chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Insomnia, Lymphadenopathy, Nasal congestion
Clinical narrative: fatigue; swollen lymph node left armpit; swollen lymph node left armpit beginning day after vaccine, currently still somewhat swollen and tender; sinus pain; congestion; full body aches; shivering/chills; hot flashes; cough; cough (from sinus drainage); headache; decreased appetite; insomnia; This is a spontaneous report from a contactable Other Health Care Professional (patient) reported for herself.   A 26-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0202) via an unspecified route of administration, administered in Arm Left on 12Jun2021 (Age at Vaccination: 26-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history includes SVT, GERD, IBS. Concomitant medication included lisdexamfetamine mesilate (VYVANSE), cyproheptadine hydrochloride (PERIACTIN), omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]), prolactin and medical marijuana taken two weeks of medication. Patient had known allergies of Sulfa drugs and Flagyl. 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. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0175) via an unspecified route of administration, administered in Arm Left on 21May2021 (Age at Vaccination: 26-years-old) as DOSE 1, SINGLE for COVID-19 immunization. On 13Jun2021, the patient experienced swollen lymph node left armpit beginning day after vaccine, currently still somewhat had swollen and tender 6 days later, sinus pain, congestion, full body aches, shivering/chills, hot flashes, cough (from sinus drainage), headache, decreased appetite, insomnia, fatigue, all began 1-2 days after vaccine and continuing presently 6 days after vaccine. No treatment was taken for adverse events. Outcome of all adverse events was not recovered.   No follow-up attempts are possible. No further information is expected.  Other medications in two weeks: Vyvanse, prolactin, Prilosec, medical marijuana
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Sinus pain, Tenderness
Clinical narrative: fatigue; swollen lymph node left armpit; swollen lymph node left armpit beginning day after vaccine, currently still somewhat swollen and tender; sinus pain; congestion; full body aches; shivering/chills; hot flashes; cough; cough (from sinus drainage); headache; decreased appetite; insomnia; This is a spontaneous report from a contactable Other Health Care Professional (patient) reported for herself.   A 26-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0202) via an unspecified route of administration, administered in Arm Left on 12Jun2021 (Age at Vaccination: 26-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history includes SVT, GERD, IBS. Concomitant medication included lisdexamfetamine mesilate (VYVANSE), cyproheptadine hydrochloride (PERIACTIN), omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]), prolactin and medical marijuana taken two weeks of medication. Patient had known allergies of Sulfa drugs and Flagyl. 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. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0175) via an unspecified route of administration, administered in Arm Left on 21May2021 (Age at Vaccination: 26-years-old) as DOSE 1, SINGLE for COVID-19 immunization. On 13Jun2021, the patient experienced swollen lymph node left armpit beginning day after vaccine, currently still somewhat had swollen and tender 6 days later, sinus pain, congestion, full body aches, shivering/chills, hot flashes, cough (from sinus drainage), headache, decreased appetite, insomnia, fatigue, all began 1-2 days after vaccine and continuing presently 6 days after vaccine. No treatment was taken for adverse events. Outcome of all adverse events was not recovered.   No follow-up attempts are possible. No further information is expected.  Other medications in two weeks: Vyvanse, prolactin, Prilosec, medical marijuana
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Pain, Rash, SARS-CoV-2 test
Clinical narrative: Headache; Rash; swollen; increased tempature at injection site; pain; dose 1- 26May2021 09:15  and dose 2- 26May2021; 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: EW0178), via an unspecified route of administration, administered in left arm on 26May2021 09:15 (at the age of 48 years) as dose 1, single for COVID-19 immunization. The patient also received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0191), via an unspecified route of administration, administered in left upper arm on 26May2021 (at the age of 48 years) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patients concomitant medications included lisinopril (LISINOPRIL); calcium (CALCIUM); colecalciferol (VIT D3); zolpidem tartrate (AMBIEN); lamotrigine (LAMICTAL); fluoxetine hydrochloride (PROZAC). Other vaccine in four weeks were none. The patient did not have covid prior vaccination. The patient had no known allergies. On 18Jun2021 the patient experienced headache, rash, swollen, increased temperature at injection site and pain included with these. The patient did not receive treatment for the events. The patient underwent lab tests and procedures which included covid test post vaccination, Nasal Swab (Biofire Diagnostic with Filmarray system): negative on 11Jun2021. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site warmth
Clinical narrative: Headache; Rash; swollen; increased tempature at injection site; pain; dose 1- 26May2021 09:15  and dose 2- 26May2021; 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: EW0178), via an unspecified route of administration, administered in left arm on 26May2021 09:15 (at the age of 48 years) as dose 1, single for COVID-19 immunization. The patient also received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0191), via an unspecified route of administration, administered in left upper arm on 26May2021 (at the age of 48 years) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patients concomitant medications included lisinopril (LISINOPRIL); calcium (CALCIUM); colecalciferol (VIT D3); zolpidem tartrate (AMBIEN); lamotrigine (LAMICTAL); fluoxetine hydrochloride (PROZAC). Other vaccine in four weeks were none. The patient did not have covid prior vaccination. The patient had no known allergies. On 18Jun2021 the patient experienced headache, rash, swollen, increased temperature at injection site and pain included with these. The patient did not receive treatment for the events. The patient underwent lab tests and procedures which included covid test post vaccination, Nasal Swab (Biofire Diagnostic with Filmarray system): negative on 11Jun2021. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Limb discomfort, Pharyngeal swelling
Clinical narrative: First night was really bad with itching all over my body/itching all over; covid arm; Swelling of throat; headache; fatigue; weakness; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0169, Expiry date: not reported), via an unspecified route of administration in right arm on 02Jun2021 11:30 (at age of 30-year-old) as dose 1, single for COVID-19 immunization in Health Clinic/facility. Medical history included asthma, attention deficit hyperactivity disorder, depression, anxiety, post-traumatic stress disorder. Concomitant medication(s) included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. The patient previously took dextromethorphan. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. On 19Jun2021 at 12:00, the patient experienced first night was really bad with itching all over my body/itching all over, covid arm, swelling of throat, headache, fatigue, weakness. First night was really bad with itching all over his body took hydroxyzine 25mg. Now two weeks in the patient had covid arm and the same side effects. Swelling of throat, itching all over with headache/fatigue/weakness. The patient had taken hydroxyzine again currently. The patient had dose 2 scheduled in 4 days. Therapeutic measures were taken as a result of the events which included hydroxyzine. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: First night was really bad with itching all over my body/itching all over; covid arm; Swelling of throat; headache; fatigue; weakness; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0169, Expiry date: not reported), via an unspecified route of administration in right arm on 02Jun2021 11:30 (at age of 30-year-old) as dose 1, single for COVID-19 immunization in Health Clinic/facility. Medical history included asthma, attention deficit hyperactivity disorder, depression, anxiety, post-traumatic stress disorder. Concomitant medication(s) included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. The patient previously took dextromethorphan. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. On 19Jun2021 at 12:00, the patient experienced first night was really bad with itching all over my body/itching all over, covid arm, swelling of throat, headache, fatigue, weakness. First night was really bad with itching all over his body took hydroxyzine 25mg. Now two weeks in the patient had covid arm and the same side effects. Swelling of throat, itching all over with headache/fatigue/weakness. The patient had taken hydroxyzine again currently. The patient had dose 2 scheduled in 4 days. Therapeutic measures were taken as a result of the events which included hydroxyzine. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives that did not itch appearing  8hrs after injection. resolved with zyrtec for about 3-4 hrs but returned and 1 pepcid OTC was given and then resolved; This is a spontaneous report from a contactable other health care professional. A 16-year-old (Age group- Adolescent (12-17 Years) non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EW0183), intramuscular, administered in right arm on 19Jun2021 at 08:30 (Age at vaccination: 16-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included seasonal allergy from an unknown date and unknown if ongoing, urticaria (Known allergies- had hives 5 yrs ago for about a month for unknown cause but none since) from an unknown date and unknown if ongoing. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) 5mg daily, acetaminophen (ACETAMINOPHEN) and ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported in two weeks. Historical vaccine included: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: EW0173) as dose 1, single intramuscular, administered in right arm on 29May2021 at 12:45 AM for COVID-19 immunization. The patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No COVID prior vaccination. Facility type vaccine at hospital and facility name. On 19Jun2021 at 16:00, the patient experienced hives that did not itch appearing 8hrs after injection. Resolved with zyrtec for about 3-4 hrs but returned and 1 pepcid otc was given and then resolved. It was reported that, adverse event treatment- Patient mother (I am her mother) and a family practice PA so treated patient with cetirizine and the pepcid as above. Post vaccination patient not tested for COVID. The outcome of the event was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pyrexia, Vaccination site pruritus, Vaccination site rash
Clinical narrative: fever; fatigue; 7 days after injection, the injection site began to itch.; rash at injection site; Had a small bump where needle was inserted; first injection the injection site was red in an oval shape around the injection area.; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 35-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0183) intramuscular, administered in Arm Left on 28May2021 16:15 (at the age of 35-years-old) as dose 1, single for COVID-19 immunization and received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0173) intramuscular, administered in Arm Right on 18Jun2021 16:15 (at the age of 35-years-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No known allergies were reported. No other vaccine in four weeks. No other medications in two weeks. No COVID prior to vaccination. No COVID tested post vaccination. On 04Jun2021 07:00, 7 days after injection, the patient experienced that the injection site began to itch. On an unspecified date in 2021, she had a small bump where needle was inserted. Gradually this become larger and on day 9 after first injection the injection site was red in an oval shape around the injection are. On 04Jun2021 07:00, she had rash at injection site. On 19Jun2021, she had fever and was fatigue. No treatment was given for adverse events. The outcome of the event the injection site was red in an oval shape around the injection area was unknown. The outcome of all other events was recovered on an unknown date in 2021.    Follow-up attempts were completed. No further information was expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: fever; fatigue; 7 days after injection, the injection site began to itch.; rash at injection site; Had a small bump where needle was inserted; first injection the injection site was red in an oval shape around the injection area.; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 35-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0183) intramuscular, administered in Arm Left on 28May2021 16:15 (at the age of 35-years-old) as dose 1, single for COVID-19 immunization and received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0173) intramuscular, administered in Arm Right on 18Jun2021 16:15 (at the age of 35-years-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No known allergies were reported. No other vaccine in four weeks. No other medications in two weeks. No COVID prior to vaccination. No COVID tested post vaccination. On 04Jun2021 07:00, 7 days after injection, the patient experienced that the injection site began to itch. On an unspecified date in 2021, she had a small bump where needle was inserted. Gradually this become larger and on day 9 after first injection the injection site was red in an oval shape around the injection are. On 04Jun2021 07:00, she had rash at injection site. On 19Jun2021, she had fever and was fatigue. No treatment was given for adverse events. The outcome of the event the injection site was red in an oval shape around the injection area was unknown. The outcome of all other events was recovered on an unknown date in 2021.    Follow-up attempts were completed. No further information was expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash, Urticaria, Vaccination site pain
Clinical narrative: Burning at injection site; Mild itch, rash/hives on fingers &palms.; Mild itch, rash/hives on fingers &palms.; Mild itch, rash/hives on fingers &palms/Continued sporadic rash/hives on hands, feet & ankles lasted thru 04/17/21. 04/24/21: Return of sporadic rash/hives on hands, feet &ankles lasted thru 04/28/21.; Later at home had mild widespread itching & slight left arm soreness.; This is a spontaneous report from a contactable consumer (patient). A 66-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8727), via an unspecified route of administration, administered in Arm Left on 13Apr2021 09:00 (at the age of 66-year-old) as single dose for COVID-19 immunisation. Medical history included Ovarian cancer survivor, allergic asthma (not chronic). Concomitant medication(s) included losartan; rosuvastatin; timolol; latanoprost; chymotrypsin, trypsin (ALPH-INTERN), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8727), via an unspecified route of administration, administered in Arm Left on 23Mar2021 09:30 (at the age of 66-year-old) as single dose for COVID-19 immunization and experienced mild widespread itching & slight left arm soreness and developed itchy rash behind right knee 42 hours later, which was confirmed as a delayed rash reaction. The patient previously took Shingrix vaccine for immunization, Sulfa drugs and experienced allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received second dose on 13Apr2021 09:00 and waited near EMTs for 30 min after 2nd dose. The patient had mild reactions began shortly after 2nd dose: Burning at injection site. Mild itch, rash/hives on fingers & palms. Later at home had mild widespread itching & slight left arm soreness. Continued sporadic rash/hives on hands, feet & ankles lasted thru 17Apr2021. From 24Apr2021: Return of sporadic rash/hives on hands, feet &ankles lasted thru 28Apr2021. The patient did not receive any treatment for the events. Outcome of events itch, rash, hives was recovered on 28Apr2021; Burning at injection site, slight left arm soreness was recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Pain in both elbows. R worse. Pain in joints of both feet. L worse; This is a spontaneous report from a contactable consumer (patient).  A 56-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: EW0182) via an unspecified route of administration, administered in left arm on 05May2021 at 13:00 (age at vaccination 56 years) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history was not reported. The patient had no known allergy. Concomitant medications included ibuprofen, unspecified ground flax seed and stool softener in two weeks. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for COVID-19 since vaccination. On 22May2021 at 13:00, the patient experienced pain in both elbows R worse; pain in joints of both feet L worse. The patient did not receive any treatment for event. Outcome of the event was resolving.   Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest X-ray, Cough, Electrocardiogram, Heart rate increased
Clinical narrative: Cough that was like a bronchitis symptom also developed; Palpitations similar to those caused by excessive caffeine appeared (heart pounding or strong heart beats rather than arrhythmia); Pharyngeal streptococcal infection; Palpitations similar to those caused by excessive caffeine appeared (heart pounding or strong heart beats rather than arrhythmia); A pyrexia of 39 degrees C developed; This is a spontaneous report received from a contactable consumer (patient). A 47-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0161), via an unspecified route of administration in left arm on 07May2021 at 14:15 (at the age of 47 years old, not pregnant at the time of vaccination) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had known allergies to Zithromax. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8727), via an unspecified route of administration in right arm on 16Apr2021 at 02:15 PM (at the age of 47 years old) for covid-19 immunisation and patient experienced no reaction. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 08May, the following day of the 2nd vaccination, a pyrexia of 39 degrees C developed. Then, from around 18May2021, palpitations similar to those caused by excessive caffeine appeared (heart pounding or strong heart beats rather than arrhythmia). She refrained from taking coffee or green tea for about 10 days, but they did not go away. They found a pharyngeal streptococcal infection on 18May2021. From around the 25May2021, cough that was like a bronchitis symptom also developed. So, she visited the Urgent Care Service on the 28May2021. Chest X-ray and electrocardiogram showed no abnormalities. COVID test was negative. The patient underwent lab tests and procedures which included body temperature: 36 degrees c centigrade on 10May2021, sars-cov-2 test (nasal swab): negative on 28May2021, chest x-ray: no abnormalities, electrocardiogram: no abnormalities. The events resulted in emergency room or doctor or other healthcare professional office/clinic visit. The patient did not received treatment due to the events. The outcome of events was recovered on an unspecified date in 2021.  Follow-Up (21Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pharyngitis streptococcal, Pyrexia, SARS-CoV-2 test
Clinical narrative: Cough that was like a bronchitis symptom also developed; Palpitations similar to those caused by excessive caffeine appeared (heart pounding or strong heart beats rather than arrhythmia); Pharyngeal streptococcal infection; Palpitations similar to those caused by excessive caffeine appeared (heart pounding or strong heart beats rather than arrhythmia); A pyrexia of 39 degrees C developed; This is a spontaneous report received from a contactable consumer (patient). A 47-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0161), via an unspecified route of administration in left arm on 07May2021 at 14:15 (at the age of 47 years old, not pregnant at the time of vaccination) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had known allergies to Zithromax. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8727), via an unspecified route of administration in right arm on 16Apr2021 at 02:15 PM (at the age of 47 years old) for covid-19 immunisation and patient experienced no reaction. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 08May, the following day of the 2nd vaccination, a pyrexia of 39 degrees C developed. Then, from around 18May2021, palpitations similar to those caused by excessive caffeine appeared (heart pounding or strong heart beats rather than arrhythmia). She refrained from taking coffee or green tea for about 10 days, but they did not go away. They found a pharyngeal streptococcal infection on 18May2021. From around the 25May2021, cough that was like a bronchitis symptom also developed. So, she visited the Urgent Care Service on the 28May2021. Chest X-ray and electrocardiogram showed no abnormalities. COVID test was negative. The patient underwent lab tests and procedures which included body temperature: 36 degrees c centigrade on 10May2021, sars-cov-2 test (nasal swab): negative on 28May2021, chest x-ray: no abnormalities, electrocardiogram: no abnormalities. The events resulted in emergency room or doctor or other healthcare professional office/clinic visit. The patient did not received treatment due to the events. The outcome of events was recovered on an unspecified date in 2021.  Follow-Up (21Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Swelling
Clinical narrative: Swelling by left armpit, between arm and breast; Swelling by left armpit, between arm and breast; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0202), via an unspecified route of administration, administered in arm left on 16Jun2021 14:00 (at the age of 56-years) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Jun2021 19:00, the patient experience Swelling by left armpit, between arm and breast. The patient did not receive any treatment for adverse event. The patient did not have Covid prior vaccination, and the patient did not test for covid post vaccination. The patient did not have known allergies. The outcome of the events was not recovered.   Follow-Up (05Aug2021), Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: . I had some symptoms (event captured as per verbatim since further clarification was unknown) but not that like fever going above 100 degree Fahrenheit; This is a spontaneous report from a contactable consumer (Patient). This is the second case out of two cases in which the female consumer reported for herself.  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: EW0176; Expiration Date: Aug2021) 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. On an unspecified date, the patient experienced pyrexia. The patient stated that she and her husband both got the Covid vaccine, Pfizer one. On an unspecified date, the patient had some symptoms (event captured as per verbatim since further clarification was unknown) but not that like fever going above 100 degree Fahrenheit. The patient underwent lab tests and procedures which included body temperature: not that like fever going above 100 degree Fahrenheit, on an unspecified date. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever going above 100 degree Fahrenheit; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (Husband). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EW0176; Expiration Date: Aug2021), via an unspecified route of administration on 18Jun2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated, yesterday on 18Jun2021, my husband and I both got the Covid vaccine, Pfizer one and he is currently having fever on 19Jun2021, and like two hours before he has taken Tylenol 400 mg but now, he is having a fever of 101.6. So, I am a little bit concerned as, is this the thing that is expected or something serious happening. Reporter stated, he is only suffering, and we both got yesterday evening. Reporter further stated, "I had some symptoms but not that like fever going above 100-degree Fahrenheit, but he is having fever about 101. So, I am little bit concerned about that. So, I just want to ask is this something that is expected or something serious happening so that I can consult a doctor and other thing. The patient underwent lab tests and procedures which included body temperature with 101.6 Fahrenheit on 19Jun2021. The patient received treatment as a result of event. The outcome of the event was reported as unknown   Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Cough, Nasal congestion, Pain
Clinical narrative: He had a lot of congestion; Body aches; Cough; This is a spontaneous report from a contactable consumer (patient) via Regulatory Authority.   A 33-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0177, expiry date: unknown), via an unspecified route of administration, administered in arm left on 17May2021 at 15:15 (at the age of 33-years-old) as dose 1, single to COVID-19 immunization at hospital. Patient medical history and family medical history was none. On an unspecified date in May2021, the patient had a lot of congestion, body aches and had cough. Caller stated he had side effects to the Pfizer Covid-19 vaccine and went to emergency room. The patient had a lot of congestion since the first dose and body aches since the first injection and also cough but after the second dose. He was discharged from the emergency room. The emergency room ran some tests and told him to take some Tylenol. He had a Covid-19 test and he was expecting a call with the results and the staff at the hospital took his temperature. He explained to the hospital staff that he was having the symptoms that are on the Covid 19 vaccine paperwork and that was the reason for his visit, since he had the two Covid 19 vaccines. He would like to point out that he asked the nurse when he was going to have the second dose, since the first vaccine he was still having side effects, he asked her if he was in danger to have the second vaccine. The nurse told him he was ok to get the second vaccine. The nurse told him he might have some muscle pain but he should not be worried about it. He provided Pfizer with what happened so far since he had the vaccine. He was not able to stand up with the muscle pain and he could not support his legs any longer. On 16Jun2021, the patient underwent lab tests and procedures which included blood work, temperature and COVID-19 virus test with unknown results. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: He had a lot of congestion; Body aches; Cough; This is a spontaneous report from a contactable consumer (patient) via Regulatory Authority.   A 33-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0177, expiry date: unknown), via an unspecified route of administration, administered in arm left on 17May2021 at 15:15 (at the age of 33-years-old) as dose 1, single to COVID-19 immunization at hospital. Patient medical history and family medical history was none. On an unspecified date in May2021, the patient had a lot of congestion, body aches and had cough. Caller stated he had side effects to the Pfizer Covid-19 vaccine and went to emergency room. The patient had a lot of congestion since the first dose and body aches since the first injection and also cough but after the second dose. He was discharged from the emergency room. The emergency room ran some tests and told him to take some Tylenol. He had a Covid-19 test and he was expecting a call with the results and the staff at the hospital took his temperature. He explained to the hospital staff that he was having the symptoms that are on the Covid 19 vaccine paperwork and that was the reason for his visit, since he had the two Covid 19 vaccines. He would like to point out that he asked the nurse when he was going to have the second dose, since the first vaccine he was still having side effects, he asked her if he was in danger to have the second vaccine. The nurse told him he was ok to get the second vaccine. The nurse told him he might have some muscle pain but he should not be worried about it. He provided Pfizer with what happened so far since he had the vaccine. He was not able to stand up with the muscle pain and he could not support his legs any longer. On 16Jun2021, the patient underwent lab tests and procedures which included blood work, temperature and COVID-19 virus test with unknown results. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: fever; nausea; tiredness; Headache; This is a spontaneous report from a contactable consumer (patient's father) reported for his daughter. A 21-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0180, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single (at the age of 21-years-old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received past drug BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0172, Expiration date: Unknown), via an unspecified route of administration on 24May2021 as dose 1, single for COVID-19 immunization and do not experience any reaction for dose 1. The patient experienced fever, nausea, tiredness and headache on an unspecified date. It was reported that she received the second dose of Pfizer vaccine last week, last Wednesday. She didn't had any reaction on the first dose but for second dose, she had fever, nausea and headache and it continued with those symptoms and it's the fifth day since the second dose. She received treatment with Tylenol and hot water for the events on an unspecified date. It was reported that she had been resting but the symptoms of the after second dose haven't disappeared. The outcome of the events was not recovered.   Information on Lot/Batch number was available. Additional information has been requested. Follow-up attempts are completed. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash
Clinical narrative: Broke out last week with a rash around rectal area about one and a half inch around and like raw meat; Very panful; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 86 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Jun2021 (Batch/Lot Number: EW0168) as DOSE 1,SINGLE for covid-19 immunisation. Medical history included glomerulonephritis from an unknown date and unknown if ongoing. Concomitant medication(s) included metformin (METFORMIN) taken for glomerulonephritis, start and stop date were not reported; losartan (LOSARTAN) taken for glomerulonephritis, start and stop date were not reported; amlodipine (AMLODIPINE) taken for glomerulonephritis, start and stop date were not reported; prednisone (PREDNISONE) taken for glomerulonephritis, start and stop date were not reported. The patient experienced broke out last week with a rash around rectal area about one and a half inch around and like raw meat on 17Jun2021 with outcome of recovered with sequelae, very panful on 17Jun2021 with outcome of recovered with sequelae. Therapeutic measures were taken as a result of rash around rectal area and pain..  Follow-Up (21Jul2021): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Mass, Pain, Pruritus, Swelling
Clinical narrative: I have been experiencing some itching like yesterday it was like really tuff and hard, really like toff, sore and hard/had some you know like soreness; Swelling; A knot in my arm; Itchy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: not reported; Expiry date: unknown), via an unspecified route of administration, administered in Arm Right on 14Jun2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced "I have been experiencing some itching like yesterday it was like really tuff and hard, really like toff, sore and hard/had some you know like soreness" on 20Jun2021, swelling, a knot in my arm and itchy in Jun2021. It was reported that patient was calling because she/he had the vaccine done on the Monday of last week and have been experiencing some itching like yesterday it was like really tuff and hard, really like toff , sore and hard, is that like known symptom that been you know kind a talked about recently or something. The patient had very itchy and swelling, some soreness but soreness is gone, and it just itchy very itchy like a knot in arm. Reporter seriousness for the events was provided as unspecified. The clinical outcome of the event pain was recovered on unspecified date in Jun2021; for swelling, mass and pruritus was unknown.  Information on lot/batch number has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Lymphadenopathy, Peripheral swelling, Skin discolouration
Clinical narrative: a small bruise under his rib cage. And today it is slightly larger/Mark, it looks like a black and blue and just purplish on his side; some swelling under his arms; I guess he has some probably some swelling of his nodes; a small bruise under his rib cage. And today it is slightly larger/Mark, it looks like a black and blue and just purplish on his side; This is a spontaneous report from a contactable consumer (patient's wife). A 68-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on 20Jun2021 12:30 (at the age of 68-year-old) (Batch/Lot Number: EW0217) as dose 2 (at age of 68-years-old), single for covid-19 immunisation. Medical history included cholesterol and the reporter also stated that the patient was diabetic. Concomitant medications included Multivitamin once a day, acetylsalicylic acid (BABY ASPIRIN) 81 mg once a day, Metformin 1000mg twice a day, Glipizide 10mg once a day, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) 20mg capsule once a day, ergocalciferol (VIT D) 25ug once a day where all for an unknown indication; start date and stop date not given. Rosuvastatin 20 mg once a day, taken for cholesterol; start date and stop date not given. Patient previously took first dose of BNT162B2 on an unspecified date for covid-19 immunisation with no events reported. The Reporter reported event described as a small bruise under his rib cage. and today it is slightly larger/mark, it looks like a black and blue and just purplish on his side, some swelling under his arms and i guess he has some probably some swelling of his nodes on  an unspecified date in Jun2021. Where the reporter said her husband experienced swelling under his arm and she also tells that she guess he had some probably some swelling of his nodes. Then he sent his mark, it looks like a black and blue and just purplish on his side. Next day it was mentioned that it was getting bigger and it was about the size of a cookie. It was mentioned that the reporter don't think patient did because he didn't had anything with him, if he took something it might be Advil or a Tylenol, but reporter was not sure if he did. Outcome of all the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Lymphadenopathy, Swelling, Vaccination site pain, Weight decreased
Clinical narrative: she woke up with bruise filling in her armpit area; she had swelling in between her chest and armpit; feeling of bruising underneath left arm; tenderness at inject site; injection site soreness; swollen lymph nodes.; 30 pound weight loss; This is a spontaneous report from a contactable consumer reported that. A 32-years-old female patient received BNT162B2 (BioNTech/Pfizer vaccine solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 20Jun2021 (Batch/Lot Number: EW0173) as DOSE 1 SINGLE for covid-19 immunization(Age at vaccination 32 years). The patient past Medical history included thyroid disorder from an unknown date and unknown if ongoing , cardiac disorder from an unknown date and unknown if ongoing And there is a heartburn medication that she takes. Concomitant medication(s) included calcium carbonate, colecalciferol (VITAMIN D 2000) taken for an unspecified indication from an unspecified start date and ongoing.  Caller has taken the first dose of the Pfizer COVID-19 vaccine. On 20Jun2021 the patient had injection site soreness, she woke up with bruise filling in her armpit area and she had swelling in between her chest, tenderness at injects site and armpit and feeling of bruising underneath left arm: Feels like she has been walking on crutches on 22Jun2021. From her understanding, she has swollen lymph nodes on unspecified date in Jun2021. Caller wanted to know if these have been reported as adverse events with the vaccine and she wanted to know how long they would last. Caller states her weight is 287 pounds with a 30-pound weight loss on unspecified date in Jun2021. But the injection site is not swollen or red or anything and the soreness in it is almost gone. Caller asks to be transferred to medical information. Caller asks if her symptoms are a known side effect of the vaccine and how long should she expect it to last. Is it something that should make her reconsider getting the second dose. The event outcome was  recovering for Vaccination site pain and  Vaccination site tenderness ,Not recovered for Bruise, Swelling, Bruising of arm, Swollen lymph nodes and weight decreased for Unknown,   PSCC Communication:  Report 1 of 2. PC filed. Unable to obtain full details as caller wished to be transferred to medical information to ask question. Warm transferred caller to Ana with Pfizer Medical Information, GRACE: INT-#.  Provided caller with phone number of #, option 3, with hours of 8a-8p, Monday-Friday, 9a-3p, Saturday and Sunday, prior to transfer, in the event of disconnection.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash, Urticaria
Clinical narrative: Started as hives and turned into rash, even around his eyes; definitely could have caused the allergic reaction; my son developed a allergic rashes over the body/Started as hives and turned into rash, even around his eyes; This is a spontaneous report from a contactable consumer. This consumer (patient's parent) reporting for a 25-year-old male patient (reporter's son) via Medical information team.  A 25-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EW0177, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 02Jun2021 at 12:30 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was reported as none and did not have any other medical condition. Patient did not have prior vaccination within four weeks. Patient did not have any typically allergies. On an unspecified date in Jun2021, the patient experienced my son developed a allergic rashes over the body/Started as hives and turned into rash, even around his eyes, definitely could have caused the allergic reaction. Reporter stated that she and her son went for their first dose of the Pfizer BioNTech Covid-19 vaccine on 02Jun2021, and scheduled for 2nd dose tomorrow. her son developed rash all over his body 19Jun2021. She reported that he doesn't typically have allergies and has not done or had anything new to cause a reaction. Think it may be from vaccine. Rash went away yesterday, so it lasted about 2 days. Urgent care prescribed prednisone, but he did not take it and rash subsided on it's own. Started as hives and turned into rash, even around his eyes. Should he get the second dose after reacting to the first. Reporter stated just have a question, my son and I both went for the Pfizer shot on June 2nd for first one and on the, it would be the 18th my son developed a allergic rashes over the body. So, as send him to the urgent care, Reporter stated can't understand that and there is nothing that could have, he doesn't have allergy and definitely could have caused the allergic reaction you know he had. So, we are wondering if it's the possible side effect from the shot because we were going to get the second shot on Wednesday, tomorrow and I am concerned if he should get it. Rash went away yesterday, so it lasted about 2 days. Urgent care prescribed prednisone, but he did not take it and rash subsided on its own. Patient did not receive any treatment for the events. On 21Jun2021, the patient recovered from the event allergic rashes over the body/Started as hives and turned into rash, even around his eyes (rash all over) and other events were unknown.  Information about lot/batch number cannot be obtained. Additional information has been requested.  No follow-up attempts are needed. No further information is expected.  Follow-up attempts are completed. No further information is expected.