chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: UNK, UNK
Symptoms: Extra dose administered, Nerve injury
Clinical narrative: nearly killed me; severe nerve damage; had two shots; This serious case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Previously administered products included RSV (On an unknown, received first dose).   On an unknown date, the patient received the 2nd dose of RSV vaccine and the 1st dose of RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine and RSV vaccine, the patient experienced near death experience (Verbatim: nearly killed me) (serious criteria GSK medically significant and life threatening), nerve damage (Verbatim: severe nerve damage) and extra dose administered (Verbatim: had two shots). The outcome of the near death experience was not reported and the outcome of the nerve damage was not resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the near death experience and nerve damage to be related to RSV vaccine and RSV vaccine.   It was unknown if the company considered the near death experience and nerve damage to be related to RSV vaccine and RSV vaccine.   Additional Information: GSK Receipt Date: 10-SEP-2023 This case was reported by a patient via interactive digital media. The patient had two shots and it nearly killed him/her. The patient was still suffering with severe nerve damage and had gone into debt to pay for his/her recovery, but the shot was free. The patient received the second dose of RSV vaccine, which led to extra dose administered.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Bedridden, Fatigue, Headache, Mobility decreased, Nausea
Clinical narrative: Could barely get out of next bed; Headache; Body aches; Fatigue; Nausea; This non-serious case was reported by a consumer and described the occurrence of headache in a 70-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) (batch number M752F) for prophylaxis.   On 07-SEP-2023, the patient received RSV vaccine 1 ml. On 07-SEP-2023, 5 hrs after receiving RSV vaccine, the patient experienced headache (Verbatim: Headache), general body pain (Verbatim: Body aches), fatigue (Verbatim: Fatigue) and nausea (Verbatim: Nausea). On 08-SEP-2023, the patient experienced bedridden (Verbatim: Could barely get out of next bed).  The patient was treated with paracetamol (Tylenol). The outcome of the headache, general body pain, fatigue, nausea and bedridden were resolving.   It was unknown if the reporter considered the headache, general body pain, fatigue, nausea and bedridden to be related to RSV vaccine.     It was unknown if the company considered the headache, general body pain, fatigue, nausea and bedridden to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 09-SEP-2023 The patient was in good health in general.  The patient had symptoms which came on suddenly 5 hours after receiving the RSV vaccine.  The patient could barely get out of bed the next day.  Now (the recent time) the patient was improving, but took Tylenol.  The patient was hoping the improvement continues.  That was the first time the patient had reacted to a vaccine headache, body aches, fatigue, nausea. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Pain
Clinical narrative: Could barely get out of next bed; Headache; Body aches; Fatigue; Nausea; This non-serious case was reported by a consumer and described the occurrence of headache in a 70-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) (batch number M752F) for prophylaxis.   On 07-SEP-2023, the patient received RSV vaccine 1 ml. On 07-SEP-2023, 5 hrs after receiving RSV vaccine, the patient experienced headache (Verbatim: Headache), general body pain (Verbatim: Body aches), fatigue (Verbatim: Fatigue) and nausea (Verbatim: Nausea). On 08-SEP-2023, the patient experienced bedridden (Verbatim: Could barely get out of next bed).  The patient was treated with paracetamol (Tylenol). The outcome of the headache, general body pain, fatigue, nausea and bedridden were resolving.   It was unknown if the reporter considered the headache, general body pain, fatigue, nausea and bedridden to be related to RSV vaccine.     It was unknown if the company considered the headache, general body pain, fatigue, nausea and bedridden to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 09-SEP-2023 The patient was in good health in general.  The patient had symptoms which came on suddenly 5 hours after receiving the RSV vaccine.  The patient could barely get out of bed the next day.  Now (the recent time) the patient was improving, but took Tylenol.  The patient was hoping the improvement continues.  That was the first time the patient had reacted to a vaccine headache, body aches, fatigue, nausea. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Swelling, Swelling face
Clinical narrative: diffuse swelling over face n bilateral sub mandibur region; neck swelling/ diffuse swelling; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of facial swelling in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included kidney transplant. Concurrent medical conditions included hypertension and diabetes.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 48 hrs after receiving Shingrix, the patient experienced facial swelling (Verbatim: diffuse swelling over face n bilateral sub mandibur region) and neck swelling (Verbatim: neck swelling/ diffuse swelling).  The outcome of the facial swelling and neck swelling were not reported.   It was unknown if the reporter considered the facial swelling and neck swelling to be related to Shingrix.     It was unknown if the company considered the facial swelling and neck swelling to be related to Shingrix.   Additional Information: GSK receipt date: 09-SEP-2023 This case was reported via interactive digital media. The patient with medical history of kidney transplant, hypertension and diabetes came with diffuse swelling over face and bilateral sub mandibular region.  Sudden diffuse swelling developed after 48 hours of taking of 1st dose Shingrix vaccine extending from inferior border of mandible till mid of neck. The reporter asked could it be delayed hypersensitivity.
Sex: U
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: my arm is very sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 08-SEP-2023, the patient received RSV vaccine. In SEP-2023, an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: my arm is very sore).  The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK receipt date: 09-SEP-2023 This case was reported the patient via interactive digital media. The patient received the dose yesterday (day before reporting) and arm was very sore. Follow-up not possible as no contact details provided.
Sex: U
Vaccine: UNK
Symptoms: Feeling abnormal, Lymphadenitis
Clinical narrative: Felt horrible; inflammatory Lymph node; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced feels awful (Verbatim: Felt horrible) and lymph node inflammation (Verbatim: inflammatory Lymph node).  The outcome of the feels awful and lymph node inflammation were not reported.   It was unknown if the reporter considered the feels awful and lymph node inflammation to be related to RSV vaccine.     It was unknown if the company considered the feels awful and lymph node inflammation to be related to RSV vaccine.   Additional Information: GSK receipt date: 09-SEP-2023 This case was reported the patient via interactive digital media. The patient regretted of taking the RSV vaccine and felt horrible after and had an inflammatory lymph node. Follow-up not possible as no contact details provided.
Age: 1.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 15 mo patient received Boostrix instead of Infanrix; 15 mo patient received Boostrix instead of Infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2B723, expiry date 17-OCT-2025) for prophylaxis.   Previously administered products included Pediarix (received 3 doses of Pediarix prior to Boostrix).   On 01-SEP-2023, the patient received Boostrix. On 01-SEP-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: 15 mo patient received Boostrix instead of Infanrix) and inappropriate age at vaccine administration (Verbatim: 15 mo patient received Boostrix instead of Infanrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 8-Sept-2023 The case was reported by registered nurse. The reporter consented to follow up. The patient received a dose of Boostrix instead of Infanrix at an inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: pharmacist called in to request information about how to proceed after administering an expired dose of Engerix-B in a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 34-year-old male patient who received HBV (Engerix B) (batch number 4345R, expiry date 11-AUG-2023) for prophylaxis.   On 06-SEP-2023, the patient received Engerix B. On 06-SEP-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: pharmacist called in to request information about how to proceed after administering an expired dose of Engerix-B in a patient).  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: 08-SEP-2023 The pharmacist reported the patient was administered with expired dose of Engerix B vaccine which led to Expired vaccine used. Th pharmacist wanted to know about how to be processed after the administration of expired vaccine. The vaccine administration facility was same as primary reporter. The reporter consented to follow up.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 19 year old received an adult dose of Engerix-B (20mcg); 19 year old received an adult dose of Engerix-B (20mcg); This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 19-year-old male patient who received HBV (Engerix B adult) (batch number PE9G5, expiry date 19-MAY-2025) for prophylaxis.   On 10-AUG-2023, the patient received Engerix B adult. On 10-AUG-2023, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: 19 year old received an adult dose of Engerix-B (20mcg)) and overdose (Verbatim: 19 year old received an adult dose of Engerix-B (20mcg)).  The outcome of the adult product administered to child and overdose were unknown.   Additional Information: GSK receipt Date: 08-SEP-2023 The reporter stated 19-year-old patient was administered adult dose of Engerix-B (20mcg) which led to overdose and adult product administered to child. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Exposure via skin contact, Incorrect dose administered
Clinical narrative: vaccine came out/leaked on the side of the syringe; RPH not sure how much of the vaccine dose the patient received but it came down the patient's arm; not sure how much of the vaccine dose the patient received but it came down the patient's arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of exposure via skin contact in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 2R375, expiry date 28-MAY-2024) for prophylaxis.   On 08-SEP-2023, the patient received Shingrix (right deltoid). On 08-SEP-2023, an unknown time after receiving Shingrix, the patient experienced exposure via skin contact (Verbatim: vaccine came out/leaked on the side of the syringe), inadvertent exposure to vaccine (Verbatim: RPH not sure how much of the vaccine dose the patient received but it came down the patient's arm) and incomplete dose administered (Verbatim: not sure how much of the vaccine dose the patient received but it came down the patient's arm).  The outcome of the exposure via skin contact, inadvertent exposure to vaccine and incomplete dose administered were unknown.   Additional Information: GSK Receipt date: 08-SEP-2023 The reporter called to inquire that how to proceed with the vaccination. The reporter reported that they attempted to administer a Shingrix dose to a patient in the morning of reporting day. The reporter stated that up on administration when pressing the vaccine in to patient's right deltoid vaccine came out or leaked on the side of the syringe and patient's arm. The reporter not sure how much of the vaccine dose the patient received but it came down the patient's arm. The reporter did not consent to follow up. The reporter stated that up on administration when pressing the vaccine in to patient's right deltoid vaccine came out or leaked on the side of the syringe and patient's arm, which led to exposure via skin contact, inadvertent exposure to vaccine.  The reporter not sure how much of the vaccine dose the patient received but it came down the patient's arm, which led to incomplete dose administered.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Lymphadenopathy, Peripheral swelling
Clinical narrative: Right arm swelling; Right Axillary Lymphadenopathy; This non-serious case was reported by a physician via call center representative and described the occurrence of swelling arm in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included breast cancer (have a history of breast cancer and with only one breast left).   On 30-AUG-2023, the patient received Arexvy (right arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced swelling arm (Verbatim: Right arm swelling) and lymphadenopathy axillary (Verbatim: Right Axillary Lymphadenopathy).  The outcome of the swelling arm and lymphadenopathy axillary were unknown.   The reporter considered the swelling arm and lymphadenopathy axillary to be possibly related to Arexvy.     The company considered the swelling arm and lymphadenopathy axillary to be possibly related to Arexvy.   Additional Information: GSK receipt date: 08-AUG-2023 The physician reported a patient received a Arexvy vaccine and the came in with right axillary lymphadenopathy and though it was cancer.  The patient did have a history of breast cancer and with only one breast left.  The physician thought the vaccine may have caused the swelling so physician wanted to gather more information. . The physician unable to provide vaccine details. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Pain in extremity
Clinical narrative: pain at the injection site after the injection, and this pain went from injection site straight to her elbow; This non-serious case was reported by a physician via sales rep and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 04-JUL-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 04-JUL-2023, immediately after receiving Shingrix, the patient experienced pain in arm (Verbatim: pain at the injection site after the injection, and this pain went from injection site straight to her elbow). The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK receipt date: 8-Sept-2023 A physician stated in his office on the day of reporting, the patient in her early 60's received the 1st dose of Shingrix around 4th July 2023, at her pharmacy, and immediately had really bad pain at the injection site after the injection, and this pain went from the injection site straight to her elbow. The patient still had this same pain, in the same area on the day of reporting. The GlaxoSmithKline field representative did not had any further information about this incident, any information about the lot/expiry, or any patient demographics. The reporter consented to follow-up.
Sex: U
Vaccine: UNK
Symptoms: Incorrect dose administered, Needle issue, Product complaint
Clinical narrative: difficulties removing the tip cup to attach the needle causing the hub to loosen; had an issue with the tip cup; needle was detached, and the majority of the vaccine was administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number J9HA9, expiry date 30-JUN-2024) for prophylaxis. This case was associated with a product complaint.   On 07-SEP-2023, the patient received FluLaval Quadrivalent 2023-2024 season. On 07-SEP-2023, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced incomplete dose administered (Verbatim: needle was detached, and the majority of the vaccine was administered). On an unknown date, the patient experienced needle issue (Verbatim: difficulties removing the tip cup to attach the needle causing the hub to loosen) and pharmaceutical product complaint (Verbatim: had an issue with the tip cup).  The outcome of the incomplete dose administered, needle issue and pharmaceutical product complaint 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: 08-SEP-2023 and 11-Sep-2023 The reporter stated that 5 prefilled Flulaval vaccines from the same batch had an issue with the tip cup. According to the reporter, the experience nurse had difficulties of removing the tip cup to attach the needle causing the hub to loosen. However, the needle was attached, and the vaccines were administered. Luer lok needles were use all the time. Reporter stated that during the administration of one vaccine, the needle was detached, and the majority of the vaccine was administered. No replacement at time. No information was provided for the patient. The reporter consented to follow up. Reporter stated that during the administration of one vaccine, the needle was detached, and the majority of the vaccine was administered, which led to incomplete dose administered.
Sex: M
Vaccine: RSV
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: Vaccine administered at inappropriate site; Pain at injection site; This non-serious case was reported by a physician via call center representative and described the occurrence of injection site pain in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 07-SEP-2023, the patient received Arexvy (unknown arm). On 07-SEP-2023, an unknown time after receiving Arexvy, the patient experienced vaccine administered at inappropriate site (Verbatim: Vaccine administered at inappropriate site). In SEP-2023, the patient experienced injection site pain (Verbatim: Pain at injection site).  The outcome of the injection site pain and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site pain to be related to Arexvy.     It was unknown if the company considered the injection site pain to be related to Arexvy.   Additional Information: GSK receipt date: 08-SEP-2023 The physician, a patient himself received Arexvy vaccine a little below the deltoid muscle of the arm yesterday (day before vaccination) and had pain at injection site The patient received vaccine below the deltoid muscle, which led to vaccine administered at inappropriate site. The reporter consented to follow up.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEPA, MENB, RV1, TDAP
Symptoms: Product storage error
Clinical narrative: she have recorded are a low of 31.62F and a high of 47.08F.; This non-serious case was reported by a consumer via call center representative and described the occurrence of product storage error in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included HAV (Havrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, Men B NVS (Bexsero) for prophylaxis and Rota (Rotarix lyophilized formulation) for prophylaxis.   On an unknown date, the patient received Boostrix, Havrix, Kinrix, Infanrix, Pediarix, Bexsero and Rotarix lyophilized formulation. On an unknown date, an unknown time after receiving Boostrix, Havrix, Kinrix, Infanrix, Pediarix, Bexsero and Rotarix lyophilized formulation, the patient experienced product storage error (Verbatim: she have recorded are a low of 31.62F and a high of 47.08F.).  The outcome of the product storage error 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: 08-SEP-2023 Office manager reported new employee did not know how to reset data logger and she has recorded the same readings on minimum and maximum long since 16Aug2023.  The readings she had recorded were a low of 31.62 degree Fahrenheit and a high of 47.08 degree Fahrenheit. He showed her how to correctly reset the thermometer and record readings, which he noted were showing a maximum of 41.29 degree Fahrenheit  and a minimum of 40.30 degree Fahrenheit at the time.  Reporter was unsure if any of the vaccines were administered after the below freezing temperature exposure, but it was a possibility. The vaccine administration facility was the same as primary reporter. The vaccine was kept under not allowable temperature, which led to Product storage error. The reporter was requested for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose of Shingrix 4 years ago. They are there for the 2nd dose but have not received it just yet.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the 1st dose 4 years ago).   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: 1st dose of Shingrix 4 years ago. They are there for the 2nd dose but have not received it just yet.).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 08-SEP-2023 The pharmacist stated that a patient received the 1st dose of Shingrix 4 years ago.  The vaccine administration facility was the same as primary reporter The 2nd dose have not received it just yet, which led to incomplete course of vaccination. The reporter consented to follow up via postal. The case is linked with US2023105911, by same reporter.; Sender's Comments:  US-GSK-US2023105911:Same reporter
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Impaired healing, Pain, Vaccination failure
Clinical narrative: Shingles / Suspected vaccination failure; small painful shingles lesion on her back; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 65-year-old 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 (had frequent shingles outbreaks).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) and the 1st dose of Shingrix. On an unknown date, 8 months after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Shingles / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: small painful shingles lesion on her back).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 11-SEP-2023  The patient received her first Shingrix dose about 11 months ago from reporting while she had an active case of shingles (one blister that was slow to heal). She received her second Shingrix dose about 8 months ago from reporting.  She just (date unclear but 8 months after her second dose) developed her first case of shingles post-vaccination. She had one small painful shingles lesion on her back. She was not recovered and had not seen her doctor yet. Nothing else was reported. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The reported consented to follow up with healthcare professional.
Sex: F
Vaccine: RSV
Symptoms: Cardiac disorder, Gait inability, Hypoxia, Intensive care, Pulmonary thrombosis
Clinical narrative: Blood clots in lungs; Unable to walk due to lack of oxygen; Unable to walk due to lack of oxygen; she has left heart damage; This serious case was reported by a consumer via call center representative and described the occurrence of pulmonary thrombosis in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included atrial fibrillation.   On 01-SEP-2023, the patient received the 1st dose of Arexvy. On 04-SEP-2023, 3 days after receiving Arexvy, the patient experienced pulmonary thrombosis (Verbatim: Blood clots in lungs) (serious criteria hospitalization and GSK medically significant), hypoxia (Verbatim: Unable to walk due to lack of oxygen) (serious criteria hospitalization and GSK medically significant) and unable to walk (Verbatim: Unable to walk due to lack of oxygen) (serious criteria hospitalization). In SEP-2023, the patient experienced heart disorder (Verbatim: she has left heart damage) (serious criteria hospitalization).  The outcome of the pulmonary thrombosis, hypoxia and unable to walk were unknown and the outcome of the heart disorder was not reported.   It was unknown if the reporter considered the pulmonary thrombosis, hypoxia, unable to walk and heart disorder to be related to Arexvy.     It was unknown if the company considered the pulmonary thrombosis, hypoxia, unable to walk and heart disorder to be related to Arexvy.   Additional Information: GSK Receipt Date: 11-SEP-2022/ 14-SEP-2023 The reporter reported that the patient received Arexvy vaccine and experienced unable to walk due to lack of oxygen. The patient went to the emergency department then sent to the cath lab where they removed multiple clots from her lungs. The patient mentioned that she had left heart damage. The patient was in intensive care for 5 days. The patient stated that she was not warned not to take the vaccine due to her existing Atrial Fibrillation status and that she would not have taken the vaccine if she had been warned. The reporter reported that please do not contact until after patient sees the doctor on 19th September 2023. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Thrombectomy
Clinical narrative: Blood clots in lungs; Unable to walk due to lack of oxygen; Unable to walk due to lack of oxygen; she has left heart damage; This serious case was reported by a consumer via call center representative and described the occurrence of pulmonary thrombosis in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included atrial fibrillation.   On 01-SEP-2023, the patient received the 1st dose of Arexvy. On 04-SEP-2023, 3 days after receiving Arexvy, the patient experienced pulmonary thrombosis (Verbatim: Blood clots in lungs) (serious criteria hospitalization and GSK medically significant), hypoxia (Verbatim: Unable to walk due to lack of oxygen) (serious criteria hospitalization and GSK medically significant) and unable to walk (Verbatim: Unable to walk due to lack of oxygen) (serious criteria hospitalization). In SEP-2023, the patient experienced heart disorder (Verbatim: she has left heart damage) (serious criteria hospitalization).  The outcome of the pulmonary thrombosis, hypoxia and unable to walk were unknown and the outcome of the heart disorder was not reported.   It was unknown if the reporter considered the pulmonary thrombosis, hypoxia, unable to walk and heart disorder to be related to Arexvy.     It was unknown if the company considered the pulmonary thrombosis, hypoxia, unable to walk and heart disorder to be related to Arexvy.   Additional Information: GSK Receipt Date: 11-SEP-2022/ 14-SEP-2023 The reporter reported that the patient received Arexvy vaccine and experienced unable to walk due to lack of oxygen. The patient went to the emergency department then sent to the cath lab where they removed multiple clots from her lungs. The patient mentioned that she had left heart damage. The patient was in intensive care for 5 days. The patient stated that she was not warned not to take the vaccine due to her existing Atrial Fibrillation status and that she would not have taken the vaccine if she had been warned. The reporter reported that please do not contact until after patient sees the doctor on 19th September 2023. The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Magnetic resonance imaging head normal, Nasal congestion, Productive cough, Rhinitis, Rhinorrhoea
Clinical narrative: coughing up phlegm; rhinitis; congestion; constant runny nose; This non-serious case was reported by a consumer via call center representative and described the occurrence of productive cough in a 55-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number DH3A2, expiry date 29-SEP-2025) for prophylaxis.   The patient's past medical history included automobile accident (due to accident patient hospitalized for her injuries).   On 16-MAY-2023, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced productive cough (Verbatim: coughing up phlegm), rhinitis (Verbatim: rhinitis), nasal congestion (Verbatim: congestion) and runny nose (Verbatim: constant runny nose).  The outcome of the productive cough, rhinitis, nasal congestion and runny nose were not resolved.   It was unknown if the reporter considered the productive cough, rhinitis, nasal congestion and runny nose to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     It was unknown if the company considered the productive cough, rhinitis, nasal congestion and runny nose to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   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: 12-SEP-2023 The patient self-reported this case. The patient was in a roll-over car accident in May 2023, while in the hospital for her injuries, the patient received Boostrix.  Since receiving Boostrix, the patient had experienced coughing up phlegm, rhinitis, constant runny nose, and congestion.  The patient saw an ENT (Ear-Nose-Throat) specialist last month and MRI of the brain was done, lab results suggest there was no leaking from the brain.  The reporter consented to follow up with healthcare professional.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: diagnosed with Shingles/suspected vaccination failure; told her she had received the complete series of Shingrix (unknown dates) and was diagnosed with Shingles; This serious case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: diagnosed with Shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: told her she had received the complete series of Shingrix (unknown dates) and was diagnosed with Shingles).  The outcome of the vaccination failure was 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.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date:12 Sep 2023 The reporter stated her friend stated after the completion of primary series of Shingrix approximately one or two months ago she was diagnosed with shingles. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The reporter did not consented to follow up. This was 1 of 2 cases reported by same reporter.; Sender's Comments:  US-GSK-US2023125323:Same reporter, different patient
Sex: M
Vaccine: UNK
Symptoms: COVID-19, Cough, Malaise, SARS-CoV-2 test positive
Clinical narrative: COVID symptoms started; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID symptoms started) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Tylenol. Past adverse reactions to the above products included No adverse event with Tylenol.    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 COVID-19 (COVID symptoms started). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID symptoms started) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Previously administered products included for Drug use for unknown indication: Vitamins.  No concomitant medication was reported.  Reportedly, the patient was vaccinated with Moderna COVID-19 vaccine.  Caller stated that a day before reporting was a 5th day of COVID symptoms stated that COVID, symptoms started like Satuday night as cough all night,  had a bad day on Sunday, has given a cough medicine and then they went to the doctor, and tested positive. Patient started taking Paxlovid evening a night before reporting day. Caller stated that when patient had a cough, was taking takes the medication a little tiny pill.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Vaccine was expired on 30-Mar-2023 and was administered on 02-Apr-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 30-Mar-2023 and was administered on 02-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Apr-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 30-Mar-2023 and was administered on 02-Apr-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 30-Mar-2023 and was administered on 02-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 30-Mar-2023 and was administered on 02-Apr-2023).    No concomitant medications were reported. No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (myocarditis) in an adult female patient 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 MYOCARDITIS (myocarditis) (seriousness criterion medically significant). The patient was treated with VITAMIN E [VITAMIN E NOS] at an unspecified dose and frequency and UBIDECARENONE (CO Q 10 [UBIDECARENONE]) at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (myocarditis) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Previous information regarding COVID-19 vaccination was not reported.  Concomitant product use was not provided by the reporter.  Patient had Myocarditis after one of her Moderna Covid-19 vaccines. Patient physician told her to take Vitamin E with Co Q Ten to combat the Myocarditis.  Company Comment This spontaneous case concerns a female patient of unknown age, with no medical history reported who experienced the seriousness medically significant expected event of myocarditis unknown days after a dose of  SPIKEVAX NOS  vaccine. Concomitant product use was not provided by the reporter. Patient had Myocarditis after one of her Moderna Covid-19 vaccines. The benefit-risk relationship of SPIKEVAX NOS  vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-739687 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739687:Patient case
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling, Wound secretion
Clinical narrative: pops, blood and puss coming out long after vaccination; swelling in the left arm pit, injected arm; This spontaneous case was reported by a consumer and describes the occurrence of WOUND SECRETION (pops, blood and puss coming out long after vaccination) and VACCINATION SITE SWELLING (swelling in the left arm pit, injected arm) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 001B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE SWELLING (swelling in the left arm pit, injected arm). On an unknown date, the patient experienced WOUND SECRETION (pops, blood and puss coming out long after vaccination). At the time of the report, WOUND SECRETION (pops, blood and puss coming out long after vaccination) and VACCINATION SITE SWELLING (swelling in the left arm pit, injected arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient did not remember how long after vaccination patient started with swelling in the left arm pit, injected arm. Patient still got it, and it swells up, pops and puss and blood came out of it. Patient had not seen a doctor and declined providing the vaccination facility contact information. Patient researched on the internet and other people have the same issue as patient had after vaccination. Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2023: Follow-Up received contains no new information
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizure; This spontaneous case was reported by a patient and describes the occurrence of SEIZURE (seizure) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Stroke in 2020. Concurrent medical conditions included Penicillin allergy.    In January 2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced SEIZURE (seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (seizure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient had 4 seizures between Jan 2022 and Feb 2022. The first seizure happened after the first dose of Moderna Covid-19 vaccine. He did not have vaccination card to provide details of their vaccine. He received the first Moderna Covid19 vaccine in Jan 2022. He not tested positive for Covid at any point. He was on blood pressure pill and heart medication. He had a mild stroke in 2020 and recovered from it. He was scared to get another vaccine.    Treatment medication not reported. Company Comment This spontaneous case concerns a 72-years-old-male patient, with medical history of  Stroke in 2020, concurrent medical condition Penicillin allergy who experienced the seriousness medically significant unexpected AESI of seizure unknown days after 1st. dose of  mRNA-1273 vaccine. He had 4 seizures between Jan 2022 and Feb 2022; the first one happened after the mentioned dose. Treatment medication not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Arthralgia, Fatigue, Gait disturbance, Muscle spasms, Musculoskeletal pain
Clinical narrative: experiencing ache on the left side of the leg/having some dull ache on the left leg; difficulty walking and sleeping; difficulty walking; difficult to go up and down the stairs; multiple cramps; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65-year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "experiencing ache on the left side of the leg/having some dull ache on the left leg"; INSOMNIA (non-serious), outcome "unknown", described as "difficulty walking and sleeping"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "difficulty walking"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "difficult to go up and down the stairs"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "multiple cramps".  Additional information: The case was reported as non-serious. The patient was experiencing ache on the left side of the leg, it has been three days. She was also having difficulty walking and sleeping. The patient was not in the Patient Assistance Program but she called because and stated that she took the Prevnar and then she was having some dull ache on the left leg. She said she doesn't have a primary doctor because she was referred to one of her primary doctors to go to ask questions. She wanted to know if that's normal or what side effect that was or stuff like that. She got it on her birthday actually. What happened was that everything was fine once she took it, in fact she wanted this one because it was the one undone in suppose to the other two that were you know, the two separate ones (further clarification was not available over the call). What happened was that she felt fine and instead she had a little dull ache on the left side of her leg but it was kind of, it just ached a little bit and she felt there were multiple cramps that could be a side effect and whatever she said ok, that's fine. She would say the past three days it's been pretty bad for her leg, it was achy and hurts, it's difficult to go up and down the stairs and she was concerned because it was even difficult to sleep, to be honest.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.