chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: She tested positive for COVID-19 on 20Sep2023 and is better now; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (She tested positive for COVID-19 on 20Sep2023 and is better now) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Sep-2023, the patient experienced COVID-19 (She tested positive for COVID-19 on 20Sep2023 and is better now). At the time of the report, COVID-19 (She tested positive for COVID-19 on 20Sep2023 and is better now) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Sep-2023, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Caller had received 3 previous Moderna shots. She tested positive for COVID-19 on 20Sep2023 and was better now. She was wondering when she can take the next Moderna vaccination. Treatment information was not reported.
Sex: U
Vaccine: UNK
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No adverse event; 2 children received the adult version of the Spikevax 2023-2024 prefilled syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (2 children received the adult version of the Spikevax 2023-2024 prefilled syringe) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030355) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On 03-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced WRONG PRODUCT ADMINISTERED (2 children received the adult version of the Spikevax 2023-2024 prefilled syringe). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (2 children received the adult version of the Spikevax 2023-2024 prefilled syringe) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (2 children received the adult version of the Spikevax 2023-2024 prefilled syringe).    No concomitant medications were reported. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-743701.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743701:1st Child case
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: her arm is really bothering her since early this morning; She received the injection on her right arm and it is tender to the touch; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (her arm is really bothering her since early this morning) and VACCINATION SITE PAIN (She received the injection on her right arm and it is tender to the touch) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032264) for COVID-19 prophylaxis.     The patient had no allergies and COVID-19.  Previously administered products included for Product used for unknown indication: Flu Shot on 13-Sep-2023. Past adverse reactions to the above products included No adverse event with Flu Shot. Concurrent medical conditions included Rotator cuff tear, Rheumatoid arthritis, Osteoarthritis and Diabetic.    On 03-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 03-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced VACCINATION SITE PAIN (She received the injection on her right arm and it is tender to the touch). On 04-Oct-2023, the patient experienced PAIN IN EXTREMITY (her arm is really bothering her since early this morning). At the time of the report, PAIN IN EXTREMITY (her arm is really bothering her since early this morning) and VACCINATION SITE PAIN (She received the injection on her right arm and it is tender to the touch) had not resolved.            The patient had 1st Dose on 15 JAN 2021 with batch number 027L20A, 2nd Dose on 12 FEB 2021 with batch number 015M20A, 3rd Dose on 22 OCT 2021 with batch number 017F21A, 4th Dose on 19 SEP 2021 with batch number AS7145B and 5th Dose on 1 JUL 2022 with batch number 05M21A.  Concomitant medication not reported.   Treatment medication not reported.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pruritus
Clinical narrative: itching/after each next dose it spread more from the arm to the shoulder and it went progressively worse until the last dose on JUN2023 when she experienced itching all over her trunk, arms and back/, it was just itching without rash; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching/after each next dose it spread more from the arm to the shoulder and it went progressively worse until the last dose on JUN2023 when she experienced itching all over her trunk, arms and back/, it was just itching without rash) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product THIOMERSAL (THIMEROSAL) for an unknown indication.    Previously administered products included for Product used for unknown indication: Otezla. Past adverse reactions to the above products included No adverse event with Otezla. Concurrent medical conditions included Psoriatic arthritis. Concomitant products included HYDROXYCHLOROQUINE PHOSPHATE (PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]) for an unknown indication.   In July 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient started THIOMERSAL (THIMEROSAL) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRURITUS (itching/after each next dose it spread more from the arm to the shoulder and it went progressively worse until the last dose on JUN2023 when she experienced itching all over her trunk, arms and back/, it was just itching without rash). At the time of the report, PRURITUS (itching/after each next dose it spread more from the arm to the shoulder and it went progressively worse until the last dose on JUN2023 when she experienced itching all over her trunk, arms and back/, it was just itching without rash) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient stated she had already received 6 Moderna COVID-19 Vaccines so far, but she mentioned she did not had the dates, only remembered her last dose of the Bivalent vaccine she got was in JUL2023.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-743895 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743895:Mono valent case
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Erythema, Injection site mass
Clinical narrative: she is getting a hard chill and fever; she is getting a hard chill and fever / Highest temperature she had was 101.7; Her arm was red and puffy; the fluid in a little puff in my arm. It just stayed there; She's not hungry; 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 number unknown (booster), 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"; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "she is getting a hard chill and fever"; Bnt162b2 (DOSE 2, 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: CHILLS (non-serious), outcome "unknown", described as "she is getting a hard chill and fever"; PYREXIA (non-serious), outcome "unknown", described as "she is getting a hard chill and fever / Highest temperature she had was 101.7"; ERYTHEMA (non-serious), PERIPHERAL SWELLING (non-serious), outcome "unknown" and all described as "Her arm was red and puffy"; DECREASED APPETITE (non-serious), outcome "unknown", described as "She's not hungry". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient confirms the Pfizer Comirnaty 2023/2024 vaccine for adults is the product she received. She wanted to know if the chills and fever are normal because all her Covid shots have been from Pfizer and it always happens. She got a hard chill the previous night that lasted about 2-3 hours and that day she is just "washed out." She's not hungry but is trying to drink fluids. She thinks he (the vaccine administrator) "got it in the wrong place" in her arm and "that's what took time for the fluid". She said usually that's never happened before, and that "everyone I've ever taken" (as reported) is gone within 12 hours. The same thing happens. He put in the wrong place in my arm. It's happened before. Like in the muscle and it didn't dissolve, it stayed there, and you could see the fluid in a little puff in my arm. It just stayed there." The patient also added that, compared to another lady she knows, she is the only one who gets these side effects. The lady she knows didn't get any side effects.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: she is getting a hard chill and fever; she is getting a hard chill and fever / Highest temperature she had was 101.7; Her arm was red and puffy; the fluid in a little puff in my arm. It just stayed there; She's not hungry; 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 number unknown (booster), 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"; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "she is getting a hard chill and fever"; Bnt162b2 (DOSE 2, 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: CHILLS (non-serious), outcome "unknown", described as "she is getting a hard chill and fever"; PYREXIA (non-serious), outcome "unknown", described as "she is getting a hard chill and fever / Highest temperature she had was 101.7"; ERYTHEMA (non-serious), PERIPHERAL SWELLING (non-serious), outcome "unknown" and all described as "Her arm was red and puffy"; DECREASED APPETITE (non-serious), outcome "unknown", described as "She's not hungry". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient confirms the Pfizer Comirnaty 2023/2024 vaccine for adults is the product she received. She wanted to know if the chills and fever are normal because all her Covid shots have been from Pfizer and it always happens. She got a hard chill the previous night that lasted about 2-3 hours and that day she is just "washed out." She's not hungry but is trying to drink fluids. She thinks he (the vaccine administrator) "got it in the wrong place" in her arm and "that's what took time for the fluid". She said usually that's never happened before, and that "everyone I've ever taken" (as reported) is gone within 12 hours. The same thing happens. He put in the wrong place in my arm. It's happened before. Like in the muscle and it didn't dissolve, it stayed there, and you could see the fluid in a little puff in my arm. It just stayed there." The patient also added that, compared to another lady she knows, she is the only one who gets these side effects. The lady she knows didn't get any side effects.   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: M
Vaccine: RSV, RVX
Symptoms: Injection site coldness, Injection site discharge, Underdose, Vaccination site reaction
Clinical narrative: little prick mark; Abrysvo administered by a brand new intern and had a kind of a leak of a liquid from the injection area; Abrysvo administered by a brand new intern and had a kind of a leak of a liquid from the injection area; 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 66-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 27Sep2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years for immunisation; for immunisation; rsv vaccine (RSV VACCINE), on 27Sep2023 as unk, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE LEAKAGE (non-serious), UNDERDOSE (non-serious) all with onset 27Sep2023, outcome "unknown" and all described as "Abrysvo administered by a brand new intern and had a kind of a leak of a liquid from the injection area"; VACCINATION SITE REACTION (non-serious) with onset 27Sep2023, outcome "unknown", described as "little prick mark". Additional information: Caller got his RSV Vaccine, Abrysvo administered by a brand new intern and had a kind of a leak of a liquid from the injection area. He stated that there was an intern there that had only been there for a couple of weeks. When he went home caller realized when he touched the bandage that there was wetness there. He remembers getting the shot and what the rite aid does, they put a little "bull's eye" and give the injection. They first wipe the skin with alcohol then do the "bull's eye" and give the injection and put over a clear bandage. As he got it, he remembers feeling coldness and wetness.  He called another pharmacy to ask if the "little thing that they put on there for "bull's eye ( or inject adhesive strip?)". Does that have a wet disinfectant or just for the shot.  The pharmacy said that it was not supposed to be wet and maybe it was leaked out. He added that he never had that. Caller stated that there is a difference in side effects from everybody but this time, there is a little prick mark there and he didn't even touch his skin but did not get any kind of pain and there was not one time in his 20 years of getting shot that he never has that. Caller woke up nothing, none of the minor stuff at all like headache, diarrhea that adults supposed to have in taking this. Caller did not even think that he got the "juice" in him at all and suspects that there might be leakage when injecting the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: back especially in one area started to be very uncomfortable. And then it became painful and this is still happening; 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.  An 83-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 03:00 as dose 1, single (Batch/Lot number: unknown) at the age of 83 years for covid-19 immunisation. The patient's relevant medical history included: "shingles" (unspecified if ongoing), notes: many years ago she had shingles, even before she had her first vaccine. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for COVID-19 immunisation, reaction(s): "feeling a little achy for 24 hours". The following information was reported: BACK PAIN (non-serious) with onset 30Sep2023, outcome "not recovered", described as "back especially in one area started to be very uncomfortable. And then it became painful and this is still happening". Therapeutic measures were taken as a result of back pain. Additional information: Caller had her Covid vaccine at 3 in the afternoon yesterday, several hours later she was having pain on a familiar area on her back, she had Shingles before, it is the same area where she had that back pain, she had that sensation, as she believes that will feel the sensation years after. The rest of the day and last night, she felt it, she is asking if there is anything in the vaccine that could cause these reactions because she had Shingles before. She had no issue with the previous covid shot except of feeling a little achy for 24 hours. She had this shot at 3pm and within several hours her back especially in one area started to be very uncomfortable. And then it became painful, and this is still happening. Caller added that many years ago she had shingles, even before she had her first vaccine. She knew that even years later she can still get residual symptoms from shingles. You don't breakout from a rash, but you still have pain and various things happening. She had some issues with that for years but are very mild. A few hours after having had the vaccination it became very exaggerated. She takes pain pills all the time for back issue and she stepped up the dosage time and she is still feels very uncomfortable.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: UNK
Symptoms: COVID-19, COVID-19 treatment, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Endometriosis" (unspecified if ongoing); "Non-radiographic axial spondyloarthritis" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Doxycycline, reaction(s): "Known allergies: doxycycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that the patient received other vaccine and medication in 2 weeks. Paxlovid was given as treatment for COVID-19 from 25Sep2023 to 28Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years 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, SINGLE, Manufacturer unknown), for Covid-19 immunisation; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer unknown), for Covid-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer unknown), for Covid-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Manufacturer unknown), for Covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Oct2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Arthritis, Gait inability
Clinical narrative: knee arthritis; cannot walk; 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 patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: ARTHRITIS (non-serious), outcome "unknown", described as "knee arthritis"; GAIT INABILITY (non-serious), outcome "unknown", described as "cannot walk".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Dizziness, Muscular weakness, Vertigo
Clinical narrative: severe muscle weakness; Joint pain; Vertigo; Dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 82-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as single dose (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history included: "knee replacement surgery", start date: Apr2023 (unspecified if ongoing). The patient took concomitant medications. The following information was reported: MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "severe muscle weakness "; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; VERTIGO (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown". Additional information: Patient had the RSV(Abrysvo) vaccine and then the following day she had a steroid shot.  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: F
Vaccine: RSV
Symptoms: Immunisation reaction, Injection site mass, Pain in extremity, Vaccination site mass, Wrong technique in product usage process
Clinical narrative: had a lump on the vaccination area/developing a lump on her arm where she had the injection; her arm was a little sore; 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 female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 20Sep2023 as single dose (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: VACCINATION SITE MASS (non-serious) with onset 2023, outcome "unknown", described as "had a lump on the vaccination area/developing a lump on her arm where she had the injection"; PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "unknown", described as "her arm was a little sore". Additional information: Reported the first week, her arm was a little sore but nothing she was concerned about however going into the 2nd week, she started developing a lump on her arm where she had the injection. States she still has the lump. She   saw her hcp yesterday who told her the lump was either due to the way it was given and there is resulting trauma at the site she had  a reaction to the shot  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was a little sore from the injection/arm with a little sore for a day; 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 73-year-old female 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: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arm was a little sore from the injection/arm with a little sore for a day".  Additional information: Consumer stated: "We have both received the Pfizer Covid 19 vaccine since it came out. Last year we got the Pfizer booster and we have not had any problems at all with it, except arm was a little sore from the injection for one day and it was gone, but nothing else. That happens with anything you get.  It wasn't a big deal. We have known people that have had COVID that have been so sick from the vaccine (manufacturer name not provided or clarified) that they are not taking it again, which is a shame. My husband and I have not had any problems with it and have been very lucky that the COVID vaccine from Pfizer has been perfect. This is the only one that we will take will be Pfizer."  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-202300317543 same reporter/drug/event, different patient;
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Pain, Pain in extremity
Clinical narrative: Body aches; Sore arm; Under arm pain; Fatigue; This is a spontaneous report received from contactable reporter (Physician).  A 49-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Oct2023 at 16:15 as dose 6 (booster), single (Lot number: HF9275) at the age of 49 years intramuscular, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing); "Uterine fibroids" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (dose 1, single; manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (dose 2, single; manufacturer unknown), for COVID-19 immunisation; COVID-19 vaccine (dose 3 (booster), single; manufacturer unknown), for COVID-19 immunisation; COVID-19 vaccine (dose 4 (booster), single; manufacturer unknown), for COVID-19 immunisation; COVID-19 vaccine (dose 5 (booster), single; manufacturer unknown), for COVID-19 immunisation. The following information was reported: PAIN (non-serious) with onset 02Oct2023, outcome "recovering", described as "Body aches"; FATIGUE (non-serious) with onset 02Oct2023, outcome "recovering"; PAIN IN EXTREMITY (non-serious) with onset 02Oct2023, outcome "recovering", described as "Sore arm"; AXILLARY PAIN (non-serious) with onset 02Oct2023, outcome "recovering", described as "Under arm pain". Therapeutic measures were not taken as a result of pain, pain in extremity, axillary pain, fatigue. Additional information: The patient had no other vaccines in four weeks. She had no COVID prior to vaccination or was tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Back disorder
Clinical narrative: side effect with my back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK DISORDER (non-serious), outcome "unknown", described as "side effect with my back". Additional information: The patient was wondering if there's something in the formulation that caused a particular side effect with my back.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 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: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), 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, single (Batch/Lot number: unknown) and as dose 4, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NYQUIL; DAYQUIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient took Paxlovid from 23Sep2023 to 27Sep023.  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: Deafness
Clinical narrative: Deaf problems; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), 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: DEAFNESS (medically significant), outcome "unknown", described as "Deaf problems". Clinical course: Caller said that her daughter took the Pfizer-BioNTech COVID-19 Vaccine (she didn't mention the formulation) and now she has deaf problems. She also said this vaccine has killed people in her family and many people in general. She wanted to know when Comirnaty became available. She asked for the Comirnaty clinical trial information.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Can increasing severity in arms pains; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Can increasing severity in arms pains".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction/allergy to the COVID-19 shot allergic reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction/allergy to the COVID-19 shot allergic reaction".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; chills; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 14:45 as dose 4 (booster), single (Lot number: HF9275) at the age of 51 years, in right arm for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 14Sep2023 as dose number unknown, single; TDAP taken for immunisation, on 14Sep2023 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (Dose number: 01, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose number: 02, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose number: 03, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 03Oct2023 at 06:30, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 03Oct2023 at 06:30, outcome "recovering". Therapeutic measures were not taken as a result of pyrexia, chills.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Thyroid disease" (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 "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative, notes: After improving and testing negative; (2023) Positive, notes: 6 days after stopping Paxlovid - high temp, positive COVID test and other symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick after a few hours; 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 patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: ILLNESS (non-serious), outcome "unknown", described as "sick after a few hours".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Myalgia, Sleep disorder
Clinical narrative: It doesn't feel comfortable, and it wakes me up; It doesn't feel comfortable, and it wakes me up; severe muscle and joint pain; severe muscle and joint pain; 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 01Oct2023 as dose 1, single (Lot number: HG4432) for covid-19 immunisation. The patient's relevant medical history included: "She had covid", start date: Jul2023 (unspecified if ongoing), notes: Caller states she had covid earlier this year in July and it wasn't as bad as what she is experiencing with the shot. The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 Immunisation, reaction(s): "severe muscle and joint pain", "severe muscle and joint pain". The following information was reported: MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 01Oct2023, outcome "recovering" and all described as "severe muscle and joint pain"; DISCOMFORT (non-serious), SLEEP DISORDER (non-serious) all with onset 02Oct2023, outcome "unknown" and all described as "It doesn't feel comfortable, and it wakes me up". Therapeutic measures were taken as a result of myalgia, arthralgia.  Additional information: The reporter stated that, "I had severe muscle and joint pain that night I received the vaccine. Monday morning, I started having this and at 4 o'clock in the morning it woke me up it was so bad." The reporter stated, "I had similar reactions to Moderna as well, but this is more severe. I do not know if it is an allergic reaction or if it is an immune response." It was stated, reporter is wondering what could be causing it, and wondering if it is something that is similar in both of these products. The reporter stated she had covid earlier this year in July and it was not as bad as what she is experiencing with the shot. Covid was longer lasting than the vaccine symptoms. Reporter further stated, the side effect of the vaccine, "It is very mild now, I am keeping taking Tylenol to keep it under control, it is a lot less than it was yesterday". "It does not feel comfortable, and it wakes me up".   The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain
Clinical narrative: Aches/Pains; Malaise; Headache; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative.  An elderly male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE as dose number unknown, single. 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: PAIN (non-serious), outcome "recovered", described as "Aches/Pains"; MALAISE (non-serious), outcome "recovered"; HEADACHE (non-serious), outcome "recovered". It was unknown if therapeutic measures were taken as a result of pain, malaise, headache.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Retching
Clinical narrative: dry-heaves; severe chills; eat very little that day of the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 10:30 as dose 1, single (Lot number: HG4633) at the age of 72 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SIMVASTATIN; LISINOPRIL; AMLODIPINE. The following information was reported: DECREASED APPETITE (non-serious) with onset 02Oct2023, outcome "recovered" (Oct2023), described as "eat very little that day of the vaccine"; CHILLS (non-serious) with onset 02Oct2023 at 22:30, outcome "recovered" (03Oct2023 at 02:30), described as "severe chills"; RETCHING (non-serious) with onset 03Oct2023, outcome "recovered" (03Oct2023), described as "dry-heaves". Therapeutic measures were not taken as a result of chills, retching, decreased appetite. Additional information: Approximately 10:30 P.M, the patient experienced a 4-hour episode of severe chills, followed by about an hour of dry-heaves. Patient eat very little that day of the vaccine, which has been his routine since he developed this reaction.   The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was a little sore from the injection/arm with a little sore for a day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 76-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 Completed, Unknown Manufacturer), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arm was a little sore from the injection/arm with a little sore for a day".  Additional information: Reporter stated: "We have both received the Pfizer Covid 19 vaccine since it came out. Last year we got the Pfizer booster and we have not had any problems at all with it, except arm was a little sore from the injection for one day and it was gone, but nothing else. That happens with anything you get. It wasn't a big deal. We have known people that have had COVID that have been so sick from the vaccine (manufacturer name not provided or clarified) that they are not taking it again, which is a shame. Reporter and her husband have not had any problems with it and have been very lucky that the COVID vaccine from Pfizer has been perfect. This is the only one that we will take will be Pfizer."  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-202300317117 same reporter/drug/event, different patient;
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Dec2022 as dose 5 (booster), single (Lot number: GJ6742) at the age of 60 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); "mild allergy-related asthma" (unspecified if ongoing), notes: mild allergy-related asthma treated with Zyrtec-D. The patient's concomitant medications were not reported. Past drug history included: Zyrtec-d for mild allergy-related asthma. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Sep2023) Negative, notes: Tested negative on 19Sep and 20Sep on home test; (20Sep2023) Negative, notes: Tested negative on 19Sep and 20Sep on home test; (21Sep2023) Positive, notes: Tested positive on 21Sep; (28Sep2023) Negative, notes: 28Sep tested negative on home test and again on 30Sep; (30Sep2023) Negative, notes: 28Sep tested negative on home test and again on 30Sep. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 21Sep2023 till 26Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300317391 same reporter/patient, different drug/AE;