chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Product use issue, Weight
Clinical narrative: He got his flu shot at the same time as he got the covid bivalent yesterday; He got his flu shot at the same time as he got the covid bivalent yesterday; He said, it's mostly his arm but little bit on his chest near his arm like upper left part of his chest; Arm being sore; soreness got worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An 8-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Dec2022 as dose 3 (booster), single (Lot number: GK1657) at the age of 8 years, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 17Dec2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Optic nerve glioma" (unspecified if ongoing), notes: Optic nerve glioma. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single; LOT# FK5618), administration date: 17Nov2021, when the patient was 7-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, single; LOT#: FK5618), administration date: 13Dec2021, when the patient was 7-year-old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Dec2022, outcome "recovering", described as "Arm being sore"; CHEST PAIN (non-serious) with onset Dec2022, outcome "unknown", described as "He said, it's mostly his arm but little bit on his chest near his arm like upper left part of his chest"; CONDITION AGGRAVATED (non-serious) with onset Dec2022, outcome "recovering", described as "soreness got worse"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 17Dec2022, outcome "unknown" and all described as "He got his flu shot at the same time as he got the covid bivalent yesterday". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chest pain, pain in extremity, condition aggravated.  Additional information: Medical Conditions was reporter as None like that but he does have a, he has a, an Optic nerve glioma (captured as provided) that is currently disabled and that's his medical condition. Regular Medications was just the multivitamins (not specifically clarified hence not captured in tab). No lab Work. So he complained about his arm being sore, kind of right away. And then he said the soreness got worse, instead of later in the evening and when he woke up this morning, but it has gotten better since then. He said, it's mostly his arm but little bit on his chest near his arm like upper left part of his chest. No treatment received.
Age: 59.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 05Oct2022 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing). 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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (18Dec2022) Positive, notes: Retested positive for COVID 3 days after finishing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: No known allergies. Received Paxlovid treatment for COVID-19 (start date:10Dec2022 and stop date:14Dec2022). Retested positive for COVID 3 days after finishing Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Feeling hot, Glycosylated haemoglobin, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: I had a little red rash and along in my arm; a little swollen and it hurts; a little red rash and along in my arm and heat; a little swollen and it hurts; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Dec2022 as dose number unknown (booster), single (Lot number: GJ6739) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Blood pressure high; "High cholesterol" (unspecified if ongoing), notes: High cholesterol; "GERD" (unspecified if ongoing), notes: GERD; "Type 2 diabetic" (unspecified if ongoing), notes: Type 2 diabetic; "vision problems" (unspecified if ongoing), notes: Avastin shots for in my right eye; "little mini stroke", start date: Dec2013 (unspecified if ongoing). Concomitant medication(s) included: METFORMIN ER oral; OZEMPIC taken for diabetes mellitus; GLIPIZIDE; LIVALO taken for blood cholesterol abnormal; EZETIMIBE oral; BABY ASPIRIN; VITAMIN D 2000; PEPCID [FAMOTIDINE] taken for gastrooesophageal reflux disease. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, Unknown manufacturer), for Covid-19 immunization. The following information was reported: RASH (non-serious) with onset Dec2022, outcome "not recovered", described as "I had a little red rash and along in my arm"; FEELING HOT (non-serious) with onset Dec2022, outcome "not recovered", described as "a little red rash and along in my arm and heat"; PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious) all with onset Dec2022, outcome "not recovered" and all described as "a little swollen and it hurts". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, pain in extremity, feeling hot, peripheral swelling. Additional Information:  Treatment: Consumer stated that When she first got home I took Tylenol and she put ice pack on it for the first 2 days, and then the last 2 days, she have aloe Vera cream in my refrigerator and she have been putting refrigerated aloe Vera cream on it and it seems to help. Consumer stated that Monday I had my A1C check and it was 7.5." (Further the result was not clarified hence, not captured in tab)
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; dose #1: Unknown / dose #2: Pfizer / dose #3: Pfizer / dose #4 Pfizer / dose #5 Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 as dose 2, single (Lot number: EW6207), in left arm, on 23Sep2021 as dose 3 (booster), single (Lot number: 30135BA), in left arm and on 02Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 62 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Sep2022 as dose 5 (booster), single (Lot number: FK9893), 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: "Obesity" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Sep2022, outcome "unknown", described as "dose #1: Unknown / dose #2: Pfizer / dose #3: Pfizer / dose #4 Pfizer / dose #5 Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Dyspnoea, Hyperhidrosis, Malaise, Nasal obstruction
Clinical narrative: I don't feel well; I am having loss of appetite; shortness of breath; I am not breathing through my nose correctly; but he was having the 'sweatery' part; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). Concomitant medication(s) included: INHALERIN taken for chronic obstructive pulmonary disease; OXYGEN taken for chronic obstructive pulmonary disease. Vaccination history included: BNT162b2 (First Shot, LOT: EL9261), administration date: 04Feb2021, when the patient was 71-year-old, for COVID-19 Immunization; BNT162b2 (Second Shot, LOT: EL9266), administration date: 25Feb2021, when the patient was 71-year-old, for COVID-19 Immunization; BNT162b2 (Third Shot, LOT: FE3592), administration date: 14Oct2021, when the patient was 72-year-old, for COVID-19 Immunization.  The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I don't feel well"; DECREASED APPETITE (non-serious), outcome "unknown", described as "I am having loss of appetite"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; NASAL OBSTRUCTION (non-serious), outcome "unknown", described as "I am not breathing through my nose correctly"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "but he was having the 'sweatery' part". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of malaise, decreased appetite, dyspnoea, nasal obstruction, hyperhidrosis.  Additional information: Patient have COPD and he was on inhaler and oxygen 20 percent on level 2. Regarding anatomical site consumer stated, Last one was on my right shoulder and before that it was in my left shoulder but my shoulder aren't sore or anything. No they are not, my shoulders are fine. Consumer stated, "he had the biotech covid 19 yesterday and he didn't get dizzy but he was having the 'sweatery' part. He don't feel well and having loss of appetite and breathing, shortness of breath. He was on oxygen 24/7 (later clarified as medical history). Put a mask on it when he try to sleep because he was not. He was not breathing through nose correctly (eventy captured conservatively). He don't think that like something. He don't know what's going on with me. But he was ok, he was existing, he was surviving and he was still eating and drinking water.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen therapy
Clinical narrative: I don't feel well; I am having loss of appetite; shortness of breath; I am not breathing through my nose correctly; but he was having the 'sweatery' part; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). Concomitant medication(s) included: INHALERIN taken for chronic obstructive pulmonary disease; OXYGEN taken for chronic obstructive pulmonary disease. Vaccination history included: BNT162b2 (First Shot, LOT: EL9261), administration date: 04Feb2021, when the patient was 71-year-old, for COVID-19 Immunization; BNT162b2 (Second Shot, LOT: EL9266), administration date: 25Feb2021, when the patient was 71-year-old, for COVID-19 Immunization; BNT162b2 (Third Shot, LOT: FE3592), administration date: 14Oct2021, when the patient was 72-year-old, for COVID-19 Immunization.  The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I don't feel well"; DECREASED APPETITE (non-serious), outcome "unknown", described as "I am having loss of appetite"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; NASAL OBSTRUCTION (non-serious), outcome "unknown", described as "I am not breathing through my nose correctly"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "but he was having the 'sweatery' part". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of malaise, decreased appetite, dyspnoea, nasal obstruction, hyperhidrosis.  Additional information: Patient have COPD and he was on inhaler and oxygen 20 percent on level 2. Regarding anatomical site consumer stated, Last one was on my right shoulder and before that it was in my left shoulder but my shoulder aren't sore or anything. No they are not, my shoulders are fine. Consumer stated, "he had the biotech covid 19 yesterday and he didn't get dizzy but he was having the 'sweatery' part. He don't feel well and having loss of appetite and breathing, shortness of breath. He was on oxygen 24/7 (later clarified as medical history). Put a mask on it when he try to sleep because he was not. He was not breathing through nose correctly (eventy captured conservatively). He don't think that like something. He don't know what's going on with me. But he was ok, he was existing, he was surviving and he was still eating and drinking water.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 51.0
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 non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 21Feb2021 at 15:30 as dose 1, single (Lot number: EN6198), in left arm, on 14Mar2021 at 14:30 as dose 2, single (Lot number: EN6206), in left arm and on 13Oct2021 at 18:30 as dose 3 (booster), single (Lot number: FH8020) at the age of 51 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), all with latency 1 year 9 months 19 days 8 hrs 30 min after the suspect product(s) administration, outcome "recovered" (11Dec2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Dec2022) Negative, notes: Tested negative on an antigen test four days after finishing last dose of paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: after receiving my third dose of the covid vaccine in my left arm, the glands in my left armpit got swollen; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 13Oct2021 at 18:30 as dose 3 (booster), single (Lot number: FH8020) at the age of 51 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Vaccine administration date: 14Mar2021, time: 02:30 PM, lot number: EN6206, dose number: 2, location: Left arm,), administration date: 14Mar2021, when the patient was 50-year-old, for COVID-19 immunization; BNT162b2 (Vaccine administration date: 21Feb2021, time: 03:30 PM, lot number: EN6198, dose number: 1, location: Left arm), administration date: 21Feb2021, when the patient was 50-year-old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 15Oct2021, outcome "unknown", described as "after receiving my third dose of the covid vaccine in my left arm, the glands in my left armpit got swollen".  Additional information: within 48 hours after receiving third dose of the covid Vaccine in left arm, the glands in left armpit got swollen and did not go down for at least a month. patients believe they remained slightly swollen for months.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; 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 following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Anti viral details, product=COVID 19 Treatment, brand=Pfizer, treatment start date=18Dec2022, indication=Treatment of COVID-19, administrator route Oral.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug to the reported events DRUG INEFFECTIVE and COVID 19 cannot be ruled out.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 73 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Feb2021 as dose 1, single (Lot number: 025A21A), in left arm, on 26Mar2021 as dose 2, single (Lot number: 028A21A), in left arm, on 05Apr2022 as dose 4 (booster), single (Lot number: 002M21A), in left arm and on 09Sep2022 at 12:15 as dose 5 (booster), single (Lot number: AS 7143C), in left arm for covid-19 immunisation. The patient's relevant medical history included: "CAD" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN, start date: Jun2015; EZETIMIBE, start date: Jun2015; GABAPENTIN, start date: Jun2015; ZOLPIDEM, start date: Jun2015. Past drug history included: Cyclobenzaprine, start date: Jun2015, stop date: Jun2015. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Oct2021, outcome "not recovered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Dec2022) Positive, notes: positive PCR test; (19Dec2022) Positive, notes: rapid at home test. Therapeutic measures were taken as a result of drug ineffective, covid-19: the patient received Paxlovid from 07Dec2022 to 11Dec2022 for COVID-19 treatment. The patient developed covid symptoms 06Dec2022; positive PCR test 24 hours later (07Dec2022), got RX for Paxlovid immediately and took Paxlovid pills for 5 days, final pill on 11Dec2022. All covid symptoms gone by 11Dec2022. Then, the patient stayed home for 5 more days, until 16Dec2022. Felt fine. On 16Dec2022, she had a doctor appointment. The doctor kept her waiting for an hour in a horribly crowded waiting room in which several people were coughing loudly. All wearing masks, but not every minute. Two days later (18Dec2022) she had symptoms; on 19Dec2022 she tested positive (rapid at home test). She did not know if this was covid rebound or if the recurrence of covid was due to her exposure to coughing people in docs waiting room on 16Dec2022.
Age: 18.0
Sex: M
Vaccine: COVID19-2
Symptoms: Erythema, Joint swelling, Peripheral swelling
Clinical narrative: knee swelling; reddish; his both hands, fingers and entire thing and the feet, on bare feet right on bottom of the feet it is swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An 18-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 18 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: BNT162b2 (First Shot: , Date of shot: 24Mar2021(Not clarified appropriately. Hence not captured in tab), LOT: ED6955), administration date: 24Mar2021, when the patient was 16-year-old, for Covid-19 immunization; BNT162b2 (Second Shot: , Date of shot: 14Apr2021 , LOT: EW0151), administration date: 14Apr2021, when the patient was 16-year-old, for Covid-19 immunization; BNT162b2 (Third Shot: , Date of shot: 25Dec2021 , LOT: Reporter stated, 33025EB, I don't know it little, 33025EB or 1B.), administration date: 25Dec2021, when the patient was 17-year-old, for Covid-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 17Dec2022, outcome "unknown", described as "his both hands, fingers and entire thing and the feet, on bare feet right on bottom of the feet it is swelling"; JOINT SWELLING (non-serious) with onset 17Dec2022, outcome "unknown", described as "knee swelling"; ERYTHEMA (non-serious) with onset 17Dec2022, outcome "unknown", described as "reddish". Therapeutic measures were taken as a result of joint swelling, erythema, peripheral swelling.  Additional information: It was reported that actually, day before yesterday, in evening, reporter son took a Pfizer vaccine, the booster, after it was a 4th and 5th combined right. So today, yesterday evening but today his both hands, fingers and entire thing and the feet, on bare feet right on bottom of the feet it is swelling. And the knees was also swelling. It was reddish and the swelling. Already he took 3 last year but this was the booster what was currently going on, he took it (Covid Vaccine Bivalent Booster). Patient did not have any prior vaccinations and did not have any medical conditions. Patient was taking regular medications such as Vitamins. Patient took treatment as Benadryl, allergic medicine.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Nasopharyngeal swab
Clinical narrative: Headache; body aches; chills; sweating; extreme fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Dec2022 at 13:00 as dose 4 (booster), single (Lot number: GJ6742) at the age of 30 years, in left 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; 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: HEADACHE (non-serious) with onset 16Dec2022, outcome "recovered" (16Dec2022 at 12:00); PAIN (non-serious) with onset 16Dec2022, outcome "recovered" (16Dec2022 at 12:00), described as "body aches"; CHILLS (non-serious) with onset 16Dec2022, outcome "recovered" (16Dec2022 at 12:00); FATIGUE (non-serious) with onset 16Dec2022, outcome "recovered" (16Dec2022 at 12:00), described as "extreme fatigue"; HYPERHIDROSIS (non-serious) with onset 16Dec2022, outcome "recovered" (16Dec2022 at 12:00), described as "sweating". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, pain, chills, hyperhidrosis, fatigue.  Additional information: Patient experienced headache, body aches, chills, sweating, extreme fatigue, felt very similar to having COVID infection. Adverse reaction started about 10 hours post vax and lasted for about 12 hours . As a treatment medication, patient took a bunch of ibuprofen.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : PFIZER INC-202201384552 Same reporter and patient, different product;
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Headache; body aches; chills; sweating; extreme fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Dec2022 at 13:00 as dose 4 (booster), single (Lot number: GJ6742) at the age of 30 years, in left 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; 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: HEADACHE (non-serious) with onset 16Dec2022, outcome "recovered" (16Dec2022 at 12:00); PAIN (non-serious) with onset 16Dec2022, outcome "recovered" (16Dec2022 at 12:00), described as "body aches"; CHILLS (non-serious) with onset 16Dec2022, outcome "recovered" (16Dec2022 at 12:00); FATIGUE (non-serious) with onset 16Dec2022, outcome "recovered" (16Dec2022 at 12:00), described as "extreme fatigue"; HYPERHIDROSIS (non-serious) with onset 16Dec2022, outcome "recovered" (16Dec2022 at 12:00), described as "sweating". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, pain, chills, hyperhidrosis, fatigue.  Additional information: Patient experienced headache, body aches, chills, sweating, extreme fatigue, felt very similar to having COVID infection. Adverse reaction started about 10 hours post vax and lasted for about 12 hours . As a treatment medication, patient took a bunch of ibuprofen.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : PFIZER INC-202201384552 Same reporter and patient, different product;
Age: 87.0
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Pain in extremity
Clinical narrative: my arm is sore; I have lost my sense of taste; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 87-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 87 years 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; Unknown Manufacturer), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "my arm is sore"; AGEUSIA (non-serious), outcome "unknown", described as "I have lost my sense of taste".  Additional information: Consumer stated, he/she got COVID vaccine Bivalent, his/her arm was sore, lost sense of taste. Asking if that one of the side effects. The patient did not had fever.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
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 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 10Apr2021 as dose 1, single (Lot number: EW0161), in right arm, on 01May2021 as dose 2, single (Lot number: EW0164), in right arm, on 23Nov2021 as dose 3 (booster), single (Lot number: FH8027), in right arm and on 09Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "thyroid removed" (not ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Jan2022. 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: (13Dec2022) Negative, notes: 4 days after first negative test result; (15Dec2022) Negative, notes: Tested negative 6 and 7 days after starting paxlovid; (16Dec2022) Negative, notes: Tested negative 6 and 7 days after starting paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had no known allergies. Patient had levothyroxine in 2 weeks. Anti-viral treatment with Paxlovid from 09Dec2022 to 14Dec2022.   No follow up attempts required. No further information expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine dose number=1, vaccine brand other=J&J/vaccine dose number=2, vaccine brand other=Moderna/vaccine dose number=3, vaccine brand=Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 3 (booster), single (Lot number: 6H9703) at the age of 34 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31Oct2021 as dose 2 (booster), single (Lot number: 939904), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 12Mar2021 as dose 1, single (Lot number: 1805031), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Grave's disease" (unspecified if ongoing), notes: Other medical history: Grave's disease. The patient's concomitant medications were not reported. Past drug history included: Vicodin, reaction(s): "Known allergies: Vicodin", notes: Known allergies: Vicodin; Doxycycline, reaction(s): "Known allergies: Doxycycline", notes: Known allergies: Doxycycline.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Oct2022, outcome "unknown", described as "vaccine dose number=1, vaccine brand other=J&J/vaccine dose number=2, vaccine brand other=Moderna/vaccine dose number=3, vaccine brand=Pfizer / BioNTech"; 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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 13Nov2022 to 18Nov2022.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine dose number=1, vaccine brand other=J&J/vaccine dose number=2, vaccine brand other=Moderna/vaccine dose number=3, vaccine brand=Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 3 (booster), single (Lot number: 6H9703) at the age of 34 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31Oct2021 as dose 2 (booster), single (Lot number: 939904), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 12Mar2021 as dose 1, single (Lot number: 1805031), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Grave's disease" (unspecified if ongoing), notes: Other medical history: Grave's disease. The patient's concomitant medications were not reported. Past drug history included: Vicodin, reaction(s): "Known allergies: Vicodin", notes: Known allergies: Vicodin; Doxycycline, reaction(s): "Known allergies: Doxycycline", notes: Known allergies: Doxycycline.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Oct2022, outcome "unknown", described as "vaccine dose number=1, vaccine brand other=J&J/vaccine dose number=2, vaccine brand other=Moderna/vaccine dose number=3, vaccine brand=Pfizer / BioNTech"; 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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 13Nov2022 to 18Nov2022.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Blood test, Physical examination
Clinical narrative: she is experiencing hair loss or hair shedding after receiving this vaccine; thinning of my hair; 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 female patient received BNT162b2 (BNT162B2), in Nov2021 as dose number 2, single (Lot number: EL9261) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, Lot number: EL8982), administration date: 05Jan2021, when the patient was 65-year-old, for COVID-19 immunization, reaction(s): "Hair shedding"; Bnt162b2 (DOSE 2, Lot number: EL9261), administration date: Feb2021, when the patient was 65 years old, for COVID-19 immunization, reaction(s): "Hair shedding". The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "she is experiencing hair loss or hair shedding after receiving this vaccine; thinning of my hair". Relevant laboratory tests and procedures are available in the appropriate section.
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pulmonary embolism; 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 male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for COVID-19 immunization; Covid-19 vaccine (Dose 2), for COVID-19 immunization.  The following information was reported: PULMONARY EMBOLISM (medically significant), outcome "unknown".  Clinical course: Caller said that he took 3 shots of Covid-19 vaccine and had a pulmonary embolism 10 days after the last shot, and he wants to know when he can get another booster shot. that resulted in other medical problems. He reported this event to Pfizer. Caller is now asking if it's safe to get another Pfizer booster in the near future, due to his previous experience. Caller also mentioned that an Hematologist told him that the pulmonary embolism has a correlation to the vaccine, however a Pulmonologist and an Internist told him they would not say this has a correlation to the vaccine. Caller also asked if the Pulmonary Embolism would be considered a severe reaction.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Fever; chills; headache; muscle soreness; right arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Dec2022 at 11:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 28 years, 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 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: PYREXIA (non-serious) with onset 18Dec2022 at 21:00, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 18Dec2022 at 21:00, outcome "recovering"; HEADACHE (non-serious) with onset 18Dec2022 at 21:00, outcome "recovering"; MYALGIA (non-serious) with onset 18Dec2022 at 21:00, outcome "recovering", described as "muscle soreness"; PAIN IN EXTREMITY (non-serious) with onset 18Dec2022 at 21:00, outcome "recovering", described as "right arm soreness". Therapeutic measures were not taken as a result of pyrexia, chills, headache, myalgia, pain in extremity.  Additional information: The patient received more than 3 doses. There were no medications in 4 weeks. There were no COVID prior vaccination. There was no COVID test post vaccination.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 32 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis and currently receiving B-cell depleter for treatment" (unspecified if ongoing), notes: currently receiving B-cell depleter for treatment; "Known allergies: Soy" (unspecified if ongoing); "Known allergies: tree nuts" (unspecified if ongoing); "Known allergies: pollen" (unspecified if ongoing); "Known allergies: animals" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" (2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 06Dec2022 to 11Dec2022. Clinical course: The lot number misplaced/discarded.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: M
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) (Pharmacist).  A 60-year-old male patient received BNT162b2 (BNT162B2), on 12Mar2021 at 09:30 as dose 1, single (Lot number: el2964), in left arm and on 09Apr2021 at 09:30 as dose 2, single (Lot number: euj46158) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "prediabetes" (unspecified if ongoing); "htn" (unspecified if ongoing); "obesity" (unspecified if ongoing); "known allergies: sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: GLUCOPHAGE oral, start date: 09Mar2021, stop date: 19Dec2022; PRAVASTATIN oral, start date: 21Jan2021, stop date: 19Dec2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 37-year-old female patient (pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Lot number: GJ2524) 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), 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: "Environmental Allergies" (unspecified if ongoing). 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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Dose: 5 (Pfizer)/ Dose: 4, 3, 2 and 1 (Moderna); COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 67 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Feb2021 as dose 1, single (Lot number: 016M20A), in left arm, on 15Mar2021 as dose 2, single (Lot number: 032M20A), in left arm, on 06Nov2021 as dose 3 (booster), single (Lot number: 058F21A), in left arm and on 04Apr2022 as dose 4 (booster), single (Lot number: 048221A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure (controlled with meditation); "High cholesterol" (unspecified if ongoing), notes: High cholesterol (controlled with medication). 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 "recovered" (Dec2022) and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Sep2022, outcome "unknown", described as "Dose: 5 (Pfizer)/ Dose: 4, 3, 2 and 1 (Moderna)". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 04Dec2022 to 09Dec2022.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: WELLBUTRIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". 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 received anti-viral treatment with Paxlovid from 11Dec2022 to 15Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization, reaction(s): "Sick". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sick".  Additional information: Patient got one and two [Pfizer COVID vaccinations] but was not going to pollute her body with any more boosters. One and two let the flu get her sick. It's best to rely on the immune system.  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-PV202200125797 Same Reporter/Patient/Drug/AE, Different Vaccine Dose;