chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Patient was administered expired MMRII; This spontaneous report was received from a nurse and refers to an 1-year-old patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions, and concomitant medications were not provided.  On 28-APR-2022, the patient was vaccinated with a expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin rHA) (M-M-R II) lot T013724, expiration date reported as 21-APR-2022 (strength, and route of administration were not provided) (expired product administered). No additional adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered
Clinical narrative: No additional AE; Caller reports an extra dose of MMR II was accidentally administered to a patient. No additional AE or PQC reported.; This spontaneous report has been received from a nurse referring a patient of unknown age and gender. The patient's medical history, historical drug, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II)  0.5 milliliter, (lot number U009511, expiration date 25-MAR-2023 , strength frequency, route and anatomical location were not reported).   On 28-APR-2022, an extra dose of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) was accidentally administered to a patient. (extra dose administered). No additional adverse events were reported.   The causal relationship between measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) and the event was not reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Patient has not had any adverse effects or symptoms from this dose.; a dose of expired MMRII was given to a patient today; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's historical condition and current condition were not reported. The patient's concomitant medication included sterile diluent (lot number: T022572 with expiration date: 12-FEB-2023).   On 29-APR-2022 (reported as today), the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) (0.5ml/once, lot number: T013727 with expiration date: 21-APR-2022, strength and route were unknown) for prophylaxis (expired product administered). The patient did not  have any adverse effects or symptoms from the dose. Vaccine had no temperature excursions and was supported per protocol.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; expired VAQTA was administered; This spontaneous report was received from Consumer, concerning a patient of unspecified age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-MAY-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 ml, lot #T037329, expiration date: 30-APR-2022, administered for prophylaxis (strength, and route of administration were not provided)(expired vaccine used).   Caller confirmed that the product had no temperature excursions and was stored properly. No additional adverse event (AE) information was provided.
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; patient was administered the first dose of the primary series of PEDVAX HIB on 16MAR2022 and the second dose on 02MAY2022; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 16-MAR-2022, the patient was vaccinated with the first dose of primary series of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (exact dose, formulation, strength, lot #, expiration date, site and route of administration were not provided) for prophylaxis. On 02-MAY-2022, the patient was vaccinated with the second dose (inappropriate schedule of product administration) of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml, lot #: U014992, expiration date: 29-OCT-2023 (formulation, strength, site and route of administration were not provided) for prophylaxis. There was no additional adverse event reported.
Sex: M
Vaccine: MMR
Symptoms: Viral titre decreased
Clinical narrative: Caller reports patient's MMR II titers were low. Rubella titer  0.98,  measles less than 13.5 and mump less than 9.0.; Caller reports patient's MMR II titers were low. Rubella titer  0.98,  measles less than 13.5 and mump less than 9.0.; Caller reports patient's MMR II titers were low. Rubella titer  0.98,  measles less than 13.5 and mump less than 9.0.; This spontaneous report was received from a nurse referring to a 28 years old male patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis.         On an unknown date, the patient's titers were low, rubella titer 0.98, measles less than 13.5 and mump less than 9.0 (units not provided). The outcome of the events was unknown. The causality assessment was not reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Patient was administered expired MMRII; Expired / Administered Vaccine Detail Summary is located within following space.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 04-MAY-2022, the patient was vaccinated with expired dose (expired product administered) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (recombinant Human albumin) lot #: T007231, expiration date: 27-FEB-2022 (exact dose, strength, site and route of administration were not provided) for prophylaxis. There was no temperature excursion reported for affected product as confirmed by reporter. There was no additional adverse event reported.
Age: 0.75
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse events reported; the administration of VARIVAX to a 9 month old Patient; This spontaneous report was received from a medical assistant and refers to a 9-month-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 09-MAY-2022, the 9-month-old patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, lot #U015844, expiration date: 19-MAY-2023, (strength, and route of administration were not provided) for prophylaxis (product administered to patient of inappropriate age). No additional adverse events reported. No product quality complaints reported.
Age: 1.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; improperly stored vaccine was administered to 10 separate patients; This spontaneous report was received from an office manager and refers to a 12-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 18-APR-2022, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot #T042013, expiration date: 22-JUL-2023 (strength, site and route of administration were not provided) for prophylaxis (Product storage error). No adverse events were reported (No adverse event).  On an unknown date, before the administration, the vaccine underwent a temperature excursion at 11.3 Celsius degrees (C) for 4 hours and 45 minutes. No previous temperature excursions were reported.   This is one of several reports from the same person.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy, Hepatitis B virus test, Injury associated with device
Clinical narrative: 5 Weeks Pregnant Received One Dose of Heplisav-B; Initial Report Received on 18-Feb-2022  Follow-up Report Received on 18-Feb-2022 included communication with the patient from the Pregnancy Registry.  An advanced nurse practitioner reported that  a 24-year-old pregnant female patient (race and ethnicity unknown), received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization at 5 weeks of gestation. The pregnant patient, who is also a nurse, additionally self-reported the event separately.   No medical history was reported. The patient's last menstrual period (LMP) was 15-Jan-2022.   No concomitant medications were reported.  On 18-Feb-2022, the patient, who is also a nurse,  was drawing blood on a patient and experienced a needle stick injury. The nurse had a hepatitis B  titer drawn, and the result was 9.9 which was considered low. A "booster" dose of HEPLISAV-B (Lot # 935842, expiration date 29-Oct-2022, and NDC # unknown) was administered intramuscularly in the right deltoid by a medical assistant.   No additional information was provided. The patient declined to participate in the Pregnancy Registry.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 83.0
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: continious deltoid muscle pain; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 83-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th October 2021, the patient received the 1st dose of Shingrix. On an unknown date, several months after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-MAY-2022 Reporter's Comments: The case was self reported by the patient. Several months after getting Shingrix vaccine, the patient had continuous deltoid muscle pain. The patient asked was this common. The patient stated there were no record of 1st dose where he/she get it and asked was there any way he/she could get them. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: MMR, VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever as high as 103.1; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included MMR (MMR vaccine) for prophylaxis.   On 2nd May 2022, the patient received Shingrix and MMR vaccine. In May 2022, 12 hrs after receiving Shingrix and MMR vaccine, the patient experienced fever. The patient was treated with ibuprofen (Motrin). On an unknown date, the outcome of the fever was recovering/resolving.   It was unknown if the reporter considered the fever to be related to Shingrix and MMR vaccine.     Additional Information: GSK Receipt Date: 03-May-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient received the Shingrix vaccine with the MMR a day before reporting and developed a fever about 12 hours after vaccination. The patient stated that it had been as high as 103.1, the patient took Motrin and the fever was then 101. The patient wanted to know if it was normal. Additional Supportive Information: The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Hypoaesthesia
Clinical narrative: Stomach pain; Numbness in toes and legs, feet and hands are numb; This case was reported by a consumer via interactive digital media and described the occurrence of stomach pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced stomach pain and numbness of extremities. On an unknown date, the outcome of the stomach pain and numbness of extremities were unknown.   It was unknown if the reporter considered the stomach pain and numbness of extremities to be related to Shingrix.     Additional Information: GSK Receipt Date: 6-May-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingrix vaccine and experienced stomach pain and numbness in toes, legs, feet and hands. Additional supportive information: The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Rash macular
Clinical narrative: Painful red blotch; Painful red blotch; This case was reported by a consumer via interactive digital media and described the occurrence of red blotches in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced red blotches and pain. On an unknown date, the outcome of the red blotches and pain were unknown.   It was unknown if the reporter considered the red blotches and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 6-May-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingrix vaccine into unknown arm and experienced painful red blotch on the same arm but not at the injection site. The patient asked was if it was normal. Additional supportive information: The follow-up would not possible, as no contact details were available.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: BOOSTRIX May 3, 2022, not needed, prior vaccination 4/28/2017; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 16-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3A745, expiry date 12th March 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Boostrix (received a dose of Boostrix on 28th April 2017).   On 3rd May 2022, the patient received the 2nd dose of Boostrix (intramuscular) .5 ml and Boostrix Pre-Filled Syringe Device. On 3rd May 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose 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: 04-May-2022 Reporter's comment: Medical Assistant was the reporter.   The reporter stated that the patient received a dose of Boostrix in left arm that was not needed.   Consented to follow-up. Additional Supportive Information: The patient received an extra dose of Boostrix, which led extra dose administered. The case was linked with case US2022AMR073182, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR073182:Same reporter
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Incorrect route of product administration
Clinical narrative: received Rotarix intramuscularly; This case was reported by a nurse via call center representative and described the occurrence of wrong route of administration in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 7H9CH, expiry date 8th July 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 4th May 2022, the patient received Rotarix lyophilized formulation (intramuscular) and Rotarix Oral Applicator Device. On 4th May 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong route of administration. On an unknown date, the outcome of the wrong route of 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: 04-May-2022 Reporter's comment: The reporter reported that the patient received a dose of Rotarix  inadvertently administered via intramuscular instead of oral. No symptoms were reported. The reporter consented to follow-up by email. Additional Supportive Information: The patient received a dose of Roatrix intramuscularly, which led to wrong route of administration. This case was identified as duplicate of US2022073859. The case US2022073859 was deleted and all future correspondence would be added in the present case which stands as case of record for this patient.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Incomplete course of vaccination, Injection site pain, Magnetic resonance imaging abnormal, Rotator cuff syndrome
Clinical narrative: Did not complete the vaccine series; Rotator cuff tear. Have surgery to get it repaired; Pain at the injection site; Pain reached his shoulder; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 28th May 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 28th May 2018, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain and shoulder pain. On 2nd June 2018, the patient experienced rotator cuff tear. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the injection site pain, shoulder pain and rotator cuff tear were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain, shoulder pain and rotator cuff tear to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-MAY-2022 Reporter's Comment: Reporter was patient who called to get additional information on side effects with Shingrix.  He stated he received his first dose of Shingrix and on the same day post vaccination the patient reported pain at the injection site.  His primary care physician referred him to an orthopedic specialist because the pain reached his shoulder and a week after vaccination a Magnetic resonance imaging (MRI) showed a rotator cuff tear.  Patient stated he did have surgery to get it repaired at the time.  Patient stated he did not complete the vaccine series and did not get the second dose.  Referred to health care professional (HCP) and provided medical advice disclaimer.  Provided information on side effects per package insert (PI). The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Received 3rd dose by error; 1st dose on 19-NOV-2019, 2nd dose 09-NOV-2022; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number NR5SZ, expiry date 22nd October 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 19th November 2019).   On 26th May 2021, the patient received the 3rd dose of Shingrix. On 9th November 2020, the patient received the 2nd dose of Shingrix. On 9th November 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 26th May 2021, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and drug dose administration interval too long were unknown.   Additional Information: GSK Receipt Date: 04-MAY-2022 Reporter's Comment: Pharmacist was looking for information if a patient received Shingrix third dose by error.  Consented to follow up by email. Additional Supportive Information: The patient received 3rd dose of Shingrix by error, which led to extra dose administered. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Dysuria, Immediate post-injection reaction, Pollakiuria, Urinary retention, Urinary tract infection
Clinical narrative: Trouble urinating, not able to empty bladder all the way; Developed a urinary tract infection; Trouble urinating; not able to empty her bladder all the way and had to go often because of that; This case was reported by a consumer via call center representative and described the occurrence of urinary retention in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure high.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, immediately after receiving Shingrix, the patient experienced urinary retention (serious criteria GSK medically significant), urinary tract infection, urination difficulty and increased urinary frequency. On an unknown date, the outcome of the urinary retention, urination difficulty and increased urinary frequency were recovering/resolving and the outcome of the urinary tract infection was recovered/resolved.   It was unknown if the reporter considered the urinary retention, urinary tract infection, urination difficulty and increased urinary frequency to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-MAY-2022 Reporter's Comment: The patient got Shingrix vaccine about 3 months ago in the left arm and shortly after the vaccine, she started having trouble urinating.   She reported that she was not able to empty her bladder all the way and had to go often because of that.   The patient also developed a urinary tract infection and her symptoms with difficulty urinating had improved and her urinary tract infection had cleared up.   The patient did not have any further information in regards to the lot or expiration date of the vaccine. The reporter did not consent to follow-up.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Asthenopia, Chest pain, Cough, Fatigue, Nasal congestion
Clinical narrative: Chest pain; Dry cough; Phlegm; Fever; Fatigue; Sore throat; Stuffy nose; Her eyes looked like they were drooping; This case was reported by a consumer via call center representative and described the occurrence of sore throat in a 17-year-old female patient who received Men B NVS (Bexsero) 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 6th May 2022, the patient received the 1st dose of Bexsero (intramuscular) .5 µl and Bexsero Pre-Filled Syringe Device. On 6th May 2022, several hours after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced sore throat, nasal stuffiness and tired eyes. On 7th May 2022, the patient experienced chest pain, dry cough, phlegm, fever and fatigue. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the sore throat, nasal stuffiness, tired eyes, chest pain, dry cough, phlegm, fever and fatigue were unknown.   It was unknown if the reporter considered the sore throat, nasal stuffiness, tired eyes, chest pain, dry cough, phlegm, fever and fatigue to be related to Bexsero and Bexsero Pre-Filled Syringe Device. 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: 09-MAY-2022 Reporter's Comments: The patient's mother reported the case.  The patient received her dose of the Bexsero vaccine in the left arm. A few hours later she began to experience a sore throat, stuffy nose and her eyes looked like they were drooping.  The mother said that she gave her a Tylenol tablet and patient went to bed.  The next morning, she had chest pain, a dry cough, phlegm, fever, and fatigue.  The mother took her to the emergency room. The mother was told these were side effects of the Bexsero vaccine by the ER (emergency room) and she was told by pediatrician that there were no side effects to the Bexsero Vaccine when she gave it to her daughter.  The reporter disconnected the call abruptly before any further inquiry.  The reporter did not consent to follow up.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Oropharyngeal pain, Productive cough, Pyrexia
Clinical narrative: Chest pain; Dry cough; Phlegm; Fever; Fatigue; Sore throat; Stuffy nose; Her eyes looked like they were drooping; This case was reported by a consumer via call center representative and described the occurrence of sore throat in a 17-year-old female patient who received Men B NVS (Bexsero) 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 6th May 2022, the patient received the 1st dose of Bexsero (intramuscular) .5 µl and Bexsero Pre-Filled Syringe Device. On 6th May 2022, several hours after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced sore throat, nasal stuffiness and tired eyes. On 7th May 2022, the patient experienced chest pain, dry cough, phlegm, fever and fatigue. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the sore throat, nasal stuffiness, tired eyes, chest pain, dry cough, phlegm, fever and fatigue were unknown.   It was unknown if the reporter considered the sore throat, nasal stuffiness, tired eyes, chest pain, dry cough, phlegm, fever and fatigue to be related to Bexsero and Bexsero Pre-Filled Syringe Device. 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: 09-MAY-2022 Reporter's Comments: The patient's mother reported the case.  The patient received her dose of the Bexsero vaccine in the left arm. A few hours later she began to experience a sore throat, stuffy nose and her eyes looked like they were drooping.  The mother said that she gave her a Tylenol tablet and patient went to bed.  The next morning, she had chest pain, a dry cough, phlegm, fever, and fatigue.  The mother took her to the emergency room. The mother was told these were side effects of the Bexsero vaccine by the ER (emergency room) and she was told by pediatrician that there were no side effects to the Bexsero Vaccine when she gave it to her daughter.  The reporter disconnected the call abruptly before any further inquiry.  The reporter did not consent to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site pain, Injection site warmth, Musculoskeletal chest pain
Clinical narrative: Right sided rib pain; Pain at the injection site; Warmth at the injection site; Feeling faint off and on.  Never fainted; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 7th May 2022, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site warmth and felt faint. On 10th May 2022, the patient experienced rib pain. On an unknown date, the outcome of the injection site pain and injection site warmth were recovered/resolved and the outcome of the felt faint and rib pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site warmth, felt faint and rib pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-MAY-2022 Reporter's Comments: The case was self reported by the patient. The patient received her dose of Shingrix vaccine and next day, she started feeling faint off and on. The patient never fainted. The patient also reported that the day after her Shingrix shot, she had pain and warmth at the injection site.  The injection site symptoms have resolved, but she was still having intermittent bouts of feeling faint. In addition, she stated that she started with right sided rib pain this morning on day of reporting. The patient did not have any further information about the vaccine or want to give any additional demographics. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 01/2021, 2nd dose not yet administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 3PD3E, expiry date 8th October 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on January 2021, batch number AL734, expiry date 8th October 2022).   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: 10-MAY-2022 Reporter's Comments: The pharmacist reported that patient has had greater than 6 months between doses and second dose not yet administered.   The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose: 09Nov2020, did not get the second dose until 03May2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 9Y92A, expiry date 2nd June 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix vaccine on 9th November 2020, batch number L7574 and expiry date 27th March 2022).   On 3rd May 2022, the patient received the 2nd dose of Shingrix. On 3rd May 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 10-MAY-2022 Reporter's Comments: The pharmacist reported that a patient received second dose of Shingrix on 3rd May 2022. The reporter gave permission for follow up. The reporter consented to follow up. Additional Supportive Information: The patient received the second dose later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: Due to "covid and other things", received the second dose  in February 2022; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in January 2021).   In February 2022, the patient received the 2nd dose of Shingrix. In February 2022, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 10-MAY-2022 Reporter's Comments: The pharmacist reported that a patient was late for the second dose of Shingrix, because of the COVID situation and other things.  The pharmacist did not want to provide more information.  Consent to follow up could not be asked. Additional Supportive Information: The pharmacist reported that a patient was late for the second dose of Shingrix, because of the COVID situation and other things, which led to social problem.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Therapeutic response unexpected
Clinical narrative: SIDE EFFECTS; LINGERING PAIN WAS GONE; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's past medical history included: physical therapy, and acupuncture, and concurrent conditions included: shoulder rotator cuff injury. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, the patient experienced side effects, and lingering pain was gone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the side effects and lingering pain was gone was not reported. This report was non-serious. This case, involving the same patient is linked to 20220513079.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Biopsy bone marrow, Epstein-Barr virus infection, Guillain-Barre syndrome, Haemorrhage subcutaneous, Laboratory test
Clinical narrative: MILD GUILLAIN-BARRE SYNDROME; BLEEDING UNDER THE SKIN; EPSTEIN-BARR VIRUS; This spontaneous report received from a patient concerned a 61 year old male of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: physical therapy, and acupuncture, and concurrent conditions included: shoulder rotator cuff injury. On an unspecified date, the patient previously received covid-19 vaccine ad26. cov2. s (dose number in series: 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered on 01-MAY-2021 for prophylactic vaccination. On an unspecified date in 2021, post the vaccination, the patient experienced side effects and lingering pain was gone (dose number in series: 1). The outcome of side effects was not reported and lingering pain was gone was recovered. On 25-OCT-2021, the patient received covid-19 vaccine ad26.cov2.s (dose number in series: 2) (suspension for injection, route of admin not reported, batch number: 1855194, expiry: UNKNOWN) dose was not reported, 1 total administered for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in 2021, the patient reported really, really sick, bleeding under the skin, mild Guillain-Barre Syndrome (GBS) and very serious Epstein-Barr Virus (EBV) (dose number in series 2). The patient stated to be in a good health. The patient's doctor had mentioned to him that bruising was normal when old and had discontinued some of patient's medications including ibuprofen. The patient had undergone numerous tests within a period of 3 months post vaccination. Laboratory data (dates unspecified) included: Bone marrow biopsy was negative for blood cancer, and unspecified tests indicated diagnosis of very serious Epstein-Barr Virus (EBV) and mild Guillain-Barre Syndrome (GBS) (dose number in series: 1). The patient's symptoms were pointing to blood cancer before the test results had arrived. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bleeding under the skin, epstein-barr virus, and mild guillain-barre syndrome. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220511951.; Sender's Comments: V0:20220513079-covid-19 vaccine ad26.cov2.s- Mild guillain-barre syndrome.. This event(s) is labeled per RSI and is therefore considered potentially related. 20220513079-covid-19 vaccine ad26.cov2.s-Bleeding under the skin. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total (first dose) administered on 2021 for prophylactic vaccination. Age at time of vaccination 38 years old. 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 06-MAY-2022 at 1:30, the patient experienced suspected COVID-19 infection (symptoms reported as vomiting, diarrhea and fever), and suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected COVID-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with Product Quality Complaint.; Sender's Comments: V0: 20220514073-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure . The event(s) has an unknown/unclear 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. Therefore, this event(s) is considered not related.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular disorder, Computerised tomogram, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: THICKNESS OF AN ARTERY IN BRAIN; PROBLEM WITH MEMORY/COULD NOT REMEMBER PRAYERS; FEELING FOGGINESS/LIKE FOGGY BRAIN/DON'T FEEL RIGHT/SOMEDAYS FEEL LIKE GOING IN BED AND SOMEDAYS DON'T FEEL LIKE/WAKE UP AT NIGHT FEELING LIKE WAS IN A COMA; FELT DIZZINESS; VERY TIRED; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: blood clot in left leg (3 to 4 years ago), and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient did not get covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 and expiry: 25-MAY-2022) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. Age at time of vaccination 68 years old. No concomitant medications were reported. On 2021, the patient experienced problem with memory/could not remember prayers, feeling fogginess/like foggy brain/don't feel right/somedays feel like going in bed and somedays don't feel like/wake up at night feeling like was in a coma, felt dizziness, and very tired. On an unspecified date, the patient experienced thickness of an artery in brain. Laboratory data (dates unspecified) included: CAT scan (NR: not provided) thickness of an artery in brain. Treatment medications (dates unspecified) included: apixaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling fogginess/like foggy brain/don't feel right/somedays feel like going in bed and somedays don't feel like/wake up at night feeling like was in a coma, felt dizziness, very tired, and problem with memory/could not remember prayers, and the outcome of thickness of an artery in brain was not reported. This report was non-serious. Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment
Clinical narrative: THICKNESS OF AN ARTERY IN BRAIN; PROBLEM WITH MEMORY/COULD NOT REMEMBER PRAYERS; FEELING FOGGINESS/LIKE FOGGY BRAIN/DON'T FEEL RIGHT/SOMEDAYS FEEL LIKE GOING IN BED AND SOMEDAYS DON'T FEEL LIKE/WAKE UP AT NIGHT FEELING LIKE WAS IN A COMA; FELT DIZZINESS; VERY TIRED; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: blood clot in left leg (3 to 4 years ago), and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient did not get covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 and expiry: 25-MAY-2022) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. Age at time of vaccination 68 years old. No concomitant medications were reported. On 2021, the patient experienced problem with memory/could not remember prayers, feeling fogginess/like foggy brain/don't feel right/somedays feel like going in bed and somedays don't feel like/wake up at night feeling like was in a coma, felt dizziness, and very tired. On an unspecified date, the patient experienced thickness of an artery in brain. Laboratory data (dates unspecified) included: CAT scan (NR: not provided) thickness of an artery in brain. Treatment medications (dates unspecified) included: apixaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling fogginess/like foggy brain/don't feel right/somedays feel like going in bed and somedays don't feel like/wake up at night feeling like was in a coma, felt dizziness, very tired, and problem with memory/could not remember prayers, and the outcome of thickness of an artery in brain was not reported. This report was non-serious. Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: PARALYZED IN THE BED; This spontaneous potential legal report received from a consumer (spouse) via social media (JNJ) through a company representative concerned a male of unspecified age, race and ethnic origin. Initial information processed with additional information received from reporter on 10-MAY-2022. 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, and batch number were not reported) dose and start therapy date were not reported, 1 total for prophylactic vaccination. The Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient was paralyzed in the bed. Reporter stated that "I would like to share with you what the J&J vaccine has done to my husband. I have photos and all medical reports. He is now paralyzed in the bed. J&J is responsible. You should reach out to me. That shot has destroyed my husband's life our life. Your vaccine is 100% responsible. You deserve to be sued. No one should go thru what we have". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of paralyzed in the bed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220514928-Covid-19 vaccine ad26.cov2.s-Paralyzed in the bed. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Coagulopathy, Gastrointestinal pain, Headache, Microvascular coronary artery disease
Clinical narrative: MICROVASCULAR CORONARY ARTERY DISEASE; LEG CRAMPS; GUT PAIN; LOWER BACK PAIN; CLOTTING PROBLEMS; REPETITIVE YAWNING; BOTH CALVES AFFECTED FOR LEG PAIN; HEADACHE; This spontaneous report received from a health care professional concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: type 1 diabetes mellitus, hypothyroid, autoimmune condition, and inflammatory disease. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 09-MAR-2021 in right arm for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 54 years old. No concomitant medications were reported.  On an unspecified date, about 3 months patient started experiencing chest pain when walking (dose number in series 1). After 6 months the chest pain presented intermittently. Patient was diagnosed with microvascular CAD (microvascular coronary artery disease) and prescribed with Imdur and Hydrochloroquine (dose number in series 1). Patient stated that her both calves were affected for the leg pain (dose number in series 1). Symptoms were most prevalent when she was exerting herself. She also displayed repetitive yawning (dose number in series 1). On an unspecified date, the patient experienced leg cramps, gut pain, lower back pain, clotting problems, and headache (dose number in series 1). The patient received additional non company suspect Moderna vaccine (dose number in series 2) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered on an unspecified date for prophylactic vaccination.  It was unknown if patient experienced any adverse reactions following administration of Moderna vaccine (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the both calves affected for leg pain, headache, leg cramps, gut pain, lower back pain, microvascular coronary artery disease, clotting problems and repetitive yawning was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220517380-covid-19 vaccine ad26.cov2.s-Microvascular coronary artery disease. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.