chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Vertigo
Clinical narrative: I received the Covid 19 SpikeVax by Moderna, my first time getting Moderna.  I've always had the Pfizer booster.  Within 2 days of getting the injection, both my ears started ringing with signs of tinnitus.  Over the next few days, the ringing never going away but increasing in intensity in both ears. By 5 days after, the ringing became intense not allowing me to sleep, relax or function property. After the first week, without any relief from the serious tinnitus, migraines starting with vertigo.  I went to Urgent Care where I was prescribed Valium to sleep, with no avail.  10 days later, my body started to shutdown, where I believe I had a TIA, not my first.  Have no relief yet with tinnitus increasing in severity.  Worried that depression is taking over.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug ineffective, Post-acute COVID-19 syndrome, Suspected COVID-19
Clinical narrative: Suspected COVID-19; Suspected COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "fatigue" (unspecified if ongoing); "heart palpitations" (unspecified if ongoing); "severe brain fog" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Suspected COVID-19".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300202270 same reporter and product, different dose and event .;
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Suspected COVID-19; Suspected COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "fatigue" (unspecified if ongoing); "heart palpitations" (unspecified if ongoing); "severe brain fog" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Suspected COVID-19".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300202270 same reporter and product, different dose and event .;
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Extra dose administered
Clinical narrative: 07-FEB-2000 (extra dose); This case was split from a legal case (2311USA004702) regarding a 6-month-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were in case 2311USA004702.  On 05-OCT-1999, 06-DEC-1999, 07-FEB-2000 (extra dose administered), and 06-NOV-2000, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) intramuscular injection for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2311USA004702:
Age: 0.5
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 02-MAY-2000 (schedule wrong); This case was split from a legal case (2311USA004702) regarding an 8-month-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were in case 2311USA004702.  On 07-FEB-2000, 02-MAY-2000 (inappropriate schedule of product administration) and 06-NOV-2000, the patient was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) intramuscular injection for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2311USA004702:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Diagnosed with/test positive for COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Diagnosed with/test positive for COVID-19) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 007M20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Codeine), Drug allergy (Morphine), Drug allergy (Valsartan), Type 2 diabetes mellitus, Hypertension and Hypothyroidism.   On 08-Feb-2021 at 9:38 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) .5 milliliter. On 08-Mar-2021 at 9:21 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In August 2022, the patient experienced COVID-19 (Diagnosed with/test positive for COVID-19). At the time of the report, COVID-19 (Diagnosed with/test positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, SARS-CoV-2 test: (Positive) Type of test: Unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   On 10-Nov-2021, the patient received third dose of mRNA-1273 and the lot number was unknown.  On 06-May-2022, the patient received fourth dose of mRNA-1273 and the lot number was unknown.  On 14-Sep-2022, the patient received fifth dose of mRNA-1273 and the lot number was unknown.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-753274 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-753274:Same reporter / Same patient (female)
Age: 86.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Dizziness, Vertigo
Clinical narrative: Vertigo; Dizziness; Chills; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  An 86-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 03Nov2023 at 13:00 as dose number unknown, 0.5 ml single (Lot number: HF5024) at the age of 86 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 03Nov2023, outcome "unknown"; DIZZINESS (non-serious) with onset 03Nov2023, outcome "unknown"; VERTIGO (non-serious) with onset 03Nov2023, outcome "unknown". Therapeutic measures were taken as a result of vertigo, dizziness.  Additional information: Caller (patient) stated that she was dealing with vertigo and dizziness. Caller mentions that she was on her second prescription of Antivert. Caller mentioned that she received the vaccine at 1 o'clock in the afternoon and on that evening, she experienced chills that she never had before followed by vertigo and dizziness. Caller also said that she's having to wait until the 18Dec2023 in order for her to get to an ENT doctor and she's not impressed with that and that's why she's making this phone call to see if other people have had the same problem because she lives in a community.   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: RSV
Symptoms: Chills, Dizziness, Vertigo
Clinical narrative: vertigo; dizziness; chills; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 99-year-old female patient received rsv 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: VERTIGO (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown"; CHILLS (non-serious), outcome "unknown". Additional information: The reporter mentioned that she knows someone because she live in a community and knows that a 99 years old had the same problem she did that's why she's asking to talk to the team.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  will be requested and submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, SARS-CoV-2 test
Clinical narrative: Severe diarrhea for over 20 days. Tested for all and any digestive infections all negative. No known reason; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 14Oct2023 at 11:00 as dose 1, single (Lot number: Unknown), in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), since 14Oct2023 (Batch/Lot number: unknown) at dose 1, single. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Penicillin, reaction(s): "Allergy". The following information was reported: DIARRHOEA (non-serious) with onset 16Oct2023, outcome "recovering", described as "Severe diarrhea for over 20 days. Tested for all and any digestive infections all negative. No known reason". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of diarrhoea.  Additional information: Dr tested for any digestive abnormality (treatment). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive other medications within 2 weeks of vaccination
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Dyspnoea, Swelling face
Clinical narrative: allergic reaction to Pfizer COVID vaccine; face swelled up; difficulty breathing; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER2613) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGY TO VACCINE (non-serious) with onset 2021, outcome "unknown", described as "allergic reaction to Pfizer COVID vaccine"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "difficulty breathing"; SWELLING FACE (non-serious) with onset 2021, outcome "unknown", described as "face swelled up".  Additional information: The patient had her first and second dose of Pfizer COVID vaccine in 2021, and she had an allergic reaction to it. She mentioned that her face swelled up and had difficulty breathing. The first shot was milder and the doctor said to take Benadryl for the second one. However, the Benadryl symptoms were worse, so she didn't take it anymore or any boosters. The patient was asking for the ingredients of Pfizer COVID vaccines. The patient further stated she got the original Pfizer Covid vaccines and had a bad allergic reaction to it. She had never had any other food or medication allergies, so she wanted to know what the ingredients were in the vaccines. She received the first Pfizer Covid vaccine and she developed swelling of the face and had trouble breathing. Her doctor told her it was important to receive the second dose and to just take Benadryl. Even with the Benadryl, she had an even worse reaction to the second dose of the Pfizer Covid vaccine. She took the second dose on 20Apr2021 and she had even more facial swelling and difficulty breathing. The patient got the Pfizer COVID vaccine, original one, got 2 doses and both caused her to have face swelling and difficulty breathing. She was calling to find out what the ingredients were. The patient stated that there was not much more she could tell other than the symptoms. Additionally, she mentioned that she was not allergic to any food or medicine, but now she had to say that she was allergic to Pfizer COVID Vaccine. She was asking for the ingredients of Pfizer COVID vaccines, since she would be having a flu shot and her pharmacist wanted to know if she was allergic to anything.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Paxlovid was taken as therapeutic measures as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Having Covid; Having Covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 72-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3, (booster) single (Batch/Lot number: unknown) and as dose 4, (booster) single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN taken for blood cholesterol. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Having Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result, notes: just took the Covid test at home. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The consumer stated having Covid, stated she was good for a year until she took her. Consumer stated, "So, if she took the vaccine a year ago and she got Covid a year after and that's the concern so, she shouldn't have got Covid." The last Covid vaccine she got was in Nov2022. All of her previous doses were Pfizer. She thought she has had 5 of them. The caller was taking Paxlovid for Covid 19. Consumer stated, she just took the Covid test at home. Paxlovid Batch/lot number: 6K2H52, Consumer stated, "she can but on the expiration date it says the expiration date, the printed is Nov2023 (Nov2023) which is this month and then they wrote on top of it, they scratched it and they said expiration 30Apr2024 (30Apr2024). So, they modified the expiration date." Dosage of Paxlovid: Consumer stated, "It's 150 milligrams and 100 milligram."   The information on the batch/lot number for BNT162B2, BNT162B2 OMI BA.4-5, BNT162B2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Lymph node pain, Lymphadenopathy, Malaise, Pain
Clinical narrative: heart is hurting; lymph glands are swollen and painful; lymph glands are swollen and painful; her whole body is aching; she still feels terrible; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 59-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Dec2023 as dose 1, single (Lot number: HM7010) for covid-19 immunisation, Device Lot Number: HM7010. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANGINA PECTORIS (medically significant), outcome "not recovered", described as "heart is hurting"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious), outcome "not recovered" and all described as "lymph glands are swollen and painful"; PAIN (non-serious), outcome "not recovered", described as "her whole body is aching"; MALAISE (non-serious), outcome "not recovered", described as "she still feels terrible". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Clinical Course: Patient felt terrible. She took a test and the test was negative. She never had COVID before. Her lymph glands were swollen and painful, she felt that she was supposed to had a reaction for only 2 to 3 days but it had been 5 days now, she added that her heart was hurting and her whole body was aching.  The information on the batch/lot number for BNT162b2 omi xbb.1.5  will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: heart is hurting; lymph glands are swollen and painful; lymph glands are swollen and painful; her whole body is aching; she still feels terrible; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 59-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Dec2023 as dose 1, single (Lot number: HM7010) for covid-19 immunisation, Device Lot Number: HM7010. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANGINA PECTORIS (medically significant), outcome "not recovered", described as "heart is hurting"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious), outcome "not recovered" and all described as "lymph glands are swollen and painful"; PAIN (non-serious), outcome "not recovered", described as "her whole body is aching"; MALAISE (non-serious), outcome "not recovered", described as "she still feels terrible". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Clinical Course: Patient felt terrible. She took a test and the test was negative. She never had COVID before. Her lymph glands were swollen and painful, she felt that she was supposed to had a reaction for only 2 to 3 days but it had been 5 days now, she added that her heart was hurting and her whole body was aching.  The information on the batch/lot number for BNT162b2 omi xbb.1.5  will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: given my family members bad side affects and blood clots; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old 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. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "given my family members bad side affects and blood clots".  Clinical information : The patient reported that Pfizer has given my family members bad side affects and blood clots . I do not approve. Reporter consider events side affects and blood clots as caused by suspect product(s).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Swelling face
Clinical narrative: she had sensitivity and mild reaction to previous Pfizer COVID-19 Vaccines including swelling in the face; she had sensitivity and mild reaction to previous Pfizer COVID-19 Vaccines including swelling in the face; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient received BNT162b2 (BNT162B2), 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: Bnt162b2 (Dose 1), for COVID-19 Immunisation, reaction(s): "Allergic reaction to drug", "Swelling of face". The following information was reported: DRUG HYPERSENSITIVITY (non-serious), SWELLING FACE (non-serious), outcome "unknown" and all described as "she had sensitivity and mild reaction to previous Pfizer COVID-19 Vaccines including swelling in the face".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Nurse.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16May2023 at 13:15 as dose 6 (booster), single (Lot number: GJ3268) at the age of 70 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's 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; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Dec2023) Negative; (11Dec2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other vaccination and did not receive any other medication in two weeks. Paxlovid was given as treatment for COVID-19 FROM 28Nov2023 to 02Dec2023; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2, BNT162B2 OMI BA.4-5 in this patient cannot be completely excluded.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; interchange of vaccine products; This is a spontaneous report received from a Physician.  An 83-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Dec2022 as dose 5 (booster), single (Lot number: CTJ3275), in left arm, on 29Apr2023 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm and on 09Sep2023 at 11:00 as dose 7 (booster), single (Batch/Lot number: unknown) at the age of 83 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Jan2021 as dose 1, single (Lot number: 012M20A), in left arm, on 23Feb2021 as dose 2, single (Lot number: 024M20A), in left arm, on 22Oct2021 as dose 3 (booster), single (Lot number: 012F21A), in left arm and on 11Apr2022 as dose 4 (booster), single (Lot number: 005M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cardiac amyloid" (unspecified if ongoing); "paroxysmal atrial fibrillation" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS, start date: 02Dec2019; TAFAMIDIS, start date: 03Feb2020; ATORVASTATIN. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Dec2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive on home Covid test. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 25Nov2023 to 30Nov2023. Clinical course: Patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy under interchange of vaccine products with the suspect vaccine BNT162b2, BNT162b2 omi ba.4-5 in this patient cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Have had pain in left arm intermittently through the day since received 2nd dose.; This is a spontaneous report received from a Consumer or other non HCP.  An elderly male patient received BNT162b2 (BNT162B2), on 16Sep2021 (Lot number: Unknown) for covid-19 immunisation. The patient's relevant medical history included: "Fracture of  C5 & C6 spine with no disability" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Left, Vaccine Administration Time: 12:15 PM), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 16Sep2021, outcome "not recovered", described as "Have had pain in left arm intermittently through the day since received 2nd dose.". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient have had pain in left arm intermittently through the day since received 2nd dose. He stated that he will not go back for 3rd because pain has not resolved since. Had injection in a.m. unsure of exact time.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "hypertrophic obstructive cardiomyopathy" (unspecified if ongoing); "Known allergies: iodides" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: EW0150) and on 27Apr2021 as dose 2, single (Lot number: EW0175) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history included: "aFib" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 04Dec2023 to 09Dec2023.  No follow-up attempts are possible.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Dose Number: 1 Moderna /Dose Number: 2 Pfizer/BioNTech; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Mar2021 at 13:00 as dose 2 (initial pfizer dose), single (Batch/Lot number: unknown) at the age of 56 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Mar2021 at 13:00 as dose 1, single), in right arm, on 15Sep2022 at 10:00 as dose 3 (booster), single), in right arm and on 08Nov2023 at 09:00 as dose 4 (booster), single), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose Number: 1 Moderna /Dose Number: 2 Pfizer/BioNTech". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlvid from 03Dec2023 to 08Dec2023.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 26Sep2023 as dose 1, single (Lot number: HG4640) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "Allergy". 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; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 5, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: testing negative on the 10th. Positive test  again today; Positive, notes: testing negative on the 10th. Positive test again today. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other vaccination and did not receive any other medication in two weeks. Paxlovid was given as treatment for COVID-19 FROM 02Dec2023 to 06Dec2023
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This is a spontaneous report received from a Consumer or other non HCP.  An 81-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Feb2021 at 13:00 as dose 2, single (Lot number: EL9261), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: comirnaty (DOSE 1, SINGLE, Batch/Lot No: EL8982, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 25Jan2021, when the patient was 81-year-old, for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, disability, medically significant, life threatening) with onset 28Feb2021 at 08:00, outcome "recovered with sequelae", described as "Stroke". The patient was hospitalized for cerebrovascular accident (start date: 2021, discharge date: 2021, hospitalization duration: 1 day(s)). The event "stroke" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of cerebrovascular accident.  Clinical course: The patient did not receive any other vaccine in four weeks and did not receive any other medication in two weeks. Patient was not tested for COVID prior to and post vaccination and the patient Recovered with lasting effects
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Overdose, Pain in extremity, Pyrexia
Clinical narrative: Fever; Headache; Pain in arm; dose 1: 06Mar2021/ dose 2: 06Mar2021; dose 1: 06Mar2021/ dose 2: 06Mar2021; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Batch/Lot number: unknown), in arm and on 06Mar2021 as dose 2, single (Lot number: ER8732), all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), OVERDOSE (non-serious) all with onset 06Mar2021, outcome "unknown" and all described as "dose 1: 06Mar2021/ dose 2: 06Mar2021"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; HEADACHE (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain in arm".  Follow-up (12Dec2023): This is a spontaneous follow-up report received from a Consumer or other non HCP. Updated information included: new events (fever, headache, and pain in arm) and clinical course of events.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: RSV
Symptoms: Drug ineffective, Respiratory syncytial virus infection
Clinical narrative: her nephew is on the hospital for 2 days with Abrysvo/caller's nephew is on the hospital with RSV; her nephew is on the hospital for 2 days with Abrysvo/caller's nephew is on the hospital with RSV; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received rsv 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: DRUG INEFFECTIVE (hospitalization, medically significant), RESPIRATORY SYNCYTIAL VIRUS INFECTION (hospitalization, medically significant), outcome "unknown" and all described as "her nephew is on the hospital for 2 days with Abrysvo/caller's nephew is on the hospital with RSV". The patient was hospitalized for drug ineffective, respiratory syncytial virus infection (hospitalization duration: 2 day(s)). Clinical course: Caller is calling in and asking if she should take test for an RSV Abrysvo because her nephew was on the hospital for 2 days with Abrysvo. Caller cannot confirm if it's Abrysvo but she said it is Pfizer Created Precautionary Manual AE form because the caller's nephew was on the hospital with RSV.  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: RSV
Symptoms: COVID-19, Mental disorder
Clinical narrative: nervous breakdown/side effects; This is a spontaneous report received from an Other HCP, Program ID.  A female patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; nirmatrelvir, ritonavir (PAXLOVID), for covid-19 treatment. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENTAL DISORDER (non-serious), outcome "unknown", described as "nervous breakdown/side effects ". The action taken for nirmatrelvir, ritonavir was unknown.  Additional information: A retired HCP calling on behalf of herself, has a Covid and is currently taking RSV and Paxlovid taking Paxlovid for 2 days. She is wondering if she will continue or discontinue taking Paxlovid due to side effects that she is encountering. She is having a nervous breakdown. She already went to her Family practice doctor about Paxlovid but no one can answer her question that's why she called.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  will be requested and submitted if and when received.
Sex: U
Vaccine: PNC20
Symptoms: Device physical property issue
Clinical narrative: There was particulate in the vaccine that I was unable to give vaccine to suspension and I could not give; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group.  A patient (no qualifiers provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE PHYSICAL PROPERTY ISSUE (non-serious), outcome "unknown", described as "There was particulate in the vaccine that I was unable to give vaccine to suspension and I could not give". Additional information: The pharmacist reported that a particulate in the Prevenar vaccine and was unable to give vaccine to suspension. The reporter was attempting to administer a Prevnar 20 before he/she administers the vaccine, he/she noticed that there was particulate in the vaccine that he/she was unable to get back into the suspension and was unable to give the vaccine.  The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Joint swelling, Pain
Clinical narrative: My rtt knee joint began to hurt; making it difficult to walk; pain; waws a little swollen; This is a spontaneous report received from an Other HCP.. The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 15Jan2021 at 15:40 as dose 1, single (Lot number: 017L20A) at the age of 64 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), described as "My rtt knee joint began to hurt"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "making it difficult to walk"; PAIN (non-serious), outcome "unknown"; JOINT SWELLING (non-serious), outcome "unknown", described as "waws a little swollen". Additional information: Patient reported, The adverse events for me was after the 1st dose given on 01/15/2021. My rt knee joint began to ache. This increased making it difficult to walk w/out pain. It also felt "tight" and was a little swollen. I scheduled an appointment w/ an orthopedic MD, but about 2 weeks before the appointment I had to jump over some boxes in a storage room and I felt an intense stabbing, searing pain. I thought I had really damaged my knee. But as I walked away the intense pain subsided and over the next few days the pain decreased. It made me wonder if there had been some fluid build up that burst when I jumped over the boxes.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: having a throbbing pain in my pinky for a very long time; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "having a throbbing pain in my pinky for a very long time". Clinical course: As reported by the patient "I got the Pfizer shot three times for covid 19 vaccine and ever since I got the shot in my left arm I've been having a throbbing pain in my pinky for a very long time."  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: felt sick for a few days after the regular shot; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old female patient received BNT162b2 (COMIRNATY), 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: MALAISE (non-serious), outcome "unknown", described as "felt sick for a few days after the regular shot". Additional information: Reporter considered the event as caused by suspect product. Patient was not sure if she wants a booster shot because she felt sick for a few days after the regular shot.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got very sick after each one; This is a spontaneous report received from a Consumer or other non HCP.  A 76-year-old female patient received BNT162b2 (COMIRNATY), 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: ILLNESS (non-serious), outcome "unknown", described as "got very sick after each one". Additional information: I have had all the covid vaccines and booster that I want. I got very sick after each one.   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-202300444910 same patient/suspect drug/similar events, different dose number;US-PFIZER INC-202300444909 same patient/suspect drug/similar events, different dose number;
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Swelling face
Clinical narrative: she had sensitivity and mild reaction to previous Pfizer COVID-19 Vaccines including swelling in the face; she had sensitivity and mild reaction to previous Pfizer COVID-19 Vaccines including swelling in the face; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient received BNT162b2 (BNT162B2 NOS), 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 HYPERSENSITIVITY (non-serious), SWELLING FACE (non-serious), outcome "unknown" and all described as "she had sensitivity and mild reaction to previous Pfizer COVID-19 Vaccines including swelling in the face".  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-202300444268 same reporter/patient/drug, different dose number/event;
Sex: U
Vaccine: COVID19
Symptoms: Immune system disorder, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: reaction site on arm red, warm, very little swelling; reaction site on arm red, warm, very little swelling; reaction site on arm red, warm, very little swelling; Immune system low; This is a spontaneous report received from a Consumer or other non HCP, Program ID: 005570.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu vaccine, for immunization, reaction(s): "negative reaction". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "reaction site on arm red, warm, very little swelling"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Immune system low". Additional information: The patient had Covid-19 vaccine more than once only reaction site on arm red, warm, very little swelling. Patient always stay around pharmacy about 45 mins- hour after receiving any shot taken at facility. Immune system low.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: alopecia; This is a spontaneous report received from a Consumer or other non HCP, Program ID: 004756.  A 3-year-old female patient received BNT162b2 (BNT162B2 NOS), 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: ALOPECIA (non-serious), outcome "unknown".  Additional information: a consumer asking if Litfulo (as reported) can be given to a 3 yrs old patient going 4 and also asking if the Pfizer covid19 vaccine has a data that if the patient took it they will have an alopecia because that's what happened to his daughter (patient).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Cardiac failure
Clinical narrative: heart failure; I have developed heart issues now; This is a spontaneous report received from a Consumer or other non HCP.  A 35-year-old 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, SINGLE; Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: CARDIAC FAILURE (medically significant), outcome "unknown", described as "heart failure"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "I have developed heart issues now".  Clinical information: Patient wanted to say ever since got second Pfizer shot have developed heart issues now. The patient was 35 years old and now patient having heart failure and have been perfectly healthy until now.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.