chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEP
Symptoms: Migraine, Urticaria
Clinical narrative: hives all over back, torso and neck; terrible migraines; This case was reported by a nurse via call center representative and described the occurrence of hives in a female patient who received HBV (Engerix B) (batch number 74EM4, expiry date 20th December 2022) for prophylaxis.   Previously administered products included Hepatitis b (the patient finished series many years ago). Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On 14th October 2021, the patient received the 2nd dose of Engerix B. On 15th October 2021, 1 days after receiving Engerix B and an unknown time after receiving ENGERIX B, the patient experienced hives and migraine. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the hives and migraine were recovered/resolved.   It was unknown if the reporter considered the hives and migraine to be related to Engerix B.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the first dose of Engerix on 15th September 2021. The patient experienced terrible migraines and hives all over back, torso and neck. The patient did not have any trouble breathing but took 4 doses of Benadryl, then everything was down. The reporter inquired for Engerix, any information available with this type of reaction and how to proceed with third dose. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus
Clinical narrative: Broke out in shingles/ small "half dollar size" spot of Shingles; itching; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced shingles and pruritus. The patient was treated with hydrocortisone (Hydrocortisone Cream). On an unknown date, the outcome of the shingles and pruritus were recovered/resolved.   It was unknown if the reporter considered the shingles and pruritus to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient.   The patient received the first dose of Shingrix at the end of August.  Within about 24 to 30 hours of receiving the vaccine, the patient experienced itching and a small half dollar size spot of Shingles on her shoulder.  The patient applied hydrocortisone cream and it resolved over a weekend.   The patient was asking if she should get the second dose Lot number and expiration date for vaccine were unknown. The reporter did not consent to follow-up. There was discrepancy in the TTO and duration of event. TTO was captured as 24 hours as per follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021221676:Same reporter - duplicate case
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: receiving expired Hiberix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-month-old male patient who received Hib (Hiberix) (batch number KP24R, expiry date 24th October 2021) for prophylaxis.   On 25th October 2021, the patient received Hiberix. On 25th October 2021, unknown after receiving Hiberix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient self-reported this case. Patient received Hiberix which was already expired on 24th October 2021.  The reporter consented to follow up.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Flushing, Malaise, Nausea
Clinical narrative: Unwell; Flushed; Mild nausea; This case was reported by a consumer via call center representative and described the occurrence of unwell in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2021, the patient received the 1st dose of Shingrix. In October 2021, less than 3 weeks after receiving Shingrix, the patient experienced unwell, flushing and nausea. The patient was treated with ambiguous medication nos (Cortisone (Nos)). On an unknown date, the outcome of the unwell, flushing and nausea were unknown.   It was unknown if the reporter considered the unwell, flushing and nausea to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient's husband. The patient received first dose of Shingrix 3 weeks before the date of reporting. Since receiving the vaccine, the patient felt unwell, had periodic mild nausea, and felt a little flushed (symptomatic). The reporter inquired if these were side effects and their duration were common. The reporter also inquired if they should get second dose. The reporter stated that his doctor prescribed Cortisone 20 mg once daily for 5 days for symptoms. The reporter consented to follow-up. The case has been linked with case US2021223603, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021223576:same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Incomplete course of vaccination, Pain, Pyrexia
Clinical narrative: fever; chills; body aches; first dose february of 2020, has not yet received her second dose; This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever, chills, general body pain and incomplete course of vaccination. On an unknown date, the outcome of the fever, chills and general body pain were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the fever, chills and general body pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The case was reported by patient herself. The patient experienced fever, chills and body aches which started the day after she was vaccinated and these symptoms resolved after a few days.  The patient did not receive the second dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. The patient did not consent to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: third dose; First dose 6/4/2018, second dose 2/13/2019; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) (batch number E3z7E, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix vaccine (1st dose received on 4th June 2018).   On 26th July 2021, the patient received the 3rd dose of Shingrix. On 13th February 2019, the patient received the 2nd dose of Shingrix. On 13th February 2019, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 26th July 2021, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and drug dose administration interval too long were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix vaccine later than recommended time frame, which led to lengthening of vaccine schedule. The patient also received the 3rd dose Shingrix, which led to extra dose administered. The pharmacist unable to provide patient details. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Shingrix probably reconstituted with regular sterile suspension; Shingrix probably reconstituted with regular sterile suspension; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number 57LJ9, expiry date 14th April 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, they found one Shingrix antigen that it was probably reconstituted with regular sterile suspension which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered, because they found a Shingrix liquid suspension that did not match with any other vial. The reporter consented to follow up via email. Nurse needed time to look patient's information.  She said that, they would call patient to revaccinate.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: received a dose that expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number B223P, expiry date June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. In October 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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. In the week of the reporting, the patient received a dose of Fluarix QIV that expired June 2021 which led to expired vaccine used. The reporter consented to follow up. Healthcare professional was agreeable to recontact but asked to follow up via email since she serviced several locations.  No further information was available while on call regarding the patient or specific date of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st Shingrix vaccine on 04/27/2018; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 27th April 2018).   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 for this report. The patient was back for 2nd Shingrix vaccination. At the time of the reporting, it was unknown if patient received 2nd Shingrix dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the adjuvant portion of the Shingrix vaccine.; received only the adjuvant portion of the Shingrix vaccine.; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced 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 applicable for this report. The pharmacist reported about 30 patients might had receive only the adjuvant portion of the Shingrix vaccine, which led inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 5.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: vaccinated with an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old female patient who received HBV (Engerix B) (batch number 2L2B9, expiry date 9th May 2021) for prophylaxis.   On 28th October 2021, the patient received Engerix B. On 28th October 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient was vaccinated with an expired dose of Engerix-B, which led to expired vaccine used. The reporter consented to follow up.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 12-year-old female patient who received HAV (Havrix) (batch number 3TZ52, expiry date 26th June 2020) for prophylaxis.   On 28th October 2021, the patient received the 2nd dose of Havrix. On 28th October 2021, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient was administered an expired dose of the Havrix vaccine, which led to expired vaccine used. The batch number and expiration date were only for Havrix dose number 2.  No information for Havrix dose number 1 was given at the time of the report. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: no record of a second dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on 20th August 2019).   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 follow: This case was reported by the physician's assistant (PA). The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter had no record of a second dose. The patient vaccination history was unknown. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection. 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 patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: FELT LOUSY; This spontaneous report received from a consumer 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, and batch number were 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 patient experienced felt lousy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt lousy was not reported. This report was non-serious. This case, from the same reporter is linked to 20211057399.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Heavy menstrual bleeding, Pain in extremity
Clinical narrative: HEAVY PERIOD; SORENESS AND ACHING OF BOTH CALVES; HEADACHE; TIRED; DIZZY ON-AND-OFF; This spontaneous report received from a patient concerned a 51 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: 1822809, expiry: UNKNOWN) dose was not reported, administered on 09-OCT-2021 16:15 for prophylactic vaccination. No concomitant medications were reported.  On 10-OCT-2021, the patient experienced dizzy on-and-off. On 10-OCT-2021, the patient experienced headache. On 10-OCT-2021, the patient experienced tired. On 26-OCT-2021, the patient experienced soreness and aching of both calves. On 28-OCT-2021, the patient experienced heavy period. Treatment medications (dates unspecified) included: arnica montana. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness and aching of both calves and heavy period, and the outcome of headache, tired and dizzy on-and-off was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired healing, Pruritus, Skin hypopigmentation, Skin lesion
Clinical narrative: SORES THAT ARE NOT HEALING; SKIN APPEARS LIGHTER IN COLOUR  IN AREAS WHERE ITCHING IS  OCCURRING; SORES ON BODY DUE TO ITCHING WHICH ARE NOT HEALING; ITCHING IN VARIOUS AREAS OF BODY; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's past medical history included: smoker, and marijuana user, and concurrent conditions included: alcohol user, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of drug abuse or illicit drug usage .The patient had no history of being sick in his life. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 19-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced itching in various areas of body. On SEP-2021, the patient experienced sores on body due to itching which are not healing. On an unspecified date, the patient experienced sores that are not healing, and skin appears lighter in colour in areas where itching is occurring. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching in various areas of body, skin appears lighter in colour in areas where itching is occurring, and sores on body due to itching which are not healing, and the outcome of sores that are not healing was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 29 years old male of an unspecified race and ethnic origin. 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, expiry: unknown) with frequency time 1 total, dose was not reported, administered on an unspecified date earlier this year (2021) for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On an unspecified date in OCT-2021, the patient had started to experience mild minimal symptoms after testing positive for Covid-19 (suspected Covid-19 infection), which indicates suspected clinical vaccination failure. Further it is reported that this is a case of breakthrough infection. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected Covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20211061474-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. 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: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: NUMEROUS BLOOD CLOTS IN RIGHT LEG; This spontaneous report received from a patient concerned a patient. The patient's height and weight were not reported. No medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total dose administered in MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date (about 6 weeks later), the patient developed numerous blood clots in right leg. In JUN-2021, the patient visited to primary doctor. The doctor asked the patient to keep an eye on the clots, as the patient had not experienced any pain. By AUG-2021, the clots started hurting, stinging, and burning. In SEP-2021, the patient called the doctor and went for examination. The doctor performed a procedure and instructed the patient to return in a month. On 20-OCT-2021, the patient had second visit to the doctor. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of numerous blood clots in right leg was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211061595-Covid-19 vaccine ad26.cov2.s- Numerous blood clots in right leg,. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia
Clinical narrative: HAVEN'T BEEN ABLE TO SLEEP FOR 2 DAYS; I AM IN SO MUCH PAIN/JOINTS FEEL LIKE THEY ARE ON  FIRE TO THE POINT WHERE I WANNA RIP MY ARMS OFF; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced haven't been able to sleep for 2 days, and i am in so much pain/joints feel like they are on fire to the point where i wanna rip my arms off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from haven't been able to sleep for 2 days, and the outcome of i am in so much pain/joints feel like they are on fire to the point where i wanna rip my arms off was not reported. This report was non-serious.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 16 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the patient experienced inappropriate age at vaccine administration. On 08-MAY-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate age at vaccine administration and off label use was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Muscle spasms, Pain in extremity, Paraesthesia, Restless legs syndrome
Clinical narrative: RESTLESS LEGS SYNDROME LIKE FEELING; FEELING THAT I HAVE TO MOVE THE LEGS; CRAMPING OF BOTH LEGS, CALVES AND BEHIND THE KNEES/CRAMPING OF BOTH THIGHS AND HAMSTRINGS; TIGHTNESS OF BOTH CALVES; PINS AND NEEDLES FEELING; This spontaneous report received from a patient concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: no alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had No known drug allergies. The patient had No History of chronic illness. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 212A21A,  expiry: UNKNOWN) dose was not reported, administered on 27-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-MAY-2020, Laboratory data included: COVID-19 virus test (NR: not provided) NEGATIVE. On 28-OCT-2021, the patient experienced restless legs syndrome like feeling. On 28-OCT-2021, the patient experienced feeling that i have to move the legs. On 28-OCT-2021, the patient experienced cramping of both legs, calves and behind the knees/cramping of both thighs and hamstrings. On 28-OCT-2021, the patient experienced tightness of both calves. On 28-OCT-2021, the patient experienced pins and needles feeling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pins and needles feeling, restless legs syndrome like feeling, cramping of both legs, calves and behind the knees/cramping of both thighs and hamstrings, tightness of both calves, and feeling that i have to move the legs. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: RESTLESS LEGS SYNDROME LIKE FEELING; FEELING THAT I HAVE TO MOVE THE LEGS; CRAMPING OF BOTH LEGS, CALVES AND BEHIND THE KNEES/CRAMPING OF BOTH THIGHS AND HAMSTRINGS; TIGHTNESS OF BOTH CALVES; PINS AND NEEDLES FEELING; This spontaneous report received from a patient concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: no alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had No known drug allergies. The patient had No History of chronic illness. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 212A21A,  expiry: UNKNOWN) dose was not reported, administered on 27-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-MAY-2020, Laboratory data included: COVID-19 virus test (NR: not provided) NEGATIVE. On 28-OCT-2021, the patient experienced restless legs syndrome like feeling. On 28-OCT-2021, the patient experienced feeling that i have to move the legs. On 28-OCT-2021, the patient experienced cramping of both legs, calves and behind the knees/cramping of both thighs and hamstrings. On 28-OCT-2021, the patient experienced tightness of both calves. On 28-OCT-2021, the patient experienced pins and needles feeling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pins and needles feeling, restless legs syndrome like feeling, cramping of both legs, calves and behind the knees/cramping of both thighs and hamstrings, tightness of both calves, and feeling that i have to move the legs. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache
Clinical narrative: BRAIN FOG; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced brain fog, headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from brain fog, headache, and fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE ADMINISTERED AFTER THE MANUFACTURER'S RECOMMENDED EXPIRATION DATE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On JUL-2021, the patient experienced vaccine administered after the manufacturer's recommended expiration date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered after the manufacturer's recommended expiration date was not reported. This report was non-serious.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: irregular pap sear; Inappropriate schedule of vaccine administered; This spontaneous report was received from a pharmacist concerning a currently 32 years old adult female patient. No information about her current condition, medical history or concomitant therapy was reported.   In 2010 (at the age of 21 years old), the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route and lot# were not reported) for prophylaxis. In 2011 (at the age of 22 years old), she received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route and lot# were not reported) for prophylaxis.   The patient stated that she had an irregular pap smear (unspecified date and result) and it was recommended that she got the shot. On an unknown date, the patient came into the pharmacy and stated to the pharmacist that she needed to get the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine per her "OBGYN" (inappropriate schedule of product administration). The series of vaccine was not completed previously. Now, the patient was 32 years old. The pharmacist wanted to know should the patient need to start over or not. The outcome of irregular pap smear was not resolved. The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not applicable.   The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Age: 27.0
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Dose of Heplisav-B was Given; Initial Report Received 22-Sep-2021  A physician reported that a 27-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history was reported.  The patient had no known allergies.   No concomitant medications were reported.  On 22-Sep-2021, an expired dose of HEPLISAV-B (Lot # 933625, Expiration Date 12-Sep-2021, NDC # 43528-003-05) was administered.  The patient reportedly did not experience any adverse reactions.   No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Administered a Dose of Heplisav-B to a 17 Year Old; Initial Report Received 28-Sep-2021  A pharmacist reported that a 17-year-old male received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history was reported.  The patient had no known allergies.   No concomitant medications were reported.  On 23-Aug-2021, a dose of HEPLISAV-B (Lot # 934967, Expiration Date 11-Apr-2022, NDC # 43528-000-305) was administered in the left arm by a pharmacist.   No adverse reactions were reported by the patient at the time of report.   No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Dose of Heplisav-B was Given; Initial Report Received 30-Sep-2021  A pharmacist reported that a 49-year-old male received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history was reported.   The patient was reportedly not taking any other medications.   On 29-Sep-2021, the patient received the first dose of HEPLISAV-B (Lot # 933624, Expiration Date 10-Aug-2021, Serial Number 101467482917, NDC # 43528-003-05) was administered in the right deltoid by a pharmacy technician.   The dose was expired at the time of vaccination.  No adverse reactions were reported at the time of report.    No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Dose of Heplisav-B Given; Initial Report Received 01-Oct-2021  A pharmacist reported that a 62-year-old female received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history was reported as organ transplant.   The patient had no known allergies.  Concomitant medications were not reported.   On 01-Oct-2021, dose 1 of HEPLISAV-B (Lot # 933623, Expiration Date 22-Aug-2021, NDC # 43528-003-01) was administered in the right arm.   The dose was expired at the time of vaccination.  No adverse reactions were reported at the time of report.    No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 22.0
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Administered Expired Dose of Heplisav-B; Initial Report Received on 18-Oct-2021  A pharmacist reported that a 22 year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 14-Oct-2021, the patient received an expired dose of HEPLISAV-B (Lot # 933625, expiration date 12-Sep-2021 and NDC # not reported) in the right deltoid from a pharmacist.   At the time of the report, the patient did not report any adverse reactions. No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 30-OCT-2021, the patient experienced body aches. On 30-OCT-2021, the patient experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and body aches. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Cardiomegaly
Clinical narrative: ENLARGED HEART; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced enlarged heart. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of enlarged heart was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Spinal pain, Vomiting
Clinical narrative: PAIN IN SPINE; SEVERE HEADACHE; VOMITING; DIARRHEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 29-OCT-2021 13:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced pain in spine, severe headache, vomiting, and diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe headache, pain in spine, vomiting and diarrhea was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Medication error, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID-19; MEDICATION ERROR; INJECTION SITE HURT A LITTLE; 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, 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. Concomitant medications included bnt 162 for prophylactic vaccination. On an unspecified date, the patient experienced tested positive for covid-19, medication error, and injection site hurt a little. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tested positive for covid-19, injection site hurt a little and medication error was not reported. This report was non-serious. This report was associated with product quality complaint : 90000200149. This case, from the same reporter is linked to 20211102956.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: VACCINE ADMINISTERED TO A 17 YEAR OLD MALE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 17 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: 2128A21A expiry: 21-DEC-2021) dose was not reported, administered on 28-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-OCT-2021, the patient experienced vaccine administered to a 17 year old male. On 28-OCT-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to a 17 year old male and off label use was not reported. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Chills, Dizziness, Fatigue
Clinical narrative: TIGHTNESS IN CHEST; HEART RATE SPIKE; HEADACHES; ACHINESS THROUGHOUT BODY AND BODY HURT; FEVER; DIZZINESS; CHILLS; FELT TIRED AND FATIGUED; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: endometriosis, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose was not reported, administered on 28-OCT-2021 20:00 for prophylactic vaccination. Concomitant medications included topiramate for drug used for unknown indication.  On 28-OCT-2021, the patient experienced felt tired and fatigued. On 29-OCT-2021, the patient experienced achiness throughout body and body hurt. On 29-OCT-2021, the patient experienced dizziness. On 29-OCT-2021, the patient experienced chills. On 29-OCT-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 101F to 102F. On 30-OCT-2021, the patient experienced tightness in chest. On 30-OCT-2021, the patient experienced heart rate spike. On 30-OCT-2021, the patient experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness throughout body and body hurt, heart rate spike, dizziness, chills, and felt tired and fatigued, and fever on 30-OCT-2021, and had not recovered from headaches, and tightness in chest. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Pain, Pyrexia
Clinical narrative: TIGHTNESS IN CHEST; HEART RATE SPIKE; HEADACHES; ACHINESS THROUGHOUT BODY AND BODY HURT; FEVER; DIZZINESS; CHILLS; FELT TIRED AND FATIGUED; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: endometriosis, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose was not reported, administered on 28-OCT-2021 20:00 for prophylactic vaccination. Concomitant medications included topiramate for drug used for unknown indication.  On 28-OCT-2021, the patient experienced felt tired and fatigued. On 29-OCT-2021, the patient experienced achiness throughout body and body hurt. On 29-OCT-2021, the patient experienced dizziness. On 29-OCT-2021, the patient experienced chills. On 29-OCT-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 101F to 102F. On 30-OCT-2021, the patient experienced tightness in chest. On 30-OCT-2021, the patient experienced heart rate spike. On 30-OCT-2021, the patient experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness throughout body and body hurt, heart rate spike, dizziness, chills, and felt tired and fatigued, and fever on 30-OCT-2021, and had not recovered from headaches, and tightness in chest. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; THE VACCINE WAS KEPT IN THE FREEZER WHEN RECEIVED (THE POSSIBILITY OF BEING FROZEN TWICE) AND LATER INJECTED; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194, expiry: 09-APR-2022) dose was not reported, administered on OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On OCT-2021, the patient experienced the vaccine was kept in the freezer when received (the possibility of being frozen twice) and later injected. On 26-OCT-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the vaccine was kept in the freezer when received (the possibility of being frozen twice) and later injected and incorrect product storage was not reported. This report was non-serious.