chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Impaired work ability, Pyrexia, Sleep disorder
Clinical narrative: headache; constipation; shilling sensations; cancel my shift; to fill very tired; a little sensation of cold; fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a 69-year-old patient who received Herpes zoster (Shingrix) (batch number NJ374) for prophylaxis.   On 03-SEP-2024 14:00, the patient received Shingrix. On 03-SEP-2024 18:00, less than a day after receiving Shingrix, the patient experienced tiredness (Verbatim: to fill very tired) and feeling cold (Verbatim: a little sensation of cold). On 04-SEP-2024, the patient experienced headache (Verbatim: headache), constipation (Verbatim: constipation), feeling abnormal (Verbatim: shilling sensations) and inability to work (Verbatim: cancel my shift). In SEP-2024, the patient experienced fever (Verbatim: fever). The patient was treated with paracetamol (Tylenol). The outcome of the tiredness, feeling cold, fever, headache, constipation, feeling abnormal and inability to work were not reported.   It was unknown if the reporter considered the tiredness, feeling cold, fever, headache, constipation, feeling abnormal and inability to work to be related to Shingrix.     It was unknown if the company considered the tiredness, feeling cold, fever, headache, constipation, feeling abnormal and inability to work to be related to Shingrix.   Additional Information: GSK receipt date: 04-SEP-2024 The patient date of year was 1955 The patient got that vaccine yesterday (day before reporting) and body reacted. begun to fill very tired with a little sensation of cold so went to bed.  The patient waked up at 2am with fever, and took 2 Tylenol and at at 5AM waked up again to cancel the shift. The patient's pocket was very sad for that because everybody needed to work. At 8am the patient decided to sleep again and waked up at 2pm with a little headache and shilling sensations and some constipation.  The patient was only taking water now (at the time of reporting). For no reason the patient would apply the second doses in 6 months.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Had the first shot and two weeks later got shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles four times in the last couple of years).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Had the first shot and two weeks later got shingles). The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.   It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-AUG-2024 This case was reported by a patient via interactive digital media. The reporter reported that even the patient broke out between the shingles vaccine treatment. The patient had the first shot and two weeks later got shingles and had to wait and additional time to get the second shot. The patient had mild cases since the vaccine. The patient hopes others had better success with treatments. Follow-up would not possible as no contact details were available.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Nasopharyngitis, Oropharyngeal pain, Pharyngeal swelling, Swelling
Clinical narrative: Swollen neck and throat leading to a sore throat.; Swollen neck and throat leading to a sore throat; Swollen neck and throat leading to a sore throat; I had received a cold due to my immunity being down; This serious case was reported by a consumer via sales rep and described the occurrence of immunodeficiency in a 55-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included immunodeficiency.   On an unknown date, the patient received the 1st dose of Shingles vaccine (right arm). On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced immunodeficiency (Verbatim: I had received a cold due to my immunity being down) (serious criteria GSK medically significant), neck swelling (Verbatim: Swollen neck and throat leading to a sore throat.), sore throat (Verbatim: Swollen neck and throat leading to a sore throat), throat swelling (Verbatim: Swollen neck and throat leading to a sore throat) and cold (Verbatim: I had received a cold due to my immunity being down). The outcome of the immunodeficiency, neck swelling, sore throat, throat swelling and cold were not reported.   It was unknown if the reporter considered the immunodeficiency, neck swelling, sore throat, throat swelling and cold to be related to Shingles vaccine.     It was unknown if the company considered the immunodeficiency, neck swelling, sore throat, throat swelling and cold to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2024112549   Additional Information: GSK Receipt Date: 10-SEP-2024 The patient received a 1st dose of Shingrix and experienced swollen neck and throat leading to a sore throat. The HCP (Healthcare professional) thought the patient had experienced cold due to his immunity being down.; Sender's Comments:  US-GSK-US2024112549:Original Case : US2024112549 second dose
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the liquid portion of this vaccine; received only the liquid portion of this vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMDBO208, expiry date 03-APR-2025) for prophylaxis.   On 27-AUG-2024, the patient received the 1st dose of Menveo. On 27-AUG-2024, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: received only the liquid portion of this vaccine) and inappropriate dose of vaccine administered (Verbatim: received only the liquid portion of this vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 06-SEP-2024 The reporter stated that he/she was the manager of a primary care office, and was reconciling vaccines, and noticed that missed 2 diluents of Menveo vaccine, and knew that somebody received the liquid portion of the 2 dose vial, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The HCP called to report that 3 patients received only the liquid part of the Menveo (2 vial) vaccine, by this, first she said that she could not find 2 liquid portion of the vaccine, so she supposed that 2 patients only received the liquid portion. Later, she said that probably 3 patients received only the liquid portion of this vaccine and she provide the information of this patients. This was 1 of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024111370:same reporter/different patient US-GSK-US2024111373:same reporter/different patient
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: pateint did not recived 2nd dose yet/delayed second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 19-SEP-2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: pateint did not recived 2nd dose yet/delayed second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 09-SEP-2024 The reporter reported that the patient had received her 1st dose of Shingrix vaccine and pharmacist was inquiring how to proceed with series. Till the time of reporting, the patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Post herpetic neuralgia
Clinical narrative: He has not yet had the second dose; Post-herpetic neuralgia; another instance of post-herpetic neuralgia; This non-serious case was reported by a consumer via call center representative and described the occurrence of post herpetic neuralgia in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (in NOV-2023).   On 02-FEB-2024, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On 02-FEB-2024, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced post herpetic neuralgia (Verbatim: Post-herpetic neuralgia). On 03-SEP-2024, the patient experienced post herpetic neuralgia (Verbatim: another instance of post-herpetic neuralgia). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: He has not yet had the second dose). In FEB-2024, the outcome of the post herpetic neuralgia was resolved (duration 5 days).  In SEP-2024, the outcome of the post herpetic neuralgia was resolved (duration 4 days). The outcome of the incomplete course of vaccination was not reported.   It was unknown if the reporter considered the post herpetic neuralgia and post herpetic neuralgia to be related to Shingrix.     It was unknown if the company considered the post herpetic neuralgia and post herpetic neuralgia to be related to Shingrix.  Additional Information: GSK Receipt Date: 09-SEP-2024 The patient self-reported this case. The patient had a history of shingles, before having his first Shingrix vaccination dose. He experienced post herpetic neuralgia for 5 days beginning the evening of his first Shingrix dose. The patient had not yet had the second dose. The patient had another instance of post herpetic neuralgia last week (from the reporting date) which lasted 4 days. Time to onset of 2nd episode of post herpetic neuralgia was 214 days with 1st dose of Shingrix vaccine. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: He needed a 4th DTaP and 3rd IPV. So we gave him a Kinrix; We noticed that the previous dose of both given in 2022 was given as a Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 5-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix. On an unknown date, an unknown time after receiving Kinrix and Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: He needed a 4th DTaP and 3rd IPV. So we gave him a Kinrix) and inappropriate age at vaccine administration (Verbatim: We noticed that the previous dose of both given in 2022 was given as a Kinrix). The outcome of the inappropriate schedule of vaccine administered was not reported and the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-SEP-2024 The other health professional reported that they had a 5 years old patient.  The patient needed a 4th DTaP and 3rd IPV.  The other health professional reported that they gave the patient a Kinrix which led to inappropriate schedule of vaccine administered.  The other health professional noticed that the previous dose of both given in 2022 was given as a Kinrix which led to inappropriate schedule of vaccine administered.  The other health professional reported the issue was that the patient was only 3 yrs 2mo at the time of that dose which led to inappropriate age at vaccination.  The other health professional asked does the patient need another dose of DTaP and IPV, if so could this be given as an iPV. The Vaccine Administration Facility was the same as Primary Reporter. No other information was provided
Age: 83.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Potential 2nd dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 83-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number HT75Z, expiry date 10-DEC-2024) for prophylaxis.   Previously administered products included Arexvy (1st dose received in AUG-2023, no exact date available).   On 08-SEP-2024, the patient received the 2nd dose of Arexvy. On 08-SEP-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: Potential 2nd dose administered). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 09-SEP-2024 A pharmacist reported that a patient who was not sure yet that he received two doses of Arexvy, but he might had received the dose last year, and another one this year, which led to extra dose administered.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: dose 1 of SHINGRIX in 2021. She states she was never told by anyone that she needed a second dose. SHINGRIX dose 2 was given yesterday; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix vaccine on 18th January 2021). Concurrent medical conditions included loss of balance (The patient had lost 80% of balance due to a (herpes) virus) and herpes virus infection (The patient had lost 80% of balance due to a (herpes) virus).   On 09-SEP-2024, the patient received the 2nd dose of Shingrix. On 09-SEP-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: dose 1 of SHINGRIX on her birthday in 2021, 18JAN2021. She states she was never told by anyone that she needed a second dose. SHINGRIX dose 2 was given yesterday). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 10-SEP-2024 The nurse reported that she received 1st dose of Shingrix vaccine on 18th January 2021.  The patient stated that she had never told by anyone that she needed a second dose.  The patient received second dose of Shingrix vaccine day before reporting. The patient had received second dose longer than recommended dose of Shingrix vaccine which led to lengthening of vaccination scheduled. The nurse also reported that she lost 80 percent of balance due to a (herpes) virus.  The reporter did not consent to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Each time, I got the Moderna covid vaccine, i git pink rash around the injection area, lasting for about a week; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE RASH (Each time, I got the Moderna covid vaccine, i git pink rash around the injection area, lasting for about a week) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Each time, I got the Moderna covid vaccine, i git pink rash around the injection area, lasting for about a week). At the time of the report, VACCINATION SITE RASH (Each time, I got the Moderna covid vaccine, i git pink rash around the injection area, lasting for about a week) had resolved.      The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   Concomitant medication was not provided. It was reported that each time patient got the Moderna Covid Vaccine, patient experienced pink rash around the injection area, and it lasted for about a week. Treatment information was not reported.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Illness
Clinical narrative: Patient was also very sick when she had the first dose of Moderna; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Patient was also very sick when she had the first dose of Moderna) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included Cataract operation in 2023, Vitrectomy and Detached retina repair (2 or 3 years ago).    On 03-Sep-2022, 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 ILLNESS (Patient was also very sick when she had the first dose of Moderna). At the time of the report, ILLNESS (Patient was also very sick when she had the first dose of Moderna) outcome was unknown.            No concomitant medication was reported.  No treatment information was reported.   This case was linked to MOD-2024-773903 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: pain; feeling sore on her arm; feeling tired; This spontaneous case was reported by a patient and describes the occurrence of PAIN (pain), PAIN IN EXTREMITY (feeling sore on her arm) and FATIGUE (feeling tired) in a 68-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pain), PAIN IN EXTREMITY (feeling sore on her arm) and FATIGUE (feeling tired). At the time of the report, PAIN (pain), PAIN IN EXTREMITY (feeling sore on her arm) and FATIGUE (feeling tired) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.   This case was linked to MOD-2024-773973 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstrual disorder
Clinical narrative: I'm curious if there's any date on if novavax has any effect on menstrual cycles. I had a rough time with Pfizer and Moderna; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of MENSTRUAL DISORDER (I'm curious if there's any date on if novavax has any effect on menstrual cycles. I had a rough time with Pfizer and Moderna) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (I'm curious if there's any date on if novavax has any effect on menstrual cycles. I had a rough time with Pfizer and Moderna). At the time of the report, MENSTRUAL DISORDER (I'm curious if there's any date on if novavax has any effect on menstrual cycles. I had a rough time with Pfizer and Moderna) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medications were reported.  The patient was curious to know if there was any date on if Novavax had any effect on menstrual cycles. The patient had a rough time with Pfizer and Moderna vaccines.  No treatment medications were reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: had active COVID the first week in August; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (had active COVID the first week in August) in a 70-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In August 2024, the patient experienced COVID-19 (had active COVID the first week in August). At the time of the report, COVID-19 (had active COVID the first week in August) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Skin ulcer
Clinical narrative: she started noticing a pain in her arm and shoulder; weakness over her arm; she could barely lift the arm; She scratches so much that she beginning to break little ulcers on her arm; it irritates her skin; she started noticing a pain in her arm and shoulder; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (she started noticing a pain in her arm and shoulder), MUSCULAR WEAKNESS (weakness over her arm), MOBILITY DECREASED (she could barely lift the arm), SKIN ULCER (She scratches so much that she beginning to break little ulcers on her arm) and SKIN IRRITATION (it irritates her skin) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.    On 08-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced PAIN IN EXTREMITY (she started noticing a pain in her arm and shoulder), MUSCULAR WEAKNESS (weakness over her arm), MOBILITY DECREASED (she could barely lift the arm), SKIN ULCER (She scratches so much that she beginning to break little ulcers on her arm), SKIN IRRITATION (it irritates her skin) and ARTHRALGIA (she started noticing a pain in her arm and shoulder). At the time of the report, PAIN IN EXTREMITY (she started noticing a pain in her arm and shoulder), MUSCULAR WEAKNESS (weakness over her arm), MOBILITY DECREASED (she could barely lift the arm), SKIN ULCER (She scratches so much that she beginning to break little ulcers on her arm), SKIN IRRITATION (it irritates her skin) and ARTHRALGIA (she started noticing a pain in her arm and shoulder) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. These symptoms started a year after she took the vaccine and that's when she actually noticed it. These symptoms happen to her left arm, where she was vaccinated. Her last vaccine was July 8, 2021. She had received the 2-dose-series. These symptoms all started happening 1 year after her second dose. She stated that she started noticing a pain in her arm and shoulder. She describes it as a weakness over her arm, she could barely lift the arm and it irritates her skin. She scratches so much that she beginning to break little ulcers on her arm. She went to the doctor about a year ago and he gave her ointment. She puts it on and it helps for about 10-15 mins. The next day she experiences the symptoms again. She states that it seems to be getting worse and making her arm feel really weak. Reporter causality was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-773895 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-773895:same reporter other people case
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.            The concomitant medication was not reported by reporter.  The treatment medication was not reported by reporter.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain, Pyrexia
Clinical narrative: body aches; lack of energy; fever; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN (body aches), ASTHENIA (lack of energy), PYREXIA (fever) and FATIGUE (Fatigue) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (nearly dying) in August 2020. Previously administered products included for Product used for unknown indication: Johnson & Johnson (Dose 1). Past adverse reactions to the above products included No adverse effect with Johnson & Johnson. Concurrent medical conditions included Chronic lymphocytic leukemia (body cannot adequately produce white blood cells that fight infections.).    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (body aches), ASTHENIA (lack of energy), PYREXIA (fever) and FATIGUE (Fatigue). At the time of the report, PAIN (body aches), ASTHENIA (lack of energy), PYREXIA (fever) and FATIGUE (Fatigue) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient received the COVID-19 vaccine as soon as it became available, starting with the Johnson & Johnson vaccine and then receiving subsequent Moderna vaccines. After these vaccinations, patient experienced fever, body aches, and fatigue with lack of energy within 24-49 hours.  No treatment medication was reported.   This case was linked to MOD-2024-773969 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Sep-2024: Live follow-up received contains non-significant information (reference number added). On 11-Sep-2024: Live significant follow-up: Additional event of asthenia was added.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: Slight head ache; fever; Arm Sore; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Slight head ache), PYREXIA (fever) and PAIN IN EXTREMITY (Arm Sore) in an elderly female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 10-Sep-2024, the patient experienced HEADACHE (Slight head ache), PYREXIA (fever) and PAIN IN EXTREMITY (Arm Sore). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, HEADACHE (Slight head ache), PYREXIA (fever) and PAIN IN EXTREMITY (Arm Sore) was resolving.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter.  Dosage text for suspect product was reported as unknown. She took ibuprofen and felt better.
Sex: U
Vaccine: COVID19
Symptoms: Intellectual disability
Clinical narrative: His kid got all retarded all of a sudden after getting the vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INTELLECTUAL DISABILITY (His kid got all retarded all of a sudden after getting the vaccine) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTELLECTUAL DISABILITY (His kid got all retarded all of a sudden after getting the vaccine) (seriousness criterion medically significant). At the time of the report, INTELLECTUAL DISABILITY (His kid got all retarded all of a sudden after getting the vaccine) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter. Company comment: This is a spontaneous case concerning a patient of an unknown age and gender, with no medical history reported who experienced unexpected serious (medically significant) event of intellectual disability after SPIKEVAX NOS (SPIKEVAX NOS) vaccination on unknown date. As reported the patient got all retarded all of a sudden after getting the vaccine. At the time of the report the outcome of the event was unknown. The benefit-risk relationship of SPIKEVAX NOS (SPIKEVAX NOS) is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2024: Live Follow-up received that contains no new information.
Age: 68.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Hypersensitivity, Pruritus, Rash
Clinical narrative: Rash; Itch; allergic reaction; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 09Sep2024 as dose 1, 0.3 ml single (Lot number: LM2212, Expiration Date: 28Mar2025) at the age of 68 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), in 09Sep2024 as dose number unknown, single (Lot number: U8489DA) for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset 10Sep2024 at 05:30, outcome "unknown"; PRURITUS (non-serious) with onset Sep2024, outcome "recovering", described as "Itch"; HYPERSENSITIVITY (non-serious) with onset Sep2024, outcome "recovering", described as "allergic reaction". Therapeutic measures were taken as a result of hypersensitivity, pruritus. Additional information: Patient stated she got an allergic reaction, a rash and the rash did not show up until the next day, the next day I show it. It nothing there after an hour, was nothing there after 15 minutes. After the next day exactly 05:30 is when she saw the rash. The patient stated it did break me out. Patient took Benadryl for the itch and it does calm the itch very well and also sleep very well, there is no itching because of the Benadryl, so the Benadryl is working. Patient counted about 9-10 spots of rash, now it is starting came to a head, where it will more likely to go away.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: the patient started presenting COVID-19 symptoms/tested positive for COVID-19; the patient started presenting COVID-19 symptoms/tested positive for COVID-19; This is a spontaneous report received from a Pharmacist from medical information team.  A 75-year-old female patient received BNT162b2 omicron (kp.2) (COVID-19 VACCINE OMICRON KP.2-MANUFACTURER UNKNOWN), on 01Sep2024 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 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Sep2024, outcome "unknown" and all described as "the patient started presenting COVID-19 symptoms/tested positive for COVID-19". The clinical course was reported as follows: Pharmacist reported that the patient received a COVID-19 booster vaccine on 01Sep2024. Then, the patient started presenting COVID-19 symptoms on 09Sep2024, and tested positive for COVID-19 on 10Sep2024. The pharmacist wanted to know if this patient could be started on nirmatrelvir, ritonavir (PAXLOVID) after COVID-19 vaccination. The patient underwent the following laboratory tests and procedures as aforementioned.     The information on the batch/lot number for BNT162b2 omicron (kp.2)  will be requested and submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 omicron (kp.2) in this patient cannot be completely excluded.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site dryness
Clinical narrative: In my injection site it developed dry brown spots; In my injection site it developed dry brown spots; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), 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: VACCINATION SITE DISCOLOURATION (non-serious), VACCINATION SITE DRYNESS (non-serious), outcome "not recovered" and all described as "In my injection site it developed dry brown spots". Additional information: Patient have Pfizer vaccines for Covid. In her injection site it developed dry brown spots and it doesn't heal. 3 different injections site. Patient is going to see a dermatologist about this issue. Patient is asking for any recommendations or advice.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400254624 same reporter, patient and product; different dose and event;US-PFIZER INC-PV202400119331 same reporter, patient and product; different dose and event;
Sex: U
Vaccine: PNC20
Symptoms: Injection site rash
Clinical narrative: A very odd rash in a large area surrounding the vaccine injection spot; This is a spontaneous report and received from Other HCPs from product quality group.  A patient (age and gender not provided) received pneumococcal 20-valent conjugate vaccine (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, 0.5 ml, single (Lot number: HP7364, Expiration Date: 30Sep2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE RASH (non-serious), outcome "unknown", described as "A very odd rash in a large area surrounding the vaccine injection spot".  Additional information: The patient had an adverse effect. There was a very odd rash in a large area surrounding the vaccine injection spot, almost wrapped completely in a strip around the upper arm. NDC number of Prevnar 20 was 00005200010.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400255878 same reporter/suspect vaccine/event; different patient;
Age: 32.0
Sex: F
Vaccine: COVID19, FLUC3
Symptoms: Asthenia, Chills, Vaccination site pain
Clinical narrative: chills; pain at the site of injection; felt weakness; This is a spontaneous report received from a Consumer or other non HCP.  A 32-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 12Sep2024 at 18:15 as dose 1, single (Lot number: Lm2215) at the age of 32 years for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 12Sep2024 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Coconut Allergy" (unspecified if ongoing). Concomitant medication(s) included: MAGNESIUM GLYCINATE. The patient also took other concomitant therapy. The following information was reported: CHILLS (non-serious) with onset 13Sep2024, outcome "recovering"; ASTHENIA (non-serious) with onset 13Sep2024, outcome "recovering", described as "felt weakness"; VACCINATION SITE PAIN (non-serious) with onset 13Sep2024, outcome "recovering", described as "pain at the site of injection". Therapeutic measures were not taken as a result of chills, vaccination site pain, asthenia.  Additional information: Patient had not received any other vaccines within 4 weeks prior to the vaccine(s). Patient had taken other medications within 2 weeks of the event starting. Approx. 12 hours after the patient was administered the vaccines, patient had pain at the site of injection and felt weakness. Patient also experienced chills. Patient had received concomitant Vitamin D Supplements, Calcium Supplements, Biotin and Collagen Supplements.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Inflammation, Oropharyngeal pain, Peripheral swelling, Rhinorrhoea
Clinical narrative: Within 4 hours of injection my arm swelled to half a tennis ball and is highly red and inflamed; Within 4 hours of injection my arm swelled to half a tennis ball and is highly red and inflamed; within same 4 hours started to have runny nose--constant dripping as of nearly 48 hours later; a bit of sore throat; Within 4 hours of injection my arm swelled to half a tennis ball and is highly red and inflamed; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 12Sep2024 at 10:00 as dose 1, single (Lot number: lm2212) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; LIPITOR; BYSTOLIC; COQ 10; VITAMIN B12 [VITAMIN B12 NOS]. The patient also took other concomitant therapy. The following information was reported: PERIPHERAL SWELLING (non-serious), INFLAMMATION (non-serious), ERYTHEMA (non-serious) all with onset 12Sep2024 at 14:00, outcome "not recovered" and all described as "Within 4 hours of injection my arm swelled to half a tennis ball and is highly red and inflamed"; OROPHARYNGEAL PAIN (non-serious) with onset 12Sep2024 at 14:00, outcome "not recovered", described as "a bit of sore throat"; RHINORRHOEA (non-serious) with onset 12Sep2024 at 14:00, outcome "not recovered", described as "within same 4 hours started to have runny nose--constant dripping as of nearly 48 hours later". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of peripheral swelling, inflammation, rhinorrhoea, oropharyngeal pain, erythema.  Additional information: Patient was reported within 4 hours of injection her arm swelled to half a tennis ball and was highly red and inflamed. Within same 4 hours started to have runny nose-constant dripping as of nearly 48 hours later. Also a bit of sore throat. she took a COVID test day after and it was negative. Patient did not receive any other vaccines on the same date as the vaccine, patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine, Patient was patient taking any other medications within 2 weeks of the event starting. The patient also took other concomitant therapy with Multi Vitamin.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Within 4 hours of injection my arm swelled to half a tennis ball and is highly red and inflamed; Within 4 hours of injection my arm swelled to half a tennis ball and is highly red and inflamed; within same 4 hours started to have runny nose--constant dripping as of nearly 48 hours later; a bit of sore throat; Within 4 hours of injection my arm swelled to half a tennis ball and is highly red and inflamed; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 12Sep2024 at 10:00 as dose 1, single (Lot number: lm2212) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; LIPITOR; BYSTOLIC; COQ 10; VITAMIN B12 [VITAMIN B12 NOS]. The patient also took other concomitant therapy. The following information was reported: PERIPHERAL SWELLING (non-serious), INFLAMMATION (non-serious), ERYTHEMA (non-serious) all with onset 12Sep2024 at 14:00, outcome "not recovered" and all described as "Within 4 hours of injection my arm swelled to half a tennis ball and is highly red and inflamed"; OROPHARYNGEAL PAIN (non-serious) with onset 12Sep2024 at 14:00, outcome "not recovered", described as "a bit of sore throat"; RHINORRHOEA (non-serious) with onset 12Sep2024 at 14:00, outcome "not recovered", described as "within same 4 hours started to have runny nose--constant dripping as of nearly 48 hours later". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of peripheral swelling, inflammation, rhinorrhoea, oropharyngeal pain, erythema.  Additional information: Patient was reported within 4 hours of injection her arm swelled to half a tennis ball and was highly red and inflamed. Within same 4 hours started to have runny nose-constant dripping as of nearly 48 hours later. Also a bit of sore throat. she took a COVID test day after and it was negative. Patient did not receive any other vaccines on the same date as the vaccine, patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine, Patient was patient taking any other medications within 2 weeks of the event starting. The patient also took other concomitant therapy with Multi Vitamin.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Infection, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Within 4 hours of injection my arm swelled to half a tennis ball and is highly red and inflamed; Within 4 hours of injection my arm swelled to half a tennis ball and is highly red and inflamed; within same 4 hours started to have runny nose--constant dripping as of nearly 48 hours later; a bit of sore throat; Within 4 hours of injection my arm swelled to half a tennis ball and is highly red and inflamed; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 12Sep2024 at 10:00 as dose 1, single (Lot number: lm2212) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; LIPITOR; BYSTOLIC; COQ 10; VITAMIN B12 [VITAMIN B12 NOS]. The patient also took other concomitant therapy. The following information was reported: PERIPHERAL SWELLING (non-serious), INFLAMMATION (non-serious), ERYTHEMA (non-serious) all with onset 12Sep2024 at 14:00, outcome "not recovered" and all described as "Within 4 hours of injection my arm swelled to half a tennis ball and is highly red and inflamed"; OROPHARYNGEAL PAIN (non-serious) with onset 12Sep2024 at 14:00, outcome "not recovered", described as "a bit of sore throat"; RHINORRHOEA (non-serious) with onset 12Sep2024 at 14:00, outcome "not recovered", described as "within same 4 hours started to have runny nose--constant dripping as of nearly 48 hours later". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of peripheral swelling, inflammation, rhinorrhoea, oropharyngeal pain, erythema.  Additional information: Patient was reported within 4 hours of injection her arm swelled to half a tennis ball and was highly red and inflamed. Within same 4 hours started to have runny nose-constant dripping as of nearly 48 hours later. Also a bit of sore throat. she took a COVID test day after and it was negative. Patient did not receive any other vaccines on the same date as the vaccine, patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine, Patient was patient taking any other medications within 2 weeks of the event starting. The patient also took other concomitant therapy with Multi Vitamin.