chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Injection site pain, Nausea, Syncope
Clinical narrative: sharp pain in stomach and back; sharp pain in stomach and back; faint; soreness at injection site; diarrhea; nausea/vomiting; nausea; dizziness; chemical feeling in her stomach; This case was reported by a consumer via call center representative and described the occurrence of faint in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th October 2021 10:00, the patient received the 1st dose of Shingrix (intramuscular). On 11th October 2021, 6 hrs after receiving Shingrix, the patient experienced faint (serious criteria GSK medically significant), injection site pain, diarrhea, vomiting, nausea and dizziness. On 14th October 2021, the patient experienced stomach pain and back pain. In October 2021, the patient experienced stomach discomfort. The patient was treated with hyoscine (Scopolamine Patch). On an unknown date, the outcome of the faint, injection site pain, diarrhea, vomiting, nausea, dizziness, stomach pain, back pain and stomach discomfort were not recovered/not resolved.   It was unknown if the reporter considered the faint, diarrhea, vomiting, nausea, dizziness, stomach pain, back pain and stomach discomfort to be related to Shingrix. The reporter considered the injection site pain to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient herself. The patient received a dose of Shingrix in right arm and about 4 hours later she experienced diarrhea, nausea/vomiting, dizziness and a sore arm at the injection site. The patient reported that approximately 6 hours after the Shingrix injection she began to feel faint while laying by the pool. The patient reported that all the previous symptoms had continued in waves for the past 10 days and was not resolved. The patient reported that she called her health care professional, who gave her the vaccine, and she told her to use a scopolamine patch behind her ear and the patient reported which helped with the dizziness. The patient reported that 3 days after receiving the Shingrix vaccine she began to experience sharp pains in her stomach and back, they come and go in waves. On 15th November 2021, the health care professional took a blood sample and told her that her sodium was low and suggested to increase her salt intake. The patient reported that for the past 10 days she could only eat bland food because of the nausea and vomiting. Less than 2 weeks after vaccination, the patient reported that her stomach feels like there was chemicals floating in her stomach. The patient did not give permission to contact health care professional. The reporter did not consent to follow-up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: sharp pain in stomach and back; sharp pain in stomach and back; faint; soreness at injection site; diarrhea; nausea/vomiting; nausea; dizziness; chemical feeling in her stomach; This case was reported by a consumer via call center representative and described the occurrence of faint in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th October 2021 10:00, the patient received the 1st dose of Shingrix (intramuscular). On 11th October 2021, 6 hrs after receiving Shingrix, the patient experienced faint (serious criteria GSK medically significant), injection site pain, diarrhea, vomiting, nausea and dizziness. On 14th October 2021, the patient experienced stomach pain and back pain. In October 2021, the patient experienced stomach discomfort. The patient was treated with hyoscine (Scopolamine Patch). On an unknown date, the outcome of the faint, injection site pain, diarrhea, vomiting, nausea, dizziness, stomach pain, back pain and stomach discomfort were not recovered/not resolved.   It was unknown if the reporter considered the faint, diarrhea, vomiting, nausea, dizziness, stomach pain, back pain and stomach discomfort to be related to Shingrix. The reporter considered the injection site pain to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient herself. The patient received a dose of Shingrix in right arm and about 4 hours later she experienced diarrhea, nausea/vomiting, dizziness and a sore arm at the injection site. The patient reported that approximately 6 hours after the Shingrix injection she began to feel faint while laying by the pool. The patient reported that all the previous symptoms had continued in waves for the past 10 days and was not resolved. The patient reported that she called her health care professional, who gave her the vaccine, and she told her to use a scopolamine patch behind her ear and the patient reported which helped with the dizziness. The patient reported that 3 days after receiving the Shingrix vaccine she began to experience sharp pains in her stomach and back, they come and go in waves. On 15th November 2021, the health care professional took a blood sample and told her that her sodium was low and suggested to increase her salt intake. The patient reported that for the past 10 days she could only eat bland food because of the nausea and vomiting. Less than 2 weeks after vaccination, the patient reported that her stomach feels like there was chemicals floating in her stomach. The patient did not give permission to contact health care professional. The reporter did not consent to follow-up.
Sex: M
Vaccine: MNQ
Symptoms: Product storage error, Wrong technique in product usage process
Clinical narrative: administered after 16 hours of reconstitution/ administered after temperature excursion; administered after 16 hours of reconstitution; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA437A, expiry date 31st October 2021) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced incorrect storage of drug and wrong technique in drug usage process. On an unknown date, the outcome of the incorrect storage of drug and wrong technique in drug usage process were unknown.  Additional details were provided as follows: The age at vaccination was not reported. the physician reported that a nurse administered a dose of Menveo after 16 hours of reconstitution, which led to incorrect storage of drug and wrong technique in drug usage process. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Second dose not yet given.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 13th June 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 to this report. The pharmacist reported that the patient did not receive 2nd dose till the time of reporting, which led to incomplete course of vaccination. The pharmacist reported that the second dose of Shingrix greater than 6 months. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: early second dose; Shingrix vaccine instead of a flu vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 57LJM, expiry date 14th April 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 24th October 2021, the patient received the 2nd dose of Shingrix. On 24th October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short and wrong vaccine administered. On an unknown date, the outcome of the drug dose administration interval too short and wrong vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received 1st dose of Shingrix vaccine on 1st October 2021 and 2nd dose of the Shingrix vaccine instead of a flu vaccine on 24th October 2021, which led to drug dose administration interval too short and wrong vaccine administered. No further information reported. The reporter consented to follow-up by email.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Administered expired havrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-year-old male patient who received HAV (Havrix) (batch number 94j24, expiry date 26th September 2021) for prophylaxis.   On 30th September 2021, the patient received Havrix. On 30th September 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 age at vaccination was not reported. The health care professional reported that the patient was administered havrix that was expired on 26th September 2021.  The patient was administered on the 30th September 2021. The reporter was consented to follow up. This case has been linked with the case US2021221679 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021221679:Same reporter. Patient 1 of 2.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4-month patient received Kinrix; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd October 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 23rd October 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The physician reported that a 4-month old male patient was administered Kinrix inadvertently, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Administration of only the diluent portion; Administration of only the diluent portion; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient 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 reported. The reported stated that there was administration of only the diluent portion of the vaccine to the  patient. The reporter did not have information regarding the date of the administration nor gender or age of the patients.  The reporter agreed to be contacted for follow-up and claimed the would try to find more details about the event. No further events were reported.  The reporter consented to follow up. The case was linked with the case US2021AMR222484 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR222484:Same reporter. Patient 2.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose 2018. Has not received the 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose 0.5 ml, in February 2018 ).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by patient herself The age at vaccination was not reported. The patient stated that she received her first dose of Shingrix in February of 2018. She had not received the second dose till the time of reporting, till the time of reporting which led to incomplete course of vaccination.  The reporter did not consent to follow-up.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: MenA vial was expired.; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA380A, expiry date 31st August 2021) for prophylaxis.   On 22nd October 2021, the patient received Menveo. On 22nd October 2021, unknown after receiving Menveo, 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 age at vaccination was not reported. The nurse stated that a patient had administered MENVEO vaccine, in which the MenA vial was expired. However, MenCYW vial was not expired (MenCYW vial Lot: AMXA380A Expiry date July 2022. The reporter gave a consent to follow-up herself. The following information about patient's initials, date of birth, gender, dose, and route of administration was not provided. The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 25th September 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient.  The patient received Shingrix in left arm.  After receiving Shingrix, the patient had left arm injection site pain that resolved after about 3 days. The reporter consented to follow up. For tolerance of 2nd occurrence, refer case US2021AMR223285.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR223285:same reporter
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 25th September 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient.  The patient received Shingrix in left arm.  After receiving Shingrix, the patient had left arm injection site pain that resolved after about 3 days. The reporter consented to follow up. For tolerance of 2nd occurrence, refer case US2021AMR223285.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR223285:same reporter
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: late second dose of Shingrix,18Aug2020 and the second one on 25Oct2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number PM35L, expiry date 4th February 2023) for prophylaxis.   Previously administered products included shingrix (1st dose received on 18th August 2020).   On 25th October 2021, the patient received the 2nd dose of Shingrix. On 25th October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: Pharmacist reported that the patient was vaccinated with 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose September 24th 2021 second dose October 23rd 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number kz455, expiry date 4th February 2023) for prophylaxis.   Concurrent medical conditions included immunocompromised (immunocompetent). Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 23rd October 2021, the patient received the 2nd dose of Shingrix. On 23rd October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: On 24th September 2021, the patient received first dose of Shingrix. The patient received second dose of Shingrix earlier than recommended interval, which led to shortening of vaccination schedule. The reporter did not consent to follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Off label use
Clinical narrative: RECEIVED 0.3 ML OF JNJ VACCINE AS A BOOSTER THIRD DOSE AFTER TWO DOSES OF PFIZER VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 46 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with bnt 162 for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) .3 ml, start therapy date was not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. Per procedure, no follow-up will be requested for this case. On an unspecified date, the patient experienced received 0.3 ml of JNJ vaccine as a booster third dose after two doses of pfizer vaccine, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received 0.3 ml of JNJ vaccine as a booster third dose after two doses of pfizer vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211045172 and 20211045143.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Off label use
Clinical narrative: 0.3 ML OF JNJ VACCINE ADMINISTERED AS BOOSTER OR THIRD DOSE AFTER TWO DOSES OF PFIZER VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 51 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with bnt 162 for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) .3 ml, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced off label use, and 0.3 ml of JNJ vaccine administered as booster or third dose after two doses of pfizer vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and 0.3 ml of JNJ vaccine administered as booster or third dose after two doses of pfizer vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211045172 and 20211045076.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Off label use
Clinical narrative: 0.3 ML OF JNJ VACCINE ADMINISTERED AS BOOSTER OR THIRD DOSE AFTER TWO DOSES OF PFIZER VACCINE; OFF-LABEL USE; This spontaneous report received from a health care professional 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 was previously treated with bnt 162 for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) .3 ml, start therapy date was not reported for prophylactic vaccination.The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced off-label use, and 0.3 ml of JNJ vaccine administered as booster or third dose after two doses of pfizer vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off-label use and 0.3 ml of JNJ vaccine administered as booster or third dose after two doses of pfizer vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211045143 and 20211045076.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Memory impairment, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; MEMORY HAD BEEN WORSE; This spontaneous report received from a patient concerned a 77 year old male, unspecified 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, intramuscular, batch number: unknown expiry date: unknown) dose was not reported, 01 total, administered on 01-MAR-2021 for covid-19 vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (Humira) (solution for injection in pre-filled pen, subcutaneous, batch number: unknown expiry date: unknown) dose, frequency, and therapy dates were not reported, used for moderate to severe adult Crohn's disease, and moderate to severe ulcerative colitis. No concomitant medications were reported at the time of reporting.  On unspecified date in SEP-2021, the patient had suspected covid-19 infection (suspected clinical vaccination failure) and memory had been worse since Covid-19. He was hospitalized for 3 weeks. The hospital discharge date was not reported. He was better as of 15-OCT-2021, but he did physical therapy two to three times a week. It was unknown if patient was enrolled in a Covid-19 vaccine trial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection, and memory had been worse, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint:90000199305.; Sender's Comments: V0: 20211050446- Covid-19 vaccine ad26.cov2.s- Suspected covid-19 infection, Memory had been worse. 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).  20211050446-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
Age: 39.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Hot flush
Clinical narrative: WARM FLASHES; PRETTY BAD HEADACHE; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: warm flashes, and pretty bad headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 Total administered on 06-OCT-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Non-company suspect drugs included: elagolix sodium (form of admin unknown, oral, batch number was not reported) dose was not reported, 2 times every 1 day, from 24-SEP-2021 for an unspecified indication. No concomitant medications were reported. On SEP-2021, the patient experienced warm flashes. On SEP-2021, the patient experienced pretty bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with elagolix sodium was not reported. The patient recovered from pretty bad headache on OCT-2021, and had not recovered from warm flashes. This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PUNCTURED VIAL OF THE VACCINE WAS ADMINISTERED EXCEEDED TIME FRAME BY 1 ONE HOUR OUTSIDE OF THE 6 HOUR TIME PERIOD; VIAL OF VACCINE WAS PUNCTURED OUTSIDE OF THE 6 HOUR TIME PERIOD; This spontaneous report received from a health care professional concerned a 48 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, and batch number: 211A21A expiry: 14-DEC-2021) dose was not reported, administered on 26-OCT-2021 15:05 for prophylactic vaccination. No concomitant medications were reported. On 26-OCT-2021, the patient experienced punctured vial of the vaccine was administered exceeded time frame by 1 one hour outside of the 6 hour time period. On 26-OCT-2021, the patient experienced vial of vaccine was punctured outside of the 6 hour time period. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the punctured vial of the vaccine was administered exceeded time frame by 1 one hour outside of the 6 hour time period and vial of vaccine was punctured outside of the 6 hour time period was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Pyrexia
Clinical narrative: HIGH BLOOD PRESSURE; LOW GRADE FEVER; 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. The patient's pre-existing medical conditions included: Patient was a pretty healthy till now. 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 01-APR-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, the patient experienced high blood pressure, and low grade fever. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever, and had not recovered from high blood pressure. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Periodontitis
Clinical narrative: PERIODONTITIS; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's past medical history included: ruptured discs in neck, and concurrent conditions included: allergic to wasps and yellow jacket stings. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen. On an unspecified date, the patient experienced periodontitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of periodontitis was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Headache, Malaise, Pain assessment, Pyrexia
Clinical narrative: SMALL BALLS IN SKULL AND SCALP/ BLOOD CLOTS/HEADACHE (8-9/10); NOSE BLEED; FEELING UNWELL; FEVER; HEADACHE (3/10); This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes for three years and was on pill medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 20GA21A, and expiry: UNKNOWN) 1 total dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-JUN-2021, the patient has not felt well since vaccination and had fever that broke within days. The patient experienced constant headache on a pain scale of 3 out 10 and was taking analgesics for three months but headache got worsened and never got better. On 19-OCT-2021 and 20-OCT-2021, the patient had nose bleed and visited emergency room on 21-OCT-2021. On 21-OCT-2021, the patient had severe headache on forehead with a pain scale of 8-9 out of 10. On the same day, the patient got Computerised tomogram which showed small blood balls in skull and scalp. The ER doctors referred the patient to neurology center, where he got admitted and had tomography done along with other exams. Chiropractors monitored the patient for stroke which was ruled out. The patient developed neck pressure at hospital but doctors disregarded and explained it was a part of symptoms and did not treat it. The doctors wanted the patient to have chiropractor check and will go to primary care tonight. The patient was hospitalized for four days and discharged on 24-OCT-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nose bleed on 21-OCT-2021, and fever, and had not recovered from feeling unwell, small balls in skull and scalp/ blood clots/headache (8-9/10), and headache (3/10). This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20211052851-COVID-19 VACCINE AD26.COV2.S- Small balls in skull and scalp/ blood clots/headache (8-9/10), Nose bleed . 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: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: SMALL BALLS IN SKULL AND SCALP/ BLOOD CLOTS/HEADACHE (8-9/10); NOSE BLEED; FEELING UNWELL; FEVER; HEADACHE (3/10); This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes for three years and was on pill medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 20GA21A, and expiry: UNKNOWN) 1 total dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-JUN-2021, the patient has not felt well since vaccination and had fever that broke within days. The patient experienced constant headache on a pain scale of 3 out 10 and was taking analgesics for three months but headache got worsened and never got better. On 19-OCT-2021 and 20-OCT-2021, the patient had nose bleed and visited emergency room on 21-OCT-2021. On 21-OCT-2021, the patient had severe headache on forehead with a pain scale of 8-9 out of 10. On the same day, the patient got Computerised tomogram which showed small blood balls in skull and scalp. The ER doctors referred the patient to neurology center, where he got admitted and had tomography done along with other exams. Chiropractors monitored the patient for stroke which was ruled out. The patient developed neck pressure at hospital but doctors disregarded and explained it was a part of symptoms and did not treat it. The doctors wanted the patient to have chiropractor check and will go to primary care tonight. The patient was hospitalized for four days and discharged on 24-OCT-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nose bleed on 21-OCT-2021, and fever, and had not recovered from feeling unwell, small balls in skull and scalp/ blood clots/headache (8-9/10), and headache (3/10). This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20211052851-COVID-19 VACCINE AD26.COV2.S- Small balls in skull and scalp/ blood clots/headache (8-9/10), Nose bleed . 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 concerned multiple patients. 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced death. On an unspecified date, the patient died from unknown cause of death. It was unknown if the autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211053420-Covid-19 vaccine ad26.cov2.s - Death. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Feeling abnormal, Insomnia, Pyrexia
Clinical narrative: AWFUL; FELT LIKE HIT BY A BUS; COULD NOT SLEEP THAT NIGHT; SORE; CHILLS; FEVER; 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: Unknown) dose was not reported, administered on MAR-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 MAR-2021, the patient experienced awful. On MAR-2021, the patient experienced felt like hit by a bus. On MAR-2021, the patient experienced could not sleep that night. On MAR-2021, the patient experienced sore. On MAR-2021, the patient experienced chills. On MAR-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the awful, felt like hit by a bus, fever, chills, could not sleep that night and sore was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: VERY MILD REACTIONS; This spontaneous report received from a patient concerned multiple patients. 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 Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced very mild reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very mild reactions was not reported. This report was non-serious. This case, from the same reporter is linked to 20211055553 and 20211055777.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold, Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: PAIN ALL THE TIME; FEEL A DIFFERENCE IN BODY; MUSCLES STIFF 24-7; CONSTANTLY COLD; MUSCLES ARE ALWAYS SORE 24-7; 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. The patient's pre-existing medical conditions included: The patient never had flu and never got cold never wore a jersey or jacket. 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 pain all the time, feel a difference in body, muscles stiff 24-7, constantly cold, and muscles are always sore 24-7. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscles are always sore 24-7, muscles stiff 24-7, pain all the time, and constantly cold, and the outcome of feel a difference in body was not reported. This report was non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Chills, Dizziness, Headache
Clinical narrative: SWEATING; CHILLS; HEADACHE; FEVER; CHEST PAIN; LITTLE DIZZY, BUT NOTHING TOO CRAZY; BODY ACHES; This spontaneous report received from a patient concerned a 50 year old male. The patient's weight was 188 pounds, and height was 68 inches. The patient's concurrent conditions included: disabled veteran (multiple chronic conditions), penicillin allergy, sulfa allergy, bee sting allergy, non smoker, and non alcoholic, and other pre-existing medical conditions included: Patient had no drug abuse and illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 19-SEP-2022) dose was not reported, administered on 26-OCT-2021 14:30 for prophylactic vaccination. No concomitant medications were reported.  On 26-OCT-2021, the patient experienced chest pain. On 26-OCT-2021, the patient experienced little dizzy, but nothing too crazy. On 26-OCT-2021, the patient experienced body aches. On 26-OCT-2021, the patient experienced chills. On 26-OCT-2021, the patient experienced headache. On 26-OCT-2021, the patient experienced fever. On 27-OCT-2021, the patient experienced sweating. Laboratory data included: Body temperature (NR: not provided) 105 F, 103 F, 102 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, and little dizzy, but nothing too crazy on 26-OCT-2021, had not recovered from body aches, headache, and fever, and the outcome of chills and sweating was not reported. This report was non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pain, Pyrexia
Clinical narrative: SWEATING; CHILLS; HEADACHE; FEVER; CHEST PAIN; LITTLE DIZZY, BUT NOTHING TOO CRAZY; BODY ACHES; This spontaneous report received from a patient concerned a 50 year old male. The patient's weight was 188 pounds, and height was 68 inches. The patient's concurrent conditions included: disabled veteran (multiple chronic conditions), penicillin allergy, sulfa allergy, bee sting allergy, non smoker, and non alcoholic, and other pre-existing medical conditions included: Patient had no drug abuse and illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 19-SEP-2022) dose was not reported, administered on 26-OCT-2021 14:30 for prophylactic vaccination. No concomitant medications were reported.  On 26-OCT-2021, the patient experienced chest pain. On 26-OCT-2021, the patient experienced little dizzy, but nothing too crazy. On 26-OCT-2021, the patient experienced body aches. On 26-OCT-2021, the patient experienced chills. On 26-OCT-2021, the patient experienced headache. On 26-OCT-2021, the patient experienced fever. On 27-OCT-2021, the patient experienced sweating. Laboratory data included: Body temperature (NR: not provided) 105 F, 103 F, 102 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, and little dizzy, but nothing too crazy on 26-OCT-2021, had not recovered from body aches, headache, and fever, and the outcome of chills and sweating was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: A LOT OF BODY ACHES; CHILLS; TIRED; This spontaneous report received from a consumer via a company representative 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 a lot of body aches, chills, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the a lot of body aches, tired and chills was not reported. This report was non-serious. This case, from the same reporter is linked to 20211055339.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Bedridden, Colonoscopy, Constipation, Gastrointestinal sounds abnormal
Clinical narrative: BOWEL SOUNDS EVEN WHEN SHE IS NOT HUNGRY; COULD NOT SLEEP; INTENSIVE STOMACH PAIN ON THE RIGHT, LEFT SIDE AND IN THE MIDDLE; DID NOT HAVE BOWEL MOVEMENT; COULD NOT GET OUT OF BED; HEADACHE; LOW-GRADE FEVER; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included: did colonoscopy and broke into rash (less rash), and concurrent conditions included: non alcoholic, and non smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient experienced hives and rash severe all over her body and red and inflamed when treated with sulfamethoxazole/trimethoprim for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A expiry: 21-DEC-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-SEP-2021, the patient experienced could not get out of bed. On 24-SEP-2021, the patient experienced headache. On 24-SEP-2021, the patient experienced low-grade fever. On 27-SEP-2021, the patient experienced intensive stomach pain on the right, left side and in the middle. On 27-SEP-2021, the patient experienced did not have bowel movement. On 27-OCT-2021, the patient experienced could not sleep. On an unspecified date, the patient experienced bowel sounds even when she is not hungry. Laboratory data (dates unspecified) included: Colonoscopy (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not get out of bed, headache, and low-grade fever on 26-SEP-2021, was recovering from intensive stomach pain on the right, left side and in the middle, and did not have bowel movement, and the outcome of bowel sounds even when she is not hungry and could not sleep was not reported. This report was non-serious.