chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered / liquid conjugate portion only / not reconstituted with the lyophilized / portion; administered / liquid conjugate portion only / not reconstituted with the lyophilized / portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient received Men CYW liquid conjugate portion only of Menveo vaccine and the vaccine was not reconstituted with the lyophilized Men A portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The health care professional did not have patient details or vaccine lot number and expiration date. The reporter consented to follow up. This case was 1 of 8 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021169160:Same reporter US-GLAXOSMITHKLINE-US2021AMR170397:Same reporter US-GLAXOSMITHKLINE-US2021AMR170398:Same reporter US-GLAXOSMITHKLINE-US2021AMR170399:Same reporter US-GLAXOSMITHKLINE-US2021AMR170403:Same reporter US-GLAXOSMITHKLINE-US2021AMR170401:Same reporter US-GLAXOSMITHKLINE-US2021AMR170402:Same reporter
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only the liquid portion / was administrated; only the liquid portion / was administrated; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (1st dose received on unknown date).   On an unknown date, the patient received the 2nd dose of Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provide are as follows: The age at vaccination was not reported. The patient received only the liquid portion of the Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter had no information regarding the patient, nor the date of the administration.  The reporter reported that they realized this happened due to the fact that they found a remaining powder portion of the vaccine without the accompanying diluent.  The reporter had no information for the lot number and expiration date of the portion administrated at the moment of the call. The reporter agreed to be contacted for follow-up through their email address. No further events were reported.  The reporter consented to follow-up. The case has been linked with case US2021AMR158869 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR158869:Same reporter
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received menveo  powder which was reconstituted with a sterile diluent; received menveo  powder which was reconstituted with a sterile diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA466A, expiry date 31st March 2022) for prophylaxis.   On 10th August 2021, the patient received the 1st dose of Menveo. On 10th August 2021, unknown after receiving Menveo, 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 provide are as follows: The age at vaccination was unknown. The patient received 1st dose of Menveo and powder was reconstituted with a sterile diluent other than the one provided, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow-up.
Age: 4.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: adult dose / administrated to 4 year old male; adult dose / administrated to 4 year old male; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 4-year-old male patient who received HBV (Engerix B adult) (batch number h2t35, expiry date 29th May 2022) for prophylaxis.   On 10th August 2021, the patient received Engerix B adult. On 10th August 2021, unknown after receiving Engerix B adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.  Additional details were provided as follows: The nurse reported that an adult dose of Engerix-b was administrated to 4 year old patient, which led to overdose and adult product administered to child. No adverse event was reported. The reporter consented to follow up.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only the liquid component /was given; only the liquid component /was given; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA466A, expiry date 31st October 2022) for prophylaxis.   On 4th August 2021, the patient received Menveo. On 4th August 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provide are as follows: The office manager reported that only the liquid component of Menveo was given to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never received the 2nd dose; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 5th October 2020, batch number 7SK92, expiry date 26th January 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were provided as follows: The age at vaccination was not applicable for this report. Health care professional reported that a patient never received the 2nd dose which led to incomplete course of vaccination. The reporter asked question if it needed repeat series. The reporter consented to follow up. VAERS details were reported for 1st dose of Shingrix.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-AUG-2021, the patient experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious. This case, from the same reporter is linked to 20210815116.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye pain, Fatigue, Feeling abnormal, Head discomfort
Clinical narrative: EYES WERE HURTING; CONGESTION; EXTREMELY BAD MEMORY FOG; BODY PAIN; BACK OF MY NECK WAS HURTING; CHILLS; FEVER; FELT VERY TIRED; HEADACHE/HEAD CONTINUES HURTING/OCCIPITAL AREA HURTING; FELT THE HEAD WAS HEAVY; BLURRY VISION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 06-AUG-2021, the patient experienced felt the head was heavy. On 06-AUG-2021, the patient experienced blurry vision. On 06-AUG-2021, the patient experienced chills. On 06-AUG-2021, the patient experienced fever. On 06-AUG-2021, the patient experienced felt very tired. On 06-AUG-2021, the patient experienced headache/head continues hurting/occipital area hurting. On 07-AUG-2021, the patient experienced eyes were hurting. On 07-AUG-2021, the patient experienced congestion. On 07-AUG-2021, the patient experienced extremely bad memory fog. On 07-AUG-2021, the patient experienced body pain. On 07-AUG-2021, the patient experienced back of my neck was hurting. Laboratory data (dates unspecified) included COVID-19 virus test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt the head was heavy, blurry vision, chills, fever, felt very tired, headache/head continues hurting/occipital area hurting, eyes were hurting, congestion, body pain, and back of my neck was hurting, and had not recovered from extremely bad memory fog. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: EYES WERE HURTING; CONGESTION; EXTREMELY BAD MEMORY FOG; BODY PAIN; BACK OF MY NECK WAS HURTING; CHILLS; FEVER; FELT VERY TIRED; HEADACHE/HEAD CONTINUES HURTING/OCCIPITAL AREA HURTING; FELT THE HEAD WAS HEAVY; BLURRY VISION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 06-AUG-2021, the patient experienced felt the head was heavy. On 06-AUG-2021, the patient experienced blurry vision. On 06-AUG-2021, the patient experienced chills. On 06-AUG-2021, the patient experienced fever. On 06-AUG-2021, the patient experienced felt very tired. On 06-AUG-2021, the patient experienced headache/head continues hurting/occipital area hurting. On 07-AUG-2021, the patient experienced eyes were hurting. On 07-AUG-2021, the patient experienced congestion. On 07-AUG-2021, the patient experienced extremely bad memory fog. On 07-AUG-2021, the patient experienced body pain. On 07-AUG-2021, the patient experienced back of my neck was hurting. Laboratory data (dates unspecified) included COVID-19 virus test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt the head was heavy, blurry vision, chills, fever, felt very tired, headache/head continues hurting/occipital area hurting, eyes were hurting, congestion, body pain, and back of my neck was hurting, and had not recovered from extremely bad memory fog. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event, Vision blurred
Clinical narrative: EYES WERE HURTING; CONGESTION; EXTREMELY BAD MEMORY FOG; BODY PAIN; BACK OF MY NECK WAS HURTING; CHILLS; FEVER; FELT VERY TIRED; HEADACHE/HEAD CONTINUES HURTING/OCCIPITAL AREA HURTING; FELT THE HEAD WAS HEAVY; BLURRY VISION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 06-AUG-2021, the patient experienced felt the head was heavy. On 06-AUG-2021, the patient experienced blurry vision. On 06-AUG-2021, the patient experienced chills. On 06-AUG-2021, the patient experienced fever. On 06-AUG-2021, the patient experienced felt very tired. On 06-AUG-2021, the patient experienced headache/head continues hurting/occipital area hurting. On 07-AUG-2021, the patient experienced eyes were hurting. On 07-AUG-2021, the patient experienced congestion. On 07-AUG-2021, the patient experienced extremely bad memory fog. On 07-AUG-2021, the patient experienced body pain. On 07-AUG-2021, the patient experienced back of my neck was hurting. Laboratory data (dates unspecified) included COVID-19 virus test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt the head was heavy, blurry vision, chills, fever, felt very tired, headache/head continues hurting/occipital area hurting, eyes were hurting, congestion, body pain, and back of my neck was hurting, and had not recovered from extremely bad memory fog. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Illness, Injection site reaction, Nausea, Pain
Clinical narrative: PRETTY SICK; BODY ACHES; LOST WEIGHT; SHOOTING PAINS; COVID ARM (FOR A WEEK); CHILLS; NAUSEA; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: immunocompromised. 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 pretty sick, body aches, lost weight, shooting pains, covid arm (for a week), chills, nausea, and fever. Laboratory data (dates unspecified) included: Lost weight (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid arm (for a week), and the outcome of pretty sick, fever, chills, body aches, nausea, lost weight and shooting pains was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Weight decreased
Clinical narrative: PRETTY SICK; BODY ACHES; LOST WEIGHT; SHOOTING PAINS; COVID ARM (FOR A WEEK); CHILLS; NAUSEA; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: immunocompromised. 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 pretty sick, body aches, lost weight, shooting pains, covid arm (for a week), chills, nausea, and fever. Laboratory data (dates unspecified) included: Lost weight (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid arm (for a week), and the outcome of pretty sick, fever, chills, body aches, nausea, lost weight and shooting pains was not reported. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Musculoskeletal stiffness, Neck pain
Clinical narrative: PAIN IN NECK AT BASE OF SKULL ON LEFT SIDE( THE PAIN HAS GOTTEN WORSE,NOW PAIN IS MORE PRONOUNCED AND IF SHE TURNS HER HEAD  A CERTAIN WAY SHE EXPERIENCES A SHARP PAIN); VACCINE EXPOSURE DURING PREGNANCY; STIFF NECK; This spontaneous pregnancy report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. It was not reported whether the patient had been pregnant before. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 09-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, the patient experienced stiff neck. On 09-AUG-2021, the patient experienced vaccine exposure during pregnancy. The date of the patient's last menstrual period and expected delivery date were not reported. On 11-AUG-2021, the patient experienced pain in neck at base of skull on left side ( the pain has gotten worse, now pain is more pronounced and if she turns her head a certain way she experiences a sharp pain). The pregnancy was continuing. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from pain in neck at base of skull on left side( the pain has gotten worse, now pain is more pronounced and if she turns her head a certain way she experiences a sharp pain), and stiff neck, and the outcome of vaccine exposure during pregnancy was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; SORENESS IN THE INJECTION ARM; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: mildly obese, and allergy to citrus. Patient had no known medical conditions. The patient experienced drug allergy when treated with macrogol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 08-JUN-2021 for prophylactic vaccination. Concomitant medications included ibuprofen.  On 08-JUN-2021, the patient experienced soreness in the injection arm and tiny headache. On 06-AUG-2021, the patient experienced sinus irritation. Patient thought it could be due to seasonal allergies. Out of caution patient performed a COVID-19 test, result was positive (suspected covid-19 and suspected clinical vaccination failure). It was reported that patient received the result on 11-AUG-2021 morning at 05:00. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, soreness in the injection arm and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210822665-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination 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: Chills, Fatigue, Lymph node pain, Pain, Pyrexia
Clinical narrative: BODY ACHES; PAIN IN THE AXILLARY LYMPH NODES OF THE ARM; CHILLS; FEVER; FATIGUE; PAIN AT INJECTION SITE; EXTREME TIREDNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination..The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced body aches. On AUG-2021, the patient experienced pain in the axillary lymph nodes of the arm. On AUG-2021, the patient experienced chills. On AUG-2021, the patient experienced fever. On AUG-2021, the patient experienced fatigue. On AUG-2021, the patient experienced pain at injection site. On AUG-2021, the patient experienced extreme tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, chills, fever, fatigue, pain at injection site, pain in the axillary lymph nodes of the arm and extreme tiredness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: BODY ACHES; PAIN IN THE AXILLARY LYMPH NODES OF THE ARM; CHILLS; FEVER; FATIGUE; PAIN AT INJECTION SITE; EXTREME TIREDNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination..The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced body aches. On AUG-2021, the patient experienced pain in the axillary lymph nodes of the arm. On AUG-2021, the patient experienced chills. On AUG-2021, the patient experienced fever. On AUG-2021, the patient experienced fatigue. On AUG-2021, the patient experienced pain at injection site. On AUG-2021, the patient experienced extreme tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, chills, fever, fatigue, pain at injection site, pain in the axillary lymph nodes of the arm and extreme tiredness was not reported. This report was non-serious.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Hunger, Poor quality product administered
Clinical narrative: EXTREMELY HUNGRY ALL DAY; RECEIVED A VACCINE THAT WAS STORED IN THE REFRIGERATOR BEYOND THE RECOMMENDED STORAGE TIME (OVER NIGHT, POTENTIALLY BETWEEN 12-24 HOURS); This spontaneous report received from a patient concerned a 46 year old male. The patient's weight was 175 pounds, and height was 69 inches. The patient's concurrent conditions included: non smoker, non alcohol user, high blood pressure, asthma, seasonal allergies, cat allergy, soap allergy, dog allergy, horses allergy, hay allergy, and fresh cut grass allergy, and other pre-existing medical conditions included: The patient have no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203AZ1A, expiry: UNKNOWN) dose was not reported, administered on 05-JUN-2021 11:00 for prophylactic vaccination. Concomitant medications included fexofenadine hydrochloride for drug used for unknown indication, glimepiride for drug used for unknown indication, losartan for drug used for unknown indication, and atenolol. On 05-JUN-2021, the patient experienced extremely hungry all day. On 05-JUN-2021, the patient experienced received a vaccine that was stored in the refrigerator beyond the recommended storage time (over night, potentially between 12-24 hours). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extremely hungry all day on 12-JUN-2021, and the outcome of received a vaccine that was stored in the refrigerator beyond the recommended storage time (over night, potentially between 12-24 hours) was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS (WORSE IN SEVERITY IN COMPARISON TO MILD); This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced side effects (worse in severity in comparison to mild). The action taken with covid-19 vaccine was not applicable. The outcome of side effects (worse in severity in comparison to mild) was not reported. This report was non-serious. This case, from the same reporter is linked to 20210826137.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: NEGATIVE REACTION TO THE VACCINE; 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced negative reaction to the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of negative reaction to the vaccine was not reported. This report was non-serious.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: VACCINE WAS  GIVEN TO A 16 YEAR OLD MALE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 16 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 12-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-AUG-2021, the patient experienced vaccine was given to a 16 year old male. On 12-AUG-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine was given to a 16 year old male was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: MILDLY SORE ARM; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced mildly sore arm, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102.8 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mildly sore arm, and fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: SLEEPLESS NIGHTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included salicylic acid. On an unspecified date, the patient experienced sleepless nights. The action taken with covid-19 vaccine was not applicable. The outcome of sleepless nights was not reported. This report was non-serious. This case, involving the same patient is linked to 20210738895.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Body ache; Left arm was super sore; A spontaneous report was received from a consumer, concerning herself, a 51-year-old female patient, who received Moderna's COVID-19 vaccine and developed left arm was super sore and body ache.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 31-Dec-2020, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly in her left arm for COVID-19 infection prophylaxis.  On 01-Jan-2021, the patient reported that she felt her left arm was super sore. Additionally, on 05-Jan-2021, she developed body ache.   Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the events left arm was super sore and body ache was considered to be unknown.; Reporter's Comments: This case concerns a 51 year-old, female patient, who experienced events of left arm was super sore and body ache.  The event of left arm was super sore occurred the next day after the first and last dose of mRNA-1273 vaccine administration. The event of body ache occurred 5 days after the first and last dose of mRNA-1273 vaccine administration.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pain, Pain in extremity
Clinical narrative: Sweating; it's hurting; Enitre body ache; A spontaneous report was received from a consumer concerning a 29-year-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced left arm hurting(pain in extremity), entire body ache (pain) and sweating (hyperhidrosis).  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 Meloxicam and Buspirone Hydrochloride.   On 05 Jan 2021, the same day as the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Patient's husband reported that she received the Moderna vaccine on 05 Jan 2021.  That day, he stated that her arm hurt and that she was having generalized aching.  The next morning, 06 Jan 2021, he reported that she was sweating.    Treatment information was not provided.   Action taken with mRNA-1273 in response to the events, left arm hurting, entire body ache and sweating, was not provided.   The seriousness criteria for all event was not reported.  The outcome of the events, left arm hurting, entire body ache and sweating was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K201A) 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. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 31-Jan-2021. On 06-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 06-Jan-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during 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.   This is a case of product exposure during pregnancy with no associated adverse events for this 28-year-old female. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy. No concomitant medications were provided by the reporter.  No treatments were provided by the reporter.; Sender's Comments: This is a case of product exposure during pregnancy with no associated adverse events for this 28-year-old female. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Injection site pain, Wound
Clinical narrative: Cut himself; Headache; Dizziness; Weakness; Pain in the injected arm; This spontaneous case was reported by a non-health professional and describes the occurrence of WOUND (Cut himself), HEADACHE (Headache), DIZZINESS (Dizziness), ASTHENIA (Weakness) and INJECTION SITE PAIN (Pain in the injected arm) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Q27L2PA) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 05-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 WOUND (Cut himself), HEADACHE (Headache), DIZZINESS (Dizziness), ASTHENIA (Weakness) and INJECTION SITE PAIN (Pain in the injected arm). At the time of the report, WOUND (Cut himself), HEADACHE (Headache), DIZZINESS (Dizziness), ASTHENIA (Weakness) and INJECTION SITE PAIN (Pain in the injected arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: body ache; fever 100.9; chills; A spontaneous report was received from a pharmacist concerning a female patient, unknown age, who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced chills, body aches and fever.   The patient's medical history was not provided. Concomitant product use was not provided.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   On 06 Jan 2021, the patient was unable to work, experienced chills, body aches, and had a fever of 100.9 °F. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The event, chills, body aches and fever, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: injection site Itching; injection site Pain; A spontaneous report was received from a female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site itching and injection site pain.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 07 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On 07 Jan 2021, after receiving the vaccine, the patient stated she had the common effects of the injection, itching and pain, but that she was ok now. The patient had asked if she could take Tylenol (acetaminophen) but it was not reported if she had taken it for treatment.  Action taken with mRNA-1273 in response to the events was not reported.   The events, injection site itching and injection site pain, was resolved on 07 Jan 2021.; Reporter'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: Abdominal pain, Nausea
Clinical narrative: Severe abdominal pain, like contraction; Feeling like she would vomit; A spontaneous report was received from a consumer, concerning her daughter, a female patient of unspecified age, who received Moderna's COVID-19 vaccine and experienced severe abdominal pain, like contraction and feeling like she would vomit.  The patient's medical history was not reported. No relevant concomitant medications were reported.   On 07 Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via unknown route for prophylaxis of COVID-19 infection.   On 07 Jan 2021, after vaccination, the patient had severe abdominal pain, like contractions. She also felt like she would vomit. No treatment information was provided.     Action taken with mRNA-1273 in response to the event were not reported.   The outcome of the events severe abdominal pain, like contraction and feeling like she would vomit were unknown.; Reporter's Comments: Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, an excluding any other etiology, a causal association cannot be excluded. Nausea is consistent with the known safety profile of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, SARS-CoV-2 test
Clinical narrative: stomach issues; headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach issues) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach issues) and HEADACHE (headache). At the time of the report, ABDOMINAL DISCOMFORT (stomach issues) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach issues) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach issues) and HEADACHE (headache). At the time of the report, ABDOMINAL DISCOMFORT (stomach issues) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: negative (Negative) negative.     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.  Company comment: Very limited information regarding this events has been provided at this time. Company assessed the events to be unlikely related to company product.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Company assessed the events to be unlikely related to company product.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Sleeping over 8 hours a day ever since; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleeping over 8 hours a day ever since) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced SOMNOLENCE (Sleeping over 8 hours a day ever since). At the time of the report, SOMNOLENCE (Sleeping over 8 hours a day ever since) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case concerns a 34-year-old of unknown gender who experienced nonserious unexpected event of somnolence.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event resolved. 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.; Reporter's Comments: This case concerns a 34-year-old of unknown gender who experienced nonserious unexpected event of somnolence.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event resolved. 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.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of the arm) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-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 PAIN IN EXTREMITY (Soreness of the arm). At the time of the report, PAIN IN EXTREMITY (Soreness of the arm) had resolved.        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.  Company comment: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Lower back pain, like at the bottom of the spine, around the kidney´s area; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Lower back pain, like at the bottom of the spine, around the kidney´s area) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-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 BACK PAIN (Lower back pain, like at the bottom of the spine, around the kidney´s area). At the time of the report, BACK PAIN (Lower back pain, like at the bottom of the spine, around the kidney´s area) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Laboratory details provided. Treatment information was provided as acetaminophen.   Reporter did not allow further contact; 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.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain, Vomiting
Clinical narrative: Severe headache; Throwing up; Nausea; Body aches; Fatigue; A spontaneous report was received from consumer who is a 49-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe headache, throwing up, nausea, body aches and fatigue.  The patient's medical history was not provided. Concomitant medications were not reported.  On 30 DEC 2020, the patient received their first dose of mRNA-1273 (Batch number: unknown) intramuscularly in her right arm for prophylaxis of COVID-19 infection.  On 30 DEC 2020, the patient experienced severe headache, throwing up, nausea, body aches and fatigue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, severe headache, throwing up, nausea, body aches and fatigue, were considered resolved; Reporter's Comments: This case concerns a 49-year-old female who experienced nonserious expected events of headache, pain, fatigue, nausea, vomiting. Event onset the same day as the first dose of mRNA-1273. Treatment not reported. Events resolved. 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.