chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Hypogeusia, Magnetic resonance imaging, Parosmia, SARS-CoV-2 test
Clinical narrative: reduction in taste and smell; reduction in taste and smell; 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 male patient received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: ER8733) at the age of 36 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies Peanuts" (unspecified if ongoing); "known allergies legumes" (unspecified if ongoing); "known allergies nuts" (unspecified if ongoing); "known allergies peas" (unspecified if ongoing). There were no concomitant medications. The following information was reported: HYPOGEUSIA (non-serious), PAROSMIA (non-serious) all with onset 19Apr2021, outcome "not recovered" and all described as "reduction in taste and smell". The events "reduction in taste and smell" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypogeusia, parosmia.  Additional Information: The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. The patient did not have Covid prior to vaccination. Two weeks after first dose, the patient began to notice reduction in taste and smell. The loss had increased. The patient's Otolaryngologist has ruled out polyps and nasal obstructions via a CT-Scan and an MRI. The patient received treatment with nasal steroid rinses. The patient had 3 additional Pfizer COVID vaccines. The patient received Dose 2, lot number: EW0169, Date: 26Apr2021, Anatomical location: Right arm. The patient received Dose 3 (BOOSTER), lot number: FJ8762, Date: 28Nov2021, Anatomical location: Right arm. The patient recently received Dose 4, lot number: GH9694, Date: 12Sep2022, Time: 04:15 PM, Anatomical location: Right arm. Post vaccination, the patient had COVID test and was found negative. The patient never contracted COVID and believe he was never been asymptomatic.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 at 10:00 as dose 2, single (Lot number: EN6208) at the age of 66 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Skin cancer (basal squamous)", start date: 2017 (ongoing), notes: 2/3 previous outpatient surgeries 1 recent radiation treatment,finally 20th treatment on 25Aug2022; "Prostate cancer", start date: Nov2019, stop date: Jan2020, notes: Surgical removal Jan2020; "Cholesterol" (ongoing); "Acid reflux" (ongoing); "Surgical removal- Jan2020", start date: Jan2020 (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN oral taken for blood cholesterol abnormal (ongoing); OMEPRAZOLE oral taken for gastrooesophageal reflux disease (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6198; Route of administration: Intramuscular; Anatomical Site: Left arm; Time of vaccination: 10:00AM), administration date: 24Feb2021, when the patient was 66-year-old, for Covid-19 immunization, reaction(s): "Injection site soreness". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "injection site soreness".  Additional information: The patient started Atorvastatin 4 years ago and Omeprazole 3 years ago
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 28Sep2021 at 10:00 as dose 3 (booster), single (Lot number: FF2589) at the age of 67 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Skin cancer (basal squamous)", start date: 2017 (ongoing), notes: 2 or 3 previous outpatient surgeries 1 recent radiation treatment (finally 20th treatment on 25Aug2022); "Prostate cancer", start date: Nov2019, stop date: Jan2020, notes: Surgical removal Jan2020; "Cholesterol" (ongoing); "Acid Reflux" (ongoing). Concomitant medication(s) included: ATORVASTATIN oral taken for blood cholesterol (ongoing); OMEPRAZOLE oral taken for gastrooesophageal reflux disease (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6198; Anatomical location: Left arm; Route of administration: Intramuscular; Time of administration: 10:00AM Est), administration date: 24Feb2021, when the patient was 66-year-old, for COVID-19 immunization, reaction(s): "injection site soreness"; BNT162b2 (DOSE 2, SINGLE; Lot number: EN6208; Anatomical location: Left arm; Route of administration: Intramuscular; Time of administration: 10:00AM Est), administration date: 17Mar2021, when the patient was 66-year-old, for COVID-19 immunization, reaction(s): "injection site soreness". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site soreness".  Additional information: Patient did not receive any vaccinations within four weeks. Patient started Atorvastatin 4years ago and Omeprazole 3 years ago. Patient had skin cancer (Basal squamous), 2 or 3 previous outpatient surgeries 1 recent radiation treatment (finally 20th treatment on 25Aug2022).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), in Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had antiviral COVID 19 Treatment with Paxlovid treatment start date was 13Sep2022. Dose 4 vaccine administration date was reported as Mar2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19-2, FLUX
Symptoms: Headache
Clinical narrative: I got an extremely bad headache, the headache is annoying; 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 (BNT162B2), on 15Sep2022 at 15:00 as dose number unknown (booster), single (Lot number: GJ5342) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), (Batch/Lot number: unknown) for influenza. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "I got an extremely bad headache, the headache is annoying".  Additional Information: The patient reported that I got an extremely bad headache, the headache was annoying. The patient also was on blood thinner(Eliquis), that blood thinner might be a possible concern. The patient also had a flu shot (Name could be not clarified further hence, suspect captured as Unspecified Flu shot) both of them today. The patient also stated that I had the Booster, the new COVID Booster today, Pfizer Booster (Clarified as COVID-19 Vaccine).The patient had it around, about 3 O' Clock in the afternoon. The patient got an extremely bad headache and thought the pharmacist could had told one of the possible side effect could be the headache. So, the patient had  to go along with that, the headache was annoying but  was reading on the website that, told the pharmacist if one had been taking Blood thinners (Later clarified as Eliquis) and the patient didn't knew to tell him that about being on blood thinner. The patient enquired if the problem was due to taking the Pfizer Booster? And had a flu shot (Name could be not clarified further hence, suspect captured as Unspecified Flu shot) both of them  same day.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested daily and went from positive to Negative; Negative, notes: Was negative for three days; Negative, notes: Was negative for three days; Negative, notes: Was negative for three days; Positive, notes: started to feel symptoms again and Tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Vaccine received. No other medication in 2 weeks. Anti viral details: product=COVID 19 Treatment, Brand=Paxlovid, Treatment start date=05Sep2022, Treatment stop date=10Sep2022, Indication=Treatment of COVID-19. Rebound Covid after taking Paxlovid. Patient tested daily and went from positive to Negative. Was negative for three days. Then started to feel symptoms again and tested positive. No known allergies. No medical history.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19-2
Symptoms: Thrombosis
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "blood clots". Clinical course: Caller is consumer calling for information on Pfizer COVID 19 vaccine gray cap Bivalent. He asks Did they fix problems with the clotting and your vaccine. Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cancer history - breast" (unspecified if ongoing), notes: Cancer history - breast and ocular melanoma, but not undergoing treatment now. In remission; "Cancer history - ocular melanoma" (unspecified if ongoing), notes: Cancer history - breast and ocular melanoma, but not undergoing treatment now. In remission. Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS], start date: 01Sep2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Sep2022) Negative; (08Sep2022) Negative; (10Sep2022) Positive; (15Sep2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19; paxlovid was taken as treatment medication from 02Sep2022 to 06Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Pollakiuria
Clinical narrative: frequent urination at night; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 10Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: POLLAKIURIA (non-serious) with onset 10Jan2022, outcome "not recovered", described as "frequent urination at night". The event "frequent urination at night" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had no other vaccine in four weeks, No COVID prior vaccination and no COVID tested post vaccination. I received my last booster on 10Jan2022 and soon after started having frequent urination at night. I saw a doctor 2/3 weeks after and all my tests turned out negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201166582 same reporter/patient/product/different dose/event in time;
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain
Clinical narrative: Aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 3 (booster), single (Lot number: 048L21F) at the age of 68 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose number: 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose number: 1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 2022, outcome "unknown", described as "Aches". Therapeutic measures were not taken as a result of pain. Additional information: However, it was also reported that the patient also received Moderna COVID 19 vaccine (Lot number: 088D21A) on 04Apr2022 (as reported, possibly discrepant, query sent) at 08:00AM as dose 4 in the right arm for COVID-19 immunisation. Patient received FLU vaccine on 09Sep2022 in the arm. The patient has no COVID prior vaccination and was not COVID tested post vaccination. The patient has no known allergies.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Pain
Clinical narrative: Aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 3 (booster), single (Lot number: 048L21F) at the age of 68 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose number: 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose number: 1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 2022, outcome "unknown", described as "Aches". Therapeutic measures were not taken as a result of pain. Additional information: However, it was also reported that the patient also received Moderna COVID 19 vaccine (Lot number: 088D21A) on 04Apr2022 (as reported, possibly discrepant, query sent) at 08:00AM as dose 4 in the right arm for COVID-19 immunisation. Patient received FLU vaccine on 09Sep2022 in the arm. The patient has no COVID prior vaccination and was not COVID tested post vaccination. The patient has no known allergies.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Relapse tested positive 15Sep2022; Relapse tested positive 15Sep2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jan2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 84 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Sulfur" (unspecified if ongoing); "Known allergies: Contrast dye" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, latency 8 days after the suspect product(s) administration, outcome "not recovered" and all described as "Relapse tested positive 15Sep2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (15Sep2022) Positive. Therapeutic measures were taken as a result of covid-19 which include from 07Sep2022 to 11Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
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 contactable reporter(s) (Other HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2020 at 08:00 as dose 1, single (Lot number: EK4175), in left arm, on 12Jan2021 at 08:00 as dose 2, single (Lot number: EK4238), in left arm, on 30Aug2021 at 09:00 as dose 3 (booster), single (Lot number: FF8199), in left arm and on 25Jan2022 at 09:00 as dose 4 (booster), single (Lot number: FL3198) at the age of 71 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient was on treatment start date: 02Sep2022, treatment stop date: 06Sep2022 and paxlovid rebound, light cough, one bout of diarrhea, some fatigue on 13Sep2022; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller on line got her 2 primary series of Pfizer COVID-19 Vaccine and first booster and tested positive for COVID in Aug.; Caller on line got her 2 primary series of Pfizer COVID-19 Vaccine and first booster and tested positive for COVID in Aug.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller on line got her 2 primary series of Pfizer COVID-19 Vaccine and first booster and tested positive for COVID in Aug.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for COVID in Aug.  Clinical Course: Patient got her 2 primary series of Pfizer COVID-19 Vaccine and first booster and tested positive for COVID in Aug. She would like to know how soon after having COVID can she get the Pfizer Bivalent Booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Malaise
Clinical narrative: Left arm pain; Dizziness; Weakness; Nausea; Vomiting; Tiredness; Headache; feeling unwell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 17:30 as dose 5 (booster), single (Lot number: GH9694) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: If COVID prior vaccination: Yes; "HIV Positive" (unspecified if ongoing). Concomitant medication(s) included: DOVATO; ALENDRONATE SODIUM; CALCIUM & VITAMIN D3. Past drug history included: Penicillin (augmentin), reaction(s): "known allergies: Penicillin (Augmentin)". Vaccination history included: BNT162b2 (Dose 4, Batch/Lot No: FM7553, Location of injection: Arm Left), administration date: 19May2022, when the patient was 56-year-old, for COVID-19 Immunization, reaction(s): "left arm pain"; BNT162b2 (Dose 3, Batch/Lot No: EW0185, Location of injection: Arm Left), administration date: 25Aug2021, when the patient was 55-year-old, for COVID-19 Immunization, reaction(s): "left arm pain"; BNT162b2 (Dose 2, Batch/Lot No: ER8731, Location of injection: Arm Left), administration date: 17Apr2021, when the patient was 55-year-old, for COVID-19 Immunization, reaction(s): "left arm pain"; BNT162b2 (Dose 1, Batch/Lot No: ER2613, Location of injection: Arm Left), administration date: 20Mar2021, when the patient was 55-year-old, for COVID-19 Immunization, reaction(s): "left arm pain". The following information was reported: DIZZINESS (non-serious) with onset 13Sep2022 at 09:00, outcome "recovering"; HEADACHE (non-serious) with onset 13Sep2022 at 09:00, outcome "recovering"; PAIN IN EXTREMITY (non-serious) with onset 13Sep2022 at 09:00, outcome "recovering", described as "Left arm pain"; NAUSEA (non-serious) with onset 13Sep2022 at 09:00, outcome "recovering"; FATIGUE (non-serious) with onset 13Sep2022 at 09:00, outcome "recovering", described as "Tiredness"; VOMITING (non-serious) with onset 13Sep2022 at 09:00, outcome "recovering"; ASTHENIA (non-serious) with onset 13Sep2022 at 09:00, outcome "recovering", described as "Weakness"; MALAISE (non-serious) with onset 13Sep2022 at 09:00, outcome "recovering", described as "feeling unwell". Therapeutic measures were not taken as a result of pain in extremity, dizziness, asthenia, nausea, vomiting, fatigue, headache, malaise.  Additional information: It was reported no seriousness criteria that is results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating, congenital anomaly/birth defect. Also reported left arm pain that evening. Dizziness, weakness, nausea, vomiting, tiredness, headache and feeling unwell started the next day. No reaction other than left arm pain with the first 4 shots. The patient was not COVID tested post vaccination and no other vaccine in four weeks.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Vomiting
Clinical narrative: Left arm pain; Dizziness; Weakness; Nausea; Vomiting; Tiredness; Headache; feeling unwell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 17:30 as dose 5 (booster), single (Lot number: GH9694) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: If COVID prior vaccination: Yes; "HIV Positive" (unspecified if ongoing). Concomitant medication(s) included: DOVATO; ALENDRONATE SODIUM; CALCIUM & VITAMIN D3. Past drug history included: Penicillin (augmentin), reaction(s): "known allergies: Penicillin (Augmentin)". Vaccination history included: BNT162b2 (Dose 4, Batch/Lot No: FM7553, Location of injection: Arm Left), administration date: 19May2022, when the patient was 56-year-old, for COVID-19 Immunization, reaction(s): "left arm pain"; BNT162b2 (Dose 3, Batch/Lot No: EW0185, Location of injection: Arm Left), administration date: 25Aug2021, when the patient was 55-year-old, for COVID-19 Immunization, reaction(s): "left arm pain"; BNT162b2 (Dose 2, Batch/Lot No: ER8731, Location of injection: Arm Left), administration date: 17Apr2021, when the patient was 55-year-old, for COVID-19 Immunization, reaction(s): "left arm pain"; BNT162b2 (Dose 1, Batch/Lot No: ER2613, Location of injection: Arm Left), administration date: 20Mar2021, when the patient was 55-year-old, for COVID-19 Immunization, reaction(s): "left arm pain". The following information was reported: DIZZINESS (non-serious) with onset 13Sep2022 at 09:00, outcome "recovering"; HEADACHE (non-serious) with onset 13Sep2022 at 09:00, outcome "recovering"; PAIN IN EXTREMITY (non-serious) with onset 13Sep2022 at 09:00, outcome "recovering", described as "Left arm pain"; NAUSEA (non-serious) with onset 13Sep2022 at 09:00, outcome "recovering"; FATIGUE (non-serious) with onset 13Sep2022 at 09:00, outcome "recovering", described as "Tiredness"; VOMITING (non-serious) with onset 13Sep2022 at 09:00, outcome "recovering"; ASTHENIA (non-serious) with onset 13Sep2022 at 09:00, outcome "recovering", described as "Weakness"; MALAISE (non-serious) with onset 13Sep2022 at 09:00, outcome "recovering", described as "feeling unwell". Therapeutic measures were not taken as a result of pain in extremity, dizziness, asthenia, nausea, vomiting, fatigue, headache, malaise.  Additional information: It was reported no seriousness criteria that is results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating, congenital anomaly/birth defect. Also reported left arm pain that evening. Dizziness, weakness, nausea, vomiting, tiredness, headache and feeling unwell started the next day. No reaction other than left arm pain with the first 4 shots. The patient was not COVID tested post vaccination and no other vaccine in four weeks.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest pain, Myalgia, Pain in extremity
Clinical narrative: He is having pain in his chest, back and shoulder area and pain is on the opposite side from where he got his shot; He is having pain in his chest, back and shoulder area and pain is on the opposite side from where he got his shot; He is having pain in his chest, back and shoulder area and pain is on the opposite side from where he got his shot; pain in my arm/The pain is on the opposite side of the shot; muscular pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown (Unknown manufacturer)), for COVID-19 immunization. The following information was reported: CHEST PAIN (non-serious), BACK PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 15Sep2022, outcome "unknown" and all described as "He is having pain in his chest, back and shoulder area and pain is on the opposite side from where he got his shot"; MYALGIA (non-serious) with onset 15Sep2022, outcome "unknown", described as "muscular pain"; PAIN IN EXTREMITY (non-serious) with onset 15Sep2022, outcome "unknown", described as "pain in my arm/The pain is on the opposite side of the shot".  Additional information: Patient reported after having COVID-19 Vaccine the bivalent formulation he experienced pain in his chest, back and shoulder area and the pain is on the opposite side from where he got his shot, muscular pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: who reported of improvement on her HSP rashes each time she had her covid 19 booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 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 included: "henoch schonlein purpura" (unspecified if ongoing), notes: I have a patient with confirmed henoch schonlein purpura. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "who reported of improvement on her HSP rashes each time she had her covid 19 booster".  Additional information: Reporter was wondering if we had encountered any reports about covid 19 vaccines helping autoimmune disease. Reporter had a patient with confirmed (Name withheld) purpura who reported of improvement on her HSP rashes each time she had her covid 19 booster.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hodgkins lymphoma", start date: 1975 (unspecified if ongoing), notes: Hodgkins lymphoma; "breast cancer", start date: 1996 (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; LIPITOR. Patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Pavloxid as treatment for Covid-19. Other medication in 2 weeks: Yes  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information the possible causal association of suspect BNT162B2 and for reported events -drug ineffective and COVID-19 cannot be excluded
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 11Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Drug allergy" (unspecified if ongoing), notes: Past drug history: unspecified drug, Reaction: Allergy. The patient's concomitant medications were not reported. 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.  Clinical course: Patient received treatment Paxlovid from 04Sep2022 to 08Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "Common Variable Immunodeficiency" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, 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 05Sep2022 to 10Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), on 13Nov2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 32 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 25Jul2022 as dose 4 (booster), single (Lot number: 056A22A) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing), notes: Immunosuppressant. The patient's concomitant medications were not reported.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 14Sep2022, outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Sep2022) Positive, notes: Positive COVID antibody test. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: The patient had received anti viral therapy with product Paxlovid which was started on 01Sep2022 and stopped on 06Sep2022 for treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: No reaction other than left arm pain with the first 4 shots.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: ER2613) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HIV positive" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Penicillin (augmentin), reaction(s): "known allergies: Penicillin (Augmentin)". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "No reaction other than left arm pain with the first 4 shots.".  Additional information: Left arm pain that evening. No reaction other than left arm pain with the first 4 shots. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Device Date was 15Sep2022. The patient did not had COVID test post vaccination. Facility type Vaccine was public Health Clinic/ Administration facility.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201167375 same patient, vaccine, event, different dose;US-PFIZER INC-202201167376 same patient, vaccine, event, different dose;US-PFIZER INC-202201167377 same patient, vaccine, event, different dose.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: No reaction other than left arm pain with the first 4 shots; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Apr2021 as dose 2, single (Lot number: ER8731) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HIV+" (unspecified if ongoing), notes: HIV+; "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: DOVATO; ALENDRONATE SODIUM; CALCIUM+D3. Past drug history included: Penicillin (augmentin), reaction(s): "Allergy Penicillin (Augmentin)", notes: Known allergies: Penicillin (Augmentin). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: ER2613, Location of injection: Arm Left), administration date: 20Mar2021, when the patient was 55-year-old, for COVID-19 Immunization, reaction(s): "No reaction other than left arm pain with the first 4 shots". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovering", described as "No reaction other than left arm pain with the first 4 shots". Therapeutic measures were not taken as a result of pain in extremity.  Additional information : The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Reported Event: Left arm pain that evening. No reaction other than left arm pain with the first 4 shots.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201167373 same patient, vaccine, event, different dose;
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: No reaction other than left arm pain with the first 4 shots.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Aug2021 as dose 3 (booster), single (Lot number: EW0185) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "HIV Positive" (unspecified if ongoing); "If COVID prior vaccination: Yes" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. The patient's concomitant medications were not reported. Past drug history included: Augmentin, reaction(s): "Known allergies: (Augmentin)", notes: Known allergies: Augmentin. Vaccination history included: BNT162b2 (Dose 2, single, Batch/Lot No: ER8731, Location of injection: Arm Left), administration date: 17Apr2021, when the patient was 55-year-old, for COVID-19 Immunization, reaction(s): "Left arm pain"; BNT162b2 (Dose 1, single, Batch/Lot No: ER2613, Location of injection: Arm Left), administration date: 20Mar2021, when the patient was 55-year-old, for COVID-19 Immunization, reaction(s): "Left arm pain". The patient had COVID prior vaccination and was not tested for COVID post vaccination. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "No reaction other than left arm pain with the first 4 shots.".  Additional information: The patient reported left arm pain that evening. Dizziness, weakness, nausea, vomiting, tiredness, headache and feeling unwell started the next day. No reaction other than left arm pain with the first 4 shots.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201167373 same patient, vaccine, event, different dose;
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: No reaction other than left arm pain with the first 4 shots; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19May2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HIV+" (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: if COVID prior vaccination: Yes. The patient's concomitant medications were not reported. Past drug history included: Penicillin (augmentin), reaction(s): "known allergies: Penicillin (Augmentin)". Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: ER2613, Location of injection: Arm Left), administration date: 20Mar2021, when the patient was 55-year-old, for COVID-19 Immunization, reaction(s): "No reaction other than left arm pain with the first 4 shots"; BNT162b2 (Dose Number: 2, Batch/Lot No: ER8731, Location of injection: Arm Left), administration date: 17Apr2021, when the patient was 55-year-old, for COVID-19 Immunization, reaction(s): "No reaction other than left arm pain with the first 4 shots"; BNT162b2 (Dose Number: 3, Batch/Lot No: EW0185, Location of injection: Arm Left), administration date: 25Aug2021, when the patient was 55-year-old, for COVID-19 Immunization, reaction(s): "No reaction other than left arm pain with the first 4 shots". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "No reaction other than left arm pain with the first 4 shots".  Additional information: It was reported that facility where the most recent COVID-19 vaccine was administered was  health clinic, administration facility. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not tested COVID post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201167373 same patient, vaccine, event, different dose;
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Malaise, Vaccination site pain
Clinical narrative: Pain at injection site; insomnia; malaise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 14Sep2022 at 16:45 as dose 4 (booster), single (Lot number: 6J2524) at the age of 46 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (not ongoing). The patient took concomitant medications. 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, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 15Sep2022 at 02:00, outcome "recovering", described as "Pain at injection site"; INSOMNIA (non-serious) with onset 15Sep2022 at 02:00, outcome "recovering"; MALAISE (non-serious) with onset 15Sep2022 at 02:00, outcome "recovering". Therapeutic measures were not taken as a result of vaccination site pain, insomnia, malaise.  Additional Information:  Other medical history: None (as reported). No other vaccine received in four weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No Known allergies. Device date updated as 15Sep2022. Reported about COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: Sore arm; body aches; head ache; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Sep2022 as dose 4 (booster), single (Lot number: FPY137) at the age of 47 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 3, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 14Sep2022, outcome "recovered" (Sep2022), described as "Sore arm"; PAIN (non-serious) with onset 14Sep2022, outcome "recovered" (Sep2022), described as "body aches"; CHILLS (non-serious) with onset 14Sep2022, outcome "recovered" (Sep2022); HEADACHE (non-serious) with onset 14Sep2022, outcome "recovered" (Sep2022), described as "head ache". Therapeutic measures were not taken as a result of pain in extremity, pain, headache, chills.  Additional information: The events were reported as non serious by the reporter. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. The facility where the most recent COVID-19 vaccine was administered was Pharmacy/Drug Store.