chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age. Initial information was processed along with the additional information received on 12-JAN-2022 and 14-JAN-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, 1 total administered to the right arm on 29-JUN-2021 for prophylactic vaccination. No adverse events were reported by the patient following vaccination with covid-19 vaccine ad26. cov2. s. (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, and batch number: 211A21A expiry: UNKNOWN) dose was not reported, 1 total administered to right arm on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-JAN-2022, following vaccination with  covid-19 vaccine ad26.cov2.s, the patient experienced itchy throat. On 10-JAN-2022, the patient experienced cough and headaches. Laboratory data included: Antigen rapid test ) which was positive (coded as suspected covid-19 infection and suspected clinical vaccination failure). (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint number 90000211135. The suspected product quality complaint  has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0:20220117083-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Injection site pain, Myalgia
Clinical narrative: PRETTY SEVERE JOINT PAIN; CHILLS; PRETTY SEVERE/EXTREME MUSCLE PAIN; FEVER; OVERALL FATIGUE; VERY MINOR INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1, unspecified manufacturer) (suspension for injection, route of admin not reported, batch number and expiry not reported) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. No adverse events reported post primary vaccination (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855191, and expiry: 11-APR-2022) dose was not reported, 1 total, administered on 05-NOV-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 05-NOV-2021, for about 24-48 hours the patient experienced pretty severe muscle pain and joint pain, chills, fever and overall fatigue. She reported extreme muscle pain was still continuing currently and the other side effects went away. She was not sure about the injection arm and assumed left arm since she was right handed, no pain at injection site or might be very minor injection site pain (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pretty severe joint pain, chills, fever, overall fatigue, and very minor injection site pain on 07-NOV-2021, and had not recovered from pretty severe/extreme muscle pain. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: PRETTY SEVERE JOINT PAIN; CHILLS; PRETTY SEVERE/EXTREME MUSCLE PAIN; FEVER; OVERALL FATIGUE; VERY MINOR INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1, unspecified manufacturer) (suspension for injection, route of admin not reported, batch number and expiry not reported) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. No adverse events reported post primary vaccination (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855191, and expiry: 11-APR-2022) dose was not reported, 1 total, administered on 05-NOV-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 05-NOV-2021, for about 24-48 hours the patient experienced pretty severe muscle pain and joint pain, chills, fever and overall fatigue. She reported extreme muscle pain was still continuing currently and the other side effects went away. She was not sure about the injection arm and assumed left arm since she was right handed, no pain at injection site or might be very minor injection site pain (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pretty severe joint pain, chills, fever, overall fatigue, and very minor injection site pain on 07-NOV-2021, and had not recovered from pretty severe/extreme muscle pain. This report was non-serious.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Tremor, Vomiting
Clinical narrative: SHAKING; FEVER; VOMITING; This spontaneous report received from a parent concerned an 18 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy to penicillin, and other pre-existing medical conditions included: The patient had no known medical conditions and takes no medications. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1), (suspension for injection, route of admin not reported, batch number: 1821288, expiry: UNKNOWN) dose was not reported, 1 total administered to right arm on 22-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-JUL-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced fever, shaking (which was within 3 to 4 hours after receiving the vaccine), and vomiting (dose number in series 1). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. Treatment medications (dates unspecified) included: paracetamol. The reporter mentioned that the symptoms lasted up to 28 to 36 hours. At the time of reporting all symptoms were resolved (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, shaking, and vomiting on JUL-2021. The patient received Pfizer vaccine (dose number in series 2), (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, start therapy date were not reported for prophylactic vaccination. No adverse events were reported following administration of Pfizer vaccine (dose number in series 2). This report was non-serious. This case, from the same reporter is linked to 20220124447.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pyrexia, Vomiting
Clinical narrative: FEEL SICK; VOMITING; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, penicillin allergy, seasonal allergy, green pepper, and mineral allergy. The patient previously received covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin not reported, and batch number: 207A21A and expiry: unknown) dose was not reported, 1 total, administered on 07-JUL-2021 to left arm for prophylactic vaccination. No adverse events were reported (dose number series1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822809 and expiry: unknown) dose was not reported, 1 total, administered on 03-JAN-2022 to left arm for prophylactic vaccination. Concomitant medications included diphenhydramine hydrochloride (Benadryl) for allergies.  On 08-JAN-2022, the patient had reaction after her booster dose including nausea, vomiting which was for an hour. The patient had fever and also felt sick. On the day of reporting (13-JAN-2022), she did not had vomiting. She saw the health care professional (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 13-JAN-2022, and the outcome of nausea, fever and feel sick was not reported. This report was non-serious.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Eye pruritus, Headache, Injection site rash
Clinical narrative: ITCHY EYES; BREATHING ISSUE; RED SPOTS; SORE ARM; BUMP BELOW INJECTION SITE; NOT ENERGETIC; SLIGHT HEADACHE ON AND OFF; This spontaneous report received from a patient concerned an 83-year-old female.  The patient's height, and weight were not reported. The patient's past medical history included: spinal surgery in 2013, and carotid artery surgery in 2010, and concurrent conditions included: asthma, chronic obstructive pulmonary disease (COPD), heart condition, pacemaker, and penicillin allergy, and other pre-existing medical conditions included the patient had allergy with unspecified pain medications and multiple other medications. The patient previously received covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) 1 total, dose was not reported, administered on unspecified date for prophylactic vaccination (Dose number in series 1). The patient experienced no adverse events following vaccination with covid-19 vaccine ad26. cov2. s (Dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A and expiry: unknown) 1 total, dose was not reported, administered at left arm on 13-JAN-2022 for prophylactic vaccination (Dose number in series 2). The patient' s concomitant medications included blood thinners, the patient stated she bruises easily with blood thinners. On 13-JAN-2022, the patient stated after receiving booster shot she had reaction, sore arm (like if someone punched in the arm), bump below the injection site, red spots, feel not energetic, slight headache on and off, itchy eyes, breathing issue (the patient stated that it might be due to her asthma) (Dose number in series 2). She took 2 Tylenol and then the headache felt better. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight headache on and off, had not recovered from bump below injection site, sore arm, not energetic, itchy eyes, and red spots, and the outcome of breathing issue was not reported. This report was non-serious.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash erythematous
Clinical narrative: ITCHY EYES; BREATHING ISSUE; RED SPOTS; SORE ARM; BUMP BELOW INJECTION SITE; NOT ENERGETIC; SLIGHT HEADACHE ON AND OFF; This spontaneous report received from a patient concerned an 83-year-old female.  The patient's height, and weight were not reported. The patient's past medical history included: spinal surgery in 2013, and carotid artery surgery in 2010, and concurrent conditions included: asthma, chronic obstructive pulmonary disease (COPD), heart condition, pacemaker, and penicillin allergy, and other pre-existing medical conditions included the patient had allergy with unspecified pain medications and multiple other medications. The patient previously received covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) 1 total, dose was not reported, administered on unspecified date for prophylactic vaccination (Dose number in series 1). The patient experienced no adverse events following vaccination with covid-19 vaccine ad26. cov2. s (Dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A and expiry: unknown) 1 total, dose was not reported, administered at left arm on 13-JAN-2022 for prophylactic vaccination (Dose number in series 2). The patient' s concomitant medications included blood thinners, the patient stated she bruises easily with blood thinners. On 13-JAN-2022, the patient stated after receiving booster shot she had reaction, sore arm (like if someone punched in the arm), bump below the injection site, red spots, feel not energetic, slight headache on and off, itchy eyes, breathing issue (the patient stated that it might be due to her asthma) (Dose number in series 2). She took 2 Tylenol and then the headache felt better. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight headache on and off, had not recovered from bump below injection site, sore arm, not energetic, itchy eyes, and red spots, and the outcome of breathing issue was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous potential legal report received from a health care professional concerned a male of unspecified age and ethnic origin.  The race of the patient was white (health care professional was not sure). The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2. (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808486, and expiry: UNKNOWN) 1 total, dose, start therapy date were not reported for prophylactic vaccination.  No concomitant medications were reported. The lot number provided was 1808486, however, the attorney thinks that there could be an error in writing the lot number as 1808986 so the reporter wanted to confirm if the lot number is valid. On an unspecified date, it was reported that the patient was diagnosed with Covid-19 (suspected covid-19 infection and suspected clinical vaccination failure), however, had no information on the type of test that was performed. The patient passed away due to Covid-19 (dose number in series 1). On an unspecified date, the patient died from suspected covid-19 infection. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with product quality complaint: 90000211973.; Sender's Comments: V0:V0: 20220127738-COVID-19 VACCINE AD26.COV2.S-Suspected covid-19. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20220127738-COVID-19 VACCINE AD26.COV2.S-Suspected clinical Vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: SUSPECTED COVID-19 INFECTION
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pyrexia
Clinical narrative: CHILLS; MORE SEVERE HEADACHE; 104 PLUS FEVER; NAUSEA; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number: unknown expiry: unknown) dose was not reported, 1 total, administered on an unspecified date in MAR-2021 for prophylactic vaccination. The patient experienced terrible reactions which include 104 plus fever, chills, nausea and terrible headache (Dose number in series 1). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 104 plus.  The patient recovered from 104 plus fever after four days, and outcome of chills, nausea and terrible headache was not reported. The patient received booster covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number: unknown expiry: unknown) dose was not reported, 1 total, administered on 14-JAN-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in JAN-2022, the patient experienced same side effects as of initial vaccination which included chills, 104 plus fever, nausea but more severe headache (Dose number in series 2). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 104 plus. Patient was wondering if that was an allergic reaction. Patient was looking for better understanding why his side effects were so severe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the more severe headache, 104 plus fever, chills and nausea was not reported. This report was non-serious. This case, involving the same patient is linked to 20220130689.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pyrexia
Clinical narrative: CHILLS; 104+ FEVER; TERRIBLE HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced terrible reaction: chills, 104+ fever (for four days), terrible headache, and nausea (Dose number in series 1). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 104+ F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 104+ fever, and the outcome of terrible headache, chills and nausea was not reported. This report was non-serious. This case, involving the same patient is linked to 20220130224 (Dose number in series 2) .
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: UNUSUAL TASTE IN MOUTH; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced unusual taste in mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unusual taste in mouth was not reported. This report was non-serious. This case, from the same reporter is linked to 20220130564.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 16 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: UNKNOWN) dose was not reported, administered on 17-JAN-2022 for prophylactic vaccination. No concomitant medications were reported. On 17-JAN-2022, the patient experienced product administered to patient of inappropriate age, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product administered to patient of inappropriate age and off label use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced possible adverse reaction. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible adverse reaction was not reported. This report was non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain
Clinical narrative: SORE THROAT; COUGH; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: UNKNOWN) dose was not reported, administered on 16-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JAN-2022, the patient experienced sore throat, and cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore throat, and cough. This report was non-serious.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Axillary pain, Fatigue, Lymphadenopathy, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), AXILLARY PAIN (sore armpits), PYREXIA (fever), FATIGUE (very tired) and LYMPHADENOPATHY (swollen and inflamed armpits) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: Pfizer on 14-May-2021 and Pfizer on 04-Jun-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concomitant products included ETHINYLESTRADIOL, ETONOGESTREL (NUVARING) for Contraception, FLUVOXAMINE MALEATE (LUVOX [FLUVOXAMINE MALEATE]) and TRAZODONE for an unknown indication. On 14-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna booster administered to 15 year old child). In January 2022, the patient experienced ASTHENIA (Weak), AXILLARY PAIN (sore armpits), PYREXIA (fever), FATIGUE (very tired) and LYMPHADENOPATHY (swollen and inflamed armpits). On 14-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna booster administered to 15 year old child) had resolved. At the time of the report, ASTHENIA (Weak), AXILLARY PAIN (sore armpits), PYREXIA (fever), FATIGUE (very tired) and LYMPHADENOPATHY (swollen and inflamed armpits) outcome was unknown. Patient did not take any Treatment medication for symptom relief.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), AXILLARY PAIN (sore armpits), PYREXIA (fever), FATIGUE (very tired) and LYMPHADENOPATHY (swollen and inflamed armpits) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: Pfizer on 14-May-2021 and Pfizer on 04-Jun-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concomitant products included ETHINYLESTRADIOL, ETONOGESTREL (NUVARING) for Contraception, FLUVOXAMINE MALEATE (LUVOX [FLUVOXAMINE MALEATE]) and TRAZODONE for an unknown indication. On 14-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna booster administered to 15 year old child). In January 2022, the patient experienced ASTHENIA (Weak), AXILLARY PAIN (sore armpits), PYREXIA (fever), FATIGUE (very tired) and LYMPHADENOPATHY (swollen and inflamed armpits). On 14-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna booster administered to 15 year old child) had resolved. At the time of the report, ASTHENIA (Weak), AXILLARY PAIN (sore armpits), PYREXIA (fever), FATIGUE (very tired) and LYMPHADENOPATHY (swollen and inflamed armpits) outcome was unknown. Patient did not take any Treatment medication for symptom relief.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I had omnicron; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (I had omnicron) 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 (I had omnicron). At the time of the report, COVID-19 (I had omnicron) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.    No treatment information provided.  Company comment:  This case concerns a patient with no reported medical history who experienced non-serious unexpected AESI of COVID-19, that occurred after the dose of the mRNA-1273 . The exact dose number and time to onset were not provided. The rechallenge was not applicable due to unspecified dose number. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient with no reported medical history who experienced non-serious unexpected AESI of COVID-19, that occurred after the dose of the mRNA-1273 . The exact dose number and time to onset were not provided. The rechallenge was not applicable due to unspecified dose number. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Hospitalisation
Clinical narrative: Rushed to the hospital the day after getting vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (Rushed to the hospital the day after getting vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (Rushed to the hospital the day after getting vaccine) (seriousness criterion hospitalization). At the time of the report, HOSPITALISATION (Rushed to the hospital the day after getting vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was provided. No treatment information was provided.  The reporter stated that the patient who was the mother-in-lawof the reporter rushed to the hospital the day after getting the vaccine.  Company comment:  This case concerns a female patient with no relevant medical history who experienced serious unexpected event of hospitalization, that occurred a day after the dose of the mRNA-1273 .  The rechallenge was not applicable due to unspecified number of doses administered. No further details were provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-447283, MOD-2022-447298, MOD-2022-447299 (Patient Link).; Sender's Comments: This case concerns a female patient with no relevant medical history who experienced serious unexpected event of hospitalization, that occurred a day after the dose of the mRNA-1273 .  The rechallenge was not applicable due to unspecified number of doses administered. No further details were provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: How long after contracting covid until I can get my booster? This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (How long after contracting covid until I can get my 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (How long after contracting covid until I can get my booster?). At the time of the report, COVID-19 (How long after contracting covid until I can get my booster?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company comment: This is a spontaneous case concerning a patient  of unknown age and gender with no reported medical history, who experienced the non-serious unexpected event COVID-19 (AESI), after receiving unspecified dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.   No Concomitant Drug details were reported.  No Treatment information was provided.   Reporter did not allow further contact; Sender's Comments: Company comment: This is a spontaneous case concerning a patient  of unknown age and gender with no reported medical history, who experienced the non-serious unexpected event COVID-19 (AESI), after receiving unspecified dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: Got covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got covid). At the time of the report, COVID-19 (Got covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Got COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company comment: This is a spontaneous case concerning a  male patient  of unknown age  with no reported medical history, who experienced the non-serious unexpected event COVID-19 (AESI), on an unknown date after receiving an unspecified dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report  No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter. Patient wanted to know where patient can get the Moderna booster shot.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jan-2022: Follow-up received and contains no new information. Sender's Comments: Company comment: This is a spontaneous case concerning a  male patient  of unknown age  with no reported medical history, who experienced the non-serious unexpected event COVID-19 (AESI), on an unknown date after receiving an unspecified dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 Disease after 2nd shot) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced COVID-19 (COVID-19 Disease after 2nd shot). At the time of the report, COVID-19 (COVID-19 Disease after 2nd shot) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: positive (Positive) Result: Patient reported positive PCR test after second shot. Company comment: This is a spontaneous case concerning a 35-year-old female immunocompromised patient, who experienced the non-serious unexpected event COVID-19, after receiving second dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report. Concomitant product use was not provided by the reporter. No treatment information provided. Sender's Comments: Company comment: This is a spontaneous case concerning a 35-year-old female immunocompromised patient, who experienced the non-serious unexpected event COVID-19, after receiving second dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: positive Covid-19 test; This spontaneous case was reported by a nurse and describes the occurrence of SARS-COV-2 TEST POSITIVE (positive Covid-19 test) 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 SARS-COV-2 TEST POSITIVE (positive Covid-19 test). At the time of the report, SARS-COV-2 TEST POSITIVE (positive Covid-19 test) 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 reported by reporter No treatment medications provided by the reporter.  Company Comment : This case concerns a patient of unknown age and gender with no medical history, who was tested positive for Covid 19 unknown days after receiving the mRNA-1273 Vaccine. The event was considered Non serious and is an AESI. The details of doses were not specified. The benefit-risk relationship of mRNA-1273 Vaccine in not affected by this report.   This case concerns a patient of unknown age and gender with no medical history, who was tested positive for Covid 19 unknown days after receiving the mRNA-1273 Vaccine. The event was considered Non serious and is an AESI. The details of doses were not specified. The benefit-risk relationship of mRNA-1273 Vaccine in not affected by this report.   Reporter did not allow further contact
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: got the Moderna primary series & booster dose & afterward tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (got the Moderna primary series & booster dose & afterward tested positive for Covid) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 SARS-COV-2 TEST POSITIVE (got the Moderna primary series & booster dose & afterward tested positive for Covid). At the time of the report, SARS-COV-2 TEST POSITIVE (got the Moderna primary series & booster dose & afterward tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: other (Positive) Positive.         No concomitant medication was reported. No treatment medication was reported.  Company Comment  This case concerns a 36-year old male patient with relevant  medical history of diabetes,  who was tested positive for Covid 19 (reported as got the Moderna primary series & booster dose & afterward tested positive for Covid) unknown days after receiving the booster dose of mRNA-1273 Vaccine. The event was considered Non serious and is an AESI. The patient was reported to have received the Moderna Primary serious and Booster doses. The benefit-risk relationship of mRNA-1273 Vaccine in not affected by this report.   This case was linked to MOD-2022-450970 (Patient Link).; Sender's Comments: This case concerns a 36-year old male patient with relevant medical history of diabetes, who was tested positive for Covid 19 (reported as got the Moderna primary series & booster dose & afterward tested positive for Covid) unknown days after receiving the booster dose of mRNA-1273 Vaccine. The event was considered Non serious and is an AESI. The patient was reported to have received the Moderna Primary serious and Booster doses. The benefit-risk relationship of mRNA-1273 Vaccine in not affected by this report.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Feeling abnormal, Pain in extremity, SARS-CoV-2 test
Clinical narrative: feeling bad; arm soreness; test positive for COVID/getting the vaccine while infected with COVID; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (test positive for COVID/getting the vaccine while infected with COVID), DRUG INEFFECTIVE (Lack of drug effect), FEELING ABNORMAL (feeling bad) and PAIN IN EXTREMITY (arm soreness) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046b21a and 008b212a) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, the patient experienced COVID-19 (test positive for COVID/getting the vaccine while infected with COVID) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced FEELING ABNORMAL (feeling bad) and PAIN IN EXTREMITY (arm soreness). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (test positive for COVID/getting the vaccine while infected with COVID) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown and FEELING ABNORMAL (feeling bad) and PAIN IN EXTREMITY (arm soreness) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication were reported.  Patient experienced arm soreness and feeling bad with the second dose but took Tylenol and felt better.  Patient took anti inflammatory and felt better.  Company Comment: This case refers to a 35-year-old female patient with no known medical history who experienced the unexpected events of COVID-19 and Drug Ineffective approximately 9 months after the second dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This case refers to a 35-year-old female patient with no known medical history who experienced the unexpected events of COVID-19 and Drug Ineffective approximately 9 months after the second dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old patient received the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient received the vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient received the vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient received the vaccine) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was not aware if the patient was on any concomitant medication and there was no information about treatment medication. Additionally, reporter did not know if the patient experienced any symptom after receiving the vaccines. Reportedly, patient received the vaccines under the Moderna Clinical Trials and asking that if he could get a booster dose of the Pfizer Vaccine.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Dysstasia, Insomnia, SARS-CoV-2 test positive
Clinical narrative: not been able to sleep; not been able to stand up; sitting up was hard; COVID/upper congestion/coughing/sitting up was hard/severe ill with COVID/he couldn't stand up and it took him 4 days to get off the bed; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Lack of drug effect), INSOMNIA (not been able to sleep), COVID-19 (COVID/upper congestion/coughing/sitting up was hard/severe ill with COVID/he couldn't stand up and it took him 4 days to get off the bed), DYSSTASIA (not been able to stand up) and SITTING DISABILITY (sitting up was hard) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031a21a and 027b21) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jul-2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (COVID/upper congestion/coughing/sitting up was hard/severe ill with COVID/he couldn't stand up and it took him 4 days to get off the bed). On an unknown date, the patient experienced INSOMNIA (not been able to sleep), DYSSTASIA (not been able to stand up) and SITTING DISABILITY (sitting up was hard). At the time of the report, DRUG INEFFECTIVE (Lack of drug effect), INSOMNIA (not been able to sleep), COVID-19 (COVID/upper congestion/coughing/sitting up was hard/severe ill with COVID/he couldn't stand up and it took him 4 days to get off the bed), DYSSTASIA (not been able to stand up) and SITTING DISABILITY (sitting up was hard) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2022, SARS-CoV-2 test positive: positive (Positive) positive.         No concomitant medication was reported.  No treatment medication was reported.  It was reported patient was good except for the upper congestion that won't go away.  Company Comment: This case refers to a 66-year-old male patient with no known medical history who experienced the unexpected events of Drug ineffective and COVID-19 approximately 3 months after the second dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case refers to a 66-year-old male patient with no known medical history who experienced the unexpected events of Drug ineffective and COVID-19 approximately 3 months after the second dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report.