chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: CRAMPING IN ARM WHERE INJECTION WAS ADMINISTERED; PAIN IN ARM WHERE THE INJECTION WAS ADMINISTERED; 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 ad26.cov2.s (suspension for injection, route of admin 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 cramping in arm where injection was administered, and pain in arm where the injection was administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in arm where the injection was administered and cramping in arm where injection was administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210842894.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: BODY PAIN; 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, 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 body pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of body pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; 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, 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 fever. Laboratory data (dates unspecified) included: Fever (NR: not provided) 102 (unit unspecified), 101 (unit unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: FEVER; LIGHT HEADACHE; This spontaneous report received from a parent concerned a 25 year old female. The patient's weight was 50 kilograms, and height was 170 centimeters. The patient's concurrent conditions included: anorexia, and other pre-existing medical conditions included: Patient was not pregnant and no breast feeding at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 18-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced fever. On AUG-2021, the patient experienced light headache. Laboratory data included: Body temperature (NR: not provided) 100.4 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and the outcome of light headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Migraine, Pyrexia
Clinical narrative: MIGRAINE; FEVER; 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, administered on 18-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 18-AUG-2021, the patient experienced migraine. On 18-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from migraine, and fever. This report was non-serious.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: DIARRHEA; This spontaneous report received from a patient concerned a 78 year old female. The patient's weight was 120 pounds, and height was 65 inches. The patient's past medical history included: dog bite, and concurrent conditions included: bipolar disorder, asthma, apples, eggs, chicken, wheat, all fruits (except carrots, potatoes, asparagus), lima beans, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included: The patient not experiencing any soreness in arm. 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 19-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 20-AUG-2021, the patient experienced diarrhea. Treatment medications (dates unspecified) included: electrolytes nos/glucose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: FEVER; EXTRA FATIGUE; 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. The patient's concurrent conditions included: sjogrens, and vaccine allergy. The patient received covid-19 vaccine ad26.cov2.s (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 fever, and extra fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and extra fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction, Therapeutic response unexpected
Clinical narrative: BAD SIDE EFFECTS FOR ABOUT A WEEK; NO STOMACH PAIN AT ALL; 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. The patient's concurrent conditions included: stomach ulcers. 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 21-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included omeprazole for pain and issue.  On an unspecified date, the patient experienced bad side effects for about a week, and no stomach pain at all. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad side effects for about a week, and the outcome of no stomach pain at all was not reported. This report was non-serious.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: VIAL PUNCTURED ON 19-AUG-2021 AT 4:35 PM AND ADMINISTERED ON 20-AUG-2021 AT 2:30 PM; This spontaneous report received from a pharmacist concerned a 33 year old male. 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: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 20-AUG-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 20-AUG-2021, the patient experienced vial punctured on 19-aug-2021 at 4:35 pm and administered on 20-aug-2021 at 2:30 pm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vial punctured on 19-aug-2021 at 4:35 pm and administered on 20-aug-2021 at 2:30 pm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a consumer via a company representative concerned a 59 year old male. 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, 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 fever. Treatment medications (dates unspecified) included: acetylsalicylic acid/caffeine/paracetamol/salicylamide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever. This report was non-serious. This case, from the same reporter is linked to 20210843017.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS ADMINISTERED OUTSIDE OF 2 HR ROOM TEMPERATURE WINDOW; VACCINE WAS ADMINISTERED OUTSIDE OF 2 HR; This spontaneous report received from a physician 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, intramuscular, batch number: Unknown) dose was not reported, administered on 20-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-AUG-2021, the patient experienced vaccine was administered outside of 2 hr room temperature window. On 20-AUG-2021, the patient experienced vaccine was administered outside of 2 hr. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was administered outside of 2 hr room temperature window and vaccine was administered outside of 2 hr was not reported. This report was non-serious.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site pruritus, Myalgia
Clinical narrative: ITCHING THAT GOES UP AND DOWN THE INJECTION SITE; LOOKED LIKE A LITTLE CUT AND RED AROUND INJECTION (LIKE SOMEBODY TOOK A SHARP BLADE TO IT); THE MUSCLE ON THE LEFT ARM HURT THAT SOMETIMES GOES DOWN THE ARM A LITTLE OR GOES UP NEAR SHOULDER; VERY TIRED AND FATIGUE; BURNING THAT GOES UP AND DOWN THE INJECTION SITE; This spontaneous report received from a patient concerned an 85 year old male. The patient's height, and weight were not reported. The patient's past medical history included: open heart surgery, pace maker, and covid-19 infection, and concurrent conditions included: non-smoker, alcohol use, penicillin allergy, and hard of hearing, and other pre-existing medical conditions included: The patient is taking medications for blood pressure, cholesterol, no illicit drug use. The patient experienced itching, shortness of breath, swelling of throat and welts when treated with sulfamethoxazole/trimethoprim, and warfarin sodium.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 19-SEP-2021) dose was not reported, administered on 11-AUG-2021 for prophylactic vaccination. Concomitant medications included lansoprazole for gastroesophageal reflux disease, and acetylsalicylic acid.  On 11-AUG-2021, the patient experienced itching that goes up and down the injection site. On 11-AUG-2021, the patient experienced looked like a little cut and red around injection (like somebody took a sharp blade to it). On 11-AUG-2021, the patient experienced the muscle on the left arm hurt that sometimes goes down the arm a little or goes up near shoulder. On 11-AUG-2021, the patient experienced very tired and fatigue. On 11-AUG-2021, the patient experienced burning that goes up and down the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from looked like a little cut and red around injection (like somebody took a sharp blade to it), itching that goes up and down the injection site, the muscle on the left arm hurt that sometimes goes down the arm a little or goes up near shoulder, very tired and fatigue, and burning that goes up and down the injection site. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; 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 not reported, batch number: Unknown) 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 chills, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Headache, Hyperhidrosis, Pain
Clinical narrative: SHAKY; FEELING PALE; SWEATING; BODYACHE; HEADACHE; FEELING WEAK; FEVER; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: lupus - low grade, and osteoporosis. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the patient experienced shaky. On 11-APR-2021, the patient experienced feeling pale. On 11-APR-2021, the patient experienced sweating. On 11-APR-2021, the patient experienced bodyache. On 11-APR-2021, the patient experienced headache. On 11-APR-2021, the patient experienced feeling weak. On 11-APR-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 100. The action taken with covid-19 vaccine was not applicable. The patient recovered from shaky, feeling pale, sweating, bodyache, headache, feeling weak, and fever on APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210842894.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Pyrexia, Tremor
Clinical narrative: SHAKY; FEELING PALE; SWEATING; BODYACHE; HEADACHE; FEELING WEAK; FEVER; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: lupus - low grade, and osteoporosis. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the patient experienced shaky. On 11-APR-2021, the patient experienced feeling pale. On 11-APR-2021, the patient experienced sweating. On 11-APR-2021, the patient experienced bodyache. On 11-APR-2021, the patient experienced headache. On 11-APR-2021, the patient experienced feeling weak. On 11-APR-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 100. The action taken with covid-19 vaccine was not applicable. The patient recovered from shaky, feeling pale, sweating, bodyache, headache, feeling weak, and fever on APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210842894.
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: EXTREME NAUSEA ABOUT 1-2 HOURS AFTER THE SHOT WAS ADMINISTERED; This spontaneous report received from a patient 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 (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. 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 extreme nausea about 1-2 hours after the shot was administered. The action taken with covid-19 vaccine was not applicable. The outcome of extreme nausea about 1-2 hours after the shot was administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Gastrointestinal disorder, Pain, Paraesthesia
Clinical narrative: GASTROINTESTINAL ISSUES; ABDOMINAL PAIN; PAINFUL WALK IN FEET; DIARRHEA; PROGRESSIVE TINGLING SENSATIONS IN LEGS AND FEET; 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 (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-JUN-2021, the patient experienced progressive tingling sensations in legs and feet. On an unspecified date, the patient experienced gastrointestinal issues, abdominal pain, painful walk in feet, and diarrhea. The action taken with covid-19 vaccine was not applicable. The outcome of the progressive tingling sensations in legs and feet, painful walk in feet, gastrointestinal issues, diarrhea and abdominal pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: LINGERING SORENESS PAIN; FEVER; 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. The patient's pre-existing medical conditions included: The patient keeping away from all flour, to avoid inflammation. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced lingering soreness pain, and fever. The action taken with covid-19 vaccine was not applicable. The outcome of the fever and lingering soreness pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: LITTLE PAIN AT THE INJECTION SITE; 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: unknown) 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 little pain at the injection site. The action taken with covid-19 vaccine was not applicable. The outcome of little pain at the injection site was not reported. This report was non-serious.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pyrexia
Clinical narrative: JOINT PAIN; FEVER; This spontaneous report received from a patient concerned a 39 year old male. 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: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 20-AUG-2021 for prophylactic vaccination.  No concomitant medications were reported. On 20-AUG-2021, the patient experienced joint pain. On 20-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from fever, and joint pain. This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Injection site pain, Muscular weakness, Paraesthesia
Clinical narrative: PAIN ON THE BACK; RASH (LOCATED ALL OVER THE BREAST); TINGLING ON LEGS AND ARMS; PAIN ON THE LEFT SIDE UNDERNEATH THE SHOULDER; WEAKNESS ON LEGS AND ARMS; INJECTION SITE PAIN (LEFT ARM); 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: amoxicillin allergy, penicillin allergy, sulfur allergy, non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient was not a drug abuse or illicit drug user. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 20-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-AUG-2021, the patient experienced pain on the back. On 21-AUG-2021, the patient experienced rash (located all over the breast). On 21-AUG-2021, the patient experienced tingling on legs and arms. On 21-AUG-2021, the patient experienced pain on the left side underneath the shoulder. On 21-AUG-2021, the patient experienced weakness on legs and arms. On 21-AUG-2021, the patient experienced injection site pain (left arm). Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from rash (located all over the breast), tingling on legs and arms, pain on the back, pain on the left side underneath the shoulder, weakness on legs and arms, and injection site pain (left arm). This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: PAIN ON THE BACK; RASH (LOCATED ALL OVER THE BREAST); TINGLING ON LEGS AND ARMS; PAIN ON THE LEFT SIDE UNDERNEATH THE SHOULDER; WEAKNESS ON LEGS AND ARMS; INJECTION SITE PAIN (LEFT ARM); 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: amoxicillin allergy, penicillin allergy, sulfur allergy, non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient was not a drug abuse or illicit drug user. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 20-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-AUG-2021, the patient experienced pain on the back. On 21-AUG-2021, the patient experienced rash (located all over the breast). On 21-AUG-2021, the patient experienced tingling on legs and arms. On 21-AUG-2021, the patient experienced pain on the left side underneath the shoulder. On 21-AUG-2021, the patient experienced weakness on legs and arms. On 21-AUG-2021, the patient experienced injection site pain (left arm). Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from rash (located all over the breast), tingling on legs and arms, pain on the back, pain on the left side underneath the shoulder, weakness on legs and arms, and injection site pain (left arm). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Injection site pain, Limb mass, Pain in extremity
Clinical narrative: LUMP IN THE ARM; RIGHT ARM IS SORE; PAIN IN SITE OF INJECTION; FATIGUE; LOSS OF ENERGY; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included: sick, and concurrent conditions included: fibromyalgia, diabetic, and cardiomyopathy, and other pre-existing medical conditions included: The patient had no known allergies. The patient experienced sick when treated with influenza vaccine.  The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, the patient experienced fatigue. On AUG-2021, the patient experienced loss of energy. On an unspecified date, the patient experienced lump in the arm, right arm is sore, and pain in site of injection. The action taken with covid-19 vaccine was not applicable. The patient recovered from lump in the arm, and pain in site of injection, and had not recovered from fatigue, loss of energy, and right arm is sore. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Suspected COVID-19
Clinical narrative: HAVING COVID AGAIN TWO DAYS AFTER VACCINATION; ARM SORENESS TO THE TOUCH JUST AROUND THE INJECTION SPOT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) 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 having covid again two days after vaccination. On AUG-2021, the patient experienced arm soreness to the touch just around the injection spot. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from arm soreness to the touch just around the injection spot, and the outcome of having covid again two days after vaccination was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: SHAKING SO BAD COULD BARELY SPEAK; 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: Unknown) 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 shaking so bad could barely speak. The action taken with covid-19 vaccine was not applicable. The outcome of shaking so bad could barely speak was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 101.7 F fever; A spontaneous report was received from a Nurse concerning herself, a female patient of an unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a fever of 101.7F/pyrexia.  The patient's medical history provided included Asthma. Relevant concomitant medication was reported which included Benralizumab.  On 22 Dec 2020, prior to the onset of symptoms, the patient received their doses of mRNA-1273 (lot/batch: 011J2A) for prophylaxis of COVID-19 infection.   On 22 Dec 2020, the patient, who was a COVID-19 IV nurse, experienced a fever of 101.7. The patient was feeling much better on 23 Dec 2020.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, 101.7 F fever, was resolving at the time of this report.   The reporter did not provide an assessment for the event of 101.7 F fever.  Follow-up received on 31 Jan 2021, 8:31 PM, included the current temperature of the patient which showed a temperature of 100° F. No additional information received.  Follow-up attempt initiated again.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot 011J2A), who experienced an expected event of fever. The event occurred the same day after the first dose of Moderna COVID-19 Vaccine administsration. The reporter did not provide the causality assessment for the event. The event of fever was considered related to Moderna COVID-19 Vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Mild soreness at site of injection; A spontaneous report was received from a Moderna employee from social media concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced mild soreness at site of injection.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unreported date in 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unreported date in 2020, the patient experienced mild soreness at the infection site. No treatment information was provided.   Action taken with the drug in response to the event was not reported.  The outcome of the event, mild soreness at site of injection, was not reported.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot-# not provided), who experienced an expected event of mild soreness at site of injection. The patient details, Lot# for the vaccine and time to onset for the events of mild soreness at site of injection was unknown. The reporter did not provide the causality assessment for the events.
Sex: U
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Pain
Clinical narrative: super achy; Kinda feels hot/cold; A spontaneous report was received from a physician concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, super achy and kinda feels hot/cold.    The patient's medical history as provided by the reporter included COVID-19. Concomitant medication were not reported.  On 22 Dec 2020, approximately one day prior to onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot # 025J20-2A) intramuscularly for prophylaxis of COVID-19 infection.  On 23 Dec 2020, the patient reported to feeling super achy and feeling hot/cold. The physician recommended APAP, however it was not confirmed as treatment.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the events, super achy and kinda feels hot/cold, were not provided.; Reporter's Comments: This case concerns a patient with a medical history of COVID-19, who received their first of two planned doses of mRNA-1273 (Lot 025J20-2A), and who experienced the unlisted events of Pain and Feeling of body temperature change.  The events were considered related to the vaccine due to the temporal relationship.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Injection site discomfort, Pyrexia
Clinical narrative: Weakness; Fever; Chills; Headache; Sore arm; A spontaneous report was received from a healthcare professional concerning a couple of patients who received Moderna's COVID-19 Vaccine and experienced fever, chills, weakness, headache, and sore arm.  The patients' medical history was not provided. Concomitant product use was not provided by the reporter.  On 23 Dec 2020, prior to the onset of the symptoms, the patients received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date in Dec 2020, a couple of patients developed side effects such as fever, chills, weakness, headache, and sore arm. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, fever, chills, weakness, headache, and sore arm were unknown.  The reporter assessed the events, fever, chills, weakness, headache, and sore arm, as related to study drug.; Reporter's Comments: This case concerns a subject, who experienced a non-serious expected event of pyrexia, chills, headache and injection site discomfort, and a non-serious unexpected event of asthenia. The event occurred approximately 1 day after the first dose of mRNA-1273 administration. A very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Joint pain; Muscles feeling sore; A spontaneous report was received from a consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced joint pain and muscles feeling sore.  The patient's medical history was not provided. Concomitant medications were not provided.  On an unspecified date in Dec 2020 prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date in Dec 2020, the patient reported on social media that they experienced a little joint pain, and their muscles felt sore. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, joint pain and muscles feeling sore, was not reported.  The reporter assessed the events, joint pain and muscles feeling sore, as related to study drug.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot-# and expiration date- unknown), reporting expected events of joint pain and muscles feeling sore. There is lack of supportive evidence indicating a temporal association between the onset of event and vaccine administration. The reporter assessed the event as related to vaccine.  However,  additional information regarding time to onset/ onset latency, patient's medical history and concomitant medications are required for further assessment.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness
Clinical narrative: Lightheadedness; Chills; A spontaneous report was received from a consumer concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills and lightheadedness.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unknown date, the patient received their first of two planned doses of mRNA-1273 (lot/batch unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient stated that they wanted to report some potential side effects of the vaccine that included some chills and lightheadedness. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events chills and lightheadedness were unknown.; Reporter's Comments: This case concerns a patient, who experienced events of chills and lightheadedness. The events occurred on an unknown date after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Redness and itchiness on neck, face and top of her head; Redness and itchiness on neck, face and top of her head; A spontaneous report was received from a physician's assistant concerning a 42-year-old female patient, who received Moderna's COVID-19 vaccine and experienced redness and itchiness on her neck, face and top of her head.   There was no medical history reported. Relevant concomitant medications were not provided.  On 24 Dec 2020, at 07:50, approximately three hours prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 24 Dec 2020, the patient experienced redness and itchiness on her neck, face and top of her head. After two hours, the symptoms resolved. The patient did not take any medications for the reported symptoms.  Action taken with mRNA-1273 in response to the events was not reported.   The events, redness and itchiness on her neck, face and top of her head, were considered resolved on 24 Dec 2020.; Reporter's Comments: This case concerns a 42 year old patient. The patient's medical history is not provided. The patient experienced an unexpected event of redness and itchiness on neck, face and top of her head. The event occurred on 24 Dec 2020 approximately three hours after the administration of the first dose of Moderna's COVID-19 vaccine. The reporter causality assessment for the event was not provided. Due to the temporal association between the event and administration of vaccine, a causal relationship, cannot be excluded. Additional information regarding patient's medical history and concomitant medicines details are required for further assessment.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: Knot like an egg on the elbow; A spontaneous report was received from a consumer concerning a 38-year old, male patient who experienced knot like an egg on the elbow.   The patient's medical history was not provided by the reporter. Concomitant product use was not provided by the reporter.   On 23 DEC 2020, the patient received one of two planned doses of mRNA-1273 (LOT/BATCH# 011J20A) by injection in the right arm for prophylaxis of COVID-19 infection.   On 24 DEC 2020, the patient developed a knot like an egg on his elbow in the left arm. The knot felt liquid inside and did not hurt. Treatment for the event included diphenhydramine HCl.   Action taken with mRNA-1273 in response to the event was not reported.   The event knot like an egg on the elbow was considered not recovered/not resolved.  The reporter did not provide an assessment for the knot like an egg on the elbow.; Reporter's Comments: This case concerns a 38-year-old, male patient. The patient's medical history was not provided. The patient experienced an unexpected event of swelling on elbow. The event occurred 1 day after one of two planned doses of mRNA-1273 (LOT/BATCH# 011J20A). Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inflammation, Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: excrutiatingly painful, like take my breath away pain when moving arm; arm seems inflamed; arm feels warm and looks red; dull ache with soreness extends all through the muscle; tingling in upper arm/neck; arm hurt similar to the flu shot; A spontaneous report was received from a physician's assistant concerning a 43 year old, female patient who developed pain in extremity, injection site inflammation, injection site erythema, myalgia and paraesthesia.    The patient's medical history included Sjogren's syndrome. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Lot # 025L20A) on  28 Dec 2020 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   Physician's assisted reported after the patient received the Moderna Covid Vaccine on 28 Dec 2020 she complained of arm hurting "similar to the flu shot". When the patient woke up the next morning, she could barely move her arm, and turning her palm up or down was "excoriatingly painful, like take my breath away pain" that was felt in her arm and shoulder. The patient described her arm as inflamed and warm and red going up into her shoulder and neck with tingling and muscle pain in her shoulder blade and back. The patient reported she believes the inflammation is due from the muscles getting irritated. She described the pain as a "dull ache" with soreness that extends all through the muscle.   Treatment for the event included ibuprofen 600 mg every 8 hours and fexofenadine 180 mg tablet in the morning.   Action taken with mRNA-1273 in response to the events was not provided.   The events, pain in extremity, injection site inflammation, injection site erythema, myalgia and paraesthesia were considered recovering.   The reporter did not provide an assessment for the event, pain in extremity, injection site inflammation, injection site erythema, myalgia and paraesthesia; Reporter's Comments: This report concerns a 43-year old female patient who experienced non-serious events pain in extremity, injection site inflammation, injection site erythema, myalgia and paraesthesia, occurring within 2 days of her receiving the mRNA-1273 (Lot # 025L20A). Events were considered as recovering after treatment with ibuprofen. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site haemorrhage
Clinical narrative: Bleeding from the arm; A spontaneous report was received from a female patient, who is physician by profession who received Moderna's COVID-19 vaccine (mRNA-1273) and developed bleeding from the arm.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 29 Dec 2020, immediately after vaccine administration,the patient experienced bleeding from the arm which was enough to reach the table her arm was resting on. She was not concerned about the bleeding but is concerned that the vaccine may have lost efficacy because of the blood lost. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, bleeding from the arm, was not reported.; Reporter's Comments: This case concerns a female patient of unknown age. The patient's medical history is not provided. The patient experienced an unexpected event of bleeding from the arm. The event occurred on 29 Dec 2020, immediately after  receiving first dose of mRNA-1273.  The sponsor assessed the event as unrelated to the mRNA-1273 vaccine.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza virus test, Injection site pruritus, Pruritus, SARS-CoV-2 test
Clinical narrative: chills; extreme itching at the injection site; systemic itching throughout her whole body; A spontaneous report was received from a pharmacist concerning a 60-year-old, female patient who was participating in the mRNA-1273 trial and who experienced extreme itching at the injection site, systemic itching throughout her whole body and chills.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 on 23-Dec-2020 intramuscularly for prophylaxis of COVID-19 infection.   Patient received her Moderna vaccine on 23-Dec-2020 and stated that she has had bad side effects continuously since then.  On 30-Dec-2020, she reported that she had extreme itching at the injection site as well as systemic itching.  She denied hives. Approximately 02-Jan-2021, patient endorsed on and off chills.   Patient reported having had two Covid-19 tests, one on 28-Dec-2020 ordered by her workplace and the other one on 31-Dec-2020 ordered by her primary physician, both of which were negative.  She stated that on 31-Dec-2020, she also had a flu test that was negative.    Patient admitted to taking diphenhydramine to help alleviate itching.  She wished to know if these side effects were normal.    Treatment for the event included diphenhydramine for itching.   Action taken with mRNA-1273 in response to the events, extreme itching at the injection site, systemic itching throughout her whole body and chills, was not provided.   The outcome of the events, extreme itching at the injection site, systemic itching throughout her whole body and chills, was not reported.  The reporter did not provide a causality assessment for the events, extreme itching at the injection site, systemic itching throughout her whole body and chills; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19 with symptoms; A spontaneous report  was received from pharmacist concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Dec 2020, prior to the onset of the events, the patient received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection.  On 30 Dec 2020, the patient tested positive for COVID-19 with symptoms.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the event, tested positive for COVID-19 with symptoms, was not reported.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested