chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the vaccine got shingles 2x afterwards/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female 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 reporter stated she the patient had Shingles vaccine and got the shingle twice afterwards. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: can still have shingle ,even after the shot. I did/ suspected vaccination failure; can still have shingle. I did; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she even after the Shingles shot still had shingle. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shot / have outbreaks/ suspected vaccination failure; outbreaks; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a 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: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles shot and still had shingles outbreak. The patient stated he/she that 3 percent that Shingles shot did not work on. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 11-year-old received an adult dose; 11-year-old received an adult dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 11-year-old female patient who received HAV (Havrix 1440 adult) (batch number G99R4, expiry date 20th May 2022) for prophylaxis.   On 23rd November 2021, the patient received Havrix 1440 adult 1 ml. On 23rd November 2021, unknown after receiving Havrix 1440 adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.  Additional details were provided as follows: The practice manager reported a 11 year old patient received an adult dose of Havrix, which led to overdose and adult product administered to child. The reporter consented to follow up. The case has been linked to US2021241775,reported by the same reporter for patient's sibling.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021241775:Same reporter
Sex: F
Vaccine: FLU4
Symptoms: Product complaint, Underdose
Clinical narrative: there wasn't the full 0.5ml in the PFS.; Administered vaccine without the full 0.5ml, less than half; This case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a adolescent female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number 579c9, expiry date 30th June 2022) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd November 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 23rd November 2021, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced accidental underdose. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the accidental underdose and pharmaceutical product complaint 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 as not reported but it could be 15 or 16 years. The reporter stated that, their nurse administered a Flulaval pre-filled syringe (PFS) to the patient and after she gave vaccine she felt there was not enough vaccine, there was not the full 0.5ml in the PFS, which led to accidental underdose.  The suspect product was not available it was in the sharps container. The needle was put on right before the injection. The volume was less than half the volume compare to other syringes.. The aspiration performed to remove bubbles. The reporter did not experienced a low fill problem with this product before. The noon nurse had put the pre-filled syringe into her pocket prior to administration and her pocket was dry).  The reporter did not observed leaks, cracks or breakage in syringe. The plunger was in its original position. No further details available but the reporter agreed to follow up via email.
Age: 40.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Plasma cell myeloma
Clinical narrative: has multiple myeloma.; first dose of SHINGRIX on 12/23/2020 and 2 dose was not administered yet; This case was reported by a other health professional via call center representative and described the occurrence of multiple myeloma in a 41-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 23rd December 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, less than 5 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced multiple myeloma (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the multiple myeloma and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the multiple myeloma to be related to Shingrix.  Additional details provided were as follows: This case was reported by regulatory authority. The age at vaccination was not applicable for the 2nd dose. The patient had a cell transplant in April 2021. The patient had multiple myeloma. Till the time of reporting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow-up.
Sex: U
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received infanrix instead of Boostrix; adult patient received Infanrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a adult patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd November 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 23rd November 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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. The nurse practitioner reported that, an adult patient received Infanrix instead of Boostrix by mistake which led to wrong vaccine administered and inappropriate age at vaccine administration. The health care professional had not available patient demographics neither lot number and expiration date. The health care professional offered to collect the information and follow up with safety. The reporter consented to follow up.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: received expired Engerix-B; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 47-year-old female patient who received HBV (Engerix B adult) (batch number 54A32, expiry date 12th November 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd November 2021, the patient received the 1st dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 22nd November 2021, unknown after receiving Engerix B adult and Engerix B 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 patient received expired dose of Engerix B adult, which led to expired vaccine used. This case was linked with case US2021243036, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021243036:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Dec2019, has not received 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 23rd December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix 50 µg. 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 patient's wife reported the case. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive his second dose, which led to incomplete course of vaccination. The reporter enquired if he still should get the 2nd dose of Shingrix. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Shingrix subcutaneously instead of IM; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number T29Y2, expiry date 8th April 2023) for prophylaxis.   On 22nd November 2021, the patient received the 1st dose of Shingrix (subcutaneous). On 22nd November 2021, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The patient received the first dose of Shingrix subcutaneously instead of Intramuscularly, which led to intramuscular formulation administered by other route. The reporter consented to follow up via email.
Sex: U
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: been giving pediatric doses of this vaccine to adults; been giving pediatric doses of this vaccine to adults; This case was reported by a other health professional via call center representative and described the occurrence of underdose in an unspecified number of patients who received DTPa (Infanrix) (batch number 23T73, expiry date 30th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced underdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the underdose and inappropriate age at vaccine administration 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 the vaccination was not applicable for this report. The reporter stated the number of patients were 58 as per his/her belief. No patient identifiers were reported. The reporter had one lot number to provide at this time, expiration date obtained from batch number identifier. The reporter stated that in a Chat with CCMA in reference to DTaP Infanrix, it came to his/her attention that out office had been giving pediatric doses of this vaccine to adults, which led to inappropriate age at vaccine administration and underdose. The reporter wanted to know how to report this and what was the recommendation to fix It. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Product Storage Error; This case was reported by a other health professional via call center representative and described the occurrence of incorrect product storage in an unspecified number of patients who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number 3K9LY, expiry date 30th June 2022) and (batch number 3P3TY, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent 2021-2022 season. On an unknown date, the dose was an unknown dose. On an unknown date, the patient started Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage 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 for this report. The vaccine coordinator requested stability data for Flulaval as the needle was placed on the PFS and was not discarded at the end of the day, but was used for 4 days after, which led to incorrect product storage. About 15 patients received the vaccines with most receiving them on 22nd November 2021.  The reporter prefers follow up be made for patient demographics, she did not wish to provide at this time. The reporter consented to follow up via post
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Urinary retention
Clinical narrative: UNABLE TO URINATE; LOWER BACK PAIN; STOMACH PAIN; This spontaneous report was received from a parent (mother) concerning her daughter, a 34 year old female. The patient's height, and weight were not reported. No past medical history and concurrent conditions were reported. On 08-APR-2021, the patient received initial Janssen COVID 19 vaccine shot for prophylactic vaccination (Janssen series 1). After initial shot, she had kidney problems started in MAY-2021. She felt really sick one day with headache, stomach ache, back ache, and throwing up. The patient went to the emergency room which revealed a 5 mm kidney stone that was taken out the next day. The patient had a headache for about a week after initial shot. The patient had not urinated on own after getting kidney stone out. In OCT-2021, she started urinating a little on her own.  The patient received Covid-19 vaccine ad26.cov2.s (Janssen series 2 Booster dose) (suspension for injection, route of admin not reported, batch number: 1855194 and expiry: 09-APR-2022) dose was not reported, 1 total, administered on right arm on 11-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-NOV-2021, the patient had not urinated since receiving her booster vaccination (unable to urinate) and she sought advice from doctors but they found nothing wrong. The patient had also been experiencing lower back pain and stomach pain since 11-NOV-2021.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unable to urinate, lower back pain, and stomach pain. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20211145488.; Sender's Comments: V0-20211144980-Covid-19 vaccine ad26.cov2.s- Unable to urinate. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nephrolithiasis, Urinary retention
Clinical narrative: KIDNEY STONE; UNABLE TO URINATE; HEADACHE; This spontaneous report received from a parent (mother) concerning her daughter, a 34 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 (Janssen series 1) (suspension for injection, route of admin not reported, batch number: 203A21A (also reported as 203AZ1A) expiry: 21-SEP-2021) dose was not reported, 1 total, administered to left arm on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the patient had a headache for about a week. In MAY-2021, the patient experienced kidney problems. She felt really sick one day with headache, stomach ache, back ache, and throwing up. The patient went to the emergency room which revealed a 5 mm kidney stone that was taken out the next day. The patient was hospitalized on an unspecified date. The patient had not urinated on her own since getting the kidney stone out. In OCT-2021 (about a month ago), she started urinating a little on her own. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 15-APR-2021, kidney stone in MAY-2021, and was recovering from unable to urinate. This report was serious (Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20211144980.; Sender's Comments: V0: 20211145488-covid-19 vaccine ad26.cov2.s- unable to urinate, kidney stone. 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: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via social media via a company representative concerned two patients of unspecified age, race and ethnicity. The patients height, and weight were not reported. None of the patients had prior issues. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch numbers were 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 patients died from unknown cause of death. One patient died within less than 48 hours and another died 5 days after. It was unspecified if an autopsy was performed. As per the reporter, "3 people within 2 miles of me died after the jab. One less than 48 hours. One 28 years old and the other 5 days after. None had prior issues" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20211154559.; Sender's Comments: V0: 20211154617-COVID-19 VACCINE AD26.COV2.S- Death. 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT IN LEGS; This spontaneous report received from a patient by a Business partner on 22-NOV-2021 was received on 23-NOV-2021 and 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)1 total, 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 blood clot in legs and then patient was prescribed with medication. Patient was treated with xarelto (rivaroxaban) for blood clot in legs . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot in legs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211155221-COVID-19 VACCINE AD26.COV2.S-Blood clots in legs. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Balanoposthitis, Blood test, C-reactive protein, C-reactive protein increased, Pyrexia
Clinical narrative: ELEVATED C-REACTIVE PROTEIN; BALANOPOSTHITIS; LONG TERM FEVER; This spontaneous report received from a patient concerned a 30 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and alcohol user, and other pre-existing medical conditions included: The patient had no known drug allergies. The patient did not have any history of drug abuse or illicit drug use. Patient never had long-term fever and balanoposthitis before vaccination. 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 18-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included sertraline hydrochloride. On 18-MAR-2021, the patient experienced long term fever. On 20-MAR-2021, the patient experienced balanoposthitis. On an unspecified date, the patient experienced elevated c-reactive protein. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Rule-out other possible causes., and C-reactive protein (NR: not provided) Elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from long term fever, and balanoposthitis, and the outcome of elevated c-reactive protein was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: PASS OUT; This spontaneous report received from a patient from social media via company representative of unspecified age, sex race and ethnicity. 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) 1 total, 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. (Dose number series was 1). No concomitant medications were reported.  On an unspecified date, the patient experienced pass out. The patient stated that "Your Covid shot made me pass out in the store. I only got yours cause it's only one shot and my job forced it on me" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pass out was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211161324-Covid-19 vaccine ad26.cov2.s-Loss of consciousness. This event(s) is considered unassessable. 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: M
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Insomnia, Malaise, Pyrexia
Clinical narrative: THIRST; BATHROOM ISSUES; UP WHOLE NIGHT; GENERAL CRAPPINESS; FEVER; HEADACHE; WEIRD NUMBING ON AND OFF, LIKE IN HANDS FOR NEXT FEW WEEKS; This spontaneous report received from a consumer via a company representative concerned a male patient of unspecified 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 AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On AUG-2021, the patient experienced thirst. On AUG-2021, the patient experienced bathroom issues. On AUG-2021, the patient experienced up whole night. On AUG-2021, the patient experienced general crappiness. On AUG-2021, the patient experienced fever. On AUG-2021, the patient experienced headache. On AUG-2021, the patient experienced weird numbing on and off, like in hands for next few weeks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, headache, thirst, bathroom issues, general crappiness, and up whole night, and the outcome of weird numbing on and off, like in hands for next few weeks was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Thirst, Unevaluable event
Clinical narrative: THIRST; BATHROOM ISSUES; UP WHOLE NIGHT; GENERAL CRAPPINESS; FEVER; HEADACHE; WEIRD NUMBING ON AND OFF, LIKE IN HANDS FOR NEXT FEW WEEKS; This spontaneous report received from a consumer via a company representative concerned a male patient of unspecified 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 AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On AUG-2021, the patient experienced thirst. On AUG-2021, the patient experienced bathroom issues. On AUG-2021, the patient experienced up whole night. On AUG-2021, the patient experienced general crappiness. On AUG-2021, the patient experienced fever. On AUG-2021, the patient experienced headache. On AUG-2021, the patient experienced weird numbing on and off, like in hands for next few weeks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, headache, thirst, bathroom issues, general crappiness, and up whole night, and the outcome of weird numbing on and off, like in hands for next few weeks was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: REALLY BAD LEG PAIN STABBING BURNING PAIN; This spontaneous report received from a consumer via a company representative (via social media) 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: 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 really bad leg pain stabbing burning pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of really bad leg pain stabbing burning pain was not reported. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: DISCOMFORT IN JOINTS; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was Healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 28-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced discomfort in joints. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of discomfort in joints was not reported. This report was non-serious. This case, involving the same patient is linked to 20211162035.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: ADVERSE REACTION TO THE COVID SHOT TO JANSSEN VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. 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 adverse reaction to the covid shot to janssen vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reaction to the covid shot to janssen vaccine was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Injection site pain, Lymphadenopathy
Clinical narrative: COULD NOT LIFT ARM; PAIN IN INJECTION SITE; LYMPH NODES IN THE UNDERNEATH OF RIGHT ARM AND BREATH; This spontaneous report received from a patient concerned a 64 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: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced could not lift arm, pain in injection site, and lymph nodes in the underneath of right arm and breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not lift arm, pain in injection site, and lymph nodes in the underneath of right arm and breath. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lethargy
Clinical narrative: LETHARGIC; SLIGHT HEADACHE; VERY TIRED; This spontaneous report received from a patient concerned a 55 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: 201A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient experienced slight headache. On 07-APR-2021, the patient experienced very tired. On 08-APR-2021, the patient experienced lethargic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargic, slight headache, and very tired on 08-APR-2021. This report was non-serious. This case, involving the same patient is linked to 20211159512.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 48 patients received an expired vaccine; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine). On 16-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The reporter reported that they had received the vaccine on 18-Oct-2021 and on the same day, the vial was stored in the refrigerator. The reporter did not realize that the vial was expired 07-Nov-2021. The reporter also reported that, it was unknown if this was the patient's first, second or booster doses. The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site induration, Vaccination site pain, Vaccination site reaction
Clinical narrative: dullness; tenderness; area looks hard and raised at injection site; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (dullness), TENDERNESS (tenderness), VACCINATION SITE INDURATION (area looks hard and raised at injection site) and VACCINATION SITE PAIN (Vaccination site pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (dullness), TENDERNESS (tenderness), VACCINATION SITE INDURATION (area looks hard and raised at injection site) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE REACTION (dullness), TENDERNESS (tenderness), VACCINATION SITE INDURATION (area looks hard and raised at injection site) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.            No concomitant medication was reported.  No treatment medication use was reported.  The patient has provided the vaccine facility center and declined the personal details.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (went to see her daughter, and she and her husband  tested positive to covid19) and DRUG INEFFECTIVE (LACK OF DRUG EFFECT) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037c21a, 013a21a and 030m20a) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, the patient experienced COVID-19 (went to see her daughter, and she and her husband  tested positive to covid19) and DRUG INEFFECTIVE (LACK OF DRUG EFFECT). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Chills, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Chills, at an unspecified dose and frequency. At the time of the report, COVID-19 (went to see her daughter, and she and her husband  tested positive to covid19) and DRUG INEFFECTIVE (LACK OF DRUG EFFECT) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive.         Patient is on concomitant medications of blood pressure medicine.  chills is a symptom of COVID-19 hence not captured.  Company Comment-  This case concerns a 79 year-old, female patient with no relevant medical history, who experienced the non serious unexpected AESI of COVID-19. The event occurred approximately 8 days after the booster dose of mRNA-1273 vaccine and 8 months after the second dose of the vaccine. Vaccination schedule was administered correctly (first and second doses administered 27 days apart). Drug ineffective was considered as an additional event. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-392008 (Patient Link).; Sender's Comments: This case concerns a 79 year-old, female patient with no relevant medical history, who experienced the non serious unexpected AESI of COVID-19. The event occurred approximately 8 days after the booster dose of mRNA-1273 vaccine and 8 months after the second dose of the vaccine. Vaccination schedule was administered correctly (first and second doses administered 27 days apart). Drug ineffective was considered as an additional event. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: (Rash) on back, chest, legs and arms; This spontaneous case was reported by a nurse and describes the occurrence of RASH ((Rash) on back, chest, legs and arms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ((Rash) on back, chest, legs and arms). At the time of the report, RASH ((Rash) on back, chest, legs and arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication information was given.   This case was linked to MOD-2021-391875, MOD-2021-392096 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Additional reporter details added
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient under age 18 /Error in administration; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under age 18 /Error in administration) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under age 18 /Error in administration). On 19-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under age 18 /Error in administration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.; Sender's Comments: Non-serious Case
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Arthralgia, Chills, Myalgia, Nasal congestion
Clinical narrative: Throat pain/sore throat/woke up at 3 am with throat killing her; Congestion; Nauseous; Fever; Chills; Body ache; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Throat pain/sore throat/woke up at 3 am with throat killing her), NASAL CONGESTION (Congestion), NAUSEA (Nauseous), PYREXIA (Fever) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Throat pain/sore throat/woke up at 3 am with throat killing her), NASAL CONGESTION (Congestion), NAUSEA (Nauseous), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body ache) and ARTHRALGIA (Joint pain). At the time of the report, OROPHARYNGEAL PAIN (Throat pain/sore throat/woke up at 3 am with throat killing her), NASAL CONGESTION (Congestion), NAUSEA (Nauseous), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body ache) and ARTHRALGIA (Joint pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: abnormal (abnormal) She had an antibody test and it showed she had great high numbers of antibodies.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was reported that the patient had hearing issues.  No concomitant medications were reported.  No treatment information were reported.   This case was linked to MOD-2021-392244 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow up received contains new events (fever, chills, body aches, joint pain, sore throat, congestion, nausea) On 24-Nov-2021: Follow up received contain no new information.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Throat pain/sore throat/woke up at 3 am with throat killing her; Congestion; Nauseous; Fever; Chills; Body ache; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Throat pain/sore throat/woke up at 3 am with throat killing her), NASAL CONGESTION (Congestion), NAUSEA (Nauseous), PYREXIA (Fever) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Throat pain/sore throat/woke up at 3 am with throat killing her), NASAL CONGESTION (Congestion), NAUSEA (Nauseous), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body ache) and ARTHRALGIA (Joint pain). At the time of the report, OROPHARYNGEAL PAIN (Throat pain/sore throat/woke up at 3 am with throat killing her), NASAL CONGESTION (Congestion), NAUSEA (Nauseous), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body ache) and ARTHRALGIA (Joint pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: abnormal (abnormal) She had an antibody test and it showed she had great high numbers of antibodies.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was reported that the patient had hearing issues.  No concomitant medications were reported.  No treatment information were reported.   This case was linked to MOD-2021-392244 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow up received contains new events (fever, chills, body aches, joint pain, sore throat, congestion, nausea) On 24-Nov-2021: Follow up received contain no new information.