chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got super super sick and didn't get the second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 27 year-old male patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got super super sick and didn't get the second dose".  Additional information: The patient stated that he got the first dose of the Pfizer-BionTech Covid-19 Vaccine a little before June, in May, around there, and got super super sick and till he did not get the second dose. He stated that, he might get the second dose later but he was not sure yet.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (29Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  Amendment: This follow-up report is being submitted to amend the previously reported information: deleted the event missed dose' and Incomplete course of vaccination' and added event got super super sick'.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Immunisation, Interchange of vaccine products, Syncope, Urinary incontinence
Clinical narrative: Fainted; Cold sweat; Urinated himself while getting a haircut; patient received one dose of COVID-19 vaccine, one dose of Janssen vaccine, and now a booster with Pfizer; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in arm left, administration date 21Dec2021 14:00 (Lot number: FH8027) at the age of 29 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Vaccination history included: Janssen vaccine (2nd dose; Lot number: 1805022; at 18:00 in the left arm), administration date: 17Mar2021, when the patient was 29 years old, for COVID-19 Immunization; COVID-19 vaccine (1st dose; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Dec2021 14:00, outcome "unknown", described as "patient received one dose of COVID-19 vaccine, one dose of Janssen vaccine, and now a booster with Pfizer"; IMMUNISATION (medically significant) with onset 21Dec2021 14:00, outcome "unknown", described as "booster"; SYNCOPE (medically significant) with onset 22Dec2021 11:30, outcome "recovering", described as "Fainted"; COLD SWEAT (non-serious) with onset 22Dec2021 11:30, outcome "recovering", described as "Cold sweat"; URINARY INCONTINENCE (non-serious) with onset 22Dec2021 11:30, outcome "recovering", described as "Urinated himself while getting a haircut". The events "fainted", "cold sweat" and "urinated himself while getting a haircut" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of syncope, cold sweat, urinary incontinence. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  Additional information: On 21Dec2021, the patient received a "booster with Pfizer." On 22Dec2021, the patient broke out into cold sweat, fainted and urinated on himself in his barber's chair while getting a haircut.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Pruritus
Clinical narrative: booster; Today it actually seems to be getting worse; had a "metal taste" in my mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 16Dec2021 17:30 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown Dose, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 17:30, outcome "unknown", described as "booster"; DYSGEUSIA (non-serious) with onset Dec2021, outcome "not recovered", described as "had a "metal taste" in my mouth"; CONDITION AGGRAVATED (non-serious) with onset 16Dec2021, outcome "not recovered", described as "Today it actually seems to be getting worse".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Dysgeusia, Immunisation
Clinical narrative: booster; Today it actually seems to be getting worse; had a "metal taste" in my mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 16Dec2021 17:30 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown Dose, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 17:30, outcome "unknown", described as "booster"; DYSGEUSIA (non-serious) with onset Dec2021, outcome "not recovered", described as "had a "metal taste" in my mouth"; CONDITION AGGRAVATED (non-serious) with onset 16Dec2021, outcome "not recovered", described as "Today it actually seems to be getting worse".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Oct2021 14:00 (Lot number: PF2593) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "polio as a child" (unspecified if ongoing); "2 knee replacements" (unspecified if ongoing), notes: 2 knee replacements; "hip replacement" (unspecified if ongoing); "R femur fracture" (unspecified if ongoing); "gall bladder surgery" (unspecified if ongoing); "appendectomy" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing), notes: Known allergies: sulfa, percodan, dairy; "Known allergies: dairy" (unspecified if ongoing), notes: Known allergies: sulfa, percodan, dairy. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, administration date 30Sep2021; LEVOTHYROXINE; AMLODIPINE; ROSUVASTATIN. Past drug history included: Percodan, reaction(s): "Known allergies: percodan", notes: Known allergies: sulfa, percodan, dairy. Vaccination history included: Bnt162b2 (Dose 2, lot number: EL6203, dose vaccine location: Right arm), administration date: 26Feb2021, when the patient was 79 years old, for Covid-19 Immunization; Bnt162b2 (Dose 1, Lot number: EL9264, dose vaccine location: Right arm), administration date: 05Feb2021, when the patient was 79 years old, for Covid-19 Immunization. No covid prior vaccination and not covid tested post vaccination. The following information was reported: BELL'S PALSY (medically significant) with onset 23Dec2021 10:00, outcome "not recovered", described as "Bell's Palsy"; IMMUNISATION (medically significant) with onset 19Oct2021 14:00, outcome "unknown", described as "Booster". The event "bell's palsy" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of bell's palsy included: prednisone & valacyclovir.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Immunisation
Clinical narrative: Bell's Palsy; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Oct2021 14:00 (Lot number: PF2593) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "polio as a child" (unspecified if ongoing); "2 knee replacements" (unspecified if ongoing), notes: 2 knee replacements; "hip replacement" (unspecified if ongoing); "R femur fracture" (unspecified if ongoing); "gall bladder surgery" (unspecified if ongoing); "appendectomy" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing), notes: Known allergies: sulfa, percodan, dairy; "Known allergies: dairy" (unspecified if ongoing), notes: Known allergies: sulfa, percodan, dairy. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, administration date 30Sep2021; LEVOTHYROXINE; AMLODIPINE; ROSUVASTATIN. Past drug history included: Percodan, reaction(s): "Known allergies: percodan", notes: Known allergies: sulfa, percodan, dairy. Vaccination history included: Bnt162b2 (Dose 2, lot number: EL6203, dose vaccine location: Right arm), administration date: 26Feb2021, when the patient was 79 years old, for Covid-19 Immunization; Bnt162b2 (Dose 1, Lot number: EL9264, dose vaccine location: Right arm), administration date: 05Feb2021, when the patient was 79 years old, for Covid-19 Immunization. No covid prior vaccination and not covid tested post vaccination. The following information was reported: BELL'S PALSY (medically significant) with onset 23Dec2021 10:00, outcome "not recovered", described as "Bell's Palsy"; IMMUNISATION (medically significant) with onset 19Oct2021 14:00, outcome "unknown", described as "Booster". The event "bell's palsy" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of bell's palsy included: prednisone & valacyclovir.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mechanical urticaria, Pruritus, Swelling, Urticaria
Clinical narrative: Hives; Itching at scalp ear and neck by night it was on whole trunk of body, itchy in same spots; Whatever would touch or lean into would have lines on skin; This spontaneous case was reported by a consumer and describes the occurrence of SKIN INFECTION (Whatever would touch or lean into would have lines on skin), URTICARIA (Hives) and PRURITUS (Itching at scalp ear and neck by night it was on whole trunk of body, itchy in same spots) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 001B21A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included AMITRIPTYLINE and MULTIVITAMIN GUMMY BEARS for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-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 SKIN INFECTION (Whatever would touch or lean into would have lines on skin). On 25-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (Hives) and PRURITUS (Itching at scalp ear and neck by night it was on whole trunk of body, itchy in same spots). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) at an unspecified dose and frequency. At the time of the report, SKIN INFECTION (Whatever would touch or lean into would have lines on skin), URTICARIA (Hives) and PRURITUS (Itching at scalp ear and neck by night it was on whole trunk of body, itchy in same spots) had not resolved.            Other treatment information includes OTC medications.  Patient stated that she had telehealth call on 26-Dec-2021 and was not prescribed anything. Patient also stated that events were ongoing and comes and goes pretty much constant.   This case was linked to MOD-2022-438403 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Skin infection, Urticaria
Clinical narrative: Hives; Itching at scalp ear and neck by night it was on whole trunk of body, itchy in same spots; Whatever would touch or lean into would have lines on skin; This spontaneous case was reported by a consumer and describes the occurrence of SKIN INFECTION (Whatever would touch or lean into would have lines on skin), URTICARIA (Hives) and PRURITUS (Itching at scalp ear and neck by night it was on whole trunk of body, itchy in same spots) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 001B21A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included AMITRIPTYLINE and MULTIVITAMIN GUMMY BEARS for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-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 SKIN INFECTION (Whatever would touch or lean into would have lines on skin). On 25-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (Hives) and PRURITUS (Itching at scalp ear and neck by night it was on whole trunk of body, itchy in same spots). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) at an unspecified dose and frequency. At the time of the report, SKIN INFECTION (Whatever would touch or lean into would have lines on skin), URTICARIA (Hives) and PRURITUS (Itching at scalp ear and neck by night it was on whole trunk of body, itchy in same spots) had not resolved.            Other treatment information includes OTC medications.  Patient stated that she had telehealth call on 26-Dec-2021 and was not prescribed anything. Patient also stated that events were ongoing and comes and goes pretty much constant.   This case was linked to MOD-2022-438403 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms
Clinical narrative: Within two minutes I was experiencing intermittent sharp pain on my lower back for approximately 10minutes duration.  Blood pressure was 200/90
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Electrocardiogram normal
Clinical narrative: Within two minutes I was experiencing intermittent sharp pain on my lower back for approximately 10minutes duration.  Blood pressure was 200/90
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: sore left arm; Received 1st Moderna dose in error/Under age 18; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received 1st Moderna dose in error/Under age 18) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Dec-2021, the patient experienced VACCINATION SITE PAIN (sore left arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received 1st Moderna dose in error/Under age 18). On 06-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received 1st Moderna dose in error/Under age 18) had resolved. At the time of the report, VACCINATION SITE PAIN (sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided. No treatment medications were provided.  It was reported that the caller reported that her daughter may receive PFIZER as her second dose.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age, Vaccination site pain
Clinical narrative: sore left arm; Received 1st Moderna dose in error/Under age 18; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received 1st Moderna dose in error/Under age 18) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Dec-2021, the patient experienced VACCINATION SITE PAIN (sore left arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received 1st Moderna dose in error/Under age 18). On 06-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received 1st Moderna dose in error/Under age 18) had resolved. At the time of the report, VACCINATION SITE PAIN (sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided. No treatment medications were provided.  It was reported that the caller reported that her daughter may receive PFIZER as her second dose.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Head discomfort, Headache, Loss of personal independence in daily activities
Clinical narrative: Brain pressure, migraine headache and severe dizziness first night after vaccine. Dizziness and headache lasted for up to a week (though not as severe). Fatigue. Barely able to keep up with daily tasks.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Brain pressure, migraine headache and severe dizziness first night after vaccine. Dizziness and headache lasted for up to a week (though not as severe). Fatigue. Barely able to keep up with daily tasks.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Mechanical urticaria, Urticaria
Clinical narrative: 13 days following vaccination (Moderna booster) onset of chronic hives and dermatographia (skin writing). Ongoing as of this date.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site cellulitis, Injection site hypoaesthesia, Injection site pain
Clinical narrative: Cellulitis to injection site. Continuing pain, numbness and burning to injection site.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Rash, Rash papular
Clinical narrative: Approximately 9 days following vaccine developed a rash around his torso/trunk that spread to his back and arms. Small pink bumps slightly raised. Minor sore throat. No other symptoms.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Acute cardiac event, Atrial fibrillation, Atrial tachycardia, Cardiac ablation, Cardiac electrophysiologic study
Clinical narrative: 10 days after the first vaccine I experienced chest pain, difficulty breathing and a rapid heart beat. 9 weeks after the second dose I had to go to the hospitial with a rapid heartbeat of 229 BPM. Since then I have experienced multiple heart events with rapid heartbeats exceeding 150 BPM and as high as 229 BPM. The cardiologist has diagnosed me with atrial fibrilation, atrial tachycardia and heart flutter. He is recommending numerous surgeries.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Cardiac monitoring, Chest X-ray, Chest pain, Dyspnoea
Clinical narrative: 10 days after the first vaccine I experienced chest pain, difficulty breathing and a rapid heart beat. 9 weeks after the second dose I had to go to the hospitial with a rapid heartbeat of 229 BPM. Since then I have experienced multiple heart events with rapid heartbeats exceeding 150 BPM and as high as 229 BPM. The cardiologist has diagnosed me with atrial fibrilation, atrial tachycardia and heart flutter. He is recommending numerous surgeries.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Heart rate increased
Clinical narrative: 10 days after the first vaccine I experienced chest pain, difficulty breathing and a rapid heart beat. 9 weeks after the second dose I had to go to the hospitial with a rapid heartbeat of 229 BPM. Since then I have experienced multiple heart events with rapid heartbeats exceeding 150 BPM and as high as 229 BPM. The cardiologist has diagnosed me with atrial fibrilation, atrial tachycardia and heart flutter. He is recommending numerous surgeries.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Urticarial rash that started within the first five hours of receiving the booster. Described as an itchy erythematous rash, like hives, that started in the back and spread to arms and legs the following day. Received treatment with Bendadryl and Zyrtec without improvement of symptoms. No previous similar episodes with other vaccines or medications. Patient with No known allergy.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Biopsy, Breast mass, Breast pain, Exposure during pregnancy
Clinical narrative: Sore arm and sore breasts. Had to have a biopsy done on my breast because there was a lump on my mammogram. Then, I got pregnant, and had a miscarriage at 18 weeks pregnant.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Mammogram, Pain in extremity
Clinical narrative: Sore arm and sore breasts. Had to have a biopsy done on my breast because there was a lump on my mammogram. Then, I got pregnant, and had a miscarriage at 18 weeks pregnant.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Hyperaesthesia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Very painful at injection site for 4 days.  Red and swollen at injection site for 4 days, at least.  One day after injection, - muscle pain all over body,  sensitive to touch, feverish - just plain miserable.  Same symptoms but  milder on next day.  Gone by day after that,
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Very painful at injection site for 4 days.  Red and swollen at injection site for 4 days, at least.  One day after injection, - muscle pain all over body,  sensitive to touch, feverish - just plain miserable.  Same symptoms but  milder on next day.  Gone by day after that,
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Tachycardia
Clinical narrative: Tachycardia, menstrual cycle abnormal
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Impaired work ability, Loss of personal independence in daily activities, Muscle spasms
Clinical narrative: Fever/chills, headache, exhausting fatigue, sever body aches that no OTC could help, muscle spasms and pain that started at 1 am the night of booster and lasted for 8 hours that I was aware of. Unable to sleep or function for 2 days- had to call in from work
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia, Sleep disorder
Clinical narrative: Fever/chills, headache, exhausting fatigue, sever body aches that no OTC could help, muscle spasms and pain that started at 1 am the night of booster and lasted for 8 hours that I was aware of. Unable to sleep or function for 2 days- had to call in from work
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Pericarditis
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pruritus, Somnolence
Clinical narrative: Extreme fatigue, sleeping 22 hours per day. Up briefly twice daily for food. Severe itching over 75% of skin area unrelieved by oral antihistamines or topical aloe Vera gel application
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring, Echocardiogram, Electrocardiogram, Heart rate increased, Magnetic resonance imaging
Clinical narrative: Accelerated heart rate
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dyspnoea, Fear, Lymphadenitis, Lymphadenopathy
Clinical narrative: My first vaccine dose I experienced no symptoms. My second dose I felt fine until 8 hours later when my heart began racing and I had severe shortness of breath. I finally called 911 they arrived and were able to have my levels come down enough that I didn?t go to the hospital.  Since then for the last year I have experienced large inflammation from my lymph nodes in both armpits.  I was told by my doctor it would go away in a month and not to worry.  It has been over 8 months.  I have swelling throughout my body and my lymph nodes in my armpits are still swollen.  I am only 34 active healthy. But this is scary! Please help!
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis, Palpitations, Swelling
Clinical narrative: My first vaccine dose I experienced no symptoms. My second dose I felt fine until 8 hours later when my heart began racing and I had severe shortness of breath. I finally called 911 they arrived and were able to have my levels come down enough that I didn?t go to the hospital.  Since then for the last year I have experienced large inflammation from my lymph nodes in both armpits.  I was told by my doctor it would go away in a month and not to worry.  It has been over 8 months.  I have swelling throughout my body and my lymph nodes in my armpits are still swollen.  I am only 34 active healthy. But this is scary! Please help!
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: Pain and Swelling of derma filler under right eye about 30 hours after dose. Fillers were placed in July (6months ago).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: I was 5 weeks pregnant at the time of taking my COVID booster.  Later we found that the fetus stopped growing around the same time as when I received the booster leading to miscarriage.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Periods twice a month.  Heavy period, i use to be low period and lots of pain like cramps all the time. Heavy headaches on daily bases.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone normal, Body temperature increased, C-reactive protein increased, Ear pain, Fatigue
Clinical narrative: On 12/15 patient started having fatigue, fever and anterior neck pain which continued for 2 weeks. Pain radiated to the ear and jaw.At the same time the neck became swollen with a palpable nodule on the LT thyroid. This progressed to right sided neck pain. Patient also intermittently experienced elevated temp at night to 100-100.5. Symptoms improved with Tylenol and Ibuprofen. This continues to be an ongoing issue
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in jaw, Platelet count increased, Pyrexia
Clinical narrative: On 12/15 patient started having fatigue, fever and anterior neck pain which continued for 2 weeks. Pain radiated to the ear and jaw.At the same time the neck became swollen with a palpable nodule on the LT thyroid. This progressed to right sided neck pain. Patient also intermittently experienced elevated temp at night to 100-100.5. Symptoms improved with Tylenol and Ibuprofen. This continues to be an ongoing issue
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate increased, Swelling, Thyroid mass, Thyroxine normal, Ultrasound thyroid abnormal
Clinical narrative: On 12/15 patient started having fatigue, fever and anterior neck pain which continued for 2 weeks. Pain radiated to the ear and jaw.At the same time the neck became swollen with a palpable nodule on the LT thyroid. This progressed to right sided neck pain. Patient also intermittently experienced elevated temp at night to 100-100.5. Symptoms improved with Tylenol and Ibuprofen. This continues to be an ongoing issue
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Injection site pain, Tinnitus, Vision blurred
Clinical narrative: Prior doses: Dose 1: only had mild soreness at injection site and tiredness rest of the day. Dose 2: dizziness, tiredness/fatigue for a couple of days  Booster: initial soreness at injection site,  ringing in ears and dizziness that come and go.  It stop  with random blurriness in vision from time to time. All  other symptoms went away but noticed my vision has been declining becoming more blurry.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea, loose watery stools. >5 times in a 12 hour period
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Swelling of eyelid
Clinical narrative: Watery eyes, swollen eyelids 16 hours after shot. Took two Benedryl
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Echocardiogram, Myocarditis, Troponin, Troponin increased
Clinical narrative: Chest pain, elevated troponin, cardiology evaluation including echocardiogram. Diagnosis of Myopericarditis
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Maternal exposure during pregnancy
Clinical narrative: contracted COVID; granddaughter is pregnant; This case was received via an unknown source (no reference has been entered for the regulatory authority) on 10-Dec-2021 and was forwarded to Moderna on 10-Dec-2021. This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of COVID-19 and MATERNAL EXPOSURE DURING PREGNANCY in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pregnant.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced COVID-19 and MATERNAL EXPOSURE DURING PREGNANCY. At the time of the report, COVID-19 outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No concomitant and treatment drugs were provided.  This is a spontaneous case concerning an adult pregnant female patient with no relevant medical history reported, who experienced the unexpected events of maternal exposure during pregnancy and Covid-19. The patient experience Covid-19 and received a dose of mRNA - 1273 vaccine on an unknown date. The last menstrual period and estimated date of delivery were also not provided. At the time of report outcome of Covid-19 was still unknown. The reporter's assessment was not provided in this case. The benefit-risk relationship of the vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Immunisation, Pain, Pyrexia
Clinical narrative: COVID-19 vaccine 3rd dose; Chills; Fever; Body aches; Blurred vision; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose: 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "COVID-19 vaccine 3rd dose"; CHILLS (non-serious), outcome "unknown", described as "Chills"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; PAIN (non-serious), outcome "unknown", described as "Body aches"; VISION BLURRED (non-serious), outcome "unknown", described as "Blurred vision". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: COVID-19 vaccine 3rd dose; Chills; Fever; Body aches; Blurred vision; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose: 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "COVID-19 vaccine 3rd dose"; CHILLS (non-serious), outcome "unknown", described as "Chills"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; PAIN (non-serious), outcome "unknown", described as "Body aches"; VISION BLURRED (non-serious), outcome "unknown", described as "Blurred vision". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: I started to feel a mild pain in the chest from the first night after my first shot of Moderna with a fever and extremely pain arm. Next day during the daytime, my fever got away, as well as the pain arm. But during the night, my chest was pain enough to wake me up and kept in pain.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Vomiting
Clinical narrative: her heart stopped/passed away; throwup; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC ARREST (her heart stopped/passed away) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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. On an unknown date, the patient experienced CARDIAC ARREST (her heart stopped/passed away) (seriousness criterion death) and VOMITING (throwup). The patient died on an unknown date. The reported cause of death was heart stopped. It is unknown if an autopsy was performed. At the time of death, VOMITING (throwup) outcome was unknown.            No concomitant medication were reported. The patient's first two doses were Moderna COVID-19 vaccine, and she was fine with the first two. The first dose was administered on 20-Mar-2021. Since the patient took the booster dose of the Moderna COVID-19 vaccine, she started to throwup. Her heart stopped and she passed away. No treatment information was provided.   Company Comment - This case concerns a female patient of unknown age with no relevant medical history, who experienced the serious (death) unexpected event of cardiac arrest. The event occurred on an unknown date after the third dose of mRNA-1273 vaccine, and the outcome was fatal. The patient died on an unknown date and the cause of death was cardiac arrest. The rechallenge was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient of unknown age with no relevant medical history, who experienced the serious (death) unexpected event of cardiac arrest. The event occurred on an unknown date after the third dose of mRNA-1273 vaccine, and the outcome was fatal. The patient died on an unknown date and the cause of death was cardiac arrest. The rechallenge was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: heart stopped
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient did not have any other adverse reactions; patient was administered an expired dose of MMR-II; This spontaneous report as received from a medical assistant refers to a female patient of unknown age.     On  06-DEC-2021, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (0.5 ml, lot # S039309 with expiration date: 04-DEC-2021, status albumin recombinant human albumin (rHA), route of administration was not reported) for prophylaxis. The patient did not have any other adverse reactions.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE reported; Expired dose of MMR II was administered to patient; MMR II vaccine was administered intramuscularly; This spontaneous report was received from a physician and refers to a 34-year-old female patient. No concurrent conditions, medical history and concomitant medications were reported.  On 08-DEC-2021, the patient was vaccinated at physician office with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA)(M-M-R II) (first dose, intramuscularly, lot # S032825, expiration date 16-OCT-2021)(exact dose unknown) for prophylaxis (Expired product administered, Incorrect route of product administration). Vaccine was prepared with diluent which had expiration date of 10-JUL-2022. Mistake made because looked at the expiration date for diluent and revealed after administration of vaccine.  The vaccine was used according to leaflet, operator of vaccine was healthcare professional and was trained. The patient did not experience any adverse events (response after administration reported as normal). No treatment was prescribed for the event.
Sex: M
Vaccine: PPV
Symptoms: Back pain, Dizziness, Dysstasia
Clinical narrative: back pain / the patient reports the back pain may be due to potential kidney pain; was unable to stand; the patient reports the back pain may be due to potential kidney pain; the patient reports after vaccination he felt light headed; This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with Pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) subcutaneously (strength, dose, frequency, site of administration, lot # and expiration date were not reported) for prophylaxis.  All information was provided by the pharmacist, who conveyed what the patient reported. On an unknown date, after the patient received the suspect vaccine, he left facility and walked across the street. The patient reported that after vaccination he felt light headed, had back pain and was unable to stand. Emergency Medical Services (EMS) were called and he felt better 10-15 minutes later. The patient reported that the vitals were normal per Emergency Medical Technicians (EMT) and he did not need transport. The patient reported that back pain might have been due to potential kidney pain caused from the vaccine.  The outcome of the events of feeling light headed, back pain, being unable to stand and kidney pain was unknown.  The reporter did not provide causality between the events of feeling lightheaded, back pain, kidney pain, being unable to stand and Pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).
Sex: U
Vaccine: HPV4
Symptoms: Incomplete course of vaccination
Clinical narrative: This spontaneous report as received from a consumer refers to a patient of unknown age and gender. Information regarding the patient medical history, concomitant medications, drug allergies or reactions  was not provided.  In August 2021 the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) 1 dosage form for prophylaxis (strength, frequency, administration route, lot number and expiry date were not provided.  On an unknown date, the patient missed her/his second dose (product dose omission issue). The patient would speak of the event with the physician.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: No additional AE; Pt was administered expired Gardasil 9; This spontaneous report as received from a nurse referring to a patient of unknown age and gender. Information regarding the patient medical history, concomitant medications, drug allergies or reactions was not provided.        On 12-SEP-2021 the patient was vaccinated with a expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1621929 that has been verified to be valid for,hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)  expiry date 12-JUN-2021 for prophylaxis (strength, dose, administration route and frequency were not provided) (expired product administered).
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: Caller states they are pregnant and received the GARDASIL vaccine; This spontaneous prospective pregnancy report was received from a female patient of unknown age and refers to herself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.   On 09-DEC-2021, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) one dose, (lot #, expiration date, site and route of administration were not reported) for prophylaxis (exposure during pregnancy). The date of Last Menstrual Period (LMP) and due date were unknown. The pregnancy outcome was pending.  The outcome of the event is unknown.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies. On 10-DEC-2021, the vaccine experienced a temperature excursion of 48.5 Fahrenheit (°F) during a time frame of 4 hours 0 minutes and 0 seconds. On 29-NOV-2021, the patient was vaccinated with one improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe (lot number T039322, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 09-SEP-2022) (frequency, route of administration, anatomical location and vaccination scheme were not reported), as prophylaxis (product storage error). There was no previous temperature excursion reported or if a data logger was used. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-2112USA005896.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional AE reported.; an expired dose of VAQTA was administered.; This spontaneous report was received from a nurse concerning a patient of unknown age. No concurrent condition, medical history, or concomitant therapy was reported.  On 15-DEC-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) (0.5 mL, strength and route were unknown; lot # T013204 has been verified to be a valid lot number, expiration date reported and confirm upon internal validation as 03-DEC-2021) for prophylaxis (expired product administered). The product had not experienced temperature excursion. There was no adverse event.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other side effects or concerns; Patient received a dose of expired PROQUAD; This spontaneous report was received from a other referring to a patient of unreported age and gender. The patient's relevant medical history and concomitant medications were not provided.   On 16-DEC-2021 the patient was vaccinated with expired measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) as prophylaxis (expired product administered) (lot number reported as S003861, expiration date-08-AUG-2020; dose, dose number, vaccination scheme, route of administration, and anatomical location of vaccination were not reported).      At the time of reporting, it was reported that no other side effects or concerns (No adverse event).
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events were reported, no further information provided; The patient received an expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) administered; At which point the medication error ocurred: Preparation for administration; This spontaneous report has been received from a pharmacist, concerning to 66-year-old female. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On 15-DEC-2021, the patient was vaccinated by a health care provider, with an expired first dose (expired product administered) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) given intramuscularly as prophylaxis (dose, anatomical location and vaccine scheme were not provided; lot number S029542 has been verified to be a valid lot number, expiration date reported and established as 10-JUN-2021). It was reported that the medication error occurred at the time of preparation for administration of the vaccine (product preparation error). Also, that the vaccine was disposed. The patient was notified, and no adverse reaction occurred (no adverse event). Subsequently, on unspecified date in December 2021, the patient was re-vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) as prophylaxis (dose, route of administration, anatomical location, vaccine scheme, lot number and expiration date were not provided).