chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: U
Vaccine: TD
Symptoms: Nerve injury, Pain, Peripheral swelling, Trigger finger
Clinical narrative: Unable to function; Cellulities; Felt Awful; Dehydrated; Swelling; Numbness; Fatigue; Muscle Aches; Trigger finger; Intermittent pain in the lower right arm; Scabbiness; Initial Telephone Call, 14 Jun 2021 Pt. reported that was administered TDVAX (MassBiologics lot #A125A) in her left arm on 11 Apr 2021 for wound management after cutting her left ring finger on a can. On the same day, pt. was prescribed the antibiotic, amoxicillin, by her doctor for wound management. Pt. stated that the vaccine site was not appropriately cleaned prior to the injection and that she was unsure if the TDVAX was administered via an intramuscular injection. On 12 Apr 2021, she felt "awful", dehydrated and fatigued. She also reported muscle aches in her lower back, and noticed that cellulitis had started to develop at the injection site.   Pt. stated that over the couple of weeks post-vaccination she developed swelling in her feet and left hand.  Due to this, she could not exercise and felt tired all the time. Pt. stated that she has Epstin-Barr Virus and that could have played a role in her reaction to the vaccine.  During this call, she also mentioned that she still feels numbness in the left hand and pain at the wound site. In addition, she could feel little lump on the injection site which was painful if she applies pressure. She added that overall, her adverse reactions were getting better as of 6/14/2021 though she was not completely recovered.  Follow-up Telephone Call, 25 Jun 2021 During this call, pt. provided more information on the diagnosis of her cellulitis - A week after vaccination, her infectious disease doctor confirmed that she had cellulitis in her left arm and mentioned that the antibiotic which she is taking for the wound management would take care of the cellulitis as well. Therefore, Dr did not prescrib treatment to address the cellulitis.  However, Dr. prescribed Meloxicam to treat her inflammation and pain.  Pt. mentioned that she was feeling better; however, the AEs she reported were not fully recovered. She also mentioned that she had some numbness in her left hand and was feeling achy.  Further, pt. reported that she had recently developed a trigger finger (her right thumb) within the past week.  Follow-up Telephone Call, 15 Jul 2021 Pt. mentioned that the cellulitis in her left arm was no longer present but that numbness in her left hand, which she believes was the result of nerve damage, was worsening. She was planning to visit the neurologist for the numbness.  Further Follow-up After this call, MassBiologics attempted to reach out to pt. several times to check the status of the numbness of her left arm and to learn about her overall health but pt. did not answer calls on 10 Aug 2021, 18 Aug 2021, email on 31 Aug 2021. Thus, MassBiologics closed this case.; Sender's Comments: The adverse event reported in this case was assessed as follow: 1) Cellulitis, Generalised muscle aches, and Swelling was assesed as Non-serious and Labeled. 2) Rest of the AEs were assessed as Non-serious and Unexpected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain
Clinical narrative: Right arm injection site has a bump; Right arm injection site is still sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Right arm injection site has a bump) and VACCINATION SITE PAIN (Right arm injection site is still sore) 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 20-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced VACCINATION SITE MASS (Right arm injection site has a bump) and VACCINATION SITE PAIN (Right arm injection site is still sore). At the time of the report, VACCINATION SITE MASS (Right arm injection site has a bump) outcome was unknown and VACCINATION SITE PAIN (Right arm injection site is still sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided. The patient had right arm injection site was still sore and had a bump/swollen No treatment medication was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Hyperhidrosis, Inflammation, Nasopharyngitis, Swelling
Clinical narrative: inflammation that was now all over my body; swollen; cold which hurting; sweating; Diarrhoea; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (inflammation that was now all over my body), SWELLING (swollen), NASOPHARYNGITIS (cold which hurting), HYPERHIDROSIS (sweating) and DIARRHOEA (Diarrhoea) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included MS, Penicillin allergy, Allergy to plants (Poison Ivy reaction), Pain and Drug allergy (Darvocet allergy). Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (inflammation that was now all over my body), SWELLING (swollen), NASOPHARYNGITIS (cold which hurting), HYPERHIDROSIS (sweating), DIARRHOEA (Diarrhoea) and VOMITING (throwing up). At the time of the report, INFLAMMATION (inflammation that was now all over my body), SWELLING (swollen), NASOPHARYNGITIS (cold which hurting), HYPERHIDROSIS (sweating), DIARRHOEA (Diarrhoea) and VOMITING (throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2022: Follow up received with significant information patient initials updated, past medical history updated,new events were added.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: inflammation that was now all over my body; swollen; cold which hurting; sweating; Diarrhoea; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (inflammation that was now all over my body), SWELLING (swollen), NASOPHARYNGITIS (cold which hurting), HYPERHIDROSIS (sweating) and DIARRHOEA (Diarrhoea) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included MS, Penicillin allergy, Allergy to plants (Poison Ivy reaction), Pain and Drug allergy (Darvocet allergy). Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (inflammation that was now all over my body), SWELLING (swollen), NASOPHARYNGITIS (cold which hurting), HYPERHIDROSIS (sweating), DIARRHOEA (Diarrhoea) and VOMITING (throwing up). At the time of the report, INFLAMMATION (inflammation that was now all over my body), SWELLING (swollen), NASOPHARYNGITIS (cold which hurting), HYPERHIDROSIS (sweating), DIARRHOEA (Diarrhoea) and VOMITING (throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2022: Follow up received with significant information patient initials updated, past medical history updated,new events were added.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Suspected covid-19 infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Suspected covid-19 infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Suspected covid-19 infection). At the time of the report, COVID-19 (Suspected covid-19 infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.         No concomitant and treatment medication was reported by patient.  It was reported that report was associated with product quality complaint- 90000209945 and 90000209947, the suspected product quality complaint had been confirmed to be voided based on the PQC evaluation, investigation performed.  It was reported that patient received Janssen COVID-19 vaccine (Dose number in series 1) additionally received booster dose of Moderna mRNA-1273 vaccine(Dose number in series 2).  Company Comment: This spontaneous case concerns a female patient, of unknown age, with history of co-suspect administration of the Janssen COVID-19 vaccine, who experienced the unexpected, non-serious AESI of COVID-19 after administration of the booster dose of the Moderna mRNA-1273 vaccine on an unspecified date. On an unspecified date, the patient tested positive for the COVID-19 virus. It was reported that the symptoms were 'extremely mild'. No further details were provided. The outcome of the event was unknown at the time of the report. The history of co-suspect administration of the Janssen COVID-19 vaccine remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a female patient, of unknown age, with history of co-suspect administration of the Janssen COVID-19 vaccine, who experienced the unexpected, non-serious AESI of COVID-19 after administration of the booster dose of the Moderna mRNA-1273 vaccine on an unspecified date. On an unspecified date, the patient tested positive for the COVID-19 virus. It was reported that the symptoms were 'extremely mild'. No further details were provided. The outcome of the event was unknown at the time of the report. The history of co-suspect administration of the Janssen COVID-19 vaccine remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient got COVID before receiving her 2nd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Patient got COVID before receiving her 2nd dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced COVID-19 (Patient got COVID before receiving her 2nd dose). At the time of the report, COVID-19 (Patient got COVID before receiving her 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.     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 information was provided. No treatment information was provided. Reporter stated that the patient's isolation period will end on Saturday. CC: This spontaneous case concerns a 73-year-old female patient with no medical history experience the Unexpected AESI event Covid-19 in association with mRNA-1273. The event occurred 26 days after the first dose of mRNA-1273. The patient was tested positive for SARS-Cov-2 infection. Details of treatment, follow-up, outcome were not reported. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 73-year-old female patient with no medical history experience the Unexpected AESI event Covid-19 in association with mRNA-1273. The event occurred 26 days after the first dose of mRNA-1273. The patient was tested positive for SARS-Cov-2 infection. Details of treatment, follow-up, outcome were not reported. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Cardiac flutter, Fatigue, Headache, Pruritus
Clinical narrative: Heart flutters; headache; itching; tired; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (heart flutters), HEADACHE (headache), PRURITUS (itching) and FATIGUE (tired) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Jul-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 CARDIAC FLUTTER (heart flutters), HEADACHE (headache), PRURITUS (itching) and FATIGUE (tired). At the time of the report, CARDIAC FLUTTER (heart flutters), HEADACHE (headache), PRURITUS (itching) and FATIGUE (tired) 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.Company comment: This is a spontaneous case concerning a 59-year-old patient of unknown gender with no reported medical history, who experienced the unexpected, non-serious, AESI event of cardiac flutter, unexpected, non-serious event of pruritus and expected, non-serious events of headache and fatigue. The events cardiac flutter, pruritus, headache and fatigue exact occurrence unknown but stated that the events occurred after the first dose of mRNA-1273 vaccine administration. No reported treatment information. The outcome of the events cardiac flutter, pruritus, headache and fatigue were unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.This case was linked to MOD-2022-456871 (Patient Link). Sender's Comments: This is a spontaneous case concerning a 59-year-old patient of unknown gender with no reported medical history, who experienced the unexpected, non-serious, AESI event of cardiac flutter, unexpected, non-serious event of pruritus and expected, non-serious events of headache and fatigue. The events cardiac flutter, pruritus, headache and fatigue exact occurrence unknown but stated that the events occurred after the first dose of mRNA-1273 vaccine administration. No reported treatment information. The outcome of the events cardiac flutter, pruritus, headache and fatigue were unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Positive COVID Disease after vaccination/just finished having COVID; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Positive COVID Disease after vaccination/just finished having COVID) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Positive COVID Disease after vaccination/just finished having COVID). At the time of the report, COVID-19 (Positive COVID Disease after vaccination/just finished having COVID) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.   Reportedly, patient was going to be 65 years old in September.  CC:This spontaneous case concerns a 64-year-old patient of unknown gender with no medical history experienced the Unexpected AESI event Covid-19 in association with mRNA-1273. The event occurred on an unknown date after the second dose of mRNA-1273.  Details of treatment, outcome were not reported. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 64-year-old patient of unknown gender with no medical history experienced the Unexpected AESI event Covid-19 in association with mRNA-1273. The event occurred on an unknown date after the second dose of mRNA-1273.  Details of treatment, outcome were not reported. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; When can I get my booster shot; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (tested positive for Covid; When can I get my booster shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for Covid; When can I get my booster shot). At the time of the report, COVID-19 (tested positive for Covid; When can I get my booster shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     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 medications were reported. No treatment medications were reported.  CC: This spontaneous case concerns a patient of unknown age/gender with no medical history experienced the Unexpected AESI event Covid -19 in association with mRNA-1273. The event occurred on an unknown date in association with first dose of mRNA-1273. Details of treatment, outcome were not reported. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age/gender with no medical history experienced the Unexpected AESI event Covid -19 in association with mRNA-1273. The event occurred on an unknown date in association with first dose of mRNA-1273. Details of treatment, outcome were not reported. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hypersomnia, Lethargy
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of LETHARGY (Lethargic), FEELING ABNORMAL (Punky), HYPERSOMNIA (Slept a lot) and FATIGUE (Tired) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 046A21A) for COVID-19 vaccination. No Medical History information was reported. On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced LETHARGY (Lethargic), FEELING ABNORMAL (Punky), HYPERSOMNIA (Slept a lot) and FATIGUE (Tired). On 06-Jun-2021, LETHARGY (Lethargic), FEELING ABNORMAL (Punky), HYPERSOMNIA (Slept a lot) and FATIGUE (Tired) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were provided. It was reported that the patient felt nothing with the first shot. This case was linked to MOD-2022-457985 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID symptoms/ got COVID; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID symptoms/ got COVID) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2022, the patient experienced COVID-19 (COVID symptoms/ got COVID). At the time of the report, COVID-19 (COVID symptoms/ got COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  No treatment medication was reported by the reporter.  COMPANY COMMENT : This is a spontaneous case concerning of unknown age of male patient with no medical history reported. who experienced the unexpected non serious AESI event of Covid-19. The events occurred after the unknown days of second dose of mRNA-1273 vaccine. The outcome of the event COVID-19 is unknown. SARS -COV-2 test was positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning of unknown age of male patient with no medical history reported. who experienced the unexpected non serious AESI event of Covid-19. The events occurred after the unknown days of second dose of mRNA-1273 vaccine. The outcome of the event COVID-19 is unknown. SARS -COV-2 test was positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose administered more than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered more than 12 hours post puncture) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer-Biontech COVID-19 Vaccine (Dose 2) and Pfizer-Biontech COVID-19 Vaccine (Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer-Biontech COVID-19 Vaccine and Pfizer-Biontech COVID-19 Vaccine. Concomitant products included NAPROXEN for an unknown indication.    On 20-Jan-2022 at 10:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered more than 12 hours post puncture). On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (dose administered more than 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other medication includes Non-product related/Other and Over the counter allergy pills.    The vial was first punctured on 19Jan2022 at 4.30PM and one dose was administered on 20-Jan-2022 at 10 AM.  Treatment details were not given.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness
Clinical narrative: Quite sick; COVID; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Quite sick) and COVID-19 (COVID) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Quite sick) and COVID-19 (COVID). At the time of the report, ILLNESS (Quite sick) and COVID-19 (COVID) outcome was unknown.            No concomitant products and treatment information were reported. It was reported that his booster is due beginning of Feb.  Company Comment: This is a spontaneous case concerning a male subject of unknown age, with unknown medical history, who experienced the non-serious unexpected events of Illness and COVID-19 (AESI). The events occurred unknown number of days after the second dose of mRNA-1273 vaccine. There is no available information regarding clinical course and treatment medication. There is also no information regarding the first dose and vaccination schedule. Rechallenge was not applicable as there was no information regarding an additional dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-286573 (Patient Link). Sender's Comments: This is a spontaneous case concerning a male subject of unknown age, with unknown medical history, who experienced the non-serious unexpected events of Illness and COVID-19 (AESI). The events occurred unknown number of days after the second dose of mRNA-1273 vaccine. There is no available information regarding clinical course and treatment medication. There is also no information regarding the first dose and vaccination schedule. Rechallenge was not applicable as there was no information regarding an additional dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Nasopharyngitis, Polymerase chain reaction
Clinical narrative: mild cold symptoms all a week; This spontaneous case was reported by an other health care professional and describes the occurrence of NASOPHARYNGITIS (mild cold symptoms all a week) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 047A21A and 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (mild cold symptoms all a week). At the time of the report, NASOPHARYNGITIS (mild cold symptoms all a week) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Investigation: negative (Negative) all my rapid screens were negative. On an unknown date, Polymerase chain reaction: positive (Positive) rapid PCR test showed positive two days later.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment drugs were reported  The caller noted that she had been experiencing mild cold symptoms all a week. She stated that all my rapid screens were negative but, my rapid PCR test showed positive two days later.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2022: Follow up received as significant information included patient details and lab data.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: I had difficulty breathing; lowoxygen level; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (I had difficulty breathing) and OXYGEN SATURATION DECREASED (lowoxygen level) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (I had difficulty breathing) (seriousness criterion hospitalization) and OXYGEN SATURATION DECREASED (lowoxygen level) (seriousness criterion hospitalization). At the time of the report, DYSPNOEA (I had difficulty breathing) and OXYGEN SATURATION DECREASED (lowoxygen level) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: low oxygen level (Low) Low oxygen level.         No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. Patient was admitted to hospital after 2nd Moderna shot because the patient had difficulty breathing and low oxygen level. Pulmonologist wrote diagnosis as side effect of shot.  Company comment: This case concerns a patient of unknown age and gender, with no medical history reported, who experienced the unexpected events of dyspnoea and oxygen saturation decreased, which required hospitalization. The events occurred on an unknown date after the second dose of mRNA-1273. As reported, patient was admitted to hospital after 2nd Moderna shot because the patient had difficulty breathing and low oxygen level. Pulmonologist wrote diagnosis as side effect of shot. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender, with no medical history reported, who experienced the unexpected events of dyspnoea and oxygen saturation decreased, which required hospitalization. The events occurred on an unknown date after the second dose of mRNA-1273. As reported, patient was admitted to hospital after 2nd Moderna shot because the patient had difficulty breathing and low oxygen level. Pulmonologist wrote diagnosis as side effect of shot. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Pruritus, Vaccination complication
Clinical narrative: weird reaction to my booster; itching bump forming on my wrist; received the vaccine on wrist; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (weird reaction to my booster), PRURITUS (itching bump forming on my wrist) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (received the vaccine on wrist) 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 January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced VACCINATION COMPLICATION (weird reaction to my booster), PRURITUS (itching bump forming on my wrist) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (received the vaccine on wrist). In January 2022, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (received the vaccine on wrist) had resolved. At the time of the report, VACCINATION COMPLICATION (weird reaction to my booster) and PRURITUS (itching bump forming on my wrist) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: It was like having Covid 2.0 over the next 30 hrs; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (It was like having Covid 2.0 over the next 30 hrs) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (I got Covid between Christmas and New Yr. last yr. and lost my sense of smell and taste.) in December 2020.    On 10-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Oct-2021, the patient experienced SUSPECTED COVID-19 (It was like having Covid 2.0 over the next 30 hrs). At the time of the report, SUSPECTED COVID-19 (It was like having Covid 2.0 over the next 30 hrs) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was reported.  The patient received their 1st dose of Moderna Covid-19 vaccine and was like having Covid 2.0 over the next 30 hours.   The patient also reported that they got Covid between Christmas and New Yr. last yr. and lost their sense of smell and taste. Reportedly, over the last 10 months their taste had been coming back pretty well.  No treatment information was provided.  Company comment: This case concerns a male patient of an unknown age, with past medical history of COVID-19 infection last year, and after first dose of mRNA-1273 the patient experienced non serious unexpected AESI of Suspected COVID-19. The patient reported "like having COVID-19" during 30 hours after first dose of mRNA-1273. No further information provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-460259 (Patient Link). Sender's Comments: This case concerns a male patient of an unknown age, with past medical history of COVID-19 infection last year, and after first dose of mRNA-1273 the patient experienced non serious unexpected AESI of Suspected COVID-19. The patient reported "like having COVID-19" during 30 hours after first dose of mRNA-1273. No further information provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash on her left arm close to where the injection/spreading on the same arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A, 031A21A and 021M20A) for COVID-19 vaccination. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and SOLIFENACIN SUCCINATE (VESICARE) for an unknown indication. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2022, the patient experienced VACCINATION SITE RASH (rash on her left arm close to where the injection/spreading on the same arm). At the time of the report, VACCINATION SITE RASH (rash on her left arm close to where the injection/spreading on the same arm) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No medical history information was reported. No Treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Feeling abnormal, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: I've lost my taste, again.; felt cruddy; feverish; 1st dose on 10-Oct-2021 and 2nd dose on 20-Nov-2021; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (I've lost my taste, again.), FEELING ABNORMAL (felt cruddy), PYREXIA (feverish) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 10-Oct-2021 and 2nd dose on 20-Nov-2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068F21A and 037F21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Lost his sense of smell & taste.Over the last 10 months his taste had been coming back pretty well.) in December 2020.   On 10-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, the patient experienced AGEUSIA (I've lost my taste, again.), FEELING ABNORMAL (felt cruddy), PYREXIA (feverish) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 10-Oct-2021 and 2nd dose on 20-Nov-2021). On 20-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 10-Oct-2021 and 2nd dose on 20-Nov-2021) had resolved. At the time of the report, AGEUSIA (I've lost my taste, again.), FEELING ABNORMAL (felt cruddy) and PYREXIA (feverish) outcome was unknown.            No concomitant medication information provided. No treatment medication information provided. The patient had Covid between Christmas & New Yr last yr & lost my sense of smell & taste. Over the last 10 months taste had been coming back pretty well. After 2 doses of Moderna Covid-19 vaccine, he had lost taste, again.  Company comment: This case concerns a male patient with no relevant medical history, who experienced non-serious unexpected AESI of ageusia, that occurred on the same day after the 2nd dose of the mRNA-1273.  Additionally, there was an inappropriate schedule of vaccine administration since time between doses was more than 35 days. The rechallenge was not applicable due to occurrence after the 2nd dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.    This case was linked to MOD-2022-460249 (Patient Link).; Sender's Comments: This case concerns a male patient with no relevant medical history, who experienced non-serious unexpected AESI of ageusia, that occurred on the same day after the 2nd dose of the mRNA-1273.  Additionally, there was an inappropriate schedule of vaccine administration since time between doses was more than 35 days. The rechallenge was not applicable due to occurrence after the 2nd dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Is a fever a side effect of the Moderna booster) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Is a fever a side effect of the Moderna booster). At the time of the report, PYREXIA (Is a fever a side effect of the Moderna booster) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medicines were reported. No treatment medicines were reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: had patients that were administered vaccine after the published expiration date. 5 doses of the Moderna covid-19; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (had patients that were administered vaccine after the published expiration date. 5 doses of the Moderna covid-19) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2022 at 11:35 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (had patients that were administered vaccine after the published expiration date. 5 doses of the Moderna covid-19). On 24-Jan-2022, EXPIRED PRODUCT ADMINISTERED (had patients that were administered vaccine after the published expiration date. 5 doses of the Moderna covid-19) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was provided. No treatment medication details was provided. No any known symptoms following vaccination.  No other adverse events .Patient has not tested positive for covid-19 and no other known allergies   Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2022: Significant follow up, case is Valid, updated reporter details, patient demographics and suspect product dose number and anatomical location were added
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Electrocardiogram, Heart rate, Heart rate increased, Palpitations
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart is pounding fast but off and on), VACCINATION COMPLICATION (She had something different on Thanksgiving Day), HEART RATE INCREASED (Every day this week heart rate is higher) and ANXIETY (Very concerned) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. Previously administered products included for COVID-19 vaccination: Johnson & Johnson COVID-19 Vaccine (lot 042A21A) on 10-Apr-2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson COVID19 Vaccine. On 24-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced PALPITATIONS (Heart is pounding fast but off and on). On 25-Nov-2021, the patient experienced VACCINATION COMPLICATION (She had something different on Thanksgiving Day). In January 2022, the patient experienced HEART RATE INCREASED (Every day this week heart rate is higher) and ANXIETY (Very concerned). At the time of the report, PALPITATIONS (Heart is pounding fast but off and on) had not resolved and VACCINATION COMPLICATION (She had something different on Thanksgiving Day), HEART RATE INCREASED (Every day this week heart rate is higher) and ANXIETY (Very concerned) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2022, Heart rate: 131 heart rate was 131. On 22-Jan-2022, Heart rate: 131 heart rate was 131. In 2022, Heart rate: high (High) Every day this week its higher. On an unknown date, Electrocardiogram: normal (normal) everything was fine. On an unknown date, Heart rate: 115 heart rate was 115. She had no side effects from the J and J. Her heart was pounding fast but off and on. She thought it should go away for a day or so, it was still there, 8 weeks later. The patient states this was from Moderna 100 percentage because she had an EKG earlier in the year. No concomitant products were reported. No treatment drugs were reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart is pounding fast but off and on), VACCINATION COMPLICATION (She had something different on Thanksgiving Day), HEART RATE INCREASED (Every day this week heart rate is higher) and ANXIETY (Very concerned) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. Previously administered products included for COVID-19 vaccination: Johnson & Johnson COVID-19 Vaccine (lot 042A21A) on 10-Apr-2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson COVID19 Vaccine. On 24-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced PALPITATIONS (Heart is pounding fast but off and on). On 25-Nov-2021, the patient experienced VACCINATION COMPLICATION (She had something different on Thanksgiving Day). In January 2022, the patient experienced HEART RATE INCREASED (Every day this week heart rate is higher) and ANXIETY (Very concerned). At the time of the report, PALPITATIONS (Heart is pounding fast but off and on) had not resolved and VACCINATION COMPLICATION (She had something different on Thanksgiving Day), HEART RATE INCREASED (Every day this week heart rate is higher) and ANXIETY (Very concerned) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2022, Heart rate: 131 heart rate was 131. On 22-Jan-2022, Heart rate: 131 heart rate was 131. In 2022, Heart rate: high (High) Every day this week its higher. On an unknown date, Electrocardiogram: normal (normal) everything was fine. On an unknown date, Heart rate: 115 heart rate was 115. She had no side effects from the J and J. Her heart was pounding fast but off and on. She thought it should go away for a day or so, it was still there, 8 weeks later. The patient states this was from Moderna 100 percentage because she had an EKG earlier in the year. No concomitant products were reported. No treatment drugs were reported.