chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Malaise, Neck pain
Clinical narrative: severe chills; sore throat; low grade fever never about 99.3; extremely tired; still feeling not right really blah; pus pockets and red throat; pus pockets and red throat; both sides of the neck hurt; This is a spontaneous report from a contactable consumer (patient). This consumer reported two reports, This is first of two reports. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EN6206), via an unspecified route of administration, administered in left arm on 10Mar2021 at 08:54 (at the age of 56-year-old) as dose number unknown, single for COVID-19 immunisation. Medical history included asthma, fibromyalgia, osteoarthritis, atrial fibrillation, several known allergies and several more condition. The patient had unknown concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had not been tested for COVID-19. On 10Mar2021 at 17:30, by evening the patient had severe chills during the night sore throat started, low grade fever never about 99.3 and the patient was extremely tired. On Sunday 14Mar2021, it was the first full day without a fever. Sore throat did not stop, and the patient was still feeling not right was really blank.  The patient saw the nurse practitioner on 16Mar2021. It was said that the patient had pus pockets and red throat, both sides of neck hurt in Mar2021. The patient was tested negative for rapid streptococcus test in Mar2021 and it was sent for culture. The patient did not receive any treatment for the reported events. The outcome was not recovered for the reported events.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021301225 Same reporter/product, different patient
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Oral pustule, Oropharyngeal pain, Pharyngeal erythema, Pyrexia, Streptococcus test
Clinical narrative: severe chills; sore throat; low grade fever never about 99.3; extremely tired; still feeling not right really blah; pus pockets and red throat; pus pockets and red throat; both sides of the neck hurt; This is a spontaneous report from a contactable consumer (patient). This consumer reported two reports, This is first of two reports. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EN6206), via an unspecified route of administration, administered in left arm on 10Mar2021 at 08:54 (at the age of 56-year-old) as dose number unknown, single for COVID-19 immunisation. Medical history included asthma, fibromyalgia, osteoarthritis, atrial fibrillation, several known allergies and several more condition. The patient had unknown concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had not been tested for COVID-19. On 10Mar2021 at 17:30, by evening the patient had severe chills during the night sore throat started, low grade fever never about 99.3 and the patient was extremely tired. On Sunday 14Mar2021, it was the first full day without a fever. Sore throat did not stop, and the patient was still feeling not right was really blank.  The patient saw the nurse practitioner on 16Mar2021. It was said that the patient had pus pockets and red throat, both sides of neck hurt in Mar2021. The patient was tested negative for rapid streptococcus test in Mar2021 and it was sent for culture. The patient did not receive any treatment for the reported events. The outcome was not recovered for the reported events.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021301225 Same reporter/product, different patient
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Palatal swelling
Clinical narrative: the roof of my mouth swelled and it went to my ears; her throat didn't close up; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization (age at vaccination 74-year-old). Medical history included historical allergy to IV dye (During this call she also mentioned having it) from an unknown date and unknown if ongoing and concomitant medications were not reported. The patient stated that she received her first Pfizer COVID vaccine dose on 25Feb2021 and 10 minutes afterwards the roof of my mouth swelled, and it went to her ears, her throat did not close up and so she did not go to get it checked out. But states that now she was due for her second shot, and she asked, should she take Benadryl beforehand to prevent a reaction, she spoke with her healthcare professional who was nonchalant about the whole thing, and he did not seem to care, she also asked her pharmacist who said there was not any contraindication to taking Benadryl prior to vaccination. She called now to get advice and guidance.The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: arm itchy; swelling in hands and arm; arm hurts; This is a spontaneous report from a contactable consumer or other non hcp (patient).     A 24-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 24Feb2021 14:00 as DOSE 1, SINGLE for covid-19 immunisation (age at vaccination 24 years). Medical history was none. Concomitant medication included ascorbic acid, betacarotene, biotin, calcium, chromium, colecalciferol, copper, eleutherococcus senticosus root, folic acid, iodine, iron, magnesium, manganese, nicotinic acid, pantothenic acid, potassium, pyridoxine hydrochloride, riboflavin, selenium, spirulina spp., vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (WOMEN'S MULTI [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;ELEUTHEROCOCCUS SENTICOSUS ROOT;FOLIC ACID;IODINE;IRON;MAGNESIUM;MANGANESE;NICOTINIC ACID;PANTOTHENIC ACID;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;SELENIUM;) taken for an unspecified indication from an unspecified start date and ongoing; biotin (BIOTIN) taken for an unspecified indication from an unspecified start date and ongoing. The patient experienced swelling in hands and arm, arm hurts on 25Feb2021, arm itchy on an unspecified date. Caller stated, she had swelling in hands and arm. Also when she laid on her arm it hurt and she was itchy. Therapeutic measures taken as a result of events included treatment with Tylenol and Advil. The events resulted in physician office visit. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Pain in extremity
Clinical narrative: brief minor nosebleed several hours after shot; sore arm for several days; This is a spontaneous report from a contactable consumer (patient). A 69-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 11Mar2021 at 16:15 (at the age of 69-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history included diabetes, high blood pressure, asthma and had nosebleeds when taking Naproxen; depression worsened on anti-depressives. The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Mar2021 at 20:00, the patient experienced brief minor nosebleed several hours after shot; sore arm for several days. Patient did not received treatment for events.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever; Diarrhea; Chills; Headache; Sore Throat; This is a spontaneous report received from a contactable consumer or other non hcp. A 23-years-old male patient received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot Number: EN6206), via an unspecified route of administration, administered in Arm Left on 08Mar2021 13:00,at the age of 23 years old, as Dose 1,single for covid-19 immunization.Medical history included none from an unknown date and unknown if ongoing.The patient's concomitant medications were not reported.The patient experienced fever, diarrhea, chills, headache and sore throat on 16Mar2021 12:00.The patient underwent lab tests and procedures which included sars-cov-2 test: unknown result on 16Mar2021 Covid test result=Pending.The patient had not received any other medication within 2 weeks.The patient had not diagnosed with covid prior to vaccination and was tested for covid post vaccination.The patient had not received any other vaccine within 4 weeks.The adverse event resulted in emergency room visit of patient.The outcome of the event was not recovered.The patient had not received any treatment for the event.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Fever; Diarrhea; Chills; Headache; Sore Throat; This is a spontaneous report received from a contactable consumer or other non hcp. A 23-years-old male patient received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot Number: EN6206), via an unspecified route of administration, administered in Arm Left on 08Mar2021 13:00,at the age of 23 years old, as Dose 1,single for covid-19 immunization.Medical history included none from an unknown date and unknown if ongoing.The patient's concomitant medications were not reported.The patient experienced fever, diarrhea, chills, headache and sore throat on 16Mar2021 12:00.The patient underwent lab tests and procedures which included sars-cov-2 test: unknown result on 16Mar2021 Covid test result=Pending.The patient had not received any other medication within 2 weeks.The patient had not diagnosed with covid prior to vaccination and was tested for covid post vaccination.The patient had not received any other vaccine within 4 weeks.The adverse event resulted in emergency room visit of patient.The outcome of the event was not recovered.The patient had not received any treatment for the event.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Fatigue, Pain in extremity, Rash
Clinical narrative: little bit of rash on her legs and a tiny bit on her arms; slight burning sensation on her left breast; left shoulder pain; tired; Soreness in her arm; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9265), via an unspecified route of administration in the left arm on 05Feb2021 at 10:00 (at the age of 72-years-old) as dose 1, single for COVID-19 immunization. Medical history included blood pressure abnormal and dermatitis from an unknown date and unknown if ongoing. Concomitant medication(s) included amlodipine besilate, valsartan (EXFORGE) taken for blood pressure abnormal from an unspecified start date and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient clarified that she received the first dose of the Pfizer COVID 19 vaccine on 05Feb2021 at 10:00AM in the left arm. That day she noticed soreness in her arm. Mentioned she took two Tylenol and the soreness went away. The second day (06Feb2021) she got really tired and noticed a slight burning sensation on her left breast, also reported left shoulder pain. A week after the first dose (on 11Feb2021) she had a little bit of rash on her legs and a tiny bit on her arms, but it was not noticeable, it did not itch; and it went away. The events did not result in emergency or physician room visit. Therapeutic measures were taken as result of soreness in her arm. The clinical outcome for the events was recovered for little bit of rash on her legs and a tiny bit on her arms on an unspecified date in 2021 and soreness in her arm on 05Feb2021, slight burning sensation on her left breast and left shoulder pain on 06Feb2021 and tired on 08Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Dry skin, Rash, Rash erythematous, Rash pruritic
Clinical narrative: a rash on her legs and it is almost like dermatitis; a rash on her legs and it is almost like dermatitis/; the rash is real light pale red bumps and itches like crazy from her knee cap; the rash is real light pale red bumps and itches like crazy from her knee cap; dry skin; This is a spontaneous report from a contactable consumer(Patient). A 73-years-old female consumer had receivedbnt162b2 (Pfizer-biontech COVID-19 vaccine, Solution for injection, Batch/lot number: EN6200) via an unspecified route of administration on25 Feb2021into left arm at 10:00 as DOSE 2, SINGLE for covid-19 immunization (at age of 72 years). The patient medical history had included blood pressure and concomitant medication involved Amlodipine besilate, valsartan (EXFORGE,5/160 mg; take once daily by mouth) for the blood pressure. It was reported that patient did not receive any vaccination within 4 weeks prior to vaccination. The patient did not have any family medical history. The patient previously took bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: EL9265) via an unspecified route of administration on 05Feb2021at 10:00 AM (at 72-year-old) in the left arm as DOSE 1, SINGLE for covid-19 immunization and experienced rash(on11Feb2021), soreness in her arm (on 5Feb2021), slight burning sensation on her left breast(on 06Feb2021) left arm shoulder pain(06Feb2021) and tired(06Mar2021). On Mar2021 the patient had experienced a rash on her legs, and it is almost like dermatitis/the rash is real light pale red bumps and itches like crazy from her kneecap all the way down to the ankle on both legs/also peppered on her arms, a little on both top part of her arms and dry skin. Therapeutic measures were taken as a result of AE and treatment included with moisturising cream and dermatitis cream. The patient did not visit to physician office. The clinical outcome of the events were not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Vaccination site rash
Clinical narrative: rash at the injection site and today it is 2 inches in diameter and itchy; rash at the injection site and today it is 2 inches in diameter and itchy; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on 13Mar2021 as dose 2, single for COVID-19 immunization. Patient historical vaccine included first dose of BNT162B2 (Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date for COVID-19 immunization and experienced sore arm. The patient's medical history and concomitant medications were not reported. The patient received second dose of vaccine on Saturday and experienced rash at the injection site and today it is 2 inches in diameter and itchy on an unspecified date in Mar2021. The outcome of the events was unknown.  No Follow-up attempts are possible. Information about lot/batch cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: I had the pain from the back of my "neck (hip)" (not clarified) although the way down to my "toes" (not clarified) all, except my left arm where I got the shot; I had the pain from the back of my "neck (hip)" (not clarified) although the way down to my "toes" (not clarified) all, except my left arm where I got the shot; I had the pain from the back of my "neck (hip)" (not clarified) although the way down to my "toes" (not clarified) all, except my left arm where I got the shot; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration, in arm left on unspecified date as DOSE 1, SINGLE for covid-19 immunization at hospital.. The patient medical history included hard of hearing problem and concomitant medications were not reported. On an unspecified date the patient had experienced the pain from the back of my "neck (hip)" (not clarified) although the way down to my "toes" (not clarified) all, except my left arm where got the shot .Therapeutics measures were taken with AE and treatment included two different pills one was stronger and one was like "buffers" (not clarified the name), they gave two different pills when patient got home It was okay. The clinical outcome of the events were recovered.  No follow up attempts are possible, information about lot/batch number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia
Clinical narrative: Chills; Myalgias/arthralgias; arthralgias; Headache; This is a spontaneous report from a Non-Contactable Other HCP (Patient). A 25-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection) via an unspecified route of administration, administered in Arm Right on 11Mar2021 at 08:00 (batch/lot number was not reported) as dose 2, single for covid-19 immunization (at the age of 25-years-old). The patient medical history was not reported. Concomitant medication(s) included ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, chromic chloride, colecalciferol, cupric oxide, cyanocobalamin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, magnesium oxide, manganese sulfate, nicotinamide, phytomenadione, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium selenate, thiamine mononitrate, zinc oxide (ONE A DAY WOMEN'S) and birth control taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. The patient previously received first dose of Covid 19 vaccine (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as single dose for COVID-19 immunization at hospital. The patient has not received any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that after receiving the second dose of vaccine on 11Mar2021 at 21:00 the patient experienced chills, myalgias/arthralgias and headache. No treatment was received in response to the adverse events. The patient was recovering from all the events at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Rash
Clinical narrative: rash; numbness; This is a spontaneous report received from a non-contactable consumer via Health Authority. A female patient (reporter's mother) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date in 2021 as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Enquired, the consumer called on behalf of her mother for information about whether a rash and numbness would be a side effect for the administration of the Pfizer's COVID-19 vaccine. The consumer reported that, the patient (mother) was administered with the first dose of the vaccine 3 weeks ago and she was feeling these symptoms since Sunday. On 14Mar2021, the patient experienced rash and numbness. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable consumer (husband) reported for a 57-years-old female patient (wife). A 57-year-old female patient received first dose of bnt162b2 (Pfizer Covid-19 Vaccine, Solution for injection, Batch/lot number: Unknown, Expiry date: unknown), via an unspecified route on 11Mar2021 (age at vaccination: 57-year-old) as a single dose for covid-19 immunization. Medical history included Multiple sclerosis and Sjogren's. The patient concomitant medications were not reported. On 12Mar2021, patient experienced fever. Reporter was requested to contact nearest Physician in case of any emergency. Patient did not receive any treatment for the event. The clinical outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: knee hurts; This is a spontaneous report from a Pfizer-sponsored program from a contactable male consumer reported for himself. A male patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on 13Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date Mar2021, the patient experienced knee hurts and asked when he can take Ibuprofen after the dose 1 since his knee hurts. The clinical outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: This is a spontaneous report received from a contactable (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 01Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller states he has the 1st dose of the Pfizer COVID19 vaccine on 01Mar2021 and was supposed to go back next Monday for the 2nd dose; states his HCP just put him on an antibiotic regimen for something he just contracted, and he wants to know if there was information related to taking the antibiotic and receiving the Pfizer COVID Vaccine. He wants to know how this medication would affect the vaccine. The outcome of the event was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Inappropriate schedule of product administration, Myalgia, SARS-CoV-2 test
Clinical narrative: I was suddenly hit with severe muscle and joint pain; I was suddenly hit with severe muscle and joint pain; Patient received first dose of vaccine on 01Mar2021 and received second dose of vaccine on 06Mar2021; This is a spontaneous report from a contactable consumer or other non hcp (patient, self-reported). A 79-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration in Arm left, on 06Mar2021 at 12:00 PM, as a single dose for COVID-19 immunization at hospital (Age at vaccination was 79 years old). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration, on 01Mar2021 at 12:30 am, as a single dose for COVID-19 immunization at hospital. The patient was not pregnant at the time of vaccination. The patient medical history included RA (rheumatoid arthritis), ISBC (irritable bowel syndrome), GERD (gastroesophageal reflux disease) and moderately high blood pressure and allergies to codene. Concomitant medication included immunosuppresent SULFASALAZINE for RA (rheumatoid arthritis). On 06Mar2021, the patient had Inappropriate schedule of product administration. It was reported that patient received first dose of vaccine on 01Mar2021 and received second dose of vaccine on 06Mar2021 and stated that on 14Mar2021 at 12:00 PM, after second vaccination she was suddenly hit with severe muscle and joint pain. It lasted for 36 hours and then gradually began to improve and the only immunosuppresent patient take was Salfasalazine for RA. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient did not receive any treatment for the events. The patient underwent SARS-CoV-2 test Nasal swab with the result of negative on 26May2020. Outcome of the events muscle pain and joint pain was recovering and outcome was unknown for the event of inappropriate schedule of product administration.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain, Pain in extremity
Clinical narrative: joint pain /shoulders hurt; muscle pain; Achiness/moderate amount of pain; sore left arm/upper arms both really hurt; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in left arm on 11Mar2021 at 10:00 A.M (at the age of 53-year-old) at single dose for COVID-19 immunisation. The patient medical history included high blood pressure and anxiety and known allergies included Peridium and Diflucan. Concomitant medications included amitriptyline and losartan (LOSARTAN). Patient did not receive other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination and was not tested for COVID since vaccination. The patient just had a bit of a sore left arm as with any other vaccine on 11Mar2021 when received the COVID vaccine. On 16Mar2021 at 09:00AM (day of report) both shoulders and upper arms both really hurt. It was like sore left arm, both of shoulders and upper arms both really hurt as well. The patient has not done any new exercise or heavy lifting recently. It felt like the joint pain and achiness that you have when you were sick with a virus. The patient does not have any other symptoms, except moderate amount of pain. The patient received ibuprofen, but it had not helped a lot. The clinical outcome of events was reported as not recovered.  No follow-up attempts are Possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: 101.6 temperature; My arm hurts a little; Chills; Weakness; This is a spontaneous report from a contactable consumer (patient herself). A 55-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: Pfizer Eng 205), dose 1 via an unspecified route of administration, administered in Arm Left on 15Mar2021 at 13:30 (at the age of 55-years-old) as a DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included rash; known allergy from an unknown date and unknown if ongoing reported as, I had rashes with unknown cause but not from food. Patient reported that, I had Covid last year (2020). Other medical history was none. The patient's concomitant medications were not reported. No other vaccine was administered in four weeks of vaccination. Patient had covid prior vaccination and has not tested for covid post vaccination. On 15Mar2021 at 19:00, the patient experienced 101.6 temperature, my arm hurts a little, chills and weakness. Patient reported that, my arm hurts a little. The next day in the afternoon I had chills and feeling weak. About 7:00 pm has a 101.6 temperature. Patient said, I had Covid last year (2020) and still has antibodies present according to my last blood test. No treatment was received for the event. The patient underwent lab tests and procedures which included pyrexia that was 101.6 on an unspecified date and sars-cov-2 test that was positive on an unspecified date. Outcome of all the events were Resolving.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Dry eye, Fatigue, Musculoskeletal chest pain
Clinical narrative: fatigue; rib cage pain; joint pain; no appetite; dry eyes; mild sinusitis; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 23Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Feb2021, consumer experienced fatigue, rib cage pain, joint pain, no appetite, dry eyes and mild sinusitis. Patient was scheduled on 16Mar2021 for her second dose. Patient asked if she can still take the second dose and what was the percentage that the vaccine will be effective. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: fatigue; rib cage pain; joint pain; no appetite; dry eyes; mild sinusitis; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 23Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Feb2021, consumer experienced fatigue, rib cage pain, joint pain, no appetite, dry eyes and mild sinusitis. Patient was scheduled on 16Mar2021 for her second dose. Patient asked if she can still take the second dose and what was the percentage that the vaccine will be effective. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Dizziness, Fatigue
Clinical narrative: sustained high fever; swelling and itching at injection site; swelling and itching at injection site; loss of appetite; nausea; chills; fatigue; joint pain; wheezing and congestion; wheezing and congestion; headache; dizziness; shaking; This is a spontaneous report from a contactable other HCP (patient herself). A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation, solution for injection, lot number: EN6208, expiry date: unknown) via unspecified route of administration, in left arm on 12Mar2021 13:45 (age at vaccination: 45-years) as dose 1, single for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Patients medical history included covid 19 in Jun2020, asthma from an unspecified date and unknown if ongoing. Concomitant medications were not reported. Patient had been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. She did not take any other vaccines in four weeks, or medications in two weeks. On 13Mar2021 04:00, patient experienced sustained high fever, swelling and itching at injection site, loss of appetite, nausea, chills, fatigue, joint pain, wheezing and congestion, headache, dizziness, shaking. Treatment received due to the adverse events was not known. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pruritus, Nasal congestion, Nausea, Pyrexia
Clinical narrative: sustained high fever; swelling and itching at injection site; swelling and itching at injection site; loss of appetite; nausea; chills; fatigue; joint pain; wheezing and congestion; wheezing and congestion; headache; dizziness; shaking; This is a spontaneous report from a contactable other HCP (patient herself). A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation, solution for injection, lot number: EN6208, expiry date: unknown) via unspecified route of administration, in left arm on 12Mar2021 13:45 (age at vaccination: 45-years) as dose 1, single for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Patients medical history included covid 19 in Jun2020, asthma from an unspecified date and unknown if ongoing. Concomitant medications were not reported. Patient had been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. She did not take any other vaccines in four weeks, or medications in two weeks. On 13Mar2021 04:00, patient experienced sustained high fever, swelling and itching at injection site, loss of appetite, nausea, chills, fatigue, joint pain, wheezing and congestion, headache, dizziness, shaking. Treatment received due to the adverse events was not known. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vaccination site swelling, Wheezing
Clinical narrative: sustained high fever; swelling and itching at injection site; swelling and itching at injection site; loss of appetite; nausea; chills; fatigue; joint pain; wheezing and congestion; wheezing and congestion; headache; dizziness; shaking; This is a spontaneous report from a contactable other HCP (patient herself). A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation, solution for injection, lot number: EN6208, expiry date: unknown) via unspecified route of administration, in left arm on 12Mar2021 13:45 (age at vaccination: 45-years) as dose 1, single for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Patients medical history included covid 19 in Jun2020, asthma from an unspecified date and unknown if ongoing. Concomitant medications were not reported. Patient had been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. She did not take any other vaccines in four weeks, or medications in two weeks. On 13Mar2021 04:00, patient experienced sustained high fever, swelling and itching at injection site, loss of appetite, nausea, chills, fatigue, joint pain, wheezing and congestion, headache, dizziness, shaking. Treatment received due to the adverse events was not known. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Contusion, Feeling hot, Headache, Hypoaesthesia
Clinical narrative: Leg feels heavy; Knee has throbbing type pain that comes in and out/; Pain in her arm; Little bruises on legs, mostly on thighs; Numbness in cheek; Tongue was a little bit numb; Cheek and face were a little bit swollen; Upper body itching; Cheek was very hot; Very strong headache; Left side of neck is stiff; This is a spontaneous report from a non-contactable consumer or other non hcp. A 49-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6202), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 13:57 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has no known allergies. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with any event, prior vaccination. On 12Mar2021 the patient experienced pain in her, numbness in cheek on 11Mar2021, tongue was a little bit numb on 11Mar2021, cheek and face were a little bit swollen on 11Mar2021, little bruises on legs, mostly on thighs on 12Mar2021, leg feels heavy on 13Mar2021, knee has throbbing type pain that comes in and out on 13Mar2021, upper body itching on 11Mar2021, cheek was very hot on 11Mar2021, very strong headache on, left side of neck is stiff on 11Mar2021. The events little bruises on legs, mostly on thighs, leg feels heavy, knee has throbbing type pain that comes in and out, very strong headache were not recovered while all other events were recovered. No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Limb discomfort, Musculoskeletal stiffness, Pain in extremity, Pruritus
Clinical narrative: Leg feels heavy; Knee has throbbing type pain that comes in and out/; Pain in her arm; Little bruises on legs, mostly on thighs; Numbness in cheek; Tongue was a little bit numb; Cheek and face were a little bit swollen; Upper body itching; Cheek was very hot; Very strong headache; Left side of neck is stiff; This is a spontaneous report from a non-contactable consumer or other non hcp. A 49-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6202), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 13:57 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has no known allergies. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with any event, prior vaccination. On 12Mar2021 the patient experienced pain in her, numbness in cheek on 11Mar2021, tongue was a little bit numb on 11Mar2021, cheek and face were a little bit swollen on 11Mar2021, little bruises on legs, mostly on thighs on 12Mar2021, leg feels heavy on 13Mar2021, knee has throbbing type pain that comes in and out on 13Mar2021, upper body itching on 11Mar2021, cheek was very hot on 11Mar2021, very strong headache on, left side of neck is stiff on 11Mar2021. The events little bruises on legs, mostly on thighs, leg feels heavy, knee has throbbing type pain that comes in and out, very strong headache were not recovered while all other events were recovered. No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Leg feels heavy; Knee has throbbing type pain that comes in and out/; Pain in her arm; Little bruises on legs, mostly on thighs; Numbness in cheek; Tongue was a little bit numb; Cheek and face were a little bit swollen; Upper body itching; Cheek was very hot; Very strong headache; Left side of neck is stiff; This is a spontaneous report from a non-contactable consumer or other non hcp. A 49-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6202), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 13:57 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has no known allergies. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with any event, prior vaccination. On 12Mar2021 the patient experienced pain in her, numbness in cheek on 11Mar2021, tongue was a little bit numb on 11Mar2021, cheek and face were a little bit swollen on 11Mar2021, little bruises on legs, mostly on thighs on 12Mar2021, leg feels heavy on 13Mar2021, knee has throbbing type pain that comes in and out on 13Mar2021, upper body itching on 11Mar2021, cheek was very hot on 11Mar2021, very strong headache on, left side of neck is stiff on 11Mar2021. The events little bruises on legs, mostly on thighs, leg feels heavy, knee has throbbing type pain that comes in and out, very strong headache were not recovered while all other events were recovered. No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dyspepsia, Nausea, Pruritus
Clinical narrative: Fever 102 degrees Fahrenheit; nausea; heartburn; red at injection shot; swollen; itchy; Chills; This is a spontaneous report from a non-contactable consumer. A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Mar2021 (at the age of 41 year) as dose number unknown, single for COVID-19 immunisation. The patient medical history was not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. The patient's concomitant medications were not reported. Patient was not pregnant at the time of vaccination. On 12Mar2021, patient experienced fever 102 degrees Fahrenheit, chills, nausea, heartburn, red at injection shot, swollen, and itchy. It was reported that no therapeutic measures were taken for the events experienced. The patient underwent lab tests and procedures on 12Mar2021 which included body temperature: 102 Fahrenheit. The outcome of events was recovering.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling, Vaccination site erythema
Clinical narrative: Fever 102 degrees Fahrenheit; nausea; heartburn; red at injection shot; swollen; itchy; Chills; This is a spontaneous report from a non-contactable consumer. A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Mar2021 (at the age of 41 year) as dose number unknown, single for COVID-19 immunisation. The patient medical history was not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. The patient's concomitant medications were not reported. Patient was not pregnant at the time of vaccination. On 12Mar2021, patient experienced fever 102 degrees Fahrenheit, chills, nausea, heartburn, red at injection shot, swollen, and itchy. It was reported that no therapeutic measures were taken for the events experienced. The patient underwent lab tests and procedures on 12Mar2021 which included body temperature: 102 Fahrenheit. The outcome of events was recovering.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Illness, Pyrexia
Clinical narrative: Got very ill with this vaccine; Fever; Chills; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (husband). This is the second case out of two cases. A male patient of unspecified age had received BNT162B2 (Pfizer-biontech covid-19 vaccine, solution for injection) via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient's medical history included Covid-19 in the month of Oct 2020. The patient concomitant was not reported. Reporter stated that after receiving the dose of vaccine on an unspecified date in Mar2021 the patient got very ill with this vaccine and had fever and chills. The outcome of the events was unknown.   No follow up attempts are possible; information on Lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Pain from shoulder to fingers in injected arm; Full-body itchy skin but no visible rash; This is a spontaneous report from a contactable consumer reported for herself. A 26-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number: EN6208) via an unspecified route of administration in arm left on 10Mar2021 as dose 1, single (age at vaccination: 26 years) for COVID-19 immunisation. Medical history included none relevant history. Concomitant medications included spironolactone (SPIRONOLACTONE) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. Other medications in two weeks were birth control and spironolactone. No COVID prior vaccination and did not tested COVID post vaccination. No known allergies. On 10Mar2021, the patient experienced full-body itchy skin but no visible rash, pain from shoulder to fingers injected arm. No treatment was received. The clinical outcome of the event was not resolved.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rhinorrhoea, Sneezing
Clinical narrative: Little headache; Sneezing; Runny Nose; This is a spontaneous report received from a contactable physician (Patient reported for herself). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 05Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications. Patient stated she took first dose on 05Mar2021. In Mar2021 She has something in her arm and a little headache. The next day, her arm was getting better. After 2 days all were normal. Then in two days, which would be 5th day, she began having sneezing and runny nose for 2 days. This is not a common symptom that people who take the vaccine experience. She would like to know if this is something serious and if she should go to the doctor. The outcome of the event headache was reported as recovered on Mar2021 and while other events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.