chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Burning sensation, Headache, Herpes zoster, Myalgia, Neck pain
Clinical narrative: I have developed full-blown shinles. I ended up in the emergency room, where I was diagnosed with shingles by a doctor; This non-serious case was reported by a consumer and described the occurrence of shingles in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure high and hypothyroidism. Concomitant products included amlodipine mesilate (Amlodipine) and levothyroxine sodium (Levothyroxine).   On 16-NOV-2023, the patient received the 1st dose of Shingrix. On 23-NOV-2023, 7 days after receiving Shingrix, the patient experienced shingles (Verbatim: I have developed full-blown shinles. I ended up in the emergency room, where I was diagnosed with shingles by a doctor). The outcome of the shingles was not resolved.   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: 25-NOV-2023 This report was submitted via the online direct entry reporting system.  The patient self-reported this case. A week after getting the Shingrix vaccine, the patient had developed full-blown shingles. The patient ended up in the emergency room, where she was diagnosed with shingles by a doctor.  They prescribed her painkillers. The patient need to include the fact that you could get shingles in the listed risks before getting the shot.  If she had known that, she never would have gotten it.  This was so painful.  The patient stated that you need to include that fact in your TV ads. The reporter consented to follow up.
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Rash
Clinical narrative: I have developed full-blown shinles. I ended up in the emergency room, where I was diagnosed with shingles by a doctor; This non-serious case was reported by a consumer and described the occurrence of shingles in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure high and hypothyroidism. Concomitant products included amlodipine mesilate (Amlodipine) and levothyroxine sodium (Levothyroxine).   On 16-NOV-2023, the patient received the 1st dose of Shingrix. On 23-NOV-2023, 7 days after receiving Shingrix, the patient experienced shingles (Verbatim: I have developed full-blown shinles. I ended up in the emergency room, where I was diagnosed with shingles by a doctor). The outcome of the shingles was not resolved.   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: 25-NOV-2023 This report was submitted via the online direct entry reporting system.  The patient self-reported this case. A week after getting the Shingrix vaccine, the patient had developed full-blown shingles. The patient ended up in the emergency room, where she was diagnosed with shingles by a doctor.  They prescribed her painkillers. The patient need to include the fact that you could get shingles in the listed risks before getting the shot.  If she had known that, she never would have gotten it.  This was so painful.  The patient stated that you need to include that fact in your TV ads. The reporter consented to follow up.
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: I have developed full-blown shinles. I ended up in the emergency room, where I was diagnosed with shingles by a doctor; This non-serious case was reported by a consumer and described the occurrence of shingles in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure high and hypothyroidism. Concomitant products included amlodipine mesilate (Amlodipine) and levothyroxine sodium (Levothyroxine).   On 16-NOV-2023, the patient received the 1st dose of Shingrix. On 23-NOV-2023, 7 days after receiving Shingrix, the patient experienced shingles (Verbatim: I have developed full-blown shinles. I ended up in the emergency room, where I was diagnosed with shingles by a doctor). The outcome of the shingles was not resolved.   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: 25-NOV-2023 This report was submitted via the online direct entry reporting system.  The patient self-reported this case. A week after getting the Shingrix vaccine, the patient had developed full-blown shingles. The patient ended up in the emergency room, where she was diagnosed with shingles by a doctor.  They prescribed her painkillers. The patient need to include the fact that you could get shingles in the listed risks before getting the shot.  If she had known that, she never would have gotten it.  This was so painful.  The patient stated that you need to include that fact in your TV ads. The reporter consented to follow up.
Age: 1.0
Sex: F
Vaccine: FLUC4, HEPA, MMRV, PNC20, FLUC4, HEPA, MMRV, PNC20, FLUX(H1N1), HEPA, MMRV, PNC20, TD, UNK, UNK, UNK
Symptoms: Death
Clinical narrative: DEATH -Died sometime in the late evening 11/25 or likely early morning 11/26. Woke up to find baby dead in her crib.
Age: 1.0
Sex: F
Vaccine: FLUC4, HEPA, MMRV, PNC20, FLUC4, HEPA, MMRV, PNC20, FLUX(H1N1), HEPA, MMRV, PNC20, TD, UNK, UNK, UNK
Symptoms: Death, Increased bronchial secretion, Lung disorder, Resuscitation
Clinical narrative: DEATH -Died sometime in the late evening 11/25 or likely early morning 11/26. Woke up to find baby dead in her crib.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac flutter, Chills, Extrasystoles, Headache, Mental impairment
Clinical narrative: pounding heartbeats; nausea; headache; fever; chills; This spontaneous case was reported by a patient and describes the occurrence of PALPITATIONS (pounding heartbeats), NAUSEA (nausea), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 208F23A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN (Dose 1, Batch no. 041A21A, Dose: 0.5 ml, Route of Administration: Intramuscular, reactions: Headache, fever, chills (shaking), nausea and rapidly pounding heartbeats.) on 10-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 3, Batch no. FJ4989, Dose: 0.3 ml, Route of Administration: Intramuscular, reactions: Headache, fever, chills (shaking), nausea and rapidly pounding heartbeats.) on 13-Apr-2022, PFIZER BIONTECH COVID-19 VACCINE (Dose 4, Batch no. GH9703, Dose: 0.3 ml, Route of Administration: Intramuscular, reactions: Headache, fever, chills (shaking) and nausea and rapidly pounding heartbeats.) on 01-Nov-2022; for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 2, Batch no. 939905, Dose: 0.5 ml, Route of Administration: Intramuscular, reactions: Headache, fever, chills (shaking) and nausea and rapidly pounding heartbeats.) on 31-Oct-2021. Past adverse reactions to the above products included Headache with COVID-19 VACCINE JANSSEN, Moderna COVID-19 Vaccine, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 24-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. In November 2023, the patient experienced PALPITATIONS (pounding heartbeats), NAUSEA (nausea), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. In November 2023, PALPITATIONS (pounding heartbeats), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever) had resolved. At the time of the report, CHILLS (chills) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2023, Heart rate: abnormal.         No concomitant medications were reported.  Approximately 12 hours after each Covid vaccine (regardless of manufacture) patient had headache, fever, chills (shaking), nausea and rapidly pounding heartbeats. Patient had a fever and very bad headache, and she was not able to think clearly, so her main concern was to take something to alleviate her headache and nausea. She took Advil and drank small sips of ginger ale. It was hours before her heartbeat returned to normal. Even after returning to normal beat, it would sometimes flutter or skip beats. This lasted for a few days. The headache and nausea last for a few days. The fever subsided after the first full day following the vaccine. It was unknown if the patient experienced any additional symptoms/events.   This case was linked to MOD-2023-751847 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Palpitations, Pyrexia, Tremor
Clinical narrative: pounding heartbeats; nausea; headache; fever; chills; This spontaneous case was reported by a patient and describes the occurrence of PALPITATIONS (pounding heartbeats), NAUSEA (nausea), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 208F23A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN (Dose 1, Batch no. 041A21A, Dose: 0.5 ml, Route of Administration: Intramuscular, reactions: Headache, fever, chills (shaking), nausea and rapidly pounding heartbeats.) on 10-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 3, Batch no. FJ4989, Dose: 0.3 ml, Route of Administration: Intramuscular, reactions: Headache, fever, chills (shaking), nausea and rapidly pounding heartbeats.) on 13-Apr-2022, PFIZER BIONTECH COVID-19 VACCINE (Dose 4, Batch no. GH9703, Dose: 0.3 ml, Route of Administration: Intramuscular, reactions: Headache, fever, chills (shaking) and nausea and rapidly pounding heartbeats.) on 01-Nov-2022; for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 2, Batch no. 939905, Dose: 0.5 ml, Route of Administration: Intramuscular, reactions: Headache, fever, chills (shaking) and nausea and rapidly pounding heartbeats.) on 31-Oct-2021. Past adverse reactions to the above products included Headache with COVID-19 VACCINE JANSSEN, Moderna COVID-19 Vaccine, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 24-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. In November 2023, the patient experienced PALPITATIONS (pounding heartbeats), NAUSEA (nausea), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. In November 2023, PALPITATIONS (pounding heartbeats), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever) had resolved. At the time of the report, CHILLS (chills) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2023, Heart rate: abnormal.         No concomitant medications were reported.  Approximately 12 hours after each Covid vaccine (regardless of manufacture) patient had headache, fever, chills (shaking), nausea and rapidly pounding heartbeats. Patient had a fever and very bad headache, and she was not able to think clearly, so her main concern was to take something to alleviate her headache and nausea. She took Advil and drank small sips of ginger ale. It was hours before her heartbeat returned to normal. Even after returning to normal beat, it would sometimes flutter or skip beats. This lasted for a few days. The headache and nausea last for a few days. The fever subsided after the first full day following the vaccine. It was unknown if the patient experienced any additional symptoms/events.   This case was linked to MOD-2023-751847 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Heart rate, Nausea, Palpitations
Clinical narrative: pounding heartbeats; nausea; headache; fever; chills; This spontaneous case was reported by a patient and describes the occurrence of PALPITATIONS (pounding heartbeats), NAUSEA (nausea), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 208F23A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN (Dose 1, Batch no. 041A21A, Dose: 0.5 ml, Route of Administration: Intramuscular, reactions: Headache, fever, chills (shaking), nausea and rapidly pounding heartbeats.) on 10-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 3, Batch no. FJ4989, Dose: 0.3 ml, Route of Administration: Intramuscular, reactions: Headache, fever, chills (shaking), nausea and rapidly pounding heartbeats.) on 13-Apr-2022, PFIZER BIONTECH COVID-19 VACCINE (Dose 4, Batch no. GH9703, Dose: 0.3 ml, Route of Administration: Intramuscular, reactions: Headache, fever, chills (shaking) and nausea and rapidly pounding heartbeats.) on 01-Nov-2022; for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 2, Batch no. 939905, Dose: 0.5 ml, Route of Administration: Intramuscular, reactions: Headache, fever, chills (shaking) and nausea and rapidly pounding heartbeats.) on 31-Oct-2021. Past adverse reactions to the above products included Headache with COVID-19 VACCINE JANSSEN, Moderna COVID-19 Vaccine, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 24-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. In November 2023, the patient experienced PALPITATIONS (pounding heartbeats), NAUSEA (nausea), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. In November 2023, PALPITATIONS (pounding heartbeats), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever) had resolved. At the time of the report, CHILLS (chills) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2023, Heart rate: abnormal.         No concomitant medications were reported.  Approximately 12 hours after each Covid vaccine (regardless of manufacture) patient had headache, fever, chills (shaking), nausea and rapidly pounding heartbeats. Patient had a fever and very bad headache, and she was not able to think clearly, so her main concern was to take something to alleviate her headache and nausea. She took Advil and drank small sips of ginger ale. It was hours before her heartbeat returned to normal. Even after returning to normal beat, it would sometimes flutter or skip beats. This lasted for a few days. The headache and nausea last for a few days. The fever subsided after the first full day following the vaccine. It was unknown if the patient experienced any additional symptoms/events.   This case was linked to MOD-2023-751847 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: pounding heartbeats; nausea; headache; fever; chills; This spontaneous case was reported by a patient and describes the occurrence of PALPITATIONS (pounding heartbeats), NAUSEA (nausea), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 208F23A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN (Dose 1, Batch no. 041A21A, Dose: 0.5 ml, Route of Administration: Intramuscular, reactions: Headache, fever, chills (shaking), nausea and rapidly pounding heartbeats.) on 10-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 3, Batch no. FJ4989, Dose: 0.3 ml, Route of Administration: Intramuscular, reactions: Headache, fever, chills (shaking), nausea and rapidly pounding heartbeats.) on 13-Apr-2022, PFIZER BIONTECH COVID-19 VACCINE (Dose 4, Batch no. GH9703, Dose: 0.3 ml, Route of Administration: Intramuscular, reactions: Headache, fever, chills (shaking) and nausea and rapidly pounding heartbeats.) on 01-Nov-2022; for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 2, Batch no. 939905, Dose: 0.5 ml, Route of Administration: Intramuscular, reactions: Headache, fever, chills (shaking) and nausea and rapidly pounding heartbeats.) on 31-Oct-2021. Past adverse reactions to the above products included Headache with COVID-19 VACCINE JANSSEN, Moderna COVID-19 Vaccine, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 24-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. In November 2023, the patient experienced PALPITATIONS (pounding heartbeats), NAUSEA (nausea), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. In November 2023, PALPITATIONS (pounding heartbeats), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever) had resolved. At the time of the report, CHILLS (chills) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2023, Heart rate: abnormal.         No concomitant medications were reported.  Approximately 12 hours after each Covid vaccine (regardless of manufacture) patient had headache, fever, chills (shaking), nausea and rapidly pounding heartbeats. Patient had a fever and very bad headache, and she was not able to think clearly, so her main concern was to take something to alleviate her headache and nausea. She took Advil and drank small sips of ginger ale. It was hours before her heartbeat returned to normal. Even after returning to normal beat, it would sometimes flutter or skip beats. This lasted for a few days. The headache and nausea last for a few days. The fever subsided after the first full day following the vaccine. It was unknown if the patient experienced any additional symptoms/events.   This case was linked to MOD-2023-751847 (Patient Link).
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: joint pain sometimes extreme; Initial information received on 24-Nov-2023 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 47-year-old male patient who had joint pain sometimes extreme after receiving influenza quadrival A-B vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 13-Nov-2023, the patient received an 0.5 ml dose of suspect influenza quadrival A-B vaccine, Suspension for injection (strength, expiry date: unknown) (lot: U8192AA) via intramuscular route in the left upper arm for Influenza (influenza immunization)  On 14-Nov-2023 the patient had an event of joint pain sometimes extreme (arthralgia) (latency: 1 day) following the administration of influenza quadrival A-B vaccine.  Reportedly, Joint pain sometimes extreme. Would go away after a few minutes. Some Joint pain seems to be lingering but not as severe.  It was unknown if any lab data/test results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Recovering / Resolving for the event.
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered to a patient past its expiration date with no reported adverse event; Initial information received on 22-Nov-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 43 years old female patient who was administered Diphtherias-2/Tetanus-5 Adsorbed Toxoids No preservative Adults [Tenivac] past its expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Nov-2023, the patient received a 0.5 ml dose of suspect Diphtherias-2/Tetanus-5 Adsorbed Toxoids No preservative Adults Suspension for injection (lot U7189AA, Expiry date: 30-Sep-2023 with unknown strength) via intramuscular route in unknown administration site as immunization which was past its expiration date with no reported adverse event (expired product administered) (Latency: same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Allodynia, Arthralgia, Decreased appetite, Disturbance in attention, Hot flush
Clinical narrative: Gradual aches and allodynia on arm/neck surrounding injection site into 10 pm with low grade fever night of injection. Take 200mg Celebrex in addition to nightly meds/supplemental Woke up 9 am with joint pain, difficulty concentrating beyond typical ADHD symptoms . Took 15mg flexeril to deal with muscle/joint pain Fever above 104°(thermometer read ?high?) peaking at 12pm sun day, with nausea, hot flashes, aches and joint tenderness, and allodynia from hips up especially in shoulders elbow and wrists. Took 200mg ibuprofen and drank 20oz liquid IV. Fever broke around 12:30, slept for 4 hours. Woke up with typical temperature 97.4 with tenderness by injection site, return of appetite, and mild aches/joint paint 9pm return of allodynia from hips to wrist/neck , temperature 97.8. Took 200mg Celebrex to stave off fever muscle aches and tension in upper back
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Gradual aches and allodynia on arm/neck surrounding injection site into 10 pm with low grade fever night of injection. Take 200mg Celebrex in addition to nightly meds/supplemental Woke up 9 am with joint pain, difficulty concentrating beyond typical ADHD symptoms . Took 15mg flexeril to deal with muscle/joint pain Fever above 104°(thermometer read ?high?) peaking at 12pm sun day, with nausea, hot flashes, aches and joint tenderness, and allodynia from hips up especially in shoulders elbow and wrists. Took 200mg ibuprofen and drank 20oz liquid IV. Fever broke around 12:30, slept for 4 hours. Woke up with typical temperature 97.4 with tenderness by injection site, return of appetite, and mild aches/joint paint 9pm return of allodynia from hips to wrist/neck , temperature 97.8. Took 200mg Celebrex to stave off fever muscle aches and tension in upper back
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Tension
Clinical narrative: Gradual aches and allodynia on arm/neck surrounding injection site into 10 pm with low grade fever night of injection. Take 200mg Celebrex in addition to nightly meds/supplemental Woke up 9 am with joint pain, difficulty concentrating beyond typical ADHD symptoms . Took 15mg flexeril to deal with muscle/joint pain Fever above 104°(thermometer read ?high?) peaking at 12pm sun day, with nausea, hot flashes, aches and joint tenderness, and allodynia from hips up especially in shoulders elbow and wrists. Took 200mg ibuprofen and drank 20oz liquid IV. Fever broke around 12:30, slept for 4 hours. Woke up with typical temperature 97.4 with tenderness by injection site, return of appetite, and mild aches/joint paint 9pm return of allodynia from hips to wrist/neck , temperature 97.8. Took 200mg Celebrex to stave off fever muscle aches and tension in upper back
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Tinnitus
Clinical narrative: I had Tennitus on both my ears.  Let ear severe.  After 10 days from my second dose I went to ER for pain in my ear.  Then got Tennitus. It's been 2 years now suffering.
Age: 1.0
Sex: M
Vaccine: FLUC4, HEPA, MMR, VARCEL
Symptoms: Measles antibody positive, Rash
Clinical narrative: He developed a rash on 10/26/23
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Malaise, Respiratory syncytial virus test positive
Clinical narrative: she and her granddaughter are positive for RSV; This non-serious case was reported by a consumer via call center representative and described the occurrence of respiratory syncytial virus test positive in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 03-NOV-2023, the patient received Arexvy (left arm). On 08-NOV-2023, 5 days after receiving Arexvy, the patient experienced respiratory syncytial virus test positive (Verbatim: she and her granddaughter are positive for RSV). The outcome of the respiratory syncytial virus test positive was not reported.   It was unknown if the reporter considered the respiratory syncytial virus test positive to be related to Arexvy.  It was unknown if the company considered the respiratory syncytial virus test positive to be related to Arexvy.   Additional Information: GSK Receipt Date: 9-NOV-2023 & 10-NOV-2023 The patient received the RSV vaccine previous week.  She got tested for RSV the day before reporting date. She had mild symptoms and had contact with an immunocompromised child. She tested positive.  She asked if that was accurate or could it be positive from just receiving the vaccine. She stated herself and her granddaughter were positive for RSV (tested on November 8, 2023) She stated that she got the RSV (AREXVY but not sure) in left arm on November 3, 2023.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Full blood count
Clinical narrative: Asthma attacks; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Asthma attacks) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Childhood asthma (She had asthma as a child but not previously as an adult).    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHMA (Asthma attacks). The patient was treated with SALBUTAMOL (PROVENTIL [SALBUTAMOL]) for Wheezing, at an unspecified dose and frequency. At the time of the report, ASTHMA (Asthma attacks) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Full blood count: 10 days after booster revealed a Hgb of 7, repeated about 5 days later and Hgb was 10 and About a week after that Hgb was 14.         No concomitant medications were reported.  Reported that patient received booster. She had asthma as a child but not previously as an adult. asthma attacks began about a week to 10 days after the booster. Have persisted for a month since but greatly tapering off in frequency recently. Patient felt well a month later except for occasional wheezing attacks.
Age: 67.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: staff gave tenivac that expired with no reported adverse event; Initial information received on 27-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 67 years old male patient to whom staff gave tenivac that expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Nov-2023, the patient received a  dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, Suspension for injection lot U7183AA, expiry date- 24-Sep-2023 via unknown route in the left deltoid for immunization, staff gave tenivac that expired with no reported adverse event (expired product administered) (latency same day).  Action taken: not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 21.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 21 year old male presented to Health Clinic for Varicella immunization administration. He was screened by 2 medics and administered varicella vaccination into right forearm. Patient reported to a senior medic 1 hour later to report  that he was having a reaction to the vaccination - redness and swelling that was continuing to spread throughout the right forearm.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache, muscle and joint pain, fever, fatigue, sore throat, chills
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Headache, muscle and joint pain, fever, fatigue, sore throat, chills
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient requested Moderna vaccine.  Patient denied having a vaccine card to be updated.  Vaccine administered by nurse who did not follow protocol for vaccine administration, by checking patient's EHR and/or registry for immunization status when vaccine card is not present.   Patient observed for recommended 15 min. with no adverse effects.  Nurse noted when updating vaccine in the EHR that patient had received current Covid vaccine 3 weeks prior to the current one that was received.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Adenomyosis, Anxiety, Arthralgia, Brain fog, Breast pain
Clinical narrative: Mentor smooth silicone bilaterally ruptured breast implants, with capsular contracture. Pathology indicated synovial metaplasia, a precancerous condition, in both capsules. Surgically removed. Symptoms gradually worsening over the last five years, with significant increase in symptoms following Covid 19 vaccinations and subsequent infection 2022. Chest and breast pain and swelling, heart palpitations with documented incidence of SVT, rashes, fevers, headaches, blurred visions, dizziness/vertigo, tinnitus, worsening Raynaud's, joint pain and swelling, cognitive impairment ("brain fog"), extreme fatigue, IBS, GERD, hormone imbalances leading to adenomyosis, endometriosis, and hysterectomy, insomnia, night sweats, extreme anxiety and panic attacks. All improved or eliminated since explant surgery.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Capsular contracture associated with breast implant, Chest pain, Cognitive disorder, Condition aggravated, Device breakage
Clinical narrative: Mentor smooth silicone bilaterally ruptured breast implants, with capsular contracture. Pathology indicated synovial metaplasia, a precancerous condition, in both capsules. Surgically removed. Symptoms gradually worsening over the last five years, with significant increase in symptoms following Covid 19 vaccinations and subsequent infection 2022. Chest and breast pain and swelling, heart palpitations with documented incidence of SVT, rashes, fevers, headaches, blurred visions, dizziness/vertigo, tinnitus, worsening Raynaud's, joint pain and swelling, cognitive impairment ("brain fog"), extreme fatigue, IBS, GERD, hormone imbalances leading to adenomyosis, endometriosis, and hysterectomy, insomnia, night sweats, extreme anxiety and panic attacks. All improved or eliminated since explant surgery.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Endometriosis, Fatigue, Gastrooesophageal reflux disease, Headache
Clinical narrative: Mentor smooth silicone bilaterally ruptured breast implants, with capsular contracture. Pathology indicated synovial metaplasia, a precancerous condition, in both capsules. Surgically removed. Symptoms gradually worsening over the last five years, with significant increase in symptoms following Covid 19 vaccinations and subsequent infection 2022. Chest and breast pain and swelling, heart palpitations with documented incidence of SVT, rashes, fevers, headaches, blurred visions, dizziness/vertigo, tinnitus, worsening Raynaud's, joint pain and swelling, cognitive impairment ("brain fog"), extreme fatigue, IBS, GERD, hormone imbalances leading to adenomyosis, endometriosis, and hysterectomy, insomnia, night sweats, extreme anxiety and panic attacks. All improved or eliminated since explant surgery.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hormone level abnormal, Hysterectomy, Infection, Insomnia, Irritable bowel syndrome
Clinical narrative: Mentor smooth silicone bilaterally ruptured breast implants, with capsular contracture. Pathology indicated synovial metaplasia, a precancerous condition, in both capsules. Surgically removed. Symptoms gradually worsening over the last five years, with significant increase in symptoms following Covid 19 vaccinations and subsequent infection 2022. Chest and breast pain and swelling, heart palpitations with documented incidence of SVT, rashes, fevers, headaches, blurred visions, dizziness/vertigo, tinnitus, worsening Raynaud's, joint pain and swelling, cognitive impairment ("brain fog"), extreme fatigue, IBS, GERD, hormone imbalances leading to adenomyosis, endometriosis, and hysterectomy, insomnia, night sweats, extreme anxiety and panic attacks. All improved or eliminated since explant surgery.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Magnetic resonance imaging abnormal, Metaplasia, Night sweats, Palpitations
Clinical narrative: Mentor smooth silicone bilaterally ruptured breast implants, with capsular contracture. Pathology indicated synovial metaplasia, a precancerous condition, in both capsules. Surgically removed. Symptoms gradually worsening over the last five years, with significant increase in symptoms following Covid 19 vaccinations and subsequent infection 2022. Chest and breast pain and swelling, heart palpitations with documented incidence of SVT, rashes, fevers, headaches, blurred visions, dizziness/vertigo, tinnitus, worsening Raynaud's, joint pain and swelling, cognitive impairment ("brain fog"), extreme fatigue, IBS, GERD, hormone imbalances leading to adenomyosis, endometriosis, and hysterectomy, insomnia, night sweats, extreme anxiety and panic attacks. All improved or eliminated since explant surgery.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Panic attack, Pathology test, Pyrexia, Rash, Raynaud's phenomenon
Clinical narrative: Mentor smooth silicone bilaterally ruptured breast implants, with capsular contracture. Pathology indicated synovial metaplasia, a precancerous condition, in both capsules. Surgically removed. Symptoms gradually worsening over the last five years, with significant increase in symptoms following Covid 19 vaccinations and subsequent infection 2022. Chest and breast pain and swelling, heart palpitations with documented incidence of SVT, rashes, fevers, headaches, blurred visions, dizziness/vertigo, tinnitus, worsening Raynaud's, joint pain and swelling, cognitive impairment ("brain fog"), extreme fatigue, IBS, GERD, hormone imbalances leading to adenomyosis, endometriosis, and hysterectomy, insomnia, night sweats, extreme anxiety and panic attacks. All improved or eliminated since explant surgery.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Supraventricular tachycardia, Surgery, Swelling, Tinnitus, Ultrasound breast abnormal
Clinical narrative: Mentor smooth silicone bilaterally ruptured breast implants, with capsular contracture. Pathology indicated synovial metaplasia, a precancerous condition, in both capsules. Surgically removed. Symptoms gradually worsening over the last five years, with significant increase in symptoms following Covid 19 vaccinations and subsequent infection 2022. Chest and breast pain and swelling, heart palpitations with documented incidence of SVT, rashes, fevers, headaches, blurred visions, dizziness/vertigo, tinnitus, worsening Raynaud's, joint pain and swelling, cognitive impairment ("brain fog"), extreme fatigue, IBS, GERD, hormone imbalances leading to adenomyosis, endometriosis, and hysterectomy, insomnia, night sweats, extreme anxiety and panic attacks. All improved or eliminated since explant surgery.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vision blurred
Clinical narrative: Mentor smooth silicone bilaterally ruptured breast implants, with capsular contracture. Pathology indicated synovial metaplasia, a precancerous condition, in both capsules. Surgically removed. Symptoms gradually worsening over the last five years, with significant increase in symptoms following Covid 19 vaccinations and subsequent infection 2022. Chest and breast pain and swelling, heart palpitations with documented incidence of SVT, rashes, fevers, headaches, blurred visions, dizziness/vertigo, tinnitus, worsening Raynaud's, joint pain and swelling, cognitive impairment ("brain fog"), extreme fatigue, IBS, GERD, hormone imbalances leading to adenomyosis, endometriosis, and hysterectomy, insomnia, night sweats, extreme anxiety and panic attacks. All improved or eliminated since explant surgery.
Age: 42.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Dizziness, Immunisation reaction, Injection site swelling, Nausea
Clinical narrative: Pt had adverse reaction to Gardasil 9 HPV vaccination 1st dose. bump immediately formed where pt was injected, 10 minutes later pt was dizzy and nauseous. Symptoms subsided without treatment and pt went home.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient is having her third shingle infection (she received both Shingrix doses) and wanted to know if she should stop Rinvoq. Recommended to talk to her rheumatologist about how long she should hold off the dose. For now, she should temporarily stop Rinvoq until she fills better. She is dealing with her 90-year-old husband who has dementia and feels she doesn't have time to be going back to the dermatologist (had an appoint. last month).
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dyspnoea
Clinical narrative: 10013963:DYSPNEA - | Patient is a 74-year old male who received two doses of the COVID 19 (Moderna) Vaccine (Jan 2021 and Feb 2021). Patient presented to Primary Care appointment on 08/22/2023 and was offered the COVID 19 booster vaccine. The patient declined the booster vaccine due to severe reaction (dyspnea) with previous COVID 19 vaccines. Reported per EUA. |  | DYSPENA |
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Blood glucose, Differential white blood cell count, Full blood count, Gaze palsy, Metabolic function test
Clinical narrative: Mom called after hours the evening of 11-27-23 @ 9pm. She had put pt to bed went in later to check on him and mom found him to be having an apparent seizure - convulsions, eyes fixed to one side and body stiffness. This lasted about 5 minutes. Mom called EMS - No known fever at the time. Mom transported him to hospital
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Musculoskeletal stiffness, Polymerase chain reaction, Seizure, Urine analysis
Clinical narrative: Mom called after hours the evening of 11-27-23 @ 9pm. She had put pt to bed went in later to check on him and mom found him to be having an apparent seizure - convulsions, eyes fixed to one side and body stiffness. This lasted about 5 minutes. Mom called EMS - No known fever at the time. Mom transported him to hospital
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: See office notes
Age: 2.83
Sex: M
Vaccine: IPV, PNC20
Symptoms: Extra dose administered
Clinical narrative: Clinical Notes:  upon review of immunization records received from previous PCP and review of VIS-IPV noted to not be on record. Discussed with mom and she was unsure. IPV given in office. Upon further review of records from clinic-IPV dates were found (had not been entered in by previous PCP). Mom aware patient had received IPV and now would have one extra and would be on no harm to patient. Mom verbalized understanding.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Pt. administered Havrix that was past date by one day (exp. 11/30/23) - given 12/1/23 Pt. tolerated vaccine well.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Site of injection is hard to the touch and very warm.  Swelling a few inches or more around the entire injection site.
Age: 1.92
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The patient was ordered Infant Moderna but Infant Pfizer was administered.  Clinic happened to be out of Infant Moderna anyway so order was changed to Infant Pfizer.  MD stated that the patient could have received either so no harm was done.
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Extra dose administered, Injection site pain
Clinical narrative: Patient received a flu shot in error. This was her 2nd flu shot of the day (the 1st was given in her doctors office). She reported a slightly more sore arm than usual at the site of administration.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Unknown if any adverse symptoms were present.  As I was unable to get in contact with family. Child was given a adult dose of Hep A.
Age: 0.33
Sex: F
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Cytogenetic analysis, Electroencephalogram abnormal, Infantile spasms, Magnetic resonance imaging normal, Metabolic function test normal
Clinical narrative: About a week after receiving 4 month vaccines at clinic, she experienced cluster of spasms/seizures. They grew in frequency over time and we were seen at hospital. An EEG was confirmed the seizure activity and doctor diagnosed her with Infantile Spasms.
Age: 0.33
Sex: F
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Seizure cluster
Clinical narrative: About a week after receiving 4 month vaccines at clinic, she experienced cluster of spasms/seizures. They grew in frequency over time and we were seen at hospital. An EEG was confirmed the seizure activity and doctor diagnosed her with Infantile Spasms.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Patient reported an adverse event of heart palpitations related to the COVID-19 Moderna vaccine. Exact date of vaccination or additional details surrounding the event are unavailable.
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Asthenia, Balance disorder, Chills, Decreased appetite, Feeling hot
Clinical narrative: At midnight 11 hours after the shot I developed chills and slight fever for 2-3 hours followed by being very hot. The next morning I had bad flu symptoms, full body aches and weakness, headache, slight loss of balance control, loss of appetite, and pain at injection site when lifting my arm. Day 2 was around 50% better but any moderate activity made me hot and sweaty. Day 3 almost back to normal.
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Headache, Hyperhidrosis, Influenza, Injection site pain, Pain
Clinical narrative: At midnight 11 hours after the shot I developed chills and slight fever for 2-3 hours followed by being very hot. The next morning I had bad flu symptoms, full body aches and weakness, headache, slight loss of balance control, loss of appetite, and pain at injection site when lifting my arm. Day 2 was around 50% better but any moderate activity made me hot and sweaty. Day 3 almost back to normal.
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Pyrexia
Clinical narrative: At midnight 11 hours after the shot I developed chills and slight fever for 2-3 hours followed by being very hot. The next morning I had bad flu symptoms, full body aches and weakness, headache, slight loss of balance control, loss of appetite, and pain at injection site when lifting my arm. Day 2 was around 50% better but any moderate activity made me hot and sweaty. Day 3 almost back to normal.
Age: 77.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: CSF glucose increased, CSF protein increased, Hypertension, Immunoglobulin therapy, Muscular weakness
Clinical narrative: Lower extremity weakness,  high BP at night, low grip strength , treated by 5 days IVIG
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood test normal, Bronchitis, Chest X-ray normal, Computerised tomogram abnormal, Dyspnoea
Clinical narrative: Started as post nasal drip then progressed to bronchitis, fever, and difficulty breathing, I ended up in 2 different ED within 24 hours.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Electrocardiogram abnormal, Pyrexia, Upper-airway cough syndrome
Clinical narrative: Started as post nasal drip then progressed to bronchitis, fever, and difficulty breathing, I ended up in 2 different ED within 24 hours.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Throat tightness
Clinical narrative: Pt left the pharmacy after receiving the vaccine. She came back a few minutes later saying that she was having a reaction to the vaccine. I asked her to sit down and breath. I asked her what reaction she was having and she said that she felt "pressure here", pointing at her trachea. She also said "I feel like I wont be able to breath".  I said I was going to call 911 and the gentleman with her said "before you do that, I'm a physician, do you have a blood pressure cuff"?. A few minutes later they decided to go to the ER
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain of skin, Tenderness, Vasculitis
Clinical narrative: SENSITIVITY AND PAIN UNDER THE SKIN THAT LEAD TO VASCULITIS
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Pt. previously had primary series of Moderna COVID vaccine in 2022, and Pfizer Bivalent vaccine in 2023.   Came on 12/1 for Pfizer 23-24 formulation.  When she woke in the morning on 12/2, she had hives all over extremities and trunk.  Mom administered one dose of zyrtec.  No further doses given, and hives did not return.
Age: 2.0
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: MMR Priorix sterile diluent was given without the power vial of vaccine. The client had no s/sx per mom after receiving vaccines on 11/15/23.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Age: 2.0
Sex: F
Vaccine: DTPPVHBHPB, HEPA, MMR, PNC15, VARCEL
Symptoms: Product preparation error
Clinical narrative: MMR Priorix given separately, syringe diluent given and vial containing powder vaccine found to be left in vaccine box and reconstituted.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: Severe vertigo started about 4 a.m. on 11/18/23 - continued through 11/21/23 - received vestibular therapy on 11/20 and 11/21 that helped to resolve the vertigo.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Erythema, Influenza like illness, Nausea, Pain in extremity
Clinical narrative: flu like  symptons, dizziness,  arm was  red, hot and  swollen, nausea.arm still red  and  sore, getting  better. using cold  pack  on  arm and  benadryl 50 mg. qd.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: flu like  symptons, dizziness,  arm was  red, hot and  swollen, nausea.arm still red  and  sore, getting  better. using cold  pack  on  arm and  benadryl 50 mg. qd.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events were reported. This patient was not old enough to receive the High Dose Flu Vaccine that I had administered.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Arthritis reactive, Borrelia test negative, Chills, Gait disturbance
Clinical narrative: Manufacturer: Seqirus  2 days post vaccine- swollen painful left knee- could not bend/hard to walk, 3 days post vaccine Right knee swollen.  Had chills as well for 2 days.    Literature notes Reactive Arthritis following flu vaccine