chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Feeling cold, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, shivers, fever and feeling cold. On an unknown date, the outcome of the injection site pain, shivers, fever and feeling cold were recovered/resolved. It was unknown if the reporter considered the injection site pain, shivers, fever and feeling cold to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced freezing and had teeth chattering shivers, fever and injection site pain. For the tolerance of 2nd dose refer linked case US2018136210 for same patient.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 65-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 28th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In July 2018, less than a day after receiving SHINGRIX, the patient experienced headache, fatigue, fever and nausea. On an unknown date, the outcome of the headache, fatigue, fever and nausea were recovered/resolved. It was unknown if the reporter considered the headache, fatigue, fever and nausea to be related to SHINGRIX. Additional details reported as follows: This case was not reported to anyone previously. On 4th May 2018, the patient received the 1st dose of SHINGRIX. The reporter woke up the next morning after receiving the SHINGRIX vaccine on left arm with the following symptoms, bad headache, a little bit of nausea, fatigue, and a fever of 100.9 degree F as of mid morning. The symptoms resolved within 36 hours. This case has been linked with US2018136246, reported by same reporter.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: 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 66-year-old male patient who received SHINGRIX for prophylaxis. On 28th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 28th July 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details reported as follows: This case was previously not reported to anyone. The reporter's husband developed a sore left arm within five hours after receiving 1st dose of SHINGRIX vaccine on left arm. The soreness was resolving. This case has been linked with US2018136244, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of suspected vaccination failure in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, several weeks after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could 71 years or 72 years. The healthcare professional reported that the patient received experienced shingles few weeks later of vaccination. Shingles did resolve within 3 to 4 weeks. The healthcare professional stated that the patient did not get vaccine at their facility so had no information on administration of product. This case was considered to be a suspected vaccination failure case, as the details regarding completion of vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of extensive swelling of vaccinated limb in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a physician assistant. The age at vaccination was not reported. The patient experienced swelling and redness around injection site. It increased on the day of reporting to width 11 mm and length 12 cm. No further information was reported. The healthcare professional reported adverse event via click to chat forum.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) for prophylaxis. On 2nd July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. The reporter considered the pain in arm to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that patient received their first dose of SHINGRIX on 2nd July 2018. The patient called the health care professional to report that while they raise their arm, they have been having arm soreness. No additional information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Impaired work ability, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX. On an unknown date, several days after receiving SHINGRIX, the patients experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not applicable for this report. The caller was a consumer considering getting SHINGRIX vaccination. The caller stated that while researching online, she read some posts from patients that had experienced flu like symptoms for several days to the point where they missed work. No other details available. The caller declined to provide her address. The patient had denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Anger, Diarrhoea, Headache, Malaise, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced headache, diarrhea, vomiting, general body pain and sickness. On an unknown date, the outcome of the headache, diarrhea, vomiting and general body pain were unknown and the outcome of the sickness was recovered/resolved. It was unknown if the reporter considered the headache, diarrhea, vomiting, general body pain and sickness to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported, however it could be 75 or 76 years. The concomitant medication included Thyroid medication. The patient received the SHINGRIX vaccination approximately three months before the date of reporting. She reported that the next day after receiving the vaccine the patient experienced events. She was sick for three weeks. The reporter was angry and would not provide any additional information. The patient had denied permission to contact their physician.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 63 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovering/resolving. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional received SHINGRIX and developed shingles over his left shoulder approximately 9 weeks later. The health care professional was the patient, he did not have lot number or expiry date of SHINGRIX given.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 68-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chemotherapy (in 2011) and radiation therapy (in 2011). Previously administered products included ZOSTAVAX. Concurrent medical conditions included breast cancer. On 17th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 18th May 2018, 1 days after receiving SHINGRIX, the patient experienced fever, tiredness and chills. On 18th May 2018, the outcome of the fever and chills were recovered/resolved. On an unknown date, the outcome of the tiredness was recovered/resolved. It was unknown if the reporter considered the fever, tiredness and chills to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left deltoid. The patient reported that about 24 hours after receiving SHINGRIX, she experienced the reaction which was described as fever (101 degree F), chills and shivering. These symptoms resolved in 2 to 3 hours. The patient also felt a little wiped out in the evening. The patient did not have the paperwork nearby to see if she had a record of the lot number and expiry date of vaccine.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 58-year-old female patient who received SHINGRIX for prophylaxis. On 26th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th July 2018, immediately after receiving SHINGRIX, the patient experienced injection site erythema. On 29th July 2018, the patient experienced injection site itching. On an unknown date, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site itching were not recovered/not resolved and the outcome of the injection site pain and injection site swelling were recovering/resolving. It was unknown if the reporter considered the injection site erythema, injection site pain, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left arm around 10:30 AM. The patient had denied permission to contact their physician.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 26th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th July 2018, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities and pain in arm. On an unknown date, the outcome of the erythema of extremities and pain in arm were recovered/resolved. Additional details were received as follows: The patient reported that at around 10:30 am her husband received a dose of SHINGRIX vaccine in left arm and experienced redness and soreness in arm. The patient had denied permission to contact their physician.
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a male patient who received SHINGRIX for prophylaxis. On 2nd June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was not recovered/not resolved. It was unknown if the reporter considered the shoulder pain to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient received SHINGRIX on the left arm. The patient reported that he experienced shoulder pain, same left shoulder as he received the injection and the pain was still present, two months later at the time of reporting. The patient stated that the pain or soreness was not getting any better or worse.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 13th July 2018, the patient received SHINGRIX. On 14th July 2018, 1 days after receiving SHINGRIX, the patient experienced rash. The patient was treated with Cortisone Cream. On an unknown date, the outcome of the rash was recovering/resolving. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. The patient noticed the rash next day after receiving the SHINGRIX, which was below the injection site. The rash was treated with cortisone cream which made it lighter.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 30th July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced headache, fever, shivering and muscle pain. On an unknown date, the outcome of the headache, fever, shivering and muscle pain were recovering/resolving. It was unknown if the reporter considered the headache, fever, shivering and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient's symptoms were improved, especially compared to a day before the date of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Incorrect dose administered, Pain, Product preparation error
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain localized in a adult patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain localized, localized erythema, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the pain localized, localized erythema, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the pain localized and localized erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The health care professional (HCP) reported that a dose of SHINGRIX administered, where the vaccine was reconstituted with sterile diluent and not the one provided with SHINGRIX vaccine, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The patient experienced very mild local redness and tenderness after vaccination with a dose of SHINGRIX. The reporter stated that he might be contacted at a later time for patient information. This case was linked to cases US2018139463 and US2018139464, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a male patient who received SHINGIRX for prophylaxis. Concomitant products included ibuprofen. On 24th July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The physician reported for himself. The patient received the SHINGRIX vaccine in the right deltoid. The patient had pain at the injection site which lasted 2 to 3 days.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, 42 days after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown. It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that, a patient reported to her today (2nd August 2018) that she had a shingles outbreak 6 weeks after receiving the vaccine. The patient reported to her doctor after she had 2 spots, which was confirmed to be shingles. This case was considered to be a suspected vaccination failure case, as the details regarding completion of vaccination schedule and laboratory confirmation for shingles were unknown. The pharmacist was unable to provide any additional information and appeared to be in a hurry, but stated that she would call back if she obtained new information. Service request number provided to her.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Myalgia, Nausea
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of muscle pain in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle pain, joint pain, nausea and chills. On an unknown date, the outcome of the muscle pain, joint pain, nausea and chills were recovered/resolved. It was unknown if the reporter considered the muscle pain, joint pain, nausea and chills to be related to SHINGRIX. Additional information was received as follows: The health care professional was the retired nurse who was self reporting this adverse event via health care professional chat to the Agency. The age at vaccination was not reported, however, it could be 61 or 62 years. The health care professional reported that the patient had 48 hours of muscle pain, joint pain, chills and nausea after receiving the dose of SHINGRIX. No other information was available, the health care professional did not have vaccine information.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and pain. The patient was treated with ALEVE. On an unknown date, the outcome of the fever and pain were recovered/resolved. It was unknown if the reporter considered the fever and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's body temperature was 100 and was aching. The patient felt better within hours. This case was linked with the case US2018GSK142191, reported for further dose of SHINGRIX. Lab Comments: On an unknown date, body temperature was 100.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: This case was reported by a non-health professional via interactive digital media and described the occurrence of pain in a adult patient who received SHINGRIX for prophylaxis. Previously experienced adverse reactions included cancer (11 years ago) and immune system disorder.  On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain and headache. On an unknown date, the outcome of the pain and headache were recovered/resolved. It was unknown if the reporter considered the pain and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient might of had the bad reaction from reduced immune system from cancer 11 years ago. The patient had 1st dose of SHINGRIX 2 months ago and had a bad reaction of aches and headaches. For tolerance effect after 2nd dose, refer case US2018GSK138651.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: This case was reported by a non-health professional via interactive digital media and described the occurrence of pain in a adult patient who received SHINGRIX for prophylaxis. Previously experienced adverse reactions included cancer (11 years ago) and immune system disorder. Previously administered products included SHINGRIX (1st dose, refer case US2018GSK135835). In April 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain and headache. On an unknown date, the outcome of the pain and headache were recovered/resolved. It was unknown if the reporter considered the pain and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient might had the bad reaction from reduced immune system from cancer 11 years ago. The patient had 1st dose of SHINGRIX 2 months ago. The patient commented on 26th April 2018 about having a 2nd dose 2 days ago. The patient had a bad reaction of aches and headaches after vaccination both doses.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose, refer case US2018GSK135832). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and pain. The patient was treated with ALEVE. On an unknown date, the outcome of the fever and pain were unknown. It was unknown if the reporter considered the fever and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's body temperature was 100.9 and was aching. The patient felt better within hours. Lab Comments: On an unknown date, body temperature was 100.9.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling (serious criteria other: serious as per reporter). On an unknown date, the outcome of the injection site swelling was unknown. It was unknown if the reporter considered the injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable. The age group was not reported but was selected as adult as per vaccine indication. The emergency room physician told to one of the patients he had been seeing a lot of swelling due to SHINGRIX in the emergency room. This case has been linked to US2018137449, reported by the same reporter.
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Drug prescribing error
Clinical narrative: Initial information received on 27-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional, Physician. This case involves an unknown patient (age and gender not specified) who received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route. It was a case of actual inappropriate age at vaccine administration and Drug prescribing error. It is also an off label use as Prescriber was using FLUZONE HIGH-DOSE in patients aged 50-64, but FLUZONE HIGH-DOSE is indicated only for patients aged 65 or older. It was unknown whether patient experienced adverse event. 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.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 31-Jul-2018 regarding an unsolicited valid non-serious case received from other health care professional. This case involves a 20 years old patient (gender unknown) who received 0.5ml dose of suspect MENACTRA, lot U5567CA, expiry date 28 Jun 2018 via intramuscular route in the left deltoid on 31-Jul-2018. The patients past medical history and family history were not provided. The patient did not receive any concomitant medication. It was an actual medication error due to expired vaccine used. It was reported that patient received MENACTRA on 31 Jul 2018 which expired on 28 Jun 2018. Patient has not experienced any adverse reactions after the injection.  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 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.
Sex: M
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Initial information regarding an unsolicited valid non-serious case was received on 31-Jul-2018 from a consumer/non- healthcare professional. This case is linked to case 2018SA212249 (same reporter). This case involves a male patient (age not reported) who was vaccinated with a dose of RABIES (HDC) VACCINE (batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patients past medical history, medical treatment, vaccination and family history were not provided. It was an actual medication error due to incomplete course of vaccination. It was reported that return home their preferred medical facilities did not have IMOVAX to finished their series. It was unknown whether the patient had any adverse event. 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.
Sex: F
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Initial information regarding an unsolicited valid non-serious case was received on 31-Jul-2018 from a consumer/non-healthcare professional. This case is linked to case 2018SA212231 (same reporter). This case involves a female patient (age not reported) who was vaccinated with 0.5 ml dose of RABIES (HDC) VACCINE (batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patients past medical history, medical treatment, vaccination and family history were not provided. It was an actual medication error due to incomplete course of vaccination. It was reported that return home their preferred medical facilities did not have IMOVAX to finish their series. It was unknown whether the patient had any adverse event. 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: 0.58
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial information received on 31-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to 2018SA212665, 2018SA212615, 2018SA212638 and 2018SA212648 (Same reporter). This case involves a 7-month old male patient who was vaccinated with third dose of PENTACEL (Batch number: C5529AA, expiration date: 04-Oct-2019 via unknown route in unknown administration site on 23-Jul-2018. Concomitant medications included HEPATITIS B VACCINE RHBSAG (HEPA-B) for Immunisation; and PREVNAR 13 for Immunisation. It was an actual medication error due to inappropriate reconstitution technique. It was reported that a lyophilized powder portion of Act-HIB that was not given from a box of 5 single doses of PENTACEL and the reporter was unsure which one of the 5 patients who received doses from this lot didn't get the ActHIB portion. It was reported that the patient had no reaction. 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: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial information received on 31-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to 2018SA212665, 2018SA212615, 2018SA212648 and 2018SA212627 (Same reporter). This case involves a two months old male patient who was vaccinated with first dose of PENTACEL (Batch number: C5529AA, expiration date: 04-Oct-2019 via unknown route in unknown administration site on 23-Jul-2018, concomitant medication PREVNAR 13 and Rotovirus. It was an actual medication error due to inappropriate reconstitution technique. It was reported that a lyophilized powder portion of ACT-HIB that was not given from a box of 5 single doses of PENTACEL and the reporter was unsure which one of the 5 patients who received doses from this lot didn't get the ACTHIB portion. It was reported that the patient had no reaction. 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: 1.42
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial unsolicited report received from a nurse on 31-Jul-2018. This case is linked to 2018SA212615, 2018SA212627, 2018SA212638 and 2018SA212648 (Same reporter). This case involves a 17-month old female patient who was vaccinated with a dose of PENTACEL (Batch number: C5529AA, expiration date: 04-Oct-2019 via unknown route in unknown administration site on 30-Jul-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate reconstitution technique. It was reported that a lyophilized powder portion of ACT-HIB that was not given from a box of 5 single doses of PENTACEL and the reporter was unsure which one of the 5 patients who received doses from this lot didn't get the ACTHIB portion. It was reported that the patient had no reaction. 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: 80.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Patient came in for pneumonia shot and had previously received PREVNAR 13 vaccination greater than 2 years ago. Patient was vaccinated with PNEUMOVAX 23 without any adverse reaction noted. Patient came into pharmacy on 8/7/18 approximately 8 PM reporting that his left arm was itchy, red and warm and had been so for a day or so. RPh on duty told patient to elevate arm, ice it, and take diphenhydramine for the itching at an appropriate allergy dose. RPh on duty instructed patient to call his prescriber to report adverse reaction or go to urgent care/ER if symptoms got worse. RPh on duty notified his physician by telephone of the reaction on 8/8/18.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Dizziness, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: Headache, sore throat, lung congestion (hacking up green mucas), dizzy, tired, chills.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Productive cough, Pulmonary congestion
Clinical narrative: Headache, sore throat, lung congestion (hacking up green mucas), dizzy, tired, chills.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blindness, Deafness, Headache, Nausea, Neurological examination
Clinical narrative: 10 min after pt received immunizations the pt complained about hearing loss, blurry/loss of vision, headache, and nausea.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Vision blurred
Clinical narrative: 10 min after pt received immunizations the pt complained about hearing loss, blurry/loss of vision, headache, and nausea.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal X-ray, Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood albumin decreased, Blood alkaline phosphatase normal
Clinical narrative: Patient was vaccinated with first dose of SHINGRIX at Pharmacy on May  9, 2018. On May 30, 2018 he was admitted to Medical Center with acute pancreatitis. He was discharged from Medical Center on 6-7-18. Pancreatitis was resolved at discharge.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood bilirubin normal, Computerised tomogram abdomen abnormal, Culture urine negative, Diverticulum intestinal, Faecaloma
Clinical narrative: Patient was vaccinated with first dose of SHINGRIX at Pharmacy on May  9, 2018. On May 30, 2018 he was admitted to Medical Center with acute pancreatitis. He was discharged from Medical Center on 6-7-18. Pancreatitis was resolved at discharge.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Flatulence, Gastrointestinal wall thickening, Glycosylated haemoglobin normal, Oedematous pancreatitis, Pancreatitis acute
Clinical narrative: Patient was vaccinated with first dose of SHINGRIX at Pharmacy on May  9, 2018. On May 30, 2018 he was admitted to Medical Center with acute pancreatitis. He was discharged from Medical Center on 6-7-18. Pancreatitis was resolved at discharge.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripancreatic fluid collection, Protein total decreased, X-ray abnormal
Clinical narrative: Patient was vaccinated with first dose of SHINGRIX at Pharmacy on May  9, 2018. On May 30, 2018 he was admitted to Medical Center with acute pancreatitis. He was discharged from Medical Center on 6-7-18. Pancreatitis was resolved at discharge.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Rash
Clinical narrative: Started with very bad headache, then a rash on the left side of his head. Rash went from center top back of head to above left eye. Rash is currently going away, still suffers bad headaches.   Treatment: short course of steroid and anti-viral medicine. Anti virus given by family physician and steroid given by ENT doctor that saw him the day after the family doctor (appointment made with ENT days prior as he had bell's palsy 1.5 years ago and thought he was getting it again, but it was shingles that he was diagnosed with by both doctors.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Altered state of consciousness, Chills, Dizziness, Dyspnoea, Head discomfort
Clinical narrative: Patient began feeling light headed and dizzy with tingling and numbness in the hands and feet about 20 minutes after receiving her 3rd hepatitis B vaccine while at the front desk of the clinic. There was no reaction to the prior Hepatitis B injections. Initially she was hyperventilating with respiratory rate of approximately 40 breaths per minute. Patient was accompanied by staff and brought to an exam room for assessment by a physician. Staff assisted patient to lie down and were able to get her to slow her respirations to about 20 breaths per minute. Her initial BP by the nurse was 80/60 with pulse of about 120. When her BP it was 132/86 and 136/84, pulse 116. We had patient attempt to sit up but she again felt like she was going to pass out and felt short of breath. Pt continued to feel unwell and began to have chills and rigors and began to feel "pressure in the head." Given her ongoing symptoms, paramedics were called and care was managed by the paramedics.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Hyperventilation, Hypoaesthesia, Malaise, Paraesthesia
Clinical narrative: Patient began feeling light headed and dizzy with tingling and numbness in the hands and feet about 20 minutes after receiving her 3rd hepatitis B vaccine while at the front desk of the clinic. There was no reaction to the prior Hepatitis B injections. Initially she was hyperventilating with respiratory rate of approximately 40 breaths per minute. Patient was accompanied by staff and brought to an exam room for assessment by a physician. Staff assisted patient to lie down and were able to get her to slow her respirations to about 20 breaths per minute. Her initial BP by the nurse was 80/60 with pulse of about 120. When her BP it was 132/86 and 136/84, pulse 116. We had patient attempt to sit up but she again felt like she was going to pass out and felt short of breath. Pt continued to feel unwell and began to have chills and rigors and began to feel "pressure in the head." Given her ongoing symptoms, paramedics were called and care was managed by the paramedics.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Feeling abnormal, Injection site warmth, Pyrexia
Clinical narrative: Warm injection site, fever, felt lousy.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Hyperacusis, Musculoskeletal stiffness, Nausea, Pain
Clinical narrative: 8 hours after receiving the Meningitis vaccination my daughter began having a severe headache. It began with the right side of her face and quickly spread to her neck and shoulders. Within an hour she said her entire right side of her body was achy and hurting. She was in so much pain she could not tolerate light or sound and was nauseous. She began spiking a low grade fever within the hour. We gave her 3 ibuprofen which did nothing for the pain or symptoms. 1 1/2-2 hours later we gave her 2 large doses of CBD oil. She could do nothing but cry and rock in pain for 3 hours straight. Finally after the 3rd hour her pain began to subside enough she could lay down and fall asleep. She continued to have a low grade fever throughout the night but it did not get any worse. She feels very achy and has a "stiff" neck and slight headache this morning.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Photophobia, Pyrexia
Clinical narrative: 8 hours after receiving the Meningitis vaccination my daughter began having a severe headache. It began with the right side of her face and quickly spread to her neck and shoulders. Within an hour she said her entire right side of her body was achy and hurting. She was in so much pain she could not tolerate light or sound and was nauseous. She began spiking a low grade fever within the hour. We gave her 3 ibuprofen which did nothing for the pain or symptoms. 1 1/2-2 hours later we gave her 2 large doses of CBD oil. She could do nothing but cry and rock in pain for 3 hours straight. Finally after the 3rd hour her pain began to subside enough she could lay down and fall asleep. She continued to have a low grade fever throughout the night but it did not get any worse. She feels very achy and has a "stiff" neck and slight headache this morning.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 05-NOV-2013, the patient was inoculated at a clinic with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 12-JUL-2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with the ZOSTAVAX vaccine by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster also known as shingles and other complications. In 2015, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. The patient was prescribed acyclovir for management of his painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.