chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Headache
Clinical narrative: Headache; Fogginess; This case was reported by a consumer via call center representative and described the occurrence of headache in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on July 2022, refer case US2022150609.).   On 16th September 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 17th September 2022, 1 days after receiving Shingrix, the patient experienced headache and foggy feeling in head. On an unknown date, the outcome of the headache and foggy feeling in head were not recovered/not resolved.   It was unknown if the reporter considered the headache and foggy feeling in head to be related to Shingrix.   Linked case(s) involving the same patient:US2022150609   Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's Comment: The reporter was a patient. The patient reported that she received 2nd dose of Shingrix vaccine. It was reported that the following day, she woke up with a headache and fogginess.  The patient stated that this was still happening, and she constantly felt this way. The reporter did consent to follow up. Additional supportive information: for the tolerance of the 1st dose, refer linked case US2022150609, reported by same reporter.; Sender's Comments:  US-GSK-US2022150609:Same reporter
Sex: F
Vaccine: PPV, PNC20, PNC15, PPV
Symptoms: Muscular weakness, Pain in extremity, Peripheral swelling
Clinical narrative: The arm she received the vaccine in started to swell adn she felt pain; The arm she received the vaccine in started to swell adn she felt pain; Suffers from short term memory loss; "When I go to raise my arm I have to use my other arm to lift it up"; This spontaneous report has been received from a consumer referring to herself, a 83-year-old female patient. The patient's pertinent medical history included hypothyroidism. Concomitant therapies included: metformin, losartan, euthyrox, glipizide, clopidogrel, atorvastatin, metoprolol, baby aspirin, and benzonatate. The patient's previous drug reactions or allergies were not provided.  On 22-MAR-2022, the patient was vaccinated with an unspecified pneumoccocal injection vaccine administered as prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number and expiration date were not provided).  On 23-MAR-2022, the patient experienced swell and pain in the arm where she received the vaccine (vaccination site swelling) (vaccination site pain). On an unknown date in 2022, when the patient went to raise her arm she had to use her other arm to lift something up (injected limb mobility decreased); additionally, she experienced short term memory loss (amnesia). At the time of reporting, she had not recovered from any of the events. The causal relationship between the events and the unspecified pneumococcal vaccine was not provided.
Sex: F
Vaccine: PPV, PNC20, PNC15, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: The arm she received the vaccine in started to swell adn she felt pain; The arm she received the vaccine in started to swell adn she felt pain; Suffers from short term memory loss; "When I go to raise my arm I have to use my other arm to lift it up"; This spontaneous report has been received from a consumer referring to herself, a 83-year-old female patient. The patient's pertinent medical history included hypothyroidism. Concomitant therapies included: metformin, losartan, euthyrox, glipizide, clopidogrel, atorvastatin, metoprolol, baby aspirin, and benzonatate. The patient's previous drug reactions or allergies were not provided.  On 22-MAR-2022, the patient was vaccinated with an unspecified pneumoccocal injection vaccine administered as prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number and expiration date were not provided).  On 23-MAR-2022, the patient experienced swell and pain in the arm where she received the vaccine (vaccination site swelling) (vaccination site pain). On an unknown date in 2022, when the patient went to raise her arm she had to use her other arm to lift something up (injected limb mobility decreased); additionally, she experienced short term memory loss (amnesia). At the time of reporting, she had not recovered from any of the events. The causal relationship between the events and the unspecified pneumococcal vaccine was not provided.
Sex: F
Vaccine: PPV, PNC20, PNC15, PPV
Symptoms: Amnesia, Injected limb mobility decreased, Vaccination site pain, Vaccination site swelling
Clinical narrative: The arm she received the vaccine in started to swell adn she felt pain; The arm she received the vaccine in started to swell adn she felt pain; Suffers from short term memory loss; "When I go to raise my arm I have to use my other arm to lift it up"; This spontaneous report has been received from a consumer referring to herself, a 83-year-old female patient. The patient's pertinent medical history included hypothyroidism. Concomitant therapies included: metformin, losartan, euthyrox, glipizide, clopidogrel, atorvastatin, metoprolol, baby aspirin, and benzonatate. The patient's previous drug reactions or allergies were not provided.  On 22-MAR-2022, the patient was vaccinated with an unspecified pneumoccocal injection vaccine administered as prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number and expiration date were not provided).  On 23-MAR-2022, the patient experienced swell and pain in the arm where she received the vaccine (vaccination site swelling) (vaccination site pain). On an unknown date in 2022, when the patient went to raise her arm she had to use her other arm to lift something up (injected limb mobility decreased); additionally, she experienced short term memory loss (amnesia). At the time of reporting, she had not recovered from any of the events. The causal relationship between the events and the unspecified pneumococcal vaccine was not provided.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nasal congestion
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Jan2021 at 14:40 as dose 1, single (Lot number: EL3246), in right arm, on 20Feb2021 at 14:30 as dose 2, single (Lot number: EN9581), in right arm, on 24Sep2021 at 12:00 as dose 3 (booster), single (Lot number: FC3182), in right arm and on 31Mar2022 at 16:20 as dose 4 (booster), single (Lot number: FJ9943), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Oct2022, outcome "unknown" and all described as "tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test: (10Oct2022) positive.  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: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Jan2021 at 14:40 as dose 1, single (Lot number: EL3246), in right arm, on 20Feb2021 at 14:30 as dose 2, single (Lot number: EN9581), in right arm, on 24Sep2021 at 12:00 as dose 3 (booster), single (Lot number: FC3182), in right arm and on 31Mar2022 at 16:20 as dose 4 (booster), single (Lot number: FJ9943), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Oct2022, outcome "unknown" and all described as "tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test: (10Oct2022) positive.  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: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-1 test, Vaccination failure
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Jan2021 at 14:40 as dose 1, single (Lot number: EL3246), in right arm, on 20Feb2021 at 14:30 as dose 2, single (Lot number: EN9581), in right arm, on 24Sep2021 at 12:00 as dose 3 (booster), single (Lot number: FC3182), in right arm and on 31Mar2022 at 16:20 as dose 4 (booster), single (Lot number: FJ9943), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Oct2022, outcome "unknown" and all described as "tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test: (10Oct2022) positive.  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.
Age: 10.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Age for Vaccine Given-
Age: 10.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Wrong Age for Vaccine Given-
Age: 81.0
Sex: M
Vaccine: COVID19, FLUX, COVID19, FLUX
Symptoms: COVID-19, Fatigue, Nausea, Pain in extremity, SARS-CoV-2 test
Clinical narrative: I tested positive for Covid-19 with home test; I felt nauseated all the time; I felt drug out & tired; I had sore arms; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (I had sore arms), FATIGUE (I felt drug out & tired), NAUSEA (I felt nauseated all the time) and COVID-19 (I tested positive for Covid-19 with home test) in an 81-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   On 14-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) at an unspecified dose. On 15-Oct-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced PAIN IN EXTREMITY (I had sore arms). On 16-Oct-2022, the patient experienced FATIGUE (I felt drug out & tired). On 17-Oct-2022, the patient experienced NAUSEA (I felt nauseated all the time). On 18-Oct-2022, the patient experienced COVID-19 (I tested positive for Covid-19 with home test). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from October 2022 to October 2022 at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (I had sore arms), FATIGUE (I felt drug out & tired), NAUSEA (I felt nauseated all the time) and COVID-19 (I tested positive for Covid-19 with home test) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Oct-2022, SARS-CoV-2 test: Positive.         Concomitant product use was not provided by the reporter. Patient received 1st dose on 06 Jan 2021, Lot: 02520A, 2nd dose on 03 Feb 2021, Lot: 032L20A, 1st booster on 19 Aug 2021, Lot: 091C21A and 2nd booster on 24 May2 022, Lot: 059A22A. On 14-Oct-2022, the patient received flu shot. As of on 25 OCT 2022, he was feeling 90% like himself.   This case was linked to MOD-2021-005974, MOD-2021-293563 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2022: Patient demographics updated. Treatment drug reported and outcome updated.
Age: 5.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 5.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 58.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Peripheral swelling, Skin discolouration
Clinical narrative: i had the regular flu shot that hospital provides. i do not know the exact name of it. my hospital has already submitted some adverse events but i have another two symptoms that have not been reported. i now have high blood pressure and a  much higher heartrate than i ever had before.
Age: 58.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Heart rate increased, Hypertension
Clinical narrative: i had the regular flu shot that hospital provides. i do not know the exact name of it. my hospital has already submitted some adverse events but i have another two symptoms that have not been reported. i now have high blood pressure and a  much higher heartrate than i ever had before.
Age: 73.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Peripheral swelling, Skin discolouration
Clinical narrative: Patient came the second day with a big bruise on her left arm, the bruise was at the injection site and extends down to her elbows. The bruise was purple to blue in color
Age: 73.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site bruising
Clinical narrative: Patient came the second day with a big bruise on her left arm, the bruise was at the injection site and extends down to her elbows. The bruise was purple to blue in color
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Bedridden, Fatigue
Clinical narrative: sore right arm; tired; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (sore right arm) and FATIGUE (tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 017F21A, 031A21A and 032M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2022, the patient experienced VACCINATION SITE PAIN (sore right arm) and FATIGUE (tired). At the time of the report, VACCINATION SITE PAIN (sore right arm) and FATIGUE (tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2022-663083, MOD-2022-663113, MOD-2022-663121, MOD-2022-663126 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Fatigue, Vaccination site pain
Clinical narrative: sore right arm; tired; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (sore right arm) and FATIGUE (tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 017F21A, 031A21A and 032M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2022, the patient experienced VACCINATION SITE PAIN (sore right arm) and FATIGUE (tired). At the time of the report, VACCINATION SITE PAIN (sore right arm) and FATIGUE (tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2022-663083, MOD-2022-663113, MOD-2022-663121, MOD-2022-663126 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: sore right arm; tired; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (sore right arm) and FATIGUE (tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 017F21A, 031A21A and 032M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2022, the patient experienced VACCINATION SITE PAIN (sore right arm) and FATIGUE (tired). At the time of the report, VACCINATION SITE PAIN (sore right arm) and FATIGUE (tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2022-663083, MOD-2022-663113, MOD-2022-663121, MOD-2022-663126 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: sore right arm; tired; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (sore right arm) and FATIGUE (tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 017F21A, 031A21A and 032M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2022, the patient experienced VACCINATION SITE PAIN (sore right arm) and FATIGUE (tired). At the time of the report, VACCINATION SITE PAIN (sore right arm) and FATIGUE (tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2022-663083, MOD-2022-663113, MOD-2022-663121, MOD-2022-663126 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Bedridden, Fatigue
Clinical narrative: really tired; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (really tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 031A21A and 032M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (really tired). At the time of the report, FATIGUE (really tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The patient received first Moderna Covid 19 vaccine booster dose on 23-Dec-2021 on right arm of administration. Patient was really tired. No treatment medications were provided   This case was linked to MOD-2022-663083, MOD-2022-663104, MOD-2022-663121, MOD-2022-663126 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Fatigue, Vaccination site pain
Clinical narrative: really tired; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (really tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 031A21A and 032M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (really tired). At the time of the report, FATIGUE (really tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The patient received first Moderna Covid 19 vaccine booster dose on 23-Dec-2021 on right arm of administration. Patient was really tired. No treatment medications were provided   This case was linked to MOD-2022-663083, MOD-2022-663104, MOD-2022-663121, MOD-2022-663126 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: really tired; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (really tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 031A21A and 032M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (really tired). At the time of the report, FATIGUE (really tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The patient received first Moderna Covid 19 vaccine booster dose on 23-Dec-2021 on right arm of administration. Patient was really tired. No treatment medications were provided   This case was linked to MOD-2022-663083, MOD-2022-663104, MOD-2022-663121, MOD-2022-663126 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: really tired; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (really tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 031A21A and 032M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (really tired). At the time of the report, FATIGUE (really tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The patient received first Moderna Covid 19 vaccine booster dose on 23-Dec-2021 on right arm of administration. Patient was really tired. No treatment medications were provided   This case was linked to MOD-2022-663083, MOD-2022-663104, MOD-2022-663121, MOD-2022-663126 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gait disturbance, Heart rate, Heart rate increased, Hypoaesthesia, Pallor
Clinical narrative: covid test result=Positive; covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 14:00 as dose 4 (booster), single (Lot number: Gh9702) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ehlers Danlos Syndrome" (unspecified if ongoing); "Known allergy: Penicillin" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Sep2022, outcome "unknown" and all described as "covid test result=Positive". The patient underwent the following laboratory tests and procedures: Heart rate: (unspecified date) 136-173, notes: my heart rate while napping was 136-173; (unspecified date) in the 60s, notes: My normal resting heart rate is in the 60s; (unspecified date) 78-164 bpm; Nasopharyngeal swab: (22Sep2022) Positive; (28Sep2022) Positive.  Clinical Course: No treatment received for Adverse event. Covid prior vaccination was yes, covid tested post vaccination was Yes.  Conclusion: The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9702. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. PGS concludes that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.; Sender's Comments: Based on limited information in the case , a possible causal association between  the reported events Drug ineffective, covid 19  and the suspect drug cannot be excluded.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Vertigo
Clinical narrative: covid test result=Positive; covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 14:00 as dose 4 (booster), single (Lot number: Gh9702) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ehlers Danlos Syndrome" (unspecified if ongoing); "Known allergy: Penicillin" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Sep2022, outcome "unknown" and all described as "covid test result=Positive". The patient underwent the following laboratory tests and procedures: Heart rate: (unspecified date) 136-173, notes: my heart rate while napping was 136-173; (unspecified date) in the 60s, notes: My normal resting heart rate is in the 60s; (unspecified date) 78-164 bpm; Nasopharyngeal swab: (22Sep2022) Positive; (28Sep2022) Positive.  Clinical Course: No treatment received for Adverse event. Covid prior vaccination was yes, covid tested post vaccination was Yes.  Conclusion: The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9702. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. PGS concludes that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.; Sender's Comments: Based on limited information in the case , a possible causal association between  the reported events Drug ineffective, covid 19  and the suspect drug cannot be excluded.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Heart rate, Nasopharyngeal swab
Clinical narrative: covid test result=Positive; covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 14:00 as dose 4 (booster), single (Lot number: Gh9702) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ehlers Danlos Syndrome" (unspecified if ongoing); "Known allergy: Penicillin" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Sep2022, outcome "unknown" and all described as "covid test result=Positive". The patient underwent the following laboratory tests and procedures: Heart rate: (unspecified date) 136-173, notes: my heart rate while napping was 136-173; (unspecified date) in the 60s, notes: My normal resting heart rate is in the 60s; (unspecified date) 78-164 bpm; Nasopharyngeal swab: (22Sep2022) Positive; (28Sep2022) Positive.  Clinical Course: No treatment received for Adverse event. Covid prior vaccination was yes, covid tested post vaccination was Yes.  Conclusion: The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9702. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. PGS concludes that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.; Sender's Comments: Based on limited information in the case , a possible causal association between  the reported events Drug ineffective, covid 19  and the suspect drug cannot be excluded.
Age: 2.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was inadvertently given two doses of Moderna COVID-19 vaccine at the visit instead of a dose of Moderna COVID vaccine and influenza vaccine. She was monitored in the clinic after the event. Patient had no immediate symptoms from the extra dose of vaccine.
Age: 2.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient was inadvertently given two doses of Moderna COVID-19 vaccine at the visit instead of a dose of Moderna COVID vaccine and influenza vaccine. She was monitored in the clinic after the event. Patient had no immediate symptoms from the extra dose of vaccine.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Exposure during pregnancy, Premature labour, SARS-CoV-2 test positive
Clinical narrative: 09/05/22 presents to Birth Center Triage for "contractions" "38w0d". PMHx of "Hypertension" "history of a prior preterm delivery at 32w after going into pre-term labor"
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Maternal exposure before pregnancy, SARS-CoV-2 test positive, Uterine contractions during pregnancy
Clinical narrative: 09/05/22 presents to Birth Center Triage for "contractions" "38w0d". PMHx of "Hypertension" "history of a prior preterm delivery at 32w after going into pre-term labor"
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: children received their first dose of the primary series with the Moderna bivalent vaccine booster; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (children received their first dose of the primary series with the Moderna bivalent vaccine booster) and NO ADVERSE EVENT (No adverse event) in a 10-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first 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 WRONG PRODUCT ADMINISTERED (children received their first dose of the primary series with the Moderna bivalent vaccine booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (children received their first dose of the primary series with the Moderna bivalent vaccine booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (children received their first dose of the primary series with the Moderna bivalent vaccine booster).    No concomitant medication were reported.   The Pharmacist administered Moderna vaccine to a family and 3 of the children received their first dose of the primary series with the Moderna bivalent vaccine booster.       No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Injury, Mobility decreased
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: INJURY (non-serious), outcome "unknown", described as "Injured by your COVID vaccines"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "Limited mobility in my right arm".  Additional information: Patient was injured by your COVID vaccines, patient have limited mobility in right arm. Patient would provide the documented proof of your vaccines. Patient offering you and your lawyers the opportunity to a private out-of court personal injury settlement without patient Lawyers involvement. Patient asking to contact if you are interested in a private settlement.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: MMR
Symptoms: Antibody test negative, Wrong technique in product usage process
Clinical narrative: Caller's son received measles, mumps and rubella half a dose and then received other half dose and ant bodies went up; Caller's son received measles, mumps and rubella half a dose and then received other half dose and ant bodies went up; This spontaneous report was received from Consumer (the patients's mother) and refers to a male patient of unknown age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient received measles, mumps and rubella half a dose and then received other half dose (wrong technique in product usage process) and antibodies went up (antibody test abnormal ). At the time of reporting, the outcome of the events was not known.  The relatedness between the event of antibodies went up and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  was not provided.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: brought back 2 weeks after the first Varicella and received a dose of MMR-II; This spontaneous report was received from a nurse referring to a 15-month-old female patient whose medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2022 (also reported as at 12 months old), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX); then, on an unspecified day in June 2022 (also reported as 2 weeks after, and as about 3 months ago), the patient received the vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). Both vaccines were subcutaneous injection formulations and were administered as prophylaxis (strengths, lot numbers, expiration dates, routes of administration, anatomical locations, and vaccine scheme were not reported). It was reported that the parents wanted to separate the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) instead of getting them together at one time; also, the reporter stated she knew it makes it invalid because the two live vaccines should have been separated by at least 4 weeks (inappropriate schedule of product administration). The nurse would like to know if the patient can get the measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (PROQUAD) when she comes back since they were out of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) by itself therefore would result in giving the patient an extra dose of varicella virus vaccine live (oka/merck) (VARIVAX).
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AE reported; pediatric patient (16 years old) was administered an adult dose of VAQTA.; This spontaneous report was received from a health care professional (HCP) referring to a 16-year-old patient of unknown gender ( reported as pediatric patient). The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 27-SEP-2022, the patient received an adult dose of hepatitis a vaccine, inactivated (VAQTA) 50/1.0 U/mL, 1 milliliter, lot # U036184 and expiration date on 02-MAR-2023, administered for prophylaxis (dose number and route of administration were not provided) (Incorrect dose administered).  No adverse event was reported.
Sex: F
Vaccine: PPV
Symptoms: Acute kidney injury, Anaemia, Asthenia, Blood creatinine abnormal, Candida infection
Clinical narrative: fever; swelling at injection site; This spontaneous report was received from a health care professional concerning a female patient currently 76 years old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) administered as prophylaxis (formulation, strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced allergy to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), with fever and swelling at injection site. The outcome of the events were not reported.   Additionally, the patient experienced acute kidney injury, metabolic acidosis, hypothyroidism, hypokalaemia, gastrointestinal disorder, malaise, pleuritic pain, blood creatinine abnormal, rash, asthenia, dyspnoea, pulmonary mass, insomnia, occult blood positive, anaemia, oesophagitis, candida infection, nausea, hypophagia, constipation, hyponatraemia, hypocalcaemia, hypomagnesaemia and vomiting (captured in MARRS# 2208USA009525).  The causal relationship between the events of fever and swelling at injection site were considered to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).   This is one of two reports from the same patient.; Sender's Comments:  US-009507513-2209USA008773: US-009507513-2208USA009525:Original Case : 2208USA009525
Sex: F
Vaccine: PPV
Symptoms: Constipation, Dyspnoea, Gastrointestinal disorder, Hypocalcaemia, Hypokalaemia
Clinical narrative: fever; swelling at injection site; This spontaneous report was received from a health care professional concerning a female patient currently 76 years old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) administered as prophylaxis (formulation, strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced allergy to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), with fever and swelling at injection site. The outcome of the events were not reported.   Additionally, the patient experienced acute kidney injury, metabolic acidosis, hypothyroidism, hypokalaemia, gastrointestinal disorder, malaise, pleuritic pain, blood creatinine abnormal, rash, asthenia, dyspnoea, pulmonary mass, insomnia, occult blood positive, anaemia, oesophagitis, candida infection, nausea, hypophagia, constipation, hyponatraemia, hypocalcaemia, hypomagnesaemia and vomiting (captured in MARRS# 2208USA009525).  The causal relationship between the events of fever and swelling at injection site were considered to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).   This is one of two reports from the same patient.; Sender's Comments:  US-009507513-2209USA008773: US-009507513-2208USA009525:Original Case : 2208USA009525
Sex: F
Vaccine: PPV
Symptoms: Hypomagnesaemia, Hyponatraemia, Hypophagia, Hypothyroidism, Injection site swelling
Clinical narrative: fever; swelling at injection site; This spontaneous report was received from a health care professional concerning a female patient currently 76 years old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) administered as prophylaxis (formulation, strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced allergy to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), with fever and swelling at injection site. The outcome of the events were not reported.   Additionally, the patient experienced acute kidney injury, metabolic acidosis, hypothyroidism, hypokalaemia, gastrointestinal disorder, malaise, pleuritic pain, blood creatinine abnormal, rash, asthenia, dyspnoea, pulmonary mass, insomnia, occult blood positive, anaemia, oesophagitis, candida infection, nausea, hypophagia, constipation, hyponatraemia, hypocalcaemia, hypomagnesaemia and vomiting (captured in MARRS# 2208USA009525).  The causal relationship between the events of fever and swelling at injection site were considered to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).   This is one of two reports from the same patient.; Sender's Comments:  US-009507513-2209USA008773: US-009507513-2208USA009525:Original Case : 2208USA009525