chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: RSV
Symptoms: Pruritus, Saliva discolouration
Clinical narrative: request information about the presence of saliva discoloration; itchiness after an administration of a dose of Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of saliva discoloration in a 88-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number ET5FD, expiry date 07-DEC-2024) for prophylaxis.   On 16-SEP-2023, the patient received the 1st dose of Arexvy. On 16-SEP-2023, less than a day after receiving Arexvy, the patient experienced saliva discoloration (Verbatim: request information about the presence of saliva discoloration) and pruritus (Verbatim: itchiness after an administration of a dose of Arexvy).  The outcome of the saliva discoloration and pruritus were unknown.   It was unknown if the reporter considered the saliva discoloration and pruritus to be related to Arexvy.     It was unknown if the company considered the saliva discoloration and pruritus to be related to Arexvy.   Additional Information: GSK receipt date: 02-OCT-2023 A pharmacist called in to request information about the presence of saliva discoloration and itchiness after an administration of a dose of Arexvy.  Partial information given. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up.
Sex: U
Vaccine: UNK
Symptoms: Immunisation reaction, Malaise
Clinical narrative: went back for the second dose and had minor reactions.; They got really ill after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (went back for the second dose and had minor reactions.) and MALAISE (They got really ill after the first dose) 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 an unknown date, the patient received second dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (went back for the second dose and had minor reactions.) and MALAISE (They got really ill after the first dose). At the time of the report, IMMUNISATION REACTION (went back for the second dose and had minor reactions.) and MALAISE (They got really ill after the first dose) outcome was unknown. Not Provided      For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Reporter mentioned that back when the vaccines first came out she spoke to 4 people who told her that they experienced strange reactions with the Moderna vaccine. They got really ill after the first dose, and 2 of them didn't go back for the second dose. Two of them went back for the second dose and had minor reactions. No treatment medication reported.  This case was for the fourth patient out of four reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-743464, MOD-2023-743551 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743464:Master Case MOD-2023-743551:Patient 4
Sex: U
Vaccine: UNK
Symptoms: Illness, Immunisation reaction
Clinical narrative: ill; minor reactions; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (ill) and IMMUNISATION REACTION (minor reactions) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for an unknown indication.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (ill) and IMMUNISATION REACTION (minor reactions). At the time of the report, ILLNESS (ill) and IMMUNISATION REACTION (minor reactions) outcome was unknown. Not Provided      For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-743464, MOD-2023-743565 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743464:Master Case MOD-2023-743565:Patient 2
Sex: F
Vaccine: UNK
Symptoms: Immunisation reaction
Clinical narrative: some unusual symptoms after receiving a recent covid shot; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (some unusual symptoms after receiving a recent covid shot) 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 dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (some unusual symptoms after receiving a recent covid shot). At the time of the report, IMMUNISATION REACTION (some unusual symptoms after receiving a recent covid shot) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: UNK
Symptoms: Feeling abnormal, Illness, Influenza like illness, Malaise
Clinical narrative: I am in bed sick as a dog; every single time I have had it I've been in bed for 2 and a half days feeling awful, like I have the flu; every single time I have had it I've been in bed for 2 and a half days feeling awful, like I have the flu; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (I am in bed sick as a dog), FEELING ABNORMAL (every single time I have had it I've been in bed for 2 and a half days feeling awful, like I have the flu) and INFLUENZA LIKE ILLNESS (every single time I have had it I've been in bed for 2 and a half days feeling awful, like I have the flu) 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 an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I am in bed sick as a dog), FEELING ABNORMAL (every single time I have had it I've been in bed for 2 and a half days feeling awful, like I have the flu) and INFLUENZA LIKE ILLNESS (every single time I have had it I've been in bed for 2 and a half days feeling awful, like I have the flu). At the time of the report, ILLNESS (I am in bed sick as a dog) outcome was unknown and FEELING ABNORMAL (every single time I have had it I've been in bed for 2 and a half days feeling awful, like I have the flu) and INFLUENZA LIKE ILLNESS (every single time I have had it I've been in bed for 2 and a half days feeling awful, like I have the flu) had resolved.            Concomitant product use was not provided by the reporter.  Patient had two Pfizer's and two Moderna's doses of Covid vaccines.  On the day of report, patient received Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) in the morning. The vaccine provider pinched the patient's skin and gave it and patient felt it like to be given underneath the skin.  It had been reported that whenever the patient received the COVID-19 vaccines, patient had the same reaction no matter which one the patient got. After receiving each and every dose, patient had been in bed for two and half days and felt awful, like patient had a flu. After getting the recent dose, the patient had been doing stuff all day long, and felt nothing. Usually by this time, the patient would be in bed, like sick as a dog.  If someone pinches the patient's arm and administered the vaccine, the patient felt it like it to be given under the skin.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: He states that typically every after immunizations he would only have fever and muscle aches but these would go away; He states that typically every after immunizations he would only have fever and muscle aches but these would go away; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (He states that typically every after immunizations he would only have fever and muscle aches but these would go away) and MYALGIA (He states that typically every after immunizations he would only have fever and muscle aches but these would go away) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A, 028L20A and 033F21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension, Anxiety and Depression. Concomitant products included TELMISARTAN for Anxiety and Depression, NYSTATIN (STATIN [NYSTATIN]) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (He states that typically every after immunizations he would only have fever and muscle aches but these would go away) and MYALGIA (He states that typically every after immunizations he would only have fever and muscle aches but these would go away). At the time of the report, PYREXIA (He states that typically every after immunizations he would only have fever and muscle aches but these would go away) and MYALGIA (He states that typically every after immunizations he would only have fever and muscle aches but these would go away) had resolved.            Patient was taking meds before going to bed statin drug. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-743833 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743833:Master case for SPIKEVAX 2023-2024 PFS
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: had swelling, in the injection site which was red and hard, she also had soreness in the muscle and took a couple of days to go down; had swelling, in the injection site which was red and hard, she also had soreness in the muscle and took a couple of days to go down; had swelling, in the injection site which was red and hard, she also had soreness in the muscle and took a couple of days to go down; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (had swelling, in the injection site which was red and hard, she also had soreness in the muscle and took a couple of days to go down), INJECTION SITE ERYTHEMA (had swelling, in the injection site which was red and hard, she also had soreness in the muscle and took a couple of days to go down) and INJECTION SITE PAIN (had swelling, in the injection site which was red and hard, she also had soreness in the muscle and took a couple of days to go down) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A, 021B21A and 025D21A) for COVID-19 prophylaxis.     The patient's past medical history included Lymph node excision (Also had radiation) in 2021.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-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 INJECTION SITE SWELLING (had swelling, in the injection site which was red and hard, she also had soreness in the muscle and took a couple of days to go down), INJECTION SITE ERYTHEMA (had swelling, in the injection site which was red and hard, she also had soreness in the muscle and took a couple of days to go down) and INJECTION SITE PAIN (had swelling, in the injection site which was red and hard, she also had soreness in the muscle and took a couple of days to go down). At the time of the report, INJECTION SITE SWELLING (had swelling, in the injection site which was red and hard, she also had soreness in the muscle and took a couple of days to go down), INJECTION SITE ERYTHEMA (had swelling, in the injection site which was red and hard, she also had soreness in the muscle and took a couple of days to go down) and INJECTION SITE PAIN (had swelling, in the injection site which was red and hard, she also had soreness in the muscle and took a couple of days to go down) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-744286 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-744286:Master case (SPIKEVAX 2023-2024 Formula)
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain in entire body; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN (pain in entire body) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (pain in entire body). At the time of the report, PAIN (pain in entire body) had resolved.            Concomitant medication information was not reported.  The patient had pain in entire body for a few days after first, second and third doses of Moderna COVID vaccine.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-742972 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742972:Case for 3rd dose of vaccine
Age: 18.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) in an 18-year-old male patient 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 COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) 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.   Concomitant medications were not reported.   Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-742650 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742650:Same reporter, Different Patient
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) in a 55-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.     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 COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) 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 medications were reported. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-742650 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742650:Same reporter, Different Patient
Sex: F
Vaccine: UNK
Symptoms: Immunisation reaction
Clinical narrative: has always has strong side effects, like 2 or 3 days; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (has always has strong side effects, like 2 or 3 days) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (has always has strong side effects, like 2 or 3 days). At the time of the report, IMMUNISATION REACTION (has always has strong side effects, like 2 or 3 days) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.   Treatment medication not reported.  The patient stated, she got all the Moderna shots and boosters and has always has strong side effects, like 2 or 3 days. Her husband took all Pfizer and never gets side effects.   This case was linked to US-MODERNATX, INC.-MOD-2023-743874 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743874:Same patient monovalent moderna vaccine
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: I did not feel good after receiving the Moderna vaccine/feel like shit afterwards; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I did not feel good after receiving the Moderna vaccine/feel like shit afterwards) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (I did not feel good after receiving the Moderna vaccine/feel like shit afterwards). At the time of the report, FEELING ABNORMAL (I did not feel good after receiving the Moderna vaccine/feel like shit afterwards) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Patient had 4 or 5 covid shots. No traumatic things.  Treatment information was not reported.
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Mobility decreased, Neck pain, Pain, Pain in extremity
Clinical narrative: hurting and was in pain/ writhing in pain from the arm, shoulder up to the neck area; arm was not mobile at all; he was screaming in pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (hurting and was in pain/ writhing in pain from the arm, shoulder up to the neck area), LIMB DISCOMFORT (arm was not mobile at all) and SCREAMING (he was screaming in pain) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-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 (hurting and was in pain/ writhing in pain from the arm, shoulder up to the neck area), LIMB DISCOMFORT (arm was not mobile at all) and SCREAMING (he was screaming in pain). The patient was treated with PARACETAMOL (TYLENOL) for Pain localised, at an unspecified dose and frequency. At the time of the report, PAIN (hurting and was in pain/ writhing in pain from the arm, shoulder up to the neck area) and SCREAMING (he was screaming in pain) had resolved and LIMB DISCOMFORT (arm was not mobile at all) 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.  Reporter stated that her husband got the Spikevax vaccine and was hurting and he was in pain. He called from work on a day before reporting (02-Oct-2023) and was requesting to be picked up. Caller was worried because he was writhing in pain from the arm, shoulder up to the neck area. She found this unusual because he was screaming in pain and the arm was not mobile at all. They read the shoulder can be impaired if the injection was given a little too high. She gave him 2 Tylenol and 12 hours later, the pain resolved.   This case was linked to US-MODERNATX, INC.-MOD-2023-743549 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743549:Wife patient case
Sex: M
Vaccine: UNK
Symptoms: Screaming
Clinical narrative: hurting and was in pain/ writhing in pain from the arm, shoulder up to the neck area; arm was not mobile at all; he was screaming in pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (hurting and was in pain/ writhing in pain from the arm, shoulder up to the neck area), LIMB DISCOMFORT (arm was not mobile at all) and SCREAMING (he was screaming in pain) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-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 (hurting and was in pain/ writhing in pain from the arm, shoulder up to the neck area), LIMB DISCOMFORT (arm was not mobile at all) and SCREAMING (he was screaming in pain). The patient was treated with PARACETAMOL (TYLENOL) for Pain localised, at an unspecified dose and frequency. At the time of the report, PAIN (hurting and was in pain/ writhing in pain from the arm, shoulder up to the neck area) and SCREAMING (he was screaming in pain) had resolved and LIMB DISCOMFORT (arm was not mobile at all) 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.  Reporter stated that her husband got the Spikevax vaccine and was hurting and he was in pain. He called from work on a day before reporting (02-Oct-2023) and was requesting to be picked up. Caller was worried because he was writhing in pain from the arm, shoulder up to the neck area. She found this unusual because he was screaming in pain and the arm was not mobile at all. They read the shoulder can be impaired if the injection was given a little too high. She gave him 2 Tylenol and 12 hours later, the pain resolved.   This case was linked to US-MODERNATX, INC.-MOD-2023-743549 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743549:Wife patient case
Sex: F
Vaccine: UNK
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Oct-2023 at 4:30 AM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 03-Oct-2023, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) had not resolved.        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 medications were reported. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-743694 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743694:Husband case
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2022, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Patient received the Moderna COVID-19 vaccine (original) primary series when it first came out and then tested positive for COVID-19 in Nov-2022. As part of the treatment, he received monoclonal antibodies. He wanted to know if there are some warnings that he should not get the SPIKEVAX (2023-2024) if he received monoclonal antibodies as part of treatment for COVID-19.
Age: 63.0
Sex: F
Vaccine: FLUX, UNK
Symptoms: Fatigue, Illness, Pain, Pyrexia
Clinical narrative: She was really really sick on Sunday night after she got the vaccine and typically has a fever; fevers; Fatigue; aches; This spontaneous case was reported by a patient and describes the occurrence of PAIN (aches), ILLNESS (She was really really sick on Sunday night after she got the vaccine and typically has a fever), PYREXIA (fevers) and FATIGUE (Fatigue) in a 63-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (INFLUENZA) for an unknown indication.    It was reported that patient had no allergies. Past medical history was nothing serious.  Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (1st dose) on 19-Feb-2021, PFIZER BIONTECH COVID-19 VACCINE (2nd dose) on 09-Mar-2021 and PFIZER BIONTECH COVID-19 VACCINE (Booster) on 09-Oct-2021; for COVID-19 prophylaxis: Moderna (W8G252) on 06-May-2022, Moderna (055F22B) on 06-Oct-2022 and Moderna (A57642B) on 04-Jun-2023. Past adverse reactions to the above products included No adverse event with Moderna, Moderna, Moderna, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Osteoporosis.   On 01-Oct-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2023, the patient received dose of INFLUENZA VACCINE (INFLUENZA) (unknown route) 1 dosage form. On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 01-Oct-2023, the patient experienced PAIN (aches), PYREXIA (fevers) and FATIGUE (Fatigue). On 08-Oct-2023, the patient experienced ILLNESS (She was really really sick on Sunday night after she got the vaccine and typically has a fever). At the time of the report, PAIN (aches), ILLNESS (She was really really sick on Sunday night after she got the vaccine and typically has a fever), PYREXIA (fevers) and FATIGUE (Fatigue) had not resolved.        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 it packed more of a punch this time. This one hit her pretty hard. She was feeling well last night and then started feeling achy and had a fever but not high. She was really sick on sunday night after she got the vaccine and typically had a fever. Patient was concerned that since it was 36 hours after the vaccine that she was still experiencing these reactions. No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Chest discomfort, Heart rate increased, Palpitations
Clinical narrative: Palpitations; Chest discomfort - some tightness; Extremely high pulse rate; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations), CHEST DISCOMFORT (Chest discomfort - some tightness) and HEART RATE INCREASED (Extremely high pulse rate) in a 69-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3832B) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypothyroidism and Cholesterolosis NOS (Takes statin for cholesterol.).    On 29-Sep-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 02-Oct-2023, the patient experienced PALPITATIONS (Palpitations), CHEST DISCOMFORT (Chest discomfort - some tightness) and HEART RATE INCREASED (Extremely high pulse rate). On 02-Oct-2023, PALPITATIONS (Palpitations), CHEST DISCOMFORT (Chest discomfort - some tightness) and HEART RATE INCREASED (Extremely high pulse rate) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Oct-2023, Heart rate: 150s, extremely high.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient takes statin for Cholesterol. Patient called her cardiologist who said that the event could have been due to dehydration or due to the vaccine. She took fluids and it was resolved. She was told to consult again if this recurs. Patient feels overwhelmed but not lethargic and very worried. Her vaccination details are as follows: First dose on18Jan2021 with lot number 012L20A, Second dose on 15Feb2021 with lot number 006M20A, third dose on 11Sep2021 with lot number 050E21A, Fourth dose on 08Apr2022 with unreadable lot number, Fifth dose on 29Apr2023 with lot number AS7144B.   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea, Fatigue, Lethargy, Myalgia, Pyrexia
Clinical narrative: lethargic; diarrhea; fever; fatigue; muscle pain; This spontaneous case was reported by a patient and describes the occurrence of LETHARGY (lethargic), DIARRHOEA (diarrhea), PYREXIA (fever), FATIGUE (fatigue) and MYALGIA (muscle pain) in a 63-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer on 26-Mar-2021, Pfizer on 16-Apr-2021, Pfizer on 22-Oct-2021 and Flu shot on 25-Sep-2023. Past adverse reactions to the above products included No adverse event with Flu shot, Pfizer, Pfizer and Pfizer.    On 02-Oct-2023 at 4:00 PM, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 03-Oct-2023 at 4:00 PM, the patient experienced PYREXIA (fever), FATIGUE (fatigue) and MYALGIA (muscle pain). On 04-Oct-2023, the patient experienced LETHARGY (lethargic). 04-Oct-2023, the patient experienced DIARRHOEA (diarrhea). On 04-Oct-2023, DIARRHOEA (diarrhea) had resolved. At the time of the report, LETHARGY (lethargic), PYREXIA (fever), FATIGUE (fatigue) and MYALGIA (muscle pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.3 F. On an unknown date, SARS-CoV-2 test: it was clear.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication were not reported by the reporter. It was reported that patient had second episode of fever on 04-OCT-2023. The treatment medication were not reported by the reporter.   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: SARS-CoV-2 test
Clinical narrative: lethargic; diarrhea; fever; fatigue; muscle pain; This spontaneous case was reported by a patient and describes the occurrence of LETHARGY (lethargic), DIARRHOEA (diarrhea), PYREXIA (fever), FATIGUE (fatigue) and MYALGIA (muscle pain) in a 63-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer on 26-Mar-2021, Pfizer on 16-Apr-2021, Pfizer on 22-Oct-2021 and Flu shot on 25-Sep-2023. Past adverse reactions to the above products included No adverse event with Flu shot, Pfizer, Pfizer and Pfizer.    On 02-Oct-2023 at 4:00 PM, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 03-Oct-2023 at 4:00 PM, the patient experienced PYREXIA (fever), FATIGUE (fatigue) and MYALGIA (muscle pain). On 04-Oct-2023, the patient experienced LETHARGY (lethargic). 04-Oct-2023, the patient experienced DIARRHOEA (diarrhea). On 04-Oct-2023, DIARRHOEA (diarrhea) had resolved. At the time of the report, LETHARGY (lethargic), PYREXIA (fever), FATIGUE (fatigue) and MYALGIA (muscle pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.3 F. On an unknown date, SARS-CoV-2 test: it was clear.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication were not reported by the reporter. It was reported that patient had second episode of fever on 04-OCT-2023. The treatment medication were not reported by the reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Lung carcinoma cell type unspecified stage IV
Clinical narrative: She was diagnosed to have stage 4 lung cancer after she got the first dose; This spontaneous case was reported by a patient and describes the occurrence of LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV (She was diagnosed to have stage 4 lung cancer after she got the first dose) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV (She was diagnosed to have stage 4 lung cancer after she got the first dose) (seriousness criterion medically significant). At the time of the report, LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV (She was diagnosed to have stage 4 lung cancer after she got the first dose) had not resolved.        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 product use was not provided by the reporter.  Patient stated that she had stage 4 lung cancer and needs to have the Moderna vaccine shot but cannot seem to find any place near her that carries it. Her previous vaccines were all Moderna.  Treatment information was not provided.  Company Comment: This is a spontaneous case concerning a female patient of unknown age, with no reported medical history, who experienced the serious (due to medically significant) unexpected, event of Lung carcinoma cell type unspecified stage IV, which occurred after the first dose of Spikevax (COVID-19 Vaccine, mRNA) 2023-2024 Formula. The outcome was reported as not recovered. The company considered the event as not related to the vaccine due to the nature of the event, lack of biological plausibility and known safety profile of the vaccine. No further clinical information was available for medical review. The benefit-risk relationship of Spikevax (COVID-19 Vaccine, mRNA) 2023-2024 Formula is not affected by this report.
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Night sweats
Clinical narrative: Bad achiness; Night sweats; Chills; Joint pain/Joint achiness; Muscle achiness; Fever; Abrupt fatigue feeling; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Bad achiness), NIGHT SWEATS (Night sweats), CHILLS (Chills), ARTHRALGIA (Joint pain/Joint achiness) and MYALGIA (Muscle achiness) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer (Reactions to the Pfizer vaccine mainly fatigue and a slight chill.) and Pfizer (Reactions to the Pfizer vaccine mainly fatigue and a slight chill.). Past adverse reactions to the above products included Chills with Pfizer; and Fatigue with Pfizer.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Bad achiness), NIGHT SWEATS (Night sweats), ARTHRALGIA (Joint pain/Joint achiness), MYALGIA (Muscle achiness) and PYREXIA (Fever). an unknown date, the patient experienced CHILLS (Chills) and FATIGUE (Abrupt fatigue feeling). At the time of the report, PAIN (Bad achiness), NIGHT SWEATS (Night sweats), CHILLS (Chills), ARTHRALGIA (Joint pain/Joint achiness), MYALGIA (Muscle achiness), PYREXIA (Fever) and FATIGUE (Abrupt fatigue feeling) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient reported that she had reactions to the Pfizer vaccine, mainly fatigue and a slight chill. 24 hours after Moderna XBB she had an abrupt fatigue feeling, chills, did not had a fever but had really bad achiness, fever, and joint pain. She had muscle achiness and joint achiness. Two nights after the vaccine she had night sweats. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2023: Live Follow-up received and had no new information.
Sex: F
Vaccine: UNK
Symptoms: Pain
Clinical narrative: Bad achiness; Night sweats; Chills; Joint pain/Joint achiness; Muscle achiness; Fever; Abrupt fatigue feeling; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Bad achiness), NIGHT SWEATS (Night sweats), CHILLS (Chills), ARTHRALGIA (Joint pain/Joint achiness) and MYALGIA (Muscle achiness) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer (Reactions to the Pfizer vaccine mainly fatigue and a slight chill.) and Pfizer (Reactions to the Pfizer vaccine mainly fatigue and a slight chill.). Past adverse reactions to the above products included Chills with Pfizer; and Fatigue with Pfizer.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Bad achiness), NIGHT SWEATS (Night sweats), ARTHRALGIA (Joint pain/Joint achiness), MYALGIA (Muscle achiness) and PYREXIA (Fever). an unknown date, the patient experienced CHILLS (Chills) and FATIGUE (Abrupt fatigue feeling). At the time of the report, PAIN (Bad achiness), NIGHT SWEATS (Night sweats), CHILLS (Chills), ARTHRALGIA (Joint pain/Joint achiness), MYALGIA (Muscle achiness), PYREXIA (Fever) and FATIGUE (Abrupt fatigue feeling) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient reported that she had reactions to the Pfizer vaccine, mainly fatigue and a slight chill. 24 hours after Moderna XBB she had an abrupt fatigue feeling, chills, did not had a fever but had really bad achiness, fever, and joint pain. She had muscle achiness and joint achiness. Two nights after the vaccine she had night sweats. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2023: Live Follow-up received and had no new information.
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Breakthrough pain
Clinical narrative: Breakthrough pain; Bilateral pain in wrists and fingers (joints); This spontaneous case was reported by a patient and describes the occurrence of BREAKTHROUGH PAIN (Breakthrough pain) and ARTHRALGIA (Bilateral pain in wrists and fingers (joints)) in a 36-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for Pneumocystis carinii pneumonia, Pneumocystis pneumonia, Pneumocystosis, Interstitial plasma cell pneumonia, Pneumocystis jiroveci pneumonia and Pneumocystis jirovecii pneumonia.     The patient's past medical history included COVID-19 (Patient was diagnosed with Covid 19) in December 2022.    On 16-Sep-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) 1 dosage form. On 22-Sep-2023, the patient experienced BREAKTHROUGH PAIN (Breakthrough pain) and ARTHRALGIA (Bilateral pain in wrists and fingers (joints)). The patient was treated with IBUPROFEN at a dose of 600 milligram twice a day and PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, BREAKTHROUGH PAIN (Breakthrough pain) and ARTHRALGIA (Bilateral pain in wrists and fingers (joints)) had not resolved.            Concomitant medication was not provided. Patient had bilateral pain in wrists and fingers (joints) increased over time. OTC NSAID usage helped but breakthrough pain continued. Patient went to PCP and was told it was likely a vaccine response.  Patient was prescribed with 50mg Diclofenac sodium, but haven't taken it yet.
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Contusion, Malaise
Clinical narrative: severe reaction with bruising on her arm; she was really sick for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (severe reaction with bruising on her arm) and MALAISE (she was really sick for 2 days) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.    Co-suspect product included non-company product VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONTUSION (severe reaction with bruising on her arm) and MALAISE (she was really sick for 2 days). At the time of the report, CONTUSION (severe reaction with bruising on her arm) outcome was unknown and MALAISE (she was really sick for 2 days) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (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.  The reporter was reporting for her neighbor who had the Spikevax Covid-19 vaccine along with a Shingrix shot and had a severe reaction with bruising on her arm. The reporter attributed it to having two vaccines at the same time. The neighbor was really sick for two days.   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2023: Live follow-up received. No new information received.
Age: 76.0
Sex: F
Vaccine: FLUX, UNK
Symptoms: Anticoagulant therapy, Asthenia, Chills, Erythema, Fatigue
Clinical narrative: Weakness; has a gigantic red welt; Spikevax on her right arm, which is very sore at the moment; chills; Tiredness; left arm is swollen; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Weakness), URTICARIA (has a gigantic red welt), VACCINATION SITE PAIN (Spikevax on her right arm, which is very sore at the moment), CHILLS (chills) and FATIGUE (Tiredness) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    The patient's past medical history included Stent placement (5 weeks ago). Previously administered products included for Product used for unknown indication: Pfizer Biontech COVID-19 vaccine (Dose 2) and Pfizer Biontech COVID-19 vaccine (Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer Biontech COVID-19 vaccine and Pfizer Biontech COVID-19 vaccine.   On 03-Oct-2023, the patient received dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 04-Oct-2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 04-Oct-2023, the patient experienced ASTHENIA (Weakness), URTICARIA (has a gigantic red welt), VACCINATION SITE PAIN (Spikevax on her right arm, which is very sore at the moment), CHILLS (chills) and FATIGUE (Tiredness). 04-Oct-2023, the patient experienced VACCINATION SITE SWELLING (left arm is swollen). At the time of the report, ASTHENIA (Weakness), URTICARIA (has a gigantic red welt), CHILLS (chills) and FATIGUE (Tiredness) had not resolved, VACCINATION SITE PAIN (Spikevax on her right arm, which is very sore at the moment) had resolved and VACCINATION SITE SWELLING (left arm is swollen) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  On 03-Oct-2023, the patient received the flu shot on left arm. The patient's left arm was swollen and had a gigantic red welt on it. The patient took 6 different pills every day as well as blood thinner.   The patient had lot of chills, weakness and tiredness.   This case was linked to US-MODERNATX, INC.-MOD-2021-018199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-018199:Same patient monovalent moderna vaccine