chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use, Underdose
Clinical narrative: OFF-LABEL USE; RECEIVED 0.3 ML OF THE JANSSEN COVID-19 VACCINE INSTEAD OF 0.5 ML; RECEIVED 0.3 ML OF JANSSEN COVID-19 VACCINE TODAY INSTEAD OF SECOND DOSE OF PFIZER COVID-19 VACCINE; This spontaneous report received from a health care professional concerned a 21 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: 30130BA and expiry: 30-NOV-2021) .3 ml, administered on 21-SEP-2021 for prophylactic vaccination. Concomitant medications included BNT 162 for prophylactic vaccination.  On 21-SEP-2021, the patient experienced off-label use. On 21-SEP-2021, the patient experienced received 0.3 ml of the janssen covid-19 vaccine instead of 0.5 ml. On 21-SEP-2021, the patient experienced received 0.3 ml of janssen covid-19 vaccine today instead of second dose of pfizer covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off-label use, received 0.3 ml of janssen covid-19 vaccine today instead of second dose of pfizer covid-19 vaccine and received 0.3 ml of the janssen covid-19 vaccine instead of 0.5 ml was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Bronchitis, Dizziness, Impaired work ability, Nausea
Clinical narrative: BRONCHITIS (FEVER AGAIN, SEVERE HEADACHE, CHILLS, SEVERE COUGH); DIZZINESS; COULD NOT WORK ONE WEEK AFTER SHOT; NAUSEA; 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  (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced bronchitis (fever again, severe headache, chills, severe cough), dizziness, could not work one week after shot, and nausea. The action taken with covid-19 vaccine  was not applicable. The patient recovered from bronchitis (fever again, severe headache, chills, severe cough), dizziness, could not work one week after shot, and nausea. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: PAIN IN ARM; ARM FELT FULL LIKE SOMETHING IN THERE; This spontaneous report received from a consumer concerned a female 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 (suspension for injection, route of admin not reported, batch number: Unknown) 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 pain in arm, and arm felt full like something in there. The action taken with covid-19 vaccine was not applicable. The outcome of the pain in arm and arm felt full like something in there was not reported. This report was non-serious. This case, from the same reporter is linked to 20210941324.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Headache, Pyrexia
Clinical narrative: THOUGHT OF GOING TO DIE; FEVER; MASSIVE AND PAINFUL HEADACHE; 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: Unk) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported.  On AUG-2021, the patient experienced thought of going to die. On AUG-2021, the patient experienced fever. On AUG-2021, the patient experienced massive and painful headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 105. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from massive and painful headache, and the outcome of thought of going to die and fever was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough, SARS-CoV-2 test negative
Clinical narrative: LOSS OF TASTE; LOSS OF SMELL; DEEP COUGH; This spontaneous report received from a patient concerned a 64 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 (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-SEP-2021, the patient experienced loss of taste. On 06-SEP-2021, the patient experienced loss of smell. On 06-SEP-2021, the patient experienced deep cough.  On 17-SEP-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from loss of taste, loss of smell, and deep cough. This report was non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH /RASH SPREAD EVERYWHERE; This spontaneous report received from a patient concerned a 34 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: 1808982, and expiry: 21-SEP-2021) dose was not reported, administered on 07-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-SEP-2021, the patient experienced rash /rash spread everywhere. Treatment medications (dates unspecified) included: triamcinolone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash /rash spread everywhere. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Hypoaesthesia, Influenza like illness, Insomnia, Muscle spasms
Clinical narrative: CANNOT SLEEP; HAD PAIN UP AND DOWN LOWER BACK LIKE SCIATIC PAIN; FELT LIKE A MUSCLE CRAMP IN THE BACK OF LEGS; WHOLE BODY UNDER SKIN WAS ON FIRE; BABY TOE ON RIGHT FOOT WAS NUMB; MILD FLU SYMPTOMS; EXCRUCIATING OVERALL NERVE PAIN INCLUDING FINGERS AND FACE; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's past medical history included: neck pain, and concurrent conditions included: chronic migraine, and other pre-existing medical conditions included: The patient never had reaction before to a vaccine. The patient was previously treated with gabapentin for neck pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: 21-SEP-2021) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. Concomitant medications included amitriptyline for chronic migraine, and venlafaxine hydrochloride. On MAY-2021, the patient experienced mild flu symptoms. On MAY-2021, the patient experienced excruciating overall nerve pain including fingers and face. On MAY-2021, the patient experienced baby toe on right foot was numb. On 20-SEP-2021, the patient experienced whole body under skin was on fire. On 21-SEP-2021, the patient experienced felt like a muscle cramp in the back of legs. On an unspecified date, the patient experienced cannot sleep, and had pain up and down lower back like sciatic pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from excruciating overall nerve pain including fingers and face, and the outcome of mild flu symptoms, cannot sleep, had pain up and down lower back like sciatic pain, felt like a muscle cramp in the back of legs, whole body under skin was on fire and baby toe on right foot was numb was not reported. This report was non-serious. This case, from the same reporter is linked to 20210941191.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Skin burning sensation
Clinical narrative: CANNOT SLEEP; HAD PAIN UP AND DOWN LOWER BACK LIKE SCIATIC PAIN; FELT LIKE A MUSCLE CRAMP IN THE BACK OF LEGS; WHOLE BODY UNDER SKIN WAS ON FIRE; BABY TOE ON RIGHT FOOT WAS NUMB; MILD FLU SYMPTOMS; EXCRUCIATING OVERALL NERVE PAIN INCLUDING FINGERS AND FACE; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's past medical history included: neck pain, and concurrent conditions included: chronic migraine, and other pre-existing medical conditions included: The patient never had reaction before to a vaccine. The patient was previously treated with gabapentin for neck pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: 21-SEP-2021) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. Concomitant medications included amitriptyline for chronic migraine, and venlafaxine hydrochloride. On MAY-2021, the patient experienced mild flu symptoms. On MAY-2021, the patient experienced excruciating overall nerve pain including fingers and face. On MAY-2021, the patient experienced baby toe on right foot was numb. On 20-SEP-2021, the patient experienced whole body under skin was on fire. On 21-SEP-2021, the patient experienced felt like a muscle cramp in the back of legs. On an unspecified date, the patient experienced cannot sleep, and had pain up and down lower back like sciatic pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from excruciating overall nerve pain including fingers and face, and the outcome of mild flu symptoms, cannot sleep, had pain up and down lower back like sciatic pain, felt like a muscle cramp in the back of legs, whole body under skin was on fire and baby toe on right foot was numb was not reported. This report was non-serious. This case, from the same reporter is linked to 20210941191.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED (VACCINE ADMINISTERED TO 2 MALES FROM AN EXPIRED LOT); .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: 042A21A, expiry: 19-SEP-2021) dose was not reported, administered on 21-SEP-2021 for prophylactic vaccination. The batch numbers were not reported and have been requested. No concomitant medications were reported. On 21-SEP-2021, the patient experienced expired vaccine administered (vaccine administered to 2 males from an expired lot). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered (vaccine administered to 2 males from an expired lot) was not reported. This report was non-serious. This case, from the same reporter is linked to 20210941889.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED TO THREE FEMALES; 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 (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 21-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-SEP-2021, the patient experienced expired vaccine administered to three females. The action taken with covid-19 vaccine  was not applicable. The outcome of expired vaccine administered to three females was not reported. This report was non-serious. This case, from the same reporter is linked to 20210941376.
Age: 63.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Musculoskeletal stiffness
Clinical narrative: STIFF IN THE MORNING; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had other concomitant therapy of steroids. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported.  On an unspecified date, the patient experienced stiff in the morning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stiff in the morning was not reported. This report was non-serious.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Redness around injection site; Pain, swelling, itchiness at the inejction site; Experienced Itchiness 2 hours after getting it; Swelling at my right arm (injection site); A spontaneous report was received from a consumer concerning a 93-years-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced itching around injection site, redness around the injection site and swelling around injection site.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Benadryl, Metoprolol, Atorvastatin, Lorazepan, Vitamin C, Euthyrox, Latanoprost, Dorzolamide/Timolol and Mupirocin.  On 16 Jan 2021, approximately two hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 042L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.    On 16 Jan 2021, the patient experienced itching around injection site, redness around the injection site and swelling around injection site Treatment for the event included ice pack and Benadryl.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events itching around injection site, redness around the injection site and swelling around injection site was not reported.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Night sweats, Pyrexia, Tremor, Vaccination site pain
Clinical narrative: Shakes; Night sweats; sore injections site arm; Fatigue; On and off fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shakes), NIGHT SWEATS (Night sweats), VACCINATION SITE PAIN (sore injections site arm), FATIGUE (Fatigue) and PYREXIA (On and off fever) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Cancer (Cancer 25 years ago.) in 1996.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced TREMOR (Shakes), NIGHT SWEATS (Night sweats), VACCINATION SITE PAIN (sore injections site arm), FATIGUE (Fatigue) and PYREXIA (On and off fever). On 05-Feb-2021, TREMOR (Shakes), NIGHT SWEATS (Night sweats), VACCINATION SITE PAIN (sore injections site arm), FATIGUE (Fatigue) and PYREXIA (On and off fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications listed.  No treatment information provided.   This case was linked to MOD-2021-265490, MOD-2021-309134 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: Follow up received 06-Sep-21: Medical history was added
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Condition aggravated, Fatigue, Lacrimation increased, Nasal congestion
Clinical narrative: They have got a little worse; sore throat; watery eyes; being congested; runny nose; tired / fatigue; back hurt; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (They have got a little worse), BACK PAIN (back hurt), OROPHARYNGEAL PAIN (sore throat), LACRIMATION INCREASED (watery eyes) and NASAL CONGESTION (being congested) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088DZ1A and 0910Z1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE, VITAMINS NOS and PROBIOTICS NOS for an unknown indication.   On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced BACK PAIN (back hurt) and FATIGUE (tired / fatigue). On 10-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), LACRIMATION INCREASED (watery eyes), NASAL CONGESTION (being congested) and RHINORRHOEA (runny nose). On an unknown date, the patient experienced CONDITION AGGRAVATED (They have got a little worse). The patient was treated with PARACETAMOL (TYLENOL) on 11-Aug-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, CONDITION AGGRAVATED (They have got a little worse) outcome was unknown and BACK PAIN (back hurt), OROPHARYNGEAL PAIN (sore throat), LACRIMATION INCREASED (watery eyes), NASAL CONGESTION (being congested), RHINORRHOEA (runny nose) and FATIGUE (tired / fatigue) had not resolved.            Patient enquired if the symptoms she was experiencing were normal and were there any recommendations for treatment.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Rhinorrhoea
Clinical narrative: They have got a little worse; sore throat; watery eyes; being congested; runny nose; tired / fatigue; back hurt; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (They have got a little worse), BACK PAIN (back hurt), OROPHARYNGEAL PAIN (sore throat), LACRIMATION INCREASED (watery eyes) and NASAL CONGESTION (being congested) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088DZ1A and 0910Z1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE, VITAMINS NOS and PROBIOTICS NOS for an unknown indication.   On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced BACK PAIN (back hurt) and FATIGUE (tired / fatigue). On 10-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), LACRIMATION INCREASED (watery eyes), NASAL CONGESTION (being congested) and RHINORRHOEA (runny nose). On an unknown date, the patient experienced CONDITION AGGRAVATED (They have got a little worse). The patient was treated with PARACETAMOL (TYLENOL) on 11-Aug-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, CONDITION AGGRAVATED (They have got a little worse) outcome was unknown and BACK PAIN (back hurt), OROPHARYNGEAL PAIN (sore throat), LACRIMATION INCREASED (watery eyes), NASAL CONGESTION (being congested), RHINORRHOEA (runny nose) and FATIGUE (tired / fatigue) had not resolved.            Patient enquired if the symptoms she was experiencing were normal and were there any recommendations for treatment.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: stored in the fridge for 40 days so 10 days over our recommended storage.; vaccine administered after beeing in the fridge for 40 days; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (stored in the fridge for 40 days so 10 days over our recommended storage.) and EXPIRED PRODUCT ADMINISTERED (vaccine administered after beeing in the fridge for 40 days) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A, 004M20A and O29L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised, Shoulder pain since 15-Aug-2021, Hyperlipidemia, Peripheral neuropathy, CVA, Osteoporosis since May 2017 and Degenerative joint disease (Exacerbation of shoulder arthritis). Concomitant products included PREGABALIN (LYRICA), ROSUVASTATIN, ASA and PRAMIPEXOLE for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (stored in the fridge for 40 days so 10 days over our recommended storage.) and EXPIRED PRODUCT ADMINISTERED (vaccine administered after beeing in the fridge for 40 days). On 31-Aug-2021, PRODUCT STORAGE ERROR (stored in the fridge for 40 days so 10 days over our recommended storage.) and EXPIRED PRODUCT ADMINISTERED (vaccine administered after beeing in the fridge for 40 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that on 21 Jul 2021 vial was initially stored in the refrigerator. Total amount of time the vial was exposed to room temperature range noted that (8° to 25°C= 46° to 77° F): went over in a vaccine cooler, so the most would be 3 hours (start and end of the clinic).  No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.   This case was linked to MOD-2021-304556 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Patient demographics, current conditions, concomitant medication, first and second dose information were added.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: I'm experiencing all over body pain. Especially in muscles in upper arms.; I'm experiencing all over body pain, Especially in muscles in upper arms.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (I'm experiencing all over body pain. Especially in muscles in upper arms.) and MYALGIA (I'm experiencing all over body pain, Especially in muscles in upper arms.) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (I'm experiencing all over body pain. Especially in muscles in upper arms.) and MYALGIA (I'm experiencing all over body pain, Especially in muscles in upper arms.). At the time of the report, PAIN IN EXTREMITY (I'm experiencing all over body pain. Especially in muscles in upper arms.) and MYALGIA (I'm experiencing all over body pain, Especially in muscles in upper arms.) outcome was unknown.            No concomitant medications provided. No treatment medications provided. Patient asked that - Has anyone complained of sudden muscle and joint pain after a few months of vaccination?   This case was linked to MOD-2021-020743 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Difficulty breathing; chills; sore arm at injection site; Aches; fever; Sore Throat; sneezing; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat), SNEEZING (sneezing), DYSPNOEA (Difficulty breathing), MYALGIA (Aches) and PYREXIA (fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E12D) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Swab) on 08-Jan-2021. Concurrent medical conditions included Drug allergy (Codeine), Drug allergy (Darvocet), Drug allergy (Dilaudid), Drug allergy (Compasine), Drug allergy (Ambian) and Asthma (Wheezing, breathing difficulties). Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) from 08-Jan-2020 to an unknown date and MONTELUKAST SODIUM (SINGULAIR) from 08-Jan-2020 to an unknown date for Asthma, CEFIXIME (FLEXERIL [CEFIXIME]) from 02-Jan-2001 to an unknown date for Muscle ache, GABAPENTIN (GABA [GABAPENTIN]) from 02-Jan-2004 to an unknown date for Pain, ROPINIROLE HYDROCHLORIDE (RAPINEROL) from 03-Jan-2011 to an unknown date for Restless legs.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), SNEEZING (sneezing), MYALGIA (Aches) and PYREXIA (fever). On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing), CHILLS (chills) and VACCINATION SITE PAIN (sore arm at injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore Throat), SNEEZING (sneezing), MYALGIA (Aches), PYREXIA (fever), CHILLS (chills) and VACCINATION SITE PAIN (sore arm at injection site) outcome was unknown and DYSPNOEA (Difficulty breathing) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Updated reporter information. updated patient demographics, added other relevant history. Added concomitant and treatment medication. Added new events.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing, Vaccination site pain
Clinical narrative: Difficulty breathing; chills; sore arm at injection site; Aches; fever; Sore Throat; sneezing; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat), SNEEZING (sneezing), DYSPNOEA (Difficulty breathing), MYALGIA (Aches) and PYREXIA (fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E12D) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Swab) on 08-Jan-2021. Concurrent medical conditions included Drug allergy (Codeine), Drug allergy (Darvocet), Drug allergy (Dilaudid), Drug allergy (Compasine), Drug allergy (Ambian) and Asthma (Wheezing, breathing difficulties). Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) from 08-Jan-2020 to an unknown date and MONTELUKAST SODIUM (SINGULAIR) from 08-Jan-2020 to an unknown date for Asthma, CEFIXIME (FLEXERIL [CEFIXIME]) from 02-Jan-2001 to an unknown date for Muscle ache, GABAPENTIN (GABA [GABAPENTIN]) from 02-Jan-2004 to an unknown date for Pain, ROPINIROLE HYDROCHLORIDE (RAPINEROL) from 03-Jan-2011 to an unknown date for Restless legs.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), SNEEZING (sneezing), MYALGIA (Aches) and PYREXIA (fever). On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing), CHILLS (chills) and VACCINATION SITE PAIN (sore arm at injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore Throat), SNEEZING (sneezing), MYALGIA (Aches), PYREXIA (fever), CHILLS (chills) and VACCINATION SITE PAIN (sore arm at injection site) outcome was unknown and DYSPNOEA (Difficulty breathing) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Updated reporter information. updated patient demographics, added other relevant history. Added concomitant and treatment medication. Added new events.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032N20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   There were 9 patients instead of 10 as initially reported. All of the patients were administered with the 1st dose,  0.5ml, intramuscular on the left deltoid. Lot number 032N20A, expiration date 27Aug2021. This case is for the 3rd patient.  No concomitant medications reported. No treatment reported.   This case was linked to MOD21-141642, MOD21-141643, MOD21-141644, MOD21-141645, MOD21-141646, MOD21-141586, MOD21-141427, MOD21-141647, MOD-2021-314573, MOD-2021-314570, MOD-2021-314517, MOD-2021-314545, MOD-2021-314555, MOD-2021-314793, MOD-2021-314805, MOD-2021-314793 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow-up received on 15-SEP-2021 contains no new information. On 15-Sep-2021: Follow-up received on 15-SEP-2021 contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: can i take anti-inflammatories after taking the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (can i take anti-inflammatories after taking the vaccine) 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 PAIN (can i take anti-inflammatories after taking the vaccine). At the time of the report, PAIN (can i take anti-inflammatories after taking the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: first vaccine she was a little tired about 5 hours later from the first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (first vaccine she was a little tired about 5 hours later from the first vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 13-Jan-2021, the patient experienced FATIGUE (first vaccine she was a little tired about 5 hours later from the first vaccine). At the time of the report, FATIGUE (first vaccine she was a little tired about 5 hours later from the first vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment information was provided.   This case was linked to MOD-2021-314586, MOD-2021-314934.   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Significant follow up received contain Significant information (Patient pregnancy status)
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Computerised tomogram, Fibrin D dimer, Heart rate
Clinical narrative: Palpitations; Really high heart rate; Chest pain; Had very high fever; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations), HEART RATE INCREASED (Really high heart rate), CHEST PAIN (Chest pain) and PYREXIA (Had very high fever) 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 February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 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 PALPITATIONS (Palpitations), HEART RATE INCREASED (Really high heart rate), CHEST PAIN (Chest pain) and PYREXIA (Had very high fever). At the time of the report, PALPITATIONS (Palpitations), HEART RATE INCREASED (Really high heart rate), CHEST PAIN (Chest pain) and PYREXIA (Had very high fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) Blood tests were done and reported to have high levels of CRT and D-dimer.. On an unknown date, Computerised tomogram: normal (normal) Patient had undergone a contrast CT looking for pulmonary embolism but found that she did not have that.. On an unknown date, Fibrin D dimer: high (High) Elevated D-dimer.. On an unknown date, Heart rate: high (High) Heart rate increased..         No concomitant medications were reported. Treatment information was not provided.  The patient was recommended for the booster shot but she was concerned due to high reactions post second shot. Three days later she had visited her doctor because of the symptoms and had undergone lab tests including blood work where reported to have elevated level of CRT. The levels of CRT and D-dimer were still elevated and reported that it took 4 -5 weeks to get past from the symptoms.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Palpitations, Pyrexia
Clinical narrative: Palpitations; Really high heart rate; Chest pain; Had very high fever; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations), HEART RATE INCREASED (Really high heart rate), CHEST PAIN (Chest pain) and PYREXIA (Had very high fever) 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 February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 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 PALPITATIONS (Palpitations), HEART RATE INCREASED (Really high heart rate), CHEST PAIN (Chest pain) and PYREXIA (Had very high fever). At the time of the report, PALPITATIONS (Palpitations), HEART RATE INCREASED (Really high heart rate), CHEST PAIN (Chest pain) and PYREXIA (Had very high fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) Blood tests were done and reported to have high levels of CRT and D-dimer.. On an unknown date, Computerised tomogram: normal (normal) Patient had undergone a contrast CT looking for pulmonary embolism but found that she did not have that.. On an unknown date, Fibrin D dimer: high (High) Elevated D-dimer.. On an unknown date, Heart rate: high (High) Heart rate increased..         No concomitant medications were reported. Treatment information was not provided.  The patient was recommended for the booster shot but she was concerned due to high reactions post second shot. Three days later she had visited her doctor because of the symptoms and had undergone lab tests including blood work where reported to have elevated level of CRT. The levels of CRT and D-dimer were still elevated and reported that it took 4 -5 weeks to get past from the symptoms.
Age: 40.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Expired product administered
Clinical narrative: expired vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine administered) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.    Co-suspect product included non-company product LOSARTAN for an unknown indication.    Concurrent medical conditions included Allergy to gold (Allergy to gold salts), Latex allergy, Drug allergy (allergy to lisinopril), Drug allergy (Allergy to Balsam Peru-zinc Oxide), ADD, Hypertension and Perioral dermatitis. Concomitant products included TACROLIMUS MONOHYDRATE (PROTOPIC) for Perioral dermatitis, VITAMIN D3 and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 10-Sep-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose and LOSARTAN (Oral) 50 mg once a day. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine administered). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment drug was provided by reporter.  concomitant medication include Multivitamin.   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Patient initial, demographic details, Allergy (Gold Salts, Latex, Lisinopril & Balsam Peru-zinc Oxide) and current conditions (HTN, facial dermatitis) added. Concomitant medications (Vitamin D3, Lexapro, Losartan, Protopic and Multivitamin) added.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: receiving an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving an expired vaccine) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving an expired vaccine). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (receiving an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test positive
Clinical narrative: As of 9/10/2021 my spike protein from the covid 19 moderna vaccine is 2,500 and is not going down from july; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Sep-2021 and was forwarded to Moderna on 13-Sep-2021.    This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 ANTIBODY TEST POSITIVE (As of 9/10/2021 my spike protein from the covid 19 moderna vaccine is 2,500 and is not going down from july) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A, 013L20A and 039k20-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 ANTIBODY TEST POSITIVE (As of 9/10/2021 my spike protein from the covid 19 moderna vaccine is 2,500 and is not going down from july). At the time of the report, SARS-COV-2 ANTIBODY TEST POSITIVE (As of 9/10/2021 my spike protein from the covid 19 moderna vaccine is 2,500 and is not going down from july) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No Treatment information was reported.  Patient reported that her spike protein from the covid 19 moderna vaccine was 2,500 and was not going down from july and this was also the result of having moderna booster on 13 Aug 2021.   This case was linked to MOD-2021-010198, MOD-2021-064882.   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Follow up Document received and includes no new information.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: I feel pretty bad body aches; I've been having a fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Sep-2021 and was forwarded to Moderna on 13-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (I feel pretty bad body aches) and PYREXIA (I've been having a fever) 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 11-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (I feel pretty bad body aches) and PYREXIA (I've been having a fever). At the time of the report, MYALGIA (I feel pretty bad body aches) and PYREXIA (I've been having a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Myalgia, Nausea, Therapeutic response unexpected
Clinical narrative: today she is fine; horribly in discomfort; arm is extremely sore; nausea/all those symptoms that were on the website; chills/all those symptoms that were on the website; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (today she is fine), DISCOMFORT (horribly in discomfort), MYALGIA (arm is extremely sore), NAUSEA (nausea/all those symptoms that were on the website) and CHILLS (chills/all those symptoms that were on the website) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced DISCOMFORT (horribly in discomfort), MYALGIA (arm is extremely sore), NAUSEA (nausea/all those symptoms that were on the website) and CHILLS (chills/all those symptoms that were on the website). On 13-Sep-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (today she is fine). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (today she is fine), DISCOMFORT (horribly in discomfort), MYALGIA (arm is extremely sore), NAUSEA (nausea/all those symptoms that were on the website) and CHILLS (chills/all those symptoms that were on the website) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Flu like symptoms; Diarrhea; Headaches; Joint pains; Chills; Fever; Vomiting; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headaches), ARTHRALGIA (Joint pains), CHILLS (Chills) and PYREXIA (Fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headaches), ARTHRALGIA (Joint pains), CHILLS (Chills), PYREXIA (Fever), DIARRHOEA (Diarrhea), VOMITING (Vomiting) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN for Fever, at a dose of 1 dosage form. On 10-Sep-2021, PYREXIA (Fever) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headaches), ARTHRALGIA (Joint pains), CHILLS (Chills), DIARRHOEA (Diarrhea), VOMITING (Vomiting) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided.   This case was linked to MOD-2021-317521 (Patient Link).