chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site pain, Peripheral swelling, Pyrexia
Clinical narrative: Primary:  arm swelling, soreness, redness at shot site...never had this in the previous 2 doses Secondary: SEVERE fever and chills over first night after shot...never anything like it...not even close...an 11 on a 1-10 scale
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Pyrexia, Rash erythematous, Rash papular, Skin warm
Clinical narrative: Fever of 103.9 for 3+ hours; took 2 doses of Tylenol and 1 dose of Motrin to bring down below 101. Large, red, raised, warm rash at sign of injection which I am now on day 3 of. The rash continues to get larger by the day.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Asthenia, Blood culture negative, Cerebrovascular accident, Death
Clinical narrative: Patient received Moderna vaccines 4/13 and 5/11/2021.  On 11/9-11/16/2021, patient was admitted to hospital with strokes.  TEE showing clot on Mitral valve.  Initial blood cultures negative.  HIV negative.  Patient was discharged to home on Lovenox.  Patient on 11/22 admitted with additional strokes, presumably cardioembolic from the clot on her mitral valve.  On 11/25 she was evaluated by cardiac surgeon who deemed patient too unstable to undergo surgery.  Emperic antibiotic started 11/25 and her repeat blood cultures (11/25 and 11/28) as well as her initial blood culture remained negative.  Patient continued to experience debilitating strokes and she was made comfort care.  Patient expired 11/29/2021.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Embolic stroke, HIV test negative, Intracardiac thrombus
Clinical narrative: Patient received Moderna vaccines 4/13 and 5/11/2021.  On 11/9-11/16/2021, patient was admitted to hospital with strokes.  TEE showing clot on Mitral valve.  Initial blood cultures negative.  HIV negative.  Patient was discharged to home on Lovenox.  Patient on 11/22 admitted with additional strokes, presumably cardioembolic from the clot on her mitral valve.  On 11/25 she was evaluated by cardiac surgeon who deemed patient too unstable to undergo surgery.  Emperic antibiotic started 11/25 and her repeat blood cultures (11/25 and 11/28) as well as her initial blood culture remained negative.  Patient continued to experience debilitating strokes and she was made comfort care.  Patient expired 11/29/2021.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site pain
Clinical narrative: Normal flu like symptoms, followed by injection site pain, sensitivity,  swelling, redness, itching, and firmness. The redness of the site has began 24 hours following injection and has continued to grow in size. All symptoms are presently happening.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Normal flu like symptoms, followed by injection site pain, sensitivity,  swelling, redness, itching, and firmness. The redness of the site has began 24 hours following injection and has continued to grow in size. All symptoms are presently happening.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site
Clinical narrative: claim of incorrect vaccine adminstration to high on arm
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PT'S MOTHER REQUESTED MODERNA FOR BOOSTER.  OUR INTERN, DIDN'T CHECK PT'S AGE (17) BEFORE GIVING THE VACCINE
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Autonomic nervous system imbalance, Back pain, Bladder catheterisation, Cardio-respiratory arrest
Clinical narrative: Received Moderna vaccine 2/26 and 3/26/2021.  On 10/26 patient developed urinary retention and was seen in ED, where a catheter was placed and he was discharged.  On 10/31, he was seen at another ED for fever up to 101 and vomiting.  He was discharged.  On 11/2, he returned to ED with progressive weakness and lethargy and another episode of urinary retention.  Patient developed neck pain radiating down to lower back and on 11/4 had MRI that showed myelitis through the entire spine, from cervical region down to the conus medullaris.  Viral panel negative.  LP contaminated with skin flora.  His symptoms continued to worsen despite maximal medical therapy.  Due to impending respiratory failure, patient was transferred to ICU.  He was intubated on 11/5.  On 11/7 patient developed severe autonomic dystonia and developed fevers up to 109.  He developed V tach, coded and expired.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Endotracheal intubation, Intensive care, Lethargy, Lumbar puncture abnormal
Clinical narrative: Received Moderna vaccine 2/26 and 3/26/2021.  On 10/26 patient developed urinary retention and was seen in ED, where a catheter was placed and he was discharged.  On 10/31, he was seen at another ED for fever up to 101 and vomiting.  He was discharged.  On 11/2, he returned to ED with progressive weakness and lethargy and another episode of urinary retention.  Patient developed neck pain radiating down to lower back and on 11/4 had MRI that showed myelitis through the entire spine, from cervical region down to the conus medullaris.  Viral panel negative.  LP contaminated with skin flora.  His symptoms continued to worsen despite maximal medical therapy.  Due to impending respiratory failure, patient was transferred to ICU.  He was intubated on 11/5.  On 11/7 patient developed severe autonomic dystonia and developed fevers up to 109.  He developed V tach, coded and expired.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging spinal abnormal, Myelitis, Neck pain, Pyrexia, Respiratory failure
Clinical narrative: Received Moderna vaccine 2/26 and 3/26/2021.  On 10/26 patient developed urinary retention and was seen in ED, where a catheter was placed and he was discharged.  On 10/31, he was seen at another ED for fever up to 101 and vomiting.  He was discharged.  On 11/2, he returned to ED with progressive weakness and lethargy and another episode of urinary retention.  Patient developed neck pain radiating down to lower back and on 11/4 had MRI that showed myelitis through the entire spine, from cervical region down to the conus medullaris.  Viral panel negative.  LP contaminated with skin flora.  His symptoms continued to worsen despite maximal medical therapy.  Due to impending respiratory failure, patient was transferred to ICU.  He was intubated on 11/5.  On 11/7 patient developed severe autonomic dystonia and developed fevers up to 109.  He developed V tach, coded and expired.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary retention, Ventricular tachycardia, Viral test negative, Vomiting
Clinical narrative: Received Moderna vaccine 2/26 and 3/26/2021.  On 10/26 patient developed urinary retention and was seen in ED, where a catheter was placed and he was discharged.  On 10/31, he was seen at another ED for fever up to 101 and vomiting.  He was discharged.  On 11/2, he returned to ED with progressive weakness and lethargy and another episode of urinary retention.  Patient developed neck pain radiating down to lower back and on 11/4 had MRI that showed myelitis through the entire spine, from cervical region down to the conus medullaris.  Viral panel negative.  LP contaminated with skin flora.  His symptoms continued to worsen despite maximal medical therapy.  Due to impending respiratory failure, patient was transferred to ICU.  He was intubated on 11/5.  On 11/7 patient developed severe autonomic dystonia and developed fevers up to 109.  He developed V tach, coded and expired.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Persistent Tinnitus in both ears.  Absolutely a problem that did not exist prior to receiving the Maderma booster  several weeks ago.  Pfizer 2 dose vaccine taken April 2021. Boost Received second week of December and within three days after, loud persistent hissing sound in all settings and surroundings.  My wife who received the same is also reporting the same condition  she too is exepireincing.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Dizziness, Dysphonia, Dyspnoea
Clinical narrative: Urticaria, Hives, Puritis, Cough, Wheezing, Rhinitis, Throat tightness, Hoarse voice, Shortness of breath within 15 of Moderna booster injection despite premedication with Prednisone 10mg, Diphenhydramine 50mg, Pepcid 20mg; and Epi 0.3IM at time of vaccination. Puritis persisted after Solumedrol 80mg IV at ER. Mild cutaneous symptoms  waxed and waned over the next 15 hours. 16 hours post vaccination pt rapidly developed skin flushing, intense global puritis, hives, wheezing, dizziness, cough, facial swelling (eyelids, lips, ear), and diarrhea. Pt took Diphenhydramine 50mg, Pepcid 20mg, and Epi 0.3mg IM, symptoms resolved. At 17 hours post vaccination global puritis and skin flushing returned and continues to wax and wane, periods of coughing and rhinitis and itchy eyes keep occurring and resolving
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Eye pruritus, Flushing, Lip swelling, Pruritus
Clinical narrative: Urticaria, Hives, Puritis, Cough, Wheezing, Rhinitis, Throat tightness, Hoarse voice, Shortness of breath within 15 of Moderna booster injection despite premedication with Prednisone 10mg, Diphenhydramine 50mg, Pepcid 20mg; and Epi 0.3IM at time of vaccination. Puritis persisted after Solumedrol 80mg IV at ER. Mild cutaneous symptoms  waxed and waned over the next 15 hours. 16 hours post vaccination pt rapidly developed skin flushing, intense global puritis, hives, wheezing, dizziness, cough, facial swelling (eyelids, lips, ear), and diarrhea. Pt took Diphenhydramine 50mg, Pepcid 20mg, and Epi 0.3mg IM, symptoms resolved. At 17 hours post vaccination global puritis and skin flushing returned and continues to wax and wane, periods of coughing and rhinitis and itchy eyes keep occurring and resolving
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinitis, Swelling face, Swelling of eyelid, Throat tightness, Urticaria
Clinical narrative: Urticaria, Hives, Puritis, Cough, Wheezing, Rhinitis, Throat tightness, Hoarse voice, Shortness of breath within 15 of Moderna booster injection despite premedication with Prednisone 10mg, Diphenhydramine 50mg, Pepcid 20mg; and Epi 0.3IM at time of vaccination. Puritis persisted after Solumedrol 80mg IV at ER. Mild cutaneous symptoms  waxed and waned over the next 15 hours. 16 hours post vaccination pt rapidly developed skin flushing, intense global puritis, hives, wheezing, dizziness, cough, facial swelling (eyelids, lips, ear), and diarrhea. Pt took Diphenhydramine 50mg, Pepcid 20mg, and Epi 0.3mg IM, symptoms resolved. At 17 hours post vaccination global puritis and skin flushing returned and continues to wax and wane, periods of coughing and rhinitis and itchy eyes keep occurring and resolving
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Urticaria, Hives, Puritis, Cough, Wheezing, Rhinitis, Throat tightness, Hoarse voice, Shortness of breath within 15 of Moderna booster injection despite premedication with Prednisone 10mg, Diphenhydramine 50mg, Pepcid 20mg; and Epi 0.3IM at time of vaccination. Puritis persisted after Solumedrol 80mg IV at ER. Mild cutaneous symptoms  waxed and waned over the next 15 hours. 16 hours post vaccination pt rapidly developed skin flushing, intense global puritis, hives, wheezing, dizziness, cough, facial swelling (eyelids, lips, ear), and diarrhea. Pt took Diphenhydramine 50mg, Pepcid 20mg, and Epi 0.3mg IM, symptoms resolved. At 17 hours post vaccination global puritis and skin flushing returned and continues to wax and wane, periods of coughing and rhinitis and itchy eyes keep occurring and resolving
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Booster shot administered to out of range group. No side affected reported from patient.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: claim to immuniztion given to hjigh on arm
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Skin easily develops rash and itchy patches after little scratching. If left alone, skin returns to normal in about 5 minutes
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Sudden heart pounding.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Incorrect dose administered
Clinical narrative: technician was administering pfizer covid shot and as she was injecting the imz, the syringe disengaged from the needle and as a result pt got lower dose than recommended (unknown exactly how much dose got into patient.) i apologized to patient. per cdc recommendation, I repeated the dose with a full amount (done in her other arm.)
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Mobility decreased, Vertigo
Clinical narrative: Vertigo I have 2 cochlear implants and suffered severe vertigo with the second that lasted for weeks.   This is the first day after but I feel pretty bad.  Too sick to get up and move around.
Sex: U
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: pts who got admitted after first dose of moderna vaccine but were already infected prior; This spontaneous case was reported by a physician and describes the occurrence of INFECTION (pts who got admitted after first dose of moderna vaccine but were already infected prior) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFECTION (pts who got admitted after first dose of moderna vaccine but were already infected prior) (seriousness criterion hospitalization). At the time of the report, INFECTION (pts who got admitted after first dose of moderna vaccine but were already infected prior) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Muscle tightness, Pain in extremity
Clinical narrative: can't walk; pain went to her heel, like it was tight,shoots up to her thigh, reinforces the pain in her thigh, it's; muscles tighten around her heel; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (can't walk), PAIN IN EXTREMITY (pain went to her heel, like it was tight,shoots up to her thigh, reinforces the pain in her thigh, it's) and MUSCLE TIGHTNESS (muscles tighten around her heel) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (can't walk), PAIN IN EXTREMITY (pain went to her heel, like it was tight,shoots up to her thigh, reinforces the pain in her thigh, it's) and MUSCLE TIGHTNESS (muscles tighten around her heel). At the time of the report, GAIT DISTURBANCE (can't walk), PAIN IN EXTREMITY (pain went to her heel, like it was tight,shoots up to her thigh, reinforces the pain in her thigh, it's) and MUSCLE TIGHTNESS (muscles tighten around her heel) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose possibly administered past 12 hours; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose possibly administered past 12 hours) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose possibly administered past 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose possibly administered past 12 hours) had resolved.            No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Inappropriate schedule of product administration, Mobility decreased, Muscular weakness
Clinical narrative: more than 42 days for administration of second dose; fever; Chills; weakness in the legs; pain in arm; Around 10 days after second shot, both husband and wife experienced pain in the low back; She has trouble walking and sitting down; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (Around 10 days after second shot, both husband and wife experienced pain in the low back), MOBILITY DECREASED (She has trouble walking and sitting down), MUSCULAR WEAKNESS (weakness in the legs), PAIN IN EXTREMITY (pain in arm) and PYREXIA (fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027HIB and 004D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included IBUPROFEN for Low back pain.   On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Dec-2021, the patient experienced MUSCULAR WEAKNESS (weakness in the legs), PYREXIA (fever) and CHILLS (Chills). On 12-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose). In December 2021, the patient experienced BACK PAIN (Around 10 days after second shot, both husband and wife experienced pain in the low back), MOBILITY DECREASED (She has trouble walking and sitting down) and PAIN IN EXTREMITY (pain in arm). On 05-Dec-2021, MUSCULAR WEAKNESS (weakness in the legs), PYREXIA (fever) and CHILLS (Chills) had resolved. On 12-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose) had resolved. In December 2021, PAIN IN EXTREMITY (pain in arm) had resolved. At the time of the report, BACK PAIN (Around 10 days after second shot, both husband and wife experienced pain in the low back) had not resolved and MOBILITY DECREASED (She has trouble walking and sitting down) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medication also includes Anti-inflammatory medication for Low back pain
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: more than 42 days for administration of second dose; fever; Chills; weakness in the legs; pain in arm; Around 10 days after second shot, both husband and wife experienced pain in the low back; She has trouble walking and sitting down; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (Around 10 days after second shot, both husband and wife experienced pain in the low back), MOBILITY DECREASED (She has trouble walking and sitting down), MUSCULAR WEAKNESS (weakness in the legs), PAIN IN EXTREMITY (pain in arm) and PYREXIA (fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027HIB and 004D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included IBUPROFEN for Low back pain.   On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Dec-2021, the patient experienced MUSCULAR WEAKNESS (weakness in the legs), PYREXIA (fever) and CHILLS (Chills). On 12-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose). In December 2021, the patient experienced BACK PAIN (Around 10 days after second shot, both husband and wife experienced pain in the low back), MOBILITY DECREASED (She has trouble walking and sitting down) and PAIN IN EXTREMITY (pain in arm). On 05-Dec-2021, MUSCULAR WEAKNESS (weakness in the legs), PYREXIA (fever) and CHILLS (Chills) had resolved. On 12-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose) had resolved. In December 2021, PAIN IN EXTREMITY (pain in arm) had resolved. At the time of the report, BACK PAIN (Around 10 days after second shot, both husband and wife experienced pain in the low back) had not resolved and MOBILITY DECREASED (She has trouble walking and sitting down) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medication also includes Anti-inflammatory medication for Low back pain
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia, Inappropriate schedule of product administration, Limb discomfort, Muscular weakness
Clinical narrative: Burning; Tingling; Numbness; Muscle ache from shoulder, bicep, forearm and hand.; Heaviness and arm feels weak; Heaviness and arm feels weak.; Dose 1: 09Aug2021; Dose 2: 14Oct2021.; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Oct2021 at 09:45 (Lot number: FF8841) at the age of 57 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "None". There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: FA7484, Anatomical Location: Left arm, Administration Time: 10:00, Route of Administration: Unknown), administration date: 09Aug2021, when the patient was 57 years old, for COVID-19 immunisation.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 14Oct2021 at 09:45, outcome "unknown", described as "Dose 1: 09Aug2021; Dose 2: 14Oct2021"; BURNING SENSATION (non-serious) with onset 01Nov2021, outcome "not recovered", described as "Burning"; PARAESTHESIA (non-serious) with onset 01Nov2021, outcome "not recovered", described as "Tingling"; HYPOAESTHESIA (non-serious) with onset 01Nov2021, outcome "not recovered", described as "Numbness"; MYALGIA (non-serious) with onset 01Nov2021, outcome "not recovered", described as "Muscle ache from shoulder, bicep, forearm and hand"; LIMB DISCOMFORT (non-serious) with onset 01Nov2021, outcome "not recovered", described as "Heaviness and arm feels weak"; MUSCULAR WEAKNESS (non-serious) with onset 01Nov2021, outcome "not recovered", described as "Heaviness and arm feels weak". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of burning sensation, paraesthesia, hypoaesthesia, myalgia, limb discomfort and muscular weakness.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient reported that the events kept getting worse daily. Since the vaccination, the patient had been tested for COVID-19 and tested negative. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Burning; Tingling; Numbness; Muscle ache from shoulder, bicep, forearm and hand.; Heaviness and arm feels weak; Heaviness and arm feels weak.; Dose 1: 09Aug2021; Dose 2: 14Oct2021.; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Oct2021 at 09:45 (Lot number: FF8841) at the age of 57 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "None". There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: FA7484, Anatomical Location: Left arm, Administration Time: 10:00, Route of Administration: Unknown), administration date: 09Aug2021, when the patient was 57 years old, for COVID-19 immunisation.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 14Oct2021 at 09:45, outcome "unknown", described as "Dose 1: 09Aug2021; Dose 2: 14Oct2021"; BURNING SENSATION (non-serious) with onset 01Nov2021, outcome "not recovered", described as "Burning"; PARAESTHESIA (non-serious) with onset 01Nov2021, outcome "not recovered", described as "Tingling"; HYPOAESTHESIA (non-serious) with onset 01Nov2021, outcome "not recovered", described as "Numbness"; MYALGIA (non-serious) with onset 01Nov2021, outcome "not recovered", described as "Muscle ache from shoulder, bicep, forearm and hand"; LIMB DISCOMFORT (non-serious) with onset 01Nov2021, outcome "not recovered", described as "Heaviness and arm feels weak"; MUSCULAR WEAKNESS (non-serious) with onset 01Nov2021, outcome "not recovered", described as "Heaviness and arm feels weak". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of burning sensation, paraesthesia, hypoaesthesia, myalgia, limb discomfort and muscular weakness.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient reported that the events kept getting worse daily. Since the vaccination, the patient had been tested for COVID-19 and tested negative. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Food allergy, Mechanical urticaria, Peripheral swelling, Pruritus
Clinical narrative: I had an allergic reaction to salmon 2 weeks following my vaccination.  After filling out my survey, I was asked to fill out this report.  My doctor indicates salmon as a common allergy and I am getting seen by an allergist hopefully in February.  I had never had a reaction to salmon prior to this event.  On both Friday the 3rd, and Saturday the 4th, my hands swelled up, I became very itchy all over, and showed signs of dermatographia.  I was provided a 5 day dose of prednisone which eliminated the itchiness and swelling, but dermatographia continued.  I was provided a second 5 day dose of prednisone, had a blood test, and have since been fine, but have been avoiding all seafood until I get an allergy test.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: Non-blanching small popular rash
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Mobility decreased, Nodule, Pain
Clinical narrative: My left arm had big knots in it and I can hardly move it. The pain is so bad that I'm taking massive amounts of Tylenol, ibuprofen, Aleve, and aspirin trying to make it tolerable. I'm also using bengay. I cannot sleep very much for the pain. I'm someone that pain is never an issue. I can put up with most pain and just wait it out, but not this. I've used ice and heat both trying to get some relief, nothing is helping. I don't know what to do at this point. They keep saying it will get better, but it's been over 2 weeks and getting worst each day!
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Myalgia
Clinical narrative: axillary lymphadenopathy supraclavicular lymphadenopathy chills, myalgias
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Continuous vertigo for many months
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Bundle branch block right, Chest X-ray normal, Computerised tomogram head normal, Decreased appetite, Dysstasia
Clinical narrative: Patient experienced a syncopal episode. Passed-out and hit his head on the floor. He has a hematoma on his head due to the fall. Patient sweating and stated he felt very tired. 911 called and was taken to the emergency room by ambulance. Several tests were completed at the ER. Patient was sent home with instructions for rest and fluids. He has been in bed all day since returning home from ER. Patient very tired, difficulty standing-up, walking and not eating much.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Fall, Fatigue, Full blood count normal, Gait disturbance
Clinical narrative: Patient experienced a syncopal episode. Passed-out and hit his head on the floor. He has a hematoma on his head due to the fall. Patient sweating and stated he felt very tired. 911 called and was taken to the emergency room by ambulance. Several tests were completed at the ER. Patient was sent home with instructions for rest and fluids. He has been in bed all day since returning home from ER. Patient very tired, difficulty standing-up, walking and not eating much.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Glomerular filtration rate normal, Haematoma, Head injury, Hyperhidrosis, Loss of consciousness
Clinical narrative: Patient experienced a syncopal episode. Passed-out and hit his head on the floor. He has a hematoma on his head due to the fall. Patient sweating and stated he felt very tired. 911 called and was taken to the emergency room by ambulance. Several tests were completed at the ER. Patient was sent home with instructions for rest and fluids. He has been in bed all day since returning home from ER. Patient very tired, difficulty standing-up, walking and not eating much.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test, Metabolic function test normal, Mobility decreased, Syncope, Troponin normal
Clinical narrative: Patient experienced a syncopal episode. Passed-out and hit his head on the floor. He has a hematoma on his head due to the fall. Patient sweating and stated he felt very tired. 911 called and was taken to the emergency room by ambulance. Several tests were completed at the ER. Patient was sent home with instructions for rest and fluids. He has been in bed all day since returning home from ER. Patient very tired, difficulty standing-up, walking and not eating much.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling from left ear down my arm to my left fingers.  It started the afternoon of my second dose and still happens three months later.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Catheterisation cardiac, Chest pain, Dyspnoea, Echocardiogram, Hyperhidrosis
Clinical narrative: Bp 220/190. Profuse sweating at rest. Short of breath. Severe chest pain. No cardiac history. Taken to ER. Given 70 micrograms Nitro drip. Oxy sat of 84.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Myocarditis
Clinical narrative: Bp 220/190. Profuse sweating at rest. Short of breath. Severe chest pain. No cardiac history. Taken to ER. Given 70 micrograms Nitro drip. Oxy sat of 84.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Myopia, Vision blurred
Clinical narrative: Extreme blurry vision- eyes will not focus with our without glasses on. Can?t see far away well. Vision problem is consistent and not intermittent.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Memory impairment, Pyrexia, Vomiting
Clinical narrative: Severe fever of 105.4, loss of consciousness from fever, vomiting.  Fever lowered with multiple ice bags and high dose Tylenol. Fever broke after 48 hours. Memory problems which lasted 4 months after vaccine.  Treatment by at home nurse during the reaction.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: no additional adverse events reported; administration of expired MMR II; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 10-DEC-2021, the patient was administered expired dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) (expired product administered) lot # S035356, expiration date 05-NOV-2021 (formulation, dose number, dose, site and route of administration not reported) for prophylaxis. No additional adverse events were reported.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No additional adverse effect reported; temperature excursions; This spontaneous report was received from a medical assistant concerning a patient of unknown age. No concurrent condition, medical history, or concomitant therapy was reported.  On 29-OCT-2021, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, and route were unknown; lot #T031820, has been verified to be a valid lot number, expiration date reported and confirm upon internal validation as 10-MAY-2022) for prophylaxis following a temperature excursion (product storage error). The reporter did not have any cycling information available, so there wasn't sufficient time and temperature data for evaluation. There was no previous temperature excursion. No adverse event was reported.       This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2112USA009917:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 70-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date on or about 2015, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) by a healthcare provider at the clinic for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unspecified date, the patient was treated by healthcare providers for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: shingles and other zoster-related conditions. The outcome of all the events were not reported. The reporter considered all the events to be related to zoster vaccine live (ZOSTAVAX).
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain of skin, Post herpetic neuralgia, Vaccination failure
Clinical narrative: This spontaneous report was received from a 77-year-old male patient who was also a resident physician via GlaxoSmithKline (US2021240625) referring to himself a 77-year-old male patient. The patient's concurrent condition was not reported. Medical history included herpes zoster. Concomitant therapies included fluticasone propionate (+) salmeterol xinafoate (ADVAIR), ipratropium bromide (+) salbutamol sulfate (DUONEB), metoprolol tartrate (LOPRESSOR), morniflumate (FLOMAX), varenicline tartrate (CHANTIX), atorvastatin calcium (LIPITOR) and apoaequorin (+) colecalciferol (PREVAGEN). On 21-FEB-2011, 03-MAR-2011 and 21-FEB-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) dose 1, 2 and 3 (strength, dose, route, lot #, expiration date and anatomical location not reported) for prophylaxis. On 27-MAR-2019, he was vaccinated with the first dose of varicella zoster vaccine rge (cho) (SHINGRIX) (strength, dose, route, lot #, expiration date and anatomical location not reported) for prophylaxis; and the second dose of varicella zoster vaccine rge (cho) (SHINGRIX) 0.5 ml was vaccinated intramuscularly in deltoid (strength, lot # and expiration date not reported) on 17-JUL-2019 (also reported as about 3 to 4 years ago from reporting date). In November 2021, more than 2 years after receiving varicella zoster vaccine rge (cho) (SHINGRIX), the patient experienced shingles, post herpetic trigeminal neuralgia and suspected vaccination failure. It was reported that sometime last week, he came down with shingles. It was also stated that the symptom dermatomal pain without rash started on 10-NOV-2021. The outcome of shingles and post herpetic trigeminal neuralgia was reported as not recovered. The outcome of suspected vaccination failure was unknown. The causality between the events shingles and post herpetic trigeminal neuralgia with both suspect vaccines were not reported. The causality between suspected vaccination failure with zoster vaccine live (ZOSTAVAX) was considered as related. The causality between suspected vaccination failure with varicella zoster vaccine rge (cho) (SHINGRIX) was not reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided. On 29-DEC-2021, the patient was vaccinated with improperly stored vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD), dose 1, (lot # T027115 and expiration date upon internal validation it was 27-FEB-2022) for prophylaxis (product storage error). The temperature and time frame was (6F to 14F) for 1hour, (14F to 46F) 26F for 1 hours. No any previous temperature excursion. No additional AEs were reported, no further information provided.
Sex: U
Vaccine: VARZOS
Symptoms: Eating disorder, Insomnia, Mobility decreased, Pain in extremity, Tearfulness
Clinical narrative: arm really sore; I could barley even use my arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got shingles at the age of 43 years) and pain.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were unknown.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingles vaccine.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The reporter also stated that, the shingles were far worse and he/she had got shingles at 43 years old and it felt like he/she was being eaten alive (no joke).  It was the most unbearable pain for like 5 solid days and the pain literally consumed the reporter. He/she could not sleep, eat, wear a shirt or even sit still and tears would just stream down the face constantly. After 5 days it was bearable but still was very painful for 2 more full weeks.  The reporter stated that, the 1st shot makes arm really sore and he/she could barley even use the arm for three days. The reporter stated that, he/she would take the shot ten times over just to keep from getting shingles ever again. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (received 1st dose at 60 years and had pain in arm, refer case US2021AMR264864). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 2nd dose 4months apart from 1st dose and his/her arm hurt. The patient truly believed that it was better than suffering with shingles. The follow-up could not be possible as no contact details were available; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR264864:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Illness
Clinical narrative: After I got the shingles; Made me so sick; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and sickness. On an unknown date, the outcome of the shingles and sickness were unknown.   It was unknown if the reporter considered the shingles and sickness to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got one Shingles shot and need 2nd shot.  The patient stated he/she got the shingles. Made so sick. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; developed shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter personally knew the patient, who received Shingles vaccine and developed shingles. The reporter stated that, it was not a vaccination if it did not prevent, it was only another money-making shot. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.    This was 1 of 7 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR265680:Same reporter US-GLAXOSMITHKLINE-US2021AMR265681:Same reporter US-GLAXOSMITHKLINE-US2021AMR265649:Same reporter US-GLAXOSMITHKLINE-US2021AMR265683:Same reporter US-GLAXOSMITHKLINE-US2021AMR265684:Same reporter US-GLAXOSMITHKLINE-US2021AMR265685:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; developed shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter personally knew the patient, who received Shingles vaccine and developed shingles. The reporter stated that, it was not a vaccination if it did not prevent, it was only another money-making shot. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.    This was 1 of 7 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR265680:Same reporter US-GLAXOSMITHKLINE-US2021AMR265681:Same reporter US-GLAXOSMITHKLINE-US2021AMR265682:Same reporter US-GLAXOSMITHKLINE-US2021AMR265649:Same reporter US-GLAXOSMITHKLINE-US2021AMR265684:Same reporter US-GLAXOSMITHKLINE-US2021AMR265685:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; developed shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter personally knew the patient, who received Shingles vaccine and developed shingles. The reporter stated that, it was not a vaccination if it did not prevent, it was only another money-making shot. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.    This was 1 of 7 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR265680:Same reporter US-GLAXOSMITHKLINE-US2021AMR265681:Same reporter US-GLAXOSMITHKLINE-US2021AMR265682:Same reporter US-GLAXOSMITHKLINE-US2021AMR265683:Same reporter US-GLAXOSMITHKLINE-US2021AMR265649:Same reporter US-GLAXOSMITHKLINE-US2021AMR265685:Same reporter