chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: "Genital warts that have been present for 5 years and no mouth ulcers at all since 1st shot and mouth ulcers are pretty common for me."; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231), via an unspecified route of administration in the left arm on 20Jan2021 at 15:00(at the age of 33-year-old), as a single dose for COVID-19 immunisation and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982), via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. Medical history included genital wart present for 5 years and mouth ulcers were pretty common. The patient did not have a history of allergies to any food or medications or other products. The patient did not receive any other medications within two weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 24May2021, the patient reported genital warts that have been present for 5 years and no change over the past 5 years have completely disappeared 3 months after 2nd shot with the exception of 1 small spot that not resembles a pimple (over10 warts to begin with). Also their was no mouth ulcers at all since1st shot and mouth ulcers are pretty common for her.  The lot number for the vaccine (PFIZER-BIONTECH COVID-19 mRNA VACCINE) was not provided and will be requested during follow up.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: elevated heart rate; During one event I had to stop the workout to catch my breath; This is a spontaneous report from a contactable consumer. A 41-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6204), via an unspecified route of administration, administered in left arm on 08Apr2021 12:00 (at the age of 41-years-old) as single dose for COVID-19 immunization in physician's office/urgent care. The patient medical history and concomitant medications were not reported. The patient has no reported allergies. Prior to the vaccination, the patient was not diagnosed with covid-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. On 08Apr2021 04:45, the patient experienced elevated heart rate and during one event I had to stop the workout to catch my breath. It was stated that noticed elevated heart rate when patient worked out. Patient iwatch tracked 15-20BPM higher than normal (patient do the exact same workout almost every day) for 48 hours after both doses. During one event patient had to stop the workout to catch my breath. Given some of the reporting of heart inflammation patient thought this would be helpful. Patient wife had the exact same reaction. Since the vaccination, the patient had not been tested positive for covid-19. The patient underwent lab tests and procedures which included heart rate 15-20 bpm on unspecified date. Treatment was not received for events. Outcome of the events was recovered on an unknown date in 2021.  Follow-up attempts are completed. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021601932 same reporter/AE/SD, different patients.;US-PFIZER INC-2021601931 same reporter/AE/SD, different patients.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Lethargy, Lip erythema, Lip pain, Lip swelling
Clinical narrative: Cough; Lethargy; Vomiting; Nausea; Slight fever; Injection site soreness; Presented with the red, very swollen, very tender lips; Presented with the red, very swollen, very tender lips; Presented with the red, very swollen, very tender lips; This is a spontaneous report from a contactable consumer. A 49-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO171) via an unspecified route of administration in the arm left on 22May2021 at 11:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included heart palpitations and acid reflux. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. The patient previously received amoxicillin (MANUFACTURER UNKNOWN), KEFLEX and morphine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The first day after vaccine the patient was feeling normal. On 24May2021, the patient had injection site soreness. On 24May2021 at 00:00 upon awakening on the second day the patient presented with the red, very swollen, very tender lips and slight fever and went to the primary care physician and was told to take 50mg Benadryl and go to bed and rest. Upon awakening on the third day on 25May2021, the patient presented with nausea, vomiting, cough, slight fever, and lethargy. The patient was still taking Benadryl for reaction along with Zofran for nausea. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with Benadryl 50mg along with Zofran for nausea. The clinical outcome of the events injection site soreness, very swollen lips, tender lips, red lips, slight fever, lethargy, nausea, vomiting and cough were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: Cough; Lethargy; Vomiting; Nausea; Slight fever; Injection site soreness; Presented with the red, very swollen, very tender lips; Presented with the red, very swollen, very tender lips; Presented with the red, very swollen, very tender lips; This is a spontaneous report from a contactable consumer. A 49-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO171) via an unspecified route of administration in the arm left on 22May2021 at 11:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included heart palpitations and acid reflux. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. The patient previously received amoxicillin (MANUFACTURER UNKNOWN), KEFLEX and morphine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The first day after vaccine the patient was feeling normal. On 24May2021, the patient had injection site soreness. On 24May2021 at 00:00 upon awakening on the second day the patient presented with the red, very swollen, very tender lips and slight fever and went to the primary care physician and was told to take 50mg Benadryl and go to bed and rest. Upon awakening on the third day on 25May2021, the patient presented with nausea, vomiting, cough, slight fever, and lethargy. The patient was still taking Benadryl for reaction along with Zofran for nausea. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with Benadryl 50mg along with Zofran for nausea. The clinical outcome of the events injection site soreness, very swollen lips, tender lips, red lips, slight fever, lethargy, nausea, vomiting and cough were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Influenza like illness, Pain, Pyrexia, Tremor
Clinical narrative: Flu-like symptoms; Body shaking; Aches; Fever abates then massive sweating.; High Fever; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 24Mar2021 at 14:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paroxetine hydrochloride (PAXIL) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the left arm on 03Mar2021 at 13:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 21:00, the patient experienced flu-like symptoms, high fever, body shaking, aches in the last 2 months, fever abated then massive sweating occurred and the duration per event was 4-6 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of flu-like symptoms, high fever, body shaking, aches and included treatment with acetaminophen/ibuprofen. Since the vaccination, the patient had been tested for COVID-19. On 10May2021, the patient underwent lab test which included rapid test and tested negative. The clinical outcome of the events flu-like symptoms, high fever, body shaking, aches and fever abated then massive sweating occurred was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: developed a rash on her back which was a delayed reaction; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date as dose 1, single for COVID-19 immunisation. The patient developed a rash on her back which was a delayed reaction on an unspecified date. The patient reported that she saw reports of delayed reaction on a website but did not have any patient specific details. The outcome of event was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis, Pain
Clinical narrative: The recovery is so painful; appendicitis; This is a follow up spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported for self. This consumer reported in response to Non-HCP letter sent. A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Rx261443606215) via an unspecified route of administration on 04May2021 as dose 2, single for COVID-19 immunisation (at the age of 54 Years). Medical history included appendectomy from 20May2021 to an unknown date. Concomitant medications were not reported. Historical vaccine includes bnt162b2 (First Dose Lot/Batch number: Rx259586906215) on 06Apr2021 for COVID-19 immunisation. On 20May2021, patient experienced appendicitis. The recovery is so painful. The patient reported, I sincerely hope there is no connection like I have been reading and hearing about. Patient was admitted to hospital due to the event. Treatment was received. Patient reported that I had never been to the hospital for medical issues. I had 2 friends call me to let me know of same experience of appendectomy within 2 weeks of 2nd vaccine. The clinical outcome of the events appendicitis was recovered and the event the recovery is so painful was recovering.  Information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Palpitations, SARS-CoV-2 test
Clinical narrative: Heart palpitations for over a month now; 31Mar2021 08:30 (Batch/Lot Number: ER8734) as DOSE 1, SINGLE/ on 31Mar2021 (Batch/Lot Number: EW0169) as DOSE 2, SINGLE; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (50-year-old age during vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 08:30 (Batch/Lot Number: ER8734) as DOSE 1, SINGLE; and via an unspecified route of administration, administered in Arm Left on 31Mar2021 (Batch/Lot Number: EW0169) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included obesity, sleep apnea treated with cpap, hypertension treated with medication all from an unknown date and unknown if ongoing. Concomitant medications included losartan/hctz, venlafaxine hydrochloride (EFFEXOR) and montelukast sodium (SINGULAIR) all taken for an unspecified indication, start and stop date were not reported. The patient previously took macrodantin and experienced allergies (known allergies). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. No other vaccine in four weeks. The patient is not pregnant at the time of vaccination. Since the vaccination, has the patient been tested for COVID-19 (Nasal Swab) on 04May2021 and was negative. The most recent COVID-19 vaccine was administered in a public Health Clinic/Veterans Administration facility. It was reported that on 23Apr2021 08:30 the patient experienced heart palpitations for over a month now. The event resulted in [Doctor or other healthcare professional office/clinic visit, Emergency room/department orurgent care]. No treatment was required. The outcome of the event was not recovered.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: Shingles on left upper leg; Nerve pain started on left upper leg and back; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the  left arm on 19Feb2021 at 10:30 (at the age of 67-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration on unknown date 2021 as a single dose for COVID-19 immunisation. Medical history reported as none. The patient had no known allergies to medications, food or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06May2021, the patient experienced nerve pain which started on left upper leg and back. Severe nerve pain was still going on at the time of this report. On 12May2021, the patient experienced shingles on left upper leg. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse events which included treatment with valacyclovir, gabapentin 100mg and hydrocodone from unknown date. The clinical outcome of the event nerve pain started on left upper leg and back and shingles on left upper leg was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Audiogram, Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 15Apr2021 and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021, the patient experienced tinnitus, which started getting very loud tinnitus 3 days after the first shot. It improved slightly a few weeks later but got worse again after the second dose. Even after 5 weeks, it did not resolve. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of tinnitus and was sought saying that there was no treatment. On an unknown date, the patient underwent audiogram and the result showed that there was no hearing loss in the tested frequencies. The clinical outcome of the event tinnitus was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: injection site pain after; chills; fever; muscle pain in whole body; feeling unwell; tiredness; headache up to 3 days; This is a spontaneous report from a contactable healthcare professional. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) in the left arm on 15May2021 at 11:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included menstrual migraine. Patient was not aware of any known allergies to food, medications or other products. Concomitant medications included oral contraceptive nos (MANUFACTURER UNKNOWN) for an unknown indication on an unknown start date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW1072) in the left arm on 24Apr2021 at 13:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date, the patient experienced injection site pain after, chills, fever, muscle pain in whole body, feeling unwell, tiredness and headache up to 3 days. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event injection site pain after, chills, fever, muscle pain in whole body, feeling unwell, tiredness and headache up to 3 days were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: injection site pain after; chills; fever; muscle pain in whole body; feeling unwell; tiredness; headache up to 3 days; This is a spontaneous report from a contactable healthcare professional. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) in the left arm on 15May2021 at 11:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included menstrual migraine. Patient was not aware of any known allergies to food, medications or other products. Concomitant medications included oral contraceptive nos (MANUFACTURER UNKNOWN) for an unknown indication on an unknown start date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW1072) in the left arm on 24Apr2021 at 13:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date, the patient experienced injection site pain after, chills, fever, muscle pain in whole body, feeling unwell, tiredness and headache up to 3 days. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event injection site pain after, chills, fever, muscle pain in whole body, feeling unwell, tiredness and headache up to 3 days were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, SARS-CoV-2 test
Clinical narrative: Severe singles started on left side of shoulder and chest; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history included Parkinson's disease. The patient did not have any known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on 19Feb2021 at 10:30 (at the age of 68-year-old) as a single dose for COVID-19 immunisation. Around 17May2021, the patient experienced severe shingles started on left side of shoulder and chest. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles and included treatment with Gabapentin. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient underwent nasal swab COVID-19 test and the result was negative. The clinical outcome of the event shingles was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Contusion, Dysuria, Kidney contusion, Renal disorder
Clinical narrative: Kidneys - hives bruising difficult urinating; Kidneys - hives bruising difficult urinating; Kidneys - hives bruising difficult urinating, back pain; Kidneys - hives bruising difficult urinating; back pain; Kidneys - hives bruising difficult urinating; This is a spontaneous report from a contactable consumer, the patient.  A 54-year-old [non-pregnant] adult female received the second dose of intramuscular BNT162B2 (solution for injection, Lot ER8736 expiry information not provided) as a single dose in the left arm on 12May2021 at 11:30 (at 54-years-old) for COVID-19 immunization. There was no medical history reported. Concomitant medications included lamotrigine (LAMICTAL); paroxetine hydrochloride (PAXIL), vitamin B NOS, and vaccinium macrocarpon (CRANBERRY). The patient denied receiving any other vaccine within four weeks of this vaccine. The patient denied any diagnosis of COVID prior to receiving the vaccine and the patient was not pregnant at the time of vaccine. The patient denied being tested for COVID-19 since receiving the vaccine. The patient previously received COVID-19 immunization with the first dose of intramuscular BNT162B2 (solution for injection, Lot ER8729 expiry information not provided) as a single dose in the left arm on 21Apr2021 at 11:30 (at 54-years-old). The patient reported that on 21May2021 at 08:30 she experienced Kidneys - hives bruising difficult urinating, and back pain; which resulted in a visit to a doctor or other healthcare professional office. Treatment for the events included unspecified medications. The outcome of the events Kidneys - hives bruising difficult urinating, and back pain was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Kidneys - hives bruising difficult urinating; Kidneys - hives bruising difficult urinating; Kidneys - hives bruising difficult urinating, back pain; Kidneys - hives bruising difficult urinating; back pain; Kidneys - hives bruising difficult urinating; This is a spontaneous report from a contactable consumer, the patient.  A 54-year-old [non-pregnant] adult female received the second dose of intramuscular BNT162B2 (solution for injection, Lot ER8736 expiry information not provided) as a single dose in the left arm on 12May2021 at 11:30 (at 54-years-old) for COVID-19 immunization. There was no medical history reported. Concomitant medications included lamotrigine (LAMICTAL); paroxetine hydrochloride (PAXIL), vitamin B NOS, and vaccinium macrocarpon (CRANBERRY). The patient denied receiving any other vaccine within four weeks of this vaccine. The patient denied any diagnosis of COVID prior to receiving the vaccine and the patient was not pregnant at the time of vaccine. The patient denied being tested for COVID-19 since receiving the vaccine. The patient previously received COVID-19 immunization with the first dose of intramuscular BNT162B2 (solution for injection, Lot ER8729 expiry information not provided) as a single dose in the left arm on 21Apr2021 at 11:30 (at 54-years-old). The patient reported that on 21May2021 at 08:30 she experienced Kidneys - hives bruising difficult urinating, and back pain; which resulted in a visit to a doctor or other healthcare professional office. Treatment for the events included unspecified medications. The outcome of the events Kidneys - hives bruising difficult urinating, and back pain was unknown.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles on forearm; rash on other side of forearm and upper arm area; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6205) via an unspecified route of administration on 16Apr2021 at 12:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included that the patient was allergic to sunblock. Concomitant medications included Allopurinol (MANUFACTURER UNKNOWN) from an unknown date and unknown if ongoing for an unknown indication. The patient also received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 25Mar2021 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21May2021 the patient experienced shingles on forearm and rash on other side of forearm and upper arm area. Therapeutic measures were not taken as a result of the events shingles on forearm and rash on other side of forearm and upper arm area. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events shingles on forearm and rash on other side of forearm and upper arm area was not resolved.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Rash macular, Rash pruritic
Clinical narrative: Red spots on front and back of my body and some on both legs; extreme itching, hundred of itchy spots; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9263) via an unspecified route of administration in the left arm on 11Feb2021 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, sarcoid and rheumatoid arthritis (RA). Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and tamsulosin (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263) via an unspecified route of administration in the left arm on 21Jan2021 as a single dose for COVID-19 immunisation. The patient also previously received niacin (MANUFACTURER UNKNOWN), methotrexate (MANUFACTURER UNKNOWN) and rosuvastatin (MANUFACTURER UNKNOWN) and developed allergy to all the drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, the patient experienced red spots on front and back of his body and some on both legs, extreme itching and hundreds of itchy spots. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with prednisolone and photo therapy. The clinical outcome for the events red spots on front and back of his body and some on both legs and extreme itching, hundreds of itchy spots were resolving.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Malaise
Clinical narrative: Felt very sick for almost 48 hours; Whole left side of the body was numb for about a day; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0186), via an unspecified route of administration in the left arm on 21May2021 at 15:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021 at 16:00, the patient felt very sick for almost 48 hours and the whole left side of the patient's body was numb for about a day. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt very sick for almost 48 hours and the whole left side of the patient's body was numb for about a day was recovered on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Myalgia
Clinical narrative: Muscle sourness; lethargy; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 22May2021 at 09:30 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 23May2021, the day after vaccination, the patient experienced muscle sourness and lethargy. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events muscle sourness and lethargy were resolved in May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Palpitations
Clinical narrative: heart racing; patient may miss second dose of vaccine; This is a spontaneous report received from a contactable consumer. This consumer (patient's mother) reported for female patient that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had allergic to shellfish, amoxicillin and nuts. It was reported that the caller refuses to give demographic information on herself or daughter. Caller was called on behalf of daughter. Caller daughter received first dose of vaccine in vaccination site. Caller would like to know if her daughter can get second dose of vaccine in name. Caller reports that her daughter has anxiety, allergies to shellfish, amoxicillin, nuts, and would like to know if her daughter anxiety could get worse after second dose. Caller reports that her daughter's heart was racing after first dose of vaccine. Caller would like to know if there are nuts and shellfish in vaccine. Caller reports that she heard on the news reports of heart inflammation or infection after someone gets the vaccine and would like to know more information about that. Caller would like to know how you would know if you are immunocompromised or what does that term mean. Caller would like to know how a person would know if they are allergic to ingredients in vaccine. Caller states that she heard that you could possibly get vaccine after 6 weeks. Caller requested more information on this. Caller was called because she was concerned about this vaccine, and she has some paperwork that she pulled up and has questions. Caller confirms she was called about the Pfizer COVID-19 Vaccine. Caller added, first of all, if somebody has the first vaccine and does it somewhere else can they do it. Caller clarified and asked can the second dose of the Pfizer COVID-19 vaccine be received if the first dose was given at a different location (patient may miss second dose of vaccine). Caller states she does not want to provide any additional details at this time regarding her or her daughter. Caller states she just has questions. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling, Tenderness
Clinical narrative: Swollen left armpit; Feeling of tenderness and pain; Feeling of tenderness and pain; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the left arm on 21May2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24May2021, the patient had swollen left armpit, it was more the feeling of tenderness and pain, not "that" swollen. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen left armpit and feeling of tenderness and pain was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal ulceration
Clinical narrative: One painful white patch showed up on uvula; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734) via an unspecified route of administration in the right arm on 05Apr2021 at 13:15 (at the age of 34-year-old) as a single dose and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8735) via an unspecified route of administration in the right arm on 26Apr2021 at 13:15 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included multiple mouth ulcers and a painful white patch in the throat from 03Apr2021 at 06:00. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fexofenadine (MANUFACTURER UNKNOWN), vitamin d not otherwise specified (NOS) (MANUFACTURER UNKNOWN), ultra nutrient multivitamin (MANUFACTURER UNKNOWN), all drugs used for an unknown indication from unknown dates. The patient previously took amoxicillin on an unknown date for unknown indication and experienced drug allergy. The patient was treated with a steroid for multiple mouth ulcers and a painful white patch in the throat which went away after two weeks in Apr2021. After the steroid treatment, on an unknown date in Apr2021, one painful white patch was showed up on the uvula. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 28Apr2021, the patient underwent a rapid COVID test and the result was negative. The clinical outcome of the event one painful white patch showed up on uvula was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Heavy menstrual bleeding, Nausea, Pain
Clinical narrative: Extremely heavy period; Fever; Headache; Body ache; Chills; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 19May2021 at 11:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included light periods for years. Concomitant medications included alprazolam (XANAX) and zolpidem tartrate (AMBIEN); all from unknown date for unspecified indication and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm on 28Apr2021 at 14:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 24May2021, five days after the vaccine, the patient experienced extremely heavy period after 73 days of no period and having light periods for years, fever, headache, body ache, chills and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extremely heavy period, fever, headache, body ache, chills and nausea were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Extremely heavy period; Fever; Headache; Body ache; Chills; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 19May2021 at 11:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included light periods for years. Concomitant medications included alprazolam (XANAX) and zolpidem tartrate (AMBIEN); all from unknown date for unspecified indication and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm on 28Apr2021 at 14:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 24May2021, five days after the vaccine, the patient experienced extremely heavy period after 73 days of no period and having light periods for years, fever, headache, body ache, chills and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extremely heavy period, fever, headache, body ache, chills and nausea were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: severe muscle pain (arms, legs, back); swelling and redness at the injection site; Redness at the injection site.; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15May2021 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have any known allergies to medications, food or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 21May2021 at 08:00 (day 7 and 8 after the first dosage), the patient experienced severe muscle pain (arms, legs, back) and swelling and redness at the injection site. No therapeutic measures were taken. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe muscle pain (arms, legs, back) and swelling and redness at the injection site was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Rash
Clinical narrative: Rash; Rash was still present and continues to provide discomfort; This is a spontaneous report from a non-contactable consumer, the patient. A non-pregnant female patient of unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration on 19Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced a rash which was still present and continued to provide discomfort. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events rash and was still present and continued to provide discomfort was not recovered at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Palpitations
Clinical narrative: Heart palpitations after the shot.; Fatigue; Headache; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0173) via an unspecified route of administration in the right arm on 12May2021 at 12:00 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. Medical history included mild heart palpitations with anxiety. The patient did not receive  any other medications in two weeks of vaccine. prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13May2021 at 17:00 after the shot, the patient experienced heart palpitations, fatigue, headache and nausea. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the event heart palpitations, fatigue, and nausea were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.