chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Back disorder, Gastritis, Muscle spasms, Pain
Clinical narrative: bad back; gastritis; leg cramps; hurts all of the time below her boob; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 63-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), 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 , four years ago ), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE, four years ago ), for Covid-19 immunization. The following information was reported: BACK DISORDER (non-serious), outcome "unknown", described as "bad back"; GASTRITIS (non-serious), outcome "unknown"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "leg cramps"; PAIN (non-serious), outcome "unknown", described as "hurts all of the time below her boob". Therapeutic measures were taken as a result of gastritis.  Additional information: The patient said she got the Pfizer COVID shots about four years ago and she recently developed some problems and she wants to know if they are as a result of the shots that she had. She received the 3 shots of the Pfizer Covid-19 vaccine when it first came out and stated that she didn't feel anything. Upon asking if she had experienced any side effects, she stated, "just my back" and that "she had a bad back anyway." She stated that "her dad had really bad gas and she had gastritis." she "had gastritis that she had to take pills and everything for. She stated "it hurts all of the time below her boob." she had been experiencing leg cramps for a while and she never experienced them before receiving the vaccine. She said she took the Pfizer COVID shots three times when COVID came out and she'd like to know if they can cause problems with her body years down the road because she has been having problems with her body and she was wondering if it is from the Pfizer shots because they did not have enough information.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling at the injection site and it is very warm and painful; Redness and swelling at the injection site and it is very warm and painful; Redness and swelling at the injection site and it is very warm and painful; Redness and swelling at the injection site and it is very warm and painful; This is a spontaneous report received from an Other HCP.  A 16-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 13Sep2024 as dose 1, 0.5 ml single (Batch/Lot number: unknown) at the age of 16 years intramuscular, in arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE PAIN (non-serious) all with onset Sep2024, outcome "recovered" and all described as "Redness and swelling at the injection site and it is very warm and painful".  Additional information: Reported as, All three of them have had redness and swelling at the injection site and it is very warm and painful. When probed to clarify if three patients experienced the same adverse events from Trumenba, Pfizer sales representative confirmed the same. Pfizer sales representative believed there was no any 4-week prior vaccination. Regarding event Start date, stated, "Like the next day". Pfizer sales representative stated, It was, for each dose that was given, they started seeing that either later on that evening or the following day. Pfizer sales representative stated, The one (first patient) that just experienced it on 08Apr, yes. She started feeling it on 09Apr, so she is still experiencing it, the other ones are not. Investigations: No.   Relatedness of drug to event: Source of assessment; Primary source reporter, Method of assessment; Global introspection, Result of Assessment; Yes.  The information on the batch/lot number for meningococcal group b Rlp2086 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500077881 Same reporter/drug/AE, different patient;US-PFIZER INC-202500078175 Same reporter/drug/AE, different patient;
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling at the injection site and it is very warm and painful; Redness and swelling at the injection site and it is very warm and painful; Redness and swelling at the injection site and it is very warm and painful; Redness and swelling at the injection site and it is very warm and painful; This is a spontaneous report received from an Other HCP.  A 16-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 08Apr2025 as dose 3, 0.5 ml, single (Batch/Lot number: unknown) at the age of 16 years intramuscular, in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: trumenba (DOSE 1, SINGLE), administration date: 28Jun2024, for Immunisation; trumenba (DOSE 2, SINGLE), administration date: 05Aug2024, for Immunisation. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 09Apr2025, outcome "not recovered" and all described as "Redness and swelling at the injection site and it is very warm and painful".  Additional information:  All three of them have had redness and swelling at the injection site and it is very warm and painful. When probed to clarify if three patients experienced the same adverse events from Trumenba, Pfizer sales representative confirmed the same. Pfizer sales representative stated, "The first dose was given on 28Jun2024 (June 28th, 2024)." Indication: Pfizer sales representative stated, "It is recommended and the physician assistance recommended it. It is a vaccine."  Pfizer sales representative stated, "Back to the first one, she actually had a total of three doses, so I am going to give you those other two doses as well. The second dose that she had was on 05Aug2024 (August 5th, 2024) and the third dose was given on 08Apr2025 (April 8th, 2025)."  When probed to clarify the start date of events for first patient as 09Apr2025, Pfizer sales representative stated, "Yes." Still experiencing: Pfizer sales representative stated, "The one (first patient) that was vaccinated on 08Apr2025, yes. She started feeling it on 09Apr2025, so she is still experiencing it, the other ones are not. Causality: Pfizer sales representative stated, "Yes."  The information on the batch/lot number for meningococcal group b Rlp2086 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500077862 Same reporter/drug/AE, different patient;US-PFIZER INC-202500078175 Same reporter/drug/AE, different patient;
Sex: M
Vaccine: COVID19
Symptoms: Flatulence
Clinical narrative: dad had really bad gas; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, 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: FLATULENCE (non-serious), outcome "unknown", described as "dad had really bad gas". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling at the injection site and it is very warm and painful; Redness and swelling at the injection site and it is very warm and painful; Redness and swelling at the injection site and it is very warm and painful; Redness and swelling at the injection site and it is very warm and painful; This is a spontaneous report received from an Other HCP.  A 17-year-old male patient received meningococcal group b Rlp2086 (TRUMENBA), on 15Jan2025 as dose 2, 0.5 ml single (Batch/Lot number: unknown) at the age of 17 years intramuscular, in arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: meningococcal group b Rlp2086 (DOSE 1; MANUFACTURER UNKNOWN), administration date: 03Jan2024, for Immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE PAIN (non-serious) all with onset Jan2025, outcome "recovered" (2025) and all described as "Redness and swelling at the injection site and it is very warm and painful".  Additional information: Reported as, All three of them have had redness and swelling at the injection site and it is very warm and painful. When probed to clarify if three patients experienced the same adverse events from Trumenba, Pfizer sales representative confirmed the same. Pfizer sales representative believed there was no any 4-week prior vaccination. Regarding event Start date, stated, "Like the next day". Pfizer sales representative stated, It was, for each dose that was given, they started seeing that either later on that evening or the following day. Pfizer sales representative stated, The one (first patient) that just experienced it on 08Apr, yes. She started feeling it on 09Apr, so she is still experiencing it, the other ones are not.  Relatedness of drug to event: Source of assessment; Primary source reporter, Method of assessment; Global introspection, Result of Assessment; Yes.  The information on the batch/lot number for meningococcal group b Rlp2086 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500077862 Same reporter/drug/AE, different patient;US-PFIZER INC-202500077881 Same reporter/drug/AE, different patient;
Sex: F
Vaccine: HEP, PNC20
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; fatigue; headache; minor fever; This is a spontaneous report received from a Consumer or other non HCP.  A 55-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 13Apr2025 at 08:15 as dose 1, single (Batch/Lot number: unknown), in arm for immunisation; hepatitis B vaccine (HEPATITIS B VACCINE), on 13Apr2025 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Sulfa and penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Apr2025, outcome "recovering", described as "Sore arm"; FATIGUE (non-serious) with onset Apr2025, outcome "recovering"; HEADACHE (non-serious) with onset Apr2025, outcome "recovering"; PYREXIA (non-serious) with onset Apr2025, outcome "recovering", described as "minor fever". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, headache, pyrexia.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: Increase blood sugar; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, 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: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "Increase blood sugar".  Additional information: Reporter stated, "administered a COVID vaccine (Clarified as Pfizer COVID-19 Vaccine) for a patient on April 1st. She was reporting a side effect of increase blood sugar ever since. Reporter just want to know if this was something that was reported to you guys in the past, there was a history.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; fever of a 101; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, 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: CHILLS (non-serious), outcome "recovering"; PYREXIA (non-serious), outcome "recovering", described as "fever of a 101". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She took a COVID Vaccine (further could not be clarified if Pfizer product, hence is this a Pfizer product tab left unchecked) on last Tuesday and then on Thursday she had chills, fever of a 101. She said, she was in bed all day, Saturday and Sunday and today she feels fine.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: PNC20
Symptoms: Pain in extremity, Rash
Clinical narrative: pain in the arm where vaccine administered as well as a rash; pain in the arm where vaccine administered as well as a rash; This is a spontaneous report received from an Other HCP.  An adult female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 04Apr2025 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE RASH (non-serious) all with onset 04Apr2025, outcome "recovered" and all described as "pain in the arm where vaccine administered as well as a rash". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site rash.  Additional information: The patient did not receive any other vaccines on the same date, any other vaccines within 4 weeks and any other medications within 2 weeks of the event. The patient experienced pain in the arm where vaccine administered as well as a rash the same day of vaccination. Both side effects lasted a few days and subsided.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: PNC20
Symptoms: Drug ineffective, Meningitis, Pneumonia, Streptococcal infection
Clinical narrative: Drug ineffective; pneumonia; meningitis; strep; This is a spontaneous report received from an Other HCP. Other Case identifier(s): 02783043 (Merck).  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; PNEUMONIA (medically significant), outcome "unknown"; MENINGITIS (medically significant), outcome "unknown"; STREPTOCOCCAL INFECTION (medically significant), outcome "unknown", described as "strep". The patient was in the hospital with strep, pneumonia, and meningitis. Unknown by reporter what the cause of the hospitalization was. Unknown by reporter what the cause of the strep, pneumonia, and meningitis was.   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with PREVNAR 20 in this patient cannot be completely excluded.  Further information like confirmative serotype results and vaccination schedule are needed for full medical assessment..
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I have COVID, and I had all the shots; I have COVID, and I had all the shots; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 61-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pneumonia" (unspecified if ongoing), notes: I have a history of pneumonia. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I have COVID, and I had all the shots".  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient requested flu vaccine but had already received at primary doctor's office. This was not disclosed to nurse. Patient did not experience any adverse effects.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Deep vein thrombosis, Erythema, Fibrin D dimer increased, Peripheral swelling
Clinical narrative: Redness noted in right leg and reported swelling up to the thigh on the morning of April 11th. He was seen in the provider office and diagnosed with Cellulitis and treated with Doxycycline. And they conducted a D-Dimer test which was elevated. He was seen again in the office on Monday April 14th and diagnosed with DVT and prescribed Eliquis
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound Doppler abnormal
Clinical narrative: Redness noted in right leg and reported swelling up to the thigh on the morning of April 11th. He was seen in the provider office and diagnosed with Cellulitis and treated with Doxycycline. And they conducted a D-Dimer test which was elevated. He was seen again in the office on Monday April 14th and diagnosed with DVT and prescribed Eliquis
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain at the injection site, injection site swelling, warm to the touch
Age: 0.75
Sex: M
Vaccine: DTAPIPVHIB, PNC20
Symptoms: Abnormal behaviour, Head banging, Infant irritability, Pyrexia, Rhinorrhoea
Clinical narrative: Mother previously chose to not to vaccinate. On 04/09/2025 at child's 12 month well baby exam appointment, mother reported on the evening of 01/16/2025, sleep pattern changed, irritable, fever hitting head on wall, runny nose, pulling hair, lasting for approximately 4 weeks (1 month)
Age: 0.75
Sex: M
Vaccine: DTAPIPVHIB, PNC20
Symptoms: Sleep disorder
Clinical narrative: Mother previously chose to not to vaccinate. On 04/09/2025 at child's 12 month well baby exam appointment, mother reported on the evening of 01/16/2025, sleep pattern changed, irritable, fever hitting head on wall, runny nose, pulling hair, lasting for approximately 4 weeks (1 month)
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Back pain, Injection site pain
Clinical narrative: 9 days of deltoid + L upper back pain
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Pain
Clinical narrative: fatigue, soreness
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rash
Clinical narrative: patient has a rash on her left arm. unable to tell if it is due to influenza or shingles vaccine.  has not worsened over time. patient will continue to monitor and take a benadryl
Age: 78.0
Sex: F
Vaccine: COVID19, PNC21
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: With about 3 hours low grade fever and chills. Arm ( injection site area) become painful and hot/ red in about a 1 by  5 inch band. The arm redness and swelling increased in size to about a 7 inch by 8 inch triangular to oval shaped patch by 4/16.  The arm was very hot to the touch and painful. the patient was advised to take diphenhydramine and acetaminophen. by 4/17 the swelling and redness had gone down somewhat. The redness area moved further down toward the elbow. The Fever and chills went away.
Age: 78.0
Sex: F
Vaccine: COVID19, PNC21
Symptoms: Pyrexia
Clinical narrative: With about 3 hours low grade fever and chills. Arm ( injection site area) become painful and hot/ red in about a 1 by  5 inch band. The arm redness and swelling increased in size to about a 7 inch by 8 inch triangular to oval shaped patch by 4/16.  The arm was very hot to the touch and painful. the patient was advised to take diphenhydramine and acetaminophen. by 4/17 the swelling and redness had gone down somewhat. The redness area moved further down toward the elbow. The Fever and chills went away.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Syncope
Clinical narrative: syncope
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Exposure to SARS-CoV-2, Viral test
Clinical narrative: Cough, exposure to COVID-19
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Back pain, Balance disorder, Chills, Diplopia, Fatigue
Clinical narrative: he tested positive for COVID-19; he tested positive for COVID-19; This is a spontaneous report received from a Physician from medical information team.  An 80-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Jan2025 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "heart attack" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 4, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3, SINGLE), for COVID-19 immunization, reaction(s): "mild COVID"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "he tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: COVID-19: (Jan2025) Positive; (Jan2025) not test positive. Clinical course: The patient received the vaccine on 06Jan2025, and by the end of the month, he had a moderate to severe reaction that doctors suspected might have been related to Guillain-Barre syndrome. He didn't test positive for COVID-19 at that time but had the impression that the vaccine was triggering an immune response against his own cells. Shortly after that, he was admitted to the hospital by the end of January, where he tested positive for COVID-19.  The information on the batch/lot number for [BNT162B2 OMICRON (KP.2)] has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with COMIRNATY in this patient cannot be completely excluded.  ,Linked Report(s) : US-PFIZER INC-202500081840 same patient, different event, different dose of vaccine;
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Hyperhidrosis, Hypoaesthesia, Neurological symptom, Pain in extremity, Poor quality sleep
Clinical narrative: he tested positive for COVID-19; he tested positive for COVID-19; This is a spontaneous report received from a Physician from medical information team.  An 80-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Jan2025 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "heart attack" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 4, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3, SINGLE), for COVID-19 immunization, reaction(s): "mild COVID"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "he tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: COVID-19: (Jan2025) Positive; (Jan2025) not test positive. Clinical course: The patient received the vaccine on 06Jan2025, and by the end of the month, he had a moderate to severe reaction that doctors suspected might have been related to Guillain-Barre syndrome. He didn't test positive for COVID-19 at that time but had the impression that the vaccine was triggering an immune response against his own cells. Shortly after that, he was admitted to the hospital by the end of January, where he tested positive for COVID-19.  The information on the batch/lot number for [BNT162B2 OMICRON (KP.2)] has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with COMIRNATY in this patient cannot be completely excluded.  ,Linked Report(s) : US-PFIZER INC-202500081840 same patient, different event, different dose of vaccine;
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: he tested positive for COVID-19; he tested positive for COVID-19; This is a spontaneous report received from a Physician from medical information team.  An 80-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Jan2025 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "heart attack" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 4, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3, SINGLE), for COVID-19 immunization, reaction(s): "mild COVID"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "he tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: COVID-19: (Jan2025) Positive; (Jan2025) not test positive. Clinical course: The patient received the vaccine on 06Jan2025, and by the end of the month, he had a moderate to severe reaction that doctors suspected might have been related to Guillain-Barre syndrome. He didn't test positive for COVID-19 at that time but had the impression that the vaccine was triggering an immune response against his own cells. Shortly after that, he was admitted to the hospital by the end of January, where he tested positive for COVID-19.  The information on the batch/lot number for [BNT162B2 OMICRON (KP.2)] has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with COMIRNATY in this patient cannot be completely excluded.  ,Linked Report(s) : US-PFIZER INC-202500081840 same patient, different event, different dose of vaccine;
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Cerebrovascular accident, Chest pain, Colitis, Dysphagia
Clinical narrative: he tested positive for COVID-19; he tested positive for COVID-19; This is a spontaneous report received from a Physician from medical information team.  An 80-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Jan2025 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "heart attack" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 4, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3, SINGLE), for COVID-19 immunization, reaction(s): "mild COVID"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "he tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: COVID-19: (Jan2025) Positive; (Jan2025) not test positive. Clinical course: The patient received the vaccine on 06Jan2025, and by the end of the month, he had a moderate to severe reaction that doctors suspected might have been related to Guillain-Barre syndrome. He didn't test positive for COVID-19 at that time but had the impression that the vaccine was triggering an immune response against his own cells. Shortly after that, he was admitted to the hospital by the end of January, where he tested positive for COVID-19.  The information on the batch/lot number for [BNT162B2 OMICRON (KP.2)] has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with COMIRNATY in this patient cannot be completely excluded.  ,Linked Report(s) : US-PFIZER INC-202500081840 same patient, different event, different dose of vaccine;
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Illness, Myalgia, Myocardial infarction, Myocarditis
Clinical narrative: he tested positive for COVID-19; he tested positive for COVID-19; This is a spontaneous report received from a Physician from medical information team.  An 80-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Jan2025 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "heart attack" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 4, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3, SINGLE), for COVID-19 immunization, reaction(s): "mild COVID"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "he tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: COVID-19: (Jan2025) Positive; (Jan2025) not test positive. Clinical course: The patient received the vaccine on 06Jan2025, and by the end of the month, he had a moderate to severe reaction that doctors suspected might have been related to Guillain-Barre syndrome. He didn't test positive for COVID-19 at that time but had the impression that the vaccine was triggering an immune response against his own cells. Shortly after that, he was admitted to the hospital by the end of January, where he tested positive for COVID-19.  The information on the batch/lot number for [BNT162B2 OMICRON (KP.2)] has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with COMIRNATY in this patient cannot be completely excluded.  ,Linked Report(s) : US-PFIZER INC-202500081840 same patient, different event, different dose of vaccine;
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pneumonia, Post-acute COVID-19 syndrome, Productive cough, Respiratory disorder, SARS-CoV-2 test
Clinical narrative: he tested positive for COVID-19; he tested positive for COVID-19; This is a spontaneous report received from a Physician from medical information team.  An 80-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Jan2025 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "heart attack" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 4, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3, SINGLE), for COVID-19 immunization, reaction(s): "mild COVID"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "he tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: COVID-19: (Jan2025) Positive; (Jan2025) not test positive. Clinical course: The patient received the vaccine on 06Jan2025, and by the end of the month, he had a moderate to severe reaction that doctors suspected might have been related to Guillain-Barre syndrome. He didn't test positive for COVID-19 at that time but had the impression that the vaccine was triggering an immune response against his own cells. Shortly after that, he was admitted to the hospital by the end of January, where he tested positive for COVID-19.  The information on the batch/lot number for [BNT162B2 OMICRON (KP.2)] has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with COMIRNATY in this patient cannot be completely excluded.  ,Linked Report(s) : US-PFIZER INC-202500081840 same patient, different event, different dose of vaccine;
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: he tested positive for COVID-19; he tested positive for COVID-19; This is a spontaneous report received from a Physician from medical information team.  An 80-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Jan2025 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "heart attack" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 4, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3, SINGLE), for COVID-19 immunization, reaction(s): "mild COVID"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "he tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: COVID-19: (Jan2025) Positive; (Jan2025) not test positive. Clinical course: The patient received the vaccine on 06Jan2025, and by the end of the month, he had a moderate to severe reaction that doctors suspected might have been related to Guillain-Barre syndrome. He didn't test positive for COVID-19 at that time but had the impression that the vaccine was triggering an immune response against his own cells. Shortly after that, he was admitted to the hospital by the end of January, where he tested positive for COVID-19.  The information on the batch/lot number for [BNT162B2 OMICRON (KP.2)] has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with COMIRNATY in this patient cannot be completely excluded.  ,Linked Report(s) : US-PFIZER INC-202500081840 same patient, different event, different dose of vaccine;
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: he tested positive for COVID-19; he tested positive for COVID-19; This is a spontaneous report received from a Physician from medical information team.  An 80-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Jan2025 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "heart attack" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 4, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3, SINGLE), for COVID-19 immunization, reaction(s): "mild COVID"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "he tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: COVID-19: (Jan2025) Positive; (Jan2025) not test positive. Clinical course: The patient received the vaccine on 06Jan2025, and by the end of the month, he had a moderate to severe reaction that doctors suspected might have been related to Guillain-Barre syndrome. He didn't test positive for COVID-19 at that time but had the impression that the vaccine was triggering an immune response against his own cells. Shortly after that, he was admitted to the hospital by the end of January, where he tested positive for COVID-19.  The information on the batch/lot number for [BNT162B2 OMICRON (KP.2)] has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with COMIRNATY in this patient cannot be completely excluded.  ,Linked Report(s) : US-PFIZER INC-202500081840 same patient, different event, different dose of vaccine;
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, X-ray limb
Clinical narrative: Acute onset of shoulder pain, post injection that has persisted for several weeks. Pain comes and goes. NSAIDs with some relief. Seeing ortho.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Osteoarthritis, X-ray limb abnormal
Clinical narrative: Acute onset of shoulder pain, post injection that has persisted for several weeks. Pain comes and goes. NSAIDs with some relief. Seeing ortho.
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: multiple patients receiving frozen MMR vaccine; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of incorrect storage of drug in a patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: multiple patients receiving frozen MMR vaccine). The outcome of the incorrect storage of drug was not applicable.   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: 08-APR-2025 The Healthcare professional emailed to inquire about multiple patients receiving frozen MMR vaccine, which led to incorrect storage of drug. In email, Healthcare did not state if vaccine was frozen before or after re-constitution.  Healthcare wondering if patients need re-vaccinated.  Was there anything you would like to share about the primary disease.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, UNK, UNK, UNK
Symptoms: Unresponsive to stimuli
Clinical narrative: Unresponsive to stimuli/was no longer responsive; Infant was pronounced deceased; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a 3-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number B532G) for prophylaxis.   Co-suspect products included HIB vaccine conj (OMPC) (PedvaxHIB) (batch number Y013470) for prophylaxis and Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) (batch number LK6650) for prophylaxis.   The patient's past medical history included hyperglycemia, neuroleptic malignant syndrome, encephalitis (non infectious), encephalopathy, meningitis, hypotonic-hyporesponsive episode and hypoglycemia. Previously administered products included Beyfortus. Concurrent medical conditions included diabetes mellitus, guillain barre syndrome and intussusception. Additional patient notes included Patient had no any allergies.   On 13-MAR-2025, the patient received the 2nd dose of Pediarix (intramuscular), the 2nd dose of PedvaxHIB (intramuscular) and the 2nd dose of Prevnar 20 (intramuscular). On 13-MAR-2025 19:00, less than a day after receiving Pediarix, the patient experienced unresponsive to stimuli (Verbatim: Unresponsive to stimuli/was no longer responsive) (serious criteria hospitalization and GSK medically significant). On 14-MAR-2025 08:14, the patient experienced unknown cause of death (Verbatim: Infant was pronounced deceased) (serious criteria death, hospitalization and GSK medically significant). The outcome of the unresponsive to stimuli was not resolved. The patient died on 14-MAR-2025. The reported cause of death was unknown.   The reporter considered the unknown cause of death and unresponsive to stimuli to be related to Pediarix and Pediarix Pre-Filled Syringe Device.     The company considered the unknown cause of death and unresponsive to stimuli to be unrelated to Pediarix and Pediarix 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: 13-APR-2025 This case was reported by a patient via interactive digital media. Patient took vaccine such as Pediarix ,Pedvax and Prevenar 20 in right and left leg respectively via intramuscularly. Consumer reported that infant was found at home unresponsive around 19:00 on 13th March 2025, father began Cardiopulmonary Resuscitation, and infant was brought to nearest hospital where the infant was then stabilized for transfer to a facility with an available pediatric provider. Infant slowly declined and was no longer responsive to treatments in ICU (intensive care unit). The reporter considered the unknown cause of death and unresponsive to stimuli to be related to PedvaxHIB  and Prevnar 20.; Sender's Comments: Death and Unresponsive to stimuli are unlisted events which are considered unrelated to GSK vaccine Pediarix and Pediarix Pre-Filled Syringe Device.; Reported Cause(s) of Death: Unknown cause of death
Vaccine: VARZOS
Symptoms: Herpes zoster, Myalgia, Pain, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; I had the vaccine before I got them. I still have pain in my bicep in my left arm; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had the vaccine before I got them. I still have pain in my bicep in my left arm). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that it was very painful. The patient had the vaccine before the patient got them. The patient had still have pain in his/her bicep in left arm. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Age: 1.5
Sex: M
Vaccine: RVX
Symptoms: Extra dose administered
Clinical narrative: Patient recieved 3rd dose of Rotarix; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 18-month-old male patient who received Rotavirus vaccine (batch number EX434, expiry date 01-JUN-2026) for prophylaxis.   Previously administered products included Rotarix (1st dose received on 15th November 2023 with lot number YL9Y9) and Rotarix (2nd dose received on 29th January 2024 with lot number 737J5 and expiry date 5th October 2025).   On 08-APR-2025, the patient received the 3rd dose of Rotavirus vaccine. On 08-APR-2025, an unknown time after receiving Rotavirus vaccine, the patient experienced extra dose administered (Verbatim: Patient recieved 3rd dose of Rotarix). The outcome of the extra dose administered was not applicable.   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: 08-APR-2025 The patient received 3rd dose of Rotarix at 18 months of age on 08th April 2025 which led to an extra dose administration.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Havrix Expired dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 2-year-old female patient who received HAV (Havrix) (expiry date 02-MAR-2025) for prophylaxis.   On 07-APR-2025, the patient received the 1st dose of Havrix. On 07-APR-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Havrix Expired dose administered). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK Receipt Date: 10-APR-2025  Pharmacist Manager reported that in one of his clinics, a female patient received Havrix first expired dose which led to Expired vaccine administered.