausea
Clinical narrative: Approximately 1-2 minutes after administered injection, employee stated not feeling well.  stated a little nauseated, and light headed, and diaphoretic.  stated left wrist felt strange.  Later stated felt odd sensation down arm after receiving the vaccine.  Asked for some water.  Denied any shortness of breath.  Vital signs 103/67, re-checked was 108/69.  Pulse 77.  Pulse oximeter was 100%.   States ate a little early today, but no lunch yet.  Had coffee today as well.   A few minutes after this, employee stated feeling better, but not 100%.  Stated nausea subsided.  Still maybe light headed.  Escorted employee to Dr. office in Employee Health.   Was evaluated by physician.  Blood pressure 149/106 in right arm.  Pulse 76.  Stated felt cold.  Temperature was 36.8.  Re-checked blood pressure in left arm and was 150/96  Re Stayed with employee until 1430 when Dr. Felt employee was  safe to drive home.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Sensory disturbance
Clinical narrative: Approximately 1-2 minutes after administered injection, employee stated not feeling well.  stated a little nauseated, and light headed, and diaphoretic.  stated left wrist felt strange.  Later stated felt odd sensation down arm after receiving the vaccine.  Asked for some water.  Denied any shortness of breath.  Vital signs 103/67, re-checked was 108/69.  Pulse 77.  Pulse oximeter was 100%.   States ate a little early today, but no lunch yet.  Had coffee today as well.   A few minutes after this, employee stated feeling better, but not 100%.  Stated nausea subsided.  Still maybe light headed.  Escorted employee to Dr. office in Employee Health.   Was evaluated by physician.  Blood pressure 149/106 in right arm.  Pulse 76.  Stated felt cold.  Temperature was 36.8.  Re-checked blood pressure in left arm and was 150/96  Re Stayed with employee until 1430 when Dr. Felt employee was  safe to drive home.
Age: 56.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Based on CDC guidelines, RSV is recommended over 60 years. My patient is 56 years old so RSV is not recommended for her age.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood urine absent, Chromaturia, Culture urine
Clinical narrative: Very dark urine
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injury associated with device
Clinical narrative: After vaccination, the provider incurred a needle stick.  The involved patient was no impacted.  Client is handling the situation
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Flushing
Clinical narrative: Patient felt "weird " and became very flushed. Resolved in less than 10 minutes but observed patient for 30 minutes
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Full blood count, Metabolic function test, Rash, Rash erythematous, Rash pruritic
Clinical narrative: within 1-2 days after Abrysvo vaccination, pt developed pruritic rash over entire body. Exam today reveals a mostly follicular pattern of erythema with a handful of erythematous patches/plaques on her right antecubital area and left lower extremity.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given HD Fluzone at the age of 64
Age: 63.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given 3 days after expiration.  Expired 09/29/2023, administered 10/02/2023. Provider advised that patient be re-immunized.  No adverse reaction to expired vaccine.
Age: 65.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 72.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Hot flush, Palpitations, Thirst, Tremor
Clinical narrative: pt given 2 vaccines; FLUZONE HD and AREXVY; approximately 5 minutes after immunization she complained of feeling like having hot flashes, heart racing and shaking; I gave her wet paper towels to put on forehead and back of neck; had tech call 911 and I measured her BP and asked her if any other symptoms, like dizziness, difficulty breathing, itching, she denied any additional symptoms.  BP was 175/101 pulse 77 at 4:20pm 10/3, 175/105 pulse 77 at 4:25pm and 174/100, pulse 72 at 4:30pm; EMS had arrived by now and their readings were 164/94, pulse 72, pO2=96; pt refused transport to  ER; stated she was feeling better but very thirsty, EMS allowed her to take a drink of water and advised her to contact 911 if she feels any symptoms or gets worse, pt acknowledged instructions given to her and asked if she could go on and do her shopping.  EMS cleared her to leave and I once again verified she was feeling better and wanted to leave and not go to ER, she stated she was feeling better and denied offer to ER; pt left pharmacy area around 5:15pm
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: I have had occasional tinnitus for as long as I could remember but it's always been a ringing nose. Mid 2021 (after my first covid vaccine) I started hearing a wind blowing type noise in my ear that I hadn't heard before and it was very frequent and lasted several months. I went to an ent and had tests done and nothing was wrong. It eventually went away. I just had it again today after I recently got my booster. I always have a high fever, muscle aches and fatigue in the days after my covid boosters.
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient developed 3 itchy red patches about 3-4 inches across on her arm adjacent to the injection site.  They have become more itchy and red over the last 2 days.  Patient hasn't taken anything yet, but I instructed her to take benadryl tablets to help with the itching and to monitor the areas to make sure they do not become larger.
Age: 21.0
Sex: F
Vaccine: COVID19-2
Symptoms: Diarrhoea, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Full body muscle pain Diarrhea Nausea Headache Fatigue (all beginning around 5pm on 10/1/23 and continuing through 10/2/23 at 7pm)
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Erythema, Peripheral swelling, Skin warm
Clinical narrative: 24 hours after receiving vaccine, the patient describes severe chill, a large red bump with a width of 3-inch bump in her arm, and it is warm to the touch. The patient presented to the pharmacy 3 days after vaccination. The patient arm was no longer swollen but remains red and warm to the touch. I recommended the patient take Benadryl at bedtime to help with the reactions.
Age: 11.0
Sex: F
Vaccine: FLUN4
Symptoms: Increased upper airway secretion
Clinical narrative: PATIENT DEVELOPD A BALL OF PHLEGM IN HER THROAT THAT WOULD NOT GO AWAY AFTER DRINKING 8 OUNCES OF WATER, PATIENT WAS GIVEN 25MG (10ML) DIPHENHYDRAMINE AND 16 OUNCES MORE OF WATER AND SYMPTOMS WENT AWAY
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Malaise, Petechiae, Rash
Clinical narrative: - stomach upset and diarrhea the first night after being vaccinated  - general malaise for a few days after vaccinated  - developed petechial rash on top of hands
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLU4, RSV
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient received  a Fluzone HD vaccine instead of a Fluarix (under 65yr).  No adverse reaction occurred.  She received the wrong dose flu shot.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Haematemesis, Headache, Nausea, Rash
Clinical narrative: Patient had a reaction 8 hours following administration of this vaccine.  She had rash, nausea and vomiting blood, headache and chills.
Age: 60.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Excruciating Pain experienced within 4 hours at site and joint
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Pain in extremity, Peripheral swelling, Shoulder operation
Clinical narrative: Sore arm, knot in arm that s still present. And needed surgery in shoulder after deterioration.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site rash, Injection site swelling, Injection site vesicles
Clinical narrative: Red rash, swelling hot, blisters spread across entire deltoid and nausea, headache    Called to report to Dr
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Nausea
Clinical narrative: Red rash, swelling hot, blisters spread across entire deltoid and nausea, headache    Called to report to Dr
Age: 65.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Patient came into the pharmacy exactly a week after his vaccines and said his right arm where he got his flu shot swelled up and he had a grapefruit sized rash. He says he's never reacted to a flu shot like that before (this is his first time getting Fluzone HD)
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Injection site haemorrhage, Loss of consciousness
Clinical narrative: Patient appeared fine after vaccine. However, injection barrier bandage used and minor bleeding noted after injection and was absorbed via bandaid. Patient then sat in chair pharmacy lobby and moment later fell from chair and family noted patient passed out for a very brief moment. Upon observation, no signs of anaphylaxis and consciousness maintained. Ems called and transported patient to hospital and patient family was followed up and was doing better afterwards and received IV fluidsat hospital.
Age: 66.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: pt developed SIRVA per patient - ended up going to urgent care next morning on 9/29/23 around noon
Age: 65.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Peripheral swelling
Clinical narrative: swelling  on her right arm
Age: 73.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Malaise, Syncope
Clinical narrative: Patient wife reported that patient suffered an episode of syncope that resulted in an emergency hospital visit and subsequent hospital stay of about 7 days and patient is still not feeling well.
Age: 16.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient felt lightheaded and passed out after he stood up right after getting the shots. Parents helped laying him down on the floor till paramedics arrived. He was alert and oriented, breaing normally by the time paramedics arrived.
Age: 72.0
Sex: F
Vaccine: COVID19-2, FLUA4, RSV
Symptoms: Erythema, Fatigue, Malaise
Clinical narrative: Patient reports that evening she started to feel unwell, very fatigued.  She developed a red patch that wrapped around her shoulder (4inches wide by 6-7inches long).  She self treated with ibuprofen.  She felt better after a week.
Age: 71.0
Sex: M
Vaccine: RSV, RSV, RSV, UNK
Symptoms: Feeling hot
Clinical narrative: Overheating
Age: 57.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Peripheral swelling, Pruritus, Rash, Rash erythematous, Rash pruritic
Clinical narrative: The patient reported that on the day of/after vaccination they experienced swelling of the arm around the vaccine site on the arm. On 10/1, after the shot was given on 09/28, the patient reported a rash starting on the left side of the face that progressed and grew larger across the face. It is red and itches, but there is no pain or blisters. The patient tried cetirizine/zyrtec and that did not alleviate any symptoms. The patient was counseled to report to their doctor and follow up. Patient said they would follow up if the situation worsened or did not improve over time. Benadryl was suggested as a nighttime option for itching, and an over the counter steroid cream for the daytime, no longer than x2 weeks, if the itching bothered the patient.
Age: 57.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Vaccination site swelling
Clinical narrative: The patient reported that on the day of/after vaccination they experienced swelling of the arm around the vaccine site on the arm. On 10/1, after the shot was given on 09/28, the patient reported a rash starting on the left side of the face that progressed and grew larger across the face. It is red and itches, but there is no pain or blisters. The patient tried cetirizine/zyrtec and that did not alleviate any symptoms. The patient was counseled to report to their doctor and follow up. Patient said they would follow up if the situation worsened or did not improve over time. Benadryl was suggested as a nighttime option for itching, and an over the counter steroid cream for the daytime, no longer than x2 weeks, if the itching bothered the patient.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Diagnostic procedure, Headache, High frequency ablation
Clinical narrative: Occipital Neuralgia (constant intense headache for 12 months, barely managed by pain medication, not impacted by migraine drugs, eventually ended only by Radio Frequency Ablation of the effected nerves in the spine done 12/7/22 and 12/21/22, one procedure for each side.  During 12 months of pain, hugely debilitating, mostly unable to work.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Injection, Occipital neuralgia, Pain, Spinal X-ray
Clinical narrative: Occipital Neuralgia (constant intense headache for 12 months, barely managed by pain medication, not impacted by migraine drugs, eventually ended only by Radio Frequency Ablation of the effected nerves in the spine done 12/7/22 and 12/21/22, one procedure for each side.  During 12 months of pain, hugely debilitating, mostly unable to work.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Occipital Neuralgia (constant intense headache for 12 months, barely managed by pain medication, not impacted by migraine drugs, eventually ended only by Radio Frequency Ablation of the effected nerves in the spine done 12/7/22 and 12/21/22, one procedure for each side.  During 12 months of pain, hugely debilitating, mostly unable to work.
Age: 88.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angiogram, Atrial fibrillation, Chest X-ray, Computerised tomogram head, Electrocardiogram
Clinical narrative: Near Syncope- new onset Atrial Fibrillation; ED visit resulting in hospitalization.
Age: 88.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fibrin D dimer, Full blood count, Metabolic function test, Presyncope, Troponin
Clinical narrative: Near Syncope- new onset Atrial Fibrillation; ED visit resulting in hospitalization.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Cough, Respiratory tract congestion
Clinical narrative: Congestion and cough
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Akinesia, Chest discomfort, Chest pain, Dizziness, Dyspnoea
Clinical narrative: On Jan 5, 2022, I received my 3rd booster covid-19 Moderna vaccine.   In June 2, 2022, I became ill.  I felt dizzy and my blood pressure (BP) was 188/140.   I was hospitalized for a couple of days and released with a BP of 156/95.  This was the beginning of my ordeal.  Thereafter, I started to feel exhausted, shortness of breath, couldn't walk steady, I felt heart palpitation, tightness in chess, sweating, and a knot feeling in the throat. There are times when I get minor pains in the left side of my chest.  I followed up with my primary physician who prescribed me Amlodipine 5mg assuming I had high BP.  My concerned was how can I have a high BP when I have always been a healthy adult and overnight, I my BP was enough to get a stoke.    I never smoked, drank alcohol, no drugs, and never took any medications.    I followed up with a cardiologist, and when I received the result, it was discovered that I had an Apical Kinesis (AK). My EKGs are now abnormal.  I have had two MRI, echocardiogram and EKG.     Hoping that with time, the AK will resolve, that is not the case with me.  I still have it and I will never feel normal again.    There are times when I am sitting at work, and all of a sudden, I feel faint. I can sleep 8-9 hours, but it seems as if I only had 2 hours as I feel extremely fatigue, light-headed, and sweating.   My third vaccine is the last one I will ever take.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Echocardiogram, Electrocardiogram abnormal, Fatigue, Gait disturbance, Hyperhidrosis
Clinical narrative: On Jan 5, 2022, I received my 3rd booster covid-19 Moderna vaccine.   In June 2, 2022, I became ill.  I felt dizzy and my blood pressure (BP) was 188/140.   I was hospitalized for a couple of days and released with a BP of 156/95.  This was the beginning of my ordeal.  Thereafter, I started to feel exhausted, shortness of breath, couldn't walk steady, I felt heart palpitation, tightness in chess, sweating, and a knot feeling in the throat. There are times when I get minor pains in the left side of my chest.  I followed up with my primary physician who prescribed me Amlodipine 5mg assuming I had high BP.  My concerned was how can I have a high BP when I have always been a healthy adult and overnight, I my BP was enough to get a stoke.    I never smoked, drank alcohol, no drugs, and never took any medications.    I followed up with a cardiologist, and when I received the result, it was discovered that I had an Apical Kinesis (AK). My EKGs are now abnormal.  I have had two MRI, echocardiogram and EKG.     Hoping that with time, the AK will resolve, that is not the case with me.  I still have it and I will never feel normal again.    There are times when I am sitting at work, and all of a sudden, I feel faint. I can sleep 8-9 hours, but it seems as if I only had 2 hours as I feel extremely fatigue, light-headed, and sweating.   My third vaccine is the last one I will ever take.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Magnetic resonance imaging, Malaise, Palpitations, Sensation of foreign body
Clinical narrative: On Jan 5, 2022, I received my 3rd booster covid-19 Moderna vaccine.   In June 2, 2022, I became ill.  I felt dizzy and my blood pressure (BP) was 188/140.   I was hospitalized for a couple of days and released with a BP of 156/95.  This was the beginning of my ordeal.  Thereafter, I started to feel exhausted, shortness of breath, couldn't walk steady, I felt heart palpitation, tightness in chess, sweating, and a knot feeling in the throat. There are times when I get minor pains in the left side of my chest.  I followed up with my primary physician who prescribed me Amlodipine 5mg assuming I had high BP.  My concerned was how can I have a high BP when I have always been a healthy adult and overnight, I my BP was enough to get a stoke.    I never smoked, drank alcohol, no drugs, and never took any medications.    I followed up with a cardiologist, and when I received the result, it was discovered that I had an Apical Kinesis (AK). My EKGs are now abnormal.  I have had two MRI, echocardiogram and EKG.     Hoping that with time, the AK will resolve, that is not the case with me.  I still have it and I will never feel normal again.    There are times when I am sitting at work, and all of a sudden, I feel faint. I can sleep 8-9 hours, but it seems as if I only had 2 hours as I feel extremely fatigue, light-headed, and sweating.   My third vaccine is the last one I will ever take.
Age: 46.0
Sex: F
Vaccine: COVID19, FLUR4
Symptoms: Dizziness, Feeling abnormal, Heart rate abnormal, Hypoaesthesia
Clinical narrative: Patient was slightly nervous before getting the vaccines. After administering the Flublok flu shot and Comirnaty Pfizer vaccine at 2:04pm in the left arm, patient began feeling uneasy.  I brought her a Gatorade to sip if needed. She described her feelings as:  Feeling of faintness, numbness in left arm, rapid heart rate. Store assistance was called. They arrived and called 911. Patient was still conscience as paramedics arrived and took her to the ambulance.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: Pain under top right arm
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Injection site erythema, Injection site pain, Injection site warmth, Product administered at inappropriate site
Clinical narrative: Cough. The injection site on the left arm is lower than the deltoid. The insertion point is red and painful to the touch. There is red streaking going down approx 2 inches on the arm that is painful and swollen to the touch. The skin is warm to the touch. We are watching it tonight and have the red area marked to see if it spreads. If it continues to spread patient will see a doctor.  The clinician who administered the vaccine did not inject correctly.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Hypoaesthesia, Mobility decreased, Pain, Pain in extremity
Clinical narrative: pt states she experienced pain an numbness down her arm the of vaccination, but only had a sore shoulder the following day. she states that 8 days later she experienced a 'frozen shoulder' where she experienced pain with movement and difficulty moving her arm.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Periarthritis
Clinical narrative: pt states she experienced pain an numbness down her arm the of vaccination, but only had a sore shoulder the following day. she states that 8 days later she experienced a 'frozen shoulder' where she experienced pain with movement and difficulty moving her arm.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: 13 days after getting the vaccine, I had extreme urticaria - hives breaking out spontaneously all over my body at different body sites and different times. Extremely itchy welts of varying sizes. This is the second time I've experienced this. The first was after my second shot in 2021 I believe. Both times Moderna.  I also experienced something that i can't say is related or not just a day or two after the vaccine thist time.  I sneezed for 36 hours straight - i have never experienced such severe sneezing in my life.  It resolved about 48 hours later.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia
Clinical narrative: patient received new comirnaty vaccine on 9/30 and stated that he has no memory of the time between 5pm on 9/30/23 and 3pm on 10/1/23.  he states that he remembers everything since around 3pm on 10/1/23 to our conversation around 12pm today, 10/2/23.  he did not report any other issues other than not being  able to remember that time period and feeling as though he was in a "blacked out state"
Age: 40.0
Sex: F
Vaccine: FLU4, HEPA, IPV, PNC20, TDAP, VARCEL
Symptoms: Hypoaesthesia, Injection site hypoaesthesia
Clinical narrative: Numbness to (R) arm from shoulder to finger tips - taken Advil
Age: 0.17
Sex: F
Vaccine: PNC15
Symptoms: Urticaria
Clinical narrative: Parents report hives approx 6 hours after injection, that resolved without medication prior to arrival at ED.
Age: 60.0
Sex: M
Vaccine: PNC20
Symptoms: Chest X-ray normal, Chills, Cough, Fatigue, Headache
Clinical narrative: 36 hours later - Shake, fever, chills, achy, fatigue, cough, sore throat, headache. Tylenol and sleep. Still with symptoms.
Age: 60.0
Sex: M
Vaccine: PNC20
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Streptococcus test negative, Tremor
Clinical narrative: 36 hours later - Shake, fever, chills, achy, fatigue, cough, sore throat, headache. Tylenol and sleep. Still with symptoms.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Moderna monovalent vaccine Lot # 015B22A expired on 2.12.22. The vaccine was administered to two patients on 2.13.22/Dose administered after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna monovalent vaccine Lot # 015B22A expired on 2.12.22. The vaccine was administered to two patients on 2.13.22/Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 41-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 13-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna monovalent vaccine Lot # 015B22A expired on 2.12.22. The vaccine was administered to two patients on 2.13.22/Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna monovalent vaccine Lot # 015B22A expired on 2.12.22. The vaccine was administered to two patients on 2.13.22/Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna monovalent vaccine Lot # 015B22A expired on 2.12.22. The vaccine was administered to two patients on 2.13.22/Dose administered after manufacturer date of expiry).    No concomitant medicine were reported. The Moderna monovalent vaccine was administered to two patients. Date the vial was initially stored in the refrigerator was 13-Feb-2023. Vial did not undergo any temperature excursions. No treatment medicine were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-710741 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710741:Another patient case
Age: 67.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Conjunctival haemorrhage
Clinical narrative: subconjunctival hemorrhage; This spontaneous case was reported by a consumer and describes the occurrence of CONJUNCTIVAL HAEMORRHAGE (subconjunctival hemorrhage) in a 67-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 202F23A) for COVID-19 prophylaxis.     Previously administered products included for Flu vaccination: FLU Shot on 07-Sep-2023. Past adverse reactions to the above products included No adverse event with FLU Shot.    On 23-Sep-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 25-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced CONJUNCTIVAL HAEMORRHAGE (subconjunctival hemorrhage) (seriousness criterion medically significant). At the time of the report, CONJUNCTIVAL HAEMORRHAGE (subconjunctival hemorrhage) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient stated that she received 6 Moderna COVID-19 vaccine so far. First Primary monovalent dose on 12JAN2021 (Lot# 039K20A & Exp. Date: unknown), second Primary monovalent dose on 10FEB2021 (Lot# 030M204 & Exp. Date: unknown), third Monovalent dose (First Booster) on 28OCT2021 (Lot# 039F21A & Exp. Date unknown), fourth Monovalent dose (second Booster) on 06MAY2022 (Lot# 038A22A & Exp. Date: unknown), fifth Bivalent Booster on 13DEC2022 (Lot# 043H22A & Exp. Date: unknown). On 25SEP2023 morning, patient woke up with Subconjunctival Hemorrhage in the right eye same side as vaccine injection. She sent pictures to her doctor and doctor confirmed Subconjunctival Hemorrhage. The doctor could not see her on 25SEP2023. Treatment information was not reported.  Company Comment This spontaneous case concerns a 67-years-old-female patient, with medical history of FLU Shot on 07-Sep-2023 and several doses of moderna Covid-19 vaccine who experienced the seriousness criterion medically significant event of conjunctival haemorrhage 2 days after 6th. dose SPIKEVAX 2023-2024 PFS vaccine. Concomitant medication details nor Treatment details were reported. The benefit-risk relationship of SPIKEVAX 2023-2024 PFS vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-741893 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Sep-2023: Live follow-up received, and no new significant information added. On 25-Sep-2023: Live follow-up received, and Batch/lot number added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741893:Different patient same reporter (Neighbours case)
Age: 67.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Conjunctival haemorrhage, No reaction on previous exposure to drug
Clinical narrative: subconjunctival hemorrhage; This spontaneous case was reported by a consumer and describes the occurrence of CONJUNCTIVAL HAEMORRHAGE (subconjunctival hemorrhage) in a 67-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 202F23A) for COVID-19 prophylaxis.     Previously administered products included for Flu vaccination: FLU Shot on 07-Sep-2023. Past adverse reactions to the above products included No adverse event with FLU Shot.    On 23-Sep-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 25-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced CONJUNCTIVAL HAEMORRHAGE (subconjunctival hemorrhage) (seriousness criterion medically significant). At the time of the report, CONJUNCTIVAL HAEMORRHAGE (subconjunctival hemorrhage) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient stated that she received 6 Moderna COVID-19 vaccine so far. First Primary monovalent dose on 12JAN2021 (Lot# 039K20A & Exp. Date: unknown), second Primary monovalent dose on 10FEB2021 (Lot# 030M204 & Exp. Date: unknown), third Monovalent dose (First Booster) on 28OCT2021 (Lot# 039F21A & Exp. Date unknown), fourth Monovalent dose (second Booster) on 06MAY2022 (Lot# 038A22A & Exp. Date: unknown), fifth Bivalent Booster on 13DEC2022 (Lot# 043H22A & Exp. Date: unknown). On 25SEP2023 morning, patient woke up with Subconjunctival Hemorrhage in the right eye same side as vaccine injection. She sent pictures to her doctor and doctor confirmed Subconjunctival Hemorrhage. The doctor could not see her on 25SEP2023. Treatment information was not reported.  Company Comment This spontaneous case concerns a 67-years-old-female patient, with medical history of FLU Shot on 07-Sep-2023 and several doses of moderna Covid-19 vaccine who experienced the seriousness criterion medically significant event of conjunctival haemorrhage 2 days after 6th. dose SPIKEVAX 2023-2024 PFS vaccine. Concomitant medication details nor Treatment details were reported. The benefit-risk relationship of SPIKEVAX 2023-2024 PFS vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-741893 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Sep-2023: Live follow-up received, and no new significant information added. On 25-Sep-2023: Live follow-up received, and Batch/lot number added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741893:Different patient same reporter (Neighbours case)
Age: 61.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Injection site mass, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: 35 hours later the site is still red, swollen, hard & still itchy; the site was very itchy, raised (size of a quarter) & red; the site was very itchy, raised (size of a quarter) & red; the site was very itchy, raised (size of a quarter) & red; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 at 13:15 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "allergies: Sulpha" (unspecified if ongoing). Concomitant medication(s) included: D3. Past drug history included: Keflex, reaction(s): "allergies: Keflex". The following information was reported: VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 26Sep2023 at 14:30, outcome "not recovered" and all described as "the site was very itchy, raised (size of a quarter) & red"; VACCINATION SITE INDURATION (non-serious) with onset 28Sep2023, outcome "not recovered", described as "35 hours later the site is still red, swollen, hard & still itchy". Therapeutic measures were not taken as a result of vaccination site pruritus, vaccination site swelling, vaccination site erythema, vaccination site induration.  Additional Information: About an hour after injection the site was very itchy, raised (size of a quarter) & red. A couple of hours after injection there was a white raised area trailing down from site. 35 hours later the site is still red, swollen, hard & still itchy. The red swollen area is about the size of a silver dollar now.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Injection site warmth
Clinical narrative: 35 hours later the site is still red, swollen, hard & still itchy; the site was very itchy, raised (size of a quarter) & red; the site was very itchy, raised (size of a quarter) & red; the site was very itchy, raised (size of a quarter) & red; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 at 13:15 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "allergies: Sulpha" (unspecified if ongoing). Concomitant medication(s) included: D3. Past drug history included: Keflex, reaction(s): "allergies: Keflex". The following information was reported: VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 26Sep2023 at 14:30, outcome "not recovered" and all described as "the site was very itchy, raised (size of a quarter) & red"; VACCINATION SITE INDURATION (non-serious) with onset 28Sep2023, outcome "not recovered", described as "35 hours later the site is still red, swollen, hard & still itchy". Therapeutic measures were not taken as a result of vaccination site pruritus, vaccination site swelling, vaccination site erythema, vaccination site induration.  Additional Information: About an hour after injection the site was very itchy, raised (size of a quarter) & red. A couple of hours after injection there was a white raised area trailing down from site. 35 hours later the site is still red, swollen, hard & still itchy. The red swollen area is about the size of a silver dollar now.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: 35 hours later the site is still red, swollen, hard & still itchy; the site was very itchy, raised (size of a quarter) & red; the site was very itchy, raised (size of a quarter) & red; the site was very itchy, raised (size of a quarter) & red; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 at 13:15 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "allergies: Sulpha" (unspecified if ongoing). Concomitant medication(s) included: D3. Past drug history included: Keflex, reaction(s): "allergies: Keflex". The following information was reported: VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 26Sep2023 at 14:30, outcome "not recovered" and all described as "the site was very itchy, raised (size of a quarter) & red"; VACCINATION SITE INDURATION (non-serious) with onset 28Sep2023, outcome "not recovered", described as "35 hours later the site is still red, swollen, hard & still itchy". Therapeutic measures were not taken as a result of vaccination site pruritus, vaccination site swelling, vaccination site erythema, vaccination site induration.  Additional Information: About an hour after injection the site was very itchy, raised (size of a quarter) & red. A couple of hours after injection there was a white raised area trailing down from site. 35 hours later the site is still red, swollen, hard & still itchy. The red swollen area is about the size of a silver dollar now.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.