chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Nasal congestion
Clinical narrative: High Fever (102+); chills; body aches; headache; congestion; fatigue; This is a spontaneous report from a contactable Other HCP (patient). A 32-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: ER8729), via an unspecified route of administration, administered in arm left on 16Jun2021 03:30 PM (at the age of 32-year-old) at a dose 2, single for COVID-19 immunization. The patient's medical history was not reported. Patient did not take concomitant medications (The patient did not receive any other medications within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: ER8729), via an unspecified route of administration, administered in arm left on 26May2021 03:30 PM (at the age of 32-year-old) at a dose 1, single for COVID-19 immunization and no reaction on previous exposure to vaccine. The patient experienced high fever (102+), chills, body aches, headache, congestion, fatigue on 17Jun2021 08:30 AM. The patient underwent lab tests and procedures which included high fever was 102+ Fahrenheit on 17Jun2021, nasal swab was negative on 19Jun2021. The patient did not receive any treatment medication for the events. Patient reported no for seriousness criteria-Results in death, seriousness criteria-life threatening, seriousness criteria-caused/prolonged hospitalization, seriousness criteria-disabling/incapacitating and seriousness criteria-congenital anomaly/birth defect. Device Date was 20Jun2021. Outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: High Fever (102+); chills; body aches; headache; congestion; fatigue; This is a spontaneous report from a contactable Other HCP (patient). A 32-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: ER8729), via an unspecified route of administration, administered in arm left on 16Jun2021 03:30 PM (at the age of 32-year-old) at a dose 2, single for COVID-19 immunization. The patient's medical history was not reported. Patient did not take concomitant medications (The patient did not receive any other medications within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: ER8729), via an unspecified route of administration, administered in arm left on 26May2021 03:30 PM (at the age of 32-year-old) at a dose 1, single for COVID-19 immunization and no reaction on previous exposure to vaccine. The patient experienced high fever (102+), chills, body aches, headache, congestion, fatigue on 17Jun2021 08:30 AM. The patient underwent lab tests and procedures which included high fever was 102+ Fahrenheit on 17Jun2021, nasal swab was negative on 19Jun2021. The patient did not receive any treatment medication for the events. Patient reported no for seriousness criteria-Results in death, seriousness criteria-life threatening, seriousness criteria-caused/prolonged hospitalization, seriousness criteria-disabling/incapacitating and seriousness criteria-congenital anomaly/birth defect. Device Date was 20Jun2021. Outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: The symptom's that I got was like inflammation in my chest and then it will go away, then probably come back in 10 minutes 15 minutes later; I was like that for three days having that inflammation; This is a spontaneous report received from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (solution for injection), via an unspecified route of administration on 29May2021 as unknown dose, single for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. On an unspecified date in 2021 the patient experienced inflammation in her chest for a while and got relived, after half an hour she experienced the same symptoms and it continued till 3 days. So the patients concern was she want to received her 2nd dose, and she want to know anybody or any case or by experience or any report that people get these type of side effects or symptoms." The outcome of the event was not recovered.  LOT NUMBER#: Consumer stated, "Let me call other sometime, as I am running out of time then I have my appointment then I need to find out a little more about, my next shot."  Follow-up attempts are possible. Information about Lot/Batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Menstrual disorder, Menstruation irregular
Clinical narrative: The second cycle after the 2nd dose was a 30 day cycle and I spotted for 10 days and currently have a medium flow; The second cycle after the 2nd dose was a 30 day cycle and I spotted for 10 days and currently have a medium flow; Chills; Body aches; Headache; Sweat for 24 hours; This is a spontaneous report from a contactable consumer. A female consumer (patient) reported for herself. A 37-year old non-pregnant female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection, Lot number: EN6202), administered in left arm on 14Apr2021 04:45 PM as dose 2, single for COVID-19 immunisation. Age at vaccination was 36-year-old. Patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications was not reported. The patient's medical history and concomitant medications was not reported. No known allergies. No relevant past drug history. Historical vaccine of BNT162B2 as first dose for Covid-19 immunisation (Time: 04:00 PM, location: Left arm, Batch/Lot number: ER2613) and events occured irregular menstrual cycle, (first cycle after the first dose was a 40 day cycle. My cycle is typically 26-28 days and VERY heavy lasting about 5 days), fatigue, arm soreness and patient underwent labs and procedure included Covid test post vaccination (Nasal swab): negative on 26Mar2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. It was reported that, the second cycle of menstruation after the 2nd dose was a 30 day cycle and she spotted for 10 days and had a medium flow at the time of this report. She stated that it was unknown when it will end. She was usually very regular. After getting the vaccine, she had no idea when her period was coming. After the 2nd vaccine she also experienced chills, body aches, headache and sweat for 24 hours. Outcome of events was unknown.  Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: The second cycle after the 2nd dose was a 30 day cycle and I spotted for 10 days and currently have a medium flow; The second cycle after the 2nd dose was a 30 day cycle and I spotted for 10 days and currently have a medium flow; Chills; Body aches; Headache; Sweat for 24 hours; This is a spontaneous report from a contactable consumer. A female consumer (patient) reported for herself. A 37-year old non-pregnant female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection, Lot number: EN6202), administered in left arm on 14Apr2021 04:45 PM as dose 2, single for COVID-19 immunisation. Age at vaccination was 36-year-old. Patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications was not reported. The patient's medical history and concomitant medications was not reported. No known allergies. No relevant past drug history. Historical vaccine of BNT162B2 as first dose for Covid-19 immunisation (Time: 04:00 PM, location: Left arm, Batch/Lot number: ER2613) and events occured irregular menstrual cycle, (first cycle after the first dose was a 40 day cycle. My cycle is typically 26-28 days and VERY heavy lasting about 5 days), fatigue, arm soreness and patient underwent labs and procedure included Covid test post vaccination (Nasal swab): negative on 26Mar2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. It was reported that, the second cycle of menstruation after the 2nd dose was a 30 day cycle and she spotted for 10 days and had a medium flow at the time of this report. She stated that it was unknown when it will end. She was usually very regular. After getting the vaccine, she had no idea when her period was coming. After the 2nd vaccine she also experienced chills, body aches, headache and sweat for 24 hours. Outcome of events was unknown.  Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Feeling abnormal, Rash
Clinical narrative: Rash all over; Does not feel good; Light-headed/ Dizzy; Started to have chest pain; This is a spontaneous report from a contactable consumer. A 31-years-old female patient received unknown dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on an unspecified date in Jun2021 (unknown Tuesday night) (Batch/Lot number was unknown) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter stated, daughter had a shot on Tuesday night in Jun2021, does not feel good and got to take her to the hospital. She was dizzy, she was light headed, now she started to have chest pain. On 18Jun2021 yesterday, she had a rash all over, took Benadryl. Subsequently in Jun2021, the rash went away. The outcome of the event rash was reported as recovered in Jun2021 and for other events was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Extreme dizziness 3 days after vaccine; This is a spontaneous report from a non-contactable consumer (patient). A 58-year-old male patient received BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown) on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to vaccination.  The patient experienced extreme dizziness 3 days after vaccine. The patient had not been tested for COVID-19 since the vaccination. No treatment received. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I started with a headache, it's been constant, it comes and goes but it's not completely gone.; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 32-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported; Expiry date: unknown), via an unspecified route of administration on Jun2021 (at the age of 32-years-old) as a single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. In Jun2021, the patient started with a headache, it's been constant, it comes and goes but it was not completely gone. The patient received the first dose of the Pfizer COVID 19 vaccine a week ago and then two days later she started having a headache that comes and goes but she still has that headache. The patient wanted to know what she could take and how long it would last. The facility agent stated she did answer her question already. She will need an interpreter. The clinical outcome of the event was not recovered.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Swelling at site of injection but only on one side; This is a spontaneous report from a contactable nurse. The reporter reported 2 reports for different patients. This is the second of 2 reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took Restylane Lyft in 2020. The patient experienced swelling at site of injection but only on one side on an unspecified date with outcome of recovered.  It resolved after about 7 days.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021751077 Same reporter/drug/AE, different patient
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Computerised tomogram, Dysgeusia, Eating disorder
Clinical narrative: Had a metallic taste in her mouth; That it is interfering with her eating; When the caller had Covid she lost her sense of taste and smell, but it was coming back.; When the caller had Covid she lost her sense of taste and smell, but it was coming back.; This is a spontaneous report from a contactable consumer reported for herself. A 68-year-old female patient first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection,Lot number: EN6207) via unspecified route of administration, administered in right arm on 13Mar2021 at 11:15 (at age of 68-years-old) as single dose for COVID-19 Immunization. Medical history includes rheumatoid arthritis, hypothyroidism, atrial fibrillation. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Caller states she has received both does of the Pfizer COIVD-19 vaccine and both time she has had a metallic taste in her mouth, so much so that it was interfering with her eating and has lost 10 pounds, She had Covid, but she was told she had no antibodies in her blood. When the caller had Covid she lost her sense of taste and smell, but it was coming back. She got her first Covid-19 Vaccine on 13Mar2021, and about a week after she noticed a metallic taste in her mouth that would come and go. First dose Metallic taste in mouth: On Saturday she got her first shot, and it was during that week that she noticed the bad taste. It was has been ongoing, and some days were worse than others.Patient visited physician office for events for first dose. She had regular bloodwork because of her arthritis. Her doctor sent her to an ENT doctor who did a CT scan of her sinuses to see if there was anything wrong that could affect her smell and taste. Patient underwent lab test and procedures include CT sinuses result was unknown on unspecified date. The outcome of events was not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Dyspnoea, Fatigue, Loss of consciousness
Clinical narrative: My daughter said her legs felt tired, she had trouble breathing, and passed out. She also ran a fever of 102. Her joints were aching; My daughter said her legs felt tired, she had trouble breathing, and passed out. She also ran a fever of 102. Her joints were aching; My daughter said her legs felt tired, she had trouble breathing, and passed out. She also ran a fever of 102. Her joints were aching; My daughter said her legs felt tired, she had trouble breathing, and passed out. She also ran a fever of 102. Her joints were aching; My daughter said her legs felt tired, she had trouble breathing, and passed out. She also ran a fever of 102. Her joints were aching; This is a spontaneous report from a contactable consumer (patient's parent). A 12-year-old female patient (reporter's daughter) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) as single dose for COVID-19 immunization. 1 day post 2nd covid vaccine, her legs felt tired, she had trouble breathing, and passed out. She also ran a fever of 102. Her joints were aching. Her symptoms improved after 1 does of Advil. Event took place after use of product. The outcome of events was unknown.  Information about lot/batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: My daughter said her legs felt tired, she had trouble breathing, and passed out. She also ran a fever of 102. Her joints were aching; My daughter said her legs felt tired, she had trouble breathing, and passed out. She also ran a fever of 102. Her joints were aching; My daughter said her legs felt tired, she had trouble breathing, and passed out. She also ran a fever of 102. Her joints were aching; My daughter said her legs felt tired, she had trouble breathing, and passed out. She also ran a fever of 102. Her joints were aching; My daughter said her legs felt tired, she had trouble breathing, and passed out. She also ran a fever of 102. Her joints were aching; This is a spontaneous report from a contactable consumer (patient's parent). A 12-year-old female patient (reporter's daughter) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) as single dose for COVID-19 immunization. 1 day post 2nd covid vaccine, her legs felt tired, she had trouble breathing, and passed out. She also ran a fever of 102. Her joints were aching. Her symptoms improved after 1 does of Advil. Event took place after use of product. The outcome of events was unknown.  Information about lot/batch number is requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Decreased appetite, Diarrhoea, Ear pain
Clinical narrative: High fever; Chills; Body aches; Headache; Loss of taste; Diarrhea; Swollen lymph nodes in arm pit and up left side of neck; Earache; Congestion; loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left at age of 56 years (not pregnant) on 17Jun2021 14:00 (Lot Number: EP7533) as single dose for covid-19 immunisation. The patient medical history included Hoshimoto's thyroiditis, hypothyroid, Sjogren's Syndrome, mixed connective tissue disease, mitral valve prolapse, fibromyalgia, carotid artery disease. Concomitant medications included unspecified drugs the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose1 at left arm at age of 56 years on 20May2021 14:00 (Lot number EW0162) for COVID-19 immunization. On 18Jun2021 03:30am, The patient experienced high fever, chills, body aches, headache, loss of taste, diarrhea, swollen lymph nodes in arm pit and up left side of neck, earache, congestion, loss of appetite. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No known allergies. No treatment received. The outcome of the event was recovering.  Lot/batch number is available; Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Nasal congestion, Pain, Pyrexia
Clinical narrative: High fever; Chills; Body aches; Headache; Loss of taste; Diarrhea; Swollen lymph nodes in arm pit and up left side of neck; Earache; Congestion; loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left at age of 56 years (not pregnant) on 17Jun2021 14:00 (Lot Number: EP7533) as single dose for covid-19 immunisation. The patient medical history included Hoshimoto's thyroiditis, hypothyroid, Sjogren's Syndrome, mixed connective tissue disease, mitral valve prolapse, fibromyalgia, carotid artery disease. Concomitant medications included unspecified drugs the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose1 at left arm at age of 56 years on 20May2021 14:00 (Lot number EW0162) for COVID-19 immunization. On 18Jun2021 03:30am, The patient experienced high fever, chills, body aches, headache, loss of taste, diarrhea, swollen lymph nodes in arm pit and up left side of neck, earache, congestion, loss of appetite. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No known allergies. No treatment received. The outcome of the event was recovering.  Lot/batch number is available; Additional information has been requested.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site swelling
Clinical narrative: Swelling at site of injection but only on one side; This is a spontaneous report from a contactable nurse. The reporter reported 2 reports for different patients. This is the first of 2 reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as a single dose, dose 2 via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization; hyaluronic acid, lidocaine (RESTYLANE LYFT), via an unspecified route of administration from Apr2021 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took Lyft from Aug2020. The patient experienced swelling at site of injection but only on one side on 2021. Last had Lyft in Aug2020 and Apr of this year 2021. Vaccines in late Mar2021 and early Apr2021. Treated with Benadryl and Ibuprofen. The action taken in response to the event for hyaluronic acid, lidocaine was unknown. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021749519 Same reporter/drug/AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Insomnia, Paranoia
Clinical narrative: I feel like my brain, the nerves I don't you know I don't sleep too well; I am going paranoid; Headache; I feel like my brain, the nerves I don't you know I don't sleep too well; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as Dose 1,Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported I took my vaccine, You know and after two days started seeing some side effect like you know the addict. I felt like a headache you know and I am going to have my 2nd shot in a 90 days. On an unspecified date ,the patient experienced headache, abnormal feeling, lack of sleep and paranoia on an unspecified date with outcome of unknown.  Product details (Expiration date, NDC# UPC# and Treatment) and Pharmacy details could not be probed as consumer was unwilling to share further information. Hence further probing could not be done.  Information about lot/batch number has been requested..
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: breaking out with a fever blister, cold sore just outside above her lip; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0196), dose 1 via an unspecified route of administration, administered in Arm Right on 18Jun2021 11:10 (at the age of 44-years-old) as dose 1, single for covid-19 immunization (for health and safety, as reported). Medical history included hypothyroidism from 2008 and ongoing (Verbatim: Hypothyroidism Patient Medical continuing: Yes), shingles from an unknown date and unknown if ongoing (Verbatim: shingles Patient Medical continuing: No), cold sores from 1993 and ongoing (Verbatim: cold sores Patient Medical continuing: Yes) since she was 16 years old, botulinum toxin injection (Botox injection) from 29May2021 to 29May2021. Reportedly, additional Information for Other Conditions was this past fall. the fall of maybe 2020. it has been within the past 2 years. anywhere between fall of 2019 to fall of 2020. Concomitant medications included levothyroxine (Manufacturer of levothyro amneal) taken for hypothyroidism from 2008 to ongoing. Caller reports she received the dtap it was greater than 30 days, received tetanus shot on 23 Apr 2021. Caller states while we are documenting everything, she does receive Botox injections in my forehead. She is wondering if that should be noted. She reports she received a Botox injection 29 May 2021. On 22Jun2021 07:00, the patient experienced breaking out with a fever blister, cold sore just outside above her lip. Reporter seriousness for breaking out with a fever blister, cold sore just outside above her lip was unspecified. Event breaking out with a fever blister, cold sore just outside above her lip was reported as worsened. She received first dose of the vaccine last Friday. She is reporting breaking out with a fever blister, cold sore just outside above her lip, states that it is progressively getting worse. Suspect product: Lot number: EW0196, She thinks it is a 9 or a 4. She thinks it could be a 9, 7 or 4. Caller confirms she received vaccination on 18 Jun 2021. No Emergency Room and Physician Office visit. Outcome of the event was not recovered.   Description of complaint: Levothyroxine: Caller states the NDC, Lot number, and expiration date are probably on the paper work they print out but it is not on the bottle. Product strength and count size dispensed: 125mcg    Follow-up attempts are needed. Additional information been requested.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching sensation in my arms and legs; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two doses. This is the first of two reports, for first dose. A 37-years-old male patient received the first  dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number and expiration date were not reported) via an unspecified route of administration at the left arm on 27Apr2021 12:30 (at the age of 37-years-old) at single dose for covid-19 immunisation. The patient medical history and concomitant medication were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient previously took omeprazole and experienced allergies to omeprazole. After the first dose the patient had an itching sensation in the arms and legs that eventually went away; no rash/hives in 2021. The patient had not been tested for COVID-19 since the vaccination. The outcome of the event was recovered in 2021.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021754038 same patient, same reporter, different dose, similar events
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Swelling
Clinical narrative: my arm pits were slightly swollen; similar itching sensation and the itching has returned and is limited to my thighs & knees, and forearms & elbow; This is a spontaneous report from a contactable consumer(patient). This consumer reported similar events for two doses. This is the second of two reports, for second dose. A 37-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number and expiration date were not reported) via an unspecified route of administration at the left arm on 18May2021 12:30 ( at the age of 37-years-old ) at single dose for covid-19 immunisation. The patient medical history was not reported. the patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included lansoprazole taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number and expiration date were not reported) via an unspecified route of administration at the left arm on 27Apr2021 12:30 (at the age of 37-years-old) at single dose for covid-19 immunisation. After the first dose the patient had an itching sensation in the arms and legs that eventually went away; no rash/hives. The patient previously took omeprazole and experienced allergies to omeprazole. After the second dose  on 18May2021 12:45 the patient had a similar itching sensation that also went away, and the arm pits were slightly swollen for a few days afterwards. The itching has returned and is limited to the thighs & knees, and forearms & elbow. No treatment was received for the events. The patient had not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered. The report was reported as non-serious.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021753984 same patient, same reporter, different dose, similar events
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Migraine, Nausea
Clinical narrative: I was pretty nauseous; pretty bad headache, I would say migraine level; pretty bad headache, I would say migraine level; This is a spontaneous report from a contactable consumer reporting on himself. A 15-years-old male patient received second dose of bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection) via an unspecified route of administration, administered in Arm Left on 19Jun2021 10:00 (Batch/Lot Number: EW0217; Expiration Date: 30Sep2021) as single dose (at age of 15-years old) for covid-19 immunization. Medical history included Allergy to penicillin (10 years ago). The patient previously received first dose of bnt162b2, solution for injection administered on 29May2021 sometime around the morning in left arm (Lot Number: EW0180 and Expiration Date: 31Aug2021) for COVID-19 immunization. There were no concomitant medications. No additional vaccines administered on same date of the Pfizer Suspect. No relevant tests done. No prior vaccinations (within 4 weeks). It was reported that, on 19Jun2021 around 06:00, migraine which began at first on the day he received the second dose of the covid vaccine, an hour or so later. Then it came back again today. Until about 10:00 it was the same, then it got better and on the same day the patient experienced pretty bad headache. On 22Jun2021 06:45, about 45 minutes afterwards he was pretty nauseous, it got a little bit worse between 8:00 and 10:00, but currently he was better. Caller's mother was also on the line. She asked, what stage should we got the doctor and wanted to know how long the side effects might last and when they should be concerned. The patient did not visit to emergency room or physician office due to adverse events. The outcome for event headache was not recovered, for nausea and migraine it was recovering. No PQC was involved.   Information on the lot/batch was available, Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: after i received the first and second vaccine i have high blood pressure that comes and goes.; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (reported for herself). A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that the patient perfectly healthy, perfect blood work and after the patient received the first and second vaccine patient has high blood pressure that comes and goes. The patient needs an explanation of what is this causing from what you made that vaccine from. The reporter stated that "please do not tell me that is not the vaccine because you have the internet full of people complaining about the same thing and that is healthy individuals lime me". The patient never had covid-19 and this vaccine is going to give her a stroke. The patient underwent lab tests and procedures which included blood pressure: high on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: developed shot breathing went to ER; This is a spontaneous report from a contactable consumer (parent). This consumer reported for a 21-year-old male patient (son) that received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The consumer reported that the son had his first shot of the vaccine and he developed shot breathing went to ER. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Vomiting
Clinical narrative: hey have been throwing up for 6 hours non-stop and that is just horrible.; extremely sick; This is a spontaneous report from a non-contactable consumer (parent) reported similar events for two patients. This is first of two reports. A patient of unspecified age (age: 15; unit: unknown) and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient had extreme side effects of the vaccine and had been throwing up for 6 hours non-stop and that was just horrible. Reporter informed that "whatever you guys are giving to these kids is really messing them up" and whatever you guys are giving people making the patient extremely sick (further clarification unknown). The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache, Hypoaesthesia, Hypoaesthesia oral, Nausea
Clinical narrative: pain in bilateral eyes; left hand and left leg numbness; tongue numbness with fasciculation to the left side; tongue numbness with fasciculation to the left side; headache; nausea; This is a spontaneous report from a contactable consumer (parent). A 13-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number ew0186, expiration date was not reported) via an unspecified route of administration at the right arm on 16Jun2021 (at the age of 13-years-old) at single dose for covid-19 immunisation. Medical history included ADD (attention deficit hyperactivity disorder) from an unknown date. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant. The patient was not pregnant at time of vaccination. Concomitant medication included ibuprofen (ADVIL) and muscle relaxer taken for unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number ew0176,expiration date was not reported) via an unspecified route of administration on 27May2021 (at the age of 13-years-old) at single dose for covid-19 immunisation and no reaction on previous exposure to drug. The patient experienced pain in bilateral eyes, left leg numbness, left hand numbness, tongue numbness with fasciculation to the left side, headache, and nausea on 17Jun2021 17:30. No treatment was received for the events. The patient had not been tested for COVID-19 since the vaccination. The outcome of the events was recovered in Jun2021. The report was reported as non-serious.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue spasm
Clinical narrative: pain in bilateral eyes; left hand and left leg numbness; tongue numbness with fasciculation to the left side; tongue numbness with fasciculation to the left side; headache; nausea; This is a spontaneous report from a contactable consumer (parent). A 13-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number ew0186, expiration date was not reported) via an unspecified route of administration at the right arm on 16Jun2021 (at the age of 13-years-old) at single dose for covid-19 immunisation. Medical history included ADD (attention deficit hyperactivity disorder) from an unknown date. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant. The patient was not pregnant at time of vaccination. Concomitant medication included ibuprofen (ADVIL) and muscle relaxer taken for unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number ew0176,expiration date was not reported) via an unspecified route of administration on 27May2021 (at the age of 13-years-old) at single dose for covid-19 immunisation and no reaction on previous exposure to drug. The patient experienced pain in bilateral eyes, left leg numbness, left hand numbness, tongue numbness with fasciculation to the left side, headache, and nausea on 17Jun2021 17:30. No treatment was received for the events. The patient had not been tested for COVID-19 since the vaccination. The outcome of the events was recovered in Jun2021. The report was reported as non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dysmenorrhoea, Menstrual disorder, Pregnancy test
Clinical narrative: Cramps are more severe during cycle; She didn't have a menstrual cycle for 43 days; This is a spontaneous report from a contactable consumer. A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 21Mar2021 11:00 (Batch/Lot Number: EN6799) as DOSE 2, SINGLE for covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. The patient previously received first single dose of bnt162b2 on 26-FEB-2021 18 : 00 (LOT: EN6023 Right arm; 48-years) single for Covid-19 immunization. patient took both doses, one was 26Feb2021 and the second one was 21Mar2021. after she had her second vaccine, dose, her cycle did not come on, so she didn't have a menstrual cycle. she didn't have a menstrual cycle for 43 days (in 2021) and she knows there has been some things out there about effecting the reproductive system of women so she just wanted to put that out there that did occur to her. Caller states up until that point she had been tracking her cycle for the last 2 years so she has detailed records of when it starts and when it ends and when it didn't come she thought, she took 2 pregnancy tests to make sure she wasn't pregnant and it just didn't come. states the last day was 02Mar2021, that was when she was supposed to have started and it never did. Caller states she started her cycle on 13Apr2021. Caller states now the cramps are more severe, but she doesn't know if that has anything to do with it. Caller states she has had to take stuff for cramps. Caller states usually she has cramps, but she's had debilitating cramps. Caller states the last cycle she had they were, but she's only had 2 cycles since this has happened. Caller confirms she only has the cramps when she is on her cycle. Caller states she's not on her period right now, she doesn't have the cramps. Caller states she was expected to have another period 02Jul2021, so one week out. On 13Apr2021, cramps are more severe during cycle: Caller states the cramps end probably close to the end of her cycle, and she has 5 day cycles, so probably about 3 days into it they stop. Caller states no, the only thing she has is the yearly exam, blood pressure, all the annual stuff, nothing out of the ordinary. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was None. Caller states no, its been a while since she's been vaccinated. The outcome of the event Menstrual cycle abnormal was recovered 13-APR-2021, rest of the event was unknown.   Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: came down with mild symptoms of shingles; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration on 30May2021 as single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. On an unknown date in Jun2021, 2 weeks later after first dose, the patient came down with mild symptoms of shingles. The patient received treatment for event. Patient stated she was on Valtrex right now and was wondering if she was able to get the second dose of Pfizer's COVID vaccine. Her second dose was due 20Jun2021 and the doctor told her to wait until her symptoms of shingles lightened up and suggested she receive the Shingrix vaccine as well. Patient was asking how long should she wait to get the COVID vaccine if she were to get the Shingrix vaccine. The outcome of event was unknown.  Information about batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: After her first dose of the vaccine she developed red welt all over her body which lasted 3-4 days/ mother broke out in red welts, like rash welts; This is a spontaneous report from a contactable consumer or other non hcp. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on 15Apr2021 (13:00-14:00) as dose 1, single for COVID-19 immunization. Medical history included Patient was on no medications, had a perfect clean bill of health, and the only thing the doctors have ever told her, was she is slightly overweight, that she's overweight, and to work on that. reporter adds that's the only bad stuff she's ever been told, as far as levels for diabetes and stuff like that they were normal and clarifies mother does not have diabetes. There were no concomitant medications. On 01May2021, at her nephew's birthday party, reporter stated that her mother broke out in red welts, like rash welts, all over her body. She told her then she needed to call the doctor, but reported her mother had ate some weird fruit that her brother had, called pine berries, and mother thought she was having a reaction to that because she had never ate that. Reporter states she told her it could be a reaction to the shot, but her mother said, no she was pretty sure. States it cleared up within 3-4 days, so she didn't worry about it. At the time of this report event outcome was recovered on an unknown date in May2021.   Information on lot/batch number has been requested.; Sender's Comments: Based on the information in the case report, A possible causal relationship between events urticaria 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.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: My first 2 periods after starting the injections where extremely heavy; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ENG202) dose 1 via an unspecified route of administration in left arm on 25Feb2021 at 08:15 AM as single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included ascorbic acid, betacarotene, biotin, calcium pantothenate, calcium phosphate dibasic, chromium picolinate, colecalciferol, cupric oxide, cyanocobalamin, ferrous fumarate, folic acid, magnesium oxide, manganese amino acid chelate, nicotinamide, phytomenadione, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol palmitate, riboflavin, selenomethionine, thiamine hydrochloride, tocopheryl acid succinate, zinc oxide (MULTI VITAMIN ONE A DAY) received in two weeks. No other vaccines received in four weeks. The patient previously took azithromycin (ZITHROMAX) and had allergies. Her first 2 periods after starting the injections where extremely heavy on 01Mar2021. She was not pregnant and not going through menopause as confirmed by her doctor. No treatment was received for AE. The outcome of event was unknown.