chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Dyspnoea, Feeling abnormal, Malaise, Pain in extremity, Respiratory syncytial virus infection
Clinical narrative: feeling so bad; feeling ill; hardly breathe over; she had a sore arm; she has had RSV/ Suspected vaccination failure; she has had RSV; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 66-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 15-NOV-2023, the patient received Arexvy (intramuscular, right arm). In NOV-2023, an unknown time after receiving Arexvy, the patient experienced vaccination failure (Verbatim: she has had RSV/ Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: she has had RSV). On 16-NOV-2023, the patient experienced pain in arm (Verbatim: she had a sore arm). On 21-NOV-2023, the patient experienced difficulty breathing (Verbatim: hardly breathe over). On 23-NOV-2023, the patient experienced feeling bad (Verbatim: feeling so bad) and feeling unwell (Verbatim: feeling ill). On 17-NOV-2023, the outcome of the pain in arm was resolved (duration 1 day). On 26-NOV-2023, the outcome of the feeling bad and feeling unwell were resolved (duration 3 days). The outcome of the vaccination failure was unknown and the outcome of the respiratory syncytial virus infection and difficulty breathing were not reported.   It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection, difficulty breathing, feeling bad, feeling unwell and pain in arm to be related to Arexvy.   It was unknown if the company considered the vaccination failure, respiratory syncytial virus infection, difficulty breathing, feeling bad, feeling unwell and pain in arm to be related to Arexvy.   Additional Information: GSK receipt date: 27-NOV-2023 On 16-NOV-2023, 1 day after receiving Arexvy, the patient experienced pain in arm.  On 21-NOV-2023, 6 days after receiving Arexvy, the patient experienced difficulty breathing.  On 23-NOV-2023, after receiving Arexvy, the patient experienced feeling bad and feeling unwell. The reporter stated that she had RSV (undiagnosed) ever since receiving the Arexvy vaccine.  The patient reported that she had a sore arm, was feeling so bad and ill and could hardly breathe over the Holiday.  The patient reported that her lungs were clear before the Arexvy vaccine.  This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming RSV were unknown at the time of reporting.  The reporter stated that the lady was very very nice and she was very helpful and knowledgeable and she had an adverse reaction to the RSV injection. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Vaccination failure
Clinical narrative: feeling so bad; feeling ill; hardly breathe over; she had a sore arm; she has had RSV/ Suspected vaccination failure; she has had RSV; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 66-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 15-NOV-2023, the patient received Arexvy (intramuscular, right arm). In NOV-2023, an unknown time after receiving Arexvy, the patient experienced vaccination failure (Verbatim: she has had RSV/ Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: she has had RSV). On 16-NOV-2023, the patient experienced pain in arm (Verbatim: she had a sore arm). On 21-NOV-2023, the patient experienced difficulty breathing (Verbatim: hardly breathe over). On 23-NOV-2023, the patient experienced feeling bad (Verbatim: feeling so bad) and feeling unwell (Verbatim: feeling ill). On 17-NOV-2023, the outcome of the pain in arm was resolved (duration 1 day). On 26-NOV-2023, the outcome of the feeling bad and feeling unwell were resolved (duration 3 days). The outcome of the vaccination failure was unknown and the outcome of the respiratory syncytial virus infection and difficulty breathing were not reported.   It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection, difficulty breathing, feeling bad, feeling unwell and pain in arm to be related to Arexvy.   It was unknown if the company considered the vaccination failure, respiratory syncytial virus infection, difficulty breathing, feeling bad, feeling unwell and pain in arm to be related to Arexvy.   Additional Information: GSK receipt date: 27-NOV-2023 On 16-NOV-2023, 1 day after receiving Arexvy, the patient experienced pain in arm.  On 21-NOV-2023, 6 days after receiving Arexvy, the patient experienced difficulty breathing.  On 23-NOV-2023, after receiving Arexvy, the patient experienced feeling bad and feeling unwell. The reporter stated that she had RSV (undiagnosed) ever since receiving the Arexvy vaccine.  The patient reported that she had a sore arm, was feeling so bad and ill and could hardly breathe over the Holiday.  The patient reported that her lungs were clear before the Arexvy vaccine.  This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming RSV were unknown at the time of reporting.  The reporter stated that the lady was very very nice and she was very helpful and knowledgeable and she had an adverse reaction to the RSV injection. The reporter consented to follow up.
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Exposure via skin contact, Underdose
Clinical narrative: he felt some of the liquid drip down his arm; dose of Arexvy in which he felt some of the liquid drip down his arm; dose of Arexvy in which he felt some of the liquid drip down his arm; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 78-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 09-OCT-2023, the patient received Arexvy. On 09-OCT-2023, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: he felt some of the liquid drip down his arm), inadvertent exposure to vaccine (Verbatim: dose of Arexvy in which he felt some of the liquid drip down his arm) and exposure via skin contact (Verbatim: dose of Arexvy in which he felt some of the liquid drip down his arm). The outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.   Additional Information: GSK Receipt date: 27-NOV-2023 The reporter reported that the patient received dose of Arexvy in which he felt some of the liquid drip down his arm, which led to incomplete dose administered. The reporter consented to follow up. Reporter reported that the some of the liquid of Arexvy vaccine drip down to patient's arm, which led to inadvertent exposure to vaccine and exposure via skin contact.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: a male patient inadvertently received 2 Boostrix shots 13 weeks apart; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 52-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID;PERTUSSIS VACCINE ACELLULAR 3-COMPONENT;TETANUS VACCINE TOXOID (BOOSTRIX).   On 27-NOV-2023, the patient received the 2nd dose of Boostrix. On 27-NOV-2023, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: a male patient inadvertently received 2 Boostrix shots 13 weeks apart). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 27-NOV-2023 The reporter was a medical assistant who stated that a male patient inadvertently received 2 Boostrix shots 13 weeks apart, first shot on 13th September 2023 and second shot on reporting day 27th November 2023. According to the reporter the mistake was happened because they did not look in their medical records.  The patient was doing fine.  Healthcare provider aware. The patient inadvertently received 2 Boostrix shots 13 weeks apart, which led to extra dose administered. The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: Hiberix was not reconstituted with the diluent that comes with it; 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 1-year-old male patient who received Hib (Hiberix) (batch number 4R9T4, expiry date 15-MAY-2024) for prophylaxis.   On 17-NOV-2023, the patient received Hiberix. On 17-NOV-2023, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Hiberix was not reconstituted with the diluent that comes with it). The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt date: 28-NOV-2023 Reporter reported that the patient received Hiberix but it was not reconstituted with the diluent that comes with it, and was reconstituted with the diluent used for Varivax (sterile water), which led to wrong solution used in drug reconstitution. The vaccine administered facility was the same as primary reporter. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles is under right breast, right chest, under armpit, under arm and around the back; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number tsj32, expiry date 31-AUG-2024) for prophylaxis.   On 31-OCT-2023, the patient received the 1st dose of Shingrix (right arm). On 13-NOV-2023, 13 days after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles is under right breast, right chest, under armpit, under arm and around the back). The patient was treated with aciclovir sodium (Acyclovir). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-NOV-2023 The patient reported she received first dose of shingles and developed shingles under her right breast, under armpit, under arm, right chest, and around the back. The patient was currently taking acyclovir for another 3 days. The patient was diagnosed with PA and was re diagnosed by the assistant nursing director. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient came into receive the 2nd dose of the Shingrix today 11/29/2023 after receiving the 1st dose in 2021.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (receiving the 1st dose in 2021).   On 29-NOV-2023, the patient received the 2nd dose of Shingrix. On 29-NOV-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patient came into receive the 2nd dose of the Shingrix today 11/29/2023 after receiving the 1st dose in 2021.). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 29-NOV-2023 The health care professional (HCP) reported that patient came into receive the 2nd dose of the Shingrix today (on the day of reporting) after receiving the 1st dose in 2021, which led to lengthening of vaccination schedule. The reporter did not consent to follow-up.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPVHIB
Symptoms: Incorrect dose administered
Clinical narrative: Pediarix and Pentacel both vaccines administered concomitantly; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 7-month-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included Pentacel (batch number PE24L, expiry date 01-APR-2025) for prophylaxis.   On 24-NOV-2023, the patient received Pediarix (right thigh) and Pentacel (left thigh). On 24-NOV-2023, an unknown time after receiving Pediarix, the patient experienced overdose (Verbatim: Pediarix and Pentacel both vaccines administered concomitantly). The outcome of the overdose 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-29-NOV-2023 The reporter was nurse The reporter reported that the patient received both the Pediarix (DTaP-IPV-HepB) and Pentacel (DTaP-IPV-Hib)  administered concomitantly on the same day which led to overdose. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Pain, Vaccination failure
Clinical narrative: States that he broke out in Shingles/suspected vaccination failure; broke out in Shingles (lack of efficacy); more severe pain in his body; he experienced head pain; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (prior had frequent bouts of Shingles). Concurrent medical conditions included lung cancer.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: States that he broke out in Shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: broke out in Shingles (lack of efficacy)), general body pain (Verbatim: more severe pain in his body) and headache (Verbatim: he experienced head pain). The outcome of the vaccination failure, shingles and general body pain were unknown and the outcome of the headache was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, general body pain and headache to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, general body pain and headache to be related to Shingrix and Shingrix.   Additional Information: RA Receipt date: 30-NOV-2023 The patient was self-reported. He had both doses of Shingrix in the recommended time and the patient could not provide the dates when the vaccines were administered.  Patient stated that he broke out in Shingles (lack of efficacy) after both doses of Shingrix were administered.  Patient reported that he experienced head pain and more severe pain in his body after the Shingrix injections and head pain was still present.  This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.  The reporter did not consent to follow-up. Consumer wanted to remain anonymous and did not want to provide any information.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient accidentally received 2nd dose of FluLaval QIV; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 58-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number A2L45, expiry date 30-JUN-2024) for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLULAVAL QUADRIVALENT).   On 28-NOV-2023, the patient received the 2nd dose of FluLaval Quadrivalent 2023-2024 season. On 28-NOV-2023, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced extra dose administered (Verbatim: Patient accidentally received 2nd dose of FluLaval QIV). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-Nov-2023 The reporter reported that the patient accidentally received second dose of FluLaval vaccine one month apart from previous dose, which led to extra dose administered. The reporter stated that the patient did not experienced any adverse reactions. The reporter did consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient not recived 2nd dose yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the 1st dose of Shingrix on November 2021).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Patient not recived 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 30-NOV-2023 and 1-Dec-2023 The reporter was the patient. The reporter stated that she never got the second one.  The reporter stated that she should had start over or simply get the booster. The reporter stated that she had good health. The patient's date of birth and consent for follow up was not obtained. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consented to follow-up.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient was about 3 months late receiving the 2nd dose of Engerix-B; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (On an unknown date received first dose).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: patient was about 3 months late receiving the 2nd dose of Engerix-B). The outcome of the drug dose administration interval too long 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: 30-NOV-2023 Reporter stated that patient was about 3 months late receiving the 2nd dose of Engerix B. Health care provider was in rush so unable to gather any information. The reporter was unable to get phone number but did get email.  The reporter was also unable to ask permission for follow up. The patient received 2nd dose of Engerix B, later than the recommended interval, which led to lengthening of vaccinations schedule.
Sex: M
Vaccine: RV1
Symptoms: Extra dose administered
Clinical narrative: administration of a third dose of Rotarix to a 6-month-old infant; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 6-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 737J5, expiry date 05-OCT-2025) for prophylaxis.   On 01-DEC-2023, the patient received the 3rd dose of Rotarix lyophilized formulation. On 01-DEC-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced extra dose administered (Verbatim: administration of a third dose of Rotarix to a 6-month-old infant). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-DEC-2023 The HCP asked if there was information about the risk of an extra dose. The nurse called to report the administration of a third dose of Rotarix to the patient, which led to extra dose administered. The reporter consented to follow up.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Triple negative breast cancer
Clinical narrative: Triple negative breast cancer; This spontaneous case was reported by a patient family member or friend and describes the occurrence of TRIPLE NEGATIVE BREAST CANCER (Triple negative breast cancer) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: COVID-19 vaccine (1st dose and Lot 025J20-2A) on 30-Dec-2020; for COVID-19 prophylaxis: Moderna COVID-19 vaccine (2nd dose ,Lot 010M20A) on 28-Jan-2021, Moderna COVID-19 vaccine (3rd dose, Lot 939906) on 25-Oct-2021, Moderna COVID-19 Vaccine (4th dose and Lot 049L21A) on 06-May-2022. Past adverse reactions to the above products included No adverse event with COVID-19 vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 vaccine and Moderna COVID-19 vaccine. Concurrent medical conditions included Hypothyroidism.   On 18-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Jul-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2023, the patient experienced TRIPLE NEGATIVE BREAST CANCER (Triple negative breast cancer) (seriousness criterion medically significant). At the time of the report, TRIPLE NEGATIVE BREAST CANCER (Triple negative breast cancer) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient had high dose FLU Shot on 13-OCT-2023. Patient had finished 12 weeks chemo on 19-OCT-2023. Patient was taking Thyroid Medication. She was scheduled to have surgery next week for lumpectomy in the breast.   This case was linked to US-MODERNATX, INC.-MOD-2023-751731.  Company comment: This spontaneous case concerns a 78-year-old, female patient with no relevant medical history, who experienced the unexpected serious (medically significant) event of triple negative breast cancer. The event occurred approximately 8 months after the fifth dose of mRNA-1273 bivalent BA.4/BA.5. The patient received chemotherapy and was scheduled for lumpectomy. No further information about the events was provided. Considering patient's advanced age as risk factor as well as lack of biological plausibility for causality the event of breast cancer is assessed as not related. The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5 is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-751731:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: still testing positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (still testing positive for COVID-19) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19.   On an unknown date, the patient received second dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (still testing positive for COVID-19). At the time of the report, COVID-19 (still testing positive for COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.         No concomitant drug was reported.  The patient had COVID-19 before getting the Moderna COVID-19 vaccine and was still testing positive for COVID-19 at the time of reporting.  No treatment drug was reported.
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: COVID-19, Fatigue, Headache, Influenza, Pain
Clinical narrative: She has also had COVID-19 twice; she has the flu; achy; tired; Headache; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (She has also had COVID-19 twice), INFLUENZA (she has the flu), PAIN (achy), FATIGUE (tired) and HEADACHE (Headache) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 0127E22A) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    The patient's past medical history included Obesity. Concurrent medical conditions included Asthma.   On 25-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (She has also had COVID-19 twice), INFLUENZA (she has the flu), PAIN (achy), FATIGUE (tired) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (She has also had COVID-19 twice), INFLUENZA (she has the flu), PAIN (achy), FATIGUE (tired) and HEADACHE (Headache) outcome was unknown.            Concomitant medication not reported.  The patient had doses on 15 APR 2021 with lot number 030B21A, 14 MAY 2021 with lot number 005C21A, 10 DEC 2021 with lot number 029H21B, 26 MAY 2022 with lot number 032A27B.   This case was linked to US-MODERNATX, INC.-MOD-2023-752214 (E2B Linked Report). This case was linked to MOD-2023-752134 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-752214:Case for Family Member
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Body temperature, Cough, Myalgia, Pyrexia, Rhinorrhoea
Clinical narrative: runny nose; coughing; Recipient had body aches; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), COUGH (coughing), MYALGIA (Recipient had body aches) and PYREXIA (low grade fever) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    No Medical History information was reported.   On 29-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 30-Nov-2023, the patient experienced RHINORRHOEA (runny nose), COUGH (coughing), MYALGIA (Recipient had body aches) and PYREXIA (low grade fever). At the time of the report, RHINORRHOEA (runny nose), COUGH (coughing), MYALGIA (Recipient had body aches) and PYREXIA (low grade fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2023, Body temperature: up to 102. In November 2023, SARS-CoV-2 test: Positive.         No concomitant drug was reported.  Within 24 hrs. of the vaccines (flu shot and Spikevax COVID shot) recipient had body aches, low grade fever, runny nose and coughing. Fever started spiking 1.5 days after the vaccines up to 102 along with ongoing coughing fits. The fever broke after 3 days. Patient tested positive with COVID 20 days before the vaccinations.  It was unknown if the patient experienced any additional symptoms/events.  No treatment drug was reported.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: SARS-CoV-2 test
Clinical narrative: runny nose; coughing; Recipient had body aches; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), COUGH (coughing), MYALGIA (Recipient had body aches) and PYREXIA (low grade fever) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    No Medical History information was reported.   On 29-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 30-Nov-2023, the patient experienced RHINORRHOEA (runny nose), COUGH (coughing), MYALGIA (Recipient had body aches) and PYREXIA (low grade fever). At the time of the report, RHINORRHOEA (runny nose), COUGH (coughing), MYALGIA (Recipient had body aches) and PYREXIA (low grade fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2023, Body temperature: up to 102. In November 2023, SARS-CoV-2 test: Positive.         No concomitant drug was reported.  Within 24 hrs. of the vaccines (flu shot and Spikevax COVID shot) recipient had body aches, low grade fever, runny nose and coughing. Fever started spiking 1.5 days after the vaccines up to 102 along with ongoing coughing fits. The fever broke after 3 days. Patient tested positive with COVID 20 days before the vaccinations.  It was unknown if the patient experienced any additional symptoms/events.  No treatment drug was reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Peripheral swelling, Pruritus, Rash
Clinical narrative: Itching; Swelling of fingers; Rash; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Itching), PERIPHERAL SWELLING (Swelling of fingers) and RASH (Rash) in a 67-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 vaccination.     asthma, allergies Patient was diagnosed with Covid 19.  The patient's past medical history included COVID-19 on 27-Sep-2022 and Asthma. Previously administered products included for Drug use for unknown indication: RSV (right arm) on 26-Oct-2023. Past adverse reactions to the above products included No adverse reaction with RSV.    On 26-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 10-Nov-2023, the patient experienced PRURITUS (Itching), PERIPHERAL SWELLING (Swelling of fingers) and RASH (Rash). The patient was treated with HYDROCORTISONE at a dose of 2.5 % percent. At the time of the report, PRURITUS (Itching), PERIPHERAL SWELLING (Swelling of fingers) and RASH (Rash) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: The inflamed sites and the results were inconclusive..     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No concomitant and treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 003kk212a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus). At the time of the report, TINNITUS (tinnitus) outcome was unknown.            No concomitant and treatment medications were reported.  It was unknown if the patient experienced any additional symptoms/events.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I had covid 3 months ago; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I had covid 3 months ago) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced COVID-19 (I had covid 3 months ago). At the time of the report, COVID-19 (I had covid 3 months ago) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Patient had received previous doses of COVID-19 vaccines and had covid 3 months ago.   Treatment information was not provided.   Reporter did not allow further contact
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pain, Skin lesion
Clinical narrative: Patient's wife reported that a few days after the immunization, her husband developed shingles.  The left side of his trunk was red and painful.  He did develop some lesions.  He visited the hospital clinic where he was prescribed Valtrex.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Blood beta-D-glucan negative, CSF glucose normal, CSF protein increased, CSF red blood cell count
Clinical narrative: PRESENTED WITH FEVER AND ALTERED MENTAL STATUS. CONDITION WORSENED 11/30 AND SHE WAS INTUBATED. MRI WITH CEREBELLAR INFLAMMATION (CEREBELLITIS). PRESUMED ENCEPHALITIS BEING TREATED WITH SOLUMEDROL AND IVIG.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: CSF white blood cell count increased, Culture negative, Cytology normal, Encephalitis, Endotracheal intubation
Clinical narrative: PRESENTED WITH FEVER AND ALTERED MENTAL STATUS. CONDITION WORSENED 11/30 AND SHE WAS INTUBATED. MRI WITH CEREBELLAR INFLAMMATION (CEREBELLITIS). PRESUMED ENCEPHALITIS BEING TREATED WITH SOLUMEDROL AND IVIG.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Flow cytometry, Gram stain negative, Herpes simplex test negative, Immunoglobulin therapy, Laboratory test normal
Clinical narrative: PRESENTED WITH FEVER AND ALTERED MENTAL STATUS. CONDITION WORSENED 11/30 AND SHE WAS INTUBATED. MRI WITH CEREBELLAR INFLAMMATION (CEREBELLITIS). PRESUMED ENCEPHALITIS BEING TREATED WITH SOLUMEDROL AND IVIG.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Magnetic resonance imaging head abnormal, Mental status changes, Pyrexia, Syncope
Clinical narrative: PRESENTED WITH FEVER AND ALTERED MENTAL STATUS. CONDITION WORSENED 11/30 AND SHE WAS INTUBATED. MRI WITH CEREBELLAR INFLAMMATION (CEREBELLITIS). PRESUMED ENCEPHALITIS BEING TREATED WITH SOLUMEDROL AND IVIG.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Varicella virus test negative, Viral test negative, West Nile virus test negative
Clinical narrative: PRESENTED WITH FEVER AND ALTERED MENTAL STATUS. CONDITION WORSENED 11/30 AND SHE WAS INTUBATED. MRI WITH CEREBELLAR INFLAMMATION (CEREBELLITIS). PRESUMED ENCEPHALITIS BEING TREATED WITH SOLUMEDROL AND IVIG.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction (redness, swelling, warm/sore). Presented shortly after vaccination, later that evening and has not resolved for a few days.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no known adverse events
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Infected skin ulcer, Peripheral swelling
Clinical narrative: Arm became red and swollen. MD prescribed antiboitics. The swelling has moved from upper arm to lower arm and an infected sore has developed.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Cerebral disorder, Extra dose administered, Pain in extremity
Clinical narrative: her brain is cluttered; 2 doses; her arm was sore for a week after the 2nd dose of the Prevnar 20.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65-year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), in Oct2023 as dose 2, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for immunisation; for immunisation. The patient's relevant medical history included: "breast cancer survivor", start date: 2001 (not ongoing), notes: began in 2001 and the other was in 2013; "five surgeries" (unspecified if ongoing); "diabetes", start date: 2008 (unspecified if ongoing); "asthma which goes further back to shortness of breath" (unspecified if ongoing), notes: began at least in the late 1990s like in 1998; "chronic bronchitis" (unspecified if ongoing), notes: began about age 25; "highly sensitive to medications" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Metformin for diabetes. Vaccination history included: Prevnar 20 (Dose 1; administered in March or April 2023), administration date: 2023, for Immunization. The following information was reported: EXTRA DOSE ADMINISTERED (non-serious) with onset Oct2023, outcome "unknown", described as "2 doses"; PAIN IN EXTREMITY (non-serious) with onset Oct2023, outcome "unknown", described as "her arm was sore for a week after the 2nd dose of the Prevnar 20."; CEREBRAL DISORDER (non-serious), outcome "unknown", described as "her brain is cluttered". Additional information: The patient on the line who is a consumer calling about an adverse event for Prevnar 20 vaccine and she received the first dose of Prevnar 20 in March or April 2023 and then there was a mix up at the pharmacy where she received a 2nd dose of the Prevnar 20 in October which is not recommended, and her arm was sore for a week after the 2nd dose of the Prevnar 20. The agent repeated the caller's email address back to her and the caller states she had trouble following this agent and does not know why her brain is cluttered. The arm soreness began the next morning after she had the 2nd dose of the Prevnar 20 and the pain was intense and was in the left arm and it was not progressing after the third day and lasted about a week. She is a person that is highly sensitive to medications and was recently prescribed simvastatin and could only take 1.5 pills and was highly sensitive to it and wondered if she should call about the 2nd vaccine regarding the Prevnar 20 and there were not any other side effects other than that really sore arm. She did not know about this until last week that she should not have gotten the 2nd dose of the Prevnar 20.  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.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Oct2023 as dose 1, single (Lot number: HG4628) at the age of 48 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "Undefined connective tissue disease" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; unknown manufacture), for Covid-19 immunization, reaction(s): "Covid-19"; Covid-19 vaccine (Dose 2; unknown manufacture), for Covid-19 immunization, reaction(s): "Covid-19"; Covid-19 vaccine (DOSE 3 (BOOSTER), Unknown Manufacturer), for Covid-19 immunization, reaction(s): "Covid-19"; Covid-19 vaccine (DOSE 4 (BOOSTER), Unknown Manufacturer), for Covid-19 immunization, reaction(s): "Covid-19". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) positive, notes: I had a positive COVID test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: For the treatment of COVID 19, patient administered Paxlovid (lot: GK4257) from 17Nov2023 to 21Nov2023. No known allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot in leg; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 90-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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: THROMBOSIS (medically significant), outcome "not recovered", described as "Blood clot in leg". Therapeutic measures were taken as a result of thrombosis. Clinical course: Caller reported that her husband has gotten all four Pfizer COVID vaccines and after the third dose, her husband developed a blood clot in his leg, and no one advised them about this. Caller stated that her husband still received the next dose. Caller also added that her husband has been on Eliquis for 3 months and her husband's provider extended the use of Eliquis. Caller was looking for information relevant to blood clot.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Limited information precludes a comprehensive causality assessment, however based on the implied temporal association, the contributory role of suspect drug BNT162B2, BNT162B2 OMI BA.4-5 cannot be excluded for the reported event. Information on details surrounding patient complete medical history and concomitant medications would aid in comprehensive medical assessment. Case will be reassessed should additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage
Clinical narrative: there is something wrong with her eye/is a bleeding at the back of her eye; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 70-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 70 years intramuscular for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: EYE HAEMORRHAGE (disability) with onset Nov2023, outcome "unknown", described as "there is something wrong with her eye/is a bleeding at the back of her eye". The event "there is something wrong with her eye/is a bleeding at the back of her eye" required physician office visit. Therapeutic measures were not taken as a result of eye haemorrhage. Clinical course: Patient got vaccinated with Pfizer Covid 19 vaccine couple of weeks ago, the patient went to the doctor as there was something wrong with her eye. Doctor informed that there was a bleeding at the back of her eye. patient wanted to know if this was a side effect of Pfizer Covid 19 vaccine. Patient did not have a bleeding disorder and did not use blood thinners. She was not implicating that this was coming from the vaccine but the only thing she did differently during that time was getting the Covid vaccine. So she wanted her to check if there was anything out there suggesting that this could be a possible side effect. Patient went to the doctor on Monday 27Nov2023. It was serious, definitely not life threatening. The worst case was that patient could lose sight in her eye. reporter stated it was potentially disabling. Treatment: At this time was none. Causality was no as per reporter. The reporter did not know exact date but some time in Nov2023. Patient was otherwise very healthy.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: The event eye haemorrhage is conservatively assessed as related to the suspect drug BNT162B2 OMI XBB.1.5 based on close temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.