chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: she had no reaction with the first or second vaccine but did have a headache with all the vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Lot number: EL9261), in left arm and on 13Feb2021 as dose 2, single (Lot number: EM9809) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mantle cell lymphoma" (unspecified if ongoing), notes: Mantle cell lymphoma in remission for 5 years; "Colon cancer" (unspecified if ongoing), notes: Colon cancer in remission for 5 years; "Aortic valve replacement", start date: 02Mar2015 (unspecified if ongoing); "her husband had lung cancer, he passed away" (unspecified if ongoing). The patient's family history included: "aortic valve replacement" (unspecified if ongoing), notes: her other daughter had an aortic valve replacement and her sister; "her son had a lung transplant" (unspecified if ongoing), notes: he was 61 years old; "Her daughter is diabetic" (unspecified if ongoing); "COPD" (unspecified if ongoing), notes: Her son had a lung transplant from COPD. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "she had no reaction with the first or second vaccine but did have a headache with all the vaccines". Therapeutic measures were not taken as a result of headache.  Additional information: The patient later had the booster of BNT162b2 on 02Sep2021, as dose 2, single (Lot number: FC3184) at the age of 80 years, in left upper arm for covid-19 immunisation and the next day her arm swelled up from the injection site to her elbow. It was warm and itchy, headache.  Follow-Up (13Apr2022): Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site inflammation, Tenderness, Vaccination site warmth
Clinical narrative: Red, warm, inflamed area around injection sight; Red, warm, inflamed area around injection sight; Red, warm, inflamed area around injection sight; Significantly tender to touch and movement; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2022 at 15:00 as dose 4 (booster), single (Lot number: Ek9895) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing); "Diverticulosis" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Known allergies: theophylline, reaction(s): "Drug allergy", notes: Known allergies: Theophylline. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer unknown), for Covid-19 immunization. The following information was reported: VACCINATION SITE WARMTH (non-serious), INJECTION SITE INFLAMMATION (non-serious), INJECTION SITE ERYTHEMA (non-serious) all with onset 06Apr2022 at 16:00, outcome "not recovered" and all described as "Red, warm, inflamed area around injection sight"; TENDERNESS (non-serious) with onset 06Apr2022 at 16:00, outcome "not recovered", described as "Significantly tender to touch and movement". Therapeutic measures were not taken as a result of vaccination site warmth, injection site inflammation, injection site erythema, tenderness.  Additional Information: Adverse event: Red, warm, inflamed area around injection sight. Significantly tender to touch and movement. Now 5 days after injection, the red inflamed area is moving down his arm. Still significantly tender to touch and movement. Patient was infected with covid prior vaccination. Post vaccination patient was not tested for covid-19.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Head titubation, Joint swelling, Tremor, Vaccination site pain
Clinical narrative: Head and neck tremors; Head tremors; arm and shot site pain; swollen joints; This is a spontaneous report received from contactable reporter consumer or other non HCP. The reporter is the patient.   51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Nov2021 at 16:15 as dose 3 (booster), single (Lot number: FJ8757) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "covid" (unspecified if ongoing), notes: If Covid prior vaccination: Yes. Concomitant medication(s) included: INFLUENZA, on 20Nov2021 as dose 1, single. Past drug history included: Protonix, reaction(s): "Known allergies: Protonix". Vaccination history included: BNT162b2 (Dose Number: 2, Product: Covid 19, Brand: Pfizer, Batch/Lot No: EW0182, Vaccine Administration Time: 10:15 AM, Location of injection: Arm Right), administration date: 16May2021, when the patient was 51-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Product: Covid 19, Brand: Pfizer, Batch/Lot No: EW017, Vaccine Administration Time: 03:30 PM, Location of injection: Arm Left), administration date: 25Apr2021, when the patient was 51-year-old, for Covid-19 Immunization. The following information was reported: TREMOR (non-serious) with onset 20Dec2021, outcome "not recovered", described as "Head and neck tremors"; HEAD TITUBATION (non-serious) with onset 20Dec2021, outcome "not recovered", described as "Head tremors"; VACCINATION SITE PAIN (non-serious) with onset 20Dec2021, outcome "not recovered", described as "arm and shot site pain"; JOINT SWELLING (non-serious) with onset 20Dec2021, outcome "not recovered", described as "swollen joints". Therapeutic measures were not taken as a result of tremor, head titubation, vaccination site pain, joint swelling.   Additional information:-The patient did not had other medical history. The patient had covid prior to vaccination. The patient did not Covid tested post vaccination. The patient did not had other medications in two weeks.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Post-acute COVID-19 syndrome
Clinical narrative: 8 hrs later, I was back on the long Covid Rollercoaster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in 2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Long COVID", start date: Feb2022 (unspecified if ongoing), notes: I have been suffering with long COVID since the 1st week of Feb. The patient's concomitant medications were not reported. The following information was reported: POST-ACUTE COVID-19 SYNDROME (non-serious) with onset 2022, outcome "unknown", described as "8 hrs later, I was back on the long Covid Rollercoaster".  Additional information: It was reported that patient have been suffering with long COVID since the 1st week of Feb. Had 1st vacation yesterday. After about 2hrs, felt like was finally on the road to recovery. 8 hrs later, was back on the long COVID Rollercoaster. Due to get 2nd Pfizer vaccine 28Apr.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Swelling
Clinical narrative: He developed tenderness and swelling in his armpit within 24 hours/swelling is not in his lymph nodes but in his rib cage; He developed tenderness and swelling in his armpit within 24 hours/swelling is not in his lymph nodes but in his rib cage; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 16-year-old male patient received BNT162b2 (COMIRNATY), on 08Apr2022 as dose 1, single (Batch/Lot number: unknown) at the age of 16 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING (non-serious), AXILLARY PAIN (non-serious) all with onset Apr2022, outcome "unknown" and all described as "He developed tenderness and swelling in his armpit within 24 hours/swelling is not in his lymph nodes but in his rib cage". The events "he developed tenderness and swelling in his armpit within 24 hours/swelling is not in his lymph nodes but in his rib cage" required physician office visit.  Additional Information: He developed tenderness and swelling in his armpit within 24 hours. He went to his pediatrician's office this morning on 11Apr2022 and the doctor said the swelling is not in his lymph nodes but in his rib cage. She advised him not to get his second dose and to follow-up with the practice if the pain gets worse or he develops a fever.  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: Limb discomfort, Pruritus, Rash
Clinical narrative: Skin rash; Red itchy disc shaped rashes appeared on legs.; Now there are numerous rashes on both legs. One on chest; Now there are numerous rashes on both legs. One on chest; Within a week after 2nd shot prickly uncomfortable sensations in legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received BNT162b2 (BNT162B2), 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: RASH (non-serious), outcome "not recovered", described as "Skin rash"; PRURITUS (non-serious), outcome "not recovered", described as "Red itchy disc shaped rashes appeared on legs."; RASH (non-serious), RASH (non-serious), outcome "not recovered" and all described as "Now there are numerous rashes on both legs. One on chest"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "Within a week after 2nd shot prickly uncomfortable sensations in legs".  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: Arthralgia, Fatigue, Feeling abnormal, Lymphatic disorder
Clinical narrative: lymphatic back up; fatigue; brain fog; joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I have a history of chronic lyme (in readmission)" (unspecified if ongoing), notes: I have a history of chronic lyme (in readmission),; "cancer" (unspecified if ongoing); "joint replacement" (unspecified if ongoing). Concomitant medication(s) included: LASIX [FUROSEMIDE]. The following information was reported: LYMPHATIC DISORDER (non-serious), outcome "unknown", described as "lymphatic back up"; FATIGUE (non-serious), outcome "unknown"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "brain fog"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain".  Additional information: 2 of the patient's doctors agree it is probably related.  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: Balance disorder, Vertigo, Visual impairment, Vomiting
Clinical narrative: Vertigo/ Caller states that her sister (81-year-old female) also experienced "similar symptoms" as she had after receiving the Pfizer Covid19 vaccine; Vertigo which has affected her balance and vision/Off balance; Vertigo which has affected her balance and vision; Throwing up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 81-year-old female patient received 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: VERTIGO (non-serious), outcome "unknown", described as "Vertigo/ Caller states that her sister (81-year-old female) also experienced "similar symptoms" as she had after receiving the Pfizer Covid19 vaccine"; BALANCE DISORDER (non-serious), outcome "unknown", described as "Vertigo which has affected her balance and vision/Off balance"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "Vertigo which has affected her balance and vision"; VOMITING (non-serious), outcome "unknown", described as "Throwing up".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Taste disorder, Thirst, Visual impairment
Clinical narrative: slight headache; things seem slightly louder and brighter; thirst; strange taste in my mouth(almost like plastic); start to feel pain in my arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old patient received BNT162b2 (BNT162B2), on 26May2021 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 37 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 26May2021 at 14:18, outcome "recovered" (May2021), described as "start to feel pain in my arm"; TASTE DISORDER (non-serious) with onset 26May2021 at 14:33, outcome "recovered" (May2021), described as "strange taste in my mouth(almost like plastic)"; THIRST (non-serious) with onset 26May2021 at 19:14, outcome "recovered" (May2021); VISUAL IMPAIRMENT (non-serious) with onset 26May2021 at 20:05, outcome "recovered" (May2021), described as "things seem slightly louder and brighter"; HEADACHE (non-serious) with onset 27May2021 at 23:24, outcome "recovered" (May2021), described as "slight headache".  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Hernia
Clinical narrative: Having a hernia surgery 28Apr2022, two and half weeks from now, he got his first booster in October; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in Oct2021 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 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization.  The following information was reported: HERNIA (medically significant), outcome "unknown", described as "Having a hernia surgery 28Apr2022, two and half weeks from now, he got his first booster in October". Is report related to a study or programme: Yes. Consumer wanted to get the booster shot, he was having surgery in a few weeks and wants to know if it is safe to get the second booster or does he need to wait until after surgery. Having a hernia surgery 28Apr2022, two and half weeks from now, he got his first booster in October, should he get the second booster now or after surgery.  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: Blood thyroid stimulating hormone, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid Rapid Test Positive; Covid Rapid Test Positive; 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 42-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EK5730, Expiration Date: 31Mar2021) and as dose 2, single (Lot number: EL3249, Expiration Date: 31May2021) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 08Feb2022, outcome "unknown" and all described as "Covid Rapid Test Positive". The patient underwent the following laboratory tests and procedures: Blood thyroid stimulating hormone: (24Jan2022) Low, notes: 0.24 (IU)ml; SARS-CoV-2 test: (08Feb2022) Positive, notes: Moderate symptoms.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EH9899), in right arm, on 13Jan2021 as dose 2, single (Lot number: EL1283), in left arm and on 30Sep2021 as dose 3 (booster), single (Lot number: 301258A) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "thyroid disease" (unspecified if ongoing). Concomitant medication(s) included: CLARITINE; SYNTHROID, start date: Feb2022; EMERGEN C, start date: 03Apr2022, stop date: 11Apr2022; TYLENOL, start date: 04Apr2022, stop date: 11Apr2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 06Apr2022 at 10:00, outcome "recovered" (11Apr2022) and all described as "indication=Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: Received other medications in 2 weeks. There were known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Nasopharyngitis, Pain
Clinical narrative: Covid positive on April 9; Covid positive on April 9; body aches; cough; Cold like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 43-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Apr2022, outcome "unknown" and all described as "Covid positive on April 9"; NASOPHARYNGITIS (non-serious) with onset 2022, outcome "unknown", described as "Cold like symptoms"; PAIN (non-serious) with onset 2022, outcome "unknown", described as "body aches"; COUGH (non-serious) with onset 2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Apr2022) Positive.  Clinical course: Event took place after use of product.  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: SARS-CoV-2 test
Clinical narrative: Covid positive on April 9; Covid positive on April 9; body aches; cough; Cold like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 43-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Apr2022, outcome "unknown" and all described as "Covid positive on April 9"; NASOPHARYNGITIS (non-serious) with onset 2022, outcome "unknown", described as "Cold like symptoms"; PAIN (non-serious) with onset 2022, outcome "unknown", described as "body aches"; COUGH (non-serious) with onset 2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Apr2022) Positive.  Clinical course: Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Trichorrhexis
Clinical narrative: Lost frontal head hair plus mode thinning of balance; Lost frontal head hair plus mode thinning of balance; Remaining hair became very brittle and course; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A male patient received BNT162b2 (BNT162B2), on 07Feb2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 82 years for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: COPD. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1:, Time: 10:00 Am, Anatomical site of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: EL3248), administration date: 05Feb2021, for COVID-19 Immunization; BNT162b2 (Dose 2:, Time: 11:00 Am, Anatomical site of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: EL9262), administration date: 26Feb2021, for COVID-19 Immunization; BNT162b2 (Dose 3:, Time: 11:30 Pm, Anatomical site of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: FD8448), administration date: 19Aug2021, for COVID-19 Immunization. The following information was reported: ALOPECIA (non-serious), ALOPECIA (non-serious) all with onset 2022, outcome "unknown" and all described as "Lost frontal head hair plus mode thinning of balance"; TRICHORRHEXIS (non-serious) with onset 2022, outcome "unknown", described as "Remaining hair became very brittle and course". Additional information -It was reported that My wife and I both received a 4th booster shot #FK9729 on 07Feb2022 and within One week we both lost frontal head hair plus mode thinning of balance, also remaining hair became very brittle and course. There were no other negative results No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Trichorrhexis
Clinical narrative: lost frontal head hair plus mode thinning of balance; lost frontal head hair plus mode thinning of balance; remaining hair became very brittle and course; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), on 07Feb2022 as dose 4, (booster), single (Lot number: FK9729) 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: ALOPECIA (non-serious), ALOPECIA (non-serious) all with onset Feb2022, outcome "unknown" and all described as "lost frontal head hair plus mode thinning of balance"; TRICHORRHEXIS (non-serious) with onset Feb2022, outcome "unknown", described as "remaining hair became very brittle and course".  No follow-up attempts are needed. No further information is expected.
Age: 63.0
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 63-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 11Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crab allergy" (unspecified if ongoing); "Lob ster allergy" (unspecified if ongoing); "Shrimp allergy" (unspecified if ongoing); "Walnut allergy" (unspecified if ongoing); "Myasthenia Gravis" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: OZEMPIC, start date: 09Dec2021, stop date: 03Apr2022. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Apr2022 at 10:00, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.Other medication in 2weeks was reported as Yes. anti viral details product=COVID 19 Treatment, Brand=Paxlovid. treatment start date=08Apr2022, treatment stop date=11Apr2022, lot number=fx8133, Indication=Treatment of COVID-19}.  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: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. (Moderna).  A female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8733) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Breast cancer" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM; ZIPRASIDONE; LORAZEPAM; GABAPENTIN; LETROZOLE; VIT C; VIT E [TOCOPHEROL]; VIT D [COLECALCIFEROL]; CALCIUM; BUPROPION. Past drug history included: Cipro, reaction(s): "Allergic to Cipro antibiotic", notes: She is allergic to Cipro Antibiotic, Bactrim, Azithromycin and Zantac, Nexium, Omeprazole, Protonix, Tizanidine and Antihistamine; Bactrim, reaction(s): "Allergic", notes: She is allergic to Cipro Antibiotic, Bactrim, Azithromycin and Zantac, Nexium, Omeprazole, Protonix, Tizanidine and Antihistamine; Azithromycin, reaction(s): "Allergic", notes: She is allergic to Cipro Antibiotic, Bactrim, Azithromycin and Zantac, Nexium, Omeprazole, Protonix, Tizanidine and Antihistamine; Zantac, reaction(s): "Allergic", notes: She is allergic to Cipro Antibiotic, Bactrim, Azithromycin and Zantac, Nexium, Omeprazole, Protonix, Tizanidine and Antihistamine; Nexium, reaction(s): "Allergic", notes: She is allergic to Cipro Antibiotic, Bactrim, Azithromycin and Zantac, Nexium, Omeprazole, Protonix, Tizanidine and Antihistamine; Omeprazole, reaction(s): "Allergic", notes: She is allergic to Cipro Antibiotic, Bactrim, Azithromycin and Zantac, Nexium, Omeprazole, Protonix, Tizanidine and Antihistamine; Protonix, reaction(s): "Allergic", notes: She is allergic to Cipro Antibiotic, Bactrim, Azithromycin and Zantac, Nexium, Omeprazole, Protonix, Tizanidine and Antihistamine; Tizanidine, reaction(s): "Allergic", notes: She is allergic to Cipro Antibiotic, Bactrim, Azithromycin and Zantac, Nexium, Omeprazole, Protonix, Tizanidine and Antihistamine; Antihistamine, reaction(s): "Allergic", notes: She is allergic to Cipro Antibiotic, Bactrim, Azithromycin and Zantac, Nexium, Omeprazole, Protonix, Tizanidine and Antihistamine. The following information was reported: FATIGUE (non-serious), outcome "recovered" (08Apr2022). Therapeutic measures were taken as a result of fatigue. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (172086). The reporter is the patient.  A 92-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3, (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19. Clinical course: Consumer called about the Paxlovid pill. She had her Pfizer COVID-19 vaccine including the booster shot. She said that she tested positive for COVID-19. She mentioned that she started taking Paxlovid yesterday. But the caller insisted on talking to a supervisor. Resolutions: Swap survey from First Connect to Paxlovid. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Fall, Feeling abnormal, Head injury
Clinical narrative: dizzy; fell down; hit my face on the ground; i am not feeling well; my immune system has been affected; i feel unbalanced and head not the same; i feel unbalanced and head not the same; was unconconsious for a second; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) 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: LOSS OF CONSCIOUSNESS (medically significant), outcome "recovered", described as "was unconconsious for a second"; DIZZINESS (non-serious), outcome "recovered", described as "dizzy"; FALL (non-serious), outcome "recovered", described as "fell down"; HEAD INJURY (non-serious), outcome "recovered", described as "hit my face on the ground"; MALAISE (non-serious), outcome "recovered", described as "i am not feeling well"; IMMUNE SYSTEM DISORDER (non-serious), outcome "recovered", described as "my immune system has been affected"; BALANCE DISORDER (non-serious), FEELING ABNORMAL (non-serious), outcome "recovered" and all described as "i feel unbalanced and head not the same". The patient became dizzy and fell down and was unconconsious for a second and patient hit face on the ground with first shot. it happened after two hours since patient got the shot. this happened just for the first one and 2nd and booster were ok. nothing at all. Patient was not feeling well since then. Patient immune system has been affected and patient felt unbalanced and head not the same can someone inform what to do.  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: Immune system disorder, Loss of consciousness, Malaise
Clinical narrative: dizzy; fell down; hit my face on the ground; i am not feeling well; my immune system has been affected; i feel unbalanced and head not the same; i feel unbalanced and head not the same; was unconconsious for a second; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) 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: LOSS OF CONSCIOUSNESS (medically significant), outcome "recovered", described as "was unconconsious for a second"; DIZZINESS (non-serious), outcome "recovered", described as "dizzy"; FALL (non-serious), outcome "recovered", described as "fell down"; HEAD INJURY (non-serious), outcome "recovered", described as "hit my face on the ground"; MALAISE (non-serious), outcome "recovered", described as "i am not feeling well"; IMMUNE SYSTEM DISORDER (non-serious), outcome "recovered", described as "my immune system has been affected"; BALANCE DISORDER (non-serious), FEELING ABNORMAL (non-serious), outcome "recovered" and all described as "i feel unbalanced and head not the same". The patient became dizzy and fell down and was unconconsious for a second and patient hit face on the ground with first shot. it happened after two hours since patient got the shot. this happened just for the first one and 2nd and booster were ok. nothing at all. Patient was not feeling well since then. Patient immune system has been affected and patient felt unbalanced and head not the same can someone inform what to do.  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: Autoimmune disorder, Encephalopathy, Feeling abnormal, Insomnia, Neurological symptom
Clinical narrative: brain- from tremors, brain fog and unexplained lesions; autoimmune disease; neuropathy; insomnia; neurological issues.; brain- from tremors, brain fog and unexplained lesions; brain- from tremors, brain fog and unexplained lesions; This is a spontaneous report received from contactable reporter(s) (Physician).  A 33-year-old female patient received 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: ENCEPHALOPATHY (medically significant), TREMOR (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "brain- from tremors, brain fog and unexplained lesions"; AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "autoimmune disease"; NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "neuropathy"; INSOMNIA (non-serious), outcome "unknown"; NEUROLOGICAL SYMPTOM (non-serious), outcome "unknown", described as "neurological issues.".  Clinical course: Reporter also reported that patient states, today marks 8 months and three days post dose of Pfizer vaccine. The nightmare that she would have never imagined would happen just basically trying to do the right thing. She had been to multiple doctors and ER visits with no help or knowledge on what to do with this. she is now suffering from an autoimmune disease, neuropathy, insomnia, and neurological issues. So many other side effects mostly dealing with the brain- from tremors, brain fog and unexplained lesions. Patient is a 33-year-old mom of 2 special needs children who solely depend on her. This experience has been debilitating and ongoing which has caused her to almost lost her job and accumulating so many medical bills and not receiving any assistance from government or health system. People our losing their lives due to these vaccines. Some of them are losing everything we have worked so hard for because these injuries are debilitating.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Tremor
Clinical narrative: brain- from tremors, brain fog and unexplained lesions; autoimmune disease; neuropathy; insomnia; neurological issues.; brain- from tremors, brain fog and unexplained lesions; brain- from tremors, brain fog and unexplained lesions; This is a spontaneous report received from contactable reporter(s) (Physician).  A 33-year-old female patient received 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: ENCEPHALOPATHY (medically significant), TREMOR (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "brain- from tremors, brain fog and unexplained lesions"; AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "autoimmune disease"; NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "neuropathy"; INSOMNIA (non-serious), outcome "unknown"; NEUROLOGICAL SYMPTOM (non-serious), outcome "unknown", described as "neurological issues.".  Clinical course: Reporter also reported that patient states, today marks 8 months and three days post dose of Pfizer vaccine. The nightmare that she would have never imagined would happen just basically trying to do the right thing. She had been to multiple doctors and ER visits with no help or knowledge on what to do with this. she is now suffering from an autoimmune disease, neuropathy, insomnia, and neurological issues. So many other side effects mostly dealing with the brain- from tremors, brain fog and unexplained lesions. Patient is a 33-year-old mom of 2 special needs children who solely depend on her. This experience has been debilitating and ongoing which has caused her to almost lost her job and accumulating so many medical bills and not receiving any assistance from government or health system. People our losing their lives due to these vaccines. Some of them are losing everything we have worked so hard for because these injuries are debilitating.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: achy arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP).  A 45-years-old female patient received BNT162b2 (BNT162B2), on 11Aug2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 11Aug2021, outcome "unknown", described as "achy arm".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 27Sep2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: After 7 days I tested negative on an antigen test; Positive, notes: Day 12. That day the symptoms returned and I tested positive on an Antigen test; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  Additional information: He was prescribed with Paxlovid in a timely fashion, and it relieved the symptoms very quickly. Thank you. After the 5 days and 5 doses, he felt great. After 7 days he tested negative on an antigen test. he was symptom free and felt great until day 12. That day the symptoms returned and he tested positive on an Antigen test. So he want to alert you to the possibility of a virus resurgence like this. Perhaps the 5 day treatment was not enough. It still did its primary duty as his symptoms are mild and he certainly do not expect to be hospitalized. But perhaps there needs to be a warning about the possibility of resurgence after a course of a Paxlovid treatment. He was recovered on 03Apr2022. He did not receive any other vaccine within 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Exposure to SARS-CoV-2, Product use issue, Urinary incontinence
Clinical narrative: exposed to COVID; she got a flu shot that same day; losing control over her urine/Constant urination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 71 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 29Sep2021 as dose number unknown, single. The patient's relevant medical history included: "Allergies" (unspecified if ongoing); "Diabetics" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 2, Anatomical site of injection: Arm left,, Batch No: EN6201), administration date: 21Feb2021, when the patient was 70-year-old, for Covid-19 Immunization, reaction(s): "losing control over her urine / constant urination"; BNT162b2 (Dose 1, Time: 15:00, Anatomical site of injection:  Arm left,, Batch No: EL9262,513121, Expiry Date:03May2021), administration date: 31Jan2021, when the patient was 70-year-old, for Covid-19 Immunization, reaction(s): "losing control over her urine / constant urination". The following information was reported: URINARY INCONTINENCE (medically significant) with onset 2021, outcome "recovered" (13Nov2021), described as "losing control over her urine/Constant urination"; PRODUCT USE ISSUE (non-serious) with onset 29Sep2021, outcome "unknown", described as "she got a flu shot that same day"; EXPOSURE TO SARS-COV-2 (non-serious), outcome "unknown", described as "exposed to COVID". The event "losing control over her urine/constant urination" required physician office visit. Reported that at the time of report it has been 6.5 weeks without an episode. She was recently exposed to COVID by a 98-year-old man that had to go to the hospital on Monday (as reported) so she was hoping she doesn't get it, stated that she knew a few people that got COVID from that man. It was stated that her doctor moved up her date for the booster because her brother isn't doing a good job with the COVID guidelines, they moved her shot up 5 weeks. Her doctor told her to wear a mask in her own house. Her doctor moved it too because she was diabetic. The action taken for influenza vaccine was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pain, Platelet factor 4
Clinical narrative: ache; all of my joints were sore the entire day; tired; 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 4 (booster), single (Lot number: 301308W) for covid-19 immunisation. The patient's relevant medical history included: "Stage 3 kidney disease" (unspecified if ongoing), notes: Stage 3 kidney disease. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Single at PM. Experienced Lost sense of taste (non serious) on 12Feb2021. Never come back and no treatment received.), for Covid-19 immunization, reaction(s): "lost sense of taste"; Covid-19 vaccine (Dose 2), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (BOOSTER)), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 09Apr2022, outcome "unknown", described as "ache"; ARTHRALGIA (non-serious) with onset 09Apr2022, outcome "unknown", described as "all of my joints were sore the entire day"; FATIGUE (non-serious) with onset 09Apr2022, outcome "unknown", described as "tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:  Took Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious Covid-19 complications). Prior Vaccination provided as None. The second booster was given in afternoon and autopsy details were not applicable. Patient had Platelet factor 4 test (Antibody test to platelet factor IV) done on 15Dec2021 and the result was positive.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Inflammation scan, Vaccination failure
Clinical narrative: I got Covid; I got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6208), on 01Apr2021 as dose 2, single (Lot number: ER7734) and on 17Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "Celiac" (unspecified if ongoing), notes: Celiac. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 2022, outcome "unknown" and all described as "I got Covid". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results; Inflammation scan: Increased. The patient mentioned that she has got the COVID virus at the end of Jan and the end of Feb  and then she mentioned again she can't get this to calm down.   No follow-up attempts are possible. No further information is expected.