chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Pyrexia
Clinical narrative: Tiredness; little fever; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Tiredness) and PYREXIA (little fever) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (first dose, batch number: 012A21A) on 27-Feb-2021, MODERNA COVID-19 VACCINE (first dose, batch number: 012A21A) on 27-Feb-2021, MODERNA COVID-19 VACCINE (second dose, batch number: 039A21A) on 27-Mar-2021, MODERNA COVID-19 VACCINE (third dose, batch number: 66F21A) on 03-Nov-2021, MODERNA COVID-19 VACCINE (fourth dose and batch number: 048L21A) on 05-Apr-2022. Past adverse reactions to the above products included Fever with MODERNA COVID-19 VACCINE; No adverse event with MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE and MODERNA COVID-19 VACCINE; and Tiredness with MODERNA COVID-19 VACCINE.    On 10-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tiredness) and PYREXIA (little fever). At the time of the report, FATIGUE (Tiredness) and PYREXIA (little fever) outcome was unknown.            The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. It was reported that with the booster, the patient was pretty good, just a little fever and tiredness.  No treatment medication was reported.   This case was linked to MOD-2023-746964 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: he reported that his girlfriend just tested positive on a home test kit; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (he reported that his girlfriend just tested positive on a home test kit) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. ASKU) 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 COVID-19 (he reported that his girlfriend just tested positive on a home test kit). At the time of the report, COVID-19 (he reported that his girlfriend just tested positive on a home test kit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) tested positive on a home test kit, but the home kit is expired..   The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-747075 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747075:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Lastly, the patient stated that she didn't have nausea with the others, I only had fever and fatigue.; Lastly, the patient stated that she didn't have nausea with the others, I only had fever and fatigue.; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Lastly, the patient stated that she didn't have nausea with the others, I only had fever and fatigue.) and FATIGUE (Lastly, the patient stated that she didn't have nausea with the others, I only had fever and fatigue.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 939903, 010M20A and 013M70A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-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 (Lastly, the patient stated that she didn't have nausea with the others, I only had fever and fatigue.) and FATIGUE (Lastly, the patient stated that she didn't have nausea with the others, I only had fever and fatigue.). At the time of the report, PYREXIA (Lastly, the patient stated that she didn't have nausea with the others, I only had fever and fatigue.) and FATIGUE (Lastly, the patient stated that she didn't have nausea with the others, I only had fever and fatigue.) outcome was unknown.            Concomitant and treatment medications were not reported.  The patient had fever and fatigue.   This case was linked to MOD-2023-747310, MOD-2023-747355 (Patient Link).
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Myalgia
Clinical narrative: Right arm is sore in the deltoid; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Right arm is sore in the deltoid) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. WAG10133) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1, Lot no. El3249) on 22-Jan-2021, Pfizer Biontech COVID-19 vaccine (Dose 2, Lot no. EK921) on 12-Feb-2021, Pfizer Biontech COVID-19 vaccine (Dose 3, Lot no. EW0187) on 01-Oct-2021, Pfizer Biontech COVID-19 vaccine (Dose 4, Lot no. GJ6739) on 14-Oct-2022 and Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine, PFIZER BIONTECH COVID-19 VACCINE, Pfizer Biontech COVID-19 vaccine, Pfizer Biontech COVID-19 vaccine and Pfizer Biontech COVID-19 vaccine.    On 25-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. On 25-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced INJECTION SITE PAIN (Right arm is sore in the deltoid). At the time of the report, INJECTION SITE PAIN (Right arm is sore in the deltoid) was resolving.            Concomitant and treatment medications were not reported.  The patient had sore right arm in the deltoid. The patient took best pain medication and put ice on it and felt better.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Skin discolouration, Vaccination site reaction
Clinical narrative: She received 3 Moderna covid-19 vaccines in the past and she got Covid arm with all of them; It was pink all the way down her arm, not just in the injection site. It was something normal with moderna Last dose: October 2022; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (She received 3 Moderna covid-19 vaccines in the past and she got Covid arm with all of them) and SKIN DISCOLOURATION (It was pink all the way down her arm, not just in the injection site. It was something normal with moderna Last dose: October 2022) in a 67-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.    Co-suspect product included non-company product POVIDONE-IODINE (COVIDON) for an unknown indication.    No Medical History information was reported.   In October 2022, the patient received third 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 started POVIDONE-IODINE (COVIDON) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE REACTION (She received 3 Moderna covid-19 vaccines in the past and she got Covid arm with all of them) and SKIN DISCOLOURATION (It was pink all the way down her arm, not just in the injection site. It was something normal with moderna Last dose: October 2022). At the time of the report, VACCINATION SITE REACTION (She received 3 Moderna covid-19 vaccines in the past and she got Covid arm with all of them) and SKIN DISCOLOURATION (It was pink all the way down her arm, not just in the injection site. It was something normal with moderna Last dose: October 2022) had resolved.            No concomitant medication was reported. The patient received 3 Moderna covid-19 vaccines in the past and she got Covid arm with all of them. Maybe with the last one it was not as bad. The patient didn´t have any other reactions. The patient didn´t check this with her doctor since she thought it was just a regular thing. It took a while to get over it, but it went away. It was pink all the way down her arm, not just in the injection site. It was something normal with moderna. No treatment medication was reported.  This case contains information about patient 1st out of 2 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-747018 (Linked Report). This case was linked to MOD-2023-747000 (Patient Link).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747018:patient 2
Sex: U
Vaccine: COVID19
Symptoms: Product contamination physical
Clinical narrative: PFS: 1 particle approximately 1 mm long floating inside the liquid; The HCP did not administer the vaccine to any patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT CONTAMINATION (PFS: 1 particle approximately 1 mm long floating inside the liquid), INTERCEPTED MEDICATION ERROR (The HCP did not administer the vaccine to any patients) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030498) for COVID-19 prophylaxis.    Suspect product included Pre-filled Syringe injection (batch no. 3030498) 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 PFS) (unknown route) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRODUCT CONTAMINATION (PFS: 1 particle approximately 1 mm long floating inside the liquid), INTERCEPTED MEDICATION ERROR (The HCP did not administer the vaccine to any patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT CONTAMINATION (PFS: 1 particle approximately 1 mm long floating inside the liquid), INTERCEPTED MEDICATION ERROR (The HCP did not administer the vaccine to any patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT CONTAMINATION (PFS: 1 particle approximately 1 mm long floating inside the liquid) and INTERCEPTED MEDICATION ERROR (The HCP did not administer the vaccine to any patients).  For Pre-filled Syringe, the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT CONTAMINATION (PFS: 1 particle approximately 1 mm long floating inside the liquid) and INTERCEPTED MEDICATION ERROR (The HCP did not administer the vaccine to any patients).    No concomitant and treatment information were reported.  Reporter reported that there was a white solid substance inside of the thawed product, it might be a crystal, but it is only 1 particle approximately 1 mm long floating inside the liquid. Vaccine was not administered to patients.  Device Problem codes
Age: 40.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Dyspepsia, Dysstasia, Vaccine positive rechallenge
Clinical narrative: she had the same reaction to the first one also/weak/no strength; she had the same reaction to the first one also/couldn't stand; she had the same reaction to the first one also/heartburn; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (she had the same reaction to the first one also/weak/no strength ), DYSSTASIA (she had the same reaction to the first one also/couldn't stand) and DYSPEPSIA (she had the same reaction to the first one also/heartburn ) in a 5-decade-old female patient 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 first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (she had the same reaction to the first one also/weak/no strength ), DYSSTASIA (she had the same reaction to the first one also/couldn't stand) and DYSPEPSIA (she had the same reaction to the first one also/heartburn ). At the time of the report, ASTHENIA (she had the same reaction to the first one also/weak/no strength ), DYSSTASIA (she had the same reaction to the first one also/couldn't stand) and DYSPEPSIA (she had the same reaction to the first one also/heartburn ) outcome was unknown. Not Provided      The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       The patient was in her 40s. No relevant concomitant medications were reported. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-746992 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746992:Different patient, same reporter
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Injection site inflammation, Injection site pain
Clinical narrative: pain in her arm; I have lost my appetite/No longer hungry; diarrhea; The shot center where the shot was is very sore and a very inflamed; The shot center where the shot was is very sore and a very inflamed; fatigued; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (pain in her arm), DECREASED APPETITE (I have lost my appetite/No longer hungry), DIARRHOEA (diarrhea), VACCINATION SITE INFLAMMATION (The shot center where the shot was is very sore and a very inflamed) and VACCINATION SITE PAIN (The shot center where the shot was is very sore and a very inflamed) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 204F23A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna Covid-19 Vaccine (023M20A) on 16-Feb-2021, Moderna Covid-19 Vaccine (023M20A) on 16-Mar-2021, Moderna Covid-19 Vaccine (939305) on 07-Nov-2021, MODERNA COVID-19 VACCINE (038A22A) on 14-May-2022, Moderna Covid-19 Vaccine (014H22A) on 24-May-2022 and Moderna Covid-19 Vaccine (059?22A) on 14-Oct-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, Moderna Covid-19 Vaccine, Moderna Covid-19 Vaccine and Moderna Covid-19 Vaccine. Concurrent medical conditions included Asthma, Hypertension and Diabetes.    On 17-Oct-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in her arm), DECREASED APPETITE (I have lost my appetite/No longer hungry), DIARRHOEA (diarrhea), VACCINATION SITE INFLAMMATION (The shot center where the shot was is very sore and a very inflamed), VACCINATION SITE PAIN (The shot center where the shot was is very sore and a very inflamed) and FATIGUE (fatigued). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in her arm), DIARRHOEA (diarrhea), VACCINATION SITE PAIN (The shot center where the shot was is very sore and a very inflamed) and FATIGUE (fatigued) had not resolved and DECREASED APPETITE (I have lost my appetite/No longer hungry) and VACCINATION SITE INFLAMMATION (The shot center where the shot was is very sore and a very inflamed) outcome was unknown.            No concomitant medication was reported.   Patient was putting ice packs on her arm.
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: pain in her arm; I have lost my appetite/No longer hungry; diarrhea; The shot center where the shot was is very sore and a very inflamed; The shot center where the shot was is very sore and a very inflamed; fatigued; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (pain in her arm), DECREASED APPETITE (I have lost my appetite/No longer hungry), DIARRHOEA (diarrhea), VACCINATION SITE INFLAMMATION (The shot center where the shot was is very sore and a very inflamed) and VACCINATION SITE PAIN (The shot center where the shot was is very sore and a very inflamed) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 204F23A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna Covid-19 Vaccine (023M20A) on 16-Feb-2021, Moderna Covid-19 Vaccine (023M20A) on 16-Mar-2021, Moderna Covid-19 Vaccine (939305) on 07-Nov-2021, MODERNA COVID-19 VACCINE (038A22A) on 14-May-2022, Moderna Covid-19 Vaccine (014H22A) on 24-May-2022 and Moderna Covid-19 Vaccine (059?22A) on 14-Oct-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, Moderna Covid-19 Vaccine, Moderna Covid-19 Vaccine and Moderna Covid-19 Vaccine. Concurrent medical conditions included Asthma, Hypertension and Diabetes.    On 17-Oct-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in her arm), DECREASED APPETITE (I have lost my appetite/No longer hungry), DIARRHOEA (diarrhea), VACCINATION SITE INFLAMMATION (The shot center where the shot was is very sore and a very inflamed), VACCINATION SITE PAIN (The shot center where the shot was is very sore and a very inflamed) and FATIGUE (fatigued). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in her arm), DIARRHOEA (diarrhea), VACCINATION SITE PAIN (The shot center where the shot was is very sore and a very inflamed) and FATIGUE (fatigued) had not resolved and DECREASED APPETITE (I have lost my appetite/No longer hungry) and VACCINATION SITE INFLAMMATION (The shot center where the shot was is very sore and a very inflamed) outcome was unknown.            No concomitant medication was reported.   Patient was putting ice packs on her arm.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspepsia
Clinical narrative: I couldn't stand, I was weak, I had no strength; heartburn; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (I couldn't stand, I was weak, I had no strength) and DYSPEPSIA (heartburn) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L28A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced ASTHENIA (I couldn't stand, I was weak, I had no strength) and DYSPEPSIA (heartburn). At the time of the report, ASTHENIA (I couldn't stand, I was weak, I had no strength) and DYSPEPSIA (heartburn) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication not reported.   2nd dose on 25Feb2021 Lot 004M20A, 3rd dose on 09Dec2021 Lot 033F21A, 4th dose on 05Apr2022 Lot 002M21A.  18 minutes after 1st Moderna vaccine patient was not able to stand, she was weak, no strength and this was frightening because she was healthy before this. The Medical team checked her, her heart was fine, and they gave her orange juice and after 3 containers of orange juice, she developed heartburn and told them to stop. After a 1 hour, she tried to stand and with the help of her husband and a medical staff, she did. She left and went home. She contacted her doctor, and doctor told her to hydrate a lot before going.  Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-746992 (Patient Link).
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Dizziness, Dyspepsia, Dysstasia
Clinical narrative: heartburn; weak, I had no strength; I couldn't stand; This spontaneous case was reported by a patient and describes the occurrence of DYSPEPSIA (heartburn), ASTHENIA (weak, I had no strength) and DIZZINESS (I couldn't stand) 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 first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPEPSIA (heartburn), ASTHENIA (weak, I had no strength) and DIZZINESS (I couldn't stand). At the time of the report, DYSPEPSIA (heartburn) and ASTHENIA (weak, I had no strength) outcome was unknown and DIZZINESS (I couldn't stand) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Information regarding previous COVID-19 vaccination doses were reported as unknown.  Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  It was reported that 18 minutes after my Moderna vaccine patient couldn't stand, she was weak, she had no strength and this was frightening because she was healthy before this. The Medical team checked me, her heart was fine and they gave her orange juice and after 3 containers of orange juice, she developed heartburn and told them to stop. After an 1 hour, she tried to stand and with the help of her husband and a medical staff, she did. Patient stated she left and went home. The patient stated that they contacted their doctor, and she told her to hydrate a lot before going.   This case was linked to US-MODERNATX, INC.-MOD-2023-746995, US-MODERNATX, INC.-MOD-2023-747450 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746995:Same patient (different vaccine) US-MODERNATX, INC.-MOD-2023-747450:Different patient (same vaccine)
Sex: F
Vaccine: COVID19
Symptoms: Coronary artery disease
Clinical narrative: She recently had a coronary stent; This spontaneous case was reported by a consumer and describes the occurrence of CORONARY ARTERY DISEASE (She recently had a coronary stent) in a female 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 dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced CORONARY ARTERY DISEASE (She recently had a coronary stent). At the time of the report, CORONARY ARTERY DISEASE (She recently had a coronary stent) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reported that patient had all her Moderna shots before and she knew that the new Moderna booster is now available at her State. patient recently had a coronary stent and on antiplatelet medication.   Reporter did not allow further contact  Company comment: This spontaneous case concerns a female patient of unknown age, with no medical history information reported, who experienced the unexpected serious (medically significant) AESI of coronary artery disease (described as She recently had a coronary stent). The event occurred on an unknown date. Temporal associating with a dose of mRNA-1273 is unclear. As reported, patient received all her Moderna shots before and recently had a coronary stent and is under antiplatelet medication. No further information about the events was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Product administered at inappropriate site, Vaccination site erythema, Vaccination site mass, Vaccination site warmth
Clinical narrative: And, um, because the pharmacist gave it, um, too low on my arm, I believe she missed the deltoid muscle completely and I reacted; I reacted with a large red, um, warm lump for three days on my arm; Warm lump for three days on my arm; I reacted with a large red, um, warm lump for three days on my arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (I reacted with a large red, um, warm lump for three days on my arm), VACCINATION SITE MASS (Warm lump for three days on my arm), VACCINATION SITE ERYTHEMA (I reacted with a large red, um, warm lump for three days on my arm) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (And, um, because the pharmacist gave it, um, too low on my arm, I believe she missed the deltoid muscle completely and I reacted) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030536) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Sep-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Subcutaneous use) .5 milliliter. In 2023, the patient experienced VACCINATION SITE WARMTH (I reacted with a large red, um, warm lump for three days on my arm), VACCINATION SITE MASS (Warm lump for three days on my arm) and VACCINATION SITE ERYTHEMA (I reacted with a large red, um, warm lump for three days on my arm). On 28-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (And, um, because the pharmacist gave it, um, too low on my arm, I believe she missed the deltoid muscle completely and I reacted). In 2023, VACCINATION SITE WARMTH (I reacted with a large red, um, warm lump for three days on my arm), VACCINATION SITE MASS (Warm lump for three days on my arm) and VACCINATION SITE ERYTHEMA (I reacted with a large red, um, warm lump for three days on my arm) had resolved. At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (And, um, because the pharmacist gave it, um, too low on my arm, I believe she missed the deltoid muscle completely and I reacted) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Subcutaneous use), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Patient had Moderna 1st dose on 11 Feb 2021 (lot number 011M20A), Moderna 2nd dose on 11 Mar 2021 (lot number 048A21A), Moderna booster on 28 Oct 2021 (lot number 046B21A), Moderna 4th dose on 20May2022 (lot number 057M21A) and Moderna 5th dose on 28Nov2022 (lot number 083B22A). Pharmacist vaccinated the patient low on her arm and she believes that the deltoid muscle was missed completely. She was wondering now if that vaccination was effective or not. No treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2023: Follow-up information included no new information.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin discolouration, Vaccination site reaction
Clinical narrative: She received 3 Moderna covid-19 vaccines in the past and she got Covid arm with all of them; pink all the way down arm, not just in the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (She received 3 Moderna covid-19 vaccines in the past and she got Covid arm with all of them) and SKIN DISCOLOURATION (pink all the way down arm, not just in the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU and ASKU) for COVID-19 prophylaxis.    Co-suspect product included non-company product POVIDONE-IODINE (COVIDON) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and POVIDONE-IODINE (COVIDON) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE REACTION (She received 3 Moderna covid-19 vaccines in the past and she got Covid arm with all of them) and SKIN DISCOLOURATION (pink all the way down arm, not just in the injection site). At the time of the report, VACCINATION SITE REACTION (She received 3 Moderna covid-19 vaccines in the past and she got Covid arm with all of them) and SKIN DISCOLOURATION (pink all the way down arm, not just in the injection site) had resolved.            Concomitant medication and treatment were not provided.  Patient has an appointment to receive the new Spikevax vaccine. She received three Moderna covid-19 vaccines in the past and she got Covid arm with all of them. Maybe with the last one it was not as bad. She didn´t have any other reactions. Now she is scared with receiving the new vaccine and she is asking some questions. She didn´t check this with her doctor since she thought it was just a regular thing. It took a while to get over it, but it went away. It was pink all the way down her arm, not just in the injection site. It was something normal with Moderna Last dose: October 2022.   This case was linked to US-MODERNATX, INC.-MOD-2023-747018 (Linked Report). This case was linked to US-MODERNATX, INC.-MOD-2023-747380 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747018:Patient 2
Sex: F
Vaccine: UNK
Symptoms: Injection site pain
Clinical narrative: The state that they had 3 previous Moderna vaccines and they always have pain at the injection site for a long time - maybe a month or even longer than that.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (The state that they had 3 previous Moderna vaccines and they always have pain at the injection site for a long time - maybe a month or even longer than that.) 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 third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form and 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 VACCINATION SITE PAIN (The state that they had 3 previous Moderna vaccines and they always have pain at the injection site for a long time - maybe a month or even longer than that.). At the time of the report, VACCINATION SITE PAIN (The state that they had 3 previous Moderna vaccines and they always have pain at the injection site for a long time - maybe a month or even longer than that.) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient wants to know how the pain at the injection should last after getting the Moderna Covid-19 vaccine. They are scheduled to have the new on this Friday, 27Oct2023. They also state that they heard other people having the same reaction. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Oct-2023: Live significant follow up added dose information and patient initial added.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Contusion, Fatigue, Headache, Joint contracture
Clinical narrative: I felt like my whole body was one big bruise; If I touched my skin, it felt like it was on fire; I literally could not move without aches everywhere; I couldn't bend my elbows cause the pain was excruciating; severe headache; exhaustion; muscle pain that was horrible; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (I felt like my whole body was one big bruise), BURNING SENSATION (If I touched my skin, it felt like it was on fire), MOVEMENT DISORDER (I literally could not move without aches everywhere), JOINT CONTRACTURE (I couldn't bend my elbows cause the pain was excruciating) and HEADACHE (severe headache) in a 60-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for Ache NOS. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included PARACETAMOL (TYLENOL) for Pain, OXYCODONE for an unknown indication.    On 23-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 24-Oct-2023, the patient experienced CONTUSION (I felt like my whole body was one big bruise), BURNING SENSATION (If I touched my skin, it felt like it was on fire), MOVEMENT DISORDER (I literally could not move without aches everywhere), JOINT CONTRACTURE (I couldn't bend my elbows cause the pain was excruciating), HEADACHE (severe headache), FATIGUE (exhaustion) and MYALGIA (muscle pain that was horrible). At the time of the report, CONTUSION (I felt like my whole body was one big bruise), BURNING SENSATION (If I touched my skin, it felt like it was on fire), MOVEMENT DISORDER (I literally could not move without aches everywhere), JOINT CONTRACTURE (I couldn't bend my elbows cause the pain was excruciating), HEADACHE (severe headache), FATIGUE (exhaustion) and MYALGIA (muscle pain that was horrible) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available.  No treatment medications were provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Skin burning sensation
Clinical narrative: I felt like my whole body was one big bruise; If I touched my skin, it felt like it was on fire; I literally could not move without aches everywhere; I couldn't bend my elbows cause the pain was excruciating; severe headache; exhaustion; muscle pain that was horrible; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (I felt like my whole body was one big bruise), BURNING SENSATION (If I touched my skin, it felt like it was on fire), MOVEMENT DISORDER (I literally could not move without aches everywhere), JOINT CONTRACTURE (I couldn't bend my elbows cause the pain was excruciating) and HEADACHE (severe headache) in a 60-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for Ache NOS. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included PARACETAMOL (TYLENOL) for Pain, OXYCODONE for an unknown indication.    On 23-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 24-Oct-2023, the patient experienced CONTUSION (I felt like my whole body was one big bruise), BURNING SENSATION (If I touched my skin, it felt like it was on fire), MOVEMENT DISORDER (I literally could not move without aches everywhere), JOINT CONTRACTURE (I couldn't bend my elbows cause the pain was excruciating), HEADACHE (severe headache), FATIGUE (exhaustion) and MYALGIA (muscle pain that was horrible). At the time of the report, CONTUSION (I felt like my whole body was one big bruise), BURNING SENSATION (If I touched my skin, it felt like it was on fire), MOVEMENT DISORDER (I literally could not move without aches everywhere), JOINT CONTRACTURE (I couldn't bend my elbows cause the pain was excruciating), HEADACHE (severe headache), FATIGUE (exhaustion) and MYALGIA (muscle pain that was horrible) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available.  No treatment medications were provided.
Age: 73.0
Sex: M
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 74-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Arteriosclerotic cardiovascular disease.    On 16-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 26-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Oct-2023, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No concomitant medication was reported.  Reportedly, patient tested positive for COVID-19, 10 days after administration. It was unknown if the patient experienced any additional symptoms/events.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nephrolithiasis
Clinical narrative: Kidney stone; patient is tired all time after receiving Moderna Covid-19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NEPHROLITHIASIS (Kidney stone) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEPHROLITHIASIS (Kidney stone) (seriousness criterion medically significant) and FATIGUE (patient is tired all time after receiving Moderna Covid-19 vaccine). At the time of the report, NEPHROLITHIASIS (Kidney stone) had not resolved and FATIGUE (patient is tired all time after receiving Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. It was unknown if the patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that the patient received Moderna Covid-19 vaccines and had a kidney stone. Also, the patient was tired all the time since receiving the Moderna Covid-19 vaccines. The patient received the most recent Spikevax dose on an unspecified date. It was reported that the patient might have received another Covid-19 booster dose at her local Pharmacy two weeks ago after Spikevax dose.  Treatment medication was not reported.  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 Nephrolithiasis and a non-serious expected event of fatigue. The event Nephrolithiasis occurred on an unknown date after a dose of mRNA-1273 (date of vaccination, dose number and onset date were not provided, hence, latency could not be estimated). Clinical course, diagnostic procedures and treatment were not provided.  The outcome of the event Nephrolithiasis was reported as not recovered. The event Nephrolithiasis is considered as not related to the vaccine due to lack of biological plausibility. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-747372 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747372:Same patient (different vaccine)
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Muscle spasms, Pain, Pyrexia
Clinical narrative: aches; but with excruciating leg cramps in the night; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), MUSCLE SPASMS (but with excruciating leg cramps in the night), PYREXIA (fever) and CHILLS (chills) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 3030478) for COVID-19 prophylaxis.     No Medical History information was reported.  On 23-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 24-Oct-2023, the patient experienced PAIN (aches), MUSCLE SPASMS (but with excruciating leg cramps in the night), PYREXIA (fever) and CHILLS (chills). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PAIN (aches), MUSCLE SPASMS (but with excruciating leg cramps in the night), PYREXIA (fever) and CHILLS (chills) was resolving.      The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.  Concomitant product use was not provided by the reporter.  The patient experienced fever, chills, aches, but with excruciating leg cramps in the night. Came on 10 hours after vaccine was given. The patient took Aleve with minimal response. She expected local pain and swelling at the injection site, but not this. Improved over the next days, but not gone yet it was unknown if the patient experienced any additional symptoms/events.
Age: 40.0
Sex: F
Vaccine: UNK, UNK
Symptoms: COVID-19
Clinical narrative: covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid) in a 5-decade-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Janssen COVID-19 Vaccine (Lot 042A21A) on 06-Apr-2021; for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE (Lot 051F21A) on 11-Nov-2021 and PFIZER BIONTECH COVID-19 VACCINE (Lot 0H9702) on 10-Oct-2022. Concurrent medical conditions included Drug allergy.    On 22-Sep-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced COVID-19 (covid). At the time of the report, COVID-19 (covid) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication and treatment were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-747371 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747371:Same Reporter (Patient 1)
Age: 40.0
Sex: F
Vaccine: UNK, UNK
Symptoms: COVID-19, Fatigue, Rhinorrhoea, Sinus disorder
Clinical narrative: covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid) in a 5-decade-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Janssen COVID-19 Vaccine (Lot 042A21A) on 06-Apr-2021; for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE (Lot 051F21A) on 11-Nov-2021 and PFIZER BIONTECH COVID-19 VACCINE (Lot 0H9702) on 10-Oct-2022. Concurrent medical conditions included Drug allergy.    On 22-Sep-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced COVID-19 (covid). At the time of the report, COVID-19 (covid) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication and treatment were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-747371 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747371:Same Reporter (Patient 1)
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Malaise, Pain in extremity
Clinical narrative: malaise; Sore arm; fever; chills; exhaustion; joint aches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise), PAIN IN EXTREMITY (Sore arm), PYREXIA (fever), CHILLS (chills) and FATIGUE (exhaustion) in a 42-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031419) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 25-Oct-2023, the patient experienced MALAISE (malaise), PAIN IN EXTREMITY (Sore arm), PYREXIA (fever), CHILLS (chills), FATIGUE (exhaustion) and ARTHRALGIA (joint aches). At the time of the report, MALAISE (malaise), PAIN IN EXTREMITY (Sore arm), PYREXIA (fever), CHILLS (chills), FATIGUE (exhaustion) and ARTHRALGIA (joint aches) was resolving.      The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.   Concomitant and treatment medications were not reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: malaise; Sore arm; fever; chills; exhaustion; joint aches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise), PAIN IN EXTREMITY (Sore arm), PYREXIA (fever), CHILLS (chills) and FATIGUE (exhaustion) in a 42-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031419) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 25-Oct-2023, the patient experienced MALAISE (malaise), PAIN IN EXTREMITY (Sore arm), PYREXIA (fever), CHILLS (chills), FATIGUE (exhaustion) and ARTHRALGIA (joint aches). At the time of the report, MALAISE (malaise), PAIN IN EXTREMITY (Sore arm), PYREXIA (fever), CHILLS (chills), FATIGUE (exhaustion) and ARTHRALGIA (joint aches) was resolving.      The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.   Concomitant and treatment medications were not reported.