chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Malaise, Muscular weakness, Paraesthesia
Clinical narrative: This is serious spontaneous case, initially received on 17-Nov-2017, from other non-health professional (consumer), concerning a 72-year-old, elderly, male patient. The patient's medical history included: cholesterol and high blood pressure (since an unspecified dates). The patient's concomitant medications included atorvastatin calcium for high cholesterol, BYSTOLIC for high blood pressure and hydrochlorothiazide for bladder (as reported). On 02-Dec-2016, the patient was administered with FLUVIRIN Thiomersal (route of administration: intramuscular, anatomical location: left arm and dose, batch number and expiry date: not reported). The reporter confirmed that the patient had no gastrointestinal infection or any other viral infections from Dec-2016. On an unspecified date in Dec-2016, after a week of vaccination, the patient got up but could not walk, had numbness and weakness in his ankles, feet and hands. He also started to experience tingling in hands and sickness. When he walked, he couldn't feel his feet. He did not know where he was going, so he had to pay attention. On 30-Jan-2017, the patient was hospitalized. On an unspecified date, cerebrospinal fluid (CSF) examination was performed, in which Guillain-Barre syndrome was diagnosed, complete blood count test was performed, results were not provided. The patient stayed in hospital for 10 weeks. The patient was treated with intravenous plasma, immunoglobulin and spinal fluids. He could walk with assistance (cane), which had not got over. On 07-Apr-2017, the patient was discharged from the hospital. At the time of this report, the patient had not yet recovered from the event Guillain-Barre syndrome. The reporter assessed the event as serious due to hospitalization and considered the causality of the event as related. Follow-up received on 14-Dec-2017: Indication of the concomitant drug Atorvastatin calcium was changed from cholesterol to high cholesterol. The event numbness of upper extremities was changed to numbness of extremities. Added new symptoms weakness of hands, tingling and malaise. The outcome of the events (hands weakness of, tingling feet/hands and sickness) was not recovered. The reporter confirmed that the patient had no gastrointestinal infection or any other viral infections from Dec-2017. The narrative was amended accordingly. Follow up report received from the reporter on 19-Jan-2018: The patient's relevant lab tests (cerebrospinal fluid [CSF] and complete blood  count test) were  added. The patient's concomitant drug (hydrochlorothiazide) was added. The narrative was amended accordingly.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Walking aid user
Clinical narrative: This is serious spontaneous case, initially received on 17-Nov-2017, from other non-health professional (consumer), concerning a 72-year-old, elderly, male patient. The patient's medical history included: cholesterol and high blood pressure (since an unspecified dates). The patient's concomitant medications included atorvastatin calcium for high cholesterol, BYSTOLIC for high blood pressure and hydrochlorothiazide for bladder (as reported). On 02-Dec-2016, the patient was administered with FLUVIRIN Thiomersal (route of administration: intramuscular, anatomical location: left arm and dose, batch number and expiry date: not reported). The reporter confirmed that the patient had no gastrointestinal infection or any other viral infections from Dec-2016. On an unspecified date in Dec-2016, after a week of vaccination, the patient got up but could not walk, had numbness and weakness in his ankles, feet and hands. He also started to experience tingling in hands and sickness. When he walked, he couldn't feel his feet. He did not know where he was going, so he had to pay attention. On 30-Jan-2017, the patient was hospitalized. On an unspecified date, cerebrospinal fluid (CSF) examination was performed, in which Guillain-Barre syndrome was diagnosed, complete blood count test was performed, results were not provided. The patient stayed in hospital for 10 weeks. The patient was treated with intravenous plasma, immunoglobulin and spinal fluids. He could walk with assistance (cane), which had not got over. On 07-Apr-2017, the patient was discharged from the hospital. At the time of this report, the patient had not yet recovered from the event Guillain-Barre syndrome. The reporter assessed the event as serious due to hospitalization and considered the causality of the event as related. Follow-up received on 14-Dec-2017: Indication of the concomitant drug Atorvastatin calcium was changed from cholesterol to high cholesterol. The event numbness of upper extremities was changed to numbness of extremities. Added new symptoms weakness of hands, tingling and malaise. The outcome of the events (hands weakness of, tingling feet/hands and sickness) was not recovered. The reporter confirmed that the patient had no gastrointestinal infection or any other viral infections from Dec-2017. The narrative was amended accordingly. Follow up report received from the reporter on 19-Jan-2018: The patient's relevant lab tests (cerebrospinal fluid [CSF] and complete blood  count test) were  added. The patient's concomitant drug (hydrochlorothiazide) was added. The narrative was amended accordingly.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Facial paralysis
Clinical narrative: This serious initial spontaneous case, received from other non-health professional (consumer) on 22-Nov-2017, concerns a 45-year-old adult female patient. The concomitant medication was not reported. On 14-Nov-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, batch number: 170103P, expiry date: May-2018 and anatomical location: left arm). On next day (on 15-Nov-2017), the patient developed Bell's palsy. Her physician was aware of this adverse event and treated with acyclovir, prednisone and physical therapy. At the time of the report, the event Bell's palsy was persistent (not recovered).
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Immobile, Pain
Clinical narrative: Immobility Left shoulder, upper arm and especially upper back/left side near centerline due to pain. Cannot take full breath due to this. Self medicated with Meloxicam 1@15 mg and Diclofenac topical gel (both prescribed for occasional use). Pain has subsided from 8/10 to 5/10. Mobility has improved to 50% normal at 1200 local time.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: Chills, body aches, headache, TYLENOL helped x 4 hours.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: Lump at injection site, hot red and itchy.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Arthralgia, Chills, Feeling hot, Headache
Clinical narrative: Mon, Jan 14 10:45am - Immunization SHINGRIX, easy, virtually pain free injection; 2:00pm - sore/achy injection site. Pain when lifting arm. No redness or swelling. 5:00pm - 99 fever. Normal body temperature is 97.6 (Not 98.6) 7:00pm - 100 fever, chills, muscle aches, joint pain, light abdominal pain  10:00pm - 102.5 fever, extremely painful joints, hot, chilled 2:00am - 102.5 fever, took 2 advil (didn't help much) Tues, Jan 15 9:00am - 101.5 fever, headache began, still sore muscles & joints 2:00pm - 100 fever, took 2 acetaminophen 3:00pm - 99.5 fever, symptom relief occurring 5:00pm - 99 fever, symptom relief continues Wed, Jan 16 9:00am - 99 fever, no aches, no joint pain, no headache,  injection site sore to the touch but not for movement I slept or was laying down the entire time during this reaction to the immunization. It rendered me unable to perform my daily activities.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities, Myalgia, Pain, Pyrexia
Clinical narrative: Mon, Jan 14 10:45am - Immunization SHINGRIX, easy, virtually pain free injection; 2:00pm - sore/achy injection site. Pain when lifting arm. No redness or swelling. 5:00pm - 99 fever. Normal body temperature is 97.6 (Not 98.6) 7:00pm - 100 fever, chills, muscle aches, joint pain, light abdominal pain  10:00pm - 102.5 fever, extremely painful joints, hot, chilled 2:00am - 102.5 fever, took 2 advil (didn't help much) Tues, Jan 15 9:00am - 101.5 fever, headache began, still sore muscles & joints 2:00pm - 100 fever, took 2 acetaminophen 3:00pm - 99.5 fever, symptom relief occurring 5:00pm - 99 fever, symptom relief continues Wed, Jan 16 9:00am - 99 fever, no aches, no joint pain, no headache,  injection site sore to the touch but not for movement I slept or was laying down the entire time during this reaction to the immunization. It rendered me unable to perform my daily activities.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: 12 hours after vaccination: chills, shaking; 20 hours after vaccination: fever (below 100), headache, fatigue, body aches; 36 hours after vaccination: symptoms resolved except for extremely sore left arm.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: 12 hours after vaccination: chills, shaking; 20 hours after vaccination: fever (below 100), headache, fatigue, body aches; 36 hours after vaccination: symptoms resolved except for extremely sore left arm.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Fatigue, Pyrexia, Rash
Clinical narrative: Starting the evening of 1/11/19 he states he felt extremely tired and took 3 naps on 1/12, "horrendous" upper body joint pain started on 1/11 evening and gone monday, fever of up to 103 F that fluctuated a little bit  and was gone by sunday night, sunday had chin to ankles rash that was eventually all "one pink blanket".
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Discomfort, Dyspnoea, Flushing, Swelling of eyelid
Clinical narrative: Based on mother's report, pt seemed uncomfortable from her vaccines in the late afternoon/early evening. Mother administered a dose of infant Tylenol. Shortly after the dose, pt developed facial flushing, eye lid swelling and labored breathing. Family activated 911 and pt was taken by ambulance to the Medical Center emergency department. Mother reports that she improved while en route to the ED. No intervention was required in the ED. She was discharged home that evening without specific treatments.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Urticaria
Clinical narrative: This spontaneous case, initially received on 15-Aug-2018, reported by a consumer, concerning 20-year-old, adult, female patient. The patient did not have any medical history and no history of allergies or allergic reactions. The patient was not taking any concomitant medications. On 23-Aug-2016, the patient was administered FLUVIRIN Thiomersal (dose: 0.5 ml, anatomical location: deltoid (not known left/right deltoid), batch number: 1618701, expiry date: 30-Apr-2017, route of administration: not reported). On the same day, about 6 to 7 hours after vaccination, the patient developed hives all over her body. It was reported that the patient was in and out of the emergency room (ER) about three times for anaphylactic issues (dates for ER visit not reported). The event hives lasted for about 10 days. The patient went to several different doctors regarding event. The patient was unsure why she had a reaction to the vaccine. It was unknown whether the patient received treatment for the events. At the time of this report, the patient had recovered from the events (reported as about 10 days after injection). The reporter considered the case as serious (medically significant). Update received on 19-Oct-2018: Non-significant case correction (IRD: 15-Aug-2018): The batch number was corrected from '161870' to '1618701' in product tab. The narrative was amended accordingly.
Age: 22.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Asthenia, Dizziness, Erythema, Fatigue, Incorrect route of product administration
Clinical narrative: Information has been received from a 22 years old male patient concerning himself. The patient was allergic to sulfur, penicillin and bee sting. There was no pertinent medical history. No information was provided about the concomitant medication. On an unknown date in October 2018 (reported as beginning of October of this year), the patient received his first dose of GARDASIL 9 (0.5 ML, intramuscularly, lot # N020139 and expiration date 14-FEB-2020) for HPV prevention. On 10-DEC-2018, the patient got his second dose of GARDASIL 9 (0.5 ML, lot # N020139 and expiration date 14-FEB-2020) intradermally into his right arm instead of intramuscular as indicated in the official Prescribing Information (incorrect route of product administration) for HPV prevention. On the same day, the patient received a TRUMENBA (dose, route and lot # were not provided) in his left arm. On an unknown date in December 2018 (reported as after he got the TRUMENBA vaccination), his left arm felt sore. On 11-DEC-2018, the patient's right arm became very sore and he also developed a giant red spot on his right arm. The patient reported that his right arm felt very inflamed and was very tender and it hurt to the touch. The patient also reported when he went to work the next day (on 11-DEC-2018), he felt weak and dizzy while at work and when he got home from work, he felt so fatigued that he slept for hours. The patient contacted his doctor's office on 12-DEC-2018 regarding his adverse experience symptoms. The patient was not prescribed any specific treatment for his adverse reaction, but he had been applying some ice on his right arm to help with the soreness and inflammation. At the time of the report, the patient felt normal and had recovered from most of his side effects, but his right arm still felt a little inflamed. The outcome of sore, a giant red spot, dizziness, weak, fatigue was reported as recovered/resolved. The outcome of left arm felt sore was unknown. The outcome of inflamed was reported as not recovered/not resolved. The causality assessment between the events and therapy with GARDASIL 9 was not provided.
Age: 22.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Inflammation, Pain in extremity, Tenderness
Clinical narrative: Information has been received from a 22 years old male patient concerning himself. The patient was allergic to sulfur, penicillin and bee sting. There was no pertinent medical history. No information was provided about the concomitant medication. On an unknown date in October 2018 (reported as beginning of October of this year), the patient received his first dose of GARDASIL 9 (0.5 ML, intramuscularly, lot # N020139 and expiration date 14-FEB-2020) for HPV prevention. On 10-DEC-2018, the patient got his second dose of GARDASIL 9 (0.5 ML, lot # N020139 and expiration date 14-FEB-2020) intradermally into his right arm instead of intramuscular as indicated in the official Prescribing Information (incorrect route of product administration) for HPV prevention. On the same day, the patient received a TRUMENBA (dose, route and lot # were not provided) in his left arm. On an unknown date in December 2018 (reported as after he got the TRUMENBA vaccination), his left arm felt sore. On 11-DEC-2018, the patient's right arm became very sore and he also developed a giant red spot on his right arm. The patient reported that his right arm felt very inflamed and was very tender and it hurt to the touch. The patient also reported when he went to work the next day (on 11-DEC-2018), he felt weak and dizzy while at work and when he got home from work, he felt so fatigued that he slept for hours. The patient contacted his doctor's office on 12-DEC-2018 regarding his adverse experience symptoms. The patient was not prescribed any specific treatment for his adverse reaction, but he had been applying some ice on his right arm to help with the soreness and inflammation. At the time of the report, the patient felt normal and had recovered from most of his side effects, but his right arm still felt a little inflamed. The outcome of sore, a giant red spot, dizziness, weak, fatigue was reported as recovered/resolved. The outcome of left arm felt sore was unknown. The outcome of inflamed was reported as not recovered/not resolved. The causality assessment between the events and therapy with GARDASIL 9 was not provided.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning to a 12 month old patient, gender unknown. Patient's information as concomitant medication, concurrent condition and medical history was not provided. On 09-JAN-2019 the patient was vaccinated with an unspecified dose of PROQUAD for prophylaxis (strength, dose, route of administration, lot # and expiration date was not provided) and on the same date, the patient was vaccinated with a dose of  M-M-R II for prophylaxis (strength, dose, route of administration, lot # and expiration date was not provided) and sterile diluent (route of administration, lot # and expiration date were not provided).No adverse effects was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On 07-MAR-2007, a healthcare provider administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On 02-SEP-2015, the patient was treated by a healthcare provider for shingles.   The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. In April 2016, the patient went to a pharmacy and was administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2017, the patient was treated by a healthcare provider at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2014, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient. In February 2017, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of his injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. On or about 27-SEP-2007, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 03-NOV-2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. In 2015, a physician administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV, TD
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: On October 5, 2018, a 4 year old female incorrectly received an injection of MassBiologics' Td vaccine (Lot # A104B1) intramuscularly in her arm; the intended drug for this patient was a routine booster dose of DTaP. The patient also received a dose of PROQUAD, manufactured by Merck Sharp & Dohme Corp., lot # unknown, during the same visit. The patient did not experience any adverse reactions after Td administration. The responsible physician reported that the reason for the medication error was unknown and that DTaP was ordered but Td was administered. Sender's Comments: This medication error was assessed as non-serious. The Td vaccine was administered to a patient that was under the prescribed age for the vaccine.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Exposure via skin contact, Needle issue, Underdose
Clinical narrative: This is a spontaneous case, initially received from a pharmacist on 14-Dec-2017, concerning a 59-year-old adult male patient. The patient's medical and medication history were not reported. On 14-Dec-2017, the patient was administered partial dose of FLUVIRIN (dose: less than 0.5ml, batch no: 179904P, expiry date: 20-May-2018, route of administration: intramuscular, anatomical location: deltoid), as vaccine leaked onto the patient's hand during administration . It was reported that, the vaccine leaked through the locker device (around needle attachment), but when a different needle was attached, again leakage was noticed. There were no signs of damage on the needle and appeared to be tightly attached. It was confirmed that leakage was due to a user error. The patient was administered with another dose of vaccine. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding product technical complaint (PTC) reference number was 1026643. Batch investigation report received from quality assurance department, that PTC was raised following a report of 2 leaking syringes of FLUVIRIN batch 179904P, although the complainant later confirmed that the leakage was due to a user error. Therefore, no investigation was performed, and the root cause was assigned as user error, and the case was not justified. It was reported that, the patient had not experienced any adverse effects. The reporter assessed this case as non-serious. Follow up received from Quality assurance department on 15-Jan-2018 and from reporter on 02-Feb-2018 (combined report): Added event drug administration error, as the patient received second dose. It was confirmed that the patient administered FLUVIRIN via intramuscular route in deltoid. Added QA investigation of FLUVIRIN batch. It was confirmed that the leakage was due to an user error, no investigation was performed. Narrative amended accordingly. Update received on 11-Nov-2018: Non-significant case correction (IRD: 14-Dec-2017): The term was changed from 'Technical complaint number' to 'PTC reference number' in notes section of additional information tab.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities
Clinical narrative: Patient reported on 1/9/19 received flu vaccine at Public Health clinic 11/09/2018. She has had difficulty since the flu shot with right arm range of motion, interfering with her daily routine/exercise. She is no longer able to do push-ups and was able to do this prior to the injection. She has difficulty with lifting her arm above her head such as in taking her shirt off. Her shoulder is slowly improving and range of motion is better. She feels like it is lingering. Her primary care physician referred her to physical therapy.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Myalgia. Headache. Low grade fever. Fatigue/Weakness.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Client called 12/28/19 to complain of redness, itching, and swelling R deltoid. Symptoms persisted client went to walk in clinic next and was told she had cellulitis. She was given Doxycycline. She returned the next day because arm was red swollen and warm with diffuse red rash. At that visit she was given ROCEPHIN. Symptoms improved after 4th day.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash erythematous
Clinical narrative: Client called 12/28/19 to complain of redness, itching, and swelling R deltoid. Symptoms persisted client went to walk in clinic next and was told she had cellulitis. She was given Doxycycline. She returned the next day because arm was red swollen and warm with diffuse red rash. At that visit she was given ROCEPHIN. Symptoms improved after 4th day.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: A RED, RAISED, CONTINUOUS RASH APPEARED AROUND THE INJECTION SITE WITH A DIAMETER AROUND 1 TO 2 INCHES.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Injection site erythema, Pruritus, Rhinorrhoea
Clinical narrative: Gave patient 0.05ml MMR Sub Q in Rt arm at 09:30am. At 09:47am patient started to have a sl runny nose and cough x 2-3times. Dr. listened to pt and chest was clear. Watched patient for next 18 minutes symptoms went away. At 10:05am gave patient 0.10ml MMR Sub Q in left arm. At 10:32 patient developed cough again, redness on left upper arm and left shoulder. C/O itching. Dr. listened to patient and ordered 25mg of BENADRYL PO. After BENADRYL given coughing, redness resolved and patient discharged to home at 12:05pm. Grandmother instructed to watch for any further complications from vaccine and report to us immediately should any occur or call 911 in case of emergency.
Age: 69.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Redness and Itchiness in Left arm, swelling and hot per MA.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Client stated that within a few hours of her SHINGRIX vaccine being administered, her deltoid region was reddened and warm to touch. Stated that over the next 24 hours the entire outer aspect of her left upper arm was affected (reddened and warm to touch), from her elbow to her shoulder. Stated that arm remained red, warm to touch and slightly swollen for at least one week, but that it eventually (in a week to ten days) became mostly just bruised. Stated the bruise did not completely disappear for up to 6 weeks post vaccination. She continued to use arm and did not describe any limitation in ROM to affected deltoid.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: MORNING AFTER: FELT FAINT, FEVER, POSSIBLE CHILLS. SLEEP RELIEVED SYMPTOMS. INJECTION SITE: SWOLLEN, RED, SORE.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Rash macular
Clinical narrative: Patient states arm has red, splotchy areas below injection site that began today. Areas observed.  Red, splotchy areas noted to right arm. Patient to follow-up with regular MD.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Pain, Swelling
Clinical narrative: Pt had pain, swelling and reported cellulitis.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging abnormal, Periarthritis, Rotator cuff repair
Clinical narrative: Patient experienced L arm/shoulder pain starting 5-7 days after vaccination that continued to worsen. Patient went to see her PCP about a week after symptoms started, decided to watch and see what happened. Continued to worsen and more difficult to move arm/shoulder. MRI done which showed rotator cuff tear but in surgery no tear found at all but MD found and diagnosed frozen shoulder. Patient had PT prior to and after surgery.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Steroid therapy
Clinical narrative: Patient experienced L arm/shoulder pain starting 5-7 days after vaccination that continued to worsen. Patient went to see her PCP about a week after symptoms started, decided to watch and see what happened. Continued to worsen and more difficult to move arm/shoulder. MRI done which showed rotator cuff tear but in surgery no tear found at all but MD found and diagnosed frozen shoulder. Patient had PT prior to and after surgery.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Patient has been experiencing numbness in left arm down to her hand and down the left leg as well. The numbness in arm has improved but still feeling pain in leg.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient reported got the shingles about 3 weeks after getting his first shot.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Erythema, Mass, Pruritus, Skin warm
Clinical narrative: Red lump; reports hot red and itchy X 5 days after vaccination- bruising and a pea size lump noted 12/4/2018.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cough, Ear discomfort, Irritability, Rash, Rash erythematous
Clinical narrative: Fuzziness, pulling at ears, red raised rash to head, back and abdomen, dry cough, and runny nose with clear mucus for about 5 days. Prescribed DiphenhydrAMINE HCl ELIXIR, 12.5 MG/5ML, 4 ml at bedtime, Orally, At HS, 3 days, 12 Milliliter.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rhinorrhoea
Clinical narrative: Fuzziness, pulling at ears, red raised rash to head, back and abdomen, dry cough, and runny nose with clear mucus for about 5 days. Prescribed DiphenhydrAMINE HCl ELIXIR, 12.5 MG/5ML, 4 ml at bedtime, Orally, At HS, 3 days, 12 Milliliter.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 05-MAY-2014, a healthcare provider administered the ZOSTAVAX to the patient. In February 2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of his injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not  limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 22-OCT-2015, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient. On 18-JAN-2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of his injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not  limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Pain, Rash, Vision blurred
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, a male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient was inoculated with the ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) for routine health maintenance and for the prevention of shingles. On an unknown date [reported as "shortly after" receiving the ZOSTAVAX, the patient developed a painful rash on the left side of his face, which was accompanied by blurry vision in his left eye, pain, weakness, and fatigue. As a result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using the ZOSTAVAX. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a proximate result of the ZOSTAVAX, the patient suffered serious physical injuries and incurred substantial medical costs and expenses, including, but not limited to, the following: The patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical expenses and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of the events were considered to be not recovered. Painful rash on the left side of his face, blurry vision in his left eye, pain, weakness, and fatigue were considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Atypical pneumonia, Pneumonia, Pulmonary mass
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, a female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 09-MAY-2016, the patient was inoculated with the ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Approximately one day after receiving the ZOSTAVAX, the patient suffered bilateral pneumonia and abnormal nodules within her lungs and was diagnosed with atypical pneumonia of an unspecified organism. As a direct and proximate result of ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of the her condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate consequence of the ZOSTAVAX, the patient sustained serious personal injuries and related losses including, but not limited to, the following: The patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, bilateral pneumonia/atypical pneumonia of an unspecified organism was determined to be medically significant. Bilateral pneumonia/atypical pneumonia of an unspecified organism and abnormal nodules within her lungs were considered to be disabling. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 16th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 16th July 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the patient experienced limbs stiffness and injection site bruising. On an unknown date, the outcome of the pain in arm, limbs stiffness and injection site bruising were recovered/resolved. It was unknown if the reporter considered the pain in arm, limbs stiffness and injection site bruising to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left arm. After vaccination, the patient experienced pain on her entire left arm which lasted the entire day and then resolved. The patient also experienced a bruise at the injection site but that did not resolve for 2 to 3 months. The bruise was black in color and the patient described, it was the worse bruise she had ever. The patient could not recall the onset of the bruise. The patient also had stiffness to her arm after the injection. At the time of reporting, all the symptoms were resolved. The contact details of the physician was provided. The reporter gave consent to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Injection site erythema, Malaise, Meningitis viral, Nuclear magnetic resonance imaging
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of viral meningitis in a 55-year-old female patient who received SHINGRIX for prophylaxis. On 20th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In December 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, pain in arm and abdominal discomfort. On 26th December 2018, the patient experienced viral meningitis (serious criteria disability and GSK medically significant) and feeling unwell. In December 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the viral meningitis, feeling unwell and abdominal discomfort were not recovered/not resolved and the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the viral meningitis, injection site erythema, pain in arm, feeling unwell and abdominal discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient experienced redness at the injection site. Her arm was also sore for about 3 days. She said that she was expecting these type of side effects so she was not surprised about having them. However, the patient did not feel well and went to emergency room on 26th December 2018 and stayed about 4 to 5 hours at the emergency room and had in the Magnetic resonance imaging (MRI) machine for an hour. They did not know what she was having. The patient received a follow up from the neurologist and she was diagnosed with viral meningitis. The patient did not know if SHINGRIX caused the viral meningitis. However, she had a lot of belly activity and she was incapacitated for several days and she was at the time of reporting not back to herself and could not drive. The patient did not consent to follow-up. The patient did not have a primary care physician.