chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Bradycardia, Condition aggravated, Confusional state, Dizziness
Clinical narrative: swelled face; Eye swelling; worsening bradycardia; Lightheadedness; Weakness; Confusion; This non-serious case was reported by a consumer and described the occurrence of facial swelling in a 67-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concurrent medical conditions included spinal column injury, back pain, bradycardia (3 year condition of bradycardia), allergy to chemicals (reactions to certain chemicals or dyes) and drug allergy (reactions to thimerosal). Concomitant products included oxycodone hydrochloride and clonidine hydrochloride.   On 02-JUL-2024, the patient received Boostrix. On 04-JUL-2024, 2 days after receiving Boostrix, the patient experienced facial swelling (Verbatim: swelled face), eye swelling (Verbatim: Eye swelling) and bradycardia (Verbatim: worsening bradycardia). In JUL-2024, the patient experienced light headedness (Verbatim: Lightheadedness), weakness (Verbatim: Weakness) and confusion (Verbatim: Confusion). On 05-JUL-2024, the outcome of the facial swelling and eye swelling were resolved (duration 1 day). The outcome of the bradycardia was not resolved and the outcome of the light headedness, weakness and confusion were not reported.   It was unknown if the reporter considered the facial swelling, eye swelling, bradycardia, light headedness, weakness and confusion to be related to Boostrix.     It was unknown if the company considered the facial swelling, eye swelling, bradycardia, light headedness, weakness and confusion to be related to Boostrix.   Additional Information: GSK Receipt Date: 11-JUL-2024 The patient self-reported this case. The patient received Boostrix tdap vaccine and his eyes and face were swelled for the entire day of the 4th July 2024 and it went away the next day, but his 3 year condition of bradycardia of anywhere from 42 to 55 bpm started falling to 35 to 40 bpm while sitting resting. The patient had started having symptoms like lightheadedness and weakness and confusion.  The patient was trying to get a pacemaker put in but his cardiologist wanted him to wait 5 weeks for testing and heart monitor and could be dead by then and was looking for another cardiologist. The patient always had reactions to certain chemicals or dyes and thimerosal. The reporter consent to follow-up.
Sex: M
Vaccine: TDAP
Symptoms: Eye swelling, Swelling face
Clinical narrative: swelled face; Eye swelling; worsening bradycardia; Lightheadedness; Weakness; Confusion; This non-serious case was reported by a consumer and described the occurrence of facial swelling in a 67-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concurrent medical conditions included spinal column injury, back pain, bradycardia (3 year condition of bradycardia), allergy to chemicals (reactions to certain chemicals or dyes) and drug allergy (reactions to thimerosal). Concomitant products included oxycodone hydrochloride and clonidine hydrochloride.   On 02-JUL-2024, the patient received Boostrix. On 04-JUL-2024, 2 days after receiving Boostrix, the patient experienced facial swelling (Verbatim: swelled face), eye swelling (Verbatim: Eye swelling) and bradycardia (Verbatim: worsening bradycardia). In JUL-2024, the patient experienced light headedness (Verbatim: Lightheadedness), weakness (Verbatim: Weakness) and confusion (Verbatim: Confusion). On 05-JUL-2024, the outcome of the facial swelling and eye swelling were resolved (duration 1 day). The outcome of the bradycardia was not resolved and the outcome of the light headedness, weakness and confusion were not reported.   It was unknown if the reporter considered the facial swelling, eye swelling, bradycardia, light headedness, weakness and confusion to be related to Boostrix.     It was unknown if the company considered the facial swelling, eye swelling, bradycardia, light headedness, weakness and confusion to be related to Boostrix.   Additional Information: GSK Receipt Date: 11-JUL-2024 The patient self-reported this case. The patient received Boostrix tdap vaccine and his eyes and face were swelled for the entire day of the 4th July 2024 and it went away the next day, but his 3 year condition of bradycardia of anywhere from 42 to 55 bpm started falling to 35 to 40 bpm while sitting resting. The patient had started having symptoms like lightheadedness and weakness and confusion.  The patient was trying to get a pacemaker put in but his cardiologist wanted him to wait 5 weeks for testing and heart monitor and could be dead by then and was looking for another cardiologist. The patient always had reactions to certain chemicals or dyes and thimerosal. The reporter consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a consumer and described the occurrence of shingles in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox.   On 08-JUN-2024, the patient received the 2nd dose of Shingrix. On 15-JUN-2024, 7 days after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt date: 15-JUL-2024 A reporter reported that shingles started a week after receiving second vaccination, she did have chickenpox when she was 5 years old.  The symptoms were treated.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: My pharmacy only gave me one dose over a year ago.; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Varicella zoster vaccine (received 1st dose over a year ago, on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: My pharmacy only gave me one dose over a year ago.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 11-JUL-2024 The patient self-reported this case. The patient's pharmacy only gave him/her one dose of Shingles vaccine over a year ago and they never said had to come back for a second shot. Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination.
Sex: U
Vaccine: MNQ
Symptoms: Intercepted product storage error, Product storage error
Clinical narrative: experienced a temperature excursion due to a fire in their county/informed the temperature excursion was 3 and a half hours for the affected vaccines; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of intercepted product storage error in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient did not receive Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced intercepted product storage error (Verbatim: experienced a temperature excursion due to a fire in their county/informed the temperature excursion was 3 and a half hours for the affected vaccines). The outcome of the intercepted product storage error was unknown.   Additional Information: GSK Receipt Date: 12-JUL-2024 The health care professional inquired if MVC4, Menveo vaccines were still viable and safe to as they experienced a temperature excursion due to a fire in their county, which led to intercepted product storage error. The generator at their facility did not turn on and reporter informed the temperature excursion was 3 and a half hours for the affected vaccines.  The health care professional requested excursion data for the medication.
Sex: M
Vaccine: VARZOS
Symptoms: Muscle rupture, Rotator cuff syndrome
Clinical narrative: bicep and rotator cuff tears in both arm; rotator cuff tear in both arms with the right arm being more severe; This serious case was reported by a consumer via call center representative and described the occurrence of torn muscle in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID-19 VACCINE, INFLUENZA VACCINE and RSV VACCINE.   In JAN-2024, the patient received the 1st dose of Shingrix (right arm). On an unknown date, 3 days after receiving Shingrix, the patient experienced torn muscle (Verbatim: bicep and rotator cuff tears in both arm) (serious criteria GSK medically significant) and rotator cuff tear (Verbatim: rotator cuff tear in both arms with the right arm being more severe). The outcome of the torn muscle and rotator cuff tear were unknown.   The reporter considered the torn muscle and rotator cuff tear to be possibly related to Shingrix.     The company considered the torn muscle to be unrelated to Shingrix. The company considered the rotator cuff tear to be possibly related to Shingrix.   Additional Information: GSK Receipt date: 10-JUL-2024 The patient wife was reported that her husband received his first dose of Shingrix in late January and 3 days after receiving Shingrix the patient developed a bicep and rotator cuff tear in both arms with the right arm being more severe.  The patient thinks this was caused by Shingrix.  The wife of patient stated that within a span of two and a half months the patient had Covid, Flu, RSV and Shingrix administered.  Shingrix was that last vaccine the patient had received, therefore, the patient thinks Shingrix caused this tear in his biceps and rotator cuff.  The vaccine was administered in the right arm and the patient was under the care of an Orthopedist.; Sender's Comments: Muscle rupture is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Age: 16.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: 2nd dose of Trumenba on 3-JUL-2024 at another clinic and 3rd dose of Bexsero at off site clinic on 10-JUL-2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number j52pn) for prophylaxis.   Co-suspect products included Meningococcal vaccine B rfHbpA/fHbpB (Trumenba) for prophylaxis.   On 01-AUG-2023, the patient received the 1st dose of Bexsero. On 03-JUL-2024, the patient received the 2nd dose of Trumenba. On 03-JUL-2024, 337 days after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: 2nd dose of Trumenba on 3-JUL-2024 at another clinic and 3rd dose of Bexsero at off site clinic on 10-JUL-2024). The outcome of the interchange of vaccine products 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: 11-JUL-2024 A pharmacist reported that a patient receives 1st dose of Bexsero on 1-AUG-2023, 2nd dose of Trumenba on 3-JUL-2024 at another clinic which led to Interchange of vaccine products and 3rd dose of Bexsero at off site clinic on 10-JUL-2024.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: low fever (99 degrees); feeling tired; pain and soreness in her right arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on an unknown date with no side effects). Concurrent medical conditions included illness (was just getting over an illness where she had fever for a month).   On 09-JUL-2024, the patient received the 2nd dose of Shingrix (right arm). On 10-JUL-2024, 1 days after receiving Shingrix, the patient experienced fever (Verbatim: low fever (99 degrees)), tiredness (Verbatim: feeling tired) and pain in arm (Verbatim: pain and soreness in her right arm). The outcome of the fever, tiredness and pain in arm were unknown.   It was unknown if the reporter considered the fever, tiredness and pain in arm to be related to Shingrix.     It was unknown if the company considered the fever, tiredness and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-JUL-2024 The patient self-reported this case. The patient got her 2nd dose of Shingrix vaccine at a local pharmacy and noticed yesterday (prior to reporting day) that was having low fever, feeling tired, had pain and soreness in her right arm. The patient lived in an (redacted) place and it was very hot had a sweater that had to tell us. The patient did not experienced these side effects with the 1st dose The patient said that she was just getting over an illness where she had fever for a month and she did not knew if the illness was returning or if the fever was caused by the vaccine.  Lot and expiration date were unknown. No additional events were reported. The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2024086624:1ST DOSE CASE
Age: 0.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered a KINRIX vaccine to a six month old; administered a KINRIX vaccine to a six month old; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 10-JUL-2024, the patient received Kinrix (intramuscular, left thigh). On 10-JUL-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administered a KINRIX vaccine to a six month old) and inappropriate schedule of vaccine administered (Verbatim: administered a KINRIX vaccine to a six month old). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-JUL-2024 The nurse from the clinic reported the child received Kinrix vaccination was given for the 6 months old child, however Kinrix was for ages 4 to 6 years old.  Upon receipt of transfer, healthcare professional clarified that this dose of Kinrix given inadvertently to 6 month old patient was dose two of the DTaP series. The patient had previously received a dose of Infanrix at age of 2 months.  Healthcare professional further provided that the patient's mother wanted to space out the vaccines and she (the mother) did not want combo vaccines given to the patient.  The reporter stated one of her staff administered a Kinrix vaccine to a six month old and she was looking for information on that. The patient received Kinrix vaccine for the 6 months old child, which led to Inappropriate age at vaccine administration and Inappropriate schedule of vaccine administered. No further details provided The reporter consented to follow up.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination, Product dose omission issue
Clinical narrative: got a first Twinrix dose on January and missed the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old male patient who received HAB (Twinrix adult) for prophylaxis.   Previously administered products included Twinrix adult (received 1st dose on 23rd January 2024).   On an unknown date, the patient did not receive the 2nd dose of Twinrix adult. On an unknown date, an unknown time after receiving Twinrix adult, the patient experienced incomplete course of vaccination (Verbatim: got a first Twinrix dose on January and missed the second dose). The outcome of the incomplete course of vaccination 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: 12-JUL-2024 Pharmacist had patient that got a first Twinrix dose on January and missed the second dose, which led to incomplete course of vaccination. The Vaccine Administration Facility was the same as Primary Reporter The reporter consent to follow up. The case is linked with US2024087723, by same reporter.; Sender's Comments:  US-GSK-US2024087723:SAme reporter/Different patient
Sex: U
Vaccine: MEN, MENB
Symptoms: Unevaluable event
Clinical narrative: that patient got a first dose of Men B vaccine (unknown brand) at 13 years of age, and then a second Men B vaccine Bexsero at 16 years of age.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of interchange of vaccine products in a 16-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included MENINGOCOCCAL VACCINE B for prophylaxis.   On an unknown date, the patient received the 2nd dose of Bexsero and the 1st dose of MENINGOCOCCAL VACCINE B. On an unknown date, an unknown time after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: that patient got a first dose of Men B vaccine (unknown brand) at 13 years of age, and then a second Men B vaccine Bexsero at 16 years of age.). The outcome of the interchange of vaccine products 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: 12-JUL-2024 Healthcare professional wanted to get information about a booster dose of Bexsero to shared with the provider because they know that patient got a first dose of Meningococcal vaccine B (unknown brand) at 13 years of age, and then a second Men B vaccine Bexsero at 16 years of age which led to interchange of vaccine products. No further information was provided.
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose not received yet; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 4-month-old male patient who received Rota (Rotarix liquid formulation) for prophylaxis.   Concomitant products included ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX).   On an unknown date, the patient did not receive the 2nd dose of Rotarix liquid formulation. On an unknown date, an unknown time after receiving Rotarix liquid formulation, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose not received yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 12-JUL-2024 The reporter reported that patient received his first dose of Rotarix liquid at 17 weeks of age and Healthcare professional would like to know if they should give 2nd dose on day of reporting. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had several patients in practice not receive second Shingrix dose within recommended time interval/ still haven't received the second dose; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patients did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: had several patients in practice not receive second Shingrix dose within recommended time interval/ still haven't received the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 15-JUL-2024 The physician stated that he had several patients in practice that not received second Shingrix dose within recommended time interval.  He stated that when he would see them for a physical it was noted that they hadn't received the second dose so he would given them a prescription and told them to get the second dose, and they come back a year later for next physical and still had not received the second dose.  He did not had any patient specific information available at the time of call. Till the time of reporting, the patients did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 0.75
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 9 months old patient received Kinrix vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old female patient who received DTPa-IPV (Kinrix) (batch number MZ379, expiry date 25-JAN-2025) for prophylaxis.   On 11-JUL-2024, the patient received Kinrix. On 11-JUL-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 9 months old patient received Kinrix vaccine). 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: 11-JUL-2024 Nurse reported that, a 9 months old patient received Kinrix vaccine as a 3rd Dtap dose and 3rd IPV dose by error which led inappropriate age at vaccine administration. Permission to have an account on Medical Information system declined.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: Suspected vaccine failure; Shingles; Drug dose administration interval too long; This serious case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 02-DEC-2021, the patient received the 2nd dose of Shingrix. On 04-DEC-2018, the patient received the 1st dose of Shingrix. On 02-DEC-2021, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Drug dose administration interval too long). In MAY-2024, the patient experienced vaccination failure (Verbatim: Suspected vaccine failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and drug dose administration interval too long were unknown and the outcome of the shingles was resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 16-JUL-2024 The reporter reported that 77-year-old patient had 2 Shingrix vaccines, first dose on 4th December 2018 and second dose 2nd December 2021. The patient got shingles on May and was getting over the disease now. The vaccine administration facility was the same as primary reporter. the patient received the 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule. This case was considered as suspected vaccination failure as laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix (Dose 1 and Dose 2).
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Intracranial aneurysm
Clinical narrative: brain aneurysm/just found two very small aneurysms on last checkup; This serious case was reported by a nurse via call center representative and described the occurrence of aneurysm cerebral in a 64-year-old female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On 20-OCT-2013, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced aneurysm cerebral (Verbatim: brain aneurysm/just found two very small aneurysms on last checkup) (serious criteria GSK medically significant). The outcome of the aneurysm cerebral was not resolved.   It was unknown if the reporter considered the aneurysm cerebral to be related to Tdap Vaccine.     The company considered the aneurysm cerebral to be unrelated to Tdap Vaccine.   Additional Information: GSK Receipt Date: 17-JUL-2024 The reporter was a nurse at the travel clinic, she had patient who was overdue for her tDap but she also had a brain aneurysm that they had been watching and they had just found two very small aneurysms on last checkup. Last tDap vaccine was administered and it was unknown which vaccine or manufacturer of last tDap vaccine.  The reporter asked, was this safe with a brain aneurysm. At the end of the call, the nurse said that they would defer the administration of the Boostrix. It was unknown whether Boostrix was administered to the patient or not, it had not been administered at the time of the reporting.; Sender's Comments: Intracranial aneurysm  is an unlisted events which is considered unrelated to GSK vaccine Tdap Vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Thymectomy
Clinical narrative: thymectomy; This serious case was reported by a pharmacist via call center representative and described the occurrence of thymectomy in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced thymectomy (Verbatim: thymectomy) (serious criteria clinically significant/intervention required). The outcome of the thymectomy was unknown.   It was unknown if the reporter considered the thymectomy to be related to Shingrix.     The company considered the thymectomy to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 17-JUL-2024 The pharmacist reported that a patient received Shingrix vaccine and experienced thymectomy. The reporter asked if a patient could receive second dose as he had thymectomy. No further information provided. The inquiry received via webform so specialist was unable to further clarify timing of thymectomy or ascertain any potential related condition, due to this inquiry regarding second dose of the vaccine, this was being submitted as a potential adverse event out of caution. All available details were being provided and no further information was available from medical information team.; Sender's Comments: Thymectomy is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site discomfort, Injection site mass, Injection site pain
Clinical narrative: fatigue; pain at the injection site with the lump remaining for weeks; pain at the injection site with the lump remaining for weeks; injection felt like syrup going in; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29-MAY-2024, the patient received the 1st dose of Shingrix. On 29-MAY-2024, less than an hour after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at the injection site with the lump remaining for weeks), injection site lump (Verbatim: pain at the injection site with the lump remaining for weeks) and injection site discomfort (Verbatim: injection felt like syrup going in). On 30-MAY-2024, the patient experienced fatigue (Verbatim: fatigue). The outcome of the injection site pain, injection site lump and fatigue were resolved and the outcome of the injection site discomfort was not reported.   It was unknown if the reporter considered the injection site pain, injection site lump, injection site discomfort and fatigue to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site lump, injection site discomfort and fatigue to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-JUL-2024 The patient self-reported this case. She received her first dose of Shingrix and the injection felt like syrup going in and immediately created a lump.   She reported having a high degree of pain at the injection site with the lump remaining for weeks.  The lump started out about 1 inch in diameter and it slowly reduced in size and at the end of June 2024, it was about half the original size. She had since recovered and the lump was gone. The reporter did not consent to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Immune-mediated myositis
Clinical narrative: Immune-Mediated Necrotizing Myopathy; This is a literature report.  A patient (age and gender not provided) received BNT162b2 (COMIRNATY NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: IMMUNE-MEDIATED MYOSITIS (medically significant), outcome "unknown", described as "Immune-Mediated Necrotizing Myopathy". Case report: SARS-CoV-2 has been associated with multiple disease processes and chronic sequela. Much less understood are the neurological effects, ranging from headaches, pro-thrombotic state, encephalitis, and myopathic processes. Many case reports have documented post-SARS-CoV-2 virus effects; however, this case highlights the possibility of a less commonly described neurological manifestation possibly related to the BNT162b2 mRNA Pfizer vaccine. There is scant literature on immune-mediated necrotizing myopathy (IMNM) triggered after COVID-19 vaccination. The BNT162b2 mRNA COVID-19 vaccine (Pfizer, BioNTech) has proven to be safe and effective in reducing transmission of COVID-19, but post-vaccination neurological events, including venous sinus thrombosis, transverse myelitis, and immune-mediated diseases, such as Guillain-Barre syndrome, have been reported. The authors reported a case of IMNM with HMG-CoA reductase antibody positivity in the setting of BNT162b2 vaccination. The patient presented with progressive muscle weakness with rhabdomyolysis and necrotizing autoimmune myopathy proven on muscle biopsy after the second dose of the BNT162b2 vaccine. Ultimately, this case report highlights the importance of clinical suspicion for early diagnosis and initiation of treatment after symptoms concerning necrotizing myopathy.  No follow-up attempts are possible.; Sender's Comments: Based on the information currently available, the possible contribution of the administration of suspect drug BNT162B2 (COMIRNATY NOS) to the occurrence of the reported event Immune-mediated necrotizing myopathy cannot be excluded due to the implied temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Corneal scar, Eye pain, Lacrimation increased, Ocular hyperaemia, Photophobia
Clinical narrative: corneal scaring; left eye as well as cloudiness and extreme pain and flare-ups of pain/cloudiness in his vision at times; left eye as well as cloudiness and extreme pain and flare-ups of pain; redness of the patient's cornea; sensitivity of light; tearing when flare ups occur; This is a spontaneous report received from a Consumer or other non HCP.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 21Jun2021 at 16:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 21 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Retinopathy of prematurity" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Single, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Single, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: CORNEAL SCAR (disability) with onset 18Jan2024 at 12:15, outcome "not recovered", described as "corneal scaring"; EYE PAIN (disability) with onset 18Jan2024 at 12:15, outcome "not recovered", described as "left eye as well as cloudiness and extreme pain and flare-ups of pain"; VISION BLURRED (disability) with onset 18Jan2024 at 12:15, outcome "not recovered", described as "left eye as well as cloudiness and extreme pain and flare-ups of pain/cloudiness in his vision at times"; OCULAR HYPERAEMIA (disability) with onset 18Jan2024 at 12:15, outcome "not recovered", described as "redness of the patient's cornea"; PHOTOPHOBIA (disability) with onset 18Jan2024 at 12:15, outcome "not recovered", described as "sensitivity of light"; LACRIMATION INCREASED (disability) with onset 18Jan2024 at 12:15, outcome "not recovered", described as "tearing when flare ups occur". The events "corneal scaring", "left eye as well as cloudiness and extreme pain and flare-ups of pain/cloudiness in his vision at times", "left eye as well as cloudiness and extreme pain and flare-ups of pain", "redness of the patient's cornea", "sensitivity of light" and "tearing when flare ups occur" required physician office visit. Therapeutic measures were taken as a result of corneal scar, vision blurred, eye pain, ocular hyperaemia, photophobia, lacrimation increased. Clinical course: The patient had developed corneal scaring of 3mm within his left eye as well as cloudiness and extreme pain and flare-ups of pain as well as redness of the patient's cornea, have a sensitivity to light and have tearing when the flare-ups occur. Also, have been noticing a cloudiness in his vision at times and his eyes start to tear up and he feel extreme pain. Doctors did not know what the issue is or how to treat the situation ever since January.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: corneal scaring; left eye as well as cloudiness and extreme pain and flare-ups of pain/cloudiness in his vision at times; left eye as well as cloudiness and extreme pain and flare-ups of pain; redness of the patient's cornea; sensitivity of light; tearing when flare ups occur; This is a spontaneous report received from a Consumer or other non HCP.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 21Jun2021 at 16:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 21 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Retinopathy of prematurity" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Single, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Single, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: CORNEAL SCAR (disability) with onset 18Jan2024 at 12:15, outcome "not recovered", described as "corneal scaring"; EYE PAIN (disability) with onset 18Jan2024 at 12:15, outcome "not recovered", described as "left eye as well as cloudiness and extreme pain and flare-ups of pain"; VISION BLURRED (disability) with onset 18Jan2024 at 12:15, outcome "not recovered", described as "left eye as well as cloudiness and extreme pain and flare-ups of pain/cloudiness in his vision at times"; OCULAR HYPERAEMIA (disability) with onset 18Jan2024 at 12:15, outcome "not recovered", described as "redness of the patient's cornea"; PHOTOPHOBIA (disability) with onset 18Jan2024 at 12:15, outcome "not recovered", described as "sensitivity of light"; LACRIMATION INCREASED (disability) with onset 18Jan2024 at 12:15, outcome "not recovered", described as "tearing when flare ups occur". The events "corneal scaring", "left eye as well as cloudiness and extreme pain and flare-ups of pain/cloudiness in his vision at times", "left eye as well as cloudiness and extreme pain and flare-ups of pain", "redness of the patient's cornea", "sensitivity of light" and "tearing when flare ups occur" required physician office visit. Therapeutic measures were taken as a result of corneal scar, vision blurred, eye pain, ocular hyperaemia, photophobia, lacrimation increased. Clinical course: The patient had developed corneal scaring of 3mm within his left eye as well as cloudiness and extreme pain and flare-ups of pain as well as redness of the patient's cornea, have a sensitivity to light and have tearing when the flare-ups occur. Also, have been noticing a cloudiness in his vision at times and his eyes start to tear up and he feel extreme pain. Doctors did not know what the issue is or how to treat the situation ever since January.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Knee arthroplasty
Clinical narrative: knee replacement surgery; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 72-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Mar2024 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Feb2021, when the patient was 69 years old, for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Comirnaty (2023-2024 formula) (DOSE 1, SINGLE), administration date: Sep2023, when the patient was 71 years old, for COVID-19 immunization. The following information was reported: KNEE ARTHROPLASTY (medically significant), outcome "unknown", described as "knee replacement surgery". Clinical course: Reporter got a Covid 19 booster, Comirnaty 2023-2024, almost 4 months ago on 30Mar2024. She got a dose of the same updated vaccine 6 months prior (that was the only one that was available). She going on an overseas trip in a month. Reporter stated that, If she got another 2023-2024 booster at the end of this month at the 4 month mark, how long will she need to wait or what the minimum interval from last dose to be able to get the new updated one (2024-2025 booster). Reporter stated that she had a knee replacement surgery scheduled on 18Nov2024, when she get back, and wanted to be protected. she always had the Pfizer Covid 19 vaccines and appreciated it being available. Received all of the recommended vaccines. First dose started out at the hospital at (Name withheld). Second dose was at a clinic, a vaccine clinic at the (name withheld).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400221119 same reporter/drug,different patient/AE;US-PFIZER INC-202400221788 same patient/product, different dose/event;
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular disorder, Depressed mood, Inflammation, Mixed dementia, Vascular dementia
Clinical narrative: vascular dementia; extra inflammation; some increase maybe in vascular part of brain; passed away from mixed dementia; went down hill; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old male patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Alzheimer's" (unspecified if ongoing); "vascular" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DEPRESSED MOOD (non-serious) with onset 2021, outcome "unknown", described as "went down hill"; VASCULAR DEMENTIA (death), outcome "fatal"; INFLAMMATION (death), outcome "fatal", described as "extra inflammation"; CEREBROVASCULAR DISORDER (death), outcome "fatal", described as "some increase maybe in vascular part of brain"; MIXED DEMENTIA (death), outcome "fatal", described as "passed away from mixed dementia". The patient date of death was 01Aug2022. Reported cause of death: "vascular dementia", "extra inflammation", "passed away from mixed dementia", "some increase maybe in vascular part of brain". It was unknown if an autopsy was performed. Caller noted this with other study, may be a coincidence, may not, but patient went down hill very fast. Patient got first COVID vaccine in Feb2021, when first available, then went down hill very quickly, more from vascular dementia, and then passed away 01Aug2022, and so is possible that it caused some increase maybe in vascular part of brain, that extra inflammation or whatever vaccine did. When initially diagnosed, may have been coincidence, but patient was in good excellent health other than the condition, and doctors thought patient might live to be 85 or 80 years old, but patient passed away 6 months before 70th birthday. Clarified and confirmed patient did not ever have Covid, as far as caller knows patient never had Covid. Patient was part of (withheld) study on patient's brain, patient passed away from mixed dementia, patient's brain was donated, had Alzheimer's and vascular, which caller clarified and confirmed started prior to patient receiving the Pfizer COVID vaccine.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Reported Cause(s) of Death: some increase maybe in vascular part of brain; vascular dementia; extra inflammation; passed away from mixed dementia
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had Covid; had Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 (BNT162B2 NOS), in 2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 09Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "had Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: after five days was negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: When patient had Covid first time she had Paxlovid and quarantined and after five days was negative and two days later it came back and was told that it was a rebound case. She was already inoculated. She had at least two booster shots one the year of 2022 and 2023 for Pfizer Covid Immunity Shot. Patient had COVID-19 in Nov2022 and has been inoculated and had her first two boosters. Later clarified either three or four boosters (as reported).   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: had covid/her second time; had covid/her second time; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 19Mar2021, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE), administration date: 09Apr2021, for COVID-19 immunisation; Bnt162b2 nos (DOSE 3 (BOOSTER), SINGLE), administration date: 2022, for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2024, outcome "not recovered" and all described as "had covid/her second time". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient clarified that this was her second time and has been a little over a year. Later clarified that it was longer than a year. Had at least two booster shots one the year of 2022 and 2023 for Pfizer Covid Immunity Shot. Does not take any medications and simply had Covid again. Was exposed to someone last week. was her second time having Covid. Was sick with Covid today right now.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400221459 same reporter/patient, different dose;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I had a vaccine, and so the first time I got COVID, I had already had the vaccines and I feel like it; I had a vaccine, and so the first time I got COVID, I had already had the vaccines and I feel like it; This is a spontaneous report received from a Nurse, Program ID.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I had a vaccine, and so the first time I got COVID, I had already had the vaccines and I feel like it". Clinical course: Patient reported that she had a vaccine, and so the first time she got COVID, she had already had the vaccines and she feel like it. She was to call for financial assistance, but she did the enrollment herself, but she kept saying that she had COVID before and that she kept talking, she figured out that she was taking Paxlovid before (later clarified the consumer has not taken Paxlovid yet) also and had the shot." Reporter stated, "she had not taken Paxlovid before, she have had COVID before but did not have Paxlovid was not around then, that can, she thought it was in Summer of 22, she was not aware of the thing around anyway, so she did not had 'affected' (word not clarified)." Reporter stated, "Yes, for the Paxlovid she had not started yet, but she thought she was connecting them to talk about the vaccines, which she had worked well 'from', so she thought it was all that understanding." She had a vaccine (unspecified vaccine), she stated that she had never had any reactions to them and she did well, through the COVID.; Sender's Comments: A causal relationship to the suspect drug BNT162b2 cannot be excluded for event drug ineffective. This case will be reassessed upon receipt of additional information.