chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray normal, Full blood count normal, Loss of consciousness, Metabolic function test normal
Clinical narrative: Pt received his 1st moderna covid 19 vaccination on 4/8/2021. He was admitted to hospital on 4/15/2021 with c/o sudden loss of consciousness x 2 that morning after his AICD fired at home. Interrogation of the AICD noted recurrent episodes of ventricular tachycardia. He also tested positive for covid 19 on admission. He was ultimately discharged/transferred to another hospital on 4/28 after 7 days having been treated with amiodarone and lidocaine drip. He was hospitalized at this facility until his discharge to a covid rehab facility on 5/5/2021 as he is still testing positive for covid 19.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Ventricular tachycardia
Clinical narrative: Pt received his 1st moderna covid 19 vaccination on 4/8/2021. He was admitted to hospital on 4/15/2021 with c/o sudden loss of consciousness x 2 that morning after his AICD fired at home. Interrogation of the AICD noted recurrent episodes of ventricular tachycardia. He also tested positive for covid 19 on admission. He was ultimately discharged/transferred to another hospital on 4/28 after 7 days having been treated with amiodarone and lidocaine drip. He was hospitalized at this facility until his discharge to a covid rehab facility on 5/5/2021 as he is still testing positive for covid 19.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's noted; temperature excursion for frozen products; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 21-APR-2021, the patient was vaccinated with dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) dose 1, lot # T013536, expiration date: 17-OCT-2021 (strength, route of administration and exact dose were not reported) for prophylaxis.  On an unknown dates, the dose of the vaccine was exposed to temperature excursion at 14.1 Fahrenheit degrees (F) for 1 hour and at 26 F for 2 hours. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported (linked report: 2104USA007089).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's noted; temperature excursion for frozen products; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 21-APR-2021, the patient was vaccinated with dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) dose 1, lot # T013536, expiration date: 17-OCT-2021 (strength, route of administration and exact dose were not reported) for prophylaxis.  On an unknown dates, the dose of the vaccine was exposed to temperature excursion at 14.1 Fahrenheit degrees (F) for 1 hour and at 26 F for 2 hours. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported (linked report: 2104USA007083).
Age: 10.0
Sex: U
Vaccine: HPV9
Symptoms: Device connection issue, Incorrect dose administered, Syringe issue
Clinical narrative: No additional AE occurred.; the patient only received half a dose; needle separating from the syringe during administration; needle separating from the syringe during administration; This spontaneous report was received from a registered medical assistant and refers to a 10-year-old patient of unknown gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 28-APR-2021, the patient was vaccinated with a half a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 ml, lot # 1687290, expiration date 06-SEP-2022 (route of administration and anatomical location were not reported) for prophylaxis. The patient received only half a dose due to the needle separating from the syringe during the administration. No adverse event (AE) occurred.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Me too have them now; Excruciating pain; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown. It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine. Additional details were provided as follows: The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. The patient also experienced excruciating pain. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided. This case had been linked with case US2021AMR093253, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR093253:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; had vaccine / had a bad case of shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient had the vaccine but still had a bad case of shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: redness in the area of the shot / about the size of her hand; This case was reported by a consumer via and described the occurrence of injection site erythema in a 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th April 2021, the patient received the 1st dose of Shingrix. In April 2021, 1 week after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The reporter reported this case for his/her aunt(patient). The patient had her Shingrix vaccine a week before reporting date. The reporter asked whether it was normal for patient to have redness in the area of the shot (about the size of her hand) a week later. The reporter also asked if it was common have redness in the area after a week. No further information available.
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: Nerve pain two weeks after her first dose; This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 12th February 2021, 14 days after receiving Shingrix, the patient experienced nerve pain. The patient was treated with gabapentin. On an unknown date, the outcome of the nerve pain was not recovered/not resolved.   It was unknown if the reporter considered the nerve pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by patient herself. The patient received 1st dose of Shingrix and experienced nerve pain. The patient was not sure whether the nerve pain was vaccine related or not.  The patient indicated that her symptoms slightly improved after her physician prescribed Gabapentin for her ongoing nerve pain condition. The patient was not able to provide Shingrix vaccine lot number and expiration date. The patient was able to provide her own email address but not her physician's email address. Hence, could not collect the patient's date of birth. The reporter consented to follow up.
Sex: U
Vaccine: DTAPIPV
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: vaccinated with Kinrix / 1st dose: 6-18-2019 / 2nd dose: 11-8-2019/ In between a Pediarix dose was administered on 10-07-2019.; vaccinated with Kinrix / 1st dose: 6-18-2019 / 2nd dose: 11-8-2019 / In between a Pediarix dose was administered on 10-07-2019.; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included DTPa-HBV-IPV (Pediarix) and DTPa-IPV (Kinrix).   On 8th November 2019, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. In November 2019, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device and Pediarix and an unknown time after receiving Kinrix, the patient experienced extra dose administered and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the extra dose administered and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional detais were provided as follows: The age at vaccination was not reported. The patient received first dose of Kinrix on 18th June 2019. On 7th October 2019, the patient received a dose of Pediarix. On 08th November 2019 the patient then receive second dose of Kinrix, which led to extra dose administered and inappropriate schedule of vaccine administration. No patient demographics was reported, no lot number and expiration of the vaccines were provided.. The patient received the doses in a different facility from where the call was made. The reporter did not consent to follow-up.
Age: 73.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Injection site discomfort, Injection site erythema
Clinical narrative: Left arm injection site discomfort / not resolved; Left arm injection site redness / resolved; This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID-19 MRNA-1273 VACCINE (COVID-19 VACCINE MODERNA) and COVID-19 MRNA-1273 VACCINE (COVID-19 VACCINE MODERNA).   On 29th March 2021, the patient received the 1st dose of Shingrix. On 29th March 2021, 10 hrs after receiving Shingrix, the patient experienced injection site discomfort and injection site erythema. On an unknown date, the outcome of the injection site discomfort was not recovered/not resolved and the outcome of the injection site erythema was recovered/resolved.   It was unknown if the reporter considered the injection site discomfort and injection site erythema to be related to Shingrix.  Additional details provided were as follows: The patient received 1st dose of Shingrix in her left arm at pharmacy and injection site redness. On the same day experienced injection site discomfort and injection site redness. The reporter consented to follow up with her Health Care Professional.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose, Wrong product administered
Clinical narrative: adult patient received a pediatric dose of Engerix-b instead of an adult dose; adult patient received a pediatric dose of Engerix-b instead of an adult dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 41-year-old female patient who received HBV (Engerix B) (batch number 722KC, expiry date 6th April 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th April 2021, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 30th April 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were 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 was reported as follows: The patient received pediatric Engerix B instead of adult Engerix B, which led to underdose and adult use of a child product. The reporter consented to follow up. No other information was available.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered, Syringe issue, Underdose
Clinical narrative: The needle came out on her arm / received half of the dose; The needle came out on her arm, thus wasting part of the dose; The needle came out on her arm, thus wasting part of the dose; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th April 2021, the patient received the 2nd dose of Shingrix. On 28th April 2021, unknown after receiving Shingrix, the patient experienced accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.  Additional information was provided as follows: This case was reported by pharmacist for herself. The pharmacist reported that she received the 2nd dose of Shingrix and the needle came out on her arm, thus wasting part of the dose, which led to accidental underdose, exposure via skin contact and Inadvertent exposure to vaccine. The patient received half of the dose. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Headache, Injection site erythema
Clinical narrative: Arm swollen at injection site; Arm / red at injection site; Warm at injection site; Extreme headache; Fever; "Not feeling well"; Stomach pain; Lightheadedness; Vomiting; Diarrhea; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 4 days after receiving Shingrix, the patient experienced headache, feeling unwell, injection site swelling, injection site erythema, injection site warmth, stomach pain, light headedness, vomiting, diarrhea and fever. On an unknown date, the outcome of the headache, feeling unwell, injection site swelling, injection site erythema, injection site warmth, stomach pain, light headedness, vomiting, diarrhea and fever were not recovered/not resolved.   It was unknown if the reporter considered the headache, feeling unwell, injection site swelling, injection site erythema, injection site warmth, stomach pain, light headedness, vomiting, diarrhea and fever to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for herself. Age at vaccination was not applicable. Patient reported that she had a shingrix shot and after 4 days experienced extreme headache not feeling well at swollen red and warm at injection site stomach pain lightheadedness vomiting and diarrhea and a fever. Caller stated she had to disconnect due to a telehealth appointment with her HCP. Unable to obtain address date of birth dose of shingrix route and dosage of vaccine lot and expiration date. Symptoms started 4 days after injection and not resolved. Unable to obtain HCP information. Did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Malaise, Pyrexia, Vomiting
Clinical narrative: Arm swollen at injection site; Arm / red at injection site; Warm at injection site; Extreme headache; Fever; "Not feeling well"; Stomach pain; Lightheadedness; Vomiting; Diarrhea; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 4 days after receiving Shingrix, the patient experienced headache, feeling unwell, injection site swelling, injection site erythema, injection site warmth, stomach pain, light headedness, vomiting, diarrhea and fever. On an unknown date, the outcome of the headache, feeling unwell, injection site swelling, injection site erythema, injection site warmth, stomach pain, light headedness, vomiting, diarrhea and fever were not recovered/not resolved.   It was unknown if the reporter considered the headache, feeling unwell, injection site swelling, injection site erythema, injection site warmth, stomach pain, light headedness, vomiting, diarrhea and fever to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for herself. Age at vaccination was not applicable. Patient reported that she had a shingrix shot and after 4 days experienced extreme headache not feeling well at swollen red and warm at injection site stomach pain lightheadedness vomiting and diarrhea and a fever. Caller stated she had to disconnect due to a telehealth appointment with her HCP. Unable to obtain address date of birth dose of shingrix route and dosage of vaccine lot and expiration date. Symptoms started 4 days after injection and not resolved. Unable to obtain HCP information. Did not consent to follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Loss of consciousness
Clinical narrative: PASSED OUT 11 HOURS FROM THE TIME OF VACCINATION; This spontaneous report received from a patient concerned a 27 year old male with unknown race and ethnicity. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, 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 patient passed out 11 hours from the time of vaccination. Patient had slept two hours with his head elevated. Near the end of his pee he passed out in the bathroom. He had another person with him, helping him stay hydrated. Temperature was staying below 100. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of passed out 11 hours from the time of vaccination was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210502538-covid-19 vaccine ad26.cov2.s-Passed out 11 hours from the time of vaccination . 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).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Groin pain
Clinical narrative: GROIN PAIN; This spontaneous report received from a patient concerned a 56 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203a21a, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced groin pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.t The patient had not recovered from groin pain. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Dyspnoea, Fatigue, Injection site indentation
Clinical narrative: COUGHING; THROBBING/PULSATING SENSATION AT INJECTION SITE; DIFFICULT TO SLEEP; INDENTATION FROM SHOULDER TO TRICEP AREA; FEELING OF PASSING OUT; VOMITING; ACHINESS/BODY ACHES; TIREDNESS; NAUSEA; INJECTION SITE SWELLING; DIFFICULTY IN BREATHING; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included swelling due to penicillins, throat closes due to marijuana, throat swelling due to marijuana, and hives in mouth due to marijuana, and concurrent conditions included type 2 diabetes, migraine, insomnia, penicillin allergy, alcohol user, smoker, and marijuana abuse, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage. The patient experienced break out in rash and feeling sick when treated with gabapentin.  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 28-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included zolpidem for insomnia, cyclobenzaprine for migraine, fluoxetine for migraine, ketorolac for migraine, and promethazine for migraine.  On 28-APR-2021, the subject experienced difficulty in breathing. On 28-APR-2021 14:00, the subject experienced indentation from shoulder to tricep area. On 28-APR-2021 14:00, the subject experienced feeling of passing out. On 28-APR-2021 14:00, the subject experienced vomiting. On 28-APR-2021 14:00, the subject experienced achiness/body aches. On 28-APR-2021 14:00, the subject experienced tiredness. On 28-APR-2021 14:00, the subject experienced nausea. On 28-APR-2021 14:00, the subject experienced injection site swelling. On 28-APR-2021 17:00, the subject experienced difficult to sleep. On 29-APR-2021, the subject experienced coughing. On 29-APR-2021, the subject experienced throbbing/pulsating sensation at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site swelling, indentation from shoulder to tricep area, tiredness, achiness/body aches, feeling of passing out, nausea, vomiting, difficulty in breathing, coughing, difficult to sleep, and throbbing/pulsating sensation at injection site. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Insomnia, Nausea, Pain
Clinical narrative: COUGHING; THROBBING/PULSATING SENSATION AT INJECTION SITE; DIFFICULT TO SLEEP; INDENTATION FROM SHOULDER TO TRICEP AREA; FEELING OF PASSING OUT; VOMITING; ACHINESS/BODY ACHES; TIREDNESS; NAUSEA; INJECTION SITE SWELLING; DIFFICULTY IN BREATHING; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included swelling due to penicillins, throat closes due to marijuana, throat swelling due to marijuana, and hives in mouth due to marijuana, and concurrent conditions included type 2 diabetes, migraine, insomnia, penicillin allergy, alcohol user, smoker, and marijuana abuse, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage. The patient experienced break out in rash and feeling sick when treated with gabapentin.  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 28-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included zolpidem for insomnia, cyclobenzaprine for migraine, fluoxetine for migraine, ketorolac for migraine, and promethazine for migraine.  On 28-APR-2021, the subject experienced difficulty in breathing. On 28-APR-2021 14:00, the subject experienced indentation from shoulder to tricep area. On 28-APR-2021 14:00, the subject experienced feeling of passing out. On 28-APR-2021 14:00, the subject experienced vomiting. On 28-APR-2021 14:00, the subject experienced achiness/body aches. On 28-APR-2021 14:00, the subject experienced tiredness. On 28-APR-2021 14:00, the subject experienced nausea. On 28-APR-2021 14:00, the subject experienced injection site swelling. On 28-APR-2021 17:00, the subject experienced difficult to sleep. On 29-APR-2021, the subject experienced coughing. On 29-APR-2021, the subject experienced throbbing/pulsating sensation at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site swelling, indentation from shoulder to tricep area, tiredness, achiness/body aches, feeling of passing out, nausea, vomiting, difficulty in breathing, coughing, difficult to sleep, and throbbing/pulsating sensation at injection site. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: COUGHING; THROBBING/PULSATING SENSATION AT INJECTION SITE; DIFFICULT TO SLEEP; INDENTATION FROM SHOULDER TO TRICEP AREA; FEELING OF PASSING OUT; VOMITING; ACHINESS/BODY ACHES; TIREDNESS; NAUSEA; INJECTION SITE SWELLING; DIFFICULTY IN BREATHING; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included swelling due to penicillins, throat closes due to marijuana, throat swelling due to marijuana, and hives in mouth due to marijuana, and concurrent conditions included type 2 diabetes, migraine, insomnia, penicillin allergy, alcohol user, smoker, and marijuana abuse, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage. The patient experienced break out in rash and feeling sick when treated with gabapentin.  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 28-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included zolpidem for insomnia, cyclobenzaprine for migraine, fluoxetine for migraine, ketorolac for migraine, and promethazine for migraine.  On 28-APR-2021, the subject experienced difficulty in breathing. On 28-APR-2021 14:00, the subject experienced indentation from shoulder to tricep area. On 28-APR-2021 14:00, the subject experienced feeling of passing out. On 28-APR-2021 14:00, the subject experienced vomiting. On 28-APR-2021 14:00, the subject experienced achiness/body aches. On 28-APR-2021 14:00, the subject experienced tiredness. On 28-APR-2021 14:00, the subject experienced nausea. On 28-APR-2021 14:00, the subject experienced injection site swelling. On 28-APR-2021 17:00, the subject experienced difficult to sleep. On 29-APR-2021, the subject experienced coughing. On 29-APR-2021, the subject experienced throbbing/pulsating sensation at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site swelling, indentation from shoulder to tricep area, tiredness, achiness/body aches, feeling of passing out, nausea, vomiting, difficulty in breathing, coughing, difficult to sleep, and throbbing/pulsating sensation at injection site. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dysstasia, Headache, Limb discomfort, Pain in extremity
Clinical narrative: UNABLE TO STAND UP; HEAVINESS IN BOTH LEGS; PAIN IN LEFT UPPER THIGH; HEADACHE; BACK ACHE; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported.  The patient's past medical history included back pain, and concurrent conditions included irritable bowel syndrome (ibsd) with major constipation, abstains alcohol, and cigarette smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of report.  The patient experienced cannot breath when treated with tetanus vaccine for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced back ache, pain in left upper thigh, headache. On 01-MAY-2021 and heaviness in both legs.  On 02-MAY-2021, the subject experienced unable to stand up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heaviness in both legs, headache, pain in left upper thigh, back ache, and unable to stand up. This report was non-serious.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: RASH ON BOTH ARMS (GOTTEN A LITTLE BIGGER); ARM ITCHING; RASH ON BOTH ARMS (ARM CREASES IN THE FRONT AND IT IS OVAL SIZE AND ABOUT 3 INCHES LONG); This spontaneous report received from a patient concerned a 45 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported batch number: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 02-MAY-2021, the subject experienced arm itching. On 02-MAY-2021, the subject experienced rash on both arms (arm creases in the front and it is oval size and about 3 inches long). Treatment medications included: cortisone. On 03-MAY-2021, the subject experienced rash on both arms (gotten a little bigger). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on both arms (arm creases in the front and it is oval size and about 3 inches long), arm itching, and rash on both arms (gotten a little bigger). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pyrexia
Clinical narrative: CHILLS; FELT WEAK; FEVERISH; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case.  No concomitant medications were reported. On an unspecified date, the subject experienced chills, feeling weak, and feverish. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, feeling weak, and feverish. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: COVID-19; The doctor had advised her that she needs to wait 90 days before receiving the second shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer and Mastectomy (left breast cancer surgery).    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (The doctor had advised her that she needs to wait 90 days before receiving the second shot). On 23-Mar-2021, PRODUCT DOSE OMISSION ISSUE (The doctor had advised her that she needs to wait 90 days before receiving the second shot) had resolved. At the time of the report, COVID-19 (COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. The patients treatment medication information included Bamlanivimab and another drug of which she does not recall.  Company comment: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.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; 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.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Intracranial aneurysm
Clinical narrative: stage 4 brain aneurysm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INTRACRANIAL ANEURYSM (stage 4 brain aneurysm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced INTRACRANIAL ANEURYSM (stage 4 brain aneurysm) (seriousness criteria hospitalization, disability and medically significant). The patient was hospitalized from 04-Apr-2021 to 23-Apr-2021 due to INTRACRANIAL ANEURYSM. At the time of the report, INTRACRANIAL ANEURYSM (stage 4 brain aneurysm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and investigations done while patient was hospitalized were not reported.  Concomitant medication 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 event, a causal relationship cannot be excluded.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Hip fracture, Hypoaesthesia, Product dose omission issue
Clinical narrative: breaking hip; Consumer put pressure on the leg and it collapsed; right leg feel asleep; Patient missed his second dose because he had to get a surgery; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HIP FRACTURE (breaking hip) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic and Overweight.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HIP FRACTURE (breaking hip) (seriousness criteria hospitalization and medically significant), FALL (Consumer put pressure on the leg and it collapsed), HYPOAESTHESIA (right leg feel asleep) and PRODUCT DOSE OMISSION ISSUE (Patient missed his second dose because he had to get a surgery). The patient was treated with Surgery for Hip fracture. At the time of the report, HIP FRACTURE (breaking hip) had not resolved, FALL (Consumer put pressure on the leg and it collapsed) and PRODUCT DOSE OMISSION ISSUE (Patient missed his second dose because he had to get a surgery) had resolved and HYPOAESTHESIA (right leg feel asleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment reported was surgery for breaking his hip. No concomitant medication information was provided.  Caregiver states the fall was not related to vaccine. Caregiver did not provided information whether consumer was hospitalized and what kind of care he got afterwards. He did not have much information since he was calling with a medical inquiry.  Company Comment: 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.; 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: Chills, Headache, Mental impairment
Clinical narrative: couldn't think of words; Severe headache - mostly on left side; severe chills; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (couldn't think of words) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001CR1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL TARTRATE (LOPRESSOR) and LATANOPROST for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced MENTAL IMPAIRMENT (couldn't think of words) (seriousness criterion medically significant), HEADACHE (Severe headache - mostly on left side) and CHILLS (severe chills). On 28-Apr-2021, MENTAL IMPAIRMENT (couldn't think of words), HEADACHE (Severe headache - mostly on left side) and CHILLS (severe chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No laboratory details was given. No treatment information was given. Patient stated two occurrences of this type of episode on 27 Apr 2021 and 28 Apr 2021.  Company comment: 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; 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. Further information has been requested
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Mental impairment, Myalgia
Clinical narrative: Cant think; Pain in arm; Fuzzy head; Arm pain,achy and everything,bodyache; slight headache; chills; feeling nauseous; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (Cant think) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014-C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021. Concomitant products included CALCIUM and ALENDRONATE SODIUM (FOSAMAX) for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced MENTAL IMPAIRMENT (Cant think) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in arm), FEELING ABNORMAL (Fuzzy head), MYALGIA (Arm pain,achy and everything,bodyache), HEADACHE (slight headache), CHILLS (chills) and NAUSEA (feeling nauseous). At the time of the report, MENTAL IMPAIRMENT (Cant think), PAIN IN EXTREMITY (Pain in arm), FEELING ABNORMAL (Fuzzy head), MYALGIA (Arm pain,achy and everything,bodyache), HEADACHE (slight headache), CHILLS (chills) and NAUSEA (feeling nauseous) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication includes Liver supplement (herb). Treatment information was not reported.  Company Comment: 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.; 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: Cant think; Pain in arm; Fuzzy head; Arm pain,achy and everything,bodyache; slight headache; chills; feeling nauseous; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (Cant think) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014-C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021. Concomitant products included CALCIUM and ALENDRONATE SODIUM (FOSAMAX) for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced MENTAL IMPAIRMENT (Cant think) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in arm), FEELING ABNORMAL (Fuzzy head), MYALGIA (Arm pain,achy and everything,bodyache), HEADACHE (slight headache), CHILLS (chills) and NAUSEA (feeling nauseous). At the time of the report, MENTAL IMPAIRMENT (Cant think), PAIN IN EXTREMITY (Pain in arm), FEELING ABNORMAL (Fuzzy head), MYALGIA (Arm pain,achy and everything,bodyache), HEADACHE (slight headache), CHILLS (chills) and NAUSEA (feeling nauseous) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication includes Liver supplement (herb). Treatment information was not reported.  Company Comment: 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.; 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: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Incomplete course of vaccination, Urinary tract infection
Clinical narrative: Urinary tract infection; More than 36 days have passed since first dose given (6Mar2021), still hasn't had 2nd dose; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced URINARY TRACT INFECTION (Urinary tract infection) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (More than 36 days have passed since first dose given (6Mar2021), still hasn't had 2nd dose). The patient was hospitalized on 02-Apr-2021 due to URINARY TRACT INFECTION. At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) and INCOMPLETE COURSE OF VACCINATION (More than 36 days have passed since first dose given (6Mar2021), still hasn't had 2nd dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not reported.   Treatment information was not reported.   It was noted by the reporter that the event "urinary tract infection" was not due to the vaccine but due to something that the patient ate.  Company comment: 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.; 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.