chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, SARS-CoV-2 test, Systemic lupus erythematosus
Clinical narrative: Had severe allergies; Got diagnosed with lupus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 (Lot number: EN6199) at the age of 36 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: er8730, Location of injection: Arm Left), administration date: 04Mar2021, when the patient was 36 years old, for COVID-19 Immunization. The following information was reported: HYPERSENSITIVITY (disability) with onset 01Jun2021, outcome "not recovered", described as "Had severe allergies"; SYSTEMIC LUPUS ERYTHEMATOSUS (disability) with onset 01Jun2021, outcome "not recovered", described as "Got diagnosed with lupus". The events "had severe allergies" and "got diagnosed with lupus" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown result. Therapeutic measures were taken as a result of hypersensitivity, systemic lupus erythematosus. Gabapentin, Prednisone and Antihistamine were taken as the AE treatment. There were no any other vaccine administered in last four weeks.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation, Joint range of motion decreased, Joint swelling, Vaccination site pain
Clinical narrative: She has significant pain in her left wrist/ painful wrist; She has significant pain in her left wrist, she states that she cannot move it, feels like it is broken but it's not; It is swollen and it's really painful; injection site sore; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "RA" (unspecified if ongoing), notes:  if she went to her HCP she was most likely going to be prescribed Prednisone or another steroid. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021, outcome "unknown", described as "Booster"; ARTHRALGIA (non-serious) with onset 04Dec2021, outcome "not recovered", described as "She has significant pain in her left wrist/ painful wrist"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 04Dec2021, outcome "not recovered", described as "She has significant pain in her left wrist, she states that she cannot move it, feels like it is broken but it's not"; JOINT SWELLING (non-serious) with onset 04Dec2021, outcome "not recovered", described as "It is swollen and it's really painful"; VACCINATION SITE PAIN (non-serious) with onset 04Dec2021, outcome "not recovered", described as "injection site sore". The events "she has significant pain in her left wrist/ painful wrist", "she has significant pain in her left wrist, she states that she cannot move it, feels like it is broken but it's not" and "it is swollen and it's really painful" were evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination site pain.  Additional Information: The injection site was not red, hot or swollen and the patient took Advil. The patient would like to know if the pain migrates away from the injection site and in her case to her wrist. The patient also would like to know if Prednisone or other steroid would cause the booster dose not effective. The patient called her  orthopedic who specializes in hand and wrist to ask them about the pain and they informed her since it was because of the vaccine that they could not see her and referred her to her primary care doctor for treatment.    The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Immunisation, Pain in extremity, Vaccination site pain
Clinical narrative: Dose number 3; Chills; pain at injection; Arm pain; Chest pain; This is a spontaneous report from a contactable reporter (consumer or non HCP).    An adult male patient received bnt162b2 (BNT162B2) (Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, DOSE 1, SINGLE, Lot No: UNKNOWN), for COVID-19 immunisation and Covid-19 vaccine (MANUFACTURER UNKNOWN, DOSE 2, SINGLE; Lot No: UNKNOWN), for COVID-19 immunisation.   The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "dose number 3"; CHILLS (non-serious), outcome "recovered", described as "chills"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "pain at injection"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arm pain"; CHEST PAIN (non-serious), outcome "recovered", described as "chest pain". It was unknown whether therapeutic measures were taken for the events chills, vaccination site pain, pain in extremity and chest pain.  Additional information: Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown if patient received any other vaccines within four weeks the prior to the COVID-19 vaccine. It was reported that during conversation with a friend, he said that he experienced chills, pain at injection, arm pain, and chest pain a day after receiving a booster dose. He said it was resolved in a few days. Since the vaccination, it was unknown whether the patient had been tested for COVID-19.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Irritability, Lethargy
Clinical narrative: Several hours later at 7pm when felt better temp was taken 99.5 degrees; Subject was irritable in the morning around 10am the next day after 2nd vaccination; Slept fine the night before, that morning was lethargic; Complained of a headache; Tired; This is a spontaneous report from a contactable reporter (Consumer or other non-HCP).  A 7-year-old male patient received bnt162b2 (BNT162B2), administration date 03Dec2021 (Lot number: FK5618) at the age of 7 years as dose 2 (tris), single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1 (TRIS), SINGLE, Lot number: FK5127, Administration time: 17:15), administration date: 08Nov2021, when the patient was 7 years old, for COVID-19 immunisation.  The following information was reported: IRRITABILITY (non-serious) with onset 04Dec2021 at 10:00, outcome "recovered" (an unknown date in Dec2021), described as "Subject was irritable in the morning around 10am the next day after 2nd vaccination"; LETHARGY (non-serious) with onset 04Dec2021 at 10:00, outcome "recovered" (an unknown date in Dec2021), described as "Slept fine the night before, that morning was lethargic"; HEADACHE (non-serious) with onset 04Dec2021 at 10:00, outcome "recovered" (an unknown date in Dec2021), described as "Complained of a headache"; FATIGUE (non-serious) with onset 04Dec2021 at 10:00, outcome "recovered" (an unknown date in Dec2021), described as "Tired"; PYREXIA (non-serious) with onset 04Dec2021 at 19:00, outcome "recovered" (an unknown date in Dec2021), described as "Several hours later at 7pm when felt better temp was taken 99.5 degrees". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of irritability, lethargy, headache, fatigue and pyrexia.  Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. The patient wouldn't let take temperature in the morning on 04Dec2021. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Several hours later at 7pm when felt better temp was taken 99.5 degrees; Subject was irritable in the morning around 10am the next day after 2nd vaccination; Slept fine the night before, that morning was lethargic; Complained of a headache; Tired; This is a spontaneous report from a contactable reporter (Consumer or other non-HCP).  A 7-year-old male patient received bnt162b2 (BNT162B2), administration date 03Dec2021 (Lot number: FK5618) at the age of 7 years as dose 2 (tris), single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1 (TRIS), SINGLE, Lot number: FK5127, Administration time: 17:15), administration date: 08Nov2021, when the patient was 7 years old, for COVID-19 immunisation.  The following information was reported: IRRITABILITY (non-serious) with onset 04Dec2021 at 10:00, outcome "recovered" (an unknown date in Dec2021), described as "Subject was irritable in the morning around 10am the next day after 2nd vaccination"; LETHARGY (non-serious) with onset 04Dec2021 at 10:00, outcome "recovered" (an unknown date in Dec2021), described as "Slept fine the night before, that morning was lethargic"; HEADACHE (non-serious) with onset 04Dec2021 at 10:00, outcome "recovered" (an unknown date in Dec2021), described as "Complained of a headache"; FATIGUE (non-serious) with onset 04Dec2021 at 10:00, outcome "recovered" (an unknown date in Dec2021), described as "Tired"; PYREXIA (non-serious) with onset 04Dec2021 at 19:00, outcome "recovered" (an unknown date in Dec2021), described as "Several hours later at 7pm when felt better temp was taken 99.5 degrees". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of irritability, lethargy, headache, fatigue and pyrexia.  Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. The patient wouldn't let take temperature in the morning on 04Dec2021. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid positive result; Covid positive result; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 23Mar2021 (Lot number: EL3247) at the age of 44 years as dose 2, single and administered in arm right, administration date 02Mar2021 (Lot number: EL3247) at the age of 44 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history and no known allergies. The concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient didn't receive any other vaccines within 4 weeks. The patient tested for COVID-19 post vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Dec2021, outcome "recovering" and all described as "Covid positive result". It was reported that Vaccinated Family members in same household also positive after a Covid exposure on 28Nov2021. 12 vaccinated family members now covid positive. The event "covid positive result" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Dec2021) positive, notes: Nasal swab. Monoclonal antibody infusion were taken as a result of the adverse events.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101733546 same reporter/drug/AE with different patient
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart palpitation 15 minutes after receiving Pfizer's COVID-19 vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A female patient received bnt162b2 (BNT162B2) (Lot number: UNKNOWN) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "heart palpitation 15 minutes after receiving Pfizer's COVID-19 vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy
Clinical narrative: Dose received: 3; Swollen lymph under armpit next to left breast; This is a spontaneous report from a non-contactable reporter (other HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date an unknown date in Dec2021 (Lot number: unknown) at the age of 28 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing) and "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: penicillin. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN), administration date: an unknown date in Feb2021, when the patient was 27 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN), administration date: an unknown date in Feb2021, when the patient was 27 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset an unknown date in Dec2021, outcome "unknown", described as "Dose received: 3"; LYMPHADENOPATHY (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "Swollen lymph under armpit next to left breast". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Influenza like illness
Clinical narrative: Dose received: 3; Flu like symptoms for 18 hours following booster shot; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   An 88-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date an unknown date in Dec2021 (Lot number: unknown) at the age of 88 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Heart disorder" (unspecified if ongoing), notes: heart disease. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN), and Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset an unknown date in Dec2021, outcome "unknown", described as "Dose received: 3"; INFLUENZA LIKE ILLNESS (non-serious) with onset an unknown date in Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Flu like symptoms for 18 hours following booster shot". Therapeutic measures were not taken as a result of influenza like illness.  Additional information: The event INFLUENZA LIKE ILLNESS was resolved after the duration of 18 hours. It was not known whether the patient had known allergies. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Pain, Pyrexia
Clinical narrative: Fever; Aches; Exhaustion; Headache; Dose received: 3; This is a spontaneous report from a contactable reporter (other HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 at 19:00 (Lot number: unknown) at the age of 42 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Seizure" (unspecified if ongoing), notes: Seizure Disorder. Concomitant medications included: TOPIRAMATE; BUSPIRONE; NAPROXEN and MELOXICAM. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, LOT NUMBER: Unknown, Anatomical location: Left arm), administration date: 09Mar2021, when the patient was 41 years old and Bnt162b2 (DOSE 1, SINGLE, LOT NUMBER: Unknown, Anatomical location: Left arm), administration date: 16Feb2021, when the patient was 41 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 at 19:00, outcome "unknown", described as "Dose received: 3"; PYREXIA (non-serious) with onset 03Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Fever"; PAIN (non-serious) with onset 03Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Aches"; FATIGUE (non-serious) with onset 03Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Exhaustion"; HEADACHE (non-serious) with onset 03Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Headache". Therapeutic measures were not taken as a result of pyrexia, pain, fatigue and headache. Additional Information: The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Immunisation, Pyrexia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 41 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 04Dec2021 (Batch/Lot number: unknown) at the age of 41 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162B2 (Dose 1), administration date: 01Mar2021, when the patient was 41 years old, for COVID-19 immunisation, reaction(s): "she was tired", "headache"; BNT162B2 (Dose 2), administration date: 22Mar2021, when the patient was 41 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 04Dec2021, outcome "unknown", described as "booster dose"; HEADACHE (non-serious) with onset 04Dec2021, outcome "not recovered", described as "Headache"; PYREXIA (non-serious) with onset 07Dec2021, outcome "unknown", described as "low grade fever (2 and a half days after the booster dose)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, pyrexia.  Additional information: The course of the event was as follows: The patient received the booster dose of the Pfizer-BioNTech COVID-19 Vaccine on Saturday, 04Dec2021. She said she had the headache since Saturday night, but it was not horrible and that she just took Advil. But this morning, 07Dec2021, she said it was really bad. She said she was been taking Advil since Saturday now. Today, 07Dec2021, she said she had low grade fever (2 and a half days after the booster dose). The thing was she felt good, like she did not had a fever. She even took a COVID test and it was negative. She was wondering if we have seen a delay in reactions as it has been 2.5 days later since getting the shot.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: tired; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 41 years as dose 1 , single and administration date 22Mar2021 (Batch/Lot number: unknown) as dose 2 , single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 02Mar2021, outcome "recovered" (2021), described as "tired"; HEADACHE (non-serious) with onset 02Mar2021, outcome "recovered" (2021), described as "Headache".  Additional Information: The patient explains that Pfizer employee reporting on the Covid 19 vaccine the booster shot, and who says she has a question. She was trying to find the information online but knows there isn't a ton out there especially about the booster shot. Caller is wondering if there is any information on having a delay in side effects. It is explained she had the booster on Saturday, 04Dec2021 and had a little headache on Sunday and Monday. Caller first states that her awareness date would be the day of the shot, that is actually when she had the headache: 04Dec2021. Later in the call, she states after the first dose she was tired and had a little bit of a headache that started and lasted just the next day; she was fine after that. Awareness date populated as 02Mar2022, the day after the first shot. Additional Vaccines Administered on Same Date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks)  none. AE(s) following prior vaccinations: With the first 2 doses she was tired and had a little bit of a headache. The first dose was on 01Mar2021 and the second dose on 22Mar2021. Caller explains that the next day after the first dose she was tired and had the headache and that was it; after that she was fine. Please confirm the awareness date of 22Mar2022 was captured correctly. After listening to the call recording, the awareness date was provided as 02Mar2021.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101739611 similar report from same reporter
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Immunisation, Lymphadenopathy, SARS-CoV-2 test, Swelling
Clinical narrative: Left side (neck) enlarged lymph nodes; Swollen neck; Numb under chin; Dose received 3; This is a spontaneous report from a contactable reporter (other healthcare professional). The reporter is the patient.  A 58-year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Nov2021 (Lot number: unknown) at the age of 58 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Gastroparesis" (unspecified if ongoing) and "Blood pressure high" (unspecified if ongoing), notes: High blood pressure. Concomitant medications included: TOPROL; LAMICTAL; PROZACTIN; BETHANECOL; NEXIUM and PEP C. Past drug history included: Morphine, reaction: "Drug allergy" and Reglan, reaction: "Drug allergy". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: UNKNOWN, Anatomical location: Left arm, Route of administration: Unspecified), administration date: 05Apr2021, when the patient was 57 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: UNKNOWN, Anatomical location: Left arm, Route of administration: Unspecified), administration date: 04May2021, when the patient was 57 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021, outcome "unknown", described as "Dose received 3"; LYMPHADENOPATHY (non-serious) with onset 03Dec2021, outcome "not recovered", described as "Left side (neck) enlarged lymph nodes"; SWELLING (non-serious) with onset 03Dec2021, outcome "not recovered", described as "swollen neck"; HYPOAESTHESIA (non-serious) with onset 03Dec2021, outcome "not recovered", described as "numb under chin". The events "Left side (neck) enlarged lymph nodes", "swollen neck" and "numb under chin" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, swelling and hypoaesthesia.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to COVID vaccine. It was reported that the reaction is 1 week after injection of booster. Since the vaccination, the patient had been tested for COVID-19. The patient underwent the following laboratory tests and procedures which included: SARS-CoV-2 test by test type nasal swab on an unknown date and the result was UNKNOWN RESULT.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Oligomenorrhoea, SARS-CoV-2 test
Clinical narrative: Prolonged irregular menstrual cycle; Prolonged irregular menstrual cycle; This is a spontaneous report from a contactable reporter (Nurse). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 07Oct2021 at 15:30 (Lot number: FC3184) at the age of 33 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing), notes: known allergies: Sulfa. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Drug allergy", notes: known allergies: Amoxicillin; Clindamycin, reaction(s): "Drug allergy", notes: known allergies: Clindamycin and Tegretol, reaction(s): "Drug allergy", notes: known allergies: Tegretol. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: FC3181; Anatomical site: left arm; Route of administration: unspecified), administration date: 15Sep2021, when the patient was 33 years old, for COVID-19 immunisation. The following information was reported: OLIGOMENORRHOEA (non-serious), MENSTRUATION IRREGULAR (non-serious) all with onset 07Oct2021, outcome "not recovered", and all described as "Prolonged irregular menstrual cycle". The event "Prolonged irregular menstrual cycle" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of oligomenorrhoea and menstruation irregular.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 01Nov2021, the patient underwent SARS-COV-2 test (Sofia) by test type nasal swab and the result was negative.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Breast pain, Dizziness, Hormone level abnormal, Muscle spasms
Clinical narrative: Hormones have changed; Major cramps; Hurting breast; Dizziness; Lumps under arm pits; This is a spontaneous report from a contactable reporter (other healthcare professional). The reporter is the patient.  A 43-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 22Oct2021 (Lot number: unknown) at the age of 43 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Sarcoidosis" (unspecified if ongoing) and "Polycystic ovarian syndrome" (unspecified if ongoing), notes: PCOS. Concomitant medications were not reported. The following information was reported: HORMONE LEVEL ABNORMAL (non-serious) with onset 10Nov2021, outcome "not recovered", described as "Hormones have changed"; MUSCLE SPASMS (non-serious) with onset 10Nov2021, outcome "not recovered", described as "Major cramps"; BREAST PAIN (non-serious) with onset 10Nov2021, outcome "not recovered", described as "Hurting breast"; DIZZINESS (non-serious) with onset 10Nov2021, outcome "not recovered", described as "Dizziness"; AXILLARY MASS (non-serious) with onset 10Nov2021, outcome "not recovered", described as "Lumps under arm pits". The events "Hormones have changed", "Major cramps", "Hurting breast", "Dizziness" and "Lumps under arm pits" were evaluated at the physician office visit.  Additional Information: It was unknown whether any therapeutic measures were taken as a result of the events. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Immunisation, Pain
Clinical narrative: Dose received: 3; Serious shortness of breath frequently during the night of receiving the Pfizer COVID-19 booster shot. I also had shortness of breath as I woke up in the morning; Very painful to stand up for about 24 hours after receiving the booster shot; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Dec2021 at 15:45 (Lot number: FH8028) at the age of 26 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Asthma" (ongoing) and "Seasonal allergy" (unspecified if ongoing), notes: known allergies: seasonal allergies. Concomitant medication included: FLOVENT INHALER taken for Asthma as needed. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EW0182; Anatomical site: right arm; Route of administration: unspecified), administration date: 03May2021, when the patient was 25 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0187; Anatomical site: right arm; Route of administration: unspecified), administration date: 26May2021, when the patient was 25 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 at 15:45, outcome "unknown", described as "Dose received: 3"; DYSPNOEA (non-serious) with onset 01Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Serious shortness of breath frequently during the night of receiving the Pfizer COVID-19 booster shot. I also had shortness of breath as I woke up in the morning"; PAIN (non-serious) with onset 01Dec2021, outcome "recovered" (02Dec2021), described as "Very painful to stand up for about 24 hours after receiving the booster shot". Therapeutic measures were not taken as a result of dyspnoea and pain.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Left arm mild soreness and mild swelling at injection site; Left arm mild soreness and mild swelling at injection site; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), intramuscular, administered in arm left, administration date 03Mar2021 (Lot number: EL3247) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Reflux" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Diagnosed with COVID-19 prior to vaccination. Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE]; SPRING VALLEY VIT D3; SUPER B COMPLEX [VITAMIN B COMPLEX]; SPRING VALLEY CALCIUM 600MG PLUS VIT D3; HEALTH VIT C 500 MG WITH ROSE HIPS; EQUATE COMPLETE MULTIVITAMIN WOMEN 50+. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 03Mar2021 14:00, outcome "recovered" (Mar2021) and all described as "Left arm mild soreness and mild swelling at injection site". Therapeutic measures were not taken as a result of pain in extremity, vaccination site swelling. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and has not been tested for COVID-19 since vaccination. The patient had no known allergies to medications, food, or other products.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: soreness at the injection site; headache; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP).  A 49-year-old female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, solution for injection), administration date 27Feb2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness at the injection site"; HEADACHE (non-serious), outcome "unknown", described as "headache". Therapeutic measures were taken as a result of headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This is a spontaneous report received from a contactable reporter (other HCP). The reporter is the patient.  A 22-year-old male patient received bnt162b2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, solution for injection), intramuscular, administered in deltoid right, administration date 08Jan2021 09:00 (Lot number: EL3248) at the age of 22 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021143210 same patient and event, different drug.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Sore, swollen submandibular lymph nodes left side; Sore, swollen submandibular lymph nodes left side; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left deltoid (Lot number: EK9231, Expiration Date: Apr2021) at the age of 63 years, as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Hypothyroidism", start date: 01Dec1979 (ongoing); "Type I Diabetes", start date: 26Oct2010 (ongoing); "Sulfa, Erythromycin, Penicillin allergy" (unspecified if ongoing); "raynauds" (unspecified if ongoing); "Shingles" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (DOSE 1, SINGLE (Lot No: EH9899)), administration date: 16Dec2020, when the patient was 63 years old, for COVID-19 immunisation, reaction(s): "Aches", "Mild nausea", "Chills", "Fever up to 100.8 for 6-8 hours", "Headache", "Fatigue". The following information was reported: LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious), outcome "recovered" and all described as "Sore, swollen submandibular lymph nodes left side". Additional information: The events resolved within 2-3 days (as reported).  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Neurological symptom, Vomiting
Clinical narrative: she experienced horrible symptoms like neuro symptoms; throwing up; dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 02Mar2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (first dose), for COVID-19 immunisation. The following information was reported: NEUROLOGICAL SYMPTOM (non-serious) with onset Mar2021, outcome "unknown", described as "she experienced horrible symptoms like neuro symptoms"; VOMITING (non-serious) with onset Mar2021, outcome "unknown", described as "throwing up"; DIZZINESS (non-serious) with onset Mar2021, outcome "unknown", described as "dizzy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: diarrhea; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; HEADACHE (non-serious), outcome "unknown", described as "headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021253629 Same product and similar event, different patient
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: chills; body aches; general fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 72 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CIMETIDINE (ongoing). Vaccination history included: Bnt162b2 (first dose), administration date: 16Jan2021, when the patient was 72 years old, for COVID-19 Immunisation, reaction(s): "Body aches/ body and leg aches", "Body aches/ body and leg aches", "Joint pain", "Fatigues", "Chills", "A lot of nausea", "Cold sweat". The following information was reported: CHILLS (non-serious), outcome "recovered", described as "chills"; PAIN (non-serious), outcome "recovered", described as "body aches"; FATIGUE (non-serious), outcome "recovered", described as "general fatigue". Therapeutic measures were taken as a result of chills, pain, fatigue.  Additional information: Tylenol was taken as treatment for the events. It was reported that the side effects were not as bad and lasted 3 days. It was also reported that the patient never had fever or arm pain with either dose. The patient has no family medical history relevant to adverse events and no relevant tests.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Poor quality sleep, Vaccination site pain
Clinical narrative: reaction in lymph nodes on both sides/ arm pits; she was awake all night; arm where the shot was placed hurt also; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program (159558). The reporter is the patient.  A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "breast cancer survivor" (not ongoing). The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "reaction in lymph nodes on both sides/ arm pits"; POOR QUALITY SLEEP (non-serious), outcome "recovered", described as "she was awake all night"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "arm where the shot was placed hurt also". Therapeutic measures were taken as a result of lymphadenopathy.  Additional information: The patient mentioned that she did lymphatic massage in arm pits, both sides. She stated all the events subsided by the next day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: chronic back pain; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "chronic back pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 16Jan2021 (Batch/Lot number: unknown) as dose 1, single and administration date 06Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arms". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Vertigo
Clinical narrative: extreme vertigo; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 25Mar2021 (Lot number: EP7534) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VERTIGO (non-serious), outcome "unknown", described as "extreme vertigo"; HEADACHE (non-serious), outcome "unknown", described as "Headache". The events "extreme vertigo" and "headache" were evaluated at the physician office visit. Therapeutic measures were taken as a result of vertigo, headache.  Additional Information: It was reported that patient having extreme vertigo and headache and have gone to Ear nose & throat specialist they advise me to do the Epley maneuver and another one Defat maneuver, Meclizine.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal tenderness, Chills, Discomfort, Feeling cold, Headache
Clinical narrative: body aches/in pain and freezing under 3 blankets; chills; Nausea; minus vomiting; abdominal tenderness; Overall extremely uncomfortable; in pain and freezing under 3 blankets; preventing sleep; Hours after initial and immediate soreness of arm; prolonged headache about an hour after vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). This consumer reported for a female patient (sister)   A female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 21Apr2021 12:45 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZYRTEC DAIICHI; XOPENEX HFA. Vaccination history included: Bnt162b2 (Dose 1, single, administration time=10:45 PM, vaccine location=Left arm.), administration date: 31Mar2021, for COVID-19 Immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21Apr2021 13:30, outcome "recovering", described as "Hours after initial and immediate soreness of arm"; HEADACHE (non-serious) with onset 21Apr2021 13:30, outcome "recovering", described as "prolonged headache about an hour after vaccine"; PAIN (non-serious) with onset 21Apr2021 23:30, outcome "recovering", described as "body aches/in pain and freezing under 3 blankets"; CHILLS (non-serious) with onset 21Apr2021 23:30, outcome "recovering", described as "chills"; SLEEP DISORDER (non-serious) with onset 21Apr2021 13:30, outcome "recovering", described as "preventing sleep"; NAUSEA (non-serious) with onset 21Apr2021 23:30, outcome "recovering", described as "Nausea"; ABDOMINAL TENDERNESS (non-serious) with onset 21Apr2021 13:30, outcome "recovering", described as "abdominal tenderness"; DISCOMFORT (non-serious) with onset 21Apr2021 13:30, outcome "recovering", described as "Overall extremely uncomfortable"; FEELING COLD (non-serious) with onset 21Apr2021 13:30, outcome "recovering", described as "in pain and freezing under 3 blankets"; VOMITING (non-serious) with onset 21Apr2021 23:30, outcome "recovering", described as "minus vomiting". Therapeutic measures were taken as a result of pain in extremity, headache, pain, chills, sleep disorder, nausea, abdominal tenderness, discomfort, feeling cold, vomiting.  Additional information: Facility type vaccine was reported as other. Adverse events were treated with self-administered tylenol and advil. COVID was not an prior vaccination and not tested post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.