chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Biopsy, Computerised tomogram abnormal, Condition aggravated, Hernia
Clinical narrative: small hernia; extremely enlarged fibroids in uterus, biopsy non-cancerous; horrible pelvic/abdominal pain, emergency CT scan; horrible pelvic/abdominal pain, emergency CT scan; small rash on lower arm; Shingrix seemed to wake-up the fibroids,  surgery scheduled 18Aug2022; This case was reported by a consumer via call center representative and described the occurrence of hernia in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included uterine fibroids.   On 10th May 2022, the patient received the 1st dose of Shingrix (intramuscular). On 13th May 2022, 3 days after receiving Shingrix, the patient experienced hernia, uterine fibroid, pelvic pain, abdominal pain, rash and condition aggravated. The patient was treated with baclofen. On an unknown date, the outcome of the hernia, uterine fibroid, pelvic pain, abdominal pain and condition aggravated were not recovered/not resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the hernia, uterine fibroid, pelvic pain, abdominal pain, rash and condition aggravated to be related to Shingrix.     Additional Information: GSK receipt date: 03-Aug-2022 Reporter's comment: The patient reported she experienced side effects after receiving her first Shingrix vaccine, in the right arm. On 13th May 2022, 3 days after the Shingrix vaccine she experienced horrible pelvic and abdominal pain on her right side and a small rash on her lower right arm. The reporter reports the pain subsided after a few days. (She did not mention the rash). On 23rd May 2022, the pelvic and abdominal pain came back, and the doctor taken urine sample and started her on Baclofen, which helped. On 5th July 2022, her daughter had to drive her to the doctor because of the abdominal and pelvic pain and she was sent for an emergency CT scan. The scan showed a small hernia and extremely enlarged fibroids in her uterus. On 12th July 2022, her gynecologist did a fibroid biopsy which cam back non-cancerous. On 18th August 2022, she scheduled for surgery to remove the fibroids. The reporter states she was fine until she had the Shingrix vaccine, It seemed to wake-up the fibroids. The reporter reports she knew she had uterine fibroids before she received the Shingrix vaccine but never had a problem or pain. The reporter did not consent to follow-up. Additional supportive information: On 5th July 2022, the patient experienced hernia, uterine fibroid and condition aggravated. However, the onset date was captured as 13th May 2022 as per the sign and symptoms.
Sex: F
Vaccine: VARZOS
Symptoms: Pelvic pain, Rash, Urine analysis, Uterine leiomyoma
Clinical narrative: small hernia; extremely enlarged fibroids in uterus, biopsy non-cancerous; horrible pelvic/abdominal pain, emergency CT scan; horrible pelvic/abdominal pain, emergency CT scan; small rash on lower arm; Shingrix seemed to wake-up the fibroids,  surgery scheduled 18Aug2022; This case was reported by a consumer via call center representative and described the occurrence of hernia in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included uterine fibroids.   On 10th May 2022, the patient received the 1st dose of Shingrix (intramuscular). On 13th May 2022, 3 days after receiving Shingrix, the patient experienced hernia, uterine fibroid, pelvic pain, abdominal pain, rash and condition aggravated. The patient was treated with baclofen. On an unknown date, the outcome of the hernia, uterine fibroid, pelvic pain, abdominal pain and condition aggravated were not recovered/not resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the hernia, uterine fibroid, pelvic pain, abdominal pain, rash and condition aggravated to be related to Shingrix.     Additional Information: GSK receipt date: 03-Aug-2022 Reporter's comment: The patient reported she experienced side effects after receiving her first Shingrix vaccine, in the right arm. On 13th May 2022, 3 days after the Shingrix vaccine she experienced horrible pelvic and abdominal pain on her right side and a small rash on her lower right arm. The reporter reports the pain subsided after a few days. (She did not mention the rash). On 23rd May 2022, the pelvic and abdominal pain came back, and the doctor taken urine sample and started her on Baclofen, which helped. On 5th July 2022, her daughter had to drive her to the doctor because of the abdominal and pelvic pain and she was sent for an emergency CT scan. The scan showed a small hernia and extremely enlarged fibroids in her uterus. On 12th July 2022, her gynecologist did a fibroid biopsy which cam back non-cancerous. On 18th August 2022, she scheduled for surgery to remove the fibroids. The reporter states she was fine until she had the Shingrix vaccine, It seemed to wake-up the fibroids. The reporter reports she knew she had uterine fibroids before she received the Shingrix vaccine but never had a problem or pain. The reporter did not consent to follow-up. Additional supportive information: On 5th July 2022, the patient experienced hernia, uterine fibroid and condition aggravated. However, the onset date was captured as 13th May 2022 as per the sign and symptoms.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired Menveo administered; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA467A, expiry date 31st March 2022) for prophylaxis.   On 28th July 2022, the patient received Menveo. On 28th July 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 03-AUG-2022 Reporter's Comment: The patient was administered with expired dose of Menveo . The reporter gave consent for safety team follow up. Additional Supportive Information: The patient was administered with expired dose of Menveo, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: dosing outside of 2-6 month window/ late for 2nd dose; This case was reported by a other health professional via sales rep 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 on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 3-Aug-2022. Reporter's Comments:  Healthcare professional inquired about dosing outside of 2 to 6 months window for the patient who was late for 2nd Shingrix dose. The consent to follow up was granted. No additional information available. Unknown if follow up was permissible. Additional Supportive Information: At the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: administrated with only the diluent; administrated with only the diluent; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amaa64oz, expiry date 30th November 2022) for prophylaxis.   On 2nd August 2022, the patient received Menveo. On 2nd August 2022, unknown after receiving Menveo, 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 Information: GSK Receipt Date: 4-Aug-2022 Reporter's comment: The patient was administrated with only the diluent of Menveo.  No adverse event was reported  The reporter consented to follow up. Consent to follow up by fax or phone Lot number provided was from the powder component. Additional Supportive Information: The patient received a dose of only the diluent portion of Menveo which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Pain in extremity, Pruritus, Rash macular, Swelling
Clinical narrative: eruption of red, swollen itchy spots; eruption of red, swollen itchy spots; eruption of red, swollen itchy spots; Nerve pain in right arm; This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes viral infection nos. Previously administered products included Shingles vaccine (Received years ago, went about 5 years of no recurrence or outbreak) and Shingrix (1st dose received in September 2021).   In February 2022, the patient received the 2nd dose of Shingrix. In March 2022, 1 month after receiving Shingrix, the patient experienced nerve pain. On an unknown date, the patient experienced red spotty rash, itchy and swelling. On an unknown date, the outcome of the nerve pain, red spotty rash, itchy and swelling were unknown.   It was unknown if the reporter considered the nerve pain, red spotty rash, itchy and swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-Aug-2022 Reporter's comment: One month later after receiving Shingrix, the patient experienced nerve pain in right arm, 2 months later eruption of red, swollen itchy spots. The patient was referred to healthcare professional. The consent to follow up was given.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Havrix expired dose administered; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number unknown, expiry date 17th June 2022) for prophylaxis.   On 4th August 2022, the patient received the 1st dose of Havrix. On 4th August 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date:04-Aug-2022 Reporter comment: A physician administered a expired dose of Havrix as a first dose. The reporter consented to follow up. Additional Supportive Information: The patient was administered an expired dose of Havrix, which led to expired vaccine used.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Dose administered after expiration date; 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 Men B NVS (Bexsero) (batch number unknown, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   In August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. In August 2022, unknown after receiving Bexsero and Bexsero 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 Information: GSK Receipt Date: 04-Aug-2022 Reporter's Comments: The reporter stated that a dose of Bexsero was administered after the expiration date. Permission was not provided to store the patients contact information. No other information was provided as the reporter was disconnected when put on hold. Additional Supportive Information: The patient received a dose of Bexsero after the expiration date, which led to expired vaccine used.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient received Pediarix instead of Kinrix; Patient had had 3 HepB doses before this Pediarix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 4977T, expiry date 5th September 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Hepatitis b vaccine (birth dose of hepatitis B vaccine and two other doses (undetermined brand)).   On 29th July 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 29th July 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered and extra dose 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.   Linked case(s) involving the same patient:  US2022115411   Additional Information: GSK Receipt Date: 04-AUG-2022.  Reporter's Comments: The nurse reported a 4 years patient received a dose of Pediarix instead of a Kinrix.  This patient had a birth dose of hepatitis B vaccine and two other doses (undetermined brand) before this Pediarix. The consent to follow up was granted. Additional Supportive Information: As patient received a dose of Pediarix instead of a Kinrix, which led to wrong vaccine administered. As per schedule patient already had 3 doses of hepatitis B vaccine and patient received Pediarix having antigen as hepatitis B, which led to extra dose administered.
Age: 8.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 8.6 yo patient received Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old female patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) 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 Dtap vaccine (4th dose received in 2015) and OPV vaccine (health care professional reported that in the past patient received Oral polio vaccine (OPV)).   On 4th August 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 4th August 2022, 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 Information: GSK Receipt Date: 05-AUG-2022 Reporter's Comment: The reporter was a nurse. The reporter stated that patient was 8 years and 6 months old, patient received Kinrix vaccine. The patient received Kinrix vaccine as 5th dose of Dtap  The health care professional was escalated to 2nd line specialist, reported that Kinrix was patient 4th dose of polio. The reporter consented to follow up. Additional supportive information: The patient received Kinirix who was older than the indicated age which led to inappropriate age at vaccine administration.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Patient got BEXSERO instead of MENVEO; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received Men B NVS (Bexsero) (batch number ABXC08AA, expiry date 31st March 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th July 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 29th July 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered 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 Information: GSK Receipt Date: 05-AUG-2022 Reporter's Comment: The reporter reported that by mistake the patient received Bexsero vaccine instead of Menveo vaccine. The reporter consented to follow up. Additional Supportive Information: The reporter reported that, mistakenly administered Bexsero instead of Menveo, which led to wrong vaccine administered.
Sex: F
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: Havrix administered instead of Engerix-B; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 21-year-old female patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 10th January 2022, the patient received Havrix. On 10th January 2022, unknown after receiving Havrix, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 04-AUG-2022 Reporter's comments: The patient was accidently given Engerix-B instead of Havrix. The reporter consented to follow-up via email. Additional supportive information: The patient was given Engerix-B instead of Havrix which led to wrong vaccine administered. As per the mail confirmation attached the correct suspected product information was Havrix administered instead of Engerix-B.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles/Suspected Vaccination Failure; shingles; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 05-Aug-2022 Reporter's Comments: The reporter stated that the patient had shingles after receiving both doses of the Shingrix vaccine. The reporter enquired if the patient could receive a third dose. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered to a 1 yr, 11 mo old; Kinrix administered, supposed to receive Dtap and Polio; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th August 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 4th August 2022, 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 Information: GSK Receipt Date: 5-Aug-2022 Reporter's comment: The patient inadvertently received a dose of Kinrix at an age of 1 year 11 months. The patient was supposed to receive separate doses of Dtap and Polio.  The reporter consented to follow up via postal. Additional supportive information: A 1 year 11 months old patient received a dose of Kinrix instead of Dtap and polio vaccine, which led to inappropriate age at vaccine administration and wrong vaccine administered.
Age: 1.83
Sex: U
Vaccine: HEPA
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: adult dose administered to 22 month old; adult dose administered to 22 month old; This case was reported by a pharmacist via call center representative and described the occurrence of adult product administered to child in a 22-month-old patient who received HAV (Havrix adult) for prophylaxis.   On 5th August 2022, the patient received Havrix adult 1 ml. On 5th August 2022, unknown after receiving Havrix adult, the patient experienced adult product administered to child and accidental overdose. On an unknown date, the outcome of the adult product administered to child and accidental overdose were unknown.     Additional Information: GSK Receipt Date: 5-Aug-2022 Reporter's comment: The health care professional reported that 1ml of havrix adult dose was administered instead of 0.5 ml to a 22 month old child. No other information available. The reporter consented to follow up. Additional supportive information: A 22 month old patient received a dose of Havrix adult dose of 1ml instead of 0.5 ml, which led to accidental overdose and adult product administered to child.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Shingrix only adjuvant; received only the adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number H755H, expiry date 9th June 2023) for prophylaxis.   On 5th August 2022, the patient received Shingrix. On 5th August 2022, 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 Information: GSK Receipt Date: 05-AUG-2022 Reporters comment: The patient received only the adjuvant AS01B of Shingrix. The reporter consented to follow up. Additional Supportive Information: The patient received only the adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Engerix 10 mcg instead 20 mcg administered; 23 YO was administered  Engerix Pediatric dose; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 23-year-old female patient who received HBV (Engerix B pediatric) (batch number LP724, expiry date 18th May 2023) for prophylaxis.   On 5th July 2022, the patient received the 1st dose of Engerix B pediatric. On 5th July 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional Information: GSK Receipt Date: 05-AUG-2022 Reporter's Comments: The patient administered a Engerix Pediatric dose (10 mcg). On 5th August 2022, the patient received second adult dose (20 mcg). The reporter asked how to proceed with the series and did patient need to restart series. No additional details provided.  The reporter did not consent to follow-up. Additional Supportive Information: The adult patient received a dose of Engerix B pediatric instead of Engerix B adult, which led to underdose and adult use of a child product.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only administered liquid component of Menveo; only administered liquid component of Menveo; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 5th August 2022, the patient received Menveo. On 5th August 2022, unknown after receiving Menveo, 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 Information: GSK Receipt Date: 05-AUG-2022 Reporter's Comments: The physician reported that a patient was inadvertently administered the liquid component of Menveo by itself (without the powder menA component).This happened on the date of reporting. The lot number was not available. The reporter did not consent to follow up. Additional Supportive Information: The physician reported that the patient was inadvertently administered the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Dysgeusia, Off label use, Suspected COVID-19
Clinical narrative: This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: any Penicillin allergy, and shell fish allergy, and other pre-existing medical conditions included: The patient was taking other medications within 2 weeks of starting COVID-19 treatment. The patient was previously treated with covid-19 vaccine ad26. cov2.s (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: 043A21A, expiry: unknown) 1 total (dose 1) dose was not reported, administered on right arm on 06-APR-2021 16:00 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received additional covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) 1 total (dose 2) dose was not reported, administered on right arm on 13-OCT-2021 16:00 for covid-19 prophylaxis which was off label use with dosing frequency. The drug was associated with Off label use. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. Concomitant medications included: Alka Seltzer cold/flu (dextromethorphan, hydrobromide, paracetamol, pseudoephedrine hydrochloride) for drug used for unknown indication. On an unspecified date, the patient had covid-19 (suspected covid-19)  (dose number in series 2). The patient received non company suspect Paxlovid (nirmatrelvir and ritonavir) (form of admin, route of admin were not reported, batch number: GA8854, expiry: unknown) dose was not reported, administered on 29-JUN-2022 for covid-19 treatment. On 30-JUN-2022 (drug start period: 259 days), the patient experienced terrible taste that lingers in mouth, equilibrium off, body aches and nausea (dose number in series 2). The patient received last dose of Paxlovid on 01-JUL-2022. On 03-JUL-2022, the patient recovered from nausea and body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and with non-company suspect (Paxlovid) was treatment discontinued on 01-JUL-2022. The patient recovered from terrible taste that lingers in mouth, and equilibrium off on 03-JUL-2022 (duration: 03 days), and the outcome of suspected covid-19 and off label use with dosing frequency was not reported. This report was non-serious.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Erythema, Guillain-Barre syndrome, Pain in extremity, Peripheral swelling
Clinical narrative: GBS; SWOLLEN BLACK AND BLUE LEFT ARM; BLACK AND BLUE LEFT ARM; BASE OF THE FEET VERY RED; LEFT ARM PAIN; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: cats allergy, and dust allergy, and other pre-existing medical conditions included: The patient never got flu shots before and never had the flu. Patient was very healthy prior to the vaccine, never missed a day of work. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205821A expiry: UNKNOWN) dose was not reported, 01 total administered at left arm on 10-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 78 years old. No concomitant medications were reported.  On 13-APR-2021, 3 days after the vaccine, the patient happened to have a blood test and saw the primary care doctor. The patient had already started to have symptoms, base of the feet very red, cannot stand to touch sheets, very sensitive. The patient used to be able to walk 4-6 miles per day now can barely walk. 1 week later the patient rolled over and fell to the floor while getting out of bed. Both legs were numb. Has progressed to tingling in legs. The primary care doctor initially let it go, and informed it was too rare. Then as symptoms gradually evolved the patient went to several specialists. The vision was affected (blurry) and swallowing became difficult, sometimes the patient could only takes liquids. The patient knew someone who got a flu shot when he was 18 and got Guillain Barre syndrome (GBS) and was paralyzed. For which the patient kept doing research and seeing specialists. The patient finally saw a neurologist, referred by the primary care physician, and got the official diagnosis of Guillain Barre last week of this report. On an unspecified date in APR-2021, the patient experienced swollen black and blue left arm lasted for weeks after vaccination, with pain.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen black and blue left arm, black and blue left arm, and left arm pain, and the outcome of gbs and base of the feet very red was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220806993- covid-19 vaccine ad26.cov2.s-GBS. This event(s) is labeled per Agency and is therefore considered potentially related.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: GBS; SWOLLEN BLACK AND BLUE LEFT ARM; BLACK AND BLUE LEFT ARM; BASE OF THE FEET VERY RED; LEFT ARM PAIN; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: cats allergy, and dust allergy, and other pre-existing medical conditions included: The patient never got flu shots before and never had the flu. Patient was very healthy prior to the vaccine, never missed a day of work. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205821A expiry: UNKNOWN) dose was not reported, 01 total administered at left arm on 10-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 78 years old. No concomitant medications were reported.  On 13-APR-2021, 3 days after the vaccine, the patient happened to have a blood test and saw the primary care doctor. The patient had already started to have symptoms, base of the feet very red, cannot stand to touch sheets, very sensitive. The patient used to be able to walk 4-6 miles per day now can barely walk. 1 week later the patient rolled over and fell to the floor while getting out of bed. Both legs were numb. Has progressed to tingling in legs. The primary care doctor initially let it go, and informed it was too rare. Then as symptoms gradually evolved the patient went to several specialists. The vision was affected (blurry) and swallowing became difficult, sometimes the patient could only takes liquids. The patient knew someone who got a flu shot when he was 18 and got Guillain Barre syndrome (GBS) and was paralyzed. For which the patient kept doing research and seeing specialists. The patient finally saw a neurologist, referred by the primary care physician, and got the official diagnosis of Guillain Barre last week of this report. On an unspecified date in APR-2021, the patient experienced swollen black and blue left arm lasted for weeks after vaccination, with pain.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen black and blue left arm, black and blue left arm, and left arm pain, and the outcome of gbs and base of the feet very red was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220806993- covid-19 vaccine ad26.cov2.s-GBS. This event(s) is labeled per Agency and is therefore considered potentially related.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: This spontaneous report received from a patient through other manufacturer (Pfizer) concerned a patient of unspecified age, sex, race and ethnicity. Initial information was processed along with the additional information received on 05-AUG-2022. The patient's weight, height, and medical history were not reported.- The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration, batch number were not reported, expiry: unknown) dose was not reported, 1 in total was administered on 12-MAR-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). No concomitant medications were reported. The patient additionally received non-company suspect vaccine Moderna Covid-19 vaccine (elasomeran) (dose number in series 2) (form of administration, route of administration, batch number were not reported, expiry: unknown), dose was not reported, administered on 14-OCT-2021 for covid-19 prophylaxis. On 15-JUL-2022, the patient was treated with non-company suspect drug Paxlovid (route of administration, batch number and expiry were not reported) dose and frequency were not reported for covid-19 treatment and last administered on 20-JUL-2022. On 26-JUL-2022, 11 days after (on day 12) non company suspect drug Paxlovid treatment (for covid-19) the patient experienced suspected covid-19 infection (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and and with Paxlovid was drug discontinued on 20-JUL-2022. The patient had not recovered from suspected covid-19 infection. This report was non-serious. This case was associated with a product quality complaint: 90000245309. Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: This spontaneous report received from a patient via other manufacturer concerned an adult female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient was previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number and expiry date  were not reported) 1 total, dose was not reported, administered on 2021 for covid-19 prophylaxis. On an unspecified date, the patient experienced grip strength decreased/cant grab things, covid-19, and painful hand (Dose number in series 1). The outcome of the painful hand, grip strength decreased/cant grab things and covid-19 was not reported. The patient received covid-19 vaccine ad26.cov2.s second dose (Dose number in series 2) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown), third dose (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total, both doses administered on an unspecified date in 2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The product was associated with Off label use (off label dosing frequency) (Dose number in series 2). No concomitant medications were reported. The patient received non-company suspect drugs included: upadacitinib (Rinvoq) (form of admin unknown, oral, batch number was not reported) dose was not reported, therapy dates were not reported for moderate to severe rheumatoid arthritis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of upadacitinib was not changed. The outcome of off label dosing frequency was not reported. This report was non-serious. This case, involving the same patient is linked to 20220805946 (dose number in series 1).
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Therapeutic product effect decreased
Clinical narrative: This spontaneous report received from a patient concerned an adult female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On an unspecified date, the patient experienced condition aggravated, and drug effect decreased/Humira stopped working. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from drug effect decreased/Humira stopped working, and the outcome of condition aggravated was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine injured. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine injured was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Injury
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced injured by the vax, and ruined my life. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injured by the vax and ruined my life was not reported. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: started to get  pain in his back, two months after his second dose, and eventually became incapacitated,; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (started to get  pain in his back, two months after his second dose, and eventually became incapacitated,) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced BACK PAIN (started to get  pain in his back, two months after his second dose, and eventually became incapacitated,) (seriousness criterion medically significant). At the time of the report, BACK PAIN (started to get  pain in his back, two months after his second dose, and eventually became incapacitated,) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Patient experienced pain still there, but he has gotten a lot better. Treatment information was not provided. Company comment: This spontaneous case concerns a 51-year-old male patient, with no medical history reported, who experienced the serious (due to medically significant) unexpected event of Back pain, approximately 2 months after the second dose of mRNA-1273 vaccine. Patient had previously received the first of mRNA-1273 vaccine, and both were administered in an appropriate schedule of vaccination. As per source document, he eventually became incapacitated, but he has gotten a lot better. No further details on clinical course, test results or treatment were reported. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 51-year-old male patient, with no medical history reported, who experienced the serious (due to medically significant) unexpected event of Back pain, approximately 2 months after the second dose of mRNA-1273 vaccine. Patient had previously received the first of mRNA-1273 vaccine, and both were administered in an appropriate schedule of vaccination. As per source document, he eventually became incapacitated, but he has gotten a lot better. No further details on clinical course, test results or treatment were reported. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis. No Medical History information was reported. On 23-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022). No concomitant product use was reported. Patient received half dose. The vial had not undergone any temperature excursions. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2022: Follow up information received includes non significant information. On 03-Aug-2022: Follow up received: Case report type, reporter details updated, patient details were added, suspect vaccine information was added, new events were added and narrative updated.