chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, SARS-CoV-2 antibody test
Clinical narrative: chest pains; This is a spontaneous report from a contactable consumer (patient herself). A 36-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8733), dose 2 via an unspecified route of administration, administered in Arm Left on 12Apr2021 at 08:45 (at the age of 36-year-old) as dose 2, single for COVID-19 immunisation. The patient received first dose of BNT162B2 (lot number: EP7554) dose 2 via an unspecified route of administration, administered in Arm Left on 21Mar2021 at 02:30 PM (at the age of 36-year-old) for COVID-19 immunization. The patient medical history reported as none and had no known allergies. The patient had no other vaccine in four weeks. It was reported that patient took concomitant medications in two weeks. The patient's concomitant medications were not reported. The patient not had covid prior vaccination. Patient stated that, she started experienced chest pains 29 hours after injection. Chest pains have been sharp and intense pressure at times. They occur for approximately up to 30 seconds and subside. Intervals of time between have been sporadic and intensity varies. They were more painful in the afternoon but have subsided slightly in pain and duration as the day continues to go on. Her sister also received the shot at on the same day exactly one minute before her (patient's sister) and she was experienced the same pains. On 13Apr2021 at 13:45, the patient experienced chest pains. The patient tested covid post vaccination. The patient underwent lab tests and procedures which included Nasal swab: negative on 02Sep2020, Nasal swab: negative on 31Oct2020. The patient received unknown treatment for the event. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021421040 same reporter/drug/AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest pains; This is a spontaneous report received from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 12Apr2021 at 08:44 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced chest pains. It was reported that patient started experiencing chest pains. Chest pains has been sharp and intense pressure at times. They occur for approximately up to 30 seconds and subside. Intervals of time between has been sporadic and intensity varies. They were more painful in the afternoon but were subsided slightly in pain and duration as the day continued to go on. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.  ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021420979 same reporter/drug/AE, different patient
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Dizziness, Dyspnoea, Heart rate
Clinical narrative: weakness; sob; Rapid heartbeat; chest pain; dizziness; This is a spontaneous report from a contactable Nurse (patient). A 43-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection,Batch/Lot number: not reported), via an unspecified route of administration, administered in Arm Right on 15Apr2021 12:00 as DOSE 2, SINGLE for COVID-19 immunisation. Facility type for vaccination was Public Health Clinic. Medical history included covid-19 and If Covid prior vaccination: Yes.The patient did not receive any other vaccine in four weeks prior to the COVID vaccine. Unknown allergies was reported. Concomitant medication(s) included pregabalin (LYRICA), ibuprofen (IBUPROFEN), sertraline (SERTRALINE) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported) administered in Arm Left on 25Mar2021 12:00 as DOSE 1, SINGLE for COVID-19 immunisation. On 15Apr2021 12:00, the patient experienced sob, rapid heartbeat, chest pain, dizziness, weakness. Patient was not received any treatment.The patient underwent lab tests and procedures which included heart rate: rapid on 15Apr2021, sars-cov-2 test: negative on 01Apr2021.The outcome of events were not recovered.   Information about lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, SARS-CoV-2 test
Clinical narrative: weakness; sob; Rapid heartbeat; chest pain; dizziness; This is a spontaneous report from a contactable Nurse (patient). A 43-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection,Batch/Lot number: not reported), via an unspecified route of administration, administered in Arm Right on 15Apr2021 12:00 as DOSE 2, SINGLE for COVID-19 immunisation. Facility type for vaccination was Public Health Clinic. Medical history included covid-19 and If Covid prior vaccination: Yes.The patient did not receive any other vaccine in four weeks prior to the COVID vaccine. Unknown allergies was reported. Concomitant medication(s) included pregabalin (LYRICA), ibuprofen (IBUPROFEN), sertraline (SERTRALINE) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported) administered in Arm Left on 25Mar2021 12:00 as DOSE 1, SINGLE for COVID-19 immunisation. On 15Apr2021 12:00, the patient experienced sob, rapid heartbeat, chest pain, dizziness, weakness. Patient was not received any treatment.The patient underwent lab tests and procedures which included heart rate: rapid on 15Apr2021, sars-cov-2 test: negative on 01Apr2021.The outcome of events were not recovered.   Information about lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dizziness, Dry eye, Eye oedema
Clinical narrative: Tiredness on 1st day.; Heart racing; chest ache; dizziness within 15 minutes; Pain at injection site within 24-48 hours.; Chills; sinus congestion; lymph nodes swelling occipital and throat; muscle ache; dry/buffy eyes; dry/buffy eyes; sore throat within 48 hrs; This is a spontaneous report from a contactable consumer or other non hcp.     A 35-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 15Apr2021 09:30 (at the age of 35 years) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included oxymetazoline. On 17Apr2021 07:00, the patient experienced tiredness on 1st day, heart racing, chest ache, dizziness within 15 minutes, pain at injection site within 24-48 hours, chills, sinus congestion, lymph nodes swelling occipital and throat, muscle ache, dry/buffy eyes, sore throat within 48 hrs. The patient underwent lab tests and procedures which included heart rate: racing. The clinical outcome of the events was resolving.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Lymphadenopathy, Myalgia, Oropharyngeal pain
Clinical narrative: Tiredness on 1st day.; Heart racing; chest ache; dizziness within 15 minutes; Pain at injection site within 24-48 hours.; Chills; sinus congestion; lymph nodes swelling occipital and throat; muscle ache; dry/buffy eyes; dry/buffy eyes; sore throat within 48 hrs; This is a spontaneous report from a contactable consumer or other non hcp.     A 35-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 15Apr2021 09:30 (at the age of 35 years) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included oxymetazoline. On 17Apr2021 07:00, the patient experienced tiredness on 1st day, heart racing, chest ache, dizziness within 15 minutes, pain at injection site within 24-48 hours, chills, sinus congestion, lymph nodes swelling occipital and throat, muscle ache, dry/buffy eyes, sore throat within 48 hrs. The patient underwent lab tests and procedures which included heart rate: racing. The clinical outcome of the events was resolving.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Sinus congestion, Vaccination site pain
Clinical narrative: Tiredness on 1st day.; Heart racing; chest ache; dizziness within 15 minutes; Pain at injection site within 24-48 hours.; Chills; sinus congestion; lymph nodes swelling occipital and throat; muscle ache; dry/buffy eyes; dry/buffy eyes; sore throat within 48 hrs; This is a spontaneous report from a contactable consumer or other non hcp.     A 35-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 15Apr2021 09:30 (at the age of 35 years) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included oxymetazoline. On 17Apr2021 07:00, the patient experienced tiredness on 1st day, heart racing, chest ache, dizziness within 15 minutes, pain at injection site within 24-48 hours, chills, sinus congestion, lymph nodes swelling occipital and throat, muscle ache, dry/buffy eyes, sore throat within 48 hrs. The patient underwent lab tests and procedures which included heart rate: racing. The clinical outcome of the events was resolving.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchospasm, Chest pain
Clinical narrative: Patient developed chest pain and feelings of bronchial constriction 2 days after receiving the vaccine.; Patient developed chest pain and feelings of bronchial constriction 2 days after receiving the vaccine.; This is a spontaneous report from a non-contactable physician. A 17-years-old (non-pregnant) female patient received first dose of bnt162b2 (BNT162B2), Formulation: Solution for injection, Batch/Lot number was not reported), via an intramuscular, administered in Arm Left on 09Apr2021 at 12:00 (at the age of 17-years-old) as DOSE 1, SINGLE for covid-19 immunisation. No, covid prior vaccination. No, known allergies. Vaccine facility type was unknown. No, other vaccine in four weeks. Other medications in two weeks was focalin, sertraline, hydroxyzine and nortriptyline. The patient medical history included postural orthostatic tachycardia syndrome, depression, anxiety, attention deficit hyperactivity. The patient concomitant medication(s) included dexamethasone, ofloxacin hydrochloride (FOCALIN [DEXAMETHASONE;OFLOXACIN HYDROCHLORIDE]) taken for an unspecified indication; sertraline taken for an unspecified indication; hydroxyzine taken for an unspecified indication; nortriptyline taken for an unspecified indication. It was reported that on 11Apr2021 at 07:00, the patient experienced patient developed chest pain and feelings of bronchial constriction 2 days after receiving the vaccine. Adverse event country was US. AE resulted to visit, Doctor or other healthcare professional office/clinic. No, treatment for AE. The outcome of event was unknown.  No follow-up attempts are possible: information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pharyngeal swelling, Throat tightness
Clinical narrative: Racing heart; tightened/swelling throat; tightened/swelling throat; This is a spontaneous report from a contactable consumer (patient). A 48-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE; Solution for Injection; Lot Number: EH6206), via an unspecified route of administration, administered in left arm on 10Mar2021 at 12:30 (at the age of  48-year-old) as dose 1, single for COVID-19 Immunization at Pharmacy or Drug Store. Medical history included Asthma from an unknown date and unknown if ongoing. Patient had known allergies to Silicone and Muscle relaxers: Skyllaxin, Flexerill. There was no Covid prior vaccination. Patient was not tested post vaccination. There were no other vaccines in four weeks. Concomitant medications in two weeks included Fluticasone Propionate, Salmeterol Xinafoate (ADVAIR); Cetirizine Hydrochloride (ZYRTEC); Montelukast and Vitamin D [Vitamin D NOS, Vitamin D Supplement]; all taken for an unspecified indications, start and stop dates were not reported. On 10Mar2021 at 15:00, about 2.5 hours after receiving the vaccine, the patient experienced Racing heart, Tightened and swelling throat. The symptoms dissipated after 30 minutes. No treatment was received for events. The outcome of event was recovered on 10Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Diarrhoea, Headache, Nausea, Pain
Clinical narrative: Itching on upper half of body and face /head within 2 minutes if vaccine; Throat closing up within 6-7 minutes of vaccine; loose stool; dehydrated; nausea; headache; pain; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).   A 61-year-old non-pregnant female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: Not reported), via an unspecified route of administration, administered in left arm on 13Apr2021 at 15:45 (at the age of 61-year-old) as dose 1, single for COVID-19 immunization. Medical history included None other than foot/ankle surgery 10 weeks ago and allergies (grass, dogs and cats) which are controlled with monthly allergy shots and occasional Allegra and Allergies to Penicillin, Sulfa, Mangos, passion fruit and coconut. Concomitant medication included fexofenadine hydrochloride (ALLEGRA) taken for Allegra (no Allegra the day of COVID) and Vitamins. The patient previously took Allegra for hypersensitivity. Patient had no other vaccine in four weeks. Patient not had Covid prior vaccination. Patient was tested Covid post vaccination. On 13Apr2021, the patient experienced itching on upper half of body and face /head within 2 minutes if vaccine, throat closing up within 6-7 minutes of vaccine, loose stool, dehydrated, nausea, headache and pain. It was reported that the patient had loose stool all week ended up in (withheld) ER on Friday. He was dehydrated and got iv and medicine for nausea and headache pain. The events resulted in Emergency room/department or urgent care. Therapeutic measures included IV fluids and medicine by iv. The patient underwent lab tests and procedures which included SARS-COV-2 antibody test: negative on 16Apr2021. The outcome of the events were not resolved.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, SARS-CoV-2 antibody test, Throat tightness
Clinical narrative: Itching on upper half of body and face /head within 2 minutes if vaccine; Throat closing up within 6-7 minutes of vaccine; loose stool; dehydrated; nausea; headache; pain; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).   A 61-year-old non-pregnant female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: Not reported), via an unspecified route of administration, administered in left arm on 13Apr2021 at 15:45 (at the age of 61-year-old) as dose 1, single for COVID-19 immunization. Medical history included None other than foot/ankle surgery 10 weeks ago and allergies (grass, dogs and cats) which are controlled with monthly allergy shots and occasional Allegra and Allergies to Penicillin, Sulfa, Mangos, passion fruit and coconut. Concomitant medication included fexofenadine hydrochloride (ALLEGRA) taken for Allegra (no Allegra the day of COVID) and Vitamins. The patient previously took Allegra for hypersensitivity. Patient had no other vaccine in four weeks. Patient not had Covid prior vaccination. Patient was tested Covid post vaccination. On 13Apr2021, the patient experienced itching on upper half of body and face /head within 2 minutes if vaccine, throat closing up within 6-7 minutes of vaccine, loose stool, dehydrated, nausea, headache and pain. It was reported that the patient had loose stool all week ended up in (withheld) ER on Friday. He was dehydrated and got iv and medicine for nausea and headache pain. The events resulted in Emergency room/department or urgent care. Therapeutic measures included IV fluids and medicine by iv. The patient underwent lab tests and procedures which included SARS-COV-2 antibody test: negative on 16Apr2021. The outcome of the events were not resolved.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Fatigue, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Initially tongue went numb the swelled slightly; Initially tongue went numb the swelled slightly; My left arm also swelled with lots of pain, then it moved to my back, shoulders, and neck with lots of stiffness as well / my hands swelled, turned red, and felt like they were on fire; extreme fatigue; my hands swelled, turned red, and felt like they were on fire; my hands swelled, turned red, and felt like they were on fire; my hands were numb; My left arm still has a knot in it; then it moved to back, shoulders and neck with lots of stiffness as well; This is a spontaneous report from a contactable consumer. This 39-year-old female consumer (patient) reported that:  A 39-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Not available/provided to reporter at the time of report completion) via an unspecified route of administration in arm left on 17Apr2021 at 13:15 (at the  age of 39-years-old) as dose 1, single for COVID-19 immunization. Patient known allergies: Bees, Mushroom, Zyrtec, and Environmental. Patient medical history includes diabetic and mixed connective tissues disease. The patient's concomitant medications were not reported. The patient other medications within 2 weeks of vaccination: yes too many to list here. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 17Apr2021 at 13:30 patient initially tongue went numb the swelled slightly, able to control with a dose of Benadryl. Patient left arm also swelled with lots of pain, then it moved to back, shoulders and neck with lots of stiffness as well. Later extreme fatigue hit through the following day. Then patient hands swelled, turned red, and felt like they were on fire. All medical facilities were closed so patient took another dose of Benadryl. Patient woke up slightly after taking, hands were numb, then ok when patient woke up from the Benadryl. Left arm still has a knot in it and hurts but patient using it. Patient received treatment for AE (Benedryl at home and from recommendation of nurse). The clinical outcome of the events was recovered with lasting effects/ Recovered with Sequel.  No follow-up attempts are possible; information about Lot/Batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Peripheral swelling, Swollen tongue, Vaccination site mass
Clinical narrative: Initially tongue went numb the swelled slightly; Initially tongue went numb the swelled slightly; My left arm also swelled with lots of pain, then it moved to my back, shoulders, and neck with lots of stiffness as well / my hands swelled, turned red, and felt like they were on fire; extreme fatigue; my hands swelled, turned red, and felt like they were on fire; my hands swelled, turned red, and felt like they were on fire; my hands were numb; My left arm still has a knot in it; then it moved to back, shoulders and neck with lots of stiffness as well; This is a spontaneous report from a contactable consumer. This 39-year-old female consumer (patient) reported that:  A 39-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Not available/provided to reporter at the time of report completion) via an unspecified route of administration in arm left on 17Apr2021 at 13:15 (at the  age of 39-years-old) as dose 1, single for COVID-19 immunization. Patient known allergies: Bees, Mushroom, Zyrtec, and Environmental. Patient medical history includes diabetic and mixed connective tissues disease. The patient's concomitant medications were not reported. The patient other medications within 2 weeks of vaccination: yes too many to list here. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 17Apr2021 at 13:30 patient initially tongue went numb the swelled slightly, able to control with a dose of Benadryl. Patient left arm also swelled with lots of pain, then it moved to back, shoulders and neck with lots of stiffness as well. Later extreme fatigue hit through the following day. Then patient hands swelled, turned red, and felt like they were on fire. All medical facilities were closed so patient took another dose of Benadryl. Patient woke up slightly after taking, hands were numb, then ok when patient woke up from the Benadryl. Left arm still has a knot in it and hurts but patient using it. Patient received treatment for AE (Benedryl at home and from recommendation of nurse). The clinical outcome of the events was recovered with lasting effects/ Recovered with Sequel.  No follow-up attempts are possible; information about Lot/Batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Limb injury
Clinical narrative: injured her foot; trouble walking; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer sponsored Program Support. 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 an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient injured her foot and she had trouble walking on an unspecified date. She was scheduled tomorrow for the second dose on 16Apr2021 and she could not stand on the line. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: The patient stated that she had a low grade fever of 99 (unit not provided) and everything hurts even while taking pain medication.; The patient stated that she had a low grade fever of 99 (unit not provided) and everything hurts even while taking pain medication.; This is a spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number: US-AMGEN-USASL2020180084). This case was split from master case #2020444687 for a female patient taking COVID Vaccine. A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included ongoing rheumatoid arthritis. Concomitant medication included etanercept (ENBREL) taken for rheumatoid arthritis, start and stop date were not reported. on an unspecified date the patient stated that she had a low-grade fever of 99 (unit not provided) and everything hurts even while taking pain medication. The patient underwent lab tests and procedures which included body temperature: 99   on   Low grade fever of 99 (unit not provided Therapeutic measures were taken as a result of the patient stated that she had a low grade fever of 99 (unit not provided) and everything hurts even while taking pain medication. (pain). Outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: weird feeling in my chest; Chest pain; This is a spontaneous report from a contactable consumer. This 51-year-old consumer reported that.  A 51-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: ER8737), dose 1 via an unspecified route of administration, administered in Arm Left on 10Apr2021 (Age at time of vaccination 51-years-old) as DOSE 1, SINGLE for covid-19 immunization. Medical history included type 1 diabetes mellitus, hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included insulin aspart (NOVOLOG) taken for type 1 diabetes mellitus, atorvastatin (ATORVASTATIN), calcium (CALCIUM), biotin (BIOTIN), iron (IRON), cetirizine hydrochloride (ZYRTEC) taken for hypersensitivity, ascorbic acid, biotin, folic acid, iodine, pantothenic acid, pyridoxine hydrochloride, retinol, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc (CENTRUM MULTIGUMMIES), colecalciferol (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported. Consumer stated due vaccination date for the second shot On 01May2021. On 10Apr2021 The patient experienced weird feeling in my chest, chest pain. Events were consider as non serious. The outcome of events were unknown.  No follow up attempts are possible. no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Hypotension, Pain in extremity
Clinical narrative: In general she feels week; pain in the arm; dizziness; chills; blood pressure measured and it was very low; This is a spontaneous report from a contactable consumer or other non HCP. A female patient of an unspecified age received bnt162b2 (bnt162b2), dose 1 via an unspecified route of administration on 31mar2021 (batch/lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 20Apr2021 18:09:46 patient experienced in general she feels week, pain in the arm, dizziness, chills, blood pressure measured, and it was very low. Outcome of events was unknown.  Revised on 06 April 2021, no reports of dizziness, the other side effects reported by caller where previously reported on the clinical trials of the vaccine. No specific contraindication for patients with asthma.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Chest discomfort, Chest pain
Clinical narrative: Severe insomnia that has persisted even as other side effects have calmed; Fever; Chills; Chest pain; Loss of appetite; pressure at the sternum; neck pain; Nausea; constipation; Severe joint pain in knees; lower back pain; This is a spontaneous report from a non- contactable consumer. A 33-years-old female patient received bnt162b2 (COVID 19, brand=Pfizer, Formulation: Solution for injection) via an unspecified route of administration in left arm on 23Mar2021 at 12:30 as dose 1, single and dose 2 via an unspecified route of administration in left arm on 13Apr2021 (at the age of 33-years-old) at 11:00 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took ibuprofen and experienced hypersensitivity. Patient is not pregnant and No other vaccine in four weeks and no other medications in two weeks. No covid prior vaccination and no covid tested post vaccination. On 13Apr2021 at 20:30, the patient experienced severe insomnia that has persisted even as other side effects have calmed, fever, reoccurring for 2 days after 2nd dose, ranging from 101.1 - 104.2, chills, chest pain, pressure at the sternum, severe joint pain in knees, pain in lower back and neck and nausea and constipation, loss of appetite. The patient underwent lab tests and procedures which included body temperature with 101.1 - 104.2. No treatment received for the adverse events. The outcome of the events were not resolved.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Constipation, Decreased appetite, Insomnia, Nausea
Clinical narrative: Severe insomnia that has persisted even as other side effects have calmed; Fever; Chills; Chest pain; Loss of appetite; pressure at the sternum; neck pain; Nausea; constipation; Severe joint pain in knees; lower back pain; This is a spontaneous report from a non- contactable consumer. A 33-years-old female patient received bnt162b2 (COVID 19, brand=Pfizer, Formulation: Solution for injection) via an unspecified route of administration in left arm on 23Mar2021 at 12:30 as dose 1, single and dose 2 via an unspecified route of administration in left arm on 13Apr2021 (at the age of 33-years-old) at 11:00 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took ibuprofen and experienced hypersensitivity. Patient is not pregnant and No other vaccine in four weeks and no other medications in two weeks. No covid prior vaccination and no covid tested post vaccination. On 13Apr2021 at 20:30, the patient experienced severe insomnia that has persisted even as other side effects have calmed, fever, reoccurring for 2 days after 2nd dose, ranging from 101.1 - 104.2, chills, chest pain, pressure at the sternum, severe joint pain in knees, pain in lower back and neck and nausea and constipation, loss of appetite. The patient underwent lab tests and procedures which included body temperature with 101.1 - 104.2. No treatment received for the adverse events. The outcome of the events were not resolved.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pyrexia
Clinical narrative: Severe insomnia that has persisted even as other side effects have calmed; Fever; Chills; Chest pain; Loss of appetite; pressure at the sternum; neck pain; Nausea; constipation; Severe joint pain in knees; lower back pain; This is a spontaneous report from a non- contactable consumer. A 33-years-old female patient received bnt162b2 (COVID 19, brand=Pfizer, Formulation: Solution for injection) via an unspecified route of administration in left arm on 23Mar2021 at 12:30 as dose 1, single and dose 2 via an unspecified route of administration in left arm on 13Apr2021 (at the age of 33-years-old) at 11:00 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took ibuprofen and experienced hypersensitivity. Patient is not pregnant and No other vaccine in four weeks and no other medications in two weeks. No covid prior vaccination and no covid tested post vaccination. On 13Apr2021 at 20:30, the patient experienced severe insomnia that has persisted even as other side effects have calmed, fever, reoccurring for 2 days after 2nd dose, ranging from 101.1 - 104.2, chills, chest pain, pressure at the sternum, severe joint pain in knees, pain in lower back and neck and nausea and constipation, loss of appetite. The patient underwent lab tests and procedures which included body temperature with 101.1 - 104.2. No treatment received for the adverse events. The outcome of the events were not resolved.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Asthenia, Blood pressure measurement, Bone pain, Chest pain
Clinical narrative: Chest pains; severe headache; lost voice; low blood pressure; weakness; nausea; shakiness; bone ache; rash on arm.; This is a spontaneous report from a contactable consumer (patient).   A 72-year-old (non-pregnant) female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8734), via an unspecified route of administration at left arm on 12Apr2021 at 9:30 (at the age of 72-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history included giant cell arteritis and fibromyalgia. The patient had allergies with penicillin and percodan. The patient's concomitant medications included prednisone, LUMIGAN (bimatoprost), dorzolamide, fluoxetine and FAMO (famotidine). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6207), via an unspecified route of administration at left arm on 22Mar2021 at 9:30 as dose 1, single for covid-19 immunisation. On 13Apr2021 at 01:00, the patient experienced chest pains, severe headache, lost voice, low blood pressure, weakness, nausea, shakiness, bone ache and rash on arm. The patient did not receive treatment for adverse event. The patient had not suffered from covid prior vaccination. The patient did not test covid post vaccination. The patient did not receive other vaccine in four weeks. The patient underwent lab tests and procedures which included blood pressure measurement: low on 13Apr2021. The outcome of the events was recovering.     No follow-up attempts are possible. No further information is expected
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypotension, Nausea, Rash, Tremor
Clinical narrative: Chest pains; severe headache; lost voice; low blood pressure; weakness; nausea; shakiness; bone ache; rash on arm.; This is a spontaneous report from a contactable consumer (patient).   A 72-year-old (non-pregnant) female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8734), via an unspecified route of administration at left arm on 12Apr2021 at 9:30 (at the age of 72-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history included giant cell arteritis and fibromyalgia. The patient had allergies with penicillin and percodan. The patient's concomitant medications included prednisone, LUMIGAN (bimatoprost), dorzolamide, fluoxetine and FAMO (famotidine). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6207), via an unspecified route of administration at left arm on 22Mar2021 at 9:30 as dose 1, single for covid-19 immunisation. On 13Apr2021 at 01:00, the patient experienced chest pains, severe headache, lost voice, low blood pressure, weakness, nausea, shakiness, bone ache and rash on arm. The patient did not receive treatment for adverse event. The patient had not suffered from covid prior vaccination. The patient did not test covid post vaccination. The patient did not receive other vaccine in four weeks. The patient underwent lab tests and procedures which included blood pressure measurement: low on 13Apr2021. The outcome of the events was recovering.     No follow-up attempts are possible. No further information is expected
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site mass, Vaccination site swelling
Clinical narrative: The second shot has been painful; there is a significant lump and swelling at the injection site; there is a significant lump and swelling at the injection site. It is extremely painful.; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 47-years-old male patient received BNT162B2 (Pfizer covid 19 vaccine, formulation: solution for injection, Batch/Lot Number: Ew0161), via an unspecified route of administration, administered in Arm Left on 15Apr2021 10:45 (at the age of 47-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: Er2613 and Expiration date was not reported), via an unspecified route of administration, administration in Arm left on 25Mar2021 10:45 as dose 1, single for COVID-19 immunisation. On 15Apr2021 15:00, the patient experienced the second shot has been painful, there is a significant lump and swelling at the injection site, there is a significant lump and swelling at the injection site. it is extremely painful. The patient did not receive treatment. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Body temperature increased, Diarrhoea, Malaise
Clinical narrative: Hives; itching of facial skin; vomiting; Diarrhoea; Nausea; Tachycardia; General malaise; weakness; temperature 100 degrees Fahrenheit; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 33-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 19Apr2021 at 12:00 AM (at the age of 33-year-old) (Batch/Lot Number: Ew0158) as dose 1, single for covid-19 immunization. The patient medical history included anxiety. The patient not had any allergies. Concomitant medication(s) included sertraline 50 mg (SERTRALINE) taken for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccine in four weeks. Prior vaccination the patient not had covid and post vaccination the patient not tested for covid. On 19Apr2021, the patient experienced hives, itching of facial skin, vomiting, diarrhoea, nausea, tachycardia, general malaise, weakness and temperature 100 degrees fahrenheit . The patient underwent lab test on 19Apr2021 and procedures which included body temperature: 100 fahrenheit temperature. The patient received treatment for the events. Outcome for all the reported events were recovered on an unspecified in Apr2021.  No follow up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pruritus, Tachycardia, Urticaria, Vomiting
Clinical narrative: Hives; itching of facial skin; vomiting; Diarrhoea; Nausea; Tachycardia; General malaise; weakness; temperature 100 degrees Fahrenheit; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 33-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 19Apr2021 at 12:00 AM (at the age of 33-year-old) (Batch/Lot Number: Ew0158) as dose 1, single for covid-19 immunization. The patient medical history included anxiety. The patient not had any allergies. Concomitant medication(s) included sertraline 50 mg (SERTRALINE) taken for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccine in four weeks. Prior vaccination the patient not had covid and post vaccination the patient not tested for covid. On 19Apr2021, the patient experienced hives, itching of facial skin, vomiting, diarrhoea, nausea, tachycardia, general malaise, weakness and temperature 100 degrees fahrenheit . The patient underwent lab test on 19Apr2021 and procedures which included body temperature: 100 fahrenheit temperature. The patient received treatment for the events. Outcome for all the reported events were recovered on an unspecified in Apr2021.  No follow up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Disturbance in attention, Dizziness, Dysgeusia, Feeling hot
Clinical narrative: couldn't see/focus & finally collapsed as I reached a cot/faded; couldn't see/focus & finally collapsed as I reached a cot; strange taste in my mouth; strong pre-syncope symptoms/faded in and out 5 times in an hour; Felt very hot; sweating profusely; weakness in arms; couldn't see/focus & finally collapsed as I reached a cot; blood pressure & heart were high; blood pressure & heart were high; shook in recovery for 5 hours; Dizziness; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0162) via an unspecified route of administration in the left arm on 16Apr2021 at 15:00 (at 46-years-old) as a single dose for COVID-19 immunisation. Medical history included Dysautonomia postural orthostatic tachycardia syndrome (POTS), Mast Cell Activation Syndrome, Ehlers Danlos Hypermobility Type, past thyroid cancer, past cerebral venous sinus thrombosis (CVST), migraines, vertigo, dystonia, Meibomian Gland Dysfunction, pituitary gland enlargement, gluten allergy, and dairy allergy, all from unknown dates and unknown if ongoing. Concomitant medications were unspecified, reported as too many to list. The patient previously received diphenhydramine hydrochloride (BENADRYL), fentanyl, and nitrous oxide, all from unknown date for unknown indications and experienced allergy. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in four weeks. The patient reported she was fine for 25 minutes and at 15:30 she began to experience strange taste in her mouth. Then she had strong pre-syncope symptoms. She felt very hot, was sweating profusely, had weakness in arms, couldn't see/focus and finally collapsed as she reached a cot. Her blood pressure and heart were high, which was not normal for her in presyncope. She reported she faded in and out 5 times in an hour, which was also not normal. She shook in recovery for 5 hours, which was also not normal for her. She reported dizziness & presyncope had persisted for 5 days so far. The patient reported medics on site took vitals and gave cool cloths. The clinical outcome of dizziness and presyncope were considered not recovered; the outcomes of the other events were reported as recovered with lasting effects. Since vaccination the patient had not been tested for COVID.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hyperhidrosis, Hypertension, Muscular weakness, Presyncope
Clinical narrative: couldn't see/focus & finally collapsed as I reached a cot/faded; couldn't see/focus & finally collapsed as I reached a cot; strange taste in my mouth; strong pre-syncope symptoms/faded in and out 5 times in an hour; Felt very hot; sweating profusely; weakness in arms; couldn't see/focus & finally collapsed as I reached a cot; blood pressure & heart were high; blood pressure & heart were high; shook in recovery for 5 hours; Dizziness; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0162) via an unspecified route of administration in the left arm on 16Apr2021 at 15:00 (at 46-years-old) as a single dose for COVID-19 immunisation. Medical history included Dysautonomia postural orthostatic tachycardia syndrome (POTS), Mast Cell Activation Syndrome, Ehlers Danlos Hypermobility Type, past thyroid cancer, past cerebral venous sinus thrombosis (CVST), migraines, vertigo, dystonia, Meibomian Gland Dysfunction, pituitary gland enlargement, gluten allergy, and dairy allergy, all from unknown dates and unknown if ongoing. Concomitant medications were unspecified, reported as too many to list. The patient previously received diphenhydramine hydrochloride (BENADRYL), fentanyl, and nitrous oxide, all from unknown date for unknown indications and experienced allergy. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in four weeks. The patient reported she was fine for 25 minutes and at 15:30 she began to experience strange taste in her mouth. Then she had strong pre-syncope symptoms. She felt very hot, was sweating profusely, had weakness in arms, couldn't see/focus and finally collapsed as she reached a cot. Her blood pressure and heart were high, which was not normal for her in presyncope. She reported she faded in and out 5 times in an hour, which was also not normal. She shook in recovery for 5 hours, which was also not normal for her. She reported dizziness & presyncope had persisted for 5 days so far. The patient reported medics on site took vitals and gave cool cloths. The clinical outcome of dizziness and presyncope were considered not recovered; the outcomes of the other events were reported as recovered with lasting effects. Since vaccination the patient had not been tested for COVID.