chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Vertigo
Clinical narrative: Could feel something spinning in my head; I was sick in bed; This spontaneous case was received on 18-Jan-2021 from other non-healthcare professional (consumer) via Agency (reference number: AU22-000094) with additional information received on 18-Dec-2021 (reference number: AU22-000095) and on 19-Jan-2022 from Agency (refenrece number: SEQW22-00271) (being processed together), and concerned a female patient of an unknown age.  The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 22-Oct-2015, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; route of administration, dose, anatomical location: not reported) as flu shot. The batch number reported was11749211A.  On an unspecified day, an unknown amount of time after receiving influenza virus vaccine polyvalent, the patient experienced feeling of something spinning in her head. Also, the patient stated that she was sick in bed for three months after receiving this vaccine. The patient reported that her neighbour had the same reaction.   The outcome of the events were unknown.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: A female patient of an unknown age was vaccinated with influenza virus vaccine polyvalent. An unknown amount of time following vaccination, the patient developed spinning sensation and sickness. Information regarding medical history, relevant diagnostic findings and concomitant medications was not provided. Causal role of the suspect vaccine is unassessable due to lack of information provided and unclear temporal relationship.; Sender's Comments: A female patient of an unknown age was vaccinated with influenza virus vaccine polyvalent. An unknown amount of time following vaccination, the patient developed spinning sensation and sickness. Information regarding medical history, relevant diagnostic findings and concomitant medications was not provided. Causal role of the suspect vaccine is unassessable due to lack of information provided and unclear temporal relationship.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Contusion, Cough, Gastrointestinal disorder, Myalgia
Clinical narrative: fever; chills; muscle ache; coughing; congestion; gastrointestinal symptoms; top of her foot became itchy; top of her foot is now bruised; This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose on an unknown date and had fever, for tolerance refer case US2022011286).   On 17th January 2022, the patient received the 2nd dose of Shingrix. In January 2022, less than a week after receiving Shingrix, the patient experienced fever, chills, muscle pain, cough, nasal congestion, gastrointestinal disorder, localized itching and contusion of foot. Rechallenge with Shingrix was positive. In January 2022, the outcome of the fever, chills, muscle pain, cough, nasal congestion, gastrointestinal disorder and localized itching were recovered/resolved. On an unknown date, the outcome of the contusion of foot was not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, muscle pain, cough, nasal congestion, gastrointestinal disorder, localized itching and contusion of foot to be related to Shingrix.     Linked case(s) involving the same patient:  US2022011286  Additional details were provided as follows: The patient received a dose of Shingrix and had experienced fever, chills, muscle ache, coughing, congestion, gastrointestinal symptoms, and the top of her foot became itchy and top of her foot was now bruised. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022011286:Same reporter, same product, same patient, different dose
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Nasal congestion, Pruritus, Pyrexia, Vaccine positive rechallenge
Clinical narrative: fever; chills; muscle ache; coughing; congestion; gastrointestinal symptoms; top of her foot became itchy; top of her foot is now bruised; This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose on an unknown date and had fever, for tolerance refer case US2022011286).   On 17th January 2022, the patient received the 2nd dose of Shingrix. In January 2022, less than a week after receiving Shingrix, the patient experienced fever, chills, muscle pain, cough, nasal congestion, gastrointestinal disorder, localized itching and contusion of foot. Rechallenge with Shingrix was positive. In January 2022, the outcome of the fever, chills, muscle pain, cough, nasal congestion, gastrointestinal disorder and localized itching were recovered/resolved. On an unknown date, the outcome of the contusion of foot was not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, muscle pain, cough, nasal congestion, gastrointestinal disorder, localized itching and contusion of foot to be related to Shingrix.     Linked case(s) involving the same patient:  US2022011286  Additional details were provided as follows: The patient received a dose of Shingrix and had experienced fever, chills, muscle ache, coughing, congestion, gastrointestinal symptoms, and the top of her foot became itchy and top of her foot was now bruised. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022011286:Same reporter, same product, same patient, different dose
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Headache, Pyrexia
Clinical narrative: Experiencing diarrhea; Fever; Being tired; Headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd January 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 23rd January 2022, 10 hrs after receiving Shingrix, the patient experienced fever, tiredness and headache. On 25th January 2022, the patient experienced diarrhea. On 24th January 2022, the outcome of the fever, tiredness and headache were recovered/resolved. On an unknown date, the outcome of the diarrhea was not recovered/not resolved.   It was unknown if the reporter considered the fever, tiredness, headache and diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The patient received a dose of Shingrix on Sunday and about 10 hours after receiving the vaccination the patient began to experienced fever, being tired, and a headache.   One day later these symptoms were recovered. Two days after receiving the vaccination, she experienced diarrhea. The patient was asking if this could be a side effect of the Shingrix. The reporter was informed as per package insert adverse events. The patient recommended follow up with health care professional if she was concerned.  No Lot number or Expiration date was known.  The patient provided health care professional contact information. The reporter consented to follow-up.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a 28 year old female. 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) dose was not reported, administered on 13-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-JAN-2022, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 antigen test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This report was associated with product quality complaint: 90000213538
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: feel very itchy; hives on her chest and back, which is sporadic, that come and go ever since then; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (feel very itchy) and URTICARIA (hives on her chest and back, which is sporadic, that come and go ever since then) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ETHINYLESTRADIOL, NORETHISTERONE ACETATE (JUNEL) for Birth control pill.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced PRURITUS (feel very itchy) and URTICARIA (hives on her chest and back, which is sporadic, that come and go ever since then). The patient was treated with CORTISONE for Adverse event, at a dose of 1 dosage form; LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form; FAMOTIDINE (PEPCID [FAMOTIDINE]) for Adverse event, at a dose of 1 dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, PRURITUS (feel very itchy) and URTICARIA (hives on her chest and back, which is sporadic, that come and go ever since then) outcome was unknown.            No medical history was reported  It was stated that the patient was 5'5 and a half tall and had no allergies. It was also reported that a week after the vaccination, the patient felt itchy and 2 days later to that had hives which stayed for about 5-10mins and were sporadic, also comes and goes ever since then. Regarding the treatment medication, the patient was given Benadryl which was shifted to or replaced with Zyrtec.   This case was linked to MOD-2022-461229 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: period was delayed, expected it first week of January; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (period was delayed, expected it first week of January) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (First dose (lot ER8733)) on 01-Apr-2021 and Pfizer (Second dose (lot ER8731)) on 22-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUATION DELAYED (period was delayed, expected it first week of January). At the time of the report, MENSTRUATION DELAYED (period was delayed, expected it first week of January) outcome was unknown.            The last period she had before taking the Moderna booster was on 05 Dec 2021, so she expected her period the first week of January. She didn't get her period until 21 Jan 2022.  No concomitant medication was reported. No treatment medication was reported.  Patient was not taking any oral contraceptives or other medications.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of COVID-19 in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient developed COVID-19. At the time of the report, COVID-19 outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. The patient received two shots of the Moderna vaccine then later contracted COVID-19. Sender's comments: This is a spontaneous case concerning a female patient, of unknown age, with no reported medical history, who experienced the unexpected event of COVID-19. The patient received 2 doses of COVID-19 with unknown dose interval. The event COVID-19 exact occurrence unknown but stated the event occurred after 2 doses of mRNA-1273 vaccine administration. No reported treatment information. The outcome of the event COVID-19 unknown. The benefit-risk relationship of mRNA-1273 vaccine not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: A patient got 0.25ml as their first dose of the Moderna COVID-19 Vaccine instead of the recommended 0.5ml; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (A patient got 0.25ml as their first dose of the Moderna COVID-19 Vaccine instead of the recommended 0.5ml) 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 27-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milligram. On 27-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (A patient got 0.25ml as their first dose of the Moderna COVID-19 Vaccine instead of the recommended 0.5ml). On 27-Dec-2021, ACCIDENTAL UNDERDOSE (A patient got 0.25ml as their first dose of the Moderna COVID-19 Vaccine instead of the recommended 0.5ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired Moderna COVID-19 booster dose administered greater than 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna COVID-19 booster dose administered greater than 12 hours post puncture) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2022 at 10:05 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna COVID-19 booster dose administered greater than 12 hours post puncture). On 25-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired Moderna COVID-19 booster dose administered greater than 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  Date the vial  initially stored in the refrigerator  was  21 Jan 2022 at 7:00 AM. Date  and time  vial was first punctured was  24 Jan 2022 at 8:45 AM vial didn't undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) 25 hours. The vial was stored post puncture at room  temperature.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site swelling
Clinical narrative: Arm pain; Injection site swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) and VACCINATION SITE SWELLING (Injection site swollen) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced PAIN IN EXTREMITY (Arm pain) and VACCINATION SITE SWELLING (Injection site swollen). At the time of the report, PAIN IN EXTREMITY (Arm pain) and VACCINATION SITE SWELLING (Injection site swollen) outcome was unknown.            Patient had arm pain and injection site was swollen from 2 months, she went to doctor, he gave her treatment as a steroid. It was reported that date of first vaccination and batch number was unknown. No concomitant medication was reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Biopsy skin, Pruritus, Rash, Urticaria
Clinical narrative: full body hives on Aug; mental anguish; horrible experience; red spots for several months; itchiness/itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness/itching), URTICARIA (full body hives on Aug), ANXIETY (mental anguish), VACCINATION COMPLICATION (horrible experience) and RASH (red spots for several months) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006b21a and 027a21a) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Depression. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma, CELECOXIB (CELEXA [CELECOXIB]) for Depression, AMLODIPINE for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PRURITUS (itchiness/itching), ANXIETY (mental anguish), VACCINATION COMPLICATION (horrible experience) and RASH (red spots for several months). In August 2021, the patient experienced URTICARIA (full body hives on Aug). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; LORATADINE (CLARITIN [LORATADINE]) for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK, qhs; LORAZEPAM (ATIVAN) for Anguish, at an unspecified dose and frequency; CORTISONE for Itching, at an unspecified dose and frequency and HYDROXYZINE for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (itchiness/itching), URTICARIA (full body hives on Aug), ANXIETY (mental anguish), VACCINATION COMPLICATION (horrible experience) and RASH (red spots for several months) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy skin: hypersensitive response (abnormal) hypersensitive response to certain drugs.         Within 1 to 2 weeks following vaccination with the second dose, patient started to experience itchiness, red spots for several months, full body hives, mental anguish, itching and horrible experience  Patient mentioned of never having this before and that the symptoms were still ongoing.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: full body hives on Aug; mental anguish; horrible experience; red spots for several months; itchiness/itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness/itching), URTICARIA (full body hives on Aug), ANXIETY (mental anguish), VACCINATION COMPLICATION (horrible experience) and RASH (red spots for several months) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006b21a and 027a21a) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Depression. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma, CELECOXIB (CELEXA [CELECOXIB]) for Depression, AMLODIPINE for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PRURITUS (itchiness/itching), ANXIETY (mental anguish), VACCINATION COMPLICATION (horrible experience) and RASH (red spots for several months). In August 2021, the patient experienced URTICARIA (full body hives on Aug). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; LORATADINE (CLARITIN [LORATADINE]) for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK, qhs; LORAZEPAM (ATIVAN) for Anguish, at an unspecified dose and frequency; CORTISONE for Itching, at an unspecified dose and frequency and HYDROXYZINE for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (itchiness/itching), URTICARIA (full body hives on Aug), ANXIETY (mental anguish), VACCINATION COMPLICATION (horrible experience) and RASH (red spots for several months) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy skin: hypersensitive response (abnormal) hypersensitive response to certain drugs.         Within 1 to 2 weeks following vaccination with the second dose, patient started to experience itchiness, red spots for several months, full body hives, mental anguish, itching and horrible experience  Patient mentioned of never having this before and that the symptoms were still ongoing.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pruritus
Clinical narrative: Itchiness around the injection site; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness around the injection site) and FATIGUE (Fatigue) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Dry skin (Dry skin which is naturally itchy) and Itchy skin (Dry skin which is naturally itchy).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness around the injection site) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE PRURITUS (Itchiness around the injection site) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the patient received the vaccine in his right arm shoulder deltoid muscle.  Concomitant medication list was not provided. Treatment information was not provided.   This case was linked to MOD-2022-461699 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2022: Updated reporter contact details.
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Insomnia, Urinary incontinence, Weight decreased
Clinical narrative: can't eat; lost weight; can't sleep; started peeing; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (can't eat), WEIGHT DECREASED (lost weight), INSOMNIA (can't sleep) and URINARY INCONTINENCE (started peeing) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEEDING DISORDER (can't eat), WEIGHT DECREASED (lost weight), INSOMNIA (can't sleep) and URINARY INCONTINENCE (started peeing). At the time of the report, FEEDING DISORDER (can't eat), WEIGHT DECREASED (lost weight), INSOMNIA (can't sleep) and URINARY INCONTINENCE (started peeing) outcome was unknown.            No concomitant medication were reported.  No treatment medication were reported.   This case was linked to MOD-2022-461423 (Patient Link).
Age: 14.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna booster given to 14 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna booster given to 14 year old) in a 14-year-old patient of an unknown 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna booster given to 14 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna booster given to 14 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test positive
Clinical narrative: completed the primary series and tested positive for COVID19; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Jan-2022 and was forwarded to Moderna on 26-Jan-2022.    This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (completed the primary series and tested positive for COVID19) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced SARS-COV-2 TEST POSITIVE (completed the primary series and tested positive for COVID19). At the time of the report, SARS-COV-2 TEST POSITIVE (completed the primary series and tested positive for COVID19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 antibody test: positive (Positive) Positive.         No concomitant medications reported by reporter No treatment medications provided by the reporter.  Company comment: This is a spontaneous case concerning a 47-year-old patient of unknown gender with no reported medical history, who experienced the unexpected, non-serious, AESI event of Covid-19 virus test positive. The patient received 2 doses of mRNA-1273 vaccine with unknown dosage interval. The event Covid-19 virus test positive occurred approximately 9 months after the second dose of mRNA-1273 vaccine administration. No reported treatment information. The outcome of the event Covid-19 virus test positive was unknown. 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 47-year-old patient of unknown gender with no reported medical history, who experienced the unexpected, non-serious, AESI event of Covid-19 virus test positive. The patient received 2 doses of mRNA-1273 vaccine with unknown dosage interval. The event Covid-19 virus test positive occurred approximately 9 months after the second dose of mRNA-1273 vaccine administration. No reported treatment information. The outcome of the event Covid-19 virus test positive was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Headache, Myalgia, Nasal congestion
Clinical narrative: Congestion; Body ache; High feve /Body temperature 100 F; Cough; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), NASAL CONGESTION (Congestion), MYALGIA (Body ache), HEADACHE (Headache) and PYREXIA (High feve /Body temperature 100 F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for Prophylactic vaccination.     Previously administered products included for Prophylactic vaccination: JANSSEN (Dose number in series 1, batch number: 1805031 and Route: right arm.) on 15-Mar-2021. Past adverse reactions to the above products included No adverse event with JANSSEN.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2021, the patient experienced COUGH (Cough) and HEADACHE (Headache). On 31-Dec-2021, the patient experienced NASAL CONGESTION (Congestion) and MYALGIA (Body ache). 31-Dec-2021, the patient experienced PYREXIA (High feve /Body temperature 100 F). On 02-Jan-2022, MYALGIA (Body ache), HEADACHE (Headache) and PYREXIA (High feve /Body temperature 100 F) had resolved. At the time of the report, COUGH (Cough) and NASAL CONGESTION (Congestion) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative. On 31-Dec-2021, Body temperature: 100 (High) 100  Fahrenheit.         Lab test: COVID 19 polymerase chain reaction (PCR) test : Awaiting result.  No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Congestion; Body ache; High feve /Body temperature 100 F; Cough; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), NASAL CONGESTION (Congestion), MYALGIA (Body ache), HEADACHE (Headache) and PYREXIA (High feve /Body temperature 100 F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for Prophylactic vaccination.     Previously administered products included for Prophylactic vaccination: JANSSEN (Dose number in series 1, batch number: 1805031 and Route: right arm.) on 15-Mar-2021. Past adverse reactions to the above products included No adverse event with JANSSEN.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2021, the patient experienced COUGH (Cough) and HEADACHE (Headache). On 31-Dec-2021, the patient experienced NASAL CONGESTION (Congestion) and MYALGIA (Body ache). 31-Dec-2021, the patient experienced PYREXIA (High feve /Body temperature 100 F). On 02-Jan-2022, MYALGIA (Body ache), HEADACHE (Headache) and PYREXIA (High feve /Body temperature 100 F) had resolved. At the time of the report, COUGH (Cough) and NASAL CONGESTION (Congestion) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative. On 31-Dec-2021, Body temperature: 100 (High) 100  Fahrenheit.         Lab test: COVID 19 polymerase chain reaction (PCR) test : Awaiting result.  No treatment medication was reported.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2022 at 11:25 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Jan-2022 at 11:25 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Jan-2022 at 11:25 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.  Vial was refrigerated on 17-Jan-2022 at 36 F and no temperature excursion happened.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Acne, Chapped lips, Hypoaesthesia oral, Lip dry, Lip erythema
Clinical narrative: my lips became swollen; chapped lips/Tight lips; dry Lips; Peeling lips; Tingling lips; Numb lips (top lip); Whiteheads around my nose; red; tight; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (my lips became swollen), CHAPPED LIPS (chapped lips/Tight lips), LIP DRY (dry Lips), LIP EXFOLIATION (Peeling lips) and PARAESTHESIA ORAL (Tingling lips) in a  patient of an unknown age and gender 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 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (my lips became swollen), CHAPPED LIPS (chapped lips/Tight lips), LIP DRY (dry Lips), LIP EXFOLIATION (Peeling lips), PARAESTHESIA ORAL (Tingling lips), HYPOAESTHESIA ORAL (Numb lips (top lip)), ACNE (Whiteheads around my nose), LIP ERYTHEMA (red) and ORAL DISCOMFORT (tight). At the time of the report, LIP SWELLING (my lips became swollen), HYPOAESTHESIA ORAL (Numb lips (top lip)) and LIP ERYTHEMA (red) had not resolved and CHAPPED LIPS (chapped lips/Tight lips), LIP DRY (dry Lips), LIP EXFOLIATION (Peeling lips), PARAESTHESIA ORAL (Tingling lips), ACNE (Whiteheads around my nose) and ORAL DISCOMFORT (tight) outcome was unknown.            No concomitant medications were reported No treatment drugs were reported.  The patient never break out with the pimples.
Sex: U
Vaccine: COVID19
Symptoms: Lip exfoliation, Lip swelling, Oral discomfort, Paraesthesia oral
Clinical narrative: my lips became swollen; chapped lips/Tight lips; dry Lips; Peeling lips; Tingling lips; Numb lips (top lip); Whiteheads around my nose; red; tight; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (my lips became swollen), CHAPPED LIPS (chapped lips/Tight lips), LIP DRY (dry Lips), LIP EXFOLIATION (Peeling lips) and PARAESTHESIA ORAL (Tingling lips) in a  patient of an unknown age and gender 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 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (my lips became swollen), CHAPPED LIPS (chapped lips/Tight lips), LIP DRY (dry Lips), LIP EXFOLIATION (Peeling lips), PARAESTHESIA ORAL (Tingling lips), HYPOAESTHESIA ORAL (Numb lips (top lip)), ACNE (Whiteheads around my nose), LIP ERYTHEMA (red) and ORAL DISCOMFORT (tight). At the time of the report, LIP SWELLING (my lips became swollen), HYPOAESTHESIA ORAL (Numb lips (top lip)) and LIP ERYTHEMA (red) had not resolved and CHAPPED LIPS (chapped lips/Tight lips), LIP DRY (dry Lips), LIP EXFOLIATION (Peeling lips), PARAESTHESIA ORAL (Tingling lips), ACNE (Whiteheads around my nose) and ORAL DISCOMFORT (tight) outcome was unknown.            No concomitant medications were reported No treatment drugs were reported.  The patient never break out with the pimples.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac stress test, Chest discomfort, Chest pain, Electrocardiogram, Headache
Clinical narrative: Started having a headache the evening of receiving the shot. Woke up the next morning with a headache and skin on upper torso feeling hot and getting a tightness in my chest. The next morning still has the headache and chest pain and the skin feeling hot was getting worse. I also started having sharp pains randomly throughout my torso area. When I woke up on Thursday my head was pounding my chest was still tight and my skin felt like it was on fire you could lay a hand on my bicep and tell a noticeable difference in the heat my upper torso was putting off it also hurt if the sun hit my bare skin if I needed to get in the sun I had to cover all parts of my skin. I had made a doctors appointment this day and I had a shooting pain on the left rear side of my neck and was immediately followed by my head hurting extremely bad on that side of my head. I went to my doctor appointment and they immediately sent me to the emergency room. My blood pressure was high and my head was hurting so bad I thought my eye was getting pushed out of my head. The gave me two shots and X-ray of my chest the pain started easing off and sent me home. The next day I felt a little bit better when I woke up but by lunch all the symptoms started to increase to what they were the day at the er. I called my doctor and they gave me two shots again. Since the shot i have an ekg And stress test and still have a headache that I have had since I got the shot still have chest tightness when I do anything physical and my pulse just jumps up for no reason.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Neck pain, Pain, Skin burning sensation, Skin warm
Clinical narrative: Started having a headache the evening of receiving the shot. Woke up the next morning with a headache and skin on upper torso feeling hot and getting a tightness in my chest. The next morning still has the headache and chest pain and the skin feeling hot was getting worse. I also started having sharp pains randomly throughout my torso area. When I woke up on Thursday my head was pounding my chest was still tight and my skin felt like it was on fire you could lay a hand on my bicep and tell a noticeable difference in the heat my upper torso was putting off it also hurt if the sun hit my bare skin if I needed to get in the sun I had to cover all parts of my skin. I had made a doctors appointment this day and I had a shooting pain on the left rear side of my neck and was immediately followed by my head hurting extremely bad on that side of my head. I went to my doctor appointment and they immediately sent me to the emergency room. My blood pressure was high and my head was hurting so bad I thought my eye was getting pushed out of my head. The gave me two shots and X-ray of my chest the pain started easing off and sent me home. The next day I felt a little bit better when I woke up but by lunch all the symptoms started to increase to what they were the day at the er. I called my doctor and they gave me two shots again. Since the shot i have an ekg And stress test and still have a headache that I have had since I got the shot still have chest tightness when I do anything physical and my pulse just jumps up for no reason.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait inability, Musculoskeletal stiffness, Pain
Clinical narrative: Severe joint pain Neck stiffness unable to move head Full body serve pain unable to walk without assistance holding onto something Any part of the body hurts on contact severely
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No Additional AE; MMR II vaccine was administered after undergoing temperature excursions; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.     On 11-JAN-2022, the patient was vaccinated with second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) (lot # T027914 and expiration date reported 18-AUG-2022), 0.5 milliliter for prophylaxis after undergoing temperature excursions (Product storage error).  The temperature of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) was 9.6 Celsius 47 and there were previous temperature excursions on 18-DEC-2021 was 13.7 Celsius for 6 hours. No additional AE. No PQC.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No Additional AE; MMR II vaccine was administered after undergoing temperature excursions; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.     On 10-JAN-2022, the patient was vaccinated with second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) (lot # T027914 and expiration date reported 18-AUG-2022), 0.5 milliliter for prophylaxis after undergoing temperature excursions (Product storage error).  The temperature of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) was 9.6 Celsius 47 and there were previous temperature excursions on 18-DEC-2021 was 13.7 Celsius for 6 hours. No additional AE. No PQC.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No Additional AE; MMR II vaccine was administered after undergoing temperature excursions; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.     On 18-JAN-2022, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) (lot # T027914 and expiration date reported 18-AUG-2022), 0.5 milliliter for prophylaxis after undergoing temperature excursions (Product storage error).  The temperature of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) was 9.6 Celsius 47 and there were previous temperature excursions on 18-DEC-2022 was 13.7 Celsius for 6 hours. No additional AE. No PQC.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No Additional AE; MMR II vaccine was administered after undergoing temperature excursions; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.     On 11-JAN-2022, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) (lot # T027914 and expiration date reported 18-AUG-2022), 0.5 milliliter for prophylaxis after undergoing temperature excursions (Product storage error).  The temperature of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) was 9.6 Celsius 47 and there were previous temperature excursions on 18-DEC-2021 was 13.7 Celsius for 6 hours. No additional AE. No PQC.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No Additional AE; MMR II vaccine was administered after undergoing temperature excursions; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.     On 12-JAN-2022, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) (lot # T027914 and expiration date reported 18-AUG-2022), 0.5 milliliter for prophylaxis after undergoing temperature excursions (Product storage error).  The temperature of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) was 9.6 Celsius 47 and there were previous temperature excursions on 18-DEC-2021 was 13.7 Celsius for 6 hours. No additional AE. No PQC.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No Additional AE; MMR II vaccine was administered after undergoing temperature excursions; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.     On 10-JAN-2022, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) (lot # T027914 and expiration date reported 18-AUG-2022), 0.5 milliliter for prophylaxis after undergoing temperature excursions (Product storage error).  The temperature of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) was 9.6 Celsius 47 and there were previous temperature excursions on 18-DEC-2021 was 13.7 Celsius for 6 hours. No additional AE. No PQC.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No Additional AE; MMR II vaccine was administered after undergoing temperature excursions; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.     On 17-JAN-2022, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) (lot # T027914 and expiration date reported 18-AUG-2022), 0.5 milliliter for prophylaxis after undergoing temperature excursions (Product storage error).  The temperature of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) was 9.6 Celsius 47 and there were previous temperature excursions on 18-DEC-2021 was 13.7 Celsius for 6 hours. No additional AE. No PQC.  This is one of several reports received from the same reporter.