chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Feb2021 at 14:30 as dose 1, single (Lot number: EN6203), in left arm, on 21Mar2021 at 14:30 as dose 2, single (Lot number: ER8727), in left arm, on 09Oct2021 at 10:30 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 09Apr2022 at 10:30 as dose 4 (booster), single (Lot number: FL3198) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HIGH BLOOD PRESSURE" (unspecified if ongoing); "PENICILLIN" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN; SPIRONOLACTONE; HYDRALAZINE; ROSUVASTATIN, stop date: 09Sep2022. Past drug history included: Phenothiazine derivates, reaction(s): "Known allergies: Phenothiazine Derivates". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Sep2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Indication=Treatment of COVID-19; (15Sep2022) Negative; (17Sep2022) Negative; (18Sep2022) Negative; (19Sep2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had received Other medication in 2 weeks. The patient had received t COVID 19 Treatment, brand- Paxlovid 300-100 mg EUA, treatment start date/ stop date - 09Sep2022/14Sep2022. The other medication in 2weeks product: olmesartan 20 mg tab brand: glenmark, spironolactone 25mg tab brand: zydus, hydralazine 25 mg tab brand: avet, Rosuvastatin 20 Mg in 2weeks stop date: 09Sep2022. The patient known allergies was penicillin and phenothiazine derivates.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Batch/Lot number: unknown), on 10Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 03Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 21May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient returned of Covid symptoms. Last dose of Paxlovid taken on 21Sep2022. Tested negative on 23Sep2022. Symptoms returned (stuffy/itchy nose, congestion) evening of 25Sep2022. Tested positive twice. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (23Sep2022) Negative; (25Sep2022) Positive, notes: Tested positive twice; (25Sep2022) Positive, notes: Tested positive twice. Therapeutic measures were taken as a result of vaccination failure, covid-19: Paxlovid from 16Sep2022 to 21Sep2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 12Feb2021 at 10:00 as dose 1, single (Lot number: EN6201), in right arm, on 03Mar2021 at 09:00 as dose 2, single (Lot number: EN6205), in right arm and on 29Sep2021 at 10:00 as dose 3 (booster), single (Lot number: 00155BA) at the age of 59 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03May2022 at 14:00 as dose 4 (booster), single (Lot number: 004M21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergy: almonds" (unspecified if ongoing), notes: almonds. penicillin, sulphamexathole; "Known allergy: penicillin" (unspecified if ongoing), notes: almonds. penicillin, sulphamexathole; "COPD (gold standard stage 1)" (unspecified if ongoing), notes: COPD (gold standard stage 1), prostatitis; "prostatitis" (unspecified if ongoing), notes: COPD (gold standard stage 1), prostatitis. Concomitant medication(s) included: FINASTERIDE, start date: Jan2010, stop date: 25Sep2022; TAMSULOSIN, start date: Jan2010, stop date: 25Sep2022. Past drug history included: Sulfamethoxazole, reaction(s): "known allergies: sulphamexathole", notes: almonds. penicillin, sulphamexathole.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. It was reported that the patient had Covid initial symptoms on 11Sep2022. The patient received full course of Paxlovid from 12sept2022 to 17Sep2022 for COVID-19.
Age: 57.0
Sex: F
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EN6204), in left arm, on 09Apr2021 as dose 2, single (Lot number: ER2613), in right arm and on 09Oct2021 as dose 3 (booster), single (Lot number: PE3590) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MRNA (MRNA 1273)), on 29Apr2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "overweight" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA [FEXOFENADINE HYDROCHLORIDE], start date: 05Sep2022; MUCINEX, start date: 05Sep2022, stop date: 14Sep2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Sep2022) Positive, notes: Positive antigen rapid test was on Day 13; (2022) Positive, notes: COVID 19 Treatment; (2022) Positive, notes: tested positive with mild symptoms after testing negative and feeling better; (2022) Negative, notes: tested positive with mild symptoms after testing negative and feeling better. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that, Patient took other medication in 2 weeks and Patient took Paxlovid for treatment covid 19, treatment start date is 07Sep2022 and treatment stop date is 12Sep2022 for indication treatment of COVID-19.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: None" (unspecified if ongoing), notes: Other medical history: None. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 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 and concomitant medications were not reported. The patient did not have any known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive, notes: Rebound COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 13Sep2022 to 15Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
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 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. 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: (unspecified date) Positive, notes: Treatment for COVID-19 Test; (25Sep2022) Positive, notes: Rebound positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient has received antiviral Pfizer drug for the treatment of COVID-19 from 15Sep2022 to 20Sep2022. Patient received vaccine and No other medication received in 2weeks. Patient had no known allergies and other medical history.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jul2022 at 09:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 33 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: 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: Negative; Negative; Negative; Negative; Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not received other medication in 2 weeks. Covid symptoms and testing positive after 5 negatives. The patient received Covid-19 treatment included PAXLOVID from 13Sep2022 to 17Sep2022. The patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site rash
Clinical narrative: arm is all swollen; it is red; she said it is painful at injection site she can feel lump; rashy; she said it is painful at injection site she can feel lump; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 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 Completed, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 24Sep2022, outcome "unknown", described as "arm is all swollen"; VACCINATION SITE ERYTHEMA (non-serious) with onset 24Sep2022, outcome "unknown", described as "it is red"; VACCINATION SITE RASH (non-serious) with onset 24Sep2022, outcome "unknown", described as "rashy"; VACCINATION SITE MASS (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 24Sep2022, outcome "unknown" and all described as "she said it is painful at injection site she can feel lump".  Additional information: Reporter stated, she was calling for her growing daughter. Her daughter had her Pfizer booster, the bivalent booster on September 21st and she called her on 24Sep2022 morning and said, her arm was all swollen and sent her a picture of it and it was red, and she said it was painful at injection site she can feel lump. It was a pretty big area that all kind of red and rashy and they were concerned, and we wanted to know what she can do about that and also, they just wanted to report it. Reporter was informed in case of any emergency can contact nearest physician/pharmacist. Reporter stated, they don't have time to call pharmacy since she was unable to get help. Her daughter was in pain. They don't know if that was serious or not or they have to try to call the hospital she guesses so next.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Illness, Nasopharyngitis
Clinical narrative: very sick at the moment; she is coughing, very sick at the moment; I have a cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient 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: ILLNESS (non-serious), outcome "unknown", described as "very sick at the moment"; COUGH (non-serious), outcome "unknown", described as "she is coughing, very sick at the moment"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "I have a cold". Additional information: The patient mentioned that she was scheduled today for the booster shot, for the second booster shot however she mentioned that she was coughing, very sick at the moment. The patient had a cold, she was coughing. The patient was sick she might have contracted a virus when she was in the hospital (Further not clarified). She didn't think it's appropriate for her to get a immunization shot. She would reschedule.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: Morning of 24Sep2022 left armpit lymph node is swollen; collarbone neck area is sore; By 9:30pm on 23Sep2022, the entire left arm became sore and tingling; By 9:30pm on 23Sep2022, the entire left arm became sore and tingling; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Sep2022 at 08:15 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Bipolar" (unspecified if ongoing), notes: Other medical history: Bipolar, ADHD, PTSD; "PTSD" (unspecified if ongoing); "ADHD" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ambien, reaction(s): "Known allergy:ambien", notes: Known allergies: Ambien. The following information was reported: PAIN IN EXTREMITY (non-serious), PARAESTHESIA (non-serious) all with onset 23Sep2022 at 21:30, outcome "not recovered" and all described as "By 9:30pm on 23Sep2022, the entire left arm became sore and tingling"; LYMPHADENOPATHY (non-serious) with onset 24Sep2022, outcome "not recovered", described as "Morning of 24Sep2022 left armpit lymph node is swollen"; NECK PAIN (non-serious) with onset 24Sep2022, outcome "not recovered", described as "collarbone neck area is sore". Therapeutic measures were not taken as a result of pain in extremity, paraesthesia, lymphadenopathy, neck pain.  Additional information:There was no other medication in four weeks. By 9:30pm on 23Sep2022, the entire left arm became sore and tingling. Morning of 24Sep2022 left armpit lymph node is swollen, collarbone neck area was sore. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Pain in extremity
Clinical narrative: Sore left arm; sore left underarm/upper side; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist). The reporter is the patient.  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 16:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 36 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 1, single), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, single), for Covid-19 immunization; Covid-19 vaccine (Dose 3, single), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Sep2022 at 04:00, outcome "recovering", described as "Sore left arm"; AXILLARY PAIN (non-serious) with onset 23Sep2022 at 04:00, outcome "recovering", described as "sore left underarm/upper side". Therapeutic measures were not taken as a result of pain in extremity, axillary pain. Additional information: Facility type vaccine was hospital. The events did not result in physician office visit or emergency room visit. There was no COVID tested post vaccination. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Myalgia, Pain in extremity
Clinical narrative: Arm pain: mild on day of vaccination, moderate next morning, then mild/gone 20+ hours post -vaccination; Moderate to mild myalgia; Moderate fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 46-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 17:00 as dose 4 (booster), single (Lot number: GJ6739) intramuscular, in right arm for covid-19 immunization; influenza vaccine (INFLUENZA), on 24Sep2022 as dose 1, single (Batch/Lot number: unknown), in left arm. The patient's relevant medical history included: "Known allergies: lactose intolerance" (unspecified if ongoing), notes: Known allergies: lactose intolerance. The patient took concomitant medications. Past drug history included: Known allergies: acetaminophen allergy, reaction(s): "Drug allergy", notes: Known allergies: Acetaminophen allergy. Vaccination history included: Covid-19 vaccine (Dose: 03), for Covid-19 immunization; Covid-19 vaccine (dose 2), for Covid-19 immunization; Covid-19 vaccine (dose 1), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 24Sep2022 at 22:00, outcome "not recovered", described as "Arm pain: mild on day of vaccination, moderate next morning, then mild/gone 20+ hours post -vaccination"; FATIGUE (non-serious) with onset 24Sep2022 at 22:00, outcome "not recovered", described as "Moderate fatigue"; MYALGIA (non-serious) with onset 24Sep2022 at 22:00, outcome "not recovered", described as "Moderate to mild myalgia". Therapeutic measures were not taken as a result of pain in extremity, myalgia, fatigue.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Muscle spasms, Nausea
Clinical narrative: Severe cramping; Nauseous; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 36-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset Sep2022, outcome "unknown", described as "Diarrhea"; NAUSEA (non-serious) with onset Sep2022, outcome "unknown", described as "Nauseous"; MUSCLE SPASMS (non-serious) with onset Sep2022, outcome "unknown", described as "Severe cramping".  Additional information: Reporter stated, "My daughter who is 36 and hardly 6 months old received the Pfizer Vaccine (Clarified as Pfizer COVID-19 Vaccine Bivalent) this morning and just about an hour ago started to eventually I don't know prior during the mid-day and then about an hour ago started to have severe cramping, nauseous and diarrhea."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Pruritus, Rash
Clinical narrative: itching/itching more severely so my entire body almost has a rash; I have got a rash/itching more severely so my entire body almost has a rash/body rash; I thought it was a dry skin/My legs specially are itching and dry; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  An 86-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I had Covid", start date: Jul2021 (unspecified if ongoing), notes: I had Covid '21Jul' after I cleared the infection and recovered. The patient took concomitant medications. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "itching/itching more severely so my entire body almost has a rash"; RASH (non-serious), outcome "unknown", described as "I have got a rash/itching more severely so my entire body almost has a rash/body rash"; DRY SKIN (non-serious), outcome "unknown", described as "I thought it was a dry skin/My legs specially are itching and dry". Therapeutic measures were taken as a result of pruritus, rash, dry skin.  Additional information: The patient had been on blood thinner (unspecified) for weeks. Ever since patient got the vaccine, after having disease, she had Covid in Jul2021, after it cleared the infection and recovered. The patient got her first Pfizer vaccine and started itching. The patient couldn't figure it out, thought it was dry skin also got a rash. She had itching more severely so her entire body almost had a rash. Her legs specially are itching and dry. She realized that she was a dried-up old lady. She had been using Cortisol as treatment. She just wanted to report the itching and the body rash. She read literature and found information about blood thinner. She mentioned that she had not taken Benadryl as she doesn't want to get sleepy (no further information).  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-202201188266 same product, patient, different AEs, different dose;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), 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's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative then positive again; Positive, notes: Tested negative then positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Pruritus, Rash
Clinical narrative: I am still itching more severely/My legs specially are itching; got a rash and going on all over my body way from my legs and throughout my back/so my entire body almost has a rash; My legs specially are itching and dry/that I am a dried up old lady; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  An 86-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I had Covid", start date: Jul2021 (unspecified if ongoing), notes: I had Covid Jul2021 after I cleared the infection and recovered. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (2ND DOSE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (3rd Booster, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (4th booster, MANUFACTURER UNKNOWN), for COVID-19 immunization; Bnt162b2 (1st dose, Itching), for COVID-19 immunization, reaction(s): "Itching"; Bnt162b2 (1st dose, I have got a rash and going on all over my body way from my legs and throughout my back), for COVID-19 immunization, reaction(s): "I have got a rash and going on all over my body way from my legs and throughout my back"; Bnt162b2 (1st dose, thought it was a dry skin), for COVID-19 immunization, reaction(s): "thought it was a dry skin". The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "I am still itching more severely/My legs specially are itching"; RASH (non-serious), outcome "unknown", described as "got a rash and going on all over my body way from my legs and throughout my back/so my entire body almost has a rash"; DRY SKIN (non-serious), outcome "unknown", described as "My legs specially are itching and dry/that I am a dried up old lady". Therapeutic measures were taken as a result of pruritus, rash, dry skin.  Additional information: Patient had been on a blood thinner for weeks. Ever since patient got the vaccine, after having disease, she had Covid "Jul2021" after it cleared the infection and recovered, she got the vaccine. After she got the first Pfizer vaccine patient started itching and couldn't figure out, thought it was a dry skin also had a rash ever since she got the vaccine. Patient (today) went and got her 5th booster needless to say, still itching more severely entire body almost had a rash. Her legs specially were itching and dry and realized that she was dried up like old lady. Patient had been using Cortisol (Intent: Treatment) and she just wanted to report the itching and the body rash.  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-202201188044 same product, patient, different AEs, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: severe headache; fever; chills; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CHILLS (non-serious) with onset 23Sep2022, outcome "not recovered"; PYREXIA (non-serious) with onset 23Sep2022, outcome "not recovered", described as "fever"; HEADACHE (non-serious) with onset 23Sep2022, outcome "not recovered", described as "severe headache".  Additional information: No covid prior vaccination and no covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Interchange of vaccine products, Off label use
Clinical narrative: Caller had a mixture of both Pfizer and Moderna; Caller had a mixture of both Pfizer and Moderna; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "occipital neuralgia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose number unknown, single), for COVID-19 immunisation, reaction(s): "headache". The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "Caller had a mixture of both Pfizer and Moderna"; HEADACHE (non-serious), outcome "unknown". Additional information: the patient had a mixture of both Pfizer and Moderna. She had pre-existing conditions prior to getting any of the Covid vaccines and that condition is occipital neuralgia. After each dose, she gets a terrible headache. The first one lasted for a few days. Then they have gotten longer in duration. Her most recent booster, the last one, just killed her.  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) : PFIZER INC-202201169646 same patient, different events after different doses of the vaccine;
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 28Apr2021 as dose 2, single (Lot number: EW0171) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing); "familial heterozygous hypocholesteremia", start date: 2015 (unspecified if ongoing); "Chronic migraine", start date: 2014 (unspecified if ongoing); "foot surgery", start date: 2021 (unspecified if ongoing). Concomitant medication(s) included: CLIMARA PRO; ESTRADIOL / NORETHINDRONE ACETATE. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EW0151), administration date: 07Apr2021, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown".  Additional information: The patient never had COVID plus test or diagnosis. The patient also felt fatigue after her second Pfizer dose but did not have the feeling in her chest. There was no product complaint associated with the case.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: burning; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 64-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Telosa Hunt Syndrome" (unspecified if ongoing); "Melanoma" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Type 1 diabetes" (unspecified if ongoing); "ran over by car" (unspecified if ongoing); "stiff shoulders" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE; ACTEMRA; MYCOPHENOLATE; CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]; NOVOLOG. The following information was reported: BURNING SENSATION (non-serious), outcome "unknown", described as "burning".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: had splitting headaches for 12 hours; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a sales representative.  A male patient 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; unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "had splitting headaches for 12 hours".  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-202201185411 same reporter/drug, event, different patients;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disease recurrence, Drug ineffective, Suspected COVID-19
Clinical narrative: I had my shots and boosters and I still had covid 3 times; I had my shots and boosters and I still had covid 3 times; I had my shots and boosters and I still had covid 3 times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient 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; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), DISEASE RECURRENCE (non-serious), outcome "unknown" and all described as "I had my shots and boosters and I still had covid 3 times".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Pain in extremity
Clinical narrative: Pfizer shot made her tired; she had a sore arm; after her 1st primary dose she slept 13 hours; 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 70-year-old female patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, 0.3ml single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Blood pressure high diagnosed most of her life; "High cholesterol" (unspecified if ongoing), notes: High cholesterol diagnosed most of her life. Her liver produces too much but it is pretty even; "thyroid" (unspecified if ongoing), notes: thyroid. The patient's family history included: "heart issues" (unspecified if ongoing), notes: Family member had 5/6 children that had heart surgery and mother had 2 heart attack and 13 bypasses. Concomitant medication(s) included: LISINOPRIL HCTZ taken for hypertension. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Pfizer shot made her tired"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "she had a sore arm"; HYPERSOMNIA (non-serious), outcome "unknown", described as "after her 1st primary dose she slept 13 hours".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock, Feeling abnormal, Gait inability, Infection, Musculoskeletal disorder
Clinical narrative: anaphylactic shock; almost died; sever neuropathy; could not walk, or use her hands; could not walk, or use her hands; severe neurological damage; experienced PEG Allergy; felt bad; had swollen throat; swollen tongue; hands and legs tingle; trigeminal neuralgia; infection against her spine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-000003467 (Novavax).  A 62-year-old female patient received BNT162b2 (BNT162B2), in 2020 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC SHOCK (medically significant), outcome "unknown"; NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "almost died"; NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "sever neuropathy"; GAIT INABILITY (medically significant), MUSCULOSKELETAL DISORDER (medically significant), outcome "unknown" and all described as "could not walk, or use her hands"; NERVOUS SYSTEM DISORDER (medically significant), outcome "unknown", described as "severe neurological damage"; POLYMERS ALLERGY (non-serious), outcome "unknown", described as "experienced PEG Allergy"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt bad"; PHARYNGEAL EDEMA (non-serious), outcome "unknown", described as "had swollen throat"; SWOLLEN TONGUE (non-serious), outcome "unknown"; PARAESTHESIA (non-serious), outcome "unknown", described as "hands and legs tingle"; TRIGEMINAL NEURALGIA (non-serious), outcome "unknown"; INFECTION (non-serious), outcome "unknown", described as "infection against her spine". On 09Sep2022, it was reported that the patient started treatment on an unspecified date in 2020 with Pfizer BioNTech COVID-19 Vaccine at an unspecified dose for Covid-19 immunization. It was reported the patient experienced PEG allergy, anaphylactic shock, felt bad, almost died, had swollen throat, swollen tongue, bedridden, sever neuropathy, could not walk, or use her hands, severe neurological damage, hands and legs tingle, trigeminal neuralgia, and infection against her spine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Near death experience, Nervous system disorder, Neuropathy peripheral, Paraesthesia, Pharyngeal oedema
Clinical narrative: anaphylactic shock; almost died; sever neuropathy; could not walk, or use her hands; could not walk, or use her hands; severe neurological damage; experienced PEG Allergy; felt bad; had swollen throat; swollen tongue; hands and legs tingle; trigeminal neuralgia; infection against her spine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-000003467 (Novavax).  A 62-year-old female patient received BNT162b2 (BNT162B2), in 2020 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC SHOCK (medically significant), outcome "unknown"; NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "almost died"; NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "sever neuropathy"; GAIT INABILITY (medically significant), MUSCULOSKELETAL DISORDER (medically significant), outcome "unknown" and all described as "could not walk, or use her hands"; NERVOUS SYSTEM DISORDER (medically significant), outcome "unknown", described as "severe neurological damage"; POLYMERS ALLERGY (non-serious), outcome "unknown", described as "experienced PEG Allergy"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt bad"; PHARYNGEAL EDEMA (non-serious), outcome "unknown", described as "had swollen throat"; SWOLLEN TONGUE (non-serious), outcome "unknown"; PARAESTHESIA (non-serious), outcome "unknown", described as "hands and legs tingle"; TRIGEMINAL NEURALGIA (non-serious), outcome "unknown"; INFECTION (non-serious), outcome "unknown", described as "infection against her spine". On 09Sep2022, it was reported that the patient started treatment on an unspecified date in 2020 with Pfizer BioNTech COVID-19 Vaccine at an unspecified dose for Covid-19 immunization. It was reported the patient experienced PEG allergy, anaphylactic shock, felt bad, almost died, had swollen throat, swollen tongue, bedridden, sever neuropathy, could not walk, or use her hands, severe neurological damage, hands and legs tingle, trigeminal neuralgia, and infection against her spine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Polymers allergy, Swollen tongue, Trigeminal neuralgia
Clinical narrative: anaphylactic shock; almost died; sever neuropathy; could not walk, or use her hands; could not walk, or use her hands; severe neurological damage; experienced PEG Allergy; felt bad; had swollen throat; swollen tongue; hands and legs tingle; trigeminal neuralgia; infection against her spine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-000003467 (Novavax).  A 62-year-old female patient received BNT162b2 (BNT162B2), in 2020 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC SHOCK (medically significant), outcome "unknown"; NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "almost died"; NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "sever neuropathy"; GAIT INABILITY (medically significant), MUSCULOSKELETAL DISORDER (medically significant), outcome "unknown" and all described as "could not walk, or use her hands"; NERVOUS SYSTEM DISORDER (medically significant), outcome "unknown", described as "severe neurological damage"; POLYMERS ALLERGY (non-serious), outcome "unknown", described as "experienced PEG Allergy"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt bad"; PHARYNGEAL EDEMA (non-serious), outcome "unknown", described as "had swollen throat"; SWOLLEN TONGUE (non-serious), outcome "unknown"; PARAESTHESIA (non-serious), outcome "unknown", described as "hands and legs tingle"; TRIGEMINAL NEURALGIA (non-serious), outcome "unknown"; INFECTION (non-serious), outcome "unknown", described as "infection against her spine". On 09Sep2022, it was reported that the patient started treatment on an unspecified date in 2020 with Pfizer BioNTech COVID-19 Vaccine at an unspecified dose for Covid-19 immunization. It was reported the patient experienced PEG allergy, anaphylactic shock, felt bad, almost died, had swollen throat, swollen tongue, bedridden, sever neuropathy, could not walk, or use her hands, severe neurological damage, hands and legs tingle, trigeminal neuralgia, and infection against her spine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP), Program ID.  A patient (no qualifiers provided) received BNT162b2 (Pfizer-BioNTech COVID-19), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got sick". Additional information: The reporter want to know what makes the Moderna COVID-19 vaccine unique and different from other COVID-19 vaccines? Reporter said that "I had moderna and had no issues, my spouse had pfizer and got sick for 2/3 days each time"  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.