chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Acute kidney injury, Atrial fibrillation
Clinical narrative: Afib and AKI
Age: 87.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Abdominal discomfort, Atrial fibrillation, Chest discomfort, Electrocardiogram abnormal, Glomerular filtration rate decreased
Clinical narrative: Afib and AKI
Age: 87.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Incorrect dose administered
Clinical narrative: Afib and AKI
Age: 12.0
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: the administration of Dtap to a 12 year old patient instead of a tDap; the administration of Dtap to a 12 year old patient instead of a tDap; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine. On an unknown date, an unknown time after receiving DTPa vaccine, the patient experienced inappropriate age at vaccine administration (Verbatim: the administration of Dtap to a 12 year old patient instead of a tDap) and wrong vaccine administered (Verbatim: the administration of Dtap to a 12 year old patient instead of a tDap). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Additional Information: GSK Receipt Date: 27-DEC-2023 The reporter was wondering if GSK could provide him/her written information regarding the administration of Dtap to a 12 year old patient instead of a tDap, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter mentioned specifically, was it harmful and what should they do as next steps. The reporter had a quality issue here, they were are working on and this would be the last thing they need. it was unknown at this point if healthcare professional (HCP) was referring to Infanrix and Boostrix or not. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Arthralgia, Injection site pain, Product administered at inappropriate site
Clinical narrative: Painful immunization - placement on arm was too high for an IM injection - causing shoulder pain. Recommended 1000 mg  tylenol with 400 mg ibuprofen every 6 hours along with heat packs to the area for 20 minutes at a time 4-6 times throughout the day. Follow-up with continued symptoms, or signs of infection.
Age: 62.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Painful immunization - placement on arm was too high for an IM injection - causing shoulder pain. Recommended 1000 mg  tylenol with 400 mg ibuprofen every 6 hours along with heat packs to the area for 20 minutes at a time 4-6 times throughout the day. Follow-up with continued symptoms, or signs of infection.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Contusion, Decreased appetite, Dizziness, Heart rate increased
Clinical narrative: Bottom of right/left foot - pain alternates as does pain in ankles and shins. Paleness. Rapid heart rate. Dizziness. Not eating or eating very little. Has IBS, however pain is not the same as IBS experience. Swollen mid-section. Left arm still swollen where shot administered - bruise gone after three plus weeks. Pain/aches alternate between left and right legs. Lower back pain that alternates between left and right sides. Contracted apparent UTI, antibiotic regime began today, January 04, 2024.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Pallor, Peripheral swelling, Swelling, Urinary tract infection
Clinical narrative: Bottom of right/left foot - pain alternates as does pain in ankles and shins. Paleness. Rapid heart rate. Dizziness. Not eating or eating very little. Has IBS, however pain is not the same as IBS experience. Swollen mid-section. Left arm still swollen where shot administered - bruise gone after three plus weeks. Pain/aches alternate between left and right legs. Lower back pain that alternates between left and right sides. Contracted apparent UTI, antibiotic regime began today, January 04, 2024.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Allergy test positive, Food allergy, Hypersensitivity
Clinical narrative: Since getting the first two doses of COVID-19 vaccines, Trenton has developed severe food and environmental allergies. He was cared for and tested by Allergist and Trenton reacted to everything including the controls. He had to be placed on prednisone in order to decrease immune response.
Age: 34.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Proquad given to 34yr old adult. Not indicated for anyone over the age of 13. Was to be regular MMR given. Patient was notified of med error. Stated that she has no symptoms or side effects of vaccine.
Age: 1.25
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Body temperature increased, Feeling hot, Influenza A virus test negative, Influenza B virus test, Polymerase chain reaction negative
Clinical narrative: Staff advised that she went to check on patient later in the afternoon after patient was napping, noted that patient "felt warm" and seemed to be "starring at the ceiling" as well as an episode of "rhythmic shaking" which lasted approximately 1 minute - resolved spontaneously prior to paramedics arriving.    Mom stated she transported patient via private vehicle to Emergency Department for further evaluation.   Patient noted to have temperature of 103.7 upon arrival.  ED performed viral testing including:  Strep A PCR; RSV PCR; Influenza A PCR; Influenza B PCR; SARS-Cov-2 PCR - which were all negative.  Patient  cleared for discharge by ED Physician.
Age: 1.25
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Staring, Streptococcus test positive, Tremor
Clinical narrative: Staff advised that she went to check on patient later in the afternoon after patient was napping, noted that patient "felt warm" and seemed to be "starring at the ceiling" as well as an episode of "rhythmic shaking" which lasted approximately 1 minute - resolved spontaneously prior to paramedics arriving.    Mom stated she transported patient via private vehicle to Emergency Department for further evaluation.   Patient noted to have temperature of 103.7 upon arrival.  ED performed viral testing including:  Strep A PCR; RSV PCR; Influenza A PCR; Influenza B PCR; SARS-Cov-2 PCR - which were all negative.  Patient  cleared for discharge by ED Physician.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Patient received   Pfizer 5-11 age group when he should have received 12+ dosing. He was underdosed.
Age: 69.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: Sore arm (2 days),  fever (2 days), chills, (2 days), upset stomach & headache & tiredness (10 days). Have been taking  flu vaccine for 20 or more years and have never reacted to a vaccine until this occurrence.
Age: 69.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pyrexia
Clinical narrative: Sore arm (2 days),  fever (2 days), chills, (2 days), upset stomach & headache & tiredness (10 days). Have been taking  flu vaccine for 20 or more years and have never reacted to a vaccine until this occurrence.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Malaise
Clinical narrative: the patient got extremely sick. almost  fainted could not eat for couple of days.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Based on information in EMR, recommended today's dose since child is age 8. Listed in EMR were doses from 12/17/21 and 10/06/2023. However, after vaccine was discussed, consent obtained, and vaccine administered, I noted in state registry a vaccine dose given 9/24/2022 and listed as invalid administration. Our medical assistant attempted to contact state registry to get more details. If September 2022 dose is actually valid, then today's dose was unnecessary. Called mom and provided her information about the vaccine dose from 2022 that we did not have listed on our records. Discussed that no adverse effect expected other than typical side effects from a flu vaccine and that vaccine today  will serve as extra protection against the flu. Mom to call if she does notice any concerning side effects.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: the administration of adjuvant portion of the Shingrix vaccine to a patient; the administration of adjuvant portion of the Shingrix vaccine to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number LT3XM, expiry date 26-SEP-2025) for prophylaxis.   On 02-JAN-2024, the patient received Shingrix. On 02-JAN-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: the administration of adjuvant portion of the Shingrix vaccine to a patient) and inappropriate dose of vaccine administered (Verbatim: the administration of adjuvant portion of the Shingrix vaccine to a patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date:02-JAN-2024 The reporter reported that the administration of adjuvant portion of the Shingrix vaccine to a patient on 2nd January 2024. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Injection site rash, Injection site reaction, Sensitive skin
Clinical narrative: 8 cm rectangular rash at injection site; skin at injection site is sensitive; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site rash in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In DEC-2023, the patient received the 1st dose of Arexvy. On an unknown date, less than 2 weeks after receiving Arexvy, the patient experienced injection site rash (Verbatim: 8 cm rectangular rash at injection site) and injection site hyperesthesia (Verbatim: skin at injection site is sensitive). The outcome of the injection site rash and injection site hyperesthesia were not resolved.   It was unknown if the reporter considered the injection site rash and injection site hyperesthesia to be related to Arexvy.    It was unknown if the company considered the injection site rash and injection site hyperesthesia to be related to Arexvy.   Additional Information: GSK Receipt Date: 02-JAN-2024 A health care professional (HCP) called on behalf of patient and stated a patient received a dose of Arexvy 14 days ago (from the reporting date) and had a 8 centimeter rectangular rash and sensitive skin at injection site. No further information was known. The reporter did not consent to follow up.
Age: 70.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Incorrect route of product administration, Product administered at inappropriate site
Clinical narrative: the RPH gave her the AREXVY vaccine in the back of her left arm towards the top. Reporter stated it was not given in the muscle; This non-serious case was reported by a consumer via call center representative and described the occurrence of intramuscular formulation administered by other route in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 20-NOV-2023, the patient received the 1st dose of Arexvy (subcutaneous, left arm). On 20-NOV-2023, an unknown time after receiving Arexvy, the patient experienced intramuscular formulation administered by other route (Verbatim: the RPH gave her the AREXVY vaccine in the back of her left arm towards the top. Reporter stated it was not given in the muscle). The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 02-Jan-2024 The patient was self-reported this case. The reporter reported that the patient received Arexvy vaccine in the back of her left arm towards the top.  The reporter stated that it was not given in the muscle, which led to Intramuscular formulation administered by other route. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Immediate post-injection reaction, Injection site pain, Product administered at inappropriate site
Clinical narrative: the RPH gave her the AREXVY vaccine in the back of her left arm towards the top. Reporter stated it was not given in the muscle; This non-serious case was reported by a consumer via call center representative and described the occurrence of intramuscular formulation administered by other route in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 20-NOV-2023, the patient received the 1st dose of Arexvy (subcutaneous, left arm). On 20-NOV-2023, an unknown time after receiving Arexvy, the patient experienced intramuscular formulation administered by other route (Verbatim: the RPH gave her the AREXVY vaccine in the back of her left arm towards the top. Reporter stated it was not given in the muscle). The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 02-Jan-2024 The patient was self-reported this case. The reporter reported that the patient received Arexvy vaccine in the back of her left arm towards the top.  The reporter stated that it was not given in the muscle, which led to Intramuscular formulation administered by other route. The reporter consented to follow up.
Sex: M
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 71 year old male patient  receives Bexsero every 3 years last dose was on 2020; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of off label use in unapproved age group in a 71-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Concurrent medical conditions included splenectomy.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced off label use in unapproved age group (Verbatim: 71 year old male patient  receives Bexsero every 3 years last dose was on 2020). The outcome of the off label use in unapproved age group was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-Jan-2023 The reporter reported that the 71 year old patient told her he receives Bexsero every 3 years because he did not had a spleen, which led to off label use in an unapproved age group. The reporter believed his last dose was in 2020, but reporter does not had any further details. The reporter consented to follow up.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: administered an expired antigen component of Hiberix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Hib (Hiberix) (batch number 4F2A9, expiry date 12-DEC-2023) for prophylaxis.   On 27-DEC-2023, the patient received Hiberix. On 27-DEC-2023, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: administered an expired antigen component of Hiberix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 02-JAN-2024 Clinical manager stated that on December 27, 2023 a patient was inadvertently administered an expired antigen component of Hiberix. The diluent was not expired. The reporter did not consent to follow-up. The patient received a Hiberix vaccine which was already expired, which led to expired vaccine used.
Sex: F
Vaccine: COVID19
Symptoms: Giant cell arteritis, Visual impairment
Clinical narrative: The reaction was though to be giant cell arteritis; patient lost most of the vision in her left eye; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VISUAL IMPAIRMENT (patient lost most of the vision in her left eye) and GIANT CELL ARTERITIS (The reaction was though to be giant cell arteritis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISUAL IMPAIRMENT (patient lost most of the vision in her left eye) (seriousness criterion medically significant) and GIANT CELL ARTERITIS (The reaction was though to be giant cell arteritis) (seriousness criterion medically significant). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, VISUAL IMPAIRMENT (patient lost most of the vision in her left eye) and GIANT CELL ARTERITIS (The reaction was though to be giant cell arteritis) outcome was unknown.            No concomitant medications were reported.  It was reported that, the reaction was thought to be giant cell arteritis and she was treated with massive doses of Prednisone, but recently the dose was tapered to zero.  It was reported that, the patient continued to be unprotected from the latest covid variations.  Company comment: This spontaneous case concerns a female patient of unknown age with no medical history information reported, who experienced the unexpected serious (medically significant) events of giant cell arteritis and visual impairment. The events occurred after the second dose of mRNA-1273. Exact temporal relation is unclear. As reported, the patient lost most of the vision in her left eye; the reaction was thought to be giant cell arteritis and patient was treated with massive doses of Prednisone, but recently the dose was tapered to zero. No further information about the events was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dactylitis
Clinical narrative: my fingers and thumbs on both hands inflamed with severe joint pain; my fingers and thumbs on both hands inflamed with severe joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DACTYLITIS (my fingers and thumbs on both hands inflamed with severe joint pain) and ARTHRALGIA (my fingers and thumbs on both hands inflamed with severe joint pain) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030336) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. In November 2023, the patient experienced DACTYLITIS (my fingers and thumbs on both hands inflamed with severe joint pain) and ARTHRALGIA (my fingers and thumbs on both hands inflamed with severe joint pain). At the time of the report, DACTYLITIS (my fingers and thumbs on both hands inflamed with severe joint pain) and ARTHRALGIA (my fingers and thumbs on both hands inflamed with severe joint pain) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient reported that within 10 days or so after receiving the vaccine her fingers and thumbs on both hands inflamed with severe joint pain. They were sticking and popping and was very painful. It was unknown if the patient experienced any additional symptoms/events.  No treatment medications were reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Lymphadenopathy, Myalgia
Clinical narrative: swollen lymph nodes; moderate to severe muscle/joint aches; moderate to severe muscle/joint aches; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes), ARTHRALGIA (moderate to severe muscle/joint aches), MYALGIA (moderate to severe muscle/joint aches) and FATIGUE (extreme fatigue) in a 53-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 27-Dec-2023, the patient experienced LYMPHADENOPATHY (swollen lymph nodes), ARTHRALGIA (moderate to severe muscle/joint aches), MYALGIA (moderate to severe muscle/joint aches) and FATIGUE (extreme fatigue). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes), ARTHRALGIA (moderate to severe muscle/joint aches), MYALGIA (moderate to severe muscle/joint aches) and FATIGUE (extreme fatigue) was resolving.            No concomitant medications were reported. The patient had slightly swollen lymph nodes within 4 hrs of injection, along with moderate to severe muscle/joint aches that started 10-12 hrs post injection and continued to increase in pain for next 12 hrs and extreme fatigue starting 4 hrs after injection. It was unknown if the patient experienced any additional symptoms/events. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: she evidently was diagnosed with some kind of reaction from, from the Moderna shot that she received on December 14th; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (she evidently was diagnosed with some kind of reaction from, from the Moderna shot that she received on December 14th) 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 14-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 30-Dec-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced IMMUNISATION REACTION (she evidently was diagnosed with some kind of reaction from, from the Moderna shot that she received on December 14th) (seriousness criterion hospitalization). The patient was hospitalized from 30-Dec-2023 to 31-Dec-2023 due to IMMUNISATION REACTION. At the time of the report, IMMUNISATION REACTION (she evidently was diagnosed with some kind of reaction from, from the Moderna shot that she received on December 14th) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       The concomitant medication was not reported by reporter.   Dosage text for suspect product was given as unknown.  The patient received Moderna vaccine on 14 Dec 2023. The doctors had run tests and they diagnosed that it was evidently a side effect of the COVID shot that she received. She was in the hospital the last 24 hours from 30 Dec 2023 till 31 Dec 2023.  The treatment medication was not reported by reporter.  Company Comment: This is a Spontaneous case reported by a patient family member, concerning a female patient of unknown age, with no medical history reported, who experienced the unexpected and serious (due to hospitalization) event of Immunisation reaction, which occurred 16 days after an unspecified dose of SPIKEVAX 2023-2024 vaccine. As reported, patient was diagnosed with some kind of reaction and was hospitalized for 1 day. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, event outcome was unknown. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Vaccination site pain
Clinical narrative: chills; nausea; fatigue; pain at site of injection; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills), NAUSEA (nausea), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain at site of injection) in a 71-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 28-Dec-2023, the patient experienced CHILLS (chills), NAUSEA (nausea), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain at site of injection). At the time of the report, CHILLS (chills), NAUSEA (nausea), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain at site of injection) had not resolved.            No concomitant medication was reported.  No treatment medication was reported.  It was unknown if the patient experienced any additional symptoms/events.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Feeding disorder, Headache, Myalgia
Clinical narrative: my entire body ached with pain in my muscles and bones and I had a severe headache; I couldn't eat a thing the following day; my entire body ached with pain in my muscles and bones and I had a severe headache; my entire body ached with pain in my muscles and bones and I had a severe headache; This spontaneous case was reported by a patient and describes the occurrence of BONE PAIN (my entire body ached with pain in my muscles and bones and I had a severe headache), FEEDING DISORDER (I couldn't eat a thing the following day), MYALGIA (my entire body ached with pain in my muscles and bones and I had a severe headache) and HEADACHE (my entire body ached with pain in my muscles and bones and I had a severe headache) in a 72-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 30-Dec-2023, the patient experienced BONE PAIN (my entire body ached with pain in my muscles and bones and I had a severe headache), FEEDING DISORDER (I couldn't eat a thing the following day), MYALGIA (my entire body ached with pain in my muscles and bones and I had a severe headache) and HEADACHE (my entire body ached with pain in my muscles and bones and I had a severe headache). At the time of the report, BONE PAIN (my entire body ached with pain in my muscles and bones and I had a severe headache), FEEDING DISORDER (I couldn't eat a thing the following day), MYALGIA (my entire body ached with pain in my muscles and bones and I had a severe headache) and HEADACHE (my entire body ached with pain in my muscles and bones and I had a severe headache) was resolving.            No concomitant medications were reported.  It was reported that, the following day of vaccination patients entire body ached with pain in muscles and bones, and he had a severe headache. Patient could not eat a thing the following day. It was reported that the patient had never experienced so much muscle pain and discomfort in his entire life. On 01 Jan 2024 patient felt much better.  No treatment medications were reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Rash pruritic
Clinical narrative: Rash all over body , it itches and it burns; Rash all over body , it itches and it burns; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BURNING SENSATION (Rash all over body , it itches and it burns) and RASH PRURITIC (Rash all over body , it itches and it burns) in an 82-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 205F23-2A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna Covid-19 vaccine (Dose 1, Lot number 013L20A) on 14-Jan-2021, Moderna Covid-19 vaccine (Dose 2, Lot number 016M20A) on 11-Feb-2021, Moderna Covid-19 vaccine (Dose 3, Lot number 046CZ1A or 046C21A) on 13-Sep-2021, MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) (Dose 4 and Lot number AS7164B) on 29-Sep-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5), Moderna Covid-19 vaccine, Moderna Covid-19 vaccine and Moderna Covid-19 vaccine. Concomitant products included INFLUENZA VACCINE for an unknown indication.    On 28-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 19-Oct-2023, the patient experienced BURNING SENSATION (Rash all over body , it itches and it burns) and RASH PRURITIC (Rash all over body , it itches and it burns). At the time of the report, BURNING SENSATION (Rash all over body , it itches and it burns) and RASH PRURITIC (Rash all over body , it itches and it burns) had not resolved.            The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The concomitant medication was not reported by reporter.   The treatment medication was not reported by reporter.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Feeling abnormal, Headache, Lethargy
Clinical narrative: he felt lethargic when he was getting up from bed; He had back pain which is still not letting up whatsoever; he does not feel steady/ , 5 days after the vaccination and he still does not feel good; headache; chills; This spontaneous case was reported by a patient and describes the occurrence of LETHARGY (he felt lethargic when he was getting up from bed), BACK PAIN (He had back pain which is still not letting up whatsoever), FEELING ABNORMAL (he does not feel steady/ , 5 days after the vaccination and he still does not feel good), HEADACHE (headache) and CHILLS (chills) in a 71-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031894) for COVID-19 prophylaxis.     Patient had no relevant medical history conditions, allergy, concomitant diseases and risk factor. Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Pfizer (lot number EN6205 , 1st dose) on 07-Mar-2021, Pfizer (lot number ER8727 , 2nd dose) on 29-Oct-2021, Pfizer (lot number CVS 1069 , Dose 3) on 23-Apr-2022, Pfizer (Dose 4) on 08-Dec-2022, Flu in October 2023 and RSV in November 2023. Past adverse reactions to the above products included No adverse event with Flu, Pfizer, Pfizer, Pfizer, Pfizer and RSV.    On 28-Dec-2023 at 4:00 PM, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 29-Dec-2023, the patient experienced LETHARGY (he felt lethargic when he was getting up from bed), BACK PAIN (He had back pain which is still not letting up whatsoever), FEELING ABNORMAL (he does not feel steady/ , 5 days after the vaccination and he still does not feel good), HEADACHE (headache) and CHILLS (chills). At the time of the report, LETHARGY (he felt lethargic when he was getting up from bed), BACK PAIN (He had back pain which is still not letting up whatsoever), FEELING ABNORMAL (he does not feel steady/ , 5 days after the vaccination and he still does not feel good), HEADACHE (headache) and CHILLS (chills) had not resolved.            No concomitant medication was reported.  No treatment medication was reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: both knees became very painful; This is a spontaneous report received from a Consumer or other non-HCP from the Medical Information Team, Program ID. The reporter is the patient.  A 69-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Aug2023 as DOSE 1, SINGLE (lot number: GJ3268) at the age of 69 years, intramuscular, administered in the left arm for COVID-19 immunization. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR taken for blood cholesterol increased. Patient had no prior vaccinations in 4 weeks. The following information was reported: ARTHRALGIA (medically significant), outcome "unknown" described as "both knees became very painful." The clinical course was reported as follows: Within 36 hrs of receipt of Pfizer covid booster, both knees became very painful. Need help with what to do. Doctors not helpful. Booster Mid Aug 2023. Therapeutic measures were taken as a result of arthralgia; patient took Celebrex for 1 month and had gel injections in both knees.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a Nurse from product quality group.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 69 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Oct2023 as dose 6 (booster), single (Lot number: 8058581) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single) and as dose 4 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "hyperthyroidism" (unspecified if ongoing); "diverticulosis" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Oct2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 18Dec2023 to 23Dec2023. Clinical Course: Patient had no known allergies.; Sender's Comments: Based on available information, a lack of efficacy under interchange of vaccine products with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19; COVID-19; Dose 1; Dose 2; Dose 3; Dose 5: Moderna / Dose 4: Pfizer; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 19May2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 65 years, in left arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 14Oct2022 as dose 5 (booster), single (Lot number: 049D22A), in left arm and on 22Aug2023 at 12:00 as dose 6 (booster), single (Lot number: AS7646C), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Mar2021 as dose 1, single (Lot number: 021B21A), in left arm, on 26Apr2021 as dose 2, single (Lot number: 048B21A,), in left arm and on 23Nov2021 as dose 3 (booster), single (Lot number: 012H21B), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19May2022, outcome "unknown", described as "Dose 1; Dose 2; Dose 3; Dose 5: Moderna / Dose 4: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures (Paxlovid treatment start date: 16Dec2023, stop date: 20Dec2023)  were taken as a result of drug ineffective, covid-19. Clinical course: Patient was healthy adult and there were no known allergies.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ashma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 13Dec2023 to 17Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Prostatic specific antigen
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm and on 06May2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 17Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 15Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 13Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "one year post-rp (robotic)" (not ongoing); "cancer-free (PSA 0.0)" (not ongoing); "congenital blebs leading to multiple spontaneous pneumothorax" (unspecified if ongoing), notes: congenital blebs leading to multiple spontaneous pneumothorax incidents in late teens; "congenital blebs leading to multiple spontaneous pneumothorax" (unspecified if ongoing), notes: congenital blebs leading to multiple spontaneous pneumothorax incidents in late teens; "partial pleurectomy, right lung" (not ongoing), notes: corrective surgery at 20, no reoccurrence in either side; "known allergies: penicillin" (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 Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Prostatic specific antigen: PSA 0.0. Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 19Dec2023 to 23Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Experienced COVID rebound; Experienced COVID rebound; Moderna: Dose Number: 3/Pfizer / BioNTech: Dose Number: 4 and 5; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 33-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Nov2023 as dose 1, single (Lot number: HG4633) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Juvenile idiopathic arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: GJ3277, Location of injection: Arm Left), administration date: 28Sep2022, when the patient was 32-year-old, reaction(s): "COVID-19 immunization"; moderna (DOSE 3 (BOOSTER), SINGLE , Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), administration date: 03Mar2022, when the patient was 31-year-old, reaction(s): "COVID-19 immunization"; Covid-19 vaccine (DOSE 2, SINGLE), reaction(s): "COVID-19 immunization"; Covid-19 vaccine (DOSE 1, SINGLE), reaction(s): "COVID-19 immunization". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2023, outcome "unknown", described as "Moderna: Dose Number: 3/Pfizer / BioNTech: Dose Number: 4 and 5"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Dec2023, outcome "unknown" and all described as "Experienced COVID rebound ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical course: The patient experienced COVID rebound accompanied by symptoms after 2 days testing negative and experiencing no symptoms  The information on the batch/lot number for BNT162b2 omi xbb.1.5  will be requested and submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old male patient received BNT162b2 (BNT162B2 NOS), on 13Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), on 11Oct2023 at 10:00 as dose number unknown, single), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prostrate cancer" (unspecified if ongoing); "ckd" (unspecified if ongoing); "gout" (unspecified if ongoing); "sinusitis" (unspecified if ongoing), notes: sinusitis symptoms are the same as when I took tramadol. Concomitant medication(s) included: LOSARTAN, start date: 02Dec2016; SIMVASTATIN, start date: 01Dec2017, stop date: 21Dec2023; METFORMIN, start date: 01Dec2017; ALLOPURINOL, start date: 01Dec2017. Past drug history included: Atropine, reaction(s): "Allergies: Atropine"; Transom, reaction(s): "Allergies: transom"; Amoxicillin, reaction(s): "Allergies: amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Covid". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from 22Dec2023 to 27Dec2023.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Dec2023 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "MGUS" (unspecified if ongoing); "known allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot: EL9264), administration date: 04Feb2021, when the patient was 65-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE, Batch/Lot: EL9267), administration date: 25Feb2021, when the patient was 66-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot: FF2593), administration date: 09Nov2021, when the patient was 66-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot: FM7553), administration date: 31May2022, when the patient was 67-year-old, for COVID-19 immunisation; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Batch/Lot: Gj2524, Anatomical location: Arm Right), administration date: 21Oct2022, when the patient was 67-year-old, for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 15Dec2023 to 19Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 29-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Sep2023 at 17:00 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "obese" (unspecified if ongoing); "PCOS" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Dec2023, outcome "recovered" (23Dec2023) and all described as "COVID 19 Treatment". The event "covid 19 treatment" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Dec2023) Negative; (18Dec2023) Positive; (23Dec2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 includes paxlovid from 19Dec2023 to 23Dec2023. Clinical Course: Patient had no known allergies.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Dec2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "T2DM" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "depression" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. 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 includes Paxlovid from 28Dec2023 to an unknown date.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.