chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Alopecia, Blood pressure increased, Blood pressure measurement, Eye irritation
Clinical narrative: Within 30 minutes- flushing, mild hives; Within 30 minutes- flushing, mild hives; Within 6 hours- headache mild visible facial swelling, Teeth pain (like after a root plaining); Within 6 hours- headache mild visible facial swelling, Teeth pain (like after a root plaining); Within 6 hours- headache mild visible facial swelling, Teeth pain (like after a root plaining); Next morning- eye irritation, elevated blood pressure. (154/86 and staying between 140-152/70-88 over the next 5 days); Next morning- eye irritation, elevated blood pressure. (154/86 and staying between 140-152/70-88 over the next 5 days); Day 3 -left lower abdominal quadrant cramping and noted an increased amount of hair loss; Day 3 -left lower abdominal quadrant cramping and noted an increased amount of hair loss; This is a spontaneous report from a contactable consumer (patient). A 43-years-old non pregnant female patient received first dose of bnt162b2 (Solution injection; Batch/Lot Number: EW0171), via an unspecified route of administration, administered in Arm Left on 27Aug2021 at 15:00 (at the age of 43-years-old) as single dose for covid-19 immunisation. Medical history included hypothyroidism, polycystic ovarian syndrome (PCOS), history of appendectomy, tonsillectomy and pelvic floor reconstruction. Patient had known allergies to penicillin, keflex, mild egg allergy food allergy from an unknown date and unknown if ongoing known allergy to penicillin, Keflex and mild egg allergy. Concomitant medications included levothyroxine, multivitamins, paracetamol (TYLENOL), loratadine (CLARITIN [LORATADINE]) and fish oil. The patient previously took keflex [cefalexin] and experienced drug allergy. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with covid prior to vaccination. Patient was not tested for covid post vaccination. On 27Aug2021 at 15:15, patient experienced within 30 minutes- flushing, mild hives, within 6 hours- headache mild visible facial swelling, teeth pain (like after a root plaining), next morning- eye irritation, elevated blood pressure (154/86 and staying between 140-152/70-88 over the next 5 days). On day 3, patient experienced left lower abdominal quadrant cramping and noted an increased amount of hair loss. The patient underwent lab tests and procedures which included blood pressure measurement which was 154/86 and staying between 140-152/70-88 over the next 5 days). Therapeutic measures were taken due to the events and patient self-medicated with benadryl on the evening of 27Aug2021. The outcome of all the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Swelling face, Toothache, Urticaria
Clinical narrative: Within 30 minutes- flushing, mild hives; Within 30 minutes- flushing, mild hives; Within 6 hours- headache mild visible facial swelling, Teeth pain (like after a root plaining); Within 6 hours- headache mild visible facial swelling, Teeth pain (like after a root plaining); Within 6 hours- headache mild visible facial swelling, Teeth pain (like after a root plaining); Next morning- eye irritation, elevated blood pressure. (154/86 and staying between 140-152/70-88 over the next 5 days); Next morning- eye irritation, elevated blood pressure. (154/86 and staying between 140-152/70-88 over the next 5 days); Day 3 -left lower abdominal quadrant cramping and noted an increased amount of hair loss; Day 3 -left lower abdominal quadrant cramping and noted an increased amount of hair loss; This is a spontaneous report from a contactable consumer (patient). A 43-years-old non pregnant female patient received first dose of bnt162b2 (Solution injection; Batch/Lot Number: EW0171), via an unspecified route of administration, administered in Arm Left on 27Aug2021 at 15:00 (at the age of 43-years-old) as single dose for covid-19 immunisation. Medical history included hypothyroidism, polycystic ovarian syndrome (PCOS), history of appendectomy, tonsillectomy and pelvic floor reconstruction. Patient had known allergies to penicillin, keflex, mild egg allergy food allergy from an unknown date and unknown if ongoing known allergy to penicillin, Keflex and mild egg allergy. Concomitant medications included levothyroxine, multivitamins, paracetamol (TYLENOL), loratadine (CLARITIN [LORATADINE]) and fish oil. The patient previously took keflex [cefalexin] and experienced drug allergy. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with covid prior to vaccination. Patient was not tested for covid post vaccination. On 27Aug2021 at 15:15, patient experienced within 30 minutes- flushing, mild hives, within 6 hours- headache mild visible facial swelling, teeth pain (like after a root plaining), next morning- eye irritation, elevated blood pressure (154/86 and staying between 140-152/70-88 over the next 5 days). On day 3, patient experienced left lower abdominal quadrant cramping and noted an increased amount of hair loss. The patient underwent lab tests and procedures which included blood pressure measurement which was 154/86 and staying between 140-152/70-88 over the next 5 days). Therapeutic measures were taken due to the events and patient self-medicated with benadryl on the evening of 27Aug2021. The outcome of all the events was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Immunisation, Off label use
Clinical narrative: four people just got the booster and they are still sick four days later from Pfizer; four people just got the booster and they are still sick four days later from Pfizer; four people just got the booster and they are still sick four days later from Pfizer; This is a spontaneous report from a contactable consumer. A patient of an unspecified age and gender received bnt162b2 (COMIRNATY; Solution for injection, Batch/Lot Number: not provided) via an unspecified route of administration on an unknown date, as dose 3, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (BNT162B2) on an unknown date as dose 1, single and second dose of bnt162b2 (BNT162B2) on an unknown date as dose 2, single both for COVID-19 immunization. The reporter reported that there were four people just got the booster and they were still sick four days later from Pfizer on an unspecified date. The outcome of event sick was not recovered.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Extra dose administered, Fatigue, Influenza like illness, Nasopharyngitis
Clinical narrative: tired; received a booster shot of the Pfizer Covid vaccine; received a booster shot of the Pfizer Covid vaccine; a deep chesty cough; cold; sore throat; flu like symptoms; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sales Representative reported for himself. A 37-years-old male patient received BNT162B2 (COMIRNATY, Solution for injection, batch/lot number: unknown), via an unknown route of administration on 26Aug2021 as dose 3, single for Covid-19 immunisation. The patient's medical history included immunocompromised. Concomitant medication was not reported. The patient received BNT162B2 (COMIRNATY, Solution for injection, batch/lot number: unknown), on an unknown date as historical vaccine as dose 1 and 2, single for Covid-19 immunisation. The patient received a booster shot of the Pfizer Covid vaccine on Thursday, 26Aug2021. He felt somewhat tired on Friday, but then experienced many more symptoms starting on Sunday and continuing to today 01Aug. Patient reports that symptoms have increased in severity since Sunday. Symptoms include a deep chesty cough, cold, sore throat and other flu like symptoms. Event took place after use of product. Patient took two Covid tests on Sunday and received two negative test results back so far. The outcome of events was unknown.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: tired; received a booster shot of the Pfizer Covid vaccine; received a booster shot of the Pfizer Covid vaccine; a deep chesty cough; cold; sore throat; flu like symptoms; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sales Representative reported for himself. A 37-years-old male patient received BNT162B2 (COMIRNATY, Solution for injection, batch/lot number: unknown), via an unknown route of administration on 26Aug2021 as dose 3, single for Covid-19 immunisation. The patient's medical history included immunocompromised. Concomitant medication was not reported. The patient received BNT162B2 (COMIRNATY, Solution for injection, batch/lot number: unknown), on an unknown date as historical vaccine as dose 1 and 2, single for Covid-19 immunisation. The patient received a booster shot of the Pfizer Covid vaccine on Thursday, 26Aug2021. He felt somewhat tired on Friday, but then experienced many more symptoms starting on Sunday and continuing to today 01Aug. Patient reports that symptoms have increased in severity since Sunday. Symptoms include a deep chesty cough, cold, sore throat and other flu like symptoms. Event took place after use of product. Patient took two Covid tests on Sunday and received two negative test results back so far. The outcome of events was unknown.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Immunisation, Off label use
Clinical narrative: stabbing, throbbing pain in and around my left ear; This was my 3rd shot; This was my 3rd shot; This is a spontaneous report from a contactable consumer or other non-HCP (patient).  A 38-years-old non pregnant female received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was FC3180) via an unspecified route of administration, administered in right arm on 02Sep2021 at 13:45, administered in right arm (age at the time of vaccination was 38-years-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization (off label use). The patient's medical history included Psoriatic Arthritis, Anxiety, Sinus Tachycardia, Asthma. The concomitant medications included Humira (ADA-LIMUMAB), Sulfasalazine, Tizanidine, Alprazonam and Zyrtec allergy (CETIRIZINE HYDROCHLORIDE) for an unspecified indication, within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no known allergies. The patient was diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. Previously, the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization; and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. On 02Sep2021, the patient experienced stabbing, throbbing pain in and around left ear (reported as: stabbing, throbbing pain in and around my left ear). No treatment was received for adverse events. The clinical outcome of the events stabbing, throbbing pain in and around left ear was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dry mouth, Fatigue, Immunisation, Off label use
Clinical narrative: Booster vaccination; Booster vaccination; Mouth sore- lasted 2 days; Dry mouth; Absolutely no energy; Exhausted; This is a spontaneous report from a contactable Nurse. A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose 3 (booster), single for covid-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration as dose 1 single and second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration as dose 2 single for COVID-19 immunization for COVID-19 immunization. Patient had no known allergies. The patient reports mouth sore- lasted 2 days and gets one every once in a while and goes away comes back for a day- it comes and goes with a dry mouth, after covid booster vaccination. Patient said that knocked her out the next day, just exhausted and absolutely no energy on an unspecified date in May2021. The outcome of events was unknown.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Oral pain
Clinical narrative: Booster vaccination; Booster vaccination; Mouth sore- lasted 2 days; Dry mouth; Absolutely no energy; Exhausted; This is a spontaneous report from a contactable Nurse. A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose 3 (booster), single for covid-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration as dose 1 single and second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration as dose 2 single for COVID-19 immunization for COVID-19 immunization. Patient had no known allergies. The patient reports mouth sore- lasted 2 days and gets one every once in a while and goes away comes back for a day- it comes and goes with a dry mouth, after covid booster vaccination. Patient said that knocked her out the next day, just exhausted and absolutely no energy on an unspecified date in May2021. The outcome of events was unknown.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: feeling tired; had a sore arm at the injection site; This is a spontaneous report from a contactable consumer (Patient). A 57-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date in 2021 as dose 3, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported.  Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date as dose 1, single for COVID-19 immunization and patient received dose 2 BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date as dose 2, single for COVID-19 immunization. On 2021, the patient reported that he received a third COVID vaccination yesterday and was feeling tired and had a sore arm at the injection site. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Limb discomfort, Lung disorder, Lymphadenopathy
Clinical narrative: Right Axillary Lymphadenopathy; Difficulties raising right arm above the head with associated swelling discomfort; Difficulties raising right arm above the head with associated swelling discomfort and difficulty expanding the lungs to breath and; Difficulties raising right arm above the head with associated swelling discomfort; difficulty expanding the lungs to breath; difficulty expanding the lungs to breath; right side chest discomfort; This is a spontaneous report from a contactable other hcp. A 41-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: FF2589), via an unspecified route of administration, administered in Arm Right on 07Sep2021 13:30 as DOSE 2, SINGLE (at the age of 41-year-old) for covid-19 immunisation. Medical history included hypothyroidism. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient previously took avelox and experienced drug hypersensitivity, biaxin and experienced drug hypersensitivity, bnt162b2 for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received dose 1 of bnt162b2 on 10Aug2021 03:30pm, Lot number: EW987. On 08Sep2021 02:15, the patient experienced right axillary lymphadenopathy within 13h of vaccine administration, difficulties raising right arm above the head with associated swelling discomfort and difficulty expanding the lungs to breath and right side chest discomfort. AE resulted in doctor or other healthcare professional office/clinic visit. The patient did not received any treatment for the events. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Peripheral swelling
Clinical narrative: Right Axillary Lymphadenopathy; Difficulties raising right arm above the head with associated swelling discomfort; Difficulties raising right arm above the head with associated swelling discomfort and difficulty expanding the lungs to breath and; Difficulties raising right arm above the head with associated swelling discomfort; difficulty expanding the lungs to breath; difficulty expanding the lungs to breath; right side chest discomfort; This is a spontaneous report from a contactable other hcp. A 41-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: FF2589), via an unspecified route of administration, administered in Arm Right on 07Sep2021 13:30 as DOSE 2, SINGLE (at the age of 41-year-old) for covid-19 immunisation. Medical history included hypothyroidism. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient previously took avelox and experienced drug hypersensitivity, biaxin and experienced drug hypersensitivity, bnt162b2 for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received dose 1 of bnt162b2 on 10Aug2021 03:30pm, Lot number: EW987. On 08Sep2021 02:15, the patient experienced right axillary lymphadenopathy within 13h of vaccine administration, difficulties raising right arm above the head with associated swelling discomfort and difficulty expanding the lungs to breath and right side chest discomfort. AE resulted in doctor or other healthcare professional office/clinic visit. The patient did not received any treatment for the events. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, Feeling abnormal, Incorrect dose administered, Lymphadenopathy
Clinical narrative: White blood cells are also affected; Her spleen doesn't work like it should; Low white blood cells count; Noticed that the "shot was running out of her arm" the vaccination provider was mopping it but she is concerned she did not receive the full dose.; Received the third dose; Received the third dose; Feels uncomfortable/Just feel like I already am missing the parts in my blood; Lymph node sides are low; she thinks that it wouldn't hurt her to re-do the vaccine because she needs the maximum dose since she's immunocompromised; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 29Aug2021 as dose 3, single for COVID-19 immunization. Medical history included end stage liver disease (pre-existing immunocompromised medical conditions), hemochromatosis (pre-existing immunocompromised medical conditions), hepatitis C (pre-existing immunocompromised medical conditions), blood damage from severe cirrhosis (pre-existing immunocompromised medical conditions), spleen itself doesn't function as well because it's like more than double the size, it's huge, it's enlarged to a gross amount in my stomach (goes down beyond/below my belly button, it's way out of my ribs like into my abdomen), so it's not working properly and called it hypoplasia and immunocompromised. The patient's concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date as dose 1 and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 08May2021, as dose 2, single for COVID-19 immunization. On an unspecified date, the patient white blood cells was also affected, her spleen doesn't work like it should, low white blood cells count, noticed that the shot was running out of her arm the vaccination provider was mopping it but she is concerned she did not receive the full dose, received the third dose, felt uncomfortable/just felt like she was already missing the parts in her blood, lymph node sides are low and she thought that it wouldn't hurt her to re do the vaccine because she needs the maximum dose since she's immunocompromised. On an unspecified date, the patient underwent lab tests and procedures which included low white blood cell count. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Spleen disorder, White blood cell disorder
Clinical narrative: White blood cells are also affected; Her spleen doesn't work like it should; Low white blood cells count; Noticed that the "shot was running out of her arm" the vaccination provider was mopping it but she is concerned she did not receive the full dose.; Received the third dose; Received the third dose; Feels uncomfortable/Just feel like I already am missing the parts in my blood; Lymph node sides are low; she thinks that it wouldn't hurt her to re-do the vaccine because she needs the maximum dose since she's immunocompromised; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 29Aug2021 as dose 3, single for COVID-19 immunization. Medical history included end stage liver disease (pre-existing immunocompromised medical conditions), hemochromatosis (pre-existing immunocompromised medical conditions), hepatitis C (pre-existing immunocompromised medical conditions), blood damage from severe cirrhosis (pre-existing immunocompromised medical conditions), spleen itself doesn't function as well because it's like more than double the size, it's huge, it's enlarged to a gross amount in my stomach (goes down beyond/below my belly button, it's way out of my ribs like into my abdomen), so it's not working properly and called it hypoplasia and immunocompromised. The patient's concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date as dose 1 and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 08May2021, as dose 2, single for COVID-19 immunization. On an unspecified date, the patient white blood cells was also affected, her spleen doesn't work like it should, low white blood cells count, noticed that the shot was running out of her arm the vaccination provider was mopping it but she is concerned she did not receive the full dose, received the third dose, felt uncomfortable/just felt like she was already missing the parts in her blood, lymph node sides are low and she thought that it wouldn't hurt her to re do the vaccine because she needs the maximum dose since she's immunocompromised. On an unspecified date, the patient underwent lab tests and procedures which included low white blood cell count. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: Headache; Slightly elevated fever; This is a spontaneous report from a contactable consumer. A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: 301358A), via intramuscular route of administration, administered in Arm Left on 12Sep2021 17:15 as dose 2, single for COVID-19 immunization (at the age of 17-year-old). The patient medical history included known allergies to Penicillin. Concomitant medications included Ibuprofen (ADVIL (IBUPROFEN)). Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0198), via an unspecified route of administration on 18Aug2021 (at the age of 17-year-old) as dose 1, single for COVID-19 immunization. It was stated that, patient did not receive any other vaccine in four weeks prior COVID vaccine. The concomitant medication (Patient took other medications in two weeks) include Advil. Patient was not diagnosed with COVID-19 prior to vaccination, and not been tested for COVID-19 since the vaccination. On 13Sep2021 07:00, the patient experienced headache and slightly elevated fever. The patient underwent lab tests and procedures which included fever: slightly elevated on an unspecified date. No therapeutic measures were taken as a result of events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Immunisation, Interchange of vaccine products, Off label use
Clinical narrative: hot flashes; got 1st 2 doses of some other companies covid vaccine/ received 3rd dose of Pfizer covid vaccine; got 1st 2 doses of some other companies covid vaccine/ received 3rd dose of Pfizer covid vaccine; got 1st 2 doses of some other companies covid vaccine/ received 3rd dose of Pfizer covid vaccine; This is a spontaneous report from a non-contactable consumer from a Pfizer sponsored program. A male patient (son in law of the reporter) of an unspecified age received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first and second doses of the COVID-19 vaccine (NON-PFIZER) on unknown dates for COVID-19 immunization.  The patient had received the BNT162b2 as the third dose but was given the first 2 doses of another company's vaccine. On an unknown date, the patient experienced hot flashes.  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.  Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Skin burning sensation, Urticaria
Clinical narrative: burning patch; broke out in hives; allergic reaction; This is a spontaneous report from a contactable consumer (patient) from the Pfizer-sponsored program. A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the left arm on 01Sep2021 at 09:00 (Batch/Lot Number: FF2588) as dose 1, single (at the age of 46-years-old) for Covid-19 immunisation. Medical history included occasional allergies seasonal. The patient's concomitant medications were not reported. There was no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccine was administered on the same date of the Pfizer suspect. The patient had no prior vaccinations (within 4 weeks). After getting the first dose of Pfizer COVID vaccine, the patient had an allergic reaction. She had a burning patch 4 hours after getting the first dose (01Sep2021 at 13:00). The patient asked if it is okay to proceed with the second dose. It was also reported that she worked as a technician and did not have a prescribing doctor. She got the first dose on 01Sep2021 at 9AM and the reaction started on her side. She went to the emergency room, and they said she broke out in hives. They saw her in the emergency room at 12:33pm so the hives started before then. They took about 4-5 days to go away. She was taking Benadryl 50mg every 6 hours for 24 hours and was told to wear loose clothing. No relevant test done. The patient recovered from the events burning patch and 'broke out in hives' on an unknown date in 2021 while the outcome of the rest of the events was unknown. The events required Emergency Room Visit.  Follow-Up (29Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Condition aggravated, Diarrhoea, Dizziness
Clinical narrative: High heart rate spikes; heart rate issues got significantly worse; Pins and needles in arms and legs; ocular migraines; anxiety; panic attacks; breathing issues; pressure in chests; fatigue; vertigo; POTS; diarrhea; nausea; ocasional dizziness; This is a spontaneous report from a contactable consumer (patient). A 35-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 14:00 (2:00 PM) (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. No medical history included and patient's concomitant medications were not reported. The patient reported that: "High heart rate spikes started 9 days after first vaccine. They continued to go unnoticed until my symptoms peaked in July. This is where my heart rate issues got significantly worse and other issues occurred. Pins and needles in arms and legs, ocular migraines, anxiety, panic attacks, breathing issues, pressure in chests, fatigue, vertigo, POTS, diarrhea, nausea". The patient also stated that: "I'm still dealing with the cardiac issues, occasional dizziness, pins and needles and GI issues". The events reported to start on 12Mar2021 at 06:00 PM. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and hospitalization for 3 days. No treatment was noted. The patient had no Covid prior vaccination. The patient is covid tested post vaccination via Nasal Swab on 25Aug2021 with negative result. The outcome of the events was not recovered
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Heart rate increased, Nausea, Ophthalmic migraine
Clinical narrative: High heart rate spikes; heart rate issues got significantly worse; Pins and needles in arms and legs; ocular migraines; anxiety; panic attacks; breathing issues; pressure in chests; fatigue; vertigo; POTS; diarrhea; nausea; ocasional dizziness; This is a spontaneous report from a contactable consumer (patient). A 35-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 14:00 (2:00 PM) (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. No medical history included and patient's concomitant medications were not reported. The patient reported that: "High heart rate spikes started 9 days after first vaccine. They continued to go unnoticed until my symptoms peaked in July. This is where my heart rate issues got significantly worse and other issues occurred. Pins and needles in arms and legs, ocular migraines, anxiety, panic attacks, breathing issues, pressure in chests, fatigue, vertigo, POTS, diarrhea, nausea". The patient also stated that: "I'm still dealing with the cardiac issues, occasional dizziness, pins and needles and GI issues". The events reported to start on 12Mar2021 at 06:00 PM. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and hospitalization for 3 days. No treatment was noted. The patient had no Covid prior vaccination. The patient is covid tested post vaccination via Nasal Swab on 25Aug2021 with negative result. The outcome of the events was not recovered
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Panic attack, Paraesthesia, Postural orthostatic tachycardia syndrome, SARS-CoV-2 antibody test negative, Vertigo
Clinical narrative: High heart rate spikes; heart rate issues got significantly worse; Pins and needles in arms and legs; ocular migraines; anxiety; panic attacks; breathing issues; pressure in chests; fatigue; vertigo; POTS; diarrhea; nausea; ocasional dizziness; This is a spontaneous report from a contactable consumer (patient). A 35-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 14:00 (2:00 PM) (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. No medical history included and patient's concomitant medications were not reported. The patient reported that: "High heart rate spikes started 9 days after first vaccine. They continued to go unnoticed until my symptoms peaked in July. This is where my heart rate issues got significantly worse and other issues occurred. Pins and needles in arms and legs, ocular migraines, anxiety, panic attacks, breathing issues, pressure in chests, fatigue, vertigo, POTS, diarrhea, nausea". The patient also stated that: "I'm still dealing with the cardiac issues, occasional dizziness, pins and needles and GI issues". The events reported to start on 12Mar2021 at 06:00 PM. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and hospitalization for 3 days. No treatment was noted. The patient had no Covid prior vaccination. The patient is covid tested post vaccination via Nasal Swab on 25Aug2021 with negative result. The outcome of the events was not recovered
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Cramping in stomach constantly; normal at first but as of 16Sep2021 she still menstruating/moderate to heavy bleeding; blood clots, bright red blood; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Fd8448), dose 1 via an unspecified route of administration, administered in Arm Left on 26Aug2021 19:00 (at the age of 48years) as dose 1, singe for Covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. There were no concomitant medications. There was no vaccine in four weeks. There were no other medications in two weeks. The patient reported that she had first vaccination shot on 26Aug2021 and she started my period on 01Sep2021. Everything was normal at first but as of 16Sep2021 she still menstruating. She had moderate to heavy bleeding and cramping in her stomach constantly. She had blood clots, bright red blood. She stated that she can't get a doctor appointment until next month but can't wait that long. There was no treatment received for the events. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Pelvic discomfort
Clinical narrative: heavy period flow; I experienced pressure and discomfort in my uterus for several days; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 30-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; #lot: EW0171) via an unspecified route of administration, administered in right arm on 28Apr2021 14:00 (at the age of 30-years-old) as single dose for covid-19 immunization. The patient had no other medical history, no known allergies and patient's concomitant medications were not reported. The patient previously received first dose of (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; #lot: EW0153) via an unspecified route of administration, administered in right arm on 05Apr2021 at 02:00 PM as single dose for covid-19 immunization and took nexplanon for birth control. Patient stated that she was very petite and have been on Nexplanon for 14 years. Patient did not receive other vaccine within 4 weeks. Patient did not have covid 19 prior vaccination. On 01May2021 08:00 AM, the patient experienced pressure and discomfort in her uterus for several days and then had a heavy period flow which lasted 7 days. While this may seem normal for some, it is not for her. Her periods are always light and spotty. She had never experienced period pain in her life. She realizes her case may be uncommon but the changes she experienced were stark and noticeable. She had a few regular periods since so she believes it was a onetime reaction, but she doesn't know for sure. Patient was not tested for covid 19 post vaccination. No treatment received for adverse events. The outcome of the event heavy period flow was recovered on 08May2021 and for remaining event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rhabdomyolysis
Clinical narrative: Slight headache; Rhabdomyolysis; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for three patients. This is second of three reports. A 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 15Sep2021 (at the age of 15-year-old) (Lot Number: FC3180; Expiration Date: 16Sep2021) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot Number and Expiration Date not reported) as dose 1, single for COVID-19 immunization. The patient experienced rhabdomyolysis on 15Sep2021. The patient went to the emergency room on 15Sep2021 and considered her a mild case of rhabdomyolysis and didn't admit her. The patient had a slight headache on 16Sep2021. The outcome of events was not recovered.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Rhabdomyolysis and the suspect drug BNT162B2  cannot be excluded. 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: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Rhabdomyolysis
Clinical narrative: Slight chest pain; Rhabdomyolysis; This is a spontaneous report from a contactable pharmacist. This pharmacist reporting same events under the same suspect product for 3 patients. This is the third of three reports This is a spontaneous report from a contactable pharmacist. A 16-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 15Sep2021 (Lot Number: FC3180; Expiration Date: 16Sep2021) (at the age of 16-years old) as dose 2, single for covid-19 immunisation. The patient had no medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient was complaining of slight chest pain and the reporter was unsure if it was rhabdomyolysis. The chest pain started on the morning of 16Sep2021. The reporter stated patient had Rhabo issues (also reported as rhabdomyolysis) in Sep2021. The reporter stated that the patient was still being evaluated at the time of reporting. The reporter questioned if there was a link between the 2nd dose and Rhabdomyolysis in younger patients as they have not seen this in the past. The reporter seriousness for slight chest pain was medically significant. The outcome of chest pain was not recovered, and outcome of rhabdomyolysis was unknown. The reporter's verbatim event relatedness of Pfizer covid 19 vaccine with slight chest pain was related.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events rhabdomyolysis  and chest pain 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Headache, Immunisation, Loss of consciousness, Lower limb fracture
Clinical narrative: passed out; Severe allergy(hives all over my body even between my fingers); had a headaches for hours and hours; broke my leg; Severe allergy(hives all over my body even between my fingers); Pfizer Biontech 3rd Booster; Pfizer Biontech 3rd Booster; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 57-years old, via an unspecified route of administration, administered in Arm Left on 10Sep2021 13:00 (Batch/Lot number was not reported) as dose 3, single for COVID-19 immunization. Medical history included asthma. The patient had no known allergies. There were no concomitant medications. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. The patient experienced severe allergy (hives all over her body even between her fingers). She was still in recuperating; she also had a headaches for hours and hours and then she was taking a shower and passed out and broke her leg multiples places. The events occurred on 11Sep2021 03:00 which resulted to healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received Prednisone 60mg 3 Times a day as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab test and procedures which included nasal swab: negative on 28Dec2020. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, SARS-CoV-2 test, Urticaria
Clinical narrative: passed out; Severe allergy(hives all over my body even between my fingers); had a headaches for hours and hours; broke my leg; Severe allergy(hives all over my body even between my fingers); Pfizer Biontech 3rd Booster; Pfizer Biontech 3rd Booster; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 57-years old, via an unspecified route of administration, administered in Arm Left on 10Sep2021 13:00 (Batch/Lot number was not reported) as dose 3, single for COVID-19 immunization. Medical history included asthma. The patient had no known allergies. There were no concomitant medications. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. The patient experienced severe allergy (hives all over her body even between her fingers). She was still in recuperating; she also had a headaches for hours and hours and then she was taking a shower and passed out and broke her leg multiples places. The events occurred on 11Sep2021 03:00 which resulted to healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received Prednisone 60mg 3 Times a day as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab test and procedures which included nasal swab: negative on 28Dec2020. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.