chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2nd dose administered from a punctured vial that was put back in fridge for a month/had been opened 30 days prior to administration, but kept refrigerated; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose administered from a punctured vial that was put back in fridge for a month/had been opened 30 days prior to administration, but kept refrigerated) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 17-Feb-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose administered from a punctured vial that was put back in fridge for a month/had been opened 30 days prior to administration, but kept refrigerated). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2nd dose administered from a punctured vial that was put back in fridge for a month/had been opened 30 days prior to administration, but kept refrigerated) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information not provided by the reporter.   This case was linked to MOD-2021-027809, MOD-2021-027810 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Patient information was updated. Start date and batch number for mRNA-1273 was provided. Reporter stated no problems after vaccine administration. The client is still not having any problems as of 26-Mar-2021.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 013L20A)  with no associated adverse events. MOD-2021-027809:same reporter, same event, different patient MOD-2021-027810:same reporter, same event, different patient
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Tremor
Clinical narrative: Feeling weak; Shakiness/ shaky after going up the stairs; Lightheadedness / dizziness; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shakiness/ shaky after going up the stairs), DIZZINESS (Lightheadedness / dizziness) and ASTHENIA (Feeling weak) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Anxiety. Concurrent medical conditions included Drug allergy (experienced a very bad reaction to Prilosec).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced TREMOR (Shakiness/ shaky after going up the stairs) and DIZZINESS (Lightheadedness / dizziness). On an unknown date, the patient experienced ASTHENIA (Feeling weak). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) for Sinusitis, at an unspecified dose and frequency. At the time of the report, TREMOR (Shakiness/ shaky after going up the stairs), DIZZINESS (Lightheadedness / dizziness) and ASTHENIA (Feeling weak) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: A spontaneous report was received from a other healthcare professional concerning a patient of unknown age, male who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced: an administration error were (where) a few drops of the vaccine came out of the syringe as the hub was not in all the way. The patient's relevant medical history was not provided. Concomitant treatments not provided. On unknown date the patient received the first of two planned doses of mRNA-1273 (Batch Number unknown) via unknown route for prophylaxis of COVID-19 infection. On 26 Feb 2021, a voicemail was received from a pharmacy student regarding a vaccine administration error while administering the vaccine to a patient. The patient was not identified. The pharmacy student was administering a dose of Moderna's COVID-19 Vaccine (mRNA-1273, lot number: unknown) to a patient. It was reported that a few drops of the vaccine came out of the syringe as the hub was not in all the way. Further information regarding the administration of the vaccine and further action were not provided by the reporter. A call-back attempt to gather more information was attempted. The caller at that time who was not identified stated they, "already had the answer to the clinical issue and did not provide any patient identifiers." Follow up: On 25 Mar 2021 Outgoing call was placed to verify the identity of the patient reported on case. Original reporter was not present at the time and I was referred to a another Pharmacist  whom the Other Healthcare Professional had instructed to be her proxy in follow-ups regarding this case. The Pharmacist confirmed the reported event and stated that the reported case involved a Male patient. She could not provide anymore information regarding the case. Treatment  was not provided. Action taken with mRNA-1272 in response to the events was Unknown. The outcome of events, administration error were a few drops of the vaccine came out of the syringe as the hub was not in all the way was Recovered / Resolved; Reporter's Comments: This report refers to a case of vaccine underdose and syringe connection issue for mRNA-1273, lot # unknown with no associated AEs
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Vacine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vacine exposure during pregnancy) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 029L20A) for COVID-19 immunisation.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 28-Aug-2021. On 12-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vacine exposure during pregnancy). On 09-Feb-2021, EXPOSURE DURING PREGNANCY (Vacine exposure during pregnancy) had resolved.            Concomitant medication was not reported. Treatment medication was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, Syringe issue
Clinical narrative: Syringe leaking; Not knowing if the full dose was given; A spontaneous report was received from a consumer concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and there is an issue with the syringe like leakage and not knowing if the full dose was given.   The patient's medical history was not provided by the reporter. No Concomitant medications were reported.  On an unknown date, the patient received their one of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.    The reporter reports the incident that there is an issue like leakage and not knowing if the full dose was given. They are also unspecified that it is Moderna COVID vaccine or a Pfizer product.  The reporter works at a medical distributor for Moderna vaccine. They have also contracts for convenient kits that go out with the customer for use with the Moderna and the Pfizer vaccines. The convenient kits are disposable to administer the vaccines. The complaints are coming that the syringe bent or one of the retractable syringes malfunctioned or there was leakage. She doesn't have any specifics.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, syringe like leakage and not knowing if the full dose was given was resolved on an unknown date.; Reporter's Comments: This report refers to a case of accidental underdose and device connection issue for mRNA-1273 (lot # unknown) with no associated AEs reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Headache, Pain in extremity, Vomiting
Clinical narrative: Arm hurt; chills; vomiting; headache; Can't keep anything down; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), CHILLS (chills), VOMITING (vomiting), HEADACHE (headache) and DISCOMFORT (Can't keep anything down) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included Fibromyalgia.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt), CHILLS (chills), VOMITING (vomiting), HEADACHE (headache) and DISCOMFORT (Can't keep anything down). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm hurt), CHILLS (chills), VOMITING (vomiting), HEADACHE (headache) and DISCOMFORT (Can't keep anything down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported Treatment information   reported was Tylenol  Arm hurt initially. Then at night woke up with chills, then was vomiting and is still vomiting. Can't keep anything down. Also has a headache. Caller vomited while on the call
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Exposure during pregnancy, Pyrexia, Vomiting
Clinical narrative: Pregnancy; Alot of vomiting; Fever and chills; Fever and chills; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy), CHILLS (Fever and chills), VOMITING (Alot of vomiting) and PYREXIA (Fever and chills) in a 32-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 013L20A) for COVID-19 vaccination.     Concomitant products included VITAMIN B6 for Vomiting, DOXYLAMINE.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 31-Aug-2021. On 19-Jan-2021, the patient experienced CHILLS (Fever and chills) and PYREXIA (Fever and chills). On 22-Jan-2021, the patient experienced VOMITING (Alot of vomiting). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). On 20-Jan-2021, CHILLS (Fever and chills) and PYREXIA (Fever and chills) had resolved. On 25-Jan-2021, VOMITING (Alot of vomiting) had resolved. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient does not mention when she had a positive pregnancy test. Her last menstrual period and estimated date of conception was not provided. The patients estimated due date is 31 Aug 2021.  No laboratory details were  provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive COVID test after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive COVID test after 1st dose) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced COVID-19 (Positive COVID test after 1st dose). At the time of the report, COVID-19 (Positive COVID test after 1st dose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.  The patient did not have any symptoms, she was exposed and then got tested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Rash, Vaccination complication
Clinical narrative: reactions 7 days after initial dose; Redness; Fatigue; Rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reactions 7 days after initial dose), ERYTHEMA (Redness), FATIGUE (Fatigue) and RASH (Rash) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION COMPLICATION (reactions 7 days after initial dose), ERYTHEMA (Redness), FATIGUE (Fatigue) and RASH (Rash). At the time of the report, VACCINATION COMPLICATION (reactions 7 days after initial dose), ERYTHEMA (Redness), FATIGUE (Fatigue) and RASH (Rash) outcome was unknown.        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.   Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2021: Follow up received on 09-FEB-2021: Phone Number & e-mail of primary reporter, secondary reporter, Report media, Suspect drug-route, date, batch, Patient DOB and events start date were added
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Injection site erythema, Rash pruritic
Clinical narrative: shingles; itchy rash over left breast, shoulder, back and abdomen; "red ring" around the site of injection,which doubled the size the next day; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles), RASH PRURITIC (itchy rash over left breast, shoulder, back and abdomen) and INJECTION SITE ERYTHEMA ("red ring" around the site of injection,which doubled the size the next day) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA ("red ring" around the site of injection,which doubled the size the next day). On 10-Feb-2021, the patient experienced RASH PRURITIC (itchy rash over left breast, shoulder, back and abdomen). On 19-Feb-2021, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles), RASH PRURITIC (itchy rash over left breast, shoulder, back and abdomen) and INJECTION SITE ERYTHEMA ("red ring" around the site of injection,which doubled the size the next day) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication for shingles steroids
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: felt weak; pain in their arm; Headache; little pain in their muscles; nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (patient 1 had a headache), ASTHENIA (felt weak), MYALGIA (little pain in their muscles), NAUSEA (nausea) and PAIN IN EXTREMITY (pain in their arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 08-Feb-2021, the patient experienced HEADACHE (patient 1 had a headache), ASTHENIA (felt weak), MYALGIA (little pain in their muscles), NAUSEA (nausea) and PAIN IN EXTREMITY (pain in their arm).            This case was linked to MOD21-024814, US-MODERNATX, INC.-MOD-2021-029243 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2021: No specific follow-up information recorded.; Sender's Comments:  MOD21-024814:Patient 2 US-MODERNATX, INC.-MOD-2021-029243:Crosslinked case
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, COVID-19, Erythema, Intentional dose omission, Ocular discomfort
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (big pinky, red reaction in the right site of her face and neck), PRURITUS (very itching), ERYTHEMA (her face is a mess), AGEUSIA (No taste for coffee) and COVID-19 (COVID-19) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced ERYTHEMA (big pinky, red reaction in the right site of her face and neck), PRURITUS (very itching) and ERYTHEMA (her face is a mess). On 26-Mar-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced AGEUSIA (No taste for coffee), OCULAR DISCOMFORT (eye issue) and INTENTIONAL DOSE OMISSION (intentional missed dose). At the time of the report, ERYTHEMA (big pinky, red reaction in the right site of her face and neck), PRURITUS (very itching), ERYTHEMA (her face is a mess), AGEUSIA (No taste for coffee) and OCULAR DISCOMFORT (eye issue) was resolving, COVID-19 (COVID-19) outcome was unknown and INTENTIONAL DOSE OMISSION (intentional missed dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. Reported that events were treated with an unspecified cream and eye drops. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: AE details and outcome.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (big pinky, red reaction in the right site of her face and neck), PRURITUS (very itching), ERYTHEMA (her face is a mess), AGEUSIA (No taste for coffee) and COVID-19 (COVID-19) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced ERYTHEMA (big pinky, red reaction in the right site of her face and neck), PRURITUS (very itching) and ERYTHEMA (her face is a mess). On 26-Mar-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced AGEUSIA (No taste for coffee), OCULAR DISCOMFORT (eye issue) and INTENTIONAL DOSE OMISSION (intentional missed dose). At the time of the report, ERYTHEMA (big pinky, red reaction in the right site of her face and neck), PRURITUS (very itching), ERYTHEMA (her face is a mess), AGEUSIA (No taste for coffee) and OCULAR DISCOMFORT (eye issue) was resolving, COVID-19 (COVID-19) outcome was unknown and INTENTIONAL DOSE OMISSION (intentional missed dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. Reported that events were treated with an unspecified cream and eye drops. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: AE details and outcome.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Injection site pain
Clinical narrative: sore left arm; Received the 2nd dose of the Moderna Covid vaccine while pregnant.; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Received the 2nd dose of the Moderna Covid vaccine while pregnant.) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 042L20A) for COVID-19 vaccination.     Concomitant products included IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), CALCIUM and ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 12-Jul-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Received the 2nd dose of the Moderna Covid vaccine while pregnant.). At the time of the report, EXPOSURE DURING PREGNANCY (Received the 2nd dose of the Moderna Covid vaccine while pregnant.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Painful L arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of   in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) dosage form. Not Provided      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.   Concomitant medication was not reported. Treatment medication was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Peripheral swelling
Clinical narrative: In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PAIN (Hamstring pain), PERIPHERAL SWELLING (swollen left leg) and ARTHRALGIA (Left shoulder Soreness). The patient was treated with OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, PAIN (Hamstring pain), PERIPHERAL SWELLING (swollen left leg) and ARTHRALGIA (Left shoulder Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Patient took Percocet and had reaction afterwards.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: pain during lifting of arm/painful; Her arm was sore; This spontaneous case was reported by a nurse and describes the occurrence of MOBILITY DECREASED (pain during lifting of arm/painful) and PAIN IN EXTREMITY (Her arm was sore) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Humerus fracture (broke the head of the humerus of her left arm). Concurrent medical conditions included Allergy (long-standing nickel allergy from foods).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (pain during lifting of arm/painful) and PAIN IN EXTREMITY (Her arm was sore). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency and IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (pain during lifting of arm/painful) and PAIN IN EXTREMITY (Her arm was sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   She went through many years of physical therapy as she couldn't lift her arm.   Upon follow-up she stated  that her left shoulder has become so painful it was affecting the nerve tissue all the way down her arm, down to her thumb. At that point, on the top of her thumb,the nerve has made her thumb bend in a strange way. She was still alternating between Tylenol and Ibuprofen. The pain was not constant it depends on how she moved her body or if she shifts her arm in the wrong way. The pain started in the deltoid and not the scapula. She thought it was originally irritated by the needle.     Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2021: Reporter's address updated,  patient's history was added and 2 new events arthralgia and neuralgia were reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Injection site discolouration, Injection site erythema
Clinical narrative: bright reddish pink circle on her arm; few pimples; blemishes; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of   in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), VALSARTAN, SIMVASTATIN and ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Illness, Influenza like illness, Parosmia
Clinical narrative: Numbness on the left side of her face; Metallic taste in her mouth; Dizziness; Flu-like symptoms; Got super sick; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), INFLUENZA LIKE ILLNESS (Flu-like symptoms), ILLNESS (Got super sick) and HYPOAESTHESIA (Numbness on the left side of her face) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced DIZZINESS (Dizziness), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and ILLNESS (Got super sick). On 04-Feb-2021, the patient experienced HYPOAESTHESIA (Numbness on the left side of her face). On 04-Feb-2021, HYPOAESTHESIA (Numbness on the left side of her face) had resolved. At the time of the report, DIZZINESS (Dizziness), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and ILLNESS (Got super sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Diarrhoea, Dizziness, Nausea
Clinical narrative: Diarrhea; Confused; Dizziness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DIZZINESS (Dizziness) and NAUSEA (Nausea) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), DIZZINESS (Dizziness) and NAUSEA (Nausea). At the time of the report, DIARRHOEA (Diarrhea), DIZZINESS (Dizziness) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. The treatment medication was Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: TCR / Outcome updated
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: little arm pain/thumb pain; 16 year old daughter got the Moderna Covid-19 vaccine on 27FEB21; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little arm pain/thumb pain) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old daughter got the Moderna Covid-19 vaccine on 27FEB21) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old daughter got the Moderna Covid-19 vaccine on 27FEB21). On an unknown date, the patient experienced PAIN IN EXTREMITY (little arm pain/thumb pain). On 27-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old daughter got the Moderna Covid-19 vaccine on 27FEB21) had resolved. At the time of the report, PAIN IN EXTREMITY (little arm pain/thumb pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness; Nausea; A spontaneous report was received from a consumer concerning a 63-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dizziness, nausea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events, dizziness, nausea.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, dizziness, nausea was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lymphadenopathy, Vaccination site reaction, Vaccination site warmth
Clinical narrative: Covid arm; Warm; The size of her fist red; Lymph node on the opposite side of her arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm), ERYTHEMA (The size of her fist red) and LYMPHADENOPATHY (Lymph node on the opposite side of her arm was swollen) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer (survivor as of 2017).    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm), ERYTHEMA (The size of her fist red) and LYMPHADENOPATHY (Lymph node on the opposite side of her arm was swollen). At the time of the report, VACCINATION SITE WARMTH (Warm), ERYTHEMA (The size of her fist red) and LYMPHADENOPATHY (Lymph node on the opposite side of her arm was swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Vaccination site mass
Clinical narrative: Shingles; Red bump on the left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Red bump on the left arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE MASS (Red bump on the left arm). The patient was treated with VALACYCLOVIR [VALACICLOVIR] for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Red bump on the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction, Chills, Dizziness, Vaccination site swelling
Clinical narrative: a bad reaction; dizzy; his arm was swollen; chills; A spontaneous report was received from a consumer concerning a 80-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events a bad reaction/adverse drug reaction, his arm was swollen/vaccination site swelling, chills, dizzy/ dizziness.  The patient's medical history included  thyroid and hypertension. Concomitant medications reported were thyroid medication, blood pressure medication, baby aspirin for drug use for unknown indication.  On 13 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced the event(s) a bad reaction, his arm was swollen, chills, dizzy.  Treatment details included paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.   On 13 Feb 2021 the outcome of event(s), a bad reaction, his arm was swollen, chills, dizzy was resolved.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Entire body rash; This spontaneous case was reported by a patient and describes the occurrence of RASH (Entire body rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced RASH (Entire body rash). At the time of the report, RASH (Entire body rash) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Rigors; Severe Fatigue; Headache; Myalgia; Nausea; Fever; This spontaneous case was reported by a physician assistant and describes the occurrence of CHILLS (Rigors), FATIGUE (Severe Fatigue), HEADACHE (Headache), MYALGIA (Myalgia) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced CHILLS (Rigors), FATIGUE (Severe Fatigue), HEADACHE (Headache), MYALGIA (Myalgia), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, CHILLS (Rigors), FATIGUE (Severe Fatigue), HEADACHE (Headache), MYALGIA (Myalgia), NAUSEA (Nausea) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. Treatment information not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Rigors; Severe Fatigue; Headache; Myalgia; Nausea; Fever; This spontaneous case was reported by a physician assistant and describes the occurrence of CHILLS (Rigors), FATIGUE (Severe Fatigue), HEADACHE (Headache), MYALGIA (Myalgia) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced CHILLS (Rigors), FATIGUE (Severe Fatigue), HEADACHE (Headache), MYALGIA (Myalgia), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, CHILLS (Rigors), FATIGUE (Severe Fatigue), HEADACHE (Headache), MYALGIA (Myalgia), NAUSEA (Nausea) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. Treatment information not provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeling abnormal, Headache, Pyrexia
Clinical narrative: shaking with chills; dizziness; weakness; had a hard time starting; fever of 100.3f; slight headache; A spontaneous report was received from a consumer concerning a 82-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever of 100.3f, shaking with chills, slight headache, dizziness, weakness, had a hard time starting/feeling abnormal.  The patient's medical history was not provided.  relevant concomitant products usage were not reported by the reporter.  On 25 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 26 Feb 2021, the patient experienced the event(s) fever of 100.3f, shaking with chills, slight headache, dizziness, weakness, had a hard time starting.  Treatment details not included.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), fever of 100, 3f, shaking with chills, slight headache, dizziness, weakness, had a hard time starting was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: shaking with chills; dizziness; weakness; had a hard time starting; fever of 100.3f; slight headache; A spontaneous report was received from a consumer concerning a 82-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever of 100.3f, shaking with chills, slight headache, dizziness, weakness, had a hard time starting/feeling abnormal.  The patient's medical history was not provided.  relevant concomitant products usage were not reported by the reporter.  On 25 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 26 Feb 2021, the patient experienced the event(s) fever of 100.3f, shaking with chills, slight headache, dizziness, weakness, had a hard time starting.  Treatment details not included.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), fever of 100, 3f, shaking with chills, slight headache, dizziness, weakness, had a hard time starting was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Dermatitis allergic, Diarrhoea
Clinical narrative: Allergic rash; pruritus; Diarrhea; Cough; Redness; Hypersensitivity reaction; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ALLERGIC (Allergic rash), PRURITUS (pruritus), DIARRHOEA (Diarrhea), COUGH (Cough) and ERYTHEMA (Redness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hay fever, Urticaria and Hypersensitivity reaction (NOS). Previously administered products included for Diphtheria: DTP (Rash Around Injection site one week after shot) on 15-Oct-2013. Past adverse reactions to the above products included Injection site rash with DTP. Concurrent medical conditions included Drug allergy (oral Ferrous Sulfate tablet -Rash) since 1982, Cosmetic allergy (Chlorohexidine Gluconate Skin Cleaner - Rash) since 2014, Hypertension since 2005, Osteoporosis since 2017 and Glaucoma since 2018. Concomitant products included BIMATOPROST (LUMIGAN) from 2018 to an unknown date for Glaucoma, LOSARTAN from 2013 to an unknown date for Hypertension, IBANDRONATE SODIUM (IBANDRONATE) from 2017 to an unknown date for Osteoporosis.   On 19-Feb-2021 at 12:05 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021 at 11:55 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced DERMATITIS ALLERGIC (Allergic rash), PRURITUS (pruritus), DIARRHOEA (Diarrhea), COUGH (Cough), ERYTHEMA (Redness), HYPERSENSITIVITY (Hypersensitivity reaction) and CHILLS (Chills). On 06-Mar-2021, DERMATITIS ALLERGIC (Allergic rash), PRURITUS (pruritus), DIARRHOEA (Diarrhea), COUGH (Cough), ERYTHEMA (Redness), HYPERSENSITIVITY (Hypersensitivity reaction) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: not reported (Inconclusive) result not reported.         Treatment medications not provided   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Additional infovaacine dose 2 added, facility details added, patient details added, concomitant added, other relevant tab updated, events added, and event date added. On 03-May-2021: Updated Patient Medical History Vaccination details, Demographics, Casualty of Primary Source Reporter, Event Outcome date, Concomitant medication details.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Pruritus
Clinical narrative: Allergic rash; pruritus; Diarrhea; Cough; Redness; Hypersensitivity reaction; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ALLERGIC (Allergic rash), PRURITUS (pruritus), DIARRHOEA (Diarrhea), COUGH (Cough) and ERYTHEMA (Redness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hay fever, Urticaria and Hypersensitivity reaction (NOS). Previously administered products included for Diphtheria: DTP (Rash Around Injection site one week after shot) on 15-Oct-2013. Past adverse reactions to the above products included Injection site rash with DTP. Concurrent medical conditions included Drug allergy (oral Ferrous Sulfate tablet -Rash) since 1982, Cosmetic allergy (Chlorohexidine Gluconate Skin Cleaner - Rash) since 2014, Hypertension since 2005, Osteoporosis since 2017 and Glaucoma since 2018. Concomitant products included BIMATOPROST (LUMIGAN) from 2018 to an unknown date for Glaucoma, LOSARTAN from 2013 to an unknown date for Hypertension, IBANDRONATE SODIUM (IBANDRONATE) from 2017 to an unknown date for Osteoporosis.   On 19-Feb-2021 at 12:05 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021 at 11:55 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced DERMATITIS ALLERGIC (Allergic rash), PRURITUS (pruritus), DIARRHOEA (Diarrhea), COUGH (Cough), ERYTHEMA (Redness), HYPERSENSITIVITY (Hypersensitivity reaction) and CHILLS (Chills). On 06-Mar-2021, DERMATITIS ALLERGIC (Allergic rash), PRURITUS (pruritus), DIARRHOEA (Diarrhea), COUGH (Cough), ERYTHEMA (Redness), HYPERSENSITIVITY (Hypersensitivity reaction) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: not reported (Inconclusive) result not reported.         Treatment medications not provided   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Additional infovaacine dose 2 added, facility details added, patient details added, concomitant added, other relevant tab updated, events added, and event date added. On 03-May-2021: Updated Patient Medical History Vaccination details, Demographics, Casualty of Primary Source Reporter, Event Outcome date, Concomitant medication details.