chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Pain in extremity
Clinical narrative: chills/shivering; Tired; Achy Joints; Achy Muscle Pain; Chills; arm was sore; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (2 years ago). Concurrent medical conditions included nerve pain (had shingles 2 years ago and still had pinched nerve pain in the center of his back from that event).   On 11-OCT-2023, the patient received the 2nd dose of Shingrix (left arm). On 11-OCT-2023, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: arm was sore). On 12-OCT-2023, the patient experienced shivering (Verbatim: chills/shivering), tiredness (Verbatim: Tired), joint pain (Verbatim: Achy Joints), muscle pain (Verbatim: Achy Muscle Pain) and chills (Verbatim: Chills). The outcome of the pain in arm, shivering, tiredness, joint pain, muscle pain and chills were not resolved.   It was unknown if the reporter considered the pain in arm, shivering, tiredness, joint pain, muscle pain and chills to be related to Shingrix.     It was unknown if the company considered the pain in arm, shivering, tiredness, joint pain, muscle pain and chills to be related to Shingrix.  Additional Information: GSK Receipt Date: 12-OCT-2023 The reporter was a patient that received his 2nd dose of Shingrix yesterday (from the reporting day), and reported that his arm was sore yesterday and was still sore today (on the day of reporting). The patient also reported this morning (on the day of reporting) 1 day after vaccination, he had chills, achy muscle pain, achy joints, was tired and shivering. The patient did not had any information about lot, expiry, or route of administration. The reporter consented to follow up.
Sex: U
Vaccine: MENB
Symptoms: Condition aggravated, Seizure, Syncope
Clinical narrative: instances of fainting; This serious case was reported by a nurse via sales rep and described the occurrence of fainting in a patient who received Men B NVS (Bexsero) for prophylaxis.   On 11-OCT-2023, the patient received Bexsero. In OCT-2023, an unknown time after receiving Bexsero, the patient experienced fainting (Verbatim: instances of fainting) (serious criteria hospitalization and GSK medically significant). The outcome of the fainting was unknown.   It was unknown if the reporter considered the fainting to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the fainting to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 12-OCT-2023 The nurse reported the one particular patient fainted after receiving a dose of Bexsero and appeared to be seizing and was taken to the hospital. She said she has had several in the past year. The nurse asked if there are instances of fainting after receiving a dose of Bexsero. She would also like to know if there was any data on increase of adverse events with Bexsero being given with another vaccine, especially Meningitis ACWY. This incident has been reported using adverse event reporting. The reporter consented to followup. This case is linked with US2023140641, same reporter.; Sender's Comments:  US-GSK-US2023140641:
Age: 60.0
Sex: M
Vaccine: RSV
Symptoms: Headache, Pain
Clinical narrative: achiness; headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a 60-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 11-OCT-2023, the patient received Arexvy. On 11-OCT-2023, less than a day after receiving Arexvy, the patient experienced pain (Verbatim: achiness) and headache (Verbatim: headache). The outcome of the pain and headache were not resolved.   It was unknown if the reporter considered the pain and headache to be related to Arexvy.     It was unknown if the company considered the pain and headache to be related to Arexvy.   Additional Information: GSK receipt date: 12-OCT-2023 The reporter was the patient who received his Arexvy vaccine yesterday (day before reporting) and had started having a headache and achiness.  This was an ongoing AE (adverse event).  The reporter said it was very mild. The consent to follow up requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Concussion, Injection site pain
Clinical narrative: Severe awful pain at the injection site left arm; out of the hospital due to a concussion; This serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20-JUL-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Severe awful pain at the injection site left arm) (serious criteria hospitalization) and concussion (Verbatim: out of the hospital due to a concussion) (serious criteria hospitalization). The outcome of the injection site pain was not resolved and the outcome of the concussion was resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix. The reporter considered the concussion to be unrelated to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix. The company considered the concussion to be unrelated to Shingrix.   Additional Information: GSK receipt date: 13-OCT-2023 The reporter was the patient who stated she received Shingrix first dose and since then she had been suffering a very severe awful pain at the injection site.  According to the reporter the physician did not understand what was going on and se will have an appointment soon for an x-ray.  The customer also stated she was out of the hospital due to a concussion that she was not linking with the vaccine.  The patient reported that she was not going to receive SHINGRIX shot 2.  Consent provided to contact treating physician.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: REACTED BADLY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: many allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced reacted badly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of reacted badly was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19, FLUX
Symptoms: Brain fog, COVID-19 immunisation, Fatigue, Headache, Musculoskeletal pain
Clinical narrative: BRAIN FOG; CONGESTION; MUSCLE AND BONE ACHES (BACK/RIBS/ARMS); HEADACHE; FATIGUE; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (pfizer) concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 (The patient was diagnosed with covid-19 infection before vaccination.), and concurrent conditions included: unspecified drug allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. Since the vaccination, the patient had not been tested positive for covid-19. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: 041A21A expiry: UNKNOWN) dose was not reported, 1 total, administered to left arm on 01-APR-2021 12:00 for covid-19 prophylaxis. No concomitant medications were reported.   It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received non-company suspect moderna covid-19 vaccine (elasomeran) (dose number in series 2) (intramuscular, form of admin was not reported, batch number: 017F21A, expiry: UNKNOWN) dose was not reported, administered to left arm on 29-OCT-2021 12:00 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination moderna covid-19 vaccine (elasomeran) (dose number in series 2). The patient additionally received non-company suspect pfizer (tozinameran) (dose number in series 3) (intramuscular, form of admin was not reported, batch number: HF9275, expiry: UNKNOWN) dose was not reported, administered to left arm on 09-OCT-2023 11:30 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 3).  The patient also received influenza vaccine (form of admin, route of admin, and batch number were not reported) dose was not reported, administered to left arm on 09-OCT-2023 for prophylactic vaccination On 09-OCT-2023 20:00, the patient experienced brain fog, congestion, muscle and bone aches (back/ribs/arms), headache, and fatigue (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, tozinameran, and influenza vaccine was not applicable. The patient recovered from brain fog, congestion, muscle and bone aches (back/ribs/arms), headache, and fatigue, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19, FLUX
Symptoms: Sinus congestion
Clinical narrative: BRAIN FOG; CONGESTION; MUSCLE AND BONE ACHES (BACK/RIBS/ARMS); HEADACHE; FATIGUE; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (pfizer) concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 (The patient was diagnosed with covid-19 infection before vaccination.), and concurrent conditions included: unspecified drug allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. Since the vaccination, the patient had not been tested positive for covid-19. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: 041A21A expiry: UNKNOWN) dose was not reported, 1 total, administered to left arm on 01-APR-2021 12:00 for covid-19 prophylaxis. No concomitant medications were reported.   It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received non-company suspect moderna covid-19 vaccine (elasomeran) (dose number in series 2) (intramuscular, form of admin was not reported, batch number: 017F21A, expiry: UNKNOWN) dose was not reported, administered to left arm on 29-OCT-2021 12:00 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination moderna covid-19 vaccine (elasomeran) (dose number in series 2). The patient additionally received non-company suspect pfizer (tozinameran) (dose number in series 3) (intramuscular, form of admin was not reported, batch number: HF9275, expiry: UNKNOWN) dose was not reported, administered to left arm on 09-OCT-2023 11:30 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 3).  The patient also received influenza vaccine (form of admin, route of admin, and batch number were not reported) dose was not reported, administered to left arm on 09-OCT-2023 for prophylactic vaccination On 09-OCT-2023 20:00, the patient experienced brain fog, congestion, muscle and bone aches (back/ribs/arms), headache, and fatigue (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, tozinameran, and influenza vaccine was not applicable. The patient recovered from brain fog, congestion, muscle and bone aches (back/ribs/arms), headache, and fatigue, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: two DVTs after getting three shots/Blood clots; This spontaneous case was reported by a patient and describes the occurrence of DEEP VEIN THROMBOSIS (two DVTs after getting three shots/Blood clots) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (two DVTs after getting three shots/Blood clots) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (two DVTs after getting three shots/Blood clots) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Patient developed two DVT's after getting three shots. Blood clots where patient never had any problems with this in life.  Treatment information was not reported. Company comment: This spontaneous case concerns a patient of unknown age and gender, with no medical history reported, who experienced unexpected serious (medically significant) AESI of Deep vein thrombosis (reported as TWO DVTS AFTER GETTING THREE SHOTS/BLOOD CLOTS) which occurred in context of receiving a dose of mRNA-1273, which was the patient's 3rd dose of COVID-19 vaccination schedule. Latency cannot be calculated due to exact vaccination date unknown and exact event onset date unknown. The patient reported developing two DVTs after getting three of Moderna shots. In addition, the patient informed that has never had any problems with blood clots in the past. Details regarding exact vaccination date, events onset date, clinical symptoms, concomitant medications and concurrent diseases, accompanying circumstances and/or risk factors, etiologic and diagnostic work up and treatment details are not available in the report. Event's outcome was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-744997 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Oct-2023: Live follow-up received, and Quality Complaint number added. On 10-Oct-2023: Live follow-up received and reference numbers added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-744997:Same reporter
Sex: U
Vaccine: UNK
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced COVID-19 (Covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. In 2023, COVID-19 (Covid-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2023, SARS-CoV-2 test: Positive and Negative.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medications were reported.  Patient tested negative for Covid after 3rd dose. Said tested positive for Covid morning and didn't start till evening. Also mentioned did have new vaccine/latest vaccine Moderna on 28-Sep-2023.   No treatment medications were provided.
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Chills, Inflammation, Myalgia, Pyrexia
Clinical narrative: inflammatory reaction; fever; chills; myalgia; arthralgia; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (inflammatory reaction), PYREXIA (fever), CHILLS (chills), MYALGIA (myalgia) and ARTHRALGIA (arthralgia) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (inflammatory reaction), PYREXIA (fever), CHILLS (chills), MYALGIA (myalgia) and ARTHRALGIA (arthralgia). At the time of the report, INFLAMMATION (inflammatory reaction), PYREXIA (fever), CHILLS (chills), MYALGIA (myalgia) and ARTHRALGIA (arthralgia) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  He stated he never had any reaction to any other vaccine except inflammatory reaction, fever, chills, myalgia, and arthralgia.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745277, US-MODERNATX, INC.-MOD-2023-745286 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745277:Master case ( New varient case) US-MODERNATX, INC.-MOD-2023-745286:monovalent case
Age: 70.0
Sex: M
Vaccine: UNK
Symptoms: Fatigue, Nausea, Pain
Clinical narrative: Body aches; Severe fatigue; Slight nausea; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Body aches), FATIGUE (Severe fatigue) and NAUSEA (Slight nausea) 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 28-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches), FATIGUE (Severe fatigue) and NAUSEA (Slight nausea). At the time of the report, PAIN (Body aches), FATIGUE (Severe fatigue) and NAUSEA (Slight nausea) outcome was unknown.            Concomitant medication was not provided. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745689 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745689:Wife case
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Immunisation reaction, Insomnia, Malaise
Clinical narrative: quite ill; lingering affects; felt like they had trouble breathing/Shortness of breath; They were not getting enough sleep; exhausted; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (quite ill), IMMUNISATION REACTION (lingering affects), DYSPNOEA (felt like they had trouble breathing/Shortness of breath), HYPOSOMNIA (They were not getting enough sleep) and FATIGUE (exhausted) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031278) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 05-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced ILLNESS (quite ill). In October 2023, the patient experienced IMMUNISATION REACTION (lingering affects), DYSPNOEA (felt like they had trouble breathing/Shortness of breath), HYPOSOMNIA (They were not getting enough sleep) and FATIGUE (exhausted). At the time of the report, ILLNESS (quite ill) and DYSPNOEA (felt like they had trouble breathing/Shortness of breath) was resolving and IMMUNISATION REACTION (lingering affects), HYPOSOMNIA (They were not getting enough sleep) and FATIGUE (exhausted) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745579 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745579:Wife's case, 6th dose
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Illness, Movement disorder, Pain in extremity
Clinical narrative: they got a little ill for a couple of days; arm being sore; couldn't get out of bed; tired; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (they got a little ill for a couple of days), PAIN IN EXTREMITY (arm being sore), MOVEMENT DISORDER (couldn't get out of bed) and FATIGUE (tired) in a 79-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049022A) for COVID-19 prophylaxis.     It was reported that patient had no known allergies.  The patient's past medical history included Spinal stenosis (spinal stenosis in the back, started off taking Lyrica and then they gave injections and it went away.). Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (041L20A, dose 1) on 29-Jan-2021, Moderna COVID-19 vaccine (023M20A. dose 2) on 27-Feb-2021, Moderna COVID-19 vaccine (033F21A, dose 3) on 01-Nov-2021, Moderna COVID-19 vaccine (001M21A and dose 4) on 18-Jan-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and Moderna COVID-19 vaccine. Concurrent medical conditions included Blood pressure (Callers takes a couple of medications. Something for her blood pressure). Concomitant products included PREGABALIN (LYRICA) for an unknown indication.    On 07-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced ILLNESS (they got a little ill for a couple of days), PAIN IN EXTREMITY (arm being sore), MOVEMENT DISORDER (couldn't get out of bed) and FATIGUE (tired). In 2022, ILLNESS (they got a little ill for a couple of days) had resolved. At the time of the report, PAIN IN EXTREMITY (arm being sore), MOVEMENT DISORDER (couldn't get out of bed) and FATIGUE (tired) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that patient was generally healthy and had some issues that come and go and haven't had any trouble with vaccinations before. It was reported that patient had flu vaccination on 13-Oct-2023. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-745579 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745579:Wife case, Master case
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Sore arm; Arm is stiff; swelling injection; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MUSCULOSKELETAL STIFFNESS (Arm is stiff) and INJECTION SITE SWELLING (swelling injection) in an 83-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch nos. 06VF22A, Q49L21A, Q77C21B and 004MA0A) for COVID-19 prophylaxis.     It was reported that patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Flu. Past adverse reactions to the above products included No adverse event with Flu.   On 02-Feb-2021, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 05-Nov-2021, received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 06-May-2022, received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2022, received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), MUSCULOSKELETAL STIFFNESS (Arm is stiff) and INJECTION SITE SWELLING (swelling injection). At the time of the report, PAIN IN EXTREMITY (Sore arm), MUSCULOSKELETAL STIFFNESS (Arm is stiff) and INJECTION SITE SWELLING (swelling injection) had not resolved. Not Provided          No concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2023-745303 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Sore arm; Arm is stiff; swelling injection; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MUSCULOSKELETAL STIFFNESS (Arm is stiff) and INJECTION SITE SWELLING (swelling injection) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004MA0A, 014M20A and Q77C21B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), MUSCULOSKELETAL STIFFNESS (Arm is stiff) and INJECTION SITE SWELLING (swelling injection). At the time of the report, PAIN IN EXTREMITY (Sore arm), MUSCULOSKELETAL STIFFNESS (Arm is stiff) and INJECTION SITE SWELLING (swelling injection) outcome was unknown. Not Provided          The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine. The dosage text was reported as unknown. The patient took dose 4 on 06-May-2022 (batch-Q49L21A) and dose 5 on 07-Oct-2022 (batch-06VF22A). No concomitant medication was reported. Patient was not taking any treatment medications.   This case was linked to MOD-2023-745303, MOD-2023-745729 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pyrexia
Clinical narrative: Had COVID-19 he had a temperature and chills and after 3 days he was gone.; Little temperature and after a day or two it went away; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Had COVID-19 he had a temperature and chills and after 3 days he was gone.) and PYREXIA (Little temperature and after a day or two it went away) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: INFLUENZA and RSV VACCINE. Past adverse reactions to the above products included No adverse effect with INFLUENZA and RSV VACCINE. Concurrent medical conditions included Hashimoto's thyroiditis.    On 07-Oct-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Had COVID-19 he had a temperature and chills and after 3 days he was gone.) and PYREXIA (Little temperature and after a day or two it went away). At the time of the report, COVID-19 (Had COVID-19 he had a temperature and chills and after 3 days he was gone.) and PYREXIA (Little temperature and after a day or two it went away) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient stated he was in clinical trials for the Moderna COVID-19 Vaccine back in 2020. The other Moderna vaccines that he took in the trials had a reaction. Now he took SPIKEVAX with influenza and RSV, but he had almost nothing. About a month ago he had a COVID-19 infection. The only difference in 3 years was he wasn't infected until a month ago. He wanted to try Paxlovid, so he went to the ER to get it which had something to do with him testing positive. His reactions from the original vaccines consisted of a little temperature and after a day or two it went away. When he had COVID-19 he had a temperature and chills and after 3 days he was gone. He said the first day if felt like he got hit by a truck. On day 2 it felt like he got run over a truck day and on day 3 it was blue skies again. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745291, US-MODERNATX, INC.-MOD-2023-745916 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745291:Same reporter, Invalid case US-MODERNATX, INC.-MOD-2023-745916:Same patient, different vaccine (Spikevax 2023-2024)
Age: 14.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Nausea
Clinical narrative: not feeling good; fatigue; joints are hurting a lot/arthritis joint pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (not feeling good), FATIGUE (fatigue) and ARTHRALGIA (joints are hurting a lot/arthritis joint pain) in a 14-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. GH9694) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1, Lot number: EW0181) on 16-Jul-2021, Pfizer (Dose 2, Lot number: EW0181) on 04-Aug-2021, Pfizer (Booster , Lot number: L3198) on 13-Jan-2022, Pfizer (Booster , Lot number: GH9694) on 16-Sep-2022 and Flu shot on 27-Sep-2023. Past adverse reactions to the above products included No adverse event with Flu shot, Pfizer, Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Asthma, Appetite lost and Nauseous. Concomitant products included PARACETAMOL (TYLENOL) for Pain, IBUPROFEN (MOTRIN CHILDS) for an unknown indication.    On 10-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 10-Oct-2023, the patient experienced FEELING ABNORMAL (not feeling good), FATIGUE (fatigue) and ARTHRALGIA (joints are hurting a lot/arthritis joint pain). At the time of the report, FEELING ABNORMAL (not feeling good) and ARTHRALGIA (joints are hurting a lot/arthritis joint pain) outcome was unknown and FATIGUE (fatigue) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient had the vaccine and reported his joints were hurting a lot, fatigue and not feeling good. One of the other vaccines, he had some of the issues too. He had some arthritis joint pain. He has been taking Tylenol and Motrin. He was high tolerance for pain.   No treatment medications were provided.
Age: 86.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Nausea, Vomiting
Clinical narrative: After taking the shot caller experienced nauseousness and vomiting at around 8pm; After taking the shot caller experienced nauseousness and vomiting at around 8pm; feeling weak; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (feeling weak), VOMITING (After taking the shot caller experienced nauseousness and vomiting at around 8pm) and NAUSEA (After taking the shot caller experienced nauseousness and vomiting at around 8pm) in an 86-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2023, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 13-Oct-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced ASTHENIA (feeling weak). On 13-Oct-2023 at 8:00 PM, the patient experienced VOMITING (After taking the shot caller experienced nauseousness and vomiting at around 8pm) and NAUSEA (After taking the shot caller experienced nauseousness and vomiting at around 8pm). At the time of the report, ASTHENIA (feeling weak), VOMITING (After taking the shot caller experienced nauseousness and vomiting at around 8pm) and NAUSEA (After taking the shot caller experienced nauseousness and vomiting at around 8pm) was resolving.        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. It was reported that after taking the shot caller experienced nauseousness and vomiting at around 8pm. She slept through the night and woke up feeling weak. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: He also had a mild case of COVID-19 in the fall of 2022.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (He also had a mild case of COVID-19 in the fall of 2022.) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (He also had a mild case of COVID-19 in the fall of 2022.). At the time of the report, COVID-19 (He also had a mild case of COVID-19 in the fall of 2022.) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient had received the Moderna original vaccine plus 2 booster vaccines in 2022. Patient also had a mild case of COVID-19 in the fall of 2022.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2023: Live follow up was received. References were added.
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: Tired/she felt tired; she felt bad for a day or 2. She didn´t feel good,; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Tired/she felt tired) and FEELING ABNORMAL (she felt bad for a day or 2. She didn´t feel good, ) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received 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 FATIGUE (Tired/she felt tired) and FEELING ABNORMAL (she felt bad for a day or 2. She didn´t feel good, ). At the time of the report, FATIGUE (Tired/she felt tired) and FEELING ABNORMAL (she felt bad for a day or 2. She didn´t feel good, ) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient received the Moderna bivalent vaccine she felt bad for a day or 2. Patient didn´t felt good, felt tired. Patient said it was the normal, no big deal. Patient didn´t had fever no rash, she was little tired. She mentioned that she was fine.  Treatment information was not reported.
Sex: U
Vaccine: UNK
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: COVID symptoms and tested positive for COVID today; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID symptoms and tested positive for COVID today) in an adult patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 16-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced COVID-19 (COVID symptoms and tested positive for COVID today). At the time of the report, COVID-19 (COVID symptoms and tested positive for COVID today) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Oct-2023, SARS-CoV-2 test: Positive.     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.   Concomitant medications were not reported.  HCP states that he had a patient who received the Spikevax 2023-2024 vaccine on 9OCT2023.  HCP wanted to know if the Spikevax vaccine can cause a false positive COVID test result a week after receiving it.   Treatment information was not reported.
Sex: F
Vaccine: UNK
Symptoms: Erythema, Peripheral swelling
Clinical narrative: her arm got real swollen and a huge, huge red patch on it; her arm got real swollen and a huge, huge red patch on it; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (her arm got real swollen and a huge, huge red patch on it) and ERYTHEMA (her arm got real swollen and a huge, huge red patch on it) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 Vaccine (Dose 2) and COVID-19 Vaccine (Dose 1). Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine and COVID-19 Vaccine.    On an unknown date, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (her arm got real swollen and a huge, huge red patch on it) and ERYTHEMA (her arm got real swollen and a huge, huge red patch on it). At the time of the report, PERIPHERAL SWELLING (her arm got real swollen and a huge, huge red patch on it) and ERYTHEMA (her arm got real swollen and a huge, huge red patch on it) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter.  Patient had the first two covid shots without any problem. Then on the 3rd booster, her arm got real swollen and a huge, huge red patch on it.   It was unknown that if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment medication use information was not provided by reporter.   Reporter did not allow further contact
Sex: M
Vaccine: UNK
Symptoms: Accidental exposure to product, Device connection issue, Exposure via eye contact, Product administration error, Syringe issue
Clinical narrative: The barrel of the syringe popped up / It separated from the needle; The medication hit the patient and as a result some of the vaccine got into his eye; The medication hit the patient and as a result some of the vaccine got into his eye; The medication hit the patient and as a result some of the vaccine got into his eye; The medication hit the patient and as a result some of the vaccine got into his eye; The medication hit the patient and as a result some of the vaccine got into his eye; This is a spontaneous report received from a contactable reporter (Pharmacist) from medical information team.  A male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation; for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), described as "The barrel of the syringe popped up / It separated from the needle"; PRODUCT ADMINISTRATION ERROR (non-serious), ACCIDENTAL EXPOSURE TO PRODUCT (non-serious), EXPOSURE VIA SKIN CONTACT (non-serious), EXPOSURE VIA EYE CONTACT (non-serious), UNDERDOSE (non-serious) and all described as "The medication hit the patient and as a result some of the vaccine got into his eye". Additional information: Caller stated they had been injecting the new Comirnaty 2023, 2024 vaccine and then the barrel of the syringe popped up as he was injecting the vaccine to a patient. Caller added it separated from the needle and the medication hit the patient and as a result some of the vaccine got into his eye. Caller wanted to know what to do about it, if he should flush the patient's eye. Caller said he's not concerned about reporting any product quality issue regarding the product but he just wanted to seek guidelines. Eye contact: Rinse thoroughly with plenty of water for at least 15 minutes, lifting lower and upper eyelids. Consult a physician. Skin contact: Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seek medical attention.  Causality for "the barrel of the syringe popped up / it separated from the needle" and "the medication hit the patient and as a result some of the vaccine got into his eye" was determined associated to device constituent of bnt162b2 omi xbb.1.5 (malfunction).  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.  Amendment: This follow-up report is being submitted to amend previous information: Suspect drug was updated from BNT162B2, BNT162B2 OMI BA.4-5 to Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula).  Amendment: This follow up report is being submitted to amend previously reported information: Suspect drug was updated from Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) to BNT162B2 OMI XBB.1.5. Device issue was added as event.
Sex: M
Vaccine: UNK
Symptoms: Underdose
Clinical narrative: The barrel of the syringe popped up / It separated from the needle; The medication hit the patient and as a result some of the vaccine got into his eye; The medication hit the patient and as a result some of the vaccine got into his eye; The medication hit the patient and as a result some of the vaccine got into his eye; The medication hit the patient and as a result some of the vaccine got into his eye; The medication hit the patient and as a result some of the vaccine got into his eye; This is a spontaneous report received from a contactable reporter (Pharmacist) from medical information team.  A male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation; for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), described as "The barrel of the syringe popped up / It separated from the needle"; PRODUCT ADMINISTRATION ERROR (non-serious), ACCIDENTAL EXPOSURE TO PRODUCT (non-serious), EXPOSURE VIA SKIN CONTACT (non-serious), EXPOSURE VIA EYE CONTACT (non-serious), UNDERDOSE (non-serious) and all described as "The medication hit the patient and as a result some of the vaccine got into his eye". Additional information: Caller stated they had been injecting the new Comirnaty 2023, 2024 vaccine and then the barrel of the syringe popped up as he was injecting the vaccine to a patient. Caller added it separated from the needle and the medication hit the patient and as a result some of the vaccine got into his eye. Caller wanted to know what to do about it, if he should flush the patient's eye. Caller said he's not concerned about reporting any product quality issue regarding the product but he just wanted to seek guidelines. Eye contact: Rinse thoroughly with plenty of water for at least 15 minutes, lifting lower and upper eyelids. Consult a physician. Skin contact: Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seek medical attention.  Causality for "the barrel of the syringe popped up / it separated from the needle" and "the medication hit the patient and as a result some of the vaccine got into his eye" was determined associated to device constituent of bnt162b2 omi xbb.1.5 (malfunction).  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.  Amendment: This follow-up report is being submitted to amend previous information: Suspect drug was updated from BNT162B2, BNT162B2 OMI BA.4-5 to Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula).  Amendment: This follow up report is being submitted to amend previously reported information: Suspect drug was updated from Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) to BNT162B2 OMI XBB.1.5. Device issue was added as event.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site cellulitis
Clinical narrative: Cellulitis in left upper arm. Warm, red and hard that spread across entire upper arm.; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 at 08:45 as dose 1, single (Lot number: HG4677) at the age of 67 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 4, Manufacturer unknown), for COVID-19 immunization. The following information was reported: VACCINATION SITE CELLULITIS (medically significant) with onset 07Oct2023 at 08:00, outcome "not recovered", described as "Cellulitis in left upper arm. Warm, red and hard that spread across entire upper arm.". Therapeutic measures were taken as a result of vaccination site cellulitis as patient received anti-inflammatory and antibiotics.   Causality for "cellulitis in left upper arm. warm, red and hard that spread across entire upper arm." was determined associated to device constituent of bnt162b2 omi xbb.1.5 (malfunction).  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported event Vaccination site cellulitis and the suspect drug cannot be excluded. The case will be reassessed once new information is available. There is a possibility of Vaccination site cellulitis having occurred as a result of malfunctioning of the device hence its association cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.