chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Weight
Clinical narrative: low grade fever; headaches; I was very tired, Tiredness; Injection site pain; site is red; slight swelling in the arm; muscle pain kind of all over; didn't feel well; whole arm was pain; had kind of few side effects for third shot; had kind of few side effects for third shot; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received third dose of bnt162b2 (Pfizer Covid-19 Vaccine, Solution for injection, Batch/lot number: EW0168, Expiry date: unknown), via an unspecified route on 16Aug2021, as a single dose for covid-19 immunization. Medical history included Crohn's disease for which patient takes chemo drug to keep Crohn's under control, asthma and patient was immuno-compromised. Concomitant medications included mother drugs: pantoprazole, mild Calcium, alendronate sodium (FOSAMAX), mercaptopurine (PURINETHOL, 6-MP) and immuno-compromise drug, a chemodrug (further clarification unknown if patient was suffering from side effects hence captured as suspect of unspecified medication). Historical vaccine included first dose of bnt162b2 (Pfizer Covid Vaccine, Solution for injection, Lot number: EN5318) on 05Feb2021 and second dose of bnt162b2 (Pfizer Covid Vaccine, Solution for injection, Lot number: EN6201) on 26Feb2021 both as a single dose for covid-19 immunization and experienced no side effects. Patient did not receive any other vaccines prior to the COVID vaccine. On an unknown date (age at the time of onset of reaction/event: 65-year-old), patient experienced few side effects for third shot: injection site pain hurt for over a week/almost a week and half. Just was started feeling better. Patient was very tired/tiredness, had headaches and muscle pain kind of all over. Also, had a low-grade fever, slight swelling in the arm, site is red, didn't feel well and whole arm was pain. Patient guess would be that the first shot to the second shot was so bad that his body did not have the chance to build up antibodies and response. So, when the third shot came around, it was really worked. Patient did not receive any treatment for the events. He was just happy that he had response. The patient underwent lab test and procedure which included weight measurement of 295 Ibs on an unknown date and 290 lbs on 29Aug2021 (actually, she was 290, measured himself today 290, not confirmed). No blood work was done. The clinical outcome of the events following third dose was patient feeling fine now, it's just, patient was trying to report what he had.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: swelling of the chin; This is a spontaneous report from a contactable consumer (patient's parent). A 19-year-old female patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date, NDC and UPC number was unknown) via an unspecified route of administration on 26Aug2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. On Aug2021, patient experienced swelling of the chin and reporter was not quite sure what to do. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on his chest and back of legs; This is a spontaneous report from a contactable pharmacist.  A 37-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number FA7485), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. After 2 days of vaccination on an unspecified date the patient experienced later developed a rash on his chest and back of legs. He had taken Benadryl and using an anti-itch cream, today it's a lot better, but not completely better. Reporter queried for should he still get the second dose or will that prevent the second dose from happening. Reporter stated that "reporter doesn't had a primary care provider. Reporter was pretty familiar with vaccine considering he give it a lot. Reporter further stated that Of course, reporter brother would be the one who gets the one reaction that reporter haven't seen or heard of. Reporter stated that could rule out anaphylaxis because it was delayed, but if he were to go to urgent care, he would had probably give him steroids. Reporter queried for are they not contraindicated to use at the same time. The outcome of the events was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Ocular hyperaemia
Clinical narrative: Same eye with redness/redness one eye left eye; Conjunctivitis; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6208, Expiration date: Not reported), via an unspecified route of administration in left arm on 14Mar2021 at 11:30 (at the age of 69-years-old) as dose 2, single for COVID-19 immunization in a hospital but not in a facility. There was no patient's relevant medical history/family medical history. There were no concomitant medications reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6200, Expiration date: Not reported), via an unspecified route of administration in left arm on 21Feb2021 at 11:30 (at the age of 68-years-old) as dose 1, single for COVID-19 immunization and woke up with one eye red and allergic conjunctivitis. No prior vaccinations within 4 weeks of COVID vaccine. After the second dose of vaccination, the patient woke up with the same problem with same time frame and same eye with redness/redness one eye left eye and conjunctivitis on 14Mar2021. The physician/doctor wanted to let him know since he was wondering why the events happened after both the vaccinations and let him know if the eye reaction doesn't clear up. The patient had not taken anything for treatment but the patient had over the counter dry eye drops which could be used for it as per the instruction by doctor. It was reported that these events require physician's office visit. There was no investigation assessment and no relevant tests done. The patient asked that these events were related to the vaccine and whether it has been reported. The outcome of the events was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Influenza like illness, Off label use, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). A 77-years-old male patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 17Aug2021 (at the age of 77-years) as dose 3, single in the left arm for covid-19 immunisation. The patient medical history included underlying mild heart issues from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 2, single for covid-19 immunisation. On 16Aug2021, the patient received 3rd dose of COVID vaccine and experienced achey flu like symptoms and arm pain. Stated 3rd dose much worse than dose 1 or 2. Reports lingering tingling all the way down left arm - dose received in left arm. Stated the arm tingling may or may not be vaccine related. 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101138191
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site discomfort
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). A 77-years-old male patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 17Aug2021 (at the age of 77-years) as dose 3, single in the left arm for covid-19 immunisation. The patient medical history included underlying mild heart issues from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 2, single for covid-19 immunisation. On 16Aug2021, the patient received 3rd dose of COVID vaccine and experienced achey flu like symptoms and arm pain. Stated 3rd dose much worse than dose 1 or 2. Reports lingering tingling all the way down left arm - dose received in left arm. Stated the arm tingling may or may not be vaccine related. 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101138191
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Headache, Nausea
Clinical narrative: This is a spontaneous report from a contactable other HCP. This other HCP reported for a 74-year-old male patient that.  A 74-year-old male patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FC3183, Expiration date: 31Oct2021), via intramuscular, administered in deltoid left on 25Aug2021 (at the age of 74-year-old) as dose 3, 0.3ml, single for COVID-19 immunization. Patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3247, Expiration date: 30May2021), via intramuscular, administered on 14Jan2021 (at the age of 74-year-old) as dose 1, single for COVID-19 immunization. Patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9262, Expiration date: 31May2021), via intramuscular, on 04Feb2021 (at the age of 74-year-old) as dose 2, single for COVID-19 immunization. The patient medical history includes Nausea, Ulcerative colitis, small bowel obstruction, Lymphocytic leukaemia, Thyroid cancer, Basal cell carcinoma all from an unspecified onset and unknown ongoing and concomitant medications were not reported. On 26Aug2021, after the vaccination, the patient experienced headaches and nausea for 5 days. reported that patients are moderately immunocompromised and has a history of leukaemia and received his 3rd dose of the vaccine at the request of the patient's haematologist. The outcome of the events was not recovered.  No follow-up attempts possible. No further information expected.  Follow-up (PRD/SRD (10Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up at-tempts have been completed and no further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest X-ray, Chills, Diarrhoea, Electrocardiogram
Clinical narrative: She had already had her vaccine and she went to get her booster last Thursday; She had already had her vaccine and she went to get her booster last Thursday; Injection site swelling; Injection site redness; Arm pain; Vomiting; Swollen lymph nodes; Diarrhea; Feeling unwell; Joint pain; Chills; Muscle pain; Tiredness; Headache; Barely walking, without throwing up or very dizzy; This is a spontaneous report from a contactable consumer (patient's mother).   A 19-year-old female patient (reporter's daughter) received third dose as booster dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EW0175), via an unspecified route of administration, in right arm on 26Aug2021 (last Thursday) (at the age of 19-year-old) at 8 or 9 as dose 3 booster, single for covid-19 immunization, at hospital facility. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EN6202), via intramuscular route, in right arm on 24Feb2021 (at the age of 18-year-old) in morning and haven't remember exact what time, as dose 1, single for covid-19 immunization and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EL9261), via intramuscular route, in right arm on 17Mar2021 (at the age of 19-year-old) in the morning, as dose 2, single for covid-19 immunization, both at hospital facility. Medical history included autism, asperger's syndrome, all the immune disorder (intent history), thyroid disorder (intent history; further clarifications unknown) and all the other health problems are due to her Hashimoto. Concomitant medications were reported as no. The patient did not receive any other vaccines within four weeks prior to the vaccination. She did not have any other medications at the time of vaccination or before vaccination. On an unspecified date in 2021, on Saturday, she took to emergency room due to arm pain, vomiting, swollen lymph nodes, diarrhea, feeling unwell, injection site redness, injection site swelling, tiredness, headache, barely walking, without throwing up or very dizzy. She has joint pain, chills, muscle pain. She has almost every side effect that all have, except for the heart. She has been sent to an endocrinologist every six month. The patient underwent lab tests and procedures which included ECG and her heart was fine, had chest X-ray at the emergency room. There was no blood work yet and she doesn't have any laboratory work done and they said due to the side effects are from the vaccine and to go away within 10 days. Therapeutic measures were reported as no. The outcome of the events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Headache, Immunisation, Lymphadenopathy
Clinical narrative: She had already had her vaccine and she went to get her booster last Thursday; She had already had her vaccine and she went to get her booster last Thursday; Injection site swelling; Injection site redness; Arm pain; Vomiting; Swollen lymph nodes; Diarrhea; Feeling unwell; Joint pain; Chills; Muscle pain; Tiredness; Headache; Barely walking, without throwing up or very dizzy; This is a spontaneous report from a contactable consumer (patient's mother).   A 19-year-old female patient (reporter's daughter) received third dose as booster dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EW0175), via an unspecified route of administration, in right arm on 26Aug2021 (last Thursday) (at the age of 19-year-old) at 8 or 9 as dose 3 booster, single for covid-19 immunization, at hospital facility. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EN6202), via intramuscular route, in right arm on 24Feb2021 (at the age of 18-year-old) in morning and haven't remember exact what time, as dose 1, single for covid-19 immunization and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EL9261), via intramuscular route, in right arm on 17Mar2021 (at the age of 19-year-old) in the morning, as dose 2, single for covid-19 immunization, both at hospital facility. Medical history included autism, asperger's syndrome, all the immune disorder (intent history), thyroid disorder (intent history; further clarifications unknown) and all the other health problems are due to her Hashimoto. Concomitant medications were reported as no. The patient did not receive any other vaccines within four weeks prior to the vaccination. She did not have any other medications at the time of vaccination or before vaccination. On an unspecified date in 2021, on Saturday, she took to emergency room due to arm pain, vomiting, swollen lymph nodes, diarrhea, feeling unwell, injection site redness, injection site swelling, tiredness, headache, barely walking, without throwing up or very dizzy. She has joint pain, chills, muscle pain. She has almost every side effect that all have, except for the heart. She has been sent to an endocrinologist every six month. The patient underwent lab tests and procedures which included ECG and her heart was fine, had chest X-ray at the emergency room. There was no blood work yet and she doesn't have any laboratory work done and they said due to the side effects are from the vaccine and to go away within 10 days. Therapeutic measures were reported as no. The outcome of the events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Off label use, Pain in extremity, Vaccination site erythema
Clinical narrative: She had already had her vaccine and she went to get her booster last Thursday; She had already had her vaccine and she went to get her booster last Thursday; Injection site swelling; Injection site redness; Arm pain; Vomiting; Swollen lymph nodes; Diarrhea; Feeling unwell; Joint pain; Chills; Muscle pain; Tiredness; Headache; Barely walking, without throwing up or very dizzy; This is a spontaneous report from a contactable consumer (patient's mother).   A 19-year-old female patient (reporter's daughter) received third dose as booster dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EW0175), via an unspecified route of administration, in right arm on 26Aug2021 (last Thursday) (at the age of 19-year-old) at 8 or 9 as dose 3 booster, single for covid-19 immunization, at hospital facility. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EN6202), via intramuscular route, in right arm on 24Feb2021 (at the age of 18-year-old) in morning and haven't remember exact what time, as dose 1, single for covid-19 immunization and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EL9261), via intramuscular route, in right arm on 17Mar2021 (at the age of 19-year-old) in the morning, as dose 2, single for covid-19 immunization, both at hospital facility. Medical history included autism, asperger's syndrome, all the immune disorder (intent history), thyroid disorder (intent history; further clarifications unknown) and all the other health problems are due to her Hashimoto. Concomitant medications were reported as no. The patient did not receive any other vaccines within four weeks prior to the vaccination. She did not have any other medications at the time of vaccination or before vaccination. On an unspecified date in 2021, on Saturday, she took to emergency room due to arm pain, vomiting, swollen lymph nodes, diarrhea, feeling unwell, injection site redness, injection site swelling, tiredness, headache, barely walking, without throwing up or very dizzy. She has joint pain, chills, muscle pain. She has almost every side effect that all have, except for the heart. She has been sent to an endocrinologist every six month. The patient underwent lab tests and procedures which included ECG and her heart was fine, had chest X-ray at the emergency room. There was no blood work yet and she doesn't have any laboratory work done and they said due to the side effects are from the vaccine and to go away within 10 days. Therapeutic measures were reported as no. The outcome of the events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vomiting
Clinical narrative: She had already had her vaccine and she went to get her booster last Thursday; She had already had her vaccine and she went to get her booster last Thursday; Injection site swelling; Injection site redness; Arm pain; Vomiting; Swollen lymph nodes; Diarrhea; Feeling unwell; Joint pain; Chills; Muscle pain; Tiredness; Headache; Barely walking, without throwing up or very dizzy; This is a spontaneous report from a contactable consumer (patient's mother).   A 19-year-old female patient (reporter's daughter) received third dose as booster dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EW0175), via an unspecified route of administration, in right arm on 26Aug2021 (last Thursday) (at the age of 19-year-old) at 8 or 9 as dose 3 booster, single for covid-19 immunization, at hospital facility. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EN6202), via intramuscular route, in right arm on 24Feb2021 (at the age of 18-year-old) in morning and haven't remember exact what time, as dose 1, single for covid-19 immunization and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EL9261), via intramuscular route, in right arm on 17Mar2021 (at the age of 19-year-old) in the morning, as dose 2, single for covid-19 immunization, both at hospital facility. Medical history included autism, asperger's syndrome, all the immune disorder (intent history), thyroid disorder (intent history; further clarifications unknown) and all the other health problems are due to her Hashimoto. Concomitant medications were reported as no. The patient did not receive any other vaccines within four weeks prior to the vaccination. She did not have any other medications at the time of vaccination or before vaccination. On an unspecified date in 2021, on Saturday, she took to emergency room due to arm pain, vomiting, swollen lymph nodes, diarrhea, feeling unwell, injection site redness, injection site swelling, tiredness, headache, barely walking, without throwing up or very dizzy. She has joint pain, chills, muscle pain. She has almost every side effect that all have, except for the heart. She has been sent to an endocrinologist every six month. The patient underwent lab tests and procedures which included ECG and her heart was fine, had chest X-ray at the emergency room. There was no blood work yet and she doesn't have any laboratory work done and they said due to the side effects are from the vaccine and to go away within 10 days. Therapeutic measures were reported as no. The outcome of the events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Immunisation, Off label use, Peripheral swelling, Pruritus
Clinical narrative: 3rd pfizer corona vaccine received; 3rd pfizer corona vaccine received; arm swelled; arm swelled,hot; itching; This is a spontaneous report from a contactable other healthcare professional received . A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration in the arm on 27Aug2021 as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization (at the age of 68-years-old). Medical history included ongoing breast cancer. Concomitant medication(s) included denosumab (PROLIA) taken for an unspecified indication from 24Aug2021 to 24Aug2021, in arm and letrozole taken for an unspecified indication, 7 days with letrozole. The patient previously took ibrance, from 26Jul2021, 100 mg daily for breast cancer, 21 days off, on hold due to labs continue to be low. Historical vaccine included first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 1 and dose 2, single for COVID-19 immunization. It was reported that, on an unspecified date in 2021, patient experienced arm swelled, hot and itching from 3rd pfizer corona vaccine received on 27Aug21. The clinical outcome for the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Immunisation, Off label use
Clinical narrative: She also received her Covid 19 booster shot. She has had some fatigue but has improved; She also received her Covid 19 booster shot. She has had some fatigue but has improved; She also received her Covid 19 booster shot. She has had some fatigue but has improved; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date (at the age of 61-years-old) as dose 3, single for COVID-19 immunisation and palbociclib (IBRANCE Batch/Lot number: UNKNOWN), via an unspecified route of administration from 01May2021 to an unspecified date, at 125 mg for an unspecified indication. The medical history of the patient included blood pressure. The concomitant medications of the patient were not reported. The patient previously received first dose of bnt162b2 (BNT162B2, solution for injection) on unspecified date (at the age of 61-years-old) as single dose and second dose of (BNT162B2, solution for injection) on unspecified date (at the age of 61-years-old) as single dose and both the doses for COVID-19 immunisation. The patient reported she took an additional week off per doctor due to WBC low. She also received her Covid 19 booster shot. On an unspecified date in 2021, she had some fatigue but had improved since her primary care doctor took her off of her blood pressure medication. The patient underwent lab tests and procedures which included WBC: low on an unspecified date. The outcome of the event fatigue was reported as resolving.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Rash macular
Clinical narrative: My face got extremely hot and red and blotchy; My face got extremely hot and red and blotchy; My face got extremely hot and red and blotchy; This is a spontaneous report from a contactable consumer. This 44-year-old non-pregnant female consumer (patient) reported that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8734, Expiry Date: not reported), via an unspecified route of administration, administered in left arm on 03Apr2021 at 11:30 (at the age of 44 years) as dose 1, single for covid-19 immunisation. Patient's known allergies were penicillin, nuts, adhesives. Other medical history: nothing current. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No Covid prior vaccination. Covid tested post second vaccination. After first dose, she had a reaction within 40 mins. Her face got extremely hot and red and blotchy and stayed like that for the day, 12hours or so. She didn't think much of it, waited for the flu like symptoms everyone else complained getting. Never got that, just a red hot face. No treatment received for AE. Device Date : 02Sep2021. The outcome of events was recovered in Apr2021.  Follow-up attempts are completed. No further information is expected
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Lymphadenopathy, Off label use
Clinical narrative: lymph node swollen on left collar bone with the 2nd dose and booster shot; Off label use; Extra dose administered; This is a spontaneous report from a contactable consumer (patient). A 36-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 30Aug2021 (at the age of 36-year-old) as dose 3 (booster), single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications reported as too many. Historical vaccines included bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 23Mar2021(at the age of 36-year-old) as dose 1, single and received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 30Aug2021 at 11:00AM (at the age of 36-year-old) as dose 2, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Patient had no known allergies. On 31Aug2021 the patient experienced lymphadenopathy, off label use, extra dose administered. It was reported that lymph node swollen on left collar bone with the 2nd dose and booster shot. Since the vaccination, the patient not tested for COVID-19. Patient was not received treatment for the events. Outcome of the event lymphadenopathy was not recovered and other 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: Extra dose administered, Hyperaesthesia, Injection site erythema, Off label use, Pruritus
Clinical narrative: she received her 3rd dose of pfizer covid vaccine; she received her 3rd dose of pfizer covid vaccine; soreness; swelling ar the injection site; little redness at the injection site; 'itching like crazy'; hard to the touch; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 72-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 3 via an unspecified route of administration on 31Aug2021 (Batch/Lot number and Expiration date was not reported) as DOSE 3, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) for covid-19 immunisation. On an unspecified date, the patient experienced she received her 3rd dose of pfizer covid vaccine, soreness, swelling at the injection site, little redness at the injection site, itching like crazy and hard to the touch. The patient stated that she received her 3rd dose of pfizer covid vaccine on tuesday (31Aug) and yesterday developed soreness, swelling and a little redness at the injection site. Also reported that the area was hard to the touch and was 'itching like crazy'. States today symptoms remain the same. She was wondering what to do and if this is normal. Stated that she called last night and spoke to an agent however the agents language was broken, and she was not sure how much information was captured. It was explained to her that we are unable to provide tx recommendations and referred to hcp if it persists or become concerning. The clinical outcome of the events was unknown.  Information about Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: she received her 3rd dose of pfizer covid vaccine; she received her 3rd dose of pfizer covid vaccine; soreness; swelling ar the injection site; little redness at the injection site; 'itching like crazy'; hard to the touch; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 72-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 3 via an unspecified route of administration on 31Aug2021 (Batch/Lot number and Expiration date was not reported) as DOSE 3, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) for covid-19 immunisation. On an unspecified date, the patient experienced she received her 3rd dose of pfizer covid vaccine, soreness, swelling at the injection site, little redness at the injection site, itching like crazy and hard to the touch. The patient stated that she received her 3rd dose of pfizer covid vaccine on tuesday (31Aug) and yesterday developed soreness, swelling and a little redness at the injection site. Also reported that the area was hard to the touch and was 'itching like crazy'. States today symptoms remain the same. She was wondering what to do and if this is normal. Stated that she called last night and spoke to an agent however the agents language was broken, and she was not sure how much information was captured. It was explained to her that we are unable to provide tx recommendations and referred to hcp if it persists or become concerning. The clinical outcome of the events was unknown.  Information about Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Constipation, Extra dose administered, Interchange of vaccine products, Nausea
Clinical narrative: Took 2 Moderna shots and waited 6 month and took a Pfizer shot 2 weeks ago.; Took 2 modarna and waited 6 month and took a Pfizer shot 2 week ago.; Took 2 modarna and waited 6 month; Body Aches; Nauseated; Constipated; Stomach ache; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), via an unspecified route of administration on an unspecified date as dose 3, single for covid-19 immunization. The patient medical history and concomitant medications were not reported (takes other medication). The patient previously received Moderna covid-19 vaccine (dose 1 and dose 2). On an unspecified date, the patient experienced took 2 modarna and waited 6 month and took a pfizer shot 2 weeks ago in 2021, body aches, nauseated, constipated, stomachache and product was used by the patient. 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: M
Vaccine: COVID19
Symptoms: Off label use, Pain
Clinical narrative: Took 2 Moderna shots and waited 6 month and took a Pfizer shot 2 weeks ago.; Took 2 modarna and waited 6 month and took a Pfizer shot 2 week ago.; Took 2 modarna and waited 6 month; Body Aches; Nauseated; Constipated; Stomach ache; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), via an unspecified route of administration on an unspecified date as dose 3, single for covid-19 immunization. The patient medical history and concomitant medications were not reported (takes other medication). The patient previously received Moderna covid-19 vaccine (dose 1 and dose 2). On an unspecified date, the patient experienced took 2 modarna and waited 6 month and took a pfizer shot 2 weeks ago in 2021, body aches, nauseated, constipated, stomachache and product was used by the patient. 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: M
Vaccine: COVID19
Symptoms: Euphoric mood, Extra dose administered, Insomnia, Off label use
Clinical narrative: since he got his third dose today; since he got his third dose today; Euphoria; Insomnia; This is a spontaneous report from a contactable other HCP (Nurse). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 3 via an unspecified route of administration on 02Sep2021 as DOSE 3, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation and dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The registered nurse calling as patient about Comirnaty who says he was trying to use the same reporting tool he used after he got the first two doses, since he got his third dose today on 02Sep2021, and was trying to report side effects. He says he reported it before, and he doesn't think it has been taken seriously at all basically, and he looked it up and hasn't seen any reporting of it anywhere. He said it sounds silly to say it, but his side effect was kind of like euphoria and insomnia in Sep2021, which was the main thing he has gotten from it, he got it and so did his father. Caller says that even if the amount of people these side effects occur in was point whatever or 0.1 percent, he thought it would be of some interest. Caller said after the one dose of the vaccine he had so much energy he hiked 7 miles. 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Abnormal menstrual cycle; This is a spontaneous report from a contactable consumer or other non HCP. This consumer   A 37-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unknown date (at the age of 37-years-old) as dose number unknown single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19. Patient was not pregnant at the time of vaccination. It was reported that on an unspecified date patient experienced abnormal menstrual cycle. It was unknown that patient received treatment. Outcome of event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered, Off label use, Pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported, Expiry Date: Unknown), dose 3 via an unspecified route of administration on an unspecified date as a DOSE 3, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a DOSE 1, SINGLE and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a DOSE 2, SINGLE both for covid-19 immunisation. No events reported after first and second dose. On an unspecified date, the patient experienced pfizer covid vaccine booster, the thirst shot (extra dose administered and off label use) on an unspecified date, injection site is swelling, and it feels I mean it is hot and it is itching a lot. Reporter stated, "What are you saying? Will I be able to talk to someone when I will call this number? So, they are not in at this time? There is no way there is anybody I can talk to them. I know it is not the giving timings now. I just need to know what I can do now if I am not going to do anything it will make matter worse." Reporter seriousness for the event was unspecified. Outcome of all the events were unknown. QR Comment: Reporter type could not be probed hence captured by default as Consumer or other non-health professional in tab. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered, Off label use, Pyrexia, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A patient, of unspecified age and gender, received the 3rd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# FF2888 and expiry date: unknown), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient previously took the first and second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection), on unspecified dates, for COVID-19 immunisation. Reportedly, patient got the booster shot and had a reaction to it, which the patient hasn't had before. The patient just wanted to know if it is one of the known reactions to the vaccination. On an unspecified date, patient experienced breaking out in hives and running a fever. When the patient got the first two because this is the third booster, patient never broke out in hives and just trying to find out if this is a side effect. The patient just woke up and had hives. The patient really wanted to know if it was normal. The patient received treatment for running a fever (pyrexia) with ibuprofen (stated as 200 mg each). The patient took two of them (400 mg total). Reporter seriousness for breaking out in hives and fever: unspecified; with outcome of unknown.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Lymphoedema, Off label use, Swelling
Clinical narrative: got the Pfizer booster; got the Pfizer booster; Lymphedema; Swelling; This is a spontaneous report from a non-contactable physician (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration, administered in arm on 21Aug2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included breast cancer (had a cancer diagnosis and had breast cancer and had gone through radiation), radiation/radiation therapy, surgery/one node that had been taken out and got a sentinel node, just one node biopsy for the 'surveillance notes' on the same arm. The patient's concomitant medications were not reported. Reportedly, the patient got the Pfizer booster on 21Aug2021 because the patient had a cancer diagnosis and had breast cancer and had gone through radiation. The patient was about to start a ARIMIDEX for oral chemotherapy and that's why the patient got the booster. So, after the patient got the injection, in 2021, the patient got swelling and then lymphedema which the patient didn't get before, even after surgery and after radiation therapy. The patient asked was that vaccine still effective because lymphedema lasted (the patient got the injection on 21Aug2021 and it was still, the swelling was just starting to go down, a little bit) and after speaking with the surgeon there was a question for the patient that the patient had, the patient did not have axillary node complete dissection, just had one node that had been taken out with no lymphedema noted after surgery (further clarification unknown). So, the patient especially being a physician, asked was the vaccine still effective when the patient got all that swelling. The patient had got a sentinel node, just one node biopsy for the 'surveillance notes' on the same arm and that was where the patient got the injection (further clarification unknown). So, the patient was trying to get advice. Outcome for swelling was recovering; lymphedema was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Long thoracic nerve palsy, Musculoskeletal discomfort, Neck pain
Clinical narrative: This is a spontaneous report from a contactable physician. A 42-year-old non pregnant female physician received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EK4176 and expiry date was not reported), via intramuscularly, in Arm Left, on 12Jan2021 at 11:00 AM (age at vaccination: 42-years-old), as dose 2 single for COVID-19 immunization. The patient's medical history included mild asthma. Concomitant medications included LO LOESTRIN FE. The patient was allergic to anesthetic. The patient did not receive any other vaccine within four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EK9231 and expiry date was not reported), via intramuscularly, in Arm right, on 22Dec2020 at 3:00 PM as dose 1 single for COVID-19 immunization. On 12Feb2021, the patient developed severe right neck/shoulder pain radiated to arm x1.5 weeks, then as pain subsided developed weakness of long thoracic nerve and anterior deltoid, EMG/NC study showed low amplitude of long thoracic nerve. The patient did not receive any treatment for adverse events. On an unspecified date, the patient underwent lab tests and procedure which included EMG/NC study showed low amplitude of long thoracic nerve and on 07Apr2021, the patient underwent SARS-CoV-2 test (Nasal Swab) which showed negative results. Outcome of the event was not recovered.  Follow-Up (10Sep2021): Follow-up attempts are completed. No further information is expected.