chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Headache, Migraine, SARS-CoV-2 test
Clinical narrative: two episodes of powerful migraine attacks on two days; headache never cleared; left with a permanent sensation, part headache and part dizziness; left with a permanent sensation, part headache and part dizziness; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8131) via an unspecified route of administration in the left arm on 08Apr2021 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma and atopic dermatitis. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 10Apr2021, the patient experienced two episodes of powerful migraine attacks on two days almost immediately following the day. On 10Apr2021, the patient also experienced the headache which was never cleared and left a permanent sensation of part headache and part dizziness. That was ongoing for full of four months and nothing patient did so far had helped to get rid of it. Since the vaccination, the patient had been tested for COVID-19. On 10Apr2021, the patient underwent lab test and procedures which included polymerase chain reaction (PCR -nasal swab) and tested negative. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with unspecified medications. The clinical outcome of the events episodes of powerful migraine attacks, headache and dizziness was not recovered at the time of reporting.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Induration
Clinical narrative: Large lump formed in left armpit; Lump is approximately the size of a peach and is very sore.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the arm left on 10Aug2021 at 11:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patien had no medical history. The patient previously received drostanolone propionate (MASTISOL) and povidone iodine (BETADINE) on unknown dates and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bupropion hydrochloride (WELLBUTRIN XL), dexlansoprazole (DEXILANT), pravastatin sodium (PRAVACHOL) and cetirizine hydrochloride (ZYRTEC); all on unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 12Aug2021 at 06:15, less than 48 hours of receiving the vaccine, the patient experienced a large lump formed in her left armpit. The lump was approximately the size of a peach and was very sore. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events large lump formed in left armpit and lump was very sore was not resolved at the time of this report.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Mass
Clinical narrative: Large lump formed in left armpit; Lump is approximately the size of a peach and is very sore.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the arm left on 10Aug2021 at 11:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patien had no medical history. The patient previously received drostanolone propionate (MASTISOL) and povidone iodine (BETADINE) on unknown dates and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bupropion hydrochloride (WELLBUTRIN XL), dexlansoprazole (DEXILANT), pravastatin sodium (PRAVACHOL) and cetirizine hydrochloride (ZYRTEC); all on unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 12Aug2021 at 06:15, less than 48 hours of receiving the vaccine, the patient experienced a large lump formed in her left armpit. The lump was approximately the size of a peach and was very sore. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events large lump formed in left armpit and lump was very sore was not resolved at the time of this report.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Biopsy breast, Breast cancer stage II, Laboratory test, Lymphadenopathy, Magnetic resonance imaging
Clinical narrative: Swollen lymph node under arm; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 07May2021 11:40 (Batch/Lot Number: ER8736) as DOSE 1, SINGLE for covid-19 immunisation at hospital. Medical history included none. Caller states that she was perfectly fine before the vaccine. There were no concomitant medications. No additional vaccines administered on same date of the pfizer suspect. Caller denied any other medications or medical conditions relevant to these events. Caller stated that she was perfectly fine before the vaccine. No prior vaccinations (within 4 weeks). No medical history (including any illness at time of vaccination) and family medical history relevant to AE(s). The patient experienced swollen lymph node under arm on 07May2021 with outcome of unknown. The caller stated that she got the first dose of the vaccine on 07May2021. As soon as she got it she said she got a swollen lymph node under her arm. She was told that this was common in women and that she would have to wait three months to get a mammogram. Caller stated she had no other medical history and no other symptoms. This lymph node came up as soon as she had her vaccine. The event required a visit to physician office.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Mammogram, Positron emission tomogram, Ultrasound scan
Clinical narrative: Swollen lymph node under arm; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 07May2021 11:40 (Batch/Lot Number: ER8736) as DOSE 1, SINGLE for covid-19 immunisation at hospital. Medical history included none. Caller states that she was perfectly fine before the vaccine. There were no concomitant medications. No additional vaccines administered on same date of the pfizer suspect. Caller denied any other medications or medical conditions relevant to these events. Caller stated that she was perfectly fine before the vaccine. No prior vaccinations (within 4 weeks). No medical history (including any illness at time of vaccination) and family medical history relevant to AE(s). The patient experienced swollen lymph node under arm on 07May2021 with outcome of unknown. The caller stated that she got the first dose of the vaccine on 07May2021. As soon as she got it she said she got a swollen lymph node under her arm. She was told that this was common in women and that she would have to wait three months to get a mammogram. Caller stated she had no other medical history and no other symptoms. This lymph node came up as soon as she had her vaccine. The event required a visit to physician office.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node under arm; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 07May2021 11:40 (Batch/Lot Number: ER8736) as DOSE 1, SINGLE for covid-19 immunisation at hospital. Medical history included none. Caller states that she was perfectly fine before the vaccine. There were no concomitant medications. No additional vaccines administered on same date of the pfizer suspect. Caller denied any other medications or medical conditions relevant to these events. Caller stated that she was perfectly fine before the vaccine. No prior vaccinations (within 4 weeks). No medical history (including any illness at time of vaccination) and family medical history relevant to AE(s). The patient experienced swollen lymph node under arm on 07May2021 with outcome of unknown. The caller stated that she got the first dose of the vaccine on 07May2021. As soon as she got it she said she got a swollen lymph node under her arm. She was told that this was common in women and that she would have to wait three months to get a mammogram. Caller stated she had no other medical history and no other symptoms. This lymph node came up as soon as she had her vaccine. The event required a visit to physician office.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Breast cancer stage II, Breast mass, Candida infection, Investigation, Pharyngitis
Clinical narrative: Swollen lymph node under arm; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 07May2021 11:40 (Batch/Lot Number: ER8736) as DOSE 1, SINGLE for covid-19 immunisation at hospital. Medical history included none. Caller states that she was perfectly fine before the vaccine. There were no concomitant medications. No additional vaccines administered on same date of the pfizer suspect. Caller denied any other medications or medical conditions relevant to these events. Caller stated that she was perfectly fine before the vaccine. No prior vaccinations (within 4 weeks). No medical history (including any illness at time of vaccination) and family medical history relevant to AE(s). The patient experienced swollen lymph node under arm on 07May2021 with outcome of unknown. The caller stated that she got the first dose of the vaccine on 07May2021. As soon as she got it she said she got a swollen lymph node under her arm. She was told that this was common in women and that she would have to wait three months to get a mammogram. Caller stated she had no other medical history and no other symptoms. This lymph node came up as soon as she had her vaccine. The event required a visit to physician office.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19, SARS-CoV-2 test positive, Sepsis, Vaccine breakthrough infection
Clinical narrative: COVID pos 8/19/2021 admitted to hospital 8/19/2021 trated with oxygen, remdesivir and dexamethasone discharged in room air on 8/25/2021
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID pos 8/19/2021 admitted to hospital 8/19/2021 trated with oxygen, remdesivir and dexamethasone discharged in room air on 8/25/2021
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Blood test abnormal, Fibrin D dimer increased, Pulmonary embolism
Clinical narrative: Started not feeling well on August 13th. Went to doctor on the 18th. Went back to doctor on 23rd still not able to breath, chest pain, very weak, back pain. Tested my blood and my d-dimer was 3619. Was taken to hospital with blood clots found out there was one in right leg and multiple PE in lungs.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Back pain, Blood test abnormal, Chest X-ray abnormal, Chest pain
Clinical narrative: Started not feeling well on August 13th. Went to doctor on the 18th. Went back to doctor on 23rd still not able to breath, chest pain, very weak, back pain. Tested my blood and my d-dimer was 3619. Was taken to hospital with blood clots found out there was one in right leg and multiple PE in lungs.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Dyspnoea, Fibrin D dimer, Malaise, Pulmonary embolism
Clinical narrative: Started not feeling well on August 13th. Went to doctor on the 18th. Went back to doctor on 23rd still not able to breath, chest pain, very weak, back pain. Tested my blood and my d-dimer was 3619. Was taken to hospital with blood clots found out there was one in right leg and multiple PE in lungs.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test, Scan with contrast, Thrombosis
Clinical narrative: Started not feeling well on August 13th. Went to doctor on the 18th. Went back to doctor on 23rd still not able to breath, chest pain, very weak, back pain. Tested my blood and my d-dimer was 3619. Was taken to hospital with blood clots found out there was one in right leg and multiple PE in lungs.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, UNK, UNK
Symptoms: COVID-19, Endotracheal intubation, Intensive care, SARS-CoV-2 test positive
Clinical narrative: REFERENCE VAERS form for initial vaccine breakthrough case info.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, UNK, UNK
Symptoms: COVID-19, Condition aggravated, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: REFERENCE VAERS form for initial vaccine breakthrough case info.
Age: 82.0
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: Presented with altered mental status, is hospitalized, and found to be positive for COVID.
Age: 82.0
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Mental status changes, SARS-CoV-2 test positive
Clinical narrative: Presented with altered mental status, is hospitalized, and found to be positive for COVID.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Blister, Fatigue, Myalgia, Rash
Clinical narrative: Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2021, the patient received the 1st dose of Shingrix. On 23rd August 2021, 4 days after receiving Shingrix, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix in left arm and 4 days after the vaccination the patient developed shingles on his left arm. The HCP (health care professional) started patient on valacyclovir and confirmed shingles diagnosis. The patient stated that he was about half way through taking the medication prescribed by HCP (health care professional) and he did not want to get the second Shingrix dose. The reporter consented to follow up.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2021, the patient received the 1st dose of Shingrix. On 23rd August 2021, 4 days after receiving Shingrix, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix in left arm and 4 days after the vaccination the patient developed shingles on his left arm. The HCP (health care professional) started patient on valacyclovir and confirmed shingles diagnosis. The patient stated that he was about half way through taking the medication prescribed by HCP (health care professional) and he did not want to get the second Shingrix dose. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Throat lesion, Tongue disorder
Clinical narrative: Numbness and tingling in feet, hands, arms and legs about 36 hours after vaccine. Tongue ulcerations with scratchy throat about 48 hours after vaccine.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Throat irritation, Tongue ulceration, X-ray normal
Clinical narrative: Numbness and tingling in feet, hands, arms and legs about 36 hours after vaccine. Tongue ulcerations with scratchy throat about 48 hours after vaccine.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: 6/13/21 Woke up w/chest Pain, difficulty breathing, and  dizzy enough to almost pass out. Admitted to hospital.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray, Chest pain, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: 6/13/21 Woke up w/chest Pain, difficulty breathing, and  dizzy enough to almost pass out. Admitted to hospital.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Presyncope
Clinical narrative: 6/13/21 Woke up w/chest Pain, difficulty breathing, and  dizzy enough to almost pass out. Admitted to hospital.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test, Fatigue, Myalgia, Nausea
Clinical narrative: upper back pain, nausea, weight loss (30 pounds), cant sleep, weakness, brain fog, depression, hair loss,
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Weight decreased
Clinical narrative: upper back pain, nausea, weight loss (30 pounds), cant sleep, weakness, brain fog, depression, hair loss,
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Asthenia, Back pain, Blood test normal, Chest X-ray normal
Clinical narrative: upper back pain, nausea, weight loss (30 pounds), cant sleep, weakness, brain fog, depression, hair loss,
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Depression, Electrocardiogram normal, Feeling abnormal, Nausea, Sleep disorder
Clinical narrative: upper back pain, nausea, weight loss (30 pounds), cant sleep, weakness, brain fog, depression, hair loss,
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Nausea, Tinnitus
Clinical narrative: Severe tinnitus, constant non-stop noticed approx two hours after, left ear, fullness, dizziness, severe ear pain on and off
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Blood test, Dizziness, Ear discomfort, Ear pain
Clinical narrative: Severe tinnitus, constant non-stop noticed approx two hours after, left ear, fullness, dizziness, severe ear pain on and off
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Severe tinnitus, constant non-stop noticed approx two hours after, left ear, fullness, dizziness, severe ear pain on and off
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dermatitis allergic
Clinical narrative: she had itching over all her face; It gets red and irritated and peels constantly.; she had itching over all her face and it was red like a sunburn; This is a spontaneous report from a contactable Other HCP (patient) reported in response to the inbound via phone which includes: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8732, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 06Apr2021 as dose 2, single for COVID-19 immunization. The patient medical history was none. Concomitant medications included cefalexin monohydrate (KEFLEX [CEFALEXIN MONOHYDRATE]), sulfamethoxazole, trimethoprim (BACTRIM), minocycline (MINOCYCLINE), prednisone (PREDNISONE) all taken for an unspecified indication, start and stop date were not reported. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER2613, Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 16Mar2021 as dose 1, single for COVID-19 immunization and experienced itching. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that after the second dose, about 48 hours after, on Apr2021, she had itching over all her face and it was red like a sunburn. It gets red and irritated and peels constantly. She has been treated with prednisone and antibiotics for this event. She has been to the doctor's office, she has been quite a few time and been given prescriptions several times. On 12May2021 was the first visit. It was explained that once she completed the antibiotics and prednisone, the symptoms flare up again. She has been tried on a several antibiotics: Keflex 750mg for 10 days, the second was Bactrim double strength DS for 7 days, and the third was Minocycline 100 capsules, twice a day for possibly a couple months though she has only been on it 3 weeks currently. She has been 3 different doses of the prednisone: 10mg. She did 3 tablets for 3 days, 2 tablets for 3 days, and then 1 tablet for 3 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (those were negative, no autoimmune shown) on 2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, SARS-CoV-2 test, Skin irritation
Clinical narrative: she had itching over all her face; It gets red and irritated and peels constantly.; she had itching over all her face and it was red like a sunburn; This is a spontaneous report from a contactable Other HCP (patient) reported in response to the inbound via phone which includes: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8732, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 06Apr2021 as dose 2, single for COVID-19 immunization. The patient medical history was none. Concomitant medications included cefalexin monohydrate (KEFLEX [CEFALEXIN MONOHYDRATE]), sulfamethoxazole, trimethoprim (BACTRIM), minocycline (MINOCYCLINE), prednisone (PREDNISONE) all taken for an unspecified indication, start and stop date were not reported. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER2613, Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 16Mar2021 as dose 1, single for COVID-19 immunization and experienced itching. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that after the second dose, about 48 hours after, on Apr2021, she had itching over all her face and it was red like a sunburn. It gets red and irritated and peels constantly. She has been treated with prednisone and antibiotics for this event. She has been to the doctor's office, she has been quite a few time and been given prescriptions several times. On 12May2021 was the first visit. It was explained that once she completed the antibiotics and prednisone, the symptoms flare up again. She has been tried on a several antibiotics: Keflex 750mg for 10 days, the second was Bactrim double strength DS for 7 days, and the third was Minocycline 100 capsules, twice a day for possibly a couple months though she has only been on it 3 weeks currently. She has been 3 different doses of the prednisone: 10mg. She did 3 tablets for 3 days, 2 tablets for 3 days, and then 1 tablet for 3 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (those were negative, no autoimmune shown) on 2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abnormal uterine bleeding, Vaginal haemorrhage
Clinical narrative: Heavy abnormal vaginal bleeding weeks before menstrual cycle; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 15Aug2021 at 18:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any concomitant medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Aug2021, the patient experienced heavy abnormal vaginal bleeding weeks before menstrual cycle. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event heavy abnormal vaginal bleeding weeks before menstrual cycle was not resolved at the time of this report.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: Heavy abnormal vaginal bleeding weeks before menstrual cycle; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 15Aug2021 at 18:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any concomitant medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Aug2021, the patient experienced heavy abnormal vaginal bleeding weeks before menstrual cycle. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event heavy abnormal vaginal bleeding weeks before menstrual cycle was not resolved at the time of this report.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Gait inability, Pain in extremity, Thrombosis
Clinical narrative: He was unable to walk; Blood clot in his leg; His calf hurt; This is a spontaneous report from a contactable other health care professional. A 60-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: FC3282), via intramuscular route, administered in Arm Left on 25Aug2021 (at the age of 60-years-old) as dose 1, single for covid-19 immunization.  Patient had no medical history. Concomitant medication included testosterone cipionate (TESTOSTERONE CYPIONATE). Prior to vaccination, not diagnosed with COVID-19, did not receive any other vaccines within 4 weeks. Since the vaccination, has the patient has not been tested for COVID-19. Patient had received other medication (testosterone cipionate) within 2 weeks of vaccination. Patients calf was hurt after the COVID-19 vaccine on 25Aug2021, the pain got worse and on 31Aug2021 morning and he was unable to walk. Since patient was unable to reach the pharmacist through phone, he had ended up going to the Urgent Care and was prescribed Eliquis for a blood clot in his leg. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Thrombosis and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait inability, Pain in extremity, Thrombosis
Clinical narrative: He was unable to walk; Blood clot in his leg; His calf hurt; This is a spontaneous report from a contactable other health care professional. A 60-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: FC3282), via intramuscular route, administered in Arm Left on 25Aug2021 (at the age of 60-years-old) as dose 1, single for covid-19 immunization.  Patient had no medical history. Concomitant medication included testosterone cipionate (TESTOSTERONE CYPIONATE). Prior to vaccination, not diagnosed with COVID-19, did not receive any other vaccines within 4 weeks. Since the vaccination, has the patient has not been tested for COVID-19. Patient had received other medication (testosterone cipionate) within 2 weeks of vaccination. Patients calf was hurt after the COVID-19 vaccine on 25Aug2021, the pain got worse and on 31Aug2021 morning and he was unable to walk. Since patient was unable to reach the pharmacist through phone, he had ended up going to the Urgent Care and was prescribed Eliquis for a blood clot in his leg. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Thrombosis and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had Covid; had Covid; cough; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for her husband that include: A male patient of an unspecified age received first dose of bnt162b2 (Comirnaty, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The caller stated that her son has already received the 1st dose of the Pfizer BioNTech Covid vaccine but was not able to get the vaccine on the recommended date due to congestion and mucus. Caller asked if her son was still eligible to receive the second dose. Caller also asked if she and her husband should get the second dose after 42 days from the first dose since they both had Covid. She and her husband recovered from Covid-19 two weeks ago and was wondering when they can get the Pfizer BioNTech Covid vaccine. She stated that they did not have the monoclonal antibody treatment and was not admitted in the hospital instead just at home. Caller also asked if it was fine for her husband to receive the vaccine even though he had cough. She said she did not think the cough was from the Covid virus but instead he got it somewhere else. The patient experienced had covid on an unspecified date, had covid on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had Covid; had Covid; cough; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for her husband that include: A male patient of an unspecified age received first dose of bnt162b2 (Comirnaty, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The caller stated that her son has already received the 1st dose of the Pfizer BioNTech Covid vaccine but was not able to get the vaccine on the recommended date due to congestion and mucus. Caller asked if her son was still eligible to receive the second dose. Caller also asked if she and her husband should get the second dose after 42 days from the first dose since they both had Covid. She and her husband recovered from Covid-19 two weeks ago and was wondering when they can get the Pfizer BioNTech Covid vaccine. She stated that they did not have the monoclonal antibody treatment and was not admitted in the hospital instead just at home. Caller also asked if it was fine for her husband to receive the vaccine even though he had cough. She said she did not think the cough was from the Covid virus but instead he got it somewhere else. The patient experienced had covid on an unspecified date, had covid on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body height, Breast pain
Clinical narrative: shoulder pain; pain on the top of her left shoulder down to her upper arm before the elbow; This is a spontaneous report from a contactable consumer (patient) via Medical Information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in the right arm on an unspecified date as dose 1, single for COVID-19 immunisation. Medical history included cancer in the left arm and had nine lymph nodes removed there. The patient's concomitant medications were not reported. The patient was asking if she should get the second shot after weird things happened after her first dose. She reported that she got the first dose on her right arm and experienced shoulder pain there (on an unspecified date). On an unspecified date, she also experienced pain on the top of her left shoulder down to her upper arm before the elbow. She mentioned she had cancer in that arm and had nine lymph nodes removed there. She didn't want to have pains like those worsened in the second dose. She was asking if this is normal. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: shoulder pain; pain on the top of her left shoulder down to her upper arm before the elbow; This is a spontaneous report from a contactable consumer (patient) via Medical Information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in the right arm on an unspecified date as dose 1, single for COVID-19 immunisation. Medical history included cancer in the left arm and had nine lymph nodes removed there. The patient's concomitant medications were not reported. The patient was asking if she should get the second shot after weird things happened after her first dose. She reported that she got the first dose on her right arm and experienced shoulder pain there (on an unspecified date). On an unspecified date, she also experienced pain on the top of her left shoulder down to her upper arm before the elbow. She mentioned she had cancer in that arm and had nine lymph nodes removed there. She didn't want to have pains like those worsened in the second dose. She was asking if this is normal. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Lymphadenopathy
Clinical narrative: Injection site pain; Severe muscle pain; Severe joint pain, including spinal pain; Spinal pain; Lymphadenopathy; Left under arm painful to touch; Fatigue; Headache; This is a spontaneous report from a contactable other healthcare professional, the patient. A 40-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) in the left arm on 30Aug2021 at 12:00 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history included crohn's disease and allergy to mussels. Prior to the vaccination, the patient was not diagnosed with COVID-19.The patient received unspecified concomitant medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took infliximab (REMICADE) and metaclopramide (REGLAN) both for unspecified indication from unknown date and experienced drug allergy.  The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 18Jan2021 at 12:00 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. On 30Aug2021 at 06:00, after the 6 hours after the vaccine, the patient experienced fatigue which subsided 24 hours post vaccine. On 30Aug2021, after the 6 hours of the vaccine, the patient experienced headache and subsided 36 hours after the vaccine.  On 31Aug2021, after the 12 hours of vaccine, the patient experienced severe joint pain, including spinal pain and subsided 36 hours after the vaccination. On 31Aug2021, started 12 hours after the post vaccine, the patient experienced injection site pain and still ongoing. On 31Aug2021, 12 hours post vaccine, severe muscle pain started and subsided 36 hours after the vaccine. On 31Aug2021, 18 hours after the vaccine, the patient experienced lymphadenopathy, left underarm swollen to baseball size and painful to touch and movement and still ongoing. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included rest and treatment with tylenol. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site pain, lymphadenopathy and swollen left underarm and left under arm painful to touch  and movement was not recovered at the time of this report. The clinical outcome of the event fatigue was recovered on 31Aug2021. The clinical outcome of the events headache, severe muscle pain, severe joint pain and spinal pain were recovered on 01Sep2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain, Pain of skin, Spinal pain
Clinical narrative: Injection site pain; Severe muscle pain; Severe joint pain, including spinal pain; Spinal pain; Lymphadenopathy; Left under arm painful to touch; Fatigue; Headache; This is a spontaneous report from a contactable other healthcare professional, the patient. A 40-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) in the left arm on 30Aug2021 at 12:00 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history included crohn's disease and allergy to mussels. Prior to the vaccination, the patient was not diagnosed with COVID-19.The patient received unspecified concomitant medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took infliximab (REMICADE) and metaclopramide (REGLAN) both for unspecified indication from unknown date and experienced drug allergy.  The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 18Jan2021 at 12:00 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. On 30Aug2021 at 06:00, after the 6 hours after the vaccine, the patient experienced fatigue which subsided 24 hours post vaccine. On 30Aug2021, after the 6 hours of the vaccine, the patient experienced headache and subsided 36 hours after the vaccine.  On 31Aug2021, after the 12 hours of vaccine, the patient experienced severe joint pain, including spinal pain and subsided 36 hours after the vaccination. On 31Aug2021, started 12 hours after the post vaccine, the patient experienced injection site pain and still ongoing. On 31Aug2021, 12 hours post vaccine, severe muscle pain started and subsided 36 hours after the vaccine. On 31Aug2021, 18 hours after the vaccine, the patient experienced lymphadenopathy, left underarm swollen to baseball size and painful to touch and movement and still ongoing. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included rest and treatment with tylenol. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site pain, lymphadenopathy and swollen left underarm and left under arm painful to touch  and movement was not recovered at the time of this report. The clinical outcome of the event fatigue was recovered on 31Aug2021. The clinical outcome of the events headache, severe muscle pain, severe joint pain and spinal pain were recovered on 01Sep2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: Injection site pain; Severe muscle pain; Severe joint pain, including spinal pain; Spinal pain; Lymphadenopathy; Left under arm painful to touch; Fatigue; Headache; This is a spontaneous report from a contactable other healthcare professional, the patient. A 40-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) in the left arm on 30Aug2021 at 12:00 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history included crohn's disease and allergy to mussels. Prior to the vaccination, the patient was not diagnosed with COVID-19.The patient received unspecified concomitant medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took infliximab (REMICADE) and metaclopramide (REGLAN) both for unspecified indication from unknown date and experienced drug allergy.  The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 18Jan2021 at 12:00 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. On 30Aug2021 at 06:00, after the 6 hours after the vaccine, the patient experienced fatigue which subsided 24 hours post vaccine. On 30Aug2021, after the 6 hours of the vaccine, the patient experienced headache and subsided 36 hours after the vaccine.  On 31Aug2021, after the 12 hours of vaccine, the patient experienced severe joint pain, including spinal pain and subsided 36 hours after the vaccination. On 31Aug2021, started 12 hours after the post vaccine, the patient experienced injection site pain and still ongoing. On 31Aug2021, 12 hours post vaccine, severe muscle pain started and subsided 36 hours after the vaccine. On 31Aug2021, 18 hours after the vaccine, the patient experienced lymphadenopathy, left underarm swollen to baseball size and painful to touch and movement and still ongoing. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included rest and treatment with tylenol. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site pain, lymphadenopathy and swollen left underarm and left under arm painful to touch  and movement was not recovered at the time of this report. The clinical outcome of the event fatigue was recovered on 31Aug2021. The clinical outcome of the events headache, severe muscle pain, severe joint pain and spinal pain were recovered on 01Sep2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.