chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Aphonia, Chest pain, Headache, Lymph node pain, Migraine
Clinical narrative: VERY SORE LYMPH NODE IN GROIN WHICH GOT MUCH BIGGER RED AND SORE; SORE CHEST; PINS AND NEEDLES; MIGRAINE; VOICE IS GOING AWAY; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. 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: unknown) dose was not reported, administered on 20-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On DEC-2021, the patient experienced voice is going away, and headache. On 20-DEC-2021, the patient experienced migraine. On 21-DEC-2021, the patient experienced very sore lymph node in groin which got much bigger red and sore, sore chest, and pins and needles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very sore lymph node in groin which got much bigger red and sore, voice is going away, and headache, and the outcome of migraine, sore chest and pins and needles was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: VERY SORE LYMPH NODE IN GROIN WHICH GOT MUCH BIGGER RED AND SORE; SORE CHEST; PINS AND NEEDLES; MIGRAINE; VOICE IS GOING AWAY; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. 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: unknown) dose was not reported, administered on 20-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On DEC-2021, the patient experienced voice is going away, and headache. On 20-DEC-2021, the patient experienced migraine. On 21-DEC-2021, the patient experienced very sore lymph node in groin which got much bigger red and sore, sore chest, and pins and needles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very sore lymph node in groin which got much bigger red and sore, voice is going away, and headache, and the outcome of migraine, sore chest and pins and needles was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blindness transient, Eye pain
Clinical narrative: COMPLETELY BLIND; HORRIBLE PAIN IN EYES; This spontaneous report received from a consumer via social media  via a company representative concerned a female 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 (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The reported stated that, "Johnson & Johnson my cousin went completely blind after the j&j vaccine. Thank God it only lasted 3 days but it scared her half to death! She also had horrible pain in her eyes." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from completely blind, and the outcome of horrible pain in eyes was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20211256346 -covid-19 vaccine ad26.cov2.s -Completely blind. 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).
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, and batch number: unknown expiry: unknown ) dose, start therapy date were not reported, dose number in series was 1, 01 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot from the shot (dose number in was series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211256517 - COVID-19 VACCINE AD26.COV2.S- Blood clot. This event is considered unassessable. The event 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.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: CHRONIC DIARRHEA; EPISODES OF  HEADACHE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: bioidentical hormone therapy, pollen allergy, alcohol user, non smoker, and menopause, and other pre-existing medical conditions included: The patient does not have history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211021A, and expiry: 04-11-2022) dose was not reported, administered on 26-NOV-2021 for prophylactic vaccination.  Concomitant medications included testosterone for drug used for unknown indication, estradiol/estriol for menopause, and progesterone for menopause.  On 02-DEC-2021, the patient experienced chronic diarrhea. On 02-DEC-2021, the patient experienced episodes of headache. Treatment medications (dates unspecified) included: acetylsalicylic acid/caffeine/paracetamol/salicylamide, bismuth subsalicylate, and acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chronic diarrhea, and episodes of headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a consumer via social media via a company representative concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: Unknown and expiry: Unknown) dose was not reported, start therapy date were not reported, (dose number in series was 1), 1 total 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 stroke (dose number in series was 1). The consumer reported as " I am waiting for my friend to get better after the stroke he had after the vaccination". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stroke. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20211256852-covid-19 vaccine ad26.cov2.s-Stroke. 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).
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Magnetic resonance imaging, Neuropathy peripheral, Sensorimotor disorder, Visual acuity tests
Clinical narrative: BILATERAL VISUAL SYMPTOMS; SENSORIMOTOR SYMPTOMS IN EXTREMITIES; OBJECTIVE WEAKNESS; NEUROPATHIC SYMPTOMS IN EXTREMITIES; This spontaneous report received from a physician concerned a 30 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was 7/52 postpartum. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, dose was not reported, administered on 15-DEC-2021 for prophylactic vaccination. The dose number in series was 1. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-DEC-2021, the patient experienced neuropathic symptoms in extremities, and objective weakness. Laboratory data included: Visual acuity tests (NR: not provided) Reduced in both eyes. On an unspecified date after vaccination, the patient experienced bilateral visual symptoms, and sensorimotor symptoms in extremities (dose number in series was 1). Laboratory data (dates unspecified) included: LP test (NR: not provided) Normal, and MRI (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bilateral visual symptoms, sensorimotor symptoms in extremities, objective weakness and neuropathic symptoms in extremities was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211257058-COVID-19 VACCINE AD26.COV2.S-neuropathic symptoms in extremities. 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).
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: BILATERAL VISUAL SYMPTOMS; SENSORIMOTOR SYMPTOMS IN EXTREMITIES; OBJECTIVE WEAKNESS; NEUROPATHIC SYMPTOMS IN EXTREMITIES; This spontaneous report received from a physician concerned a 30 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was 7/52 postpartum. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, dose was not reported, administered on 15-DEC-2021 for prophylactic vaccination. The dose number in series was 1. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-DEC-2021, the patient experienced neuropathic symptoms in extremities, and objective weakness. Laboratory data included: Visual acuity tests (NR: not provided) Reduced in both eyes. On an unspecified date after vaccination, the patient experienced bilateral visual symptoms, and sensorimotor symptoms in extremities (dose number in series was 1). Laboratory data (dates unspecified) included: LP test (NR: not provided) Normal, and MRI (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bilateral visual symptoms, sensorimotor symptoms in extremities, objective weakness and neuropathic symptoms in extremities was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211257058-COVID-19 VACCINE AD26.COV2.S-neuropathic symptoms in extremities. 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).
Sex: U
Vaccine: COVID19
Symptoms: Cardiac operation
Clinical narrative: HEART SURGERY; 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 not reported, batch number: UNKNOWN) dose was not reported, (Dose number in series:1) administered on APR-2021 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 SEP-2021, the patient experienced heart surgery.(Dose number in series:1)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart surgery was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: VERY SICK; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, 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 or lot number. No concomitant medications were reported. On an unspecified date, the patient experienced very sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very sick was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: 21-DEC-2021) dose was not reported, administered on 23-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-DEC-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This report was associated with product quality complaint: 90000208947.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a patient via social media 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 (dose number in series 1) (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 06-MAY-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 25-MAY-2021, reporter stated that "Same here....vaccine on May 6 stroke on May 25. " The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211258275-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Stroke. 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).
Sex: U
Vaccine: COVID19
Symptoms: Cardiac monitoring, Cerebrovascular accident
Clinical narrative: 2 STROKES ON BOTH SIDES OF HEAD; This spontaneous report received from a patient via a company representative via social media 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 (Janssen series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, start therapy date was 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 had stroke and as per the reporter "I took the one shot Johnson & Johnson and had 2 strokes on both sides of my head and have been on a heart monitor since."   Laboratory data (dates unspecified) included: Cardiac monitoring (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 2 strokes on both sides of head was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211258341 -JANSSEN COVID-19 VACCINE Ad26.COV2.S -       2 strokes on both sides of head -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).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: ARM PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 31 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: 217A21A, and expiry: UNKNOWN) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced arm pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm pain at injection site. This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user (one glass a month), and non smoker, and other pre-existing medical conditions included: no relevant medical history and no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1820096 expiry: UNKNOWN) dose was not reported, 1 total, administered on 27-MAY-2021 for prophylactic vaccination (dose number in series is 1). No concomitant medications were reported.  On 26-DEC-2021, at evening, the patient experienced symptoms of dry cough, dry throat and headache. On 27-DEC-2021, on the day of reporting, the patient tested positive with rapid home test (suspected clinical vaccination failure and suspected covid-19 infection). 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 report was associated with product quality complaint: 90000209034.; Sender's Comments: V0-20211258550-Covid-19 vaccine ad26.CoV-2.s- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
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 white, non Hispanic or Latino male of unspecified age. 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, batch number and expiry were not reported) dose was not reported, dose number in series 1, administered 1 in total on 27-APR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-DEC-2021, patient experienced chills, headaches, body aches and cough (dose number in series 1). On 25-DEC-2021, antigen rapid test was performed and the results came out to be negative. On 27-DEC-2021, patient took another antigen rapid test (BinaxNOW) twice and the results came out to be positive (suspected clinical vaccination failure, and suspected covid-19 infection). 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 report was associated with a product quality complaint 90000209037; Sender's Comments: V0: 20211258606-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
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: VERY FAINT METALLIC TASTE (5 MINUTES AFTER THE VACCINE WHEN STARTED SALIVATING); This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: multiple sclerosis, and other pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835 expiry: UNKNOWN) dose was not reported, administered on 27-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-DEC-2021, the patient experienced very faint metallic taste (5 minutes after the vaccine when started salivating). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very faint metallic taste (5 minutes after the vaccine when started salivating). This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIRED EASIER AS LONG TERM SIDE EFFECT; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was very healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-AUG-2021, the patient experienced tired easier as long term side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired easier as long term side effect. This report was non-serious. This case, from the same reporter is linked to 20211259114.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Headache, Malaise, SARS-CoV-2 test
Clinical narrative: FELT LITTLE SICK; HEADACHE IN ONE SIDE OF HEAD; This spontaneous report received from a patient concerned a 67 year old female.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821287, expiry: 30-OCT-2021) dose was not reported, administered on 19-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-DEC-2021, the patient experienced felt little sick, and headache in one side of head. On 16-DEC-2021, Laboratory data included: Antibody test (NR: not provided) 57.9, has antibodies, and SARS-CoV-2 rapid diagnostic test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache in one side of head and felt little sick was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID MONTHS AFTER THE VACCINE; This spontaneous report received from a patient via social media, 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 covid months after the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid months after the vaccine was not reported. This report was non-serious. This report was associated with product quality complaint: 90000208881.
Sex: U
Vaccine: COVID19
Symptoms: Anger, Emotional distress, Irritability, Mood altered
Clinical narrative: EXTREMELY IRRITABLE; LITTLE THINGS SET ME OFF; ANGER ISSUES; REALLY SUFFERING; 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 was not reported, administered on SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On SEP-2021, the patient experienced extremely irritable, little things set me off, anger issues, and really suffering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extremely irritable, little things set me off, anger issues, and really suffering. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Lichen planus
Clinical narrative: LICHEN PLANUS (NOW STARTING TO SCAR FROM THE RASH); This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, 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 lichen planus (now starting to scar from the rash). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lichen planus (now starting to scar from the rash). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Lung disorder
Clinical narrative: HAS THEM IN BOTH LUNGS; This spontaneous report received from a consumer via a company representative concerned a 40 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, 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 has them in both lungs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of has them in both lungs was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: SHORTNESS OF BREATH; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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 was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shortness of breath was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: CONSTANT HEADACHES AS LONG TERM SIDE EFFECTS; This spontaneous report received from a consumer concerned a male of unspecified age. 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: unknown) dose was not reported, administered on NOV-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 constant headaches as long term side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from constant headaches as long term side effects. This report was non-serious. This case, from the same reporter is linked to 20211258623.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: 2 doses of the firs dose of the Moderna vaccine the same day; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (2 doses of the firs dose of the Moderna vaccine the same day) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced EXTRA DOSE ADMINISTERED (2 doses of the firs dose of the Moderna vaccine the same day). In February 2021, EXTRA DOSE ADMINISTERED (2 doses of the firs dose of the Moderna vaccine the same day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided by the reporter. No treatment information provided.  Patient got the second dose at day 28.   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Non-significant follow-up document appended.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12 year old received Moderna lot number 076c21a; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received Moderna lot number 076c21a) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21a) for COVID-19 vaccination.     No Medical History information was reported.  On 28-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received Moderna lot number 076c21a). On 28-Oct-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received Moderna lot number 076c21a) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medication were provided.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used/19 patients received an expired booster; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/19 patients received an expired booster) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/19 patients received an expired booster). On 30-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/19 patients received an expired booster) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.  HCP states that they had two lots from the Moderna vaccine in the freezer. They pulled one or two vials for a clinic yesterday, 30Nov2021, and administered 19 doses (all boosters).   17 patient identifiers and all  were monitored for at least 15 minutes after the injection with no adverse events reported.  Also stated that vial does not undergo any temperature excursions.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 5 doses administered more than 12 hours after 1st puncture of the vials; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses administered more than 12 hours after 1st puncture of the vials) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-2021 at 2:32 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses administered more than 12 hours after 1st puncture of the vials). On 21-Sep-2021, EXPIRED PRODUCT ADMINISTERED (5 doses administered more than 12 hours after 1st puncture of the vials) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator 9Sep2021 Date and time vial was first punctured: 16Sep2021 at 11:45 am  No concomitant medication was provided.            No treatment information was provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vision blurred
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of VISION BLURRED (Blurred vision) and HEADACHE (Headache) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 027H21B) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.   On 31-Dec-2020, the patient 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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced VISION BLURRED (Blurred vision) and HEADACHE (Headache). At the time of the report, VISION BLURRED (Blurred vision) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment reported
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccinated after the excursion; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccinated after the excursion) and PRODUCT STORAGE ERROR (Product storage error) 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 EXPIRED PRODUCT ADMINISTERED (Vaccinated after the excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccinated after the excursion) had resolved and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.  The facility had a 20 minute excursion in the freezer that the Moderna COVID-19 vials were stored in. The excursion was on Sunday.   This case was linked to MOD-2021-404757, MOD-2021-404629, MOD-2021-404754, MOD-2021-404644, MOD-2021-404793, MOD-2021-404722, MOD-2021-404660, MOD-2021-404699 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: Experienced Appendicitis after receiving the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (Experienced Appendicitis after receiving the Moderna 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.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced APPENDICITIS (Experienced Appendicitis after receiving the Moderna vaccine) (seriousness criterion medically significant). At the time of the report, APPENDICITIS (Experienced Appendicitis after receiving the Moderna vaccine) outcome was unknown.            Concomitant product use was not provided by the reporter.   No treatment information was provided. Company Comment This case concerns a female patient of unknown age, with no relevant medical history reported, who experienced the unexpected event of appendicitis (AESI). The event occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient of unknown age, with no relevant medical history reported, who experienced the unexpected event of appendicitis (AESI). The event occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine past published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past published expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050e21a) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past published expiry). On 16-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received vaccine past published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Vertigo
Clinical narrative: migraines (after 2nd dose); vertigo (after 2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraines (after 2nd dose)) and VERTIGO (vertigo (after 2nd dose)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia and Arthritis.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (migraines (after 2nd dose)) and VERTIGO (vertigo (after 2nd dose)). At the time of the report, MIGRAINE (migraines (after 2nd dose)) and VERTIGO (vertigo (after 2nd dose)) outcome was unknown.            No concomitant medication were reported.  No treatment information was provided by the reporter.  It was unknown if the IM injection was given into the left or right deltoid.   This case was linked to MOD-2021-402734 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dyspepsia, Fatigue, Feeling of body temperature change
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (heartburn), ILLNESS (in bed sick), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), FATIGUE (fatigue) and CHILLS (chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 044A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Hypothyroidism, Hypertension and Triglycerides. Concomitant products included CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE (CHONDROITIN GLUCOSAMIN) for Arthritis, ALLOPURINOL, BIOTIN, CALCIUM CITRATE, CELECOXIB, CLONAZEPAM, COLLAGEN, DILTIAZEM, CONJUGATED LINOLEIC ACID, LINUM USITATISSIMUM SEED OIL, UBIDECARENONE (COQ10 [CONJUGATED LINOLEIC ACID;LINUM USITATISSIMUM SEED OIL;UBIDECARENONE]), ESOMEPRAZOLE, GABAPENTIN, BISACODYL (LAXATIVE [BISACODYL]), GLIPIZIDE, HYDROCHLOROTHIAZIDE, LORATADINE, LOSARTAN, IRON, PAROXETINE, DOCUSATE SODIUM (STOOL SOFTENER), DENOSUMAB (PROLIA), RISPERIDONE, ROSUVASTATIN, LEVOTHYROXINE SODIUM (SYNTHROID), HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ), CURCUMA LONGA ROOT, PIPER NIGRUM FRUIT (TURMERIC CURCUMIN [CURCUMA LONGA ROOT;PIPER NIGRUM FRUIT]) and COLECALCIFEROL (VITAMIN D3) for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, the patient experienced DYSPEPSIA (heartburn), ILLNESS (in bed sick), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), FATIGUE (fatigue), CHILLS (chills), NAUSEA (nausea), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and VACCINATION SITE PAIN (arm little sore). The patient was treated with CALCIUM CARBONATE, MAGNESIUM CARBONATE (TUMS [CALCIUM CARBONATE;MAGNESIUM CARBONATE]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPEPSIA (heartburn) and VACCINATION SITE PAIN (arm little sore) had not resolved and ILLNESS (in bed sick), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), FATIGUE (fatigue), CHILLS (chills), NAUSEA (nausea), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.