chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Initial COVID-19 infection prior to Paxlovid treatment; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Initial COVID-19 infection prior to Paxlovid treatment) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had no allergy.  Concomitant products included SERTRALINE for an unknown indication.    On 07-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (Initial COVID-19 infection prior to Paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-May-2022 to 19-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Initial COVID-19 infection prior to Paxlovid treatment) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The patient previously received a COVID-19 vaccine.  Company Comment: This spontaneous case concerns a 67-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, described as initial COVID-19 infection prior to Paxlovid treatment, that occurred approximately 2.5 months after receiving mRNA-1273 given as fourth dose in the COVID-19 vaccination series. Patient presented with rebound COVID-19 symptoms and a positive SARS-CoV-2 test 4 days after completion of a 3-day-course of Nirmatrelvir, Ritonavir (Paxlovid) for the initial COVID-19 infection. No information was provided on the previous 3 doses of COVID-19 vaccines received by the patient prior to current mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 67-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, described as initial COVID-19 infection prior to Paxlovid treatment, that occurred approximately 2.5 months after receiving mRNA-1273 given as fourth dose in the COVID-19 vaccination series. Patient presented with rebound COVID-19 symptoms and a positive SARS-CoV-2 test 4 days after completion of a 3-day-course of Nirmatrelvir, Ritonavir (Paxlovid) for the initial COVID-19 infection. No information was provided on the previous 3 doses of COVID-19 vaccines received by the patient prior to current mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid-19 prior to Paxlovid treatment; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19 prior to Paxlovid treatment) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder NOS.    On 06-Mar-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 COVID-19 (covid-19 prior to Paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 18-May-2022 to 21-May-2022 for COVID-19 treatment, at a dose of Unknown. At the time of the report, COVID-19 (covid-19 prior to Paxlovid treatment) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was unknown if the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient had Paxlovid- severe diarrhea and vomiting. Dizziness and high blood pressure abnormal. Device Date : 26May2022 Patient previously received a COVID-19 Vaccine. Treatment information was not provided.  Company comment-This spontaneous case concerns a patient of unknown age and gender with relevant medical history of Autoimmune disorder reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving the first dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid for Covid-19 from 18th to 21st May2022. Patient experienced Diarrhoea, Vomiting, Dizziness and Hypertension, hospitalized for 3 days after Paxlovid treatment. The current pandemic situation of COVID-19 may remain as confounder and relevant medical history as risk factor to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with relevant medical history of Autoimmune disorder reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving the first dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid for Covid-19 from 18th to 21st May2022. Patient experienced Diarrhoea, Vomiting, Dizziness and Hypertension, hospitalized for 3 days after Paxlovid treatment. The current pandemic situation of COVID-19 may remain as confounder and relevant medical history as risk factor to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Very bitter taste which went away after last dose but strangely reoccurred 10 days later/COVID-19 recurrence; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Very bitter taste which went away after last dose but strangely reoccurred 10 days later/COVID-19 recurrence) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included ROSUVASTATIN for an unknown indication.    On 17-Nov-2021, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, the patient experienced COVID-19 (Very bitter taste which went away after last dose but strangely reoccurred 10 days later/COVID-19 recurrence). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 11-May-2022 to 16-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Very bitter taste which went away after last dose but strangely reoccurred 10 days later/COVID-19 recurrence) had resolved with sequelae.            Reportedly, the patient received other medications or products within 2 weeks of starting COVID-19 treatment and the patient previously received a COVID-19 Vaccine.  Device Date was reported as 25-May-2022.  Company Comment: This spontaneous case concerns a patient of unknown gender and age, with no relevant medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19,  which occurred approximately 6 months after a dose of mRNA-1273 vaccine administration, given as the fourth dose. Patient reported very bitter taste which went away after last dose of Paxlovid but noticed reoccurrence 10 days later. The ongoing COVID-19 pandemic could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown gender and age, with no relevant medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19,  which occurred approximately 6 months after a dose of mRNA-1273 vaccine administration, given as the fourth dose. Patient reported very bitter taste which went away after last dose of Paxlovid but noticed reoccurrence 10 days later. The ongoing COVID-19 pandemic could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Patient developed rash after 10 hours ,had to ice her leg afterwards; This case was received via another Manufacturer on 27-May-2022 and was forwarded to Moderna on 27-May-2022. This spontaneous case was reported by a consumer and describes the occurrence of RASH (Patient developed rash after 10 hours ,had to ice her leg afterwards) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Patient developed rash after 10 hours ,had to ice her leg afterwards). At the time of the report, RASH (Patient developed rash after 10 hours ,had to ice her leg afterwards) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  Reported that after 10 hours of vaccination patient developed rash due to which she had to ice her leg afterwards.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: she had "normal side effects:; This spontaneous case was reported by a nurse and describes the occurrence of IMMUNISATION REACTION (she had "normal side effects:) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (she had "normal side effects:). At the time of the report, IMMUNISATION REACTION (she had "normal side effects:) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2022-578759, MOD-2022-578783 (Patient Link).
Age: 39.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Blood testosterone, COVID-19, SARS-CoV-2 test
Clinical narrative: Rebound positive test; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound positive test) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Sleep apnea and Obesity. Concomitant products included TESTOSTERONE, SIMVASTATIN and FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY ELLIPTA) for an unknown indication.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2022 at 6:00 PM, the patient experienced COVID-19 (Rebound positive test). At the time of the report, COVID-19 (Rebound positive test) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2022, SARS-CoV-2 test: positive (Positive) Rebound positive test. On an unknown date, Blood testosterone: low (Low) Low. On an unknown date, SARS-CoV-2 test: positive (Positive) positive.         The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. No treatment medications were provided. Device date was reported as 25-May-2022. Company comment: This spontaneous case concerns a 39-year-old, male patient with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 14 days after administration of third dose of mRNA-1273, the second dose of mRNA-1273 was given 13 months prior, the first dose of mRNA-1273 was given on an unknown date. On May 25, 2022, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 39-year-old, male patient with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 14 days after administration of third dose of mRNA-1273, the second dose of mRNA-1273 was given 13 months prior, the first dose of mRNA-1273 was given on an unknown date. On May 25, 2022, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Took Paxlovid on day 1 of being positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Took Paxlovid on day 1 of being positive) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (No, unknown historical drug.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 25-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2022, the patient experienced COVID-19 (Took Paxlovid on day 1 of being positive). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 11-May-2022 to 15-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. In May 2022, COVID-19 (Took Paxlovid on day 1 of being positive) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2022, SARS-CoV-2 test: positive (Positive) Positive. In May 2022, SARS-CoV-2 test: negative (Negative) Negative and positive (Positive) Positive.         It was reported that patient symptoms returned on Day 12. Patient thought they were allergies. Patient tested positive again for COVID 19 on day 16.  The patient had received any other medications/products within 2 weeks of starting COVID-19 treatment. The patient had previously receive a COVID-19 Vaccine. Device Date reported as 26-May-2022  Company comment: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history who experienced the unexpected non serious of COVID 19 which occurred approximately 9 months after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 11-May to 15-May. Patient tested negative 7 days after testing positive. Symptoms returned on day 12 and patient tested positive again for COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history who experienced the unexpected non serious  of COVID 19 which occurred approximately 9 months after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 11-May to 15-May. Patient tested negative 7 days after testing positive. Symptoms returned on day 12 and patient tested positive again for COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Erythema, Inappropriate schedule of product administration, Skin burning sensation
Clinical narrative: Burning scalp after receiving the 1st booster dose; Red scalp after receiving the 1st booster dose; Hair loss after receiving the 1st booster dose/Bald spots after receiving the 1st booster dose; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a patient and describes the occurrence of SKIN BURNING SENSATION (Burning scalp after receiving the 1st booster dose), ERYTHEMA (Red scalp after receiving the 1st booster dose), ALOPECIA (Hair loss after receiving the 1st booster dose/Bald spots after receiving the 1st booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K21A, 024M20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Aspirin) and Drug allergy (simvastatin).   On 27-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 23-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SKIN BURNING SENSATION (Burning scalp after receiving the 1st booster dose), ERYTHEMA (Red scalp after receiving the 1st booster dose) and ALOPECIA (Hair loss after receiving the 1st booster dose/Bald spots after receiving the 1st booster dose). At the time of the report, SKIN BURNING SENSATION (Burning scalp after receiving the 1st booster dose), ERYTHEMA (Red scalp after receiving the 1st booster dose), ALOPECIA (Hair loss after receiving the 1st booster dose/Bald spots after receiving the 1st booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            No concomitant medication information was provided.  The caller is a consumer who explains that she received the first dose of the Moderna Covid 19 vaccine on 27Jan2021 and a week after she developed really bad itchy scalp, dry scalp like dandruff and after her hair started coming out. It took her months to grow her hair back. She explained that last month she received the first booster dose of the Moderna Covid 19 vaccine and the symptoms came back, her scalp was burning a lot and it was really red she had been applying sulfate to her hair and she said that for this reason her scalp was not itchy like last time, but she was loosing a lot of hair and said she had bald spots.  Treatment was mentioned as sulfates.   Patient had not tested positive for Covid 19.   This case was linked to MOD-2022-578382 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Burning scalp after receiving the 1st booster dose; Red scalp after receiving the 1st booster dose; Hair loss after receiving the 1st booster dose/Bald spots after receiving the 1st booster dose; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a patient and describes the occurrence of SKIN BURNING SENSATION (Burning scalp after receiving the 1st booster dose), ERYTHEMA (Red scalp after receiving the 1st booster dose), ALOPECIA (Hair loss after receiving the 1st booster dose/Bald spots after receiving the 1st booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K21A, 024M20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Aspirin) and Drug allergy (simvastatin).   On 27-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 23-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SKIN BURNING SENSATION (Burning scalp after receiving the 1st booster dose), ERYTHEMA (Red scalp after receiving the 1st booster dose) and ALOPECIA (Hair loss after receiving the 1st booster dose/Bald spots after receiving the 1st booster dose). At the time of the report, SKIN BURNING SENSATION (Burning scalp after receiving the 1st booster dose), ERYTHEMA (Red scalp after receiving the 1st booster dose), ALOPECIA (Hair loss after receiving the 1st booster dose/Bald spots after receiving the 1st booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            No concomitant medication information was provided.  The caller is a consumer who explains that she received the first dose of the Moderna Covid 19 vaccine on 27Jan2021 and a week after she developed really bad itchy scalp, dry scalp like dandruff and after her hair started coming out. It took her months to grow her hair back. She explained that last month she received the first booster dose of the Moderna Covid 19 vaccine and the symptoms came back, her scalp was burning a lot and it was really red she had been applying sulfate to her hair and she said that for this reason her scalp was not itchy like last time, but she was loosing a lot of hair and said she had bald spots.  Treatment was mentioned as sulfates.   Patient had not tested positive for Covid 19.   This case was linked to MOD-2022-578382 (Patient Link).
Sex: U
Vaccine: COVID19, UNK
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: face was beginning to turn red; Developing urticaric rash; Rash quickly spread to lower abdomen, up trunk to arms and neck; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (face was beginning to turn red), URTICARIA (Developing urticaric rash) and RASH (Rash quickly spread to lower abdomen, up trunk to arms and neck) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 007M20A and 037K20A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19.    Past medications reported as adhesive and latex with allergy as an reaction.  Previously administered products included for Drug use for unknown indication: doxycycline. Past adverse reactions to the above products included Allergy NOS with doxycycline. Concurrent medical conditions included Migraine, Polycystic ovarian syndrome, Restless leg syndrome, Dysmenorrhea, Scoliosis and ADD.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (Oral) at an unspecified dose. On 25-May-2022 at 12:00 PM, the patient experienced ERYTHEMA (face was beginning to turn red), URTICARIA (Developing urticaric rash) and RASH (Rash quickly spread to lower abdomen, up trunk to arms and neck). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 50 milligram. At the time of the report, ERYTHEMA (face was beginning to turn red), URTICARIA (Developing urticaric rash) and RASH (Rash quickly spread to lower abdomen, up trunk to arms and neck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported.  The patient had received COVID-19 vaccine previously.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for covid on April 7. eight days later on April 15 tested negative and felt good. new symptoms appeared on April 18 and tested positive again; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid on April 7. eight days later on April 15 tested negative and felt good. new symptoms appeared on April 18 and tested positive again) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012f2a) for COVID-19 vaccination.     The patient's past medical history included Mitral valve prolapse. Concurrent medical conditions included Cervical dystonia and Drug allergy (unspecified drug allergy). Concomitant products included ACYCLOVIR [ACICLOVIR] from 01-Jan-2009 to an unknown date for an unknown indication.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced COVID-19 (tested positive for covid on April 7. eight days later on April 15 tested negative and felt good. new symptoms appeared on April 18 and tested positive again). On 15-Apr-2022, COVID-19 (tested positive for covid on April 7. eight days later on April 15 tested negative and felt good. new symptoms appeared on April 18 and tested positive again) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2022, SARS-CoV-2 test: postive (Positive) Positive. On 15-Apr-2022, SARS-CoV-2 test: negative (Negative) Negative. On 18-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive.         On 07 Apr 2022 patient started Pfizer medication as a treatment of COVID-19 and date of last administration was 11 May 2022.  Device Date was reported as 27 May 2022.  Company comment- This spontaneous case concerns a 67-year-old female patient with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 5 months and 13 days after vaccination with a third dose of mRNA-1273. 5 months and 13 days after vaccination with mRNA-1273 the patient tested positive for Covid-19. Eight days later, she tested negative and felt good. 3 days after, new symptoms appeared and tested positive again. The outcome of the events was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 67-year-old female patient with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 5 months and 13 days after vaccination with a third dose of mRNA-1273. 5 months and 13 days after vaccination with mRNA-1273 the patient tested positive for Covid-19. Eight days later, she tested negative and felt good. 3 days after, new symptoms appeared and tested positive again. The outcome of the events was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Patient had tick bourn illness. Patient had allergic reaction to unspecified drug.  The patient's past medical history included Chronic fatigue syndrome. Concurrent medical conditions included Asthma. Concomitant products included BECLOMETASONE DIPROPIONATE (QVAR), PREGABALIN, TRAZODONE, FAMOTIDINE (PEPCID [FAMOTIDINE]), ETHINYLESTRADIOL, NORGESTIMATE (SPRINTEC), DOXYCYCLINE and SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM DS) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 07-May-2022 to 12-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Company Comment: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving a dose of mRNA-1273 vaccine (dose number not specified). It was reported that patient was treated with Paxlovid for Covid-19. 1 week after the treatment with paxlovid patient experienced rebound symptoms and was tested positive for covid-19 as on 19-May-2022. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving a dose of mRNA-1273 vaccine (dose number not specified). It was reported that patient was treated with Paxlovid for Covid-19. 1 week after the treatment with paxlovid patient experienced rebound symptoms and was tested positive for covid-19 as on 19-May-2022. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 after Moderna Dose 4; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 after Moderna Dose 4) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.    On 02-Apr-2022 at 10:00 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 after Moderna Dose 4). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 07-May-2022 to 11-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19 after Moderna Dose 4) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medication was provided by the reporter.  The patient did not took any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine.  Device Date was reported as 29May2022.  Company Comment: This spontaneous case concerns a patient, of unknown age and unknown gender, with no relevant medical history reported, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 1 month after receiving the fourth dose of the mRNA-1273 vaccine. The patient took and completed a 5-day course of Paxlovid (nirmatrelvir, ritonavir) from 07May2022 to 11May2022. It was reported that the patient developed COVID-19 rebound 2 weeks after treatment with Paxlovid. The patient tested positive for SARS-CoV-2 unknown number of days after testing negative for SARS-CoV-2. The patient experienced bad cold symptoms and fever, and was still experiencing the symptoms at the time of the report. 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 and unknown gender, with no relevant medical history reported, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 1 month after receiving the fourth dose of the mRNA-1273 vaccine. The patient took and completed a 5-day course of Paxlovid (nirmatrelvir, ritonavir) from 07May2022 to 11May2022. It was reported that the patient developed COVID-19 rebound 2 weeks after treatment with Paxlovid. The patient tested positive for SARS-CoV-2 unknown number of days after testing negative for SARS-CoV-2. The patient experienced bad cold symptoms and fever, and was still experiencing the symptoms at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 026B21A) for COVID-19 vaccination.  Concurrent medical conditions included Drug allergy (Allergy to Demirol) and Drug allergy (Allergy to Loritab). Concomitant products included IPRATROPIUM BROMIDE from 26-May-2022 to 26-May-2022 and AZELASTINE HCL from 26-May-2022 to 26-May-2022 for an unknown indication.  On 04-Mar-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021 at 3:15 PM, 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 COVID-19 (Covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 26-May-2022 to 28-May-2022 for COVID-19 treatment, at a dose of 1 dosage form. At the time of the report, COVID-19 (Covid-19) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  It was reported that the patient received unspecified medications/products within 2 weeks of starting COVID-19 treatment. The patient had trouble swallowing, throat tigtness hoarseness (lost voice) night sweats on 27-May-2022 14:00 with outcome as recovering. The device date reported as 29-May-2022.  Company Comment: This is a spontaneous case concerning a 69-year-old female patient with no reported medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred approximately 1 month after receiving the second dose of mRNA-1273 Vaccine. No clinical or treatment details were given. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 69-year-old female patient with no reported medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred approximately 1 month after receiving the second dose of mRNA-1273 Vaccine. No clinical or treatment details were given. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, COVID-19, Nervousness, SARS-CoV-2 test
Clinical narrative: COVID-19; Jittery and anxious; Jittery and anxious; This spontaneous case was reported by a patient and describes the occurrence of NERVOUSNESS (Jittery and anxious), ANXIETY (Jittery and anxious) and COVID-19 (COVID-19) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.    On 22-Apr-2022 at 12:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2022 at 12:15 PM, the patient experienced NERVOUSNESS (Jittery and anxious) and ANXIETY (Jittery and anxious). On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 21-May-2022 to 25-May-2022 for COVID-19, at an unspecified dose and frequency. On 27-May-2022, NERVOUSNESS (Jittery and anxious) and ANXIETY (Jittery and anxious) had resolved. At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Company comment: This spontaneous case concerns a 76-year-old male patient, with no relevant medical history, who experienced the unexpected non-serious AESI COVID-19 that occurred on an unknown date after receiving the mRNA-1273 vaccine as 4th dose. Twenty nine days post vaccination, patient took Paxlovid for 5 days. No lab test reported. Clinical course was not reported. The outcome of event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed non-serious based on medical judgment.; Sender's Comments: This spontaneous case concerns a 76-year-old male patient, with no relevant medical history, who experienced the unexpected non-serious AESI COVID-19 that occurred on an unknown date after receiving the mRNA-1273 vaccine as 4th dose. Twenty nine days post vaccination, patient took Paxlovid for 5 days. No lab test reported. Clinical course was not reported. The outcome of event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed non-serious based on medical judgment.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Rebound of Covid-19 Awful taste while taking; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Rebound of Covid-19 Awful taste while taking) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2022, the patient experienced COVID-19 (Rebound of Covid-19 Awful taste while taking). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-May-2022 to 22-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound of Covid-19 Awful taste while taking) had not resolved.            It was reported that the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.   It was reported that the patient previously received a COVID-19 Vaccine.  On 29-May-2022 at 16:30, the patient experienced rebound of Covid-19 Awful taste while taking.  The device date reported as 29-May-2022.  Company Comment: This spontaneous case concerns a 48-year-old, female patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19, described as rebound infection. The event occurred after receiving mRNA-1273 as third COVID-19 vaccine dose, which was administered on an unknown date. The patient initially received a complete course of NIRMATRELVIR/RITONAVIR (Paxlovid) but noted re-occurrence of symptoms 7 days post-treatment. Details on presenting symptoms, COVID-19 tests conducted and additional treatment administered, if any, were not provided in the case. The ongoing COVID-19 pandemic remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 48-year-old, female patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19, described as rebound infection. The event occurred after receiving mRNA-1273 as third COVID-19 vaccine dose, which was administered on an unknown date. The patient initially received a complete course of NIRMATRELVIR/RITONAVIR (Paxlovid) but noted re-occurrence of symptoms 7 days post-treatment. Details on presenting symptoms, COVID-19 tests conducted and additional treatment administered, if any, were not provided in the case. The ongoing COVID-19 pandemic remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Rebound COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound COVID) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Drug name not reported).    On 21-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Rebound COVID). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 07-May-2022 to 11-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound COVID) was resolving.            No concomitant medication was reported.  The patient previously received a COVID-19 Vaccine. It was reported that he patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  Device Date : 29-May-2022.  Company Comment: This spontaneous case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected non-serious AESI of COVID-19 that occurred 4 months and 2 days after receiving the mRNA-1273 vaccine as 3rd dose. Patient took Paxlovid for 5 days as treatment regimen. Twelve days after completion of Paxlovid, patient reported rebound COVID. No laboratory tests were reported. Clinical course was not reported. At the time of reporting, the outcome of event was resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed non-serious based on medical judgment.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected non-serious AESI of COVID-19 that occurred 4 months and 2 days after receiving the mRNA-1273 vaccine as 3rd dose. Patient took Paxlovid for 5 days as treatment regimen. Twelve days after completion of Paxlovid, patient reported rebound COVID. No laboratory tests were reported. Clinical course was not reported. At the time of reporting, the outcome of event was resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed non-serious based on medical judgment.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 25052C21A) for COVID-19 vaccination.     Concurrent medical conditions included GERD. Concomitant products included OMEPRAZOLE for an unknown indication.    On 24-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 24-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2022, SARS-CoV-2 test: negative (Negative) Negative and positive (Positive) Positive.         The patient previously received a COVID-19 Vaccine.  The indication for Paxlovid was Treatment of COVID-19.  The device date was provided as 28-May-2022.  Company comment: This spontaneous case concerns a 39-year-old male patient with no relevant medical history, who experienced the unexpected non-serious AESI of Covid-19, seven months after receiving mRNA-1273 vaccine as 3rd dose. The patient was treated with Paxlovid (Nirmatrelvir + Ritonavir) for Covid-19. Two and a half days after finishing the course, the patient tested positive for SARS-CoV-2 test. The outcome was reported as unknown. Details of symptoms, clinical course, further investigation reports and treatment were not provided. Details of previous two doses were not provided. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 39-year-old male patient with no relevant medical history, who experienced the unexpected non-serious AESI of Covid-19, seven months after receiving mRNA-1273 vaccine as 3rd dose. The patient was treated with Paxlovid (Nirmatrelvir + Ritonavir) for Covid-19. Two and a half days after finishing the course, the patient tested positive for SARS-CoV-2 test. The outcome was reported as unknown. Details of symptoms, clinical course, further investigation reports and treatment were not provided. Details of previous two doses were not provided. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.