chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old patient was inadvertently administered FLUBLOK QUADRIVALENT/ no AE; Initial information received on 21-Sep-2021 regarding an unsolicited valid non-serious case received from a pharmacist and consumer/non-healthcare professional via call center via Agency (Reference number- 00779084).  This case involves a 16-year-old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Product administered to patient of inappropriate age).  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  On 17-Sep-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: QFAA2103 and expiry date: 25-May-2022) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration (latency: same day).  It was reported "Call received from Pharmacist reporting a 16 year old patient was inadvertently administered FLUBLOK QUADRIVALENT. Caller with question on whether we have any safety information on administering FLUBLOK QUADRIVALENT to a pediatric patient."  At the time of reporting, no adverse event was reported.  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 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.
Sex: U
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: Fluzone Quad was given to a patient instead of the recommended Fluzone HD with no reported adverse event; Initial information received on 21-Sep-2021 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves elderly (patient was over the age of 65) and unknown gender for patient whom INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] was given to a patient instead of the recommended INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] (wrong product administered).   The patient medical history, medical treatment(s), vaccination(s), concomitant medication, and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site prophylactic vaccination.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site prophylactic vaccination.  It was case of actual medication error due to wrong product administered (Latency: on the same day).  Details of laboratory data not reported.  At the time of report no adverse event was reported.  At time of reporting, the outcome was unknown for the event.  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.  There will be no information available on the batch number for this case.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Tachycardia
Clinical narrative: Light headed when standing, rapid heart beat ,short of breath; Light headed when standing, rapid heart beat ,short of breath; Light headed when standing, rapid heart beat ,short of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Light headed when standing, rapid heart beat ,short of breath), DIZZINESS (Light headed when standing, rapid heart beat ,short of breath) and TACHYCARDIA (Light headed when standing, rapid heart beat ,short of breath) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lumbar spondylosis, COPD and Migraine.    On 13-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced DYSPNOEA (Light headed when standing, rapid heart beat ,short of breath), DIZZINESS (Light headed when standing, rapid heart beat ,short of breath) and TACHYCARDIA (Light headed when standing, rapid heart beat ,short of breath). At the time of the report, DYSPNOEA (Light headed when standing, rapid heart beat ,short of breath), DIZZINESS (Light headed when standing, rapid heart beat ,short of breath) and TACHYCARDIA (Light headed when standing, rapid heart beat ,short of breath) had not resolved.            No concomitant medications were reported. Treatment information was not provided.  The patient while standing heart races got light headed and experienced shortness of breath on walk. She was not sure whether the side effects were serious.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE; expired PROQUAD on 09/17/2021 which had underwent a previous temperature excursion.; expired PROQUAD on 09/17/2021 which had underwent a previous temperature excursion.; Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent condition, concomitant medication and medical history were not reported.   On 17-SEP-2021, the patient was vaccinated with an expired Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot# S022109, expiration date: 12-JAN-2021; dose, frequency, route unknown) for prophylaxis (Expired product administered). The vaccine had underwent a previous temperature excursion of -10 to 8 Celsius degrees for 5 hours 15 minutes on 07-SEP-2021 (Product storage error). No additional adverse event (AE).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot but did get shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles shot but did get shingles, but not bad. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/have the vaccine but still got Shingles; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received the shot of Shingles vaccine and still got hit will shingles. Follow-up would not be possible as no contact details available. The case is considered as suspected vaccination failure since the details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: sick; This case was reported by a consumer and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient for himself/herself. Age at vaccination was not reported. The patient received the shot of Shingles vaccine and it made him/her sick. Follow-up would not be possible as no contact detail available.
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, Incorrect dose administered
Clinical narrative: 30 male patient received an expired pediatric dose of ENGERIX-B; expired pediatric dose of ENGERIX-B; 30 male patient received an expired pediatric dose of ENGERIX-B; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 30-year-old male patient who received HBV (Engerix B pediatric) (batch number AN3NC, expiry date 3rd June 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th September 2021, the patient received Engerix B pediatric .5 ml and Engerix B Pre-Filled Syringe Device. On 20th September 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose, expired vaccine used and adult use of a child product. On an unknown date, the outcome of the underdose, expired vaccine used and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: Pharmacist reported that a 30 year old male patient received pediatric dose of Engerix B on the 20th September 2021, which got expired on 3rd June 2021, which led to expired vaccine used, adult use of a child product and underdose. No further details were provided at the time of the call. The reporter consented to follow up by email.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: Redness; Sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 85-year-old female patient who received Herpes zoster (Shingrix) (batch number P7N2H, expiry date 30th January 2023) for prophylaxis.   On 20th September 2021, the patient received the 1st dose of Shingrix. In September 2021, less than a week after receiving Shingrix, the patient experienced erythema and pain in arm. On an unknown date, the outcome of the erythema was recovering/resolving and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the erythema and pain in arm to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient experienced redness and a sore arm after dose one of Shingrix. The patient came to the pharmacy and showed the redness and it had already begun to fade and the current status was unknown. Health care professional noted that she had a picture she could send if safety required it and asked to request during follow-up if photo was required.  The reporter did not provide address details.  The reporter consented to follow up. No additional information was provided.
Sex: M
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: IV dose of Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a adult male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 16th September 2021, the patient received Boostrix (intravenous). On 16th September 2021, unknown after receiving Boostrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details provided were as follows: Age at vaccination was not reported but could be 43 or 34 years old at the time of reporting. Pharmacy intern reported that he patient received a dose of Boostrix by intravenous route, which led to intramuscular formulation administered by other route. Reporter did not have any patient information aside from gender. No vaccine information available to reporter. The reporter did not agree nor declined to follow-up they just have to check with their supervisors. The reporter consented to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age, sex, race, and ethnic origin. 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 administration, and batch number were not reported) dose, start therapy date were not reported, 1 total administered 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 suspected clinical vaccination failure, and suspected covid 19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid 19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20210945662-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Nurse inadvertently injected a Moderna Covid-19 vaccine to a patient as a second dose who had received the Pfizer Vaccine as their first dose; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Nurse inadvertently injected a Moderna Covid-19 vaccine to a patient as a second dose who had received the Pfizer Vaccine as their first dose) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 12-Aug-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 10-Sep-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 received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 10-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Nurse inadvertently injected a Moderna Covid-19 vaccine to a patient as a second dose who had received the Pfizer Vaccine as their first dose). On 10-Sep-2021, INTERCHANGE OF VACCINE PRODUCTS (Nurse inadvertently injected a Moderna Covid-19 vaccine to a patient as a second dose who had received the Pfizer Vaccine as their first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported. Patient did not report any adverse events with both Pfizer and Moderna vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow up added- Pfizer start date was added.; Sender's Comments: This case concerns a 23 year-old male patient with no reported medical history, who experienced the unexpected event of Interchange of vaccine products. The event occurred on the same day as the first dose of Moderna COVID-19 vaccine, which followed a previous dose of Pfizer COVID-19 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Giant lump pumped out from underneath arm, it was a lymph node/ Had a giant lymph node pop out under arm; Fever/ High fever; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Giant lump pumped out from underneath arm, it was a lymph node/ Had a giant lymph node pop out under arm) and PYREXIA (Fever/ High fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Recovered from COVID).    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Giant lump pumped out from underneath arm, it was a lymph node/ Had a giant lymph node pop out under arm) and PYREXIA (Fever/ High fever). At the time of the report, LYMPHADENOPATHY (Giant lump pumped out from underneath arm, it was a lymph node/ Had a giant lymph node pop out under arm) and PYREXIA (Fever/ High fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was provided. No treatment medication was provided.  The patient had fever and was close to be put in hospital and it got recovered.   This case was linked to MOD-2021-052537, MOD-2021-325988 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Follow-up received: Patient demographic details (age and gender) and suspect start date was updated.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12 year old patient receiving a dose of the Moderna COVID19 vaccine; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old patient receiving a dose of the Moderna COVID19 vaccine) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062e21a) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old patient receiving a dose of the Moderna COVID19 vaccine). On 13-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old patient receiving a dose of the Moderna COVID19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported by the reporter Treatment drugs were not reported by the reporter; Sender's Comments: This case concerns a  12 year-old male patient with no reported medical history, who experienced the  unexpected event of Product administered to patient of inappropriate age.  The event occurred on the day of the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose) 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.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided by the reporter. Treatment medication was not provided.; Sender's Comments: This case concerns a patient of unknown age or gender, with no reported medical history, who experienced the unexpected event of Product dose omission issue. The event occurred an unknown number of days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever) and dyspnea (difficulty breathing) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concomitant products included Eliquis (apixaban). On Sep 9, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 10, 2021, patient experienced pyrexia (fever). On Sep 15, 2021, patient experienced dyspnea (difficulty breathing). On Sep 11, 2021, pyrexia (fever) resolved. At the time of the report, dyspnea (difficulty breathing) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No treatment medication reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Headache, Motor dysfunction
Clinical narrative: she was very faint; Diarrhea; weakness; had a fever of 100 degrees; headache; Nausea; Loss use of right hand; sore arm; it was very painful like some stepped on her right hand, hand started hurting and continued to get worse; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (it was very painful like some stepped on her right hand, hand started hurting and continued to get worse), DIZZINESS (she was very faint), MOTOR DYSFUNCTION (Loss use of right hand), DIARRHOEA (Diarrhea) and ASTHENIA (weakness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014FZ1A, 012M20A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Allergy to nuts, Fish allergy, Fruit allergy and Ulcerative colitis (In remission due to Entyvio infusions) since May 2019. Concomitant products included VEDOLIZUMAB (ENTYVIO), PREGNENOLONE, ESTROGEN NOS;TESTOSTERONE and PROGESTERONE for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021 at 10:15 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced PAIN IN EXTREMITY (it was very painful like some stepped on her right hand, hand started hurting and continued to get worse) and VACCINATION SITE PAIN (sore arm). On 09-Sep-2021 at 4:00 PM, the patient experienced MOTOR DYSFUNCTION (Loss use of right hand). On an unknown date, the patient experienced DIZZINESS (she was very faint), DIARRHOEA (Diarrhea), ASTHENIA (weakness), PYREXIA (had a fever of 100 degrees), HEADACHE (headache) and NAUSEA (Nausea). On 10-Sep-2021, PAIN IN EXTREMITY (it was very painful like some stepped on her right hand, hand started hurting and continued to get worse), MOTOR DYSFUNCTION (Loss use of right hand) and VACCINATION SITE PAIN (sore arm) had resolved. At the time of the report, DIZZINESS (she was very faint), DIARRHOEA (Diarrhea), ASTHENIA (weakness), PYREXIA (had a fever of 100 degrees), HEADACHE (headache) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included Thyroid, Desiccated taken daily orally started in year 2011  No treatment information was not provided.  Patient reported to have taken an Entyvio infusion earlier that same week on 9/7/2021.   Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Follow up received on 21-09-2021 contains significant information: Event information, Concomitant medication, Patient history updated, Batch number updated
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: she was very faint; Diarrhea; weakness; had a fever of 100 degrees; headache; Nausea; Loss use of right hand; sore arm; it was very painful like some stepped on her right hand, hand started hurting and continued to get worse; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (it was very painful like some stepped on her right hand, hand started hurting and continued to get worse), DIZZINESS (she was very faint), MOTOR DYSFUNCTION (Loss use of right hand), DIARRHOEA (Diarrhea) and ASTHENIA (weakness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014FZ1A, 012M20A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Allergy to nuts, Fish allergy, Fruit allergy and Ulcerative colitis (In remission due to Entyvio infusions) since May 2019. Concomitant products included VEDOLIZUMAB (ENTYVIO), PREGNENOLONE, ESTROGEN NOS;TESTOSTERONE and PROGESTERONE for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021 at 10:15 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced PAIN IN EXTREMITY (it was very painful like some stepped on her right hand, hand started hurting and continued to get worse) and VACCINATION SITE PAIN (sore arm). On 09-Sep-2021 at 4:00 PM, the patient experienced MOTOR DYSFUNCTION (Loss use of right hand). On an unknown date, the patient experienced DIZZINESS (she was very faint), DIARRHOEA (Diarrhea), ASTHENIA (weakness), PYREXIA (had a fever of 100 degrees), HEADACHE (headache) and NAUSEA (Nausea). On 10-Sep-2021, PAIN IN EXTREMITY (it was very painful like some stepped on her right hand, hand started hurting and continued to get worse), MOTOR DYSFUNCTION (Loss use of right hand) and VACCINATION SITE PAIN (sore arm) had resolved. At the time of the report, DIZZINESS (she was very faint), DIARRHOEA (Diarrhea), ASTHENIA (weakness), PYREXIA (had a fever of 100 degrees), HEADACHE (headache) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included Thyroid, Desiccated taken daily orally started in year 2011  No treatment information was not provided.  Patient reported to have taken an Entyvio infusion earlier that same week on 9/7/2021.   Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Follow up received on 21-09-2021 contains significant information: Event information, Concomitant medication, Patient history updated, Batch number updated
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Malaise, Peripheral swelling, Pyrexia
Clinical narrative: hasn't felt very well; a knot on the arm which is swollen and red; a knot on the arm which is swollen; a knot on the arm which is swollen and red; a real bad headache; a fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (hasn't felt very well), SKIN MASS (a knot on the arm which is swollen and red), PERIPHERAL SWELLING (a knot on the arm which is swollen), ERYTHEMA (a knot on the arm which is swollen and red) and HEADACHE (a real bad headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (hasn't felt very well), SKIN MASS (a knot on the arm which is swollen and red), PERIPHERAL SWELLING (a knot on the arm which is swollen), ERYTHEMA (a knot on the arm which is swollen and red), HEADACHE (a real bad headache) and PYREXIA (a fever). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, MALAISE (hasn't felt very well), SKIN MASS (a knot on the arm which is swollen and red), PERIPHERAL SWELLING (a knot on the arm which is swollen), ERYTHEMA (a knot on the arm which is swollen and red), HEADACHE (a real bad headache) and PYREXIA (a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. Patient had a Flu shot on her right arm.   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Skin mass
Clinical narrative: hasn't felt very well; a knot on the arm which is swollen and red; a knot on the arm which is swollen; a knot on the arm which is swollen and red; a real bad headache; a fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (hasn't felt very well), SKIN MASS (a knot on the arm which is swollen and red), PERIPHERAL SWELLING (a knot on the arm which is swollen), ERYTHEMA (a knot on the arm which is swollen and red) and HEADACHE (a real bad headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (hasn't felt very well), SKIN MASS (a knot on the arm which is swollen and red), PERIPHERAL SWELLING (a knot on the arm which is swollen), ERYTHEMA (a knot on the arm which is swollen and red), HEADACHE (a real bad headache) and PYREXIA (a fever). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, MALAISE (hasn't felt very well), SKIN MASS (a knot on the arm which is swollen and red), PERIPHERAL SWELLING (a knot on the arm which is swollen), ERYTHEMA (a knot on the arm which is swollen and red), HEADACHE (a real bad headache) and PYREXIA (a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. Patient had a Flu shot on her right arm.   Reporter did not allow further contact
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Received the first dose on 09JUN2021; This case was received via Regulatory Authority (Reference number: US-irms-MOD21-144332) on 16-Sep-2021 and was forwarded to Moderna on 16-Sep-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Received the first dose on 09JUN2021) in a 28-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received the first dose on 09JUN2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Received the first dose on 09JUN2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  Treatment medications was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Follow up received confirms that patient did not experienced any adverse events so the case is invalid.
Age: 0.33
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Heat at the site of the vaccination; Itchiness at the site of the vaccination; Reddness at the site of the vaccination; Swelling at the site of the vaccination; Severe Pain at the site of the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Heat at the site of the vaccination), VACCINATION SITE PRURITUS (Itchiness at the site of the vaccination), VACCINATION SITE ERYTHEMA (Reddness at the site of the vaccination), VACCINATION SITE SWELLING (Swelling at the site of the vaccination) and VACCINATION SITE PAIN (Severe Pain at the site of the vaccination) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 003C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.   On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-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 VACCINATION SITE WARMTH (Heat at the site of the vaccination), VACCINATION SITE PRURITUS (Itchiness at the site of the vaccination), VACCINATION SITE ERYTHEMA (Reddness at the site of the vaccination), VACCINATION SITE SWELLING (Swelling at the site of the vaccination) and VACCINATION SITE PAIN (Severe Pain at the site of the vaccination). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Heat at the site of the vaccination), VACCINATION SITE PRURITUS (Itchiness at the site of the vaccination), VACCINATION SITE ERYTHEMA (Reddness at the site of the vaccination), VACCINATION SITE SWELLING (Swelling at the site of the vaccination) and VACCINATION SITE PAIN (Severe Pain at the site of the vaccination) outcome was unknown.            Treatment also included ice pack for adverse events.   This case was linked to MOD-2021-322203 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Nausea, Photophobia
Clinical narrative: headache; nausea; chills; sensitive eyes; slept for 3-4 hours.; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), NAUSEA (nausea), CHILLS (chills), PHOTOPHOBIA (sensitive eyes) and INSOMNIA (slept for 3-4 hours.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concomitant products included VERAPAMIL HYDROCHLORIDE for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache), NAUSEA (nausea), CHILLS (chills), PHOTOPHOBIA (sensitive eyes) and INSOMNIA (slept for 3-4 hours.). At the time of the report, HEADACHE (headache), NAUSEA (nausea), CHILLS (chills), PHOTOPHOBIA (sensitive eyes) and INSOMNIA (slept for 3-4 hours.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment drug information was provided.   This case was linked to MOD-2021-322601 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Sep-2021: significant follow up ammended- Events added.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Angiopathy, Arthralgia, Chills, Dizziness, Feeling abnormal
Clinical narrative: Brain fog; Dizzy; Intense restriction of blood vessels; Could not sleep; Pain in shoulders; Whole body chills between breathing cycles; Headache; Nausea; Barfed; Numbing of pinky and ring finger on left hand; Entire left arm has tremor; Left and right side of body contracting from arm down to feet; Intense heat; Increase in white count; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbing of pinky and ring finger on left hand), TREMOR (Entire left arm has tremor), MUSCLE CONTRACTIONS INVOLUNTARY (Left and right side of body contracting from arm down to feet), FEELING HOT (Intense heat) and WHITE BLOOD CELL COUNT INCREASED (Increase in white count) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Myositis.    On 17-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, the patient experienced WHITE BLOOD CELL COUNT INCREASED (Increase in white count). On an unknown date, the patient experienced HYPOAESTHESIA (Numbing of pinky and ring finger on left hand), TREMOR (Entire left arm has tremor), MUSCLE CONTRACTIONS INVOLUNTARY (Left and right side of body contracting from arm down to feet), FEELING HOT (Intense heat), FEELING ABNORMAL (Brain fog), DIZZINESS (Dizzy), ANGIOPATHY (Intense restriction of blood vessels), INSOMNIA (Could not sleep), ARTHRALGIA (Pain in shoulders), CHILLS (Whole body chills between breathing cycles), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Barfed). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ELECTROLYTES NOS at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Numbing of pinky and ring finger on left hand), TREMOR (Entire left arm has tremor), MUSCLE CONTRACTIONS INVOLUNTARY (Left and right side of body contracting from arm down to feet), FEELING HOT (Intense heat), WHITE BLOOD CELL COUNT INCREASED (Increase in white count), FEELING ABNORMAL (Brain fog), DIZZINESS (Dizzy), ANGIOPATHY (Intense restriction of blood vessels), INSOMNIA (Could not sleep), ARTHRALGIA (Pain in shoulders), CHILLS (Whole body chills between breathing cycles), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Barfed) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Sep-2021, White blood cell count: increased (High) Increase in white count.         No concomitant medications were provided.   This case was linked to MOD-2021-322771, MOD-2021-322850 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Hypoaesthesia, Insomnia, Muscle contractions involuntary
Clinical narrative: Brain fog; Dizzy; Intense restriction of blood vessels; Could not sleep; Pain in shoulders; Whole body chills between breathing cycles; Headache; Nausea; Barfed; Numbing of pinky and ring finger on left hand; Entire left arm has tremor; Left and right side of body contracting from arm down to feet; Intense heat; Increase in white count; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbing of pinky and ring finger on left hand), TREMOR (Entire left arm has tremor), MUSCLE CONTRACTIONS INVOLUNTARY (Left and right side of body contracting from arm down to feet), FEELING HOT (Intense heat) and WHITE BLOOD CELL COUNT INCREASED (Increase in white count) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Myositis.    On 17-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, the patient experienced WHITE BLOOD CELL COUNT INCREASED (Increase in white count). On an unknown date, the patient experienced HYPOAESTHESIA (Numbing of pinky and ring finger on left hand), TREMOR (Entire left arm has tremor), MUSCLE CONTRACTIONS INVOLUNTARY (Left and right side of body contracting from arm down to feet), FEELING HOT (Intense heat), FEELING ABNORMAL (Brain fog), DIZZINESS (Dizzy), ANGIOPATHY (Intense restriction of blood vessels), INSOMNIA (Could not sleep), ARTHRALGIA (Pain in shoulders), CHILLS (Whole body chills between breathing cycles), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Barfed). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ELECTROLYTES NOS at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Numbing of pinky and ring finger on left hand), TREMOR (Entire left arm has tremor), MUSCLE CONTRACTIONS INVOLUNTARY (Left and right side of body contracting from arm down to feet), FEELING HOT (Intense heat), WHITE BLOOD CELL COUNT INCREASED (Increase in white count), FEELING ABNORMAL (Brain fog), DIZZINESS (Dizzy), ANGIOPATHY (Intense restriction of blood vessels), INSOMNIA (Could not sleep), ARTHRALGIA (Pain in shoulders), CHILLS (Whole body chills between breathing cycles), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Barfed) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Sep-2021, White blood cell count: increased (High) Increase in white count.         No concomitant medications were provided.   This case was linked to MOD-2021-322771, MOD-2021-322850 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Tremor, Vomiting, White blood cell count, White blood cell count increased
Clinical narrative: Brain fog; Dizzy; Intense restriction of blood vessels; Could not sleep; Pain in shoulders; Whole body chills between breathing cycles; Headache; Nausea; Barfed; Numbing of pinky and ring finger on left hand; Entire left arm has tremor; Left and right side of body contracting from arm down to feet; Intense heat; Increase in white count; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbing of pinky and ring finger on left hand), TREMOR (Entire left arm has tremor), MUSCLE CONTRACTIONS INVOLUNTARY (Left and right side of body contracting from arm down to feet), FEELING HOT (Intense heat) and WHITE BLOOD CELL COUNT INCREASED (Increase in white count) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Myositis.    On 17-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, the patient experienced WHITE BLOOD CELL COUNT INCREASED (Increase in white count). On an unknown date, the patient experienced HYPOAESTHESIA (Numbing of pinky and ring finger on left hand), TREMOR (Entire left arm has tremor), MUSCLE CONTRACTIONS INVOLUNTARY (Left and right side of body contracting from arm down to feet), FEELING HOT (Intense heat), FEELING ABNORMAL (Brain fog), DIZZINESS (Dizzy), ANGIOPATHY (Intense restriction of blood vessels), INSOMNIA (Could not sleep), ARTHRALGIA (Pain in shoulders), CHILLS (Whole body chills between breathing cycles), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Barfed). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ELECTROLYTES NOS at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Numbing of pinky and ring finger on left hand), TREMOR (Entire left arm has tremor), MUSCLE CONTRACTIONS INVOLUNTARY (Left and right side of body contracting from arm down to feet), FEELING HOT (Intense heat), WHITE BLOOD CELL COUNT INCREASED (Increase in white count), FEELING ABNORMAL (Brain fog), DIZZINESS (Dizzy), ANGIOPATHY (Intense restriction of blood vessels), INSOMNIA (Could not sleep), ARTHRALGIA (Pain in shoulders), CHILLS (Whole body chills between breathing cycles), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Barfed) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Sep-2021, White blood cell count: increased (High) Increase in white count.         No concomitant medications were provided.   This case was linked to MOD-2021-322771, MOD-2021-322850 (Patient Link).