chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Nasopharyngitis, Paraesthesia
Clinical narrative: tingling in head, both sides of fingers and toes; cold-like symptoms; This non-serious case was reported by a consumer via call center representative and described the occurrence of cold symptoms in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis.   On 27-OCT-2024, the patient received the 2nd dose of Shingrix (right arm) and Influenza vaccine (left arm). On 27-OCT-2024, less than a day after receiving Shingrix, the patient experienced cold symptoms (Verbatim: cold-like symptoms). On 31-OCT-2024, the patient experienced tingling of extremity (Verbatim: tingling in head, both sides of fingers and toes). On 28-OCT-2024, the outcome of the cold symptoms was resolved (duration 1 day). The outcome of the tingling of extremity was not resolved.   It was unknown if the reporter considered the cold symptoms and tingling of extremity to be related to Shingrix.     It was unknown if the company considered the cold symptoms and tingling of extremity to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-OCT-2024 The patient self-reported this case. She received 2nd dose of Shingrix vaccine and Flu shot and that night she had cold-like symptoms that went away the next day.  She stated today (on the reporting day) she was experiencing tingling on both sides of fingers and toes and tingling in her head. It was unknown if the reporter considered the cold symptoms and tingling of extremity to be related to Influenza vaccine.
Sex: F
Vaccine: MENB, MENB
Symptoms: Extra dose administered
Clinical narrative: third dose was given on Oct 30th 2024.; the second on Dec 16th 2021.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 22-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero (received 1st dose on 25th March 2021).   On 30-OCT-2024, the patient received the 3rd dose of Bexsero. On 16-DEC-2021, the patient received the 2nd dose of Bexsero. On 16-DEC-2021, not applicable after receiving Bexsero and an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too long (Verbatim: the second on Dec 16th 2021.). On 30-OCT-2024, the patient experienced drug dose administration interval too long (Verbatim: third dose was given on Oct 30th 2024.). The outcome of the drug dose administration interval too long and drug dose administration interval too long were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-OCT-2024 A medical assistant called to ask for recommendations on this situation that a patient received two doses of Bexsero in 2021. The first dose on 25th March 2021 and the second dose on 16th December 2021 which led to drug dose administration interval too long. A third dose was given on 30th October 2024 which led to drug dose administration interval too long. The healthcare professional asked for safety data about this extra dose given. According to PI before August 2024 the Bexsero schedule consists of two doses.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: received only the diluent of HIBERIX; received only the diluent of HIBERIX; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in an specified number of patients who received Hib (Hiberix) (batch number 7ac3c, expiry date 30-SEP-2025) for prophylaxis.   On an unknown date, the patients received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: received only the diluent of HIBERIX ) and inappropriate dose of vaccine administered (Verbatim: received only the diluent of HIBERIX ). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 31-OCT-2024 The reporter reported that the two patients received only the diluent of Hiberix vaccine (inappropriate reconstitution technique), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.   No further information was known including demographics, DOB, gender, date of administration or site of administration.   The reporter stated both patients would be revaccinated.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of product administration
Clinical narrative: Patient received FluLaval subcutaneously; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 6-year-old male patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 495MK, expiry date 30-JUN-2025) for prophylaxis.   On 26-SEP-2024, the patient received FluLaval 2024-2025 season (subcutaneous). On 26-SEP-2024, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced intramuscular formulation administered by other route (Verbatim: Patient received FluLaval subcutaneously). The outcome of the intramuscular formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-NOV-2024 Other HCP reported that a patient received FluLaval subcutaneously, which led to Intramuscular formulation administered by other route. This case has been linked to the case US2024136180 reported by the same reporter.; Sender's Comments:  US-GSK-US2024136180:Same reporter/Different patinet
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Menveo given in error instead of Bexsero; got the 2nd dose of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Menveo (received the first dose of Menveo on 17th July 2024) and Bexsero (received the first dose of Bexsero on 17th July 2024).   On 01-NOV-2024, the patient received the 2nd dose of Menveo. On an unknown date, the patient did not receive Bexsero. On 01-NOV-2024, an unknown time after receiving Menveo and not applicable after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Menveo given in error instead of Bexsero) and extra dose administered (Verbatim: got the 2nd dose of Menveo). The outcome of the wrong vaccine administered and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-NOV-2024 The nurse reported that Menveo was administered to a patient instead of indicated Bexsero which led to wrong vaccine administered. The patient received the first dose of Menveo and Bexsero. Then the patient got the 2nd dose of Menveo which led to extra dose administered. The nurse reported that Bexsero had not been administered at the moment of the reporting and the patient was following a 3 doses schedule.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Constipation, Fatigue, Hyperhidrosis, Injection site pain
Clinical narrative: stomach upset; nervousness; blurred vision; tiredness; sweating; weakness and she was dropping things; constipation; injection site pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-OCT-2024, the patient received the 2nd dose of Shingrix (intramuscular, unknown deltoid). On 25-OCT-2024, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: injection site pain). On 27-OCT-2024, the patient experienced upset stomach (Verbatim: stomach upset), nervous (Verbatim: nervousness), blurred vision (Verbatim: blurred vision), tiredness (Verbatim: tiredness), sweating (Verbatim: sweating), weakness (Verbatim: weakness and she was dropping things) and constipation (Verbatim: constipation). The outcome of the injection site pain was resolving and the outcome of the upset stomach, nervous, blurred vision, tiredness, sweating, weakness and constipation were not resolved.   It was unknown if the reporter considered the injection site pain, upset stomach, nervous, blurred vision, tiredness, sweating, weakness and constipation to be related to Shingrix.     It was unknown if the company considered the injection site pain, upset stomach, nervous, blurred vision, tiredness, sweating, weakness and constipation to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-NOV-2024 The patient self-reported this case. She received her second Shingrix dose and that day, she had injection site pain and was not resolved completely, but the pain had lessened. Two days after vaccination, she developed blurred vision, nervousness, stomach upset, tiredness, weakness, sweating, constipation and she was dropping things and continued. She saw her physician earlier that week and her physician recommended her to drink water, rest, and call GSK if symptoms continued.  She has another call in to her physician because the symptoms were continuing a week after vaccination. She did not knew the lot number and expiration date.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Nervousness, Vision blurred
Clinical narrative: stomach upset; nervousness; blurred vision; tiredness; sweating; weakness and she was dropping things; constipation; injection site pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-OCT-2024, the patient received the 2nd dose of Shingrix (intramuscular, unknown deltoid). On 25-OCT-2024, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: injection site pain). On 27-OCT-2024, the patient experienced upset stomach (Verbatim: stomach upset), nervous (Verbatim: nervousness), blurred vision (Verbatim: blurred vision), tiredness (Verbatim: tiredness), sweating (Verbatim: sweating), weakness (Verbatim: weakness and she was dropping things) and constipation (Verbatim: constipation). The outcome of the injection site pain was resolving and the outcome of the upset stomach, nervous, blurred vision, tiredness, sweating, weakness and constipation were not resolved.   It was unknown if the reporter considered the injection site pain, upset stomach, nervous, blurred vision, tiredness, sweating, weakness and constipation to be related to Shingrix.     It was unknown if the company considered the injection site pain, upset stomach, nervous, blurred vision, tiredness, sweating, weakness and constipation to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-NOV-2024 The patient self-reported this case. She received her second Shingrix dose and that day, she had injection site pain and was not resolved completely, but the pain had lessened. Two days after vaccination, she developed blurred vision, nervousness, stomach upset, tiredness, weakness, sweating, constipation and she was dropping things and continued. She saw her physician earlier that week and her physician recommended her to drink water, rest, and call GSK if symptoms continued.  She has another call in to her physician because the symptoms were continuing a week after vaccination. She did not knew the lot number and expiration date.
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Incomplete course of vaccination
Clinical narrative: did not receive the 3rd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 5-year-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Previously administered products included Pediarix (received 1st dose on 15th July 2021) and Pediarix (received 2nd dose on 21st September 2021).   On an unknown date, the patient did not receive the 3rd dose of Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced incomplete course of vaccination (Verbatim: did not receive the 3rd dose). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-NOV-2024 The reporter reported that the patient had received a Pediarix was given to an 8 years old 2 times. The reporter asked how effective will the hep b and polio. The Vaccine Administration Facility is the same as Primary Reporter. the patient received only 2 doses back in 2021 15th July 2021 and 21 September 2021 and did not receive the 3rd dose which led to incomplete course of vaccination.
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: adult dose given to a pediatric patient; adult dose given to a pediatric patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 9-year-old female patient who received HAV (Havrix adult) (batch number 3S54K, expiry date 18-DEC-2025) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: adult dose given to a pediatric patient) and adult product administered to child (Verbatim: adult dose given to a pediatric patient). The outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 01-NOV-2024 The registered nurse asks about any concern about an adult dose given to a pediatric patient, which led to adult use of a child product and overdose.  No further information was provided from the registered nurse´s end. The vaccine administration facility was the same as primary reporter.
Sex: U
Vaccine: HIBV
Symptoms: Wrong product administered
Clinical narrative: hiberix administered in our office that should have been a havirix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a patient who received Hib (Hiberix) for prophylaxis.   Co-suspect products included HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Hiberix and Havrix. On an unknown date, an unknown time after receiving Hiberix and not applicable after receiving Havrix, the patient experienced wrong vaccine administered (Verbatim: hiberix administered in our office that should have been a havirix). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-NOV-2024  The other health professional reported that they had a hiberix administered in their office that should have been a Havirix which led to wrong vaccine administered.  The other health professional asked was there a way GlaxoSmithKline could provide me with guidance to say. The other health professional asked what steps need to be taken for the patient  The other health professional asked was there any harm to the patient if they got the wrong vaccine. No further information was available.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Product Used; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix 720) (batch number D7HA9, expiry date 27-OCT-2024) for prophylaxis.   On 01-NOV-2024, the patient received Havrix 720. On 01-NOV-2024, an unknown time after receiving Havrix 720, the patient experienced expired vaccine used (Verbatim: Expired Product Used). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 01-NOV-2024 The nurse reported that  a patient was administered a dose of Havrix which had an expired, which led to expired vaccine used.   The nurse did not had any patient details at the time of reporting. The vaccine administration facility was the same as primary reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: got a patient have one dose of Shingrix back in April 2019, and they're wanting the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in April 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: got a patient have one dose of Shingrix back in April 2019, and they're wanting the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-NOV-2024 The pharmacist reported that they got a patient have one dose of Shingrix back in April 2019 and they were wanting the 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never receive the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 24-JAN-2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never receive the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-NOV-2024 Pharmacist reported that a patient received a dose of Shingrix and never received the 2nd dose.  The reporter wanted to know if he/she should restart the series. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to an incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose was more than 6 months ago; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix on 23rd May 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: first dose was more than 6 months ago). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-NOV-2024 The nurse reported that the female patient was in the office currently who wanted to receive Shingrix shot 2 but that the patient's first dose was more than 6 months ago. Till the time of reporting the patient did not receive the second dose of Shingrix which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; patient that has all the shots of Shingrix (2 doses) then the patient developed shingles and the doctor ordered to repeat the doses; patient that has all the shots of Shingrix (2 doses) then the patient developed shingles and the doctor ordered to repeat the doses; This serious case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number D294J, expiry date 22-MAR-2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number D294J, expiry date 22-MAR-2021) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix and not applicable after receiving Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles), extra dose administered (Verbatim: patient that has all the shots of Shingrix (2 doses) then the patient developed shingles and the doctor ordered to repeat the doses) and circumstance or information capable of leading to medication error (Verbatim: patient that has all the shots of Shingrix (2 doses) then the patient developed shingles and the doctor ordered to repeat the doses). The outcome of the vaccination failure was not reported and the outcome of the shingles, extra dose administered and circumstance or information capable of leading to medication error were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix, Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 14-NOV-2024 The patient that had all the shots of Shingrix (2 doses) then the patient developed shingles and the doctor ordered to repeat the doses which led to, circumstance or information capable of leading to medication error and extra dose administered. The reporter asked question did the patient needs to repeat the doses. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles infection were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1, Dose 2 and Dose 3).
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; diagnosed with shingles 3 times; 2nd dose possibly received early; This serious case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Patient was diagnosed with Shingles in 2021).   In MAR-2022, the patient received the 2nd dose of Shingrix. In JAN-2022, the patient received the 1st dose of Shingrix. In MAR-2022, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: 2nd dose possibly received early). On an unknown date, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: diagnosed with shingles 3 times). The outcome of the vaccination failure and drug dose administration interval too short were unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 18-NOV-2024 The patient completed Shingrix series in January and March of 2022. The patient was diagnosed with shingles 3 times after completion of the vaccination series with Shingrix to which reporter referred as lack of effect. She did not provide the dates of vaccination or other pertinent details regarding the shingles. The patient received 2nd dose of Shingrix, earlier than the recommended interval, which led to shortening of vaccinations schedule.  This case was considered as suspected vaccination failure as details time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about  time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Brain fog, Chills
Clinical narrative: back ache; ver frequent urination causing irritation; weakness; flushed and puffy face; flushed and puffy face; brain fog; red and swollen arm at injection site; high fever; severe headache; chills; joint and muscle ache; fatigue; joint and muscle ache; red and swollen arm at injection site; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (back ache), POLLAKIURIA (ver frequent urination causing irritation), ASTHENIA (weakness), FLUSHING (flushed and puffy face) and SWELLING FACE (flushed and puffy face) in a 70-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 17-Nov-2024, the patient experienced BACK PAIN (back ache), POLLAKIURIA (ver frequent urination causing irritation), ASTHENIA (weakness), FLUSHING (flushed and puffy face), SWELLING FACE (flushed and puffy face), BRAIN FOG (brain fog), VACCINATION SITE SWELLING (red and swollen arm at injection site), PYREXIA (high fever), HEADACHE (severe headache), CHILLS (chills), MYALGIA (joint and muscle ache), FATIGUE (fatigue), ARTHRALGIA (joint and muscle ache) and VACCINATION SITE ERYTHEMA (red and swollen arm at injection site). At the time of the report, BACK PAIN (back ache), POLLAKIURIA (ver frequent urination causing irritation), ASTHENIA (weakness), FLUSHING (flushed and puffy face), SWELLING FACE (flushed and puffy face), BRAIN FOG (brain fog), VACCINATION SITE SWELLING (red and swollen arm at injection site), PYREXIA (high fever), HEADACHE (severe headache), CHILLS (chills), MYALGIA (joint and muscle ache), FATIGUE (fatigue), ARTHRALGIA (joint and muscle ache) and VACCINATION SITE ERYTHEMA (red and swollen arm at injection site) had not resolved.      No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms or events. No treatment medications were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Flushing, Headache, Myalgia, Pollakiuria
Clinical narrative: back ache; ver frequent urination causing irritation; weakness; flushed and puffy face; flushed and puffy face; brain fog; red and swollen arm at injection site; high fever; severe headache; chills; joint and muscle ache; fatigue; joint and muscle ache; red and swollen arm at injection site; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (back ache), POLLAKIURIA (ver frequent urination causing irritation), ASTHENIA (weakness), FLUSHING (flushed and puffy face) and SWELLING FACE (flushed and puffy face) in a 70-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 17-Nov-2024, the patient experienced BACK PAIN (back ache), POLLAKIURIA (ver frequent urination causing irritation), ASTHENIA (weakness), FLUSHING (flushed and puffy face), SWELLING FACE (flushed and puffy face), BRAIN FOG (brain fog), VACCINATION SITE SWELLING (red and swollen arm at injection site), PYREXIA (high fever), HEADACHE (severe headache), CHILLS (chills), MYALGIA (joint and muscle ache), FATIGUE (fatigue), ARTHRALGIA (joint and muscle ache) and VACCINATION SITE ERYTHEMA (red and swollen arm at injection site). At the time of the report, BACK PAIN (back ache), POLLAKIURIA (ver frequent urination causing irritation), ASTHENIA (weakness), FLUSHING (flushed and puffy face), SWELLING FACE (flushed and puffy face), BRAIN FOG (brain fog), VACCINATION SITE SWELLING (red and swollen arm at injection site), PYREXIA (high fever), HEADACHE (severe headache), CHILLS (chills), MYALGIA (joint and muscle ache), FATIGUE (fatigue), ARTHRALGIA (joint and muscle ache) and VACCINATION SITE ERYTHEMA (red and swollen arm at injection site) had not resolved.      No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms or events. No treatment medications were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling face, Vaccination site erythema, Vaccination site swelling
Clinical narrative: back ache; ver frequent urination causing irritation; weakness; flushed and puffy face; flushed and puffy face; brain fog; red and swollen arm at injection site; high fever; severe headache; chills; joint and muscle ache; fatigue; joint and muscle ache; red and swollen arm at injection site; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (back ache), POLLAKIURIA (ver frequent urination causing irritation), ASTHENIA (weakness), FLUSHING (flushed and puffy face) and SWELLING FACE (flushed and puffy face) in a 70-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 17-Nov-2024, the patient experienced BACK PAIN (back ache), POLLAKIURIA (ver frequent urination causing irritation), ASTHENIA (weakness), FLUSHING (flushed and puffy face), SWELLING FACE (flushed and puffy face), BRAIN FOG (brain fog), VACCINATION SITE SWELLING (red and swollen arm at injection site), PYREXIA (high fever), HEADACHE (severe headache), CHILLS (chills), MYALGIA (joint and muscle ache), FATIGUE (fatigue), ARTHRALGIA (joint and muscle ache) and VACCINATION SITE ERYTHEMA (red and swollen arm at injection site). At the time of the report, BACK PAIN (back ache), POLLAKIURIA (ver frequent urination causing irritation), ASTHENIA (weakness), FLUSHING (flushed and puffy face), SWELLING FACE (flushed and puffy face), BRAIN FOG (brain fog), VACCINATION SITE SWELLING (red and swollen arm at injection site), PYREXIA (high fever), HEADACHE (severe headache), CHILLS (chills), MYALGIA (joint and muscle ache), FATIGUE (fatigue), ARTHRALGIA (joint and muscle ache) and VACCINATION SITE ERYTHEMA (red and swollen arm at injection site) had not resolved.      No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms or events. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Near death experience
Clinical narrative: He was near death twice; the customer got our updated vaccine for the last two years and got sick as a dog; This spontaneous case was reported by a patient and describes the occurrence of NEAR DEATH EXPERIENCE (He was near death twice) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEAR DEATH EXPERIENCE (He was near death twice) (seriousness criterion medically significant) and ILLNESS (the customer got our updated vaccine for the last two years and got sick as a dog). At the time of the report, NEAR DEATH EXPERIENCE (He was near death twice) and ILLNESS (the customer got our updated vaccine for the last two years and got sick as a dog) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were provided   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2024: Live follow up received with no new information.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and CHILLS (chills). At the time of the report, PYREXIA (fever) and CHILLS (chills) had resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment information was provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: he has got covid 4 times; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (he has got covid 4 times) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (he has got covid 4 times). At the time of the report, COVID-19 (he has got covid 4 times) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Suspect vaccine dosage text was reported as unknown.  Patient had taken the last vaccine 2.5years ago and he had got covid 4 times leading him to miss important familial events. Patient wanted to know if there was anything different or a new technology for the current vaccine compared to the past one. Reporter causality was not reported.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Coagulopathy, Deep vein thrombosis
Clinical narrative: blood clotting issues; deep vein thrombosis; This is a spontaneous report received from an Other HCP, Program ID.  A 69-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, 30 ug single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COAGULOPATHY (medically significant), outcome "unknown", described as "blood clotting issues"; DEEP VEIN THROMBOSIS (medically significant), outcome "unknown". Clinical course: the patient reported that he has had blood clotting issues/deep vein thrombosis starting after he had his last covid vaccine. he will discuss with his doctor regarding having another covid vaccination. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events coagulopathy, and deep vein thrombosis and the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: FLUX
Symptoms: Asthenia, Chills, Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: tottered into the kitchen were i promptly passed out/ unconscious; sweats; chills; feeling very weak; Initial information received on 22-Nov-2024 regarding an unsolicited valid  serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who had passed out collapsed unconscious, chills, sweats and feeling very weak after receiving influenza USP trival A-B high dose subvirion vaccine.  The patient's past medical history, medical treatment(s), Concomitant medications, vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown dose of suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (Unknown strength, dose and expiry date) with lot UT8437AA via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient developed passed out. collapsed. unconscious (loss of consciousness), chills, sweats (hyperhidrosis) and feeling very weak (asthenia) (approximately a few hours latency) following the administration of influenza USP trival A-B high dose subvirion vaccine.   Reportedly, I noticed nurses in the halfway giving free flu shots. I have not designed to accept flu shots in the past 17 years but, for some unknown reason, this time I did. That night, around midnight I woke up with chills and sweats, feeling very weak. I tottered into the kitchen where I promptly passed out. Collapsed. Unconscious. I dont know how long I was out - I had guess between 5 and 30 minutes. That was the first time I ever passed out from any medication or injury. I ended up going back to bed four times the following day, lost most of the second day, and part of the third. I have been informed that others have had similar reactions. I have learned that you are the manufacturer of the vaccine I was given and that the batch number was UT8437AA. Since collapsing unconscious is not one of the known side-effects of the vaccine.  Action taken was not applicable for all the events  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was recovered/ resolved for the event loss of consciousness after 5-30 minutes and  Unknown for the rest of the events.  Seriousness criteria: This event loss of consciousness was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 29-Nov-2024: This case involves an unknown age and unknown gender patient who had passed out collapsed unconscious, after receiving influenza USP trival A-B high dose subvirion vaccine. Further information regarding allergic history, medical history, concomitant medication and tolerance,  laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administration of an expired dose of ACTHIB to a patient with no reported adverse event; Initial information received on 19-Nov-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old female patient who had administration of an expired dose of HIB (PRP/T) Vccine [ACT-HIB] to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal vaccine conj (Pneumococcal conjugate vaccine) for Immunisation; Polio vaccine (Polio) for Immunisation; and Hepatitis b vaccine (Hepatitis b vaccine) for Immunisation.  On 18-Nov-2024, the patient received a dose 3 of 0.5 ml of suspect HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) lot UJ978AA, Expiry date: 08-Nov-2024, strength was unknown via intramuscular route in the right thigh for Immunization and administration of an expired dose of acthib to a patient with no reported adverse event (expired product administered) (latency : same day).  Reportedly "This situation is pre-assessed as a medication error/an inappropriate use due to the administration of an expired dose of ACTHIB to a patient. Caller reported that an expired dose of ACTHIB was administered to a patient."  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 the 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: M
Vaccine: UNK
Symptoms: Erythema, Pruritus
Clinical narrative: His arm just got red; Itchy; This spontaneous case, initially received on 13-Nov-2024, was reported by a health professional and concerns an elderly male patient.  Administration of company suspect drug: On 08-Nov-2024, the patient received Fluad (TIV) for Flu immunization, route of administration: not reported. Dose regimen: 0.5 ml, Lot number: 388476. CSL Seqirus Batch number to be matched.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 08-Nov-2024, the patient experienced His arm just got red (outcome: Not recovered / Not resolved), Itchy (outcome: Not recovered / Not resolved).  Patient just had a reaction to one of the flu shots. So, it should have been just the high dose flu vaccine, he just had a reaction to it, patient's arm just got red. It was red and itchy. It was reported that it will get better, just to look at it, Dr. confirmed he'll get better on his own.   Fluad (TIV) action taken: Not Applicable  Reporter assessment: The reporter considered the events as non-serious and did not provide the causality assessment.; Reporter's Comments: The events are related to Fluad (TIV)
Age: 39.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Painfull swelling not localized in the injection site, including like a foot and then her hand; Painfull swelling not localized in the injection site, including like a foot and then her hand; Painfull swelling not localized in the injection site, including like a foot and then her hand; This spontaneous case, initially received on 14-Nov-2024, was reported by a health professional and concerns an adult female patient.  Administration of company suspect drug(s): On 08-Nov-2024, the patient received Flucelvax (TIV) for Flu immunization, Dose regimen: 0.5 ml, Rout of administration: not reported, Anatomical location: not reported. Lot number: 388523. CSL Seqirus Batch number: 388523  No additional suspect drugs.  Adverse reactions/events and outcomes: On 08-Nov-2024, the patient experienced Painfull swelling not localized in the injection site, including like a foot and then her hand (outcome: Not recovered / Not resolved), Painfull swelling not localized in the injection site, including like a foot and then her hand (outcome: Not recovered / Not resolved), Painfull swelling not localized in the injection site, including like a foot and then her hand (outcome: Not recovered / Not resolved).  Reporter asked assistance on an adverse reaction that was reported regarding a vaccine and then trying to find resources on how to manage that. She experienced swelling that was not localized to the injection site, so kind of randomly threw out, including like a foot and then her hand as well. Painful swelling.  Flucelvax (TIV) action taken: Not Applicable  Reporter's causality: The reporter assessed the events as non-serious and did not provide the causality assessment.; Reporter's Comments: All events are related.
Age: 43.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache
Clinical narrative: Headaches; This spontaneous case, initially received on 14-Nov-2024, was reported by a non health professional and concerns an adult female patient.  Past medical history included spleen removal when teenager, Immune thrombocytopenic purpura. At the time of the event the patient had allergy NOS.  Administration of company suspect drug(s): On 07-Oct-2024, the patient received Flucelvax (TIV) for Influenza immunization, Dose regimen: 0.5 ml, Route of administration: not reported, Anatomical location: not reported, Lot number: No batch number available and will be requested upon follow-up.  Non-company suspect drugs: Also on 07-Oct-2024, patient received Novavax COVID-19 Vaccine (COVID-19 vaccine prot. subunit (NVX CoV 2373)), Indication: COVID-19 immunization. Dose regimen: 0.5 ml, Route of administration: intramuscular, Anatomical location: not reported, Lot number: No batch number available and will not be requested upon follow-up..  Adverse reactions/events and outcomes: On 07-Oct-2024, the patient experienced headaches that started in the night after having the vaccine (outcome: Unknown).  Flucelvax (TIV) action taken: Not Applicable Treatment medication: Methylprednisolone, Tylenol     Reporter's assessment: The reporter assessed the event Headaches as non-serious. The reporter considered the event Headaches related to the administration of Novavax COVID-19 Vaccine but did not provide causality assessment for Flucelvax (TIV).; Reporter's Comments: Event is rconsidered elated.