chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive; tested positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A male patient 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: however her husband tested positive.  Additional information: Caller, a patient got a Pfizer covid-19 vaccines shot with her husband however her husband tested positive. Caller wanted to know if it is the effects of a vaccine. When caller came on the line: stated: me and my husband had any covid vaccine available since the beginning of covid, we never had covid before, got the latest Pfizer covid vaccine 2023-2024 formulation and her husband tested positive and she is testing right now and looks like may be testing positive as well however not sure at the time of the call, asking if the antibodies in the vaccination are triggering the covid? Would them taking covid vaccination on Thursday make them test positive for covid after vaccination?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received bnt162b2 (BNT162B2), on 25Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes and a touch of heart disease" (unspecified if ongoing), notes: Diabetes and a touch of heart disease; "Diabetes and a touch of heart disease" (unspecified if ongoing), notes: Diabetes and a touch of heart disease; "known allergies: Sulfa drugs" (unspecified if ongoing), notes: known allergies: Sulfa drugs. 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid was taken as treatment for COVID-19 from 30Sep2023. The patient was taking other medication/products within 2 weeks of starting COVID-19 treatment and the patient previously received a COVID-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Vaccination site reaction
Clinical narrative: We got our shots (flu and COVID-19) a couple of days ago at our local withheld pharmacy. For the  1st time in my memory, I "suffered" some reactions, primarily in my upper left arm; where both shots; This is a spontaneous report received from non-contactable reporter(s) (Physician).  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 28Sep2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose number: Unknown, Previous COVID shots were from Moderna.), for COVID-19 Immunization. The following information was reported: VACCINATION SITE REACTION (non-serious) with onset 28Sep2023, outcome "unknown", described as "We got our shots (flu and COVID-19) a couple of days ago at our local withheld pharmacy. For the  1st time in my memory, I "suffered" some reactions, primarily in my upper left arm; where both shots". Additional information: Patient got  shots (flu and COVID-19) a couple of days ago at local pharmacy. For the 1st time in  memory, patient "suffered" some reactions, primarily in upper left arm; where both shots were administered. Maybe patient can blame Pfizer. Previous COVID shots were from Moderna."  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: 78.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administration error
Clinical narrative: Patient was given a dose of Moderna Spikevax vaccine in error as he had previously received a dose of Pfizer vaccine on 9/28/2023 at a different pharmacy.  He has not experienced any side effects of the additional vaccine thus far.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient has severe pain, redness, swelling  on the site of injection .Her arm is red about 8 cm diameter and swell up about an hour after the vaccine and continue until 10/5/23. Patient said she is in so much pain that she couldn't move her arm up the next day. We advise patient to take Motrin for pain/swelling and Benadryl for itchiness. We call and follow  up with her today 10/5/23. She is getting much better and has no questions.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Patient has severe pain, redness, swelling  on the site of injection .Her arm is red about 8 cm diameter and swell up about an hour after the vaccine and continue until 10/5/23. Patient said she is in so much pain that she couldn't move her arm up the next day. We advise patient to take Motrin for pain/swelling and Benadryl for itchiness. We call and follow  up with her today 10/5/23. She is getting much better and has no questions.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Employee reports hives and itchiness on trunk, thighs.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Patient told me prior to administration that she has alpha-gal syndrome and I looked over ingredient list and nothing stuck out to me as something she should react to. She said she had no issues with previous doses. I administered the vaccine and the patient came back 10-20 minutes later saying her hands were starting to itch and it was one of her first reactions that she usually has with her alpha gal. She stated she had already taken 50mg diphenhydramine (what she usually does when this occurs) and asked to see the ingredient list herself. She agreed there didn't seem to be anything that would affect her alpha-gal. She said she felt okay and also had prednisone at home and would talk to her allergist. I called her around 5pm this evening to check in and she said she was feeling totally fine now.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Gait disturbance, Malaise, Muscle spasms
Clinical narrative: Sore injection site; general unwell feeling; chills; severe body aches; unable to walk from body pain; back spasms; sore muscles for 48 hours; loss of appetite; 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 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 12:00 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUAD), on 30Sep2023 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "thyroid low" (unspecified if ongoing); "gastroparesis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 5), for COVID-19 Immunization; Covid-19 vaccine (Dose 4), for COVID-19 Immunization; Covid-19 vaccine (Dose 3), for COVID-19 Immunization; Covid-19 vaccine (Dose 2), for COVID-19 Immunization; Covid-19 vaccine (Dose 1), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 30Sep2023 at 17:00, outcome "recovering", described as "Sore injection site"; MUSCLE SPASMS (non-serious) with onset 30Sep2023 at 17:00, outcome "recovering", described as "back spasms"; CHILLS (non-serious) with onset 30Sep2023 at 17:00, outcome "recovering"; MALAISE (non-serious) with onset 30Sep2023 at 17:00, outcome "recovering", described as "general unwell feeling"; DECREASED APPETITE (non-serious) with onset 30Sep2023 at 17:00, outcome "recovering", described as "loss of appetite"; PAIN (non-serious) with onset 30Sep2023 at 17:00, outcome "recovering", described as "severe body aches"; MYALGIA (non-serious) with onset 30Sep2023 at 17:00, outcome "recovering", described as "sore muscles for 48 hours"; GAIT DISTURBANCE (non-serious) with onset 30Sep2023 at 17:00, outcome "recovering", described as "unable to walk from body pain". Therapeutic measures were taken as a result of vaccination site pain, malaise, chills, pain, gait disturbance, muscle spasms, myalgia, decreased appetite.  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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Vaccination site pain
Clinical narrative: Sore injection site; general unwell feeling; chills; severe body aches; unable to walk from body pain; back spasms; sore muscles for 48 hours; loss of appetite; 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 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 12:00 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUAD), on 30Sep2023 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "thyroid low" (unspecified if ongoing); "gastroparesis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 5), for COVID-19 Immunization; Covid-19 vaccine (Dose 4), for COVID-19 Immunization; Covid-19 vaccine (Dose 3), for COVID-19 Immunization; Covid-19 vaccine (Dose 2), for COVID-19 Immunization; Covid-19 vaccine (Dose 1), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 30Sep2023 at 17:00, outcome "recovering", described as "Sore injection site"; MUSCLE SPASMS (non-serious) with onset 30Sep2023 at 17:00, outcome "recovering", described as "back spasms"; CHILLS (non-serious) with onset 30Sep2023 at 17:00, outcome "recovering"; MALAISE (non-serious) with onset 30Sep2023 at 17:00, outcome "recovering", described as "general unwell feeling"; DECREASED APPETITE (non-serious) with onset 30Sep2023 at 17:00, outcome "recovering", described as "loss of appetite"; PAIN (non-serious) with onset 30Sep2023 at 17:00, outcome "recovering", described as "severe body aches"; MYALGIA (non-serious) with onset 30Sep2023 at 17:00, outcome "recovering", described as "sore muscles for 48 hours"; GAIT DISTURBANCE (non-serious) with onset 30Sep2023 at 17:00, outcome "recovering", described as "unable to walk from body pain". Therapeutic measures were taken as a result of vaccination site pain, malaise, chills, pain, gait disturbance, muscle spasms, myalgia, decreased appetite.  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: 28.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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) from product quality group. The reporter is the patient.  A 29-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 28 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Lot number: ER8735), on 05May2021 as dose 2, single (Lot number: ER8735) and on 23Nov2021 as dose 3 (booster), single (Lot number: EW0183) for covid-19 immunisation. The patient's relevant medical history included: "Chronic migraine" (unspecified if ongoing); "IBS (constipation)" (unspecified if ongoing), notes: IBS (constipation); "mild sleep apnea" (unspecified if ongoing), notes: mild sleep apnea. Concomitant medication(s) included: TOPIRAMATE, start date: 01Jul2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  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.
Age: 50.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 23Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. 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 and covid-19 with Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient received bnt162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6204), in left arm, on 27Mar2021 as dose 2, single (Lot number: ER8727), in left arm, on 04Oct2021 as dose 3 (booster), single (Lot number: EW0196), in left arm and on 08Jun2022 as dose 4 (booster), single (Lot number: FP4554), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Sep2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Sep2023) positive; (24Sep2023) negative; (25Sep2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was given from 18Sep2023 to 22Sep2023.
Sex: M
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 non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 47-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 4 (booster), single (Lot number: gj5342), 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "mild hypertension" (unspecified if ongoing), notes: mild hypertension; "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), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Sep2023) Unknown results; (23Sep2023) Unknown results; (24Sep2023) Unknown results; (25Sep2023) Unknown results; (26Sep2023) Unknown results; (27Sep2023) Unknown results; (28Sep2023) Positive, notes: but could barley see the T line; (29Sep2023) Positive, notes: but could barley see the T line; (30Sep2023) Positive, notes: within 30 seconds of testing and since then; (01Oct2023) Positive, notes: within 30 seconds of testing and since then; (02Oct2023) Positive, notes: within 30 seconds of testing and since then. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19, 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 26-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Dec2022 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 25 years, in left arm 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: "Shellfish allergy" (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 "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive again approximately 5 days after testing negative after round of Paxlovid completed; Negative, notes: after round of Paxlovid completed. Therapeutic measures were taken as a result of drug ineffective, covid-19: the patient received treatment with Paxlovid from 22Sep2023 to 26Sep2023.   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.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Dose 1,2,3,5 Comirnaty vaccine; Dose 4: Moderna vaccine; 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 56-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: ER8729), on 30Apr2021 as dose 2, single (Lot number: EW0179) and on 30Nov2021 as dose 3 (booster), single (Lot number: 330308D) for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 26Apr2022 as dose 4 (booster), single (Lot number: 005M21A) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: OSSOPAN BMD, start date: 13Jan2021; MULTI-VITAMINS VITAFIT, start date: 13Jan2021; ESTROGEN, start date: 16Jan2023; VIT D3, start date: 13Jan2021; PROGESTERONE, start date: 16Jan2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovered" (21Sep2023) and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "recovered", described as "Dose 1,2,3,5 Comirnaty vaccine; Dose 4: Moderna vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Sep2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 16Sep2023 to 21Sep2023. 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.
Age: 44.0
Sex: M
Vaccine: COVID19-2, FLUR4
Symptoms: Abdominal discomfort, Dizziness, Headache
Clinical narrative: Lightheadedness, feeling faint, headache, upset stomach
Age: 12.0
Sex: F
Vaccine: DTAPIPV, MNQ, TDAP
Symptoms: Wrong product administered
Clinical narrative: QUADRACEL (DTAP/IPV) VACCINE WAS GIVEN IN ERROR.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Influenza like illness, Pain in extremity
Clinical narrative: Patient had flu like symptoms the day after vaccination. Patient developed pain in both of her thighs 5 days after vaccination described as a clenching/tightness. She had husband message them and the pain went minimized.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Pt presented to clininc complaining of redness at injection site.  3" reddened area at site, oval shape.  Reports that the site is very itchy.  States that the redenss was there the next am after receieving the injection.  Believes it is improving, but wanted us to see it.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood culture, Blood lactate dehydrogenase, COVID-19, Cough, Exposure during pregnancy
Clinical narrative: Currently pregnant patient (30 weeks) vaccinated 10/6/2021; presented to the ED on 10/1/2023 with fever, cough, rhinorrhea, body aches.  Tested positive for COVID during that visit.  Admitted to the OB unit for observation 10/1/2023.  Discharged 10/2/2023.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Laboratory test, Metabolic function test, Pain, Pyrexia
Clinical narrative: Currently pregnant patient (30 weeks) vaccinated 10/6/2021; presented to the ED on 10/1/2023 with fever, cough, rhinorrhea, body aches.  Tested positive for COVID during that visit.  Admitted to the OB unit for observation 10/1/2023.  Discharged 10/2/2023.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive, Tachycardia, Treponema test, Urine analysis
Clinical narrative: Currently pregnant patient (30 weeks) vaccinated 10/6/2021; presented to the ED on 10/1/2023 with fever, cough, rhinorrhea, body aches.  Tested positive for COVID during that visit.  Admitted to the OB unit for observation 10/1/2023.  Discharged 10/2/2023.
Age: 80.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath, difficulty breathing, administered IM epi-pen, called EMS
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Injection site induration, Injection site pain, Pain in extremity
Clinical narrative: Woke up day after with VERY sore arm; more so thanin past. By noon the day after vaccine, pain increased and a hard, medium sized ball  (i.e., just smaller than a gall ball) formed at injection site. By 10pm the evening after vaccine, the hard ball shape had grown to just smaller than a baseball. Very intense pain without even touching. Had a video ER visit aound 11pm. No signs of infection per se; however, certaintly a REACTION. The pain has subsided; however, the hard "ball" is still on left arm. Has reduced in size to that of a grape and is remaining contstant.  In addition, three days ago, I began to have short (i.e., ~one second) stabbing pains in the left side of my chest near my heart. The stabbing sensations have continued peroidically with no accompanying symtoms (e.g., shortness of breath, arm tingling, etc.).  I am very concerned.  NOTE:  COMIRNATY VACCINE - no side effects with previus Pfizer C19 vaccines.
Age: 74.0
Sex: M
Vaccine: FLUA4
Symptoms: Limb discomfort, Muscle spasms, Neuralgia, Pain in extremity
Clinical narrative: MUSCLE SPASM, NERVE PAIN, HEAVY FEELING IN ARM AND IN SEVERE PAIN
Age: 34.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Apr2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in right 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Sep2023, outcome "recovered" (30Sep2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Sep2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received the Paxlovid treatment from 21Sep2023 to 25Sep2023. Patient Tested negative for Covid on 30Sep, 10 days after Covid symptoms began and after finishing 5 days of paxlovid treatment.  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-202300316749 same patient, different event/drug;
Age: 35.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 37-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 09Dec2021 as dose 3 (booster), single (Lot number: F58757) at the age of 35 years, in right arm 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 Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 28Sep2023 to 02Oct2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300316023 same reporter/patient, different drug/AE;
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 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 16Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) 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 was not reported. The patient took concomitant medications. 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". 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 with Paxlovid from 24Sep2023 to 29Sep2023.  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-202300316460 same patient, different drug/events;
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Jul2023 as dose number unknown, single (Lot number: GK0928) at the age of 64 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 03Apr2022 as dose number unknown, single (Lot number: FJ9943), in left arm for covid-19 immunisation. The patient's relevant medical history included: "menopause", start date: 23Jul2023, stop date: 23Jul2023; "Kidney stones" (unspecified if ongoing). Concomitant medication(s) included: POTASSIUM CITRATE, start date: May2021. Past drug history included: Compazine for Drug Allergy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient took Paxlovid as treatment from 19Sep2023 to 23Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300316087 same patient, different product/event;
Age: 48.0
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) (Physician). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in right 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovering" and all described as "COVID 19 Treatment". Paxlovid was taken as therapeutic measures from 21Sep2023 to 25Sep2023 as a result of drug ineffective, covid-19.  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: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300316245 Same reporter/patient; different drug/AE;
Age: 76.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Apr2023 as dose 6 (booster), single (Lot number: GJ3268) at the age of 76 years, in right 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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing), notes: controlled with medication; "high cholesterol" (unspecified if ongoing), notes: controlled with medication. Concomitant medication(s) included: BENAZEPRIL, start date: May2010; ATORVASTATIN, start date: Jun2010, stop date: 20Sep2023. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive, notes: Treatment of Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 21Sep2023 to 25Sep2023. Clinical course: The patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300316246 same reporter/patient, different drug/AE;
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Dose 5: Moderna; Dose 4/dose 3/dose 2/dose 1: Pfizer; 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 64-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 07Feb2021 as dose 1, single (Lot number: EL9264), in left arm, on 01Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 30Sep2021 as dose 3 (booster), single (Lot number: 30155BA), in left arm and on 31May2022 as dose 4 (booster), single (Lot number: CUS9282) at the age of 62 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24Oct2022 as dose 5 (booster), single (Lot number: 059F2219), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. 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"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose 5: Moderna; Dose 4/dose 3/dose 2/dose 1: Pfizer". Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid treatment from 23Sep2023 to 27Sep2023.  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-202300316280 same patient, different drug/AE;
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Covid-19; Covid-19; Pfizer Dose 1,2,3; Moderna Dose: 4; 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), on 22Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 12Apr2021 as dose 2, single (Lot number: EW0158), in left arm and on 01Dec2021 as dose 3 (booster), single (Lot number: 33030BD) at the age of 64 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Apr2022 as dose 4 (booster), single (Lot number: 033K21-2A), in left arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 23Sep2022 as dose 5 (booster), single (Lot number: AS7146B), in left arm and on 05May2023 as dose 6 (booster), single (Lot number: AS7173B), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Apr2022, outcome "unknown", described as "Pfizer Dose 1,2,3; Moderna Dose: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received COVID 19 Treatment (Paxlovid). Treatment stop date 28Sep2023. Known allergies: No.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300316477 Same patient, different drug and event;
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: According to patient, patient regularly has Joint pain/soreness. But one day after the vaccine (09/29/2023) Patient was having stabbing pain on her left knee which she never had it before. It was up to the point where it was hard for her to walk. She never had this type of pain before. The pain slowly decreased after 2 days from the vaccine date.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness, Tinnitus
Clinical narrative: I developed, and still have, hearing loss and tinnitus
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, COVID-19, Cough, Hypoxia, Nausea
Clinical narrative: no adverse reaction to vaccine, but tested positive for COVID on 9/30/2023 upon presentation to the ED with symptoms of  nausea, nonproductive coughing, rhinorrhea, congestion and generalized weakness.  Admitted to the Adult Care unit x 2 days due to her age, weakness, and mild hypoxia.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: no adverse reaction to vaccine, but tested positive for COVID on 9/30/2023 upon presentation to the ED with symptoms of  nausea, nonproductive coughing, rhinorrhea, congestion and generalized weakness.  Admitted to the Adult Care unit x 2 days due to her age, weakness, and mild hypoxia.
Age: 11.0
Sex: M
Vaccine: HPV9, HPV9, MNQ, MNQ, TDAP, TDAP
Symptoms: Blister, Diarrhoea, Peripheral swelling, Vomiting
Clinical narrative: Blisters and Swelling on left arm , Diarrhea, Vomiting for 1d.   Treatment : Amoxicillin, diphenhydrAMINE, Ondansetron
Age: 70.0
Sex: M
Vaccine: FLU4, RSV, VARZOS
Symptoms: Fatigue, Palpitations
Clinical narrative: Patient said he had heart palpitations that started after the vaccinations and continued the second day.  Patient also felt very exhausted.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 51.0
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) from product quality group. The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 20Dec2021 at 13:00 as dose 3 (booster), single (Lot number: FD7218) at the age of 51 years, in left arm 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: "High cholesterol" (unspecified if ongoing); "Overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reporter is the patient. No known allergies. Patient received anti viral treatment with Paxlovid from 15Sep2023 to 19Sep2023.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Patient says she experienced a sore arm and pain in shoulder that never went away. She believes it was from vaccine.  She has pain in shoulder in middle of the night and states throbbing.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Myalgia, Pain, Pain in extremity
Clinical narrative: I had pain in my arm which got worse into Friday night and into Saturday; Had a pain in a tiny spot, in a muscle /The pain, I couldn't even lift my leg for that muscle.; The pain I couldn't even lift my leg for that muscle; pain in my arm increased; 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 77-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose1; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose2; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose3; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose4; unknown manufacturer), for COVID-19 immunization. The following information was reported: MYALGIA (non-serious) with onset 29Sep2023, outcome "not recovered", described as "Had a pain in a tiny spot, in a muscle /The pain, I couldn't even lift my leg for that muscle."; PAIN IN EXTREMITY (non-serious) with onset 29Sep2023, outcome "not recovered", described as "I had pain in my arm which got worse into Friday night and into Saturday"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 29Sep2023, outcome "not recovered", described as "The pain I couldn't even lift my leg for that muscle"; PAIN (non-serious) with onset 29Sep2023, outcome "not recovered", described as "pain in my arm increased". 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: Atrial fibrillation
Clinical narrative: atrial fibrillation; 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 elderly male patient received bnt162b2 (BNT162B2), on 19Jan2021 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: ATRIAL FIBRILLATION (medically significant) with onset 2021, outcome "unknown". Clinical course: Reporter stated that he received 3 doses of the Pfizer BioNTech COVID-19 vaccines on 19Jan2021, 05Feb2021 and 06Oct2021 all from Pfizer and mentioned that he had atrial fibrillation and would like to know if he could get another shot of the vaccine. Reporter was over 75.  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-202300315993 Same patient/same product, different dose (dose 3)/event;US-PFIZER INC-202300317384 Same patient/same product, different dose (dose 2)/event;
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Inappropriate schedule of product administration
Clinical narrative: Atrial fibrillation; Inappropriate schedule of vaccine administered; 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 elderly male patient received bnt162b2 (BNT162B2), on 05Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE), administration date: 19Jan2021, for COVID-19 immunisation, reaction(s): "Atrial fibrillation". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 05Feb2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; ATRIAL FIBRILLATION (medically significant), outcome "unknown". Clinical course: Caller stated that he received 3 doses of the Pfizer BionTech COVID-19 vaccines on 19Jan2021, 05Feb2021 and 06Oct2021. Caller stated that he received a fourth shot but, he was not sure. Caller would like to know if he could get another COVID-19 vaccine if there was a fourth and fifth shot. Caller mentioned that he was over 75 years. He had Atrial fibrillation and wanted to know if there was any risk Precautionary AE form created.  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-202300317383 same patient/event, different dose;US-PFIZER INC-202300315993 same patient/event, different dose;
Age: 65.0
Sex: F
Vaccine: 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 67-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 07Apr2022 as dose 4 (booster), single (Lot number: Fs9943) at the age of 65 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: En6199), in left arm, on 01Apr2021 as dose 2, single (Lot number: Ep7533), in left arm and on 20Oct2021 at 11:00 as dose 3 (booster), single (Lot number: Ff2590), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lanolin, reaction(s): "Known allergies: Lanolin". 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". 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 (Paxlovid).