chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Shingrix if adjuvant portion is given only and if other diluent was used for reconstitution of Shingrix vaccine; Inappropriate dose of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix if adjuvant portion is given only and if other diluent was used for reconstitution of Shingrix vaccine) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 07-DEC-2023 It was reported that pharmacist requested data on the revaccination of Shingrix if adjuvant portion was given only and if other diluent was used for reconstitution of Shingrix vaccine.  Healthcare professional was not sure which even occurred but an extra vial (unknown which vial) remains after nursing completed inventory at the clinic.  Per healthcare professional, it was the patient's 1st dose in the Shingrix series.   The incident occurred in the clinic between 22-NOV-2023 and 06-DEC-2023. Exact patient and date unknown. The patient received only adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: is late for the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18 or 19th June 2022).   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: is late for the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-DEC-2023 Pharmacist reported that the patient was late for the 2nd dose. The reporter consented to follow-up via email. Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Injection site nodule, Skin ulcer
Clinical narrative: open sore at the elbow region on the left arm; Knot underneath the injection site of left deltoid; This serious case was reported by a pharmacist via call center representative and described the occurrence of injection site nodule in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 75Bs5, expiry date 31-JAN-2025) for prophylaxis.   On 01-NOV-2023, the patient received Arexvy (intramuscular, left gluteal). On 02-NOV-2023, 1 days after receiving Arexvy, the patient experienced injection site nodule (Verbatim: Knot underneath the injection site of left deltoid) (serious criteria clinically significant/intervention required). On 07-DEC-2023, the patient experienced skin ulcer (Verbatim: open sore at the elbow region on the left arm) (serious criteria clinically significant/intervention required). The patient was treated with cefalexin (Keflex). The outcome of the injection site nodule was resolved and the outcome of the skin ulcer was not resolved.   It was unknown if the reporter considered the injection site nodule and skin ulcer to be related to Arexvy.     It was unknown if the company considered the injection site nodule and skin ulcer to be related to Arexvy.   Additional Information: GSK Receipt Date: 08-DEC-2023 The pharmacist reported on behalf of the patient who received her Arexvy vaccine and she had a knot come up under the injection site of left arm that required a visit to her healthcare professional and  started on a course of Keflex. No further information was given. However, 7 days after receiving the Keflex her symptoms cleared up. Same patient came back to the pharmacy with a open sore in her elbow region on the same left arm that the injection was given. The pharmacist called to report adverse event and spoke to medical information for further questions about the Arexvy vaccine. Adverse event filed. The reporter consented to follow up. No healthcare professional information was given.
Age: 89.0
Sex: F
Vaccine: RSV
Symptoms: Carditis, Dyspnoea, Endocarditis, Fatigue, General physical health deterioration
Clinical narrative: felt like heart attack; lining of heart inflamed; pneumonia; having trouble breathing; general lack of health; increase tiredness; This serious case was reported by a consumer via call center representative and described the occurrence of heart attack in a 89-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   In OCT-2023, the patient received the 1st dose of Arexvy (unknown arm) and COVID-19 vaccine (unknown arm). On an unknown date, several days after receiving Arexvy, the patient experienced heart attack (Verbatim: felt like heart attack) (serious criteria GSK medically significant), endocarditis (Verbatim: lining of heart inflamed) (serious criteria GSK medically significant), pneumonia (Verbatim: pneumonia) (serious criteria GSK medically significant), difficulty breathing (Verbatim: having trouble breathing), decreased immune responsiveness (Verbatim: general lack of health) and fatigue (Verbatim: increase tiredness). The outcome of the heart attack, endocarditis and pneumonia were unknown and the outcome of the difficulty breathing, decreased immune responsiveness and fatigue were not resolved.   The reporter considered the heart attack and endocarditis to be related to Arexvy. It was unknown if the reporter considered the pneumonia, difficulty breathing, decreased immune responsiveness and fatigue to be related to Arexvy.     The company considered the heart attack and endocarditis to be related to Arexvy. It was unknown if the company considered the pneumonia, difficulty breathing, decreased immune responsiveness and fatigue to be related to Arexvy.   Additional Information: GSK Receipt Date: 08-DEC-2023 The reporter was a patient. The patient received Arexvy and covid 19 vaccine at her pharmacy. Patient received injection in each arm. A few days' letter of vaccination, the patient felt like she was having a heart attack and she went to hospital; there she was told the lining of her heart was inflamed and that it was due to receiving both vaccines at the same time. The patient reported that a few days later she had trouble breathing and she went to hospital, there she was treated for pneumonia and fluid was removed from her lungs. Patient stated that she had problems breathing, general lack of health and increase tiredness at reporting time. The reporter considered the heart attack and endocarditis to be related to Covid 19 vaccine. It was unknown if the reporter considered the pneumonia, difficulty breathing, decreased immune responsiveness and fatigue to be related to Covid 19 vaccine.    The reporter consented to follow up.
Age: 89.0
Sex: F
Vaccine: RSV
Symptoms: Pneumonia
Clinical narrative: felt like heart attack; lining of heart inflamed; pneumonia; having trouble breathing; general lack of health; increase tiredness; This serious case was reported by a consumer via call center representative and described the occurrence of heart attack in a 89-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   In OCT-2023, the patient received the 1st dose of Arexvy (unknown arm) and COVID-19 vaccine (unknown arm). On an unknown date, several days after receiving Arexvy, the patient experienced heart attack (Verbatim: felt like heart attack) (serious criteria GSK medically significant), endocarditis (Verbatim: lining of heart inflamed) (serious criteria GSK medically significant), pneumonia (Verbatim: pneumonia) (serious criteria GSK medically significant), difficulty breathing (Verbatim: having trouble breathing), decreased immune responsiveness (Verbatim: general lack of health) and fatigue (Verbatim: increase tiredness). The outcome of the heart attack, endocarditis and pneumonia were unknown and the outcome of the difficulty breathing, decreased immune responsiveness and fatigue were not resolved.   The reporter considered the heart attack and endocarditis to be related to Arexvy. It was unknown if the reporter considered the pneumonia, difficulty breathing, decreased immune responsiveness and fatigue to be related to Arexvy.     The company considered the heart attack and endocarditis to be related to Arexvy. It was unknown if the company considered the pneumonia, difficulty breathing, decreased immune responsiveness and fatigue to be related to Arexvy.   Additional Information: GSK Receipt Date: 08-DEC-2023 The reporter was a patient. The patient received Arexvy and covid 19 vaccine at her pharmacy. Patient received injection in each arm. A few days' letter of vaccination, the patient felt like she was having a heart attack and she went to hospital; there she was told the lining of her heart was inflamed and that it was due to receiving both vaccines at the same time. The patient reported that a few days later she had trouble breathing and she went to hospital, there she was treated for pneumonia and fluid was removed from her lungs. Patient stated that she had problems breathing, general lack of health and increase tiredness at reporting time. The reporter considered the heart attack and endocarditis to be related to Covid 19 vaccine. It was unknown if the reporter considered the pneumonia, difficulty breathing, decreased immune responsiveness and fatigue to be related to Covid 19 vaccine.    The reporter consented to follow up.
Age: 19.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: nquiring about Twinrix and what information is available about the information of how to proceed after an expired dose was given; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 19-year-old female patient who received HAB (Twinrix) (batch number 2KE44, expiry date 22-SEP-2023) for prophylaxis.   On 08-DEC-2023, the patient received the 2nd dose of Twinrix. On 08-DEC-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: nquiring about Twinrix and what information is available about the information of how to proceed after an expired dose was given). The outcome of the expired vaccine used was unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt Date: 08-DEC-2023 The reporter inquired about Twinrix and what information was available about the information of how to proceed after an expired dose was given, which led to expired vaccine used. The partial information about the event and patient were given. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Device issue, No adverse event
Clinical narrative: the staff members administering the vaccine encountered an issue whereupon attempting to inject a patient, the plunger would not move; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of DEVICE ISSUE (the staff members administering the vaccine encountered an issue whereupon attempting to inject a patient, the plunger would not move) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032707) for COVID-19 prophylaxis.    Co-suspect product included Pre-filled Syringe injection (batch no. 3032707) for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE ISSUE (the staff members administering the vaccine encountered an issue whereupon attempting to inject a patient, the plunger would not move) and NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE ISSUE (the staff members administering the vaccine encountered an issue whereupon attempting to inject a patient, the plunger would not move) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The Device problem code for Spikevax syringe include FDA code 1670, IMDRF code A23 which include Use of Device Problem.  Customer reported that one of the staff members administering the vaccine encountered an issue whereupon attempting to inject a patient, the plunger would not move. The shot has since been discarded to box, and they are requesting credit.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Pruritus, Urticaria
Clinical narrative: itching, hives. She has these on her neck arms and trunk; dry skin; itching, hives. She has these on her neck arms and trunk; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching, hives. She has these on her neck arms and trunk), DRY SKIN (dry skin) and URTICARIA (itching, hives. She has these on her neck arms and trunk) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (Dose 2) and Moderna  (Dose 1). Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE and Moderna .    On an unknown date, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching, hives. She has these on her neck arms and trunk), DRY SKIN (dry skin) and URTICARIA (itching, hives. She has these on her neck arms and trunk). The patient was treated with ZOLEDRONIC ACID (XOLAREX) at a dose of 3 injections. At the time of the report, PRURITUS (itching, hives. She has these on her neck arms and trunk), DRY SKIN (dry skin) and URTICARIA (itching, hives. She has these on her neck arms and trunk) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The Moderna vaccine (she got the 1st two then the booster) and it was after the 3rd dose (12 days after that) when she had the symptoms. This woman was given double doses of anti histamines and when the hives did not resole, she was given Xolar and after 3 injections - it finally resolved.   This case was linked to US-MODERNATX, INC.-MOD-2023-753307, US-MODERNATX, INC.-MOD-2023-753341 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-753307:Different patient, same reporter US-MODERNATX, INC.-MOD-2023-753341:Case for patient
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling
Clinical narrative: Tiny bit of swelling for 2 days; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (Tiny bit of swelling for 2 days) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (Tiny bit of swelling for 2 days). At the time of the report, SWELLING (Tiny bit of swelling for 2 days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  The patient received her second Moderna Covid-19 vaccine on 05-Feb-2021 lot number 010M20A expiration date was not provided. Vaccine was received in the right arm. No adverse events were reported. The patient received her third Moderna covid-19 vaccine on 29-Oct-2021, lot number 006D21A expiration date was 21-Nov-2021, patient received the vaccine in her right arm. No adverse events that the patient could recall. The patient received her fourth Moderna Covid 19 vaccine on 18-May-2022 lot number 038A22A expiration date was not known. Patient received the vaccine in her right arm. No adverse events that the patient could recall. The patient received her fifth Moderna Covid-19 vaccine on 20-Nov-2022 lot number o52D22A expiration date was not known. Patient received the vaccine in her right arm. No adverse events that the patient could recall. The patient received her sixth Moderna Covid-19 vaccine as Spikevax 2023 2024 on 24-Nov-2023, patient did not had the lot number or expiration date. Patient received in her right arm.  It was reported that the patient had a tiny bit of swelling for 2 days.  Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Neck pain, Pain in extremity
Clinical narrative: Tiny bit of swelling for 2 days; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (Tiny bit of swelling for 2 days) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (Tiny bit of swelling for 2 days). At the time of the report, SWELLING (Tiny bit of swelling for 2 days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  The patient received her second Moderna Covid-19 vaccine on 05-Feb-2021 lot number 010M20A expiration date was not provided. Vaccine was received in the right arm. No adverse events were reported. The patient received her third Moderna covid-19 vaccine on 29-Oct-2021, lot number 006D21A expiration date was 21-Nov-2021, patient received the vaccine in her right arm. No adverse events that the patient could recall. The patient received her fourth Moderna Covid 19 vaccine on 18-May-2022 lot number 038A22A expiration date was not known. Patient received the vaccine in her right arm. No adverse events that the patient could recall. The patient received her fifth Moderna Covid-19 vaccine on 20-Nov-2022 lot number o52D22A expiration date was not known. Patient received the vaccine in her right arm. No adverse events that the patient could recall. The patient received her sixth Moderna Covid-19 vaccine as Spikevax 2023 2024 on 24-Nov-2023, patient did not had the lot number or expiration date. Patient received in her right arm.  It was reported that the patient had a tiny bit of swelling for 2 days.  Treatment information was not provided.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, Dry skin, Pruritus, Rash, Urticaria
Clinical narrative: itching; hives; Rash on neck arms and trunk; dry skin; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching), DRY SKIN (dry skin), URTICARIA (hives) and RASH (Rash on neck arms and trunk) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     Patient had no relevant medical history conditions, allergy, concomitant diseases and risk factor.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (1st dose , 007M20A) on 29-Jan-2021, Moderna COVID-19 vaccine (2nd dose , lot number 023M20A) on 26-Feb-2021, Moderna COVID-19 vaccine (3rd dose , lot number 067F21A) on 16-Nov-2021, Moderna COVID-19 vaccine (4th dose  andlot number 037A22B) on 27-May-2022; for Product used for unknown indication: Shingrix vaccine in January 2022 and Shingrix vaccine in April 2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Shingrix vaccine and Shingrix vaccine.    On 02-Aug-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced DRY SKIN (dry skin) and RASH (Rash on neck arms and trunk). On 13-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced PRURITUS (itching) and URTICARIA (hives). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]) at a dose of 2 dosage form, in the morning and LEVOCABASTINE HYDROCHLORIDE (ZYRTEC [LEVOCABASTINE HYDROCHLORIDE]) at a dose of 2 dosage form, in evening. At the time of the report, PRURITUS (itching), DRY SKIN (dry skin) and URTICARIA (hives) had not resolved and RASH (Rash on neck arms and trunk) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: no underlying condition or any autoimmune disease.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient stated that she had the Moderna vaccine on 02-Aug-2023 and 2 weeks after (later on during the call she said 11 days after) started having itching, hives. She had these on her neck arms and trunk. She's gone through skin biopsies and consulted a rheumatologist. She was on a double dose antihistamine. Patient was told to get the next Moderna vaccine but was advised to get a high dose of antihistamine starting 3 days before the administration.   This case was linked to US-MODERNATX, INC.-MOD-2023-753321 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-753321:Case for different patient
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not reported. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac discomfort, Heart rate, Neck pain
Clinical narrative: not able to move her neck, it was very painful; her heart drops; This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (not able to move her neck, it was very painful) and CARDIAC DISCOMFORT (her heart drops) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included Hormone implant. Previously administered products included for COVID-19 prophylaxis: Moderna (Dose 2) and Moderna (Dose 1). Past adverse reactions to the above products included No adverse event with Moderna and Moderna. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for Hormone implant.    On 02-Dec-2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (not able to move her neck, it was very painful) and CARDIAC DISCOMFORT (her heart drops). The patient was treated with PARACETAMOL (TYLENOL) for Neck pain, at an unspecified dose and frequency. At the time of the report, NECK PAIN (not able to move her neck, it was very painful) and CARDIAC DISCOMFORT (her heart drops) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: Her heart drops.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient stated that, she experienced a reaction following administration of the vaccine. Patient received so far 3 Moderna COVID19 vaccine doses in total. Patient received her last dose on last Sunday 02-Dec-2023 at 5 PM. She did not have her vaccination records at the time of the call. Following vaccination 1 week exactly after, almost to the hour patient was not able to move her neck, it was very painful, her heart drops, could not move her neck more than a Quarter of the way, left side being the worst. The patient was treated with Tylenol which was not helping.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac operation
Clinical narrative: I got it just before open heart surgery; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC OPERATION (I got it just before open heart surgery) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Aug-2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC OPERATION (I got it just before open heart surgery). At the time of the report, CARDIAC OPERATION (I got it just before open heart surgery) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter. Patient received Moderna covid-19 booster dose. Patient asked if the patient could receive the present booster dose. No treatment  medications provided by the reporter.
Sex: U
Vaccine: RSV
Symptoms: Product container issue
Clinical narrative: went to reconstitute one and then vial adapter failed to puncture and the vial 'cracked'; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group, Program ID.  A patient (no qualifiers provided) did not receive rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HF5012, Expiration Date: Jan2025) for immunisation, Device Lot Number: F673, Device Expiration Date: 01Jul2027. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "Went to reconstitute one and then vial adapter failed to puncture".  Causality for "went to reconstitute one and then vial adapter failed to puncture" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). Additional information included: Pharmacist reported that they were about to give the Abrysvo and went to reconstitute one and then vial adapter failed to puncture and the vial 'cracked' (word not clarified) and they are looking to report for replacement for Abrysvo. There was no patient involvement, it was not able to be used. There are a couple of them in the refrigerator, reporter just got the next one ready. Adapter: Lot#: F673, Expiration Date: 01Jul2027; Syringe: Lot# GY5655, Expiration Date: Feb2026, NDC# 00069025201; Vial: Lot# HF5012, Expiration Date: Jan2025, NDC# 00069020701; NDC# 00069034405, this is for the box. About strength: It was a 5 count box, but it was 1 single vial out of that 5 count that had the problem. The sample of the product is available to be returned. Packaging sealed and intact. Reporter was informed not to discard the product as a prepaid mailer might be sent within 3 to 10 business days for review by quality department if needed and got reporter' reassurance.
Sex: U
Vaccine: RSV
Symptoms: Bedridden
Clinical narrative: bedridden for weeks after receiving Abrysvo; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  An elderly patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BEDRIDDEN (prolonged hospitalization), outcome "unknown", described as "bedridden for weeks after receiving Abrysvo". It was unknown if therapeutic measures were taken as a result of bedridden. The product was administrated during existing hospitalization.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event bedridden and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300441617 same reporter/drug/AE, different patient;US-PFIZER INC-202300441618 same reporter/drug/AE, different patient;
Sex: U
Vaccine: RSV
Symptoms: Bedridden
Clinical narrative: resident was bedridden for weeks after receiving Abrysvo; This is a spontaneous report received from contactable reporter (Pharmacist) from a sales representative.  An elderly patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BEDRIDDEN (caused and prolonged hospitalization), outcome "unknown", described as "resident was bedridden for weeks after receiving Abrysvo". It was unknown if therapeutic measures were taken as a result of bedridden.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event bedridden and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300441591 same reporter/drug/AE, different patient;US-PFIZER INC-202300441618 same reporter/drug/AE, different patient;
Sex: U
Vaccine: RSV
Symptoms: Bedridden
Clinical narrative: bedridden for weeks after receiving Abrysvo; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  An elderly patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BEDRIDDEN (prolonged hospitalization), outcome "unknown", described as "bedridden for weeks after receiving Abrysvo". It was unknown if therapeutic measures were taken as a result of bedridden. The product was administrated during existing hospitalization.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event bedridden and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300441617 same reporter/drug/AE, different patient;US-PFIZER INC-202300441591 same reporter/drug/AE, different patient;
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug ineffective, Post-acute COVID-19 syndrome, Suspected COVID-19
Clinical narrative: Drug ineffective; Suspected COVID-19; long covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; SUSPECTED COVID-19 (medically significant), outcome "unknown"; POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "long covid". Clinical Course: It was reported that Patient was an early case of Covid and now had been diagnosed with long covid by Privacy health system. Patient created a detailed timeline of illness that he could share as well. Patient was asking if there was any way to get original formula.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300202270 same reporter and product, different dose and event;
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Drug ineffective; Suspected COVID-19; long covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; SUSPECTED COVID-19 (medically significant), outcome "unknown"; POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "long covid". Clinical Course: It was reported that Patient was an early case of Covid and now had been diagnosed with long covid by Privacy health system. Patient created a detailed timeline of illness that he could share as well. Patient was asking if there was any way to get original formula.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300202270 same reporter and product, different dose and event;
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "known allergies: Doxycycline" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO, start date: 01Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, Covid-19 with Paxlovid from 06Dec2023 to 10Dec2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2, BNT162B2 OMI BA.4-5 cannot be fully excluded.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Swelling face
Clinical narrative: face swelled up; had difficulty breathing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 51-year-old female patient received bnt162b2 (BNT162B2), on 20Apr2021 as dose 2, single (Lot number: ER8735) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/Lot number: ER2613), administration date: 30Mar2021, for COVID-19 immunisation, reaction(s): "face swelled up", "had difficulty breathing". The following information was reported: SWELLING FACE (medically significant), outcome "not recovered", described as "face swelled up"; DYSPNOEA (medically significant), outcome "not recovered", described as "had difficulty breathing". The events "face swelled up" and "had difficulty breathing" required physician office visit. Therapeutic measures were taken as a result of swelling face, dyspnoea. Clinical course: The patient had her first and second dose of Pfizer COVID vaccine in 2021, and she had an allergic reaction to it. She mentioned that her face swelled up and had difficulty breathing. The first shot was milder and her doctor told her it was important to receive the second dose and to just take Benadryl. Even with the Benadryl she had an even worse reaction to the second dose of the Pfizer Covid vaccine and she did not took it anymore or any boosters. The patient never had any other food or medication allergies so she wanted to know what the ingredients were in the vaccines.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300444315 same patient/reporter/AE, different doses (Dose 1);
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine dose number=6, 5, 4, vaccine brand other=Moderna/vaccine dose number=3 vaccine brand=Pfizer/BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received bnt162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm, on 05Oct2023 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm and on 15Nov2023 as dose 6 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Jun2022, outcome "unknown", described as "Vaccine dose number=6, 5, 4, vaccine brand other=Moderna/vaccine dose number=3 vaccine brand=Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 02Dec2023 to 07Dec2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient may have been administered a dose of ACTHIB that was inadvertently reconstituted with sterile water instead of the provided ACTHIB diluent with no reported adverse event; Initial information received from RA on 11-Dec-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 1 years old male patient who experienced patient may have been administered a dose of HIB (PRP/T) vaccine [ACT-HIB] that was inadvertently reconstituted with sterile water instead of the provided acthib diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (daptacel), measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar ra 27/3), varicella zoster vaccine live (oka/merck) (proquad) and hepatitis a vaccine inact (vaqta).  On 08-Dec-2023, the patient received 0.5 ml (TOTAL) dose of suspect hib (prp/t) vaccine Powder and solvent for solution for injection (lot- UJ862AA and expiration date- 24-Mar-2024) via intramuscular route in the right thigh (strength: not provided) for Immunisation (product preparation error) (latency- same day).  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.08
Sex: M
Vaccine: DTAP
Symptoms: Medication error, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: inadvertently administered DAPTACEL instead of a HEP-B vaccine, with no reported adverse event; DAPTACEL administered to1 month old child, with no reported adverse event; Initial information received from RA on 11-Dec-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 4 weeks old male patient who inadvertently administered diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] instead of a hep-b vaccine, with no reported adverse event and daptacel administered to1 month old child, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Dec-2023, the patient received 0.5 ml dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection (lot- C6013AA and expiration date- 06-JUL-2024) via intramuscular route in unknown administration site (strength: not provided) for Immunisation (wrong product administered) and (product administered to patient of inappropriate age) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.