chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Arm swelling; Unable to stand without falling; Unable to stand without falling; Very dizzy; Severe fatigue; Migraine/sledgehammer feeling in my head and temp; Migraine/sledgehammer feeling in my head and temp; Chills; High fever; Vomited; Chest palpitations; A 43-years-old non pregnant female patient received second dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 20Apr2021 (at the age of 43-years-old) as single dose for covid-19 immunisation. Medical history was none. Patient had no known allergies. The patient concomitant medications were not reported. Patient previously received first dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 30Mar2021 as single dose for covid-19 immunisation. 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 had not been tested for COVID-19. On 20Apr2021, 7 hours after the vaccination, patient experienced arm swelling, unable to stand without falling, very dizzy, severe fatigue, migraine/sledgehammer feeling in my head and temp, chills, high fever, vomited 4 times and chest palpitations. Patent reported that she started recommended medication and will seek medical care. The outcome of all the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Bronchospasm
Clinical narrative: experienced short episode of bronchospasm; This is a spontaneous report from a contactable physician (pulmonologist).  A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, batch number and expiry date were no reported) via an unspecified route of administration on an unspecified date as Dose 1 single for COVID-19 immunization. Medical history included with longstanding asthma on an unknown date and ongoing and was controlled on ICS (inhaled corticosteroid)/LABA (long-acting beta-agonist). Concomitant medications were not reported. On an unspecified date, the patient experienced a short episode of bronchospasm with first dose of Pfizer BNT vaccine within 10 minutes of administration. The patient's second dose was scheduled on 10May2021. Outcome of bronchospasm was unknown at the time of reporting.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: left knee was extremely sore; i can barely walk; This is a spontaneous report from a contactable consumer or other non hcp the patient reported.  A 55-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. Historical vaccine, the patient took first dose bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced, since 11 days of second shot it worsened every morning when he woke up and he could barely walk and his left knee was extremely sore. The outcome of the events was not recovered.   No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Cough, Dizziness, Gait disturbance, Pain in extremity
Clinical narrative: the pneumonia vaccine left her arm sore; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (reported as fall; Batch/Lot number was not reported) as Dose number unknown, single for immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 27Mar2021 11:40 for COVID-19 immunization and experienced Coughing, feeling dizzy and Lightheadedness, Weakness and Trouble Walking. It was reported that the patient got both flu and pneumonia vaccines in the fall and the pneumonia vaccine left her arm sore for a few days. The outcome of the event was unknown.  No follow-up attempts are needed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood bilirubin increased
Clinical narrative: elevated bilirubin; This is a spontaneous report from a contactable Health care professional (pharmacist). This pharmacist reported for a patient (3rd patient in 3 other patients) via medical information team. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported, Expiry date: unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patients medical history and concomitant medications were not reported. On unspecified date, the patient experienced elevated bilirubin. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021470248 same reporter/drug/AE, different patients (3rd of 3 patients)
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pain, Tongue disorder
Clinical narrative: Pain; Thickening of tongue; Extreme fatigue; Headaches; Joint aches; This is a spontaneous report received from Novo Nordisk. This other company reported on behalf of non-contactable reporter/consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: not provided; Expiration date: not provided) via an unspecified route of administration on an unspecified date as dose number unknown, single for Covid-19 immunization. The patients medical history was not reported. The patients concomitant medications included semaglutide (OZEMPIC) and insulin degludec (TRESIBA). On an unspecified date, the patient, who was receiving therapy with Ozempic, Tresiba, and the Pfizer COVID vaccine, reported experiencing pain, extreme fatigue, headaches, joint aches, and thickening of the tongue as side effects. The patient took rest. The clinical outcome of events was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Contusion
Clinical narrative: just so much anxiety with the vaccine; bruising/bruising on her extremities, her upper thighs and arms; This is a spontaneous report from a contactable Nurse reported that. A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 28Mar2021 13:30 (age at vaccination 36-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included constipation and food allergy from an unknown date and unknown if ongoing. Concomitant medication included sertraline hydrochloride (ZOLOFT) 12.5 mg, daily within two weeks. Patient was not pregnant at the time of vaccination. The patient experienced bruising/bruising on her extremities, her upper thighs, and arms on an unspecified date Apr2021, just so much anxiety with the vaccine on an unspecified date. Ever since received the first vaccine dose, I have been bruising very easily anytime there is contact made to my body. Consumer was calling regarding the Pfizer COVID vaccine. She confirms she already filled and adverse reaction form online on Pfizer website. She is calling today because she is looking for advice. She has been bruising a ton since the vaccine and her legs have bruises all over them. She is just bruising super easily. She is just trying to figure out if this could be from the vaccine. She held off on her second dose. She just doesn't know what to do. There is just so much anxiety with the vaccine, but the bruising is new for her. Caller states he is calling on behalf of his daughter (as reported), the patient had her vaccine 3-4 weeks ago and about a week after she experienced bruising on her extremities, her upper thighs and arms and states their question is, should she get the second shot. Reporter clarifies that the bruising comes in waves, it got better and almost went away and then it came back again. Reporter stated the bruising started about a week after the vaccine, exact date unknown. The patient has stated that she had not been diagnosed with COVID -19 prior to vaccination and not been tested since the vaccination. AE bruising results in physician office visit. No other vaccine received prior to vaccination with in four weeks. No treatment was received for the adverse events.The patient underwent lab tests and procedures which included blood test and result was had blood work done that came back fine on an unspecified date. Outcome of the events bruising was not recovered, and anxiety was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtain. No further information was expected.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion
Clinical narrative: just so much anxiety with the vaccine; bruising/bruising on her extremities, her upper thighs and arms; This is a spontaneous report from a contactable Nurse reported that. A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 28Mar2021 13:30 (age at vaccination 36-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included constipation and food allergy from an unknown date and unknown if ongoing. Concomitant medication included sertraline hydrochloride (ZOLOFT) 12.5 mg, daily within two weeks. Patient was not pregnant at the time of vaccination. The patient experienced bruising/bruising on her extremities, her upper thighs, and arms on an unspecified date Apr2021, just so much anxiety with the vaccine on an unspecified date. Ever since received the first vaccine dose, I have been bruising very easily anytime there is contact made to my body. Consumer was calling regarding the Pfizer COVID vaccine. She confirms she already filled and adverse reaction form online on Pfizer website. She is calling today because she is looking for advice. She has been bruising a ton since the vaccine and her legs have bruises all over them. She is just bruising super easily. She is just trying to figure out if this could be from the vaccine. She held off on her second dose. She just doesn't know what to do. There is just so much anxiety with the vaccine, but the bruising is new for her. Caller states he is calling on behalf of his daughter (as reported), the patient had her vaccine 3-4 weeks ago and about a week after she experienced bruising on her extremities, her upper thighs and arms and states their question is, should she get the second shot. Reporter clarifies that the bruising comes in waves, it got better and almost went away and then it came back again. Reporter stated the bruising started about a week after the vaccine, exact date unknown. The patient has stated that she had not been diagnosed with COVID -19 prior to vaccination and not been tested since the vaccination. AE bruising results in physician office visit. No other vaccine received prior to vaccination with in four weeks. No treatment was received for the adverse events.The patient underwent lab tests and procedures which included blood test and result was had blood work done that came back fine on an unspecified date. Outcome of the events bruising was not recovered, and anxiety was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtain. No further information was expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Contusion
Clinical narrative: has been bruising pretty badly anytime that she gets bumped; This is a spontaneous report from a contactable other hcp (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not reported) via an unspecified route of administration on 28Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In 2021 patient experienced has been bruising pretty badly anytime that she gets bumped it was reported that caller states that since her first dose of the COVID Vaccine she has been bruising pretty badly anytime that she gets bumped. States its not spontaneous bruising; but it was bruising with minor things. Says that this was new for her. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion
Clinical narrative: has been bruising pretty badly anytime that she gets bumped; This is a spontaneous report from a contactable other hcp (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not reported) via an unspecified route of administration on 28Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In 2021 patient experienced has been bruising pretty badly anytime that she gets bumped it was reported that caller states that since her first dose of the COVID Vaccine she has been bruising pretty badly anytime that she gets bumped. States its not spontaneous bruising; but it was bruising with minor things. Says that this was new for her. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Urticaria
Clinical narrative: allergic reaction; big bumps; itchy at the back; This is a spontaneous report from a Pfizer sponsored program. This contactable consumer (patient's son) reported for a female patient (reporter's mother). A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on 25Apr2021 (Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 on an unspecified date for covid-19 immunisation. The patient experienced allergic reaction with big bumps and itchy at the back on an unspecified date. Outcome of all events were 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: Hypersensitivity, Pruritus, Urticaria
Clinical narrative: allergic reaction with big bumps, itchy at the back; allergic reaction with big bumps, itchy at the back; allergic reaction with big bumps, itchy at the back; This is a spontaneous report from a consumer (patient) from a Pfizer sponsored program support. A male patient of an unknown age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot/batch number was not reported) via an unspecified route of administration on 25Apr2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. Historical vaccine included the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot/batch number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. It was reported that the patient had the second dose of the Pfizer COVID-19 vaccine last night 25APR2021 and had an allergic reaction with big bumps, itchy at the back. The outcome of the events was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Dyspnoea, Fatigue, Headache
Clinical narrative: dose 1: 31Jan2021 and dose 2: 14Mar2021; dose 1: 31Jan2021 and dose 2: 14Mar2021; Headache; temperature; body aches; sore throat; exhaustion; nausea; difficulty breathing; congestion-sinus; This is a spontaneous report from a contactable consumer (patient) reported in response to non-health care professional letter sent. A 77-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6207, expiration date was not reported), via intramuscular, administered in upper left arm on 14Mar2021 (at the age of 77-years-old) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (lot number: EL9263, expiration date was not reported), via intramuscular, administered in upper left arm on 31Jan2021 (at the age of 77-years-old) as dose 1, single for covid-19 immunization. It was reported that on 02Apr2021 the patient experienced severe headache, temperature (101), body aches, bad sore throat, exhaustion, nausea, difficulty breathing, congestion sinus. Onset time: 4 days (as reported). Adverse events required to visit physician office. The patient underwent lab tests and procedures which included covid antibody blood test (sars-cov-2 antibody test): negative on 02Feb2021, Covid-19 (sars-cov-2 test): negative on 08Feb2021, Covid-19 (sars-cov-2 test): negative on 11Feb2021, temperature (Body temperature): 101 on 02Apr2021. No treatment was received for the adverse events. The reporter assessed the case as non-serious. The outcome of the events was recovered on an unspecified date of 2021.  No follow-up attempts are needed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Nausea, Off label use, Oropharyngeal pain, Pain
Clinical narrative: dose 1: 31Jan2021 and dose 2: 14Mar2021; dose 1: 31Jan2021 and dose 2: 14Mar2021; Headache; temperature; body aches; sore throat; exhaustion; nausea; difficulty breathing; congestion-sinus; This is a spontaneous report from a contactable consumer (patient) reported in response to non-health care professional letter sent. A 77-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6207, expiration date was not reported), via intramuscular, administered in upper left arm on 14Mar2021 (at the age of 77-years-old) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (lot number: EL9263, expiration date was not reported), via intramuscular, administered in upper left arm on 31Jan2021 (at the age of 77-years-old) as dose 1, single for covid-19 immunization. It was reported that on 02Apr2021 the patient experienced severe headache, temperature (101), body aches, bad sore throat, exhaustion, nausea, difficulty breathing, congestion sinus. Onset time: 4 days (as reported). Adverse events required to visit physician office. The patient underwent lab tests and procedures which included covid antibody blood test (sars-cov-2 antibody test): negative on 02Feb2021, Covid-19 (sars-cov-2 test): negative on 08Feb2021, Covid-19 (sars-cov-2 test): negative on 11Feb2021, temperature (Body temperature): 101 on 02Apr2021. No treatment was received for the adverse events. The reporter assessed the case as non-serious. The outcome of the events was recovered on an unspecified date of 2021.  No follow-up attempts are needed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test, Sinus congestion
Clinical narrative: dose 1: 31Jan2021 and dose 2: 14Mar2021; dose 1: 31Jan2021 and dose 2: 14Mar2021; Headache; temperature; body aches; sore throat; exhaustion; nausea; difficulty breathing; congestion-sinus; This is a spontaneous report from a contactable consumer (patient) reported in response to non-health care professional letter sent. A 77-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6207, expiration date was not reported), via intramuscular, administered in upper left arm on 14Mar2021 (at the age of 77-years-old) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (lot number: EL9263, expiration date was not reported), via intramuscular, administered in upper left arm on 31Jan2021 (at the age of 77-years-old) as dose 1, single for covid-19 immunization. It was reported that on 02Apr2021 the patient experienced severe headache, temperature (101), body aches, bad sore throat, exhaustion, nausea, difficulty breathing, congestion sinus. Onset time: 4 days (as reported). Adverse events required to visit physician office. The patient underwent lab tests and procedures which included covid antibody blood test (sars-cov-2 antibody test): negative on 02Feb2021, Covid-19 (sars-cov-2 test): negative on 08Feb2021, Covid-19 (sars-cov-2 test): negative on 11Feb2021, temperature (Body temperature): 101 on 02Apr2021. No treatment was received for the adverse events. The reporter assessed the case as non-serious. The outcome of the events was recovered on an unspecified date of 2021.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Depressed mood, Fear, Tremor
Clinical narrative: experiencing a sinking feeling, like my heart is sinking, along with the anxity/feelings of fear; Tremors and anxiety attacks. The tremors are very frequent, several times per hour, and some have quivering of the lip and upper body.; Tremors and anxiety attacks. The tremors are very frequent, several times per hour, and some have quivering of the lip and upper body.; experiencing a sinking feeling, like my heart is sinking, along with the anxity/feelings of fear; This is a spontaneous report from a contactable consumer (Patient reported for herself).   A 42-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: ER8731), via an unspecified route of administration, in right arm on 09Apr2021 14:15 (at the age of 42-years-old) as a dose 1, single for COVID-19 immunization. The patient medical history included epilepsy from an unspecified date and breast cancer in unspecified date of 2013. Patient was allergic to sulfa drug. The concomitant medication of the patient included brivaracetam (BRIVIACT), eslicarbazepine acetate (APTIOM) and cetirizine hydrochloride (ZYRTEC ALLERGY). The patient did not receive any other vaccines within four weeks. Patient had not COVID prior to vaccination. Patient was not tested for COVID post vaccination. On 14Apr2021 the patient experienced a sinking feeling, like her heart was sinking, along with the anxiety/feelings of fear. On 14Apr2021 the patient also experienced tremors and anxiety attacks. Patient reported that tremors were very frequent, several times per hour, and some had quivering of the lip and upper body. Patient received the treatment of 2nd pill Aptiom recommended by her neurologist for the reported events. Outcome for all the reported events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: Pain at the injection site; Low grade temp; Fatigue; Sore arm; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced pain at the injection site, low grade temp, fatigue and sore arm on an unspecified date. The patient was calling about the Pfizer Covid 19 vaccine. The patient had a question if he should get another dose of the vaccine he states he was vaccinated with both doses, the second dose received 2 weeks ago. The patient states after the first vaccine, he was fine. The patient reported that he had fatigue, low grade fever and a sore arm after the first vaccine on an unspecified date. The lab data included Low grade temp on an unspecified date. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Joint swelling, Oedema peripheral
Clinical narrative: Lower limb edema; Ankles and toes inflammation; Ankles and toes inflammation; This is a spontaneous report from a contactable consumer (patient).  A 72-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration, in left arm on 26Apr2021 10:00 AM as dose 2, single for COVID-19 immunization. Medical history included hypertension and allergic asthma. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6206) via an unspecified route of administration, in left arm, on 04Apr2021 10:00 AM as dose 1, single for COVID-19 immunization. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Patient had no known allergies. Patient did not receive any other vaccines in 4 weeks. patient had not received any other medications in 2 weeks of vaccination. Prior to vaccination, the patient not had COVID-19 and was not tested for COVID-19 post vaccination. The patient experienced lower limb edema and ankles and toes inflammation on 27Apr2021 12:00 PM. Outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site swelling
Clinical narrative: Armpit on same side shot was administered is swollen and tender.; Armpit on same side shot was administered is swollen and tender.; This is a spontaneous report received from a non-contactable consumer or other non hcp. A 33-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: unknown) via an unspecified route of administration in Arm Left on 31Mar2021 09:00 (age at vaccination 33years old) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks and other medications within 2 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in workplace clinic. Medical history included sleep apnoea syndrome from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Since the vaccination, the patient had not been tested positive for COVID-19. On 24Apr2021 at 06:45 the patient experienced armpit on same side shot was administered is swollen and tender. The clinical outcome of the event was not recovered.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Cough, Fatigue, Headache
Clinical narrative: sore arm; nausea; insomnia; tiredness; headache; muscle pain; sharp chest pain; weakness; difficulty moving; coughing; runny nose; watery eyes; This is a spontaneous report from a contactable consumer (patient, self-reported). A 19-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration in Arm left on 23Apr2021 at 14:30 PM (at the age of 19-year-old) as single dose for COVID-19 immunization in Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient did not test for COVID-19. Historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration in Arm left, on 26Mar2021 at 12:30 PM, as single dose for COVID-19 immunisation. On 24Apr2021 at 06:15 AM, the patient experienced side effects such as sore arm, nausea, insomnia, tiredness, headache, muscle pain, sharp chest pain, weakness, difficulty moving, coughing, runny nose, and watery eyes. The AE did not result in emergency room/physician office visit. The patient did not receive any treatment for the events. Outcome of the events were recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Lacrimation increased, Movement disorder, Myalgia, Nausea
Clinical narrative: sore arm; nausea; insomnia; tiredness; headache; muscle pain; sharp chest pain; weakness; difficulty moving; coughing; runny nose; watery eyes; This is a spontaneous report from a contactable consumer (patient, self-reported). A 19-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration in Arm left on 23Apr2021 at 14:30 PM (at the age of 19-year-old) as single dose for COVID-19 immunization in Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient did not test for COVID-19. Historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration in Arm left, on 26Mar2021 at 12:30 PM, as single dose for COVID-19 immunisation. On 24Apr2021 at 06:15 AM, the patient experienced side effects such as sore arm, nausea, insomnia, tiredness, headache, muscle pain, sharp chest pain, weakness, difficulty moving, coughing, runny nose, and watery eyes. The AE did not result in emergency room/physician office visit. The patient did not receive any treatment for the events. Outcome of the events were recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rhinorrhoea
Clinical narrative: sore arm; nausea; insomnia; tiredness; headache; muscle pain; sharp chest pain; weakness; difficulty moving; coughing; runny nose; watery eyes; This is a spontaneous report from a contactable consumer (patient, self-reported). A 19-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration in Arm left on 23Apr2021 at 14:30 PM (at the age of 19-year-old) as single dose for COVID-19 immunization in Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient did not test for COVID-19. Historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration in Arm left, on 26Mar2021 at 12:30 PM, as single dose for COVID-19 immunisation. On 24Apr2021 at 06:15 AM, the patient experienced side effects such as sore arm, nausea, insomnia, tiredness, headache, muscle pain, sharp chest pain, weakness, difficulty moving, coughing, runny nose, and watery eyes. The AE did not result in emergency room/physician office visit. The patient did not receive any treatment for the events. Outcome of the events were recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Hip Joint and leg pain; Hip Joint and leg pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 48-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was Er8733 and expiration date was not reported), via an unspecified route of administration, administered in left arm on 05Apr2021 at 16:45 (Age at vaccination was 48 years) as dose 1, single for covid-19 immunisation. Medical history included hip surgery. Patient did not have known allergies. The patient did not diagnosed covid prior to vaccination. The patient's concomitant medications were not reported. The patient previously took microgestin. The patient did not took other vaccine in four weeks. On 24Apr2021 at 18:00 the patient experienced hip joint and leg pain. The patient did not tested covid post vaccination. The patient did not receive any treatment. The outcome of event was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Left arm was red and swollen; Left arm was red and swollen; This is a spontaneous report from a contactable consumer (patient's mother).  A 26-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: ER8731 and expiry date was not reported), via an unspecified route of administration into left arm on 20Apr2021 at 15: 00 (at the age of 26-year-old) as Dose 2, single for COVID-19 immunization. Medical history and family history was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EP6955) via an unspecified route of administration on 28Mar2021 at 14: 00 for Covid-19 immunization after being exposed to hundreds of kids at skatepark. The patient's concomitant medications were not reported. Patient did not receive prior vaccinations within 4 weeks and did not receive any additional vaccines while taking BNT162B2. On 22Apr2021, the patient's Left arm was red and swollen after getting second shot of the Pfizer Covid vaccine. Treatment information and laboratory data was not reported. The outcome of adverse events was not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chills, Dyspnoea, Exposure to SARS-CoV-2, Headache
Clinical narrative: slight headache/bad headache; trouble breathing; fever; chills; vomiting; a feeling of rubbery legs; Stayed in bed Wed and Thurs; She had been spending time with her boyfriend and her family. It turned out her boyfriend and his family all have had COVID; This is a spontaneous report from a contactable consumer via Pfizer sales representative. This consumer reported for 16-year-old female patient (grandniece) that:  A16-year-old female patient received dose 1, single BNT162B2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: 0158) via unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient had experienced slight headache/bad headache after receiving her first injection. She also experienced trouble breathing, fever, chills, vomiting and a feeling of rubbery legs. She spent time with her boyfriend and her family, it turned out her boyfriend and his family all had COVID, on an unspecified date. The outcome for the event She had been spending time with her boyfriend and her family. It turned out her boyfriend and his family all have had COVID was unknown and rest all the events was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pyrexia, Vomiting
Clinical narrative: slight headache/bad headache; trouble breathing; fever; chills; vomiting; a feeling of rubbery legs; Stayed in bed Wed and Thurs; She had been spending time with her boyfriend and her family. It turned out her boyfriend and his family all have had COVID; This is a spontaneous report from a contactable consumer via Pfizer sales representative. This consumer reported for 16-year-old female patient (grandniece) that:  A16-year-old female patient received dose 1, single BNT162B2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: 0158) via unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient had experienced slight headache/bad headache after receiving her first injection. She also experienced trouble breathing, fever, chills, vomiting and a feeling of rubbery legs. She spent time with her boyfriend and her family, it turned out her boyfriend and his family all had COVID, on an unspecified date. The outcome for the event She had been spending time with her boyfriend and her family. It turned out her boyfriend and his family all have had COVID was unknown and rest all the events was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Fatigue, Headache, Inappropriate schedule of product administration
Clinical narrative: Severe muscle pain; headache; heavy chest feeling; extreme tiredness/weakness; extreme tiredness/weakness; the patient had received second dose very early; This is a Spontaneous report from a contactable consumer. A 66-years-old non pregnant female patient reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection (Batch/Lot Number: ER8734)), via unspecified route of administration, in the Left arm on 23Apr2021 08:30 for as DOSE 2, SINGLE forcovid-19 immunization (Age at vaccination:66-years-old). The patient medical history included VSD lower left chamber, anxiety and pancreatitis. The patient reported allergy to Cleocin. The patient had not received any other vaccine within 4 weeks and the patient was not diagnosed with covid 19 before or after vaccination. The patient's concomitant medications included Levoxyl, labetalol, isosorbide mononitrate, and celexa which she received within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EW0150), via unspecified route of administration, in the Left arm on 06Apr2021 10:00 at single dose, for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnose with COVID-19 prior to vaccination. On 23Apr2021 08:45 the patient experienced Severe muscle pain, headache, heavy chest feeling and extreme tiredness/weakness12+ hours after shot. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Severe muscle pain; headache; heavy chest feeling; extreme tiredness/weakness; extreme tiredness/weakness; the patient had received second dose very early; This is a Spontaneous report from a contactable consumer. A 66-years-old non pregnant female patient reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection (Batch/Lot Number: ER8734)), via unspecified route of administration, in the Left arm on 23Apr2021 08:30 for as DOSE 2, SINGLE forcovid-19 immunization (Age at vaccination:66-years-old). The patient medical history included VSD lower left chamber, anxiety and pancreatitis. The patient reported allergy to Cleocin. The patient had not received any other vaccine within 4 weeks and the patient was not diagnosed with covid 19 before or after vaccination. The patient's concomitant medications included Levoxyl, labetalol, isosorbide mononitrate, and celexa which she received within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EW0150), via unspecified route of administration, in the Left arm on 06Apr2021 10:00 at single dose, for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnose with COVID-19 prior to vaccination. On 23Apr2021 08:45 the patient experienced Severe muscle pain, headache, heavy chest feeling and extreme tiredness/weakness12+ hours after shot. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Back pain, Neck pain, Peripheral swelling, Vaccination site haematoma
Clinical narrative: Terrible backache; hematoma at the injection site after the second vaccine; along with some bleeding at the injection site; ache in neck; swelling under arm; This is a spontaneous report from a contactable consumer (patient) via medical information team received from a Pfizer-sponsored Pro-gram .  A 70-years-old 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 12Feb2021 as single dose for covid-19 immunization. Patient previously received her BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on approximately 22Jan2021 as dose 1, single for covid-19 immunization and she experienced chills, fatigue, headache, neckache, pain under her arm which she believes was a swollen lymphnode (swelling went away the following day) on an unknown date in 2021. A week later, she experienced hip bursitis for which she received several weeks of physical therapy after the 1st Pfizer shot, she had difficulty moving in and out of bed, she also stated that she had a reaction to an antibiotic 5 years ago (does not specify which one). Patient was upset that she tested negative for antibodies after the vaccine series. Concomitant medication included mycophenolate mofetil (MYCOPHENOLATE) taken for immunosuppression from an unknown date. She was concerned and upset that the vaccine may not work for her because she was immunosuppressed. On unspecified date in Feb2021 patient stated that she experienced a backache afterwards. She states the hip bursitis went away after the second dose. She also stated that she experienced a hematoma at the injection site after the second vaccine, along with some bleeding at the injection site. Patient queried for if the bursitis was a normal and/or reported side effect of the vaccine. patient also experienced Terrible backache, ache in neck, swelling under arm. Went for antibody test which came back negative. Doctor told her it does not mean the vaccine did not work but that they do not know how effective it may be. Patient was upset that information about immunosuppressed individuals and the Covid vaccine was not more out there for the public to know. She was upset that this population was no included in the clinical trials and was upset that she had been told to proceed with her life as if she wasn't vaccinated. Patient was instructed to wearing a mask and social distancing after receiving the vaccine. outcome of events was unknown.  No follow-up attempts are needed. Information out batch/lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: Terrible backache; hematoma at the injection site after the second vaccine; along with some bleeding at the injection site; ache in neck; swelling under arm; This is a spontaneous report from a contactable consumer (patient) via medical information team received from a Pfizer-sponsored Pro-gram .  A 70-years-old 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 12Feb2021 as single dose for covid-19 immunization. Patient previously received her BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on approximately 22Jan2021 as dose 1, single for covid-19 immunization and she experienced chills, fatigue, headache, neckache, pain under her arm which she believes was a swollen lymphnode (swelling went away the following day) on an unknown date in 2021. A week later, she experienced hip bursitis for which she received several weeks of physical therapy after the 1st Pfizer shot, she had difficulty moving in and out of bed, she also stated that she had a reaction to an antibiotic 5 years ago (does not specify which one). Patient was upset that she tested negative for antibodies after the vaccine series. Concomitant medication included mycophenolate mofetil (MYCOPHENOLATE) taken for immunosuppression from an unknown date. She was concerned and upset that the vaccine may not work for her because she was immunosuppressed. On unspecified date in Feb2021 patient stated that she experienced a backache afterwards. She states the hip bursitis went away after the second dose. She also stated that she experienced a hematoma at the injection site after the second vaccine, along with some bleeding at the injection site. Patient queried for if the bursitis was a normal and/or reported side effect of the vaccine. patient also experienced Terrible backache, ache in neck, swelling under arm. Went for antibody test which came back negative. Doctor told her it does not mean the vaccine did not work but that they do not know how effective it may be. Patient was upset that information about immunosuppressed individuals and the Covid vaccine was not more out there for the public to know. She was upset that this population was no included in the clinical trials and was upset that she had been told to proceed with her life as if she wasn't vaccinated. Patient was instructed to wearing a mask and social distancing after receiving the vaccine. outcome of events was unknown.  No follow-up attempts are needed. Information out batch/lot number cannot be obtained.