chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fibromyalgia
Clinical narrative: fibromyalgia/ and after the last bivalent booster it really started hitting him pretty bad.; This spontaneous case was reported by a patient and describes the occurrence of FIBROMYALGIA (fibromyalgia/ and after the last bivalent booster it really started hitting him pretty bad.) in a 54-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     It was reported that patient had no relevant medical history conditions, allergy, concomitant diseases and risk factor. It was reported that patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Drug use for unknown indication: FLU. Past adverse reactions to the above products included No adverse event with FLU.    On 23-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced FIBROMYALGIA (fibromyalgia/ and after the last bivalent booster it really started hitting him pretty bad.). The patient was treated with DULOXETINE HYDROCHLORIDE (CYMBALTA) at an unspecified dose and frequency. At the time of the report, FIBROMYALGIA (fibromyalgia/ and after the last bivalent booster it really started hitting him pretty bad.) had not resolved. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Company Comment:  This spontaneous case concerns a 54-years-old-male patient, with medical history of previously administered FLU vaccine, treated with duloxetine who experienced the  unexpected event (AESI) fibromyalgia unknown days after 4th. dose of  mRNA-1273 BIVALENT.222 (ORIGINAL AND OMICRON BA.4/BA.5) vaccine. At the time of the report, FIBROMYALGIA had not resolved. The benefit-risk relationship of mRNA-1273 BIVALENT.222 (ORIGINAL AND OMICRON BA.4/BA.5) vaccine is not affected by this report.   This case was linked to MOD-2023-738990 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Peripheral swelling
Clinical narrative: shortness of breath; swollen legs; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) and PERIPHERAL SWELLING (swollen legs) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056M21A, 069F1A and U03A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 10-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) .5 milliliter. On 15-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to .5 microgram. On 26-Apr-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath) and PERIPHERAL SWELLING (swollen legs). At the time of the report, DYSPNOEA (shortness of breath) and PERIPHERAL SWELLING (swollen legs) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient could now walk 100 feet and had to stop and catch my breath. It was unknown if the patient experienced any additional symptoms/events.  Treatment medications were not reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Fibromyalgia
Clinical narrative: Fibromyalgia/Pain all over/Stiffness; This spontaneous case was reported by a patient and describes the occurrence of FIBROMYALGIA (Fibromyalgia/Pain all over/Stiffness) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A, 011J20A and 030L20A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: FLU I. Past adverse reactions to the above products included No adverse event with FLU I.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FIBROMYALGIA (Fibromyalgia/Pain all over/Stiffness). The patient was treated with DULOXETINE HYDROCHLORIDE (CYMBALTA) at an unspecified dose and frequency. At the time of the report, FIBROMYALGIA (Fibromyalgia/Pain all over/Stiffness) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient did not have any relevant medical history/conditions, allergy, concomitant diseases and risk factor. No concomitant medication was reported. Company comment This spontaneous case concerns a 54-year-old male patient with no relevant medical history reported, who experienced the unexpected, non-serious AESI of Fibromyalgia and received the 4 doses of mRNA-1273. It was reported that after the 1st monovalent booster he started developing mild symptoms of fibromyalgia, and after the last bivalent booster they were worse. A specific date when symptoms started was not provided, it happened gradually, but about 2 months after the third dose of mRNA-1273, he was in so much pain all over even when doing normal things. Pain and stiffness were what he first noticed first. He was treated with Cymbalta (Duloxetine). The event had not yet recovered at the time of the last observation. No further clinical information was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2023-738995 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; A patient had received a dose of the Moderna Bivalent COVID-19 vaccine more than 12 hours after the initial vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient had received a dose of the Moderna Bivalent COVID-19 vaccine more than 12 hours after the initial vial puncture) and NO ADVERSE EVENT (No Adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Aug-2023 at 10:00 AM, the patient received dose of mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (unknown route) 1 dosage form. On 25-Aug-2023 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient had received a dose of the Moderna Bivalent COVID-19 vaccine more than 12 hours after the initial vial puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient had received a dose of the Moderna Bivalent COVID-19 vaccine more than 12 hours after the initial vial puncture) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A patient had received a dose of the Moderna Bivalent COVID-19 vaccine more than 12 hours after the initial vial puncture).    It was unknown patient did receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  The vial was initially punctured on 24-AUG-2023 at 12:00 PM. No reported symptoms. No additional doses, medications, or treatments. No treatment information was reported.
Age: 4.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Patient received vaccine 31 days after refrigerated.; No adverse event; 4-year-old patient received an expired 3rd dose Moderna Bivalent Pink Cap COVID-19 vaccine on 31AUG2023, beyond 30 days use by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4-year-old patient received an expired 3rd dose Moderna Bivalent Pink Cap COVID-19 vaccine on 31AUG2023, beyond 30 days use by date.), PRODUCT STORAGE ERROR (Patient received vaccine 31 days after refrigerated.) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (first dose ,Lot AS1414B) on 27-Jun-2022, Moderna COVID-19 vaccine (second dose and Lot AS1412B) on 02-Aug-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine and Moderna COVID-19 vaccine.    On 31-Aug-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-Aug-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (4-year-old patient received an expired 3rd dose Moderna Bivalent Pink Cap COVID-19 vaccine on 31AUG2023, beyond 30 days use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received vaccine 31 days after refrigerated.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4-year-old patient received an expired 3rd dose Moderna Bivalent Pink Cap COVID-19 vaccine on 31AUG2023, beyond 30 days use by date.), PRODUCT STORAGE ERROR (Patient received vaccine 31 days after refrigerated.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (4-year-old patient received an expired 3rd dose Moderna Bivalent Pink Cap COVID-19 vaccine on 31AUG2023, beyond 30 days use by date.) and PRODUCT STORAGE ERROR (Patient received vaccine 31 days after refrigerated.).    No concomitant medication was reported. t was reported that looked up date was 22-Nov-2023. No treatment medication was reported.
Sex: U
Vaccine: UNK
Symptoms: Cough, Feeling abnormal, Headache, Pyrexia
Clinical narrative: Feel horrible; coughing; headache; fever; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Feel horrible), COUGH (coughing), HEADACHE (headache) and PYREXIA (fever) in an adult patient of an unknown gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Feb-2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 01-Sep-2023, the patient experienced FEELING ABNORMAL (Feel horrible), COUGH (coughing), HEADACHE (headache) and PYREXIA (fever). At the time of the report, FEELING ABNORMAL (Feel horrible) outcome was unknown and COUGH (coughing), HEADACHE (headache) and PYREXIA (fever) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that additional laboratory/diagnostic tests were done, and it was concluded positive. No treatment information was reported.
Age: 53.0
Sex: F
Vaccine: PNC20
Symptoms: Fatigue, Headache, Injected limb mobility decreased, Joint range of motion decreased
Clinical narrative: I could barely lift my left arm last night; Been tired and headache all day; Been tired and headache all day; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 53-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 25Aug2023 as dose number unknown, single (Lot number: GD8455) at the age of 53 years, in left arm for immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), FATIGUE (non-serious) all with onset 26Aug2023, outcome "recovering" and all described as "Been tired and headache all day"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 26Aug2023, outcome "recovering", described as "I could barely lift my left arm last night". Therapeutic measures were not taken as a result of joint range of motion decreased, headache, fatigue.
Age: 56.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Fatigue, Influenza like illness, Nausea, Pain
Clinical narrative: flu-like symptoms such as nausea, fatigue, and aches; This is a spontaneous report received from a contactable reporter (Other HCP).  A 56-year-old female patient (not pregnant) received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), on 28Aug2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for immunisation; varicella zoster vaccine (VARICELLA ZOSTER VACCINE), on 28Aug2023 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "diabetes type 2" (unspecified if ongoing); "Allergies: Cream cheese" (unspecified if ongoing). Concomitant medications (in two weeks) included: TRULICITY (manufacturer: Eli Lily), start date: 17Aug2023; METFORMIN, start date: 14Aug2023; FAMOTIDINE TEVA, start date: 14Aug2023; RAMIPRIL ZYDUS, start date: 14Aug2023; ROSUVASTATIN GLENMARK, start date: 14Aug2023. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 29Aug2023 at 07:30, outcome "not recovered", described as "flu-like symptoms such as nausea, fatigue, and aches". Therapeutic measures were not taken as a result of influenza like illness. Additional information: The vaccine was administered at the pharmacy or drug store. There was no other vaccine in four weeks. Upon follow up on 30Aug2023, the reporter was confirmed to be in direct contact with the reporter.  The information on the batch/lot number for pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.
Sex: F
Vaccine: MENB
Symptoms: Chills, Headache, Irritability
Clinical narrative: Fever; Frequent chills; Irritability; Fatigue; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 17-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; CHILLS (non-serious), outcome "unknown", described as "Frequent chills"; IRRITABILITY (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown". Therapeutic measures were not taken as a result of pyrexia, chills, irritability, fatigue, headache. The information on the batch/lot number for meningococcal group b Rlp2086 has been requested and will be submitted if and when received.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Pain in extremity
Clinical narrative: Left arm remained sore until; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient received BNT162b2 (BNT162B2), on 20Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 83 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "2 pregnancies", start date: 1964 (unspecified if ongoing), notes: Second pregnancy: 1966, Pertinent details: Cesarian births; "Temporal arthritis", start date: 2013, stop date: 2015, notes: Pertinent details: Took prednisone to stop the pain.; "Low thyroid" (ongoing), notes: Onset date: greater than 10 yrs, Pertinent details: medication; "High blood pressure" (ongoing), notes: Onset date: greater than 15 , Pertinent details: medication; "Blood thinner" (ongoing); "Allergy" (ongoing), notes: Onset date: greater than 6 mos, Pertinent details: medication. Concomitant medication(s) included: LEVOTHYROXINE oral taken for hypothyroidism (ongoing); HYDROCHLOROTHIAZIDE oral taken for hypertension (ongoing); ASPIRIN 81 taken for blood disorder (ongoing); LORATADINE oral taken for hypersensitivity (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot number: EN6198, Route of Administration: Intramuscular, Anatomical Site of Injection: Left Arm), administration date: 04Mar2021, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot number: EN6205, Route of Administration: Intramuscular, Anatomical Site of Injection: Left Arm), administration date: 26Mar2021, for COVID-19 immunization; Shingrix (DOSE NUMBER UNKNOWN , SINGLE, 3 (illegible) of shingles , Onset date: onsets, 1. 18 yrs old, 2. 20 yrs +, 3. my 60 yr old, Pertinent details: Had shingrix vaccine within the last 8 yrs had the previous shingles vaccine also.), for Shingles immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Left arm remained sore until". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: There was no Family medical history relevant to adverse events (AEs). There was specific relevant test for Thromboembolic events with Thrombocytopenia. Patient preferencing her written response by stating that in 2021 she had a blood test taken after living with her husband who was diagnosed with having covid-19. The results of her blood test determined that she was immune to covid. Yet she still took her first dose of covid 19 on 04Mar2021, because she was afraid that she might come down with it and she did not want to infect anyone else. She was expecting a new great grandchild within a couple of months, plus she was continuing to go to the senior centre for exercise etc.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300231375 same patient, same product, different dose (dose 4) and events.;
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Pain in extremity
Clinical narrative: minor sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 2, SINGLE), administration date: 01Apr2021, when the patient was 60-year-old, for Covid-19 Immunization, reaction(s): "atrial fibrillation", "heart palpitations", "some very slight lesser functioning on the left side of her heart"; Bnt162b2 (DOSE 1, SINGLE, Date: In spring of 2021, believes Mar2021, NDC, lot, expiry: Unknown, vaccination card is at home), administration date: Mar2021, when the patient was 60 years old, for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "minor sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter and her husband were both vegan. When possible, they try to avoid products derived from animals. That was one of the reasons they went with the Pfizer BioNTech Covid 19 vaccine. They try to use vegan products within reason and know sometimes things come from cell lines, and it's not like a hamster or cow has to be slaughtered to make each vaccine. Same argument even from fetuses, that it's a cell line not that it's not continuous. She just wanted to let Pfizer know that, when possible, it would be great if products were not manufactured using animal products. Each of them had 6 shots of the Pfizer Covid vaccine, two of the initial and 4 boosters. She only had a reaction after the second shot, not the boosters that are spaced out for 6 months. She had no bad reactions other of the Pfizer Covid vaccines other than minor sore arm with any of the subsequent boosters. She's had no bad reactions with any subsequent boosters other than a sore arm. Reporter stated reporter's husband had sore arm, and maybe was feeling a little beat-up next day, and caller had a similar type thing with all doses. All doses were given 6 months apart, 3rd dose was probably late Sep2021, then 4th dose given 6 months after, so each time like late September and maybe late sometime in April. The patient then was brought back in for unofficial mini echo a couple months later before end of year, either Nov2021 or Dec2021 and function was normal by that time. Reportedly, serious: no.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300289194 same patient and event, different dose;
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Echocardiogram, Pain in extremity
Clinical narrative: minor sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 2, Single), administration date: 01Apr2021, when the patient was 60-year-old, for Covid-19 immunization, reaction(s): "Atrial fibrillation", "heart palpitations", "some very slight lesser functioning on the left side of her heart"; Bnt162b2 (Dose 1, Single), administration date: Mar2021, when the patient was 60 years old, for Covid-19 immunization; Bnt162b2 (Dose 3, Single), administration date: Sep2021, when the patient was 61 years old, for Covid-19 immunization, reaction(s): "minor sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "minor sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller female, her and her husband are both over 60 and are both vegan. When possible, they try to avoid products derived from animals. That is one of the reasons they went with the Pfizer BioNTech Covid 19 vaccine. Each of them has had 6 shots of the Pfizer Covid vaccine, two of the initial and 4 boosters. She only had a reaction after the second shot, not the boosters that are spaced out for 6 months. She suspects because of the closeness of the time table, just the three weeks instead of 6 months. And its not definite, she can't tie it all together but she experienced heart palpitations for the first time. She had no bad reactions other of the Pfizer Covid vaccines other than minor sore arm with any of the subsequent boosters. 3rd, 4th, 5th, and 6th doses: Dates was Unknown at time of call, that information is at home on vaccination card, but thinks all doses were given 6 months apart, 3rd dose was probably late Sep2021, then 4th dose given 6 months after, so each time like late Sep and maybe late sometime in Apr.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300289194 same patient and event, different dose;
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: minor sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 2, SINGLE), administration date: 01Apr2021, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "atrial fibrillation", "heart palpitations", "some very slight lesser functioning on the left side of her heart"; Bnt162b2 (DOSE 1, SINGLE), administration date: Mar2021, when the patient was 60 years old, for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: Sep2021, when the patient was 61 years old, for COVID-19 immunization, reaction(s): "minor sore arm"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), administration date: Apr2022, when the patient was 61 years old, for COVID-19 immunization, reaction(s): "minor sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "minor sore arm". Additional information: the dose was given in late Sep2022.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300289194 same patient and event, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: minor sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Apr2023 as dose 6 (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: BNT162b2 (DOSE 2), administration date: 01Apr2021, when the patient was 60-year-old, for Covid-19 immunization, reaction(s): "Atrial fibrillation", "heart palpitations", "some very slight lesser functioning on the left side of her heart"; Bnt162b2 (DOSE 1), administration date: Mar2021, when the patient was 60 years old, for Covid-19 immunization; Bnt162b2 (DOSE 3), administration date: Sep2021, when the patient was 61 years old, for Covid-19 immunization, reaction(s): "minor sore arm"; Bnt162b2 (DOSE 4), administration date: Apr2022, when the patient was 61 years old, for COVID-19 immunization, reaction(s): "minor sore arm"; Bnt162b2 (DOSE 5), administration date: Sep2022, for Covid-19 immunization, reaction(s): "minor sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "minor sore arm". Additional information: the dose was given maybe late sometime in Apr2023.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300289194 same patient and event, different dose;
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: sore arm; maybe was feeling a little beat up next day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 IMMUNIZATION, reaction(s): "feeling a little beat up next day", "Sore Arm"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 IMMUNIZATION, reaction(s): "feeling a little beat up next day", "Sore Arm"; Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 IMMUNIZATION, reaction(s): "feeling a little beat up next day", "Sore Arm"; Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 IMMUNIZATION, reaction(s): "feeling a little beat up next day", "Sore Arm"; Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE), for COVID-19 IMMUNIZATION, reaction(s): "feeling a little beat up next day", "Sore Arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; MALAISE (non-serious), outcome "unknown", described as "maybe was feeling a little beat up next day". Additional information: the patient was vegan.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300289475 Same patient/vaccine, different dose, similar event;US-PFIZER INC-202300289476 Same patient/vaccine, different dose, similar event;US-PFIZER INC-202300289477 Same patient/vaccine, different dose, similar event;US-PFIZER INC-202300289478 Same patient/vaccine, different dose, similar event;US-PFIZER INC-202300289479 Same patient/vaccine, different dose, similar event;
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Frequent bowel movements
Clinical narrative: could not have bowel movements like almost every time I will eat and turn and go the restroom/ kept having more frequent bowel movement; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient received BNT162b2 (BNT162B2), on 13Aug2021 as dose 1, single (Batch/Lot number: unknown) at the age of 36 years, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FREQUENT BOWEL MOVEMENTS (non-serious) with onset Aug2021, outcome "recovered" (Nov2021), described as "could not have bowel movements like almost every time I will eat and turn and go the restroom/ kept having more frequent bowel movement". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: the patient drink lots of water, do not drink any alcohol never have, never smoked or anything and was very healthy. the patient got the first vaccine around 13Aug2021. Though when she got the first one she had mild side effects but did not really think about it when she could not have bowel movements like almost every time she will eat and turn and go the restroom so it did not downed her this medicine. The patient did not have much attention to from Aug until Sep2021, after getting vaccinated she kept having more frequent bowel movement like if she would eat something or as soon as it with hit the bottom of her stomach, she have to go to use the bathroom so from there with that happened for a while until maybe Nov2021.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300289453 same patient/drug, different dose/event;US-PFIZER INC-202300289452 same patient/drug, different dose/event;
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: sore arm; feeling a little beat up the next day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 65-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; MALAISE (non-serious), outcome "unknown", described as "feeling a little beat up the next day".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300289406 Same patient/vaccine, different dose, similar event;
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: sore arm; feeling a little beat up the next day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 65-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; MALAISE (non-serious), outcome "unknown", described as "feeling a little beat up the next day".  Additional information: The patient had no side effects but only had minor side effects like a sore arm and feeling a little beat up the next day. He had 6 shots of the Pfizer Covid vaccine, two of the initial and 4 boosters.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300289406 Same patient/vaccine, different dose, similar event;
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: sore arm; feeling a little beat up the next day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown), for COVID-19 immunization, reaction(s): "feeling a little beat up the next day", "sore arm"; Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), for COVID-19 immunization, reaction(s): "feeling a little beat up the next day", "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; MALAISE (non-serious), outcome "unknown", described as "feeling a little beat up the next day".  Additional information: The patient had no side effects but only had minor side effects like a sore arm and feeling a little beat up the next day. He had 6 shots of the Pfizer Covid vaccine, two of the initial and 4 boosters.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300289406 Same patient/vaccine, different dose, similar event;
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: sore arm; feeling a little beat up the next day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), for COVID-19 immunization, reaction(s): "feeling a little beat up the next day", "sore arm"; Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown), for COVID-19 immunization, reaction(s): "feeling a little beat up the next day", "sore arm"; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 3 (BOOSTER), SINGLE; Lot number: unknown), for Covid-19 Immunization, reaction(s): "feeling a little beat up the next day", "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; MALAISE (non-serious), outcome "unknown", described as "feeling a little beat up the next day".  Additional information: The patient had no side effects but only had minor side effects like a sore arm and feeling a little beat up the next day. He had 6 shots of the Pfizer Covid vaccine, two of the initial and 4 boosters.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300289406 Same patient/vaccine, different dose, similar event;
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: 24 hour after vaccine patient reported erythema, edema, and pruritis at injection site.  Reported with first vaccine had mild injection site reaction but reaction with second dose was more severe. Denied systemic symptoms including but not limited to sore throat, fevers, chills, sweats etc.  discussed on the phone, mark the outside edge of the swelling with the pen. Start taking Bendryl every 4 hours as needed. Hold hydroxyzine while taking Bendryl. Increase Pepcid to 20 mg twice daily for 7 days. Apply cool compresses to the site. If the area gets larger, or you develop systemic symptoms, report to the ER. Pt reported that symptoms start to improve the following day without worsening.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Therapy change
Clinical narrative: 24 hour after vaccine patient reported erythema, edema, and pruritis at injection site.  Reported with first vaccine had mild injection site reaction but reaction with second dose was more severe. Denied systemic symptoms including but not limited to sore throat, fevers, chills, sweats etc.  discussed on the phone, mark the outside edge of the swelling with the pen. Start taking Bendryl every 4 hours as needed. Hold hydroxyzine while taking Bendryl. Increase Pepcid to 20 mg twice daily for 7 days. Apply cool compresses to the site. If the area gets larger, or you develop systemic symptoms, report to the ER. Pt reported that symptoms start to improve the following day without worsening.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Injection site bruising
Clinical narrative: Patient complained of bad bruising  at the injection site that started the day after the shot. She reported it on the 9th day after the shot. The bruising is still present, but patient states it is getting better.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: sore arm; feeling a little beat up the next day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), for COVID-19 immunization, reaction(s): "feeling a little beat up the next day", "sore arm"; Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown), for COVID-19 immunization, reaction(s): "feeling a little beat up the next day", "sore arm"; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 3 (BOOSTER), SINGLE; Lot number: unknown), for Covid-19 Immunization, reaction(s): "feeling a little beat up the next day", "sore arm"; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE; Lot number: unknown), for Covid-19 Immunization, reaction(s): "feeling a little beat up the next day", "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; MALAISE (non-serious), outcome "unknown", described as "feeling a little beat up the next day".  Additional information: The patient had no side effects but only had minor side effects like a sore arm and feeling a little beat up the next day. He had 6 shots of the Pfizer Covid vaccine, two of the initial and 4 boosters.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300289406 Same patient/vaccine, different dose, similar event;
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Inappropriate schedule of product administration, Pruritus, Rash, Skin fissures
Clinical narrative: eczema; rashes; skin sheds severely; itch all over; Dose Number: 1 01May2021 Dose: 2 15May2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 28 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Anatomical location: Left arm), administration date: 01May2021, when the patient was 28-year-old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (medically significant) with onset 15May2021, outcome "unknown", described as "Dose Number: 1 01May2021 Dose: 2 15May2021"; ECZEMA (disability, medically significant) with onset 01Jul2021, outcome "not recovered"; PRURITUS (disability, medically significant) with onset 01Jul2021, outcome "not recovered", described as "itch all over"; RASH (disability, medically significant) with onset 01Jul2021, outcome "not recovered", described as "rashes"; SKIN FISSURES (disability, medically significant) with onset 01Jul2021, outcome "not recovered", described as "skin sheds severely". The events "eczema", "rashes", "skin sheds severely" and "itch all over" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of eczema, rash, skin fissures, pruritus.  Clinical course: It was reported that I have never experienced eczema in my life until after receiving 2 doses of the Covid vaccine. Shortly after receiving my doses, my arms began breaking out in eczema rashes. That was over 2 years ago. Since then the eczema has spread throughout my entire body. My skin sheds severely and I itch all over with no relief. It has only started and gotten worse after the vaccine. The patient has not received any other vaccine in four weeks or medication in two weeks. Steroids, creams, allergy meds were taken as treatment . Patient was not tested for covid prior or post vaccination.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: dizzy; nauseous; vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A 67-year-old female patient received PF-06928316 (ABRYSVO), on 27Aug2023 at 17:00 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VERTIGO (non-serious) with onset Aug2023, 7 hrs after the suspect product(s) administration, outcome "unknown"; DIZZINESS (non-serious) with onset 28Aug2023, outcome "not recovered", described as "dizzy"; NAUSEA (non-serious) with onset 28Aug2023, outcome "unknown", described as "nauseous". The event "vertigo" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had the Rsv Abrysvo injection on Sunday (27Aug2023) 5:00 pm and woke up the following Monday (28Aug2023) morning dizzy & nauseous. It is now 4 days later and the patient continue to wake become dizzy when moving out of bed and moving my head. The patient said she seemed to be having an adverse reaction to the vaccine. The patient had vertigo and sent the patient to the ER to get a CT scan. She was currently waiting to speak to the doctor in the ER. She read somewhere online that there were small cases of meningitis. She can move her neck so its not meningitis.   The information on the batch/lot number for PF-06928316 has been requested and will be submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 01Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; fluoxetine hydrochloride (PROZAC), (Batch/Lot number: unknown) at 20 mg. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: TOVIAZ, start date: 01Nov2020; ESTRADIOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 20Aug2023 to 24Aug2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.