chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Influenza like illness, Nasal congestion, Pain, Pain in extremity
Clinical narrative: respiratory issues.; Long covid; congestion; cough; sore arm; flu like symptoms; ache/pain; This spontaneous case was reported by a patient and describes the occurrence of RESPIRATORY DISORDER (respiratory issues.), POST-ACUTE COVID-19 SYNDROME (Long covid), NASAL CONGESTION (congestion), COUGH (cough) and PAIN IN EXTREMITY (sore arm) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia (She had 3 pneumonia vaccine. Since then, she has not had pneumonia.) and Premature atrial contraction (She had double heartbeat PAC (Premature Atrial contraction)). Previously administered products included for COVID-19 prophylaxis: Moderna vaccine (Dose 1 lot number 014M20A) on 12-Feb-2021, Moderna vaccine (Dose 2 lot number 032M20A) on 12-Mar-2021, Moderna vaccine (Dose 3 lot number 034F21A) on 15-Nov-2021 and Moderna vaccine (Dose 4 lot number 004M21A) on 27-May-2022. Past adverse reactions to the above products included No adverse event with Moderna vaccine, Moderna vaccine, Moderna vaccine and Moderna vaccine. Concurrent medical conditions included Allergy (has allergies all her life) and Blood pressure.    On 31-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced RESPIRATORY DISORDER (respiratory issues.), POST-ACUTE COVID-19 SYNDROME (Long covid), NASAL CONGESTION (congestion), COUGH (cough), PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (flu like symptoms) and PAIN (ache/pain). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, RESPIRATORY DISORDER (respiratory issues.), POST-ACUTE COVID-19 SYNDROME (Long covid), NASAL CONGESTION (congestion) and COUGH (cough) had not resolved and PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (flu like symptoms) and PAIN (ache/pain) was resolving.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   She has taken the booster every 6 months since then. She took antibiotic and steroid. All the symptoms of respiratory issues. It would get better and come back. She has not taken a booster since then. Her ENT Doctor rule out long COVID-19. She did not have any other symptoms. Phlegm she has to spit every morning. The steroid help took right after Christmas (Prednisone) she had all the symptoms except fever. On Feb 2020 for 3 weeks she was very sick. She took antibodies and self-medicated which did not help. No sense of smell or taste for a week. She takes blood pressure medication. She was incorrectly diagnosed with asthma and was taking asthma medication for 11 years.
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Post-acute COVID-19 syndrome, Respiratory disorder
Clinical narrative: respiratory issues.; Long covid; congestion; cough; sore arm; flu like symptoms; ache/pain; This spontaneous case was reported by a patient and describes the occurrence of RESPIRATORY DISORDER (respiratory issues.), POST-ACUTE COVID-19 SYNDROME (Long covid), NASAL CONGESTION (congestion), COUGH (cough) and PAIN IN EXTREMITY (sore arm) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia (She had 3 pneumonia vaccine. Since then, she has not had pneumonia.) and Premature atrial contraction (She had double heartbeat PAC (Premature Atrial contraction)). Previously administered products included for COVID-19 prophylaxis: Moderna vaccine (Dose 1 lot number 014M20A) on 12-Feb-2021, Moderna vaccine (Dose 2 lot number 032M20A) on 12-Mar-2021, Moderna vaccine (Dose 3 lot number 034F21A) on 15-Nov-2021 and Moderna vaccine (Dose 4 lot number 004M21A) on 27-May-2022. Past adverse reactions to the above products included No adverse event with Moderna vaccine, Moderna vaccine, Moderna vaccine and Moderna vaccine. Concurrent medical conditions included Allergy (has allergies all her life) and Blood pressure.    On 31-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced RESPIRATORY DISORDER (respiratory issues.), POST-ACUTE COVID-19 SYNDROME (Long covid), NASAL CONGESTION (congestion), COUGH (cough), PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (flu like symptoms) and PAIN (ache/pain). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, RESPIRATORY DISORDER (respiratory issues.), POST-ACUTE COVID-19 SYNDROME (Long covid), NASAL CONGESTION (congestion) and COUGH (cough) had not resolved and PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (flu like symptoms) and PAIN (ache/pain) was resolving.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   She has taken the booster every 6 months since then. She took antibiotic and steroid. All the symptoms of respiratory issues. It would get better and come back. She has not taken a booster since then. Her ENT Doctor rule out long COVID-19. She did not have any other symptoms. Phlegm she has to spit every morning. The steroid help took right after Christmas (Prednisone) she had all the symptoms except fever. On Feb 2020 for 3 weeks she was very sick. She took antibodies and self-medicated which did not help. No sense of smell or taste for a week. She takes blood pressure medication. She was incorrectly diagnosed with asthma and was taking asthma medication for 11 years.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pain in extremity, Pyrexia, Vaccination site erythema
Clinical narrative: sore arm; little fever; tiredness; achy joints; she noticed a red spot on the injection site; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (little fever), FATIGUE (tiredness), ARTHRALGIA (achy joints) and VACCINATION SITE ERYTHEMA (she noticed a red spot on the injection site) in a 71-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included Pre-diabetic. Previously administered products included for Product used for unknown indication: covid-19 vaccine (Lot number: EN6198) on 05-Mar-2021, covid-19 vaccine (lot number: ER7828) on 26-Mar-2021, covid-19 vaccine (lot number: FF2590) on 23-Oct-2021 and covid-19 vaccine (lot number: 049L27A) on 15-May-2022. Past adverse reactions to the above products included No adverse event with covid-19 vaccine, covid-19 vaccine, covid-19 vaccine and covid-19 vaccine. Concurrent medical conditions included Blood pressure high and Stress.    On 13-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 14-Nov-2023, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (little fever), FATIGUE (tiredness) and ARTHRALGIA (achy joints). In November 2023, the patient experienced VACCINATION SITE ERYTHEMA (she noticed a red spot on the injection site). At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (little fever), FATIGUE (tiredness), ARTHRALGIA (achy joints) and VACCINATION SITE ERYTHEMA (she noticed a red spot on the injection site) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  A consumer stated that she had the Spikevax on 13-Nov-2023.   On 14-Nov-2023, she had a little fever, achy joints and tiredness and sore arm. The pharmacist, she stated did not use the usual band aid - it was like a foam that was placed on the injection site and it came off last night, 15-Nov-2023. That was when she noticed a red spot on the injection site.  No treatment medication information was provided.
Age: 53.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Arthropathy, Pain in extremity, Pyrexia, Trigger finger
Clinical narrative: his hands were screwed up. He could not make a fist.; trigger finger; He states that his feet hurt a little bit, but not a lot; fever; This spontaneous case was reported by a patient and describes the occurrence of ARTHROPATHY (his hands were screwed up. He could not make a fist.), TRIGGER FINGER (trigger finger), PAIN IN EXTREMITY (He states that his feet hurt a little bit, but not a lot) and PYREXIA (fever) in a 53-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (He stated that all the previous vaccines he received were Pfizer. His last shot was in 2022.) in 2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.   On 13-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 14-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced ARTHROPATHY (his hands were screwed up. He could not make a fist.). In November 2023, the patient experienced TRIGGER FINGER (trigger finger), PAIN IN EXTREMITY (He states that his feet hurt a little bit, but not a lot) and PYREXIA (fever). At the time of the report, ARTHROPATHY (his hands were screwed up. He could not make a fist.), TRIGGER FINGER (trigger finger), PAIN IN EXTREMITY (He states that his feet hurt a little bit, but not a lot) and PYREXIA (fever) had not resolved.            No concomitant medications were reported.  The patient received Spikevax vaccine on 13-Nov-2023 around 6 PM in the left arm. He had received a Flu shot in the right arm at the same time. He stated that all the previous vaccines he received were of Pfizer. His last shot was in 2022. On 14-Nov-2023, in the morning, his hands were screwed up. He could not make a fist. He now had trigger fingers. He stated that he never had trigger fingers prior to vaccination. He refused to share the physician's name who diagnosed him with trigger fingers. The physician told him that he had trigger finger in 8 fingers. He had a little fever. He stated that his left hand was much worst than the right hand. He still could not use the left hand to hold anything. The right hand was a little better. He stated that his feet hurt a little bit, but not a lot.  No treatment medications were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This prompted her to test for COVID, which came back positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (This prompted her to test for COVID, which came back positive) in a 69-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031912) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (dose 1, lot no. 004M10A) on 12-Feb-2021, Moderna COVID-19 vaccine (dose 2, lot no. 0011321A) on 13-Mar-2021, Moderna COVID-19 vaccine (dose 3, lot no. 024D21A) on 22-Oct-2021, Moderna COVID-19 vaccine (dose 4, lot no. 008W214) on 12-Apr-2022, MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) (dose 5 and lot no. AS7164B) on 30-Sep-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5), Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and Moderna COVID-19 vaccine.    On 03-Nov-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 14-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced COVID-19 (This prompted her to test for COVID, which came back positive). At the time of the report, COVID-19 (This prompted her to test for COVID, which came back positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2023, SARS-CoV-2 test: Positive.         No concomitant medications were reported.  The patient stated that on 14-Nov-2023, she woke up with her throat feeling terrible. Her head hurt with a pounding headache. She was sneezing and blowing her nose and had a whole body ache. This prompted her to test for COVID, which came back positive. She also felt like a sloth and did not want to move at all. She says that she was still coughing and her throat still felt sore, but it was not as bad as before. She also still had a headache but that too, was not as bad as before. She felt like she was on the "uptick" with her symptoms. She said that it felt like COVID was more prevalent than the flu, but goes unnoticed because people were only doing home tests.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-750144 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750144:Daughter case
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Illness
Clinical narrative: Caller was bedridden with Moderna; When they get the shot they get sick for 3 days; This spontaneous case was reported by a patient and describes the occurrence of BEDRIDDEN (Caller was bedridden with Moderna) and ILLNESS (When they get the shot they get sick for 3 days) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 039B21A and 001B21A) for COVID-19 prophylaxis.     The patient's past medical history included Acid reflux (esophageal) and Hepatitis B (Hep B Carrier). Concomitant products included ENTECAVIR, FAMOTIDINE, VITAMINS NOS and ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced ILLNESS (When they get the shot they get sick for 3 days). On an unknown date, the patient experienced BEDRIDDEN (Caller was bedridden with Moderna). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Mar-2021, ILLNESS (When they get the shot they get sick for 3 days) had resolved. At the time of the report, BEDRIDDEN (Caller was bedridden with Moderna) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered BEDRIDDEN (Caller was bedridden with Moderna) to be related. No further causality assessment was provided for ILLNESS (When they get the shot they get sick for 3 days).    Reported that when patient got the shot, she got sick for 3 days. She was bedridden with Moderna. She took Tylenol and weathered it at home. Patient most likely would have gotten the flu shot.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This prompted her to test for COVID, which came back positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (This prompted her to test for COVID, which came back positive) in a 39-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Nov-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 14-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced COVID-19 (This prompted her to test for COVID, which came back positive). At the time of the report, COVID-19 (This prompted her to test for COVID, which came back positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Nov-2023, SARS-CoV-2 test: (Positive) This prompted her to test for COVID, which came back positive..     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.    Caller stated that she and her daughter received a dose of the Spikevax 2023-2024 vaccine on 3 NOV 2023. This was the patients sixth dose. Caller states that on 14 NOV 2023, she woke up with her throat feeling terrible. Her head hurt with a pounding headache. She was sneezing and blowing her nose and had a whole body ache. This prompted her to test for COVID, which came back positive. She also felt like a sloth and did not want to move at all. She says that she was still coughing and her throat still feels sore, but it was not as bad as before. She also still has a headache but that too, was not as bad as before. She felt like she was on the "uptick" with her symptoms. She says that it feels like COVID is more prevalent than the flu, but goes unnoticed because people are only doing home tests.   This case was linked to US-MODERNATX, INC.-MOD-2023-750124 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750124:Daughter case
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cystitis
Clinical narrative: felt like I had a bladder infection; This spontaneous case was reported by a patient and describes the occurrence of CYSTITIS (felt like I had a bladder infection) in a 71-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058492) for COVID-19 prophylaxis.     The patient's past medical history included Knee replacement in September 2023.    On 16-Nov-2023 at 5:00 PM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In November 2023, the patient experienced CYSTITIS (felt like I had a bladder infection). The patient was treated with AMOXICILLIN for Bladder infection, at an unspecified dose and frequency. At the time of the report, CYSTITIS (felt like I had a bladder infection) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reported that after administration of vaccine patient felt like she had a bladder infection and took left over Amoxicillin. Patient stated it was prescribed for a bladder infection.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Feeling abnormal, Heart rate, Influenza A virus test
Clinical narrative: Polio; Not eating; Noticeably feeling bad; feeling lousy; Croupy cough; Went to bed right after and he has been in bed ever since; Muscle pains; This serious, initial spontaneous safety report from Country was received by Novavax on 08-NOV-2023 from a consumer via the contact center.  A male of 27 years was vaccinated with intramuscular use Novavax Covid-19 Vaccine and Adjuvanted (2023-2024 Formula) 0.5 milliliter suspect Covid-19 vaccine dose 5 on the right side on 01-NOV-2023 at 4:30 PM at a pharmacy.  The following medical history was reported: Hypertension, Hypersensitivity to Accutane (isotretinoin), Haldol (haloperidol), and cephalosporins, and previous vaccinations with Pfizer COVID-19 vaccination (tozinameran), primary series, on 20-MAR-2021 (unknown which primary series dose was administered on this date) and on an unspecified date, first booster on 09-APR-2021 and second booster on 23-OCT-2021.  The following concomitant medications were reported: levothyroxine, olanzapine, benztropine, lithium carbonate, and "listerol".  On 04-NOV-2023 around 4 PM, 2 days 7 hrs 30 minutes after vaccination, the individual experienced noticeably feeling bad (PT: Feeling abnormal). He didn't want to eat (PT: Decreased appetite). He went straight to bed and had been there ever since (PT: Unevaluable event), and had continued to eat. On an unspecified day in NOV-2023, after vaccination, the individual had muscle pains (PT: Myalgia) and thought he might have polio (PT: Poliomyelitis) (Serious: Medically Significant), and had a croupy cough (PT: Cough) he thought was weird. He went to an urgent care on 06-NOV-2023, in which the doctor listened to his heart (115 beats/minute), and tested him for Influenza A & B, for which he was negative. He took a rapid COVID-19 test at home, and that was negative. The clinical impression of the doctor was that the symptoms were side effects of the Novavax COVID-19 Vaccine.  Relevant lab tests included: Influenza A virus test (Result: negative; 06-NOV-2023), Influenza B virus test (Result: negative; 06-NOV-2023), SARS-CoV-2 test (Result: negative; 06-NOV-2023) and Heart rate (Result:115 heart beats per minute; 06-NOV-2023).  At the time of reporting, the event outcomes of Feeling abnormal, Cough, and Myalgia were not recovered/not resolved, and event outcomes of Poliomyelitis, Decreased appetite and Unevaluable event were unknown.  Lot number was requested but unknown.; Sender's Comments: This 27 year-old male experienced: Poliomyelitis, Decreased appetite, Unevaluable event, Feeling abnormal, Cough and Myalgia after vaccination with Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter. The event Poliomyelitis was assessed as serious. The events Decreased appetite, Unevaluable event, Feeling abnormal, Cough and Myalgia were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) and the reported events is considered Possible.
Sex: U
Vaccine: COVID19
Symptoms: Influenza B virus test, Myalgia, Poliomyelitis, SARS-CoV-2 test, Unevaluable event
Clinical narrative: Polio; Not eating; Noticeably feeling bad; feeling lousy; Croupy cough; Went to bed right after and he has been in bed ever since; Muscle pains; This serious, initial spontaneous safety report from Country was received by Novavax on 08-NOV-2023 from a consumer via the contact center.  A male of 27 years was vaccinated with intramuscular use Novavax Covid-19 Vaccine and Adjuvanted (2023-2024 Formula) 0.5 milliliter suspect Covid-19 vaccine dose 5 on the right side on 01-NOV-2023 at 4:30 PM at a pharmacy.  The following medical history was reported: Hypertension, Hypersensitivity to Accutane (isotretinoin), Haldol (haloperidol), and cephalosporins, and previous vaccinations with Pfizer COVID-19 vaccination (tozinameran), primary series, on 20-MAR-2021 (unknown which primary series dose was administered on this date) and on an unspecified date, first booster on 09-APR-2021 and second booster on 23-OCT-2021.  The following concomitant medications were reported: levothyroxine, olanzapine, benztropine, lithium carbonate, and "listerol".  On 04-NOV-2023 around 4 PM, 2 days 7 hrs 30 minutes after vaccination, the individual experienced noticeably feeling bad (PT: Feeling abnormal). He didn't want to eat (PT: Decreased appetite). He went straight to bed and had been there ever since (PT: Unevaluable event), and had continued to eat. On an unspecified day in NOV-2023, after vaccination, the individual had muscle pains (PT: Myalgia) and thought he might have polio (PT: Poliomyelitis) (Serious: Medically Significant), and had a croupy cough (PT: Cough) he thought was weird. He went to an urgent care on 06-NOV-2023, in which the doctor listened to his heart (115 beats/minute), and tested him for Influenza A & B, for which he was negative. He took a rapid COVID-19 test at home, and that was negative. The clinical impression of the doctor was that the symptoms were side effects of the Novavax COVID-19 Vaccine.  Relevant lab tests included: Influenza A virus test (Result: negative; 06-NOV-2023), Influenza B virus test (Result: negative; 06-NOV-2023), SARS-CoV-2 test (Result: negative; 06-NOV-2023) and Heart rate (Result:115 heart beats per minute; 06-NOV-2023).  At the time of reporting, the event outcomes of Feeling abnormal, Cough, and Myalgia were not recovered/not resolved, and event outcomes of Poliomyelitis, Decreased appetite and Unevaluable event were unknown.  Lot number was requested but unknown.; Sender's Comments: This 27 year-old male experienced: Poliomyelitis, Decreased appetite, Unevaluable event, Feeling abnormal, Cough and Myalgia after vaccination with Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter. The event Poliomyelitis was assessed as serious. The events Decreased appetite, Unevaluable event, Feeling abnormal, Cough and Myalgia were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) and the reported events is considered Possible.
Sex: U
Vaccine: RSV
Symptoms: Fatigue, Injection site pain
Clinical narrative: Three patients have been seen in follow-up visits and have reported mild injection site pain; fatigue; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  An elderly patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), in Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Oct2023, outcome "unknown", described as "Three patients have been seen in follow-up visits and have reported mild injection site pain"; FATIGUE (non-serious) with onset Oct2023, outcome "unknown". Therapeutic measures were not taken as a result of vaccination site pain, fatigue.  Additional information: It was reported that the RSV older adult vaccine was prescribed to approximately 7 patients. Three patients have been seen in follow-up visits and have reported mild injection site pain and fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300362628 Same product and event; different patient;US-PFIZER INC-202300362807 Same product and event; different patient;
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 43-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "known allergies: Second generation cephalosporins" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid treatment from 01Nov2023 to 05Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a vaccine varies individually and can be affected by different factors including product potency. However, a contributory role of bnt162b2 omi xbb.1.5 to the events Vaccination failure and Covid-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300367219 same patient/vaccine, different drug/event (Paxlovid case);
Sex: M
Vaccine: RSV
Symptoms: Diarrhoea
Clinical narrative: came down with chronic diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 06Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset Oct2023, outcome "recovered", described as "came down with chronic diarrhea". Additional information: the patient received the vaccine on 06Oct2023, stating this was about 5 weeks ago. A week later after getting the vaccine, the patient came down with chronic diarrhea and it has persisted for a solid four weeks.         The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and  when received.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: got hives all over her arms, chest and neck.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 61-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Nov2023 at 11:00 as dose 1, single (Lot number: HG5967) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "help her sleep" (unspecified if ongoing), notes: taking a bunch of medicine to help her sleep. The patient's concomitant medications were not reported. Vaccination history included: comirnaty (DOSE 1, single, Lot number: EH9899, Anatomical Site: left arm), administration date: 18Dec2020, when the patient was 58-year-old, for covid-19 immunisation, reaction(s): "without any problems"; comirnaty (DOSE 2, single, Lot number: EK9231, Anatomical Site: left arm), administration date: 08Jan2021, when the patient was 58-year-old, for covid-19 immunisation, reaction(s): "without any problems"; comirnaty (DOSE 3, single, Lot number: FF2590, Anatomical Site: left arm), administration date: 06Oct2021, when the patient was 59-year-old, for covid-19 immunisation, reaction(s): "without any problems"; comirnaty original/omicron ba.4-5 (DOSE 4, single, Lot number: GH9693, Anatomical Site: left arm), administration date: 13Oct2022, when the patient was 60-year-old, for covid-19 immunisation, reaction(s): "without any problems"; Flu vaccine (definitely not within 4 weeks of booster), for immunisation. The following information was reported: URTICARIA (medically significant) with onset 06Nov2023 at 12:00, outcome "not recovered", described as "got hives all over her arms, chest and neck.". The events "got hives all over her arms, chest and neck." required emergency room visit. Therapeutic measures were taken as a result of urticaria. Clinical course: Patient clarified that last one (refers to dose 4) was 13Oct2022, she just figured that it would be good thing because she works in hospital. So many people come in with Covid, thought she should get booster. Because she works at hospital, they make sure she has flu vaccination, was definitely not within 4 weeks of booster. Patient has had other Pfizer vaccinations without any problems. This time, she got Pfizer Covid-19 booster at 11AM on 06Nov2023 and noticed hives within the hour (also reported as about hour after shot at 11AM), she had really bad reaction: got hives all over her arms, chest and neck. Patient had to go to emergency room (clarified admission to hospital was not involved), everyone at the emergency room asked what was happening to her neck, was scratching like crazy. They (HCPs) prescribed her Prednisone 60mg per day for 5 days. Aside from the Prednisone, she has been taking BENADRYL. As soon as she came off it, the hives came back but not as severe. She is still getting hives. The events "got hives all over her arms, chest and neck." required emergency room visit. Therapeutic measures were taken as a result of urticaria. Outcome of the event was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid and have been very sick ever since; tested positive for Covid and have been very sick ever since; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  An 80-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "not recovered" and all described as "tested positive for Covid and have been very sick ever since". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) positive, notes: One month later tested positive for Covid. Clinical course: One month later patient tested positive for Covid and had been very sick ever since. The patient was fully vaccinated and never had Covid.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300186615 same reporter/drug/event, different patient;
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 13:00 as dose1, single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Nov2023) negative. Therapeutic measures were taken as a result of vaccination failure, Covid-19 with Paxlovid from 31Oct2023 to 04Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300370083 Same reporter/patient, different drug, different AE;
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 05Nov2023 to 09Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300370233 Same patient/same product, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment
Clinical narrative: sometimes I don't remember very well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "sometimes I don't remember very well".
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Ageusia
Clinical narrative: taste is off; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Nov2023 as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 09Nov2023 as dose 1, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, lot number unknown), for COVID-19 immunisation; Bnt162b2 (Dose 2, lot number unknown), for COVID-19 immunisation; Bnt162b2 (Dose 3 (booster), lot number unknown), for COVID-19 immunisation; Bnt162b2 (Dose 4 (booster), lot number unknown), for COVID-19 immunisation; Bnt162b2 (Dose 5 (booster), lot number unknown), for COVID-19 immunisation. The following information was reported: AGEUSIA (non-serious) with onset Nov2023, outcome "not recovered", described as "taste is off". Additional information: the patient mentioned he has been with Pfizer when it comes to his COVID-19 vaccinations. He started with 2 Pfizer shots and at least three boosters after that. Caller mentioned that he got the flu vaccine on one arm in the morning and then a few hours later in the afternoon, he got the Pfizer Covid-19 vaccine on another arm on the same day, 09Nov2023. Three days later, he noticed that his "taste is off" and adds "I can taste things up front and then as I continue to chew, the taste is like paste or something." "It is still going on today... about 4 or 5 days now."  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: 102 degrees fever; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 72-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "102 degrees fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller is calling in regard a patient who took the Prevnar 13 vaccine but experienced a 102 degrees fever. She wants to know if the patient can take Prevnar 20.   The information on the batch/lot number for pneumococcal 13-val conj vac (dipht crm197 protein) has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she tested positive for COVID; she tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group, Program ID. The reporter is the patient.  A 70-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Nov2023 at 10:15 as dose 1, single (Lot number: HF9298) at the age of 70 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 27Oct2023 as dose 2, single (Batch/Lot number: unknown). The patient's relevant medical history included: "High Blood Pressure" (ongoing), notes: High Blood Pressure; "Cholesterol" (ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension. Vaccination history included: Bnt162b2 (Dose 1, LOT#: EL9262), administration date: Jan2021, when the patient was 67 years old, for COVID-19 immunization; Bnt162b2 (Dose 2, LOT#: EN6199), administration date: Jul2022, when the patient was 69 years old, for COVID-19 immunization, reaction(s): "had no problem at all"; Flu shot (Dose 1), administration date: Jul2022, when the patient was 69 years old, for immunization, reaction(s): "had no problem at all". The patient had never had Covid. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Nov2023, outcome "recovering" and all described as "she tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Nov2023) positive, notes: tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient took Lisinopril for High blood pressure which it was under control she took something for Cholesterol. She received Comirnaty booster, the newest formulation on last Thursday (09Nov2023), and on Sunday night (12Nov2023) she started feeling chills and got tired, by Monday (13Nov2023), she came up with all of them (headache, diarrhea, fever, chills, upset stomach, cough), then on Tuesday (14Nov2023), she tested herself in which she was positive for COVID. she had no idea how she would have gotten COVID as they did everything outside. She went to church inside and was recently exposed to someone who had pneumonia, and she didn't go around big groups of people and they were very careful. She had been prescribed Paxlovid, however she wasn't going to take it as she wasn't getting worse, and was only getting better or maintaining. The patient had taken Mucinac (usually took three times a day, took at 6:30 in the morning then at like 3:30 in the afternoon and then took later on before went to bed at around eleven, three capsules, three times a day), Tylenol and Advil for treatment. Mucinac took two and today (16Nov2023), she cut it back to one because some of them was giving her horrible diarrhea and she did not know what that was.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300380669 Same patient/drug, different dose/event;
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Medical assistant stated that the wrong vaccine was pulled from the refrigerator and there was no double check done prior to administration.; This spontaneous report was received from Other Health Professional and refers to a 6-month-old female. The patient's pertinent medical history and concomitant therapies were not reported.  On 08-NOV-2023, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, one time, lot # w029533, expiration date: 07-OCT-2024, administered intramuscularly for prophylaxis (strength was not provided).  On 08-NOV-2023, the medical assistant stated that the wrong vaccine (Wrong vaccine administered) was pulled from the refrigerator and there was no double check done prior to administration.
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Illness
Clinical narrative: Had to call in sick to work; This is a spontaneous report received from non-contactable reporter(s) (Pharmacist). The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COVID-19 VACCINE OMI XBB.1.5 - MANUFACTURER UNKNOWN), on 13Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), on 13Nov2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 14Nov2023, outcome "unknown", described as "Had to call in sick to work". Additional information: reporter got the Covid booster and the Shringrex Vaccine on the same day and the following day had to call in sick to work. Caller does not know whose Covid Booster it is, who manufactured the Covid Booster, but wanted to report details provided.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Macular Rash across abdomen and the back 3 days after vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Lot number: Unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH MACULAR (non-serious), 3 days after the suspect product(s) administration, outcome "recovered", described as "Macular Rash across abdomen and the back 3 days after vaccination". Therapeutic measures were not taken as a result of rash macular.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: since I began taking my first Covid vaccine, i began getting rash, thought just getting the hives from something; since I began taking my first Covid vaccine, i began getting rash, thought just getting the hives from something; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), as dose 1, 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: RASH (non-serious), URTICARIA (non-serious), outcome "unknown" and all described as "since I began taking my first Covid vaccine, i began getting rash, thought just getting the hives from something". The event "since i began taking my first covid vaccine, i began getting rash, thought just getting the hives from something" required physician office visit. The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PVSame product and patient; different dose and events Same product and patient; different dose and events;