chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Differential white blood cell count, Dizziness, Fibrin D dimer, Full blood count, Headache
Clinical narrative: Chest pain, sever abdominal pain, headache , dizziness, pain in legs, diarrhea
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Microscopy, Pain in extremity, Red cell distribution width normal, Troponin I
Clinical narrative: Chest pain, sever abdominal pain, headache , dizziness, pain in legs, diarrhea
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypoaesthesia, Pruritus, Rash
Clinical narrative: Rash, itchy, redness, numbness on my lower face, underneath my chin and the whole front of my neck.  Started about 4 or 5 hours after the shot.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle tightness, Neck pain
Clinical narrative: I woke up to grab a snack. I noticed a neck spasm of the left side of my body. It is extremely painful and incredibly tight. No other info at this time. I took a muscle relaxer prescribed for MVA trauma to see if that helps (Robaxin).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Really sick; body aches; Fever; chills; sleepy; weak; feel bad/miserable; Faint; Nauseous; headache; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: EL3302) via an unspecified route of administration in the left arm on 01Mar2021 at 11:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis, appendix cancer, ileostomy, kidney transplant, MTHFR, cerebral meningitis and brain surgery; heart murmur and stage 5 renal failure (unknown cause). The patient had allergy to shrimp and narcotics. Concomitant medications included mycophenolate mofetil (CELLCEPT), loperamide hydrochloride (IMODIUM), levetiracetam (KEPPRA), pantoprazole (MANUFACTURER UNKNOWN) and tacrolimus (PROGRAF). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 03Mar2021, the patient started to feel bad- nauseous, headache, fatigue and faint. On 04Mar2021, the patient was really sick-nauseous, headache, fatigue, faint, body aches, fever, chills, sleepy and weak. On 05Mar2021, the patient had headache, chills, sleepy, miserable, weak and faint. On 06Mar2021, the patient had headache, fatigue, sleepy, a bit better, not so miserable, weak but still felt faint. On 07Mar2021, the patient had headache, fatigue, really miserable again, chills, sleepy and faint. On 08Mar2021, the patient had small fatigue and was a bit better. From 09Mar2021 to 12Mar2021, the patient was doing great with occasional nap, was gaining strength back and was not so faint. On 13Mar2021, the patient had bad fatigue, miserable, faint again. On 14Mar2021, the patient felt occasional faint, sleepy, fatigue and was gaining strength back. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient had not received any treatment for the reported events. The clinical outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: RMH (Medical History#5 verbatim updated to brain surgery and recoded to Brain operation NOS, Medical History#3 verbatim updated to Stage 5 Renal failure, and Medical History#7 verbatim updated to MTHFR), Suspect details (Start Date/Time and Stop Date/Time updated to 01-MAR-2021 11:00, Vaccine Facility Information added), Concomitant Medication (Cellcept coded via WHO), Event details (Description as reported for event Felt faint updated to faint, Event feel bad added and coded to feeling bad, Event Really sick added and coded to sickness).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Nausea, Pain, Pyrexia
Clinical narrative: Really sick; body aches; Fever; chills; sleepy; weak; feel bad/miserable; Faint; Nauseous; headache; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: EL3302) via an unspecified route of administration in the left arm on 01Mar2021 at 11:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis, appendix cancer, ileostomy, kidney transplant, MTHFR, cerebral meningitis and brain surgery; heart murmur and stage 5 renal failure (unknown cause). The patient had allergy to shrimp and narcotics. Concomitant medications included mycophenolate mofetil (CELLCEPT), loperamide hydrochloride (IMODIUM), levetiracetam (KEPPRA), pantoprazole (MANUFACTURER UNKNOWN) and tacrolimus (PROGRAF). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 03Mar2021, the patient started to feel bad- nauseous, headache, fatigue and faint. On 04Mar2021, the patient was really sick-nauseous, headache, fatigue, faint, body aches, fever, chills, sleepy and weak. On 05Mar2021, the patient had headache, chills, sleepy, miserable, weak and faint. On 06Mar2021, the patient had headache, fatigue, sleepy, a bit better, not so miserable, weak but still felt faint. On 07Mar2021, the patient had headache, fatigue, really miserable again, chills, sleepy and faint. On 08Mar2021, the patient had small fatigue and was a bit better. From 09Mar2021 to 12Mar2021, the patient was doing great with occasional nap, was gaining strength back and was not so faint. On 13Mar2021, the patient had bad fatigue, miserable, faint again. On 14Mar2021, the patient felt occasional faint, sleepy, fatigue and was gaining strength back. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient had not received any treatment for the reported events. The clinical outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: RMH (Medical History#5 verbatim updated to brain surgery and recoded to Brain operation NOS, Medical History#3 verbatim updated to Stage 5 Renal failure, and Medical History#7 verbatim updated to MTHFR), Suspect details (Start Date/Time and Stop Date/Time updated to 01-MAR-2021 11:00, Vaccine Facility Information added), Concomitant Medication (Cellcept coded via WHO), Event details (Description as reported for event Felt faint updated to faint, Event feel bad added and coded to feeling bad, Event Really sick added and coded to sickness).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Really sick; body aches; Fever; chills; sleepy; weak; feel bad/miserable; Faint; Nauseous; headache; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: EL3302) via an unspecified route of administration in the left arm on 01Mar2021 at 11:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis, appendix cancer, ileostomy, kidney transplant, MTHFR, cerebral meningitis and brain surgery; heart murmur and stage 5 renal failure (unknown cause). The patient had allergy to shrimp and narcotics. Concomitant medications included mycophenolate mofetil (CELLCEPT), loperamide hydrochloride (IMODIUM), levetiracetam (KEPPRA), pantoprazole (MANUFACTURER UNKNOWN) and tacrolimus (PROGRAF). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 03Mar2021, the patient started to feel bad- nauseous, headache, fatigue and faint. On 04Mar2021, the patient was really sick-nauseous, headache, fatigue, faint, body aches, fever, chills, sleepy and weak. On 05Mar2021, the patient had headache, chills, sleepy, miserable, weak and faint. On 06Mar2021, the patient had headache, fatigue, sleepy, a bit better, not so miserable, weak but still felt faint. On 07Mar2021, the patient had headache, fatigue, really miserable again, chills, sleepy and faint. On 08Mar2021, the patient had small fatigue and was a bit better. From 09Mar2021 to 12Mar2021, the patient was doing great with occasional nap, was gaining strength back and was not so faint. On 13Mar2021, the patient had bad fatigue, miserable, faint again. On 14Mar2021, the patient felt occasional faint, sleepy, fatigue and was gaining strength back. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient had not received any treatment for the reported events. The clinical outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: RMH (Medical History#5 verbatim updated to brain surgery and recoded to Brain operation NOS, Medical History#3 verbatim updated to Stage 5 Renal failure, and Medical History#7 verbatim updated to MTHFR), Suspect details (Start Date/Time and Stop Date/Time updated to 01-MAR-2021 11:00, Vaccine Facility Information added), Concomitant Medication (Cellcept coded via WHO), Event details (Description as reported for event Felt faint updated to faint, Event feel bad added and coded to feeling bad, Event Really sick added and coded to sickness).
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Anxiety, Condition aggravated, Laboratory test, Nervousness, Palpitations
Clinical narrative: Interfere with her medicine; Anxiety; Panic attacks; Racing heart; Feeling of uneasiness; This is a spontaneous report from a contactable consumer (patient) reported herself. A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration in left arm (left shoulder) on 15Mar2021 (at the age of 58-years-old) as dose 1, single for COVID-19 immunization; fluoxetine hydrochloride (Prozac, Formulation: tablet, Batch/Lot number: not reported), via oral route, once daily for anxiety. The patient's medical history included high cholesterol and blood pressure high; from an unknown date and unknown if ongoing. The patient's concomitant medications included losartan tablet taken orally once daily for blood pressure high; atorvastatin tablet taken orally once daily for high cholesterol; from an unknown date. The patient stated that after vaccination she did not have any reactions until ten days but later on an unspecified date in Mar2021 (22Mar2021 or 23Mar2021), the patient had experienced sudden anxiety, panic attacks, racing heart, general feeling of uneasiness. On an unknown date, Interfere with her medicine. The patient reported that she was on Prozac (her anxiety medication) from 21 years and queried if vaccine had interacted with the drug. The patient also was on other unspecified medications and asked if vaccine could have interacted with them. The patient stated that she was yet to receive second dose on 05Apr2021, but she was concerned about the interaction with her medicine and was very nervous. The patient underwent lab tests and procedures which included weight: 119 or 120 lbs. Therapeutic measures were taken as a result of anxiety, panic attacks, racing heart, feeling of uneasiness and included half of the Xanax when felt necessary. The outcome of the events anxiety, panic attacks, racing heart was recovering. The outcome of the event feeling of uneasiness was not recovered, while the outcome of the event interfere with her medicine was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Panic attack
Clinical narrative: Interfere with her medicine; Anxiety; Panic attacks; Racing heart; Feeling of uneasiness; This is a spontaneous report from a contactable consumer (patient) reported herself. A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration in left arm (left shoulder) on 15Mar2021 (at the age of 58-years-old) as dose 1, single for COVID-19 immunization; fluoxetine hydrochloride (Prozac, Formulation: tablet, Batch/Lot number: not reported), via oral route, once daily for anxiety. The patient's medical history included high cholesterol and blood pressure high; from an unknown date and unknown if ongoing. The patient's concomitant medications included losartan tablet taken orally once daily for blood pressure high; atorvastatin tablet taken orally once daily for high cholesterol; from an unknown date. The patient stated that after vaccination she did not have any reactions until ten days but later on an unspecified date in Mar2021 (22Mar2021 or 23Mar2021), the patient had experienced sudden anxiety, panic attacks, racing heart, general feeling of uneasiness. On an unknown date, Interfere with her medicine. The patient reported that she was on Prozac (her anxiety medication) from 21 years and queried if vaccine had interacted with the drug. The patient also was on other unspecified medications and asked if vaccine could have interacted with them. The patient stated that she was yet to receive second dose on 05Apr2021, but she was concerned about the interaction with her medicine and was very nervous. The patient underwent lab tests and procedures which included weight: 119 or 120 lbs. Therapeutic measures were taken as a result of anxiety, panic attacks, racing heart, feeling of uneasiness and included half of the Xanax when felt necessary. The outcome of the events anxiety, panic attacks, racing heart was recovering. The outcome of the event feeling of uneasiness was not recovered, while the outcome of the event interfere with her medicine was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Excessive sweating; Generalized myalgia; This is a spontaneous report received from a non-contactable nurse, the patient. A 50-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via intramuscular route in the left arm on 24Mar2021 at 10:45 (At the age of 50-year-old) as single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications administered within two weeks of vaccination included nasal spray (MANUFACTURER UNKNOWN) and diphenhydramine hydrochloride (BENADRYL) both for an unspecified indication since an unspecified date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via intramuscular route in the left arm on 04Mar2021 as single dose for COVID-19 immunisation. The patient was allergic to montelukast sodium (SINGULAIR). 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 had not received any other vaccines within 4 weeks prior to the vaccine. On 25Mar2021 at 2:00, the patient underwent body temperature recording and the result was 102.8. On 25Mar2021 at 2:00, the patient experienced Fever of 102.8, chills and excessive sweating and generalized myalgia. The adverse event had not resulted in doctor or other healthcare professional office/clinic visit/ emergency visit/ department or urgent care. Therapeutic measures were taken as a result of fever, chills, excessive sweating and generalized muscle aches which included treatment with ibuprofen. The clinical outcome of fever, chills, excessive sweating and generalized muscle aches was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: updated VAERS Primary Reporter Addl Qualification as patient, Relevant Med History updated, Age for Historical Vaccine removed, Patient Route of Administration updated as intramuscular and removed from Parent Route of Administration, vaccination Facility Country added and Lab data test as reported updated as Body temperature.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: Joint paiin; injection site pain; This is a spontaneous report received from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on an unknown date and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK5730) via an unspecified route of administration in the left arm on an unknown date both as a single dose, for COVID-19 immunisation. Medical history included Sulpha drugs allergies and concomitant medication was 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. On an unknown date, the patient experienced joint pain and injection site pain. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of joint pain and vaccination site pain were unknown at the time of this report.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: updated Anatomical Location for dose 1 and dose 2 and updated narrative.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Mammogram
Clinical narrative: Saw two lumps in armpit and thinks they are lymph nodes; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 62 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 21Mar2021 17:10 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included blood cholesterol from an unknown date and unknown if ongoing. Grandmother dies of breast cancer and mother dies from lung cancer. Patient states that she is on 2 different types of cholesterol medications. Concomitant medication(s) included SIMVASTATIN taken for blood cholesterol increased, start and stop date were not reported. The patient experienced two lumps in armpit and thinks they are lymph nodes as axillary mass on 25Mar2021 with outcome of not recovered. The patient underwent lab tests and procedures which included mammogram: normal.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained..
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: This is a spontaneous report from a contactable consumer (Patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number and Expiry Date: not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Reporter stated she was still experiencing a lump under her right armpit on an unspecified date, and she did not know if it was her gland that was swollen. Reporter queried that if the lump would go away on its own, or did she need to be concerned, and see her doctor. Reporter clarified that she received both doses of the COVID-19 Vaccine, and the vaccine was administered in her right arm. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in arm of injection for both shots; This is a spontaneous report from a non-contactable consumer (patient) received . A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 26Jan2021 at 11:30 (Batch/Lot Number: EL3247) (at the age of 31 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Concomitant medications included ibuprofen (ADVIL) 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-19 vaccine. The patient experienced soreness in arm of injection for both shots on an unspecified date in 2021. The patient received no treatment for the event. The outcome of event was recovered on an unspecified date in 2021. The patient also received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in left arm on 16Feb2021 at 13:30 (Batch/Lot Number: EL3247) for COVID-19 immunisation and experienced soreness in arm of injection for both shots, after second shot: severe headache, body aches, tiredness, thirst.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021228721 Same reporter, suspect drug, patient and events; different dose
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Limb mass, Pain in extremity, Peripheral swelling, Vaccination site swelling
Clinical narrative: she "felt aching under her arm/armpit"/it became painful; swelling below the arm crease and a hard lump; swelling below the arm crease and a hard lump; swelling and itching at the injection site; swelling and itching at the injection site; This is a spontaneous report from a contactable consumer or other non hcp. A 37-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 27Mar2021(at 37-years of age) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The historical vaccine includes bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date (at 37-years of age) as DOSE 1, SINGLE for COVID-19 immunisation. On an unspecified date the patient felt aching under her arm/armpit/it became painful, swelling below the arm crease and a hard lump, swelling and itching at the injection site. The events outcome was reported as unknown.   No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pain
Clinical narrative: Super sore/pain in the pea sized lump under her left collarbone; A pea size lump under her clavicle; This is a spontaneous report from a contactable consumer. A 29-year-old female patient (Patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6207), via an unspecified route of administration, administered in Arm Left on 19Mar2021 12:00 (at the age of 29-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took tetanus vaccine on Jul2020, over the summer and experienced nausea and headache. The patient taken unspecified medication for years. On 26Mar2021, the patient experienced a pea size lump under her clavicle and then on 28Mar2021, the patient had super sore/pain in the pea sized lump under her left collarbone. The patient asked about the Covid 19 vaccine, her first dose. She has questions regarding the vaccine and reactions. She had no initial reaction at all but about a week later to the day of her first Covid 19 vaccine she noticed a pea sized lump under her left collarbone in the same side she got the Covid 19 vaccine. The pain in the pea sized lump under her left collarbone came a couple days later on about Sunday, 28Mar2021. It's pretty painful to wear even a sports bra, use a seatbelt or anything like that. Some of her friends said it might be a lymph node and she wanted to report it and see if it's been reported before. She needs to decide if she should go see a doctor. The outcome of the event a pea size lump under her clavicle was unknown and for event super sore/pain in the pea sized lump under her left collarbone was not recovered.  Follow up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: chronic pain; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program  support. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported, NDC number, UPC number, expiry date: unknown) via an unspecified route of administration on 10Mar2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced chronic pain on an unspecified date in Mar2021 and she took Oxycodone for her chronic pain prior to the second dose. She received the second dose on 31MAR2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: yellow bruise the size of a $.50 piece manifested at injection site; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206 and Expiration date: Unknown) via an unspecified route of administration in the arm left on 08Mar2021 at 09:55 (at the age of 72-year-old) as a dose 1, single for COVID-19 immunization. The patient medical history included high cholesterol, acute sleep apnea (using CPAP), and penicillin allergy. Concomitant medications included unspecified medications taken within two weeks of vaccination. The patient previously took minocin and experienced specific allergy (drug). The patient previously took bactrim and experienced specific allergy (drug). 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 an unspecified date in Mar2021, the patient experienced yellow bruise the size of a dollar.50 piece manifested at injection site (vaccination site bruising). The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. The clinical outcome of the event yellow bruise the size of a dollar.50 piece manifested at injection site was reported as resolved after one week of the vaccination on an unspecified date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity
Clinical narrative: bruising; sore arm; This is a spontaneous report from a contactable consumer (patient) or other non hcp.   A 62-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6203, Expiry date: unknown) via an unspecified route of administration, administered in Arm Right on 04Mar2021, at 11:15 as dose 1, single for (at the age of 62-years-old) for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. The patient medical history was not reported. Patient had no known allergies. Concomitant medication(s) included zinc; fish oil; vitamin d [vitamin d nos] 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. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient did not tested for COVID-19. Allergies to medications, food, or other products was not reported. On an unspecified date in March2021, patient experienced bruising, sore arm. The patient did not received any treatment for event. The outcome of events recovered on unspecified date in March2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021392354 Same patient, same product with different dose, partial same event
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain, SARS-CoV-2 test, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP (patient himself). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6206) via intramuscular route of administration in left deltoid (Left shoulder) on 13Mar2021 at 10:27 (age at the time of vaccination was 26-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history included asthma and allergy from 10May2001 and still ongoing, ongoing dust allergy, ongoing allergy to animal allergy to cat, dogs, ongoing mycotic allergy (molds like alternaria alternata) and weakened immune system due to doing inhaled with corticosteroids from 10May2001 and still ongoing. The concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR) via nasal route of administration (inhalation), taken as a strength of 500/50 mcg for asthma maintenance from Dec2020 and still ongoing, salbutamol (ALBUTEROL HFA (Pro Air)) via nasal route of administration (inhalation) taken for asthma (rescue inhaler) from 2001 and still ongoing, montelukast sodium (MONTELUKAST SODIUM) via oral route of administration taken as a dose of 10mg for Allergy/Asthma from 2019 and still ongoing, azelastine (AZELASTINE) via nasal route of administration (inhalation) taken as a dose of 137 ug (mcg) for allergy from Feb2021 and still ongoing. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9266) via intramuscular route of administration in right deltoid (Right shoulder) on 21Feb2021 at 13:55 (age at the time of vaccination was 26-year-old) as dose 1, single for COVID-19 immunization and experienced 2 days Fatigue and aches on 21Feb2021 at 14:30. The vaccination facility type reported as other. The vaccine was not administered at military facility. The Prior vaccinations (within 4 weeks) reported as none. The patient experienced fatigue, aches, nausea, vomiting on 13Mar2021 at 12:00. The patient underwent lab tests and procedures which included sars-cov-2 test (Covid-19 Active infection) with results not detected, Likely other sickness on 29Aug2020. The duration of all events reported as 3 days. No treatment received for the events. The clinical outcome of all events was recovered on an unspecified date in 2021. No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Influenza like illness
Clinical narrative: Muscle pain; joint pain; nausea; Headache; weakness; fatigue; injection site pain; flu like aches; Pains; This is a spontaneous report from a contactable consumer or other non hcp. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Pfizer6207) via an unspecified route of administration in the arm left on 05Apr2021 at 13:15 (at the age of 63-year-old) as dose 2, single for COVID-19 immunisation. Medical history included Known allergy: penicillin. Concomitant medications included buspirone, omeprazole and escitalopram. The patient previously took zithromycin and experienced stomach cramps. The patient also took amoxicillin, and experienced drug allergy. The patient received first dose of BNT162B2 on 16Mar2021 at 12:45 (lot number: EN6202, Location: left arm) for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 06Apr2021 at 12:00, the patient experienced muscle pain, joint pain, nausea, headache, weakness, fatigue, injection site pain, flu like aches and pains. No therapeutic measures were taken as a result of the events. The adverse events did not result in doctor or other healthcare professional office, or clinic visit and emergency room or department or urgent care. The outcome of all the events were resolved on Apr2021. No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Vaccination site pain
Clinical narrative: Muscle pain; joint pain; nausea; Headache; weakness; fatigue; injection site pain; flu like aches; Pains; This is a spontaneous report from a contactable consumer or other non hcp. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Pfizer6207) via an unspecified route of administration in the arm left on 05Apr2021 at 13:15 (at the age of 63-year-old) as dose 2, single for COVID-19 immunisation. Medical history included Known allergy: penicillin. Concomitant medications included buspirone, omeprazole and escitalopram. The patient previously took zithromycin and experienced stomach cramps. The patient also took amoxicillin, and experienced drug allergy. The patient received first dose of BNT162B2 on 16Mar2021 at 12:45 (lot number: EN6202, Location: left arm) for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 06Apr2021 at 12:00, the patient experienced muscle pain, joint pain, nausea, headache, weakness, fatigue, injection site pain, flu like aches and pains. No therapeutic measures were taken as a result of the events. The adverse events did not result in doctor or other healthcare professional office, or clinic visit and emergency room or department or urgent care. The outcome of all the events were resolved on Apr2021. No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash, Urticaria
Clinical narrative: Hives; Swollen lymph nodes in neck; Rash on legs; This is a spontaneous report from a non-contactable consumer, the patient. A 71-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 26Feb2021 at 16:00 (at the age of 71-years-old) as dose 1, single for COVID-19 immunization. Medical history included Chronic Obstructive Pulmonary Disease (COPD), asthma with many allergies and fibro. The patient was allergic to gatorade. Concomitant medications included valaciclovir hydrochloride (VALTREX), duloxetine hydrochloride (CYMBALTA), montelukast sodium (MONTELUKAST), esomeprazole magnesium (NEXIUM) and pravastatin sodium (PRAVASTATIN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received sulfur and experienced 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. On 28Feb2021, the patient experienced hives, swollen lymph nodes in neck and rash on legs. 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. The clinical outcome of the events hives, swollen lymph nodes in neck and rash on legs resolved on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Lightheadedness; headache for more than two days; Nausea; fever for two days; Chills; Exhaustion; Muscle pain; Upset stomach; Injection site throbbing; All over body pain; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EW0150) via an unspecified route of administration in the right arm on 06Apr2021 at 08:30 (at the age of 67-years-old) as a dose 2, single for COVID-19 immunisation. Medical history included diabetic, chronic obstructive pulmonary disease, obesity, depression, and hypertension pulmonary (pulmonary hypertension). Concomitant medications taken within two weeks prior to vaccination included sertraline hydrochloride (ZOLOFT), gabapentin, diltiazem, bupropion and unspecified medication all from unknown date for unknown indication. The patient previously took DEMEROL and experienced drug allergy in the form of itching, also received statin drugs and experienced allergy as severe muscle pain. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection Lot Number: EN6202) via an unspecified route of administration in the right arm on 13Mar2021 at 13:30 (at the age of 67-years-old) as a dose 1, single 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 vaccination. On 06Apr2021 at 09:30, the patient experienced light headedness, headache for more than two days, nausea, fever for two days, chills, exhaustion, muscle pain, upset stomach, injection site throbbing and all over body pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event headache was recovered after for more than two days on an unknown date in Apr2021, of fever was recovered after two days on 08Apr2021 and of light headedness, nausea, chills, exhaustion, muscle pain, upset stomach, injection site throbbing, all over body pain were resolving at the time of this report.  No follow-up attempts were needed. No further information was expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Lightheadedness; headache for more than two days; Nausea; fever for two days; Chills; Exhaustion; Muscle pain; Upset stomach; Injection site throbbing; All over body pain; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EW0150) via an unspecified route of administration in the right arm on 06Apr2021 at 08:30 (at the age of 67-years-old) as a dose 2, single for COVID-19 immunisation. Medical history included diabetic, chronic obstructive pulmonary disease, obesity, depression, and hypertension pulmonary (pulmonary hypertension). Concomitant medications taken within two weeks prior to vaccination included sertraline hydrochloride (ZOLOFT), gabapentin, diltiazem, bupropion and unspecified medication all from unknown date for unknown indication. The patient previously took DEMEROL and experienced drug allergy in the form of itching, also received statin drugs and experienced allergy as severe muscle pain. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection Lot Number: EN6202) via an unspecified route of administration in the right arm on 13Mar2021 at 13:30 (at the age of 67-years-old) as a dose 1, single 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 vaccination. On 06Apr2021 at 09:30, the patient experienced light headedness, headache for more than two days, nausea, fever for two days, chills, exhaustion, muscle pain, upset stomach, injection site throbbing and all over body pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event headache was recovered after for more than two days on an unknown date in Apr2021, of fever was recovered after two days on 08Apr2021 and of light headedness, nausea, chills, exhaustion, muscle pain, upset stomach, injection site throbbing, all over body pain were resolving at the time of this report.  No follow-up attempts were needed. No further information was expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: fever; Head aches; anxiety; arm sore; nausea; This is a spontaneous report from a non-contactable consumer (patient) or other non hcp. A 25-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: En6198) via an unspecified route of administration, administered in Arm Left on 26Feb2021 17:30 (at the age of 25-years-old) as dose 1, single for COVID-19 immunization. Medical history included colitis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior to the vaccination. No COVID tested post vaccination. Not diagnosed with COVID-19 since the vaccination. On 26Feb2021, the patient experienced fever, headache, anxiety, arm sore and nausea. No treatment was given for adverse events. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts were possible. No further information was expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Body temperature increased, Chills, Nausea
Clinical narrative: Body temperature 102.5; Chills; Weakness; Nausea (no vomiting); Eyesight difficulty (unable to focus); Pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown) via an unspecified route of administration in the arm left on 24Mar2021 at 16:30 (age at vaccination was 66-year-old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included diabetes, liver problems and high triglycerides from an unknown date and unknown if ongoing. Patient had no known allergies. Concomitant medications included gabapentin, atorvastatin and fenofibrate. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown) (age at vaccination was 66-year-old) via an unspecified route of administration in the arm left on 03Mar2021 at 16:30 as DOSE 1, SINGLE for COVID-19 immunisation and experienced pain at injection site. 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 25Mar2021 at 12:00, the patient experienced peaked body temperature approximately 8 hours after vaccine at 102.5 (units unknown), chills, weakness, nausea (no vomiting), eyesight difficulty (unable to focus) and pain at injection site. Therapeutic measures were not taken as a result of these events. On an unknown date, body temperature was 97.8 (units unknown). The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The outcome of the events was recovered in 2021.  No follow-up attempts are needed. Information about lot number cannot be obtained.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vision blurred
Clinical narrative: Body temperature 102.5; Chills; Weakness; Nausea (no vomiting); Eyesight difficulty (unable to focus); Pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown) via an unspecified route of administration in the arm left on 24Mar2021 at 16:30 (age at vaccination was 66-year-old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included diabetes, liver problems and high triglycerides from an unknown date and unknown if ongoing. Patient had no known allergies. Concomitant medications included gabapentin, atorvastatin and fenofibrate. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown) (age at vaccination was 66-year-old) via an unspecified route of administration in the arm left on 03Mar2021 at 16:30 as DOSE 1, SINGLE for COVID-19 immunisation and experienced pain at injection site. 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 25Mar2021 at 12:00, the patient experienced peaked body temperature approximately 8 hours after vaccine at 102.5 (units unknown), chills, weakness, nausea (no vomiting), eyesight difficulty (unable to focus) and pain at injection site. Therapeutic measures were not taken as a result of these events. On an unknown date, body temperature was 97.8 (units unknown). The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The outcome of the events was recovered in 2021.  No follow-up attempts are needed. Information about lot number cannot be obtained.