chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Headache, Hyperacusis, Hyperaesthesia
Clinical narrative: Severe joint inflammation & Pain, lasting over 3 months (so far) despite treatment with Diclofenac nsaid & Methylprednisolone Dosepack (2 weeks post-vaccine April 14-19). Severe Daily Vaccine Headache and Migraines (different symptoms & treatments). Daily migraines continuing over 3 months later. Vaccine Headaches Occasionally still. Migraines include sensitivities to light, Sound, Touch, Smell & taste. Frequency of Nurtec ODT & Sumatriptan is rendering them less effective. I have appt with clinic in July 20th after managing chronic migraines for over 12 years. Botox, Aimovig, Bio-identical HRT, Dietary restrictions, Supplements are no longer enough to keep migraines down to moderate levels, JOINT PAIN started next day after vaccine, was not "arthritic achiness", but "joints of FIRE! Waking me out of a Deep Sleep!" pain that some days made it difficult to even walk in the house. (I used to walk a mile several days per week.) Norco resorted to occasionally in order to sleep or function. Steroids decreased severity somewhat, but pain persists. Relief creams used frequently. VACCINE HEADACHES starting day of vaccine, did not have sensory sensitivities (as with Migraine), but were severe. Migraine meds ineffective. Discovered that Cambia (diclofenac powder) did reduce. This is the only nsaid I am able to tolerate. I now take diclofenac tabs (Voltaren) occasionally when HA & joint pain get intolerable. STEROID pack did greatly reduce the severity & frequency of the vaccine headaches, migraines & even the severity of the joint pain. But the moderate joint pain & daily migraines persist. My fear is that the vaccine was a trigger for a lifetime problem that may be disabling. (Note that before my over-reactions, I was a strong promoter for Vaccine, & as Medical Technologist, was quite excited for the new mRNA possibilities.) These are the longer-term effects that have me worried. I also experienced short-term symptoms. Within 5 minutes (no wait in clinic after #2), my entire shot arm had tingling & numbness all the way down, including my hand. Severe arm pain started an hour later & continued for a week. For 2-3 days, fever, chills, extreme fatigue, indicating the vaccine had triggered immune response. Also extreme body weakness; climbing stairs was like climbing a mountain. Joint pain started in previously injured joints (ankles, 1 knee, back) then spread to other joints, including my hands. Knees & ankles remain the worst, sometimes debilitating, along with my lower back. Migraines nearly Daily with meds becoming less effective. Seeking more expert help for this at clinic.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Inflammation, Migraine, Pain in extremity
Clinical narrative: Severe joint inflammation & Pain, lasting over 3 months (so far) despite treatment with Diclofenac nsaid & Methylprednisolone Dosepack (2 weeks post-vaccine April 14-19). Severe Daily Vaccine Headache and Migraines (different symptoms & treatments). Daily migraines continuing over 3 months later. Vaccine Headaches Occasionally still. Migraines include sensitivities to light, Sound, Touch, Smell & taste. Frequency of Nurtec ODT & Sumatriptan is rendering them less effective. I have appt with clinic in July 20th after managing chronic migraines for over 12 years. Botox, Aimovig, Bio-identical HRT, Dietary restrictions, Supplements are no longer enough to keep migraines down to moderate levels, JOINT PAIN started next day after vaccine, was not "arthritic achiness", but "joints of FIRE! Waking me out of a Deep Sleep!" pain that some days made it difficult to even walk in the house. (I used to walk a mile several days per week.) Norco resorted to occasionally in order to sleep or function. Steroids decreased severity somewhat, but pain persists. Relief creams used frequently. VACCINE HEADACHES starting day of vaccine, did not have sensory sensitivities (as with Migraine), but were severe. Migraine meds ineffective. Discovered that Cambia (diclofenac powder) did reduce. This is the only nsaid I am able to tolerate. I now take diclofenac tabs (Voltaren) occasionally when HA & joint pain get intolerable. STEROID pack did greatly reduce the severity & frequency of the vaccine headaches, migraines & even the severity of the joint pain. But the moderate joint pain & daily migraines persist. My fear is that the vaccine was a trigger for a lifetime problem that may be disabling. (Note that before my over-reactions, I was a strong promoter for Vaccine, & as Medical Technologist, was quite excited for the new mRNA possibilities.) These are the longer-term effects that have me worried. I also experienced short-term symptoms. Within 5 minutes (no wait in clinic after #2), my entire shot arm had tingling & numbness all the way down, including my hand. Severe arm pain started an hour later & continued for a week. For 2-3 days, fever, chills, extreme fatigue, indicating the vaccine had triggered immune response. Also extreme body weakness; climbing stairs was like climbing a mountain. Joint pain started in previously injured joints (ankles, 1 knee, back) then spread to other joints, including my hands. Knees & ankles remain the worst, sometimes debilitating, along with my lower back. Migraines nearly Daily with meds becoming less effective. Seeking more expert help for this at clinic.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Parosmia, Photophobia, Pre-existing disease, Pyrexia
Clinical narrative: Severe joint inflammation & Pain, lasting over 3 months (so far) despite treatment with Diclofenac nsaid & Methylprednisolone Dosepack (2 weeks post-vaccine April 14-19). Severe Daily Vaccine Headache and Migraines (different symptoms & treatments). Daily migraines continuing over 3 months later. Vaccine Headaches Occasionally still. Migraines include sensitivities to light, Sound, Touch, Smell & taste. Frequency of Nurtec ODT & Sumatriptan is rendering them less effective. I have appt with clinic in July 20th after managing chronic migraines for over 12 years. Botox, Aimovig, Bio-identical HRT, Dietary restrictions, Supplements are no longer enough to keep migraines down to moderate levels, JOINT PAIN started next day after vaccine, was not "arthritic achiness", but "joints of FIRE! Waking me out of a Deep Sleep!" pain that some days made it difficult to even walk in the house. (I used to walk a mile several days per week.) Norco resorted to occasionally in order to sleep or function. Steroids decreased severity somewhat, but pain persists. Relief creams used frequently. VACCINE HEADACHES starting day of vaccine, did not have sensory sensitivities (as with Migraine), but were severe. Migraine meds ineffective. Discovered that Cambia (diclofenac powder) did reduce. This is the only nsaid I am able to tolerate. I now take diclofenac tabs (Voltaren) occasionally when HA & joint pain get intolerable. STEROID pack did greatly reduce the severity & frequency of the vaccine headaches, migraines & even the severity of the joint pain. But the moderate joint pain & daily migraines persist. My fear is that the vaccine was a trigger for a lifetime problem that may be disabling. (Note that before my over-reactions, I was a strong promoter for Vaccine, & as Medical Technologist, was quite excited for the new mRNA possibilities.) These are the longer-term effects that have me worried. I also experienced short-term symptoms. Within 5 minutes (no wait in clinic after #2), my entire shot arm had tingling & numbness all the way down, including my hand. Severe arm pain started an hour later & continued for a week. For 2-3 days, fever, chills, extreme fatigue, indicating the vaccine had triggered immune response. Also extreme body weakness; climbing stairs was like climbing a mountain. Joint pain started in previously injured joints (ankles, 1 knee, back) then spread to other joints, including my hands. Knees & ankles remain the worst, sometimes debilitating, along with my lower back. Migraines nearly Daily with meds becoming less effective. Seeking more expert help for this at clinic.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Serum ferritin increased, Sleep disorder, Taste disorder, Therapeutic product effect decreased
Clinical narrative: Severe joint inflammation & Pain, lasting over 3 months (so far) despite treatment with Diclofenac nsaid & Methylprednisolone Dosepack (2 weeks post-vaccine April 14-19). Severe Daily Vaccine Headache and Migraines (different symptoms & treatments). Daily migraines continuing over 3 months later. Vaccine Headaches Occasionally still. Migraines include sensitivities to light, Sound, Touch, Smell & taste. Frequency of Nurtec ODT & Sumatriptan is rendering them less effective. I have appt with clinic in July 20th after managing chronic migraines for over 12 years. Botox, Aimovig, Bio-identical HRT, Dietary restrictions, Supplements are no longer enough to keep migraines down to moderate levels, JOINT PAIN started next day after vaccine, was not "arthritic achiness", but "joints of FIRE! Waking me out of a Deep Sleep!" pain that some days made it difficult to even walk in the house. (I used to walk a mile several days per week.) Norco resorted to occasionally in order to sleep or function. Steroids decreased severity somewhat, but pain persists. Relief creams used frequently. VACCINE HEADACHES starting day of vaccine, did not have sensory sensitivities (as with Migraine), but were severe. Migraine meds ineffective. Discovered that Cambia (diclofenac powder) did reduce. This is the only nsaid I am able to tolerate. I now take diclofenac tabs (Voltaren) occasionally when HA & joint pain get intolerable. STEROID pack did greatly reduce the severity & frequency of the vaccine headaches, migraines & even the severity of the joint pain. But the moderate joint pain & daily migraines persist. My fear is that the vaccine was a trigger for a lifetime problem that may be disabling. (Note that before my over-reactions, I was a strong promoter for Vaccine, & as Medical Technologist, was quite excited for the new mRNA possibilities.) These are the longer-term effects that have me worried. I also experienced short-term symptoms. Within 5 minutes (no wait in clinic after #2), my entire shot arm had tingling & numbness all the way down, including my hand. Severe arm pain started an hour later & continued for a week. For 2-3 days, fever, chills, extreme fatigue, indicating the vaccine had triggered immune response. Also extreme body weakness; climbing stairs was like climbing a mountain. Joint pain started in previously injured joints (ankles, 1 knee, back) then spread to other joints, including my hands. Knees & ankles remain the worst, sometimes debilitating, along with my lower back. Migraines nearly Daily with meds becoming less effective. Seeking more expert help for this at clinic.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Paraesthesia
Clinical narrative: ON 07/27/2027 AT 620PM Pt. calls to report that she had episodes of tingling to her fingers of the left hand intermittently on the fourth day after Moderna vaccine administration. Pt. also reports that she had episodes of tingling sensation of the fingers of the right hand, right after administration of the Moderna vaccine which was administered to the right arm on 07/23/2021. After 30 min wait pt . stated that tingling of the right hand fingers had resolved. On 7/27/2021 during the phone conversation pt was instructed to fu with her PCP for tingling sensation of the fingers and if indicated by pcp referral to neruologist for eval of tingling sensation of her fingers . Pt verbalizes understanding and in agreement with plan.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Chest pain, Chills, Diarrhoea
Clinical narrative: 5/13/21 Started stomach flu S/S: n&v, diarrhea for 2 days, then weakness began and was ongoing and still present 6/10/21 Legs started feeling heavy and hurting, no energy. Elbow and knee joint pain, terrible headaches (8-10 on pain scale). Chills but no fever 6/22/21 Chest pain off and on
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram abnormal, Gastroenteritis viral, Headache, Limb discomfort, Nausea
Clinical narrative: 5/13/21 Started stomach flu S/S: n&v, diarrhea for 2 days, then weakness began and was ongoing and still present 6/10/21 Legs started feeling heavy and hurting, no energy. Elbow and knee joint pain, terrible headaches (8-10 on pain scale). Chills but no fever 6/22/21 Chest pain off and on
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: 5/13/21 Started stomach flu S/S: n&v, diarrhea for 2 days, then weakness began and was ongoing and still present 6/10/21 Legs started feeling heavy and hurting, no energy. Elbow and knee joint pain, terrible headaches (8-10 on pain scale). Chills but no fever 6/22/21 Chest pain off and on
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Mobility decreased, Nasopharyngitis, Pain
Clinical narrative: I received the shot on 05/01/2021. For a couple of days I was feeling like I was catching a cold and was very tired. Tuesday morning I was having trouble getting out of bed,walking and going to the bathroom.I called my Dr. and she prescribed a pain medication and a muscle relaxer. A couple of days after I went to her office. She gave me more medication and referral for aqua therapy. As of today i am still unable to sit or stand for very long. There are nights that I can't sleep. All of the pain i am referring to is on the right side of my body.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hospitalisation
Clinical narrative: 1st shot server reaction went too hospital
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Patient came in for second COVID vaccine. Patient verbalized that he received is first dose Moderna vaccine on 6/12/2021. RN used state immunization system to verify receipt of a covid vaccine and type given. Documentation in system was Moderna as the vaccine given on 6/12/2021. RN administered the Moderna vaccine to patient. Before leaving clinic, patient presented his vaccine card from 6/12/2021 that showed Pfizer as vaccine given, which was also consistent with patient's signed registration /vaccine administration paperwork from 6/12/2021 (verified by RN). Patient received Pfizer vaccines on 6/12/2021 and Moderna vaccine on 7/13/2021. Patient displayed no adverse reactions.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Fall, Gout, Laboratory test, Muscular weakness
Clinical narrative: Severe back pain, body tremors, leg weakness causing falls, loss of use of fingers and loss of all hand sensation making it impossible to pick up or grasp items, gout flare up, vision changes
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Visual impairment
Clinical narrative: Severe back pain, body tremors, leg weakness causing falls, loss of use of fingers and loss of all hand sensation making it impossible to pick up or grasp items, gout flare up, vision changes
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Dysgeusia, Magnetic resonance imaging head normal, SARS-CoV-2 test negative
Clinical narrative: Gradual onset of loss of taste early 2021, patient thinks after first COVID vaccine 2/26/2021. Continuous symptom. Worsened over first several weeks and then plateaued and has stayed stable. CHaracter is " everything tastes like metal" and "can't taste anything." No previous dysgeusia. COVID antigen test for these symptoms reported as negative twice. No headache, diplopia, new or worse dysphagia, dysarthria, numbness, tingling, lateralizing neurologic dysfunction, weight loss, or fever.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: Pt received vaccine was instructed to wait the required time. Within 10 minutes patient stated her throat was starting to close. He friend alerted the medical staff and was immediately taken to our emergency room. Vitals taken, examined by physician, epi pen 0.3mg given. Within few minutes patient stated she was feeling better and could swallow. Pt was monitored for 30 minutes and rechecked by physician and released home.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Contusion, Culture urine, Differential white blood cell count, Ecchymosis
Clinical narrative: 4/4/21 - ITCH HANDS - NIGHT - CLARITIN 4/5/21 - WORSE - Hands & Feet - continued with CLARITIN 4/6/21 - Called PCP office - use Benadryl - (ALL BODY) 4/9/21 - ER - Dx. Pruritus -    Test - Estimated Glomerular Filtration Rate          - Basic Metabolic Panel - BMP          -CBC WITH DIFF  D/C with FAMOTIDINE 20MG, Prednisone 20MG, Omeprazole 4/10/21 ER DX. FLANK PAIN, BACK PAIN  Tests - Urinalysis with Reflex CULTURE  D/C with MEDS Famotidine 20MG, Omeprazole 20mg, Prednisone 20MG x2 4/14/21 - PCP visit - Finish Prednisone, start Medrol 4/15/21, continue Zyrtec, add Benadryl if needed, Platelets - X-ray. 4/19/21 - ECCHYMOSIS, SKIN PROBLEM - ER (Bruise)              - Estimated Glomerular, Filtration Rate              - Basix Metabolic Panel - BMP              - CBC WITH Diff.              - Hepatic Function Panel              - PT-INR) Prothrombin Time)     D/C with meds - Omeprazole 20mg  Last Zyrtec was on May 4, 2021 - Had some itch every-so-often after that. Itch gone by the middle of May 2021. AMEN!
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Flank pain, Full blood count, Glomerular filtration rate, International normalised ratio, Liver function test
Clinical narrative: 4/4/21 - ITCH HANDS - NIGHT - CLARITIN 4/5/21 - WORSE - Hands & Feet - continued with CLARITIN 4/6/21 - Called PCP office - use Benadryl - (ALL BODY) 4/9/21 - ER - Dx. Pruritus -    Test - Estimated Glomerular Filtration Rate          - Basic Metabolic Panel - BMP          -CBC WITH DIFF  D/C with FAMOTIDINE 20MG, Prednisone 20MG, Omeprazole 4/10/21 ER DX. FLANK PAIN, BACK PAIN  Tests - Urinalysis with Reflex CULTURE  D/C with MEDS Famotidine 20MG, Omeprazole 20mg, Prednisone 20MG x2 4/14/21 - PCP visit - Finish Prednisone, start Medrol 4/15/21, continue Zyrtec, add Benadryl if needed, Platelets - X-ray. 4/19/21 - ECCHYMOSIS, SKIN PROBLEM - ER (Bruise)              - Estimated Glomerular, Filtration Rate              - Basix Metabolic Panel - BMP              - CBC WITH Diff.              - Hepatic Function Panel              - PT-INR) Prothrombin Time)     D/C with meds - Omeprazole 20mg  Last Zyrtec was on May 4, 2021 - Had some itch every-so-often after that. Itch gone by the middle of May 2021. AMEN!
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Platelet count, Prothrombin time, Pruritus, Skin disorder
Clinical narrative: 4/4/21 - ITCH HANDS - NIGHT - CLARITIN 4/5/21 - WORSE - Hands & Feet - continued with CLARITIN 4/6/21 - Called PCP office - use Benadryl - (ALL BODY) 4/9/21 - ER - Dx. Pruritus -    Test - Estimated Glomerular Filtration Rate          - Basic Metabolic Panel - BMP          -CBC WITH DIFF  D/C with FAMOTIDINE 20MG, Prednisone 20MG, Omeprazole 4/10/21 ER DX. FLANK PAIN, BACK PAIN  Tests - Urinalysis with Reflex CULTURE  D/C with MEDS Famotidine 20MG, Omeprazole 20mg, Prednisone 20MG x2 4/14/21 - PCP visit - Finish Prednisone, start Medrol 4/15/21, continue Zyrtec, add Benadryl if needed, Platelets - X-ray. 4/19/21 - ECCHYMOSIS, SKIN PROBLEM - ER (Bruise)              - Estimated Glomerular, Filtration Rate              - Basix Metabolic Panel - BMP              - CBC WITH Diff.              - Hepatic Function Panel              - PT-INR) Prothrombin Time)     D/C with meds - Omeprazole 20mg  Last Zyrtec was on May 4, 2021 - Had some itch every-so-often after that. Itch gone by the middle of May 2021. AMEN!
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis, X-ray
Clinical narrative: 4/4/21 - ITCH HANDS - NIGHT - CLARITIN 4/5/21 - WORSE - Hands & Feet - continued with CLARITIN 4/6/21 - Called PCP office - use Benadryl - (ALL BODY) 4/9/21 - ER - Dx. Pruritus -    Test - Estimated Glomerular Filtration Rate          - Basic Metabolic Panel - BMP          -CBC WITH DIFF  D/C with FAMOTIDINE 20MG, Prednisone 20MG, Omeprazole 4/10/21 ER DX. FLANK PAIN, BACK PAIN  Tests - Urinalysis with Reflex CULTURE  D/C with MEDS Famotidine 20MG, Omeprazole 20mg, Prednisone 20MG x2 4/14/21 - PCP visit - Finish Prednisone, start Medrol 4/15/21, continue Zyrtec, add Benadryl if needed, Platelets - X-ray. 4/19/21 - ECCHYMOSIS, SKIN PROBLEM - ER (Bruise)              - Estimated Glomerular, Filtration Rate              - Basix Metabolic Panel - BMP              - CBC WITH Diff.              - Hepatic Function Panel              - PT-INR) Prothrombin Time)     D/C with meds - Omeprazole 20mg  Last Zyrtec was on May 4, 2021 - Had some itch every-so-often after that. Itch gone by the middle of May 2021. AMEN!
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Clostridium test, Impaired work ability, Occult blood, Parasite stool test
Clinical narrative: I have had intermittent breathing, reflux, nausea (like morning sickness) and major diarrhea since having Covid. Exposed Jan 3, 2021. Person who exposed me found out their 1/4/21 test was +. I tested Ned on 1/8/21 but on 1/10/21 started not breathing well at all. Got tested and it was now +. No cough but head and body aches, lots of diarrhea and nausea and major breathing issues. NO ER. I have my own nebulizer and treatments. Note: I was even on a Z pack since 12/31/21 for upper respiratory issues when I contracted Covid. Since the second shot on 4-9-21 ALL of these symptoms came back and I missed several days of work in April due to the side effects.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory disorder, Symptom recurrence
Clinical narrative: I have had intermittent breathing, reflux, nausea (like morning sickness) and major diarrhea since having Covid. Exposed Jan 3, 2021. Person who exposed me found out their 1/4/21 test was +. I tested Ned on 1/8/21 but on 1/10/21 started not breathing well at all. Got tested and it was now +. No cough but head and body aches, lots of diarrhea and nausea and major breathing issues. NO ER. I have my own nebulizer and treatments. Note: I was even on a Z pack since 12/31/21 for upper respiratory issues when I contracted Covid. Since the second shot on 4-9-21 ALL of these symptoms came back and I missed several days of work in April due to the side effects.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Computerised tomogram, Deafness permanent, Deafness unilateral, Headache
Clinical narrative: One week and a day after receiving the vaccine, I was running an indoor track meet. Following the race (400 meters, masked), I had an intense headache, and then hearing loss in my right ear. The headache went away within minutes; the hearing loss turned out to be permanent.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Magnetic resonance imaging
Clinical narrative: One week and a day after receiving the vaccine, I was running an indoor track meet. Following the race (400 meters, masked), I had an intense headache, and then hearing loss in my right ear. The headache went away within minutes; the hearing loss turned out to be permanent.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: 08-03-2021 / 0854 - Patient received Moderna vaccine 0.5 ml / lot 088D21A - Error because patient received Pfizer on 2/10/21 lot EL9261
Age: 0.58
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; Moderna Covid-19 monovalent were administered BUD/Patient was given Moderna Covid vaccine within 4 days of expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD/Patient was given Moderna Covid vaccine within 4 days of expiration date.) and NO ADVERSE EVENT (No Adverse Event) in a 7-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1412B and AS1412B) for COVID-19 prophylaxis.     Patient never been diagnosed or tested positive for COVID-19. Patient had none acute and Chronic illness at the time of vaccination and up to one month before.  Concomitant products included INFLUENZA VACCINE (FLUZONE [INFLUENZA VACCINE]) for an unknown indication.   On 04-Jan-2023 at 3:16 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 08-Feb-2023 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 08-Feb-2023 at 3:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD/Patient was given Moderna Covid vaccine within 4 days of expiration date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD/Patient was given Moderna Covid vaccine within 4 days of expiration date.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD/Patient was given Moderna Covid vaccine within 4 days of expiration date.) and NO ADVERSE EVENT (No Adverse Event) to be not related.    No concomitant information was reported. Anatomical site given as for both vaccines LVL. The event did not cause the patient to seek medical care. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713271 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Live significant follow-up appended - Patient demographics updated On 28-Feb-2023: Live follow-up appended On 28-Feb-2023: Live follow-up appended On 04-Apr-2023: Significant follow-up: Dosage information, reporter updated and Event details updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713271:Patient 13
Age: 0.67
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; Moderna Covid-19 monovalent were administered BUD/Patient was given Moderna Covid vaccine within 4 days of expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD/Patient was given Moderna Covid vaccine within 4 days of expiration date) and NO ADVERSE EVENT (No Adverse Event) in an 8-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1412B and AS1412B) for COVID-19 prophylaxis.     Patient had no chronic or long-standing health condition.  Patient had no acute illness at the time of vaccination and up to one month before.  The patient never been diagnosed with/ tested positive for COVID-19.    On 07-Feb-2023 at 10:03 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 08-Mar-2023 at 2:33 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 07-Feb-2023 at 10:03 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD/Patient was given Moderna Covid vaccine within 4 days of expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD/Patient was given Moderna Covid vaccine within 4 days of expiration date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD/Patient was given Moderna Covid vaccine within 4 days of expiration date).    Concomitant medications details were not reported by the reporter. This case contains information for the 5th of 15 patients reported by the reporter. Treatment details were not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-713271 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Live significant follow-up appended - Patient demographics updated On 28-Feb-2023: Live follow-up appended On 28-Feb-2023: Live follow-up appended On 04-Apr-2023: Reporter Information and Patient Details were added. Vaccine Information, event verbatim and narrative were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713271:Patient 5
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: LOUD RINGING IN EARS
Age: 63.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Muscle spasms, Musculoskeletal stiffness, Neck pain, Neuralgia
Clinical narrative: Systemic: Altered taste to acidic/hot temperature foods-hyperguesia-was told to report to the clinic to report to VAERS-didnt start til 3/2023-Mild
Age: 63.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Hypergeusia, Taste disorder
Clinical narrative: Systemic: Altered taste to acidic/hot temperature foods-hyperguesia-was told to report to the clinic to report to VAERS-didnt start til 3/2023-Mild
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Dry mouth, Fatigue, Malaise
Clinical narrative: Neuropathy; Fatigue; Dry mouth; Heart racing/ heart palpitations; I am not feeling good; Heart issues; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "Neuropathy"; FATIGUE (non-serious), outcome "unknown"; DRY MOUTH (non-serious), outcome "unknown"; PALPITATIONS (non-serious), outcome "unknown", described as "Heart racing/ heart palpitations"; MALAISE (non-serious), outcome "unknown", described as "I am not feeling good"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "Heart issues". The events "neuropathy", "fatigue", "dry mouth", "heart racing/ heart palpitations", "i am not feeling good" and "heart issues" required physician office visit. Therapeutic measures were not taken as a result of neuropathy peripheral, fatigue, dry mouth, palpitations, malaise, cardiac disorder. Clinical Course: Patient states she got 2 Pfizer shots. (Covid Vaccine) she want to say that back in 2020 when it first came out. But lately they have noticed like fatigue a lot and dry mouth a lot and her heart was racing and she had heart palpitations and she never had that before." Treatment: Consumer stated, "No, she had those symptoms going on from the past few days. She put a phone call to her BPT doctor to let them know. He knows she had been having problems. She also got neuropathy from him soon. Patient stated, she was told by her own PCT doctor that the symptoms she was having and then she started having were due to the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19  are  related to BNT162b2 cannot be excluded.  This case will be reassessed should additional information become available.,Linked Report(s) : US-PFIZER INC-202300130563 same patient and drug, different event/ dose;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Movement disorder, Palpitations
Clinical narrative: Neuropathy; Fatigue; Dry mouth; Heart racing/ heart palpitations; I am not feeling good; Heart issues; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "Neuropathy"; FATIGUE (non-serious), outcome "unknown"; DRY MOUTH (non-serious), outcome "unknown"; PALPITATIONS (non-serious), outcome "unknown", described as "Heart racing/ heart palpitations"; MALAISE (non-serious), outcome "unknown", described as "I am not feeling good"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "Heart issues". The events "neuropathy", "fatigue", "dry mouth", "heart racing/ heart palpitations", "i am not feeling good" and "heart issues" required physician office visit. Therapeutic measures were not taken as a result of neuropathy peripheral, fatigue, dry mouth, palpitations, malaise, cardiac disorder. Clinical Course: Patient states she got 2 Pfizer shots. (Covid Vaccine) she want to say that back in 2020 when it first came out. But lately they have noticed like fatigue a lot and dry mouth a lot and her heart was racing and she had heart palpitations and she never had that before." Treatment: Consumer stated, "No, she had those symptoms going on from the past few days. She put a phone call to her BPT doctor to let them know. He knows she had been having problems. She also got neuropathy from him soon. Patient stated, she was told by her own PCT doctor that the symptoms she was having and then she started having were due to the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19  are  related to BNT162b2 cannot be excluded.  This case will be reassessed should additional information become available.,Linked Report(s) : US-PFIZER INC-202300130563 same patient and drug, different event/ dose;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Dry mouth, Fatigue, Malaise, Neuropathy peripheral
Clinical narrative: Neuropathy; Fatigue; Dry mouth; Heart racing/ heart palpitations; I am not feeling good; Heart issues; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "Neuropathy"; FATIGUE (non-serious), outcome "unknown"; DRY MOUTH (non-serious), outcome "unknown"; PALPITATIONS (non-serious), outcome "unknown", described as "Heart racing/ heart palpitations"; MALAISE (non-serious), outcome "unknown", described as "I am not feeling good"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "Heart issues". The events "neuropathy", "fatigue", "dry mouth", "heart racing/ heart palpitations", "i am not feeling good" and "heart issues" required physician office visit. Therapeutic measures were not taken as a result of neuropathy peripheral, fatigue, dry mouth, palpitations, malaise, cardiac disorder. Clinical Course: Patient states she got 2 Pfizer shots. (Covid Vaccine) she want to say that back in 2020 when it first came out. But lately they have noticed like fatigue a lot and dry mouth a lot and her heart was racing and she had heart palpitations and she never had that before." Treatment: Consumer stated, "No, she had those symptoms going on from the past few days. She put a phone call to her BPT doctor to let them know. He knows she had been having problems. She also got neuropathy from him soon. Patient stated, she was told by her own PCT doctor that the symptoms she was having and then she started having were due to the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19  are  related to BNT162b2 cannot be excluded.  This case will be reassessed should additional information become available.,Linked Report(s) : US-PFIZER INC-202300130563 same patient and drug, different event/ dose;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: Neuropathy; Fatigue; Dry mouth; Heart racing/ heart palpitations; I am not feeling good; Heart issues; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "Neuropathy"; FATIGUE (non-serious), outcome "unknown"; DRY MOUTH (non-serious), outcome "unknown"; PALPITATIONS (non-serious), outcome "unknown", described as "Heart racing/ heart palpitations"; MALAISE (non-serious), outcome "unknown", described as "I am not feeling good"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "Heart issues". The events "neuropathy", "fatigue", "dry mouth", "heart racing/ heart palpitations", "i am not feeling good" and "heart issues" required physician office visit. Therapeutic measures were not taken as a result of neuropathy peripheral, fatigue, dry mouth, palpitations, malaise, cardiac disorder. Clinical Course: Patient states she got 2 Pfizer shots. (Covid Vaccine) she want to say that back in 2020 when it first came out. But lately they have noticed like fatigue a lot and dry mouth a lot and her heart was racing and she had heart palpitations and she never had that before." Treatment: Consumer stated, "No, she had those symptoms going on from the past few days. She put a phone call to her BPT doctor to let them know. He knows she had been having problems. She also got neuropathy from him soon. Patient stated, she was told by her own PCT doctor that the symptoms she was having and then she started having were due to the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19  are  related to BNT162b2 cannot be excluded.  This case will be reassessed should additional information become available.,Linked Report(s) : US-PFIZER INC-202300130563 same patient and drug, different event/ dose;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Stroke".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Twinrix on Aug2022; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 32-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received on August 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Twinrix on Aug2022). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-MAR-2023 The pharmacist had a patient who received one dose of Twinrix and then Heplisav on January 2023. At the moment of the call, the health care professional (HCP) was not on the pharmacy, so it was not possible to had details such as Twinrix lot number or patient´s date of birth. The reporter consented to follow up via email.    Till the time of reporting, the patient did not receive 2nd dose of Twinrix (for Hepatitis A component), which led to incomplete course of vaccination
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only liquid portion given; Only liquid portion given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) (batch number JN93X, expiry date 07-JUL-2024) for prophylaxis.   On 27-MAR-2023, the patient received Shingrix. On 27-MAR-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Only liquid portion given) and inappropriate dose of vaccine administered (Verbatim: Only liquid portion given). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-MAR-2023 The reporter reported that the patient was administered only with the liquid portion. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter asked how to proceed. The vaccine administration facility is the same as primary reporter. The reporter did not consent to follow up.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Reconstituted with Sterile Diluent; Reconstituted with Sterile Diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 28-MAR-2023, the patient received Menveo. On 28-MAR-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Reconstituted with Sterile Diluent) and inappropriate dose of vaccine administered (Verbatim: Reconstituted with Sterile Diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 28-MAR-2023 The health care professional (HCP) reported that a patient received the 2-vial Presentation of Menveo reconstituted with sterile diluent instead of the supplied Liquid conjugate. No reactions reported. The reporter did not consent to follow-up. The patient 2-vial Presentation of Menveo reconstituted with sterile diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired Menveo administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 22-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA701A, expiry date 28-FEB-2023) for prophylaxis.   On 01-MAR-2023, the patient received Menveo. On 01-MAR-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Expired Menveo administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 29-MAR-2023 The licensed vocational nurse (LVN) reported that a patient received an expired dose of Menveo. The reporter consented to follow up via email. The patient received an expired dose of Menveo, which led to expired vaccine used.
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 20-year-old male patient who received Men B NVS (Bexsero) (batch number 59M3M, expiry date 28-FEB-2023) for prophylaxis.   On 29-MAR-2023, the patient received the 1st dose of Bexsero. On 29-MAR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Bexsero administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-MAR-2023 A medical assistant called in to report that a patient was accidentally administered an expired dose of Bexsero.  Information about vaccine and patient was given. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.      The patient accidentally received expired dose of Bexsero, which led to expired vaccine used
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Bexsero given 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 11-year-old male patient who received Men B NVS (Bexsero) (batch number 25DB5, expiry date 31-JUL-2025) for prophylaxis.   On 29-MAR-2023, the patient received the 1st dose of Bexsero (intramuscular, unknown arm) .5 mg/ml. On 29-MAR-2023, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Bexsero given instead of Menveo). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 29-MAR-2023 The nurse reported the administering nurse reports she misunderstood the physician and gave the Bexsero vaccine instead of Menveo, in an unknown arm.   The nurse reported the mother of the patient was aware that her patient received a different vaccine than the physician ordered.  No further comment. Both the reporter and the physician gave permission for GlaxoSmithKline (GSK) to contact them in this case. The patient received Bexsero instead of Menveo, which led to wrong vaccine administered.