chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality sleep
Clinical narrative: Overnight started to feel minor chills; Joint aches; Tiredness; A bit of a temperature; Did not sleep well; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number EP-6955) via an unspecified route of administration, administered arm left on 24Mar2021 11:45 (age at the time of vaccination 58 years) as dose 2, single for COVID-19 immunisation at workplace clinic. The patient's medical history included high blood pressure and cholesterol. List of any other medications the patient received within 2 weeks of vaccination included lisinopril, atorvastatin (LIPITOR), multivitamin, acetylsalicylic acid (ASPIRIN LOW), multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no allergies to medications, food, or other products. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. He was not diagnosed with covid-19 prior vaccination. The patient experienced on 25Mar2021 at 4:00, overnight started to feel minor chills, joint aches and tiredness. He did not sleep well last night, woke up this morning with chills and a bit of a temperature. He was not received treatment received for the adverse event. Since the vaccination, the patient was not tested for COVID-19. The patient underwent lab test and procedure included body temperature: a bit of a temperature on 25Mar2021. Event took place after use of product. The outcome of chills, joint aches and tiredness was recovering and outcome for other events was unknown.  No follow-up attempts were needed. No further information was expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Allergic reaction; Hives; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: ER8727, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 20Mar2021 (at the age of 52-years-old) as dose 1, single for COVID-19 immunisation. The patient has no relevant medical history. Concomitant medications included metformin taken for an unspecified indication, start and stop date were not reported. On an unspecified date in Mar2021, the patient experienced allergic reaction and hives. It was further reported that the approximately 8 hours after the vaccine, the patient had an allergic reaction and some hives. He contacted his primary physician and was told to take Benadryl as treatment which he did. He was recommended not to take the second dose but asked him to call in report the side effects. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: little bit of itching on skin; This is a spontaneous report from a contactable consumer (patient).   A 51-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date, at the age of 51-years-old, (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced have a little bit of itching on skin. The outcome of the event was unknown.  No treatment was received for the events.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Bone disorder, Dizziness, Erythema, Feeling abnormal
Clinical narrative: Asthma; Osteoporosis; She hurt a bone on her spine; She checked her face for swelling and noted it was bright red like a sunburn; She checked her face for swelling and noted it was bright red like a sunburn; Inside her nose it felt funny, and in the outside of her eyes it felt funny; Her tongue felt a little roughed up; Felt woozy; Trouble seeing a little bit; This is a spontaneous report from a Contactable Consumer (patient).   A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration on 24Mar2021 as single dose for COVID-19 immunization. Patient had no relevant medical history. The patient's concomitant medications were not reported. The patient got the first dose of the Pfizer Covid 19 vaccine yesterday and experienced asthma, osteoporosis, hurt a bone on her spine and takes prolia shots. The patient received the first dose and waited 15 minutes and they told her she could leave. While the patient was driving, inside her nose it felt funny and in the outside of her eyes it felt funny, the patient checked her face for swelling and noted it was bright red like a sunburn. The patient took Benadryl and her tongue felt a little roughed up and the patient did not had trouble breathing but felt woozy, had trouble seeing a little bit but stated it might had been complicated by the Benadryl since the patient never takes that medication. The patient get the second dose if the patient takes a Benadryl before the shot. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Osteoporosis, Swelling face, Tongue disorder, Visual impairment
Clinical narrative: Asthma; Osteoporosis; She hurt a bone on her spine; She checked her face for swelling and noted it was bright red like a sunburn; She checked her face for swelling and noted it was bright red like a sunburn; Inside her nose it felt funny, and in the outside of her eyes it felt funny; Her tongue felt a little roughed up; Felt woozy; Trouble seeing a little bit; This is a spontaneous report from a Contactable Consumer (patient).   A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration on 24Mar2021 as single dose for COVID-19 immunization. Patient had no relevant medical history. The patient's concomitant medications were not reported. The patient got the first dose of the Pfizer Covid 19 vaccine yesterday and experienced asthma, osteoporosis, hurt a bone on her spine and takes prolia shots. The patient received the first dose and waited 15 minutes and they told her she could leave. While the patient was driving, inside her nose it felt funny and in the outside of her eyes it felt funny, the patient checked her face for swelling and noted it was bright red like a sunburn. The patient took Benadryl and her tongue felt a little roughed up and the patient did not had trouble breathing but felt woozy, had trouble seeing a little bit but stated it might had been complicated by the Benadryl since the patient never takes that medication. The patient get the second dose if the patient takes a Benadryl before the shot. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Oropharyngeal discomfort, Pain in extremity
Clinical narrative: fatigue; pain in her arm; short of breath; throat feels closed up, a little sore, scratchy and horse; This is a spontaneous report from a contactable consumer or other non hcp. A 55-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on 21Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient had the first dose of the Pfizer Covid 19 vaccine on Sunday.  Sunday night she began having fatigue.  Monday she had pain in her arm that has now subsided. Late Tuesday into Wednesday she felt short of breath, throat feels closed up, a little sore, scratchy and horse.  Yesterday she felt fine and was able to go running. Outcome of the events fatigue, pain in extremity was unknown, for the events oropharyngeal discomfort, dyspnoea was recovered,   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hypokinesia, Influenza like illness
Clinical narrative: chills; felt really tired; headaches; muscle pain couldn't lift his hands above his head; muscle pain couldn't lift his hands above his head; fever; nauseated; felt unwell; felt like he had the flu again; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (Age:65; unit: unknown) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient's medical history included patient covid from Oct2020 and he was hospitalized for 7 days. The patient's concomitant medications were not reported. The patient previously 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 an unspecified date as dose 1, single for covid-19 immunisation. On the 1st dose, it was a 'normal needle', he had no side effects. On an unspecified date, the patient experienced chills, felt really tired, headaches, muscle pain couldn't lift his hands above his head, fever, nauseated, felt unwell and felt like he had the flu again. It was reported that the Patient would turn 66 on 28Mar2021. The patient had since received both doses of the Pfizer covid vaccine. On his 2nd dose, the guy who gave him the shot 'kind of massaged it in somehow. It was un-comfortable.' After the 2nd dose of the vaccine, he felt like he had covid again. The patient wanted to know whether it was okay for the nurse to massage the injection site after administering the covid vaccine and wanted to know for how long he could experience the side effects of the covid vaccine. He asked why he only had side effects after the 2nd dose of the covid vaccine. The outcome of events was unknown for all events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, Pyrexia
Clinical narrative: chills; felt really tired; headaches; muscle pain couldn't lift his hands above his head; muscle pain couldn't lift his hands above his head; fever; nauseated; felt unwell; felt like he had the flu again; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (Age:65; unit: unknown) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient's medical history included patient covid from Oct2020 and he was hospitalized for 7 days. The patient's concomitant medications were not reported. The patient previously 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 an unspecified date as dose 1, single for covid-19 immunisation. On the 1st dose, it was a 'normal needle', he had no side effects. On an unspecified date, the patient experienced chills, felt really tired, headaches, muscle pain couldn't lift his hands above his head, fever, nauseated, felt unwell and felt like he had the flu again. It was reported that the Patient would turn 66 on 28Mar2021. The patient had since received both doses of the Pfizer covid vaccine. On his 2nd dose, the guy who gave him the shot 'kind of massaged it in somehow. It was un-comfortable.' After the 2nd dose of the vaccine, he felt like he had covid again. The patient wanted to know whether it was okay for the nurse to massage the injection site after administering the covid vaccine and wanted to know for how long he could experience the side effects of the covid vaccine. He asked why he only had side effects after the 2nd dose of the covid vaccine. The outcome of events was unknown for all events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: a rash that is on her torso/Body Rash; This is a spontaneous report from a contactable other hcp.    A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 intramuscular, administered in Deltoid Left on 05Mar2021 16:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypertension She is hypertensive, and her cholesterol is on the high side, blood cholesterol abnormal from an unknown date and unknown if ongoing She is hypertensive and her cholesterol is on the high side. Concomitant medication in not reported.  Caller received the second dose of the Covid vaccine and reports a week and a half after administration, she is experiencing a rash that is on her torso. Caller states that she has never had it on her face and consulted with her doctor. Caller states that she does not have discomfort, the rash is only an annoyance. Caller asked if there has been any report of body rash after receiving the Covid vaccine. ER or physician's office required.  She was concerned because it did not get better.  She made an appointment with her PCP yesterday.  They gave her a Steroid injection.  She does not remember the name of the steroid injection and did not have a dose, lot or expiration.  She was using topical ointment to see if it helped, and it did not. It was Triamcinolone 0.1%.  She does not have a dose, lot or expiration.  They were just getting it ready for her at the pharmacy.  There was no dose, just put thin coating on area twice daily.  She used it all and does not have a sample to send. Description of complaint: She does not remember the name of the steroid injection and did not have a dose, lot or expiration.  She was using topical ointment to see if it helped, and it did not. It was Triamcinolone 0.1%.  She does not have a dose, lot or expiration.  They were just getting it ready for her at the pharmacy.There was no dose, just put thin coating on area twice daily.  She used it all and does not have a sample to send. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: was just tired; a little bit of headache, nothing too crazy; Sore throat; Diarrhea; Sore throat hurt and making me cough a lot; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EP7534, Expiry date: unknown) via an unspecified route of administration in the left upper arm on 20Mar2021 as a single dose for covid-19 immunization. Medical history included none. The patient's concomitant medications were not reported. On 21Mar2021, night after first dose of the covid shot patient was just tired, experienced a little bit of headache, nothing too crazy, not quite herself, she could function most out of the day, today she woke up and she a little bit sore throat and she was having with fluid. She was more concerned about the first dose as her sore throat hurt, making her cough a lot. Patient also had diarrhea a couple of times. So patient was not sure that she should be concerned or normal. She would like to know if this was like normal side effects. The second dose of bnt162b2 was due on 10April 2021. Therapeutic measures taken as a result of the events included treatment with Tylenol 500 mg like 2 hours ago, she took one Tylenol today for tiredness, a little bit of headache and sort throat. The clinical outcome of all events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Broke out in a rash and heard people say that is normal.; This is a spontaneous report from a contactable consumer (patient) reported for herself.  A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at an unknown route on an unknown date, dose number unknown, single for COVID-19 immunization. The patient was allergic to bactrim, nickel and gold from an unknown date and unknown if ongoing. The patient medical history were not reported. The concomitant medications included baby aspirin. The patient had broke out in a rash and heard people say that is normal. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin irritation
Clinical narrative: rash under her breasts, on her back, her thighs, and up on her stomach; itching and scratching; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6208, Expiration date: Unknown), via an unspecified route of administration, administered in arm right on 07Mar2021 at 10:45 (age at vaccination was 68 years) as DOSE 1, SINGLE for covid-19 immunisation. Vaccine was not administered at facility. No additional vaccine was administered on same date of the pfizer suspect. No prior vaccination within 4 weeks. Medical history was not reported. Concomitant medications included hydrochlorothiazide taken for blood pressure abnormal, fluticasone propionate (FLOVENT) taken for lung disorder; both from an unspecified start date and ongoing. Additional context stated, the patient took the Pfizer shot on 07Mar2021 and it didn't affect her right then and then on 09Mar2021 the patient started breaking out in a rash and ever since she had been breaking out on her body constantly. She stated that the rash was under her breasts, on her back, her thighs, and up on her stomach. She also experienced itching and scratching. The rash was getting worse. The patient did wind up going to the doctor and got some medicine to help with the itching and stuff. On 21Mar2021, the patient went to see a doctor at an urgent care and was prescribed Prednisone tablets and a cream. On an unspecified date in Mar2021, reported as last night, it was the first time that the patient got a good nights sleep since she started Prednisone and the cream. She stated that she was itching again on an unspecified date in Mar2021 (reported as this morning) and took Prednisone and put the cream on again. Events resulted in visit to physician's office. No investigation assessment was reported. Therapeutic measures were taken as result of the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Formication, Headache
Clinical narrative: nausea; slight headache; bad body aches; chills; fever; I felt like the flu/ Flu like symptoms; My body has that creepy crawly feeling; Mainly feels like body and joint ache; Fatigue; This is a spontaneous report from a contactable consumer or other non hcp.    A 64-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications. It was reported that, Consumer stated, had my second Covid-19 vaccine the Pfizer on Monday morning. It is third day, and still experiencing side-effects, is that normal to have 3 days later I still have flu like symptoms, Chills, Fever, my fever does get down, mostly body aches, chills and headache, a very mild headache, but mainly feels like body and joint ache, fatigue, again my fever did get away when I took Tylenol just wanted to know if it is normal because had it on Monday here it is Thursday and feel like it's just the side-effects. Consumer stated, On Tuesday felt the flu persisting all day. Yesterday went to work and I didn't had fever but had body chills, still have Body aches, chills, fatigue and slight headache. Consumer stated, "The first night took Aspirin and Caffeine 250 mg for headache and this morning I took acetaminophen 2 tablets at once, 650 mg. That's the only thing she have taken. The outcome of the events was unknown.  follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nausea, Pain, Pyrexia
Clinical narrative: nausea; slight headache; bad body aches; chills; fever; I felt like the flu/ Flu like symptoms; My body has that creepy crawly feeling; Mainly feels like body and joint ache; Fatigue; This is a spontaneous report from a contactable consumer or other non hcp.    A 64-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications. It was reported that, Consumer stated, had my second Covid-19 vaccine the Pfizer on Monday morning. It is third day, and still experiencing side-effects, is that normal to have 3 days later I still have flu like symptoms, Chills, Fever, my fever does get down, mostly body aches, chills and headache, a very mild headache, but mainly feels like body and joint ache, fatigue, again my fever did get away when I took Tylenol just wanted to know if it is normal because had it on Monday here it is Thursday and feel like it's just the side-effects. Consumer stated, On Tuesday felt the flu persisting all day. Yesterday went to work and I didn't had fever but had body chills, still have Body aches, chills, fatigue and slight headache. Consumer stated, "The first night took Aspirin and Caffeine 250 mg for headache and this morning I took acetaminophen 2 tablets at once, 650 mg. That's the only thing she have taken. The outcome of the events was unknown.  follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: broke out into hives; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 18Mar2021 (reported as Thursday) as dose 1, single for COVID-19 immunisation. Medical history included that the patient normally gets hives when she gets a virus, that was how the virus processes out of her body. She also got the virus from different allergic reactions and penicillin and sulfa antibiotics and she could not take those medications anymore. The patient's concomitant medications were not reported. The patient reported that she got the COVID-19 vaccine on 18Mar2021 (Thursday). On 20Mar2021 (Saturday) morning, she broke out into hives. The patient stated that she was nervous about going back for the second vaccine since she had hives this time around. The patient called the health department, but they were no help and they told her because it was so new and they did not have a lot of data, they were not sure what she should do. She also spoke with the pharmacist. The patient stated that she was told they (the pharmacist) do not think she should receive the second vaccine. The patient was told to contact Pfizer. The patient was worried about the anaphylactic thing, the second one had a lot more side effects, the first one was kind of easy to get through. The patient wanted to know if she should get the second vaccine, and she did not know if she should. The outcome of the event broke out into hives was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Fatigue, Insomnia
Clinical narrative: 2 days after vaccine lost sense of taste badly Lasting loss for now Unable to enjoy food Some loss of smell too Mild : tired , can't sleep; 2 days after vaccine lost sense of taste badly Lasting loss for now Unable to enjoy food Some loss of smell too Mild : tired , can't sleep; 2 days after vaccine lost sense of taste badly Lasting loss for now Unable to enjoy food Some loss of smell too Mild : tired , can't sleep; 2 days after vaccine lost sense of taste badly Lasting loss for now Unable to enjoy food Some loss of smell too Mild : tired , can't sleep; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 54-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 22Mar2021 14:00 (at the age of 54 years) (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included no from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Mar2021, 2 days after vaccine, the patient experienced lost sense of taste badly Lasting loss for now Unable to enjoy food Some loss of smell too Mild: tired, can't sleep. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was not recovered at the time of report.  Information about lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hordeolum
Clinical narrative: I've had eye styes after each dose of covid-19 vaccine; This is a spontaneous report from a contactable pharmacist (patient). A 37-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: unknown) via an unspecified route of administration on 27Feb2021 at 11:00 (at the age of 37-years-old) in left arm as a single dose for covid-19 immunization and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EP6955) via an unspecified route of administration on 20Mar2021 at 11:00 (at the age of 37-years-old) in left arm as a single dose for covid-19 immunization. The patient medical history was not reported. Patient had no known allergies and illness. There were no concomitant medications. No other vaccines were given within 4 weeks or no other medications were given within 2 weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination the patient had not been tested for covid-19. On 20Mar2021 at 19:00, the patient experienced eye styes after each dose of covid-19 vaccine. Symptoms include swollen red eyelids, pain in the eyelids, crusty discharge around the eye in the morning. The patient did not receive any treatment. The clinical outcome of the event was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Eating disorder, Haemoptysis, Pain
Clinical narrative: He is coughing up blood; He is doubled over in pain and can't eat.; Having really bad stomach pain and cough/very strong abdominal pain; He is doubled over in pain and can't eat.; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EN6205, Expiry date: unknown) (age at the time of vaccination was 61 years), administered in Arm Right on 24Mar2021 at 15:00 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included heart attack no investigation was done, sleep, blood pressure high, reflux. Concomitant medications included amlodipine for blood pressure high, esomeprazole for reflux, aspirin for heart attack and trazodone for sleep, blood thinner, mood drug. The patient did not take any other vaccine in four weeks prior COVID -19 vaccine. The patient received Pfizer COVID vaccine first dose on 24Mar2021 at 15:00 PM in the right arm and has been having really bad stomach pain at around 11:00 PM and cough. On 25Mar2021, the patient was coughing up blood at around 04:00 AM. It was bright red, all blood and more than streaks about once an hour whenever he feels like he has to give a deep cough. The patient planning to receive the next dose on 14Apr2021 at 15:00. Adds he was having double over in pain and can't eat. Stated he tried to eat some cereal but it hurt his stomach even worse. States he didn't think it was bad enough to go to the emergency room unless his wife makes him. Advised the patient to consult his physician about seeking medical help. The outcome of the event he is doubled over in pain and can't eat was unknown and other events were not resolved.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pyrexia, Somnolence, Vaccination site pain
Clinical narrative: extreme exhaustion; cannot get out of bed and is sleeping all the time; had normal pain at her injection site; slight fever; some joint aching; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 62-years-old female patient received first dose of bnt162b2(PFIZER-BIONTECH COVID -19 VACCINE, Solution for injection, Lot Number and Expiry date was not reported) via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. It was reported that patient was experiencing extreme exhaustion. She had to call in sick to work as she was not able to get out of bed and was sleeping all the time. She wanted to know if this was normal and if it might be the same after her second vaccine. She states she had normal pain at her injection site, a slight fever and some joint aching like the flu, but not after the vaccine, but the exhaustion was so not like her as she normally had a lot of energy. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Eye pain, Inflammation, Insomnia
Clinical narrative: feels discomfort even touching her eyelashes; pain in the back of an eye; she could not sleep due to the eye pain; soreness in her arm; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 22Mar2021 (at the of 65 years) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 22Mar2021 the patient experienced soreness in her arm. On 24Mar2021 pain in the back of an eye, she could not sleep due to the eye pain, feels discomfort even touching her eyelashes. The outcome of the events was soreness in her arm recovered on 23Mar2021, pain in the back of an eye not recovered, she could not sleep due to the eye pain, feels discomfort even touching her eyelashes unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: low-grade fever after the first dose, 99.3°F; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported via an unspecified route of administration on an unspecified date at a Dose 1, Single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced low-grade fever after the first dose, 99.3 degree Fahrenheit. The reporter had scheduled for the second dose of Pfizer's COVID-19 vaccine on 02Apr2021. Around that time, she was also due for Prolia injectable, a biologic which she gets every 6 months. She queried if there an interval to wait and if she can take NSAIDS. The patient underwent lab tests and procedures which included body temperature: 99.3 degree Fahrenheit on an unknown date. The reporter consider event as non-serious. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphonia, Eye swelling, Fatigue, Lip swelling, Swelling
Clinical narrative: swelling in his eyes & lips; swelling in his eyes & lips; hoarseness in his throat/hoarse throat and voice; swelling in this neck; little fatigue; This is a spontaneous report from a contactable consumer (patient's wife) reported for a patient. A 74-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER7613, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 22Mar2021 at 10:00 am (age at vaccination was 74 years) as dose 2, single for COVID-19 immunization. The patient did not have any medical history. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was 74 years) as dose 1, single for COVID-19 immunization and experienced hoarseness in the throat and swelling to eyes and lips and neck. The vaccine was not administered at facility. There was no history of any previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines were administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the Pfizer-BioNTech COVID-19 Vaccine second dose last Monday, 22Mar2021. On 25Mar2021 at 3:00 am (morning), the patient had some swelling in his eyes & lips, hoarseness in his throat/hoarse throat and voice and swelling in his neck. The patient also had a little fatigue but took Benadryl. The patient noticed that he had swelling to his eyes, lips and down on his neck. He had hoarseness in the throat and his voice was also hoarse. The reporter noticed that after she talked to him that morning. He had not had any treatment for that event. That happened before, about 3 weeks ago also but she blamed it on a powerbowl, it had seaweed and all kinds of stuff like that in it for health, she just dismissed it. Now it had happened again. The reporter asked, that may not be related, but if it was, it would be a relief and wanted to know when one gets the COVID shot was it possible to get the reaction several days after. The patient had that reaction about 3 weeks ago for him but the reporter didn't document it then. The reporter wasn't sure if this was related to the vaccine but she thought it was weird. The reporter added that they both took Benadryl when they got home on 22Mar2021 after both receiving the second vaccine dose. The adverse events did not require a visit to Emergency Room or Physician Office. No relevant tests were done. The outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# and expiry date: not reported), via an unspecified route of administration, on Mar 6, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unspecified date in Mar 2021, patient experienced neck and shoulder pain. Caller wanted to know if the patient could take prednisone for their neck and shoulder pain (after the first dose of the Pfizer COVID-19 vaccine and while the patient gets second dose). Patient will be having the 2nd dose Mar 27, 2021. Outcome of the event: unknown. No follow-up attempts needed. Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pharyngeal paraesthesia, Swelling face
Clinical narrative: Mild face swelling; Tingling in throat; This is a spontaneous report received from contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received 1st dose in the morning, then  in the afternoon they had some mild face swelling and tingling in throat. She did have a dentist appointment that afternoon and they referred her to the ER. The ER did not document any anaphylactic reaction. The patient was fine and they sent her home. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Rash, Urticaria
Clinical narrative: hives; rash; inflammation; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 07Mar2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced hives, rash and inflammation on 14Mar2021. The patient received treatment for the events where she was already taken medications (unspecified). Reporter wants to know if it would be okay if she receives the 2nd dose 4 weeks after the 1st dose instead. The outcome of all the events not recovered.   No follow-up attempts are possible; information about lot/batch cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Pruritus
Clinical narrative: chest tightness; systemic itching; This is a spontaneous report from a contactable other health care professional (Nurse). A female patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. Patient's relevant medical history included anaphylactic response to vinegar from an unknown date and unknown if ongoing. Concomitant medications were not reported. On an unspecified date, after getting the first dose of the bnt162b2 vaccine, the patient had developed chest tightness and systemic itching 30 minutes after. Therapeutic measures were taken which was given herself with Benadryl and Albuterol for her reactions experienced. Patient wanted to know if the Pfizer COVID-19 vaccine has vinegar components in it. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: right shoulder and left knee are experiencing moderate pain; This is a spontaneous report from a contactable consumer (patient). A 37-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP6955) via an unspecified route of administration, administered in Arm Left on 24Mar2021 02:15 (at the age of 37-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Not allergies reported. The patient experienced right shoulder and left knee are experiencing moderate pain on 25Mar2021 08:00. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site pain
Clinical narrative: arm vaccine was injected into hurting really bad; itching in arm, chest, and back; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration on 12Mar2021 (Batch/Lot number was not reported) as Dose1, Single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in 2021, the patient had experienced bad itching. She added that on arm vaccine was injected into was hurting really bad for a few days and had itching in arm, chest, and back. She wanted to know what this itching could be and then it dawned on her that when talking to somebody else who had adverse reaction to a different shot that this could be a reaction to this shot. She added that she lives alone, and nobody had been in her house in a year, and she only goes to her mothers. She stated it had to be a reaction to the shot. She enquired whether she could take Benadryl or if she should visit her physician. She was a retired principal and had been secluded in her home for a year. She added that this was not bed lice and not scabies and that she had not been to a hotel. Patient stated that itching started on her back. Her arm hurt really bad, and it was in pain. After 3 or 4 days then her arm stopped hurting and the itching began. Itching was not as prominent on her arm as it was on her chest. She queried if anybody had experienced the same side effect. At the time of this report, the outcome of event arm vaccine was injected into hurting really bad was recovered on an unknown date in 2021 and itching in arm, chest, and back was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Epistaxis, Muscle twitching
Clinical narrative: eye and muscle twitching; muscle twitching in her arms and behind her legs/twitching behind her calf and thigh. Every once in a while she feels a twitch twitch kind of thing; nosebleeds; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6198, expiry date: Jun2021) via unspecified route on an unknown date as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer-BioNTech COVID-19 vaccine. The patient experienced symptoms like eye and muscle twitching with nosebleeds. She specified the nosebleed occurred twice, while her eye and muscle twitching are still happening. She added the muscle twitching was in her arms and behind her legs. It was reported that side effects were a couple of times she had a nose bleed and then she has been feeling like a little eye twitching and the same twitching behind her calf and thigh. Every once in a while she feels a twitch twitch kind of thing. She asked if she should receive the second dose of the vaccine given her reaction to the first. She specified her doctor recommended her to call Pfizer. The outcome of the events eye and muscle twitching and muscle twitching in her arms and behind her legs was not resolved and outcome of the event nosebleeds was unknown.  No follow up attempts are possible. No further information was expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cold sweat, Fall, Feeling cold
Clinical narrative: she fell/ended up on the floor; cold sweat; shakes were a little bit better/hard shakes; couldn't get warm; chills; fever; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 71-year-old female patient received bnt162b2 first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6203, Expiration date: unknown) as single dose, administered in Arm Right on 05Mar2021 13:00 (at the age of 70-year-old), as dose 1, single for covid-19 immunisation. The Medical history and concomitant medications were not reported. No family history reported. No prior Vaccinations (within 4 weeks). On 22Mar2021 patient experienced chills, fever, shakes were a little bit better/hard shakes, couldn't get warm and on 23Mar2021 she fell/ended up on the floor, cold sweat. It was reported that scheduled to receive the second dose of the Pfizer-BioNTech COVID-19 Vaccine today, 25Mar2021. Last Monday, 22Mar2021, Caller reported to have had chills, fever (all day until night) Caller had 2 blankets on, and heaters. Caller also mentioned that she fell, and that yesterday, the shakes were a little bit better but she also had a high fever. Reports on Monday she had hard shakes, could not get warm; this went on for several hours then at midnight it went the opposite and she broke out with a cold sweat. Her temperature was 101.2. Adds on Tuesday, late afternoon the same thing happened, she had hard shakes with chills and her temperature was 101.4; then she went to the bathroom and she does not know what happened next but she ended up on the floor. Adds then Wednesday the chills and shakes were less but she still had a 102. Fever. Now she is asking for a should she get the next shot or can she wait. Clarifies she had the first dose of the Pfizer COVID 19 vaccine on 05Mar2021 at 1300 pm in the right arm. She is scheduled for the second dose today on 25Mar2021 but she does not think she can make it. Patient did not visited Emergency Room or Physician Office. The patient underwent lab tests and procedures which included body temperature: 101.2 on an unspecified date and body temperature wass101.4 on 23Mar2021 , body temperature: 102 on 24Mar2021. The outcome of event recovering for hard shakes, Chills and Fever, cold sweat was not Recovered, she fell/ended up on the floor was Recovered on 23Mar2021.  No follow-up attempts are possible. No further information is expected.