chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: I had my 2nd Shingrix vaccine 3 days ago / now feeling much better; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2021, the patient received the 2nd dose of Shingrix. In June 2021, less than a week after receiving Shingrix, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was recovering/resolving.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself/himself. The age at vaccination was not reported. The patient had received dose of Shingrix vaccine 3 days ago and was now feeling much better. The patient was asking if it was safe to have an intense gym workout today (day of reporting) and do he/she need rest following the vaccine for a specific period. Follow up was not possible as no contact details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received a shingles vaccine 3 years ago and did not receive the 2nd dose.; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster Shingrix for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 years ago).   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 reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. The reporter verified that the patient received Shingrix. If so, could she still receive the 2nd dose. Follow up was not possible as no contact details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Pain, Swelling
Clinical narrative: soreness /and pain; dizziness; swelling; This case was reported by a other health professional via sales rep and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain, dizziness and swelling. The patient was treated with morphine. On an unknown date, the outcome of the pain, dizziness and swelling were unknown.   It was unknown if the reporter considered the pain, dizziness and swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix and had soreness, dizziness, swelling and pain. The patient went to Emergency room and received morphine as a treatment. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: a patient / only received the first dose. It has been at least 1 year; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date, atleast 1 year prior to reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter mentioned that, it has been atleast one year, patient has received 1st dose of Shingrix. The reporter asked if patient should start over and do 2 doses or just give a booster. This case has been linked with US2021AMR134422, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR134422:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has been at least 1 year since they received the first dose; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on unknown date, atleast 1 year from reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter mentioned that, it has been atleast one year, patient has received 1st dose of Shingrix. The reporter asked if they should start over and do 2 doses or just give a booster. This case has been linked with US2021AMR134420, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR134420:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Needle issue, Underdose
Clinical narrative: there was a gap between the needle and the barrel / fluid came out of the gap when trying to inject vaccine in deltoid; This case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th June 2021, the patient received Shingrix. On 14th June 2021, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional gave a shingrix vaccination, but there was a gap between the needle and the barrel. The fluid came out of the gap when trying to inject vaccine in deltoid, which led to incomplete dose administration. The reporter disconnected the chat prior to providing any information about the patient's experience or if this was a potential product quality complaint. The reporter did not consent to follow up.  No additional data was available except what was presented in this adverse event report.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose 20 months ago and has not received dose two; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019, 20 months prior from the reporting date).   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 reported as follows: The reporter was a pharmacy intern. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Injection site discolouration, Injection site reaction, Injection site swelling, Pain in extremity
Clinical narrative: site reaction; swelling, huge welt the size of the palm of her hand that was raised half and inch; swelling, huge welt the size of the palm of her hand that was raised half and inch and changed different colors; bruising; arm soreness; huge welt the size of the palm of her hand that was raised half; This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a 58-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) for prophylaxis.   On 13th October 2018, the patient received the 1st dose of Fluarix Quadrivalent 2018-2019 season (intramuscular). On 14th October 2018, 1 days after receiving Fluarix Quadrivalent 2018-2019 season, the patient experienced injection site reaction, swelling, skin coloring, contusion, pain in arm and welts. On an unknown date, the outcome of the injection site reaction, swelling, skin coloring, contusion, pain in arm and welts were recovered/resolved.   It was unknown if the reporter considered the injection site reaction, swelling, skin coloring, contusion, pain in arm and welts to be related to Fluarix Quadrivalent 2018-2019 season.  Additional details were provided as follows: The case was reported by the consumer for herself. The patient received Fluarix in her left arm and experienced a site reaction,had swelling, huge welt the size of the palm of her hand that was raised half and inch and changed different colors, she also had bruising and arm soreness. No further information was reported. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: site reaction; swelling, huge welt the size of the palm of her hand that was raised half and inch; swelling, huge welt the size of the palm of her hand that was raised half and inch and changed different colors; bruising; arm soreness; huge welt the size of the palm of her hand that was raised half; This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a 58-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) for prophylaxis.   On 13th October 2018, the patient received the 1st dose of Fluarix Quadrivalent 2018-2019 season (intramuscular). On 14th October 2018, 1 days after receiving Fluarix Quadrivalent 2018-2019 season, the patient experienced injection site reaction, swelling, skin coloring, contusion, pain in arm and welts. On an unknown date, the outcome of the injection site reaction, swelling, skin coloring, contusion, pain in arm and welts were recovered/resolved.   It was unknown if the reporter considered the injection site reaction, swelling, skin coloring, contusion, pain in arm and welts to be related to Fluarix Quadrivalent 2018-2019 season.  Additional details were provided as follows: The case was reported by the consumer for herself. The patient received Fluarix in her left arm and experienced a site reaction,had swelling, huge welt the size of the palm of her hand that was raised half and inch and changed different colors, she also had bruising and arm soreness. No further information was reported. The reporter consented to follow up.
Age: 0.58
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Infant less than 4 years received on April 2021 a Kinrix / at 8 months of age; Infant less than 4 years received on April 2021 a Kinrix / at 8 months of age; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-month-old female 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.   Previously administered products included Pentacel (1st dose received at 2 months of age) and Pentacel (2nd dose received at 4 months of age).   In April 2021, the patient received the 3rd dose of Kinrix and Kinrix Pre-Filled Syringe Device. In April 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered 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 are as follows: The reporter stated that, since the office was out of Pentacel, the staff gave Kinrix as dose 3 to 8 months old patient, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. The patient's initials and lot number not provided on call (not asked as reporter became frustrated with questions but did consent to follow up via email).  The reporter added that, there might be more patients this occurred with; the staff was currently auditing patient charts to see if there were additional patients impacted.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021131693:FU deleted
Sex: U
Vaccine: DTAP
Symptoms: Incomplete course of vaccination
Clinical narrative: 8yo who has not completed the DTaP series / has sustained dog bite; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 8-year-old patient who received DTPa (DTaP vaccine) for prophylaxis.   Previously administered products included DTaP Vaccine (on an unknown date, received previous unspecified number of doses). Concurrent medical conditions included dog bite (had sustained dog bite).   On an unknown date, the patient received DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported are as follows: The age at vaccination not applicable for this report. Nurse Practitioner reported that, the patient did not complete the DTaP series and had sustained dog bite. Adverse event was captured via chat, unsure if this was a GSK vaccine or not as brand name was not provided by Health care professional and chat was disconnected by Health care professional  prior to providing any additional details about scheduling of DTaP or demographic details. It was not specified, how many doses the patient had received but stated that, the series was not completed. No additional data provided and only contact information provided was email address and zip code. The reporter did not consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nausea, Pain in extremity
Clinical narrative: redness; nausea; arm  soreness; This case was reported by a nurse via call center representative and described the occurrence of erythema in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included levothyroxine.   On 28th April 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced erythema, nausea and pain in arm. On an unknown date, the outcome of the erythema, nausea and pain in arm were unknown.   It was unknown if the reporter considered the erythema, nausea and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient experienced redness, nausea and arm soreness. The patient takes glucozone and levothyroxine and her weight was only 85 pounds. No information about lot number and expiration date from shingrix first dose. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: First Shingrix vaccine in August 2020 / Second Shingrix vaccine late due to Covid-19 restrictions; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received in August 2020,intramuscularly).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The case was reported by the consumer for himself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix  due to Covid-19 restrictions, which led to social problem. No further information was reported. The reporter did not consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: received an expired dose of Shingrix today; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number EH9Z7, expiry date 8th March 2021) for prophylaxis.   On 17th June 2021, the patient received the 2nd dose of Shingrix. On 17th June 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient received expired dose of Shingrix, which led to expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received / first dose / on 17Dec2019 / has not received the second dose yet; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 17th December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The VAERS details for 1st dose were updated. The reporter consented to follow up.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: expired 5/25/21, administered on 6/15/21; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Infanrix) (batch number unknown, expiry date 25th May 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th June 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 15th June 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received an expired dose of Infanrix vaccine, which led to expired vaccine used. No further information was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the adjuvant component; received only the adjuvant component; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) (batch number L4LHS, expiry date unknown) for prophylaxis.   On 17th June 2021, the patient received Shingrix. On 17th June 2021, 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 patient received only adjuvant component of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No expiration date was reported. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, Heart rate, Nausea
Clinical narrative: CONFIRMED COVID-19 INFECTION (LETHARGIC); CONFIRMED CLINICAL VACCINATION FAILURE; HEADACHE; FEELING WORN OUT; NAUSEA; This spontaneous report received from a patient concerned a 66 year old female of an unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included chronic obstructive pulmonary disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A and expiry: unknown) dose was not reported, 1 total administered on 08-MAR-2021 for prophylactic vaccination. The patient could not recall the vaccination site. Concomitant medications were not reported. On 08-MAR-2021, after the vaccination, patient developed nausea, headache and felt really worn out for 3 days and then the symptoms went away. On 05-JUN-2021, the patient started to feel lethargic, wicked headache and the oxygen kept going low and the pulse rate was high. On 09-JUN-2021, the patient decided to get tested for COVID and the result went positive. The patient had confirmed clinical vaccination failure. Patient was hospitalised until 12-JUN-2021 and was probably to be discharged the next day. Patient stated that was taking a lot of medications including prednisone, antiviral and anti-bacterial drugs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, feeling worn out, and nausea on 11-MAR-2021, and the outcome of confirmed clinical vaccination failure and confirmed covid-19 infection (lethargic) was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000182633. The suspected product quality complaint has been confirmed to be not voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0;20210626624-covid-19 vaccine ad26.cov2.s -confirmed 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  V0;20210626624-covid-19 vaccine ad26.cov2.s -confirmed covid-19 infection . 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
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED COVID-19 INFECTION (LETHARGIC); CONFIRMED CLINICAL VACCINATION FAILURE; HEADACHE; FEELING WORN OUT; NAUSEA; This spontaneous report received from a patient concerned a 66 year old female of an unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included chronic obstructive pulmonary disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A and expiry: unknown) dose was not reported, 1 total administered on 08-MAR-2021 for prophylactic vaccination. The patient could not recall the vaccination site. Concomitant medications were not reported. On 08-MAR-2021, after the vaccination, patient developed nausea, headache and felt really worn out for 3 days and then the symptoms went away. On 05-JUN-2021, the patient started to feel lethargic, wicked headache and the oxygen kept going low and the pulse rate was high. On 09-JUN-2021, the patient decided to get tested for COVID and the result went positive. The patient had confirmed clinical vaccination failure. Patient was hospitalised until 12-JUN-2021 and was probably to be discharged the next day. Patient stated that was taking a lot of medications including prednisone, antiviral and anti-bacterial drugs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, feeling worn out, and nausea on 11-MAR-2021, and the outcome of confirmed clinical vaccination failure and confirmed covid-19 infection (lethargic) was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000182633. The suspected product quality complaint has been confirmed to be not voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0;20210626624-covid-19 vaccine ad26.cov2.s -confirmed 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  V0;20210626624-covid-19 vaccine ad26.cov2.s -confirmed covid-19 infection . 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
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Injection site pruritus, Injection site rash, Pain in extremity
Clinical narrative: VERTIGO; ITCHING AROUND RIGHT ARM; RASH AROUND RIGHT ARM; SHARP PAIN IN RIGHT ARM; DIZZINESS; HEADACHE; This spontaneous report received from a patient concerned a 37 year old female of an unspecified race and ethnic origin. The patient's weight was 160 pounds, and height was 64 inches. The patient's past medical history included covid 19 and concurrent conditions included non-alcohol user, and non-smoker. The patient's other pre-existing medical conditions included that she had no known allergies and had no history of drug abuse or illicit drug usage. The patient was not pregnant at the time of this report. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, and expiry: unknown) dose was not reported, with frequency 1 total administered at right arm on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-FEB-2021, Laboratory data included: Covid-19 virus test which revealed that she was positive for Covid-19. On 11-APR-2021, after receiving the vaccine, the patient experienced headache. On an unspecified date in MAY-2021 (reported as about one month ago), the patient was hospitalized (date unspecified) and was diagnosed with vertigo. On an unspecified date in MAY-2021 (reported as five to six weeks post vaccination), the patient developed dizziness. On an unspecified date in JUN-2021 (reported as started approximately one week ago from the date of reporting), the patient experienced sharp pain in right arm which was very uncomfortable. On an unspecified date, the patient developed rash and itching around the area in her right arm where the vaccine was given. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itching around right arm, rash around right arm, dizziness, sharp pain in right arm, vertigo and headache was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210626989-covid-19 vaccine ad26.cov2.s-Vertigo. 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vertigo
Clinical narrative: VERTIGO; ITCHING AROUND RIGHT ARM; RASH AROUND RIGHT ARM; SHARP PAIN IN RIGHT ARM; DIZZINESS; HEADACHE; This spontaneous report received from a patient concerned a 37 year old female of an unspecified race and ethnic origin. The patient's weight was 160 pounds, and height was 64 inches. The patient's past medical history included covid 19 and concurrent conditions included non-alcohol user, and non-smoker. The patient's other pre-existing medical conditions included that she had no known allergies and had no history of drug abuse or illicit drug usage. The patient was not pregnant at the time of this report. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, and expiry: unknown) dose was not reported, with frequency 1 total administered at right arm on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-FEB-2021, Laboratory data included: Covid-19 virus test which revealed that she was positive for Covid-19. On 11-APR-2021, after receiving the vaccine, the patient experienced headache. On an unspecified date in MAY-2021 (reported as about one month ago), the patient was hospitalized (date unspecified) and was diagnosed with vertigo. On an unspecified date in MAY-2021 (reported as five to six weeks post vaccination), the patient developed dizziness. On an unspecified date in JUN-2021 (reported as started approximately one week ago from the date of reporting), the patient experienced sharp pain in right arm which was very uncomfortable. On an unspecified date, the patient developed rash and itching around the area in her right arm where the vaccine was given. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itching around right arm, rash around right arm, dizziness, sharp pain in right arm, vertigo and headache was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210626989-covid-19 vaccine ad26.cov2.s-Vertigo. 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: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Oedema peripheral, Pruritus
Clinical narrative: SWOLLEN  LEGS AND FEET; SWOLLEN KNEES AND HANDS; ITCHINESS ON AFFECTED AREAS; This spontaneous report received from a patient concerned a 39 year old male. The patient's weight was 210 pounds, and height was 157.48 centimeters. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808986 and expiry: UNKNOWN) dose was not reported, administered on 30-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-JUN-2021, the subject experienced swollen legs and feet. On 06-JUN-2021, the subject experienced swollen knees and hands. On 06-JUN-2021, the subject experienced itchiness on affected areas. The action taken with covid-19 vaccine was not applicable. The patient recovered with sequelae from itchiness on affected areas, and had not recovered from swollen legs and feet, and swollen knees and hands. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: FEVER; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced fever, headache, and fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The outcome of the fever, headache and fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: SHIVERS; FEVER; This spontaneous report received from a patient 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 (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced shivers, and fever. The action taken with covid-19 vaccine was not applicable. The patient recovered from shivers, and fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: PASSED AWAY; COVID-19; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age. Initial information was processed with the additional information received from central complaint vigilance on 15-JUN-2021. 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 not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient got COVID-19 and passed away. The patient died from unknown cause of death. It was unknown if autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of COVID-19 was not reported. This report was serious (Death). This report was associated with product quality complaint: 90000182715. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20210635272.; Sender's Comments: V0; 20210629346-covid-19 vaccine ad26.cov2.s Passed away. 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
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Balance disorder, Chills, Fatigue
Clinical narrative: UNEXPLAINED SEVERE, CUTTING, HOT, DEEP, INTERNAL-TORNADO LIKE PAIN TO LEFT SHOULDER; EXTREME FATIGUE AND UNABLE TO CARE FOR MYSELF/3 VERY STRANGE EPISODES WHICH LEFT HER VERY DRAINED; FEEL WEAK; DIZZY/OFF BALANCE; HURT ALL OVER/INCREASE IN NECK AND BACK PAIN; TEETH CHATTERING; This spontaneous report received from a patient concerned a 73 year old female. The patient's weight was 220 pounds, and height was 67 inches. The patient's past medical history included right shoulder arthroscopy, and weakness, and concurrent conditions included chronic pain homebound patient with scoliosis, bone spurs, spine curvature /abnormalities, abnormal muscles, degenerative disc disease, penicillin allergy, non alcoholic, non smoker, and sick w/ scoliosis at age 16, and other pre-existing medical conditions included the patient had allergies and no drug abuse or illicit drug usage.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. Concomitant medications included hydromorphone hydrochloride, and oxycodone. On 11-JUN-2021, the subject experienced dizzy/off balance. On 11-JUN-2021, the subject experienced hurt all over/increase in neck and back pain. On 11-JUN-2021, the subject experienced teeth chattering. On 11-JUN-2021, the subject experienced feel weak. On 13-JUN-2021, the subject experienced unexplained severe, cutting, hot, deep, internal-tornado like pain to left shoulder. On 13-JUN-2021, the subject experienced extreme fatigue and unable to care for myself/3 very strange episodes which left her very drained. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from feel weak, teeth chattering, dizzy/off balance, hurt all over/increase in neck and back pain, unexplained severe, cutting, hot, deep, internal-tornado like pain to left shoulder, and extreme fatigue and unable to care for myself/3 very strange episodes which left her very drained. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: UNEXPLAINED SEVERE, CUTTING, HOT, DEEP, INTERNAL-TORNADO LIKE PAIN TO LEFT SHOULDER; EXTREME FATIGUE AND UNABLE TO CARE FOR MYSELF/3 VERY STRANGE EPISODES WHICH LEFT HER VERY DRAINED; FEEL WEAK; DIZZY/OFF BALANCE; HURT ALL OVER/INCREASE IN NECK AND BACK PAIN; TEETH CHATTERING; This spontaneous report received from a patient concerned a 73 year old female. The patient's weight was 220 pounds, and height was 67 inches. The patient's past medical history included right shoulder arthroscopy, and weakness, and concurrent conditions included chronic pain homebound patient with scoliosis, bone spurs, spine curvature /abnormalities, abnormal muscles, degenerative disc disease, penicillin allergy, non alcoholic, non smoker, and sick w/ scoliosis at age 16, and other pre-existing medical conditions included the patient had allergies and no drug abuse or illicit drug usage.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. Concomitant medications included hydromorphone hydrochloride, and oxycodone. On 11-JUN-2021, the subject experienced dizzy/off balance. On 11-JUN-2021, the subject experienced hurt all over/increase in neck and back pain. On 11-JUN-2021, the subject experienced teeth chattering. On 11-JUN-2021, the subject experienced feel weak. On 13-JUN-2021, the subject experienced unexplained severe, cutting, hot, deep, internal-tornado like pain to left shoulder. On 13-JUN-2021, the subject experienced extreme fatigue and unable to care for myself/3 very strange episodes which left her very drained. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from feel weak, teeth chattering, dizzy/off balance, hurt all over/increase in neck and back pain, unexplained severe, cutting, hot, deep, internal-tornado like pain to left shoulder, and extreme fatigue and unable to care for myself/3 very strange episodes which left her very drained. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Arthralgia, Diarrhoea, Fatigue
Clinical narrative: CALL OFF WORK; JOINT PAIN; NAUSEA; HEADACHE; FATIGUE/ TIREDNESS; ARM ACHE; NEUROPATHY; DIARRHEA; BODYACHE AND LITTLE SHARP PAINS EVERYWHERE; SWOLLEN LYMPH NODES; BLURRY VISION; LETHARGIC; STOMACH CRAMPS; SWEATS; VOMITING; STOMACH DISCOMFORT; This spontaneous report received from a patient concerned a 48 year old female of unspecified ethnic origin. The patient's weight was 195 pounds and height was 70 inches. The patient's past medical history included Covid-19 (DEC-2020) and concurrent conditions included Hashimoto's disease, thyroid disease, blood pressure, leukocytosis, celiac disease, anemia, and auto immune disease. She had loss of smell, loss of taste since last 6 months. Patient was non alcohol user and non smoker. She was on a gluten free diet. The patient experienced drug allergy when treated with Dilaudid and Neomycin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A and expiry: 23-JUN-2021) dose was not reported, 1 total dose administered on 10-JUN-2021 at 15:15 to right arm for prophylactic vaccination. Concomitant medications included Synthroid (levothyroxine sodium), hydrochlorothiazide and Claritin D (Loratadine/pseudoephedrine sulfate). On 12-JUN-2021, the patient experienced neuropathy, diarrhea, body ache, little sharp pains everywhere, swollen lymph nodes, blurry vision, lethargy/ tiredness, stomach cramps, sweats, vomiting, arm ache, nausea and headache. On 13-JUN-2021, the patient experienced joint pain. On JUN-2021, the patient experienced stomach discomfort and fatigue. On 14-JUN-2021 patient reported that she had to call off work and she did not have fever. She had not seen her doctor yet but would call the doctor. Treatment medications (dates unspecified) included: Aspirin (acetylsalicylic acid), Tylenol (paracetamol) and Ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neuropathy on JUN-2021, was recovering from nausea, and vomiting, had not recovered from diarrhea, bodyache and little sharp pains everywhere, arm ache, headache, swollen lymph nodes, blurry vision, lethargic, stomach cramps, sweats, joint pain, stomach discomfort, and fatigue/ tiredness, and the outcome of call off work was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210629819-  JANSSEN COVID-19 VACCINE Ad26.COV2.S- Neuropathy. 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.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Impaired work ability, Lethargy, Lymphadenopathy
Clinical narrative: CALL OFF WORK; JOINT PAIN; NAUSEA; HEADACHE; FATIGUE/ TIREDNESS; ARM ACHE; NEUROPATHY; DIARRHEA; BODYACHE AND LITTLE SHARP PAINS EVERYWHERE; SWOLLEN LYMPH NODES; BLURRY VISION; LETHARGIC; STOMACH CRAMPS; SWEATS; VOMITING; STOMACH DISCOMFORT; This spontaneous report received from a patient concerned a 48 year old female of unspecified ethnic origin. The patient's weight was 195 pounds and height was 70 inches. The patient's past medical history included Covid-19 (DEC-2020) and concurrent conditions included Hashimoto's disease, thyroid disease, blood pressure, leukocytosis, celiac disease, anemia, and auto immune disease. She had loss of smell, loss of taste since last 6 months. Patient was non alcohol user and non smoker. She was on a gluten free diet. The patient experienced drug allergy when treated with Dilaudid and Neomycin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A and expiry: 23-JUN-2021) dose was not reported, 1 total dose administered on 10-JUN-2021 at 15:15 to right arm for prophylactic vaccination. Concomitant medications included Synthroid (levothyroxine sodium), hydrochlorothiazide and Claritin D (Loratadine/pseudoephedrine sulfate). On 12-JUN-2021, the patient experienced neuropathy, diarrhea, body ache, little sharp pains everywhere, swollen lymph nodes, blurry vision, lethargy/ tiredness, stomach cramps, sweats, vomiting, arm ache, nausea and headache. On 13-JUN-2021, the patient experienced joint pain. On JUN-2021, the patient experienced stomach discomfort and fatigue. On 14-JUN-2021 patient reported that she had to call off work and she did not have fever. She had not seen her doctor yet but would call the doctor. Treatment medications (dates unspecified) included: Aspirin (acetylsalicylic acid), Tylenol (paracetamol) and Ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neuropathy on JUN-2021, was recovering from nausea, and vomiting, had not recovered from diarrhea, bodyache and little sharp pains everywhere, arm ache, headache, swollen lymph nodes, blurry vision, lethargic, stomach cramps, sweats, joint pain, stomach discomfort, and fatigue/ tiredness, and the outcome of call off work was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210629819-  JANSSEN COVID-19 VACCINE Ad26.COV2.S- Neuropathy. 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.