chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Worst case of flu ever-when I got my flu shot; Initial information received on 16-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced worst case of flu ever-when i got my flu shot while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine (strength, formulation, dose, frequency: unknown) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for Prophylactic vaccination.   On an unknown date the patient developed a non-serious worst case of flu ever-when i got my flu shot (influenza) (unknown latency) following the administration of Influenza Vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (Worst case of flu ever-when I got my flu shot).  At time of reporting, the outcome was Unknown for the event worst case of flu ever-when i got my flu shot.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: had a very bad flu; Initial information received on 16-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a patient of unknown demographics who had a very bad flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE (formulation, strength: unknown) produced by unknown manufacturer lot number not reported in unknown administration site as prophylactic vaccination. Information on batch number cannot be requested.  On an unknown date the patient developed a non-serious event "had a very bad flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE . It was reported "The last 25 years I got flu shot only once. I had a very bad flu that year. Never before and never after. So no more flu shot for me."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (had a very bad flu).  At time of reporting, the outcome was Unknown for the event had a very bad flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: literally quit getting the flu when I quit getting the flu shot; Initial information received on 17-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional (hcp).  This case involves a patient (unknown age and gender) who literally quit getting the flu when quit getting the flu shot while receiving vaccine INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, frequency: unknown) (lot number and expiry date: not reported) via unknown route in unknown administration site for Immunisation. There will be no information available on the batch number for this case.  On an unknown date the patient developed a non-serious event "literally quit getting the flu when i quit getting the flu shot (influenza)" (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, "This case is received from Social media. Hello, The following potential adverse event has been found on a public post for Flu Shot Social media page. Product Name: Product name was not provided. Since this is a public post on the Sanofi flu shot campaign, we are assuming the consumer is referring to the Sanofi flu vaccine. Author/Reporter Comment: I literally quit getting the flu when I quit getting the flu shot. Patient ID: Not Provided. It is unknown if patient's physician provided consent to be contacted Age group is actually not provided It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine: Influenza Vaccine: Sanofi flu shot".  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (literally quit getting the flu when I quit getting the flu shot).  At time of reporting, the outcome was Unknown for the event literally quit getting the flu when i quit getting the flu shot.
Sex: U
Vaccine: TDAP
Symptoms: Anosmia
Clinical narrative: lost sense of smell; Initial information received from the regulatory agency on 18-Jan-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves patient  of unknown demographics who had lost sense of smell while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE  Suspension for injection (strength, formulation, frequency, route, lot number and expiry date was unknown) in unknown administration site for prophylactic vaccination. Information for the batch and expiry date was requested.  On an unknown date the patient developed a non-serious event "lost sense of smell" (anosmia) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (lost sense of smell).  At time of reporting, the outcome was Unknown for the event lost sense of smell.  Reporter causality: related
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: guillain barre syndrome; Initial information received on 17-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional.  This case involves an unknown age female patient who experienced guillain barre syndrome while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Influenza Vaccine (formulation, strength: unknown) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site as prophylactic vaccination. Information on batch number was requested.  On an unknown date the patient developed guillain barre syndrome (guillain-barre syndrome) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (guillain barre syndrome).  At time of reporting, the outcome was Unknown for the event guillain barre syndrome.; Sender's Comments: Sanofi Company Comment dated 24-Jan-2022. This case involves an unknown age female patient who experienced guillain barre syndrome while receiving vaccine Influenza Vaccine. Based upon the reported information, the role of a vaccine cannot be assessed  Further information regarding time to onset, concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case.
Sex: U
Vaccine: FLUX
Symptoms: COVID-19, Pain in extremity
Clinical narrative: my arm still hurts and just after getting the shot i got corona; my arm still hurts and just after getting the shot i got corona; Initial information received on 16-Jan-2022 regarding an unsolicited valid Social media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced my arm still hurts and just after getting the shot i got corona and my arm still hurts and just after getting the shot i got corona while receiving vaccine Influenza Vaccine.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect Influenza Vaccine (strength, formulation, dose, frequency: unknown) produced by unknown manufacturer lot number not reported in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious my arm still hurts and just after getting the shot i got corona (vaccination site pain) (unknown latency) following the administration of Influenza Vaccine. On an unknown date the patient developed a non-serious my arm still hurts and just after getting the shot i got corona (covid-19) (unknown latency) following the administration of Influenza Vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (my arm still hurts and just after getting the shot i got corona, my arm still hurts and just after getting the shot i got corona).  At time of reporting, the outcome was Unknown for the event my arm still hurts and just after getting the shot i got corona and was Unknown for the event my arm still hurts and just after getting the shot i got corona.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: every one I know who got the flu shot is sick; Initial information received on 18-Jan-2022 regarding an unsolicited valid Social Media non-serious case was received from the consumer.  This case involves an unknown age and unknown gender patient who reported that everyone he/she knew who got the flu shot was sick, while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, dosage regimen, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination. Information on batch number was requested.   On an unknown date, the patient developed a non-serious event 'everyone i know who got the flu shot is sick' (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "everyone I know who got the flu shot is sick. And those of us who didn't never died or went to the hospital. Im done with them."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (everyone I know who got the flu shot is sick).  At time of reporting, the outcome was Unknown for the event (everyone i know who got the flu shot is sick).
Age: 5.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Off label use, Product administered to patient of inappropriate age
Clinical narrative: Flublok given to pediatric patients, with no reported adverse event; Initial information received on 14-Jan-2022 regarding an unsolicited valid non-serious case was received from a pharmacist.  This case involves a 5 year old pediatric female patient who was given INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Jan-2022, the patient received 0.5 ml, total dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2125, expiry date: 30-Jun-2022) via intramuscular route in the left deltoid as prophylactic vaccination.  On 13-JAN-2022 the patient developed a non-serious "flublok given to pediatric patients, with no reported adverse event (off label use)" same day following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Flublok given to pediatric patients, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event flublok given to pediatric patients, with no reported adverse event.
Age: 9.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Off label use, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK to a pediatric patient, with no reported adverse event; Initial information received on 14-Jan-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 9 years old female patient who experienced 'flublok to a pediatric patient, with no reported adverse event' while receiving vaccine influenza quadrivalent recombinant vaccine (Flublok Qiv).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Jan-2022, the patient received suspect influenza quadrivalent recombinant vaccine at a dose of 0.5ml total (once) (strength and formulation: unknown) with lot QFAA2125, expiry date of 30-Jun-2022 via intramuscular route in left deltoid (off label use) (latency: same day).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events ( FLUBLOK to a pediatric patient, with no reported adverse event).  Outcome: unknown
Age: 0.17
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Medication error, Product administered to patient of inappropriate age
Clinical narrative: Patient is almost 2 months old, and was inadvertently administered a 0.5 mL dose of Fluzone Quadrivalent from the 5mL multi-dose vial today (14 Jan 2022).; Initial information received on 14-Jan-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 58 days old female patient who is almost 2 months old, and was inadvertently administered a 0.5 ml dose of fluzone quadrivalent from the 5ml multi-dose vial today (14 jan 2022). while receiving vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT MULTIDOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ695AA via unknown route in unknown administration site.  On 14-JAN-2022 the patient developed a non-serious patient is almost 2 months old, and was inadvertently administered a 0.5 ml dose of fluzone quadrivalent from the 5ml multi-dose vial today (14 jan 2022). (product administered to patient of inappropriate age) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Patient is almost 2 months old, and was inadvertently administered a 0.5 mL dose of Fluzone Quadrivalent from the 5mL multi-dose vial today (14 Jan 2022).).  At time of reporting, the outcome was Unknown for the event patient is almost 2 months old, and was inadvertently administered a 0.5 ml dose of fluzone quadrivalent from the 5ml multi-dose vial today (14 jan 2022)..   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: received an expired dose of ADACEL with no reported adverse event; Initial information received on 17-Jan-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 11 years old male patient who had received an expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA).  On 17-Jan-2020, the patient received a 0.5ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE  (strength, frequency was unknown, lot C5631AA and expiry date was unknown) via intramuscular route in unknown administration site for prophylactic vaccination. Information for the batch and expiry date was requested.  On 17-JAN-2022 the patient developed a non-serious event "received an expired dose of adacel with no reported adverse event" (expired product administered) 2 years following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (received an expired dose of ADACEL with no reported adverse event).  At time of reporting, the outcome was Unknown for the event received an expired dose of adacel with no reported adverse event.   Reporter Causality: Related
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, Visual impairment
Clinical narrative: very hard to see and she needs a magnifying glass; patient had been given an expired vaccine; Initial information received on 19-Jan-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 17 years old female patient who had been given an expired vaccine and very hard to see and she needs a magnifying glass and patient  while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL [POLIO VACCINE INACT 3V (VERO)]).  On 29-Dec-2021, the patient received a  0.5ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE  once (strength, formulation was unknown, lot E563088 and expiry date: 21-Nov-2021 via intramuscular route in the right arm for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "very hard to see and she needs a magnifying glass" (visual impairment) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date the patient developed a non-serious event "patient had been given an expired vaccine" (expired product administered) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported"Physician states that Adacel was given to a teenager and it was one month expired. " Is it necessary to redo the shot and any issues to be concerned about?" Additional Description of event Adverse events :PTC(product technical complaint) : Physician states that the NDC  (unspecified abbreviation) is very hard to see and she needs a magnifying glass."  PTC assessment medical/Physical : Physical  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the events (patient had been given an expired vaccine, very hard to see and she needs a magnifying glass).  At time of reporting, the outcome was Unknown for the event patient had been given an expired vaccine and was Unknown for the event very hard to see and she needs a magnifying glass.  Reporter causality: Related
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Diarrhoea, Fatigue, Lethargy
Clinical narrative: Nausea, Diarrhea, Sneezing, Fever, Chills, Arm Pain, Chest Pain, Extreme Fatigue, Lethargy - all symptoms began the day after my vaccine (1/25) and are still persisting now (1/27)
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Sneezing
Clinical narrative: Nausea, Diarrhea, Sneezing, Fever, Chills, Arm Pain, Chest Pain, Extreme Fatigue, Lethargy - all symptoms began the day after my vaccine (1/25) and are still persisting now (1/27)
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Moderate fever for 24 hours (103F), mild fever for 24 hours (100F), muscle pain, chills, sore throat, moderate headache >48 hours.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy test, Antinuclear antibody, Blood test, Laboratory test, Lip swelling
Clinical narrative: The first 2 doses were no issues. 3 days after getting the booster, I developed some hives on my neck. Since then, I have had an internally itchy face, internally itchy forehead, internally itchy hands, cheekbones, tight lip, tight side lip, swollen lip sensation, swollen tongue sensation, itchy tongue sensation, full body flare ups, puffy eyes and post nasal drip for the last 3 months. Each symptom comes and goes as it pleases. We checked autoimmune diseases, and blood tested for different allergens and even had my sinuses checked. My symptoms dont all happen at once but atleast one or the other is constantly happening and it comes and goes as it pleases.  As a background, I am not allergic or have not been allergic to anything my whole life (I have been vegetarian all my life). No particular food allergies, no laundry detergent allergies, no environmental allergies. This started happening 3 days after I took the booster. I tried changing my diet and checking if its some food; changed locations in case its some environment and it has still not gone.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Periorbital swelling, Pruritus, Rheumatoid factor, Sjogren's syndrome, Swollen tongue
Clinical narrative: The first 2 doses were no issues. 3 days after getting the booster, I developed some hives on my neck. Since then, I have had an internally itchy face, internally itchy forehead, internally itchy hands, cheekbones, tight lip, tight side lip, swollen lip sensation, swollen tongue sensation, itchy tongue sensation, full body flare ups, puffy eyes and post nasal drip for the last 3 months. Each symptom comes and goes as it pleases. We checked autoimmune diseases, and blood tested for different allergens and even had my sinuses checked. My symptoms dont all happen at once but atleast one or the other is constantly happening and it comes and goes as it pleases.  As a background, I am not allergic or have not been allergic to anything my whole life (I have been vegetarian all my life). No particular food allergies, no laundry detergent allergies, no environmental allergies. This started happening 3 days after I took the booster. I tried changing my diet and checking if its some food; changed locations in case its some environment and it has still not gone.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Tryptase, Upper-airway cough syndrome, Urticaria
Clinical narrative: The first 2 doses were no issues. 3 days after getting the booster, I developed some hives on my neck. Since then, I have had an internally itchy face, internally itchy forehead, internally itchy hands, cheekbones, tight lip, tight side lip, swollen lip sensation, swollen tongue sensation, itchy tongue sensation, full body flare ups, puffy eyes and post nasal drip for the last 3 months. Each symptom comes and goes as it pleases. We checked autoimmune diseases, and blood tested for different allergens and even had my sinuses checked. My symptoms dont all happen at once but atleast one or the other is constantly happening and it comes and goes as it pleases.  As a background, I am not allergic or have not been allergic to anything my whole life (I have been vegetarian all my life). No particular food allergies, no laundry detergent allergies, no environmental allergies. This started happening 3 days after I took the booster. I tried changing my diet and checking if its some food; changed locations in case its some environment and it has still not gone.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 3 patients received vaccine from vial opened more than 12 hours ago; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients received vaccine from vial opened more than 12 hours ago) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021 at 4:20 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients received vaccine from vial opened more than 12 hours ago). On 15-Dec-2021, EXPIRED PRODUCT ADMINISTERED (3 patients received vaccine from vial opened more than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.  It was reported that 3 patients came in for the Moderna COVID -19 vaccine and were administered vaccine from a Moderna Covid-19 vial that had been left out at room temperature and was punctured on 14-Dec-2021. The vial was stored post puncture in room temperature. The vial did not  undergo any temperature excursions. No other adverse reactions were reported.   This case was linked to MOD-2022-459148, MOD-2022-459165 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Overdose
Clinical narrative: booster was 0.5 ml; she is pregnant and has a little concern; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of OVERDOSE (booster was 0.5 ml) and MATERNAL EXPOSURE DURING PREGNANCY (she is pregnant and has a little concern) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016J212A, 009C21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 23-Jul-2022. On 21-Jan-2022, the patient experienced OVERDOSE (booster was 0.5 ml) and MATERNAL EXPOSURE DURING PREGNANCY (she is pregnant and has a little concern). On 21-Jan-2022, MATERNAL EXPOSURE DURING PREGNANCY (she is pregnant and has a little concern) had resolved. At the time of the report, OVERDOSE (booster was 0.5 ml) outcome was unknown.            No concomitant and treatment medications were provided. The patient declined to enroll in pregnancy registry.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a patient concerned an adult male of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20220147325-COVID-19 VACCINE AD26.COV2.S- blood clot. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms.; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms.) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 047A21A) for COVID-19 vaccination.     Concomitant products included PREDNISONE, FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) and FAMOTIDINE for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms.). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms.) outcome was unknown.            The patient received her first Moderna Covid-19 vaccine dose on 25-Mar-2021 and no adverse reactions reported. Patient did go to see her Physician and was prescribed Prednisone, Allegra and Famotidine. Famotidine gave the patient heart burn and indigestion.   This case was linked to MOD-2022-456661 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: have a fever; whole body hurts; feel like throwing up; This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (have a fever), MYALGIA (whole body hurts) and NAUSEA (feel like throwing up) 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 23-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2022, the patient experienced PYREXIA (have a fever), MYALGIA (whole body hurts) and NAUSEA (feel like throwing up). At the time of the report, PYREXIA (have a fever), MYALGIA (whole body hurts) and NAUSEA (feel like throwing up) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No any concomitant medications were reported. No any treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (positive COVID) 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 COVID-19 (positive COVID). At the time of the report, COVID-19 (positive COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         No Concomitant medications were reported. No treatment medications were reported. Patient's husband got Pfizer Vaccine and did not get COVID positive.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred an unknown duration after the third dose of mRNA-1273 vaccine administered on an unknown date for the indication of COVID-19 vaccination. SARS-CoV-2 test done on an unknown date was positive. At the time of report outcome of the event was Unknown. Further details about the event are not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred an unknown duration after the third dose of mRNA-1273 vaccine administered on an unknown date for the indication of COVID-19 vaccination. SARS-CoV-2 test done on an unknown date was positive. At the time of report outcome of the event was Unknown. Further details about the event are not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: got covid omnicrom the Monday after Christmas I have not had my booster dose of Moderna; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (got covid omnicrom the Monday after Christmas I have not had my booster dose of Moderna) 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 COVID-19 (got covid omnicrom the Monday after Christmas I have not had my booster dose of Moderna). At the time of the report, COVID-19 (got covid omnicrom the Monday after Christmas I have not had my booster dose of Moderna) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. It was reported that the patient got COVID omicron the Monday after Christmas had not received booster dose yet.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred on 23-Jan-22, an unknown duration after the unknown dose of mRNA-1273 vaccine administered on an unknown date for the indication of COVID-19 vaccination. At the time of report outcome of the event was Unknown. Further details about the event are not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred on 23-Jan-22, an unknown duration after the unknown dose of mRNA-1273 vaccine administered on an unknown date for the indication of COVID-19 vaccination. At the time of report outcome of the event was Unknown. Further details about the event are not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: brain fog; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (brain fog) 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 FEELING ABNORMAL (brain fog). At the time of the report, FEELING ABNORMAL (brain fog) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Pyrexia, Vaccination site pain
Clinical narrative: low grade fever/low grade fever that comes and goes; feels heavy; right arm was achy/arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (feels heavy), VACCINATION SITE PAIN (right arm was achy/arm hurts) and PYREXIA (low grade fever/low grade fever that comes and goes) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 701-224) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE.    On 13-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced LIMB DISCOMFORT (feels heavy) and VACCINATION SITE PAIN (right arm was achy/arm hurts). On 23-Jan-2022, the patient experienced PYREXIA (low grade fever/low grade fever that comes and goes). The patient was treated with ACETYLSALICYLIC ACID (ASPIRINE) for Adverse event, at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (feels heavy) and PYREXIA (low grade fever/low grade fever that comes and goes) outcome was unknown and VACCINATION SITE PAIN (right arm was achy/arm hurts) had not resolved.            Patient was icing his arm down Patient is feeling better but arm is still achy No concomitant medications was reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Had a fever for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Had a fever for 2 days) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (COVID-19 infection) in March 2020 and Cardiomyopathy. Concomitant products included CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for Inflammation, VITAMIN D NOS for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, 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 PYREXIA (Had a fever for 2 days). At the time of the report, PYREXIA (Had a fever for 2 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant and treatment included medications to lower blood pressure and heart rate.   This case was linked to MOD-2022-460491 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose on 18 Jan 2021 and Second dose on 10 Mar 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18 Jan 2021 and Second dose on 10 Mar 2021) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder, Blood pressure high and Cholesterol. Concomitant products included METOPROLOL for Blood pressure high, ATORVASTATIN for Cholesterol, ACETYLSALICYLIC ACID (BABY ASPIRIN) for Heart disorder, POTASSIUM CHLORIDE (KLOR-CON), LYSINE, TOCOPHEROL (VITAMIN E [TOCOPHEROL]), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and VITAMIN B NOS for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18 Jan 2021 and Second dose on 10 Mar 2021). On 10-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18 Jan 2021 and Second dose on 10 Mar 2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took Circicimide as concomitant.  Treatment details was not reported by the reporter.    This case was linked to MOD-2022-460617 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Received the vaccine being pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Received the vaccine being pregnant) 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 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 MATERNAL EXPOSURE DURING PREGNANCY (Received the vaccine being pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Received the vaccine being pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported. No concomitant medication was reported.  No lab tests was performed. It was reported that consent for follow up was denied.   Reporter did not allow further contact
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Myalgia, Nausea
Clinical narrative: headache; muscle pain; joint pain; fever of 100.2 degrees Farenheight; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), PYREXIA (fever of 100.2 degrees Farenheight) and NAUSEA (nausea) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and o47B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jan-2022, the patient experienced HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), PYREXIA (fever of 100.2 degrees Farenheight) and NAUSEA (nausea). On 25-Jan-2022, NAUSEA (nausea) had resolved. At the time of the report, HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever of 100.2 degrees Farenheight) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2022, Body temperature: 100.2 (High) 100.2 degrees Fahrenheit.         No concomitant medication provided. No treatment medication provided. Patient had no side effects after first and second dose.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2022: Follow up was received and contains no new information.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: headache; muscle pain; joint pain; fever of 100.2 degrees Farenheight; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), PYREXIA (fever of 100.2 degrees Farenheight) and NAUSEA (nausea) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and o47B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jan-2022, the patient experienced HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), PYREXIA (fever of 100.2 degrees Farenheight) and NAUSEA (nausea). On 25-Jan-2022, NAUSEA (nausea) had resolved. At the time of the report, HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever of 100.2 degrees Farenheight) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2022, Body temperature: 100.2 (High) 100.2 degrees Fahrenheit.         No concomitant medication provided. No treatment medication provided. Patient had no side effects after first and second dose.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2022: Follow up was received and contains no new information.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Urticaria. Started treatment with zyrtec today, no outcomes yet.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Malaise, Ocular hyperaemia, Rash erythematous, Vaccine positive rechallenge
Clinical narrative: side effects that included a rash on face and chest/redness on my chest; ill; weak; red mask across my eyes; This case was reported by a consumer via interactive digital media and described the occurrence of red rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of rash (received 1st dose on an unknown date and had rash on face and chest, for tolerance refer case US2022AMR011098).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced red rash, unwell, weakness and eye red. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the red rash, unwell, weakness and eye red were unknown.   It was unknown if the reporter considered the red rash, unwell, weakness and eye red to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR011098  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported. The patient received a dose of Shingles shot and experienced side effects that included a rash on his/her face and chest. Ever since then, every time he/she got ill or weak, he/she had the same symptoms as a red mask across eyes and redness on his/her chest. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR011098:same patient - 1st dose