chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4, FLU4
Symptoms: Medication error, Wrong product administered
Clinical narrative: patient was given FLUZONE QIV T instead of FLUZONE HIGH-DOSE QUADRIVALENT with no AE; Initial information regarding an unsolicited valid non-serious was received from other health professional via Medical Information (Reference number- 00770131) and transmitted to Sanofi on 15-Sep-2021.  This case involves a 66 years old patient with unknown gender who was given INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 15-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ705AA and expiry date: 30-Jun-2022) via unknown route at an unknown administration site for prophylactic vaccination instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date were not reported) (wrong product administered).  It was reported "Nurse states that a 66 year old patient was given FLUZONE QIV T instead of FLUZONE HIGH-DOSE QUADRIVALENT and wanted to know if any additional protection was required for the patient. Caller asked if the patient needed an additional 0.2 ml since the FLUZONE HIGH-DOSE QUADRIVALENT contains 0.7ml per vaccine. Caller states that she is in the process of reaching out to the patient and wanted to know if she needed to have them return for a second vaccination."  It was a case of actual medication error due to wrong vaccine administered (latency: same day).  At the time of reporting, the patient experienced no adverse 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 legal guidelines. 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: M
Vaccine: FLUR4
Symptoms: Tachycardia
Clinical narrative: Tachycardia; nitial information received on 16-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via Media Information (under reference 00772775).  This case involves a male patient (over 65years of age) who had tachycardia, after receiving QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV).  The patient's past medical history included lung cancer (Lung neoplasm malignant), had a lung tumor removed (Pulmonary resection) with caller did not say when the tumor was removed and Tobacco user with had not smoked in twenty years.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  At the time of the event, the patient was suffering from COPD (Chronic obstructive pulmonary disease).  On an unknown date, the patient received a dose of suspect FLUBLOK QIV (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious tachycardia (unknown latency) following the administration of vaccine.  It was reported "he is concerned with his HCP wanting to administer FLUBLOCK; caller would rather have FLUZONE HIGH DOSE (522 - FLZ HD HV QIV) and would like to have an HCP agent give him some information regarding if he should ask for the FLUZONE HD caller states that he is trying to be cautious in his choice for a flu vaccine due to the current pandemic number levels and would like the vaccine that is best for his age group and health conditions; at time of call all agents were busy and caller agreed to a call back; caller states it is best to reach him until 12:00pm - 1:00pm. A consumer reporting that he tends to get side effects to allergy meds described as getting tachycardia; that the caller did report in passing that he received the Flublok last year and was told that this is a high dose; that his pharmacist confirmed that the Flublok was not the high dose."  No laboratory data were reported.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Age: 66.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Nurse was supposed to vaccinate the patient with Adacel, however vaccinated them with Daptacel instead in error with no A/E; Inappropriate age at vaccine administration with no A/E; Initial information was received on 16-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via phone call (under Medical Information Inquiry Number: 00773248).  This case is linked to cluster cases 2021SA310131and 2021SA311632.  This case involves a 66-years old female patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].(wrong product administered and product administered to patient of inappropriate age).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.    On 10-Aug-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number: C5687AA and expiry date 09-Dec -2021 via intramuscular route in the deltoid for prophylactic vaccination.  It was an actual medication error due to Wrong vaccine administered and inappropriate age at vaccine administration (same day latency).  It was reported "Director of Quality stated that a nurse was supposed to vaccinate three patients with Adacel, however vaccinated them with Daptacel instead in error. The caller asked if the patient's should be injected with Adacel now, or if the Daptacel was sufficient. The caller stated that this occurred because the Daptacel and Adacel sound the same. No additional Adverse events  were reported as a result of this.Patient two Pasteur adverse event reporting refunds/credits would not be issued due to adverse events."  At the time of reporting, no adverse event 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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: ordered Boostrix (Tdap), but instead Adacel (Tdap) was inadvertently administered to the patient with no reported adverse event; Initial information was received on 17-Sep-2021 regarding an unsolicited valid non-serious case received from a nurse via physician via phone  This case involves a 11-years old female patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) (wrong product administered).  The patient's past vaccination included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTaP).  The patient's medical history, past medical treatments and family history were not provided.   On 13-Sep-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number: C5667AA and expiry date: 26-Sep-2021 via intramuscular route in the left arm for prophylactic vaccination.  It was an actual medication error due to Wrong vaccine administered (same day latency).  It was reported "Nurse calling to see what they need to watch for after a patient was given the ADACEL vaccination instead of the Boostrix. Nurse stated that the physician had ordered Boostrix (Tdap), but instead Adacel (Tdap) was inadvertently administered to the patient. No concomitant vaccines were given. Patient had received DTaP in the past, but this was the patient's first Tdap dose."  At the time of reporting, no adverse event 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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, Hypoaesthesia, Hypoaesthesia oral, Incorrect route of product administration
Clinical narrative: Numbness on right side of my face; Numbness on tongue; Inappropriate route of vaccination; Olfactory (smelling smoke) hallucinations; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Olfactory (smelling smoke) hallucinations), HYPOAESTHESIA (Numbness on right side of my face), HYPOAESTHESIA ORAL (Numbness on tongue) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination ) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included Migraine. Concurrent medical conditions included Environmental allergy.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Cutaneous) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced HALLUCINATION (Olfactory (smelling smoke) hallucinations). On an unknown date, the patient experienced HYPOAESTHESIA (Numbness on right side of my face), HYPOAESTHESIA ORAL (Numbness on tongue) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination ). At the time of the report, HALLUCINATION (Olfactory (smelling smoke) hallucinations) had not resolved, HYPOAESTHESIA (Numbness on right side of my face) and HYPOAESTHESIA ORAL (Numbness on tongue) outcome was unknown and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination ) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Cutaneous), the reporter did not provide any causality assessments.   No concomitant medical information were reported. No treatment information was reported.; Sender's Comments: This case concerns a 42 year-old, female subject, with medical history of environmental allergies and migraine, who experienced the unexpected event of Hallucination. The event occurred approximately 6 days after the first dose of Spikevax. The rechallenge was not applicable as the event happened after the first dose. The medical history of environmental allergies and migraine remain confounders. The benefit-risk relationship of Spikevax is not affected by this report. The event was captured as serious as per IME list, however, reporter and the company physician consider the reported event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Ear swelling, Fatigue, Pain, Swelling
Clinical narrative: weak; tired; swell around ear; swell around head; very pain full; This case was reported by a consumer via (GSK Chatbot) interactive digital media and described the occurrence of weakness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2021, the patient received Shingrix. In September 2021, less than 2 weeks after receiving Shingrix, the patient experienced weakness, tiredness, ear swelling, swelling and pain. The patient was treated with antivirals nos. On an unknown date, the outcome of the weakness, tiredness, ear swelling, swelling and pain were unknown.   It was unknown if the reporter considered the weakness, tiredness, ear swelling, swelling and pain to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient was weak and tired post vaccination. The patient had swelling around the ear and head and it was very pain full.  The patient was treated with antiviral medications.  The patient asked if he/she was contagious.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Chills
Clinical narrative: Felt weak; Chills; This case was reported by a consumer via media and described the occurrence of feelings of weakness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included COVID VACCINE (patient's covid shots gave soreness on arm).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced feelings of weakness and chills. On an unknown date, the outcome of the feelings of weakness and chills were recovered/resolved.   It was unknown if the reporter considered the feelings of weakness and chills to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. IThe patient recently updated their vaccines and got their second booster for shingles.  The patient felt weak and had the chills for two days, nonetheless felt fine. The patient also stated that shingles in older adults could lead to many ailments including fibromyalgia. The reporter stated that it was better to get vaccinated than running the risk of coming down with a worst outcome.
Sex: U
Vaccine: VARZOS
Symptoms: Gait disturbance, Herpes zoster, Mobility decreased
Clinical narrative: shingles; trouble walking; trouble sitting; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles, walking difficulty and mobility decreased. On an unknown date, the outcome of the shingles, walking difficulty and mobility decreased were unknown.   It was unknown if the reporter considered the shingles, walking difficulty and mobility decreased to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received the dose of Shingles vaccine after a week experienced Shingles and had trouble in sitting and walking. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This shot hurts; This case was reported by a consumer via interactive digital media and described the occurrence of pain 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 pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles shot and shot was hurts. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: get the shingles even with the shot/ shingle shot, came down with the 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 female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years 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: This case was reported by the patient's friend. The age at vaccination was not reported. The reporter stated that the shingles were not prevented and one could still get the shingles even with the shot. The patient had the Shingles shot and a few years later, she came down with the shingles.  The reporter saw them, as did her doctor. 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 and laboratory confirmation for shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shingles shot and then got the shingles/suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male 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's wife. The age at vaccination was not reported. The patient got the shingles shot and then right afterwards got the shingles. 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: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: No antibodies after fully vaccination as a child; This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 19-year-old female patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional details were provided as follows: The age at vaccination was not reported. There were no antibodies for Hepatitis B after receiving Hepatitis B full vaccination as a child. On 14th September 2021, the patient received an adult dose of Engerix B with batch number N4GN4 and expiry date 2nd January 2023. The nurse utilized an alternate dosage given 1 ml dose to 19 years of age.  The reporter did not consent to follow-up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose 6/3/2020, second dose on 5/26/2021; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 3rd June 2020 via intramuscularly on an unknown arm).   On 26th May 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 26th May 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: This case was reported by patient herself.  The patient received 2nd dose delayed than the recommended schedule, which led to lengthening of vaccination schedule. The reporter did not consent to follow-up.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received HBV (Engerix B) (batch number HN5BE, expiry date 16th September 2021) for prophylaxis.   On 17th September 2021, the patient received Engerix B 10 ug. On 17th September 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received expired Engerix-B 10 microgram vaccine, the vaccine was expired on 16th September 2021, which led to expired vaccine used. The pharmacist was not allowed to provide patient´s details The reporter consented to follow up.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: never completed the dosing series; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received on 30th April 2016 with batch number 35G7C and expiry date 1st February 2019.).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received 1st dose of Engerix-B and patient never completed the dosing series.  Till the time of reporting, the patient did not receive the 2nd dose of the vaccine, which led to incomplete course of vaccination. The reporter consented to follow up. This case has been linked to the case US2021199896 and US2019215432 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021199896:same reporter US-GLAXOSMITHKLINE-US2019215432:same reporter
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED PRODUCT ADMINISTERED; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-SEP-2021, the patient experienced expired product administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired product administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210943895.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 not reported, batch number: 042A21A, expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Redness from the top of the leg to the arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness from the top of the leg to the arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness from the top of the leg to the arm). On 28-Jul-2021, ERYTHEMA (Redness from the top of the leg to the arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow up information received :Outcome of the event updated
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Product dose omission issue, Vaccination site erythema
Clinical narrative: more than 36 days since the first dose and she did not get the second; arm was red from the vaccination site to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (arm was red from the vaccination site to the elbow) and PRODUCT DOSE OMISSION ISSUE (more than 36 days since the first dose and she did not get the second) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     Treatment medications was not reported.  The patient's past medical history included COVID-19 in November 2020. Concomitant products included WARFARIN, METOPROLOL, PRAVASTATIN and EZETIMIBE (ZETIA) for an unknown indication.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm was red from the vaccination site to the elbow). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (more than 36 days since the first dose and she did not get the second). At the time of the report, VACCINATION SITE ERYTHEMA (arm was red from the vaccination site to the elbow) and PRODUCT DOSE OMISSION ISSUE (more than 36 days since the first dose and she did not get the second) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications was not reported   Reporter did not allow further contact
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Covid arm after 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Covid arm after 1st shot) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-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 VACCINATION COMPLICATION (Covid arm after 1st shot). At the time of the report, VACCINATION COMPLICATION (Covid arm after 1st shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication and treatment medications reported.   This case was linked to MOD-2021-317570 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Product dose omission issue
Clinical narrative: I was taking an antibiotic so I couldn't get the dose; I was taking an antibiotic so I couldn't get the dose when it was due; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (I was taking an antibiotic so I couldn't get the dose) and PRODUCT DOSE OMISSION ISSUE (I was taking an antibiotic so I couldn't get the dose when it was due) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (I was taking an antibiotic so I couldn't get the dose when it was due). On an unknown date, the patient experienced ADVERSE EVENT (I was taking an antibiotic so I couldn't get the dose). On 14-Sep-2021, PRODUCT DOSE OMISSION ISSUE (I was taking an antibiotic so I couldn't get the dose when it was due) had resolved. At the time of the report, ADVERSE EVENT (I was taking an antibiotic so I couldn't get the dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment information was provided. On 23-Aug-2021, Original 2nd dose was due. On 03-Sep-2021, patient completed antibiotic therapy.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Injection site pain
Clinical narrative: I am anxious about my sinus allergies; Arm tenderness; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (I am anxious about my sinus allergies) and INJECTION SITE PAIN (Arm tenderness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic sinusitis (just stuffy nose and a bit of drainage).    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, the patient experienced INJECTION SITE PAIN (Arm tenderness). On an unknown date, the patient experienced ANXIETY (I am anxious about my sinus allergies). At the time of the report, ANXIETY (I am anxious about my sinus allergies) outcome was unknown and INJECTION SITE PAIN (Arm tenderness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       6 hours after the vaccination Patient experienced  tenderness in the arm.No concomitant medications were reported. No treatment medications were reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Pain in arm/ Sore arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm/ Sore arm) and HEADACHE (Headache) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 022B21A) for COVID-19 vaccination.     The patient's past medical history included Liver transplantation in February 2021. Concurrent medical conditions included Spleen disorder NOS (A blood clot that burst in spleen.) since 05-Aug-2021 and Pancreatic insufficiency (Exocrine pancreatic insufficiency(EPI)). Concomitant products included MYCOPHENOLATE MOFETIL (MYCOPHENOLATE) and TACROLIMUS for an unknown indication.   On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-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 PAIN IN EXTREMITY (Pain in arm/ Sore arm) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Pain in arm/ Sore arm) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On unknown date patient had CT Scan and the result was not provided. The concomitant medications include other antirejection medications No treatment information provided.   This case was linked to MOD-2021-320594 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pancreatic disorder, Spleen disorder, Splenic infarction
Clinical narrative: splenic infarctions; Disorder spleen; Radiating pain; some issues with her pancreas; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of SPLENIC INFARCTION (splenic infarctions) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MYCOPHENOLATE MOFETIL (MYCOPHENOLATE) and TACROLIMUS for an unknown indication.   On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-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 SPLENIC INFARCTION (splenic infarctions) (seriousness criterion medically significant), SPLEEN DISORDER (Disorder spleen), PAIN (Radiating pain), PANCREATIC DISORDER (some issues with her pancreas) and MYALGIA (Myalgia). At the time of the report, SPLENIC INFARCTION (splenic infarctions), SPLEEN DISORDER (Disorder spleen), PAIN (Radiating pain), PANCREATIC DISORDER (some issues with her pancreas) and MYALGIA (Myalgia) outcome was unknown.            No treatment information reported.   Company Comment: This case refers to a 57-year-old female patient with no specified medical history who experienced the unexpected events of Splenic Infarction, Spleen Disorder, Myalgia, Pain and Pancreatic Disorder on an unspecified date after the administration of  COVID-19 Vaccine Moderna. No causality assessment was provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-320491 (Patient Link).; Sender's Comments: This case refers to a 57-year-old female patient with no specified medical history who experienced the unexpected events of Splenic Infarction, Spleen Disorder, Myalgia, Pain and Pancreatic Disorder on an unspecified date after the administration of  COVID-19 Vaccine Moderna. No causality assessment was provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown.            Concomitant product details was not reported.  Treatment details was not reported .
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Sometimes it's fine but like last night it woke the patient up 5-6 times; Between the shoulder blade and elbow, it itches and burns/injection area itches and burns; Injection area seems swollen at times; Between the shoulder blade and elbow, it itches and burns/injection area itches and burns; When the patient puts the hand on the arm, it feels very hot/injection area very hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (When the patient puts the hand on the arm, it feels very hot/injection area very hot), INSOMNIA (Sometimes it's fine but like last night it woke the patient up 5-6 times), VACCINATION SITE PAIN (Between the shoulder blade and elbow, it itches and burns/injection area itches and burns), VACCINATION SITE SWELLING (Injection area seems swollen at times) and VACCINATION SITE PRURITUS (Between the shoulder blade and elbow, it itches and burns/injection area itches and burns) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced VACCINATION SITE WARMTH (When the patient puts the hand on the arm, it feels very hot/injection area very hot), VACCINATION SITE PAIN (Between the shoulder blade and elbow, it itches and burns/injection area itches and burns), VACCINATION SITE SWELLING (Injection area seems swollen at times) and VACCINATION SITE PRURITUS (Between the shoulder blade and elbow, it itches and burns/injection area itches and burns). On 15-Sep-2021, the patient experienced INSOMNIA (Sometimes it's fine but like last night it woke the patient up 5-6 times). At the time of the report, VACCINATION SITE WARMTH (When the patient puts the hand on the arm, it feels very hot/injection area very hot), INSOMNIA (Sometimes it's fine but like last night it woke the patient up 5-6 times), VACCINATION SITE PAIN (Between the shoulder blade and elbow, it itches and burns/injection area itches and burns), VACCINATION SITE SWELLING (Injection area seems swollen at times) and VACCINATION SITE PRURITUS (Between the shoulder blade and elbow, it itches and burns/injection area itches and burns) outcome was unknown.            No concomitant medications reported. No treatment information was provided.  The itching was not a rash or red in color but was most prominent at one area and was annoying to the patient.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: did not receive their second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not receive their 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.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not receive their second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not receive their second dose) 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 concomitant medication were reported. No treatment medication were reported. It was reported that, patient who had received first dose of Moderna vaccine more than 35 days ago without getting second dose.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: feels a fever coming on/fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (feels a fever coming on/fever) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced PYREXIA (feels a fever coming on/fever). At the time of the report, PYREXIA (feels a fever coming on/fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided. No treatment medications were provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Follow up received on 16 Sep 2021 contains updated consent information.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Interchange of vaccine products
Clinical narrative: Previously received a complete series of a non-WHO approved vaccine; Moderna vaccine were inadvertently given past the vaccine beyond-use-date (i.e. past 30 days at fridge temperature) of 05-Sep-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine were inadvertently given past the vaccine beyond-use-date (i.e. past 30 days at fridge temperature) of 05-Sep-2021) and INTERCHANGE OF VACCINE PRODUCTS (Previously received a complete series of a non-WHO approved vaccine in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE INACT W.VIRION NIV-2020-770 ([COVID-19 VACCINE INACT W.VIRION NIV-2020-770]) for COVID-19 vaccination.    No Medical History information was reported.   On 13-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient received first dose of COVID-19 VACCINE INACT W.VIRION NIV-2020-770 ([COVID-19 VACCINE INACT W.VIRION NIV-2020-770]) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine were inadvertently given past the vaccine beyond-use-date (i.e. past 30 days at fridge temperature) of 05-Sep-2021). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Previously received a complete series of a non-WHO approved vaccine ()). On 13-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine were inadvertently given past the vaccine beyond-use-date (i.e. past 30 days at fridge temperature) of 05-Sep-2021) had resolved. At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Previously received a complete series of a non-WHO approved vaccine had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported. The date of manufacture of vaccine was reported as 12-Mar-2021. The date that the vial was 30 days in the refrigerator was 05-Sep-2021.   This case was linked to MOD-2021-320340, MOD-2021-320812, MOD-2021-320833, MOD-2021-320902, MOD-2021-321000, MOD-2021-321030, MOD-2021-321058, MOD-2021-321061, MOD-2021-321072, MOD-2021-321076, MOD-2021-321086, MOD-2021-321106 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: joint pain; muscle pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain) and MYALGIA (muscle pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, the patient experienced ARTHRALGIA (joint pain) and MYALGIA (muscle pain). At the time of the report, ARTHRALGIA (joint pain) and MYALGIA (muscle pain) outcome was unknown.            No concomitant drug information  was provided, No Treatment drug information  was provided,
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: experienced soreness  at the injection and states that "if I push on it, it is still there"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (experienced soreness  at the injection and states that "if I push on it, it is still there") in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (experienced soreness  at the injection and states that "if I push on it, it is still there"). At the time of the report, VACCINATION SITE PAIN (experienced soreness  at the injection and states that "if I push on it, it is still there") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.