chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Illness, Pain, Pyrexia
Clinical narrative: Was real sick for about 4-5 days; Fever; Stomachache; Body aches; This is a spontaneous report from a contactable consumer. An unspecified age male patient received first dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on unknown date at single dose for covid-19 immunization. Medical history included she says she wondered if it was a reaction, because she was sick, with aching arms, and aches all over, and she is wondering if she should get second shot. The patient's concomitant medications were not reported. It was reported that Consumer says that she and her husband went somewhere to have their first COVID-19 vaccine and are due again for the second dose on 11Feb, which is next Thursday. Caller says she has been having a reaction, and they called the paramedics, but they said that there was no need to take her to the hospital, and knew what it was. Caller says she had fever, stomachache, and body aches. Caller says something about 11 days she is supposed have second shot, it is due 11Feb. Unable to clarify with caller as she continued speaking. Caller says she was told to call here and called her doctor and he said he had the same thing as a reaction from his too, and she was told to take Tylenol and drink a lot of liquids. She says she wondered if it was a reaction, because she was sick, with aching arms, and aches all over, and she is wondering if she should get second shot. Caller(s) clarify it was the paramedic guy, and not her doctor, who said he had been real sick for about 4-5 days after getting his first dose of the vaccine. The outcome of the events "Unknown".  Information on the lot/ batch number has been requested.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pain, Pruritus, Skin injury
Clinical narrative: blister on top/she got sores that look like a bite with a blister on top/blisters like a bite over arms, stomach and feet; then it leaves a sore/she got sores that look like a bite with a blister on top; little bumps itch so bad/it itches like hell/itches to high heaven; it is just clear fluid that comes out/break the blister, a clear liquid comes out; This is a spontaneous from a contactable consumer(patient herself). An 87-year-od female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA, formulation: solution for injection, lot number: not reporter, expiry date: not reported) Vaccine via an unknown route of administration on 25Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced blister on top/she got sores that look like a bite with a blister on top/blisters like a bite over arms, stomach and feet, then it leaves a sore/she got sores that look like a bite with a blister on top, little bumps itch so bad/it itches like hell/itches to high heaven, it is just clear fluid that comes out/break the blister, a clear liquid comes out. Caller was wondering if was a known side effect and if there are recommendations for her about her second dose because she was supposed to have the second dose on 15Feb2021. Caller did not provide a reference number for her report from yesterday. The patient did not undergo any lab investigations. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Taste disorder, Tongue dry, Tremor
Clinical narrative: headache; a strange, indescribable taste in her mouth that sort of resembles soap; shakiness; a thick feeling on her tongue with the taste buds feeling indescribable, prominent and dry; is really tired enough to want to lie down and sleep; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on 16Feb2021 13:20 as SINGLE DOSE for covid-19 immunisation. Medical history included respiratory tract infection from an unknown date and unknown if ongoing Treated with Mucinex DM, drug hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took mucinex for respiratory tract infection. On an unspecified date, the patient experienced headache, a strange, indescribable taste in her mouth that sort of resembles soap, shakiness, a thick feeling on her tongue with the taste buds feeling indescribable, prominent and dry , is really tired enough to want to lie down and sleep. The patient underwent lab tests and procedures which included x-ray: respiratory infection. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the events was unknown.  Information about lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: headache; a strange, indescribable taste in her mouth that sort of resembles soap; shakiness; a thick feeling on her tongue with the taste buds feeling indescribable, prominent and dry; is really tired enough to want to lie down and sleep; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on 16Feb2021 13:20 as SINGLE DOSE for covid-19 immunisation. Medical history included respiratory tract infection from an unknown date and unknown if ongoing Treated with Mucinex DM, drug hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took mucinex for respiratory tract infection. On an unspecified date, the patient experienced headache, a strange, indescribable taste in her mouth that sort of resembles soap, shakiness, a thick feeling on her tongue with the taste buds feeling indescribable, prominent and dry , is really tired enough to want to lie down and sleep. The patient underwent lab tests and procedures which included x-ray: respiratory infection. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the events was unknown.  Information about lot/ batch number has been requested.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Vaccination site pain
Clinical narrative: Injection site soreness; headache; body aches; This is a spontaneous report from a non-contactable consumer, the patient. This 44 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) , single dose, dose 2 via unknown route of administration in the left arm on 16Feb2021 at 13:30 (at the age of 44 years-old) for COVID-19 vaccination. Medical history was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) on 26Jan2021 at 2: 15 PM. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. The patient did not receive any concomitant medications. The patient was not on any medications in two weeks. On 16Feb2021 at 16:00, the patient experienced injection site soreness, headache and body aches. No treatment was received for injection site soreness, headache and body aches. The clinical outcome of injection site soreness, headache and body aches was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dyspnoea, Pruritus
Clinical narrative: Itching; short of breath at times; diarrhea; This is a spontaneous report from a contactable male consumer (patient) received from Pfizer sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 28Jan2021 as single dose for covid-19 immunisation. Medical history included stent placement from an unknown date and unknown if ongoing (Had a stent put in on December). Concomitant medication included metformin clopidogrel bisulfate. The patient experienced itching, short of breath at times and diarrhea. The action taken in response to the event for BNT162B2 was not applicable. The outcome of events was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Pain, Pruritus
Clinical narrative: Itching; short of breath at times; diarrhea; This is a spontaneous report from a contactable male consumer (patient) received from Pfizer sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 28Jan2021 as single dose for covid-19 immunisation. Medical history included stent placement from an unknown date and unknown if ongoing (Had a stent put in on December). Concomitant medication included metformin clopidogrel bisulfate. The patient experienced itching, short of breath at times and diarrhea. The action taken in response to the event for BNT162B2 was not applicable. The outcome of events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dysphonia, Hypersensitivity
Clinical narrative: She has immediate hoarseness; trouble swallowing after a couple hours; allergic reaction to the covid vaccine; This is a spontaneous report from a contactable consumer. A 85-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: Solution for injection), 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 andc oncomitant medications were not reported. The patient stated her mom had an allergic reaction to the covid vaccine. she believed she may be allergic to peg. She enquired if vaccine without peg would be made in future for people who cannot take it. she stated that her Mom is 85 years old and really needs this vaccine and stated if she just take a chance with it again. She has immediate hoarseness of voice and trouble swallowing after a couple hours which resolved by next day.The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Dysgeusia, Nightmare
Clinical narrative: Metallic taste strong at time of vaccine, every day afterwards sometimes with eating sometimes not with food; very vivid dreams every night-sometimes nightmares, usually don't remember dreaming at all; very vivid dreams every night-sometimes nightmares, usually don't remember dreaming at all; This is a spontaneous report from a contactable Other-HCP (patient reported herself). A 42-year-old non-pregnant female patient received BNT162B2 (COVID-19, Pfizer, Formulation: Solution for injection, Lot number: EL3247) via an unspecified route of administration on 29Jan2021 12:00 PM at single dose to her left arm for Covid-19 immunization. She was allergic to Sulfa-thrush. No Covid was tested prior or post vaccination. Concomitant medications included (BENADRYL) every night and paracetamol (TYLENOL) 1-2 times a week bef. On 29Jan2021, the patient experienced metallic taste strong at time of vaccine, every day afterwards sometimes with eating sometimes not with food, very vivid dreams every night-sometimes nightmares, usually did not remember dreaming at all. She did not take any treatment in response to the events. Outcome of the events was not recovered.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Headache; fatigue; sore arm; This is a spontaneous report from a contactable consumer (patient herself). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot Number: EL3302), via intramuscular in right arm on 05Feb2021 16:00 at a single dose for COVID-19 immunization. Medical history included Migraines and aortic valve insufficiency. Concomitant medications included acetyl carnitine hydrochloride (NEUROTIN), candesartan cilexetil (ATACAND), rosuvastatin calcium (CRESTOR), allopurinol (ELAVIL), topiramate (TOPAMAX) and calcium on unknown date. On 06Feb2021, the patient experienced headache, fatigue and sore arm. Treatment information was reported no. The outcome of the events was recovered on Mar2021.  No follow up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Nausea
Clinical narrative: Headache; Nausea; localized, large red spot where she received the injection; This is a spontaneous report from a contactable consumer. A 72-year-old female consumer(patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL9264, Expiration date: unknown) via an intramuscular route of administration in left arm on 28Jan2021 at 9:30 am as single dose for COVID-19 Immunization. The patient's medical history included Osteopenia(ongoing) diagnosed 20 years ago, patient had allergies with grasses, trees, and dust. The patient also allergic to penicillin and Succinylcholine, which is a muscle relaxer. The patient clarified she shouldn't say allergic, but more so hypersensitive. The patient reported that she took nothing but over-the-counter supplements. On 06Feb2021 patient experienced localized, large red spot where she received the injection, Headache and Nausea. The patient also stated that 9 days after vaccination she developed "COVID arm", she clarified it was a localized, large red spot where she had received the injection, she had no reaction or redness or anything else when she received the injection on 28Jan2021. After 9 days of vaccination, on 06Feb2021 (Saturday)the patient first noticed the spot at the injection site she also had a headache and nausea. She was actually awakened at 2am on 06Feb2021 by the headache. She did not notice the spot at the injection site at this time, but she wasn't looking for it. Caller didn't notice the spot until taking a shower. She confirms she recovered completely from the headache and nausea on 08Feb2021 and the spot was also gone. The patient did not require hospitalization. The outcome for the events was recovered on 08Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: horrible rash on both armpits; This is a spontaneous report received from a contactable consumer (reporting on herself). A 72-years-old female patient received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and Expiry date not reported), via intramuscular route of administration in right arm on 06Feb2021 16:00 as a single dose for COVID-19 immunization. Medical history included ongoing autoimmune thyroiditis (Hashimoto's disease) diagnosed 30 years ago. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for autoimmune thyroiditis (Hashimoto's disease) (75mg once a day). It was reported that patient was calling about the Pfizer covid vaccine. She went Saturday (06Feb2021) at 16:00 for her first dose of the shot. Within 3 hours she developed a horrible rash on both of her armpits, still has the rash. She was afraid to get the second dose. Advised to contact hcp. She was in the hospital waiting to get a lung scan, it was outpatient. For treatment she declines any, She was going to her primary doctor at 13:45 today. She was told to schedule her own second appointment which she thought was weird since most people get the second appointment with the first dose. Advised to contact facility. No history of previous immunization with the Pfizer vaccine or any other additional vaccine (within 4 weeks) that was administered on the same date as the Pfizer suspect.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Skin burning sensation
Clinical narrative: She is feeling burns in her skin; muscles hurt; her head also hurts; This is a spontaneous report from a. A contactable female consumer (patient herself) of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: Solution for injection), dose 2 via an unspecified route of administration on 10Feb2021 (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 caller got the 2nd dose yesterday. She is feeling burns in her skin, her muscles hurt, and her head also hurts. She would like to know if she can take Tylenol or not.The outcome of the events was unknown  information about lot/batch number requested.
Sex: F
Vaccine: COVID19
Symptoms: Seasonal allergy
Clinical narrative: seasonal allergy; This is a spontaneous report from a  sponsored program. A contactable consumer reported that a female patient of an unspecified age received first dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medication were not reported. The reporter stated that got the first dose 2 weeks ago, in between doses she got seasonal allergy on 2021. She was asking if it is okay to get her injection for her allergies and if it will weaken her immune system. Due dose of second shot is on the 23Feb2021. The outcome of the event was reported as unknown.   information about lot/batch number requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Pain in extremity
Clinical narrative: Loss of energy; Loss of energy; Headache; very tired; arm sore; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route of administration, administered in Arm Left on 03Feb2021 at 12:05 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's concomitant medications were not reported. The patient previously administered first of BNT162B2 on13Jan2021 for covid-19 immunisation and experienced Headache, loss of taste, very tired, arm sore. The patient experienced headache, very tired, arm sore, loss of energy on 03Feb2021 and patient again experienced loss of energy on 04Feb2021. The patient did not received any treatment for the events. The outcome of the events arm sore was reported as unknown and other events was reported as Recovered.   Information of Lot/ Batch number have been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Discomfort, Fatigue, Illness
Clinical narrative: much more sore than after the first vaccination.; she felt "off"as if she was getting sick; She felt very fatigued and weak; She felt very fatigued and weak; Her arm was very sore; pain in her neck and upper back and a sharp pain in her left axilla; tingling in her fingers when she explores the axilla; discomfort; just localized tenderness; pain in her neck and upper back and a sharp pain in her left axilla; This is a spontaneous report from a contactable nurse communicated to Pfizer sales representative. A female patient of an unspecified age received second dose bnt162b2 (Solution for injection) via an unspecified route of administration, administered in arm left on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included  first dose bnt162b2 (Solution for injection) for covid-19 immunization and had sore than after the first vaccination. On an unknown date, the afternoon after receiving the second dose of BNT162b2 in her left arm, states that she felt "off' as if she was getting sick. She felt very fatigued and weak. Her arm was very sore, much more sore than after the first vaccination. She reported that her daughter also had the same reaction as she did, with severe fatigue and feelings of being ill but with no fever and a very sore arm. The next day stated that she had pain in her neck and upper back and a sharp pain in her left axilla. She describes the pain as if 'someone injected the axilla with a long needle. When she examined the axilla, pressing into her arm pit she reported a sharp pain that radiated down her left arm and wrapped around her thumb. She also reports tingling in her fingers when she explores the axilla. The discomfort has lasted 72 hours after her vaccination. She cannot feel a lump on her axilla, just localized tenderness. The outcome of the event was recovered on unknown date and other events were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Neck pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: much more sore than after the first vaccination.; she felt "off"as if she was getting sick; She felt very fatigued and weak; She felt very fatigued and weak; Her arm was very sore; pain in her neck and upper back and a sharp pain in her left axilla; tingling in her fingers when she explores the axilla; discomfort; just localized tenderness; pain in her neck and upper back and a sharp pain in her left axilla; This is a spontaneous report from a contactable nurse communicated to Pfizer sales representative. A female patient of an unspecified age received second dose bnt162b2 (Solution for injection) via an unspecified route of administration, administered in arm left on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included  first dose bnt162b2 (Solution for injection) for covid-19 immunization and had sore than after the first vaccination. On an unknown date, the afternoon after receiving the second dose of BNT162b2 in her left arm, states that she felt "off' as if she was getting sick. She felt very fatigued and weak. Her arm was very sore, much more sore than after the first vaccination. She reported that her daughter also had the same reaction as she did, with severe fatigue and feelings of being ill but with no fever and a very sore arm. The next day stated that she had pain in her neck and upper back and a sharp pain in her left axilla. She describes the pain as if 'someone injected the axilla with a long needle. When she examined the axilla, pressing into her arm pit she reported a sharp pain that radiated down her left arm and wrapped around her thumb. She also reports tingling in her fingers when she explores the axilla. The discomfort has lasted 72 hours after her vaccination. She cannot feel a lump on her axilla, just localized tenderness. The outcome of the event was recovered on unknown date and other events were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: much more sore than after the first vaccination.; she felt "off"as if she was getting sick; She felt very fatigued and weak; She felt very fatigued and weak; Her arm was very sore; pain in her neck and upper back and a sharp pain in her left axilla; tingling in her fingers when she explores the axilla; discomfort; just localized tenderness; pain in her neck and upper back and a sharp pain in her left axilla; This is a spontaneous report from a contactable nurse communicated to Pfizer sales representative. A female patient of an unspecified age received second dose bnt162b2 (Solution for injection) via an unspecified route of administration, administered in arm left on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included  first dose bnt162b2 (Solution for injection) for covid-19 immunization and had sore than after the first vaccination. On an unknown date, the afternoon after receiving the second dose of BNT162b2 in her left arm, states that she felt "off' as if she was getting sick. She felt very fatigued and weak. Her arm was very sore, much more sore than after the first vaccination. She reported that her daughter also had the same reaction as she did, with severe fatigue and feelings of being ill but with no fever and a very sore arm. The next day stated that she had pain in her neck and upper back and a sharp pain in her left axilla. She describes the pain as if 'someone injected the axilla with a long needle. When she examined the axilla, pressing into her arm pit she reported a sharp pain that radiated down her left arm and wrapped around her thumb. She also reports tingling in her fingers when she explores the axilla. The discomfort has lasted 72 hours after her vaccination. She cannot feel a lump on her axilla, just localized tenderness. The outcome of the event was recovered on unknown date and other events were unknown.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Felt tired; This is a spontaneous report from a contactable consumer. This consumer (Patient's wife) reported for a 75-Year-old male patient that he (weight; 65.77 kg, height; 183 cm) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EN5318), NDC number, UPC number, expiry date; unknown, via an unspecified route of administration from an unspecified date to an unspecified date at single dose for covid-19 immunization. Is covid 19 vaccine a Pfizer product; Yes, covid 19 vaccine manufacturer: unspecified. Patient's medical history and concomitant medications were not reported. Patient experienced sore arm and felt tired on an unknown date. When probed for the concern, reporter stated, "Recently my husband (Name), we have different names. He went got his Covid shot with your type shot and he brought the information back home and I found this number. I do not have a computer that is why I am using this number to call and ask this question. First one I am 80 years old, I have an aortic stenosis, my heart valve not working exactly you know perfect and I wanted to know now here he had not too much of a reaction he has sore arm and felt tired this morning. He had the shot yesterday. Now I am sort of concerned about how my reactions going to be with the heart this way." When asked about receiving the shot, reporter stated, "No." Reporter stated, "First of all, I wonder why they had not called me. I am older than him and I wonder why they have not called me yet. My doctor said I am on the list but we are here in the (Place name) and that is where he went." The reporter was provided with the number of Pfizer Medical information as (Phone number) followed by option 3 and timings as 8 am to 11 pm Monday to Friday and 8 am to 8 pm on Saturday and Sunday as per EST. When paraphrased the concern, reporter stated, "Yeah but he is younger than I am he did enroll well but I am more concerned because of my heart." Email address: Reporter stated, "I do not have that right now." Height and weight: Reporter stated, "I want information for me not for him." Country of incidence: Reporter stated, "The only thing he had was the sore arm but I am not calling about him. I am calling about my heart not his experience." When told that no further probing would be done if do not want to proceed and when told about the Pfizer medical information department, caller stated, "That is mainly all I wanted was to call that number." Product details and pharmacy details could not be probed as the consumer was unwilling to complete the report. Hence limited information available over the call. The outcome of events was unknown.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pain in extremity
Clinical narrative: I did not know I was pregnant until the week after the vaccine; mild arm soreness; This is a spontaneous report from a contactable other health care professional (reported for herself). A 40-year-old pregnant female patient received first dose of BNT162B2 (COVID 19, Pfizer, Formulation: Solution for injection, Lot number: EL3302) via an unspecified route of administration on 11Jan2021 at single dose to her left arm for Covid-19 immunization. The patient's medical history included polycystic ovarian syndrome (PCOS) and Covid-19 (prior to vaccination, the patient diagnosed with COVID-19). Patient's last menstrual period date was 01Dec2020, pregnancy due date was 13Sep2021 and gestation period when reaction/event was observed in the fetus was six weeks. Concomitant medications (other medications the patient received within 2 weeks of vaccination) included metformin, minerals NOS/vitamins NOS (PRENATAL VITAMINS), curcuma longa (TURMERIC) and fish oil. Facility the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. It was reported that, first dose had no issues, mild arm soreness, she did not know she was pregnant until the week after the vaccine in 2021. On advice of her OB that she could take TYLENOL for any possible fever side effects, she decided to take the second dose. Outcome of the event mild arm soreness was recovered on an unspecified date in 2021whereas other events was unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive for COVID today; I tested positive for COVID today; This is a spontaneous report from a nurse (patient). A 46-years-old female patient received first dose of BNT162B2( PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, via intramuscular route of administration, administered in Arm Left on 19Dec2020 07:45, Lot Number: EJ1685 as single dose and second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, via intramuscular route of administration, administered in Arm Left on 05Jan2021 13:45, Lot Number: EJ1685 for COVID-19 immunization. Medical history included Autoimmune disease, psoriatic arthropathy, endometriosis, migraine, seasonal allergy, herpes ophthalmic, ocular herpes from an unknown date and unknown if ongoing. Concomitant medication(s) included estradiol, pantoprazole and acyclovir taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 for COVID-19 immunization, azithromycin and experienced drug hypersensitivity. The patient underwent lab tests and procedures which included body temperature: 100 on 17Feb2021, SARS-COV-2 test: positive on 19Feb2021 and on 17Feb2021. The patient experienced i tested positive for covid today and cannot smell on 19Feb2021 and on 17Feb2021 05:00 the patient experienced nasal congestion, headache, low grade temp (100), chills. The outcome of events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: fever; body aches; This is a spontaneous report from a contactable other health care professional (patient himself) via medical information team. A 43-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 08Feb2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that on 18Feb2021, the patient developed fever and body aches and getting a coronavirus test. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, SARS-CoV-2 test
Clinical narrative: Pain n swelling on the injection site on the left arm; Pain n swelling on the injection site on the left arm; This is a spontaneous report received from a contactable consumer (Patient). A 57-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number/ expiration date: unknown) via unspecified route of administration at left arm on 10Feb2021, 01:00 at single dose for COVID-19 Immunization. The patient's medical history included Diabetes dm. Concomitant medications were not reported. No known allergies reported. The patient did not receive any other vaccination within 4 weeks. No Covid-19 prior vaccination and covid tested post vaccination yes. On 12Jun2020 the patient was tested for COVID-19 (Nasal-swab) result negative. On 10Feb2021 at 01:00 PM, the patient had Pain and swelling on the injection site on the left arm. The patient did not receive any treatment for the event. Outcome of the event was not resolved.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 23Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date Jan2021, patient experienced arm being sore (pain in extremity). The patient reported that, in the back of card issued to her, was given time to return for second dose on 23Feb2021. The patient enquired about getting second dose, if she has to go early like she did the first time and get in line. The outcome for the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nose bleed; This is a spontaneous case from a contactable lawyer. This lawyer reporting for a female consumer. This is the second case out of the two cases. An unspecified age of non- pregnant is unknown female patient received first dose of BNT162B2 (BNT162B2, Solution for injection, Lot number: not provided), via an unspecified route of administration on unknown date at single dose for covid-19 immunisation. The patient had no family history and medical history. The patient's concomitant medications were not reported. It was reported that on unknown date I was talking to my daughter and she has a friend whose mother lives in the same area and had her first Pfizer vaccine (Unspecified Vaccine, Pfizer) and had a small nosebleed right afterwards and then when she has second vaccine, she had another, a very bad, I had no nose bleed like this before like my husband is a Physician that I never had anything like this before, this is very serious kind of situation to happen, and this after the very first vaccine that I had. So, that's what I wanted to tell you that is going on, I am not going to take second. How long I am going to wait, how long I am going to test my antibody and see that I don't have any more antibodies and go take 'Moderna'. Have you heard anything like this?". The outcome of the events was "Unknown". Information for lot/batch number was requested.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: unable to use arm because it was painful; This is a spontaneous report from a contactable consumer, the patient. A 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: FM9209), via an unspecified route of administration, in the left arm on 09Feb2021 at 4:00 PM (at the age of 88-years-old) as single dose for protection from COVID/COVID-19 immunisation. The patient had no medical history. The patient did not receive any concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient did not underwent any lab investigation. The patient did not administered any vaccines on same date of the suspect vaccine. Caller received the BNT162B2 vaccine on Tuesday afternoon on 09Feb2021. On 10Feb2021 the next morning he was unable to use his arm because it was painful. He was not able to put his coat on to go outside. Today when he woke it was 90% better and a little later it was 100% better like he had a new arm. He saw the list of reactions that painful muscles was listed. This was a lack of use of his arm because of the pain. The patient did not visit to physician office or emergency room. Outcome of the event was recovered on 11Feb2021.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Nightmare
Clinical narrative: Joint pain; Nightmares; This is a spontaneous report from a contactable consumer (patient herself). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration at the age of 59-years on 04Feb2021 at a single dose for COVID-19 immunisation. The patient's medical history included asthma and emphysema. Concomitant medications included montelukast sodium (SINGULAIR) at 10 mg for asthma, formoterol fumarate, glycopyrronium bromide (BEVESPI AEROSPHERE) at 9 mcg and beclometasone dipropionate (QVAR) at 80 mcg. Consumer stated, "I would like report some Covid side effects but I am having troubles reading my lot number, so I have to get my lot number first so then I can go ahead and report side effects." Consumer stated about lot number, "On my vaccination record I can E and I can't tell she write 1 or L and then its 9265." When probed for the side effects, consumer stated, "Beside the joint pain on an unspecified date, which I can read on my printouts it's typical, I am also having nightmares on an unspecified date." Consumer stated, "I was taking the naproxen (ALEVE) afterwards as treatment." Due date of second vaccine is 28Feb2021. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Investigation
Clinical narrative: his pulse shoot up to 118; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received bnt162b2 (BNT162B2), dose 1, via an unspecified route of administration, on 12Feb2021 (Batch/Lot Number: EL9266) as SINGLE DOSE for covid-19 immunisation.  Medical history included hypertension, type 2 diabetes mellitus, blood cholesterol abnormal, Chronic cough spread on by allergy to oak. He got oak pollen allergy that's pretty bad it causes him to cough a lot, during the allergy season, he got the chronic cough, it's been looked at, they are trying to figure it out. Prior to vaccination (unspecified date), the patient was diagnosed with COVID-19. Patient was taking other medication, for high blood pressure, type 2 diabetes and cholesterol (all unspecified "don't have the exact names"). On 12Feb2021, the patient experienced his pulse shoot up to 118; it has gotten back into the 100, it does goes up into the 90's which is high for him. Patient had lab test and procedures on an unspecified date and stated "everything was good in the blood work"The outcome of event was recovering. patient did not receive treatment for the event but he went to the hospital on Saturday to get it checked out and they told him it was likely a reaction to the shot and they said it might have been too quick and that's what they told him at the hospital, so yeah they send me home and told me to rest.  Follow-up attempts are completed. The information on the batch/lot number has been obtained.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), (Batch/Lot Number: Unknown), via an unspecified route of administration, on an unspecified date as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had side effects on an unspecified date. The patient has not had the second shot. Patient was asking "if you have an allergic reaction, does Pfizer advice you to get second shot or should not take the second shot" (further clarification unknown if consumer had an allergic reaction). Outcome of event was unknown.  Information about lot/ batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: very sore left arm; body aches; mild headache; fatigue; This is a spontaneous report from a contactable consumer (patient herself) of 42-years-old female received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and Lot number: EL3247) via an unspecified route in left arm on 26Jan2021 10:45 am and second dose on 16Feb2021 13:45 pm via unspecified route in left arm both as single dose for covid-19 immunisation. Patient medical history included overactive bladder, premature ovarian insufficiency and known allergies were reported as yes. Concomitant medications were not reported. Patient took other medications within two weeks before vaccination and had not received other vaccines within four weeks. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with covid-19 prior to the vaccination. On 16Feb2021 23:30 the patient experienced very sore left arm, body aches, mild headache, and fatigue. The patient was not tested for covid-19 post vaccination. The outcome of the events is recovering.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: Chest pain and pressure; Chest pain and pressure; Unable to gasp air and hard time breathing; This is a spontaneous report from a contactable consumer, the patient.  A 43-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration in the left arm on 22Feb2021 at 14:00 (at the age of 43-years-old) as a single dose for COVID-19 immunization. Medical history included rheumatoid arthritis. The patient had no known allergies. Concomitant medication included methotrexate from an unknown date at an unknown dose, for an unknown indication. Prior to the vaccination the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (Lot number unknown) on 03Feb2021 at 15:00  (at the age of 43-years-old) via an unspecified route of administration in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  On 23Feb2021 at 04:00 the patient experienced chest pain and pressure, the patient was unable to gasp air and hard time breathing. The events were reported as non-serious.  The patient did not receive treatment for the events. The clinical outcome of the events chest pain and pressure and unable to gasp air and hard time breathing was recovering.  It was also reported that since the vaccination, the patient has not been tested for COVID-19.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive after the first dose; tested positive after the first dose; This is a spontaneous report from Pfizer sponsored program. A contactable consumer reported similar event for two patients (mother and father). This is first of two reports. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was tested positive after the first dose on an unspecified date in 2021. Outcome of the event was unknown. Reporter was asking if they could take the second dose after they tested positive or they had to wait for a certain time before getting the second dose.  Information for lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021206551 Different product, same product/event
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: slight arm discomfort; This is a spontaneous report from a contactable consumer (patient). A 71-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, via an unspecified route of administration, administered in Arm Right on 05Feb2021 13:00 (Batch/Lot Number: EN9581) 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 administrated first dose of BNT162B2 (Batch/Lot Number: EL3249), on 15Jan2021, at 01:00 PM, administered in Left arm for COVID-19 immunisation and experienced cold/chill sensation at injection site, bleeding through bandage (ceased quickly), residual discomfort at injection site and very large bruise at injection site. The patient experienced slight arm discomfort on an unspecified date. The report considered as a non serious. The outcome of the event was reported as unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: Sore arm extending up to neck; Sore arm extending up to neck; fatigue; This is a spontaneous report from a contactable nurse reporting for herself.  A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 25Feb2021 at 12:30 (at the age of 57 years old) (Batch/Lot Number: EL3247) as a single dose for COVID-19 immunisation.  Medical history included sjogren's syndrome from an unknown date, breast cancer female with radiation from an unknown date, cholecystectomy from an unknown date, right knee arthroscopic surgery for chondromalacia from an unknown date, bilaterial fusion L4/L5 from an unknown date, vertigo from an unknown date, and allergy to bee sting from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included hydroxychloroquine sulfate (PLAQUENIL) taken for an unspecified indication, start and stop date were not reported; vitamin d nos (VITAMIN D NOS) taken for an unspecified indication, start and stop date were not reported; berberis vulgaris root, camellia sinensis leaf extract, coptis chinensis root, curcuma longa rhizome, fallopia japonica root with rhizome, origanum vulgare leaf, rosmarinus officinalis leaf, scutellaria baicalensis root, zingiber officinale rhizome (ZYFLAMEND) taken for an unspecified indication, start and stop date were not reported; glucosamine (GLUCOSAMINE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced sore arm extending up to neck on 25Feb2021 at 17:00 with outcome of recovering, and fatigue on 25Feb2021 at 17:00 with outcome of recovering. Treatment was not received for the events. It was also reported that since the vaccination, the patient had not been tested for COVID-19.