chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Nervousness, Pain
Clinical narrative: Twelve hours post-injection, fever, chills, fatigue, shakey, aches. Continued for 23 hours and counting. Injection site pain moderate for 20 hours.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Twelve hours post-injection, fever, chills, fatigue, shakey, aches. Continued for 23 hours and counting. Injection site pain moderate for 20 hours.
Age: 26.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Pain in extremity, Pallor, Peripheral coldness, Skin discolouration
Clinical narrative: At 12 PM I got my annual flu vaccine in my left arm at 11:50 AM and only symptom was injection site soreneds prior to COVID-19 Comirnaty vaccination  At 3:30 PM, I got my COVID-19 Comirnaty vaccine and before I even left the facility at 4:00 I became cold to the touch (hands, fingers, wrists arms, toes, feet, ears, nose, lower legs, around the eyes, cheeks) and skin turned pale and a purple hue in these regions. It has almost been a week and I am still cold to the touch in these areas just 30 min after vaccination and a sore arm on that side too.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Dizziness, Hyperhidrosis, Immediate post-injection reaction, Joint hyperextension
Clinical narrative: Patient was given covid vaccination (spikeVax). After vaccination patient immediately complained that he was feeling dizzy. Patient was responsive and stated that he feels this way when he gets his blood drawn, but had never experineced it after vaccinations. Patient was being monitored by the pharmacist in the IMZ room while in as he was seated in the chair.  Pharmacist continued to talk to patient for a few minutes. He kept responding and said he was going to be ok. Patient became very pale and sweaty but could hear him talk very faintly. Pharmacist informed Staff to call EMT and notify managment immediately. EMT was notified by staff at 5:42 pm. Patient suddenly lost conciousness, and had unconrolled urination and would not respond back.His symptoms appeared to be seizure like, body shakes and hyperflexion of arms.Shortly after Patient gained conciousness again, and became responsing was able to talk to the pharmacist. Pharmacist measured patients BP 105/65 HR 93 (5:45pm) and Blood Glucose 92(5:47PM) . Emt Arrived at the pharmacy at 5:48 and evaluated patient. Patinet was responsive and answered all the questions emt asked, he was then taken to the hospital for further follow up . Patient was  seated in the IMZ chair the entire time, and there was no incidence of patient falling or injury. Furthermore there was no signs of rash or allergic reaction.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Pallor, Seizure like phenomena, Tremor, Unresponsive to stimuli
Clinical narrative: Patient was given covid vaccination (spikeVax). After vaccination patient immediately complained that he was feeling dizzy. Patient was responsive and stated that he feels this way when he gets his blood drawn, but had never experineced it after vaccinations. Patient was being monitored by the pharmacist in the IMZ room while in as he was seated in the chair.  Pharmacist continued to talk to patient for a few minutes. He kept responding and said he was going to be ok. Patient became very pale and sweaty but could hear him talk very faintly. Pharmacist informed Staff to call EMT and notify managment immediately. EMT was notified by staff at 5:42 pm. Patient suddenly lost conciousness, and had unconrolled urination and would not respond back.His symptoms appeared to be seizure like, body shakes and hyperflexion of arms.Shortly after Patient gained conciousness again, and became responsing was able to talk to the pharmacist. Pharmacist measured patients BP 105/65 HR 93 (5:45pm) and Blood Glucose 92(5:47PM) . Emt Arrived at the pharmacy at 5:48 and evaluated patient. Patinet was responsive and answered all the questions emt asked, he was then taken to the hospital for further follow up . Patient was  seated in the IMZ chair the entire time, and there was no incidence of patient falling or injury. Furthermore there was no signs of rash or allergic reaction.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary incontinence
Clinical narrative: Patient was given covid vaccination (spikeVax). After vaccination patient immediately complained that he was feeling dizzy. Patient was responsive and stated that he feels this way when he gets his blood drawn, but had never experineced it after vaccinations. Patient was being monitored by the pharmacist in the IMZ room while in as he was seated in the chair.  Pharmacist continued to talk to patient for a few minutes. He kept responding and said he was going to be ok. Patient became very pale and sweaty but could hear him talk very faintly. Pharmacist informed Staff to call EMT and notify managment immediately. EMT was notified by staff at 5:42 pm. Patient suddenly lost conciousness, and had unconrolled urination and would not respond back.His symptoms appeared to be seizure like, body shakes and hyperflexion of arms.Shortly after Patient gained conciousness again, and became responsing was able to talk to the pharmacist. Pharmacist measured patients BP 105/65 HR 93 (5:45pm) and Blood Glucose 92(5:47PM) . Emt Arrived at the pharmacy at 5:48 and evaluated patient. Patinet was responsive and answered all the questions emt asked, he was then taken to the hospital for further follow up . Patient was  seated in the IMZ chair the entire time, and there was no incidence of patient falling or injury. Furthermore there was no signs of rash or allergic reaction.
Age: 84.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient was requesting a few vaccines, ultimately settling on TDAP and pneumonia 20. However, rsv and tdap was written on the release form, and given at administration. This was his 2nd rsv vaccination in just over a month.  the patent realized the mistake the next day. The patient reports no adverse reaction.
Age: 74.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Chills, Feeling abnormal, Headache, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Within minutes of injections of both shots felt odd in the head followed by peripheral numbness left side of head which progressed to the left lip area.  The following days had headaches, the need to nap or nod off frequently, occasional chills and just not felling normal.
Age: 74.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Increased need for sleep, Sensory disturbance
Clinical narrative: Within minutes of injections of both shots felt odd in the head followed by peripheral numbness left side of head which progressed to the left lip area.  The following days had headaches, the need to nap or nod off frequently, occasional chills and just not felling normal.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Mass
Clinical narrative: Patient had a sand dollar size lump form shortly after injection, and has had pain at injection site since. Has had difficulty moving arm. Vaccine may have been administered too high up on the shoulder. Patient following up with primary care md, will try to manage with over the counter treatment options.
Age: 0.4
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Hypophagia, Pallor, Sleep apnoea syndrome
Clinical narrative: Mom reported today (10/5/23) at time of 2 mo. visit after receiving vaccines all extremities turned pale and stayed that way 5-10 min. Mom stated baby was sleepy for 3D and did not eat well. This incident was not documented in chart and nurse had no recollection of being notified no phone calls were received following. Mom refused vaccines at todays visit.
Age: 0.4
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Decreased appetite, Pallor, Somnolence
Clinical narrative: Mom reported today (10/5/23) at time of 2 mo. visit after receiving vaccines all extremities turned pale and stayed that way 5-10 min. Mom stated baby was sleepy for 3D and did not eat well. This incident was not documented in chart and nurse had no recollection of being notified no phone calls were received following. Mom refused vaccines at todays visit.
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: sore left arm; body aches; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm), PAIN (body aches), HEADACHE (headache) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7148B and 033K21-2A) for COVID-19 prophylaxis.     The patient's past medical history included Autoimmune disorder in 2005, Arthropod bite in 2005 and Lyme disease (with MS Symptoms).   On 05-Apr-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Sep-2022, received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore left arm), PAIN (body aches), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (sore left arm), PAIN (body aches), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.   Treatment medication not reported.  The patient was on blood pressure medication.  The patient received her fourth vaccine on 05-Apr-2022 vaccine listed as Spikevax moderna on the card lot number 033K21-2A expiration date 20-May-2022. Patient received the vaccine in her left arm. Patient had a sore left arm, body aches, headache, and fatigue. The patient received her fifth vaccine on 13-Sep-2022 vaccine listed as Moderna Bivalent Spikevax lot number AS7148B expiration date is not known. Patient received the vaccine in her left arm. Patient had a sore left arm, body aches, headache, and fatigue.   This case was linked to US-MODERNATX, INC.-MOD-2023-744170 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-744170:case
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Deep vein thrombosis
Clinical narrative: DVT/PE and CHF, symptom onset per documentation 1-2 days prior to vaccination, was seen in and treated in ED and during hospitalization  3 days after vaccination
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Atrophy, Balance disorder, Carpal tunnel syndrome, Cubital tunnel syndrome, Fall
Clinical narrative: Painful swollen arm then paralysis lasting now after seeking many many dr appts & ex rays .. MRI?s? blood tests? pain & 4 rounds of pt.. neurologist & nuero surgeon  have ruled out several diseases but paralysis is spreading to left leg now. Was just left arm & hand but? getting worse!
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site bruising, Injection site discolouration, Injection site indentation
Clinical narrative: Painful swollen arm then paralysis lasting now after seeking many many dr appts & ex rays .. MRI?s? blood tests? pain & 4 rounds of pt.. neurologist & nuero surgeon  have ruled out several diseases but paralysis is spreading to left leg now. Was just left arm & hand but? getting worse!
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities, Monoplegia, Muscle spasticity, Musculoskeletal disorder
Clinical narrative: Painful swollen arm then paralysis lasting now after seeking many many dr appts & ex rays .. MRI?s? blood tests? pain & 4 rounds of pt.. neurologist & nuero surgeon  have ruled out several diseases but paralysis is spreading to left leg now. Was just left arm & hand but? getting worse!
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nerve conduction studies abnormal, Pain, Pain in extremity, Periarthritis, Ulnar nerve injury
Clinical narrative: Painful swollen arm then paralysis lasting now after seeking many many dr appts & ex rays .. MRI?s? blood tests? pain & 4 rounds of pt.. neurologist & nuero surgeon  have ruled out several diseases but paralysis is spreading to left leg now. Was just left arm & hand but? getting worse!
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Weight decreased, Wrong technique in product usage process, X-ray abnormal
Clinical narrative: Painful swollen arm then paralysis lasting now after seeking many many dr appts & ex rays .. MRI?s? blood tests? pain & 4 rounds of pt.. neurologist & nuero surgeon  have ruled out several diseases but paralysis is spreading to left leg now. Was just left arm & hand but? getting worse!
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Electromyogram, Magnetic resonance imaging spinal, Monoplegia, Nerve conduction studies
Clinical narrative: Painful swollen arm then paralysis lasting now after seeking many many dr appts & ex rays .. MRI?s? blood tests? pain & 4 rounds of pt.. neurologist & nuero surgeon  have ruled out several diseases but paralysis is spreading to left leg now. Was just left arm & hand but? getting worse!
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Painful swollen arm then paralysis lasting now after seeking many many dr appts & ex rays .. MRI?s? blood tests? pain & 4 rounds of pt.. neurologist & nuero surgeon  have ruled out several diseases but paralysis is spreading to left leg now. Was just left arm & hand but? getting worse!
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Sex: U
Vaccine: COVID19-2, COVID19
Symptoms: Blood test, Platelet count, Thrombocytopenia
Clinical narrative: end up admitted to hospital with ITP; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Jul2023 as dose number unknown, 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: IMMUNE THROMBOCYTOPENIA (hospitalization) with onset 2023, 5 weeks after the suspect product(s) administration, outcome "unknown", described as "end up admitted to hospital with ITP". The patient was hospitalized for immune thrombocytopenia (start date: 05Sep2023, discharge date: 2023). The event "end up admitted to hospital with itp" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Platelet count: 53,000. Clinical course: The patient had the COVID vaccine on 25Jul and 5 weeks later end up admitted to hospital with ITP (Immune thrombocytopenia) from 05Sep2023 and discharged, the 2 more ER (Emergency Room) visits after that platelets then 53,000 had to had blood work every week and patient's hematologist will decide the medication patient need. All this because of COVID vaccine. It was also reported that patient discharged on 11Sep2024.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19-2, COVID19
Symptoms: Immune thrombocytopenia, Platelet count
Clinical narrative: end up admitted to hospital with ITP; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Jul2023 as dose number unknown, 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: IMMUNE THROMBOCYTOPENIA (hospitalization) with onset 2023, 5 weeks after the suspect product(s) administration, outcome "unknown", described as "end up admitted to hospital with ITP". The patient was hospitalized for immune thrombocytopenia (start date: 05Sep2023, discharge date: 2023). The event "end up admitted to hospital with itp" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Platelet count: 53,000. Clinical course: The patient had the COVID vaccine on 25Jul and 5 weeks later end up admitted to hospital with ITP (Immune thrombocytopenia) from 05Sep2023 and discharged, the 2 more ER (Emergency Room) visits after that platelets then 53,000 had to had blood work every week and patient's hematologist will decide the medication patient need. All this because of COVID vaccine. It was also reported that patient discharged on 11Sep2024.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 76.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Arthralgia, Back pain, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Pain at injection site; Swollen at injection site; Solid red patch on arm /Skin red; Itching red patches; Joint pain; Muscle pain/muscle aches in her back and legs; Fatigue; Area hot to touch; painful upper arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included diabetes.   On 29-SEP-2023, the patient received Arexvy (intramuscular, left arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: Pain at injection site), injection site swelling (Verbatim: Swollen at injection site), erythema (Verbatim: Solid red patch on arm /Skin red), pruritus (Verbatim: Itching red patches), joint pain (Verbatim: Joint pain), muscle pain (Verbatim: Muscle pain/muscle aches in her back and legs), fatigue (Verbatim: Fatigue), feeling hot (Verbatim: Area hot to touch) and pain in arm (Verbatim: painful upper arm).The outcome of the injection site pain, injection site swelling, erythema and pruritus were not resolved and the outcome of the joint pain, muscle pain, fatigue and feeling hot were unknown and the outcome of the pain in arm was resolving.   It was unknown if the reporter considered the injection site pain, injection site swelling, erythema, pruritus, joint pain, muscle pain, fatigue, feeling hot and pain in arm to be related to Arexvy.     It was unknown if the company considered the injection site pain, injection site swelling, erythema, pruritus, joint pain, muscle pain, fatigue, feeling hot and pain in arm to be related to Arexvy.   Additional Information: GSK receipt date: 04-OCT-2023 The reporter was the patient.  The Lot and expiration date were not available but patient provided the NDC number for the vaccine. The patient reported that she was administered the Arexvy vaccine on Friday at a local pharmacy. The patient reported that she was a diabetic and took medications for this.  She had taken many vaccines in the past 5 years and had mild common reactions but not as with the Arexvy vaccine.  The patient reported that the vaccine was injected in the left arm.  The patient reported that one (1) inch below the injection site it there were red patches that had been expanding and growing from ½ a dollar size and now was to a huge red 3X4 inches patch that it itching. The patient reported that feeling very fatigue, muscle aches in her back and legs and joint pain.  The patient reported that swelling at the injection site, painful injection site and hot to touch and solid red patch on the arm that had expanded and she had pain in the upper arm.  The patient reported that she took pictures and shared with her health care provider (HCP). The patient reported that at the time of reporting it was still red, itches, and sore and swollen but the pain was diminishing.  It had not been resolved. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Injection site swelling, Injection site warmth, Myalgia, Pain, Pain in extremity
Clinical narrative: Pain at injection site; Swollen at injection site; Solid red patch on arm /Skin red; Itching red patches; Joint pain; Muscle pain/muscle aches in her back and legs; Fatigue; Area hot to touch; painful upper arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included diabetes.   On 29-SEP-2023, the patient received Arexvy (intramuscular, left arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: Pain at injection site), injection site swelling (Verbatim: Swollen at injection site), erythema (Verbatim: Solid red patch on arm /Skin red), pruritus (Verbatim: Itching red patches), joint pain (Verbatim: Joint pain), muscle pain (Verbatim: Muscle pain/muscle aches in her back and legs), fatigue (Verbatim: Fatigue), feeling hot (Verbatim: Area hot to touch) and pain in arm (Verbatim: painful upper arm).The outcome of the injection site pain, injection site swelling, erythema and pruritus were not resolved and the outcome of the joint pain, muscle pain, fatigue and feeling hot were unknown and the outcome of the pain in arm was resolving.   It was unknown if the reporter considered the injection site pain, injection site swelling, erythema, pruritus, joint pain, muscle pain, fatigue, feeling hot and pain in arm to be related to Arexvy.     It was unknown if the company considered the injection site pain, injection site swelling, erythema, pruritus, joint pain, muscle pain, fatigue, feeling hot and pain in arm to be related to Arexvy.   Additional Information: GSK receipt date: 04-OCT-2023 The reporter was the patient.  The Lot and expiration date were not available but patient provided the NDC number for the vaccine. The patient reported that she was administered the Arexvy vaccine on Friday at a local pharmacy. The patient reported that she was a diabetic and took medications for this.  She had taken many vaccines in the past 5 years and had mild common reactions but not as with the Arexvy vaccine.  The patient reported that the vaccine was injected in the left arm.  The patient reported that one (1) inch below the injection site it there were red patches that had been expanding and growing from ½ a dollar size and now was to a huge red 3X4 inches patch that it itching. The patient reported that feeling very fatigue, muscle aches in her back and legs and joint pain.  The patient reported that swelling at the injection site, painful injection site and hot to touch and solid red patch on the arm that had expanded and she had pain in the upper arm.  The patient reported that she took pictures and shared with her health care provider (HCP). The patient reported that at the time of reporting it was still red, itches, and sore and swollen but the pain was diminishing.  It had not been resolved. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Pain at injection site; Swollen at injection site; Solid red patch on arm /Skin red; Itching red patches; Joint pain; Muscle pain/muscle aches in her back and legs; Fatigue; Area hot to touch; painful upper arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included diabetes.   On 29-SEP-2023, the patient received Arexvy (intramuscular, left arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: Pain at injection site), injection site swelling (Verbatim: Swollen at injection site), erythema (Verbatim: Solid red patch on arm /Skin red), pruritus (Verbatim: Itching red patches), joint pain (Verbatim: Joint pain), muscle pain (Verbatim: Muscle pain/muscle aches in her back and legs), fatigue (Verbatim: Fatigue), feeling hot (Verbatim: Area hot to touch) and pain in arm (Verbatim: painful upper arm).The outcome of the injection site pain, injection site swelling, erythema and pruritus were not resolved and the outcome of the joint pain, muscle pain, fatigue and feeling hot were unknown and the outcome of the pain in arm was resolving.   It was unknown if the reporter considered the injection site pain, injection site swelling, erythema, pruritus, joint pain, muscle pain, fatigue, feeling hot and pain in arm to be related to Arexvy.     It was unknown if the company considered the injection site pain, injection site swelling, erythema, pruritus, joint pain, muscle pain, fatigue, feeling hot and pain in arm to be related to Arexvy.   Additional Information: GSK receipt date: 04-OCT-2023 The reporter was the patient.  The Lot and expiration date were not available but patient provided the NDC number for the vaccine. The patient reported that she was administered the Arexvy vaccine on Friday at a local pharmacy. The patient reported that she was a diabetic and took medications for this.  She had taken many vaccines in the past 5 years and had mild common reactions but not as with the Arexvy vaccine.  The patient reported that the vaccine was injected in the left arm.  The patient reported that one (1) inch below the injection site it there were red patches that had been expanding and growing from ½ a dollar size and now was to a huge red 3X4 inches patch that it itching. The patient reported that feeling very fatigue, muscle aches in her back and legs and joint pain.  The patient reported that swelling at the injection site, painful injection site and hot to touch and solid red patch on the arm that had expanded and she had pain in the upper arm.  The patient reported that she took pictures and shared with her health care provider (HCP). The patient reported that at the time of reporting it was still red, itches, and sore and swollen but the pain was diminishing.  It had not been resolved. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Arthralgia, Back pain, Erythema, Fatigue, Feeling hot
Clinical narrative: Pain at injection site; Swollen at injection site; Solid red patch on arm /Skin red; Itching red patches; Joint pain; Muscle pain/muscle aches in her back and legs; Fatigue; Area hot to touch; painful upper arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included diabetes.   On 29-SEP-2023, the patient received Arexvy (intramuscular, left arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: Pain at injection site), injection site swelling (Verbatim: Swollen at injection site), erythema (Verbatim: Solid red patch on arm /Skin red), pruritus (Verbatim: Itching red patches), joint pain (Verbatim: Joint pain), muscle pain (Verbatim: Muscle pain/muscle aches in her back and legs), fatigue (Verbatim: Fatigue), feeling hot (Verbatim: Area hot to touch) and pain in arm (Verbatim: painful upper arm).The outcome of the injection site pain, injection site swelling, erythema and pruritus were not resolved and the outcome of the joint pain, muscle pain, fatigue and feeling hot were unknown and the outcome of the pain in arm was resolving.   It was unknown if the reporter considered the injection site pain, injection site swelling, erythema, pruritus, joint pain, muscle pain, fatigue, feeling hot and pain in arm to be related to Arexvy.     It was unknown if the company considered the injection site pain, injection site swelling, erythema, pruritus, joint pain, muscle pain, fatigue, feeling hot and pain in arm to be related to Arexvy.   Additional Information: GSK receipt date: 04-OCT-2023 The reporter was the patient.  The Lot and expiration date were not available but patient provided the NDC number for the vaccine. The patient reported that she was administered the Arexvy vaccine on Friday at a local pharmacy. The patient reported that she was a diabetic and took medications for this.  She had taken many vaccines in the past 5 years and had mild common reactions but not as with the Arexvy vaccine.  The patient reported that the vaccine was injected in the left arm.  The patient reported that one (1) inch below the injection site it there were red patches that had been expanding and growing from ½ a dollar size and now was to a huge red 3X4 inches patch that it itching. The patient reported that feeling very fatigue, muscle aches in her back and legs and joint pain.  The patient reported that swelling at the injection site, painful injection site and hot to touch and solid red patch on the arm that had expanded and she had pain in the upper arm.  The patient reported that she took pictures and shared with her health care provider (HCP). The patient reported that at the time of reporting it was still red, itches, and sore and swollen but the pain was diminishing.  It had not been resolved. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Pain at injection site; Swollen at injection site; Solid red patch on arm /Skin red; Itching red patches; Joint pain; Muscle pain/muscle aches in her back and legs; Fatigue; Area hot to touch; painful upper arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included diabetes.   On 29-SEP-2023, the patient received Arexvy (intramuscular, left arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: Pain at injection site), injection site swelling (Verbatim: Swollen at injection site), erythema (Verbatim: Solid red patch on arm /Skin red), pruritus (Verbatim: Itching red patches), joint pain (Verbatim: Joint pain), muscle pain (Verbatim: Muscle pain/muscle aches in her back and legs), fatigue (Verbatim: Fatigue), feeling hot (Verbatim: Area hot to touch) and pain in arm (Verbatim: painful upper arm).The outcome of the injection site pain, injection site swelling, erythema and pruritus were not resolved and the outcome of the joint pain, muscle pain, fatigue and feeling hot were unknown and the outcome of the pain in arm was resolving.   It was unknown if the reporter considered the injection site pain, injection site swelling, erythema, pruritus, joint pain, muscle pain, fatigue, feeling hot and pain in arm to be related to Arexvy.     It was unknown if the company considered the injection site pain, injection site swelling, erythema, pruritus, joint pain, muscle pain, fatigue, feeling hot and pain in arm to be related to Arexvy.   Additional Information: GSK receipt date: 04-OCT-2023 The reporter was the patient.  The Lot and expiration date were not available but patient provided the NDC number for the vaccine. The patient reported that she was administered the Arexvy vaccine on Friday at a local pharmacy. The patient reported that she was a diabetic and took medications for this.  She had taken many vaccines in the past 5 years and had mild common reactions but not as with the Arexvy vaccine.  The patient reported that the vaccine was injected in the left arm.  The patient reported that one (1) inch below the injection site it there were red patches that had been expanding and growing from ½ a dollar size and now was to a huge red 3X4 inches patch that it itching. The patient reported that feeling very fatigue, muscle aches in her back and legs and joint pain.  The patient reported that swelling at the injection site, painful injection site and hot to touch and solid red patch on the arm that had expanded and she had pain in the upper arm.  The patient reported that she took pictures and shared with her health care provider (HCP). The patient reported that at the time of reporting it was still red, itches, and sore and swollen but the pain was diminishing.  It had not been resolved. The reporter consented to follow up.
Age: 5.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Wrong product administered
Clinical narrative: It is unclear if patient received adult RSV by accident or Flu vaccination as her brother was also present and one received each shot before it was known that this was wrongly given at an outside clinic site in the local community (suppose to receive seasonal Flu)  (we are unclear exactly which RSV she might have received). Mom was told that patient was the one who likely received the RSV vaccine.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Facial spasm, Gastrointestinal pain, Muscle tightness, Neck pain, Pyrexia
Clinical narrative: I have developed symptoms of tetanus after receiving the covid 19 vaccine.; My symptoms include jaw contraction/Jaw spasm; stomach spasms; severe neck pain; fever; facial spasms; high blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: TETANUS (medically significant), outcome "unknown", described as "I have developed symptoms of tetanus after receiving the covid 19 vaccine."; TRISMUS (medically significant), outcome "unknown", described as "My symptoms include jaw contraction/Jaw spasm"; ABDOMINAL PAIN UPPER (medically significant), outcome "unknown", described as "stomach spasms"; NECK PAIN (medically significant), outcome "unknown", described as "severe neck pain"; PYREXIA (medically significant), outcome "unknown", described as "fever"; FACIAL SPASM (medically significant), outcome "unknown", described as "facial spasms"; HYPERTENSION (medically significant), outcome "unknown", described as "high blood pressure". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High. Clinical course: Patient had developed symptoms of tetanus after recieving the covid 19 vaccine. Patient symptoms include jaw contraction, stomach spasms, severe neck pain, fever, high blood pressure, facial spasms.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tetanus
Clinical narrative: I have developed symptoms of tetanus after receiving the covid 19 vaccine.; My symptoms include jaw contraction/Jaw spasm; stomach spasms; severe neck pain; fever; facial spasms; high blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: TETANUS (medically significant), outcome "unknown", described as "I have developed symptoms of tetanus after receiving the covid 19 vaccine."; TRISMUS (medically significant), outcome "unknown", described as "My symptoms include jaw contraction/Jaw spasm"; ABDOMINAL PAIN UPPER (medically significant), outcome "unknown", described as "stomach spasms"; NECK PAIN (medically significant), outcome "unknown", described as "severe neck pain"; PYREXIA (medically significant), outcome "unknown", described as "fever"; FACIAL SPASM (medically significant), outcome "unknown", described as "facial spasms"; HYPERTENSION (medically significant), outcome "unknown", described as "high blood pressure". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High. Clinical course: Patient had developed symptoms of tetanus after recieving the covid 19 vaccine. Patient symptoms include jaw contraction, stomach spasms, severe neck pain, fever, high blood pressure, facial spasms.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Seizure, Vomiting
Clinical narrative: I have developed symptoms of tetanus after receiving the covid 19 vaccine.; My symptoms include jaw contraction/Jaw spasm; stomach spasms; severe neck pain; fever; facial spasms; high blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: TETANUS (medically significant), outcome "unknown", described as "I have developed symptoms of tetanus after receiving the covid 19 vaccine."; TRISMUS (medically significant), outcome "unknown", described as "My symptoms include jaw contraction/Jaw spasm"; ABDOMINAL PAIN UPPER (medically significant), outcome "unknown", described as "stomach spasms"; NECK PAIN (medically significant), outcome "unknown", described as "severe neck pain"; PYREXIA (medically significant), outcome "unknown", described as "fever"; FACIAL SPASM (medically significant), outcome "unknown", described as "facial spasms"; HYPERTENSION (medically significant), outcome "unknown", described as "high blood pressure". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High. Clinical course: Patient had developed symptoms of tetanus after recieving the covid 19 vaccine. Patient symptoms include jaw contraction, stomach spasms, severe neck pain, fever, high blood pressure, facial spasms.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.