chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got covid; got covid; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 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 included: "splenic marginal zone lymphoma" (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 21Aug2023, outcome "unknown" and all described as "got covid".  Clinical course: Caller stated she had splenic marginal zone lymphoma, she got covid 21Aug, "2923" (as reported) and want to know when it was best for her to get the new Pfizer covid 19 vaccine. She knew the guidelines it said 3 months. Caller stated she might have to get treatment in November with rituximab and bendamustine which was not 100% but for sure rituximab. Caller stated she was one of the first to get Pfizer's covid 19 vaccine she was working in the ER when Covid came out and she was happy to get it.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many other factors. The association between the event lack of effect (COVID-19) with BNT162b2 NOS can not be fully excluded.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient took Paxlovid from 26Sep2023 as treatment for the events.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Sudden hearing loss
Clinical narrative: Sudden hearing loss; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 5, 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 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: SUDDEN HEARING LOSS (medically significant), outcome "unknown".  Clinical course details: Patient states she wants to ask about sudden hearing loss after the vaccination and states she experienced this after the 5th dose. She also stated that there is a lot of information on the internet about sudden hearing loss. Patient states it was the bivalent vaccine that was given last year, confirmed she received the bivalent.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rhinorrhoea, Sneezing
Clinical narrative: sneezing in my nose, it's running now; runny nose; slight headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 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; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2: unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster): unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 4 (Booster): unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 5 (Booster): unknown manufacturer), for COVID-19 immunization.  The following information was reported: HEADACHE (non-serious) with onset 26Sep2023, outcome "unknown", described as "slight headache"; RHINORRHOEA (non-serious) with onset 28Sep2023, outcome "not recovered", described as "runny nose"; SNEEZING (non-serious) with onset 28Sep2023, outcome "not recovered", described as "sneezing in my nose, it's running now".  Additional information: The reporter called in because she had her COVID shot last Tuesday and she's sneezing and slight headache wondering if it's a reaction to the vaccine. Caller confirmed inquiry above. Caller confirmed that she received the Pfizer COVID vaccine and this was her shot number 6. Caller added "If she took a COVID test would she test positive if she had the vaccine recently." Caller would like to know if she will have a positive COVID-19 test result if she just recently received the vaccine. Upon providing response, Caller stated "she doesn't feel bad except that she was sneezing in her nose, it's running now." Consumer stated, "Right. she had a headache that day, but she has had the runny nose and sneezing really developed yesterday and today. When asked vaccination card handy with her consumer stated, she do not, they did not give her one. She can get her vaccination card, want her last one, she has had 5. They didn't give her a vaccination card, you want the last number that she has.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disease recurrence, Drug ineffective, Suspected COVID-19
Clinical narrative: Caller had COVID last Mar and Apr and she already had 2 shots of COVID vaccine and 2 shots of booster; Caller had COVID last Mar and Apr and she already had 2 shots of COVID vaccine and 2 shots of booster; Caller had COVID last Mar and Apr and she already had 2 shots of COVID vaccine and 2 shots of booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 73-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Caller had COVID last Mar and Apr and she already had 2 shots of COVID vaccine and 2 shots of booster"; DISEASE RECURRENCE (medically significant) with onset Apr2023, outcome "unknown", described as "Caller had COVID last Mar and Apr and she already had 2 shots of COVID vaccine and 2 shots of booster". Additional information: Caller had COVID last Mar and Apr and she already had 2 shots of COVID vaccine and 2 shots of booster, she was told that she cannot take the new booster since she had COVID last Mar and Apr. she wanted to know if this is true. Caller mentioned she has received 2 COVID shots and 2 boosters. She had COVID on Apr and May this year and wanted to know if she can receive the new COVID vaccine formulation as she has had a previous COVID infection.  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: M
Vaccine: COVID19
Symptoms: Chest X-ray, Fibrin D dimer, Fibrin D dimer increased, SARS-CoV-2 test
Clinical narrative: His D-dimer is a little elevated; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: FIBRIN D DIMER INCREASED (non-serious), outcome "unknown", described as "His D-dimer is a little elevated". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fibrin d dimer increased.  Additional information: The patient reported that he and his wife had COVID about two to three weeks ago. Since then he has had Long COVID; consisting of a low grade fever, heavy chest, not pain or anything, just heavy breathing. He had a chest x ray and that looked fine. His D-dimer is a little elevated. He has a CT angiogram on 11Oct2023. He is on a blood thinner now just in case. He was fully vaccinated, no problems with that, boosters and everything with that, he was just waiting for this new one to come out and he got COVID.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300314987 same patient, different vaccine dose/AE;
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: she doesn't feel the same as she normal feels; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization; Bnt162b2 (Dose 3 booster), for COVID-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (Dose 4 booster/bivalent), for COVID-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (Dose 5 booster/bivalent), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 29Sep2023, outcome "recovered" (Sep2023), described as "she doesn't feel the same as she normal feels". Additional information: The patient reported that she has always gotten the Pfizer shots, and doesn't want to mix it with Moderna or anything like that. She had RA and some other health issues. As of this shot, it was her 6th Pfizer COVID vaccine. She never had any side effects or issues, and she sat for 15 minutes and said she doesn't feel the same as she normally feels, but it was nothing major. It has been a couple of hours at the time of report and she doesn't have anything going on now.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300314865 Same patient/vaccine, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Salivary hypersecretion, Vomiting
Clinical narrative: she had a huge headache; your mouth get watery when you are about to throw up; she felt like vomiting/ I felt like, you know how you get your mouth get watery when you are about to throw up, that's when, I felt it in my throat; vomiting/threw up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 41-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 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: NAUSEA (non-serious) with onset 29Sep2023, outcome "unknown", described as "she felt like vomiting/ I felt like, you know how you get your mouth get watery when you are about to throw up, that's when, I felt it in my throat"; HEADACHE (non-serious) with onset 29Sep2023, outcome "unknown", described as "she had a huge headache"; VOMITING (non-serious) with onset 29Sep2023, outcome "unknown", described as "vomiting/threw up"; SALIVARY HYPERSECRETION (non-serious) with onset 29Sep2023, outcome "unknown", described as "your mouth get watery when you are about to throw up". Therapeutic measures were taken as a result of headache.  Additional Information: The patient had a COVID Pfizer Vaccine shot, yesterday (28Sep2023) and then today (29Sep2023), she had a huge headache and then she took a Ibuprofen (Batch/lot number: FH1138) and she threw it up like right away. After she took the Ibuprofen for her headache, she threw it all up and she was just wondering if that was one of the symptoms. The patient asked if it was normal. Right after she took Ibuprofen, she lay down and then she felt like, how one's mouth get watery when one's about to throw up, that's when she felt it in her throat and went to the bathroom and she threw up within 10 minutes. When asked for lot number of COVID Vaccine, patient stated that they just gave her a receipt. They didn't give her a vaccination card, just a receipt.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste immediately upon receiving dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 12:00 as dose 4 (booster), single (Lot number: HH7995) at the age of 52 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 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DYSGEUSIA (non-serious) with onset 30Sep2023 at 12:00, outcome "not recovered", described as "Metallic taste immediately upon receiving dose". Therapeutic measures were not taken as a result of dysgeusia.  Additional information: Patient did not receive any other vaccine in four weeks. Patient was not tested for COVID prior or post vaccination. Patient had no known allergies.
Sex: F
Vaccine: RSV
Symptoms: Pain, Swelling
Clinical narrative: she has the pain, the swelling; she has the pain, the swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 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: PAIN (non-serious), SWELLING (non-serious), outcome "unknown" and all described as "she has the pain, the swelling".  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: I have a little bit of fever; My arms hurt; I am feeling pretty weak; My joint hurts; My muscle hurts; 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 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 29Sep2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: ASTHENIA (non-serious) with onset 30Sep2023, outcome "unknown", described as "I am feeling pretty weak"; PYREXIA (non-serious) with onset 30Sep2023, outcome "unknown", described as "I have a little bit of fever"; PAIN IN EXTREMITY (non-serious) with onset 30Sep2023, outcome "unknown", described as "My arms hurt"; ARTHRALGIA (non-serious) with onset 30Sep2023, outcome "unknown", described as "My joint hurts"; MYALGIA (non-serious) with onset 30Sep2023, outcome "unknown", described as "My muscle hurts". Additional information: Patient was wondering if patient could take some Tylenol or some Ibuprofen or something along that one.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 52.0
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 contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Jun2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), 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: "Asthma" (unspecified if ongoing); "Kidney stones" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid taken as treatment, Treatment start date: 27Sep2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest X-ray, Drug ineffective, Fibrin D dimer, Post-acute COVID-19 syndrome
Clinical narrative: tested positive for COVID after receiving Pfizer COVID 19 vaccinations; tested positive for COVID after receiving Pfizer COVID 19 vaccinations; Long Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; 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: POST-ACUTE COVID-19 SYNDROME (medically significant) with onset 2023, outcome "unknown", described as "Long Covid"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "tested positive for COVID after receiving Pfizer COVID 19 vaccinations". The clinical course was reported as follows: The patient informed that he was fully vaccinated and had boosters, then he got COVID about two to three weeks ago. Since then, he has had Long COVID; consisting of a low grade fever, heavy chest (not painful, just heavy breathing). He had a chest X ray and that looked fine. His D-dimer was a little elevated. CT angiogram was scheduled for 11Oct2023. He was put on a blood thinner. The patient underwent the aforementioned laboratory tests and procedures.   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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300314650 same patient, different vaccine dose/AE;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: tested positive for COVID after receiving Pfizer COVID 19 vaccinations; tested positive for COVID after receiving Pfizer COVID 19 vaccinations; Long Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; 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: POST-ACUTE COVID-19 SYNDROME (medically significant) with onset 2023, outcome "unknown", described as "Long Covid"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "tested positive for COVID after receiving Pfizer COVID 19 vaccinations". The clinical course was reported as follows: The patient informed that he was fully vaccinated and had boosters, then he got COVID about two to three weeks ago. Since then, he has had Long COVID; consisting of a low grade fever, heavy chest (not painful, just heavy breathing). He had a chest X ray and that looked fine. His D-dimer was a little elevated. CT angiogram was scheduled for 11Oct2023. He was put on a blood thinner. The patient underwent the aforementioned laboratory tests and procedures.   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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300314650 same patient, different vaccine dose/AE;
Sex: M
Vaccine: COVID19
Symptoms: Coeliac disease, Haemolytic anaemia, Immune-mediated dermatitis
Clinical narrative: celiac disease; developed dermatitis, which is immune mediated; hemolytic anemia; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 78-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 as dose number unknown, single (Lot number: HF9275) for covid-19 immunisation. The patient's relevant medical history included: "immunologic problem" (unspecified if ongoing); "allergic to sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient reported that he had an immunologic problem, that's why he was making sure he was up to date with his COVID vaccines. When he got the latest booster vaccine, there was no package insert that was found in the box of the vaccine. It did not mention in the labeling that the vaccine was a monovalent formulation. He developed celiac disease and then developed dermatitis, which was immune mediated. First choice of drug was Dapsone, and anti-leprosy drug, but he developed hemolytic anemia. The second choice of drugs were sulfa drugs, which he can't take because he was allergic to sulfa drugs. They were trying to find something to work. States the vaccine he got would cover omicron variant was his main concern. The subvariants bothering humans right now were EG5 and BA286. Outcome of the events was unknown.; Sender's Comments: Based on the information provided, and a temporal association, a causal association between reported events and suspect BNT162B2 omi xbb.1.5 cannot be excluded. This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza like illness
Clinical narrative: I've been in bed for 2 and a half days feeling awful, like I have the flu; I've been in bed for 2 and a half days feeling awful, like I have the flu; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 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: INFLUENZA LIKE ILLNESS (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "I've been in bed for 2 and a half days feeling awful, like I have the flu".  Additional information: The patient had two Pfizer and two Moderna COVID-19 vaccines and it's always the same reaction no matter which one she gets.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza like illness
Clinical narrative: I've been in bed for 2 and a half days feeling awful, like I have the flu; I've been in bed for 2 and a half days feeling awful, like I have the flu; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 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: INFLUENZA LIKE ILLNESS (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "I've been in bed for 2 and a half days feeling awful, like I have the flu".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300315029 Same reporter/patient, different dose;US-PFIZER INC-202300314661 Same reporter/patient, drug, different dose/event;
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20May2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), 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: "known allergies: Penicillin" (unspecified if ongoing); "known allergies: Sulfa" (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 Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with PAXLOVID from 16Sep2023 to 20Sep2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300314612 Same patient different drug/event;
Sex: F
Vaccine: COVID19, 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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered with sequelae" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: Tested positive again 8 days after last Paxlovid dose; (2023) Positive, notes: Tested positive again 8 days after last Paxlovid dose. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid (lot number: GG0127) from 01Sep2023 to 06Sep2023. The patient received another 5 day course of Paxlovid after testing positive again 8 days after last Paxlovid dose, and had symptoms.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound COVID infection with positive COVID at home test 30Sep2023; Rebound COVID infection with positive COVID at home test 30Sep2023; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 34-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "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 30Sep2023, outcome "not recovered" and all described as "Rebound COVID infection with positive COVID at home test 30Sep2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Sep2023) Positive, notes: Rebound COVID infection with positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was taken as treatment, Treatment start date: 22Sep2023 and Treatment stop date: 27Sep2023   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose 1-4 Moderna; Dose 5: Pfizer/Biontech vaccine; Dose 6: Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 24Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 13Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm, on 14May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 24May2023 at 14:00 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing); "Elevated blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESYLATE, start date: 15Jun2022, stop date: 29Sep2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Nov2022, outcome "recovered", described as "Dose 1-4 Moderna; Dose 5: Pfizer/Biontech vaccine; Dose 6: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Sep2023, outcome "recovered" (Sep2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 20Sep2023 to 24Sep2023. Clinical course: After finishing the full course of Paxlovid, patient was symptom free. She tested negative on day 6 but then tested positive on day 8. She had minor oral surgery on 19Sep and then tested positive for COVID the next day. Patient had no known allergies. As mentioned above, apart from that her only long-term health issues were glaucoma, elevated blood pressure and high cholesterol.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300314595 Same patient different drug/event;
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Vaccination site pain
Clinical narrative: headache; Extreme soreness at injection site; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 17:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "hemochromatosis" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: Codeine" (unspecified if ongoing). Concomitant medication(s) included: EFFEXOR; SPIRONOLACTON; B12 [CYANOCOBALAMIN]; D3. Vaccination history included: Covid-19 vaccine (Primary immunization series completed.), for COVID-19 immunization; Covid-19 vaccine (DOSE 3,(BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 29Sep2023, outcome "recovering", described as "Extreme soreness at injection site"; PAIN (non-serious) with onset 29Sep2023, outcome "recovering", described as "body aches"; HEADACHE (non-serious) with onset 29Sep2023, outcome "recovering". Therapeutic measures were not taken as a result of headache, vaccination site pain, pain.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 20Sep2023 to 25Sep2023. Clinical course: Patient had no known allergies.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300314687 same patient, different drug/events;
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: she is getting a hard chill and fever; she is getting a hard chill and fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), 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: PYREXIA (non-serious), CHILLS (non-serious), outcome "unknown" and all described as "she is getting a hard chill and fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She wants to know if the chills and fever are normal because all of her Covid shots have been Pfizer and it always happens.   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-202300315379 Same patient/vaccine, different dose/events (dose 2);US-PFIZER INC-202300314657 Same patient/vaccine, different dose/events (dose 3);
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: she is getting a hard chill and fever; she is getting a hard chill and fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2), as dose 2, 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: Bnt162b2 (Dose 1, single), for Covid-19 Immunization, reaction(s): "she is getting a hard chill and fever", "she is getting a hard chill and fever". The following information was reported: PYREXIA (non-serious), CHILLS (non-serious), outcome "unknown" and all described as "she is getting a hard chill and fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The caller confirmed the Pfizer Comirnaty 2023/2024 vaccine for adults was the product she received. She experienced hard chill and fever and wanted to know if the chills and fever could have been considered normal because all of her Covid shots have been Pfizer and it had always happened.  She got a hard chill last night that lasted about 2-3 hours and then she was just "washed out." She was not hungry but was trying to drink fluids. Every time within the end of the day or 12 hours later, she had a hard chill and a fever. Highest temperature she had was 101.7 She added that she thought the vaccine administrator "got it in the wrong place" in her arm and that was what took time for the fluid. Usually that never happened before and if ever it was gone within 12 hours. The same thing happens. He put in the wrong place in her arm. It had never happened before. Like in the muscle and it did not dissolve. it stayed there. The lady she knew did not get any side effects.  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-202300314657 same reporter/ patient different event dose number;US-PFIZER INC-202300315378 same reporter/ patient/ event  different dose number;
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Neck pain
Clinical narrative: Pain in neck and back on right side; Pain in neck and back on right side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 at 17:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid cancer" (unspecified if ongoing), notes: other medical history: Thyroid cancer; "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. Concomitant medication(s) included: TYLENOL. The following information was reported: NECK PAIN (non-serious), BACK PAIN (non-serious) all with onset 29Sep2023, outcome "recovering" and all described as "Pain in neck and back on right side". Therapeutic measures were taken as a result of neck pain, back pain. Additional information: Patient did not receive any other vaccine in four weeks. Other medications received in two weeks were Tylenol and multi vitamins. Patient did not have covid-19 prior to vaccination and was not tested for covid post vaccination. Patient took Tylenol and drank water as treatment for events.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID 19; 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 male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26May2023 at 10:00 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2 NOS), on 03Oct2022 at 10:00 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient had no known allergies. The following information was reported: COVID-19 (medically significant) with onset Sep2023, outcome "recovered" (Sep2023), described as "COVID 19"; DRUG INEFFECTIVE (medically significant) with onset Sep2023, outcome "recovered" (Sep2023). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 18Sep2023 to 23Sep2023.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300314716 same patient, different drug/AE;
Sex: M
Vaccine: COVID19
Symptoms: Bone cancer, Metastases to bone
Clinical narrative: developed bone cancer in the injection arm at the site; Bone metastasis; This is a spontaneous report received from contactable reporter(s) (Physician).  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history included: "kidney cancer" (unspecified if ongoing); "nephrectomy", start date: 2008 (unspecified if ongoing), notes: The patient has had a nephrectomy 15 years ago. The patient's concomitant medications were not reported. The following information was reported: BONE CANCER (medically significant), outcome "unknown", described as "developed bone cancer in the injection arm at the site"; METASTASES TO BONE (medically significant), outcome "unknown", described as "Bone metastasis".  Clinical course details: The reporter is an oncologist and he said that he had a patient that had kidney cancer. The patient has had a nephrectomy 15 years ago and had no problems with any metastasis or cancer until he received the COVID-19 vaccination and the reason he told, it was related to the vaccine with his advancing and his recurrence because he developed bone cancer in the injection arm at the site, Bone metastasis.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the limited information provided in this case, a contributory role of the suspect product BNT162b2 (COMIRNATY) to the reported events cannot be excluded. There is very limited information provided in this report. Case will be reassessed upon receipt of additional information.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Drug ineffective, Hyperhidrosis, Interchange of vaccine products
Clinical narrative: COVID 19; COVID 19; Pfizer / BioNTech; Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 20Sep2023 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15May2023 at 12:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypo parathyroid" (unspecified if ongoing); "THoracid aortic aneurysm" (unspecified if ongoing). Concomitant medication(s) included: SENSIPAR, start date: 01Oct2021, stop date: 20Sep2023; POTASSIUM, start date: 01Apr2020; MAGNESIUM, start date: 01Oct2020; VIT D3, start date: 01Oct2020; VIT B12, start date: 01Oct2020; VIT C, start date: 01Oct2020; LORATADINE, start date: 01Oct2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Pfizer / BioNTech; Moderna". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: day 7. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 22Sep2023 to 26Sep2023.  Clinical course: Paxlovid rebound. Free of symptoms on 5th day after Paxlovid treatment. Tested negative for Covid on at-home test on day 7. On day 8, at 5pm fever 100.7, achey, chills/sweat, congestion, sore throat and sneezing.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.