chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer, Full blood count, Hyperhidrosis, Lipids, Metabolic function test
Clinical narrative: I was driving in my car and i felt my chest pounding fast.  I used my pulse ox machine to check my pulse, and it was at 160. I almost passed out driving. I pulled over, called an ambulance. When they got there 5 minutes later my pupse was 145. I was nauseous, light headed, dizzy and it felt like my heart was coming out of my chest. I went to the ER where they performed various tests. See below.  On 5/4.  I had another bad tachy episode while at work, where my pulse got to 160.  I was able to bring it down, but it took my 1 hrs to not feel dizzy and light headed again. I was again nauseous, dizxy, chest pounding, sweating.   I got an appointment with my PCP that day and had further tests.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palpitations, Thyroxine free, Troponin
Clinical narrative: I was driving in my car and i felt my chest pounding fast.  I used my pulse ox machine to check my pulse, and it was at 160. I almost passed out driving. I pulled over, called an ambulance. When they got there 5 minutes later my pupse was 145. I was nauseous, light headed, dizzy and it felt like my heart was coming out of my chest. I went to the ER where they performed various tests. See below.  On 5/4.  I had another bad tachy episode while at work, where my pulse got to 160.  I was able to bring it down, but it took my 1 hrs to not feel dizzy and light headed again. I was again nauseous, dizxy, chest pounding, sweating.   I got an appointment with my PCP that day and had further tests.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypopnoea, Limb discomfort, Musculoskeletal stiffness, Paraesthesia, Unresponsive to stimuli
Clinical narrative: Immediately following a Moderna vaccination, the patient starting feeling tingling in her feet and hands.  Her legs became heavy followed by stiffness in her legs and arms.  Her eyes were wide open and she became unresponsive to our questions.  Patient's breathing shallowed and was given one dose of an Epi-Pen.  The patient immediately responded and she could again control her eyes and was talking.  The patient slowly started to stiffen up,  losing control of her eye movement and her breathing was once again shallow with her lips becoming bluish in color.   We administered a second Epi-Pen and the patient responded for about three minutes when the paramedics arrived.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Loss of consciousness, Rash, Seizure
Clinical narrative: Immediately following a Moderna vaccination, the patient starting feeling tingling in her feet and hands.  Her legs became heavy followed by stiffness in her legs and arms.  Her eyes were wide open and she became unresponsive to our questions.  Patient's breathing shallowed and was given one dose of an Epi-Pen.  The patient immediately responded and she could again control her eyes and was talking.  The patient slowly started to stiffen up,  losing control of her eye movement and her breathing was once again shallow with her lips becoming bluish in color.   We administered a second Epi-Pen and the patient responded for about three minutes when the paramedics arrived.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue
Clinical narrative: Immediately following a Moderna vaccination, the patient starting feeling tingling in her feet and hands.  Her legs became heavy followed by stiffness in her legs and arms.  Her eyes were wide open and she became unresponsive to our questions.  Patient's breathing shallowed and was given one dose of an Epi-Pen.  The patient immediately responded and she could again control her eyes and was talking.  The patient slowly started to stiffen up,  losing control of her eye movement and her breathing was once again shallow with her lips becoming bluish in color.   We administered a second Epi-Pen and the patient responded for about three minutes when the paramedics arrived.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Syncope
Clinical narrative: Nausea, dizziness, fainting. Pt was caught before hitting the floor, taken to a room for observation, and given water, Gatorade, and ice. He sat for 30 minutes under observation.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Condition aggravated, Diplopia, Magnetic resonance imaging, Multiple sclerosis relapse
Clinical narrative: Double Vision - believed to be an MS flare up
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pyrexia
Clinical narrative: fever; shortness of breath; This is a spontaneous report from a contactable consumer (patient's husband). A female patient (reporter's wife) of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced fever, shortness of breath. Reporter wanted to know if she could take Tylenol for these symptoms. Response: Spoke from attached document and stated that Pfizer is unable to provide treatment recommendations for patients. There was no PQC. The event was non-serious. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort
Clinical narrative: she felt like she has "cotton in the ear"; "partially-blocked ear similar to an infection".; This is a spontaneous report from a contactable consumer (patient).  A 70-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 13Apr2021 (Lot Number: ER8733) as single dose for covid-19 immunisation. Patient's medical history and concomitant medications was reported as none. The patient previously took the first dose of BNT162B2 in Arm Left on 21Mar2021 (lot: EN6208) for COVID-19 immunisation. The patient received the second dose of the Pfizer-BioNTech COVID-19 Vaccine last Tuesday, 13APR2021. The patient reported that by Friday or Saturday (Apr2021), she felt like she has "cotton in the ear"; "partially-blocked ear similar to an infection". The patient didn't have any side effects, she more or less has a quick question. She felt like there was  cotton in her ear, after getting it. She asked if that is a side effect to the Covid shot. She was  not sure if it is associated. She wondered if this feeling of cotton in her ear will clear up or what's going on. It felt like it was blocked.  She didn't feel so bad right now. It gets worse later in the day. She had a physical in January and there was nothing wrong with her ears at the time.  The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: losing a lot of weight; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 65-year-old female patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. Co-suspect drug included palbociclib (IBRANCE) from an unknown date at 125 mg for an unknown indication. Medical history and concomitant medications were not reported. The patient stated she just got her vaccine. Patient stated she was doing "no carb, no sugar" and she was losing a lot of weight, patient could stand to lose a few pounds. The action taken in response to event for palbociclib was unknown. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dermatitis contact, Pain in extremity, Urticaria
Clinical narrative: Contact dermatitis to face from chemicals from cleaning; sore arm; hives; burning; This is a spontaneous report  from a contactable consumer (patient). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Deltoid Right on 16Apr2021 08:30 (Batch/Lot Number: ER8731) at the age of 59-years-old as single dose for covid-19 immunization. Medical history included heart disease diagnosed in 2003 and She had a heart attack. Family medical history: high blood pressure and heart disease. Mother had Diabetes. The patient's concomitant medications were not reported. The patient previously got the 1st dose of BNT162B2 on 24Mar2021 Lot ER8727, it was also injected on right arm in the muscle for covid-19 immunization. She got the second shot on Friday (on 16Apr2021) and all had was sore arm. There were no side effects. On the second day on 17Apr2021, or actually the night, she was cleaning and got contact dermatitis on her face. She was not wearing gloves and touched her face. She got contact dermatitis to face from the chemical. She went to an Urgent Care and was prescribed Prednisone 10mg. She took 5 of them on Saturday, 4 on Sunday and 3 today. Now it was gone, so she was not going to finish out day 2 and day 1. Her doctor told her not to. No emergency Room (ER) or physician's office required. She would like to know if taking the Prednisone will effect the efficacy of the vaccine. It was not from the vaccine. It was from the chemical. She got hives and burning on an unknown date in Apr2021. The outcome of the event contact dermatitis to face was recovering, and the outcome of the other events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: The event dermatitis contact is attributed to chemicals from cleaning product and assessed unrelated to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dyspepsia, Paraesthesia, Vaccination site pain
Clinical narrative: I became dizzy, my head was spinning and I vomited twice.; I became dizzy, my head was spinning and I vomited twice.; I became dizzy, my head was spinning and I vomited twice.; My stomach was boiling, like a volcano was about to erupt.; I have a dull ache or pain over my heart area; feeling of tingling over my right nostril, like a cold was coming on; had pain at the injection site on my right arm, the arm where I got the shot.  I had pain for 3 days.; This is a spontaneous report from a contactable consumer (Patient). A 73-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 on an unknown date for covid-19 immunization. The patient received the second dose of the Pfizer BioNTech covid vaccine and this time he had pain at the injection site on his right arm, the arm where he got the shot. He had pain for 3 days. Today on 19Apr2021, while at work he became dizzy, his head was spinning and he vomited twice. His stomach was boiling, like a volcano was about to erupt. He came home and have been resting. His head was just spinning and he had dizziness. Now he have a dull ache or pain over his heart area. All this happened at about 11am when he came home and then decided to not go back to work this afternoon. The dizziness was finally feel better. But he still have the dull pain over his heart area. This morning he had a feeling of tingling over his right nostril, like a cold was coming on. He rubbed garlic over it and ate a piece of garlic. He was not sure if that affected things with the vaccine. The outcome of the event 'pain at the injection site on his right arm' was recovered in 3 days, the outcome of the event dizziness was recovering, the outcome of the event 'dull pain over his heart area' was not recovered, and the outcome of the other events was unknown.   No follow-p attempts are needed. Information about Lot/Batch number cannot to obtained.
Sex: M
Vaccine: COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: I became dizzy, my head was spinning and I vomited twice.; I became dizzy, my head was spinning and I vomited twice.; I became dizzy, my head was spinning and I vomited twice.; My stomach was boiling, like a volcano was about to erupt.; I have a dull ache or pain over my heart area; feeling of tingling over my right nostril, like a cold was coming on; had pain at the injection site on my right arm, the arm where I got the shot.  I had pain for 3 days.; This is a spontaneous report from a contactable consumer (Patient). A 73-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 on an unknown date for covid-19 immunization. The patient received the second dose of the Pfizer BioNTech covid vaccine and this time he had pain at the injection site on his right arm, the arm where he got the shot. He had pain for 3 days. Today on 19Apr2021, while at work he became dizzy, his head was spinning and he vomited twice. His stomach was boiling, like a volcano was about to erupt. He came home and have been resting. His head was just spinning and he had dizziness. Now he have a dull ache or pain over his heart area. All this happened at about 11am when he came home and then decided to not go back to work this afternoon. The dizziness was finally feel better. But he still have the dull pain over his heart area. This morning he had a feeling of tingling over his right nostril, like a cold was coming on. He rubbed garlic over it and ate a piece of garlic. He was not sure if that affected things with the vaccine. The outcome of the event 'pain at the injection site on his right arm' was recovered in 3 days, the outcome of the event dizziness was recovering, the outcome of the event 'dull pain over his heart area' was not recovered, and the outcome of the other events was unknown.   No follow-p attempts are needed. Information about Lot/Batch number cannot to obtained.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Herpes zoster, Musculoskeletal chest pain, Pruritus
Clinical narrative: chest pressure; shingles/rash; itch and rash and tenderness on his rib cage; itch and rash and tenderness on his rib cage; chest pain; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for a 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 10Apr2021 11:00 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included ongoing Cholesterol. Concomitant medication included ongoing atorvastatin taken for blood cholesterol. Patient investigation assessment was No. The patient developed a rash from 16Apr2021. They figured out in the hospital that it was probably shingles. It had developed even more. They want to give him Valacyclovir. He came down with an itch and rash and tenderness on his rib cage from 16Apr2021. He slept on his chest and had pressure on his chest from 18Apr2021 to 19Apr2021. He went to the hospital to rule out a heart attack. The patients father passed away a long time ago of the heart attack and thought it was that as well.  He went to the emergency room and was brought in the hospital under observation status. He was diagnosed with shingles at the hospital from 19Apr2021. They were on the right side. The itching, tenderness and pain got worse on Sunday with chest pain from Apr2021. Patient has not received Valacyclovir yet. The hospital was waiting to give it until after caller speaks with Pfizer. The patient was currently waiting to get the antiviral medication for shingles. The outcome of the event chest pressure was recovered on 19Apr2021, of shingles/rash was not recovered, of other event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza, Malaise, Nausea
Clinical narrative: I have been sick with a low grade temperature; I am tired; achy; chills; maybe I had the flu; Low grade fever; Nausea; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 29Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient got her first Pfizer shot on the 29th and was due to go for her second shot tomorrow. She has been sick with a low grade temperature but was feeling much better now. She got a Covid test today but the results won't be back for three days and she fly back home on Friday. She was tired and achy and have the chills. She thought maybe she had the flu. A day and a half ago she started experiencing a little chill, a low grade fever, and nausea. She doesn't know if these symptoms are from the vaccine, she thought she had the flu. Outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: I have been sick with a low grade temperature; I am tired; achy; chills; maybe I had the flu; Low grade fever; Nausea; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 29Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient got her first Pfizer shot on the 29th and was due to go for her second shot tomorrow. She has been sick with a low grade temperature but was feeling much better now. She got a Covid test today but the results won't be back for three days and she fly back home on Friday. She was tired and achy and have the chills. She thought maybe she had the flu. A day and a half ago she started experiencing a little chill, a low grade fever, and nausea. She doesn't know if these symptoms are from the vaccine, she thought she had the flu. Outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: slept all day after second shot; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not provided. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date in last weekend of Feb2021 at single dose for COVID-19 immunization. Patient mentioned that she had no reactions and slept all day in Mar2021 after second shot. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Migraine
Clinical narrative: Horrible migrainous headache; he also felt tired and fatigued; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that the 34-year-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Right on 11Apr2021 15:30 (Batch/Lot Number: EW0151) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE) on 21Mar2021 for covid-19 immunisation. The patient experienced horrible migrainous headache on 11Apr2021 evening with outcome of not recovered, he also felt tired and fatigued on 11Apr2021 15:30PM with outcome of recovered. Therapeutic measures were taken as a result of horrible migrainous headache.  The clinical course was reported as follows: I was having some complications with my vaccine. I received my 2nd vaccination 8 days ago and hours after I got the vaccine I come down with a horrible migrainous headache. It has been 8 days now and it has not subsided. Is it common to last this long? Is it something I should be worried about? Side effects (such as fever, chills, tiredness, and headache) throughout the body were more common after the second dose of the vaccine. Consumer calling states he received the second dose of the Pfizer COVID 19 vaccine last Sunday. Reports a few hours later he had a horrible migraine headache and has had it for eight days now. Adds nothing will stop it, no matter how much Tylenol he takes. Adds he doesn't usually have headaches. Later clarifies it was pharmacy brand acetaminophen he has taken for the migraine. Provides UPS50428317112; lot S210022; expiration date AUG2023 for the acetaminophen. Consumer states he received the first dose of the Pfizer COVID 19 vaccine on 21MAR2021 at 1530PM in the right arm. Then he received the second dose on 11APR2021 at 1530PM in the right arm. By the evening after the second dose he had the headache. Adds he also felt tired and fatigued but he took a nap and that went away. Adds he figured a couple of days is okay but a week is too long and he is worried. He is asking should he be worried; how long before he should go to see a doctor? Advised caller call center does not provide medical advice. Vaccination Facility was pharmacy. No Vaccine Administered at (name) Facility. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No AE(s) require a visit to Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks) was none. Patient's Medical History (including any illness at time of vaccination) was none. Family History was none. Relevant test was none.   No follow-up attempts are needed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: feeling unwell; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer reported that a 99-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 24Mar2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The caller was calling regarding her sister who was due for her 2nd Pfizer shot at the date of reporting, received 1st Pfizer shot on 24Mar2021. Caller did not elaborate but sister was feeling unwell (onset date not specified) at the date of reporting and would like to reschedule 2nd dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue with second COVID vaccine; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of Covid-19 vaccine (unspecified trade name or manufacture) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization.  The patient medical history and concomitant medications were not reported. The patient experienced fatigue with second COVID vaccine on an unspecified date with outcome of unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever 12 days out from the vaccination/fever averages 100F during the day; This is a spontaneous report received from a contactable pharmacist (patient himself). A 60-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown and Expiry date: Unknown), via an unspecified route of administration on 07Apr2021 (at the age of 60-year-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. On an unspecified date in Apr2021, the patient reported to have a fever 12 days out from the vaccination, his fever averaged 100 Fahrenheit during the day. There was no other symptoms. The patient's laboratory test and procedure on an unknown date included body temperature: 100F during the day. The clinical outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain through the whole night; This is a Spontaneous report from a Pfizer Sponsored Pfizer Rx Pathways Program. A contactable consumer (patient) reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain through the whole night on 14Apr2021. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Chills; fever; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced chills , fever on an unspecified date with outcome of unknown. Events took place after use of product.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypersensitivity, Hyperventilation, Muscle spasms, Nervousness
Clinical narrative: hesitant and nervous to get the second dose; felt like paranoid; hyperventilating; Heart beating fast for about 5 -10 minutes; Muscle spasms; Her allergies were trying to activate; This is a spontaneous report from a contactable consumer (patient). This 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 02Apr2021  11:56  (Lot Number: EW0150) as single dose for covid-19 immunisation. Medical history included two weeks prior to receiving the Covid vaccine she was on antibiotics for diverticulitis from Mar2021 for 10 days. Two weeks prior to receiving the Covid vaccine she was on antibiotics for diverticulitis for 10 days. She wonders if she should have waited longer. Concomitant medications included ongoing Zinc from Mar2020 at 50mg daily to keep immune system fully activated, she thinks she needs more, ongoing Vitamin D3 from Mar2020 at 5,000IU/125mcg every other day to keep immune system fully activated, ongoing bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lact, bacillus casei, lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10) from 2020 at 10,000,000,000 viral daily to keep good bacteria in her stomach to keep immunity good, and ongoing Multivitamin from Mar2020 at every other day to keep immune system fully activated. She received the first dose of the Covid-19 vaccine on 02Apr2021. She was fine until that night, early in the morning. 03Apr2021 at 2:00 am she was paranoid and was hearing a voice. She felt like she was hyperventilating a little bit on 03Apr2021. That lasted for 10 minutes and went away. The next morning on 03Apr2021 her heart was beating fast. That lasted for 5-10 minutes. She felt like she was having muscle spasms on 03Apr2021 that lasted for 5 minutes. She felt like her allergies were trying to activate on 03Apr2021. She took an allergy pill and it worked for her allergies to keep them from acting up. After that she didn't experience anything else. She was hesitant and nervous to get the second dose. The second dose is scheduled 23Apr2021. She was taking Metronidazole 500mg twice daily for 10 days. No emergency room and physician office. Outcome of the event paranoid and heard a voice, hyperventilating, heart was beating fast, Muscle spasms was recovered on 03Apr2021. Outcome of the event allergies were trying to activate was recovered on 04Apr2021. Outcome of other event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Paranoia
Clinical narrative: hesitant and nervous to get the second dose; felt like paranoid; hyperventilating; Heart beating fast for about 5 -10 minutes; Muscle spasms; Her allergies were trying to activate; This is a spontaneous report from a contactable consumer (patient). This 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 02Apr2021  11:56  (Lot Number: EW0150) as single dose for covid-19 immunisation. Medical history included two weeks prior to receiving the Covid vaccine she was on antibiotics for diverticulitis from Mar2021 for 10 days. Two weeks prior to receiving the Covid vaccine she was on antibiotics for diverticulitis for 10 days. She wonders if she should have waited longer. Concomitant medications included ongoing Zinc from Mar2020 at 50mg daily to keep immune system fully activated, she thinks she needs more, ongoing Vitamin D3 from Mar2020 at 5,000IU/125mcg every other day to keep immune system fully activated, ongoing bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lact, bacillus casei, lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10) from 2020 at 10,000,000,000 viral daily to keep good bacteria in her stomach to keep immunity good, and ongoing Multivitamin from Mar2020 at every other day to keep immune system fully activated. She received the first dose of the Covid-19 vaccine on 02Apr2021. She was fine until that night, early in the morning. 03Apr2021 at 2:00 am she was paranoid and was hearing a voice. She felt like she was hyperventilating a little bit on 03Apr2021. That lasted for 10 minutes and went away. The next morning on 03Apr2021 her heart was beating fast. That lasted for 5-10 minutes. She felt like she was having muscle spasms on 03Apr2021 that lasted for 5 minutes. She felt like her allergies were trying to activate on 03Apr2021. She took an allergy pill and it worked for her allergies to keep them from acting up. After that she didn't experience anything else. She was hesitant and nervous to get the second dose. The second dose is scheduled 23Apr2021. She was taking Metronidazole 500mg twice daily for 10 days. No emergency room and physician office. Outcome of the event paranoid and heard a voice, hyperventilating, heart was beating fast, Muscle spasms was recovered on 03Apr2021. Outcome of the event allergies were trying to activate was recovered on 04Apr2021. Outcome of other event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Lymphadenopathy, Myalgia, Tenderness
Clinical narrative: Pain in muscle around injection site ~2.5hrs in spread thru my entire upper arm and shoulder; Dose 2: Pain in muscle around injection site ~2.5hrs in spread thru my entire upper arm and shoulder; pain in my chest wall and around the lymph system surrounding left breast, started first near sternum, then spread above left breast implant.; soreness and tenderness in addition spread up to armpit and along to left side along breast; Dose 2: Pain in muscle around injection site ~2.5hrs in spread thru my entire upper arm and shoulder; lymph swelling; This is a spontaneous report from a contactable consumer. A 37-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 09Apr2021 11:30 (Batch/Lot Number: EW0153) as single dose for covid-19 immunisation.  Medical history included hypothyroidism, autoimmune thyroiditis, Hashimoto's, asthma, fibromyalgia, arrhythmia, hypersensitivity to Norco, Rondac Cough Syrup. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication(s) included levothyroxine sodium (TIROSINT); levocetirizine dihydrochloride (XYZAL); salbutamol (VENTOLIN [SALBUTAMOL]); iron (IRON); ascorbic acid; cholecalciferol; magnesium sulfate; zinc chloride. The patient previously took dose 1 bnt162b2 on 12Mar2021, , lot number: EN6199, in left arm for covid-19 immunisation. The patient experienced pain in muscle around injection site, 2.5hrs in spread thru my entire upper arm and shoulder, (like simultaneously pulled all muscles & got punched in shoulder joint; hard to lift arm or pick anything up for 2 days). Then 7hrs in, pain in my chest wall and around the lymph system surrounding left breast, started first near sternum, then spread above left breast implant. Came and went for 4 days, then soreness and tenderness in addition spread up to armpit and along to left side along breast. It is been 9 days now. Have not had appointment with physician yet, but am booking today and wanted to report here first. Event onset time was 09Apr2021 06:30 PM. Checking to see if Pfizer will cover the cost of CT ordered by physician following weeks of lymph swelling and pain which prompted CT to be ordered. Outcome was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in muscle around injection site ~2.5hrs in spread thru my entire upper arm and shoulder; Dose 2: Pain in muscle around injection site ~2.5hrs in spread thru my entire upper arm and shoulder; pain in my chest wall and around the lymph system surrounding left breast, started first near sternum, then spread above left breast implant.; soreness and tenderness in addition spread up to armpit and along to left side along breast; Dose 2: Pain in muscle around injection site ~2.5hrs in spread thru my entire upper arm and shoulder; lymph swelling; This is a spontaneous report from a contactable consumer. A 37-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 09Apr2021 11:30 (Batch/Lot Number: EW0153) as single dose for covid-19 immunisation.  Medical history included hypothyroidism, autoimmune thyroiditis, Hashimoto's, asthma, fibromyalgia, arrhythmia, hypersensitivity to Norco, Rondac Cough Syrup. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication(s) included levothyroxine sodium (TIROSINT); levocetirizine dihydrochloride (XYZAL); salbutamol (VENTOLIN [SALBUTAMOL]); iron (IRON); ascorbic acid; cholecalciferol; magnesium sulfate; zinc chloride. The patient previously took dose 1 bnt162b2 on 12Mar2021, , lot number: EN6199, in left arm for covid-19 immunisation. The patient experienced pain in muscle around injection site, 2.5hrs in spread thru my entire upper arm and shoulder, (like simultaneously pulled all muscles & got punched in shoulder joint; hard to lift arm or pick anything up for 2 days). Then 7hrs in, pain in my chest wall and around the lymph system surrounding left breast, started first near sternum, then spread above left breast implant. Came and went for 4 days, then soreness and tenderness in addition spread up to armpit and along to left side along breast. It is been 9 days now. Have not had appointment with physician yet, but am booking today and wanted to report here first. Event onset time was 09Apr2021 06:30 PM. Checking to see if Pfizer will cover the cost of CT ordered by physician following weeks of lymph swelling and pain which prompted CT to be ordered. Outcome was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity
Clinical narrative: lower back and upper right leg pain; lower back and upper right leg pain; This is a spontaneous report received from a contactable consumer (patient). A 50-year-old female patient received the second dose of BNT162B2 (COMIRNATY, batch/lot number and expiration date not provided), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced lower back and upper right leg pain 24 hours after 2nd vaccine administration. 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: Rash
Clinical narrative: the rash on her son's back, chest & right arm pit; This is a spontaneous report from a contactable nurse (patient's parent). An 18-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Apr2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not provided. Patient had a rash on 15Apr2021/ 16Apr2021, the rash on back, chest and right armpit, not on the vaccination site. The reporting nurse asked if there is a possibility that the vaccine caused the rash, if patient can still take the 2nd shot. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: feeling a metallic taste in her mouth; This is a spontaneous report from a non-contactable consumer report for daughter. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 12Apr2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced feeling a metallic taste in her mouth. Event outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Sinusitis, Viral infection
Clinical narrative: sore arm; chills; sinus was inflamed; viral infection; This is a spontaneous report from Pfizer sponsored program from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included stroke in Feb2021, thrombosis in sinus cavity. The patient's concomitant medications were not reported. In 2021, the patient experienced sinus was inflamed. It was a virus actually. No effects after the first shot, just a sore arm, got the chills (2021). Started to feel better. Thought it was sinus but a viral infection. It was completely gone. The outcome of the events sore arm and chills was recovering, of the other events was recovered on an unspecified date in 2021.  No follow-up attempts are needed. Information about Batch/Lot number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: tooth pain; This is a spontaneous report from Pfizer sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient wanted to know if he can take pain medication for his tooth pain. Clarified that the pain started after he received his first covid vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: broke out in hives; itchy a few days; rashes after eating peanuts; This is a spontaneous report from a contactable consumer reported for his friend. An adult female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 09Apr2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced broke out in hives and was itchy a few days after receiving her first dose, now she said she seems to develop rashes after eating peanuts that she had not had before. Outcome of the events was unknown.    No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Dyspnoea, Headache, Nausea
Clinical narrative: panicking/panics; short winded; Chills; Nausea; little headache; Back ache; This is a spontaneous report received from a contactable consumer (the patient). A 73-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0164), via an unspecified route of administration, in right arm on 15Apr2021 at age of 73-year-old at single dose for COVID-19 immunisation. Medical history included high blood pressure diagnosed 12 years ago, diabetes mellitus diagnosed 12 years ago, depression diagnosed 2 years ago, COVID back in Mar2020. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8732) via an unspecified route of administration, in right arm on 26Mar2021 at age of 73-year-old for COVID-19 immunisation. No other products. The caller was calling about the Pfizer covid shot. The caller had her second dose of the vaccine about an hour ago (15Apr2021). When the caller got home she was okay but currently she was having chills, no fever, nausea, she is having some side effects (15Apr2021). The caller didn't have any allergies. The caller wanted to know if there was something she could drink or if they were going to be there. The caller was short winded but it was easing off. The caller had a back ache and a little headache (15Apr2021). The caller panics a lot too so maybe the panicking was what was causing this. The caller didn't have an allergic reaction that she knows of. The caller wanted to know if this would go away. It seems like it was kind of calming down currently. No investigation assessment. The outcome of events "short winded", "chills", "nausea" was recovering, the outcome of "panicking/panics" was recovered on 15Apr2021, the outcome of other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Panic reaction
Clinical narrative: panicking/panics; short winded; Chills; Nausea; little headache; Back ache; This is a spontaneous report received from a contactable consumer (the patient). A 73-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0164), via an unspecified route of administration, in right arm on 15Apr2021 at age of 73-year-old at single dose for COVID-19 immunisation. Medical history included high blood pressure diagnosed 12 years ago, diabetes mellitus diagnosed 12 years ago, depression diagnosed 2 years ago, COVID back in Mar2020. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8732) via an unspecified route of administration, in right arm on 26Mar2021 at age of 73-year-old for COVID-19 immunisation. No other products. The caller was calling about the Pfizer covid shot. The caller had her second dose of the vaccine about an hour ago (15Apr2021). When the caller got home she was okay but currently she was having chills, no fever, nausea, she is having some side effects (15Apr2021). The caller didn't have any allergies. The caller wanted to know if there was something she could drink or if they were going to be there. The caller was short winded but it was easing off. The caller had a back ache and a little headache (15Apr2021). The caller panics a lot too so maybe the panicking was what was causing this. The caller didn't have an allergic reaction that she knows of. The caller wanted to know if this would go away. It seems like it was kind of calming down currently. No investigation assessment. The outcome of events "short winded", "chills", "nausea" was recovering, the outcome of "panicking/panics" was recovered on 15Apr2021, the outcome of other events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: Got her 1st dose and then fell; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 15Apr2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient husband) reporting for her wife that a female patient of an unspecified age received Covid-19 vaccine (unspecified trade name or manufacture), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported.  The patient got her 1st dose and then fell on an unspecified date with outcome of unknown. Her HCP put her on Naproxen. He wants to know if that will interfere with the Covid vaccine.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration
Clinical narrative: got black and blue in the shot area; This is a spontaneous report from a contactable consumer reported for his girlfriend. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the COVID vaccine and she got black and blue in the shot area on an unknown date. Th outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.