chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: ANTH, HEP, SMALL, TYP
Symptoms: Influenza B virus test positive, Influenza virus test positive, Metabolic function test normal, Nuclear magnetic resonance imaging thoracic normal, Palpitations
Clinical narrative: The patient is a healthy 19 yo male with a history of CP who received SPV #1 (ACA Lot number the V03019C) on 26 September, 2018 to his R upper arm in addition to Hep B (SKB lot #1034864), typhoid (lot #N1k12) & Anthrax (MIP #FAV570A). He reports he has a history of chest pain intermittent sharp fleeting 1-2 times a month at mid chest he reports he did not take time to have this evaluated. He reports approximately 1 week after SPV receipt he developed new severe sharp, aching near continuous chest pain midsternal and periphery to the heart area 8-9 out of 10. He reports it was worse supine and would wake him from sleep. It continued throughout the day and worsened at night. It would improve after sitting up and have episodes of 10-15 seconds of worsening pain. He states he experienced shortness of breath prior to this onset that would improve with deep breathing and that this was worsened with the onset of his pain. He describes palpitations when awoken at night with the pain which have improved. He denies peripheral edema, nausea or vomiting, or diaphoresis. He saw PCP day 7, but had normal exam & EKG. He was seen again on day 16 and had EKG ST elevation changes consistent with pericariditis.
Age: 19.0
Sex: M
Vaccine: ANTH, HEP, SMALL, TYP
Symptoms: Sleep disorder, Troponin normal
Clinical narrative: The patient is a healthy 19 yo male with a history of CP who received SPV #1 (ACA Lot number the V03019C) on 26 September, 2018 to his R upper arm in addition to Hep B (SKB lot #1034864), typhoid (lot #N1k12) & Anthrax (MIP #FAV570A). He reports he has a history of chest pain intermittent sharp fleeting 1-2 times a month at mid chest he reports he did not take time to have this evaluated. He reports approximately 1 week after SPV receipt he developed new severe sharp, aching near continuous chest pain midsternal and periphery to the heart area 8-9 out of 10. He reports it was worse supine and would wake him from sleep. It continued throughout the day and worsened at night. It would improve after sitting up and have episodes of 10-15 seconds of worsening pain. He states he experienced shortness of breath prior to this onset that would improve with deep breathing and that this was worsened with the onset of his pain. He describes palpitations when awoken at night with the pain which have improved. He denies peripheral edema, nausea or vomiting, or diaphoresis. He saw PCP day 7, but had normal exam & EKG. He was seen again on day 16 and had EKG ST elevation changes consistent with pericariditis.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Mobility decreased, Musculoskeletal pain, Tenderness
Clinical narrative: Inject hit something solid...shoulder pain immediate...upper deltoid tenderness...pain unresolved .... range of mobility compromised. Limited ability to raise arm above shoulder. Limited ability to raise arm up in front of self.
Age: 26.0
Sex: M
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Immediately after needle removed from arm patient had convulsive syncopal episode which lasted under 1 minute. Patient was monitored for approximately 45 minutes following and allowed to leave the clinic once he felt well and vitals were stable.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Started having numbness bilateral lower extremities and upper extremities - distal to proximal - went to the ER 12/12/18 and was admitted, diagnosed with Guillian-Barre and treated with IV IG x 5 days.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Abscess drainage, Atypical mycobacterium test positive, Incisional drainage, Injection site erythema, Injection site pain
Clinical narrative: Client provided the vaccine on approximately 10/13. Presented to Express clinic on 11/19 with complaints of "sore know on his left upper arm that is getting larger, red, and sore to touch after provided a flu vaccine injection one month ago" at his place of employment. A 2 cm X 2 cm abscess drained per I and D with culture sent on purulent discharge. Culture resulted growth of Mycobacterium Fortuitum Complex that was sensitive to Ciprofloxacin. Client was initially treated with doxycycline which only provided intermediate coverage and had resistance to other antibiotics. Client placed on Ciprofloxacin on 12/19 as the wound continued to be open but not draining.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Purulent discharge
Clinical narrative: Client provided the vaccine on approximately 10/13. Presented to Express clinic on 11/19 with complaints of "sore know on his left upper arm that is getting larger, red, and sore to touch after provided a flu vaccine injection one month ago" at his place of employment. A 2 cm X 2 cm abscess drained per I and D with culture sent on purulent discharge. Culture resulted growth of Mycobacterium Fortuitum Complex that was sensitive to Ciprofloxacin. Client was initially treated with doxycycline which only provided intermediate coverage and had resistance to other antibiotics. Client placed on Ciprofloxacin on 12/19 as the wound continued to be open but not draining.
Age: 18.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Client got his second dose of Hep A and 3rd dose of Hep B to soon.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pustule, Injection site reaction
Clinical narrative: Patient states that she developed redness, swelling and a pustular head at the site of her last HPV9 injection, which was on August 6, 2018. Since that times she has had a tender lump at the site. Over the last month she noticed that it is grown, swollen, developed a pustular head. About a week ago she noticed that it has opened and was draining purulent fluid. Draining has since stopped and her skin is now soft and non-tender.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site swelling, Purulent discharge
Clinical narrative: Patient states that she developed redness, swelling and a pustular head at the site of her last HPV9 injection, which was on August 6, 2018. Since that times she has had a tender lump at the site. Over the last month she noticed that it is grown, swollen, developed a pustular head. About a week ago she noticed that it has opened and was draining purulent fluid. Draining has since stopped and her skin is now soft and non-tender.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Rash macular, Rash papular
Clinical narrative: Rash appearing 2-3 hours after vaccine administration. Erythematous macular popular rash on abdomen, back, Left arm. Not itchy, not painful, not vesicular. No mucosal involvement. No fevers, chills, evidence of systemic involvement. Rash stable in appearance and distribution at time of clinic visit which was 1 week after vaccine administration.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Rash appearing 2-3 hours after vaccine administration. Erythematous macular popular rash on abdomen, back, Left arm. Not itchy, not painful, not vesicular. No mucosal involvement. No fevers, chills, evidence of systemic involvement. Rash stable in appearance and distribution at time of clinic visit which was 1 week after vaccine administration.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Rash macular, Rash papular
Clinical narrative: Rash around belly button, shoulder, and back - does not itch.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Rash around belly button, shoulder, and back - does not itch.
Age: 30.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The patient received the GARDASIL 9 vaccine on 12/17/18 instead of the TDaP she was supposed to receive. She is 30 weeks pregnant with EDD 2/17/2019. Upon the MA realizing what happened, she notified the physician. The physician contacted the patient and no adverse reaction occurred with the patient.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram head normal, Facial paralysis
Clinical narrative: Right Sided Bell's Palsy Developed 2 days following the Immunization. No other signs of infection. Not recovered currently.
Sex: M
Vaccine: VARZOS
Symptoms: Transient ischaemic attack
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of ministroke in a male patient who received SHINGRIX for prophylaxis. On 1st December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced ministroke (serious criteria GSK medically significant). On an unknown date, the outcome of the ministroke was unknown. It was unknown if the reporter considered the ministroke to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient did not experience any harm to his system. The reporter wanted to know, if it was okay to take the 2nd dose on 17th December 2018.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient was inoculated with ZOSTAVAX vaccine (date of vaccination, lot# and route not specified) for routine health maintenance for the prevention of shingles. The vaccine did not prevent shingles but rather caused the patient to contract a persistent strain of herpes zoster in 2017. After receiving ZOSTAVAX the patient developed a painful rash accompanied by persistent pain. In response to these complaints, the patient presented to a physician and was diagnosed as suffering from shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other 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 conditions. On or about 13-MAY-2010, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 01-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 conditions. In 2012, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2013, 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: 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 providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 28-NOV-2012, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 08-DEC-2012, 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: U
Vaccine: HEP
Symptoms: Bronchospasm, Reaction to excipient
Clinical narrative: This case was reported by a pharmacist and described the occurrence of bronchospasm in a patient who received ENGERIX B for prophylaxis. On an unknown date, the patient received ENGERIX B at an unknown dose. On an unknown date, unknown after receiving ENGERIX B, the patient experienced bronchospasm and reaction to drug excipient. On an unknown date, the outcome of the bronchospasm and reaction to drug excipient were unknown. The reporter considered the bronchospasm and reaction to drug excipient to be possibly related to ENGERIX B. Additional details were reported as follows: The age at vaccination was not reported. The reporter had a patient who had a bronchospasm reaction to ENGERIX-B possibly due to the yeast component. This patient wants to get the SHINGRIX vaccine at the time of reporting. As far as the patient could tell from the PPI's this should be fine but reporter just wanted to verify that there were no ingredient duplications between the two vaccines.
Sex: U
Vaccine: FLUX
Symptoms: Facial paralysis
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of Bell's palsy in a child patient who received unspecified Influenza vaccine for prophylaxis. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced Bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the Bell's palsy was unknown.  It was unknown if the reporter considered the Bell's palsy to be related to Influenza vaccine. Additional information received as follows: The age at vaccination was not applicable for this report. The reporter heard that the patients were getting the flu shot and then they were coming in with Bell's Palsy. The reporter's grand daughter of age 8 years had a chicken pox shot and got Guillain Barre Syndrome. The patient was recovered after a couple of months. That was 2 years before the reporting time. The patient was slurring and could barely walk. Till the reporting time, the patient's mother was upset over what happened. The hospital would not admit it was the shot.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex, Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of ophthalmic herpes zoster in a 75-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), herpes zoster and herpes simplex type I reactivation. The patient was treated with VALTREX. On an unknown date, the outcome of the ophthalmic herpes zoster, herpes zoster and herpes simplex type I reactivation were recovering/resolving. It was unknown if the reporter considered the ophthalmic herpes zoster, herpes zoster and herpes simplex type I reactivation to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported but, it could be 74 or 75 years. The patient developed severe reaction to vaccine with ophthalmic and facial distribution of herpes zoster and reactivation at the same time of herpes simplex virus (HSV) I. The patient was treated with VALTREX full dose for 10 days and it took almost 4 weeks for her to get better. The reporter wanted to know, if the patient could be given 2nd dose of vaccine and if the patient should be pre-medicated or should be treated during when the symptoms were back.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Diarrhoea, Gastroenteritis norovirus, Injection site pain, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of gastroenteritis norovirus in a 72-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included dehydration (might have been slightly dehydrated). On 8th December 2018 19:00, the patient received the 1st dose of SHINGRIX. On 8th December 2018, 45 min after receiving SHINGRIX, the patient experienced gastroenteritis norovirus (serious criteria GSK medically significant), vomiting, diarrhea, weakness and injection site pain. On 11th December 2018, the outcome of the gastroenteritis norovirus, vomiting, diarrhea, weakness and injection site pain were recovered/resolved. The reporter considered the gastroenteritis norovirus, vomiting and diarrhea to be unrelated to SHINGRIX. It was unknown if the reporter considered the weakness and injection site pain to be related to SHINGRIX. Additional details were received as follows: This case was reported via online chat. The patient asked if their dose could be compromised. The patient stated that they were a nutritionist and declined to provide additional information during the chat. The patient stated that she might have been slightly dehydrated as she had just came from the gym but was feeling good She was drinking water prior to getting the injection. Around 7 pm, the patient received SHINGRIX. The patient became sick with norovirus 45 minutes after a dose of SHINGRIX. The patient stated that 45 minutes after vaccination, she became sick with norovirus and the patient was asking if the 1st dose was compromised. When asked to the patient if her Norovirus was confirmed, she said it was not confirmed but she knew several other friends in her community who she had contact with and they all had the same symptoms of throwing up and having diarrhea. She said this lasted for 5 hours then she was able to start drinking water but she was very weak. The patient did not think SHINGRIX caused her GI symptoms. On 11th December 2018, she felt perfect. Her symptoms were resolved. About 48 hours after receiving SHINGRIX, the arm where the injection was given was sore. In December 2018, injection site sore resolved. Follow up information was received from consumer on 12th December 2018: After 45 minutes later, the patient was thrown up with the norovirus and was sick for the next five hours. The patient was frightened that could have ruined the shot and that might not be fully effective. The outcome of the sick were unknown. It was unknown if the reporter considered the sick to be related to SHINGRIX. Lab Comments: On an unknown date, the patients became sick with norovirus.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of gastroenteritis norovirus in a 72-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included dehydration (might have been slightly dehydrated). On 8th December 2018 19:00, the patient received the 1st dose of SHINGRIX. On 8th December 2018, 45 min after receiving SHINGRIX, the patient experienced gastroenteritis norovirus (serious criteria GSK medically significant), vomiting, diarrhea, weakness and injection site pain. On 11th December 2018, the outcome of the gastroenteritis norovirus, vomiting, diarrhea, weakness and injection site pain were recovered/resolved. The reporter considered the gastroenteritis norovirus, vomiting and diarrhea to be unrelated to SHINGRIX. It was unknown if the reporter considered the weakness and injection site pain to be related to SHINGRIX. Additional details were received as follows: This case was reported via online chat. The patient asked if their dose could be compromised. The patient stated that they were a nutritionist and declined to provide additional information during the chat. The patient stated that she might have been slightly dehydrated as she had just came from the gym but was feeling good She was drinking water prior to getting the injection. Around 7 pm, the patient received SHINGRIX. The patient became sick with norovirus 45 minutes after a dose of SHINGRIX. The patient stated that 45 minutes after vaccination, she became sick with norovirus and the patient was asking if the 1st dose was compromised. When asked to the patient if her Norovirus was confirmed, she said it was not confirmed but she knew several other friends in her community who she had contact with and they all had the same symptoms of throwing up and having diarrhea. She said this lasted for 5 hours then she was able to start drinking water but she was very weak. The patient did not think SHINGRIX caused her GI symptoms. On 11th December 2018, she felt perfect. Her symptoms were resolved. About 48 hours after receiving SHINGRIX, the arm where the injection was given was sore. In December 2018, injection site sore resolved. Follow up information was received from consumer on 12th December 2018: After 45 minutes later, the patient was thrown up with the norovirus and was sick for the next five hours. The patient was frightened that could have ruined the shot and that might not be fully effective. The outcome of the sick were unknown. It was unknown if the reporter considered the sick to be related to SHINGRIX. Lab Comments: On an unknown date, the patients became sick with norovirus.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Hyperaesthesia, Pain in extremity, Pancreatic failure, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pancreatic insufficiency in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 16th October 2018, the patient received the 1st dose of SHINGRIX. On 17th October 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm, swelling arm and increased skin sensitivity. In December 2018, the patient experienced pancreatic insufficiency (serious criteria GSK medically significant). On an unknown date, the patient experienced diarrhea. On an unknown date, the outcome of the pancreatic insufficiency and diarrhea were unknown and the outcome of the pain in arm, swelling arm and increased skin sensitivity were recovered/resolved. It was unknown if the reporter considered the pancreatic insufficiency, pain in arm, swelling arm, increased skin sensitivity and diarrhea to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right arm. The patient stated that she noted next day she had tremendous arm pain, swelling and sensitivity. Those events were lasted for about 5 days and resolved. Less than a year after vaccination, the patient experienced diarrhea and pancreatic insufficiency. The patient recalled she had diarrhea for a couple of months also, but not sure of the actual start date. She also noted that last week, in December 2018, she was diagnosed with pancreatic insufficiency and was being placed on enzymes. She had a scheduled CT scan next week and a follow up appointment with her physician on 14th January 2019 for the results. The patient had nothing else new besides the vaccine, and was not sure what had caused the issues. The patient consented to follow up.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 12-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA344670, 2018SA344695, 2018SA344687 and 2018SA344689. This case involves a 70 years old male patient in which 0.5 ml of FLUZONE HIGH DOSE was potentially out of range between 32 F and 47 F for 7 days  and exposed to freezing temperature (lot number: U1994AA, expiry date: 09-Apr-2019) via unknown route in right deltoid on 03-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines were given. It was a case of actual medication error due to incorrect product storage. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 12-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA344665, 2018SA344687, 2018SA344695 and 2018SA344689. This case involves a 78 years old female patient in which 0.5 ml of FLUZONE HIGH DOSE was potentially out of range for 7 days between 32 Fahrenheit and 47 F and exposed to freezing temperature (lot number: UJ006AA, expiry date: 30-APR-2019) via unknown route in the left deltoid on 04-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines were given. It was a case of actual medication error due to incorrect product storage. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 12-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA344665, 2018SA344695, 2018SA344670 and 2018SA344689. This case involves a 71 years old female patient in which 0.5 ml of FLUZONE HIGH DOSE was potentially out of range for 7 days between 32 Fahrenheit and 47 F and exposed to freezing temperature (lot number: UJ006AA, expiry date: 14-APR-2019) via unknown route in the left deltoid on 04-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines were given. It was a case of actual medication error due to incorrect product storage. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 12-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA344670, 2018SA344695, 2018SA344665, and 2018SA344687 same reporter. This case involves a 67 years old female patient who received vaccine FLUZONE HIGH DOSE lot UHJ006AA, expiry date: 14-APR-2019 via unknown route in the left deltoid on 06-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 12-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA344670, 2018SA344665, 2018SA344687 and 2018SA344689 (same reporter). This case involves an adult patient (age and gender was not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (lot number and expiry date was not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was not reported whether the patient experienced any adverse events. The doses are considered to be non-valid and should be repeated. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 3.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a physician. This case is linked to case 2018SA322952 (same reporter). This case involves a 3 years old female patient who was vaccinated with 0.5 ml dose of IPOL (batch number: N1K921M, expiry date: 14 Nov 2019) via intramuscular route on 20 Nov 2018. The patients past medical history included tongue geographic and underweight. It was also reported that, the patient had no known drug allergy. The patients past medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to incorrect product storage. It was reported that the patient received the vaccine which was out of the acceptable temperature range (might not be effective). It was reported that the patient did not experience any adverse event. It was also reported that, the patient did not need to be revaccinated. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Condition aggravated, Crying, Eczema, Headache
Clinical narrative: He got really irritable, cried a lot, complained about pain in his legs, was acting out, screaming, swollen at injection site, had a fever for 2 days, headache, his eczema got worse.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Injection site swelling, Irritability, Pain in extremity, Pyrexia, Screaming
Clinical narrative: He got really irritable, cried a lot, complained about pain in his legs, was acting out, screaming, swollen at injection site, had a fever for 2 days, headache, his eczema got worse.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache
Clinical narrative: Fatigue, upset stomach, headache.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Crying, Dyspnoea, Insomnia, Pyrexia
Clinical narrative: My daughter started having strained breathing, mid grade fever, fits of crying, troubled sleep for a few days.
Age: 8.0
Sex: M
Vaccine: FLUC4
Symptoms: Fatigue, Immediate post-injection reaction, Posture abnormal, Presyncope
Clinical narrative: The student received a flu shot during a school-based clinic. Immediately after receiving the flu vaccine, he appeared to have a vasovagal reaction, slumping down in his chair and immediately perking up. He returned to class. The school nurse checked on him, and he said he was fine. Student teacher then brought him down to the health room later to rest. He returned to class. Adults and mom reported he seemed tired the rest of the day. Next day was back to normal.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, soreness and slight swelling at injection site.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Body temperature, Cough, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling and redness to outer portion of left arm, coughing, congestion. Injection site painful and warm to touch. Temperature  noticed this morning, did not take temp.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site warmth, Respiratory tract congestion
Clinical narrative: Swelling and redness to outer portion of left arm, coughing, congestion. Injection site painful and warm to touch. Temperature  noticed this morning, did not take temp.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Rash
Clinical narrative: Pt received SHINGRIX 12/11/18 at 10:37 am called office 12/14/18 at 1:12 pm reporting adverse rxn. (L) arm swelling at injection site 12/13/18 pm, developed a rash of her torso, resolved with 2 BENADRYL, she mainly called to make me aware as rash had resolved and (L) arm injection site swelling was improving.
Age: 0.67
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to currently 8-month-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2018, the patient was vaccinated with improperly stored dose of ROTATEQ lot # R002516, expiry date 13-SEP-2018, orally (exact dose and dose number were not reported) for prophylaxis. The administered dose of vaccine underwent a temperature excursion between 9 and 25 degrees Celsius for 12.5 hours. Temperature excursion was detected by digital data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1812USA006405: US-009507513-1812USA006406.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication. On 10-DEC-2018, the patient was inadvertently vaccinated with an expired dose of VARIVAX lot number M048200 and expiration date of 07-DEC-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). The lot and expiry for water sterile diluent used to reconstitute VARIVAX was unknown. No adverse effects were 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 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 conditions. In 2008, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2011, 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 conditions. On or about 08-FEB-2012, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 15-DEC-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: 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 providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2014, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 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: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a male patient who received 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 pain in arm. On an unknown date, the outcome of the pain in arm was unknown.  It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient experienced sore arm. No additional adverse event information was provided.
Sex: F
Vaccine: TDAP
Symptoms: Pruritus
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of itchy upper limbs in a female patient who received dTpa vaccine for prophylaxis. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced itchy upper limbs. On an unknown date, the outcome of the itchy upper limbs was unknown. It was unknown if the reporter considered the itchy upper limbs to be related to dTpa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient received Tdap vaccine and developed itchiness on her arm. She would like to know if your product contain a common preservative Dodecyl gallate, which was also known as Dodecyl 3,4,5-Trihydroxybenzoate, Dodecyl ester of gallicacid, E312, Lauryl gallate.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. In December 2018, the patient received the 2nd dose of SHINGRIX. In December 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm, fever, dizziness, headache and tiredness. On an unknown date, the outcome of the pain in arm and fever were recovered/resolved and the outcome of the dizziness, headache and tiredness were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, fever, dizziness, headache and tiredness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had her 2nd shingles shot a little over a week ago, from the date of reporting. The patient no longer had the soreness on her arm and light fever, but she at the time of reporting felt dizzy, headache, and tired. The patient was wanted to know how long should she expect this to last.