chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypersensitivity, Hypotension, Palpitations, Urticaria
Clinical narrative: Allergic reaction; broke out in hives; blood pressure was low; heart rate was pounding; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EN6203), via an unspecified route of administration, administered in left arm on 23Feb2021 (age at vaccination was 71-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history included atrial fibrillation (diagnosed two years ago; treated with unspecified medication), arthritis (diagnosed quite a while ago; probably been since the 90s), a lot of allergies (especially food allergies that come on in her 60s, she didn't have many before that, then she got old, and doesn't know what happened. The patient cannot have any dairy products at all and allergic to almost all of it), GERD (gastrooesophageal reflux disease) from an unspecified date on 2000, glaucoma from an unspecified date on 2005, nerve injury (right leg from her right total knee replacement) from 29Jan2008, and generalized anxiety disorder from an unspecified date on 2019. Concomitant medications (other products) were reported none. The patient have not had any other recent vaccinations or started any new medications. On 23Feb2021, the patient experienced allergic reaction (5-10 minutes after vaccination), broke out in hives, blood pressure was low and heart rate was pounding. It was reported that her appointment of vaccination was at 11:15. The patient took two diphenhydramine (BENADRYL) after she broke out in hives, and talked to the nurse who had her go lay down on the cot and took her blood pressure which was low. It was reported that her heart rate was pounding, but she didn't have any way to test that and neither did they. The patient's hives went away after she went home then fell asleep because of the medication and reported that she felt better. The reporter wants to know if she needs to do anything (like take diphenhydramine) before getting her second dose on 16Mar2021. The patient underwent lab test and procedure which included blood pressure with a result of low on 23Feb2021. Therapeutic measures were taken as a result of the events (allergic reaction and broke out in hives) included receiving two diphenhydramine of unknown dose (reported as normal dose that you can buy at the store). The outcome of the event broke out in hives was recovered on 23Feb2021, allergic reaction and heart rate was pounding were recovering while unknown for blood pressure was low.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin discolouration, Skin hyperpigmentation
Clinical narrative: discoloration of the skin; there are little spots,black spotches,they are not itchy but they were not there before; feeling itchy; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient (Age: 57; units: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 03Mar2021 (Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had previously received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine) on unspecified date as single dose for COVID-19 immunization. The patient received the 2nd dose of the Pfizer Covid vaccine on Wednesday, 03Mar2021. She received it in her left arm however she says on her right arm there are little spots, black splotches, they are not itchy but they were not there before skin discoloration. The patient had discoloration of the skin. She does report feeling itchy, but not in that area. The events occurred on an unspecified date in 2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Dyspnoea, Fatigue
Clinical narrative: shortness of breath; tiredness; urine turned dark; This is a spontaneous report from a contactable consumer. This consumer reported similar events for herself and her sister. This is first of two reports (for her sister).   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. The reporter's sister experienced shortness of breath, tiredness and her urine turned dark on an unknown date. She's trying to report everything and trying to find out what she could about this. She would like to know if these side effects were normal and related to the vaccine and if they have been reported. The events were reported as not serious. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021247575 same report/drug/AE, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling
Clinical narrative: swelling; redness; This is a spontaneous report from a contactable pharmacist received via regulatory authority. A non-pregnant 68-year-old female patient (reporter's mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number and Expiration date: not reported) via an unspecified route of administration, administered on the left arm on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included vitamin D3 taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. On unspecified dates, the patient experienced swelling and redness for 9 days. The patient recovered from the reported events on unspecified dates.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Sciatica
Clinical narrative: Inflammatory flare up; sciatic nerve flare up that had previously been inactive for a long period of time; Finger joint inflammation flare up; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6203), via an unspecified route of administration in left arm, on 01Mar2021 at 03:15 PM (15:15) (at the age of 39 years), as dose 1, single, for COVID-19 immunization.  The patient's medical history included lumbar herniation discectomy or laminectomy, allergies to surgical tape, sciatic nerve flare up (previously been inactive for a long period of time), finger joint inflammation, and minor injuries. The patient's concomitant medication included levocetirizine dihydrochloride (XYZAL). The patient previously took codeine and doxycycline and experienced allergies to both medications. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. On 03Mar2021 at 07:00 AM (48 hours after receiving the first dose of COVID-19 vaccine), the patient experience an inflammatory flare up only in areas where she had previous injuries such as a sciatic nerve flare up that had previously been inactive for a long period of time and a finger joint inflammation flare up in the area. The patient had previously had minor injuries. Treatment to the events included NSAID medication. The patient has not been tested for COVID-19 post vaccination. The patient was recovering from the events.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Rash, Vaccination site swelling
Clinical narrative: Swollen vaccination site; rash; redness; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9269), via an unspecified route of administration, administered in arm left on 25Feb2021 15:00 (at the age of 80-years-old) as dose 2, single for covid-19 immunisation. The patient medical history included blood pressure and diabetes. There were no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as 1st dose for covid-19 immunisation. The patient previously took tetratcycline, and experienced allergy. On 03Mar2021, the patient experienced swollen vaccination site, rash and redness. No treatment was received for the reported events. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Dizziness
Clinical narrative: feeling extremely dizzy; I could not get the taste of food; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 03Mar2021 02:30 (Lot Number: EN6203) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history was reported as none. Patient had no allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 03Mar2021, the patient was feeling extremely dizzy and could not get the taste of food the first two days. Patient was feeling less dizzy on  05Mar2021. No treatment was received for the events. At the time of report, the patient was recovering from the events.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on leg; This is a spontaneous report from a contactable consumer (patient's relative). An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration on an unspecified date (lot number was not reported) as dose 1, single for COVID-19 immunization. Medical history included urinary tract infection. Concomitant medication included unspecified antibiotic taken for urinary tract infection. On an unspecified date, after the vaccination, the experienced rash on leg. The reporter wanted to know are rashes reported or a potential risk of the vaccine. The 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Pruritus
Clinical narrative: Itching on scalp, inside ears, and inside nose.  It started about 20 minutes after injection. I asked the woman that was in the observation area if I could take an Allegra if these symptoms continued.; This is the reaction the patient normally have to some medications that she is allergic to; This is a spontaneous report from a contactable consumer.   A non-significant 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 15Feb2021 16:00 (Batch/Lot Number: EL9266) as dose 1, single (at the age of 64 years old)  for COVID-19 immunisation.  Medical history included none. Concomitant medication included pravastatin taken for an unspecified indication, start and stop date were not reported. On 15Feb2021 16:30, the patient experienced itching on scalp, inside ears, and inside nose. It started about 20 minutes after injection. The patient asked the woman that was in the observation area if she could take an ALLEGRA if these symptoms continued. They were mild. The patient took an ALLEGRA and 20 minutes later the itchiness was gone. This is the reaction the patient normally have to some medications that she is allergic to. No COVID prior to vaccination and after vaccination. The outcome of the events was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Petechiae, SARS-CoV-2 test
Clinical narrative: rash/petechial rash on both legs/rash appeared as flat red dots; This is a spontaneous report from a contactable consumer (patient). A 75-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in arm left on 23Feb2021 at 10:30 (at the age of 75-years-old) as dose 2, single for COVID-19 immunisation. Medical history included osteoarthritis and penicillin allergy from an unknown date. Concomitant medications included estradiol and omeprazole taken for an unspecified indication, start and stop dates were not reported. The patient previously took amoxicillin;clavulanic acid (AUGMENTIN) and experienced allergies. The patient previously received the first dose of bnt162b2 (Batch/Lot Number: EL9264), administered in left arm on 02Feb2021 at 01:00 PM (at the age of 75-years-old) for COVID-19 immunisation. The patient experienced rash on 27Feb2021. The event resulted in physician office visit. The clinical course was as follows: She noticed a rash on my right leg below the knee on 27Feb; on 28Feb the rash appeared on both right and left legs below my knees. The rash appeared as flat red dots that did not burn or itch. The rash spread to above the knees by 01Mar; she called my physician on 01Mar and made an appointment for 04Mar. She informed it was petechial rash on both legs. Blood tests ordered and came back normal. She was reporting this because her physician believes the rash is a side effect of the COVID vaccine she received on 23Feb. There was no treatment received for the events. The patient underwent lab tests and procedures which included blood test: normal on an unspecified date, SARS-COV-2 test (Nasal Swab and Novel Coronavirus COVID 19): negative on 03Mar2021. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Pyrexia
Clinical narrative: Under arm pain so bad cannot lift arm; Temperature of 102 Fahrenheit; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration, administered in right arm on 01Mar2021 18:15 (at the age of 70-year-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not have covid prior to vaccination. The patient previously took first dose of bnt162b2 on 09Feb2021 at 18:15 in the right arm for covid-19 immunization. The patient experienced under arm pain so bad cannot lift arm and temperature of 102 Fahrenheit on 02Mar2021. No treatment was given in response to the event. The patient was not tested for covid post vaccination. The patient had not recovered from both events at the time of the report.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Small facial rash (on upper lip); This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in arm right on 05Mar2021 14:00 (at the age of 20-years-old) as dose 1, single for covid-19 immunisation. It was unknown if the patient was pregnant at the time of vaccination. The patient had no known medical history. Concomitant medication included as prenatal vitamin. The patient experienced small facial rash (on upper lip) on 05Mar2021 18:00 with outcome of not recovered. It was unknown if the patient received treatment for the reported event.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Rhinorrhoea
Clinical narrative: nose started producing a very thick mucous; coughing; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6205, expiry date not reported), via an unspecified route of administration, administered in the right arm on 27Feb2021 15:15 (at the age of 55 years old) as dose 1, single for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medications included budesonide, and budesonide, formoterol fumarate (SYMBICORT), both taken for an unspecified indication, start and stop date were not reported. The patient previously took acetylsalicylic acid (ASPIRINE) and iodine and reported had known allergies to them. The patient was not pregnant at the time of vaccination and of the events. The vaccine was administered in the hospital. There was no other vaccine in four weeks. On 27Feb2021 at 11:00 pm, the patient's nose started producing a very thick mucous and then spent coughing every night. At the time of the report, patient was doing very well, without coughing, since patient had a batch of 5 days of prednisone just 2 weeks before. On the following day, some "head". The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient had recovered from cough on an unspecified date in 2021. The outcome of the event nose started producing a very thick mucous was recovering.   No follow-up attempts are possible No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: Chills; Body Ache; Fever 100.4F; This is a spontaneous report from a non-contactable consumer (patient) received via COVAES. A non-pregnant 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EJ1685  and Expiration date: not reported) via an unspecified route of administration, administered on the left arm on 04Mar2021 15:30 (at the age of 48 years old) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were reported as none. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. On 05Mar2021 12:00, the patient experienced chills, body ache, and fever 100.4F. The patient did not receive any treatment and recovered from the events on unspecified dates in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Psoriasis flair up; This is a spontaneous report from a Pfizer-sponsored program 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 12Feb2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 23Feb2021, she had a psoriasis flair up and was wondering about taking the 2nd dose of the vaccine on 05Mar2021. The 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.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Vaccination site mass
Clinical narrative: black bump on the injection site; his legs are itching (burning); his legs are itching (burning); This is a spontaneous report from a contactable consumer (patient's daughter) received from Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number was not reported) on 29Jan2021 for COVID-19 immunisation. The patient experienced black bump on the injection site, his legs were itching (burning) on Feb2021. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Rash
Clinical narrative: Tightness in chest; Shortness of breath; Egg size rash on arm; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 75-years-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date (lot number was not reported) as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced tightness in chest, shortness of breath, and egg size rash on arm. Therapeutic measures were not taken as result of the events. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Fatigue, Pain
Clinical narrative: soreness; fatigue; increased blood pressure; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from company (manufacturer control number: EC-2021-089016), for BNT162B2. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown) dose 2 via an unspecified route of administration in Dec2020 as dose 2, single for covid-19 immunisation. Co-suspect reported as Lenvima 05Dec2020 to 05Dec2020 at 20 mg, daily for an unspecified indication. The patient medical history included Endometrial Cancer, had mild food poisoning from eating some bad peanut butter on 27Feb2021. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown) via an unspecified route of administration as dose 1, single for covid-19 immunisation. Concomitant medication was not reported. The patient experienced soreness, fatigue and increased blood pressure. On unspecified dates patient underwent lab test and procedure blood pressure measurement: increased and then improved. The clinical outcome of events soreness, fatigue were unknown and outcome of the event increased blood pressure was resolving. After soreness, fatigue these symptoms patient was stopped taking Lenvima for about 4 days resulting blood pressure improved. The action taken for Lenvima was temporarily withdrawn on 05Dec2020.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: a little rash on the arm; This is a spontaneous report from a contactable consumer. This consumer reported similar event for two patients. This is the second of the two reports. 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 an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced a little rash on the arm on an unspecified date. The patient recovered from the little rash on the arm, which went away, on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s): PFIZER INC-2021252201 Same reporter, suspect drug, similar event; different patient
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pyrexia
Clinical narrative: Chills; Muscle aches; Fever; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received second dose on bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration, administered in the left arm on an unspecified date at 10:00 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 on an unspecified date at 14:05, via unspecified route of administration in the left arm and experienced soreness at injection (Left arm) for covid-19 immunisation, and tested positive for covid-19 three days after receiving the vaccine. On an unspecified date about 12 hours after the second dose, the patient developed chills, muscle aches, and fever of 101.30 F. The events did not require emergency room visit or physician office visit. The patient recovered from  all the events on an unspecified date about 5hrs after they developed.      No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Severe rash; spots all over the leg; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration, on 24Feb2021, as dose 1, single, for COVID-19 immunization. The patient's medical history included not had an immune system and immunoglobulins. The patient's concomitant medications included treatment with unspecified immunoglobulins (IVIG). The patient got the first COVID-19 shot last Wednesday (24Feb2021) and had a reaction in Feb2021, a severe rash. The patient went to emergency room on Friday night (26Feb2021) and they said it was something called like 'pilaris' or something like that. The patient had like spots all over the leg and they called it something, it starts with the 'P', like 'pilaris' or 'PV' or something or 'P dye' like something (patient was not sure about the name of condition). The patient did not have an immune system and goes to get an IVIG (unspecified medication) every four weeks, so the patient was wondering if he/she should go ahead with that. The patient was awake all night and wondering like if he/she should or not and asked for the company's opinion. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Eye haemorrhage, Neoplasm malignant
Clinical narrative: Severe rash; spots all over the leg; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration, on 24Feb2021, as dose 1, single, for COVID-19 immunization. The patient's medical history included not had an immune system and immunoglobulins. The patient's concomitant medications included treatment with unspecified immunoglobulins (IVIG). The patient got the first COVID-19 shot last Wednesday (24Feb2021) and had a reaction in Feb2021, a severe rash. The patient went to emergency room on Friday night (26Feb2021) and they said it was something called like 'pilaris' or something like that. The patient had like spots all over the leg and they called it something, it starts with the 'P', like 'pilaris' or 'PV' or something or 'P dye' like something (patient was not sure about the name of condition). The patient did not have an immune system and goes to get an IVIG (unspecified medication) every four weeks, so the patient was wondering if he/she should go ahead with that. The patient was awake all night and wondering like if he/she should or not and asked for the company's opinion. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This is a spontaneous report received from a contactable consumer (patient) based on the information received by Pfizer (Case ID: GI-2021-2524). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced allergic reaction. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain in extremity, Weight increased
Clinical narrative: gained weight; muscle and joint aches/ very sore muscles and joints; muscle and joint aches/ very sore muscles and joints; sore arm; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in arm, on 12Feb2021 (Batch/Lot Number: EM9809; Expiration Date: unspecified date in Jun2021) (at the age of 73 years old) as dose 1, single for COVID-19 immunisation in a clinic. Medical history included arthritis (diagnosed years ago). There were no concomitant medications. The patient reported that she has not had any other recent vaccinations or started any new medications. The patient experienced gained weight, muscle and joint aches/ very sore muscles and joints, and sore arm on an unspecified date. Clinical course was reported as follows. The patient reported that after she got her first shot, for two weeks there were no symptoms, but then her muscles were killing her. The patient reported that after she got her first dose, she started having muscle aches, almost the whole week. She said, when she first got the vaccine she had a sore arm, but other than that she was good. The patient also reported that her muscle and joint aches have got that much better that they are almost gone now, but it was almost a week. The patient reported that she has arthritis that was diagnosed years ago, but these pains were complete different. She experienced very sore muscles and joints, so she was wondering if symptoms can start that late from first shot, and if it was okay to get second shot. The patient used arthritis gel, exercised, and did hot showers as treatments for the muscle and joint aches/ very sore muscles and joints, and sore arm . The patient said that the aches were gone now, and she was like back to normal. The patient recovered from muscle and joint aches/ very sore muscles and joints, and sore arm on an unspecified date. The outcome for event gained weight was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: half of upper lip swelled; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the left arm, on 03Mar2021 09:30 (Batch/lot number: EN6205), at age 74 years old, as dose 1, single, for COVID-19 immunisation. The patient has no medical history and concomitant medications. The patient reported that he took the initial COVID-19 shot on 03Mar2021 at 9:30 AM and after he went home, he ate a bowl of jambalaya and half of his upper lip swelled. The patient wanted to know if this could be due to the vaccine. He stated that he has never had an allergic reaction to anything in his life and from where he lives, they eat a lot of different foods. The patient put something cold on his lip which prevented it from swelling any bigger, but it was still swollen. The outcome of the event was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: swollen and itchy arm; swollen and itchy arm; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in right arm on 28Feb2021 15:00 (at the age of 61-year-old)(Batch/Lot Number: SN6205) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of bnt162b2 for covid-19 immunisation on 07Feb2021. On 02Mar2021, the patient experienced swollen and itchy arm. The patient did not received treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash pruritic, Vaccination site pain, Weight
Clinical narrative: Itchy rash all over my body; Right hand was sore; the injection site was sore; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL9269; Expiration Date: 31May2021), via an unspecified route of administration, administered in right arm on 22Feb2021 10:30 (at the age of 78 years old) as dose number unknown, single for covid-19 immunisation. Medical history included Blood pressure (abnormal) from an unknown date and unknown if ongoing. Concomitant medications included lisinopril taken for blood pressure measurement (blood pressure abnormal) from 2000 and ongoing at an unknown dose (reported as 10/12.5 mg), once a day; rosuvastatin at 5 mg, once a day taken for an unspecified indication, start and stop date were not reported; and omeprazole (PRILOSEC) taken for an unspecified indication, start and stop date were not reported. The patient was also concomitantly taking, unspecified vitamins. Patient got the shot on 22Feb2021 and that was about 10:30 in the morning and then when patient woke up the next morning, 23Feb2021, patient had a rash, itchy rash all over my body. It lasted most of the day, but it was gone by the next evening. So, patient only had it for one day, the itchy rash. Patient's right hand was sore, and the injection site was sore (23Feb2021). This only lasted for one day and by that time the pain was gone. The soreness started "the next day on the arm". The sore arm was with patient for a few days. Weight on an unspecified date "was about 165." Patient did not receive treatment for events and stated, that she did not do anything. It was itchy, but she could live with it. At the time of the report, patient didn't have a sore arm now, and patient didn't have a rash now. The rash, maybe 24 hours and the rash was gone. The event itchy rash recovered on 24Feb2021, while the events right hand was sore and the injection site was sore were recovered on an unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Broke out with a rash starting at her shoulder down to her elbow; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration in Feb2021 (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Feb2021, after the vaccination, the patient broke out with a rash starting at her shoulder down to her elbow. The patient wanted to know if its normal or not. The 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.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nasopharyngitis, Sneezing
Clinical narrative: sneezing; chills; colds; This is a spontaneous report from a Pfizer sponsored program COVAX Support. A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient stated that he was supposed to get the 2nd dose but he was experiencing sneezing, chills and colds. The outcome of the events was unknown.   No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inflammation, Rash
Clinical narrative: rash appeared on my chest/ spread first to my back, then my arms, and eventually my legs/ rash on my body; face turned red and inflamed; face turned red and inflamed; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via an unspecified route of administration, administered in the left arm on 02Mar2021 09:00 (at the age of 72-year-old) as single dose for covid-19 immunisation. The patient's medical history was not reported. The patient did not have covid prior to vaccination. The patient was not pregnant at the time of vaccination. The patient was taking an unspecified concomitant medication. The patient previously took bnt162b2 for covid-19 immunization and patient experienced headache in the evening after the first shot. It was reported that headache in the event went away with Tylenol and another headache in the morning that also went away with Tylenol. The patient also previously took Tylenol for headache and erythromycin and experienced drug allergy. It was reported that on 02Mar2021 at 15:00 reported as about six hours after the second shot, her face turned red and inflamed. About 4 hours later a rash appeared on her chest which took about 12 hours to spread first to her back, then her arms, and eventually her legs. Now, 48 hours later, her face was a little better, but the rash on her body remained. It does not itch. No treatment was given in response to the event. Patient was not tested for covid post vaccination. The patient was not recovered from rash while recovering from face turned red and inflamed.    No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular, Urticaria
Clinical narrative: large red raised rash/welt; large red raised rash/welt; large red raised rash/welt; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received second dose of BNT162B2 (brand=Pfizer), lot number: EL9266, via an unspecified route of administration in the left arm on 16Feb2021 as single dose for COVID-19 immunisation. No relevant medical history. No covid prior vaccination. No known allergies. Concomitant medication included sodium chloride (MURO 128) eye ointment. The patient previously received first dose of BNT162B2 (brand=Pfizer) for COVID-19 immunisation on 21Jan2021 05:45 PM (lot number: EL3247). With the first vaccine, it was extremely painful and she was unable to move her arm for several days on 23Jan2021 12:00 AM. About 2 days after vaccine (18Feb2021), a large red raised rash/welt appeared on upper left arm. No treatment for the events. No covid test post vaccination. The patient recovered from all events on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Peripheral swelling
Clinical narrative: arm got really sore and it swelled up; arm got really sore and it swelled up; joint hurt; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced arm got really sore and it swelled up and joint hurt and it lasted 2 days. The patient just wondered if the other one will be worse than this one. The outcome of the events was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Ocular hyperaemia
Clinical narrative: Under eye redness; dry skin; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 02Mar2021 17:15 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 09Feb2021 17:00 for COVID-19 immunisation. On 03May2021, the patient experienced under eye redness and dry skin. No treatment was received for the events. Vaccination facility type was pharmacy/drug store. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and has not been tested for COVID post vaccination. The 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: Epistaxis
Clinical narrative: First nose bleed ever and it was a big one. I thought it was dry air but another one of my friends had the same thing happen to her; This is a spontaneous report from a contactable consumer. This consumer reported similar events for himself and his friend. This is the second of two reports.   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced first nose bleed. It was reported that " First nose bleed ever and it was a big one. I thought it was dry air but another one of my friends had the same thing happen to her." The outcome of the event was recovered. The patient did not have COVID prior vaccination. The patient was not COVID tested post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021240217 Same report/drug/AE, different patients
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Tightness of chest; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 02Mar2021 13:00 (Batch/Lot Number: EL9269) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Uterine Cancer (treated with surgery followed by chemotherapy). The patient's concomitant medications were not reported. On 02Mar2021 13:45, the patient experienced tightness of chest. The patient did not receive treatment for the event. The outcome of the event was recovered. The patient did not have COVID prior vaccination. The patient was not covid test post vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Pain in extremity
Clinical narrative: Armpit is hurting; I had pain in my arm for a day; This is a spontaneous report from a Pfizer-sponsored program COVAX Support. A contactable male consumer reported for himself.  A male patient of 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 an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced Pain under her armpit and pain in arm for a day. The patient stated that her armpit is hurting due to the side effect after getting the dose of the Pfizer Covid-19 Vaccine. The patient stated that she got her COVID vaccine, Pfizer shot last Thursday and she just been having pain under her armpit since then she was wondering is that normal. The patient had pain about a week. The reporter confirmed and stated that pin under armpit when she got the vaccine, she had pain in her arm for a day. The out-come of the events were unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait inability
Clinical narrative: severe hip joint pain; wasn't able to walk; This is a spontaneous report from a contactable other health professional (patient). A non-pregnant 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 22Feb2021 at 15:15 (Batch/Lot number was not reported; at the age of 82 years old) as dose 1, single for COVID-19 immunisation.  Medical history included chronic back pain and 25-year breast cancer survivor. No known allergies. Concomitant medication included atenolol and unspecified statin medication. No history of COVID prior to vaccination and has not been tested for COVID post vaccination. No other vaccine in four weeks. The patient experienced severe hip joint pain and wasn't able to walk on 23Feb2021 at 09:00 am. It eased off on the third day, and it was gone by the end of the fourth day. The patient did not receive treatment for the events. The patient recovered from the events in Feb2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.