chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Nausea
Clinical narrative: nausea; flushing; This is a spontaneous report from a non-contactable Pharmacist.  A 22-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 03Jun2021 (Batch/Lot Number: ew0151) age at vaccination of 22-years-old, as single dose (dose number unknown), for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient was not pregnant and was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea on 03Jun2021 and flushing on 03Jun2021. Therapeutic measure was taken as a result of the events and included administration of Zofran. IT was unknown if patient had Covid prior vaccination nor if she was Covid tested post vaccination. The patient recovered from the event on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Body temperature, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; This is a spontaneous report from a contactable consumer. A 12-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation; dupilumab (DUPIXENT, Lot number was not reported) via subcutaneous route of administration from an unspecified date to an unspecified date, at 200 mg for severe persistent asthma. The patient medical history was not reported. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR HFA) taken for an unspecified indication, start and stop date were not reported. On an unspecified date the patient experienced fever. It was reported that on 31Aug2021, the patient developed a non-serious event missed dose (product dose omission issue) (unknown latency). It was not reported if the patient received a corrective treatment for the event. The patient underwent lab tests and procedures which included fever resulted as unknown, sars-cov-2 test resulted as unknown. The clinical outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Slight tingling in both calves when resting. Sensation goes away when moving.; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for himself that,  A 58-years-old male patient received bnt162b2 (BNT162B2, formulation solution for injection, Batch/Lot number was: 301458A) (at the age of 58 years old), dose 3 intramuscular, administered in deltoid right on 23Sep2021 09:00 as dose 3 (booster), single for covid-19 immunisation, historical vaccine, the patient took first dose bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EN6198, Expiration Date: Jun2021), dose 1 intramuscular, administered in left deltoid on 02Mar2021 as dose 1, single for covid-19 immunisation, historical vaccine, the patient took second dose bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EN6199, Expiration Date: Jun2021), dose 1 intramuscular, administered in right deltoid on 23Mar2021 as dose 2, single for covid-19 immunisation and influenza vaccine (FLU), intramuscular in left deltoid from 23Sep2021 (Batch/Lot number was not reported) to 23Sep2021, at UNK, single for immunisation. The patient medical history was not reported. There were no concomitant medications. It was reported that on 25Sep2021, patient experienced slight tingling in both calves when resting. Sensation went away when moving. No weakness or pain. This was actually third shot but that was not a choice on prior page. He did not experience any of those symptoms on prior two doses. Light tingling in both calves and both fore arms. Tingling was mild and transient. Sometimes just calves tingle, other times one or both fore arms tingles. Sometimes all limbs tingles. No rhymes or reason. Very transient. Becoming less apparent recently. Not received the treatment. The outcome for the event was recovering.  Follow-up attempts are completed. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pruritus, Psoriasis, Swelling, Urticaria
Clinical narrative: Total 15 Large hives/welts swelling itchy; Total 15 Large hives/welts swelling itchy; Total 15 Large hives/welts swelling itchy; 3 nickel size patches of psoriasis on right arm; Chills throughout; This is a spontaneous report received from a contactable consumer. This 62-year-old female consumer(patient) reported for herself that:  A 62-years-old non-pregnant female patient received bnt162b2 (BNT162B2, solution for Injection, lot Number was Fd8448) via intramuscular route of administration in arm left on 24Aug2021 13:00 (Age at vaccination: 62-years-old) as DOSE 2, SINGLE for covid-19 immunization. Patient had no known allergies. The patient other medical history includes excellent health. Concomitant medications were not reported. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient previously received bnt162b2 (BNT162B2, solution for Injection, lot Number was Fa7405) via unspecified route of administration on 01Aug2021 as DOSE 1, SINGLE for covid-19 immunization within 4 weeks of vaccination. On 21Sep2021 at 13:00 patient experienced total 15 large hives/welts swelling itchy started back of calf. Day 1  had 3 hives, Day 2-3 more on back thigh, 3 nickel size patches of psoriasis on right arm. Lasting week then fading after Avenno bath soaks and plenty water. Spread and got wet pustual at one point. Applied hydrocortisone cream. Psoriasis still present. Chills throughout. The clinical outcome of the event was recovering.   No follow-up attempts are possible; No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Musculoskeletal stiffness, Myalgia, Nausea
Clinical narrative: Rigors; Severe myalgias; Neck stiffness; Nausea; This is a spontaneous report from a contactable physician (patient) reported for herself. A 26-year-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 3 via an unspecified route of administration, administered in left arm on 29Sep2021 at 14:15 (at the age of 26-year-old) (Batch/Lot Number: PfizerFF8841) as dose 3 (booster), single for covid-19 immunisation and influenza vaccine (INFLUENZA), via an unspecified route of administration from 29Sep2021 (Batch/Lot number was not reported) to 29Sep2021, at unspecified dose for an unspecified indication. Medical history included ADD (attention deficit hyperactivity disorder), asthma and hypermobile ehlers danlos, all from an unknown date and unknown if ongoing. Patient previously took first dose and second dose of BNT162B2 on an unspecified date in 2021 for covid-19 immunisation. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), acetaminophen and bupropion, where all the medications were taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. On 30Sep2021 at 03:30 the patient experienced rigors, severe myalgias, neck stiffness and nausea. Patient did not receive any other vaccines within 4 weeks to the COVID vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. Patient did not receive treatment post onset of the event. Outcome of all the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Pfizer Covid 19: tender to his left arm/Pfizer Covid 19: minor pain to his left arm when he pressed on the area; Pfizer Covid 19: tender to his left arm/Pfizer Covid 19: minor pain to his left arm when he pressed on the area; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on an unspecified date as DOSE 1, SINGLE, dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation; influenza vaccine (FLU VACCINE VII), via an unspecified route of administration from 24Sep2021 (Batch/Lot number was not reported) to 24Sep2021, at DOSE NUMBER UNKNOWN, SINGLE for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced pfizer covid 19: tender to his left arm/pfizer COVID- 19: minor pain to his left arm when he pressed on the area.Stated that with the first two shots that it was tender but no pain unless he pressed on the area and then it was minor. Stated the Pfizer COVID 19 shot was to his left arm. Stated that the right arm is where he got the flu shot and both arms felt the same. Stated that he wanted to say thanks for providing the vaccine The outcome of event was unknown.  The lot number for the vaccine, BNT162B2 was not provided and will be requested during follow up.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Throat irritation, Vaccination failure
Clinical narrative: Covid + (PCR)/ breakthrough case; Covid + (PCR)/ breakthrough case; Scratchy throat; Initial case contained only non-serious Adverse Events (not fully processed yet), upon FU PRD/SRD 13Oct2021, events: Covid + (PCR) were reported as serious. FU PRD/SRD 13Oct2021 is considered as significant. This is a spontaneous report from a contactable consumer via Pfizer colleague. This consumer reported similar events for two patients. This is the first of two reports.  A 31-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm on 22Apr2021 (Lot Number: EP6955; Expiration Date: 30Jun2021), and dose 1 intramuscular, administered in Arm on 01Apr2021 (Lot Number: EP6955; Expiration Date: 30Jun2021); both as single doses (at the age of 30-years-old) for COVID-19 immunization. There were no medical history and no concomitant medications. The patient experienced COVID + (PCR) on 28Sep2021 and scratchy throat on an unspecified date in 2021 (Event took place after use of product). The patient had breakthrough case. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Sep2021. No treatment received. The outcome of the events COVID was recovered on an unspecified date, while for scratchy throat was unknown.  Follow-Up (26Oct2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101108291 same reporter and drug, different patients, similar events
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Breast swelling, Breast tenderness, Immunisation
Clinical narrative: Off-label use; Booster; Product use for unapproved combination; I am experiencing swelling and pain/tenderness at my armpit/breast; I am experiencing swelling and pain/tenderness at my armpit/breast; I am experiencing swelling and pain/tenderness at my armpit/breast; I am experiencing swelling and pain/tenderness at my armpit/breast; I am experiencing swelling and pain/tenderness at my armpit/breast; Lymph node swelling; I am experiencing swelling and pain/tenderness at my armpit/breast; This is a spontaneous report from a contactable consumer (patient).  A 34-years-old non pregnant female patient received third (Booster), dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: 30155BA and expiry date was not reported), via intramuscularly, in Arm Left on 30Sep2021 at 11:30 AM (At the age of 34-years-old), as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation and influenza vaccine (FLU VACCINE VII, lot number was not reported), via an unspecified route of administration in right arm, on 30Sep2021, at DOSE NUMBER UNKNOWN, SINGLE for an unspecified indication. The patient medical history included known allergy: Nons from an unknown date and unknown if ongoing Known. Patient was not pregnant at the time of vaccination Concomitant medications included levothyroxine and birth control taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. the patient was not diagnosed with COVID prior to vaccination. The patient was not tested for COVID-19 post vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL0142 and expiry date was not reported), via intramuscularly, in Arm Left on 05Jan2021 at 05:30 PM, as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9262 and expiry date was not reported), via intramuscularly, in Arm Left on 28Jan2021 at 05:30 PM, as dose 2, single for covid-19 immunisation. It was reported that patient had booster dose (off label use) and product use for unapproved combination (product use issue) on an unspecified date. It was reported that less than 48 hours of Pfizer booster on 02Oct2021 05:30 patient experiencing swelling and pain/tenderness at my armpit/breast on the side the vaccine was administered. Lymph node swelling. No Prolonged Hospitalization for events. It was unknown whether the patient receive any treatment for the events. The events were assessed as Non serious by reporter. The Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Off label use, Product use issue, Swelling, Tenderness
Clinical narrative: Off-label use; Booster; Product use for unapproved combination; I am experiencing swelling and pain/tenderness at my armpit/breast; I am experiencing swelling and pain/tenderness at my armpit/breast; I am experiencing swelling and pain/tenderness at my armpit/breast; I am experiencing swelling and pain/tenderness at my armpit/breast; I am experiencing swelling and pain/tenderness at my armpit/breast; Lymph node swelling; I am experiencing swelling and pain/tenderness at my armpit/breast; This is a spontaneous report from a contactable consumer (patient).  A 34-years-old non pregnant female patient received third (Booster), dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: 30155BA and expiry date was not reported), via intramuscularly, in Arm Left on 30Sep2021 at 11:30 AM (At the age of 34-years-old), as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation and influenza vaccine (FLU VACCINE VII, lot number was not reported), via an unspecified route of administration in right arm, on 30Sep2021, at DOSE NUMBER UNKNOWN, SINGLE for an unspecified indication. The patient medical history included known allergy: Nons from an unknown date and unknown if ongoing Known. Patient was not pregnant at the time of vaccination Concomitant medications included levothyroxine and birth control taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. the patient was not diagnosed with COVID prior to vaccination. The patient was not tested for COVID-19 post vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL0142 and expiry date was not reported), via intramuscularly, in Arm Left on 05Jan2021 at 05:30 PM, as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9262 and expiry date was not reported), via intramuscularly, in Arm Left on 28Jan2021 at 05:30 PM, as dose 2, single for covid-19 immunisation. It was reported that patient had booster dose (off label use) and product use for unapproved combination (product use issue) on an unspecified date. It was reported that less than 48 hours of Pfizer booster on 02Oct2021 05:30 patient experiencing swelling and pain/tenderness at my armpit/breast on the side the vaccine was administered. Lymph node swelling. No Prolonged Hospitalization for events. It was unknown whether the patient receive any treatment for the events. The events were assessed as Non serious by reporter. The Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Skin discolouration, Vaccination site pain, Vaccination site warmth
Clinical narrative: booster dose for the patient on 27Sep2021; booster dose for the patient on 27Sep2021; warm sensations at and near injection site and pain; warm sensations at and near injection site and pain; Little small blisters and purple skin color developed near right above injection site area the evening of and the next day; Little small blisters and purple skin color developed near right above injection site area the evening of and the next day; This is a spontaneous report from a contactable pharmacist. A 67-year-old non-pregnant female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FC3181), via intramuscular route of administration in right arm on 27Sep2021 at 11:00 (at the age of 67 years old, not pregnant at the time of vaccination) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE), via an unspecified route of administration in left arm from 27Sep2021 (Batch/Lot Number: UJ768AA) to 27Sep2021, at DOSE NUMBER UNKNOWN, SINGLE for influenza immunization. The patient medical history and concomitant medications were not reported. The patient had no known allergies. Historical vaccine included first dose of BNT162B2 on 05Feb2021 and second dose on 26Feb2021 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. Since the vaccination, the patient hasn't been tested for COVID-19. On 28Sep2021 patient experienced warm sensations at and near injection site and pain. Little small blisters and purple skin color developed near right above injection site area the evening of and the next day. It was a booster dose for the patient on 27Sep2021. Patient previously received 1st and 2nd dose on 05Feb2021 and 26Feb2021 respectively. Therapeutic measures were taken as a result of warm sensations at and near injection site and pain, little small blisters and purple skin color developed near right above injection site area the evening of and the next day with oral Antibiotic Clindamycin 300mg and Topical Mupirocin 2% Oint. The events resulted in doctor or other healthcare professional office/clinic visit. No prolonged hospitalization required. Reporter considered events as non-serious. The action taken in response to the events for influenza vaccine inact split 3v was not applicable. The outcome of evens was unknown.  Follow-Up (06Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Oral mucosal blistering, Product use issue, SARS-CoV-2 test
Clinical narrative: oral blisters/sores mainly on tongue; oral blisters/sores mainly on tongue; 12Sep2021: Fluzone Quad/ 12Sep2021: Pfizer; This is a spontaneous report from a contactable consumer (patient herself). A 29-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: FE3590; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 03Oct2021 11:30 (at the age of 29-years-old) as DOSE 2, SINGLE and patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: 301308A; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 12Sep2021 11:30 (at the age of 29-years-old) as DOSE 1, SINGLE both for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient had also received the influenza vaccine inact split 4v (FLUZONE QUADRIVALENT), via an unspecified route of administration on 12Sep2021 (Batch/Lot number was not reported) as a SINGLE DOSE for immunization. Medical history included COVID-19 from Jan2021 to an unspecified date. Other medical history: COVID-19 at beginning of third trimester of pregnancy in January 2021. Severe preeclampsia resulting in hospitalization, emergency c-section 3 months early. There were no concomitant medications. Patient had not any known allergies. Patient did not any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. The patient experienced oral blisters/sores mainly on tongue (oral mucosal blistering and glossodynia) on 12Sep2021 14:30. On same day patient had 12sep2021: fluzone quad/ 12sep2021: pfizer (product use issue). Patient did not receive any treatment for adverse event. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on Jan2021. Since the vaccination, patient has not been tested for COVID-19. The outcome of events oral blisters/sores mainly on tongue was recovered with sequelae.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Lymphadenopathy, Pain, Product use issue, Swelling
Clinical narrative: a lymph node just above left collarbone swelled up to the size of a nickel,swollen lymph nodes; The area was painful without being touched; swelling; Patient has taken BNT162B2 along with Flu vaccination on 02Oct2021; Patient received BNT162B2 vaccine on Leg Left; This is a spontaneous report received from a non-contactable consumer (patient) reported for self. A 45-years-old non-pregnant female patient received third dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: 30145BA), via an unspecified route of administration, administered in Leg Left on 02Oct2021 16:00PM as DOSE 3, SINGLE (at the age of 45) for covid-19 immunization (Pharmacy or Drug Store); influenza vaccine (FLU VACCINE VII, Batch/Lot number was not reported), via an unspecified route of administration on 02Oct2021 as DOSE 1, SINGLE for influenza immunization. Medical history included seasonal allergies and allergies to latex from an unknown date and unknown if ongoing. The patients concomitant medications were not reported. Patient was not having covid prior vaccination and not been tested covid post vaccination. Patient was not taken any other vaccine in four weeks and was not pregnant at the time of vaccination. Historical vaccine included BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK5730) via an unspecified route of administration, administered in Left arm on 27Dec2020 as DOSE 1, SINGLE, dose 2 BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK5730) via an unspecified route of administration, administered in Left arm on 18Jan2021as DOSE 2, SINGLE (at the age of 44) for covid-19 immunization. The patient experienced that a lymph node just above my left collarbone swelled up to the size of a nickel, swollen lymph nodes, the area was painful without being touched and swelling all on 03Oct2021 16:15 PM. Patient has taken BNT162B2 along with Flu vaccination and patient received BNT162B2 vaccine on leg left on 02Oct2021. The patient has received any treatments for the events a lymph node just above left collarbone swelled up to the size of a nickel, swollen lymph nodes, area was painful without being touched and swelling. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Immunisation, Off label use
Clinical narrative: Off label use; Booster; Headache; Dizziness; Feeling off; I feel abnormal off; I am just feeling really bad; This is a spontaneous report from a contactable consumer (Patient). A 68-year-old male patient received received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EW0179 and Expiration date was not reported), dose 3, via an intramuscular route of administration, on 01Oct2021 (age at vaccination was 68 years) as dose 3 (booster), single for COVID-19 immunization; LAMOTRIGINE via an unspecified route of administration on an unspecified date (Dose: 325 mg, Batch/Lot number was not reported) for an unspecified indication. The patient medical history included Bipolar disorder, High blood pressure and Hiatus hernia from an unknown date and unknown if ongoing. The concomitant included Prevacid. Historical vaccines included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiry Date were not provided), via an unspecified route of administration, on an unspecified date as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiry Date were not provided), via an unspecified route of administration, on an unspecified date as dose 2, single for COVID-19 immunization. Reporter stated, was 2 thing actually, for 2 different people yesterday, he had the booster shot and afterwards and today he experienced headache and some dizziness and feeling off and then he woke up today and after about an hour he was having the same reaction. The reporter stated that, the same reaction the headache was mild with milder headache okay he was sort of little dizzy and he felt abnormal off okay. Patient did not receive any treatment for the events.The outcome of events eadache and Dizziness was unknown and for remaining event was not recovered. Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Disorientation, Dizziness, Fatigue, Vertigo
Clinical narrative: Off label use; Booster; Headache; Dizziness; Feeling off; I feel abnormal off; I am just feeling really bad; This is a spontaneous report from a contactable consumer (Patient). A 68-year-old male patient received received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EW0179 and Expiration date was not reported), dose 3, via an intramuscular route of administration, on 01Oct2021 (age at vaccination was 68 years) as dose 3 (booster), single for COVID-19 immunization; LAMOTRIGINE via an unspecified route of administration on an unspecified date (Dose: 325 mg, Batch/Lot number was not reported) for an unspecified indication. The patient medical history included Bipolar disorder, High blood pressure and Hiatus hernia from an unknown date and unknown if ongoing. The concomitant included Prevacid. Historical vaccines included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiry Date were not provided), via an unspecified route of administration, on an unspecified date as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiry Date were not provided), via an unspecified route of administration, on an unspecified date as dose 2, single for COVID-19 immunization. Reporter stated, was 2 thing actually, for 2 different people yesterday, he had the booster shot and afterwards and today he experienced headache and some dizziness and feeling off and then he woke up today and after about an hour he was having the same reaction. The reporter stated that, the same reaction the headache was mild with milder headache okay he was sort of little dizzy and he felt abnormal off okay. Patient did not receive any treatment for the events.The outcome of events eadache and Dizziness was unknown and for remaining event was not recovered. Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Axillary pain, Swelling
Clinical narrative: I have swollen under my left armpit and very painful to touch, it makes it hard to do lay on left side or do anything with my left arm; I have swollen under my left armpit and very painful to touch, it makes it hard to do lay on left side or do anything with my left arm; This is a spontaneous report from a contactable nurse (patient). A 36-year-old non-pregnant female patient had received second dose bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: 30155BA) via an unspecified route of administration into arm left (at age of 36 year) on unspecified date as DOSE 2, SINGLE for covid-19 immunization. The patient medical history had included allergies for Penicillin, gluten, egg and latex. The patient concomitant medication had included Cetrizine hydrochloride (Zyrtec) for unknown indication and Diphenhydramine (Benadryl ) for unknown indication. It was reported that patient was not pregnant at the time of vaccination. Patient did not received any vaccination within 4 weeks prior to vaccination. The patient was not diagnosed with COVID-19 Prior to vaccination and Since the vaccination, the patient had not been tested for COVID-19. The patient previously took first dose bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: FD0809) via an unspecified route of administration into arm left on unspecified date as DOSE 1, SINGLE for covid-19 immunization.On 03Oct2021;03:00 the patient had experienced swollen under the left armpit and very painful to touch, it makes it hard to do lay on left side or do anything with the left arm. The clinical outcome of the events were not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Nausea
Clinical narrative: migraine headache; fatigue; nausea; 56 y/o male received Comirnaty booster vaccine the evening of 01Oct2021; 56 y/o male received Comirnaty booster vaccine the evening of 01Oct2021; This is a spontaneous report from a Non-contactable consumer (patient). A 56-years-old male patient received third dose of BNT162b2 (COMIRNATY, solution for injection, Lot Number: 30145BA), via an unspecified route on 01Oct2021 (at the age of 56-years) as dose 3 (booster), single for covid-19 immunisation. The patient medical history included migraine headaches. The patient concomitant medications were not reported. Patient previously received first dose BNT162b2 (COMIRNATY, solution for injection, Lot Number: unknown), via an unspecified route on unspecified date (at the age of 56-years) as dose 1, single and second dose BNT162b2 (COMIRNATY, solution for injection, Lot Number: unknown), via an unspecified route on 08Jan2021 (at the age of 56-years) as dose 2, single for covid-19 immunisation experienced migraine headaches. Patient received Comirnaty booster vaccine the evening of 01Oct2021. The patient experienced a classic migraine headache with fatigue and nausea on 02Oct2021. Patient took sumatriptan 50 mg PO and slept an additional 3 hours mid-day on 02Oct2021, with immediate resolution of all of these symptoms upon awakening. He had a long history of migraine headaches and experienced the same symptoms after dose # 2 of the Pfizer-BioNTech COVID-19 vaccine on 08Jan2021, however that time the migraine, fatigue and nausea persisted intermittently over 2 days before they completely resolved. The outcome of the events migraine headache with fatigue and nausea was resolved on 02Oct2021.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Heart rate increased, Hypotension, Influenza like illness
Clinical narrative: Very high heart rate/ heart beating very fast around 160bpm.; Blood pressure did also drop very low a few times; had the common flu like symptoms; Is Pregnant: Yes; This is a spontaneous report from a contactable consumer. This 31-year-old female consumer (patient) reported for herself that: A 31-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: 301308A), via an unspecified route of administration, administered in right arm on 01Oct2021 13:00 as DOSE 2, SINGLE and dose 1 received via an unspecified route of administration, administered in right arm on 10Sep2021 13:00 (Lot Number: FF8841) as DOSE 1, SINGLE both doses taken for COVID-19 immunization (at the age of 31-year-old). Medical history included allergies: Sulfa and allergies: Bee stings (honey bee, yellow jacket, wasps) from an unknown date and unknown if ongoing. Concomitant medications included aspirin [acetylsalicylic acid], cetirizine hydrochloride (ZYRTEC) and iron. The patient previously took amoxicillin and experienced allergies: amoxicillin. No other vaccines within 4 weeks prior to the COVID vaccine. Patient received following medications within 2 weeks of vaccination: Prenatal Vitamin, Low Dose Aspirin, Zyrtec, Iron. The patient did not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since the vaccination. On 01Oct2021 23:00 after the second dose of vaccination, the patient experienced very high heart rate/ heart beating very fast around 160bpm, blood pressure did also drop very low a few times, had the common flu like symptoms and patient was pregnant. Seriousness of the events reported as non-serious. The patient did not receive any treatment for events. The mother reported she became pregnant while taking bnt162b2. The mother was 29 Weeks pregnant at the onset of the event. The mother was due to deliver on 13Dec2021. On 01Oct2021, the patient underwent lab tests and procedures which included blood pressure: very low, heart rate: 160 bpm (High). On 03Oct2021, heart rate: little higher than normal. The patient required to visit physician office, and not hospitalization prolonged. The outcome of the events was recovering.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Very high heart rate/ heart beating very fast around 160bpm.; Blood pressure did also drop very low a few times; had the common flu like symptoms; Is Pregnant: Yes; This is a spontaneous report from a contactable consumer. This 31-year-old female consumer (patient) reported for herself that: A 31-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: 301308A), via an unspecified route of administration, administered in right arm on 01Oct2021 13:00 as DOSE 2, SINGLE and dose 1 received via an unspecified route of administration, administered in right arm on 10Sep2021 13:00 (Lot Number: FF8841) as DOSE 1, SINGLE both doses taken for COVID-19 immunization (at the age of 31-year-old). Medical history included allergies: Sulfa and allergies: Bee stings (honey bee, yellow jacket, wasps) from an unknown date and unknown if ongoing. Concomitant medications included aspirin [acetylsalicylic acid], cetirizine hydrochloride (ZYRTEC) and iron. The patient previously took amoxicillin and experienced allergies: amoxicillin. No other vaccines within 4 weeks prior to the COVID vaccine. Patient received following medications within 2 weeks of vaccination: Prenatal Vitamin, Low Dose Aspirin, Zyrtec, Iron. The patient did not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since the vaccination. On 01Oct2021 23:00 after the second dose of vaccination, the patient experienced very high heart rate/ heart beating very fast around 160bpm, blood pressure did also drop very low a few times, had the common flu like symptoms and patient was pregnant. Seriousness of the events reported as non-serious. The patient did not receive any treatment for events. The mother reported she became pregnant while taking bnt162b2. The mother was 29 Weeks pregnant at the onset of the event. The mother was due to deliver on 13Dec2021. On 01Oct2021, the patient underwent lab tests and procedures which included blood pressure: very low, heart rate: 160 bpm (High). On 03Oct2021, heart rate: little higher than normal. The patient required to visit physician office, and not hospitalization prolonged. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Hypotension
Clinical narrative: very dizzy since this morning, couldn''t get up from the bed; blood pressure is very low; This is a spontaneous case received from a contactable consumer (patient). A female patient of unspecified age received third dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration, administered on 30Sep2021 as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose and second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration, administered on an unspecified date for COVID-19 immunization. On an unspecified date in 2021, the patient reported that she was very dizzy since morning and could not get up from her bed and her blood pressure is very low. The patient underwent lab tests and procedures which included blood pressure: blood pressure is very low on an unspecified date in 2021. The outcome of the event very dizzy since this morning and could not get up from her bed was not recovered and event (hypotension) was unknown.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Headache, Nasal congestion
Clinical narrative: Dose 3 of BNT162B2 and Infuenza vaccine on same date; Dose 3 of BNT162B2 and Infuenza vaccine on same date; Sore Left arm; headache; tiredness; sneezing; congestion; dry cough; low grade fever; chills; coughing turned slightly productive; This is a spontaneous report from a non-contactable physician (patient). A 62-years-old male patient received booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0161), via an unspecified route of administration, administered in left arm on 27Sep2021 (at the age of 62 years) as dose 3 (booster), single for COVID-19 immunization; and influenza vaccine inact split 4v (AFLURIA QUADRIVALENT) (Lot Number: P100350391), via an unspecified route of administration on right arm on 27Sep2021 as dose 1, single for immunisation. Medical history included hypertension, and secondary glaucoma L-eye, both from an unknown date and unknown if ongoing. Patient had corneal transplant - L eye on an unknown date. Concomitant medications received within two weeks of vaccination included losartan; timolol maleate (TIMOPTIC); and prednisolone (ophthalmic), all taken for an unspecified indication, start and stop date were not reported. Patient previously took first dose of bnt162b2 (Lot number: EK9231) on 23Dec2020 as dose 1, single and second dose of bnt162b2 (Lot number: EK4176) on 13Jan2021 as dose 2, single, both via an unspecified route of administration, administered in left arm, for COVID-19 immunization. Patient had no known allergies. No other vaccine in four weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Sep2021, the patient experienced sore Left arm for first 24 hours of vaccination. About 24 hours after dose, patient experienced headache, tiredness, sneezing, congestion, and dry cough. Then after 24-48 hours, patient had low grade fever and chills. After 48-72 hours, patient had coughing turned slightly productive, sneezing, and congestion, Dose 3 of BNT162B2 and Infuenza vaccine on same date on 27Sep2021. It was reported that, all the symptoms essentially resolved after 96 hours from dose. Patient did not received any treatment for events. The outcome of all the events were recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Pain in extremity, Product use issue, Productive cough, Pyrexia
Clinical narrative: Dose 3 of BNT162B2 and Infuenza vaccine on same date; Dose 3 of BNT162B2 and Infuenza vaccine on same date; Sore Left arm; headache; tiredness; sneezing; congestion; dry cough; low grade fever; chills; coughing turned slightly productive; This is a spontaneous report from a non-contactable physician (patient). A 62-years-old male patient received booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0161), via an unspecified route of administration, administered in left arm on 27Sep2021 (at the age of 62 years) as dose 3 (booster), single for COVID-19 immunization; and influenza vaccine inact split 4v (AFLURIA QUADRIVALENT) (Lot Number: P100350391), via an unspecified route of administration on right arm on 27Sep2021 as dose 1, single for immunisation. Medical history included hypertension, and secondary glaucoma L-eye, both from an unknown date and unknown if ongoing. Patient had corneal transplant - L eye on an unknown date. Concomitant medications received within two weeks of vaccination included losartan; timolol maleate (TIMOPTIC); and prednisolone (ophthalmic), all taken for an unspecified indication, start and stop date were not reported. Patient previously took first dose of bnt162b2 (Lot number: EK9231) on 23Dec2020 as dose 1, single and second dose of bnt162b2 (Lot number: EK4176) on 13Jan2021 as dose 2, single, both via an unspecified route of administration, administered in left arm, for COVID-19 immunization. Patient had no known allergies. No other vaccine in four weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Sep2021, the patient experienced sore Left arm for first 24 hours of vaccination. About 24 hours after dose, patient experienced headache, tiredness, sneezing, congestion, and dry cough. Then after 24-48 hours, patient had low grade fever and chills. After 48-72 hours, patient had coughing turned slightly productive, sneezing, and congestion, Dose 3 of BNT162B2 and Infuenza vaccine on same date on 27Sep2021. It was reported that, all the symptoms essentially resolved after 96 hours from dose. Patient did not received any treatment for events. The outcome of all the events were recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: Dose 3 of BNT162B2 and Infuenza vaccine on same date; Dose 3 of BNT162B2 and Infuenza vaccine on same date; Sore Left arm; headache; tiredness; sneezing; congestion; dry cough; low grade fever; chills; coughing turned slightly productive; This is a spontaneous report from a non-contactable physician (patient). A 62-years-old male patient received booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0161), via an unspecified route of administration, administered in left arm on 27Sep2021 (at the age of 62 years) as dose 3 (booster), single for COVID-19 immunization; and influenza vaccine inact split 4v (AFLURIA QUADRIVALENT) (Lot Number: P100350391), via an unspecified route of administration on right arm on 27Sep2021 as dose 1, single for immunisation. Medical history included hypertension, and secondary glaucoma L-eye, both from an unknown date and unknown if ongoing. Patient had corneal transplant - L eye on an unknown date. Concomitant medications received within two weeks of vaccination included losartan; timolol maleate (TIMOPTIC); and prednisolone (ophthalmic), all taken for an unspecified indication, start and stop date were not reported. Patient previously took first dose of bnt162b2 (Lot number: EK9231) on 23Dec2020 as dose 1, single and second dose of bnt162b2 (Lot number: EK4176) on 13Jan2021 as dose 2, single, both via an unspecified route of administration, administered in left arm, for COVID-19 immunization. Patient had no known allergies. No other vaccine in four weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Sep2021, the patient experienced sore Left arm for first 24 hours of vaccination. About 24 hours after dose, patient experienced headache, tiredness, sneezing, congestion, and dry cough. Then after 24-48 hours, patient had low grade fever and chills. After 48-72 hours, patient had coughing turned slightly productive, sneezing, and congestion, Dose 3 of BNT162B2 and Infuenza vaccine on same date on 27Sep2021. It was reported that, all the symptoms essentially resolved after 96 hours from dose. Patient did not received any treatment for events. The outcome of all the events were recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 83-years-old patient of an unspecified gender received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, batch or lot number was not reported) via an unspecified route of administration on 24Sep2021 as dose 3, booster, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, batch or lot number was not reported) via an unspecified route of administration on unspecified date in 2021 (at the age of 83 years) as, single dose for covid 19 immunization. On 26Sep2021, two days later, the patient experienced one episode of diarrhea and next one was a loose stool. Patient stated small side effect of the third booster shot. Consumer stated that patient got third extra strong booster shot on the 24th of September when patient was 83. Two days later patient had one episode of diarrhea and the next one was a loose stool. The outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.