chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 90-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CHF" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Stage 3 renal failure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive, notes: Got COVID end of Jan2023. Therapeutic measures were taken as a result of drug ineffective, covid-19. 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.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162b2, BNT162b2 omi ba.4-5 in this patient cannot be completely excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: el9264), on 23Feb2021 as dose 2, single (Lot number: en6201), in right arm, on 21Oct2021 as dose 3 (booster), single (Lot number: fh8020), in right arm and on 22Jul2022 as dose 4 (booster), single (Lot number: fp7100), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin, shell fish; "Known allergies: shell fish" (unspecified if ongoing), notes: Known allergies: penicillin, shell fish. Concomitant medication(s) included: LIPITOR, start date: 01Jan2000, stop date: 24Aug2023; PROZAC, start date: 01Jan2000; D3, start date: 01Jan2000; B12 [CYANOCOBALAMIN], start date: 01Jan2000; FISH OIL, start date: 01Jan2000; CALCIUM 600 + D, start date: 01Jan2000. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Aug2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Aug2023) positive, notes: I tested positive for COVID on Friday; (04Sep2023) Negative, notes: Tested negative for COVID on 04Sep; (06Sep2023) positive, notes: tested positive for COVID 06Sep2023. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient took Paxlovid from 25Aug2023 to 30Aug2023.  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: 1.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Syringe issue
Clinical narrative: Majority of vaccine contents leaked out of the syringe as it was being administered. Patient had no complications after vaccine was given.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Head injury, Syncope
Clinical narrative: HPV and Menveo vaccines given by medical assistant, after 2nd vaccine was given patient had syncopal episode and fell off the exam table.  Medical assistant called physician into the room immediately.  Patient was prone on the floor and alert.  (Mother and medical assistant report that patient fell to right side into the wall and then fell onto the floor).  Patient wanted to sit up and sat up slowly.  She sat up on the floor with support.  She appeared pale, but was alert and oriented x3.  She had a faint red spot on her right forehead and no other injury noted.  She reported no pain.  Vitals were collected and monitored until EMS arrived.  Blood pressure was low.  EMS was called and EMS arrived.  EMS monitored her with EKG and blood pressure until ambulance transported her.  She remained stable and alert.  She was transported to the hospital for monitoring.  Parents agreed with this plan.  Reviewed with parent and confirmed patient never had an incident like this before.  Patient's sister has vasovagal episodes with needles, so we suspect this was a similar episode.  Advised parent that this would be considered an adverse event related to the vaccine.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 72.0
Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19-2, COVID19-2
Symptoms: Blindness unilateral, Computerised tomogram, Magnetic resonance imaging, Panic reaction, Visual acuity tests
Clinical narrative: 3 DAYS AFTER MY VACCINATION AT PHARMACY I WOKE UP BLIND IN MY RIGHT EYE. THE WEEK BEFORE I SAW MY OPTOMITRIST FOR MY NEW EYEGLASS PRESCRIPTION. ON THIS MORNING THEY CALLED ME IN THE MIDST OF MY PANIC TO TELL ME MY GLASSES WAS READY TO BE PICKED UP AND I EXPLAINED I WAS BLIND IN MY EYE. THEY SCHEDULED ME IMMEDIATLEY WITHIN 2 HOURS TO SEE MY DOCTOR AGAIN. DR. EXAMINED ME AND HIS ASSOCIATE, HE COLDN'T FIND A BLOCKAGE IN MY EYE AFTER SEVERAL VISUAL TEST AND RECOMMENDED I GO TO THE E.R. IMMEDIATELY FOLLOWING I WENT TO HOSPITAL AND WAS ADMITTED FOR 2 DAYS WITH NO RELIEF.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Swelling
Clinical narrative: Redness and swelling of arm and shoulder and chest
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 39.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Syringe issue
Clinical narrative: Medical assistant states they did not have concerns about the pre-filled gardasil syringe upon attaching safety-glide needle to prepared for administration. Upon medical assistant putting the needle into the patient's L deltoid, as she began attempting to push on the syringe to inject the glass vaccine syringe malfunctioned and the glass broke. The medical assistant was then unable to push the vaccine into the patient's deltoid, and the syringe separated completely from the needle, leaving the safety-glide needle alone in the patient's arm. The medical assistant carefully took the needle out of the patient's deltoid and immediately discarded this needle into the sharps container. There was no immediate adverse effect for this patient (aside from needing to receive a second "injection" with a needle), and this patient then was then administered a subsequently prepared different dose of HPV vaccine without issue during the same visit.  The medical assistant involved immediately reported this to their supervisor.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Confusional state, Dizziness, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: About 5-10 minutes after vaccine was given syncope occurred. I experienced light headedness, extreme diaphoresis, ringing in the both ears, & became pale immediately prior to losing consciousness for about 60 seconds. When I regained consciousness, I still was experiencing diaphoresis, ears ringing,  and I was confused; this lasted about 30 minutes before subsiding.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Syncope, Tinnitus
Clinical narrative: About 5-10 minutes after vaccine was given syncope occurred. I experienced light headedness, extreme diaphoresis, ringing in the both ears, & became pale immediately prior to losing consciousness for about 60 seconds. When I regained consciousness, I still was experiencing diaphoresis, ears ringing,  and I was confused; this lasted about 30 minutes before subsiding.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Malaise
Clinical narrative: Chills, sweats, not feeling well.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Angiogram cerebral normal, Asthenia, Blood lactic acid, Chest X-ray normal, Chills
Clinical narrative: Nausea, generalized weakness, body aches, fever/chills, mumbling and babbling, rapid speech. She felt like she was having a stroke. Started when she woke up the morning after the vaccine was given.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram head normal, Electrocardiogram QRS complex abnormal, Electrocardiogram ST-T segment abnormal, Electrocardiogram abnormal, Feeling abnormal
Clinical narrative: Nausea, generalized weakness, body aches, fever/chills, mumbling and babbling, rapid speech. She felt like she was having a stroke. Started when she woke up the morning after the vaccine was given.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count, Influenza virus test negative, Metabolic function test, Monocyte count, Nausea
Clinical narrative: Nausea, generalized weakness, body aches, fever/chills, mumbling and babbling, rapid speech. She felt like she was having a stroke. Started when she woke up the morning after the vaccine was given.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Neutrophil count, Pain, Perfusion brain scan, Procalcitonin, Pyrexia
Clinical narrative: Nausea, generalized weakness, body aches, fever/chills, mumbling and babbling, rapid speech. She felt like she was having a stroke. Started when she woke up the morning after the vaccine was given.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Scan with contrast normal, Sinus rhythm, Speech disorder
Clinical narrative: Nausea, generalized weakness, body aches, fever/chills, mumbling and babbling, rapid speech. She felt like she was having a stroke. Started when she woke up the morning after the vaccine was given.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Troponin, Urine analysis, White blood cell count increased
Clinical narrative: Nausea, generalized weakness, body aches, fever/chills, mumbling and babbling, rapid speech. She felt like she was having a stroke. Started when she woke up the morning after the vaccine was given.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Gait disturbance, Mobility decreased
Clinical narrative: patient could not get out of bed after several attempts, was able to get to the bathroom from bed ok overnight, she is taking shuffling steps, legs won't straighten
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Fatigue, Pain, Painful respiration, Pyrexia
Clinical narrative: I had fever and body aches , and I was tired. I expected those symptoms, but I didn?t anticipate having chest pain and more pain on inhalation deep to my chest.
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Headache, Hypoaesthesia, Neck pain, Pain in extremity
Clinical narrative: right arm pain, right hand numbness/tingling, headache, right neck and shoulder pain
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Paraesthesia
Clinical narrative: right arm pain, right hand numbness/tingling, headache, right neck and shoulder pain
Age: 56.0
Sex: M
Vaccine: UNK, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There was no actual adverse effect to patient. The error was injection of the vaccine to patient under 60 years of age
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Feeling hot, Paraesthesia
Clinical narrative: Pt got vaccine around 4:30pm. Said he had no history of adverse reaction to vaccines. Left. Came back 30-45 minutes later with complaints of tingling and "feeling warm" in his legs. Monitored pt for 10 minutes. His condition had then spread to tingling all over. Called 911. While waiting for ambulance, pt remembers having this reaction before with vaccines just not as severe and not as soon after. EMTs took him to hospital. Unknown what happened after he left the pharmacy.
Age: 1.5
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Tremor
Clinical narrative: Generalized shaking for > 1 minute, < 5 minute History consistent with simple febrile seizure
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site hypersensitivity, Swelling
Clinical narrative: MMRV given Had injection site allergic reaction vs. significant swelling
Age: 0.08
Sex: F
Vaccine: UNK
Symptoms: CSF white blood cell count, Electrocardiogram abnormal, Full blood count, Lethargy, Pyrexia
Clinical narrative: She was given her two month old vaccines around 930am. Around 6pm the same day exhibited signs of a fever (101.2) and was lethargic - parent called doctors office and was told to take her to the ER. At the ER her fever went to 102.2, and had tachycardia.
Age: 0.08
Sex: F
Vaccine: UNK
Symptoms: Tachycardia, Urine analysis
Clinical narrative: She was given her two month old vaccines around 930am. Around 6pm the same day exhibited signs of a fever (101.2) and was lethargic - parent called doctors office and was told to take her to the ER. At the ER her fever went to 102.2, and had tachycardia.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Hypersensitivity, Injection site reaction, Rash, Swelling face, Urticaria
Clinical narrative: Patient received scheduled childhood izs @ 1100 9/6/23. Had allergic reaction @ 150 9/6/23; presented to my office with left thigh site reaction, diffuse rash with hives (head to toe), facial swelling, and wheezing. No strider or airway compromise, VS WNL. Tx with 25mg IM Benadryl, 5mg PO Dexamethasone, and 0.5ml 2.25/ racepinephrine neb. Monitored & DC home with Rx for prednisone taper, epipen jr, & OTC Benadryl.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Wheezing
Clinical narrative: Patient received scheduled childhood izs @ 1100 9/6/23. Had allergic reaction @ 150 9/6/23; presented to my office with left thigh site reaction, diffuse rash with hives (head to toe), facial swelling, and wheezing. No strider or airway compromise, VS WNL. Tx with 25mg IM Benadryl, 5mg PO Dexamethasone, and 0.5ml 2.25/ racepinephrine neb. Monitored & DC home with Rx for prednisone taper, epipen jr, & OTC Benadryl.
Age: 2.58
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Provider administered covid-19 Bivalent Booster 0.2 mL (NDC 80777-0283-99) instead of Moderna Bivalent dose 0.25 mL (NDC 80777-282-99) as first dose in primary series. No adverse reaction.
Age: 67.0
Sex: M
Vaccine: PNC15, UNK, PNC15
Symptoms: Asthenia, C-reactive protein normal, CSF culture, CSF glucose normal, CSF lymphocyte count increased
Clinical narrative: Patient notice weakness developing in his bilateral lower extremities 2 days prior to arrival in ED (8/11). Admitted 8/13. Diagnosed with GBS. Patient developed respiratory distress 5 days after (8/18) admit requiring intubation, transfer to ICU and plasma phoresis. Extubated 8/29. Currently improved and in neuro unit requiring PT/OT
Age: 67.0
Sex: M
Vaccine: PNC15, UNK, PNC15
Symptoms: CSF protein increased, CSF test abnormal, CSF white blood cell count increased, Depressed level of consciousness, Endotracheal intubation
Clinical narrative: Patient notice weakness developing in his bilateral lower extremities 2 days prior to arrival in ED (8/11). Admitted 8/13. Diagnosed with GBS. Patient developed respiratory distress 5 days after (8/18) admit requiring intubation, transfer to ICU and plasma phoresis. Extubated 8/29. Currently improved and in neuro unit requiring PT/OT
Age: 67.0
Sex: M
Vaccine: PNC15, UNK, PNC15
Symptoms: Fall, Gram stain negative, Head injury, Herpes simplex test negative, Hypoaesthesia
Clinical narrative: Patient notice weakness developing in his bilateral lower extremities 2 days prior to arrival in ED (8/11). Admitted 8/13. Diagnosed with GBS. Patient developed respiratory distress 5 days after (8/18) admit requiring intubation, transfer to ICU and plasma phoresis. Extubated 8/29. Currently improved and in neuro unit requiring PT/OT
Age: 67.0
Sex: M
Vaccine: PNC15, UNK, PNC15
Symptoms: Imaging procedure artifact, Laboratory test normal, Magnetic resonance imaging spinal abnormal, Pain in extremity, Red blood cell sedimentation rate normal
Clinical narrative: Patient notice weakness developing in his bilateral lower extremities 2 days prior to arrival in ED (8/11). Admitted 8/13. Diagnosed with GBS. Patient developed respiratory distress 5 days after (8/18) admit requiring intubation, transfer to ICU and plasma phoresis. Extubated 8/29. Currently improved and in neuro unit requiring PT/OT
Age: 67.0
Sex: M
Vaccine: PNC15, UNK, PNC15
Symptoms: Respiratory disorder, Respiratory failure, Spinal disorder, Spondylolisthesis, Thecal sac compression
Clinical narrative: Patient notice weakness developing in his bilateral lower extremities 2 days prior to arrival in ED (8/11). Admitted 8/13. Diagnosed with GBS. Patient developed respiratory distress 5 days after (8/18) admit requiring intubation, transfer to ICU and plasma phoresis. Extubated 8/29. Currently improved and in neuro unit requiring PT/OT
Age: 67.0
Sex: M
Vaccine: PNC15, UNK, PNC15
Symptoms: Vertebral foraminal stenosis
Clinical narrative: Patient notice weakness developing in his bilateral lower extremities 2 days prior to arrival in ED (8/11). Admitted 8/13. Diagnosed with GBS. Patient developed respiratory distress 5 days after (8/18) admit requiring intubation, transfer to ICU and plasma phoresis. Extubated 8/29. Currently improved and in neuro unit requiring PT/OT
Age: 67.0
Sex: M
Vaccine: PNC15, UNK, PNC15
Symptoms: Endotracheal intubation, Guillain-Barre syndrome, Intensive care, Laboratory test, Lumbar puncture
Clinical narrative: Patient notice weakness developing in his bilateral lower extremities 2 days prior to arrival in ED (8/11). Admitted 8/13. Diagnosed with GBS. Patient developed respiratory distress 5 days after (8/18) admit requiring intubation, transfer to ICU and plasma phoresis. Extubated 8/29. Currently improved and in neuro unit requiring PT/OT
Age: 67.0
Sex: M
Vaccine: PNC15, UNK, PNC15
Symptoms: Magnetic resonance imaging spinal abnormal, Muscular weakness, Plasmapheresis, Respiratory distress, Spondylolisthesis
Clinical narrative: Patient notice weakness developing in his bilateral lower extremities 2 days prior to arrival in ED (8/11). Admitted 8/13. Diagnosed with GBS. Patient developed respiratory distress 5 days after (8/18) admit requiring intubation, transfer to ICU and plasma phoresis. Extubated 8/29. Currently improved and in neuro unit requiring PT/OT
Age: 67.0
Sex: M
Vaccine: PNC15, UNK, PNC15
Symptoms: Spondylolysis, Thecal sac compression, Vertebral foraminal stenosis
Clinical narrative: Patient notice weakness developing in his bilateral lower extremities 2 days prior to arrival in ED (8/11). Admitted 8/13. Diagnosed with GBS. Patient developed respiratory distress 5 days after (8/18) admit requiring intubation, transfer to ICU and plasma phoresis. Extubated 8/29. Currently improved and in neuro unit requiring PT/OT
Age: 67.0
Sex: M
Vaccine: PNC15, UNK, PNC15
Symptoms: Ascending flaccid paralysis, Guillain-Barre syndrome, Imaging procedure, Laboratory test
Clinical narrative: Patient notice weakness developing in his bilateral lower extremities 2 days prior to arrival in ED (8/11). Admitted 8/13. Diagnosed with GBS. Patient developed respiratory distress 5 days after (8/18) admit requiring intubation, transfer to ICU and plasma phoresis. Extubated 8/29. Currently improved and in neuro unit requiring PT/OT
Age: 67.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site pain, Loss of personal independence in daily activities, Pain in extremity, Sleep disorder
Clinical narrative: Chronic pain in arm
Age: 67.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain in extremity
Clinical narrative: Chronic pain in arm
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Decreased appetite, Myalgia
Clinical narrative: Fatigue; Decreased appetite; myalgias/polymyalgias; arthralgia left hip; Overdose; This non-serious case was reported by a consumer and described the occurrence of myalgia in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number 5954H) for prophylaxis.   Concurrent medical conditions included type ii diabetes mellitus. Concomitant products included metformin, empagliflozin (Jardiance), pravastatin and ramipril.   On 29-AUG-2023, the patient received Shingrix 1 ml. On 29-AUG-2023, an unknown time after receiving Shingrix, the patient experienced overdose (Verbatim: Overdose). On 30-AUG-2023, the patient experienced myalgia (Verbatim: myalgias/polymyalgias) and arthralgia (Verbatim: arthralgia left hip). On an unknown date, the patient experienced fatigue (Verbatim: Fatigue) and decreased appetite (Verbatim: Decreased appetite).  On 03-SEP-2023, the outcome of the myalgia and arthralgia were resolved (duration 4 days). The outcome of the fatigue and decreased appetite were not reported and the outcome of the overdose was unknown.   It was unknown if the reporter considered the myalgia, arthralgia, fatigue and decreased appetite to be related to Shingrix.     It was unknown if the company considered the myalgia, arthralgia, fatigue and decreased appetite to be related to Shingrix.   Additional Information: GSK receipt date: 04-SEP-2023 The patient self-reported this case (Internist). The reporter stated that myalgia's accompanied by low grade fatigue, decreased appetite, severe polymyalgia's large muscle groups , arthralgia left hip. The symptoms were treated. The reporter gave permission to contact. The patient received 1ml of Shingrix dose, which led to overdose.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Decreased appetite, Fatigue, Incorrect dose administered, Myalgia
Clinical narrative: Fatigue; Decreased appetite; myalgias/polymyalgias; arthralgia left hip; Overdose; This non-serious case was reported by a consumer and described the occurrence of myalgia in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number 5954H) for prophylaxis.   Concurrent medical conditions included type ii diabetes mellitus. Concomitant products included metformin, empagliflozin (Jardiance), pravastatin and ramipril.   On 29-AUG-2023, the patient received Shingrix 1 ml. On 29-AUG-2023, an unknown time after receiving Shingrix, the patient experienced overdose (Verbatim: Overdose). On 30-AUG-2023, the patient experienced myalgia (Verbatim: myalgias/polymyalgias) and arthralgia (Verbatim: arthralgia left hip). On an unknown date, the patient experienced fatigue (Verbatim: Fatigue) and decreased appetite (Verbatim: Decreased appetite).  On 03-SEP-2023, the outcome of the myalgia and arthralgia were resolved (duration 4 days). The outcome of the fatigue and decreased appetite were not reported and the outcome of the overdose was unknown.   It was unknown if the reporter considered the myalgia, arthralgia, fatigue and decreased appetite to be related to Shingrix.     It was unknown if the company considered the myalgia, arthralgia, fatigue and decreased appetite to be related to Shingrix.   Additional Information: GSK receipt date: 04-SEP-2023 The patient self-reported this case (Internist). The reporter stated that myalgia's accompanied by low grade fatigue, decreased appetite, severe polymyalgia's large muscle groups , arthralgia left hip. The symptoms were treated. The reporter gave permission to contact. The patient received 1ml of Shingrix dose, which led to overdose.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis acneiform, Rash, Rash pruritic
Clinical narrative: rash on right leg/patient described the rash as itchy; Patient described the rash as itchy and looked like little pimples; This spontaneous report was received from a physician and refers to a 27 year old female patient. The patient's concurrent conditions included allergy to ciprofloxacin (CIPRO). Her medical history and concomitant medications were not reported.  On 14-JUN-2023, the patient was vaccinated with the fist dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # U029496, expiration date not provided but upon internal review stablished as 21-SEP-2023) administered intramuscular (IM) in the left upper arm as routine vaccination.  On 18-JUN-2023 (also reported as 3 - 4 days after receiving vaccine), the patient experienced several lesions of rash on her right leg which were itchy and looked like little pimples (rash pruritic, dermatitis acneiform). No treatment was given for these events, and on 02-JUL-2023, the patient recovered from the events (also reported as lasted for about 2 weeks). On 21-AUG-2023, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # W089697, expiration date not provided but upon internal review stablished as 13-DEC-2024) administered in the left upper arm (route of administration not provided) as routine vaccination.  Causality assessment between the events and varicella virus vaccine live (oka/merck)(VARIVAX) was not provided.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pharmacist calls to report female patient received 1st dose 11/30/2022.  2nd dose 9/5/2023.  GARDASIL 9.  No further AE.  No PQC  See request case#02465379; No further AE; This spontaneous report has been received from a pharmacist, regarding a 35-years-old patent of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 30-NOV-2022 and 05-SEP-2023, the patient was vaccinated with the first and second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, as prophylaxis (strengths, doses, routes and anatomical locations of administration, lot numbers and expiration dates were not reported) (Inappropriate schedule of vaccine administered).  No additional adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No Additional AE/PQC; HBP reports that a patient was inadvertently given a dose of GARDASIL 9 after it suffered a TE. The supported TE case number is 02465608. Other AE cases reported from the same office ( same day ) are 02465656 and 02465659. No Additional AE/PQC.; This spontaneous report has been received from a office manager, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 16-AUG-2023, the patient was vaccinated with an improperly storage dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliters as prophylaxis (lot number: W012142, which was determined to be valid as syringe formulation, with an expiration date on 14-DEC-2024) (strength, scheme, route and anatomical location of administration were not reported) (Product storage error).  The administered dose underwent a temperature excursion of 50 degrees Fahrenheit for 36 minutes. No previous temperature excursion was reported.   No additional adverse event was provided.  This case is one of three reports from the same reported
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No Additional AE/PQC; patient was inadvertently given a dose of ROTATEQ after it suffered a TE; This spontaneous report has been received from an office manager and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 29-AUG-2023, the patient was inadvertently vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter (mL) after it had suffered a temperature excursion (product storage error) (lot #number 938977 has been determined to be valid for rotavirus vaccine, live, oral, pentavalent (ROTATEQ), with an expiration date established as 30-APR-2024), administered for prophylaxis (strength, and route of administration were not provided). The temperature excursion had a timeframe of 36 minutes at a temperature on 50 degrees Fahrenheit (F). No additional adverse events were reported.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Electric shock sensation, Grip strength decreased, Hypoaesthesia, Nerve injury, Pain
Clinical narrative: numbness down his arm (Left) radiating to his fingertips; shooting; he has less grip in the affected(Left) hand; nerve damage; electrical sensation (like he is being shocked); This non-serious case was reported by a consumer via call center representative and described the occurrence of numbness in hand in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (For tolerance of 1st dose refer case US2023AMR120556).   On 18-AUG-2023, the patient received the 2nd dose of Shingrix (left deltoid). In AUG-2023, less than 3 weeks after receiving Shingrix, the patient experienced numbness in hand (Verbatim: numbness down his arm (Left) radiating to his fingertips), shooting pain (Verbatim: shooting), grip strength decreased (Verbatim: he has less grip in the affected(Left) hand), nerve damage (Verbatim: nerve damage) and electric shock sensation (Verbatim: electrical sensation (like he is being shocked)).  The outcome of the numbness in hand, shooting pain, grip strength decreased, nerve damage and electric shock sensation were not resolved.   It was unknown if the reporter considered the numbness in hand, shooting pain, grip strength decreased, nerve damage and electric shock sensation to be related to Shingrix.     It was unknown if the company considered the numbness in hand, shooting pain, grip strength decreased, nerve damage and electric shock sensation to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR120556   Additional Information: GSK Receipt Date: 31-AUG-2023 It was reported that after the second Shingrix vaccine, the patient experienced a shooting, electrical sensation (like he was being shocked), and numbness down his arm (Left) radiating to his fingertips. He stated he had nerve damage, as he had less grip in the affected (Left) hand. Both doses of the vaccine were administered in the upper left arm. The reporter consented to follow up. For tolerance of 1st dose refer case US2023AMR120556.; Sender's Comments:  US-GSK-US2023AMR120556:1st dose
Age: 16.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong product administered
Clinical narrative: Administered Shingrix instead of Menveo; a 16 year old was administered shingrix instead of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 16-year-old male patient who received Herpes zoster (Shingrix) (batch number 3ZX3E, expiry date 02-JUL-2025) for prophylaxis.   Additional patient notes included the patient was not immunocompromised.   On 10-AUG-2023, the patient received the 1st dose of Shingrix. On 10-AUG-2023, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: Administered Shingrix instead of Menveo) and inappropriate age at vaccine administration (Verbatim: a 16 year old was administered shingrix instead of Menveo).  The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 31-AUG-2023 A 16-year-old was administered Shingrix instead of Menveo, which led to Wrong vaccine administered and Inappropriate age at vaccine administration. The reporter consented to follow up. This case was 1 of 2 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2023119224:2nd Report
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; This serious initial spontaneous safety report was received by Novavax on 05-SEP-2023 from a consumer, via the contact center.  A 78 year-old female of was vaccinated with intramuscular use Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine dose 1 on 26-OCT-2022, and dose 2 on 16-NOV-2022 on the right side at a clinic.  The following medical history was reported: Blood cholesterol abnormal, Diabetes mellitus, Drug hypersensitivity (Antibiotics that ends with -illin), Food allergy (nuts, berries, and anything from the ocean), Hypertension, Neoplasm malignant, and amoxicillin drug allergy. Additionally, the individual had never received any other Covid-19 vaccination and never tested positive for Covid-19.   The individual's reported concomitant medications included an unspecified blood thinner, an unspecified diabetes medication, and unspecified painkillers.  On 18-JAN-2023, 2 months 2 days after vaccination with dose 2, the individual experienced a heart attack (PT: Myocardial infarction) (Serious: Hospitalization and Medically Significant) which was reportedly "due to preexisting cholesterol issues." The individual was hospitalized on 18-JAN-2023. Subsequently, the individual underwent a stent operation as treatment and the symptoms resolved.  On 18-JAN-2023 the event outcome of Myocardial infarction was recovered/resolved.; Sender's Comments: This 78 year-old female experienced: Myocardial infarction after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Myocardial infarction was reported as serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported event is considered Possible.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 at 11:30 as dose 4 (booster), single (Lot number: GJ5342) at the age of 60 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Mar2021 at 14:00 as dose 1, single (Lot number: ER8734), in left arm, on 20Apr2021 at 14:00 as dose 2, single (Lot number: ER8736), in left arm and on 26Nov2021 at 14:00 as dose 3 (booster), single (Lot number: 330268D), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "thyroiditis (positive antibodies)" (unspecified if ongoing); "asthma" (unspecified if ongoing); "HTN" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro abx, reaction(s): "known allergies: Cipro Abx". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 28Aug2023 to 01Sep2023. Clinical course: This is patient's first time having Covid since getting 4 Vaccines. Severe nausea, abdominal pain, sinus congestion, and mucus. Fatigue. Patient contracted Covid from a family member who returned from (name) antigen positive for Covid.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Jan2023 at 11:30 as dose 5 (booster), single (Lot number: GL0446) at the age of 61 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6199), on 02Apr2021 as dose 2, single (Lot number: EW0150), on 11Jan2022 as dose 3 (booster), single (Lot number: FL3198) and on 18Aug2022 as dose 4 (booster), single (Lot number: FP7137), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "GERD" (unspecified if ongoing); "ADHD" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: nsaids, reaction(s): "Known allergies: NSAIDs". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Treatment was Paxlovid. Treatment start date was 26Aug2023 and treatment stop date was 30Aug2023. Lot number was GF7893.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient had no known allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 26Aug2023 to 01Sep2023.   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: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 at 13:15 as dose 5 (booster), single (Lot number: GH9693) at the age of 75 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "migraine headaches" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing); "known allergies: soy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 25Aug2023 to 29Aug2023.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Stiffness on either side of the neck. Difficulty turning head side to side or up and down.  It began after rubbing the vaccination area. It continued through the night and subsided by the end of the next day.
Sex: U
Vaccine: HEP
Symptoms: Headache, Malaise, Oropharyngeal pain, Rhinorrhoea, Throat irritation
Clinical narrative: headache, runny nose, and sore/itchy throat; headache, runny nose, and sore, itchy throat; headache, runny nose, and sore,itchy throat; headache, runny nose, and sore/itchy throat; they were not feeling well; This spontaneous report has been received from a consumer, regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 30-AUG-2023, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (strength, dose, route of administration, lot number and expiration date were not provided).  On an unknown date in 2023, the patient not feeling well (malaise), the patient developed Headache, runny nose (Rhinorrhoea), sore troat (Oropharyngeal pain), and itchy throat (Throat irritation). The outcome of the aforementioned events was unknown at the time of the report, as well as the action taken with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) regarding the events.  The causality assessment between Headache, Rhinorrhoea, Oropharyngeal pain, Throat irritation, Malaise and the suspect vaccinate was reported as related.
Sex: F
Vaccine: RSV
Symptoms: Abdominal pain upper, Asthenia, Hepatic pain, Pyrexia, Vomiting projectile
Clinical narrative: weakness all over; had projectile vomiting along with horrible pain in her stomach and liver area; had projectile vomiting along with horrible pain in her stomach and liver area; having a fever of 101; had projectile vomiting along with horrible pain in her stomach and liver area; This non-serious case was reported by a consumer via call center representative and described the occurrence of weakness generalized in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 03-SEP-2023, the patient received the 1st dose of Arexvy (intramuscular, right deltoid). On 03-SEP-2023, less than a day after receiving Arexvy, the patient experienced weakness generalized (Verbatim: weakness all over), hepatic pain (Verbatim: had projectile vomiting along with horrible pain in her stomach and liver area), vomiting projectile (Verbatim: had projectile vomiting along with horrible pain in her stomach and liver area), fever (Verbatim: having a fever of 101) and stomach pain (Verbatim: had projectile vomiting along with horrible pain in her stomach and liver area).  On 05-SEP-2023, the outcome of the hepatic pain, vomiting projectile, fever and stomach pain were resolved (duration 2 days). The outcome of the weakness generalized was not resolved.   It was unknown if the reporter considered the weakness generalized, hepatic pain, vomiting projectile, fever and stomach pain to be related to Arexvy.     It was unknown if the company considered the weakness generalized, hepatic pain, vomiting projectile, fever and stomach pain to be related to Arexvy.   Additional Information: GSK Receipt date: 05-SEP-2023 The patient self-reported this case.  The symptoms started on the day of the vaccination and the patient complains of fever of 101 that had now resolved.  The reporter also stated that she had projectile vomiting along with horrible pain in her stomach and liver area that had now both resolved.  The reporter stated that she had weakness, and this symptom was ongoing and she had not stated any of this to the HCP (healthcare professional) but will do so.
Age: 94.0
Sex: F
Vaccine: RSV
Symptoms: Injection site rash, Rash erythematous, Rash papular
Clinical narrative: rash around the injection site of the left arm and extending down to her elbow; little red bumps; This non-serious case was reported by a consumer via call center representative and described the occurrence of red rash in a 94-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 29-AUG-2023, the patient received Arexvy (intramuscular, left arm). On 30-AUG-2023, 1 days after receiving Arexvy, the patient experienced red rash (Verbatim: rash around the injection site of the left arm and extending down to her elbow) and papular rash (Verbatim: little red bumps).  The outcome of the red rash was not resolved and the outcome of the papular rash was not reported.   It was unknown if the reporter considered the red rash and papular rash to be related to Arexvy.     It was unknown if the company considered the red rash and papular rash to be related to Arexvy.   Additional Information: GSK Receipt date: 31-AUG-2023 The reporter was the son of the patient, he reported his mother received the Arexvy Vaccine and the next day they observed a rash around the injection site of the left arm and extending down to her elbow.  When asking to describe the rash he stated there were little red bumps, the mother did not stated it was itchy.  The reporter gives permission to contact the healthcare professional. The reporter consented to follow up.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test positive
Clinical narrative: Breakthrough case Dose 1: Pfizer, EL9261, 1/25/2021 Dose 2: Pfizer, EN6201, 2/15/2021
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Breast pain, Headache, Muscle spasms
Clinical narrative: Had a side effect after receiving the Zoster vaccine. Extreme body aches. Muscle and joint pain. Stomach pain. Very painful headaches. Also strange spasm like pain in my breast.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: Had a side effect after receiving the Zoster vaccine. Extreme body aches. Muscle and joint pain. Stomach pain. Very painful headaches. Also strange spasm like pain in my breast.