chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Tinnitus
Clinical narrative: Developed tinnitus shortly after second dose/tinnitus came on gradually/tinnitus intense at first, then backed off/tinnitus comes and goes, it flares back up sometimes; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Developed tinnitus shortly after second dose/tinnitus came on gradually/tinnitus intense at first, then backed off/tinnitus comes and goes, it flares back up sometimes) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 008B21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced TINNITUS (Developed tinnitus shortly after second dose/tinnitus came on gradually/tinnitus intense at first, then backed off/tinnitus comes and goes, it flares back up sometimes). The patient was treated with GINKGO BILOBA (GINGKO BILOBA) for Adverse event, at an unspecified dose and frequency. At the time of the report, TINNITUS (Developed tinnitus shortly after second dose/tinnitus came on gradually/tinnitus intense at first, then backed off/tinnitus comes and goes, it flares back up sometimes) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: result not reported Result not reported.         Patient went to an ENT physician and had undergone MRI (Magnetic resonance imaging) scan, went through bunch of testing and the physician thought the adverse event was vaccine related.  Treatment medications included steroids and Gingko.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick for 3 days each; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Sick for 3 days each) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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, the patient experienced ILLNESS (Sick for 3 days each). At the time of the report, ILLNESS (Sick for 3 days each) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2022-437432 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chronic spontaneous urticaria
Clinical narrative: chronic spontaneous urticaria; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC SPONTANEOUS URTICARIA (chronic spontaneous urticaria) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 CHRONIC SPONTANEOUS URTICARIA (chronic spontaneous urticaria). At the time of the report, CHRONIC SPONTANEOUS URTICARIA (chronic spontaneous urticaria) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment drug information was provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: a little nausea; low fever; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (a little nausea) and PYREXIA (low fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER on 26-Apr-2021 and PFIZER on 17-May-2021. Past adverse reactions to the above products included No adverse event with PFIZER and PFIZER.    On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (a little nausea) and PYREXIA (low fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. At the time of the report, NAUSEA (a little nausea) and PYREXIA (low fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: low fever (abnormal) low fever.         No concomitant medication was provided by the reporter.   This case was linked to MOD-2022-437606 (Patient Link).
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Mass, Pruritus, Urticaria, Wheezing
Clinical narrative: Hives and itchiness in the scull,freaking out on hives; Hives and itchiness  on the insides of their thighs,spread to their legs and arms and hands; Wheezing randomly; A lump in the upper chest area; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives and itchiness in the scull,freaking out on hives), PRURITUS (Hives and itchiness  on the insides of their thighs,spread to their legs and arms and hands), WHEEZING (Wheezing randomly) and MASS (A lump in the upper chest area) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0691T21A, 026A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-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 23-Dec-2021, the patient experienced URTICARIA (Hives and itchiness in the scull,freaking out on hives), PRURITUS (Hives and itchiness  on the insides of their thighs,spread to their legs and arms and hands), WHEEZING (Wheezing randomly) and MASS (A lump in the upper chest area). At the time of the report, URTICARIA (Hives and itchiness in the scull,freaking out on hives), PRURITUS (Hives and itchiness  on the insides of their thighs,spread to their legs and arms and hands), WHEEZING (Wheezing randomly) and MASS (A lump in the upper chest area) had not resolved.            No concomitant medications were reported   No treatment information was provided  Patient state he did not have Covid-19 nor a heart condition diagnosed before
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick fur 3 days each; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Sick fur 3 days each) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick fur 3 days each). At the time of the report, ILLNESS (Sick fur 3 days each) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2022-437388 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Cough, Myalgia, Pyrexia
Clinical narrative: cOugh; Fever; Body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (cOugh), PYREXIA (Fever) and MYALGIA (Body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (cOugh), PYREXIA (Fever) and MYALGIA (Body aches). At the time of the report, COUGH (cOugh), PYREXIA (Fever) and MYALGIA (Body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  No treatment information was provided.  Patient  took a rapid test and tested positive.   Reporter did not allow further contact
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: onset of his hives 2 months ago: started in his legs and went up to the rest of the body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (onset of his hives 2 months ago: started in his legs and went up to the rest of the body) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-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 URTICARIA (onset of his hives 2 months ago: started in his legs and went up to the rest of the body). At the time of the report, URTICARIA (onset of his hives 2 months ago: started in his legs and went up to the rest of the body) outcome was unknown.            Concomitant medication of the patient was about 7 or 8 of them (not specified).  The patient ad no treatment for the symptoms. The patient would visit his doctor in coming days because a friend that had the same, told him it was hives and that their doctor prescribed them prednisone.   This case was linked to MOD-2022-437658 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired and needed to sleep; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired and needed to sleep) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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, the patient experienced FATIGUE (tired and needed to sleep). At the time of the report, FATIGUE (tired and needed to sleep) outcome was unknown.            Patient had 1st dose on 01 May 2021. Concomitant medications were not reported. Treatment medications were not reported   This case was linked to MOD-2022-437577 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain
Clinical narrative: I hurt; felt horrible for a week; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (I hurt) and FEELING ABNORMAL (felt horrible for a week) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (I hurt) and FEELING ABNORMAL (felt horrible for a week). At the time of the report, PAIN (I hurt) and FEELING ABNORMAL (felt horrible for a week) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: little sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (little sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (little sick). At the time of the report, MALAISE (little sick) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported  After 1st dose patient felt a little sick, got scared and decided not to receive the 2nd dose.  No treatment drugs were reported   This case was linked to MOD-2022-437588 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Movement disorder, Muscle disorder, Pain in extremity
Clinical narrative: not able to raise their left hand to high; minor muscle issue; little hurt, when turning the light, on their left arm; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (not able to raise their left hand to high), MUSCLE DISORDER (minor muscle issue) and PAIN IN EXTREMITY (little hurt, when turning the light, on their left arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 030B21A and 045A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MOVEMENT DISORDER (not able to raise their left hand to high), MUSCLE DISORDER (minor muscle issue) and PAIN IN EXTREMITY (little hurt, when turning the light, on their left arm). At the time of the report, MOVEMENT DISORDER (not able to raise their left hand to high), MUSCLE DISORDER (minor muscle issue) and PAIN IN EXTREMITY (little hurt, when turning the light, on their left arm) outcome was unknown.            No concomitant drug details were reported. No treatment details were reported.   This case was linked to MOD-2022-437569, MOD-2022-437875 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: alternate dosing interval; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (alternate dosing interval) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051c21a and 018b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (alternate dosing interval). On 10-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (alternate dosing interval) had resolved.            Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-437575 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: suspected delayed onset systemic allergic response to the Moderna booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ALLERGY TO VACCINE (suspected delayed onset systemic allergic response to the Moderna booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (suspected delayed onset systemic allergic response to the Moderna booster). At the time of the report, ALLERGY TO VACCINE (suspected delayed onset systemic allergic response to the Moderna booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Ear pruritus, Lip pruritus, Mechanical urticaria, Oral pruritus
Clinical narrative: dermatographia; heartburn; intense itchiness; tingling; itching of mouth; itching of lips; itchy inner ear canal; broke out in fully body hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (broke out in fully body hives), MECHANICAL URTICARIA (dermatographia), DYSPEPSIA (heartburn), PRURITUS (intense itchiness) and PARAESTHESIA (tingling) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 048B21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL BETADEX CLATHRATE (YAZ) for Birth control, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced URTICARIA (broke out in fully body hives). On an unknown date, the patient experienced MECHANICAL URTICARIA (dermatographia), DYSPEPSIA (heartburn), PRURITUS (intense itchiness), PARAESTHESIA (tingling), ORAL PRURITUS (itching of mouth), LIP PRURITUS (itching of lips) and EAR PRURITUS (itchy inner ear canal). The patient was treated with PREDNISONE for Adverse event, at a dose of For 5 days of steroid and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 4x recommended dose level of allergy OTC medications. At the time of the report, URTICARIA (broke out in fully body hives) had not resolved and MECHANICAL URTICARIA (dermatographia), DYSPEPSIA (heartburn), PRURITUS (intense itchiness), PARAESTHESIA (tingling), ORAL PRURITUS (itching of mouth), LIP PRURITUS (itching of lips) and EAR PRURITUS (itchy inner ear canal) outcome was unknown.            Patient reported 10 days after receiving the booster she broke out in fully body hives and States the symptoms are still ongoing 50 days after booster dose. Patient also  reported that it feels like anaphylaxis but its not, it is a immune response. 1200 patients also reported same side effects.   This case was linked to MOD-2022-437613 (Patient Link).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Urticaria
Clinical narrative: dermatographia; heartburn; intense itchiness; tingling; itching of mouth; itching of lips; itchy inner ear canal; broke out in fully body hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (broke out in fully body hives), MECHANICAL URTICARIA (dermatographia), DYSPEPSIA (heartburn), PRURITUS (intense itchiness) and PARAESTHESIA (tingling) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 048B21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL BETADEX CLATHRATE (YAZ) for Birth control, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced URTICARIA (broke out in fully body hives). On an unknown date, the patient experienced MECHANICAL URTICARIA (dermatographia), DYSPEPSIA (heartburn), PRURITUS (intense itchiness), PARAESTHESIA (tingling), ORAL PRURITUS (itching of mouth), LIP PRURITUS (itching of lips) and EAR PRURITUS (itchy inner ear canal). The patient was treated with PREDNISONE for Adverse event, at a dose of For 5 days of steroid and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 4x recommended dose level of allergy OTC medications. At the time of the report, URTICARIA (broke out in fully body hives) had not resolved and MECHANICAL URTICARIA (dermatographia), DYSPEPSIA (heartburn), PRURITUS (intense itchiness), PARAESTHESIA (tingling), ORAL PRURITUS (itching of mouth), LIP PRURITUS (itching of lips) and EAR PRURITUS (itchy inner ear canal) outcome was unknown.            Patient reported 10 days after receiving the booster she broke out in fully body hives and States the symptoms are still ongoing 50 days after booster dose. Patient also  reported that it feels like anaphylaxis but its not, it is a immune response. 1200 patients also reported same side effects.   This case was linked to MOD-2022-437613 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pollakiuria
Clinical narrative: Urinating a lot after first shot; Headache after first shot; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Urinating a lot after first shot) and HEADACHE (Headache after first shot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced POLLAKIURIA (Urinating a lot after first shot) and HEADACHE (Headache after first shot). At the time of the report, POLLAKIURIA (Urinating a lot after first shot) and HEADACHE (Headache after first shot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient states that she does not have a history of urinary tract infection. No concomitant medications was reported. Treatment medications was not provided.   This case was linked to MOD-2022-437614, MOD-2022-437623 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm was a little sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was a little sore at the injection site) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (First dose) on 26-Apr-2021 and Pfizer (Second dose) on 17-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced VACCINATION SITE PAIN (Arm was a little sore at the injection site). At the time of the report, VACCINATION SITE PAIN (Arm was a little sore at the injection site) had resolved.            Concomitant information was not provided.  Treatment information was not provided.   This case was linked to MOD-2022-437393 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Dyspepsia, Ear pruritus, Mechanical urticaria, Oral pruritus, Paraesthesia
Clinical narrative: dermatographia; heartburn; intense itchiness; tingling; itching of mouth and lips; itchy inner ear canal/ it "feels like anaphylaxis but its not, it is a immune response"; fully body hives; This spontaneous case was reported by a non-health professional and describes the occurrence of MECHANICAL URTICARIA (dermatographia), DYSPEPSIA (heartburn), PRURITUS (intense itchiness), PARAESTHESIA (tingling) and ORAL PRURITUS (itching of mouth and lips) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 025B21A and 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL BETADEX CLATHRATE (YAZ), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced URTICARIA (fully body hives). On an unknown date, the patient experienced MECHANICAL URTICARIA (dermatographia), DYSPEPSIA (heartburn), PRURITUS (intense itchiness), PARAESTHESIA (tingling), ORAL PRURITUS (itching of mouth and lips) and EAR PRURITUS (itchy inner ear canal/ it "feels like anaphylaxis but its not, it is a immune response"). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MECHANICAL URTICARIA (dermatographia), DYSPEPSIA (heartburn), PRURITUS (intense itchiness), PARAESTHESIA (tingling), ORAL PRURITUS (itching of mouth and lips) and EAR PRURITUS (itchy inner ear canal/ it "feels like anaphylaxis but its not, it is a immune response") outcome was unknown and URTICARIA (fully body hives) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Adderall 5mg (stopped due to suspected reaction), 4x recommended dose level of allergy OTC medications, 5 days of prednisone steroid.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: dermatographia; heartburn; intense itchiness; tingling; itching of mouth and lips; itchy inner ear canal/ it "feels like anaphylaxis but its not, it is a immune response"; fully body hives; This spontaneous case was reported by a non-health professional and describes the occurrence of MECHANICAL URTICARIA (dermatographia), DYSPEPSIA (heartburn), PRURITUS (intense itchiness), PARAESTHESIA (tingling) and ORAL PRURITUS (itching of mouth and lips) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 025B21A and 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL BETADEX CLATHRATE (YAZ), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced URTICARIA (fully body hives). On an unknown date, the patient experienced MECHANICAL URTICARIA (dermatographia), DYSPEPSIA (heartburn), PRURITUS (intense itchiness), PARAESTHESIA (tingling), ORAL PRURITUS (itching of mouth and lips) and EAR PRURITUS (itchy inner ear canal/ it "feels like anaphylaxis but its not, it is a immune response"). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MECHANICAL URTICARIA (dermatographia), DYSPEPSIA (heartburn), PRURITUS (intense itchiness), PARAESTHESIA (tingling), ORAL PRURITUS (itching of mouth and lips) and EAR PRURITUS (itchy inner ear canal/ it "feels like anaphylaxis but its not, it is a immune response") outcome was unknown and URTICARIA (fully body hives) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Adderall 5mg (stopped due to suspected reaction), 4x recommended dose level of allergy OTC medications, 5 days of prednisone steroid.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Nausea
Clinical narrative: Weakness for 2 days after 2nd shot; Nausea after for 2 days 2nd shot; Headache for 2 days after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness for 2 days after 2nd shot), NAUSEA (Nausea after for 2 days 2nd shot) and HEADACHE (Headache for 2 days after 2nd shot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In June 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced ASTHENIA (Weakness for 2 days after 2nd shot), NAUSEA (Nausea after for 2 days 2nd shot) and HEADACHE (Headache for 2 days after 2nd shot). In June 2021, ASTHENIA (Weakness for 2 days after 2nd shot), NAUSEA (Nausea after for 2 days 2nd shot) and HEADACHE (Headache for 2 days after 2nd shot) had resolved.            No concomitant product information was provided. No treatment information was provided.   This case was linked to MOD-2022-437599, MOD-2022-437623, MOD-2022-437623 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: half Moderna dose was accidentally given; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (half Moderna dose was accidentally given) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) UNK dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (half Moderna dose was accidentally given). At the time of the report, ACCIDENTAL UNDERDOSE (half Moderna dose was accidentally given) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details was reported. No treatment details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: And I had a terrible time with both the other doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (And I had a terrible time with both the other doses) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (And I had a terrible time with both the other doses). At the time of the report, VACCINATION COMPLICATION (And I had a terrible time with both the other doses) outcome was unknown.            No concomitant and treatment information were reported by the reporter The patient reported that she had a terrible time with both the other doses, but it wasn't as severe as this booster dose.   This case was linked to MOD-2022-437625, MOD-2022-437608 (Patient Link).   Reporter did not allow further contact
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Pain, Pruritus, Rash
Clinical narrative: If he scratches, the area becomes red; If he scratches, the area becomes raised; Rash left arm  (not injection site); Palms of his hands started itching/ Itching moves around from behind ear, to Calf, to Feet/ itching is in random body parts.; Sleep it off; Achy; Fatigue /Tired; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (If he scratches, the area becomes red), RASH PAPULAR (If he scratches, the area becomes raised), PRURITUS (Palms of his hands started itching/ Itching moves around from behind ear, to Calf, to Feet/ itching is in random body parts.), SOMNOLENCE (Sleep it off) and PAIN (Achy) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A, 040A21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced SOMNOLENCE (Sleep it off), PAIN (Achy) and FATIGUE (Fatigue /Tired). On 22-Dec-2021, the patient experienced PRURITUS (Palms of his hands started itching/ Itching moves around from behind ear, to Calf, to Feet/ itching is in random body parts.). On 25-Dec-2021, the patient experienced RASH (Rash left arm  (not injection site)). On an unknown date, the patient experienced ERYTHEMA (If he scratches, the area becomes red) and RASH PAPULAR (If he scratches, the area becomes raised). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (If he scratches, the area becomes red), RASH PAPULAR (If he scratches, the area becomes raised) and RASH (Rash left arm  (not injection site)) had not resolved and PRURITUS (Palms of his hands started itching/ Itching moves around from behind ear, to Calf, to Feet/ itching is in random body parts.), SOMNOLENCE (Sleep it off), PAIN (Achy) and FATIGUE (Fatigue /Tired) outcome was unknown.            No Concomitant Drug details were reported.  As a treatment patient took antihistamine.   This case was linked to MOD-2022-437642 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Somnolence
Clinical narrative: If he scratches, the area becomes red; If he scratches, the area becomes raised; Rash left arm  (not injection site); Palms of his hands started itching/ Itching moves around from behind ear, to Calf, to Feet/ itching is in random body parts.; Sleep it off; Achy; Fatigue /Tired; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (If he scratches, the area becomes red), RASH PAPULAR (If he scratches, the area becomes raised), PRURITUS (Palms of his hands started itching/ Itching moves around from behind ear, to Calf, to Feet/ itching is in random body parts.), SOMNOLENCE (Sleep it off) and PAIN (Achy) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A, 040A21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced SOMNOLENCE (Sleep it off), PAIN (Achy) and FATIGUE (Fatigue /Tired). On 22-Dec-2021, the patient experienced PRURITUS (Palms of his hands started itching/ Itching moves around from behind ear, to Calf, to Feet/ itching is in random body parts.). On 25-Dec-2021, the patient experienced RASH (Rash left arm  (not injection site)). On an unknown date, the patient experienced ERYTHEMA (If he scratches, the area becomes red) and RASH PAPULAR (If he scratches, the area becomes raised). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (If he scratches, the area becomes red), RASH PAPULAR (If he scratches, the area becomes raised) and RASH (Rash left arm  (not injection site)) had not resolved and PRURITUS (Palms of his hands started itching/ Itching moves around from behind ear, to Calf, to Feet/ itching is in random body parts.), SOMNOLENCE (Sleep it off), PAIN (Achy) and FATIGUE (Fatigue /Tired) outcome was unknown.            No Concomitant Drug details were reported.  As a treatment patient took antihistamine.   This case was linked to MOD-2022-437642 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pollakiuria, Polyuria
Clinical narrative: Urinating a lot after booster; Tremendous amount of urine after booster; Rough Headache after booster; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Urinating a lot after booster), POLYURIA (Tremendous amount of urine after booster) and HEADACHE (Rough Headache after booster) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced POLLAKIURIA (Urinating a lot after booster), POLYURIA (Tremendous amount of urine after booster) and HEADACHE (Rough Headache after booster). At the time of the report, POLLAKIURIA (Urinating a lot after booster), POLYURIA (Tremendous amount of urine after booster) and HEADACHE (Rough Headache after booster) outcome was unknown.            No concomitant were reported.  Patient stated that patient did not have a history of UTI and dose not think it was UTI.  No treatment were reported.   This case was linked to MOD-2022-437599, MOD-2022-437614 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.            No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2022-437352 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Nausea, Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: swollen L lyphm node did go down in 2-3 weeks; sorness of L arm next day for less than 24 hrs / soreness at injection site; moderate fussyness feeling for 30 hrs; Had moderate tiredness for 24 hrs; very slight nausea for 3 hrs; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (moderate fussyness feeling for 30 hrs), VACCINATION SITE LYMPHADENOPATHY (swollen L lyphm node did go down in 2-3 weeks), FATIGUE (Had moderate tiredness for 24 hrs), NAUSEA (very slight nausea for 3 hrs) and VACCINATION SITE PAIN (sorness of L arm next day for less than 24 hrs / soreness at injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Hypothyroidism. Concomitant products included LEVOTHYROXINE from 1997 to an unknown date, ALBUTEROL [SALBUTAMOL] from 1998 to an unknown date, VITAMIN D NOS from 2004 to an unknown date and VITAMIN E NOS from 1998 to an unknown date for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE PAIN (sorness of L arm next day for less than 24 hrs / soreness at injection site). On an unknown date, the patient experienced FEELING ABNORMAL (moderate fussyness feeling for 30 hrs), VACCINATION SITE LYMPHADENOPATHY (swollen L lyphm node did go down in 2-3 weeks), FATIGUE (Had moderate tiredness for 24 hrs) and NAUSEA (very slight nausea for 3 hrs). In January 2021, VACCINATION SITE PAIN (sorness of L arm next day for less than 24 hrs / soreness at injection site) had resolved. At the time of the report, FEELING ABNORMAL (moderate fussyness feeling for 30 hrs), VACCINATION SITE LYMPHADENOPATHY (swollen L lyphm node did go down in 2-3 weeks), FATIGUE (Had moderate tiredness for 24 hrs) and NAUSEA (very slight nausea for 3 hrs) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication details were reported. The patient reported that the first dose was the most effective.   This case was linked to MOD-2021-434069, MOD-2022-437656 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain
Clinical narrative: Achy after second shot; Tired/fatigue after second shot; A little nausea after second shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy after second shot), FATIGUE (Tired/fatigue after second shot) and NAUSEA (A little nausea after second shot) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 040A21A) for COVID-19 vaccination.     The patient's past medical history included Adverse food reaction (Food reactions).   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PAIN (Achy after second shot), FATIGUE (Tired/fatigue after second shot) and NAUSEA (A little nausea after second shot). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. In April 2021, PAIN (Achy after second shot), FATIGUE (Tired/fatigue after second shot) and NAUSEA (A little nausea after second shot) had resolved.            No concomitant medication reported. No treatment information was provided.  The patient experienced no adverse effect after receiving first dose and had experienced the adverse events for 1.5 days after receiving second dose. The patient had a medical history of food reactions but nothing similar to that extent.   This case was linked to MOD-2022-437621 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 036L21A and 036L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-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 PAIN (Pain). At the time of the report, PAIN (Pain) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  Reporter stated that patient had no reaction for first two doses.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Jan-2022: Contains no new information.