chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: HAIR LOSS TO THE POINT OF BALD SPOTS ON SCALP/NOTICED EXCESSIVE HAIR LOSS ON BACK OF HEAD/NEW PATCH OF HAIR MISSING FROM FRONT OF MY HEAD; This spontaneous report received from a patient via a company representative 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: 211A21A expiry: UNKNOWN) dose was not reported, administered on 20-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-OCT-2021, the patient experienced hair loss to the point of bald spots on scalp/noticed excessive hair loss on back of head/new patch of hair missing from front of my head. The action taken with covid-19 vaccine  was not applicable. The outcome of hair loss to the point of bald spots on scalp/noticed excessive hair loss on back of head/new patch of hair missing from front of my head was not reported. This report was non-serious. This case, from the same reporter is linked to 20211046106.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: FLOP LIKE A FISH IN PAIN IN HEART; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced flop like a fish in pain in heart. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flop like a fish in pain in heart was not reported. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cough, Fatigue, Headache
Clinical narrative: BODY ACHES; COUGH; NASAL CONGESTION; SNEEZING; CHILLS; WEAKNESS; TIREDNESS; HEADACHES; This spontaneous report received from a patient concerned an 82 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: 212A21A expiry: UNKNOWN) dose was not reported, administered on 13-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-OCT-2021, the patient experienced body aches. On 17-OCT-2021, the patient experienced cough. On 17-OCT-2021, the patient experienced nasal congestion. On 17-OCT-2021, the patient experienced sneezing. On 17-OCT-2021, the patient experienced chills. On 17-OCT-2021, the patient experienced weakness. On 17-OCT-2021, the patient experienced tiredness. On 17-OCT-2021, the patient experienced headaches. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from chills, body aches, weakness, cough, tiredness, nasal congestion, headaches, and sneezing. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Pain, Sneezing
Clinical narrative: BODY ACHES; COUGH; NASAL CONGESTION; SNEEZING; CHILLS; WEAKNESS; TIREDNESS; HEADACHES; This spontaneous report received from a patient concerned an 82 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: 212A21A expiry: UNKNOWN) dose was not reported, administered on 13-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-OCT-2021, the patient experienced body aches. On 17-OCT-2021, the patient experienced cough. On 17-OCT-2021, the patient experienced nasal congestion. On 17-OCT-2021, the patient experienced sneezing. On 17-OCT-2021, the patient experienced chills. On 17-OCT-2021, the patient experienced weakness. On 17-OCT-2021, the patient experienced tiredness. On 17-OCT-2021, the patient experienced headaches. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from chills, body aches, weakness, cough, tiredness, nasal congestion, headaches, and sneezing. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Swollen tongue
Clinical narrative: SWELLING OF THE TONGUE; SWELLING OF THE THROAT; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced swelling of the tongue, and swelling of the throat. The action taken with covid-19 vaccine was not applicable. The outcome of the swelling of the tongue and swelling of the throat was not reported. This report was non-serious. This case, from the same reporter is linked to 20211046395 and 20211039784.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Pyrexia
Clinical narrative: SICK; WORST FEVER AT NIGHT; 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, 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 sick, and worst fever at night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick, and the outcome of worst fever at night was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Cold sweat, Pyrexia
Clinical narrative: COLD SWEAT; QUITE SEVERE 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. 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 cold sweat, and quite severe fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sweat, and quite severe fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: SORE ARM; 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. 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. 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 sore arm, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: BODY ACHES; CHILLS; 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 expiry: UNKNWON) 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 chills, and body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and body aches was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia
Clinical narrative: FELT CRUMMY; DELTOID PAIN/ SORE DELTOID; This spontaneous report received from a patient concerned a 59 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: unknown) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the patient experienced felt crummy. On 13-MAR-2021, the patient experienced deltoid pain/ sore deltoid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt crummy, and deltoid pain/ sore deltoid on 14-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20211047299.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 24 HOURS WITH A TOUGH 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, 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 24 hours with a tough fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 24 hours with a tough fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned 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: 1821281 expiry: 21-OCT-2021) dose was not reported, administered on 22-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-OCT-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine  was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211047333.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Injection site pain, Insomnia, Joint range of motion decreased
Clinical narrative: MOBILITY ISSUES; CAN NOT SLEEP; CAN NOT MOVE SHOULDER (HER BLOUSE HURTS ON HER SKIN, CAN NOT GET SEATBELT ON)/CAN NOT LIFT BAG; SHOULDER INFLAMMATION; CAN NOT DO MUCH OF WHAT SHE USED TO DO; SEVERE PAIN IN ENTIRE SHOULDER AREA (SUPERFICIAL PAIN AND DEEPER PAIN INSIDE THE SHOULDER, AMPLIFIED PAIN RESPONSE THAT BOTH GROSS AND MORE MINUTE); FELT SICK; INTENSE INJECTION SITE PAIN; FEVER; This spontaneous report received from a consumer concerned a 71 year old female. The patient's height, and weight were not reported. The patient's past medical history included: car accident, and shoulder was hurt. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the patient experienced severe pain in entire shoulder area (superficial pain and deeper pain inside the shoulder, amplified pain response that both gross and more minute). On 13-MAR-2021, the patient experienced felt sick. On 13-MAR-2021, the patient experienced intense injection site pain. On 13-MAR-2021, the patient experienced fever. On an unspecified date, the patient experienced mobility issues, can not sleep, can not move shoulder (her blouse hurts on her skin, can not get seatbelt on) /can not lift bag, shoulder inflammation, and can not do much of what she used to do. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt sick, and fever on 23-MAR-2021, and had not recovered from intense injection site pain, severe pain in entire shoulder area (superficial pain and deeper pain inside the shoulder, amplified pain response that both gross and more minute), can not move shoulder (her blouse hurts on her skin, can not get seatbelt on)/can not lift bag, shoulder inflammation, mobility issues, can not sleep, and can not do much of what she used to do. This report was non-serious. This case, from the same reporter is linked to 20211047262.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Malaise, Mobility decreased, Pyrexia
Clinical narrative: MOBILITY ISSUES; CAN NOT SLEEP; CAN NOT MOVE SHOULDER (HER BLOUSE HURTS ON HER SKIN, CAN NOT GET SEATBELT ON)/CAN NOT LIFT BAG; SHOULDER INFLAMMATION; CAN NOT DO MUCH OF WHAT SHE USED TO DO; SEVERE PAIN IN ENTIRE SHOULDER AREA (SUPERFICIAL PAIN AND DEEPER PAIN INSIDE THE SHOULDER, AMPLIFIED PAIN RESPONSE THAT BOTH GROSS AND MORE MINUTE); FELT SICK; INTENSE INJECTION SITE PAIN; FEVER; This spontaneous report received from a consumer concerned a 71 year old female. The patient's height, and weight were not reported. The patient's past medical history included: car accident, and shoulder was hurt. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the patient experienced severe pain in entire shoulder area (superficial pain and deeper pain inside the shoulder, amplified pain response that both gross and more minute). On 13-MAR-2021, the patient experienced felt sick. On 13-MAR-2021, the patient experienced intense injection site pain. On 13-MAR-2021, the patient experienced fever. On an unspecified date, the patient experienced mobility issues, can not sleep, can not move shoulder (her blouse hurts on her skin, can not get seatbelt on) /can not lift bag, shoulder inflammation, and can not do much of what she used to do. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt sick, and fever on 23-MAR-2021, and had not recovered from intense injection site pain, severe pain in entire shoulder area (superficial pain and deeper pain inside the shoulder, amplified pain response that both gross and more minute), can not move shoulder (her blouse hurts on her skin, can not get seatbelt on)/can not lift bag, shoulder inflammation, mobility issues, can not sleep, and can not do much of what she used to do. This report was non-serious. This case, from the same reporter is linked to 20211047262.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE (VACCINE WAS HELD OUTSIDE OF THE FRIDGE AT ROOM TEMPERATURE  FOR 4 HOURS); OUT OF SPECIFICATION PRODUCT USE/ADMINISTRATION ERROR; This spontaneous report received from a pharmacist 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: 1855194, and expiry: 09-APR-2022) dose was not reported, administered on 22-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-OCT-2021, the patient experienced incorrect product storage (vaccine was held outside of the fridge at room temperature for 4 hours). On 22-OCT-2021, the patient experienced out of specification product use/administration error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use/administration error and incorrect product storage (vaccine was held outside of the fridge at room temperature for 4 hours) was not reported. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 60 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: 1821281 expiry: 21-OCT-2021) dose was not reported, administered on 22-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-OCT-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine  was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211047292.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; BAD 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 APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced chills, and bad fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bad fever and chills was not reported. This report was non-serious.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Blood test, Ultrasound scan
Clinical narrative: SHARP ACUTE PAIN IN LEFT SIDE OF ABDOMEN IN FRONT AND BACK AS WELL; This spontaneous report received from a patient concerned a 28 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: environmental allergies. 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-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the patient experienced sharp acute pain in left side of abdomen in front and back as well. On JUL-2021, Laboratory data included: Blood test (NR: not provided) Negative, and Diagnostic ultrasound (NR: not provided) No abnormalities found. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sharp acute pain in left side of abdomen in front and back as well. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Muscle atrophy, Musculoskeletal stiffness, Neuralgia, Pain
Clinical narrative: MUSCLE WASTING; NERVE PAIN; PAIN IN LEFT SHOULDER; STIFFNESS; PAIN; 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 was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the patient experienced stiffness. On MAY-2021, the patient experienced pain. On an unspecified date, the patient experienced muscle wasting, nerve pain, and pain in left shoulder. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from pain in left shoulder, muscle wasting, and nerve pain, and the outcome of stiffness and pain was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue
Clinical narrative: FATIGUE; This spontaneous report received from a patient concerned a 4 decade 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, intramuscular, batch: 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. 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 fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from fatigue. This report was non-serious.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Ocular hyperaemia
Clinical narrative: BLOODY EYE (EYE WITH BUSTED  BLOOD, WHITE  PART OF RIGHT EYE WAS RED); This spontaneous report received from a patient concerned a 30 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 was not reported, administered on 21-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-OCT-2021, the patient experienced bloody eye (eye with busted blood, white part of right eye was red). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bloody eye (eye with busted blood, white part of right eye was red) was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia
Clinical narrative: ALMOST COULD NOT STAND UP; DIZZINESS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient was part of the Ensemble trial and received a placebo but then was given the Janssen COVID-19 vaccine after the trial ended. 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. 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 almost could not stand up, and dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the almost could not stand up and dizziness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: ACHES; CHILLS; 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  (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 fever, chills, and aches. The action taken with covid-19 vaccine  was not applicable. The patient recovered from fever, chills, and aches. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Peripheral swelling
Clinical narrative: SWELLING IN LOWER LEGS; 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: Unk) 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 25-OCT-2021, the patient experienced swelling in lower legs. Laboratory data (dates unspecified) included: Blood test (NR: not provided) No blood clots found. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from swelling in lower legs. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: SITE OF INJECTION VERY PAINFUL (COULD NOT SLEEP ON ARM); This spontaneous report received from a consumer concerned a 27 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced site of injection very painful (could not sleep on arm). The action taken with covid-19 vaccine  was not applicable. The patient recovered from site of injection very painful (could not sleep on arm). This report was non-serious. This case, from the same reporter is linked to 20211044978.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Product administered to patient of inappropriate age
Clinical narrative: tingling in his feet; he was underage; numbness in his feet; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPOAESTHESIA (numbness in his feet), PARAESTHESIA (tingling in his feet) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (he was underage) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jul-2021, the patient experienced HYPOAESTHESIA (numbness in his feet). On an unknown date, the patient experienced PARAESTHESIA (tingling in his feet) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (he was underage). On 28-Jul-2021, HYPOAESTHESIA (numbness in his feet) had resolved. At the time of the report, PARAESTHESIA (tingling in his feet) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (he was underage) 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 medication was provided by the reporter.   The treatment information was not reported.  It was reported that the patient received 1st Moderna dose with immunizer not aware of age below 18 until preparing for 2nd dose. After interviewing patient prior to second dose he mentioned tingling in his feet after the 1st vaccine.   Resolved before 2nd dose was due.   This case was linked to MOD-2021-339395 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up received and patient demographics updated. event (numbness in his feet) onset date updated. On 01-Oct-2021: Follow up received, reporter contact details/patient birth year updated, event end date added.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Limb discomfort
Clinical narrative: leg problem after the 2nd dose; 1st dose 05Feb2021; 2nd dose 21Aug2021; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (leg problem after the 2nd dose) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 039K209) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 21-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 05Feb2021; 2nd dose 21Aug2021). On an unknown date, the patient experienced LIMB DISCOMFORT (leg problem after the 2nd dose) (seriousness criterion hospitalization). At the time of the report, LIMB DISCOMFORT (leg problem after the 2nd dose) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 05Feb2021; 2nd dose 21Aug2021) had resolved.            Concomitant medications was not provided by the reporter Treatment information was not provided.  On 08-Oct-2021, he again experienced the same leg problem this time more extensive than the 1st one. He was admitted in the hospital for the night. MRI was done and they could not find anything wrong with him.  This case concerns Inappropriate schedule of product administration in a 77 year-old male patient with no medical history provided, who experienced the unexpected non-serious event of Limb discomfort. The event of Limb discomfort occurred an unknown number of days after the second dose of mRNA-1273 vaccine. Rechallenge considered positive based on report of reoccurrence of event after third dose. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report. The seriousness criteria of hospitalization is removed for this event since the source document does not support this seriousness criteria.   This case was linked to MOD-2021-350768 (Patient Link).; Sender's Comments: This case concerns Inappropriate schedule of product administration in a 77 year-old male patient with no medical history provided, who experienced the unexpected non-serious event of Limb discomfort. The event of Limb discomfort occurred an unknown number of days after the second dose of mRNA-1273 vaccine. Rechallenge considered positive based on report of reoccurrence of event after third dose. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report. The seriousness criteria of hospitalization is removed for this event since the source document does not support this seriousness criteria.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: little headache; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (little headache) and MYALGIA (muscle aches) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011120A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced HEADACHE (little headache) and MYALGIA (muscle aches). At the time of the report, HEADACHE (little headache) and MYALGIA (muscle aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by reporter. The patient was prescribed some medications for two weeks for his blood pressure   This case was linked to MOD-2021-353242, MOD-2021-353246.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site rash
Clinical narrative: She's starting to want to itch; Has a rash, it's on her arm (not the one she took the shot at); Also a bit on the arm on the injection, more on the elbow and down; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (She's starting to want to itch), RASH (Has a rash, it's on her arm (not the one she took the shot at)) and VACCINATION SITE RASH (Also a bit on the arm on the injection, more on the elbow and down) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     The patient's past medical history included Rash. Concurrent medical conditions included Penicillin allergy (Had rashes) and Sulfonamide allergy (Allergic to sulfa . Had rashes). Concomitant products included LISINOPRIL, LEVOTHYROXINE, EZETIMIBE and METOPROLOL for an unknown indication.    On 14-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced RASH (Has a rash, it's on her arm (not the one she took the shot at)) and VACCINATION SITE RASH (Also a bit on the arm on the injection, more on the elbow and down). On an unknown date, the patient experienced PRURITUS (She's starting to want to itch). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PRURITUS (She's starting to want to itch) outcome was unknown and RASH (Has a rash, it's on her arm (not the one she took the shot at)) and VACCINATION SITE RASH (Also a bit on the arm on the injection, more on the elbow and down) was resolving.            Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: Significant information: Events Outcome reported
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose administered past the 30-day use; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   HCP didn't provide information for if the dose administered past the 30-day use by date was the first or second shot Event verbatim stated that updated patient info.  No concomitant medications information was reported. No treatment medications were provided.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site bruising, Vaccination site pain, Vaccination site swelling
Clinical narrative: This morning, he found a bruise around injection site that is about 5 inches spread and 4 inches in diameter.; Next day, he started with full body aches.; It is puffing and sore.; It is puffing and sore.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (This morning, he found a bruise around injection site that is about 5 inches spread and 4 inches in diameter.), MYALGIA (Next day, he started with full body aches.), VACCINATION SITE SWELLING (It is puffing and sore.) and VACCINATION SITE PAIN (It is puffing and sore.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091021A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included INSULIN, METFORMIN, LISINOPRIL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and PRAVASTATIN for an unknown indication.    On 12-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (This morning, he found a bruise around injection site that is about 5 inches spread and 4 inches in diameter.), MYALGIA (Next day, he started with full body aches.), VACCINATION SITE SWELLING (It is puffing and sore.) and VACCINATION SITE PAIN (It is puffing and sore.). The patient was treated with ACETYLSALICYLIC ACID, CHLORPHENAMINE MALEATE, PHENYLEPHRINE BITARTRATE (ALKA SELTZER PLUS COLD FORMULA) at a dose of 1 dosage form once a day. At the time of the report, VACCINATION SITE BRUISING (This morning, he found a bruise around injection site that is about 5 inches spread and 4 inches in diameter.), MYALGIA (Next day, he started with full body aches.), VACCINATION SITE SWELLING (It is puffing and sore.) and VACCINATION SITE PAIN (It is puffing and sore.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Spikevax) (Unknown) was not applicable
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses were administered expired yesterday 14Oct2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were administered expired yesterday 14Oct2021) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were administered expired yesterday 14Oct2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were administered expired yesterday 14Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nausea
Clinical narrative: felt like she had the flu; felt nauseous; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like she had the flu) and NAUSEA (felt nauseous) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A and 006D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like she had the flu) and NAUSEA (felt nauseous). At the time of the report, INFLUENZA LIKE ILLNESS (felt like she had the flu) and NAUSEA (felt nauseous) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-354446 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Fatigue, Headache, Musculoskeletal discomfort
Clinical narrative: dry cough; congestion; bone and joint icky; Red rash and a bruise on the injection site; Fever; strong headache; Lot of fatigue; Arm swelling and pain; Arm swelling and pain; Red rash and a bruise on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (dry cough), NASAL CONGESTION (congestion), MUSCULOSKELETAL DISCOMFORT (bone and joint icky), VACCINATION SITE BRUISING (Red rash and a bruise on the injection site) and PYREXIA (Fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy.    On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced COUGH (dry cough), NASAL CONGESTION (congestion), MUSCULOSKELETAL DISCOMFORT (bone and joint icky), VACCINATION SITE BRUISING (Red rash and a bruise on the injection site), PYREXIA (Fever), HEADACHE (strong headache), FATIGUE (Lot of fatigue), VACCINATION SITE PAIN (Arm swelling and pain), VACCINATION SITE SWELLING (Arm swelling and pain) and VACCINATION SITE RASH (Red rash and a bruise on the injection site). At the time of the report, COUGH (dry cough) and NASAL CONGESTION (congestion) had not resolved and MUSCULOSKELETAL DISCOMFORT (bone and joint icky), VACCINATION SITE BRUISING (Red rash and a bruise on the injection site), PYREXIA (Fever), HEADACHE (strong headache), FATIGUE (Lot of fatigue), VACCINATION SITE PAIN (Arm swelling and pain), VACCINATION SITE SWELLING (Arm swelling and pain) and VACCINATION SITE RASH (Red rash and a bruise on the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Body temperature: 101.6 (High) 101.6.         No concomitant medications were provided. Patient stated that having a rare disease and after finish radiation hcp recommended get a 3rd dose.   This case was linked to MOD-2021-354688, MOD-2021-354613 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pyrexia, Vaccination site bruising, Vaccination site pain, Vaccination site rash
Clinical narrative: dry cough; congestion; bone and joint icky; Red rash and a bruise on the injection site; Fever; strong headache; Lot of fatigue; Arm swelling and pain; Arm swelling and pain; Red rash and a bruise on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (dry cough), NASAL CONGESTION (congestion), MUSCULOSKELETAL DISCOMFORT (bone and joint icky), VACCINATION SITE BRUISING (Red rash and a bruise on the injection site) and PYREXIA (Fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy.    On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced COUGH (dry cough), NASAL CONGESTION (congestion), MUSCULOSKELETAL DISCOMFORT (bone and joint icky), VACCINATION SITE BRUISING (Red rash and a bruise on the injection site), PYREXIA (Fever), HEADACHE (strong headache), FATIGUE (Lot of fatigue), VACCINATION SITE PAIN (Arm swelling and pain), VACCINATION SITE SWELLING (Arm swelling and pain) and VACCINATION SITE RASH (Red rash and a bruise on the injection site). At the time of the report, COUGH (dry cough) and NASAL CONGESTION (congestion) had not resolved and MUSCULOSKELETAL DISCOMFORT (bone and joint icky), VACCINATION SITE BRUISING (Red rash and a bruise on the injection site), PYREXIA (Fever), HEADACHE (strong headache), FATIGUE (Lot of fatigue), VACCINATION SITE PAIN (Arm swelling and pain), VACCINATION SITE SWELLING (Arm swelling and pain) and VACCINATION SITE RASH (Red rash and a bruise on the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Body temperature: 101.6 (High) 101.6.         No concomitant medications were provided. Patient stated that having a rare disease and after finish radiation hcp recommended get a 3rd dose.   This case was linked to MOD-2021-354688, MOD-2021-354613 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: dry cough; congestion; bone and joint icky; Red rash and a bruise on the injection site; Fever; strong headache; Lot of fatigue; Arm swelling and pain; Arm swelling and pain; Red rash and a bruise on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (dry cough), NASAL CONGESTION (congestion), MUSCULOSKELETAL DISCOMFORT (bone and joint icky), VACCINATION SITE BRUISING (Red rash and a bruise on the injection site) and PYREXIA (Fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy.    On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced COUGH (dry cough), NASAL CONGESTION (congestion), MUSCULOSKELETAL DISCOMFORT (bone and joint icky), VACCINATION SITE BRUISING (Red rash and a bruise on the injection site), PYREXIA (Fever), HEADACHE (strong headache), FATIGUE (Lot of fatigue), VACCINATION SITE PAIN (Arm swelling and pain), VACCINATION SITE SWELLING (Arm swelling and pain) and VACCINATION SITE RASH (Red rash and a bruise on the injection site). At the time of the report, COUGH (dry cough) and NASAL CONGESTION (congestion) had not resolved and MUSCULOSKELETAL DISCOMFORT (bone and joint icky), VACCINATION SITE BRUISING (Red rash and a bruise on the injection site), PYREXIA (Fever), HEADACHE (strong headache), FATIGUE (Lot of fatigue), VACCINATION SITE PAIN (Arm swelling and pain), VACCINATION SITE SWELLING (Arm swelling and pain) and VACCINATION SITE RASH (Red rash and a bruise on the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Body temperature: 101.6 (High) 101.6.         No concomitant medications were provided. Patient stated that having a rare disease and after finish radiation hcp recommended get a 3rd dose.   This case was linked to MOD-2021-354688, MOD-2021-354613 (Patient Link).