chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (hives) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 031L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Allergic to: Sulfa), Drug allergy (Codeine), Shellfish allergy, Lactose intolerant and Allergy to arthropod bite (sensitive to bug bite).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PREDNISONE at a dose of a shot. At the time of the report, URTICARIA (hives) had resolved.            No concomitant medication was reported. After the 2nd shot, the patient had an allergic reaction. The patient had hives on pressure points, then it spread all over the body, and came together, it was itchy, raised and red. The patient took Benadryl but it did not work. The patient went to the emergency room and they gave a shot of prednisone and it went away. The patient took the first monovalent Booster, dose 3 on 01-Feb-2022 (Lot 037F21A & Exp. Date unknown), 2nd monovalent booster, dose 4 on 28-Apr-2022 (Lot 046L21A & Exp. Date: unknown). and bivalent Booster, dose 5 on Dec-2022.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Loss of personal independence in daily activities, Pain
Clinical narrative: She got the shot on her left arm and started experiencing soreness on 30OCT2023.; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PAIN (She got the shot on her left arm and started experiencing soreness on 30OCT2023.) in a 69-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 3080536) for COVID-19 prophylaxis.     Patient was not diagnosed with COVID-19.  Previously administered products included for Product used for unknown indication: Flu shot on 06-Oct-2023. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Breast cancer metastatic since 2011, Allergy to chemicals and Drug allergy.    On 29-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 30-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced INJECTION SITE PAIN (She got the shot on her left arm and started experiencing soreness on 30OCT2023.). At the time of the report, INJECTION SITE PAIN (She got the shot on her left arm and started experiencing soreness on 30OCT2023.) had not resolved.            It was reported that patient had receives previous vaccines four weeks prior to Covid-19 vaccine.  Concomitant product use was not provided by the reporter.  NDC number of the suspect vaccine was 80777-0102-93.  It was reported that She got the shot on her left arm and started experiencing soreness on 30-Oct-2023. This was her fifth dose and she did not remember ever experiencing a sore arm like this with her previous doses. She had received all Moderna COVID-19 vaccines in the past. She said that her arm was still sore at the time of reporting and she was surprised that it would last this long. She reported that the intensity of the soreness had remained the same over the days and had not gone down. She could not do much when she needs to mover her arm, as it hurts. She said that she felt throbbing in her arm. She had never had this issue with other her previous doses.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-747942.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747942:Monovalent case
Age: 78.0
Sex: M
Vaccine: UNK
Symptoms: Balance disorder, Chills, Dizziness, Fatigue, Muscular weakness
Clinical narrative: fatiguing; chills; having trouble with his balance; tremors/shaking; vertigo; muscle weakness; dizziness; This spontaneous case was reported by a patient and describes the occurrence of BALANCE DISORDER (having trouble with his balance), TREMOR (tremors/shaking), VERTIGO (vertigo), MUSCULAR WEAKNESS (muscle weakness) and DIZZINESS (dizziness) in a 78-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032086) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Drug use for unknown indication: Metoprolol Tartrate, Mirabegron, Omeprazole and Rosuvastatin; for Post-traumatic stress disorder: Sertraline; for Mood swings: Sertraline. Past adverse reactions to the above products included No adverse event with Metoprolol Tartrate, Mirabegron, Omeprazole, Rosuvastatin, Sertraline and Sertraline. Concurrent medical conditions included Aortic stenosis (since about 5 years ago, pretty stable during that time.), Mood swings and Post-traumatic stress disorder.    On 30-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. In October 2023, the patient experienced BALANCE DISORDER (having trouble with his balance), TREMOR (tremors/shaking), VERTIGO (vertigo), MUSCULAR WEAKNESS (muscle weakness), DIZZINESS (dizziness) and CHILLS (chills). On 01-Nov-2023, the patient experienced FATIGUE (fatiguing). At the time of the report, BALANCE DISORDER (having trouble with his balance), TREMOR (tremors/shaking), VERTIGO (vertigo), MUSCULAR WEAKNESS (muscle weakness), DIZZINESS (dizziness), FATIGUE (fatiguing) and CHILLS (chills) was resolving.            It was reported that patient had no any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  It was reported that approximately 15 hours later he woke up at 3 am with chills so bad that he could not stop shaking, he put on more clothes, but he also felt muscle weakness and was having trouble with his balance, the room was spinning, like vertigo and some dizziness and it was very fatiguing. Currently he felt better, still kind of tired but better, it was still ongoing but improving. It was strange to him this reaction because he used to be in pretty good shape in spite of his age.  Treatment information was not provided.   This case was linked to MOD-2023-748020, MOD-2023-747999 (Patient Link).
Age: 78.0
Sex: M
Vaccine: UNK
Symptoms: Sleep disorder, Tremor, Vertigo
Clinical narrative: fatiguing; chills; having trouble with his balance; tremors/shaking; vertigo; muscle weakness; dizziness; This spontaneous case was reported by a patient and describes the occurrence of BALANCE DISORDER (having trouble with his balance), TREMOR (tremors/shaking), VERTIGO (vertigo), MUSCULAR WEAKNESS (muscle weakness) and DIZZINESS (dizziness) in a 78-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032086) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Drug use for unknown indication: Metoprolol Tartrate, Mirabegron, Omeprazole and Rosuvastatin; for Post-traumatic stress disorder: Sertraline; for Mood swings: Sertraline. Past adverse reactions to the above products included No adverse event with Metoprolol Tartrate, Mirabegron, Omeprazole, Rosuvastatin, Sertraline and Sertraline. Concurrent medical conditions included Aortic stenosis (since about 5 years ago, pretty stable during that time.), Mood swings and Post-traumatic stress disorder.    On 30-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. In October 2023, the patient experienced BALANCE DISORDER (having trouble with his balance), TREMOR (tremors/shaking), VERTIGO (vertigo), MUSCULAR WEAKNESS (muscle weakness), DIZZINESS (dizziness) and CHILLS (chills). On 01-Nov-2023, the patient experienced FATIGUE (fatiguing). At the time of the report, BALANCE DISORDER (having trouble with his balance), TREMOR (tremors/shaking), VERTIGO (vertigo), MUSCULAR WEAKNESS (muscle weakness), DIZZINESS (dizziness), FATIGUE (fatiguing) and CHILLS (chills) was resolving.            It was reported that patient had no any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  It was reported that approximately 15 hours later he woke up at 3 am with chills so bad that he could not stop shaking, he put on more clothes, but he also felt muscle weakness and was having trouble with his balance, the room was spinning, like vertigo and some dizziness and it was very fatiguing. Currently he felt better, still kind of tired but better, it was still ongoing but improving. It was strange to him this reaction because he used to be in pretty good shape in spite of his age.  Treatment information was not provided.   This case was linked to MOD-2023-748020, MOD-2023-747999 (Patient Link).
Sex: U
Vaccine: UNK
Symptoms: Arthralgia
Clinical narrative: I am experiencing joint soreness in my knees; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (I am experiencing joint soreness in my knees) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (I am experiencing joint soreness in my knees). At the time of the report, ARTHRALGIA (I am experiencing joint soreness in my knees) outcome was unknown.      The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient experienced joint soreness in knees.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2023: Live follow-up information received included updated reporter details and reference ID's.
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea, Headache, Hyperhidrosis, Pyrexia, Vomiting
Clinical narrative: Hot Sweats; she has a headache without fever; Bad diarrhea; vomiting; fever; This spontaneous case was reported by a nurse and describes the occurrence of HYPERHIDROSIS (Hot Sweats), DIARRHOEA (Bad diarrhea), VOMITING (vomiting), PYREXIA (fever) and HEADACHE (she has a headache without fever) in a 77-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu Vaccine (Flu 2 weeks before the Spikevax). Past adverse reactions to the above products included No adverse event with Flu Vaccine. Concurrent medical conditions included Hypertension.    On 26-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 27-Oct-2023, the patient experienced DIARRHOEA (Bad diarrhea), VOMITING (vomiting) and PYREXIA (fever). On 01-Nov-2023, the patient experienced HYPERHIDROSIS (Hot Sweats) and HEADACHE (she has a headache without fever). At the time of the report, HYPERHIDROSIS (Hot Sweats) outcome was unknown and DIARRHOEA (Bad diarrhea), VOMITING (vomiting), PYREXIA (fever) and HEADACHE (she has a headache without fever) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.   The patient had vaccine on 26 Oct 2023 and 30 hours after that night of 27 Oct 2023 had a lousy, bad diarrhea, vomiting and fever. They can't figure out if this was due to the vaccine or she just caught a virus. On 1 Nov 2023, she was generally feeling good, but she had a headache without fever and hot sweats.  Treatment medication not reported.
Sex: F
Vaccine: UNK
Symptoms: Brain fog, Decreased appetite, Fatigue, Hypersomnia, Influenza like illness
Clinical narrative: sore arm; flu like symptoms; loss of appetite; she slept a lot for a few days; She has this fog going on; Her fatigue is much more than it normally is; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (flu like symptoms), DECREASED APPETITE (loss of appetite), HYPERSOMNIA (she slept a lot for a few days) and BRAIN FOG (She has this fog going on) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 21-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (flu like symptoms), DECREASED APPETITE (loss of appetite), HYPERSOMNIA (she slept a lot for a few days), BRAIN FOG (She has this fog going on) and FATIGUE (Her fatigue is much more than it normally is). At the time of the report, PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (flu like symptoms) and DECREASED APPETITE (loss of appetite) had not resolved and HYPERSOMNIA (she slept a lot for a few days), BRAIN FOG (She has this fog going on) and FATIGUE (Her fatigue is much more than it normally is) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication and treatment medication were not reported.  Patient received SPIKEVAX on 21-OCT-2023. She previously received Pfizer COVID-19 vaccinations. She states she had the general side effect such as sore arm, flu like symptoms and she slept a lot for a few days. She has this fog going on, she is experiencing loss of appetite, she eats because she knows she has to, she is hopeful that eating would help her fatigue. Her fatigue is much more than it normally is.  Company comment: This spontaneous case concerns a female patient of unknown gender, with no medical history information reported, who experienced the unexpected non serious AESI of hypersomnia along with other non serious events. The event occurred after a dose of SPIKEVAX 2023-2024. As reported, patient had the general side effect such as sore arm, flu like symptoms and she slept a lot for a few days. She has this fog going on, she is experiencing loss of appetite, she eats because she knows she has to, she is hopeful that eating would help her fatigue. Patient's fatigue was much more than it normally is, as reported. No further information about the events was provided. The benefit-risk relationship of SPIKEVAX 2023-2024 is not affected by this report.
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: sore arm; flu like symptoms; loss of appetite; she slept a lot for a few days; She has this fog going on; Her fatigue is much more than it normally is; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (flu like symptoms), DECREASED APPETITE (loss of appetite), HYPERSOMNIA (she slept a lot for a few days) and BRAIN FOG (She has this fog going on) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 21-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (flu like symptoms), DECREASED APPETITE (loss of appetite), HYPERSOMNIA (she slept a lot for a few days), BRAIN FOG (She has this fog going on) and FATIGUE (Her fatigue is much more than it normally is). At the time of the report, PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (flu like symptoms) and DECREASED APPETITE (loss of appetite) had not resolved and HYPERSOMNIA (she slept a lot for a few days), BRAIN FOG (She has this fog going on) and FATIGUE (Her fatigue is much more than it normally is) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication and treatment medication were not reported.  Patient received SPIKEVAX on 21-OCT-2023. She previously received Pfizer COVID-19 vaccinations. She states she had the general side effect such as sore arm, flu like symptoms and she slept a lot for a few days. She has this fog going on, she is experiencing loss of appetite, she eats because she knows she has to, she is hopeful that eating would help her fatigue. Her fatigue is much more than it normally is.  Company comment: This spontaneous case concerns a female patient of unknown gender, with no medical history information reported, who experienced the unexpected non serious AESI of hypersomnia along with other non serious events. The event occurred after a dose of SPIKEVAX 2023-2024. As reported, patient had the general side effect such as sore arm, flu like symptoms and she slept a lot for a few days. She has this fog going on, she is experiencing loss of appetite, she eats because she knows she has to, she is hopeful that eating would help her fatigue. Patient's fatigue was much more than it normally is, as reported. No further information about the events was provided. The benefit-risk relationship of SPIKEVAX 2023-2024 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 08-Sep-2023, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Sep-2023, SARS-CoV-2 test: Positive.         Concomitant medication not reported.   Patient already received 5 Moderna COVID-19 doses, 2 doses of the primary series and 3 boosters, but did not remember the dates. On 8 Sep 2023 he tested positive to COVID-19 but did not have any symptoms and was in quarantine for 5 days.  Treatment medication not reported.   Reporter did not allow further contact
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Psoriasis
Clinical narrative: after her last dose of the vaccine she had "severe flu like symptoms" worse than she's ever had in her life; psoriasis; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (psoriasis) and INFLUENZA LIKE ILLNESS (after her last dose of the vaccine she had "severe flu like symptoms" worse than she's ever had in her life) in a 7-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A, 027L20A and 002M21A) for COVID-19 prophylaxis.     Concomitant products included GUSELKUMAB (TREMFYA) for Psoriasis.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2020, the patient experienced PSORIASIS (psoriasis). In April 2022, the patient experienced INFLUENZA LIKE ILLNESS (after her last dose of the vaccine she had "severe flu like symptoms" worse than she's ever had in her life). At the time of the report, PSORIASIS (psoriasis) had not resolved and INFLUENZA LIKE ILLNESS (after her last dose of the vaccine she had "severe flu like symptoms" worse than she's ever had in her life) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2023-748136 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748136:Same Reporter
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: testing positive for Covid; testing positive for Covid; vaccine brand other=Moderna/Pfizer/BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received bnt162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL8982), in left arm, on 24Feb2021 at 13:30 as dose 2, single (Lot number: EN6203), in left arm and on 05Oct2021 as dose 3 (booster), single (Lot number: FF2857) at the age of 73 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18May2022 as dose 4 (booster) single (Lot number: 038A22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Pen" (unspecified if ongoing); "Known allergies: ace inhibitors, arb blockers" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "depression" (unspecified if ongoing); "gout" (unspecified if ongoing); "degenerative arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18May2022, outcome "unknown", described as "vaccine brand other=Moderna/Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "testing positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: 7 days after testing positive for Covid and starting Paxlovid within 12 hour of onset of fever to 101.5, myalgias, extreme weakness and feeling better. Paxlovid start date 06Oct2023 to stop date: 11Oct2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300351260 same patient, different drug/ event;
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; vaccine brand other=Moderna,; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 27Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 17Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 02May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), 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 08Sep2022, outcome "unknown", described as "vaccine brand other=Moderna,"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: Covid-19 Treatment; (15Oct2023) positive, notes: I experienced fever and tested positive for COVID 15Oct2023. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: She experienced fever and tested positive for COVID 15Oct2023. Only other symptom was mild nasal stuffiness. Started Paxlovid that night, took the 5-day course. Patient had no known allergies.  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-202300351207  same patient, different drug/AE;
Age: 66.0
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Aug2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (26Oct2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Oct2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 20Oct2023 to 24Oct2023.  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-202300351409 same patient different drug/event;
Age: 25.0
Sex: F
Vaccine: COVID19, FLUC4, RSV
Symptoms: Accidental exposure to product, Maternal exposure before pregnancy
Clinical narrative: RSV was given inadvertently vaccinator thought patient fell in the 32-36 week category of eligibility so ABRYSVO was given in addition to the covid and flu shot. Spoke to patient and they were not wanting to escalate any further so reporting due diligence
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9, MENB, TDAP, VARCEL
Symptoms: Injection site bruising, Pain in extremity, Product administered to patient of inappropriate age, Product administration error, Wrong product administered
Clinical narrative: I noted on November 2, 2023, that I gave the patient the wrong vaccine.  He was supposed to receive MCV4 (Menveo) instead of Bexsero since he was only 14 years old.  I called the patient down to the health center from class, on November 3, 2023,  and asked him about any possible reactions from his vaccines he received a week earlier.  He stated that only had sore arms but did have a small bruise on his right arm, however, he did receive 2 other vaccines in that same arm, in the same vicinity as the Men B, that same day.  I explained to him what happened and that I would be calling his parents to inform them also.  I was unable to reach his parents so will try again on Monday, November 6, 2023.  I spoke with the patient's mom later in the evening and explained to her the error that was made and let her know that she may get some follow up calls about this.  Explained to her that she shouldn't notice any problems at this point, being 1 week after the vaccine but if she did she could contact her son's dr. office or our office with any questions.  Just a note that mom does not speak the language.
Age: 6.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Underdose, Wrong patient
Clinical narrative: Patient and his younger brother were in office for Flu and Covid vaccines. I was assisting a newer M.A. in drawing up/administering.  Discussed vaccinating different ages and encouraged drawing separate trays and labeling each with name/age as with Covid vaccine. We prepared two separate trays each labeled for the boys with their separate ages, 5-11 (Patient) and brother (6m-<5yrs.) Brother was going to go first, then did not want to.  Brother was crying. Patient said he would go first.  I had Brother's tray and administered the Flu and YOUNG CHILD Covid to Patient who should have gotten the 5-11 dose. I realized my error immediately afterwards as having grabbed the wrong tray.  We took a time out, I explained my error to co-worker. I had staff re-draw the 6m-<5yr dose, verified, and we went back in. I apologized to mom and explained what had happened, that Patient got the dose intended for a younger child. Told mom that I will find out from Health Dept. what to do. Mom expressed understanding and will wait to hear what is recommended. Staff administered the imms to Brother with the correct dosing. I apologized to mom again.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Lip blister, Oral mucosal blistering, Rash macular, SARS-CoV-2 test
Clinical narrative: Blister inside my mouth; Face had blisters. Also had blisters on each ear; Blister on my upper lip, lower lip; Face had red blotches; 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 male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 at 17:00 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: ORAL MUCOSAL BLISTERING (medically significant) with onset 17Oct2023 at 12:00, outcome "recovering", described as "Blister inside my mouth"; LIP BLISTER (medically significant) with onset 17Oct2023 at 12:00, outcome "recovering", described as "Blister on my upper lip, lower lip"; BLISTER (medically significant) with onset 17Oct2023 at 12:00, outcome "recovering", described as "Face had blisters. Also had blisters on each ear"; RASH MACULAR (medically significant) with onset 17Oct2023 at 12:00, outcome "recovering", described as "Face had red blotches". The events "blister inside my mouth", "face had blisters. also had blisters on each ear", "blister on my upper lip, lower lip" and "face had red blotches" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Oct2023) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of oral mucosal blistering, blister, lip blister, rash macular. Clinical course: Patient reported that after 3 days of vaccination his face had red blotches and blisters. Also had blisters on each ear, but on his upper lip, lower lip and inside his mouth. On 23Oct2023. He went to hospital emergency room for sodium chloride IV (intravenous) and prednisone pills.  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: 88.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cellulitis, SARS-CoV-2 test positive, Tenderness
Clinical narrative: INPATIENT PROGRESS NOTE    Date of Service 10/31/2023  Hospital Day(s): 4        Patient is a 91 Y female with PMH of Afib / coumadin, Eczema, HTN, S/P PPM,  Hypothyroidism, Pulmonary Nodule, RLS, RA in Remission, Venous Insufficiency / Venous Stasis. Patient was on duricef for 7 day on 10/18/29023. Completed antibiotic therapy, but did not improve. Admitted for Left LE cellulitis. Started on IV vanc/zosyn, now on ceftriaxone and vanc. Incidentally found to be covid positive   Subjective: - Seen at bedside with sons - reports tenderness of left leg with touch and movement     MAR reviewed.     Physical Exam: Patient Vitals for the past 24 hrs:
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Local reaction, Product administered to patient of inappropriate age
Clinical narrative: Patient given high dose flu instead of regular dose flu in error. patient's mother is monitoring patient for increased intensity of local reaction.
Age: 21.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Eye movement disorder, Muscle rigidity, Unresponsive to stimuli
Clinical narrative: She had an anxiety prior to injection.  after the shot, her body went rigid, eyes rolled back, became unresponsive
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Staff did not reconstitute the covid 6mo-4 year vaccine vial and drew up 0.3mL of the vial. Patient received COVID 19- 2023-2024 Pfizer formula without proper reconstruction
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction, Swollen tongue, Urticaria
Clinical narrative: Patient contacted the pharmacy around 8:05 AM the day after her immunization stating that she was developing welts near the injection site that were spreading across her upper body. The pharmacist advised the patient to seek emergency treatment, the patient was agreeable. The pharmacist followed up with the patient that afternoon, where the patient reported that she had gone to an urgent care clinic where they noticed her tongue was swelling and sent her to an emergency department. The patient was then treated with IV medications, steroids, and discharged her with further medication for home. As of 5:30 PM the patient stated that she was feeling better.   I was not involved in the treatment of the patient's reaction. I administered the vaccine and advised her the following morning to seek emergency treatment.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: raised, painful, itching, warm area below injection site still present 7 days after injection
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt called 11/3/23 at 9:35am asking which vaccine she received in the lower quadrant of her right arm as she experienced redness and swelling around the injection site. She had received Comirnaty by pfizer in the lower position of her right arm with the flucelvax in the upper area. She said she woke up on 11/1/23 with redness and swelling at this site, and went to the emergency room. They prescribed her prednisone and referred her to follow up with her primary care doctor. She wanted to be sure which vaccine to report to her doctor that caused the reaction. She stated that the prednisone seemed to be working to remove the swelling and redness at this time.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Dose #6: Pfizer/ Dose #7: Moderna; 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.  An 83-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Apr2023 at 13:15 as dose 6 (booster), single (Lot number: GJ6796), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Sep2023 at 15:15 as dose 7 (booster), single (Lot number: AU3832B), 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), 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: "Type II Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Allergy: Tetracycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Sep2023 at 15:15, outcome "unknown", described as "Dose #6: Pfizer/ Dose #7: Moderna". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid used for COVID 19 treatment, from 17Oct2023 to 21Oct2023.
Age: 31.0
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 32-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 17Dec2021 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 31 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 included: "ADHD" (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 Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 21Oct2023 to 26Oct2023. Clinical course: The patient had no known allergies.  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-202300352179 Same reporter/patient, different drug, different AE.;
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Had a heart attack the next day after this vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 29-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "Had a heart attack the next day after this vaccine". Clinical course: Reporter stated that he knew a 29 year old person who had a heart attack the next day after this vaccine.  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-202300352878 Same product, different event /patient;
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: Developed cancer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "Developed cancer". Clinical course: Reporter stated that their brother developed cancer because of the Pfizer shot, not a vaccine but the shot because it does not prevent anything.  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-202300352863 Same product, different patient/event;
Sex: U
Vaccine: PNC20
Symptoms: Needle issue, Poor quality product administered, Syringe issue
Clinical narrative: When they put the needle out of the patient and they went to activate the safety feature of the needle the tip just break off; it is the actual syringe that broke; When they put the needle out of the patient and they went to activate the safety feature of the needle the tip just break off; it is the actual syringe that broke; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), on 31Oct2023 as dose number unknown, single (Lot number: HF1068, Expiration Date: Aug2024) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEEDLE ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) and all described as "When they put the needle out of the patient and they went to activate the safety feature of the needle the tip just break off; it is the actual syringe that broke".  The reporter considered "when they put the needle out of the patient and they went to activate the safety feature of the needle the tip just break off; it is the actual syringe that broke" associated to device constituent of pneumococcal 20-val conj vac (dipht crm197 protein). Causality for "when they put the needle out of the patient and they went to activate the safety feature of the needle the tip just break off; it is the actual syringe that broke" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht crm197 protein) (malfunction).  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300353439 Same reporter/drug/event for different patients.;US-PFIZER INC-202300353440 Same reporter/drug/event for different patients.;
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain in extremity, Vaccination site pain
Clinical narrative: migraine headache; Injection site pain; pain in her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 60-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for covid-19 immunization.  The following information was reported: MIGRAINE (disability), outcome "unknown", described as "migraine headache"; VACCINATION SITE PAIN (medically significant), outcome "unknown", described as "Injection site pain"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in her arm". Therapeutic measures were taken as a result of vaccination site pain.  Clinical information: The reporter is the mother of a patient who experienced pain in her arm and migraine headache after receiving her second shot of the Pfizer COVID-19 vaccine and now totally disabled. The reporter is looking for any solution on how to stop the headaches. The reporter mentioned that her daughter was recommended by a doctor to have surgery to relieve the injection site pain but may cause more problems. The reporter stated that a different doctor did the operation and after the procedure, her daughter had more migraines and the migraine just got worse. The reporter stated that they will be doing a CT-Scan next to see what is going on. Informed the reporter that included in the other reported side effects of the Pfizer BioNTech COVID-19 vaccine are Injection site pain/tenderness, redness and swelling, headache, dizziness and nausea.  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: Neoplasm malignant
Clinical narrative: got cancer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "got cancer". Clinical course: Reporter was called and mentioned that her brother got cancer because of the Covid-19 vaccine. Created manual AE form because the reporter brother had cancer after receiving the Covid-19 shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: UNK
Symptoms: Neoplasm malignant
Clinical narrative: her brother got cancer because of the vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), 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: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "her brother got cancer because of the vaccine". Clinical course: Caller was calling in about the covid-19 vaccine, caller wanted to know why it was called vaccine if it is a shot. Caller mentioned that vaccine was meant to prevent something. Reporter mentioned that she knew many people who have gotten the quote unquote vaccine. Also, she was asking why Pfizer was continuing to provide something that was proven to create situations such as cancer, heart attacks etc. to a very large percentage of the population. She further asked that why were they being allowed to do this and under what approval they were allowed to provide something that created these situations. She mentioned that her brother got cancer because of the vaccine. She said that she guarantees that she will join any class action. Caller wanted to know how many vaccines Pfizer have. She also mentioned that the vaccine has side effect that has been devastating to the entire world and she hoped that Pfizer run out of business. Also mentioned that 80% of the population was suffering because of this. She also said that Pfizer is a criminal organization and will be sued. Caller refused to provide manual AE form because caller's brother got cancer after the vaccine was administered. Caller mentioned the Pfizer COVID vaccine was shoving down the throats of people in the country and around the world.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.