chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 59 years old female patient who experienced generalized body aches and arm pain at injection site, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in the left arm. On an unknown date, the patient developed a non-serious generalized body aches and arm pain at injection site, following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Relevant tests were not reported. Final diagnosis was generalized body aches and experienced arm pain at injection site. It was not reported if the patient received a corrective treatment. The event outcome was not reported for generalized body aches and experienced arm pain at injection site. List of documents held by sender: none.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 61 years old male patient who received vaccine FLUZONE QUADRIVALENT. The patient's past medical history and family history were not provided. The patient did not receive any concomitant medication. On 01-Oct-2018, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6310NA, expiry date 30 Jun 2019 via IV route in unknown administration site. It was an actual medication error due to inappropriate route of vaccination. It was reported that inpatient was administered FLUZONE QUADRIVALENT 0.5mL IV prior to his discharge from hospital today. It was unknown whether patient experienced any adverse reaction 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 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: U
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 65 years old patient (gender not reported) who experienced reactions to the FLUZONE HD because it was too strong of a dose, while she received vaccines FLUZONE HIGH DOSE. The patients past vaccination(s) included FLUZONE QUADRIVALENT was received twice in two separate visits. The patients past medical history, medical treatment(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and Exp. Date not reported) via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious reaction (adverse drug reaction) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was reported that; patient has reactions to the FLUZONE HD because it is too strong of a dose but last year received the QUAD FLUZONE (not HD) twice in two separate visits to get the full recommended HD dose for her age of over 65. No information about relevant tests reported. Final diagnosis was reactions to the fluzone hd. No information about corrective treatment reported. The patient outcome was unknown for event. List of documents held by sender: none.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 16 year old male patient. The patient's medical history and concomitant medications were not reported. On 08-JUN-2016, the patient was vaccinated with GARDASIL (strength, dose, route were unknown) lot # M003659 and expiry date 20-SEP-2017 for immunization at physician office. On 08-JUN-2016, on the same day, when the patient was leaving the office, he fainted in the elevator (syncope). The outcome of syncope was reported as recovered. The causality assessment was not provided.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 76-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of abdominal discomfort (experienced fever, chills, malaise and fatigue after 1st dose received on 7th May 2018, refer case US2018GSK181075). On 6th August 2018, the patient received the 2nd dose of SHINGRIX. On 7th August 2018, 1 days after receiving SHINGRIX, the patient experienced fatigue, chills, malaise, fever and upset stomach. In August 2018, the patient experienced injection site warmth, injection site erythema and injection site swelling. Rechallenge with SHINGRIX was positive. In August 2018, the outcome of the injection site warmth, injection site erythema and injection site swelling were recovered/resolved. On an unknown date, the outcome of the fatigue, chills, malaise, fever and upset stomach were recovered/resolved. It was unknown if the reporter considered the fatigue, chills, injection site warmth, malaise, injection site erythema, injection site swelling, fever and upset stomach to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The next day after receiving SHINGRIX, the experienced upset stomach, fever, chills, malaise and fatigue. The patient stated that these symptoms started to resolve after a few days and then got worse a few days later. The patient stated that on the 5th or 6th day following the 2nd dose of SHINGRIX, she noticed a pronounced red circle that was larger than a half dollar on her left arm that was puffy and warm to the touch. The patient stated that the puffiness and warm to touch only lasted for 1 hour, however, the red circle lasted for a few days. On 13th August 2018, one week later the patient went to see the doctor for the symptoms that occurred after the 2nd dose.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Malaise, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 76-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of abdominal discomfort (experienced fever, chills, malaise and fatigue after 1st dose received on 7th May 2018, refer case US2018GSK181075). On 6th August 2018, the patient received the 2nd dose of SHINGRIX. On 7th August 2018, 1 days after receiving SHINGRIX, the patient experienced fatigue, chills, malaise, fever and upset stomach. In August 2018, the patient experienced injection site warmth, injection site erythema and injection site swelling. Rechallenge with SHINGRIX was positive. In August 2018, the outcome of the injection site warmth, injection site erythema and injection site swelling were recovered/resolved. On an unknown date, the outcome of the fatigue, chills, malaise, fever and upset stomach were recovered/resolved. It was unknown if the reporter considered the fatigue, chills, injection site warmth, malaise, injection site erythema, injection site swelling, fever and upset stomach to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The next day after receiving SHINGRIX, the experienced upset stomach, fever, chills, malaise and fatigue. The patient stated that these symptoms started to resolve after a few days and then got worse a few days later. The patient stated that on the 5th or 6th day following the 2nd dose of SHINGRIX, she noticed a pronounced red circle that was larger than a half dollar on her left arm that was puffy and warm to the touch. The patient stated that the puffiness and warm to touch only lasted for 1 hour, however, the red circle lasted for a few days. On 13th August 2018, one week later the patient went to see the doctor for the symptoms that occurred after the 2nd dose.
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Malaise, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a 18-year-old male patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, less than an hour after receiving BEXSERO, the patient experienced fever, fatigue and feeling unwell. The patient was treated with BENADRYL. On an unknown date, the outcome of the fever, fatigue and feeling unwell were recovered/resolved. It was unknown if the reporter considered the fever, fatigue and feeling unwell to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. Within 1 hour after receiving BEXSERO, the patient developed high grade fever of 102 to 103 degrees F, fatigue and overall ill feeling which lasted for about 48 hours. The patient was treated with BENADRYL at which symptoms have completely resolved. No further details were reported regarding the events. Lab Comments: Lab test was done on an unknown date.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Paraesthesia, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 77-year-old female patient who received SHINGRIX for prophylaxis. On 10th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 22nd September 2018, 12 days after receiving SHINGRIX, the patient experienced shingles, pruritus, tingling and erythema. On an unknown date, the outcome of the shingles, pruritus and tingling were not recovered/not resolved and the outcome of the erythema was unknown. It was unknown if the reporter considered the shingles, pruritus, tingling and erythema to be related to SHINGRIX. Additional details were provided as follows: The patient stated that she noticed red marks around her waist and on her back that were itchy and tingling. The patient went to visit her primary doctor and her primary doctor referred her to another physician. The physician then diagnosed the patient with Shingles. The patient stated that the doctor did not prescribe anything for the Shingles. This case has been linked with US2018174666, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a male patient 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 erythema. On an unknown date, the outcome of the erythema was unknown. It was unknown if the reporter considered the erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller stated that her pharmacist informed her that the patient who received SHINGRIX (unsure of which dose) came in to the pharmacy to report that he had red marks around his waist that he believed to be shingles. The caller stated that the pharmacist told her that although the patient believed it to be Shingles, the pharmacist did not think that the red marks were shingles. The caller did not had any additional information regarding this event. The reporter also reported an adverse event on behalf of herself, refer linked case US2018174665.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Injection site warmth, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema, injection site warmth and swelling. On an unknown date, the outcome of the erythema, injection site warmth and swelling were recovered/resolved. It was unknown if the reporter considered the erythema, injection site warmth and swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced adverse events of swelling, redness, and injection site was hot to the touch. The HCP was unable to provide lot number or expiry date or patient demographics at the time of reporting but would follow up once they were found. This case was linked with US2018GSK180378, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Oral herpes
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of cold sore mouth in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included cold sore mouth. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, several days after receiving SHINGRIX, the patient experienced cold sore mouth. On an unknown date, the outcome of the cold sore mouth was unknown. It was unknown if the reporter considered the cold sore mouth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Few days after receiving SHINGRIX, the patient experienced oral cold sores. The healthcare professional did not have access to any patient. The healthcare professional did not have access to any vaccine information at this time. The healthcare professional stated he could call back with the information later if needed.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Immediate post-injection reaction, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of back pain in a 64-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020) for prophylaxis. Previously administered products included ZOSTAVAX (received in 2014). Concurrent medical conditions included atrial fibrillation. Concomitant products included CARDIZEM, flecainide, LIPITOR and XARELTO. On 8th June 2018, the patient received the 1st dose of SHINGRIX. On 8th June 2018, immediately after receiving SHINGRIX, the patient experienced back pain and fever. On 13th June 2018, the outcome of the back pain and fever were recovered/resolved. It was unknown if the reporter considered the back pain and fever to be related to SHINGRIX. Additional details were provided as follows: The patient experienced pain across top of back and fever, both events began immediately and resolved in 4 to 5 days. The fever has resolved without sequelae. The patient experienced the adverse event after 2nd dose for tolerance see linked case US2018GSK181164.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in a adult male patient who received SHINGRIX for prophylaxis. On 24th September 2018, the patient received SHINGRIX. On 25th September 2018, 1 days after receiving SHINGRIX, the patient experienced pain and tiredness. On an unknown date, the outcome of the pain and tiredness were not recovered/not resolved. It was unknown if the reporter considered the pain and tiredness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician was reporting the case for himself. On the day of reporting, he felt achy and tired.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling jittery
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of jitteriness in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. In September 2018, less than a year after receiving SHINGRIX, the patient experienced jitteriness. On an unknown date, the outcome of the jitteriness was unknown. The reporter considered the jitteriness to be unrelated to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional stated that the patient received 1st dose of SHINGRIX 8 weeks ago from the reporting date. The patient received a steroid injection about a week ago from the reporting date. The patient experienced the expected jitteriness after receiving the steroid injection. The healthcare professional did not feel the jitteriness was related to SHINGRIX since it was expected with steroids. The healthcare professional did not wish to provide additional information since she felt jitteriness was related to steroid injection and not SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Myalgia, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hives in a adult female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 3 hrs after receiving SHINGRIX, the patient experienced hives, and less than a month after vaccination the patient experienced chills, tiredness, muscle pain and influenza-like symptoms. The patient was treated with BENADRYL. On an unknown date, the outcome of the hives, chills, tiredness, muscle pain and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the hives, chills, tiredness, muscle pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. No exact date or patient information was known. Only the first initial was known. The patient experienced hives 3 to 4 hours after her dose and the hives presented about the neck, arm, and back. The patient took BENADRYL and the event resolved after an unspecified period of time.
Sex: U
Vaccine: MNQ
Symptoms: Dyspnoea, Hypoaesthesia, Incorrect dose administered, Product preparation error
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of difficulty breathing in an unspecified number of the patients who received MENVEO for prophylaxis. Co-suspect products included ROCEPHIN for an unknown indication. On an unknown date, the patient received MENVEO at an unknown dose and ROCEPHIN at an unknown dose and frequency. On an unknown date, unknown after receiving MENVEO, the patient experienced difficulty breathing, numbness in fingers, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the difficulty breathing, numbness in fingers, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the difficulty breathing and numbness in fingers to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not applicable for this report. The healthcare professional reported that MENVEO liquid component was inadvertently mixed with ROCEPHIN and administered to an unknown number of patients for an unknown period of time, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This was a vaccine administration error. The MENVEO liquid component was mixed with rocephin instead of mixing ROCEPHIN with diluent. After receiving vaccination, the unspecified number of the patients experienced some numbness in fingers and difficulty breathing. It was unknown if the reporter considered the difficulty breathing and numbness in fingers to be related to ROCEPHIN. No additional details were available.
Sex: F
Vaccine: TDAP
Symptoms: Cough
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cough in a elderly female patient who received dTpa vaccine for prophylaxis. On an unknown date, the patient received dTpa vaccine. On an unknown date, 14 days after receiving dTpa vaccine, the patient experienced cough. On an unknown date, the outcome of the cough was not recovered/not resolved. It was unknown if the reporter considered the cough to be related to dTpa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient received TDAP booster dose about 8 weeks before the date of reporting in expectation of 2 new grandsons. The patient do not know if it was given intramuscular but said it was in the upper arm. She took no other medications. Two weeks after receiving the vaccine, she developed a cough which remained. The patient stated, one baby came early and was in neonatal intensive care unit (NICU) and there was no way they would let her in with the cough. The patient stated, the vaccine was supposed to kill the virus and asked what was up with this. The reporter would see the doctor the afternoon on the date of reporting and will try and get lot number, expiration date and other information. This case has been linked with case US2018176409, reported by the same reporter.
Sex: M
Vaccine: TDAP
Symptoms: Cough
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cough in a elderly male patient who received dTpa vaccine for prophylaxis. On an unknown date, the patient received dTpa vaccine. On an unknown date, 14 days after receiving dTpa vaccine, the patient experienced cough. On an unknown date, the outcome of the cough was not recovered/not resolved. It was unknown if the reporter considered the cough to be related to dTpa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter was the patient's wife and the patient got vaccinated with Tdap booster two days before his wife did about 8 weeks (2 months before the reporting date) in expectation of 2 new grandsons. The patient took cholesterol and triglyceride reducers as concomitant drugs. The patient started coughing about 2 weeks later. One baby came early, was in Neonatal intensive care unit (NICU) and there was no way they would let him in with that cough. The vaccine was supposed to be killed virus, not live. This case has been linked with case US2018176406 (wife's case) reported by the same reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Decreased appetite, Immobile, Pain
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of immobile in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, 12 hrs after receiving SHINGRIX, the patient experienced immobile (serious criteria GSK medically significant), pain, appetite absent, weakness, joint pain and sleepiness. On an unknown date, the outcome of the immobile was recovered/resolved and the outcome of the pain, appetite absent, weakness, joint pain and sleepiness were unknown. It was unknown if the reporter considered the immobile, pain, appetite absent, weakness, joint pain and sleepiness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was unable to move for 16 hours. The patient had to crawl to the bathroom because she was too weak to stand. Her joints were also painful. The patient slept through the day not eating but only drinking water when she would wake.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of immobile in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, 12 hrs after receiving SHINGRIX, the patient experienced immobile (serious criteria GSK medically significant), pain, appetite absent, weakness, joint pain and sleepiness. On an unknown date, the outcome of the immobile was recovered/resolved and the outcome of the pain, appetite absent, weakness, joint pain and sleepiness were unknown. It was unknown if the reporter considered the immobile, pain, appetite absent, weakness, joint pain and sleepiness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was unable to move for 16 hours. The patient had to crawl to the bathroom because she was too weak to stand. Her joints were also painful. The patient slept through the day not eating but only drinking water when she would wake.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, Injection site erythema, Seizure
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of seizure in a 16-year-old female patient who received MENVEO (batch number M17075, expiry date July 2019) for prophylaxis. Previously administered products included MENVEO (1st dose received on 27th March 2018). On 27th September 2018, the patient received the 2nd dose of MENVEO (intramuscular) .5 ml. On 28th September 2018, 1 days after receiving MENVEO, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the patient experienced injection site erythema and extra dose administered. On an unknown date, the outcome of the seizure and injection site erythema were recovering/resolving and the outcome of the extra dose administered was unknown. It was unknown if the reporter considered the seizure and injection site erythema to be related to MENVEO. Additional details were provided as follows: The healthcare professional (HCP) reported that the patient experienced two seizures following a dose of MENVEO which was administered in error. The HCP stated that the patient received 1st of MENVEO, and also received their 2nd dose in error, which led to extra dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin exfoliation
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of skin peeling in a 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 skin peeling and rash. On an unknown date, the outcome of the skin peeling and rash were unknown. It was unknown if the reporter considered the skin peeling and rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a rash and the bottom of her feet were peeling. The reporter agreed to be followed up.
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: This case was reported by a other health professional and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose and Influenza vaccine Quadrivalent unspecified season at an unknown dose. On 20th September 2018, less than a year after receiving SHINGRIX and unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm and influenza-like symptoms. On an unknown date, the outcome of the pain in arm and influenza-like symptoms were unknown. It was unknown if the reporter considered the pain in arm and influenza-like symptoms to be related to SHINGRIX and Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at the vaccination was not reported. The patient received Flu shot of unknown brand. The case was linked to the case US2018GSK176991, reported by the same reporter.
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: This case was reported by a other health professional and described the occurrence of pain in arm in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose and Influenza vaccine Quadrivalent unspecified season at an unknown dose. On 20th September 2018, less than a year after receiving SHINGRIX and unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm and influenza-like symptoms. On an unknown date, the outcome of the pain in arm and influenza-like symptoms were unknown. It was unknown if the reporter considered the pain in arm and influenza-like symptoms to be related to SHINGRIX and Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at the vaccination was not reported. The patient received Flu shot of unknown brand. The case was linked to the case US2018GSK176949, reported by the same reporter.
Sex: U
Vaccine: MNQ
Symptoms: Vaccination complication
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in a patient who received Meningococcal ACWY Vaccine (potential MENVEO) for prophylaxis. On an unknown date, the patient received Meningococcal ACWY Vaccine (potential MENVEO) at an unknown dose. On an unknown date, unknown after receiving Meningococcal ACWY Vaccine (potential MENVEO), the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Meningococcal ACWY Vaccine (potential MENVEO). Additional information received as follows: The age at vaccination was not reported. The reporter would like to report an adverse reaction to meningitis vaccine MCV4. The reporter asked if he or she could report it through email or need to call. The reporter was asking for the contact number.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a adult patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced erythema, injection site warmth and swelling. On an unknown date, the outcome of the erythema, injection site warmth and swelling were unknown. It was unknown if the reporter considered the erythema, injection site warmth and swelling to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced adverse events of swelling, redness, and injection site was hot to the touch. The healthcare professional (HCP) was unable to provide lot number, expiry date or patient demographics at the time of reporting but would follow up once they were found. This case was linked with US2018174667, reported by the same reporter.
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, 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 elderly female patient who received Flu 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 injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. Sometimes when the patient gets her flu vaccine she gets a bump or redness at the injection site. Other times she had no reaction at all. The patient had denied permission to contact their physician. This case has been linked with the case US2018174634, reported by the same reporter.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Malaise, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 76-year-old female patient who received Shingrix for prophylaxis. On 7th May 2018, the patient received the 1st dose of Shingrix. On 8th May 2018, 1 days after receiving Shingrix, the patient experienced fatigue, chills, malaise, fever and upset stomach. On an unknown date, the outcome of the fatigue, chills, malaise, fever and upset stomach were recovered/resolved. It was unknown if the reporter considered the fatigue, chills, malaise, fever and upset stomach to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix on left arm. The patient stated that the symptoms started to resolve 2 days after receiving the Shingrix. The patient did not visit the doctor for these symptoms. For tolerance to the next dose, refer case US2018174563.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Burning sensation, Immediate post-injection reaction, Musculoskeletal discomfort, Musculoskeletal pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of back pain in a 64-year-old female patient who received Shingrix (batch number 524S7, expiry date 31st August 2021) for prophylaxis. Previously administered products included Zostavax (received in 2014) and Shingrix with an associated reaction of pyrexia (1st dose received on 8th June 2018, for tolerance refer case US2018174928). Concurrent medical conditions included atrial fibrillation. Concomitant products included Cardizem, flecainide, Lipitor and Xarelto. On 7th September 2018, the patient received the 2nd dose of Shingrix. On 7th September 2018, immediately after receiving Shingrix, the patient experienced back pain, burning sensation, musculoskeletal discomfort and scapula pain. In September 2018, the patient experienced fever. The patient was treated with Tylenol. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the back pain, burning sensation and musculoskeletal discomfort were unchanged and the outcome of the fever was recovered/resolved and the outcome of the scapula pain was unknown. It was unknown if the reporter considered the back pain, burning sensation, musculoskeletal discomfort, fever and scapula pain to be related to Shingrix. Additional details were provided as follows: The patient experienced pain in same area across top of back as pain after 1st dose, musculoskeletal discomfort, pain across the lateral upper back (across scapula), burning sensation across top of back, all of these events began immediately after receiving dose continued at the time of reporting. The patient tried Tylenol without relief. The fever had resolved without sequelae.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of back pain in a 64-year-old female patient who received Shingrix (batch number 524S7, expiry date 31st August 2021) for prophylaxis. Previously administered products included Zostavax (received in 2014) and Shingrix with an associated reaction of pyrexia (1st dose received on 8th June 2018, for tolerance refer case US2018174928). Concurrent medical conditions included atrial fibrillation. Concomitant products included Cardizem, flecainide, Lipitor and Xarelto. On 7th September 2018, the patient received the 2nd dose of Shingrix. On 7th September 2018, immediately after receiving Shingrix, the patient experienced back pain, burning sensation, musculoskeletal discomfort and scapula pain. In September 2018, the patient experienced fever. The patient was treated with Tylenol. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the back pain, burning sensation and musculoskeletal discomfort were unchanged and the outcome of the fever was recovered/resolved and the outcome of the scapula pain was unknown. It was unknown if the reporter considered the back pain, burning sensation, musculoskeletal discomfort, fever and scapula pain to be related to Shingrix. Additional details were provided as follows: The patient experienced pain in same area across top of back as pain after 1st dose, musculoskeletal discomfort, pain across the lateral upper back (across scapula), burning sensation across top of back, all of these events began immediately after receiving dose continued at the time of reporting. The patient tried Tylenol without relief. The fever had resolved without sequelae.
Age: 46.0
Sex: M
Vaccine: FLUX, TDAP
Symptoms: Chills, Dizziness, Electrocardiogram, Heart rate increased, Hyperhidrosis
Clinical narrative: Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 46 years old male patient who experienced the next morning at around 5:30 am his heart rate was around 152, patient stated that by around 12:30am - 1am he was woken up due to shivering, he was diaphoretic and dizzy, he was diaphoretic and dizzy and said that his pulse was 106 at the doctors/ the lowest the heart rate would go to was 110, while he received vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE for Immunisation. On 27-Sep-2018, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot number not reported via intramuscular route. On 28-Sep-2018, the patient developed a non-serious the next morning at around 5:30 am his heart rate was around 152/ his pulse was 106 at the doctors/ the lowest the heart rate would go to was 110, non-serious patient stated that by around 12:30am -1am he was woken up due to shivering, he was diaphoretic and dizzy (hyperhidrosis) and diaphoretic and dizzy, (latency unknown) following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. (Other relevant tests included Patient did an EKG (Electrocardiogram) while he was at the office.) Final diagnosis was said that his pulse was 106 at the doctors/ the lowest the heart rate would go to was 110/ his pulse was 106 at the doctors/ the lowest the heart rate would go to was 110, he was diaphoretic and dizzy, he was diaphoretic and dizzy, patient stated that by around 12:30am- 1am he was woken up due to shivering and the next morning at around 5:30 am his heart rate was around 152. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for the next morning at around 5:30 am his heart rate was around 152, as Unknown for patient stated that by around 12:30am- 1am he was woken up due to shivering, as Unknown for he was diaphoretic and dizzy, as Unknown for he was diaphoretic and dizzy and as Recovered / Resolved on an unknown date for said that his pulse was 106 at the doctors/ the lowest the heart rate would go to was 110.
Sex: U
Vaccine: FLU4
Symptoms: Wrong drug administered
Clinical narrative: Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves an 81 years old patient (gender not reported) who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT instead of FLUZONE HIGH DOSE (batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date. The patients medical history and concomitant medications were not reported. It was an actual medication error due wrong vaccine administered. No information about any adverse event reported. 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.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 60 years old female who was accidentally vaccinated with a dose of FLUZONE HIGH DOSE (lot UJ000AB, expiration date 28-MAR-2019) via intramuscular route in the right deltoid on 14-Sep-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration and overdose. No side effects have been reported at that time. 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: U
Vaccine: FLUX
Symptoms: Wrong drug administered
Clinical narrative: Initial unsolicited report received from pharmacist on 27-Sep-2018. This case is linked to case 2018SA272287. This case involves a [59 years old] (unknown gender) patient who was vaccinated with a dose of TUBERSOL (Batch number: C5482AB, expiration date, dose, route and site of administration was not reported) on an unknown date. The patients was positive to PPD previously. The patients past concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered (accidentally gave them IM Tubersol instead of flu vaccination). It was unknown whether patient experienced any adverse event following vaccination. 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: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from Other health care professional via Sales Representative. This case involves Child female patient (age unknown) who received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, concomitant medication and family history were not provided. On an unknown date in July 2018, the patient received a second dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported, expiry date end of June via unknown route in unknown administration site. It was an actual medication error due to expired vaccine used. It was reported that an expired Pediatric FLUZONE QUADRIVALENT was administered to a child 2 days after it expired. It was unknown whether patient experienced any adverse reaction 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: F
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2018SA274330 (same reporter). This case involves a female patient (age was not reported) who received a 0.5 mL dose of FLUBLOK QIV (lot number, expiry date, dose in series and site of administration was not reported) via intramuscular route on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was reported that vaccine had been over a total of 24 hours out of range, too warm (excursion). No known adverse reaction, symptoms were reported. 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.