chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Anti-thyroid antibody increased, Pyrexia
Clinical narrative: she had mild fever and questioning on raised TPO antibody level; raised TPO antibody level after the vaccine; This non-serious case was reported by a consumer via patient support programs and described the occurrence of fever in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: she had mild fever and questioning on raised TPO antibody level) and thyroid peroxidase antibody increased (Verbatim: raised TPO antibody level after the vaccine). The outcome of the fever and thyroid peroxidase antibody increased were not reported.   It was unknown if the reporter considered the fever and thyroid peroxidase antibody increased to be related to Shingrix.     It was unknown if the company considered the fever and thyroid peroxidase antibody increased to be related to Shingrix.   Additional Information: RA Receipt Date - 04-DEC-2023 The patient stated that she had mild fever and questioning on raised thyroid peroxidase (TPO) antibody level after the vaccine. No other information was provided. The reporter consented to follow-up.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: Vaccine exposure during pregnancy; This non-serious prospective pregnancy case was reported by a consumer and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Vaccine exposure during pregnancy ). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 36 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date:02-DEC-2023 The reporter stated that pregnant females administered Arexvy vaccine. The patient administered outside of approved indication. The patients were yet to be informed. This case had been linked with US2023AMR169833, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR169833:same reporter
Sex: U
Vaccine: RSV
Symptoms: Cough, Impaired work ability, Malaise, Respiratory syncytial virus infection
Clinical narrative: Cough; Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cough in a 62-year-old patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. In NOV-2023, an unknown time after receiving Arexvy, the patient experienced sickness (Verbatim: Sick). On an unknown date, the patient experienced cough (Verbatim: Cough). The outcome of the cough and sickness were not reported.   It was unknown if the reporter considered the cough and sickness to be related to Arexvy.     It was unknown if the company considered the cough and sickness to be related to Arexvy.   Additional Information: GSK Receipt Date: 02-DEC-2023 This case was reported by patient via (Open field AE monitoring) interactive digital media. The patient reported that he/she was diagnosed this past (illegible) with RSV.  The video really explained the feelings he/she had with this virus and just started a new PT (illegible) and had been out sick for a week and the cough was the worst. Follow up was not possible, as no contact details were available.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: patient received expired dose of Havrix vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 3-year-old male patient who received HAV (Havrix) (expiry date 30-NOV-2023) for prophylaxis.   On 01-DEC-2023, the patient received the 2nd dose of Havrix (lt. vastus lateralis). On 01-DEC-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: patient received expired dose of Havrix vaccine). The outcome of the expired vaccine used was unknown.   Additional Information: RA Receipt date: 01-DEC-2023 The healthcare professional stated that a patient received expired dose of Havrix vaccine which led to expired vaccine used. The reporter consented to follow up.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: received an expired dose of Menveo; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number L542P, expiry date 31-OCT-2023) for prophylaxis.   On 26-NOV-2023, the patient received Menveo. On 26-NOV-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: received an expired dose of Menveo). The outcome of the expired vaccine used was unknown.   Additional Information: RA Receipt Date: 04-DEC-2023 The pharmacist reported that the patient received an expired dose of Menveo, which led to expired vaccine used. The reporter consented to the follow-up.
Age: 53.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 53 years old accidentally received a dose of Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 53-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 9B2Y4, expiry date 20-OCT-2024) for prophylaxis.   On 09-SEP-2023, the patient received Arexvy. On 09-SEP-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 53 years old accidentally received a dose of Arexvy). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 04-DEC-2023 The pharmacist stated that a patient who was 53 years old accidentally received a dose of Arexvy which led to Inappropriate age at vaccine administration. The caller declined to provide initials and follow-up from Safety.  The reporter did not consent to follow-up.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: the patient reported her employer requires her to have the Menveo or Menactra; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 21-year-old female patient who received Men B NVS (Bexsero) (batch number 9R42C, expiry date 30-JUN-2024) for prophylaxis.   On 04-DEC-2023, the patient received the 1st dose of Bexsero (intramuscular, left arm) .5 ml. On 04-DEC-2023, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: the patient reported her employer requires her to have the Menveo or Menactra). The outcome of the wrong vaccine 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: 04-DEC-2023 The pharmacist reported that the patient received a Bexsero vaccine in her left arm. After giving Bexsero to the patient, the patient reported that her employer required her to had the Menveo or Menactra, which led to wrong vaccine administered. Caller transferred to MI for next steps. The reporter might follow-up with the pharmacy in this case. The reporter consented to follow up.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only the liquid portion of Menveo was administered to a patient; only the liquid portion of Menveo was administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA960A, expiry date 31-AUG-2024) for prophylaxis.   On 04-DEC-2023, the patient received Menveo. On 04-DEC-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: only the liquid portion of Menveo was administered to a patient) and inappropriate dose of vaccine administered (Verbatim: only the liquid portion of Menveo was administered to a patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: RA receipt date: 04-DEC-2023 The Office manager called to report that, only the liquid portion of Menveo was administered to a patient which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Central serous chorioretinopathy
Clinical narrative: CSR. Central serous retinopathy in right eye due to blood vessels bursting at random; This spontaneous case was reported by a consumer and describes the occurrence of CENTRAL SEROUS CHORIORETINOPATHY (CSR. Central serous retinopathy in right eye due to blood vessels bursting at random) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049c21a, 013h21b and 025c21a) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. In 2022, the patient experienced CENTRAL SEROUS CHORIORETINOPATHY (CSR. Central serous retinopathy in right eye due to blood vessels bursting at random) (seriousness criterion medically significant). At the time of the report, CENTRAL SEROUS CHORIORETINOPATHY (CSR. Central serous retinopathy in right eye due to blood vessels bursting at random) was resolving.            No relevant concomitant medications were reported.  It is unknown if the patient experienced any additional symptoms/events. No treatment medication reported.  Company Comment: This is a spontaneous case concerning a 39 year-old, female patient with no reported medical history, who experienced the serious (due to medically significant) unexpected, event of Central serous chorioretinopathy, which occurred after the mRNA-1273 vaccine, dose number not provided. Temporal association cannot be assessed due to lack of information on exact onset date of the event and vaccination date. Patient reported Central serous retinopathy in right eye due to blood vessels bursting at random. The outcome was reported as recovering. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Feeling abnormal, Immunisation reaction
Clinical narrative: she was because she was around him and felt awful and rotten; She mentioned that she and her son had a mild case; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (she was because she was around him and felt awful and rotten) and IMMUNISATION REACTION (She mentioned that she and her son had a mild case) in an 85-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 015H22A and 065H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (031M20A) on 12-Feb-2021, Moderna covid-19 vaccine (001B21A) on 12-Mar-2021, Moderna covid-19 vaccine (012F21A) on 09-Nov-2021 and Moderna covid-19 vaccine (002M21A) on 10-Apr-2022. Past adverse reactions to the above products included No adverse event with Moderna covid-19 vaccine, Moderna covid-19 vaccine, Moderna covid-19 vaccine and Moderna covid-19 vaccine.   On 11-Nov-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 05-Apr-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. In 2022, the patient experienced FEELING ABNORMAL (she was because she was around him and felt awful and rotten) and IMMUNISATION REACTION (She mentioned that she and her son had a mild case). At the time of the report, FEELING ABNORMAL (she was because she was around him and felt awful and rotten) and IMMUNISATION REACTION (She mentioned that she and her son had a mild case) outcome was unknown.            No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-752716 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-752716:Son case
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid 19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (covid 19) in a 55-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: Positive.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication not reported.   Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-752727 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-752727:Mother case
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Immunisation reaction
Clinical narrative: Patient was worse, it was throwing her into auto immune disease because of her doctor's recommendation to get the shot.; had a very bad reaction at six days out; This spontaneous case was reported by a patient family member or friend and describes the occurrence of AUTOIMMUNE DISORDER (Patient was worse, it was throwing her into auto immune disease because of her doctor's recommendation to get the shot.) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   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 AUTOIMMUNE DISORDER (Patient was worse, it was throwing her into auto immune disease because of her doctor's recommendation to get the shot.) (seriousness criterion medically significant) and IMMUNISATION REACTION (had a very bad reaction at six days out). At the time of the report, AUTOIMMUNE DISORDER (Patient was worse, it was throwing her into auto immune disease because of her doctor's recommendation to get the shot.) and IMMUNISATION REACTION (had a very bad reaction at six days out) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient had Moderna two of them the second one at her doctor's recommendation, even though she had a very bad reaction at six days out. It was worse, throwing her into auto immune disease because of her doctor's recommendation to get the shot. No treatment information was reported.  Company Comment This spontaneous case concerns a female patient of an unknown age patient with no medical history reported who experienced the seriousness criterion medically significant unexpected event of autoimmune disorder and the unexpected event of immunization reaction unknown days after a dose of mRNA-1273.815 vaccine. Concomitant medication nor Treatment details were reported. At the time of the report, the event´s outcome was unknown. The benefit-risk relationship of mRNA-1273.815  vaccine is not affected by this report.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Dysphonia, Laryngoscopy
Clinical narrative: hoarseness; dizziness; diarrhea; This spontaneous case was reported by a patient and describes the occurrence of DYSPHONIA (hoarseness), DIZZINESS (dizziness) and DIARRHOEA (diarrhea) in a 95-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030536) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (lot 012620A) on 19-Jan-2021, Moderna covid-19 vaccine (lot 012M20A) on 16-Feb-2021, Moderna covid-19 vaccine (lot 033B21A) on 27-Aug-2021, Moderna covid-19 vaccine (lot 068H21A) on 21-Mar-2022, MODERNA COVID-19 VACCINE and BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) (lot 023H22A) on 28-Apr-2023. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5), Moderna covid-19 vaccine, Moderna covid-19 vaccine, Moderna covid-19 vaccine and Moderna covid-19 vaccine. Concurrent medical conditions included Drug allergy (Prednisone).    On 04-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 04-Oct-2023, the patient experienced DYSPHONIA (hoarseness), DIZZINESS (dizziness) and DIARRHOEA (diarrhea). At the time of the report, DYSPHONIA (hoarseness) and DIZZINESS (dizziness) had not resolved and DIARRHOEA (diarrhea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Laryngoscopy: Not found anything strange.         No concomitant medication was reported.  Patient experienced dizziness (she has trouble ambulating) and she needed to be careful when she turned her head in bed, and it doesn't seem to have anything to do with the crystals in her ear. Patient visited to her nose and throat doctor on 7-DEC-2023 because she was concerned, and doctor did her a fiber optic laryngoscopy but did not find anything strange and only recommended her to drink hot tea and a lot of water, but nothing changed. No treatment information was reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchy hives all over her body except her head and face; Itchy hives all over her body except her head and face; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy hives all over her body except her head and face) and URTICARIA (Itchy hives all over her body except her head and face) in a 50-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.  On 03-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 05-Dec-2023, the patient experienced PRURITUS (Itchy hives all over her body except her head and face) and URTICARIA (Itchy hives all over her body except her head and face). At the time of the report, PRURITUS (Itchy hives all over her body except her head and face) and URTICARIA (Itchy hives all over her body except her head and face) had not resolved.      The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.    Concomitant product use was not provided by the reporter.  The events reported were itchy hives all over her body except her head and face. It was unknown if the patient experienced any additional symptoms/events.  Treatment information was not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: Break through infection; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (Break through infection) in a 62-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.  On 16-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 05-Dec-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced INFECTION (Break through infection). At the time of the report, INFECTION (Break through infection) outcome was unknown.      The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The events reported was break through infection. It was unknown if the patient experienced any additional symptoms/events.  Treatment information was not provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Redness & slight swelling at injection site.; Redness & slight swelling at injection site.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness & slight swelling at injection site.) and VACCINATION SITE SWELLING (Redness & slight swelling at injection site.) in a 75-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032679) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 08-Dec-2023, the patient experienced VACCINATION SITE ERYTHEMA (Redness & slight swelling at injection site.) and VACCINATION SITE SWELLING (Redness & slight swelling at injection site.). At the time of the report, VACCINATION SITE ERYTHEMA (Redness & slight swelling at injection site.) and VACCINATION SITE SWELLING (Redness & slight swelling at injection site.) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/event. No treatment medications were reported.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Chest discomfort, Chest pain, Fatigue, Pyrexia
Clinical narrative: Patient reported feeling soreness to chest on 12/09/23 upon waking up; 5/10 on a numerical scale as per patient. Patient reported that she would feel the pressure upon deep breathing in and out. Patient also developed a fever and felt tired that same day (12/09/23) . As per patient symptoms resolved the following day (12/10/23) upon waking up . Patient has not had any further symptoms up to today.
Age: 61.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Acupuncture, Bell's palsy, Cellulitis, Chills, Computerised tomogram neck
Clinical narrative: Fatigue on Oct 19, Oct 21-23, Nov 7-19 Involuntary shivers and chills for 2 hours at sundown on 10/21/23 Neck swelling below jaw - location varied from both sides to more on right side, with swelling under the tongue on both sides that at times interfered with speech, from Oct 23-Nov 17, 2023 Fever 101 degrees F on November 8, 2023 Neck pain on right side, especially when opening mouth more than a little, Nov 7-8, 2023 Nerve pain on surface of skull around left ear with tinnitis and left lip twitching,  Nov 11-Nov 14, 2023 Bell's Palsy on left side of face affecting eyelid, cheek, lips and tongue, Nov 13-Dec 10, 2023. Some improvement but not yet fully healed as of today.  Doctor visits: Oct 24 with Dr. (walk-in clinic), Nov 8 w/ Dr. (walk-in clinic), Nov 12 w/ Dr., (walk-in clinic), Nov 13 w/ Dr. (scheduled follow-up). Nurse consultation on Nov 7 and Nov 15. On Nov 8, Dr. advised me to go to the Emergency Room due to symptoms of fever, neck swelling/pain, and swelling under the tongue. The right side of the neck was painful and had more swelling. The left side of my neck was not as bad. I was at the ER for 2.5 hours on 11/8/2023. At the ER, a CT scan led to diagnosis of cellulitis in soft tissues of the neck below jaw. I was prescribed antibiotics (Augmentin) and sent home. Dr. prescribed antiviral on Nov 13 based on my pain around the ear/tinnitus and bumpy tongue due to my concern that these symptoms had also preceded my Bell's Palsy that had occurred in February 2023. Dr. prescribed Prednisone on Nov 14 in response to my email that I had developed Bell's Palsy (facial paralysis on left side) on the evening of Nov 13. From a referral by Dr., on Nov 21 I had an appointment with Dr. an Ear, Nose and Throat specialist. He made a series of other referrals y for MRI, neurology and evaluation for Melkersson-Rothenthal syndrome that I am following up on and that will take months to complete. On Nov 16, I began weekly acupuncture treatment and that has made noticeable improvement in my Bell's Palsy. On Dec 1, I began weekly Osteopathic  treatment with Dr. The last of my prescribed medicines was completed, so at the time of filling out this form I am taking no medication (neither OTC nor prescription). I started eating probiotics around Nov 16 (plain yogurt and kombucha) as part of my recovery after taking antibiotics. I have had many vaccinations over the years with only mild responses (a day feeling tired and/or a sore arm, and sometimes imperceptible response). I've never had such dramatic shivers/chills leading to nearly two months (and counting) of not feeling well. Please note that I had none of the typical upper respiratory infection symptoms - no cough, no sore throat, no nasal or sinus congestion and no ear infection.
Age: 61.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Facial paralysis, Fatigue, Headache, Influenza virus test negative, Malaise
Clinical narrative: Fatigue on Oct 19, Oct 21-23, Nov 7-19 Involuntary shivers and chills for 2 hours at sundown on 10/21/23 Neck swelling below jaw - location varied from both sides to more on right side, with swelling under the tongue on both sides that at times interfered with speech, from Oct 23-Nov 17, 2023 Fever 101 degrees F on November 8, 2023 Neck pain on right side, especially when opening mouth more than a little, Nov 7-8, 2023 Nerve pain on surface of skull around left ear with tinnitis and left lip twitching,  Nov 11-Nov 14, 2023 Bell's Palsy on left side of face affecting eyelid, cheek, lips and tongue, Nov 13-Dec 10, 2023. Some improvement but not yet fully healed as of today.  Doctor visits: Oct 24 with Dr. (walk-in clinic), Nov 8 w/ Dr. (walk-in clinic), Nov 12 w/ Dr., (walk-in clinic), Nov 13 w/ Dr. (scheduled follow-up). Nurse consultation on Nov 7 and Nov 15. On Nov 8, Dr. advised me to go to the Emergency Room due to symptoms of fever, neck swelling/pain, and swelling under the tongue. The right side of the neck was painful and had more swelling. The left side of my neck was not as bad. I was at the ER for 2.5 hours on 11/8/2023. At the ER, a CT scan led to diagnosis of cellulitis in soft tissues of the neck below jaw. I was prescribed antibiotics (Augmentin) and sent home. Dr. prescribed antiviral on Nov 13 based on my pain around the ear/tinnitus and bumpy tongue due to my concern that these symptoms had also preceded my Bell's Palsy that had occurred in February 2023. Dr. prescribed Prednisone on Nov 14 in response to my email that I had developed Bell's Palsy (facial paralysis on left side) on the evening of Nov 13. From a referral by Dr., on Nov 21 I had an appointment with Dr. an Ear, Nose and Throat specialist. He made a series of other referrals y for MRI, neurology and evaluation for Melkersson-Rothenthal syndrome that I am following up on and that will take months to complete. On Nov 16, I began weekly acupuncture treatment and that has made noticeable improvement in my Bell's Palsy. On Dec 1, I began weekly Osteopathic  treatment with Dr. The last of my prescribed medicines was completed, so at the time of filling out this form I am taking no medication (neither OTC nor prescription). I started eating probiotics around Nov 16 (plain yogurt and kombucha) as part of my recovery after taking antibiotics. I have had many vaccinations over the years with only mild responses (a day feeling tired and/or a sore arm, and sometimes imperceptible response). I've never had such dramatic shivers/chills leading to nearly two months (and counting) of not feeling well. Please note that I had none of the typical upper respiratory infection symptoms - no cough, no sore throat, no nasal or sinus congestion and no ear infection.
Age: 61.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Muscle twitching, Neck pain, Neuralgia, Pain, Pyrexia
Clinical narrative: Fatigue on Oct 19, Oct 21-23, Nov 7-19 Involuntary shivers and chills for 2 hours at sundown on 10/21/23 Neck swelling below jaw - location varied from both sides to more on right side, with swelling under the tongue on both sides that at times interfered with speech, from Oct 23-Nov 17, 2023 Fever 101 degrees F on November 8, 2023 Neck pain on right side, especially when opening mouth more than a little, Nov 7-8, 2023 Nerve pain on surface of skull around left ear with tinnitis and left lip twitching,  Nov 11-Nov 14, 2023 Bell's Palsy on left side of face affecting eyelid, cheek, lips and tongue, Nov 13-Dec 10, 2023. Some improvement but not yet fully healed as of today.  Doctor visits: Oct 24 with Dr. (walk-in clinic), Nov 8 w/ Dr. (walk-in clinic), Nov 12 w/ Dr., (walk-in clinic), Nov 13 w/ Dr. (scheduled follow-up). Nurse consultation on Nov 7 and Nov 15. On Nov 8, Dr. advised me to go to the Emergency Room due to symptoms of fever, neck swelling/pain, and swelling under the tongue. The right side of the neck was painful and had more swelling. The left side of my neck was not as bad. I was at the ER for 2.5 hours on 11/8/2023. At the ER, a CT scan led to diagnosis of cellulitis in soft tissues of the neck below jaw. I was prescribed antibiotics (Augmentin) and sent home. Dr. prescribed antiviral on Nov 13 based on my pain around the ear/tinnitus and bumpy tongue due to my concern that these symptoms had also preceded my Bell's Palsy that had occurred in February 2023. Dr. prescribed Prednisone on Nov 14 in response to my email that I had developed Bell's Palsy (facial paralysis on left side) on the evening of Nov 13. From a referral by Dr., on Nov 21 I had an appointment with Dr. an Ear, Nose and Throat specialist. He made a series of other referrals y for MRI, neurology and evaluation for Melkersson-Rothenthal syndrome that I am following up on and that will take months to complete. On Nov 16, I began weekly acupuncture treatment and that has made noticeable improvement in my Bell's Palsy. On Dec 1, I began weekly Osteopathic  treatment with Dr. The last of my prescribed medicines was completed, so at the time of filling out this form I am taking no medication (neither OTC nor prescription). I started eating probiotics around Nov 16 (plain yogurt and kombucha) as part of my recovery after taking antibiotics. I have had many vaccinations over the years with only mild responses (a day feeling tired and/or a sore arm, and sometimes imperceptible response). I've never had such dramatic shivers/chills leading to nearly two months (and counting) of not feeling well. Please note that I had none of the typical upper respiratory infection symptoms - no cough, no sore throat, no nasal or sinus congestion and no ear infection.
Age: 61.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: SARS-CoV-2 test negative, Swelling, Swelling face, Swollen tongue, Tinnitus
Clinical narrative: Fatigue on Oct 19, Oct 21-23, Nov 7-19 Involuntary shivers and chills for 2 hours at sundown on 10/21/23 Neck swelling below jaw - location varied from both sides to more on right side, with swelling under the tongue on both sides that at times interfered with speech, from Oct 23-Nov 17, 2023 Fever 101 degrees F on November 8, 2023 Neck pain on right side, especially when opening mouth more than a little, Nov 7-8, 2023 Nerve pain on surface of skull around left ear with tinnitis and left lip twitching,  Nov 11-Nov 14, 2023 Bell's Palsy on left side of face affecting eyelid, cheek, lips and tongue, Nov 13-Dec 10, 2023. Some improvement but not yet fully healed as of today.  Doctor visits: Oct 24 with Dr. (walk-in clinic), Nov 8 w/ Dr. (walk-in clinic), Nov 12 w/ Dr., (walk-in clinic), Nov 13 w/ Dr. (scheduled follow-up). Nurse consultation on Nov 7 and Nov 15. On Nov 8, Dr. advised me to go to the Emergency Room due to symptoms of fever, neck swelling/pain, and swelling under the tongue. The right side of the neck was painful and had more swelling. The left side of my neck was not as bad. I was at the ER for 2.5 hours on 11/8/2023. At the ER, a CT scan led to diagnosis of cellulitis in soft tissues of the neck below jaw. I was prescribed antibiotics (Augmentin) and sent home. Dr. prescribed antiviral on Nov 13 based on my pain around the ear/tinnitus and bumpy tongue due to my concern that these symptoms had also preceded my Bell's Palsy that had occurred in February 2023. Dr. prescribed Prednisone on Nov 14 in response to my email that I had developed Bell's Palsy (facial paralysis on left side) on the evening of Nov 13. From a referral by Dr., on Nov 21 I had an appointment with Dr. an Ear, Nose and Throat specialist. He made a series of other referrals y for MRI, neurology and evaluation for Melkersson-Rothenthal syndrome that I am following up on and that will take months to complete. On Nov 16, I began weekly acupuncture treatment and that has made noticeable improvement in my Bell's Palsy. On Dec 1, I began weekly Osteopathic  treatment with Dr. The last of my prescribed medicines was completed, so at the time of filling out this form I am taking no medication (neither OTC nor prescription). I started eating probiotics around Nov 16 (plain yogurt and kombucha) as part of my recovery after taking antibiotics. I have had many vaccinations over the years with only mild responses (a day feeling tired and/or a sore arm, and sometimes imperceptible response). I've never had such dramatic shivers/chills leading to nearly two months (and counting) of not feeling well. Please note that I had none of the typical upper respiratory infection symptoms - no cough, no sore throat, no nasal or sinus congestion and no ear infection.
Age: 60.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Audiogram, Computerised tomogram, Tinnitus
Clinical narrative: Severe tinnitus
Age: 60.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Acoustic stimulation tests, Loss of personal independence in daily activities, Migraine, Sleep disorder, Tinnitus
Clinical narrative: Severe tinnitus
Age: 60.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Vertigo
Clinical narrative: Severe tinnitus
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Herpes zoster
Clinical narrative: Outbreak of shingles noted December 8, 2023.
Age: 89.0
Sex: F
Vaccine: COVID19-2, RSV
Symptoms: Asthenia
Clinical narrative: patient felt generalized weakness after the vaccine, patient advised to follow up with PCP if it doesn't subside
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19; COVID-19; interchange of vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received bnt162b2 (BNT162B2), on 22Jan2021 at 10:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 09Sep2021 as dose 3 (booster), single (Lot number: 301458a) at the age of 73 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 09Sep2022 as dose 5 (booster), single (Lot number: as7145b), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), on 10Oct2023 at 15:00 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Prostate cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Apr2022, outcome "unknown", described as "interchange of vaccines"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, which included treatment with Paxlovid from 22Nov2023 to 27Nov2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Jun2023 as dose number unknown, single (Lot number: GJ6743) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chemo treatment at present" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received anti-viral COVID-19 treatment with Paxlovid from 26Nov2023 to 30Nov2023. The patient had no known allergies.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 10Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: She had no known allergies. She received Paxlovid (Lot number: GK5777) as a treatment for the event from 08Dec2023 to 06Dec2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by varied factors; however, a contributory role of the suspect product to the reported Drug ineffective, COVID-19 cannot be ruled out.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 06Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 20Dec2021 as dose 3 (booster), single (Lot number: FJ620), in left arm and on 09Dec2022 as dose 4 (booster), single (Lot number: GJ6796) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "peanut allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received anti-viral Covid 19 treatment with Paxlovid from 28Nov2023 to 02Dec2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 13-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), in Jan2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (2023) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive; (2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had Covid. She started Paxlovid from Nov2023 after testing positive till Nov2023. The symptoms improved and the full course of Paxlovid was completed. Patient tested negative. Patient resumed activities outside quarantine. No Known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received bnt162b2 (BNT162B2), on 02Feb2021 at 14:30 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes paxloid from 08Dec2023- 10Dec2023.   Additional information: No other medications was given in two weeks.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Nov2022 as dose 4 (booster), single (Lot number: G56738) at the age of 66 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EL9264), in left arm, on 26Feb2021 as dose 2, single (Lot number: EN6202) and on 11Oct2021 as dose 3 (booster), single (Lot number: 301558A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Reactive airway disease" (unspecified if ongoing), notes: Other medical history: reactive airway disease; "GERD" (unspecified if ongoing), notes: Other medical history: GERD; "upper respiratory disease" (unspecified if ongoing), notes: Other medical history: upper respiratory disease. The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Known allergies: Tetracycline", notes: Known allergies: Tetracycline; Levaquin, reaction(s): "Known allergies: Levaquin", notes: Known allergies: Levaquin,; Naproxen, reaction(s): "Known allergies: naproxen", notes: Known allergies: naproxen,; Amitiza, reaction(s): "Known allergies: amitiza", notes: Known allergies: amitiza. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Other medication in 2weeks reported no.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis
Clinical narrative: localized cellulitis after vaccination; Initial information was received on 01-Dec-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2023SA378450(CLUSTER) and 2023SA378451(CLUSTER).  This case involves a 2 years old female patient who experienced localized cellulitis after vaccination after receiving influenza quadrival A-B vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Oct-2023, the patient received a dose of 0.5 ml of suspect influenza quadrival A-B vaccine  (Suspension for injection) (lot UT8219KA, Expiry date:30-Jun-2024 with strength was unknown) via intramuscular route in the left thigh for Immunization.  On an unknown date the patient developed localized cellulitis after vaccination (cellulitis) (unknown latency) following the administration of influenza quadrival A-B vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event.