chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Reaction to the shot in term of pain in the arm; This is a spontaneous report received from an Other HCP.  A 55-year-old female patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto", start date: 1997 (ongoing), notes: thyroid still functioning; "sulfa allergy" (unspecified if ongoing); "constipation" (ongoing); "parathyroid removal", start date: 2010 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Reaction to the shot in term of pain in the arm". Additional information: Vaccination facility type was pharmacy/drug store. Vaccine was not administered at facility.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300414510 same patient/product, different event/vaccine dose;US-PFIZER INC-202300447639 same patient/product, different event/vaccine dose;US-PFIZER INC-202300447641 same patient/product, different event/vaccine dose;US-PFIZER INC-202300447642 same patient/product, different event/vaccine dose;US-PFIZER INC-202300447640 same patient/product, different event/vaccine dose;
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Reaction to the shot in term of pain in the arm; This is a spontaneous report received from an Other HCP.  A 55-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto", start date: 1967 (ongoing), notes: thyroid still functioning; "Known allergies: Sulfa" (unspecified if ongoing); "Constipation" (ongoing); "Parathyroid removal" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: comirnaty (DOSE 1, SINGLE), administration date: 12Mar2021, for COVID-19 immunisation.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Reaction to the shot in term of pain in the arm".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300414510 Same patient, partial same event, different dose;US-PFIZER INC-202300447636 Same patient/event, different dose;US-PFIZER INC-202300447641 same patient/product, different event/vaccine dose;
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Reaction to the shot in term of pain in the arm significantly worst then prior shots ON; This is a spontaneous report received from an Other HCP.  A 57-year-old female patient received BNT162b2 (BNT162B2), on 23Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 55 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulfa, reaction(s): "allergy". Vaccination history included: BNT162b2 (dose 1, lot number unknown), administration date: 12Mar2021, for COVID-19 immunisation, reaction(s): "Reaction to the shot in term of pain in the arm significantly worst then prior shots ON"; BNT162b2 (dose 2, lot number unknown), administration date: 01Apr2021, for COVID-19 immunisation, reaction(s): "Reaction to the shot in term of pain in the arm significantly worst then prior shots ON". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Reaction to the shot in term of pain in the arm significantly worst then prior shots ON".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300414510 Same patient, partial same event, different dose;US-PFIZER INC-202300447636 Same patient/event, different dose;US-PFIZER INC-202300447641 same patient/product, different event/vaccine dose;
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: reaction to the shot in term of pain in the arm; This is a spontaneous report received from an other HCP. A 56-year-old female patient (not pregnant) received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 06Aug2022 as dose 4 (booster), single (lot number FP4554) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto", start date: 1997 (ongoing), notes: thyroid still functioning; "sulfa allergy" (unspecified if ongoing); "constipation" (ongoing); "parathyroid removal", start date: 2010 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (dose 1, lot number unknown), administration date: 12Mar2021, for covid-19 immunisation, reaction: "reaction to the shot in term of pain in the arm"; BNT162b2 (dose 2, lot number unknown), administration date: 01Apr2021, for covid-19 immunisation, reaction: "reaction to the shot in term of pain in the arm"; BNT162b2 (dose 3 (booster), IM/arm left, lot FH8030), administration date: 23Nov2021, for covid-19 immunisation, reaction: "reaction to the shot in term of pain in the arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "reaction to the shot in term of pain in the arm".  Additional Information: The patient was reporting on the 6th dose: reaction to the shot in term of pain in the arm significantly worst than prior shots.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300414510 same patient/product, different event/vaccine dose;US-PFIZER INC-202300447636 same patient/product, different event/vaccine dose;US-PFIZER INC-202300447639 same patient/product, different event/vaccine dose;US-PFIZER INC-202300447640 same patient/product, different event/vaccine dose;US-PFIZER INC-202300447642 same patient/product, different event/vaccine dose;
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Reaction to the shot in term of pain in the arm significantly worst then prior shots ON; The initial case was missing the following minimum criteria: no specfic product. Upon receipt of follow-up information on 08Dec2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from an Other HCP.  A 56-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Dec2022 as dose 5 (booster), single (Lot number: GJ6739) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto", start date: 1997 (ongoing); "Parathyroid removal", start date: 2010 (unspecified if ongoing); "Constipation" (ongoing); "Known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, lot number unknown), administration date: 12Mar2021, for COVID-19 immunisation, reaction(s): "Pain in the arm"; BNT162b2 (DOSE 2, lot number unknown), administration date: 01Apr2021, for COVID-19 immunisation, reaction(s): "Pain in the arm"; BNT162b2 (DOSE 3 (booster), lot number:  FH8030; route: intramuscular; site: left arm), administration date: 23Nov2021, for COVID-19 immunisation, reaction(s): "Pain in the arm"; BNT162b2 (DOSE 4 (booster), lot number: FP4554; site: left arm), administration date: 06Aug2022, for COVID-19 immunisation, reaction(s): "Pain in the arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01Dec2022, outcome "unknown", described as "Reaction to the shot in term of pain in the arm significantly worst then prior shots ON".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300414510 Same patient, partial same event, different dose;US-PFIZER INC-202300447636 Same patient/event, different dose;US-PFIZER INC-202300447641 same patient/product, different event/vaccine dose;
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Generalized anxiety disorder" (unspecified if ongoing); "Known allergies: Floxin and epinephrine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 02Dec2023 to 07Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 46.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity, Psoriasis
Clinical narrative: extreme pain in the arms and hands like glass shards poking me; psoriasis in the scalp, neck and upper back/shoulder blades; This is a spontaneous report received from a Consumer or other non HCP.  A 46-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Oct2023 at 14:00 as dose 1, 0.3 ml single (Lot number: hf9300) at the age of 46 years, in left arm for covid-19 immunisation; influenza vaccine (FLUZONE NO PRESERVATIVE), on 28Oct2023 as dose 1, single (Lot number: 49281-423-88/U8201EA), in arm for immunisation. The patient's relevant medical history included: "unobstructive cardiomyopathy" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination. Concomitant medication(s) included: METFORMIN; CANDESARTAN; CARVEDILOL; SYNTHROID. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; Manufacturer unknown), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Nov2023, outcome "not recovered", described as "extreme pain in the arms and hands like glass shards poking me"; PSORIASIS (non-serious) with onset 05Nov2023, outcome "not recovered", described as "psoriasis in the scalp, neck and upper back/shoulder blades". The events "extreme pain in the arms and hands like glass shards poking me" and "psoriasis in the scalp, neck and upper back/shoulder blades" required physician office visit. Therapeutic measures were taken as a result of pain in extremity, psoriasis. Additional information: Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not was tested for COVID-19 since vaccination. Treatment: topical steroids and itch lotion.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid treatment; covid treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 51-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 12:00 as dose 1, single (Lot number: Hg4229) at the age of 51 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: moderna (DOSE 3 (BOOSTER), SINGLE, Batch/Lot number: 077c21b, Anatomical location: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 09Nov2021, when the patient was 49-year-old, for COVID-19 immunisation; pfizer / biontech (DOSE 4 (BOOSTER), SINGLE, Batch/Lot number: Gh8703, Anatomical location: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 08Oct2022, when the patient was 50-year-old, for COVID-19 immunisation; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (Dec2023) and all described as "covid treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) Negative. Therapeutic measures (Paxlovid) were taken as a result of vaccination failure, covid-19 from 03Dec2023 to 08Dec2023. Clinical course: Patient had no known allergies.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: contracted covid; contracted covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 72-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Aug2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "contracted covid". Clinical course: Caller stated that she received the Pfizer Covid booster vaccine in August when the guidance was for 65 years and older to receive an additional booster. Caller stated that she contracted covid at the end of September in which she provided that she was traveling, and thinks she might had contracted covid there, possibly the new variant. Caller was asking how long she needs to wait until she could receive the new formulation 2023-2024 Comirnaty. Caller asked how long should she wait after having covid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Covid-19 treatment; Covid 19 treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 41-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "high uric acid" (unspecified if ongoing). Concomitant medication(s) included: ALLOPURINOL, start date: 01Apr2009; FENOFIBRATE, start date: 09Aug2017; LEVOTHYROXINE, start date: 27Jul2018. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 19Feb2021, when the patient was 39-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 26Mar2021, when the patient was 39-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 22Oct2022, when the patient was 40-year-old, for COVID-19 immunisation. The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "unknown", described as "Covid 19 treatment"; VACCINATION FAILURE (medically significant) with onset 2023, outcome "unknown", described as "Covid-19 treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 02Dec2023 to 06Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 06Dec2023 to 10Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive to COVID-19; positive to COVID-19; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 (COMIRNATY NOS), 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), outcome "unknown" and all described as "positive to COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive through a rapid test. Clinical course: Reporter's wife tested positive through PCR and her daughter through a rapid test and also mentioned her daughter did have the 2 COVID-19 shots from Pfizer but he only got 1 about 2 years ago.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "known allergies: Compazine". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (2023) and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Negative. Therapeutic measures were taken as a result of Vaccination failure, covid-19 which included Paxlovid from 04Dec2023 to 09Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 01Jan2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 44 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "elevated blood pressure" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR oral, start date: Jan2020; ADVAIR oral, start date: Jan2020; LOSARTAN oral, start date: Jan2022. Past drug history included: Theophylline, reaction(s): "Known allergies: Theophylline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from 13Dec2023 to Dec2023.
Sex: U
Vaccine: PNC20
Symptoms: Poor quality product administered
Clinical narrative: it was not mixing thoroughly and there are sentiments and dark chunks in the vial; The initial case was missing the following minimum criteria: product complaint only. Upon receipt of follow-up information on 06Dec2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP from product quality group, Program ID.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: GT6702, Expiration Date: 01Oct2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIQUID PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown", described as "it was not mixing thoroughly and there are sentiments and dark chunks in the vial". Additional information: Calling about Prevnar 20 that is showing sediments. Even after shaking it, the sediment is still there. The sediment seems to be whitish chunks. So the facility did not use the Prevnar 20 with sediment on the patient. Prevnar 20 is in the customer's possession. Customer had 1 carton of 10 Prevnar 20. Exact number of Prevnar 20 with the sediment is unknown.   Causality for "it was not mixing thoroughly and there are sentiments and dark chunks in the vial" 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) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pyrexia, Rash
Clinical narrative: rash over many areas of my body; Then rash became itchy in several places - no blistering, no oozing - just very itchy.; fever; chills; sweats; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization; Original pfizer vaccines (dose number unknown), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), 12 hrs after the suspect product(s) administration, outcome "recovered", described as "fever"; CHILLS (non-serious), 12 hrs after the suspect product(s) administration, outcome "recovered"; HYPERHIDROSIS (non-serious), 12 hrs after the suspect product(s) administration, outcome "recovered", described as "sweats"; HEADACHE (non-serious), 12 hrs after the suspect product(s) administration, outcome "recovered"; RASH (non-serious), outcome "unknown", described as "rash over many areas of my body"; RASH PRURITIC (non-serious), outcome "unknown", described as "Then rash became itchy in several places - no blistering, no oozing - just very itchy.". Additional information: Latest pfizer covid booster reaction: 12 hrs. After injection - had fever, chills, sweats, headache (know all are possible reaction), all lasted about 24 hrs. After all these subsided, developed rash over many areas of  body, lasted about 48 hrs. Then rash became itchy in several places - no blistering, no oozing - just very itchy.  The patient had somewhat similar response to last 2-3 boosters but not as bad as this one; nothing with original pfizer vaccines.
Sex: U
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: rash over many areas of my body; Then rash became itchy in several places - no blistering, no oozing - just very itchy.; fever; chills; sweats; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization; Original pfizer vaccines (dose number unknown), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), 12 hrs after the suspect product(s) administration, outcome "recovered", described as "fever"; CHILLS (non-serious), 12 hrs after the suspect product(s) administration, outcome "recovered"; HYPERHIDROSIS (non-serious), 12 hrs after the suspect product(s) administration, outcome "recovered", described as "sweats"; HEADACHE (non-serious), 12 hrs after the suspect product(s) administration, outcome "recovered"; RASH (non-serious), outcome "unknown", described as "rash over many areas of my body"; RASH PRURITIC (non-serious), outcome "unknown", described as "Then rash became itchy in several places - no blistering, no oozing - just very itchy.". Additional information: Latest pfizer covid booster reaction: 12 hrs. After injection - had fever, chills, sweats, headache (know all are possible reaction), all lasted about 24 hrs. After all these subsided, developed rash over many areas of  body, lasted about 48 hrs. Then rash became itchy in several places - no blistering, no oozing - just very itchy.  The patient had somewhat similar response to last 2-3 boosters but not as bad as this one; nothing with original pfizer vaccines.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 66-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. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: The patient agree that getting this vaccination is important to stay heathy. She had no reactions to the vaccination; except a sore arm.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Brain fog, Fatigue, Palpitations
Clinical narrative: brain fog; extreme fatigue; heart palpitations; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), (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: BRAIN FOG (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "extreme fatigue"; PALPITATIONS (non-serious), outcome "unknown", described as "heart palpitations".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300444830 same reporter and product, different dose and event .;US-PFIZER INC-202300444826 same reporter and product, different dose and event .;US-PFIZER INC-202300444829 same reporter and product, different dose and event .;US-PFIZER INC-202300444825 same reporter and product, different dose and event;US-PFIZER INC-202300444827 same reporter and product, different dose and event .;US-PFIZER INC-202300444828 same reporter and product, different dose and event .;
Sex: F
Vaccine: COVID19
Symptoms: Post-acute COVID-19 syndrome
Clinical narrative: Long covid; This is a spontaneous report received from a Consumer or other non HCP.  A 47-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. The following information was reported: POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "Long covid".  Additional information: Patient was kind of worried thinking about long covid and the side effects from it.    No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: got so sick with the booster; This is a spontaneous report received from a Consumer or other non HCP, Program ID: .  A 78-year-old female patient received BNT162b2 (COMIRNATY), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE (manufacturer unknown)), for covid-19 immunization; Covid-19 vaccine (DOSE 2 SINGLE (manufacturer unknown)), for covid-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "got so sick with the booster".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: severe tinnitus; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 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, bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, Batch/Lot number: unknown), for COVID-19 immunization, reaction(s): "had a shingles breakout after the first vaccination (booster)". The following information was reported: TINNITUS (non-serious) with onset 2023, outcome "unknown", described as "severe tinnitus".  Additional information: The patient has had severe tinnitus since the last vaccination. The patient really wanted to continue the vaccine, but was concerned about hearing.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300243385 same reporter, patient, and product; different dose and event;
Sex: M
Vaccine: COVID19
Symptoms: Nail growth abnormal
Clinical narrative: his toe nails are growing 6 inches long every hour since he got vaccinated; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  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: NAIL GROWTH ABNORMAL (non-serious), outcome "unknown", described as "his toe nails are growing 6 inches long every hour since he got vaccinated".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Cardiomegaly
Clinical narrative: I have an enlarged heart; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A patient (age and gender not provided) 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: CARDIOMEGALY (non-serious), outcome "unknown", described as "I have an enlarged heart".  Additional information: Patient's doctor was leaning towards all the Covid shots the patient got.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: vaccinated and still got covid19; vaccinated and still got covid19; This is a spontaneous report received from a 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "vaccinated and still got covid19".  Clinical course: The reporter wanted to know the components of Pfizer covid19 vaccine and asking why are they still getting covid19 after they got vaccinated. He also stated that his mom and dad were vaccinated and still got covid19 and his toe nails are growing 6 inches long every hour since he got vaccinated.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: vaccinated and still got covid19; vaccinated and still got covid19; This is a spontaneous report received from a Consumer or other non HCP.  A 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. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "vaccinated and still got covid19".  Clinical course: The reporter wanted to know the components of Pfizer covid19 vaccine and asking why are they still getting covid19 after they got vaccinated. He also stated that his mom and dad were vaccinated and still got covid19 and his toe nails are growing 6 inches long every hour since he got vaccinated.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I tested positive for Covid on 12Dec; I tested positive for Covid on 12Dec; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 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; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Dec2023, outcome "unknown" and all described as "I tested positive for Covid on 12Dec". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Dec2023) positive. Clinical course: Following 3 Pfizer Covid vaccinations in 2020 and 2021, patient received the Comirnaty vaccination on 27Sep2023. Patient tested positive for Covid on 12Dec. Patent was very disappointed in this, and hope that they were keeping track of this, as they admit that this vaccination was not effective for all.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Disease recurrence, Drug ineffective, Suspected COVID-19
Clinical narrative: Covid twice; Covid twice; Covid twice; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DISEASE RECURRENCE (medically significant), SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Covid twice".  Clinical information: Concern: Patient have had all the previous vaccines & boosters. Unfortunately, patient had 2 very different & very bad flares of CSIU after getting them &/or having Covid twice. They were each 14+ months in duration. Patient can not deal with that again. So that is why Patient will not get the new booster. Medical Information: Forwarded: N/A, no medical inquiry asked.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Headache, Menstruation irregular, Pain, Stress
Clinical narrative: menstrual cycle is severly delayed; menstrual cramps; headaches; stress; pain; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2023 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: MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "menstrual cycle is severly delayed"; DYSMENORRHOEA (non-serious), outcome "unknown", described as "menstrual cramps"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; STRESS (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown". Additional information: Patient stated, "I was vaccinated again in October and once again the vaccine has severely altered my menstrual cycle again. Whenever I receive the Pfizer Covid vaccine, my menstrual cycle is severely delayed. I have yet to start my menstrual cycle since getting vaccinated in October 2023. I have been vaccinated five times. I am tired that my menstrual cycle is severely altered when I get the vaccination. Many women, including myself, are having our menstrual periods skip for a month or severely delaying it by 45 or 49 days or longer. Unfortunately, we have severe menstrual cramps and headaches while we are waiting for our period to start. There's nothing worse than having cramping for a couple of weeks until your period starts again because you were vaccinated. Prior to this vaccination I have no health issues. I had to go to the doctors because the cramps were so bad, and they had to prescribe narcotics. Prior to being vaccinated for COVID-19, my periods were very regular and relatively pain-free. It's getting to the point that I no longer want to be vaccinated for the COVID-19 because of the stress and pain I experience. However, because I teach at three schools' kindergarten through fifth grade I am in contact with well over 2000 students plus staff. I have to protect myself from getting COVID-19."  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: He got COVID-19; He got COVID-19; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "He got COVID-19". Clinical course: Caller mentioned that he got COVID-19 and he even got the vaccine in October this year which helped.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: stabbing arm pain after being given the vaccine; restrictive range of motion; Initial information received on 07-Dec-2023 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 27 years old male patient who experienced stabbing arm pain after being given the vaccine and restrictive range of motion after receiving vaccine Influenza Quadrival A-B vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 01-Dec-2023, the patient received 0.5 ml dose of suspect Influenza Quadrival A-B vaccine Suspension for injection (lot number and expiry: not reported) via unknown route in the right shoulder for immunization.  On an unknown date, the patient developed stabbing arm pain after being given the vaccine (vaccination site pain) and restrictive range of motion (injected limb mobility decreased) (unknown latency) following the administration of Influenza Quadrival A-B vaccine.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for both events.  At time of reporting, the outcome was Not Recovered / Not Resolved for both events.
Sex: U
Vaccine: MEN
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: MenQuadfi was administered when it was intended to give a vaccine against meningococcal B with no reported adverse event; Initial information was received on 11-Dec-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and gender patient to whom meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was administered when it was intended to give a vaccine against meningococcal b with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Dec-2023, the patient received a 0.5 ml, total dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine (Solution for injection) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for Immunization and menquadfi was administered when it was intended to give a vaccine against meningococcal b with no reported adverse event (wrong product administered) (latency: same day). The information on the batch number was requested.  Reportedly, Can a patient who received MENQUADFI in error on Friday be given BEXSERO today.  Action taken: not applicable.   Outcome: Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, IPV
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: PEDIARIX and IPOL were administered on the same day (with no reported adverse event); Initial information received on 12-Dec-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 3 years old female patient where reported reported that pediarix and IPV (VERO) [IPOL] were administered on the same day (with no reported adverse event).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR), varicella zoster vaccine (varicella vaccine), hepatitis a vaccine, pneumococcal vaccine, diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (dtap) and hepatitis b vaccine for Prophylactic vaccination.  On 08-Dec-2023, the patient received 0.5 ml (TOTAL) dose of suspect IPV (VERO) Suspension for injection lot W1C751M via intramuscular route in the thigh nos (vastus lateralis) (strength and expiration date: not provided) for Immunisation and received a dose of suspect Pediarix not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site (formulation, strength and expiration date: not provided) for Immunisation (extra dose administered) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.