chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Monocyte count increased, Monocyte percentage increased
Clinical narrative: Monocytes were at 18.4% (high); This case was reported by a consumer via call center representative and described the occurrence of monocytes increased in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included aml leukemia.   On 2nd August 2021, the patient received the 1st dose of Shingrix (intramuscular). On 4th August 2021, 2 days after receiving Shingrix, the patient experienced monocytes increased. On an unknown date, the outcome of the monocytes increased was not recovered/not resolved.   It was unknown if the reporter considered the monocytes increased to be related to Shingrix.  Additional details were reported as follows This case was patients daughter reported for her mother. Reported that her mother received her first dose of shingrix. Also reported about her mother was in remission for AML Leukemia. The patient blood drawn and test results was her monocytes was at 18.4% (high). The patient experienced monocytes increased the outcome was not recovered. Did not consent to follow-up. The caller does not give permission to contact.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration
Clinical narrative: purple line at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site coloration in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st August 2021, the patient received the 1st dose of Shingrix. On 4th August 2021, 3 days after receiving Shingrix, the patient experienced injection site coloration. On an unknown date, the outcome of the injection site coloration was unknown.   It was unknown if the reporter considered the injection site coloration to be related to Shingrix.  Additional details were provided as follows: The patient reported the case for herself. The patient received dose on Shingrix and experienced a purple line at the injection site. The patient does not know the lot number or expiration date. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Blood test abnormal, Chills, Lymphocyte count decreased, Monocyte count decreased, Pain
Clinical narrative: Chills; Body ache; Vomits; Low monocytes; Low lymphocytes; This case was reported by a nurse via call center representative and described the occurrence of chills in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, general body pain, vomiting, monocytes decreased and lymphocyte count decreased. On an unknown date, the outcome of the chills, general body pain, vomiting, monocytes decreased and lymphocyte count decreased were unknown.   It was unknown if the reporter considered the chills, general body pain, vomiting, monocytes decreased and lymphocyte count decreased to be related to Shingrix.  Additional details were reported as follows: This case was reported by a nurse. The age at vaccination was not reported. The nurse reported that the patient experienced vomits,body ache and chills after receiving Shingrix. Nurse also reported that patient had llow monocytes and low lymphocytes. Consent to follow.
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Chills; Body ache; Vomits; Low monocytes; Low lymphocytes; This case was reported by a nurse via call center representative and described the occurrence of chills in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, general body pain, vomiting, monocytes decreased and lymphocyte count decreased. On an unknown date, the outcome of the chills, general body pain, vomiting, monocytes decreased and lymphocyte count decreased were unknown.   It was unknown if the reporter considered the chills, general body pain, vomiting, monocytes decreased and lymphocyte count decreased to be related to Shingrix.  Additional details were reported as follows: This case was reported by a nurse. The age at vaccination was not reported. The nurse reported that the patient experienced vomits,body ache and chills after receiving Shingrix. Nurse also reported that patient had llow monocytes and low lymphocytes. Consent to follow.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event, Herpes zoster
Clinical narrative: "shingles rash" on his "torso side and back".; shingles rash" on his "torso side and back".; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th July 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a month after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were reported as follows: This case was reported by the son of the patient. He reported that his father received his first dose of shingrix and experienced shingles rash on his torso side and back. He was not sure what side the rash was on.  He could not answer other questions asked. The reporter said he would get more information and call GlaxoSmithKline back. Adverse event filed with limited information
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late second dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the drug dose administration interval too long to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had received a late second dose of Shingrix, which led to lengthening of vaccination schedule. The reporter did not know the date of the administration of the second dose, nor lot number or expiration date. The reporter did not consent nor declined consent to be contacted for follow up. No further events were reported.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: late second dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number F49L5, expiry date 1st December 2021) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 21st December 2019, batch number 7RK7K, expiry date 26th November 2021).   On 27th October 2020, the patient received the 2nd dose of Shingrix. On 27th October 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received Shingrix second dose later than the recommended interval, which led to lengthening of vaccination schedule. The reporter wanted to know if the patient should repeat schedule. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Acne, Pain, Pruritus, Social problem
Clinical narrative: 1st / dose on December 2019 / COVID pandemic / 2nd dose / August 3rd, 2021; 24 hours later / I had "stinging; 24 hours later / I had itching; It "looked like a pimple"; This case was reported by a consumer via call center representative and described the occurrence of stinging in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in December 2019).   On 3rd August 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 3rd August 2021, unknown after receiving Shingrix, the patient experienced social problem. In August 2021, the patient experienced stinging, pruritus and pimples. On an unknown date, the outcome of the stinging, pruritus, pimples and social problem were unknown.   It was unknown if the reporter considered the stinging, pruritus and pimples to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient himself. The age at vaccination was not reported. The patient received 2nd dose of Shingrix, 20 months after receiving 1st dose because of COVID pandemic. 24 hours after vaccination, the patient experienced stinging and itching on the right side of back and his spouse indicated that it was looked like a pimple. Not all information was available. Lot and expiry date were not provided. The reporter did not want to provide demographics. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Sterile water was used to reconstitute the lyophilized powder; Sterile water was used to reconstitute the lyophilized powder; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The nurse reported that sterile water was used to reconstitute the lyophilized powder of Shingrix, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No adverse event was reported. The reporter consented to follow up.
Sex: U
Vaccine: HEP, HEPA, TDAP
Symptoms: Product storage error
Clinical narrative: vaccines / been exposed to temperatures in the 50s Farenheit degrees / up to 30 patients could have received vaccines exposed to that temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unknown number of patients who received HAV (Havrix) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Havrix, Engerix B and Boostrix. On an unknown date, unknown after receiving Havrix, Engerix B and Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. A nurse practitioner reported that the system that monitored the temperature of the refrigerator that stored Havrix, Engerix-B and Boostrix had a glitch. The provider did not had data for May-June and July 2021 but suspects the vaccines might have exposed to temperatures in the 50s degree F (as reported).  The nurse practitioner mentioned that an average of 08 to 10 patients were vaccinated per month in the facility and thus, her calculation was that up to 30 patients could have received vaccines exposed to that temperature excursion. No more information was available at the time of reporting. The reporter consented to follow up.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Incorrect route of product administration
Clinical narrative: patient was administer rotarix via intramuscularly; This case was reported by a nurse via call center representative and described the occurrence of inappropriate route of vaccination in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number x5z5z, expiry date 9th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 4th August 2021, the patient received the 1st dose of Rotarix lyophilized formulation (intramuscular) and Rotarix Oral Applicator Device. On 4th August 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that the patient was administered with Rotarix intramuscularly, which led to inappropriate route of vaccination. The reporter consented to follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; SORE ARM; This spontaneous report received from a patient concerned a 34 year old female.  Initial information was processed with the additional information received on 06-AUG-2021. 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, and batch number:1808986 expiry: UNKNOWN) dose was not reported, 1 total administered on 01-JUN-2021 around 12:00 for prophylactic vaccination. No concomitant medications were reported.  On 01-JUN-2021, right after the vaccination, the patient experienced sore arm which worsened after 3-7 days, and then it lingered and had gone away after 3 weeks. On 05-AUG-2021, the patient got an antibody tests done (antibody neutralizer SARS-COV-2), which had come back as less than 10% (confirmed immunological vaccine failure). The HCP told the patient that less than 10% result could be considered as negative. The patient had results in the hand and the PCP(primary care physician) was aware of the results. Laboratory data included: COVID-19 antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 22-JUN-2021, and had not recovered from confirmed immunological vaccine failure. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000188681.; Sender's Comments: V0-20210810669-covid-19 vaccine ad26.cov2.s-Confirmed Immunological Vaccine Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: CHILLS; LOW-GRADE 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced chills, and low-grade fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from low-grade fever, and chills. This report was non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Gastric cancer, Small cell lung cancer
Clinical narrative: SMALL CELL CANCER 13.33MM IN STOMACH AREA; SMALL CELL CANCER 13.33MM IN LUNG AREA; This spontaneous report received from a patient concerned a 50 year old White Caucasian and not Hispanic or Latino male. The patient's height, and weight were not reported. The patient had no known allergies. The patient had no known drug allergies and had no previously known medical conditions. The patient had no current medication use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 10-APR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-APR-2021 (3 days after vaccination), the patient had stomach pains and was admitted to the hospital. They found patient had small cell cancer 13.33mm in stomach and lung area. The patient did not think it was due to the vaccine or might be the vaccine brought out the symptoms, but patient was not sure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the small cell cancer 13.33mm in stomach area and small cell cancer 13.33mm in lung area was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210815327-covid-19 vaccine ad26.cov2.s - Small cell cancer 13.33mm in stomach area, Small cell cancer 13.33mm in lung area. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Condition aggravated, Feeling abnormal, Pyrexia
Clinical narrative: FEEL HORRIBLE; FEEL WORSE; 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 Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 06-AUG-2021, the patient experienced feel horrible. On 06-AUG-2021, the patient experienced feel worse. On 06-AUG-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.7. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, feel horrible, and feel worse. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: ON AND OFF TINGLING; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 an unspecified date, the patient experienced on and off tingling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of on and off tingling was not reported. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; A spontaneous report (United States) was received from a healthcare professional concerning a 39 years old, female patient who received the vaccine during pregnancy/vaccine exposure during pregnancy.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included multivitamins.  On 11 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 11 Jan 2021, the patient was administered the vaccine during pregnancy.Patient wanted to report a first trimester pregnancy.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The event vaccine administered during pregnancy was considered resolved on 11 Jan 2021.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 39-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Nausea, Vaccination site pain
Clinical narrative: Little bit diarrhea; Lot of pain at site of injection; Heavy joint pain; Little nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Little bit diarrhea), VACCINATION SITE PAIN (Lot of pain at site of injection), ARTHRALGIA (Heavy joint pain) and NAUSEA (Little nausea) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Little bit diarrhea), VACCINATION SITE PAIN (Lot of pain at site of injection), ARTHRALGIA (Heavy joint pain) and NAUSEA (Little nausea). At the time of the report, DIARRHOEA (Little bit diarrhea), VACCINATION SITE PAIN (Lot of pain at site of injection), ARTHRALGIA (Heavy joint pain) and NAUSEA (Little nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Lots of body ache; Chills; fever 101.5 last night, today 99.6; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (lots of body ache), CHILLS (Chills) and PYREXIA (fever 101.5 last night, today 99.6) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.  Concomitant products included ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), Ocuvite 50+, SPIRONOLACTONE, PREDNISONE, HYDROCHLOROTHIAZIDE, IRBESARTAN, ESOMEPRAZOLE, EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE (TRUVADA TM), ATORVASTATIN, TAMSULOSIN, Breo, UMECLIDINIUM BROMIDE (INCRUSE) and MEBEVERINE for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN (lots of body ache), CHILLS (Chills) and PYREXIA (fever 101.5 last night, today 99.6). At the time of the report, PAIN (lots of body ache), CHILLS (Chills) and PYREXIA (fever 101.5 last night, today 99.6) 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.   No treatment medications were provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Peripheral swelling, Pyrexia, Rash
Clinical narrative: Swelling of some fingers in both hands; Bad body rash; Aches; Joint pain; High fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (Swelling of some fingers in both hands), RASH (Bad body rash), MYALGIA (Aches), ARTHRALGIA (Joint pain) and PYREXIA (High fever) in a 25-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 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling of some fingers in both hands), RASH (Bad body rash), MYALGIA (Aches), ARTHRALGIA (Joint pain) and PYREXIA (High fever). The patient was treated with CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swelling of some fingers in both hands), RASH (Bad body rash) and PYREXIA (High fever) outcome was unknown and MYALGIA (Aches) and ARTHRALGIA (Joint pain) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Receive vaccine while pregnant; A spontaneous report was received from a consumer concerning a 37 years old, female patient who received the vaccine during pregnancy/vaccine exposure during pregnancy.   The patient's medical history included ventricular tachycardia, allergies, asthma, and atrial fibrillation. Products known to have been used by the patient, within two weeks prior to the event, included progesterone.  On 16 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 042L20A) in the arm for prophylaxis of COVID-19 infection.   On 16 Jan 2021, the patient was administered the vaccine during pregnancy. The patient is on the week 16 of her pregnancy.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The event vaccine administered during pregnancy was considered resolved on 16 Jan 2021.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing, Vaccination site pain
Clinical narrative: Sneezing a little bit; Running nose; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezing a little bit), RHINORRHOEA (Running nose) and VACCINATION SITE PAIN (Pain at the injection site) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history). Concomitant products included ESOMEPRAZOLE MAGNESIUM (NEXIUM MUPS [ESOMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced SNEEZING (Sneezing a little bit), RHINORRHOEA (Running nose) and VACCINATION SITE PAIN (Pain at the injection site). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, SNEEZING (Sneezing a little bit), RHINORRHOEA (Running nose) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid-19; This spontaneous case was reported by a nurse and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for Covid-19) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for Covid-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, SARS-CoV-2 test: positive (Positive) POSITIVE.     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 were not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up received on 04-JUN-2021 contains Non Significant information. Contact information updated. On 02-Jul-2021: Follow up information received on 02-Jul-2021 and determined causality was updated as per medical reviewer comment.; Sender's Comments: This case concerns a 25-year-old female with a nonserious unexpected event of COVID-19. Event onset within 1 month after first dose mRNA-1273. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: severe head ache; A temperature of 101.4F; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe head ache) and PYREXIA (A temperature of 101.4F) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced HEADACHE (severe head ache) and PYREXIA (A temperature of 101.4F). At the time of the report, HEADACHE (severe head ache) and PYREXIA (A temperature of 101.4F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment details was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Pyrexia, Somnolence
Clinical narrative: High fever; Pain and soreness near the injection site; Headache; Sleepy; A spontaneous report was received from a caregiver, concerning his 19-year-old son, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced high fever 102 Fahrenheit (F), pain and soreness near the injection site, headache and sleepy.  The patient's medical history included COVID-19. Concomitant medications were not reported.  On 11 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 01EJ20A) in his left shoulder area for the prophylaxis of COVID-19 infection.  On 12 Jan 2021, the patient experienced high fever of 102 F, pain and soreness near the injection site, headache and was sleepy. The caregiver stated that patient had COVID-19 earlier this year.  Treatment for the events was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, high fever, pain, soreness near the injection site, headache and sleepy, were considered not resolved.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Dizziness, Heart rate increased, Pain, Temperature intolerance
Clinical narrative: Swelling; irritation under armpits (lymphnodes); mild pain; mild itching that developed into a welt; Itching/itching sensation; light sorness for 2-3 days at the injection site; Light headedness; heat wave sensation; Rapid heart rate; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Light headedness), TEMPERATURE INTOLERANCE (heat wave sensation), HEART RATE INCREASED (Rapid heart rate), PAIN (mild pain) and VACCINATION SITE URTICARIA (mild itching that developed into a welt) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced DIZZINESS (Light headedness), TEMPERATURE INTOLERANCE (heat wave sensation), HEART RATE INCREASED (Rapid heart rate) and VACCINATION SITE PAIN (light sorness for 2-3 days at the injection site). On 08-Jan-2021, the patient experienced PAIN (mild pain), VACCINATION SITE URTICARIA (mild itching that developed into a welt), VACCINATION SITE PRURITUS (Itching/itching sensation) and AXILLARY PAIN (irritation under armpits (lymphnodes)). On 11-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling). At the time of the report, DIZZINESS (Light headedness), TEMPERATURE INTOLERANCE (heat wave sensation), HEART RATE INCREASED (Rapid heart rate) and VACCINATION SITE PAIN (light sorness for 2-3 days at the injection site) had resolved and PAIN (mild pain), VACCINATION SITE URTICARIA (mild itching that developed into a welt), VACCINATION SITE PRURITUS (Itching/itching sensation), VACCINATION SITE SWELLING (Swelling) and AXILLARY PAIN (irritation under armpits (lymphnodes)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.   No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Patient details updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: Swelling; irritation under armpits (lymphnodes); mild pain; mild itching that developed into a welt; Itching/itching sensation; light sorness for 2-3 days at the injection site; Light headedness; heat wave sensation; Rapid heart rate; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Light headedness), TEMPERATURE INTOLERANCE (heat wave sensation), HEART RATE INCREASED (Rapid heart rate), PAIN (mild pain) and VACCINATION SITE URTICARIA (mild itching that developed into a welt) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced DIZZINESS (Light headedness), TEMPERATURE INTOLERANCE (heat wave sensation), HEART RATE INCREASED (Rapid heart rate) and VACCINATION SITE PAIN (light sorness for 2-3 days at the injection site). On 08-Jan-2021, the patient experienced PAIN (mild pain), VACCINATION SITE URTICARIA (mild itching that developed into a welt), VACCINATION SITE PRURITUS (Itching/itching sensation) and AXILLARY PAIN (irritation under armpits (lymphnodes)). On 11-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling). At the time of the report, DIZZINESS (Light headedness), TEMPERATURE INTOLERANCE (heat wave sensation), HEART RATE INCREASED (Rapid heart rate) and VACCINATION SITE PAIN (light sorness for 2-3 days at the injection site) had resolved and PAIN (mild pain), VACCINATION SITE URTICARIA (mild itching that developed into a welt), VACCINATION SITE PRURITUS (Itching/itching sensation), VACCINATION SITE SWELLING (Swelling) and AXILLARY PAIN (irritation under armpits (lymphnodes)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.   No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Patient details updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Skin tightness, Vaccination site movement impairment, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: skin feels more firm; injection site is warm to touch; injection site is swollen about hand size; injection site was so painful; The injection site was painful/same symptoms of pain at injection site/was awakened because my injection site was so painful; had limited range of motion in that arm/again experiencing reduced range of motion; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (The injection site was painful/same symptoms of pain at injection site/was awakened because my injection site was so painful), SKIN TIGHTNESS (skin feels more firm), VACCINATION SITE WARMTH (injection site is warm to touch), VACCINATION SITE MOVEMENT IMPAIRMENT (had limited range of motion in that arm/again experiencing reduced range of motion) and VACCINATION SITE PAIN (injection site was so painful) in a 49-year-old female patient who received mRNA-1273 (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (The injection site was painful/same symptoms of pain at injection site/was awakened because my injection site was so painful) and VACCINATION SITE MOVEMENT IMPAIRMENT (had limited range of motion in that arm/again experiencing reduced range of motion). On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (injection site was so painful). On 12-Jan-2021, the patient experienced SKIN TIGHTNESS (skin feels more firm), VACCINATION SITE WARMTH (injection site is warm to touch) and VACCINATION SITE SWELLING (injection site is swollen about hand size). On 08-Jan-2021, VACCINATION SITE PAIN (The injection site was painful/same symptoms of pain at injection site/was awakened because my injection site was so painful) had resolved. At the time of the report, SKIN TIGHTNESS (skin feels more firm), VACCINATION SITE WARMTH (injection site is warm to touch), VACCINATION SITE MOVEMENT IMPAIRMENT (had limited range of motion in that arm/again experiencing reduced range of motion), VACCINATION SITE PAIN (injection site was so painful) and VACCINATION SITE SWELLING (injection site is swollen about hand size) outcome was unknown.      The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment for the events was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itchiness around the injection site; redness around the injection site; puffiness/raised on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness around the injection site), VACCINATION SITE ERYTHEMA (redness around the injection site) and VACCINATION SITE SWELLING (puffiness/raised on the injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included PAROXETINE, VITAMIN C [ASCORBIC ACID] and ELDERBERRY [SAMBUCUS NIGRA] for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness around the injection site), VACCINATION SITE ERYTHEMA (redness around the injection site) and VACCINATION SITE SWELLING (puffiness/raised on the injection site). On 15-Jan-2021, VACCINATION SITE SWELLING (puffiness/raised on the injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itchiness around the injection site) and VACCINATION SITE ERYTHEMA (redness around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: itchy at injection site; red at injection site; looks more like a bruise; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (looks more like a bruise), VACCINATION SITE PRURITUS (itchy at injection site) and VACCINATION SITE ERYTHEMA (red at injection site) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced CONTUSION (looks more like a bruise). On 13-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchy at injection site) and VACCINATION SITE ERYTHEMA (red at injection site). At the time of the report, CONTUSION (looks more like a bruise), VACCINATION SITE PRURITUS (itchy at injection site) and VACCINATION SITE ERYTHEMA (red at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Pyrexia
Clinical narrative: Body aches and pain; Fever of 100 degrees; Severe Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches and pain), PYREXIA (Fever of 100 degrees) and HEADACHE (Severe Headache) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced MYALGIA (Body aches and pain), PYREXIA (Fever of 100 degrees) and HEADACHE (Severe Headache). At the time of the report, MYALGIA (Body aches and pain), PYREXIA (Fever of 100 degrees) and HEADACHE (Severe Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Body temperature: 101° (High) Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment medications included Paracetamol and Ibuprofen.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate abnormal
Clinical narrative: very fast heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE ABNORMAL (very fast heartbeat) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced HEART RATE ABNORMAL (very fast heartbeat). At the time of the report, HEART RATE ABNORMAL (very fast heartbeat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included thyroid pills and pressure pills. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.  Elderly age along with underlying condition may have been contributory.