chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse event; PROQUAD with half the dose in one arm and half the dose in the other arm; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent medications, pertinent medical history, drug reactions or allergies were not reported.  On 22-APR-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter (strength, route of administration were not reported, lot # T030479 has been verified to be a valid lot number, expiration date was 07-MAR-2022) for prophylaxis, with half the dose in one arm and half the dose in the other arm (product administered at inappropriate site). The patient received the full dose and had no additional adverse event.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: No adverse event; expired dose of ROTATEQ was administered; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported.  On 03-MAY-2021, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot # 1660991, expiration date 27-APR-2021 (dose and route of administration were not reported) for prophylaxis. No additional adverse event or product quality concern was reported.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Skin discomfort, Vaccination failure
Clinical narrative: I had 3 shots and still had shingles\ suspected Vaccination failure; I had 3 shots and still had shingles; It felt like someone with a shovel digging under my skin; I had 3 shots and still had 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, skin discomfort and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles, skin discomfort and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and skin discomfort to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. The patient had 3 shots of shingles vaccine and still had shingles. The patient received 3rd dose as extra dose which led to extra dose administration. The patient felt like someone with a shovel digging under skin. This case was considered as suspected vaccination failure since details regarding time to onset and laboratory test confirming shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Mobility decreased, Pyrexia, Rash, Skin exfoliation
Clinical narrative: arm froze up; broke out in a rash; ran fever; lost the skin on my hands; sick for the next 10 months; This case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 9 months after receiving Shingles vaccine, the patient experienced mobility decreased, rash, fever, skin loss and sickness. On an unknown date, the outcome of the mobility decreased, rash, fever, skin loss and sickness were unknown.   It was unknown if the reporter considered the mobility decreased, rash, fever, skin loss and sickness 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's arm froze up, he or she broke out in a rash, ran fever, lost the skin on hands and sick for the next 10 months.  The patient was not getting second dose. The patient wanted to but was not able to post a pic.
Sex: M
Vaccine: MENB
Symptoms: Incomplete course of vaccination
Clinical narrative: 15 YOA was given one dose of Bexsero / have not provided the second dose yet / has not come back for second dose / asked if she should administer it after a month; This case was reported by a nurse via sales rep and described the occurrence of incomplete course of vaccination in a 15-year-old male patient who received Men B NVS (Bexsero) 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.   Previously administered products included Bexsero (1st dose received on an unknown date at the age of 15 year old).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The 15 year old was given one dose of Bexsero immediately before traveling/moving. The Nurse knew about the ACIP recommendation and the vaccine indication but had not provided the second dose yet with the concern about what to do with a 15 year old vaccinated.  The patient did not come back for second dose, which led to incomplete course of vaccination. The nurse was concern about giving the vaccine to a 15 year old , as they follow the ACIP recommendations. She also understand that Bexsero was approved for 10 to 25 year old age. She wanted to find more information on how to proceed with the second dose. The nurse asked if she should administer it after a month, when the patient turns 16 or restart the series then. No further information was reported. Reporter did not consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: The second time is much worse / Got the shot and had a violent reaction/ Suspected vaccination failure; Second time is much worse / got the shot after I broke out the first time and had a violent reaction; 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.   The patient's past medical history included shingles.   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 provided as follows: The patient self reported the case. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient said that the second time was much worse. The patient got the shot after breaking out the first time and had a violent reaction. 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: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; me also on my right foot; 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 provided as follows: The case was reported by the patient herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received the dose of Shingles vaccine and had shingles. It was stated that patient also on his/her right foot and had the shot. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case was linked with US2021AMR097839 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR097839: US-GLAXOSMITHKLINE-US2021097954:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; also on my right foot; 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 provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received the dose of Shingles vaccine and had shingles. It was stated that patient also on his/her right foot and had the shot. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case was linked with US2021AMR097825 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR097825:
Sex: M
Vaccine: VARZOS
Symptoms: Illness, Malaise
Clinical narrative: go to er 4 time-after2nd shot; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was not recovered/not resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows:  The case was reported by the wife of the patient. The age at vaccination was not reported.  The patient received Shingles vaccine and felt ill pass. The patient went to emergency room 4 time.
Sex: M
Vaccine: TDAP
Symptoms: Incomplete course of vaccination
Clinical narrative: have only had like one dose of DTaP / HCP didn´t have information about which vaccine it was administered to the patient; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 8-year-old male patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   Previously administered products included Tdap (received 1st dose of Boostrix on unknown date).   On an unknown date, the patient received the 2nd dose of Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, 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. Till the time of reporting, the patient did not receive 2nd dose of Tdap vaccine, which led to incomplete course of vaccination. The patient received 1st dose of series in foreign country and healthcare professional (HCP) did not had information about which vaccine was administered. The HCP was not agreeable to recontact as she couldn´t provide more information about the 1st dose that patient received in the foreign country. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: delayed second dose of shingrix / first dose July 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in July 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: The age at vaccination was not applicable to this report. Till the time of reporting patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The pharmacist asked can the series be continued or should it be restarted. No further information was reported. Reporter did not consented to follow-up.
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: pediatric male patient / received / an adult dose from Engerix-B; pediatric male patient / received / an adult dose from Engerix-B; This case was reported by a pharmacist and described the occurrence of adult product administered to child in a adolescent male patient who received HBV (Engerix B adult) (batch number 2793Z, expiry date 5th February 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 an unknown date, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose 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 were provided as follows: The age at vaccination was not reported. Pediatric patient received a maladministration of Engerix-B, as the pharmacist gave to him  an adult dose from Engerix-B vaccine, which led to adult product administered to child and overdose. Health care provider would provide the data after callback. Pharmacist did not have the data when the communication was ongoing. The reporter consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Malaise, Pain in extremity, Product preparation issue, Tremor
Clinical narrative: dint feel good; shaking; arm hurt a little bit; only the diluent portion of shingrix (2nd dose) was administered; only the diluent portion of shingrix (2nd dose) was administered; This case was reported by a nurse via call center representative and described the occurrence of malaise in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced malaise, tremor, pain in arm, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the malaise, tremor and pain in arm were recovered/resolved and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the malaise, tremor and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The only diluent portion of Shingrix was administered to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patent was called back for another dose. The reporter was concerned that was it ok to give the 2nd shot again as the patient developed side effects to the diluent did not feel good shaking, arm hurt a little bit, no rashes and was fine at the time of reporting. The HCP was not comfortable in giving patient details and vaccine details was not available. The reporter did not consent to follow up.
Age: 44.0
Sex: F
Vaccine: VARZOS
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: A physician prescribe Shingrix  to a 44 years old female patient; A physician prescribe Shingrix  to a 44 years old female patient; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 44-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (chronic).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration and off label use. On an unknown date, the outcome of the inappropriate age at vaccine administration and off label use were unknown.  Additional details were provided as follows: The pharmacist reported that the physician prescribed Shingrix to the 44 years old patient because she had chronic shingles, which led to inappropriate age at vaccine administration and off label use. The reporter consented to follow up.
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: Would like to get the 3rd dose this month (May2021); May have received the 1st dose of Twinrix in Aug2019 / late 2nd dose in May 2020; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on August 2019).   In May 2020, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. In May 2020, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination 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 age at vaccination was not reported for 2nd dose.  The age at vaccination was not applicable for 3rd dose.  The HCP did not have the patient's 1st initial and stated the last initial. Patient received 2nd dose later than the recommended interval, which led to lengthening of vaccine schedule. No symptoms were reported. The patient reported that he would like to get the 3rd dose in this month on May 2021. Till the time of reporting, patient did not receive the 3rd dose, which led to incomplete course of vaccination. The reporter stated he had to look further into patient history as the patient did not receive Twinrix at his facility. The reporter did not consent to follow up.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PUNCTURED VIAL WAS IN THE FRIDGE FOR LONGER THAN THE 6 HOURS; DOSE FROM THIS VIAL WAS ADMINISTERED TO PATIENT; .This spontaneous report received from a pharmacist concerned a 58 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no allergy info on file. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, expiry: 23-JUN-2021) dose was not reported, administered on 28-APR-2021 11:30 at left arm for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the subject experienced punctured vial was in the fridge for longer than the 6 hours. On 28-APR-2021, the subject experienced dose from this vial was administered to subject. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the punctured vial was in the fridge for longer than the 6 hours was not reported. This report was non-serious. This case, from the same reporter is linked to 20210502575 and 20210501669.
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Thrombosis
Clinical narrative: BLOOD CLOTS; UNABLE TO WALK/TEMPORARY DISABLED; This spontaneous report received from a source from a consumer via a company representative 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 administration not reported, batch number: Unknown) frequency one total, 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.  The consumer reported that the patient on an unspecified date experienced blood clots and was unable to walk. The patient was under doctor care and was temporary disabled. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots, and unable to walk/temporary disabled. This report was serious (Other Medically Important Condition, and Disability Or Permanent Damage).; Sender's Comments: 20210502999-covid-19 vaccine ad26.cov2.s-Blood clots, unable to walk. This event(s) is considered un-assessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM PAIN; This spontaneous report received from a patient concerned a female 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) dose was not reported, administered on 02-APR-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-APR-2021, the subject experienced arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Pyrexia
Clinical narrative: CHILLS; FEVER (TEMPERATURE IT WAS 101.1); This spontaneous report received from a patient concerned a 70 year old female. The patient's weight, height, and medical history were not reported. The patient experienced bad reaction when treated with influenza vaccine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced chills, and fever (temperature it was 101.1). Laboratory data (dates unspecified) included: Body temperature increased (NR: not provided) 101.1 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever (temperature it was 101.1). This report was non-serious.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Muscle spasms, Muscle twitching, Myalgia
Clinical narrative: BLOOD PRESSURE WENT UP TO 192; SPASM; NERVE END HURT/PAIN; MUSCLE TWITCHING; MUSCLE ACHE; PAIN IN LEG; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included lupus, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse/illicit drug use. she was allergic to some unspecified medications.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 04ZA114, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced pain in leg. On an unspecified date, the subject experienced blood pressure went up to 192, spasm, nerve end hurt/pain, muscle twitching, and muscle ache. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) went up to 192 (unit not provided), 120/70 (normal) (unit not provided). Treatment medications (dates unspecified) included: clonidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood pressure went up to 192, spasm, nerve end hurt/pain, muscle twitching, pain in leg, and muscle ache. This report was non-serious.; Sender's Comments: V0:As per standard protocol, No MAC comment is required for non serious case
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: BLOOD PRESSURE WENT UP TO 192; SPASM; NERVE END HURT/PAIN; MUSCLE TWITCHING; MUSCLE ACHE; PAIN IN LEG; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included lupus, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse/illicit drug use. she was allergic to some unspecified medications.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 04ZA114, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced pain in leg. On an unspecified date, the subject experienced blood pressure went up to 192, spasm, nerve end hurt/pain, muscle twitching, and muscle ache. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) went up to 192 (unit not provided), 120/70 (normal) (unit not provided). Treatment medications (dates unspecified) included: clonidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood pressure went up to 192, spasm, nerve end hurt/pain, muscle twitching, pain in leg, and muscle ache. This report was non-serious.; Sender's Comments: V0:As per standard protocol, No MAC comment is required for non serious case
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Myalgia, Pruritus
Clinical narrative: HIVES ON LEGS AND RIGHT ARM; PRURITIS; JOINT PAIN; GENERAL MUSCLES ACHES; FATIGUE; FEVER; This spontaneous report received from a patient concerned a 35 year old female. The patient's weight was 62 kilograms, and height was 166 centimeters. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included patient had no known allergies, no drug abuse or illicit drug usage and no pertinent medical history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-MAY-2021, treatment medications included: paracetamol. On 02-MAY-2021, the subject experienced pruritis. On 02-MAY-2021, the subject experienced joint pain. On 02-MAY-2021, the subject experienced general muscles aches. On 02-MAY-2021, the subject experienced fatigue. On 02-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 37.4 to 37.8 C. On 03-MAY-2021, treatment medications included: camphor/diphenhydramine hydrochloride/zinc oxide. On 03-MAY-2021 13:00, the subject experienced hives on legs and right arm. Additional treatment medications (dates unspecified) included: mometasone furoate, levocetirizine dihydrochloride, and loratadine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint pain, general muscles aches, fatigue, and fever on 02-MAY-2021, and had not recovered from pruritis, and hives on legs and right arm. This report was non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria
Clinical narrative: HIVES ON LEGS AND RIGHT ARM; PRURITIS; JOINT PAIN; GENERAL MUSCLES ACHES; FATIGUE; FEVER; This spontaneous report received from a patient concerned a 35 year old female. The patient's weight was 62 kilograms, and height was 166 centimeters. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included patient had no known allergies, no drug abuse or illicit drug usage and no pertinent medical history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-MAY-2021, treatment medications included: paracetamol. On 02-MAY-2021, the subject experienced pruritis. On 02-MAY-2021, the subject experienced joint pain. On 02-MAY-2021, the subject experienced general muscles aches. On 02-MAY-2021, the subject experienced fatigue. On 02-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 37.4 to 37.8 C. On 03-MAY-2021, treatment medications included: camphor/diphenhydramine hydrochloride/zinc oxide. On 03-MAY-2021 13:00, the subject experienced hives on legs and right arm. Additional treatment medications (dates unspecified) included: mometasone furoate, levocetirizine dihydrochloride, and loratadine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint pain, general muscles aches, fatigue, and fever on 02-MAY-2021, and had not recovered from pruritis, and hives on legs and right arm. This report was non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Injection site mass, Nausea
Clinical narrative: NAUSEA; DIARRHEA; TIRED; LUMP ON INJECTION SITE; This spontaneous report received from a patient concerned a 50 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 expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 12-APR-2021, the subject experienced lump on injection site. On 13-APR-2021, the subject experienced tired. On 14-APR-2021, the subject experienced diarrhea. On an unspecified date, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lump on injection site on 26-APR-2021, nausea, and tired on 19-APR-2021, and had not recovered from diarrhea. This report was non-serious.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: BAD RASH ALL OVER HER BODY; This spontaneous report received from a consumer concerned an 86 year old female. 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, and batch number were not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-APR-2021, the subject experienced bad rash all over her body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad rash all over her body. This report was non-serious.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis, Rash
Clinical narrative: PSORIASIS  GETTING WORSE, LEGS, ARMS, BACK, NECK, HEAD HAS PSORIATIC PIMPLES AND PSORIATIC BREAKOUT; SKIN SLOWLY STARTED BREAKING OUT; This spontaneous report received from a patient concerned a 71 year old male. The patient's weight was 180 pounds, and height was 70 inches. The patient's past medical history included psoriasis, and concurrent conditions included non-smoker, and alcohol user, and other pre-existing medical conditions included the patient had not taken any medication for many years. patient did not have no known allergies and did not have history of drug abuse or illicit drug. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced psoriasis getting worse, legs, arms, back, neck, head has psoriatic pimples and psoriatic breakout. On APR-2021, the subject experienced skin slowly started breaking out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from psoriasis getting worse, legs, arms, back, neck, head has psoriatic pimples and psoriatic breakout, and the outcome of skin slowly started breaking out was not reported. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: BLURRED VISION TO RIGHT EYE; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and cigarette smoker, and other pre-existing medical conditions included patient had no known drug allergies and patient did not have 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: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 29-APR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 01-MAY-2021, the subject experienced blurred vision to right eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blurred vision to right eye. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, SARS-CoV-2 antibody test, Sinus congestion, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; CONGESTION; SORE ARM AT THE INJECTION; HEADACHE; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight was 288 pounds, and height was 67 inches. The patient's concurrent conditions included diabetic ii, gout, high blood pressure, sesame seeds allergy (lips swell), non alcohol user, and non smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient was previously treated with allopurinol, sitagliptin, amlodipine, hydrochlorothiazide, valsartan, and cetirizine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, administered on 20-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the patient experienced congestion, sore arm at the injection and headache. On 27-APR-2021, the patient took SARS-CoV-2 IgG antibody test and result was negative 1.4 (coded as confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from congestion on 23-MAR-2021, sore arm at the injection on 27-MAR-2021, and headache on 20-MAR-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210509655-covid-19 vaccine ad26.cov2.s-Therapy non-responder. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, SPECIAL SITUATIONS.  20210509655-covid-19 vaccine ad26.cov2.s-congestion. This event is considered Unassessable. The event 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.   20210509655-covid-19 vaccine ad26.cov2.s-Sore arm at the injection,headache . This event is labeled per RSI and is therefore considered potentially related.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Electromyogram, Heart rate, Heart rate decreased, Hypoaesthesia, Hypokinesia
Clinical narrative: Passed out; Right arm became norm down to her fingers; No longer move right arm from elbow down to fingers / lost functioning completely in the entire right arm; Terrible pain in the entire right arm; Heart rate dropped; Vomited; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), HYPOAESTHESIA (Right arm became norm down to her fingers), HYPOKINESIA (No longer move right arm from elbow down to fingers / lost functioning completely in the entire right arm), PAIN IN EXTREMITY (Terrible pain in the entire right arm), HEART RATE DECREASED (Heart rate dropped) and VOMITING (Vomited). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), HYPOAESTHESIA (Right arm became norm down to her fingers), HYPOKINESIA (No longer move right arm from elbow down to fingers / lost functioning completely in the entire right arm), PAIN IN EXTREMITY (Terrible pain in the entire right arm), HEART RATE DECREASED (Heart rate dropped) and VOMITING (Vomited) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electromyogram: unknown (Inconclusive) result unknown. On an unknown date, Heart rate: low (Low) Drop in heart rate was reported. On an unknown date, Spinal X-ray: normal (normal) Reported to be normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included the use of ibuprofen and oral steroid prednisone.   A week later the patient's arm was still very painful and some functioning had returned but not up to 50%. Company comment: 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.   This case was linked to MOD21-083933 (E2B Linked Report).; 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. MOD21-083933:2nd dose
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Pain in extremity, Spinal X-ray, Vomiting
Clinical narrative: Passed out; Right arm became norm down to her fingers; No longer move right arm from elbow down to fingers / lost functioning completely in the entire right arm; Terrible pain in the entire right arm; Heart rate dropped; Vomited; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), HYPOAESTHESIA (Right arm became norm down to her fingers), HYPOKINESIA (No longer move right arm from elbow down to fingers / lost functioning completely in the entire right arm), PAIN IN EXTREMITY (Terrible pain in the entire right arm), HEART RATE DECREASED (Heart rate dropped) and VOMITING (Vomited). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), HYPOAESTHESIA (Right arm became norm down to her fingers), HYPOKINESIA (No longer move right arm from elbow down to fingers / lost functioning completely in the entire right arm), PAIN IN EXTREMITY (Terrible pain in the entire right arm), HEART RATE DECREASED (Heart rate dropped) and VOMITING (Vomited) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electromyogram: unknown (Inconclusive) result unknown. On an unknown date, Heart rate: low (Low) Drop in heart rate was reported. On an unknown date, Spinal X-ray: normal (normal) Reported to be normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included the use of ibuprofen and oral steroid prednisone.   A week later the patient's arm was still very painful and some functioning had returned but not up to 50%. Company comment: 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.   This case was linked to MOD21-083933 (E2B Linked Report).; 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. MOD21-083933:2nd dose
Age: 56.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chills, Contusion, Dry skin, Fatigue, Gastrointestinal disorder
Clinical narrative: colon stenosis; unspecified disorder of intestine; dry skin; Laceration; Wound healing delayed; bruise; nightmares; general body pain; Muscle ache; fatigue; fever; chills; This spontaneous case was reported by a non-health professional and describes the occurrence of LARGE INTESTINAL STENOSIS (colon stenosis) in a 56-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for an unknown indication.    The patient's past medical history included Stomach pain, Diarrhea (two to three formed stools per day), Constipation and Surgery (Surgery to remove affected portions of his intestines.) in 1991.   On 23-Jun-2020, the patient started ADALIMUMAB (HUMIRA) (unknown route) 40 mg. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LARGE INTESTINAL STENOSIS (colon stenosis) (seriousness criterion medically significant), GASTROINTESTINAL DISORDER (unspecified disorder of intestine), DRY SKIN (dry skin), SKIN LACERATION (Laceration), IMPAIRED HEALING (Wound healing delayed), CONTUSION (bruise), NIGHTMARE (nightmares), PAIN (general body pain), MYALGIA (Muscle ache), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills). At the time of the report, LARGE INTESTINAL STENOSIS (colon stenosis), GASTROINTESTINAL DISORDER (unspecified disorder of intestine), DRY SKIN (dry skin), SKIN LACERATION (Laceration), IMPAIRED HEALING (Wound healing delayed), CONTUSION (bruise), NIGHTMARE (nightmares), PAIN (general body pain), MYALGIA (Muscle ache), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.  Company comment: Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.