chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not go back for the second dose patient has not received another 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 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 19th July 2019, batch number:9X374 and expiry date: 10th October 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: did not go back for the second dose patient has not received another dose).The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 05-SEP-2023 The patient did not go back for the second dose of Shingrix. At the time of reporting, the patient had not received another dose. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix , which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: MMR vaccine was used to reconstitute shingrix and it was administered to a patient; MMR vaccine was used to reconstitute shingrix and it was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 34MK3, expiry date 08-JUL-2024) for prophylaxis.   On 29-AUG-2023, the patient received Shingrix. On 29-AUG-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: MMR vaccine was used to reconstitute shingrix and it was administered to a patient) and inappropriate dose of vaccine administered (Verbatim: MMR vaccine was used to reconstitute shingrix and it was administered to a patient).The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 05-SEP-2023 The reporter called to report the diluent for MMR vaccine was used to reconstitute Shingrix and it was administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consent to follow-up.
Sex: U
Vaccine: RSV
Symptoms: Incorrect dose administered, Product preparation issue, Single component of a two-component product administered
Clinical narrative: Arexvy adjuvant was administered without being reconstituted with the lyophilized antigen portion; Arexvy adjuvant was administered without being reconstituted with the lyophilized antigen portion; 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 RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 01-SEP-2023, the patient received Arexvy. On 01-SEP-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: Arexvy adjuvant was administered without being reconstituted with the lyophilized antigen portion) and inappropriate dose of vaccine administered (Verbatim: Arexvy adjuvant was administered without being reconstituted with the lyophilized antigen portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 05-SEP-2023 The reporter stated that a peer contacted him stating they believed that a dose of Arexvy adjuvant was administered without being reconstituted with the lyophilized antigen portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. They were going back to watch video evidence to determine which patient it was and when it occurred. At this time, no additional information was available. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: efficacy data on second SHINGRIX shot being given at 30 days instead of 60 days; This non-serious case was reported by a physician via sales rep and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: efficacy data on second SHINGRIX shot being given at 30 days instead of 60 days).The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 05-SEP-2023 The Medical Information Department received the following inquiry throughout channel that healthcare professional requesting safety and efficacy data on second Shingrix shot being given at 30 days instead of 60 days. The reporter consented to follow up. The patient received 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
Sex: U
Vaccine: UNK
Symptoms: Peripheral swelling, Weight decreased
Clinical narrative: legs swelled up twice as big as normally; Down from 60 to 45 ecogram; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (legs swelled up twice as big as normally) and WEIGHT DECREASED (Down from 60 to 45 ecogram) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.    Co-suspect product included non-company product TAFAMIDIS (VYNDAMAX) for Amyloidosis.    Concurrent medical conditions included Sarcoidosis, Aneurysm of heart, Amyloidosis, Leg cramps and Swelling of legs. Concomitant products included METOPROLOL for Heart disorder, UBIDECARENONE (COQ-10) for Leg cramps, PREDNISONE for Sarcoidosis, FUROSEMIDE for Swelling of legs, COLECALCIFEROL (D3), CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and MAGNESIUM for an unknown indication.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. and TAFAMIDIS (VYNDAMAX) (unknown route) 61 milligram. On an unknown date, the patient experienced PERIPHERAL SWELLING (legs swelled up twice as big as normally) and WEIGHT DECREASED (Down from 60 to 45 ecogram). At the time of the report, PERIPHERAL SWELLING (legs swelled up twice as big as normally) and WEIGHT DECREASED (Down from 60 to 45 ecogram) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: Down from 60 to 45 ecogram.         Patient had the ecogram and at time injection range was 60 and then noticed, it started in early 2019 and coming forward, strength was kind of diminished and patient went to cardiologist, patient was running out of steam and cannot keep up to on a morning walk and marked it down then COVID yet the offices down nothing else was done. Patient took the third shot and legs swelled up twice as big as normally they are and patient went right over to family doctor, and doctor said you got the heart problem this was not the shot and thought it might be the Amyloidosis and they did a check and heart was 45.  No treatment medications were provided.   Reporter did not allow further contact
Sex: M
Vaccine: UNK
Symptoms: Condition aggravated, Psoriasis
Clinical narrative: My psoriasis started to get worse when I had Covid vaccine (Moderna); This spontaneous case was reported by a patient and describes the occurrence of PSORIASIS (My psoriasis started to get worse when I had Covid vaccine (Moderna)) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Psoriasis. Concomitant products included APREMILAST (OTEZLA) for Psoriasis.    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 PSORIASIS (My psoriasis started to get worse when I had Covid vaccine (Moderna)). At the time of the report, PSORIASIS (My psoriasis started to get worse when I had Covid vaccine (Moderna)) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Patient reported that, he was being considered for drug Llumya because he was treated for several years for psoriasis with Otezla and was working fine but last year psoriasis got worse.   Treatment information was not reported.   Reporter did not allow further contact
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient have been administered vaccine after the published expiration date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient have been administered vaccine after the published expiration date.) and NO ADVERSE EVENT (No adverse event) in a 49-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Aug-2023 at 2:44 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 26-Aug-2023 at 2:44 PM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient have been administered vaccine after the published expiration date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient have been administered vaccine after the published expiration date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient have been administered vaccine after the published expiration date.).    Concomitant product use was not provided by the reporter. Patient has no acute illnesses at the time of vaccination and up to one month before. It has been reported that vaccines were in special deep freezer setup for the storage. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-739012 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739012:Same reporter ((Patient initial -C-L Gender- Female))
Age: 23.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; The vaccine expired on 13-Jun-2023 and was administered on 25-Aug-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 13-Jun-2023 and was administered on 25-Aug-2023) and NO ADVERSE EVENT (No adverse event) in a 23-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     The patient was not diagnosed with or tested positive for COVID-19. The patient not had acute illness at the time of vaccination and up to one month before.     On 25-Aug-2023 at 9:42 AM, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 25-Aug-2023 at 9:42 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 13-Jun-2023 and was administered on 25-Aug-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 13-Jun-2023 and was administered on 25-Aug-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 13-Jun-2023 and was administered on 25-Aug-2023).    No concomitant medications were reported.  No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-739012 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739012:Same reporter (Patient initial -G-L Gender- Female)
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: Sore shoulder; tired; This spontaneous case was reported by a nurse and describes the occurrence of ARTHRALGIA (Sore shoulder) and FATIGUE (tired) in a 61-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 939909) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Influenza vaccine. Past adverse reactions to the above products included No adverse event with Influenza vaccine. Concurrent medical conditions included Asthma, Irritable bowel syndrome, Chronic migraine, Allergy to NSAIDs, Gluten intolerance and Cystitis interstitial. Concomitant products included BACLOFEN, RIZATRIPTAN, PSEUDOEPHEDRINE and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for an unknown indication.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Sore shoulder) and FATIGUE (tired). At the time of the report, ARTHRALGIA (Sore shoulder) and FATIGUE (tired) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient took OTC nasal spray as concomitant drug.  In Feb2022, she had bladder pain that was worse than her usual bladder pain. She has also had a chronic migraine which she felt was leveling out now, as well as fatigue. She believed she has an undiagnosed history of interstitial cystitis, and thought her increased bladder pain was due to a UTI.  She has not taken any medications or treatments for her symptoms.   This case was linked to US-MODERNATX, INC.-MOD-2023-710279 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710279:Master case, Bivalent dose
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product temperature excursion issue
Clinical narrative: VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE; no adverse event; VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE), PRODUCT TEMPERATURE EXCURSION ISSUE (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (no adverse event) in a 31-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular use) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE), PRODUCT TEMPERATURE EXCURSION ISSUE (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular use), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and PRODUCT TEMPERATURE EXCURSION ISSUE (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE).    Concomitant medications were not reported.  It was unknown if the patient experienced any additional symptoms/events. Treatment medications were not reported.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient have been administered vaccine after the published expiration date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient have been administered vaccine after the published expiration date.) and NO ADVERSE EVENT (No adverse event) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Patient has been diagnosed with/tested positive for covid-19.).    On 26-Aug-2023 at 2:28 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 26-Aug-2023 at 2:28 PM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient have been administered vaccine after the published expiration date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient have been administered vaccine after the published expiration date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient have been administered vaccine after the published expiration date.).    Concomitant product use was not provided by the reporter. Patient has no acute illnesses at the time of vaccination and up to one month before. It has been reported that vaccines were in special deep freezer setup for the storage. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Sep-2023: Follow up has significant information: Report type has been updated from invalid to spontaneous. Reporter detail, Patient demographics, other relevant history, vaccine Information, Event verbatim and I-narrative has been updated.
Sex: F
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: His daughter got COVID-19 2 months ago.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (His daughter got COVID-19 2 months ago.) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2023, the patient experienced COVID-19 (His daughter got COVID-19 2 months ago.). At the time of the report, COVID-19 (His daughter got COVID-19 2 months ago.) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   It was unknown if the patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. It was reported that the patient had COVID-19, 2 months ago. The patient had pills and she was okay now. The patient got a Moderna vaccination in the beginning. Doctor said the patient had a light case of corona. The patient took medication for 5 days.   Reporter did not allow further contact
Sex: F
Vaccine: UNK
Symptoms: Arthralgia
Clinical narrative: Shoulder pain got better over time; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder pain got better over time) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Shoulder pain got better over time). At the time of the report, ARTHRALGIA (Shoulder pain got better over time) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       Concomitant medication was not provided. Treatment information was not reported.
Age: 69.0
Sex: M
Vaccine: UNK
Symptoms: Gait disturbance, Weight decreased
Clinical narrative: can't walk; lost 80 pounds body weight; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (can't walk) and WEIGHT DECREASED (lost 80 pounds body weight) in a 69-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) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (can't walk) and WEIGHT DECREASED (lost 80 pounds body weight). At the time of the report, GAIT DISTURBANCE (can't walk) and WEIGHT DECREASED (lost 80 pounds body weight) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, weight: lost 80 pounds.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product temperature excursion issue
Clinical narrative: Vaccine given after expiration date due to temperature change in storage; Vaccine given after expiration date due to temperature change in storage; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given after expiration date due to temperature change in storage), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine given after expiration date due to temperature change in storage) and NO ADVERSE EVENT (no adverse event) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given after expiration date due to temperature change in storage), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine given after expiration date due to temperature change in storage) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given after expiration date due to temperature change in storage), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine given after expiration date due to temperature change in storage) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular use) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular use), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine given after expiration date due to temperature change in storage) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine given after expiration date due to temperature change in storage).    No concomitant medications were reported.  It was unknown if the patient experienced any additional symptoms/events.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2023: Follow up added with no new information received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product temperature excursion issue
Clinical narrative: VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE; No adverse event; VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE), PRODUCT TEMPERATURE EXCURSION ISSUE (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE), PRODUCT TEMPERATURE EXCURSION ISSUE (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and PRODUCT TEMPERATURE EXCURSION ISSUE (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE).    Concomitant medication was not reported. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE; GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE), PRODUCT TEMPERATURE EXCURSION ISSUE (GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (no adverse event) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. 04821A) 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE), PRODUCT TEMPERATURE EXCURSION ISSUE (GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE), PRODUCT TEMPERATURE EXCURSION ISSUE (GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (no adverse event) outcome was unknown.     For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and PRODUCT TEMPERATURE EXCURSION ISSUE (GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact.
Age: 63.0
Sex: M
Vaccine: PNC20
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: very red; very swelled, raised area; itchy; painful; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 63-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 26Aug2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for pneumonia. The patient's relevant medical history was not reported. Concomitant medication(s) included: POTASSIUM CHLORIDE. The following information was reported: ERYTHEMA (non-serious), outcome "not recovered", described as "very red"; SWELLING (non-serious), outcome "not recovered", described as "very swelled, raised area"; PRURITUS (non-serious), outcome "not recovered", described as "itchy"; PAIN (non-serious), outcome "not recovered", described as "painful". Therapeutic measures were not taken as a result of erythema, swelling, pruritus, pain. Additional information: It has been getting progressively worst.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) 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's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID-19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 from 22Aug2023 till 26Aug2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300292723 same patient different drug/events;
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose 1/Dose 2/ Dose 3/Dose 4: Moderna Covid-19 Vaccine; Dose 5: Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 02Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 30Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 05Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Sep2022, outcome "unknown", described as "Dose 1/Dose 2/ Dose 3/Dose 4: Moderna Covid-19 Vaccine; Dose 5: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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.
Sex: F
Vaccine: RSV
Symptoms: Rash
Clinical narrative: rash over chest/rash from the neck down to above bra line/'very angry red'; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received PF-06928316 (ABRYSVO), on 01Sep2023 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: RASH ERYTHEMATOUS (non-serious) with onset 02Sep2023, outcome "recovering", described as "rash over chest/rash from the neck down to above bra line/'very angry red'".  Additional information: Patient is reporting adverse event from Abryovo; reports rash over chest. Asking for treatment recommendations. Patient confirms she had the vaccine on Friday 01Sep2023 given by a pharmacist and the next day (either in the morning when she woke up or during the day) she developed a rash from the neck down to above bra line. She didn't pay attention to it at first 'but it grew' and became 'very angry red' yesterday and today. It seems to have stopped today but it is not responding (unclear of how it is not responding). Concerned the vaccine gave her RSV if it is a live vaccine. States she doesn't get rashes. Confirmed she is over 60 years of age. Patient is asking if it is a live vaccine.  The information on the batch/lot number for PF-06928316 has been requested and will be submitted if and when received.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), in Jan2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "Congenital Heart Defect" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Aug2023, outcome "recovered" (2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Aug2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.Clinical course: Patient had Paxlovid Treatment from 26Aug2023 to 30Aug2023. The patient did not have any known allergies  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300293516 same patient, different drug/event;
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Severe allergic reaction; This is a spontaneous report received from contactable reporter(s) (Physician and Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001120.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, 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: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Severe allergic reaction".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A female patient 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. The patient's relevant medical history included: "My husband and I have auto-immune diseases" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "sick".  Additional information: Patient reported that her husband and she had auto-immune diseases. Every time they had taken a Covid shot or booster, they got really sick for at least 5 days and wanted to know if there were ways to avoid becoming sick after every shot.  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: Linked Report(s) : US-PFIZER INC-PV202300151354 same reporter/product/event, different patient;
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: really sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient 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. The patient's relevant medical history included: "My husband have auto-immune diseases" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "really sick".  Additional information: Reporter and her husband have auto-immune diseases. Every time they taken a Covid shot or booster, they gotten really sick for at least 5 days. Reporter asked if there ways they can avoid becoming sick after every shot.  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: Linked Report(s) : US-PFIZER INC-PV202300151351 same reporter/product/event, different patient;
Age: 16.0
Sex: M
Vaccine: MEN
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Patient received a dose of Menquadfi after temperature excursion(max temperature was 14.6C; low temperature 0.1C, excursion lasted a total of 12 hours and 10 minutes) with no reported adverse event; Initial information received on 05-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA272373(CLUSTER).  This case involves a 16 years old male patient who received a dose of menquadfi after temperature excursion(max temperature was 14.6c; low temperature 0.1c, excursion lasted a total of 12 hours and 10 minutes) 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 meningococcal vaccine B RFHBP/NADA/NHBA OMV (Bexsero) for Prophylactic vaccination.  On 28-Aug-2023, the patient received 0.5 ml dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, Solution for injection lot U7633AB expiry- 25-Apr-2028 via intramuscular route in the left arm for immunization (strength: unknown), patient received a dose of menquadfi after temperature excursion(max temperature was 14.6c; low temperature 0.1c, excursion lasted a total of 12 hours and 10 minutes) with no reported adverse event (poor quality product administered) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event poor quality product administered  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: 12.0
Sex: M
Vaccine: MEN
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: MENQUADFI was administered after experiencing a temperature excursion that was not covered by the extended data with no reported adverse event; Initial information received on 05-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA272367(CLUSTER).  This case involves a 12 years old male patient who was administered MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI after experiencing a temperature excursion that was not covered by the extended data 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 HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Prophylactic vaccination.  On 28-Aug-2023, the patient received 0.5 ml of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE, Solution for injection lot U7633AB, expiry- 25-APR-2028  via intramuscular route in the left arm for immunization (strength: unknown) menquadfi was administered after experiencing a temperature excursion that was not covered by the extended data with no reported adverse event (poor quality product administered) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event poor quality product administered  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: 69.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Discomfort, Muscle tightness, Pain
Clinical narrative: Within an hour of getting the vaccines, the left side of my neck began to tighten up( 3/10). Three hours later it had increased in severity to 6/10 and I took 2 Tylenols as instructed by my pharmacist. These did not help. 4 hours later, still at 6-7/10, I took an Ibuprofen 800mg with relief going down to 3-4/10. The following morning ( this am), initially the pain was 1/10, more of an inconvenient tightenting. After an hour the pain had increased to 4/10, mostly with an up and down motion of the head. Side to side motion maybe a 1/10. 3 hours later,  discomfort reduced to 2/10, not noticible while working. There is no tenderness at the injection sites.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pain
Clinical narrative: flu like symptoms, headache, shiver, chills, body aches and pain
Age: 43.0
Sex: F
Vaccine: DT
Symptoms: Cognitive disorder, Dyspnoea, Hypertension, Visual impairment
Clinical narrative: Shortness of breath high blood pressure cognitive changes vision changes
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Pyrexia, Rash
Clinical narrative: rash and fever.  Treatment: benadryl, ibuprofen, tylenol, cold compress
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Crying
Clinical narrative: Pt had inconsolable crying at night for over 2 hours within 24 hours of receiving the injection. This continued for 3 days after the injection.
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Headache, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Swollen area about the size of softball at injection site for a week, hot to the touch, fever for three days(between 99.4 - 101.00), headache, not feeling well, fatigue.
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Swollen area about the size of softball at injection site for a week, hot to the touch, fever for three days(between 99.4 - 101.00), headache, not feeling well, fatigue.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: No know adverse events noted. Recent finding of a sustainability window for the lot number of COVID vaccine received.
Age: 8.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: MD called patient parent to let her know patient was given DTaP instead of TDap, no adverse reaction noted.
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: No adverse event noted.  Recent finding of a sustainability window for the lot number of COVID vaccine received.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Coronary artery thrombosis, Myocardial infarction
Clinical narrative: Myocardial infarction caused by a blood clot, heart attack
Age: 58.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Hyperhidrosis, Loss of consciousness, Peripheral coldness
Clinical narrative: Loss of consciousness, cold extremities, profuse sweating.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness
Clinical narrative: Severe generalized muscle weakness
Age: 18.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: No adverse event noted. Recent finding of a sustainability window for the lot number of COVID vaccine received.
Age: 27.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Patient received vaccine outside of the window making it invalid (vaccine had been removed from ultra-freeze for longer than 10 weeks).