chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: the patient received a dose of Bexsero and was supposed to get the MenQuadFour; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received Men B NVS (Bexsero) (batch number ES49H, expiry date 31-MAY-2027) for prophylaxis.   Co-suspect products included Meningococcal vaccine A/C/Y/W for prophylaxis.   On an unknown date, the patient received Bexsero and did not receive Meningococcal vaccine A/C/Y/W. On an unknown date, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: the patient received a dose of Bexsero and was supposed to get the MenQuadFour). 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: 15-OCT-2024 The nurse reported that they administered a wrong vaccine to a 11 years old patient, the patient received a dose of Bexsero instead of a dose of the MenQuadFour (Meningococcal A, C, W, Y) vaccine which led to wrong vaccine administered.  The nurse asked do GlaxoSmithKline had any recommendations regarding this situation.
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Erythema, Influenza like illness, Peripheral swelling, Pruritus
Clinical narrative: Arm swollen; Bright red arm; Itching arm; Flu like symptoms; Shortness of breath; This non-serious case was reported by a consumer via call center representative and described the occurrence of swelling arm in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 14-OCT-2024, the patient received Shingles vaccine. In OCT-2024, an unknown time after receiving Shingles vaccine, the patient experienced swelling arm (Verbatim: Arm swollen), erythema of extremities (Verbatim: Bright red arm), itchy upper limbs (Verbatim: Itching arm), influenza-like symptoms (Verbatim: Flu like symptoms) and shortness of breath (Verbatim: Shortness of breath). The outcome of the swelling arm, erythema of extremities, itchy upper limbs, influenza-like symptoms and shortness of breath were unknown.   It was unknown if the reporter considered the swelling arm, erythema of extremities, itchy upper limbs, influenza-like symptoms and shortness of breath to be related to Shingles vaccine.     It was unknown if the company considered the swelling arm, erythema of extremities, itchy upper limbs, influenza-like symptoms and shortness of breath to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-OCT-2024 The member of public (patient) reported that received a shingles vaccine (said it was a recombinant zoster vaccine, not confirming was a Shingrix vaccine) and was experiencing some reactions due to the vaccine´s administration.  The patient experienced shortness of breath, arm swollen, bright red arm, itching arm and flu-like symptoms after a Shingles vaccine.  The vaccine service center described and the patient had talked to the Centers for Disease Control and Prevention  (who told her "GSK provides this product") and wanted to know more information or advise about ingredients that may cause that symptoms.  Non confirmation of product´s brand name, vaccine´s lot number and expiration date confirmed as requested from the patient´s end.
Age: 9.0
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Maladministration of adult dose to a pediatric patient; Maladministration of adult dose to a pediatric patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult product administered to child in a 9-year-old patient who received HAV (Havrix adult) 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 adult product administered to child (Verbatim: Maladministration of adult dose to a pediatric patient) and overdose (Verbatim: Maladministration of adult dose to a pediatric patient). The outcome of the adult product administered to child and overdose 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: 14-NOV-2024 The pharmacist reported that maladministration of an adult dose of Havrix in a child patient, which led to adult product administered to child and overdose. The vaccination date, vaccine detail and the patient demographics were requested in that call, unfortunately pharmacist was not at the site at the time of call. The vaccine administration facility was the same as primary reporter.
Age: 34.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Wrong Product Administered; 34 year patient received Shingrix; 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 34-year-old female patient who received Herpes zoster (Shingrix) (batch number 425CR, expiry date 10-AUG-2026) for prophylaxis.   Co-suspect products included Varicella (Varicella vaccine) for prophylaxis.   On 17-OCT-2024, the patient received Shingrix. On an unknown date, the patient received Varicella vaccine. On 17-OCT-2024, an unknown time after receiving Shingrix and not applicable after receiving Varicella vaccine, the patient experienced wrong vaccine administered (Verbatim: Wrong Product Administered) and inappropriate age at vaccine administration (Verbatim: 34 year patient received Shingrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 17-OCT-2024 The medical assistant reported that a patient was supposed to be administered a varicella vaccine but she was inadvertently administered Shingrix instead, which led to wrong vaccine administered. The medical assistant called to inquire if they could go ahead and administer a varicella vaccine on the same day, but at the time of call the varicella vaccine has not yet been administered. The patient received dose of Shingrix at an inappropriate age, which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Administration of 2 powder portions with 1 liquid portion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate reconstitution technique in a 86-year-old male patient who received Herpes zoster (Shingrix) (batch number FJ987, expiry date 16-JUL-2026) for prophylaxis.   On 17-OCT-2024, the patient received the 1st dose of Shingrix. On 17-OCT-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate reconstitution technique (Verbatim: Administration of 2 powder portions with 1 liquid portion). The outcome of the inappropriate reconstitution technique was unknown.   Additional Information: GSK Receipt date: 17-OCT-2024 The pharmacist reported that they had a situation, in which they had a shingles vaccine(Shingrix), that they were diluting and once it was diluted it was added to an additional powder and it was given to patient which led inappropriate reconstitution technique. So they need to saw if there was any data or anything like that happening. The health care professional mentioned that the lot number was the same for the 2 powder portions that the patient received, also confirmed that this was related to the Shingrix vaccine. The vaccine administration facility was the same as primary reporter.
Age: 72.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number A2F3R, expiry date 26-OCT-2026) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (Arexvy) (batch number 49H4G, expiry date 15-OCT-2025) for prophylaxis.   On 17-OCT-2024, the patient received the 1st dose of Shingrix and the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Shingrix and Arexvy, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 17-OCT-2024 The pharmacist reported that the nurses gave vaccine Arexvy and Shingles and the Arexvy vaccine for RSV, they mixed one, but one of the patient declined, so it was around like 1 o'clock before the day of reporting, they mixed them and put them back in the fridge, cause they did not want and then the reporter was not thinking and administered to someone who wanted it on the reporting day morning. The reporter was calling to ask about the effectiveness. Vaccine stored outside recommended conditions and administered to patient, which led to incorrect storage of drug.
Age: 61.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Engerix-B administration of a pediatric dose to an adult/Pharmacist reported that on 9/25/2024 two adults 9 a female and a male) patients received Engerix-B pediatric formulation by error as a first dose; Engerix-B administration of a pediatric dose to an adult/Pharmacist reported that on 9/25/2024 two adults 9 a female and a male) patients received Engerix-B pediatric formulation by error as a first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 61-year-old female patient who received HBV (Engerix B pediatric) (batch number EP724, expiry date 14-MAR-2025) for prophylaxis.   On 25-SEP-2024, the patient received the 1st dose of Engerix B pediatric. On 25-SEP-2024, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Engerix-B administration of a pediatric dose to an adult/Pharmacist reported that on 9/25/2024 two adults 9 a female and a male) patients received Engerix-B pediatric formulation by error as a first dose) and accidental underdose (Verbatim: Engerix-B administration of a pediatric dose to an adult/Pharmacist reported that on 9/25/2024 two adults 9 a female and a male) patients received Engerix-B pediatric formulation by error as a first dose). The outcome of the adult use of a child product and accidental underdose were unknown.   Additional Information: GSK Receipt Date: 17-OCT-2024 The pharmacist reported that the adult patient received Engerix-B pediatric formulation by error, which led adult use of a child product and accidental underdose. The patient was going to travel, so if the pharmacist administer a new shot on the day of reporting, could he/she administer the second dose on 28 days or 30 days exactly. The administration facility same as the primary reporter. This case is linked with US2024128121, reported by same reporter.; Sender's Comments:  US-GSK-US2024128121:Same reporter, different patient
Age: 56.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: patients received Engerix-B pediatric formulation by error as a first dose; patients received Engerix-B pediatric formulation by error as a first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 56-year-old male patient who received HBV (Engerix B pediatric) (batch number EP724, expiry date 14-MAR-2025) for prophylaxis.   On 25-SEP-2024, the patient received the 1st dose of Engerix B pediatric. On 25-SEP-2024, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: patients received Engerix-B pediatric formulation by error as a first dose) and accidental underdose (Verbatim: patients received Engerix-B pediatric formulation by error as a first dose). The outcome of the adult use of a child product and accidental underdose were unknown.   Additional Information: GSK Receipt Date: 17-OCT-2024 The pharmacist reported that the adult patient received Engerix-B pediatric formulation by error, which led adult use of a child product and accidental underdose. The patient was going to travel, so if the pharmacist administer a new shot on the day of reporting, could he/she administer the second dose on 28 days or 30 days exactly. The administration facility same as the primary reporter. This case is linked with US2024128119, reported by same reporter.; Sender's Comments:  US-GSK-US2024128119:Same reporter, different patient
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: administration to pregnant patients; administration to pregnant patients; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: administration to pregnant patients) and product use in unapproved population (Verbatim: administration to pregnant patients). The outcome of the vaccine exposure during pregnancy and product use in unapproved population were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 30-OCT-2024 The reporter called inquiring if Arexvy was safe for pregnant woman.  The office was giving it to pregnant patient.  The reporter stated that there was pregnant patient who received Arexvy recently, which led to vaccine exposure during pregnancy and product use in unapproved population. The reporter had no additional information but would ask nurse practitioner to call with more details.   No lot/expiration date available.  No patient details were available.  No dates of administration available. This was 1 of 3 linked cases, reported by the same reporter.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Joint injury, Nerve injury, Neuropathy peripheral, Pain
Clinical narrative: neuropathy; heart problems; NERVE DAMAGE; PAIN; JOINT DAMAGE; This spontaneous report received from a health care professional . The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose, from 14-OCT-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient had nothing but heart problems neuropathy, nerve damage, joint damage, and pain every day (dose series 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart problems, neuropathy, nerve damage, pain and joint damage was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;   Neuropathy peripheral; The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Device issue, No adverse event
Clinical narrative: I was removing the stopper on the Moderna Spikevax (COVID) vaccine syringe and I heard a crack; reported this to my manager/This did not reach a patient.; No adverse effect; This spontaneous case was reported by a nurse and describes the occurrence of DEVICE ISSUE (I was removing the stopper on the Moderna Spikevax (COVID) vaccine syringe and I heard a crack), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (reported this to my manager/This did not reach a patient.) and NO ADVERSE EVENT (No adverse effect) in a patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043836) for COVID-19 prophylaxis.    Co-suspect product included Pre-filled Syringe injection (batch no. 3043836) for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE ISSUE (I was removing the stopper on the Moderna Spikevax (COVID) vaccine syringe and I heard a crack), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (reported this to my manager/This did not reach a patient.) and NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE ISSUE (I was removing the stopper on the Moderna Spikevax (COVID) vaccine syringe and I heard a crack), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (reported this to my manager/This did not reach a patient.) and NO ADVERSE EVENT (No adverse effect) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that while removing the stopper of the Moderna Spikevax (COVID) vaccine syringe and the reporter heard a crack. Once the reporter got the stopper off, she noticed the tip of the syringe did not look even and looked like it had a sharp edge.  Reporter immediately disposed of the syringe in the sharps container and reported to the manager.  It was reported that this did not reach a patient. Reporter was in the nurses area preparing the vaccine.  The Device problem code for Spikevax syringe include FDA code 4013, IMDRF code A051102 which include Sharp Edges and FDA code 2588, IMDRF code A0203 which include Defective device.  The device was malfunctioned, and the malfunction type was CIRM.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Nov-2024: Live follow-up received is non-significant. Reference number was added. On 07-Nov-2024: Live follow-up received is contains no new information.
Age: 73.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Vestibular disorder
Clinical narrative: Came down with vestibular; This spontaneous case was reported by a patient and describes the occurrence of VESTIBULAR DISORDER (Came down with vestibular) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 006M20A) for COVID-19 prophylaxis.    Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication.    No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2022, the patient received dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced VESTIBULAR DISORDER (Came down with vestibular). At the time of the report, VESTIBULAR DISORDER (Came down with vestibular) outcome was unknown.            No concomitant medication was reported.  It was reported that 14 to 15 days after patient second Moderna shot, patient came down with vestibular. It was taking 10 months and Patient has visited to doctor and hospital several time to detect. Patient was firmly believed it was these shot that caused this condition. It made patient life a living hell.  Patient really did not expect a response of this letter, but patient had got this off chest. Patient heard a lot about pharmaceutical and greed but Patient to know several people with same condition in a small circle of friend and relatives was peculiar to say the least, patient was not talking about the card.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-776693 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-776693:Invalid case for at least 4 other patients
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Mechanical urticaria
Clinical narrative: Dermatographia as a rash that moved around the body itchy and looked like he was scratched by a bear. Quite, quite disturbing; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MECHANICAL URTICARIA (Dermatographia as a rash that moved around the body itchy and looked like he was scratched by a bear. Quite, quite disturbing) in a 34-year-old male 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 MECHANICAL URTICARIA (Dermatographia as a rash that moved around the body itchy and looked like he was scratched by a bear. Quite, quite disturbing). At the time of the report, MECHANICAL URTICARIA (Dermatographia as a rash that moved around the body itchy and looked like he was scratched by a bear. Quite, quite disturbing) had resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient developed Dermatographia post administration of the booster dose of the Moderna COVID-19 vaccine. Reporter described dermatographia as a rash that moved around the body, itchy and looked like he was scratched by a bear, and it was quite disturbing. Patient was relieved after several months. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2024: Live follow up received and updated references.
Age: 44.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Body temperature, Fatigue, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Pain; Soreness in arm of injection; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), VACCINATION SITE PAIN (Soreness in arm of injection), PYREXIA (Fever) and FATIGUE (Fatigue) in a 44-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication.    The patient's past medical history included COVID-19 in February 2024. Concurrent medical conditions included Hypertension.   On 08-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On 09-Nov-2024, the patient experienced PAIN (Pain), VACCINATION SITE PAIN (Soreness in arm of injection), PYREXIA (Fever) and FATIGUE (Fatigue). The patient was treated with Ibuprofen (oral use) at a dose of 400 milligram three times a day. On 12-Nov-2024, PAIN (Pain), VACCINATION SITE PAIN (Soreness in arm of injection), PYREXIA (Fever) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2024, Body temperature: Abnormal.     The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.     No concomitant medications were reported. Reporter causality was not reported The patient did not experience any additional symptoms/events. The patient did not have any additional medical history, concomitant disease or risk factor.  There were no lab data/results available. It was reported that patient had temperature deregulation on 09-Nov-2024 and recovered on12-Nov-2024.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Rash
Clinical narrative: Broke out in a skin rask; GI issues; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Broke out in a skin rask) and GASTROINTESTINAL DISORDER (GI issues) in a 39-year-old 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) (Intramuscular use) 1 dosage form. On 01-Nov-2024, the patient experienced RASH (Broke out in a skin rask) and GASTROINTESTINAL DISORDER (GI issues). At the time of the report, RASH (Broke out in a skin rask) and GASTROINTESTINAL DISORDER (GI issues) had resolved.            Concomitant medication was not provided. Treatment information was not reported.
Age: 86.0
Sex: F
Vaccine: COVID19, RVX
Symptoms: Headache, Malaise
Clinical narrative: felt sick the next day - just didn't feel good; pains in her head; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (felt sick the next day - just didn't feel good) and HEADACHE (pains in her head) in an 86-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043822) for COVID-19 prophylaxis.    Co-suspect product included non-company product RSV vaccine for Respiratory syncytial virus immunization.    The patient's past medical history included Coagulation disorder. Previously administered products included for Product used for unknown indication: Pfizer COVID-19 Vaccine (Dose 1), Pfizer COVID-19 Vaccine (Dose 2), Pfizer COVID-19 Vaccine (Dose 5), Pfizer COVID-19 Vaccine (Dose 4) and Pfizer COVID-19 Vaccine (Dose 3). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 Vaccine, Pfizer COVID-19 Vaccine, Pfizer COVID-19 Vaccine, Pfizer COVID-19 Vaccine and Pfizer COVID-19 Vaccine. Concomitant products included Influenza vaccine from 15-Oct-2024 to 15-Oct-2024 for an unknown indication.   On 07-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form and dose of RSV vaccine (unknown route) 1 dosage form. On 09-Nov-2024, the patient experienced MALAISE (felt sick the next day - just didn't feel good) and HEADACHE (pains in her head). At the time of the report, MALAISE (felt sick the next day - just didn't feel good) and HEADACHE (pains in her head) was resolving.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. The concomitant medication was not reported by reporter. It was reported that patient didn't notice that bleeding disorders and taking blood thinners was a consideration when getting the vaccine. Patient started a blood thinner on 01-Sep-2024. Patient was not sure if this was a reaction or not. She was feeling better now. She felt sick the next day just didn't feel good, can't pinpoint it. She got her COVID vaccine and RSV vaccine on the same day. She would like to know if pains in her head could be from that not a headache just pains in her head. The next day after getting the vaccine. She didn't feel well, and on Saturday for sure. She started having pains in her head on the back of the right side of her head. The pain comes and goes, and she still have it. The pain didn't just sit there and didn't hit like a headache.
Sex: F
Vaccine: PNC20
Symptoms: Syringe issue
Clinical narrative: the Prevnar 20 shot and when pharmacist injected it, all of the medication shot out like the neck of the vaccine instead of through the needle; All shot out the side of the syringe instead of going in /reporter did grab another vaccine; Not through the needle, through like the neck of the syringe, like the syringe that the Prevnar comes in/there must have been like a crack or something in there; This is a spontaneous report received from a Pharmacist.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: LC5482, Expiration Date: Jan2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY DEVICE USED (non-serious), described as "the Prevnar 20 shot and when pharmacist injected it, all of the medication shot out like the neck of the vaccine instead of through the needle"; INCORRECT DOSE ADMINISTERED BY DEVICE (non-serious), described as "All shot out the side of the syringe instead of going in /reporter did grab another vaccine"; DEVICE BREAKAGE (non-serious), described as "Not through the needle, through like the neck of the syringe, like the syringe that the Prevnar comes in/there must have been like a crack or something in there". Additional information: The pharmacist attempted to give a patient, the Prevnar 20 shot and when pharmacist injected it, all of the medication shot out like the neck of the vaccine instead of through the needle. So, there must have been like a crack or something in there, reporter was not sure. Not through the needle, through like the neck of the syringe, like the syringe that the Prevnar comes in, it's kind of just squirted out of the side of that. So, reporter was ressuming there must have been a crack or something in there. All shot out the side of the syringe instead of going in and when reporter asked the patient, if they felt anything going, they said no, they could not feel anything injected but it was a very fast steady stream. So, reporter did not think that they got really any of the medication and so, based on that observance, then reporter did give her, reporter did grab another vaccine, same LOT and NDC, that one worked just fine and she did comment, okay patient felt that injection that time. So, reporter did not believe patient got really any of the first one vaccine. Patient was administered with another shot. NDC number of Prevnar 20: 0005200001.  Causality for "the prevnar 20 shot and when pharmacist injected it, all of the medication shot out like the neck of the vaccine instead of through the needle", "all shot out the side of the syringe instead of going in /reporter did grab another vaccine" and "not through the needle, through like the neck of the syringe, like the syringe that the prevnar comes in/there must have been like a crack or something in there" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea, Flushing, Overdose, Product administered to patient of inappropriate age
Clinical narrative: patient is nine and they gave her the adult dose by mistake; patient is nine and they gave her the adult dose by mistake/ they gave her adult dose 0.3; can't breath it was like for a second; her face got flash; Anxiety; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 9-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) at the age of 9 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), outcome "unknown", described as "patient is nine and they gave her the adult dose by mistake"; OVERDOSE (non-serious), outcome "unknown", described as "patient is nine and they gave her the adult dose by mistake/ they gave her adult dose 0.3"; DYSPNOEA (non-serious), outcome "recovered", described as "can't breath it was like for a second"; FLUSHING (non-serious), outcome "recovered", described as "her face got flash"; ANXIETY (non-serious), outcome "recovered". The events "patient is nine and they gave her the adult dose by mistake", "patient is nine and they gave her the adult dose by mistake/ they gave her adult dose 0.3", "can't breath it was like for a second", "her face got flash" and "anxiety" required physician office visit.  Additional information: the reporter did call patient's pediatrician. Patient had her shot on 4:15 and it's around quarter to seven here. So, it's been little over two hours and she is been okay. As soon as she got shot she stood up and then like for a second she said, she feels like, she can't breath it was like for a second but her face got flash and then she was fine. Reporter thinks it was the anxiety and she is completely find the entire family state of Pharmacy for 30 minutes after completely fine. She came home and ate, she is drinking she is completely fine no fever or nothing. So far there is nothing like threatening, nothing serious at this point. It's just managing the side effects which might be a little bit intense. It was more intense than she usually gets because of the extra dose.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Headache, Product administered to patient of inappropriate age
Clinical narrative: headache; Gave my 9-year-old son, the adult vaccine; Gave my 9-year-old son, the adult vaccine; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 9-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 09Nov2024 at 11:30 as dose 1, single (Batch/Lot number: unknown) at the age of 9 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer covid-19 vaccine (Lot number: SL8094, Dose number unknown), for Covid-19 immunisation; Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunisation. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), ACCIDENTAL OVERDOSE (non-serious) all with onset 09Nov2024 at 11:30, outcome "unknown" and all described as "Gave my 9-year-old son, the adult vaccine"; HEADACHE (non-serious) with onset 11Nov2024, outcome "unknown".  Additional information: Caller on behalf of his 9-year-old son, who inadvertently received a dose of Comirnaty (adult dose) last Saturday. The children and the reporter just got their COVID vaccines and unfortunately the pharmacy made a mistake and gave the 9-year-old son, the adult vaccine (Clarified as Pfizer COVID vaccine) and the reporter just looking for information online on the, what to do in that case, the pharmacist just kind of shrug the shoulders and said sorry and the reporter was just kind of looking for information. The patient did not had vaccines administered on the same date of the Pfizer vaccine. The patient did not had vaccines administered within four weeks prior to the first administration date of the Pfizer COVID vaccine. He consulted this with his pharmacist, but he couldn't help him. He was looking for safety information regarding safety concerns that they may need to be aware of. The patient had a headache at the moment of the call.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction, Respiratory disorder
Clinical narrative: Clarified, the other 2 patients mentioned by reporter, experienced breathing problems and heart attack; Clarified, the other 2 patients mentioned by reporter, experienced breathing problems and heart attack; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), RESPIRATORY DISORDER (non-serious), outcome "unknown" and all described as "Clarified, the other 2 patients mentioned by reporter, experienced breathing problems and heart attack". Clinical course: The other 2 patients mentioned by the reporter, experienced breathing problems and heart attack.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400298231 Same reporter/vaccine, different patient/event;US-PFIZER INC-202400298511 Same reporter/vaccine, different patient/event;
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Myocardial infarction
Clinical narrative: heart attack; breathing problems; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack"; DYSPNOEA (non-serious), outcome "unknown", described as "breathing problems ". Clinical course: The reporter had 2 other friends that had different issues, breathing problems and heart attack. That was all the reporter gave.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400298510 Same reporter/vaccine/event, different patient;
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Weight
Clinical narrative: accidentally gave a double dose; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old female patient received BNT162b2 omicron (kp.2) (BNT162B2 OMICRON (KP.2)), on 08Nov2024 at 10:30 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: Diagnosed years ago. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 08Nov2024 at 10:30, outcome "unknown", described as "accidentally gave a double dose". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient reported that she received a covid vaccine this morning and the pharmacy accidentally gave a double dose. She stated that she had all of her vaccines and boosters. Received the dose at 10:30 am on 08Nov2024. She said that she got 2 injections of the Pfizer Covid-19 vaccines. Reported that the pharmacist prepared 2 injections, one for her and one for her husband, but her husband was not brought back at the same time as her. The pharmacist accidentally gave her both of the injections.  Other conditions: She said that she had other health conditions, but nothing relevant. No Investigations and other products reported.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a consumer, Program ID.  A patient (age and gender not provided) received BNT162b2 OMI XBB.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Primary immunization series completed; manufacturer unknown), for COVID-19 immunization; COVID-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19. The patient had original COVID-19 vaccine and every available booster, but the patient got COVID-19 within 6 months and had to be treated for continued symptoms after finishing nirmatrelvir/ ritonavir (PAXLOVID). The patient asked what are the storage and pre-administration processes that the administering facility is to follow to assure that the dose administered to the patient is viable.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain in extremity, Vaccination site pain
Clinical narrative: Pain in the injection site; sore arm; Chills; Feels a little blah and needs to lay down; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 10Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Latex allergy" (unspecified if ongoing), notes: 10 years ago. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE via intramuscular in right arm), administration date: 10Jan2021, when the patient was 66-year-old, for COVID-19 immunisation, reaction(s): "Pain in the injection site", "sore arm", "Chills", "Feels a little blah and needs to lay down"; BNT162b2 (DOSE 2, SINGLE via intramuscular in right arm), administration date: 09Feb2021, when the patient was 67-year-old, for COVID-19 immunisation, reaction(s): "Pain in the injection site", "sore arm", "Chills", "Feels a little blah and needs to lay down". The following information was reported: CHILLS (non-serious) with onset 2021, outcome "recovered"; MALAISE (non-serious) with onset 2021, outcome "recovered", described as "Feels a little blah and needs to lay down"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered", described as "Pain in the injection site"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered", described as "sore arm".  Additional information: The patient reported that she has been fully vaccinated since 2021 with Pfizer's COVID 19 vaccines. The patient stated had 8 COVID shots and had a sore arm every time and 7 of those were Pfizer. The patient had never had symptoms with the administration of the COMIRNATY vaccine outside of the expected symptoms like pain in the injection site. The patient had no previous investigations. With the Pfizer COVID-19 vaccine, she gets a sore arm, chills, and feels a little blah and needs to lay down for a little and then feels fine. All have been like that except the later vaccine, she didn't feel anything until she woke up in the middle of the night. She usually gets her vaccine during the day and then lays down for a couple of hours and feels good. The events were considered non-serious.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400297861 Same patient and product; different dose and event;
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain in extremity, Vaccination site pain
Clinical narrative: Pain in the injection site; chills; sore arm; feels a little blah and needs to lay down; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Latex allergy" (unspecified if ongoing), notes: about 10 years ago. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: unknown, Route of administration: Intramuscular; Anatomical location: Right arm), administration date: 10Jan2021, when the patient was 66-year-old, for Covid-19 Immunization, reaction(s): "Pain in the injection site", "sore arm", "Chills", "Feels a little blah and needs to lay down"; BNT162b2 (DOSE 2, SINGLE; Lot number: unknown, Route of administration: Intramuscular; Anatomical location: Right arm), administration date: 09Feb2021, when the patient was 67-year-old, for Covid-19 Immunization, reaction(s): "Pain in the injection site", "sore arm", "Chills", "Feels a little blah and needs to lay down"; BNT162b2 (DOSE 3 (BOOSTER), Lot number: unknown, Route of administration: Intramuscular; Anatomical location: Right arm), administration date: 10Sep2021, when the patient was 67-year-old, for Covid-19 Immunization, reaction(s): "Pain in the injection site", "sore arm", "Chills", "Feels a little blah and needs to lay down". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Pain in the injection site"; CHILLS (non-serious), outcome "recovered"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm"; MALAISE (non-serious), outcome "recovered", described as "feels a little blah and needs to lay down".  Additional information: The patient reported that she has been fully vaccinated since 2021 with Pfizer's COVID 19 vaccines. The patient stated had 8 COVID shots and had a sore arm every time and 7 of those were Pfizer. The patient had never had symptoms with the administration of the COMIRNATY vaccine outside of the expected symptoms like pain in the injection site. The patient had no previous investigations. With the Pfizer COVID-19 vaccine, she gets a sore arm, chills, and feels a little blah and needs to lay down for a little and then feels fine. All have been like that except the later vaccine, she didn't feel anything until she woke up in the middle of the night. She usually gets her vaccine during the day and then lays down for a couple of hours and feels good. The events were considered non-serious.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400297861 Same reporter, patient / different AE, vaccine dose;