chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: I had mild fatigue; Fever; Chills; Fluzone High-Dose Quadrivalent Syringe shoulder; 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 patient received bnt162b2 (BNT162B2), intramuscular, administration date 25Sep2021 16:00 (Lot number: FF2589) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine inact split 4v (FLUZONE HIGH DOSE QUADRIVALENT), administration date 25Sep2021 (Batch/Lot number: unknown) as unk, single. Relevant medical history included: "BPH" (ongoing); "Inflammation" (ongoing); "Anxiety" (unspecified if ongoing); "Shoulder Occusion", start date: 02Jan2005 (unspecified if ongoing), notes: Pertinent details: Fixed; "Shoulder RCT", start date: 02Jan2006 (unspecified if ongoing), notes: Pertinent details: Repaired; "Kidney Stone", start date: 02Jan2017 (unspecified if ongoing), notes: Pertinent details: Removed; "Lymes", start date: 01Aug2020 (unspecified if ongoing), notes: Treated with antibiotics. Concomitant medication(s) included: TERAZOSIN taken for benign prostatic hyperplasia, start date: Jan2016 (ongoing); MELOXICAM taken for inflammation, start date: Jan2018 (ongoing); BUSPIRONE taken for anxiety, start date: Jan2017 (ongoing); IBUPROFEN taken for inflammation, start date: Jan2000 (ongoing). Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization; Bnt162b2 (2nd dose), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 26Sep2021, outcome "recovered" (28Sep2021), described as "I had mild fatigue"; PYREXIA (non-serious) with onset 26Sep2021, outcome "recovered" (28Sep2021), described as "Fever"; CHILLS (non-serious) with onset 26Sep2021, outcome "recovered" (28Sep2021), described as "Chills"; OFF LABEL USE (non-serious) with onset 25Sep2021, outcome "unknown", described as "Fluzone High-Dose Quadrivalent Syringe shoulder". Relevant laboratory tests and procedures are available in the appropriate section.Therapeutic measures were not taken as a result of fatigue, pyrexia, chills.I had mild fatigue, fever, chills, I did not treat with NSAIDS, wanting the vaccine to take full effect before or after. No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstruation delayed
Clinical narrative: After receiving the second vaccine, my menstrual cycle was late 5 days. The cramps are excessive and bleeding/clots heavy.; After receiving the second vaccine, my menstrual cycle was late 5 days. The cramps are excessive and bleeding/clots heavy.; After receiving the second vaccine, my menstrual cycle was late 5 days. The cramps are excessive and bleeding/clots heavy.; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 2021 (Lot number: FF2587) at the age of 35 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FC3181, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM, Verbatim:menstrual cycle started 4 days early), administration date: 20Aug2021, when the patient was 35 years old, for Covid-19 immunization, reaction(s): "menstrual cycle started 4 days early". The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), MENSTRUATION DELAYED (non-serious), DYSMENORRHOEA (non-serious) all with onset 2021, outcome "unknown" and all described as "After receiving the second vaccine, my menstrual cycle was late 5 days. The cramps are excessive and bleeding/clots heavy.". Therapeutic measures were not taken as a result of heavy menstrual bleeding, menstruation delayed, dysmenorrhoea.  Additional information: It was reported that after receiving the first vaccine, patient menstrual cycle started 4 days early and was lighter than normal. After receiving the second vaccine, my menstrual cycle was late 5 days. The cramps are excessive and bleeding/clots heavy. I have never had disruptions in my cycle regardless of life changes, stressors, etc. I know my body is reacting to this vaccine based off my cycle history and the symptoms I am experiencing. I am regular with a 28-day cycle. Never early. Never late. It was reported that patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No covid prior vaccination. No covid tested post vaccination. No Known allergies ware reported Device Date: 30Oct2021.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Heavy menstrual bleeding, Menstrual disorder, Menstruation irregular
Clinical narrative: Menstrual Cycle stopped 3 days after 2nd dose and didn't return for 3 months.; Cycle has been extremely heavy upon return and off schedule.; Chronic fatigue and tingles in legs for 3 months after 2nd dose.; Chronic fatigue and tingles in legs for 3 months after 2nd dose.; Cycle has been extremely heavy upon return and off schedule.; Joint pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21May2021 11:00 (Lot number: EW0182) at the age of 48 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Penicillin for allergy, notes: known allergies: penicillin. Vaccination history included: Bnt162b2 (Dose: 1st, Lot number: EW0126, Dose administration: 11:00 am, Left arm), administration date: 30Apr2021, when the patient was 48 years old, for Covid-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "recovering", described as "Joint pain"; MENSTRUATION IRREGULAR (non-serious) with onset 24May2021, outcome "recovering", described as "Menstrual Cycle stopped 3 days after 2nd dose and didn't return for 3 months."; HEAVY MENSTRUAL BLEEDING (non-serious), MENSTRUAL DISORDER (non-serious) all with onset 2021, outcome "recovering" and all described as "Cycle has been extremely heavy upon return and off schedule."; PARAESTHESIA (non-serious), FATIGUE (non-serious) all with onset 2021, outcome "recovering" and all described as "Chronic fatigue and tingles in legs for 3 months after 2nd dose.". Therapeutic measures were not taken as a result of arthralgia, menstruation irregular, heavy menstrual bleeding, paraesthesia, fatigue, menstrual disorder.  Additional information: It was unknown if patient was covid prior vaccination and did not test for covid post vaccination. It was unknown if patient received other vaccine in four weeks. Other medications in two weeks was reported as 'no'  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Menstrual Cycle stopped 3 days after 2nd dose and didn't return for 3 months.; Cycle has been extremely heavy upon return and off schedule.; Chronic fatigue and tingles in legs for 3 months after 2nd dose.; Chronic fatigue and tingles in legs for 3 months after 2nd dose.; Cycle has been extremely heavy upon return and off schedule.; Joint pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21May2021 11:00 (Lot number: EW0182) at the age of 48 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Penicillin for allergy, notes: known allergies: penicillin. Vaccination history included: Bnt162b2 (Dose: 1st, Lot number: EW0126, Dose administration: 11:00 am, Left arm), administration date: 30Apr2021, when the patient was 48 years old, for Covid-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "recovering", described as "Joint pain"; MENSTRUATION IRREGULAR (non-serious) with onset 24May2021, outcome "recovering", described as "Menstrual Cycle stopped 3 days after 2nd dose and didn't return for 3 months."; HEAVY MENSTRUAL BLEEDING (non-serious), MENSTRUAL DISORDER (non-serious) all with onset 2021, outcome "recovering" and all described as "Cycle has been extremely heavy upon return and off schedule."; PARAESTHESIA (non-serious), FATIGUE (non-serious) all with onset 2021, outcome "recovering" and all described as "Chronic fatigue and tingles in legs for 3 months after 2nd dose.". Therapeutic measures were not taken as a result of arthralgia, menstruation irregular, heavy menstrual bleeding, paraesthesia, fatigue, menstrual disorder.  Additional information: It was unknown if patient was covid prior vaccination and did not test for covid post vaccination. It was unknown if patient received other vaccine in four weeks. Other medications in two weeks was reported as 'no'  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site vesicles
Clinical narrative: Developed a blister like lesion at the site of injection/It was a clear fluid filled lesion just below the skin; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  A 12 year-old male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, 30 ug single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose,3 0mcg dose), for COVID-19 immunization. The following information was reported: VACCINATION SITE VESICLES (non-serious) with onset 2021, outcome "not recovered", described as "Developed a blister like lesion at the site of injection/It was a clear fluid filled lesion just below the skin". Additional information: Patient is a 12year old boy who received 2 30mcg doses of the Vaccine. One day after the 2nd dose he developed a blister like lesion at the site of injection. It was a clear fluid filled lesion just below the skin. It has persisted for 5 days although on day 5 the fluid drained from the "blister".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Head discomfort, Heart rate, Heart rate increased
Clinical narrative: slight pressure in the front of my head; lightheaded spells; fast heart beat; 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 33 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 22Oct2021 15:00 (Lot number: 320308D) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Verbatim: High blood pressure. The patient took concomitant medications. The following information was reported: HEAD DISCOMFORT (non-serious), outcome "unknown", described as "slight pressure in the front of my head"; DIZZINESS (non-serious), outcome "unknown", described as "lightheaded spells"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "fast heart beat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of head discomfort, dizziness, heart rate increased. Additional information The patient had been having since the first shot just over 2 weeks ago slight pressure in the front of head and lightheaded spells. He did experience a fast heart beat when had the lightheaded spells. No treatment and this has been going on since that shot its been constant for 2 weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, COVID-19, Cough, Fall, SARS-CoV-2 test positive
Clinical narrative: Covid19 breakthrough.  1st Vaccine on 03/18/2021.  88 y/o with pmhx-HTN, Asthma, leukemia and malignant neoplasm of glottis presents to ED with lower back pain from fall.  Daugher found pt of floor after 6 hours and brought to ED for eval.  Pt also presents with cough x2 days.  Denies Sob, fever, chills or CP.  Room air sat 91%.  Started on IV steroids and Remdesivir.
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: Covid19 breakthrough.  1st Vaccine on 03/18/2021.  88 y/o with pmhx-HTN, Asthma, leukemia and malignant neoplasm of glottis presents to ED with lower back pain from fall.  Daugher found pt of floor after 6 hours and brought to ED for eval.  Pt also presents with cough x2 days.  Denies Sob, fever, chills or CP.  Room air sat 91%.  Started on IV steroids and Remdesivir.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness postural, Headache, Pain in extremity
Clinical narrative: Woke with headache, extremely sore arm, was dizzy upon standing (went away soon after), temperature 99.8
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Mammogram, Ultrasound breast
Clinical narrative: Developed lump in right breast approximately 1 week after vaccination. Evaluated by 2 healthcare providers. Mammogram and ultrasound showed no abnormal findings, but lump is still present today, 6 months after vaccination.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Achromobacter infection, COVID-19, Chest X-ray abnormal, Dyspnoea, Lung disorder
Clinical narrative: Covid19 breakthrough. 1st Vaccine received on 02/15/2021. 49 y/o with PMHX of Sarcoidosis, Pulmonary HTN/Fibrosis, Asthma, HTN, chronic Bronchiectasis presents to ED with c/o cough and SOB after going to the movies 2 weeks ago. Patient tested positive at Urgent Care where had room air sat of 70%. Cough productive with purulent sputum-per ID had recent MDR achromobacter and received ABX. CXR-chronic reticulonodular dz. Immunocompromised on Humira.  Started on IV Abx/steroids and Remdesivir.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Productive cough, SARS-CoV-2 test positive, Sputum purulent, Vaccine breakthrough infection
Clinical narrative: Covid19 breakthrough. 1st Vaccine received on 02/15/2021. 49 y/o with PMHX of Sarcoidosis, Pulmonary HTN/Fibrosis, Asthma, HTN, chronic Bronchiectasis presents to ED with c/o cough and SOB after going to the movies 2 weeks ago. Patient tested positive at Urgent Care where had room air sat of 70%. Cough productive with purulent sputum-per ID had recent MDR achromobacter and received ABX. CXR-chronic reticulonodular dz. Immunocompromised on Humira.  Started on IV Abx/steroids and Remdesivir.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest X-ray, Headache, Influenza virus test negative, Malaise
Clinical narrative: Fever 100 by 9pm,  102 by Midnight, which progressed to 105 by 4AM.   ER visit malaise, back & neck pain, and headache.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pyrexia, SARS-CoV-2 test negative, Urine analysis
Clinical narrative: Fever 100 by 9pm,  102 by Midnight, which progressed to 105 by 4AM.   ER visit malaise, back & neck pain, and headache.
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Computerised tomogram, Myasthenia gravis
Clinical narrative: Myesthenia Gravis
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Vaginal haemorrhage
Clinical narrative: When I received my second dose of the Pfizer vaccine 12/6/21 I was 6w1d pregnant. I started spotting blood 12/20/21 and miscarried 12/22/21 at 8w3d pregnant.  I have never experienced a miscarriage before and successfully delivered a baby 5/2/20 with no complications. I have No medical conditions that would cause me to miscarriage.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Allodynia, Back pain, Burning sensation
Clinical narrative: low back pain with allodynia in area - burning feeling with no rash/redness/swelling. Started on Medrol Dose Pack started on 12/29/21. Finished steroid 6 days later. No continued back pain or sensitivity at this time.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chills, Cough, Oropharyngeal pain, Pain
Clinical narrative: Covid19 Breakthrough.  1st vaccine received on 06/04/2021.  80 y/o presents with hx of testing + for covid19 2 days ago and now returns with continued c/o sore throat, cough, fever, chills, body aches and syncopal episodes x2 lasting several minutes.  Pt receiving low dose steroids.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive, Syncope, Vaccine breakthrough infection
Clinical narrative: Covid19 Breakthrough.  1st vaccine received on 06/04/2021.  80 y/o presents with hx of testing + for covid19 2 days ago and now returns with continued c/o sore throat, cough, fever, chills, body aches and syncopal episodes x2 lasting several minutes.  Pt receiving low dose steroids.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Tinnitus, Vibratory sense increased
Clinical narrative: Possible Tinnitus; ear feels clogged; heavy vibrating when any noise/music; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Oct2021 15:30 (Lot number: FF2590) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hashimoto's disease" (unspecified if ongoing); "Penicillin" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE SODIUM. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0172, Location of injection: Arm Left, Vaccine Administration Time: 01:30 PM), administration date: 23Apr2021, when the patient was 45 years old, for Covid-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 29Oct2021 13:00, outcome "not recovered", described as "Possible Tinnitus"; EAR DISCOMFORT (non-serious) with onset 29Oct2021 13:00, outcome "not recovered", described as "ear feels clogged"; VIBRATORY SENSE INCREASED (non-serious) with onset 29Oct2021 13:00, outcome "not recovered", described as "heavy vibrating when any noise/music". The events "possible tinnitus", "ear feels clogged" and "heavy vibrating when any noise/music" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus, ear discomfort, vibratory sense increased.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: zero outbreaks; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY), administration date 06Jun2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "herpes", start date: 2018 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose no=1), for COVID-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "zero outbreaks". Additional information The caller  contracted "herpes" in 2018. The caller stated that he is embarrassed about this but since getting the 2nd dose of the Pfizer COVID 19 Vaccine him nor his wife have had a herpes outbreak. They received their 2nd dose of the vaccine 06Jun2021. The caller stated that he generally has 3 outbreaks a year. he had since had zero outbreaks. Caller wanted to know if we have seen this correlation before or if he had gotten "lucky." He would like to report this possible positive event to Pfizer.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101548714 Same Reporter/Drug/AE, Different Patient
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Magnetic resonance imaging, Parosmia, Tinnitus
Clinical narrative: extremities are burning/facial burning that comes and goes; ringing in the ears (constant); Phantom smells (cigarette smoke); This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team.  A 48 year-old male patient received bnt162b2 (BNT162B2), administration date 21Apr2021 (Batch/Lot number: unknown) as dose 2, single 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. The following information was reported BURNING SENSATION (non-serious) with onset 2021, outcome unknown; TINNITUS (non-serious) with onset 2021, outcome unknown; PAROSMIA (non-serious) with onset 2021, outcome unknown. The events extremities are burning/facial burning that comes and goes, ringing in the ears (constant), and phantom smells (cigarette smoke) were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Patient had seen and been evaluated by ENT (Ear, Nose, And Throat doctor), Neurology, and had an MRI (Magnetic Resonance Imaging), which showed nothing, and no one had come up with anything. Patient was very upset. Pharmacist stated that he/she was a healthcare provider and would like to discuss how to treat an adverse event that occurred in the patient.  Follow-up attempts have been completed, information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pruritus
Clinical narrative: Persistent upper body itching; booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) and other contactable consumer. The reporter is the patient.  A 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Sep2021 13:00 (Batch/Lot number: unknown) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included polymyalgia rheumatica (unspecified if ongoing); inactive sarcoidosis (unspecified if ongoing). The patient took concomitant medications. Vaccination history included Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 03:15 PM), administration date: 02Mar2021, when the patient was 77 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available, provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 09:15 AM), administration date: 12Feb2021, when the patient was 77 years old, for Covid-19 immunization. The following information was reported IMMUNISATION (non-serious) with onset 29Sep2021 13:00, outcome unknown; PRURITUS (non-serious) with onset 06Nov2021 12:00, outcome not recovered. The event persistent upper body itching was evaluated at the physician office visit. Therapeutic measures were taken as a result of pruritus.  No other vaccine in four weeks. Other medications in two weeks. No Covid prior vaccination. No Covid tested post vaccination. No Known allergies. AE treatment included Claritin and Cortizone 10.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dizziness, Feeling abnormal, Hypersensitivity
Clinical narrative: diagnosed with covid; bit unstable; allergic reaction; The lips of her mouth swelled; rash appeared on his body/in special on the face; A little dizzy; constant coughing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 8 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Nov2021 17:30 (Lot number: FL007) at the age of 8 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "known_allergies: Alimentos" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Flu vaccine (Manufacturer: Sanofi pauster , Batch lot no: UT7397LA, Route: Intramuscular , anatomical site of injection: Right deltoid), administration date: 03Nov2021. The following information was reported: COVID-19 (medically significant), outcome "unknown", described as "diagnosed with covid"; HYPERSENSITIVITY (non-serious) with onset 17Nov2021 21:45, outcome "recovering", described as "allergic reaction"; LIP SWELLING (non-serious) with onset 17Nov2021 21:45, outcome "recovering", described as "The lips of her mouth swelled"; RASH (non-serious) with onset 17Nov2021 21:45, outcome "recovering", described as "rash appeared on his body/in special on the face"; DIZZINESS (non-serious) with onset 17Nov2021 21:45, outcome "recovering", described as "A little dizzy"; COUGH (non-serious) with onset 17Nov2021 21:45, outcome "recovering", described as "constant coughing"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "bit unstable". The events "allergic reaction", "the lips of her mouth swelled", "rash appeared on his body/in special on the face", "a little dizzy" and "constant coughing" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: investigation: (12Feb2021) unknown result; sars-cov-2 test: (12Feb2021) positive. It was unknown if therapeutic measures were taken as a result of hypersensitivity, lip swelling, rash, dizziness, cough.  Clinical course: Facility where the most recent COVID-19 vaccine was administered at pharmacy or drug store. Patient was not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient received Other vaccine in four weeks. Patient was diagnosed with covid. My son life was at risk from the vaccine.  Follow-up attempts are completed. No further information is expected.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Lip swelling, Rash, SARS-CoV-2 test
Clinical narrative: diagnosed with covid; bit unstable; allergic reaction; The lips of her mouth swelled; rash appeared on his body/in special on the face; A little dizzy; constant coughing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 8 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Nov2021 17:30 (Lot number: FL007) at the age of 8 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "known_allergies: Alimentos" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Flu vaccine (Manufacturer: Sanofi pauster , Batch lot no: UT7397LA, Route: Intramuscular , anatomical site of injection: Right deltoid), administration date: 03Nov2021. The following information was reported: COVID-19 (medically significant), outcome "unknown", described as "diagnosed with covid"; HYPERSENSITIVITY (non-serious) with onset 17Nov2021 21:45, outcome "recovering", described as "allergic reaction"; LIP SWELLING (non-serious) with onset 17Nov2021 21:45, outcome "recovering", described as "The lips of her mouth swelled"; RASH (non-serious) with onset 17Nov2021 21:45, outcome "recovering", described as "rash appeared on his body/in special on the face"; DIZZINESS (non-serious) with onset 17Nov2021 21:45, outcome "recovering", described as "A little dizzy"; COUGH (non-serious) with onset 17Nov2021 21:45, outcome "recovering", described as "constant coughing"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "bit unstable". The events "allergic reaction", "the lips of her mouth swelled", "rash appeared on his body/in special on the face", "a little dizzy" and "constant coughing" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: investigation: (12Feb2021) unknown result; sars-cov-2 test: (12Feb2021) positive. It was unknown if therapeutic measures were taken as a result of hypersensitivity, lip swelling, rash, dizziness, cough.  Clinical course: Facility where the most recent COVID-19 vaccine was administered at pharmacy or drug store. Patient was not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient received Other vaccine in four weeks. Patient was diagnosed with covid. My son life was at risk from the vaccine.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pain in extremity, Pyrexia
Clinical narrative: arthritic pain in the distal interphalangeal joints of both hands; arthritic pain in the distal interphalangeal joints of both hands; Pyrexia/fever; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 71 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date Feb2021 (Batch/Lot number: unknown) at the age of 71 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Comirnaty (She thinks the patient had his first dose in middle of Jan2021), administration date: Jan2021, when the patient was 71 years old, for COVID-19 IMMUNIZATION. The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset Feb2021, outcome "not recovered" and all described as "arthritic pain in the distal interphalangeal joints of both hands"; PYREXIA (non-serious) with onset Feb2021, outcome "unknown", described as "Pyrexia/fever"; CHILLS (non-serious) with onset Feb2021, outcome "unknown", described as "chills". Therapeutic measures were taken as a result of pain in extremity, arthralgia.  Additional information: She wants to know if arthritis has been reported after the Comirnaty vaccine. She reports that a male aged 71 or so reported arthritic pain in the distal interphalangeal joints of both hands. She does not have specific dates that he received the vaccine but reports it was soon after the second dose. New event Pyrexia/fever, chills. Again, she was not sure at this point whether patient feels it's getting worse. Patient does mention the pain regularly, but caller was not sure if the pain was persisting/improving/worsening. She knows patient's pain was really bad because he was putting Voltaren on it. Caller doesn't think the Voltaren helped much. Caller doesn't recall patient having any severe reactions with either dose. Patient had some pyrexia, the usual things that a person gets after the first and second dose. Patient was not really sick. Thinks patient got chills and fever and it went away. Nothing that caller would think was unusual.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash on injection arm/ huge rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 22Mar2021 09:02 (Lot number: EN6206) at the age of 70 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Shingrix, start date: 2017, reaction(s): "Rash", notes: Caller states she had previous reactions to Shingrix like a rash from this one. The following information was reported: VACCINATION SITE RASH (non-serious) with onset 24Mar2021, outcome "recovered" (27Mar2021), described as "Rash on injection arm/ huge rash". Therapeutic measures were taken as a result of vaccination site rash.  Additional information: Vaccination facility type was noted as pharmacy or drug store. Family medical history relevant to adverse events noted as none. 4 years ago, patient had a severe reaction to part 1 of the Shingrex shot. Reporter stated she had a huge rash 2 weeks after the injection, 4 times the size of what she got with the Pfizer which covered her entire arm. Patient received a topical steroid cream. Reporter stated the rash was lumpy, hot and red and all over her arm from the injection site to her elbow. Reporter stated after her first vaccination on 22Mar2021, she had a huge rash as well that happened pretty quickly and lasted a couple of days. Reporter stated with all 3 vaccines she got a rash on the arm. Caller stated she went to her dermatologist in Apr2021 for her rash and her told her to take Zyrtec 10mg twice a day for 2 weeks which was inconvenient because she was too tired, but it did not help.   Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Arthritis, Chronic pigmented purpura, Rash
Clinical narrative: I have also developed arthritis in my ankles, knees and wrist since that time; Schambergs Capartis on both legs.; rash to both legs; joint pain; 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), intramuscular, administered in arm left, administration date 05Mar2021 (Lot number: EN6205) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart Problems", start date: 2014 (ongoing); "Contrast Dye" (unspecified if ongoing); "Hypertension" (ongoing); "chest pains" (unspecified if ongoing); "Heart attack" (unspecified if ongoing); "triple bypass", start date: 2015 (unspecified if ongoing); "back pain", start date: 1979 (ongoing); "fell-ruptured lumbar disc" (unspecified if ongoing). Family history included: "breast cancer" (unspecified if ongoing), notes: Grandmother+3 sisters diagnosed with breast cancer,; "stroke" (unspecified if ongoing), notes: Father died as result of stroke. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer,, brand unknown=False,, lot number=Em9810,, lot unknown=False,, administration date=11Feb2021, dose number=1, Anatomical site of injection: Left Arm, Route of administration: Intramuscular), administration date: 11Feb2021, when the patient was 74 years old, for COVID-19 Immunization. The following information was reported: ARTHRALGIA (disability) with onset May2021, outcome "not recovered", described as "joint pain"; RASH (medically significant) with onset 07Jun2021, outcome "recovered", described as "rash to both legs"; ARTHRITIS (non-serious) with onset 15Aug2021, outcome "not recovered", described as "I have also developed arthritis in my ankles, knees and wrist since that time"; CHRONIC PIGMENTED PURPURA (non-serious) with onset 15Aug2021, outcome "not recovered", described as "Schambergs Capartis on both legs.". The events "joint pain", "rash to both legs" and "i have also developed arthritis in my ankles, knees and wrist since that time" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of arthralgia. Therapeutic measures were taken as a result of rash, arthritis, chronic pigmented purpura.  Clinical information: The patient did not receive any medication within 4 weeks prior to vaccinations. The patient did not have covid prior to vaccination. The patient did not test positive for Covid post vaccination. The patient received 3rd dose (Batch/Lot: Pfizer booster 33030BN) of injection on 26Nov2021 administered in Left Arm.   No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Electrocardiogram, Endoscopy, Laboratory test, Nausea
Clinical narrative: I have also developed arthritis in my ankles, knees and wrist since that time; Schambergs Capartis on both legs.; rash to both legs; joint pain; 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), intramuscular, administered in arm left, administration date 05Mar2021 (Lot number: EN6205) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart Problems", start date: 2014 (ongoing); "Contrast Dye" (unspecified if ongoing); "Hypertension" (ongoing); "chest pains" (unspecified if ongoing); "Heart attack" (unspecified if ongoing); "triple bypass", start date: 2015 (unspecified if ongoing); "back pain", start date: 1979 (ongoing); "fell-ruptured lumbar disc" (unspecified if ongoing). Family history included: "breast cancer" (unspecified if ongoing), notes: Grandmother+3 sisters diagnosed with breast cancer,; "stroke" (unspecified if ongoing), notes: Father died as result of stroke. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer,, brand unknown=False,, lot number=Em9810,, lot unknown=False,, administration date=11Feb2021, dose number=1, Anatomical site of injection: Left Arm, Route of administration: Intramuscular), administration date: 11Feb2021, when the patient was 74 years old, for COVID-19 Immunization. The following information was reported: ARTHRALGIA (disability) with onset May2021, outcome "not recovered", described as "joint pain"; RASH (medically significant) with onset 07Jun2021, outcome "recovered", described as "rash to both legs"; ARTHRITIS (non-serious) with onset 15Aug2021, outcome "not recovered", described as "I have also developed arthritis in my ankles, knees and wrist since that time"; CHRONIC PIGMENTED PURPURA (non-serious) with onset 15Aug2021, outcome "not recovered", described as "Schambergs Capartis on both legs.". The events "joint pain", "rash to both legs" and "i have also developed arthritis in my ankles, knees and wrist since that time" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of arthralgia. Therapeutic measures were taken as a result of rash, arthritis, chronic pigmented purpura.  Clinical information: The patient did not receive any medication within 4 weeks prior to vaccinations. The patient did not have covid prior to vaccination. The patient did not test positive for Covid post vaccination. The patient received 3rd dose (Batch/Lot: Pfizer booster 33030BN) of injection on 26Nov2021 administered in Left Arm.   No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Ultrasound scan
Clinical narrative: I have also developed arthritis in my ankles, knees and wrist since that time; Schambergs Capartis on both legs.; rash to both legs; joint pain; 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), intramuscular, administered in arm left, administration date 05Mar2021 (Lot number: EN6205) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart Problems", start date: 2014 (ongoing); "Contrast Dye" (unspecified if ongoing); "Hypertension" (ongoing); "chest pains" (unspecified if ongoing); "Heart attack" (unspecified if ongoing); "triple bypass", start date: 2015 (unspecified if ongoing); "back pain", start date: 1979 (ongoing); "fell-ruptured lumbar disc" (unspecified if ongoing). Family history included: "breast cancer" (unspecified if ongoing), notes: Grandmother+3 sisters diagnosed with breast cancer,; "stroke" (unspecified if ongoing), notes: Father died as result of stroke. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer,, brand unknown=False,, lot number=Em9810,, lot unknown=False,, administration date=11Feb2021, dose number=1, Anatomical site of injection: Left Arm, Route of administration: Intramuscular), administration date: 11Feb2021, when the patient was 74 years old, for COVID-19 Immunization. The following information was reported: ARTHRALGIA (disability) with onset May2021, outcome "not recovered", described as "joint pain"; RASH (medically significant) with onset 07Jun2021, outcome "recovered", described as "rash to both legs"; ARTHRITIS (non-serious) with onset 15Aug2021, outcome "not recovered", described as "I have also developed arthritis in my ankles, knees and wrist since that time"; CHRONIC PIGMENTED PURPURA (non-serious) with onset 15Aug2021, outcome "not recovered", described as "Schambergs Capartis on both legs.". The events "joint pain", "rash to both legs" and "i have also developed arthritis in my ankles, knees and wrist since that time" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of arthralgia. Therapeutic measures were taken as a result of rash, arthritis, chronic pigmented purpura.  Clinical information: The patient did not receive any medication within 4 weeks prior to vaccinations. The patient did not have covid prior to vaccination. The patient did not test positive for Covid post vaccination. The patient received 3rd dose (Batch/Lot: Pfizer booster 33030BN) of injection on 26Nov2021 administered in Left Arm.   No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Headache, Pain, Pyrexia
Clinical narrative: Headache; fever; shaking; dizziness; body ache; stomach cramps; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Nov2021 12:45 (Batch/Lot number: unknown) at the age of 16 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADDERALL. The following information was reported: HEADACHE (non-serious) with onset 28Nov2021 08:15, outcome "not recovered", described as "Headache"; PYREXIA (non-serious) with onset 28Nov2021 08:15, outcome "not recovered", described as "fever"; TREMOR (non-serious) with onset 28Nov2021 08:15, outcome "not recovered", described as "shaking"; DIZZINESS (non-serious) with onset 28Nov2021 08:15, outcome "not recovered", described as "dizziness"; PAIN (non-serious) with onset 28Nov2021 08:15, outcome "not recovered", described as "body ache"; ABDOMINAL PAIN UPPER (non-serious) with onset 28Nov2021 08:15, outcome "not recovered", described as "stomach cramps". Therapeutic measures were not taken as a result of headache, pyrexia, tremor, dizziness, pain, abdominal pain upper.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Headache; fever; shaking; dizziness; body ache; stomach cramps; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Nov2021 12:45 (Batch/Lot number: unknown) at the age of 16 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADDERALL. The following information was reported: HEADACHE (non-serious) with onset 28Nov2021 08:15, outcome "not recovered", described as "Headache"; PYREXIA (non-serious) with onset 28Nov2021 08:15, outcome "not recovered", described as "fever"; TREMOR (non-serious) with onset 28Nov2021 08:15, outcome "not recovered", described as "shaking"; DIZZINESS (non-serious) with onset 28Nov2021 08:15, outcome "not recovered", described as "dizziness"; PAIN (non-serious) with onset 28Nov2021 08:15, outcome "not recovered", described as "body ache"; ABDOMINAL PAIN UPPER (non-serious) with onset 28Nov2021 08:15, outcome "not recovered", described as "stomach cramps". Therapeutic measures were not taken as a result of headache, pyrexia, tremor, dizziness, pain, abdominal pain upper.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), outcome "not recovered", described as "Itching". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101671141 same patient/drug, different dose, similar event.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: I have an allergy that has developed since I received the first two doses.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single and administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "I have an allergy that has developed since I received the first two doses.".  Additional information: Patient received the first two doses this past summer and hoping to get a booster, but want to confirm the source of the  first after speaking with allergist.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.