chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Balance disorder, Balance disorder
Clinical narrative: She said that she had no smell, no taste, and no balance after taking them; She said that she had no smell, no taste, and no balance after taking them; She said that she had no smell, no taste, and no balance after taking them; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "multiple sclerosis" (unspecified if ongoing); "cholesterol abnormal" (unspecified if ongoing). Concomitant medication(s) included: COLESTID taken for blood cholesterol abnormal. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "no taste", "no smell", "no balance". The following information was reported: ANOSMIA (non-serious), AGEUSIA (non-serious), BALANCE DISORDER (non-serious), outcome "unknown" and all described as "She said that she had no smell, no taste, and no balance after taking them".  Additional information: She was taking Colestid which was a medication for cholesterol. She took 2 packets of it every day then she was made to take these huge pills that she really has trouble swallowing. She also wanted to know if Pfizer had a program for Eliquis and Gemtesa where she could get them at a cheaper price. She further stated that she has multiple sclerosis, and she had to take three shots of the Pfizer COVID vaccine because she was in the (PRIVACY) and she could not get them to check her blood thinner without taking the shots. She said that she had no smell, no taste, and no balance after taking the Pfizer COVID vaccine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500038008 Same patient/ product/ AEs, different doses.;US-PFIZER INC-202500069091 Same patient/ product/ AEs, different doses.;
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Balance disorder
Clinical narrative: no smell; no taste; no balance; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "multiple sclerosis" (ongoing); "cholesterol" (unspecified if ongoing). Concomitant medication(s) included: COLESTID taken for blood cholesterol abnormal. Vaccination history included: Bnt162b2 (dose 1, single), for covid-19 immunization, reaction(s): "no taste", "no smell", "no balance"; Bnt162b2 (dose 2, single), for covid-19 immunization, reaction(s): "no taste", "no smell", "no balance". The following information was reported: ANOSMIA (non-serious), outcome "unknown", described as "no smell"; AGEUSIA (non-serious), outcome "unknown", described as "no taste"; BALANCE DISORDER (non-serious), outcome "unknown", described as "no balance".  Additional information: The caller (patient) stated that she has multiple sclerosis and she had to take three shots of the Pfizer COVID vaccine because she was in the state of PRIVACY and she could not get them to check her blood thinner without taking the shots. She said that she had no smell, no taste, and no balance after taking them.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500038008 Same patient/ product/ AEs, different doses.;US-PFIZER INC-202500069090 Same patient/ product/ AEs, different doses.;
Sex: M
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Haemangioma, Ultrasound scan
Clinical narrative: She had to take the vaccine (2 doses of Pfizer COVID-19)/She had a baby boy; he had a segmental scrotal hemangioma on R scrotum; This is a spontaneous report received from a Nurse.  A neonate male patient was exposed to BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), transplacental, administration details for the mother: not provided as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The mother of the patient was 29 years old. The patient's relevant medical history was not reported. The mother's relevant medical history was not reported. The mother had no concomitant medications. No other vaccine same date. No other vaccine in four weeks. No other medications in two weeks. The mother's vaccination history included: Pfizer covid-19 vaccine (She had to take the vaccine (2 doses of Pfizer COVID-19).), for COVID-19 immunization. The following information was reported: HAEMANGIOMA (congenital anomaly) with onset 11Dec2024, outcome "recovering", described as "he had a segmental scrotal hemangioma on R scrotum"; EXPOSURE DURING PREGNANCY (congenital anomaly), outcome "recovering", described as "She had to take the vaccine (2 doses of Pfizer COVID-19)/She had a baby boy". The event "he had a segmental scrotal hemangioma on r scrotum" required physician office visit. The patient underwent the following laboratory tests and procedures: Ultrasound scan: (26Mar2025) Normal; (26Mar2025) Normal; (26Mar2025) Normal; (26Mar2025) Normal. Therapeutic measures were taken as a result of exposure during pregnancy, haemangioma. Clinical course: Patient's mom had to take the vaccine (2 doses of Pfizer COVID-19). She began working there in 2019. She had a baby boy. He was seen by a pediatric urologist as well as a pediatric dermatologist. He was put on topical timolol and the hemangioma is almost gone at dermatology f/u apt on 26Mar2025. He had a scrotal Ultrasound which was normal and on 26Mar2025 he also had an ultrasound of lumbar spine, kidney, and bladder to rule out lumbar syndrome. All ultrasounds were normal.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: There is not a reasonable possibility that the reported event scrotal hemangioma was related to the suspect product event most likely due to patient underlying contributory factors. 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.,Linked Report(s) : US-PFIZER INC-202500069056 same reporter/drug, different patient/event (mom case);
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy
Clinical narrative: may have developed GBS; This is a spontaneous report received from a Pharmacist from a sales representative.  An adult (18-64 years) female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for maternal immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "may have developed GBS". It was unknown if therapeutic measures were taken as a result of guillain-barre syndrome. It was reported by a pharmacist that she knew someone who was pregnant that received Abrysvo and may have developed GBS.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Guillain-Barre syndrome and the suspect drug RSV VACCINE PROT.SUBUNIT PREF 2V cannot be excluded. The case will be reassessed once new information is available.  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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: she had joint pain with the "first series" of covid vaccines which was awhile; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 47-year-old female patient received BNT162b2 (BNT162B2), in Dec2020 as dose 2, single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history included: "little bit fat" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), administration date: Dec2020, when the patient was 47 years old, for Covid-19 Immunization, reaction(s): "she had joint pain with the "first series" of covid vaccines which was awhile". The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "she had joint pain with the "first series" of covid vaccines which was awhile".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500069247 same reporter/patient, different vaccine dose/event;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid after Vaccine; Covid after Vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Completed; Manufacturer unknown), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid after Vaccine". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: the reporter (patient's wife) stated they both had covid and took Paxlovid. Reporter said she was having severe hip pain and her, and her husband had all their covid shots (Pfizer Shots) and she does not understand why she still got covid. They never had Covid, they took all the shots and everything they needed to do.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. Follow-up (03Apr2025): Follow-up attempts are completed. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500039765 Same reporter/product/event, different patient;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid after Pfizer Covid vaccines; Covid after Pfizer Covid vaccines; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 72-year-old male 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: "heart condition" (unspecified if ongoing); "pacemaker defibrillator" (unspecified if ongoing); "Heart attack" (unspecified if ongoing); "anemia" (unspecified if ongoing); "pylori infection" (unspecified if ongoing); "cholesterol control" (unspecified if ongoing); "COVID-19", start date: 2021 (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS oral taken for myocardial infarction, start date: 2018 (ongoing); CLOPIDOGREL oral taken for anaemia, pyloric abscess, start date: 2015 (ongoing); ATORVASTATIN oral taken for blood cholesterol increased, start date: 2010 (ongoing). Past drug history included: Paxlovid for COVID-19 treatment. Vaccination history included: Comirnaty (DOSE 1), for COVID-19 immunization; Comirnaty (DOSE 2), for COVID-19 immunization; Comirnaty (DOSE NUMBER UNKNOWN (BOOSTER)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Mar2025, outcome "unknown" and all described as "Covid after Pfizer Covid vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Mar2025) Positive.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray, Drug ineffective
Clinical narrative: diagnosed with Covid; diagnosed with Covid; This is a spontaneous report received from a Consumer or other non HCP.  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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with Covid". The event "diagnosed with covid" required emergency room visit. The patient underwent the following laboratory tests and procedures: Chest X-ray: (2024) lung were fine, notes: had chest X-ray a year earlier to check for something and patient's lung were fine. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical details: the patient started feeling bad, he/she went to a urgent care, they diagnosed the patient with Covid. He/She doesn't like being sick and he/she had the previous Pfizer Covid shots. They recommended Paxlovid and patient started taking it.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: RSV
Symptoms: Device connection issue, Needle issue, Soft tissue foreign body
Clinical narrative: needle stayed in patient's arm; This is a spontaneous report received from a Pharmacist.  A patient (age and gender not provided) received respiratory syncytial virus vaccine prot.subunit pref 2v (ABRYSVO), 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: DEVICE ISSUE (non-serious), outcome "unknown", described as "needle stayed in patient's arm".  Additional information: It was reported that the needle stayed in patient's arm. Only luer lock and syringe came back from patient's arm. Reporter was unaware if patient was administered with the product or not, only that, the needle stayed in the patient's arm.  Causality for "needle stayed in patient's arm" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The event needle device issue is assessed unrelated to the suspect product, possibly due to the device constituent
Age: 79.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site reaction, Pyrexia, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Horrible red rash on the left upper arm, it was painful and itching/ rash extended all around my left upper arm; Horrible red rash on the left upper arm, it was painful and itching/ rash extended all around my left upper arm; Horrible red rash on the left upper arm, it was painful and itching/ rash extended all around my left upper arm; Horrible red rash on the left upper arm, it was painful and itching/ rash extended all around my left upper arm; a low grade fever; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 06Jan2025 at 10:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 79 years, in left arm for immunisation. The patient had no relevant medical history. The patient took concomitant medications. Past drug history included: Demerol, reaction(s): "Drug Allergy", notes: in the 1980's. The following information was reported: VACCINATION SITE RASH (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 13Jan2025 at 07:00, outcome "recovered" (07Feb2025) and all described as "Horrible red rash on the left upper arm, it was painful and itching/ rash extended all around my left upper arm"; PYREXIA (non-serious) with onset 2025, outcome "recovered" (2025), described as "a low grade fever". Therapeutic measures were taken as a result of vaccination site rash, vaccination site erythema, vaccination site pain, vaccination site pruritus.  Additional information: She took Prevnar 20 on 06Jan2025 at 10:00 AM. On 13Jan2025, she woke up with a horrible red rash on my left upper arm. It was painful and itching. As the day progressed the rash extended all around my left upper arm. She had the Prevnar vaccine on 06Jan2025 at the doctor's office. Benadryl and Advil relieved the symptoms some. She sent a message to the nurse practitioner and was instructed to monitor her arm, take the Benadryl and Papin relievers. Should she develop shortness of breath or other serious symptoms to go to an ER for treatment. The rash itched for approximately 2 weeks and the rash started fading after about a week. She continued taking the Benadryl and Advil for "203" weeks. The symptoms were reported to the doctor's office on the 13Jan2025 and an update reported through massaging on the 16Jan2025. She did develop a low-grade fever, and the itching continued over several weeks. It was reported that the patient did not receive any other vaccines on the same date as Prevnar 20. The patient was taking other medications within 2 weeks prior to the event onset date. The patient did not receive any other vaccines within 4 weeks prior to Prevnar 20.  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.
Age: 78.0
Sex: F
Vaccine: PNC20
Symptoms: Abdominal pain upper
Clinical narrative: Horrible stomach pain which lasted probably 27 to 30 hours; This is a spontaneous report received from a Consumer or other non HCP.  A 78-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 02Apr2025 at 03:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 78 years intramuscular, in right arm for immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "Macular degeneration" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL] taken for vitamin d decreased; PEPCID [FAMOTIDINE] taken for gastrooesophageal reflux disease; AREDS taken for macular degeneration. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), outcome "recovered", described as "Horrible stomach pain which lasted probably 27 to 30 hours". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of abdominal pain upper. 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.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster reactivation
Clinical narrative: Shingles reactivation days after receiving the COVID-19 vaccine; This is a spontaneous report received from a Nurse from a sales representative.  A female patient (not pregnant) 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: HERPES ZOSTER REACTIVATION (non-serious), outcome "recovered", described as "Shingles reactivation days after receiving the COVID-19 vaccine". It was unknown if therapeutic measures were taken as a result of herpes zoster reactivation.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Pelvic pain
Clinical narrative: severe pain in my pelvic area; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on 25Mar2025, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PELVIC PAIN (medically significant) with onset 2021, outcome "not recovered", described as "severe pain in my pelvic area". Therapeutic measures were taken as a result of pelvic pain.  Clinical course: Within weeks of taking the 2nd shot, the patient had severe pain in pelvic area. This has gone on for 3 years. It destroyed patient's life. The patient now getting treatment through removal of proteins from body, which has helped and would began additional treatment with weekly injections for the next 30 weeks. The patient thought the spike was supposed to stay in the arm. Also saw a video of an individual in your study that was paralyzed from after the second shot but this was never reported by you or to the public. The patient wanted to get information regarding an email that he thought he have received from Pfizer regarding his Pfizer Covid-19 Vaccination. He said it contains information regarding the vaccine such as the date and time and the vaccine number. He also said that he have received something from the mail from Pfizer but he have tossed it and not sure what it was. He wanted to find the email and if Pfizer have it on their records as well as the one he have received in the mail. He shared that he have experienced adverse events after getting the Pfizer Covid-19 vaccine such as his body still producing spike proteins, 3 years after getting the vaccine. He confirmed he have not reported these before as he was not sure if it was due to the vaccine that time.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: felt worse compared to actually catching the Covid-19 virus; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Jul2024 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: MALAISE (non-serious), outcome "unknown", described as "felt worse compared to actually catching the Covid-19 virus".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pain
Clinical narrative: Breath (short right side); Pain on right side; This is a spontaneous report and received from consumers.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient is not allergic to any previous vaccination, medications, food or other products. Vaccination history included: influenza vaccine (DOSE 1; MANUFACTURER UNKNOWN; annual), administration date: 02Sep2018, when the patient was 38-year-old, for Immunization; influenza vaccine (DOSE 2; MANUFACTURER UNKNOWN; annual), administration date: 15Oct2019, when the patient was 39-year-old, for Immunization; influenza vaccine (DOSE 3; MANUFACTURER UNKNOWN; annual), administration date: 07Jan2021, when the patient was 41-year-old, for Immunization; mmr vaccine (DOSE 1; MANUFACTURER UNKNOWN), administration date: 01Oct2020, when the patient was 40-year-old, for Immunization; mmr vaccine (DOSE 2; MANUFACTURER UNKNOWN), administration date: 14Oct2020, when the patient was 40-year-old, for Immunization; pcv23 (DOSE 1; MANUFACTURER UNKNOWN), administration date: 15Oct2019, when the patient was 39-year-old, for Immunization; tdap (DOSE 1; MANUFACTURER UNKNOWN), administration date: 01Sep2017, when the patient was 37-year-old, for Immunization; influenza quad (DOSE 1; MANUFACTURER UNKNOWN), administration date: 07Jan2021, when the patient was 41-year-old, for Immunization. The following information was reported: DYSPNOEA (disability) with onset 2021, outcome "not recovered", described as "Breath (short right side)"; PAIN (disability) with onset 2021, outcome "not recovered", described as "Pain on right side". The events "breath (short right side)" and "pain on right side" required physician office visit.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500020171 Same patient and product; different dose and event;US-PFIZER INC-202500067033 Same patient and product; different dose and event;
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Influenza
Clinical narrative: flu; sick; headaches; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An adult female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for covid-19 immunization; Covid-19 vaccine (Dose 2, manufacturer unknown), for covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches"; INFLUENZA (non-serious), outcome "unknown", described as "flu"; ILLNESS (non-serious), outcome "unknown", described as "sick". Additional information: patient stated "I put the vaccine for the covid 3 times and make headaches. And the last year the flu and sick more." No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: It almost killed him/her. developed 3 pulmonary embolisms and 5 DVTs from it; It almost killed him/her. developed 3 pulmonary embolisms and 5 DVTs from it; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 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: PULMONARY EMBOLISM (medically significant, life threatening), DEEP VEIN THROMBOSIS (medically significant, life threatening), outcome "unknown" and all described as "It almost killed him/her. developed 3 pulmonary embolisms and 5 DVTs from it". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Vaccine: RSV
Symptoms: Arthralgia, Gait disturbance, Mobility decreased, Nodule, Pain
Clinical narrative: joints painful; knots in joints, on knees, elbows, fingers; hard to walk; hard to move arms fingers; PAIN 8-10; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 02Mar2025 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 2025, outcome "unknown", described as "PAIN 8-10"; MOBILITY DECREASED (non-serious) with onset 2025, outcome "unknown", described as "hard to move arms fingers"; GAIT DISTURBANCE (non-serious) with onset 2025, outcome "unknown", described as "hard to walk"; ARTHRALGIA (non-serious) with onset 2025, outcome "unknown", described as "joints painful"; NODULE (non-serious) with onset 2025, outcome "unknown", described as "knots in joints, on knees, elbows, fingers". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient had problem after getting vax on 02Mar2025 Abrysvo, joints painful, knots in joints, on knees, elbows, fingers, ,hard to walk ,move arms fingers, now pain 8-10. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a consumer, Program ID.  A female patient received BNT162b2 OMI XBB.1.5 (COMIRNATY (2023-2024 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. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included nirmatrelvir/ritonavir (PAXLOVID). Previously, they never had COVID-19, they took all the shots and everything they needed to do. The patient and her husband both had COVID-19 after the vaccine and took nirmatrelvir/ritonavir (PAXLOVID). The patient and her husband had all their COVID-19 shots, and she does not understand why she still got COVID-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500070471 Same reporter, product, and event; different patient;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Physician, Program ID.  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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (CoVID-19) with the suspect product BNT162B2 OMICRON (KP.2) cannot be fully excluded.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: 2-3 Bleeding Breakthroughs per month; Additional information: The patient did not receive any other vaccines on the same date as the vaccine(s). The patient did not receive any other vaccines within 4 weeks prior to the vaccine(s). Dose 2. was given on 14Jan2021 (Pfizer Covid shot) Lot #EL3302- given via intramuscular route in left deltoid. Patient was having regular periods on birth control pills around 2016-2020. Stopped birth control on 2019.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had COVID last year, about the same time in Jan/still has COVID 19; had COVID; had COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An 80-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history included: "cancer removed", start date: Apr2023 (unspecified if ongoing), notes: removed from right lung, and part of the lung was gone; "emphysema" (ongoing); "COPD" (ongoing); "Covid-19", start date: Jan2023, stop date: 2023. The patient's concomitant medications were not reported. Past drug history included: Paxlovid, start date: Jan2023, for Covid-19. Vaccination history included: Bnt162b2 (Primary immunization series compelete), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovered" and all described as "had COVID"; DISEASE RECURRENCE (medically significant) with onset Jan2025, outcome "not recovered", described as "had COVID last year, about the same time in Jan/still has COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient called in stating that she needs financial assistance for Paxlovid. The patient informed that the doctor called it in because she had COVID last year, about the same time in Jan. She had all her shots and booster but she came up with it anyways. She went over to pick up the medicine which was paid for, quite a bit was paid for last year by the government, she guessed, and this year they want withheld for the prescription. The patient informed the she had it (referring to Paxlovid) last year, and it worked beautifully. The patient again confirmed that it was Jan of last year that she had COVID. She confirmed that she took Paxlovid in Jan2023. The patient informed that she need to pick up the prescription today. Cause she still has COVID 19 and when asked, she confirmed she took the medication previously, it worked very well for her. She has been a Pfizer member ever since 2001, all her shots were through them.  The information on the batch/lot number for BNT162B2 OMI XBB.1.5 will be requested and submitted if and when received.
Age: 16.0
Sex: M
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: menquadfi was already given to 3 patients temperature reached: lowest temp of negative 0.6°c and max temp of 6.3°cduration: 25 hrs with no reported ae; Initial information received on 24-Mar-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old male patient who received Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] its temperature reached: lowest temp of negative 0.6°c and max temp of 6.3°c duration: 25 hrs with no reported ae (adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Meningococcal vaccine B (MENB) for Immunisation.  On 19-Mar-2025, the patient received a 0.5ml dose of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (lot U8369BA, standard strength) (frequency-once, expiry 31-Mar-2028) via intramuscular route in the right arm for Immunization and was already given to 3 patients temperature reached: lowest temp of negative 0.6°c and max temp of 6.3°cduration: 25 hrs with no reported ae (poor quality product administered) (latency-same day).  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2025SA086720:02460337 US-SA-2025SA087172:02460337
Vaccine: DTAP, DTAPIPV, DTAPIPVHIB, FLU3, HIBV, MEN, TDAP
Symptoms: Product storage error
Clinical narrative: low temperature reached: negative 0.1 c to negative 13.0 C,duration: 1 hour and 15 minutes,Human error: Yes, with no reported AE; Initial information received on 26-Mar-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Influenza USP trival A-B vaccine - unspecified [Fluzone UNSP], Diphtheria-15/Tetanus/5 AC pertussis vaccine [Daptacel], Diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel], Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi], HIB (PRP/T) vaccine [ACT-HIB], Diphtheria-15/Tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] and Diphtheria/tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] that had temperature excursion low temperature reached: negative 0.1 c to negative 13.0 c,duration: 1 hour and 15 minutes,human error: yes, with no reported ae.  On an unknown date, the suspect Diphtheria-15/Tetanus/5 AC pertussis vaccine Suspension for injection (strength-unknown) (lot 3CA55C1, expiry date- 31-Aug-202), the suspect Diphtheria/Tetanus/5 hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine (lot UK020AA, UK196AA expiry date-30-Jun-2025, 30-Mar-2026), the suspect of suspect USP trival A-B vaccine - unspecified Suspension for injection (lot UT8423MA, expiry date-31-Aug-2026), the suspect of Diphtheria-15/Tetanus/5 Hybrid AC pertussis/IPV (MRC5) vaccine Suspension for injection (lot U8209CB, U7838AA, expiry date- 31-May-2026, 27-Jul-2025), the suspect of HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot UK170AB, UK193AA, expiry date- 30-Mar-2026 and 31-Oct-2025), the suspect of  Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (lot U8194AA, U8438AA, expiry date- 30-Mar-2026 and 31-Oct-2025) and the suspect Diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (lot U8252AA, U7928AA, U8274AA, 3CA17C1, expiry date- 31-May-2026, 23-Nov-2025, 31-Aug-2026, 28-Feb-2026) all with (strength-unknown) via unknown route in unknown administration site for Immunization and had temperature excursion low temperature reached: negative 0.1 c to negative 13.0 c,duration: 1 hour and 15 minutes,human error: yes, with no reported ae (product storage error) (unknown latency).  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: MEN
Symptoms: Expired product administered, No adverse event
Clinical narrative: MENQUADFI was administered past the expiration date with no reported AE; Initial information received on 26-Mar-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age female patient who received Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was administered past the expiration date with no reported ae.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 19-Mar-2025, the patient received an unknown dose of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (strength, lot number-unknown) (expiry date- 11-Mar-2025) via unknown route in unknown administration site for Immunization and was administered past the expiration date with no reported ae (expired product administered) (latency- 1 day).  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: inappropriate use due to administering an expired vaccine to a patient with no reported adverse event; Initial information received on 26-Mar-2025 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who received Diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] its inappropriate use due to administering an expired vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Mar-2025, the patient received an unknown dose of suspect Diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (lot number, strength-unknow) (expiry date-21-Mar-2025) via unknown route in unknown administration site for Immunization and its inappropriate use due to administering an expired vaccine  with no reported adverse event (expired product administered).  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Vaccine: IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: receiving an extra dose of the IPOL with no adverse event; Initial information received on 27-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and gender patient for whom  IPV (VERO) [IPOL] receiving an extra dose of the ipol with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect IPV (VERO) [IPOL]; Suspension for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation), receiving an extra dose of the ipol with no adverse event  (extra dose administered) (unknown latency).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Expired product administered, No adverse event
Clinical narrative: menquadfi vaccine was administered 2-weeks past the expiration date with no reported adverse event; Initial information received on 27-Mar-2025 regarding an unsolicited valid  non-serious case received from a Nurse.  This case involves a 18 years old male patient who had received Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] was administered 2-weeks past the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Meningococcal vaccine B rfHbp/NadA/NHBA OMV (Bexsero) and Influenza vaccine (Influenza) for Immunisation.  On 27-Mar-2025, the patient received a dose of 0.5 ml of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine (Solution for injection) lot U7595AA, Expiry date: 11-Mar-2025 (Expired product administered) via intramuscular route in the left deltoid for Immunization (strength was unknown) with no reported adverse event (latency: same day).  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion for IPOL , Maximum/minimum temperature reached: coldest 1.5 degrees 90 hours and 35 minutes and administered post excursion with no reported adverse event; Initial information received on 31-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case was linked to US-SA-2025SA094105.  This case involves an 11 years old male patient who received IPV (Vero) [IPol] following a temperature excursion of 90 hours and 35 minutes with maximum/minimum temperature reached: coldest 1.5 degrees, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis A vaccine and hepatitis B vaccine  both for Immunisation.  On an unknown date, the patient received 0.5ml (Dose 3) (once) dose of suspect IPV (Vero), Suspension for injection, Strength standard, expiry date 31-Oct-2026 and lot X1C891M via subcutaneous route in the left arm for Immunisation, which was exposed to a temperature excursion for 90 hours and 35 minutes with maximum/minimum temperature reached: coldest 1.5 degrees, with no reported adverse event (product storage error).  Reportedly, reason of the excursion: unknown; duration of temperature excursion: 90 hours and 35 minutes maximum/minimum temperature reached: coldest 1.5 degrees; administered post excursion Yes;  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2025SA094105:2025SA094105