chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Itchy welts; 4-5 Welts; welts warm to touch; Swollen welts; Red welts in arm; Arm soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th October 2021, the patient received the 1st dose of Shingrix. On 15th October 2021, less than a day after receiving Shingrix, the patient experienced injection site pain. On 16th October 2021, the patient experienced welts, skin warm, swelling and erythema. On 17th October 2021, the patient experienced pruritus. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the welts, skin warm, erythema and pruritus were not recovered/not resolved and the outcome of the swelling was recovering/resolving.   It was unknown if the reporter considered the injection site pain, welts, skin warm, swelling, erythema and pruritus to be related to Shingrix.   Additional details were reported as follows: The case was reported by the patient. Age at vaccination was not reported. The patient reported receiving 1st dose of Shingrix and experienced arm soreness (at the injection site) in the left arm on the same day.  The patient reported 4/5 welts formed on Saturday from the day of reporting approximately 3 inches below the injection site.  The patient said welts were approximately 6 by 4 inches in size, warm to the touch, swollen, itchy, and red.  The swelling seems to had decreased, but there has been no change in the other characteristics of the welts.  The itching did not begin until Sunday from the day of reporting.  All symptoms were approximately 3 inches below, not at, the injection site.  The only symptom experienced at injection site was soreness.  Redness from the welts had spread down the upper portion of the arm and into the inner arm. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Urticaria
Clinical narrative: Itchy welts; 4-5 Welts; welts warm to touch; Swollen welts; Red welts in arm; Arm soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th October 2021, the patient received the 1st dose of Shingrix. On 15th October 2021, less than a day after receiving Shingrix, the patient experienced injection site pain. On 16th October 2021, the patient experienced welts, skin warm, swelling and erythema. On 17th October 2021, the patient experienced pruritus. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the welts, skin warm, erythema and pruritus were not recovered/not resolved and the outcome of the swelling was recovering/resolving.   It was unknown if the reporter considered the injection site pain, welts, skin warm, swelling, erythema and pruritus to be related to Shingrix.   Additional details were reported as follows: The case was reported by the patient. Age at vaccination was not reported. The patient reported receiving 1st dose of Shingrix and experienced arm soreness (at the injection site) in the left arm on the same day.  The patient reported 4/5 welts formed on Saturday from the day of reporting approximately 3 inches below the injection site.  The patient said welts were approximately 6 by 4 inches in size, warm to the touch, swollen, itchy, and red.  The swelling seems to had decreased, but there has been no change in the other characteristics of the welts.  The itching did not begin until Sunday from the day of reporting.  All symptoms were approximately 3 inches below, not at, the injection site.  The only symptom experienced at injection site was soreness.  Redness from the welts had spread down the upper portion of the arm and into the inner arm. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Lacrimation increased
Clinical narrative: eyes were watering / patient's eyes really watered the pillow; Watering was a burning sensation; This case was reported by a pharmacist via call center representative and described the occurrence of watering eyes in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 2232K, expiry date 13th November 2022) for prophylaxis.   On 23rd July 2021, the patient received the 1st dose of Shingrix. On 23rd July 2021, 1 hr after receiving Shingrix, the patient experienced watering eyes and burning sensation. On an unknown date, the outcome of the watering eyes was unknown and the outcome of the burning sensation was recovered/resolved.   It was unknown if the reporter considered the watering eyes and burning sensation to be related to Shingrix.  Additional details were reported as follows: The pharmacist called and inquired if this reaction occurred, any efficacy or immunity of 1st dose if patient did not get the 2nd dose of Shingrix. The pharmacist reported that patient received the 1st dose of Shingrix and an hour after the patient's eyes were watering. Then later on the patient's eyes really watered the pillow and completely soaked it.  Watering was a burning sensation, it resolved on its own after 2/3 days later. A couple of weeks later the patient went to the eye doctor and doctor reported no damage to the eyes. Patient was scheduled for 2nd dose this Friday on 22nd October 2021. The reporter consented to follow up.
Age: 0.17
Sex: F
Vaccine: HIBV, RV1
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: wrong diluent used for the reconstitution of Hiberix and Rotarix; wrong diluent used for the reconstitution of Hiberix and Rotarix; Rotarix vaccine was injected and Hiberix was given orally.; Vaccine Administered at Inappropriate site/ Hiberix given orally; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number NK245, expiry date 27th June 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis and Hib (Hiberix) (batch number PJ7ER, expiry date 13th November 2022) for prophylaxis.   On 18th October 2021, the patient received Rotarix lyophilized formulation, Rotarix Oral Applicator Device and Hiberix (oral). On 18th October 2021, unknown after receiving Rotarix lyophilized formulation, Rotarix Oral Applicator Device and Hiberix, the patient experienced wrong solution used in drug reconstitution, inappropriate dose of vaccine administered, inappropriate route of vaccination and intramuscular formulation administered by other route. On an unknown date, the outcome of the wrong solution used in drug reconstitution, inappropriate dose of vaccine administered, inappropriate route of vaccination and intramuscular formulation administered by other route were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter called from medical facility to report that a Medical assistant at the facility used the diluent for the Rotarix vaccine to reconstitute the Hiberix vaccine and the diluent for the Hiberix vaccine was used to reconstitute the Rotarix vaccine, which led to wrong solution used in drug reconstitution, inappropriate dose of vaccine administered for both the vaccines. Then the Rotarix vaccine was injected and the Hiberix vaccine was given orally, which led to inappropriate route of vaccination and intramuscular formulation administered by other route respectively. The patient did not experience any adverse effects. The reporter asked for recommendations on what she should do. The reporter consented to follow up.
Age: 26.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: DOB Nov 9th 1994, received a Kinrix dose; Kinrix instead of Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 26-year-old female patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th October 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 19th October 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong 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 as follows: The patient received a Kinrix dose by mistake, which led to inappropriate age at vaccine administration and wrong vaccine administered. The patient went t facility to be administered with Boostrix. The reporter consented to follow up.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Malaise, Paraesthesia oral, Throat irritation
Clinical narrative: Mild malaise.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Tachycardia
Clinical narrative: chills                                                                  onset:   10 hours after injection,  lasting  9 hours tachycardia            hr to 120s                onset:   11 hours after injection, persisting overnight  (approx  8 hours) soreness at/around injection              onset:   day 1 after injection, persisting  2 days
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Hyperhidrosis, Myalgia, Perineal pain
Clinical narrative: About 12 hours after receipt of vaccine, developed chills, diaphoresis, diffuse myalgias, diffuse arthralgias About 34 hours after receipt of vaccine, developed achy testicular pain and what can best be described as achy deep perineal pain, where i would imagine my prostate is located.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Testicular pain
Clinical narrative: About 12 hours after receipt of vaccine, developed chills, diaphoresis, diffuse myalgias, diffuse arthralgias About 34 hours after receipt of vaccine, developed achy testicular pain and what can best be described as achy deep perineal pain, where i would imagine my prostate is located.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: received Kinrix when was 2 YO; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number 75F53, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th April 2018, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 16th April 2018, 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 patient was 5 years old at the time of reporting. The patient younger than indicated age, received a dose of Kinrix at 2 years, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Did not return to receive the second dose; 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 male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 8th May 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received first Shingrix dose, however did not return within the recommended time frame to receive the second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient did not receive the 1st dose of Shingrix at the pharmacy, so lot number, expiration date, and site of injection was unknown. The reporter consented to follow up. This case has been linked to US2021216652, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021216652:Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Did not return to receive 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 8th May 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received first Shingrix dose, however did not return within the recommended time frame to receive the second dose. till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The patient did not receive the 1st dose of Shingrix at the pharmacy, so lot number, expiration date, and site of injection is unknown. The reporter consented to follow up. This case has been linked to US2021216650, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021216650:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: vials were not refrigerated; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug 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 incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The patient received Shingrix adjuvant and antigen vials from another pharmacy. The reporter stated that, vials were not refrigerated by patient before patient brought vials to her for administration, which led to incorrect storage of drug. The reporter inquired about vaccine stability and if still okay to reconstitute and administer vaccine. No additional details were provided by the reporter. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Dizziness; Arm Pain; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a female 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 dizziness and pain in arm. On an unknown date, the outcome of the dizziness and pain in arm were unknown.   It was unknown if the reporter considered the dizziness and pain in arm to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient's brother. The age at vaccination was not reported. The patient experienced dizziness and arm pain. The reporter declined to give further information and demographic information for the patient. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021216665:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received 3rd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient might have inadvertently received a 3rd dose of Shingrix, which led to extra dose administered. The reporter consented to follow up.
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: expired vaccines; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA396A, expiry date 31st August 2021) for prophylaxis.   On 15th September 2021, the patient received Menveo. On 15th September 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. On 15th September 2021, the patient received Menveo which was already expired on 31st August 2021. The reporter was looking to see if there was any information on expired vaccines. The reporter did not have patient's date of birth as he/she was not at work and did not know it and gender were female. The reporter consented to follow up via email.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: 3rd dose administered; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number PM35L, expiry date 4th February 2023) for prophylaxis.   On 19th October 2021, the patient received the 3rd dose of Shingrix. On 19th October 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient received a 3rd dose of Shingrix, which led to extra dose administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of the Shingrix vaccine in 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 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, the patient did not receive 2nd dose of Shingrix, wich led to incomplete course of vaccination. The reporter consented to follow up. This case was linked with case US2021218230, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021218230:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Since Sep2019, did not return for 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 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, the patient did not return within the recommended time frame to receive the second dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia
Clinical narrative: Patient got Covid-19 pneumonia two weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (Patient got Covid-19 pneumonia two weeks ago) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 7006 3200 03 and 7006 3200 03) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Sep-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Sep-2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced COVID-19 PNEUMONIA (Patient got Covid-19 pneumonia two weeks ago) (seriousness criterion medically significant). At the time of the report, COVID-19 PNEUMONIA (Patient got Covid-19 pneumonia two weeks ago) outcome was unknown.            Concomitant products were not provided. Treatment medication were not reported. The caller was a clinical trial participant from the Phase 3 of the Moderna Clinical trials. The patient received his first Moderna Covid-19 vaccine. No adverse events reported. The patient received his second Moderna Covid-19 vaccine. No adverse events reported. The patient got Covid-19  Pneumonia two weeks ago (as reported). The patient received his second Moderna Covid-19 vaccine on  30SEP2020  lot number 7006 3200 03  No Adverse Events reported  Patient provides   permission for Safety to contact him. Patient prefers to be contacted via telephone. The patient got Covid-19  Pneumonia 2 weeks ago.  Company comment: This case concerns a 64-year-old male patient with no reported relevant medical history, who experienced the unexpected serious AESI event of COVID-19 pneumonia. The event occurred on unknown date in 2021 after the second dose of Moderna COVID-19 Vaccine administered on 30-SEP-2020. The rechallenge was not applicable since no events were reported after the first dose and no additional dosing was expected. The benefit-risk relationship is not affected by this report. Additional information has been requested.; Sender's Comments: This case concerns a 64-year-old male patient with no reported relevant medical history, who experienced the unexpected serious AESI event of COVID-19 pneumonia. The event occurred on unknown date in 2021 after the second dose of Moderna COVID-19 Vaccine administered on 30-SEP-2020. The rechallenge was not applicable since no events were reported after the first dose and no additional dosing was expected. The benefit-risk relationship is not affected by this report. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Delirium, Exposure during pregnancy, Fatigue
Clinical narrative: JOINT PAIN; FEVER; HEADACHE; NAUSEA; DELIRIOUS; MATERNAL EXPOSURE DURING PREGNANCY; CHILLS; SORE ARM; FEELING UNWELL; FATIGUE; This solicited pregnancy report received from a consumer concerned a 19 year old female. The patient was enrolled in a non-company sponsored study. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. It was not reported whether the patient had been pregnant before and pregnancy was still ongoing. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on 17-JUN-2021 for covid-19 immunisation. 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 JUN-2021, the patient was pregnant when she had vaccine. The date of the patient's last menstrual period was on  04-JUN-2021 and expected delivery date was on 11-MAR-2022. Gestational age was 1 week and 6 days. On 17-JUN-2021 the patient experienced delirious, maternal exposure during pregnancy, chills, sore arm, feeling unwell, fatigue and nausea, she saw things that were not there or did not happen and even got sent home for work as she was slower and was unable to fully use her brain. She stayed in bed for several days, exhausted, feeling gross and being sent home from work with a fever and unable to fully think clearly. On 18-JUN-2021, the patient experienced fever and headache. On 20-JUN-2021, the patient experienced joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from delirious, and fatigue on 21-JUN-2021, joint pain, and fever on 22-JUN-2021, chills on 20-JUN-2021, sore arm on 19-JUN-2021, feeling unwell on 28-JUN-2021, and headache, and nausea on 24-JUN-2021, and the outcome of maternal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and delirious, joint pain, chills, sore arm, feeling unwell, fatigue, fever, headache, and nausea was related, and between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related.   This report was serious (Disability Or Permanent Damage).; Sender's Comments: V0: 20211040520-COVID-19 VACCINE AD26.COV2.S-delirious. This event(s) is considered related. 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: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea, Pain in extremity, Pyrexia
Clinical narrative: JOINT PAIN; FEVER; HEADACHE; NAUSEA; DELIRIOUS; MATERNAL EXPOSURE DURING PREGNANCY; CHILLS; SORE ARM; FEELING UNWELL; FATIGUE; This solicited pregnancy report received from a consumer concerned a 19 year old female. The patient was enrolled in a non-company sponsored study. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. It was not reported whether the patient had been pregnant before and pregnancy was still ongoing. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on 17-JUN-2021 for covid-19 immunisation. 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 JUN-2021, the patient was pregnant when she had vaccine. The date of the patient's last menstrual period was on  04-JUN-2021 and expected delivery date was on 11-MAR-2022. Gestational age was 1 week and 6 days. On 17-JUN-2021 the patient experienced delirious, maternal exposure during pregnancy, chills, sore arm, feeling unwell, fatigue and nausea, she saw things that were not there or did not happen and even got sent home for work as she was slower and was unable to fully use her brain. She stayed in bed for several days, exhausted, feeling gross and being sent home from work with a fever and unable to fully think clearly. On 18-JUN-2021, the patient experienced fever and headache. On 20-JUN-2021, the patient experienced joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from delirious, and fatigue on 21-JUN-2021, joint pain, and fever on 22-JUN-2021, chills on 20-JUN-2021, sore arm on 19-JUN-2021, feeling unwell on 28-JUN-2021, and headache, and nausea on 24-JUN-2021, and the outcome of maternal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and delirious, joint pain, chills, sore arm, feeling unwell, fatigue, fever, headache, and nausea was related, and between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related.   This report was serious (Disability Or Permanent Damage).; Sender's Comments: V0: 20211040520-COVID-19 VACCINE AD26.COV2.S-delirious. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative via social media concerned more than 88 patients of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patients received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and expiry date: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, it was reported that "88 +people have died from your fault vaccine!!!" It was unknown if an autopsy was performed or not.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211034004- COVID-19 VACCINE AD26.COV2.S- Death. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis, Pericarditis
Clinical narrative: PERICARDITIS; MYOCARDITIS; This spontaneous report received from a patient via a company representative 161 patients of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch numbers: unknown, Expiry: unknown) dose, start therapy date were not reported 1 total for prophylactic vaccination. The batch numbers were not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patients experienced pericarditis, and myocarditis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pericarditis and myocarditis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20211035322- covid-19 vaccine ad26.cov2.s Myocarditis, Pericarditis. 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: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer and 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, and batch number: 207A21A expiry: UNKNOWN) dose, start therapy date were not reported, with frequency time 1 total for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient was transmitted to displaced specialty unit (DSU) for Covid-19 infection after receiving the vaccine. The patient's Covid-19 infection resulted in suspected clinical vaccination failure. He was not doing good. On an unspecified date, the patient was hospitalized. Number of days hospitalized and discharged date were not provided. They wanted to know if the patient could take Pfizer Covid vaccine series. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the event of suspected Covid-19 infection and suspected clinical vaccination failure not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000198444.; Sender's Comments: V0: 20211037891-Covid-19 vaccine ad26.cov2.s-suspected Covid-19 infection. 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). 20211037891-Covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Intentional product misuse, Joint range of motion decreased, Musculoskeletal stiffness, Pain
Clinical narrative: ACHE; STIFFNESS\UNABLE TO STRAIGHTEN BOTH ELBOW; SWELLING; JOINT RANGE OF MOTION DECREASED; PAIN IN HAND; ARTHRITIC PAINS/JOINT PAIN/PAIN IN WRIST; SUSPECTED COVID-19; INTENTIONAL MISUSE IN PRODUCT USE DURATION; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, administered on 28-JUL-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: upadacitinib (form of admin unknown, oral, batch number was not reported) dose and frequency were not reported from an unspecified date to 26-JUL-2021, dose and frequency were not reported from 03-AUG-2021 to AUG-2021, and dose and frequency were not reported from 10-AUG-2021 for moderate to severe rheumatoid arthritis. Concomitant medications included methotrexate, and prednisone.  On JUL-2021, the patient experienced intentional misuse in product use duration. On 01-AUG-2021, the patient experienced suspected covid-19. On 21-AUG-2021, the patient experienced stiffness\unable to straighten both elbow. On 21-AUG-2021, the patient experienced swelling. On 21-AUG-2021, the patient experienced joint range of motion decreased. On 21-AUG-2021, the patient experienced pain in hand. On 21-AUG-2021, the patient experienced arthritic pains/joint pain/pain in wrist. On an unspecified date, the patient experienced ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with upadacitinib was withdrawn on AUG-2021. The patient was recovering from suspected covid-19, had not recovered from ache, stiffness\unable to straighten both elbow, swelling, pain in hand, joint range of motion decreased, and arthritic pains/joint pain/pain in wrist, and the outcome of intentional misuse in product use duration was not reported. 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: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity, Suspected COVID-19, Swelling
Clinical narrative: ACHE; STIFFNESS\UNABLE TO STRAIGHTEN BOTH ELBOW; SWELLING; JOINT RANGE OF MOTION DECREASED; PAIN IN HAND; ARTHRITIC PAINS/JOINT PAIN/PAIN IN WRIST; SUSPECTED COVID-19; INTENTIONAL MISUSE IN PRODUCT USE DURATION; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, administered on 28-JUL-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: upadacitinib (form of admin unknown, oral, batch number was not reported) dose and frequency were not reported from an unspecified date to 26-JUL-2021, dose and frequency were not reported from 03-AUG-2021 to AUG-2021, and dose and frequency were not reported from 10-AUG-2021 for moderate to severe rheumatoid arthritis. Concomitant medications included methotrexate, and prednisone.  On JUL-2021, the patient experienced intentional misuse in product use duration. On 01-AUG-2021, the patient experienced suspected covid-19. On 21-AUG-2021, the patient experienced stiffness\unable to straighten both elbow. On 21-AUG-2021, the patient experienced swelling. On 21-AUG-2021, the patient experienced joint range of motion decreased. On 21-AUG-2021, the patient experienced pain in hand. On 21-AUG-2021, the patient experienced arthritic pains/joint pain/pain in wrist. On an unspecified date, the patient experienced ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with upadacitinib was withdrawn on AUG-2021. The patient was recovering from suspected covid-19, had not recovered from ache, stiffness\unable to straighten both elbow, swelling, pain in hand, joint range of motion decreased, and arthritic pains/joint pain/pain in wrist, and the outcome of intentional misuse in product use duration was not reported. This report was non-serious.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: NASTY SIDE EFFECTS; 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 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 nasty side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of nasty side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20211039531.
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Blood test, Culture stool, Diarrhoea, Hepatic enzyme increased
Clinical narrative: ISSUES WITH PANCREAS; ISSUES WITH LIVER; ISSUES WITH KIDNEY; ITCHING; ELEVATED LIVER ENZYMES; PANCREATIC DEFICIENCY; DIARRHEA (AT ONE POINT WAS NOT ABLE TO LEAVE THE HOUSE BECAUSE OF THE DIARRHEA); This spontaneous report received from a patient via a company representative concerned an 80 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sensitive to all medications, and gout, and other pre-existing medical conditions included: The patient was on medication for gout, but that has been stopped. The patient doctors advised not to take the booster. 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 03-MAY-2021 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 issues with pancreas, issues with liver, issues with kidney, itching, elevated liver enzymes, pancreatic deficiency, and diarrhea ( at one point was not able to leave the house because of the diarrhea). Laboratory data (dates unspecified) included: Allergy test (NR: not provided) Not Reported, Negative, Blood test (NR: not provided) Elevated liver enzymes, Lab test (NR: not provided) No positive results, and Stool culture (NR: not provided) No positive results. Treatment medications (dates unspecified) included: pancreatin, prednisone, and colestipol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated liver enzymes, and pancreatic deficiency, was recovering from diarrhea ( at one point was not able to leave the house because of the diarrhea), and itching, and the outcome of issues with pancreas, issues with liver and issues with kidney was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Liver disorder, Pancreatic disorder, Pancreatic enzyme abnormality, Pruritus
Clinical narrative: ISSUES WITH PANCREAS; ISSUES WITH LIVER; ISSUES WITH KIDNEY; ITCHING; ELEVATED LIVER ENZYMES; PANCREATIC DEFICIENCY; DIARRHEA (AT ONE POINT WAS NOT ABLE TO LEAVE THE HOUSE BECAUSE OF THE DIARRHEA); This spontaneous report received from a patient via a company representative concerned an 80 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sensitive to all medications, and gout, and other pre-existing medical conditions included: The patient was on medication for gout, but that has been stopped. The patient doctors advised not to take the booster. 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 03-MAY-2021 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 issues with pancreas, issues with liver, issues with kidney, itching, elevated liver enzymes, pancreatic deficiency, and diarrhea ( at one point was not able to leave the house because of the diarrhea). Laboratory data (dates unspecified) included: Allergy test (NR: not provided) Not Reported, Negative, Blood test (NR: not provided) Elevated liver enzymes, Lab test (NR: not provided) No positive results, and Stool culture (NR: not provided) No positive results. Treatment medications (dates unspecified) included: pancreatin, prednisone, and colestipol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated liver enzymes, and pancreatic deficiency, was recovering from diarrhea ( at one point was not able to leave the house because of the diarrhea), and itching, and the outcome of issues with pancreas, issues with liver and issues with kidney was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Renal disorder
Clinical narrative: ISSUES WITH PANCREAS; ISSUES WITH LIVER; ISSUES WITH KIDNEY; ITCHING; ELEVATED LIVER ENZYMES; PANCREATIC DEFICIENCY; DIARRHEA (AT ONE POINT WAS NOT ABLE TO LEAVE THE HOUSE BECAUSE OF THE DIARRHEA); This spontaneous report received from a patient via a company representative concerned an 80 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sensitive to all medications, and gout, and other pre-existing medical conditions included: The patient was on medication for gout, but that has been stopped. The patient doctors advised not to take the booster. 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 03-MAY-2021 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 issues with pancreas, issues with liver, issues with kidney, itching, elevated liver enzymes, pancreatic deficiency, and diarrhea ( at one point was not able to leave the house because of the diarrhea). Laboratory data (dates unspecified) included: Allergy test (NR: not provided) Not Reported, Negative, Blood test (NR: not provided) Elevated liver enzymes, Lab test (NR: not provided) No positive results, and Stool culture (NR: not provided) No positive results. Treatment medications (dates unspecified) included: pancreatin, prednisone, and colestipol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated liver enzymes, and pancreatic deficiency, was recovering from diarrhea ( at one point was not able to leave the house because of the diarrhea), and itching, and the outcome of issues with pancreas, issues with liver and issues with kidney was not reported. This report was non-serious.