chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hyperhidrosis, Influenza like illness, Nasal discomfort, Pain, Pain in extremity
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of EPISTAXIS (Nosebleed), NASAL DISCOMFORT (She kept feeling something in her nose/The capillaries in her nose started to get very red and inflamed, like getting a nosebleed), CAPILLARY FRAGILITY (She noticed broken capillaries on the side), PAIN (Pain in all of my body/ she had minor pains in her body) and PAIN IN EXTREMITY (Pains in my legs/Pain was excruciating in my thighs/ The pain was excruciating and she couldn't walk. It was unbelievable pain) in a 48-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Non-smoker. Previously administered products included for Product used for unknown indication: Flu shot (A month before the Moderna bivalent.) in September 2022. Past adverse reactions to the above products included No adverse effect with Flu shot. Concurrent medical conditions included Hypertension. Concomitant products included LOSARTAN for an unknown indication.             Company comment: This spontaneous case concerns a 48-year-old female patient, with no reported medical history, who experienced the non-serious unexpected  of arthritis (like inflammation, arthritis) after receiving a dose of mRNA-1273.222 vaccine. Patient states that after vaccination she experienced pain in the legs and head and all of her body, like inflammation, arthritis. She says her doctor has told her to give it time and has been using heating pads and paracetamol as treatment. No further information on diagnostic tests or clinical assessment was provided. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 48-year-old female patient, with no reported medical history, who experienced the non-serious unexpected of arthritis (like inflammation, arthritis) after receiving a dose of mRNA-1273.222 vaccine. Patient states that after vaccination she experienced pain in the legs and head and all of her body, like inflammation, arthritis. She says her doctor has told her to give it time and has been using heating pads and paracetamol as treatment. No further information on diagnostic tests or clinical assessment was provided. The benefit-risk relationship of vaccine is not affected by this report.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of EPISTAXIS (Nosebleed), NASAL DISCOMFORT (She kept feeling something in her nose/The capillaries in her nose started to get very red and inflamed, like getting a nosebleed), CAPILLARY FRAGILITY (She noticed broken capillaries on the side), PAIN (Pain in all of my body/ she had minor pains in her body) and PAIN IN EXTREMITY (Pains in my legs/Pain was excruciating in my thighs/ The pain was excruciating and she couldn't walk. It was unbelievable pain) in a 48-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Non-smoker. Previously administered products included for Product used for unknown indication: Flu shot (A month before the Moderna bivalent.) in September 2022. Past adverse reactions to the above products included No adverse effect with Flu shot. Concurrent medical conditions included Hypertension. Concomitant products included LOSARTAN for an unknown indication.             Company comment: This spontaneous case concerns a 48-year-old female patient, with no reported medical history, who experienced the non-serious unexpected  of arthritis (like inflammation, arthritis) after receiving a dose of mRNA-1273.222 vaccine. Patient states that after vaccination she experienced pain in the legs and head and all of her body, like inflammation, arthritis. She says her doctor has told her to give it time and has been using heating pads and paracetamol as treatment. No further information on diagnostic tests or clinical assessment was provided. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 48-year-old female patient, with no reported medical history, who experienced the non-serious unexpected of arthritis (like inflammation, arthritis) after receiving a dose of mRNA-1273.222 vaccine. Patient states that after vaccination she experienced pain in the legs and head and all of her body, like inflammation, arthritis. She says her doctor has told her to give it time and has been using heating pads and paracetamol as treatment. No further information on diagnostic tests or clinical assessment was provided. The benefit-risk relationship of vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Felt did not get up and go to do anything, after COVID-19 vaccination) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphoid leukemia.    Concurrent medical conditions included Chronic lymphoid leukemia.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose. On an unknown date, the patient experienced GAIT DISTURBANCE (Felt did not get up and go to do anything, after COVID-19 vaccination). At the time of the report, GAIT DISTURBANCE (Felt did not get up and go to do anything, after COVID-19 vaccination) outcome was unknown.            No concomitant product reported by the reporter.  The reporter's causality for the event of felt did not get up and go to do anything, after COVID-19 vaccination with drug Ibrutinib was not provided. It was unknown if patient was enrolled in COVID-19-Vaccine trial.  No treatment medication reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: allergic reaction; This spontaneous case was reported by a pharmacist and describes the occurrence of ALLERGY TO VACCINE (allergic reaction) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     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 ALLERGY TO VACCINE (allergic reaction). At the time of the report, ALLERGY TO VACCINE (allergic reaction) 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 medication information was provided.  The pharmacist wants to know the molecular weight of polyethylene glycol which is present in the Moderna vaccine.   No treatment medication were provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Immunisation reaction, Oral discomfort
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA ORAL (numbness in tongue,numbness in lips), ORAL DISCOMFORT (tickling) and IMMUNISATION REACTION (unspecified mild reaction to Moderna regular booster) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2022, the patient experienced IMMUNISATION REACTION (unspecified mild reaction to Moderna regular booster). On 17-Sep-2022, the patient experienced HYPOAESTHESIA ORAL (numbness in tongue,numbness in lips) and ORAL DISCOMFORT (tickling). At the time of the report, HYPOAESTHESIA ORAL (numbness in tongue,numbness in lips) and ORAL DISCOMFORT (tickling) had not resolved and IMMUNISATION REACTION (unspecified mild reaction to Moderna regular booster) outcome was unknown.            No concomitant medications were reported. Patient received latest booster of Moderna COVID-19 Vaccine on 16-Jul-2022 and experienced a mild reaction (not specified what kind of reaction).  On 17-Sep-2022 patient reported numbness in tongue and lips and tickling which was still ongoing Caller visited cardiologists and neurologists and they could not find another cause for these symptoms, other than the vaccine. Reports did not specify date of 1st and 2nd dose of vaccine. It was reported that treatment received was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: got some reactions after about 3-4 days; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION COMPLICATION (got some reactions after about 3-4 days) in a  patient of an unknown age and gender 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 VACCINATION COMPLICATION (got some reactions after about 3-4 days). At the time of the report, VACCINATION COMPLICATION (got some reactions after about 3-4 days) 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.   Concomitant medication was not reported. The patient has been brought to a location (was told the Infectious Disease) and stayed there for 4 days (almost 5 days). The patient was given some antibiotics, but they don't seem to work. Patient had been in and out of the Hospital.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthritis, Gout, Inflammation, Pain, Pain in extremity
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (right hand swell), PARAESTHESIA (right hand became very sensitive to touch), GOUT (could be gout), ARTHRITIS (could be arthritis) and PAIN (pain) in a 67-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 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: FLU [INFLUENZA VACCINE] (many years ago that the patient took the flu vaccine). Past adverse reactions to the above products included No adverse event with FLU [INFLUENZA VACCINE]. Concomitant products included VITAMINS NOS for an unknown indication.    On 25-Oct-2022, 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. In October 2022, the patient experienced PERIPHERAL SWELLING (right hand swell), PARAESTHESIA (right hand became very sensitive to touch), GOUT (could be gout), ARTHRITIS (could be arthritis), PAIN (pain), INFLAMMATION (inflammation), PAIN IN EXTREMITY (pain on the right thumb and it went up to where the injection site was on the right arm/thumb sore that if they touch anything it painful) and PERIPHERAL SWELLING (right thumb pretty large). The patient was treated with INDOMETHACIN [INDOMETACIN] for Pain and Inflammation, at a dose of UNK, tid. At the time of the report, PERIPHERAL SWELLING (right hand swell), PARAESTHESIA (right hand became very sensitive to touch), GOUT (could be gout), ARTHRITIS (could be arthritis), PAIN (pain), INFLAMMATION (inflammation), PAIN IN EXTREMITY (pain on the right thumb and it went up to where the injection site was on the right arm/thumb sore that if they touch anything it painful) and PERIPHERAL SWELLING (right thumb pretty large) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: not broken.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Paraesthesia, Peripheral swelling, X-ray
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (right hand swell), PARAESTHESIA (right hand became very sensitive to touch), GOUT (could be gout), ARTHRITIS (could be arthritis) and PAIN (pain) in a 67-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 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: FLU [INFLUENZA VACCINE] (many years ago that the patient took the flu vaccine). Past adverse reactions to the above products included No adverse event with FLU [INFLUENZA VACCINE]. Concomitant products included VITAMINS NOS for an unknown indication.    On 25-Oct-2022, 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. In October 2022, the patient experienced PERIPHERAL SWELLING (right hand swell), PARAESTHESIA (right hand became very sensitive to touch), GOUT (could be gout), ARTHRITIS (could be arthritis), PAIN (pain), INFLAMMATION (inflammation), PAIN IN EXTREMITY (pain on the right thumb and it went up to where the injection site was on the right arm/thumb sore that if they touch anything it painful) and PERIPHERAL SWELLING (right thumb pretty large). The patient was treated with INDOMETHACIN [INDOMETACIN] for Pain and Inflammation, at a dose of UNK, tid. At the time of the report, PERIPHERAL SWELLING (right hand swell), PARAESTHESIA (right hand became very sensitive to touch), GOUT (could be gout), ARTHRITIS (could be arthritis), PAIN (pain), INFLAMMATION (inflammation), PAIN IN EXTREMITY (pain on the right thumb and it went up to where the injection site was on the right arm/thumb sore that if they touch anything it painful) and PERIPHERAL SWELLING (right thumb pretty large) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: not broken.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Vaccination complication
Clinical narrative: Arm swelling/ swelling in my arm; Arm pain; The vaccine knocked me on my butt every single time; High fever/ fever; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (Arm swelling/ swelling in my arm), PAIN IN EXTREMITY (Arm pain), VACCINATION COMPLICATION (The vaccine knocked me on my butt every single time) and PYREXIA (High fever/ fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K21A, 026021A, 014M20A and 007M20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm swelling/ swelling in my arm), PAIN IN EXTREMITY (Arm pain), VACCINATION COMPLICATION (The vaccine knocked me on my butt every single time) and PYREXIA (High fever/ fever). At the time of the report, PERIPHERAL SWELLING (Arm swelling/ swelling in my arm), PAIN IN EXTREMITY (Arm pain), VACCINATION COMPLICATION (The vaccine knocked me on my butt every single time) and PYREXIA (High fever/ fever) outcome was unknown.            Concomitant medications included unspecified high blood pressure medication. Patient does not remember arm of administration for dose 1 and 2. No treatment medications were reported.   o
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: close friend having adverse side affects over the past three days; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION COMPLICATION (close friend having adverse side affects over the past three days) in a  patient of an unknown age and gender 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. In October 2022, the patient experienced VACCINATION COMPLICATION (close friend having adverse side affects over the past three days). At the time of the report, VACCINATION COMPLICATION (close friend having adverse side affects over the past three days) 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.       Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Joint range of motion decreased, Pyrexia
Clinical narrative: Could not move arm after covid-19 vaccination; fever; This spontaneous case was reported by a consumer and describes the occurrence of JOINT RANGE OF MOTION DECREASED (Could not move arm after covid-19 vaccination) and PYREXIA (fever) in a 70-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 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis. Concurrent medical conditions included Ulcerative colitis.   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)) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML, Citrate free. In September 2022, the patient experienced JOINT RANGE OF MOTION DECREASED (Could not move arm after covid-19 vaccination) and PYREXIA (fever). At the time of the report, JOINT RANGE OF MOTION DECREASED (Could not move arm after covid-19 vaccination) and PYREXIA (fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103. Concomitant medications were not reported.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial. Treatment medications were not reported.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Illness, Incorrect route of product administration
Clinical narrative: Sick; vaccine given by subcutaneous route; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine given by subcutaneous route) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination, COVID-19 VACCINE for COVID-19 vaccination and ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 02-Feb-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Subcutaneous) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 01-Mar-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Subcutaneous) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient received dose of COVID-19 VACCINE (Subcutaneous) 1 dosage form. On 25-Sep-2021, received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Subcutaneous) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML Citrate free, Single Dose Pen. On 15-Jan-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine given by subcutaneous route). On an unknown date, the patient experienced ILLNESS (Sick). At the time of the report, ILLNESS (Sick) was resolving and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine given by subcutaneous route) outcome was unknown.      No concomitant medications were reported.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial. The reporter's causality for the event of sick with Adalimumab Solution for Injection, Pfizer BioNTech COVID-19 vaccine (Tozinameran) and COVID-19 vaccine (COVID-19 vaccine) was reasonable possibility. No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Headache, Spinal pain
Clinical narrative: Patient had a burning pain in her spine within 5 minutes of getting the Moderna shot; Patient had strong pain in her spine that went up to her head; Patient had strong pain in her spine that went up to her head; This spontaneous case was reported by a pharmacist and describes the occurrence of BURNING SENSATION (Patient had a burning pain in her spine within 5 minutes of getting the Moderna shot), SPINAL PAIN (Patient had strong pain in her spine that went up to her head) and HEADACHE (Patient had strong pain in her spine that went up to her head) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (Patient had a burning pain in her spine within 5 minutes of getting the Moderna shot), SPINAL PAIN (Patient had strong pain in her spine that went up to her head) and HEADACHE (Patient had strong pain in her spine that went up to her head). At the time of the report, BURNING SENSATION (Patient had a burning pain in her spine within 5 minutes of getting the Moderna shot), SPINAL PAIN (Patient had strong pain in her spine that went up to her head) and HEADACHE (Patient had strong pain in her spine that went up to her head) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The patient started treatment on an unspecified date with Moderna COVID-19 vaccine at dose 2 for an unspecified indication. The patient had a burning pain in spine within 5 minutes of getting the Moderna shot.  It was reported that patient's doctor and her neurologist said she should not take any m-RNA vaccine longer.  No treatment medication were provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test, Throat irritation
Clinical narrative: Sore throat which is not horrible but not comfortable; Had little irritation on the throat; This spontaneous case was reported by a patient and describes the occurrence of THROAT IRRITATION (Had little irritation on the throat) and OROPHARYNGEAL PAIN (Sore throat which is not horrible but not comfortable) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 060D22A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (had headache and fever, took Paxlovid 4 days as not felt so good after taking it so she did not complete the 5 days.) in March 2022. Previously administered products included for Product used for unknown indication: Flu vaccine (in 2 weeks ago (from 01Nov2022)) in October 2022. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Hypertension, Diabetes, Asthma and Drug allergy (Levaquin).    On 29-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 31-Oct-2022, the patient experienced THROAT IRRITATION (Had little irritation on the throat). On 01-Nov-2022, the patient experienced OROPHARYNGEAL PAIN (Sore throat which is not horrible but not comfortable). At the time of the report, THROAT IRRITATION (Had little irritation on the throat) and OROPHARYNGEAL PAIN (Sore throat which is not horrible but not comfortable) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2022, SARS-CoV-2 test: (Positive) positive.         Patient received first dose of Moderna COVID-19 vaccine on 28-Jan-2021 (lot number - 012M20A), second dose on 01-Mar-2021 (lot number - unknown), 1st booster dose on 17-Sep-2021 (lot number - 040C21A), 2nd booster dose on 03-May-2022 (lot number - 056M21A). Concomitant medications included long list of unspecified medications, so the patient did not provide the names. Adverse event did not cause patient to seek medical care.  The patient did not have experienced a similar event in the past.  Patient has not consulted their healthcare provider. No treatment medications were reported.    This case was linked to MOD-2022-667346 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; receiving a bivalent dose of the Moderna COVID19 vaccine as a second dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (receiving a bivalent dose of the Moderna COVID19 vaccine as a second dose) and NO ADVERSE EVENT (No adverse event) in a 32-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 052d22a) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Oct-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 31-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (receiving a bivalent dose of the Moderna COVID19 vaccine as a second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (receiving a bivalent dose of the Moderna COVID19 vaccine as a second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (receiving a bivalent dose of the Moderna COVID19 vaccine as a second dose).    No concomitant medications was reported.  It was reported that patient took first dose of COVID-19 vaccine on 6-Feb-2022 with lot number 045g21a.  No treatment drug details was reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Influenza virus test, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (tested positive for COVID) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027e22a) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis in the past before. The patient had no history relating to mentioned adverse event and both Acute and Chronic illnesses at the time of vaccination.  Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE on 24-Aug-2022; for Hormone replacement therapy: femhrt. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE; and TIA with femhrt. Concurrent medical conditions included Arthritis (patient experienced achy joints in the past.), Spinal disorder NOS and Drug allergy (to some medications not true allergies but side effects).    On 27-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 31-Oct-2022, the patient experienced COVID-19 (tested positive for COVID). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for COVID) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2022, Oxygen saturation: 93 % and 91 %. On 31-Oct-2022, Influenza virus test: Negative. On 31-Oct-2022, SARS-CoV-2 test: Positive.     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 information provided Patient received 1st dose on 14Jan2021 with lot 041l20a Patient received 2nd dose 11Feb2021 with lot 024m20a Patient received1st booster 25Oct2021 with lot 0760217 Patient received 2nd booster 20April2022 with lot 005m214 It was reported that following vaccination within 18 hours of vaccination patient started to experience: was very sick, clearing her throat briefly, headache, cough, joints aching, fatigue and weakness. The patient sought medical care to get testing done. Patient tested for COVID on 31-Oct-2022 and on 01-Nov-2022 she was told she was positive.   This case was linked to MOD-2022-667354, MOD-2022-667365 (Patient Link).
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 25SEP2022 and administered on 28OCT2022; No adverse event; Moderna bivalent administered after 30 day beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna bivalent administered after 30 day beyond use date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25SEP2022 and administered on 28OCT2022) and NO ADVERSE EVENT (No adverse event) in an 88-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-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 28-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna bivalent administered after 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25SEP2022 and administered on 28OCT2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna bivalent administered after 30 day beyond use date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25SEP2022 and administered on 28OCT2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna bivalent administered after 30 day beyond use date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25SEP2022 and administered on 28OCT2022).    No concomitant medication were reported.  The Moderna COVID-19 bivalent booster dose were administered after a beyond use date of 25-OCT-2022. Unbroken carton with unknown vial size. The vial was initially stored in the refrigerator on 25-SEP-2022. The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-667362 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-667362:male patient
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This spontaneous case was reported by a patient family member or friend and describes the occurrence of TINNITUS (tinnitus) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067h21a, 017b21a and 027a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-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 TINNITUS (tinnitus). At the time of the report, TINNITUS (tinnitus) outcome was unknown. No concomitant medications was provided. Caller stated it was very unusual to develop tinnitus following vaccination with the Moderna COVID19 vaccine. No treatment medications was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza, Myalgia, Pain in extremity, Vaccination site cellulitis
Clinical narrative: left arm was Itchy; hot to the touch; believes that she had cellulitis on the left arm; her left arm was red; had a headache; had muscle pain/Body ache; felt like she had the flu; she woke up with a swollen left arm; pain in the legs; left arm injection site was sore; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (felt like she had the flu), VACCINATION SITE PRURITUS (left arm was Itchy), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE CELLULITIS (believes that she had cellulitis on the left arm) and PAIN IN EXTREMITY (pain in the legs) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy and Sulfonamide allergy (allergic to Sulfa).    On 26-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Oct-2022, the patient experienced VACCINATION SITE PAIN (left arm injection site was sore). On 27-Oct-2022, the patient experienced INFLUENZA (felt like she had the flu), PAIN IN EXTREMITY (pain in the legs), VACCINATION SITE SWELLING (she woke up with a swollen left arm), HEADACHE (had a headache) and MYALGIA (had muscle pain/Body ache). On 28-Oct-2022, the patient experienced VACCINATION SITE PRURITUS (left arm was Itchy), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE CELLULITIS (believes that she had cellulitis on the left arm) and VACCINATION SITE ERYTHEMA (her left arm was red). The patient was treated with PARACETAMOL (TYLENOL) on 29-Oct-2022 for Vaccination site pain, at an unspecified dose and frequency; PREDNISONE on 29-Oct-2022 at an unspecified dose and frequency; LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) on 29-Oct-2022 at an unspecified dose and frequency; LORATADINE (CLARITINE ALLERGY) on 29-Oct-2022 at an unspecified dose and frequency and AZITHROMYCIN (ZITHROMAX) on 29-Oct-2022 at an unspecified dose and frequency. On 29-Oct-2022, MYALGIA (had muscle pain/Body ache) had resolved. At the time of the report, INFLUENZA (felt like she had the flu), VACCINATION SITE PRURITUS (left arm was Itchy), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE CELLULITIS (believes that she had cellulitis on the left arm), PAIN IN EXTREMITY (pain in the legs), VACCINATION SITE PAIN (left arm injection site was sore), VACCINATION SITE SWELLING (she woke up with a swollen left arm), VACCINATION SITE ERYTHEMA (her left arm was red) and HEADACHE (had a headache) outcome was unknown.            Concomitant medication was not reported. Urgent care gave her nasal spray (does not recall the name).   This case was linked to MOD-2022-667370 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: left arm was Itchy; hot to the touch; believes that she had cellulitis on the left arm; her left arm was red; had a headache; had muscle pain/Body ache; felt like she had the flu; she woke up with a swollen left arm; pain in the legs; left arm injection site was sore; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (felt like she had the flu), VACCINATION SITE PRURITUS (left arm was Itchy), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE CELLULITIS (believes that she had cellulitis on the left arm) and PAIN IN EXTREMITY (pain in the legs) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy and Sulfonamide allergy (allergic to Sulfa).    On 26-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Oct-2022, the patient experienced VACCINATION SITE PAIN (left arm injection site was sore). On 27-Oct-2022, the patient experienced INFLUENZA (felt like she had the flu), PAIN IN EXTREMITY (pain in the legs), VACCINATION SITE SWELLING (she woke up with a swollen left arm), HEADACHE (had a headache) and MYALGIA (had muscle pain/Body ache). On 28-Oct-2022, the patient experienced VACCINATION SITE PRURITUS (left arm was Itchy), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE CELLULITIS (believes that she had cellulitis on the left arm) and VACCINATION SITE ERYTHEMA (her left arm was red). The patient was treated with PARACETAMOL (TYLENOL) on 29-Oct-2022 for Vaccination site pain, at an unspecified dose and frequency; PREDNISONE on 29-Oct-2022 at an unspecified dose and frequency; LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) on 29-Oct-2022 at an unspecified dose and frequency; LORATADINE (CLARITINE ALLERGY) on 29-Oct-2022 at an unspecified dose and frequency and AZITHROMYCIN (ZITHROMAX) on 29-Oct-2022 at an unspecified dose and frequency. On 29-Oct-2022, MYALGIA (had muscle pain/Body ache) had resolved. At the time of the report, INFLUENZA (felt like she had the flu), VACCINATION SITE PRURITUS (left arm was Itchy), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE CELLULITIS (believes that she had cellulitis on the left arm), PAIN IN EXTREMITY (pain in the legs), VACCINATION SITE PAIN (left arm injection site was sore), VACCINATION SITE SWELLING (she woke up with a swollen left arm), VACCINATION SITE ERYTHEMA (her left arm was red) and HEADACHE (had a headache) outcome was unknown.            Concomitant medication was not reported. Urgent care gave her nasal spray (does not recall the name).   This case was linked to MOD-2022-667370 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Headache, Nausea, Paraesthesia, Pyrexia
Clinical narrative: Burning; her hands and feet started falling asleep/tingling in her hands and feet; low grade fever; Nausea; Headache; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (her hands and feet started falling asleep/tingling in her hands and feet), BURNING SENSATION (Burning), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (low grade fever) in a 78-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.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 1), Pfizer vaccine (Dose 4), Pfizer vaccine (Dose 3) and Pfizer vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer vaccine, Pfizer vaccine, Pfizer vaccine and Pfizer vaccine.    On 17-Oct-2022 at 4:00 PM, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 18-Oct-2022, the patient experienced NAUSEA (Nausea) and HEADACHE (Headache). On 18-Oct-2022 at 3:00 AM, the patient experienced PARAESTHESIA (her hands and feet started falling asleep/tingling in her hands and feet) and PYREXIA (low grade fever). On 18-Oct-2022 at 5:00 AM, the patient experienced BURNING SENSATION (Burning). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; DIMENHYDRINATE (DRAMAMINE) at an unspecified dose and frequency and KETOROLAC TROMETHAMINE (TORADOL) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (her hands and feet started falling asleep/tingling in her hands and feet), BURNING SENSATION (Burning), NAUSEA (Nausea) and PYREXIA (low grade fever) outcome was unknown and HEADACHE (Headache) had not resolved.            No concomitant medications was reported. Patient received the dose at 4:00 PM. By 3:00 AM the following morning the hands and feet started falling asleep and had a low grade fever. By 5:00 AM patient started to experience burning where the tingling in the hands and feet had been. Patient also started to have nausea and a headache. Patient had taken Tylenol, Dramamine, and used Sea Bands for the symptoms. Patient went to the ER for the symptoms at 9:00 AM where her headache had increased to a 6/10. Patient received blood work, and was given an IV with Toradol and IV fluids, after which the headache became worse.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Fatigue, Insomnia, Pain, Pain in extremity
Clinical narrative: She could barely sleep her arm  hurts and she woke up screaming; After the second dose she was hurting so bad; Dizzy; After each shot her arm was very sore/After the second dose she was hurting so bad; Tired; This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (She could barely sleep her arm  hurts and she woke up screaming), PAIN (After the second dose she was hurting so bad), DIZZINESS (Dizzy), PAIN IN EXTREMITY (After each shot her arm was very sore/After the second dose she was hurting so bad) and FATIGUE (Tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included Accident automobile (She was a passenger in a car accident.) and Fusion of vertebra (Currently she had six screws and fusion in her back). Concurrent medical conditions included Blood pressure high (She was taking high blood pressure medication.), Back disorder (She was  taking back problem medication.), Degenerative disc disease, Sciatica and COPD (She was taking oxygen for COPD). Concomitant products included OXYGEN for COPD.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced DIZZINESS (Dizzy), PAIN IN EXTREMITY (After each shot her arm was very sore/After the second dose she was hurting so bad) and FATIGUE (Tired). On an unknown date, the patient experienced INSOMNIA (She could barely sleep her arm  hurts and she woke up screaming) and PAIN (After the second dose she was hurting so bad). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INSOMNIA (She could barely sleep her arm  hurts and she woke up screaming), PAIN (After the second dose she was hurting so bad), DIZZINESS (Dizzy), PAIN IN EXTREMITY (After each shot her arm was very sore/After the second dose she was hurting so bad) and FATIGUE (Tired) outcome was unknown.            The patient had no allergies with medications, food and other products.  There was no medical history related to mentioned AE and there was no acute and chronic illnesses at the time of vaccination.  There was no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.   The patient mentioned that her left arm  was hurting for 3 months since she got the shot last year. When she went to the hospital, they just prescribe her ibuprofen and did not do much to help. She was putting cream  in the area to help with the pain. She could barely sleep her arm hurts and she woke up screaming. She felt very dizzy and tired every time she got a shot. After each shot her arm  was very sore. After the second dose she was hurting so bad that she decided she had to go to her doctor to get the next shot.   This case was linked to MOD-2022-667455, MOD-2022-667545 (Patient Link).