chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Blood test, Chest pain, Electrocardiogram, Heart rate increased
Clinical narrative: Angina; chest pain; fast heartbeat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 07Feb2022 (Lot number: FL3198) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Hypertension. Concomitant medication(s) included: AMLODIPINE taken for hypertension. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer, LOT# (First shot): ER8736, Anatomical Location: Left arm), for covid 19 immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer, LOT# (Second shot): Consumer stated, "It might be FC3180 (Later clarified as FC3180).", Anatomical Location: Left arm), for covid 19 immunization. The following information was reported: ANGINA PECTORIS (medically significant) with onset 08Feb2022, outcome "unknown", described as "Angina"; CHEST PAIN (non-serious) with onset 08Feb2022, outcome "unknown", described as "chest pain"; HEART RATE INCREASED (non-serious) with onset 08Feb2022, outcome "unknown", described as "fast heartbeat ". The events "angina", "chest pain" and "fast heartbeat " were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: unknown result; electrocardiogram: unknown result. Patient had to go to the Emergency Room the next day because of fast heartbeat and Angina, chest pain.  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute motor axonal neuropathy, Basophil count decreased, Basophil percentage increased, Blood copper normal, Blood zinc normal
Clinical narrative: bilateral upper extremity weakness. He reports being in his usual state of health until late July- early August 2021 in which he started to notice his hands were weaker and he was having trouble at work . He received his J&J vaccine on July 8th. He feels that his weakness peaked around August and has been fairly stable since that time. Denies any sensory symptoms such as numbness, tingling, pain. Denies swallowing or breathing issues and never had any lower extremity weakness.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electromyogram, Eosinophil count decreased, Eosinophil percentage increased, Full blood count, Guillain-Barre syndrome
Clinical narrative: bilateral upper extremity weakness. He reports being in his usual state of health until late July- early August 2021 in which he started to notice his hands were weaker and he was having trouble at work . He received his J&J vaccine on July 8th. He feels that his weakness peaked around August and has been fairly stable since that time. Denies any sensory symptoms such as numbness, tingling, pain. Denies swallowing or breathing issues and never had any lower extremity weakness.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haematocrit decreased, Loss of personal independence in daily activities, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal, Muscular weakness
Clinical narrative: bilateral upper extremity weakness. He reports being in his usual state of health until late July- early August 2021 in which he started to notice his hands were weaker and he was having trouble at work . He received his J&J vaccine on July 8th. He feels that his weakness peaked around August and has been fairly stable since that time. Denies any sensory symptoms such as numbness, tingling, pain. Denies swallowing or breathing issues and never had any lower extremity weakness.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Scan with contrast normal, Treponema test negative
Clinical narrative: bilateral upper extremity weakness. He reports being in his usual state of health until late July- early August 2021 in which he started to notice his hands were weaker and he was having trouble at work . He received his J&J vaccine on July 8th. He feels that his weakness peaked around August and has been fairly stable since that time. Denies any sensory symptoms such as numbness, tingling, pain. Denies swallowing or breathing issues and never had any lower extremity weakness.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal, Muscular weakness
Clinical narrative: bilateral upper extremity weakness. He reports being in his usual state of health until late July- early August 2021 in which he started to notice his hands were weaker and he was having trouble at work . He received his J&J vaccine on July 8th. He feels that his weakness peaked around August and has been fairly stable since that time. Denies any sensory symptoms such as numbness, tingling, pain. Denies swallowing or breathing issues and never had any lower extremity weakness.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness, Tinnitus
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Aug2021 11:00 (Lot number: FD0809) at the age of 48 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Sinusitis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: CLARITIN D 12 HOUR. Past drug history included: Ceftin, reaction(s): "Known allergies: Ceftin". The following information was reported: DEAFNESS (medically significant) with onset Feb2022, outcome "not recovered", described as "moderate hearing loss"; TINNITUS (non-serious) with onset 26Aug2021 13:00, outcome "not recovered", described as "ear ringing". The events "moderate hearing loss" and "ear ringing" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: acoustic stimulation tests: (Feb2022) moderate hearing loss; sars-cov-2 test: (unspecified date) unknown result, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of deafness, tinnitus. Clinical course: 2 hours after first vaccine ear ringing started. 6 months later ears are still ringing. Hearing test Feb2022 moderate hearing loss.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Deafness, SARS-CoV-2 test, Tinnitus
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Aug2021 11:00 (Lot number: FD0809) at the age of 48 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Sinusitis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: CLARITIN D 12 HOUR. Past drug history included: Ceftin, reaction(s): "Known allergies: Ceftin". The following information was reported: DEAFNESS (medically significant) with onset Feb2022, outcome "not recovered", described as "moderate hearing loss"; TINNITUS (non-serious) with onset 26Aug2021 13:00, outcome "not recovered", described as "ear ringing". The events "moderate hearing loss" and "ear ringing" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: acoustic stimulation tests: (Feb2022) moderate hearing loss; sars-cov-2 test: (unspecified date) unknown result, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of deafness, tinnitus. Clinical course: 2 hours after first vaccine ear ringing started. 6 months later ears are still ringing. Hearing test Feb2022 moderate hearing loss.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fall, Feeling abnormal, Pyrexia, Syncope
Clinical narrative: IMPRESSION:  1. Malignant neoplasm of upper lobe of left lung (HCC) (Primary) -     CT Chest wo Contrast; Future; Expected date: 04/26/2022   2. Metastatic cancer to bone (HCC)   3. Lung cancer metastatic to brain (HCC)   4. Renal mass of unknown nature   5. Encounter for antineoplastic chemotherapy      1)  Current status: Known to have progressive disease by 1/13/22 CT but not 1/5/2022 MRI brain.  Started alimita 2/1/22.  She received B12 1/4/22.   - Will give B12 and cycle 3 today.  -- CT and MRI after cycle 4.  2) Arthritis and myositis resolved and off steroids.  Noted improvement in ESR and CRP, and negative CK.  - Repeat today.    PLAN:    1. Diagnostics: I obtained or arranged the following:  Add CK, ESR and CRP to chemotherapy labs.   I plan a NC CT CAP, and MRI after 4 tx (after vacation) and before a bit dealyed cycle 5.  2. Therapeutics:   Alimita q 21 to started 2/1/22.  Reduce for age?   CRE has been good.  Due for B12   3. Referrals:  None 4. RTN: Three weeks     CC:     Feels good now, but one day after COVID 4-fever and fainted.  Injured right shoulder, face and left rib.  Now with mild rib pain only (and bruise on face).  INTERVAL HISTORY:   Alimta given and steroids held.   ROS:           Review of Systems  Constitutional: Positive for malaise/fatigue. Negative for chills and fever.  HENT: Negative for sore throat.   Eyes: Negative for blurred vision.  Respiratory: Negative for shortness of breath.   Cardiovascular: Negative for chest pain and leg swelling.  Gastrointestinal: Negative for constipation, diarrhea, nausea and vomiting.  Genitourinary: Negative for dysuria.  Musculoskeletal: Negative for falls, joint pain and myalgias.  Neurological: Positive for tremors. Negative for tingling and weakness.  Psychiatric/Behavioral: Negative for depression (mood is improved. ).    The patient reports no joint pain
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest injury, Contusion, Face injury, Fatigue, Limb injury
Clinical narrative: IMPRESSION:  1. Malignant neoplasm of upper lobe of left lung (HCC) (Primary) -     CT Chest wo Contrast; Future; Expected date: 04/26/2022   2. Metastatic cancer to bone (HCC)   3. Lung cancer metastatic to brain (HCC)   4. Renal mass of unknown nature   5. Encounter for antineoplastic chemotherapy      1)  Current status: Known to have progressive disease by 1/13/22 CT but not 1/5/2022 MRI brain.  Started alimita 2/1/22.  She received B12 1/4/22.   - Will give B12 and cycle 3 today.  -- CT and MRI after cycle 4.  2) Arthritis and myositis resolved and off steroids.  Noted improvement in ESR and CRP, and negative CK.  - Repeat today.    PLAN:    1. Diagnostics: I obtained or arranged the following:  Add CK, ESR and CRP to chemotherapy labs.   I plan a NC CT CAP, and MRI after 4 tx (after vacation) and before a bit dealyed cycle 5.  2. Therapeutics:   Alimita q 21 to started 2/1/22.  Reduce for age?   CRE has been good.  Due for B12   3. Referrals:  None 4. RTN: Three weeks     CC:     Feels good now, but one day after COVID 4-fever and fainted.  Injured right shoulder, face and left rib.  Now with mild rib pain only (and bruise on face).  INTERVAL HISTORY:   Alimta given and steroids held.   ROS:           Review of Systems  Constitutional: Positive for malaise/fatigue. Negative for chills and fever.  HENT: Negative for sore throat.   Eyes: Negative for blurred vision.  Respiratory: Negative for shortness of breath.   Cardiovascular: Negative for chest pain and leg swelling.  Gastrointestinal: Negative for constipation, diarrhea, nausea and vomiting.  Genitourinary: Negative for dysuria.  Musculoskeletal: Negative for falls, joint pain and myalgias.  Neurological: Positive for tremors. Negative for tingling and weakness.  Psychiatric/Behavioral: Negative for depression (mood is improved. ).    The patient reports no joint pain
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Musculoskeletal chest pain, Pyrexia, Syncope, Tremor
Clinical narrative: IMPRESSION:  1. Malignant neoplasm of upper lobe of left lung (HCC) (Primary) -     CT Chest wo Contrast; Future; Expected date: 04/26/2022   2. Metastatic cancer to bone (HCC)   3. Lung cancer metastatic to brain (HCC)   4. Renal mass of unknown nature   5. Encounter for antineoplastic chemotherapy      1)  Current status: Known to have progressive disease by 1/13/22 CT but not 1/5/2022 MRI brain.  Started alimita 2/1/22.  She received B12 1/4/22.   - Will give B12 and cycle 3 today.  -- CT and MRI after cycle 4.  2) Arthritis and myositis resolved and off steroids.  Noted improvement in ESR and CRP, and negative CK.  - Repeat today.    PLAN:    1. Diagnostics: I obtained or arranged the following:  Add CK, ESR and CRP to chemotherapy labs.   I plan a NC CT CAP, and MRI after 4 tx (after vacation) and before a bit dealyed cycle 5.  2. Therapeutics:   Alimita q 21 to started 2/1/22.  Reduce for age?   CRE has been good.  Due for B12   3. Referrals:  None 4. RTN: Three weeks     CC:     Feels good now, but one day after COVID 4-fever and fainted.  Injured right shoulder, face and left rib.  Now with mild rib pain only (and bruise on face).  INTERVAL HISTORY:   Alimta given and steroids held.   ROS:           Review of Systems  Constitutional: Positive for malaise/fatigue. Negative for chills and fever.  HENT: Negative for sore throat.   Eyes: Negative for blurred vision.  Respiratory: Negative for shortness of breath.   Cardiovascular: Negative for chest pain and leg swelling.  Gastrointestinal: Negative for constipation, diarrhea, nausea and vomiting.  Genitourinary: Negative for dysuria.  Musculoskeletal: Negative for falls, joint pain and myalgias.  Neurological: Positive for tremors. Negative for tingling and weakness.  Psychiatric/Behavioral: Negative for depression (mood is improved. ).    The patient reports no joint pain
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Myocarditis, Troponin increased
Clinical narrative: Myocarditis. Presented to ED with 3 days of progressive substernal chest pain starting the day after he received the second vaccine. Chest pain episodes were intermittent, happening at times of rest, would last 1.5-3 hours, resolving spontaneously. Chest pain episodes associated with shortness of breath, mild nausea, diaphoresis and feelings of racing heart. Admitted for observation and treated with as needed NSAIDs and a dose of corticosteroid.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Echocardiogram normal, Electrocardiogram normal, Hyperhidrosis
Clinical narrative: Myocarditis. Presented to ED with 3 days of progressive substernal chest pain starting the day after he received the second vaccine. Chest pain episodes were intermittent, happening at times of rest, would last 1.5-3 hours, resolving spontaneously. Chest pain episodes associated with shortness of breath, mild nausea, diaphoresis and feelings of racing heart. Admitted for observation and treated with as needed NSAIDs and a dose of corticosteroid.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Nausea, Palpitations, Troponin increased
Clinical narrative: Myocarditis. Presented to ED with 3 days of progressive substernal chest pain starting the day after he received the second vaccine. Chest pain episodes were intermittent, happening at times of rest, would last 1.5-3 hours, resolving spontaneously. Chest pain episodes associated with shortness of breath, mild nausea, diaphoresis and feelings of racing heart. Admitted for observation and treated with as needed NSAIDs and a dose of corticosteroid.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dysmenorrhoea, Heavy menstrual bleeding, Hypomenorrhoea, Vaccine positive rechallenge
Clinical narrative: I usually don?t get periods because I?m on the depo shot and this also happened to me after I got my second shot. My period has been going for 3 weeks now and will come out of no where with horrible cramps and passing clots and goes back and forth from very light flow to open the flood gates flow. Very uncomfortable and last time it did not return to normal until after I got my next depo birth control shot.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Rash, Rash erythematous, Rash papular
Clinical narrative: Day after receiving booster, I had a 104 temperature with flu like symptoms. Symptoms lessened on day two but a severe headache continued for two days. On 3/15 my right arm started to have raised red bumps that only got worse each day following. By 3/20 the rash had spread to both arms and chest. Advice prescribed Zyrtec. No relief from Zyrtec and on 3/21 the rash had spread to my stomach. As of today, 3/24 the rash continues to itch and is all over my body. Advice prescribed a med but  it take it because i am allergic to steroids!
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Day after receiving booster, I had a 104 temperature with flu like symptoms. Symptoms lessened on day two but a severe headache continued for two days. On 3/15 my right arm started to have raised red bumps that only got worse each day following. By 3/20 the rash had spread to both arms and chest. Advice prescribed Zyrtec. No relief from Zyrtec and on 3/21 the rash had spread to my stomach. As of today, 3/24 the rash continues to itch and is all over my body. Advice prescribed a med but  it take it because i am allergic to steroids!
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Arthralgia, Depression, Dyspnoea, Exercise tolerance decreased
Clinical narrative: Chronic fatigue, brain fog, exercise intolerance, anxiety, depression, frequent menses, headaches, shortness of breath, chronic left shoulder pain.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Polymenorrhoea
Clinical narrative: Chronic fatigue, brain fog, exercise intolerance, anxiety, depression, frequent menses, headaches, shortness of breath, chronic left shoulder pain.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient failed to inform staff that they had previously received covid booster and booster was administered. Patient did not have original vaccine card. When records were pulled, previous booster dose was in records. So booster dose given on 3/24/22 was a second booster. patient observed for 15 minutes. AOx3, respirations equal and unlabored, no signs of acute distress. patient reports no adverse signs or symptoms. patient educated to follow up with medical if any adverse reactions occur. Patient educated on the common and the severe possible symptoms and side affects of covid vaccine. patient verbalized understanding.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Mobility decreased, Pregnancy, Pregnancy test positive
Clinical narrative: I received a positive pregnancy test 3/22/22. The same day, my arm began to hurt at my injection site and the pain has increased such that I can no longer pick up my toddler and hold him. It doesn?t feel like a pulled muscle; it?s a sharp acute pain centered where I got my three injections on my left arm (which I can pinpoint because they hit a certain area of a tattoo I have.)
Age: 39.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Blindness transient, Bone disorder, Decreased appetite, Impaired driving ability
Clinical narrative: Nerve damage, muscle weakness, loss of appetite, bone weakness, neuropathy, drop foot, vision loss (vision came back) hospital for months, out of work, can?t drive,
Age: 39.0
Sex: F
Vaccine: UNK
Symptoms: Impaired work ability, Muscular weakness, Nerve injury, Neuropathy peripheral, Peroneal nerve palsy
Clinical narrative: Nerve damage, muscle weakness, loss of appetite, bone weakness, neuropathy, drop foot, vision loss (vision came back) hospital for months, out of work, can?t drive,
Age: 15.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There was no adverse reaction that occured; MMRV was given to a 15 yr old child and should not have been used. There was no adverse reaction that occured; This spontaneous report was received from a registered nurse, referring to a 15-year-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions and allergies were not reported. Concomitant medications included hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX), hepatitis b vaccine rhbsag (yeast) (ENGERIX-B), influenza vaccine inact split 4v (FLUZONE QUADRIVALENT), hepatitis a vaccine inact (HAVRIX), polio vaccine inact 3v (vero) (IPOL POLIO VACCINE) and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA).  On 23-OCT-2019, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, administered subcutaneously in the right arm, lot number S012533, expiration date was not reported, but upon internal validation was established as 20-OCT-2020 (strength was not reported) as prophylaxis (product administered to patient of inappropriate age). There was no adverse reaction that occurred.  The outcome of product administered to patient of inappropriate age was reported as recovered/resolved.  Follow-up information was received from the nurse on 15-MAR-2022. The nurse reported it was so long time ago that she wouldn't have information. No further information is available.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; a patient received improperly stored vaccine; This spontaneous report has been received from a medical assistant referring to a 12-month-old patient of unspecified age. The patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies were not reported.   On 04-MAR-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliters (ml) once (route of administration, anatomical site of vaccination, and vaccine scheme were not reported; lot number U022321 has been verified to be valid, expiration date reported and established as 15-JUL-2023) as prophylaxis.   The vaccine was exposed to a temperature excursion of minus 8.1 degrees Celsius during a time frame of 4 hours (product storage error). There was not a previous temperature excursion and no additional adverse events were reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No addittional adverse events reported; she administered a dose of VARIVAX via the intramuscular route; This spontaneous report was received from a pharmacist referring to a patient of unreported age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 11-MAR-2022, the patient was vaccinated by the pharmacist with a 0.5 ml dose of varicella virus vaccine live (oka/merck)(VARIVAX) via the intramuscular route (incorrect route of product administration ) for prophylaxis (lot # T032317, expiration date: 22-SEP-2022; vaccination scheme frequency and anatomical location not reported). No additional adverse event (AE) reported (no adverse event ).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; An expired dose of PROQUAD was administered to a 5 years old patient; This spontaneous report was received from a medical assistant and refers to a 5-year-old patient with unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-MAR-2022, the patient was vaccinated with an expired dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (lot #T030943 with an expiration date on 09-MAR-2022) administered for prophylaxis (strength, anatomical location and route of administration were not provided) (expired product administered).   No additional adverse events were reported.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; including any and all of its sequelae; Information has been received regarding a case in litigation from a lawyer and referred to a 68 years old male patient (pt). His age at vaccination was 66 years old (also reported as 67 years old). No information was provided regarding the pt's medical history, allergies, drug reactions, concurrent conditions or concomitant medications. In March 2013, the pt was administered zoster vaccine live (ZOSTAVAX) by the physician (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. As a result of his receipt of zoster vaccine live (ZOSTAVAX), in October 2014, the pt was caused to suffer shingles, including any and all of its sequelae. As a result of his receipt of zoster vaccine live (ZOSTAVAX), the pt had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the pt was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions the pt required and/or will require more health care and services and did incur medical, health, incidental and related expenses. The pt was informed and believed and further alleges that he would in the future be required to obtain further medical and/or hospital care, attention, and services. The outcome of the events was considered as not recovered. The reporter considered the events was related to the suspect vaccine.  The reporter considered the events to be disability.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination, Pain
Clinical narrative: Never took the 2nd dose, never will, pharmacist agrees; 1st dose CAUSED MY shingles within 2 days; Pain, suffered for nearly 3 weeks; This case was reported by a nurse via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles, pain and incomplete course of vaccination. The patient was treated with hydrocodone and calamine + zinc oxide (Calamine Lotion). On an unknown date, the outcome of the shingles and pain were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   The reporter considered the shingles to be related to Shingrix. It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix and experienced shingles within 2 days. The patient also experienced pain. The patient took Hydrocodone, used ice cold, wet wash cloths and Calamine lotion on them to ease the pain for nearly 3 weeks. The vaccine caused him/her shingles even though advertising sats it's a dead virus.  The patient stated Shingrix refused to compensate him/her the nearly $200 price as well as the doctor visited (to be diagnosed with shingles after he/she got the shot), pain medications etc. The patient advised against taking Shingrix. he/she was one of many who contracted Shingles from the 1st dose of it. The patient also stated that  it's a dead virus (supposedly) but his/her was apparently live and he/she suffered for nearly 3 weeks with it. The patient shall never take the 2nd dose and the pharmacist agreed he/she shouldn't. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR047714:Same reporter. Hearsay case.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Small outbreaks; Painful; 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had Shingrix and the Zoster vaccine and the patient still get small but painful outbreaks. It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Zoster vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory test confirmation regarding shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Condition aggravated, Gait disturbance, Herpes zoster, Neuralgia
Clinical narrative: suspected Vaccination failure; Shingles bother the skin tissue; five days that I could not walk without a cane; very debilitating; shingles affect the nerves; bother the skin tissue; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (experienced first outbreak 34 years ago).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, walking difficulty, debility, neuralgia and skin disorder. On an unknown date, the outcome of the vaccination failure, shingles, walking difficulty, debility, neuralgia and skin disorder were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, walking difficulty, debility, neuralgia and skin disorder to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient stated that the shingles were horrible. The patient had first break up was 34 years ago. The patient took a daily medication that suppresses them. Missing one day of medications was bad.  The patient had both vaccines. The stated that he/she did not believe those work because his/her doctor said stop taking the medications because he/she had the vaccine. And physician would not give a new script until he/she was reevaluated which got to the point of five days that the patient could not walk without a cane. Very debilitating. The patient reported that the shingles not only bother the skin tissue but worse they affect the nerves. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles not reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Skin disorder, Vaccination failure, Walking aid user
Clinical narrative: suspected Vaccination failure; Shingles bother the skin tissue; five days that I could not walk without a cane; very debilitating; shingles affect the nerves; bother the skin tissue; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (experienced first outbreak 34 years ago).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, walking difficulty, debility, neuralgia and skin disorder. On an unknown date, the outcome of the vaccination failure, shingles, walking difficulty, debility, neuralgia and skin disorder were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, walking difficulty, debility, neuralgia and skin disorder to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient stated that the shingles were horrible. The patient had first break up was 34 years ago. The patient took a daily medication that suppresses them. Missing one day of medications was bad.  The patient had both vaccines. The stated that he/she did not believe those work because his/her doctor said stop taking the medications because he/she had the vaccine. And physician would not give a new script until he/she was reevaluated which got to the point of five days that the patient could not walk without a cane. Very debilitating. The patient reported that the shingles not only bother the skin tissue but worse they affect the nerves. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles not reported.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Feeling abnormal, Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; I developed shingles on eye; shingles on head, scalp, forehead, nose and inside the upper lip; Absolutely awful!; I had all three shingles shots.; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), shingles, feels awful and extra dose administered. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, shingles, feels awful and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles and feels awful to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient stated that he/she had all three shingles shots. Despite that the patient developed shingles on the right side of my head, scalp, forehead, eye, nose and inside the upper lip. It was absolutely awful. The follow up would not be possible since no contact details provided. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles not reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had both shots and still got them/suspected vaccination failure; got them; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had both shots and still got shingles. The doctor said vaccine made them not as bad, they suck big time. This case was considered as suspected vaccination failure since the details regarding  time to onset and laboratory confirmation was not provided. Note: the event feeling bad was not coded as event as it seems that it was physician opinion.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenopia, Fatigue, Loss of personal independence in daily activities
Clinical narrative: Couldn't keep eyes open; Extremely tired.; Had to leave work; This case was reported by a consumer via interactive digital media and described the occurrence of eye tired in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 17th March 2022, the patient received the 1st dose of Shingles vaccine. In March 2022, less than a week after receiving Shingles vaccine, the patient experienced eye tired, tiredness and activities of daily living impaired. On an unknown date, the outcome of the eye tired, tiredness and activities of daily living impaired were unknown.   It was unknown if the reporter considered the eye tired, tiredness and activities of daily living impaired to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had his/her Shingles shot day before reporting (yesterday).  The patient had to leave work and he/she could not keep his/her eyes open. The patient was extremely tired. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: gave an expired vaccine; This case was reported by a other health professional via interactive digital media and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number 2224M, expiry date 10th March 2022) for prophylaxis.   On 18th March 2022, the patient received Engerix B. On 18th March 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the nurse accidently gave an expired vaccine to the patient, the vaccine expired on 10th March 2022, which led to expired vaccine used. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Broke out with shingles after 2nd vaccine/Suspected vaccination failure; Broke out with 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient stated that he/she was vaccinated with shingles vaccine and broke out with shingles after second vaccine.  The patient also stated that the 4 percent of the population would have this happen. Follow up would not be possible, no contact details were provided. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles not reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR051254:Same reporter. Hearsay case.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Got vx years ago. Have shingles since 02Feb/Suspected vaccination failure; Have shingles since 02Feb; Pain; 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 2nd February 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient had the vaccine years ago. The patient had shingles since 2nd February 2022.  The patient could not think of any pain worse than this. The patient thought the medical community should put more focus on the pain and try to come up with a cure.  This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not reported. Note: The year of event onset not reported conservatively considered as February 2022.
Sex: U
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Pretty bad, tinnitus in both ears with other reactions; This case was reported by a consumer via interactive digital media and described the occurrence of tinnitus in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of adverse reaction (had the first shot on an unknown date with not much reaction).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, several hours after receiving Shingles vaccine, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was not recovered/not resolved.   It was unknown if the reporter considered the tinnitus to be related to Shingles vaccine.     Additional details reported were as follows: The age at vaccination was not reported. The patient's second shot was pretty bad. Hours after receiving 2nd dose of Shingles vaccine, the patient experienced tinnitus in both ears along with other reactions and never went away.  The reporter knew several other people that also had this reaction. This case was linked with case US2022AMR051452, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR051408:Same reporter. 1st dose. US-GLAXOSMITHKLINE-US2022AMR051452:Same reporter. Hearsay
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Vaccination failure
Clinical narrative: got both shots recent vaccine, still get them/suspected vaccination failure; recurring shingles; horrible headaches; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (the patient had shingles 3 times in late 30s).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and headache. On an unknown date, the outcome of the vaccination failure, shingles and headache were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and headache to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient got shingles vaccine, still got shingles 2 to 3 times a year. The patient got both shots of the recent vaccine but still get shingles.  The worst was the horrible headaches for a week before the breakout. The doctor said it's a combination of patient's immune system and genetics that he/she get recurring shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles not reported.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got both shots, got shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient got both shingles shot still experienced shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles not reported.