chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose of Havrix was given 3 weeks before the correct schedule; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 19-month-old male patient who received HAV (Havrix) (batch number YR532, expiry date 9th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (1st dose received on 28th December 2020).   On 7th June 2021, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On 7th June 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: The patient received booster dose of Havrix  3 weeks before, which led to shortening of vaccination schedule. The reporter consent to follow up via email.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling of body temperature change, Hyperhidrosis, Nausea, Pain in extremity, Rash
Clinical narrative: arm started hurting; developed a rash below injection site,; was feeling cold and hot; sweating; nausea; vomiting; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis (in the wrist and hand).   On 5th June 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th June 2021, 1 days after receiving Shingrix, the patient experienced pain in arm, rash, feeling hot and cold, sweating, nausea and vomiting. On an unknown date, the outcome of the pain in arm, rash, feeling hot and cold, sweating, nausea and vomiting were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, rash, feeling hot and cold, sweating, nausea and vomiting to be related to Shingrix.  Additional details were provided as follows:  On Saturday, the patient received Shingrix vaccine in right arm and on Sunday the arm started hurting and developed a rash below injection site, was feeling cold and hot, sweating, had nausea and vomiting. The reporter did not consent to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: arm started hurting; developed a rash below injection site,; was feeling cold and hot; sweating; nausea; vomiting; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis (in the wrist and hand).   On 5th June 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th June 2021, 1 days after receiving Shingrix, the patient experienced pain in arm, rash, feeling hot and cold, sweating, nausea and vomiting. On an unknown date, the outcome of the pain in arm, rash, feeling hot and cold, sweating, nausea and vomiting were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, rash, feeling hot and cold, sweating, nausea and vomiting to be related to Shingrix.  Additional details were provided as follows:  On Saturday, the patient received Shingrix vaccine in right arm and on Sunday the arm started hurting and developed a rash below injection site, was feeling cold and hot, sweating, had nausea and vomiting. The reporter did not consent to follow up.
Age: 52.0
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered Bexsero to a 52 year old patient; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 52-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA77AA, expiry date 31st October 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th May 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 7th May 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The patient received a dose of Bexsero at an age of 52 years old which led to inappropriate age at vaccine administration. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: missed the second dose/ at appropriate time, first dose was administered on 17Sept2019 /second dose has not been administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 17th September 2019 with batch number 3FJ59 and expiry date 27th November 2021).   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 information was provided as follows: The age at vaccination was not applicable for this report. The patient missed the second dose of Shingrix at appropriate time and did not receive it till the time of reporting which led to incomplete course of vaccination. VAERS details were reported for 1st dose of Shingrix. The reporter consented to follow up via email. This case has been linked with US2021122643 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021122643:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: missed the second dose /at appropriate time/ first dose was administered on 17Sept2019 /second dose has not been administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 17th September 2019 with batch number 3FJ59 and expiry date 27th November 2021).   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 information was provided as follows: The age at vaccination was not applicable for this report. The patient missed the second dose of Shingrix at appropriate time and did not receive it till the time of reporting which led to incomplete course of vaccination. VAERS details were reported for 1st dose of Shingrix. The reporter consented to follow up via email. This case has been linked with US2021122641 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021122641:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received dose 1 / in late 2020, specific date not known / say he was beyond the recommended 6 month window; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date in late 2020).   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 details were provided as follows: This case was reported by the patient himself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose shingrix which led to incomplete course of vaccination. The patient did not wish to provide any demographics, just wanted his question answered. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received a Shingrix dose with only the liquid portion, without the lyophilized portion; received a Shingrix dose with only the liquid portion, without 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 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 7BC5F, expiry date 4th October 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, 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 informed that a patient received a Shingrix dose with only the liquid portion, without the lyophilized portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: frozen havrix was administered to a patient. Havrix was below 32°F (below freezing )for several minutes; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 11-year-old male patient who received HAV (Havrix) (batch number J34DR, expiry date 28th January 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The office manager reported that a frozen Havrix was administered to a patient, which led to incorrect storage of drug. Havrix was below 32 degree Fahrenheit (below freezing) for several minutes. The reporter enquired about revaccination. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received / first dose / about a year ago / was not informed about her second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose about a year ago).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). 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 details were provided as follows: The age at vaccination was not applicable to this report. Reporter is the patient. The patient inquired about getting a second dose of Shingrix vaccine. The patient received her first dose of Shingrix about a year ago, and due to system glitch at the pharmacy, patient was not informed about her second dose, which led to incomplete course of vaccination. The reporter did not have the following information from the first dose of Shingrix: lot no, expiration date, dose, and date of administration. The reporter gave a consent to follow-up with HCP.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: had the first (1/24/2020) and second (2/5/2021) dose; received a third dose of Shingrix today/ had the first (1/24/2020) / second (2/5/2021) dose; This case was reported by a pharmacist and described the occurrence of extra dose administered in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number 3K743, expiry date 7th October 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 24th January 2020).   On 7th June 2021, the patient received the 3rd dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 7th June 2021, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the extra dose administered and drug dose administration interval too long were unknown.  Additional details were provided as follows: The age at vaccination was reported. Pharmacist reported that she had a patient that came in today for what was supposed to be the 2nd dose of Shingrix.  The patient called about an hour later stating that she had received 2 doses 1st on 24th January 2020 and 2nd on 5th February 2021 already, making the dose administered today the 3rd dose, which led to extra dose administered and drug dose administration interval too long. No vaccine information for the first 2 doses as they were administered at another pharmacy/facility.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021122682:same reporter - same patient - FU
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: MAJOR FLU LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a male of unspecified age. 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, and batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination.  The batch number is not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced major flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of major flu like symptoms was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Crying, Feeling abnormal, Pain in extremity
Clinical narrative: FELT WOBBLY; MILDLY SORE ARM; TEARY FOR NO REASON OR SOBBING (OVER EVERYTHING SEVERAL TIMES A DAY); EVERYTHING HURT HER FEELING; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included doesn't metabolize alcohol, and menopause, and other pre-existing medical conditions included patient had nothing wrong and had no ongoing medical issues, patient was not on medication of any kind and had not taken any medication after shot. the patient had pms (premenstrual syndrome) (wanted to cry over everything, no anger though). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, and expiry: UNKNOWN) dose was not reported, administered on 09-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced teary for no reason or sobbing (over everything several times a day). On MAY-2021, the subject experienced everything hurt her feeling. On 09-MAY-2021, the subject experienced felt wobbly. On 09-MAY-2021, the subject experienced mildly sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from teary for no reason or sobbing (over everything several times a day), everything hurt her feeling, and mildly sore arm on MAY-2021, and had not recovered from felt wobbly. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Expired product administered, SARS-CoV-2 antibody test negative
Clinical narrative: ANTIBODY TEST NEGATIVE; EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with celecoxib, and tetracycline. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 26-MAY-2021 at 09:55 am for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced expired vaccine administered. On 02-JUN-2021, the subject experienced antibody test negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the antibody test negative and expired vaccine administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: LIL BRAIN FOG; ARM SORENESS; 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: Unk) dose was not reported, administered on 02-JUN-2021 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 03-JUN-2021, the subject experienced lil brain fog. On 03-JUN-2021, the subject experienced arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lil brain fog and arm soreness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain in extremity, Pain of skin
Clinical narrative: SKIN PAIN; DIZZY; ARM HURTS; HEADACHE; 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: 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 2021, the subject experienced skin pain. On 2021, the subject experienced dizzy. On 2021, the subject experienced arm hurts. On 2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and skin pain, and the outcome of arm hurts and dizzy was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: FLARED UP ALL OF MY CHRONIC PAIN FOR 2-3 WEEKS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced flared up all of my chronic pain for 2-3 weeks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flared up all of my chronic pain for 2-3 weeks was not reported. This report was non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myalgia, Nasopharyngitis, Pyrexia, Thirst
Clinical narrative: REALLY COLD; SWEATY; VERY VERY THIRSTY; FEVERISH; DEEP MUSCLE ACHES IN THE BACK AND SHOULDERS AND NECK; This spontaneous report received from a patient concerned a 22 year old female. The patient's weight was 73 kilograms, and height was 72 inches. The patient's concurrent conditions included alcohol user, and smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient have no history of drug abuse or illicit drug usage. the patient have no history of hospitalizations within the last month; no medical conditions; takes no medications regularly.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 05-JUN-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On 05-JUN-2021, the subject experienced really cold. On 05-JUN-2021, the subject experienced sweaty. On 05-JUN-2021, the subject experienced very very thirsty. On 05-JUN-2021, the subject experienced feverish. On 05-JUN-2021, the subject experienced deep muscle aches in the back and shoulders and neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from really cold, sweaty, very very thirsty, and feverish on 06-JUN-2021, and had not recovered from deep muscle aches in the back and shoulders and neck. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Vision blurred
Clinical narrative: RED SPOT WITHIN LEFT EYE; BLURRED VISION; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 20SA21A expiry: UNKNOWN) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. Concomitant medications included amlodipine, hydrocortisone, levothyroxine, paroxetine, and prednisone non-company. On 05-JUN-2021, the subject experienced red spot within left eye. On 05-JUN-2021, the subject experienced blurred vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the red spot within left eye and blurred vision was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Dizziness, Fatigue, Injection site pain
Clinical narrative: COUGHING ALL DAY WITH DRY COUGH; FEELING DIZZY; FATIGUE; FEVER; NAUSEAOUS; SHARP PAIN IN THE UPPER RIGHT SHOULDER NEAR INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and gall bladder taken out, and concurrent conditions included long covid hauler.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 02-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-JUN-2021, the subject experienced sharp pain in the upper right shoulder near injection site pain. On 03-JUN-2021, the subject experienced coughing all day with dry cough. On 03-JUN-2021, the subject experienced feeling dizzy. On 03-JUN-2021, the subject experienced fatigue. On 03-JUN-2021, the subject experienced fever. On 03-JUN-2021, the subject experienced nauseaous. Laboratory data included: Body temperature (NR: not provided) 101 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, was recovering from coughing all day with dry cough, and had not recovered from fatigue, nauseaous, feeling dizzy, and sharp pain in the upper right shoulder near injection site pain. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: COUGHING ALL DAY WITH DRY COUGH; FEELING DIZZY; FATIGUE; FEVER; NAUSEAOUS; SHARP PAIN IN THE UPPER RIGHT SHOULDER NEAR INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and gall bladder taken out, and concurrent conditions included long covid hauler.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 02-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-JUN-2021, the subject experienced sharp pain in the upper right shoulder near injection site pain. On 03-JUN-2021, the subject experienced coughing all day with dry cough. On 03-JUN-2021, the subject experienced feeling dizzy. On 03-JUN-2021, the subject experienced fatigue. On 03-JUN-2021, the subject experienced fever. On 03-JUN-2021, the subject experienced nauseaous. Laboratory data included: Body temperature (NR: not provided) 101 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, was recovering from coughing all day with dry cough, and had not recovered from fatigue, nauseaous, feeling dizzy, and sharp pain in the upper right shoulder near injection site pain. This report was non-serious.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Genital herpes
Clinical narrative: HERPES INFECTION; This spontaneous report received from a consumer concerned a 71 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no significant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: 23-JUN-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced herpes infection. On 02-JUN-2021, treatment medications included: valaciclovir hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from herpes infection. This report was non-serious. This case, from the same reporter is linked to 20210612299.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Disturbance in attention, Dizziness
Clinical narrative: HEART BURN; CHEST PAIN; DIZZINESS; FOGGINESS; CONCENTRATION ISSUES; FATIGUE/ TIRED; HEADACHES; This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's past medical history included rash, itchy, and gastrointestinal issues, and concurrent conditions included depression, egg allergy, chicken allergy, non alcoholic, non smoker, stress, and family problems, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 16-APR-2021, the subject experienced heart burn. On 16-APR-2021, the subject experienced chest pain. On 16-APR-2021, the subject experienced dizziness. On 16-APR-2021, the subject experienced fogginess. On 16-APR-2021, the subject experienced concentration issues. On 16-APR-2021, the subject experienced fatigue/ tired. On 16-APR-2021, the subject experienced headaches. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Negative, Chest X-ray (NR: not provided) Negative, and Electrocardiogram (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, heart burn, dizziness, headaches, fogginess, concentration issues, and fatigue/ tired. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case was assessed as non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Electrocardiogram, Fatigue, Feeling abnormal, Headache
Clinical narrative: HEART BURN; CHEST PAIN; DIZZINESS; FOGGINESS; CONCENTRATION ISSUES; FATIGUE/ TIRED; HEADACHES; This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's past medical history included rash, itchy, and gastrointestinal issues, and concurrent conditions included depression, egg allergy, chicken allergy, non alcoholic, non smoker, stress, and family problems, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 16-APR-2021, the subject experienced heart burn. On 16-APR-2021, the subject experienced chest pain. On 16-APR-2021, the subject experienced dizziness. On 16-APR-2021, the subject experienced fogginess. On 16-APR-2021, the subject experienced concentration issues. On 16-APR-2021, the subject experienced fatigue/ tired. On 16-APR-2021, the subject experienced headaches. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Negative, Chest X-ray (NR: not provided) Negative, and Electrocardiogram (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, heart burn, dizziness, headaches, fogginess, concentration issues, and fatigue/ tired. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case was assessed as non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Diarrhoea, Feeling abnormal, Nausea
Clinical narrative: DIARRHEA; STOMACH FELT BIG; UPSET STOMACH; NAUSEA; FEELING BAD AT NIGHT; This spontaneous report received from a consumer concerned a 41 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: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 30-MAY-2021 11:00 for prophylactic vaccination. No concomitant medications were reported.  On 30-MAY-2021, the subject experienced feeling bad at night. On an unspecified date, the subject experienced diarrhea, stomach felt big, upset stomach, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stomach felt big, diarrhea, feeling bad at night, upset stomach, and nausea. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS BEYOND THE USE DATE FROM RECOMMENDED OR ACCEPTABLE STORAGE EXCURSIONS (THE INCORRECT EXPIRATION DATE OF THE VACCINE BATCH WAS RECORDED AS 02-JUN-2021 INSTEAD OF 01-JUN-2021 AND THE DOSES WERE ADMINISTERED); This spontaneous report received from a pharmacist concerned multiple patients.  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 subject experienced vaccine was beyond the use date from recommended or acceptable storage excursions (the incorrect expiration date of the vaccine batch was recorded as 02-jun-2021 instead of 01-jun-2021 and the doses were administered). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine was beyond the use date from recommended or acceptable storage excursions (the incorrect expiration date of the vaccine batch was recorded as 02-jun-2021 instead of 01-jun-2021 and the doses were administered) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENTS RECEIVED EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned multiple patients (7 patients). 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: 1805031, expiry: 26-MAY-2021) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  28-MAY-2021, the subject experienced subjects received expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patients received expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210612634, 20210611858 and 20210614876.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Fatigue, Mammogram, Ultrasound breast
Clinical narrative: A LUMP UNSPECIFIED IN THE AUXILIARY TAIL OF THE RIGHT BREAST (DISAPPEARED AROUND 2 WEEKS AND REAPPEARED ON 02-JUN-2021 WITH CHANGE IN THE SIZE); TIRED; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included pneumonia, and concurrent conditions included environmental allergies, asthma, and smoker. The patient experienced anaphylactic reaction (not confirmed) when treated with levofloxacin, and drug allergy ( dropped her blood pressure very low) when treated with morphine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included epinephrine for asthma, omeprazole, and vitamin d.  On 06-APR-2021, the subject experienced tired. On 20-APR-2021, the subject experienced a lump unspecified in the auxiliary tail of the right breast (disappeared around 2 weeks and reappeared on 02-jun-2021 with change in the size). Laboratory data (dates unspecified) included: Mammogram (NR: not provided) lump in right breast, and Ultrasound breast (NR: not provided) Lump in right breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired, and had not recovered from a lump unspecified in the auxiliary tail of the right breast (disappeared around 2 weeks and reappeared on 02-jun-2021 with change in the size). This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred, Visual impairment
Clinical narrative: BLURRED VISION EXPERIENCED TWO TIMES MORE; VISUAL DISTURBANCE, AT DISTANCE OF 10 FEET AND MORE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  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 20-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced blurred vision experienced two times more, and visual disturbance, at distance of 10 feet and more. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blurred vision experienced two times more, and visual disturbance, at distance of 10 feet and more. This report was non-serious.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTERED AFTER THE 6 HOUR REFRIGERATION LIMIT; INCORRECT STORAGE OF DRUG; This spontaneous report received from a health care professional concerned an 82 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. the patient took regular medications but medical history and medications were unknown.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced incorrect storage of drug. On 04-JUN-2021, the subject experienced administered after the 6 hour refrigeration limit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered after the 6 hour refrigeration limit and incorrect storage of drug was not reported. This report was non-serious. This case, from the same reporter is linked to 20210611838 and 20210612869.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: CHILLS; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and chills was not reported. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Acrochordon, Injection site pain
Clinical narrative: SKIN TAG / SPOT ON SITE OF INJECTION APPEARS RAISED AND BLACK; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included patient has no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 260A21A, and expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced injection site pain. On an unspecified date, the subject experienced skin tag / spot on site of injection appears raised and black. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain, and the outcome of skin tag / spot on site of injection appears raised and black was not reported. This report was non-serious.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Pyrexia
Clinical narrative: BONE PAIN IN RIGHT SOLE OF FEET AND BOTH ARMS, FINGERS AS WELL AS WRISTS ON BOTH HANDS; INTERMITTENT FEVER; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and alcohol user, and other pre-existing medical conditions included no known allergies and no 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: 1808986, expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced bone pain in right sole of feet and both arms, fingers as well as wrists on both hands. On 02-JUN-2021, the subject experienced intermittent fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from intermittent fever on 05-JUN-2021, and had not recovered from bone pain in right sole of feet and both arms, fingers as well as wrists on both hands. This report was non-serious.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site reaction
Clinical narrative: TWITCHING AT THE INJECTION SITE; This spontaneous report received from a pharmacist concerned a 31 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and alcoholic, and other pre-existing medical conditions included the patient had no known allergies. The patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821281 expiry: 23-JUL-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the subject experienced twitching at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from twitching at the injection site on 07-JUN-2021. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Crying, Feeding disorder, Feeling hot, Feeling jittery
Clinical narrative: JITTERY; WARMTH FELT LIKE BREAKING OUT; SORENESS; SEVERE ANXIETY/PANIC ATTACK; UNABLE TO EAT; UNABLE TO SLEEP; HYPERACTIVITY; UNCONTROLLABLE SOBBING; IRRATIONAL THOUGHTS; INJECTION SITE PAIN; HEADACHE; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced jittery. On JUN-2021, the subject experienced warmth felt like breaking out. On JUN-2021, the subject experienced soreness. On JUN-2021, the subject experienced severe anxiety/panic attack. On JUN-2021, the subject experienced unable to eat. On JUN-2021, the subject experienced unable to sleep. On JUN-2021, the subject experienced hyperactivity. On JUN-2021, the subject experienced uncontrollable sobbing. On JUN-2021, the subject experienced irrational thoughts. On JUN-2021, the subject experienced injection site pain. On JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the jittery, warmth felt like breaking out, injection site pain, soreness, severe anxiety/panic attack, unable to eat, unable to sleep, hyperactivity, uncontrollable sobbing, irrational thoughts and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Injection site pain, Insomnia, Pain, Psychomotor hyperactivity
Clinical narrative: JITTERY; WARMTH FELT LIKE BREAKING OUT; SORENESS; SEVERE ANXIETY/PANIC ATTACK; UNABLE TO EAT; UNABLE TO SLEEP; HYPERACTIVITY; UNCONTROLLABLE SOBBING; IRRATIONAL THOUGHTS; INJECTION SITE PAIN; HEADACHE; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced jittery. On JUN-2021, the subject experienced warmth felt like breaking out. On JUN-2021, the subject experienced soreness. On JUN-2021, the subject experienced severe anxiety/panic attack. On JUN-2021, the subject experienced unable to eat. On JUN-2021, the subject experienced unable to sleep. On JUN-2021, the subject experienced hyperactivity. On JUN-2021, the subject experienced uncontrollable sobbing. On JUN-2021, the subject experienced irrational thoughts. On JUN-2021, the subject experienced injection site pain. On JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the jittery, warmth felt like breaking out, injection site pain, soreness, severe anxiety/panic attack, unable to eat, unable to sleep, hyperactivity, uncontrollable sobbing, irrational thoughts and headache was not reported. This report was non-serious.