chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, Dysgeusia, Hypersensitivity
Clinical narrative: Metal taste after 2nd vaccine; my mouth tongue throat nose gums were numb; my mouth tongue throat nose gums were numb; allergic reaction to COVID-19 vaccine; felt like my throat was closing; I have no taste or smell; I have no taste or smell; Right hand wrist turned red itchy burning; Right hand wrist turned red itchy burning; my mouth tongue throat nose gums were numb; This is a spontaneous report from a contactable consumer or other non hcp. A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EP7533), dose 2 via an unspecified route of administration, administered in Arm Right on 04Apr2021 as dose 2, single (age at vaccination 64-year-old) for covid-19 immunisation. Medical history included asthma, Penicillin Allergy from an unknown date. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination. other medications taken in two weeks. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on 14Jan2021 (age at vaccination 64-year-old), administration site (Right arm), administered at 01:00 PM, lot number EN6208 for COVID-19 Immunization and experienced Metal taste after 1st vaccine lasted 4/5. The patient experienced metal taste after 2nd vaccine, my mouth tongue throat nose gums were numb, felt like my throat was closing, i have no taste or smell, right hand wrist turned red itchy burning and allergic reaction to COVID-19 vaccine on 04Apr2021 13:00. It was reported that Metal taste after 1st vaccine lasted 4/5 Days Metal taste after 2nd vaccine within 30 minutes her mouth tongue throat nose gums were numb felt like her throat was closing, she had no taste or smell Right hand wrist turned red itchy burning Went to ER received Prednisone and Benadryl. Discharge papers state allergic reaction to COVID-19 vaccine 04May21 Still have symptoms. Therapeutic measures were taken as a result of events includes Prednisone and Benadryl. The outcome for all events was recovering.   No follow up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021372991 same patient, different vaccine dose, partial same event
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Pharyngeal hypoaesthesia, Rash pruritic, Throat tightness
Clinical narrative: Metal taste after 2nd vaccine; my mouth tongue throat nose gums were numb; my mouth tongue throat nose gums were numb; allergic reaction to COVID-19 vaccine; felt like my throat was closing; I have no taste or smell; I have no taste or smell; Right hand wrist turned red itchy burning; Right hand wrist turned red itchy burning; my mouth tongue throat nose gums were numb; This is a spontaneous report from a contactable consumer or other non hcp. A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EP7533), dose 2 via an unspecified route of administration, administered in Arm Right on 04Apr2021 as dose 2, single (age at vaccination 64-year-old) for covid-19 immunisation. Medical history included asthma, Penicillin Allergy from an unknown date. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination. other medications taken in two weeks. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on 14Jan2021 (age at vaccination 64-year-old), administration site (Right arm), administered at 01:00 PM, lot number EN6208 for COVID-19 Immunization and experienced Metal taste after 1st vaccine lasted 4/5. The patient experienced metal taste after 2nd vaccine, my mouth tongue throat nose gums were numb, felt like my throat was closing, i have no taste or smell, right hand wrist turned red itchy burning and allergic reaction to COVID-19 vaccine on 04Apr2021 13:00. It was reported that Metal taste after 1st vaccine lasted 4/5 Days Metal taste after 2nd vaccine within 30 minutes her mouth tongue throat nose gums were numb felt like her throat was closing, she had no taste or smell Right hand wrist turned red itchy burning Went to ER received Prednisone and Benadryl. Discharge papers state allergic reaction to COVID-19 vaccine 04May21 Still have symptoms. Therapeutic measures were taken as a result of events includes Prednisone and Benadryl. The outcome for all events was recovering.   No follow up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021372991 same patient, different vaccine dose, partial same event
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Facial numbness on the right side of the face; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 49-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: E78732, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 28Mar2021 (age at vaccination was 49 years) as dose 1, single for COVID-19 immunization. The patient's medical history included ongoing diabetes mellitus from 2007, blood pressure high, obesity and heart problems. Concomitant medications included canagliflozin (INVOKANA [CANAGLIFLOZIN]), sitagliptin (JANUVIA [SITAGLIPTIN]) and pioglitazone (PIOGLITAZONE) all taken for an unspecified indication. On 28Mar2021, about 30 minutes after receiving the vaccine, the patient ended up getting facial numbness on the right side of the face and it had not gone away way yet. The patient asked if that was normal. The due date of second shot was reported as 18Apr2021. The outcome of the event was not resolved.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: experienced numbness in her mouth that subsided after about 1 hour; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Formulation: Solution for injection, Lot number: ER8733), via an unspecified route of administration on 01Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included food allergy and takes immunosuppressive medicine. The patient concomitant medication was not reported. The patient experienced numbness in her mouth that subsided after about 1 hour on 01Apr2021. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Body temperature, Cardiac disorder, Chills
Clinical narrative: Periodic heart breaking; Shortness of breath; Heartbeat is racing; Fever is 99.1 to 102.9 °F; Soreness of joint/feeling soreness in her joint; Pain at injection site of vaccine; Headache; Chills; Loss of appetite/does not have an appetite to eat; Feeling tired, tired all over her body; Not feeling well; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 52-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER2613; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in Arm Right on 30Mar2021 (at the age of 52-year-old) as dose 2, single for covid-19 immunization. Medical history included asthma, COPD, Acid reflux, narcolepsy, seizures and sinus tachycardia from an unknown date and unknown if ongoing. Concomitant medications included metoprolol (formulation: Tablet, strength: 25 mg) taken for sinus tachycardia and Multivitamin taken for an unspecified indication start and stop dates were not reported. Historical vaccine included that patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number was not reported), via an unspecified route of administration on 09Mar2021 (at the age of 52-year-old) as dose 1, single for covid-19 immunization. The patient reported after having second dose she had shortness of breath, and fever, the fever was 99.1 to 102.9 fahrenheit and she had also experienced periodic heartbreaking and her heartbeat was racing and she was feeling soreness in her joint, she was feeling tired, tired all over her body and she also experience chills, headache, pain at injection site of vaccine she was not nauseated but she does not have an appetite to eat. She added, she had other medications that she normally takes but she had not taken them since she was not feeling well, she do not want to risk more issues. She takes medication for asthma, COPD, seizures, reflux, and narcolepsy. She had not taken any meds today; she took meds all yesterday, so she stopped all meds (unspecified Medications) today so that she do not have any interaction. Patient was drinking coffee and staying in bed. The patient underwent lab tests and procedures which included blood test 2 weeks ago, on an unspecified date in Feb2021 before the COVID shot and COVID test done in last month on an unspecified date in Feb2021. The outcome of all events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dyspnoea, Fatigue, Headache, Malaise
Clinical narrative: Periodic heart breaking; Shortness of breath; Heartbeat is racing; Fever is 99.1 to 102.9 °F; Soreness of joint/feeling soreness in her joint; Pain at injection site of vaccine; Headache; Chills; Loss of appetite/does not have an appetite to eat; Feeling tired, tired all over her body; Not feeling well; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 52-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER2613; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in Arm Right on 30Mar2021 (at the age of 52-year-old) as dose 2, single for covid-19 immunization. Medical history included asthma, COPD, Acid reflux, narcolepsy, seizures and sinus tachycardia from an unknown date and unknown if ongoing. Concomitant medications included metoprolol (formulation: Tablet, strength: 25 mg) taken for sinus tachycardia and Multivitamin taken for an unspecified indication start and stop dates were not reported. Historical vaccine included that patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number was not reported), via an unspecified route of administration on 09Mar2021 (at the age of 52-year-old) as dose 1, single for covid-19 immunization. The patient reported after having second dose she had shortness of breath, and fever, the fever was 99.1 to 102.9 fahrenheit and she had also experienced periodic heartbreaking and her heartbeat was racing and she was feeling soreness in her joint, she was feeling tired, tired all over her body and she also experience chills, headache, pain at injection site of vaccine she was not nauseated but she does not have an appetite to eat. She added, she had other medications that she normally takes but she had not taken them since she was not feeling well, she do not want to risk more issues. She takes medication for asthma, COPD, seizures, reflux, and narcolepsy. She had not taken any meds today; she took meds all yesterday, so she stopped all meds (unspecified Medications) today so that she do not have any interaction. Patient was drinking coffee and staying in bed. The patient underwent lab tests and procedures which included blood test 2 weeks ago, on an unspecified date in Feb2021 before the COVID shot and COVID test done in last month on an unspecified date in Feb2021. The outcome of all events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Periodic heart breaking; Shortness of breath; Heartbeat is racing; Fever is 99.1 to 102.9 °F; Soreness of joint/feeling soreness in her joint; Pain at injection site of vaccine; Headache; Chills; Loss of appetite/does not have an appetite to eat; Feeling tired, tired all over her body; Not feeling well; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 52-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER2613; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in Arm Right on 30Mar2021 (at the age of 52-year-old) as dose 2, single for covid-19 immunization. Medical history included asthma, COPD, Acid reflux, narcolepsy, seizures and sinus tachycardia from an unknown date and unknown if ongoing. Concomitant medications included metoprolol (formulation: Tablet, strength: 25 mg) taken for sinus tachycardia and Multivitamin taken for an unspecified indication start and stop dates were not reported. Historical vaccine included that patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number was not reported), via an unspecified route of administration on 09Mar2021 (at the age of 52-year-old) as dose 1, single for covid-19 immunization. The patient reported after having second dose she had shortness of breath, and fever, the fever was 99.1 to 102.9 fahrenheit and she had also experienced periodic heartbreaking and her heartbeat was racing and she was feeling soreness in her joint, she was feeling tired, tired all over her body and she also experience chills, headache, pain at injection site of vaccine she was not nauseated but she does not have an appetite to eat. She added, she had other medications that she normally takes but she had not taken them since she was not feeling well, she do not want to risk more issues. She takes medication for asthma, COPD, seizures, reflux, and narcolepsy. She had not taken any meds today; she took meds all yesterday, so she stopped all meds (unspecified Medications) today so that she do not have any interaction. Patient was drinking coffee and staying in bed. The patient underwent lab tests and procedures which included blood test 2 weeks ago, on an unspecified date in Feb2021 before the COVID shot and COVID test done in last month on an unspecified date in Feb2021. The outcome of all events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP. A (non-pregnant) female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date in Mar 2021, single dose, for COVID-19 immunization. It was unknown prior to vaccination, if the patient diagnosed with COVID-19 or not. The patient's medical history and concomitant medications not reported. Reason why batch/lot is unknown: it was not available/provided to reporter at the time of report completion. Facility where the most recent COVID-19 vaccine was administered: unknown. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever and chills on an unspecified date in Mar 2021. It was unknown if treatment was received for the adverse events. It was unknown if since the vaccination, the patient tested for COVID-19. The outcome of the events: resolved on an unspecified date in 2021. No follow-up attempts needed. Information about lot/batch number cannot be obtained.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Heart rate at 150 for the whole day and next day following first vaccination injection; This is a spontaneous report from a contactable consumer (patient). A 21-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 16Mar2021 at 08:00 (age at vaccination 21-years-old) as DOSE 1, SINGLE for covid-19 immunization. Facility type of vaccine was at a hospital. Medical history included covid-19 from an unknown date and unknown if ongoing (If covid prior vaccination: yes). The patient's concomitant medications were not reported. If other vaccine in four weeks reported as no. Covid tested post vaccination was reported as no. On 16Mar2021, the patient experienced heart rate at 150 for the whole day and next day following first vaccination injection. The event did not result in emergency room/ physician office visit. The patient underwent lab tests and procedures which included heart rate which showed 150 on 16Mar2021. The patient was not treated for the event. The outcome of the event was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Rosacea
Clinical narrative: Rosacea flared up; face turning red and burning/severe redness; face turning red and burning/burning my cheeks; This is a spontaneous report from a contactable consumer (patient). A 62-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 10:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for Covid-19 immunisation at Hospital. Medical history included ongoing Rosacea and Known allergies: sulfa and sulfur from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took dose 1 of BNT162B2 as single dose for covid-19 immunisation on 23Feb2021. There were no other vaccine in four weeks and no other medications in two weeks. There was no Covid prior vaccination and patient did not tested Covid post vaccination. The patient experienced Rosacea flared up, Face turning red and burning my cheeks, burning/severe redness on 23Mar2021 about a week later after vaccine second dose. Stated it was pretty upsetting because she had it under control. Patient went to her general doctor to see if the vaccine affected my biome or the bacteria in my system; she said try a probiotic for a month. AE resulted in: Doctor or other healthcare professional office/clinic visit. Treatment was received for adverse events (AE). AE treatment was topical cream, probiotic. The outcome of events was not recovered.  Batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: fever; intense headache; This is a spontaneous report from a contactable consumer (patient), or other non-HCP reported for herself. A 61-years-old female patient received second dose of bnt162b2 (BNT162B2; Solution for injection), via an unspecified route of administration and on an unspecified date as dose 2, single for covid-19 immunisation (age at vaccination 61-years-old). The patient medical history and Concomitant medications were not reported. The patient experienced fever and intense headache on an unspecified date. She took Tylenol to manage the symptoms. She mentioned she did not talk to safety yet. Consumer would like to know if she is protected from the COVID19 virus as she would need her hair done 11 days after completing the dose. She mentioned that someone told her that it takes 14 days for someone to be protected after completing the vaccination series. She mentioned that she would be wearing an N95 mask when she does this activity. Response: Affirming to consumer's safety precaution of still wearing N95 mask even after completing the vaccination series." At the time of this report, outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: fever; headache; This is a spontaneous report received from a consumer(patient). A 56-Years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and Expiry Date were not reported) dose 1, via on an unspecified route on 22Mar2021 as DOSE 1, SINGLE for COVID-19 Immunization (at the age of 56-Years-Old). Medical history included Leukaemia and Lymphoma on an unknown date. The concomitant medications were not reported. It was reported, is it normal to have fever of 99 degrees and headache for 2 weeks after the first Pfizer covid-19 vaccine. And asked what is the incidence of these and how long do they last and are side effects worse with the second injection and this male consumer reported receiving his first injection of the Pfizer covid-19 vaccine about two weeks ago. Ever since the injection, he had been experiencing headaches every day and fever off and on. The consumer has a history of leukaemia and lymphoma and is being treated with Imbruvica. The consumer also takes hydrocodone as well as some other unspecified medications and that he's not sure if that's part of the side effects that he is experiencing or not. Caller reported that he was told not to take Aleve, so he has been taking Tylenol for his headache and also doesn't last all day, but that most of the day he has a headache even if he takes Tylenol and also stated, he did not want to return a sample of the acetaminophen if a sample was requested that he just wanted something that worked for his pain (included Tylenol, Acetaminophen 500 mg; 100 tablets (Lot Number: ACA120055/A, Expiry date: Apr2022)). Once in a while he had a fever after receiving the Covid-19 vaccine, but the fever goes away quickly. The patient needed to reschedule second vaccine appointment for next week has a dental appointment the day before scheduled vaccine. The patient underwent lab tests and procedures which included fever of 99 degrees after first vaccine on an unspecified date. The clinical outcome of the events were unknown.     Further information needed, Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: numbness in the face; This is a spontaneous case received from a contactable Nurse. A 66-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Mar2021, as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient experienced "numbness in the face",  which was still ongoing. She had been experiencing it for over 2 weeks now after first dose of vaccine. Outcome of the event was not resolved.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.  Information about lot/batch number has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Infection, White blood cell count, White blood cell count increased
Clinical narrative: white cell count is up; might have an infection I am fighting; This is a spontaneous report from a contactable consumer (reporting himself) or other non hcp. A 63-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number : ER8734, Expiry date: unknown), via an unspecified route of administration in left arm on 15Mar2021 (age at the time of vaccination was 63-year-old) as dose single for COVID-19 immunization. The patient's medical history included blood cholesterol increased and hypertension (take medication so its fine for both), blood triglycerides, Simvastatin for Triglyceride, benign prostatic hyperplasia  and Tamsulosin for Prostate. The patient's concomitant medications included lisinopril taken for hypertension, simvastatin taken for blood triglycerides and tamsulosin  taken for benign prostatic hyperplasia. On an unspecified date, the patient experienced white cell count was up and might have an infection that the patient fighting. The high was 10.8. The caller enquired stated my wife and got second dose of Pfizer today. Is there a difference in the first dose and the second dose. Has this been seen after getting the vaccine. Transferring agent stated, the patient had received both doses of Pfizer COVID-19 vaccine and  the patient had some blood work done last week and the patient's white blood count was up to 11.1 on 30Mar2021. On paraphrasing concern, consumer stated, correct. When probed for the date of both vaccination: The patient got the second dose than go back to, the patient was assuming, that the patient got the first dose on 15Mar2021. When probed for the date of laboratory investigation, consumer stated, the patient thought it was last Tuesday so that would have been 30Mar2021. When probed for the name of facility, consumer stated, actually it was a headquarter. The patient thought first and second shot at the same site. When probed for the expiration date, consumer stated, its just says 2nd dose COVID-19 date which was yesterday, Manufacture Pfizer LOT number that the patient just gave, the patient can peel the sticker off that the patient's wife put on. When probed if the consumer was HCP, Consumer stated, that the patient was retired. When probed for the Unit of lab result : consumer stated, no the patient did not have that information. When probed for the any other further Lab test: consumer stated, no but they want me to back in 3 months and do it again, Its not high, There high was 10.8 and the patient was 11.1 which was very minimal but that was the high 10.8 want the patient to down about 9 or something the patient thought 9 point something. The clinical outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pollakiuria, Pyrexia
Clinical narrative: Fever; Chills; Headache; Nausea; Excessive urination at night; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 05Apr2021 at 10:00 (at the age of 48-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 15Mar2021 at 09:45, as a single dose for COVID-19 immunisation. On 05Apr2021 at 21:00, the patient experienced fever, chills, headache, nausea and excessive urination at night. The patient did not receive any treatment for the events. The adverse events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events fever, chills, headache, nausea and excessive urination at night was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Country select in patient tab. 2. Vaccination Facility Country select. 3. 'The patient did not receive any medication within two weeks of vaccination' deleted in narrative since not reported. 4. Narrative 'The patient did not receive any other medications or vaccines within 4 weeks prior to the vaccination' update as 'The patient did not receive any other vaccines within 4 weeks prior to the vaccination'.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Tired; Body aches; Night sweats; Nausea; Headache; Dizzy; chills; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm left on 30Mar2021 at 10:15(at the age of 48-year-old) as a dose2, single for COVID-19 immunization. No relevant medical history. The patient did not have any allergies to medications, food, or other products. The patient received other medications within two weeks of vaccination which are unspecified. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm left on 06Mar2021 at 12:30(at the age of 48-year-old) as a dose1, single for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021 at 23:15, approximately 13 hours after 2nd dose, she had night sweats, nausea and headache. she was also dizzy. Then she had chills. This lasted approximately 4-5 hours off and on. The symptoms subsided gradually. On 31Mar2021 she was tired and had body aches for another 18 hours. The patient did not receive any treatment for the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event night sweats, nausea, headache, dizzy was recovered in 2021. The clinical outcome of the event chills was recovered on an unspecified date in Mar2021. The clinical outcome of the event tired body aches was recovered on 01Ap2021.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1.  For event Tired and Body aches, Event onset date updated to 01-Apr-2021 01:30, stop date updated to 01-Apr-2021 19:30.  For event chills, Event top date field warning justification was checked.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pain
Clinical narrative: Tired; Body aches; Night sweats; Nausea; Headache; Dizzy; chills; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm left on 30Mar2021 at 10:15(at the age of 48-year-old) as a dose2, single for COVID-19 immunization. No relevant medical history. The patient did not have any allergies to medications, food, or other products. The patient received other medications within two weeks of vaccination which are unspecified. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm left on 06Mar2021 at 12:30(at the age of 48-year-old) as a dose1, single for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021 at 23:15, approximately 13 hours after 2nd dose, she had night sweats, nausea and headache. she was also dizzy. Then she had chills. This lasted approximately 4-5 hours off and on. The symptoms subsided gradually. On 31Mar2021 she was tired and had body aches for another 18 hours. The patient did not receive any treatment for the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event night sweats, nausea, headache, dizzy was recovered in 2021. The clinical outcome of the event chills was recovered on an unspecified date in Mar2021. The clinical outcome of the event tired body aches was recovered on 01Ap2021.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1.  For event Tired and Body aches, Event onset date updated to 01-Apr-2021 01:30, stop date updated to 01-Apr-2021 19:30.  For event chills, Event top date field warning justification was checked.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain, Pyrexia
Clinical narrative: Fever; Ache; He felt like he was run over by a Mack truck, and then the Mack truck ran over him again.; This is a spontaneous report received from a contactable consumer. A 6-decade-old adult male patient received BNT162B2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. Medical history included heart transplant. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced fever, ache and he felt like he was run over by a mack truck, and then the mack truck ran over him again. The outcome of events was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: Skip periods and have not had period or any spotting for 6 months up until a week after the first shot; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 12Mar2021 at 12:15 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine, birth control and infrequent menstruation- oligomenorrhoea (take birth control continuously so skip her periods and have not had her period or any spotting for 6 months up until a week after her first shot). Concomitant medications included amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (ADDERALL); fluconazole, vitamin D NOS (MANUFACTURER UNKNOWN) and birth control (unspecified), all for unknown indication and from an unknown date. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient had been on birth control continuously hence skipped periods and not had period or any spotting for 6 months up until a week after first shot on 16Mar2021. On 16Mar2021, the patient had spotting menstrual. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event spotting menstrual was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021384998 same reporter/product/event , different patient.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen Supraclavicular lymph node on left side. Tender to touch; Swollen Supraclavicular lymph node on left side. Tender to touch; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old (non-pregnant) female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown) via an unspecified route of administration, administered in the left arm on 01Apr2021 at 08:30 (at the age of 40-year-old) at dose 2, single for COVID-19 immunisation. Medical history included asthma. Concomitant medications were not reported. The patient previously received first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown) via an unspecified route of administration, administered in the left arm on 11Mar2021 at 08:30 (at the age of 39-year-old) at dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 10:00, the patient experienced swollen supraclavicular lymph node on left side and tender to touch. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of the events swollen supraclavicular lymph node on left side and tender to touch were not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment (27Jul2021): This follow-up report is being submitted to amend previously reported information: For Historical Vaccine: Age updated from 40 years to 39 years per vaccination date-11Mar2021 and DOB-this also need be updated in consolidated narrative. Event Coding Swollen lymph nodes updated as Lymph nodes cervical swollen.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Mobility decreased, Myalgia
Clinical narrative: Severe deltoid pain onset 18hrs after injection; Decreased mobility of shoulder; Minimal bruising; This is a spontaneous report from a contactable physician. A 56-year-old non-pregnant female patient received the unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown) via intramuscular route of administration, administered in the arm right on 31Mar2021 at 16:15 (at the age of 56-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included latex allergy (allergic to latex). The patient concomitant medications included baclofen from an unknown date and for unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 01Apr2021, after 18 hours of injection, the patient experienced severe deltoid pain, decreased mobility of shoulder continuing 5 days post-vaccination and no skin reaction other than minimal bruising. The adverse events result in a visit to the doctors or other healthcare professional office/clinic visit. The patient received prednisolone as a treatment medication for the reported events. The clinical outcome of the events severe deltoid pain decreased mobility of shoulder, minimal bruising was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment (PRD/SRD 28Jul2021): This follow-up report is being submitted to amend previously reported information: vaccination facility country added; final sentence updated to No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site mass
Clinical narrative: Bump formed at the site of first shot (left arm); This is a spontaneous report from a contactable consumer, the patient. A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN,) dose 1 via an unspecified route of administration in the left arm on 10Mar2021 (at the age of 52-years-old) as a dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On unknown date in 2021, the patient experienced bump formed at the site (left arm). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 01Apr2021, the patient underwent the lab test covid-19, and the result was negative. The patient did not receive any treatment for the events. The clinical outcome of the event bump formed at the site (left arm) was unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Contraindication to vaccination
Clinical narrative: he does take medications for heart issues; wondering if there is any contraindication for using Augmentin and getting the vaccine; This is a spontaneous report from a contactable consumer (patient himself). A 73-year-old male patient received first dose of BNT162B2 (BNT162B2, formulation: Solution for injection, Lot Number: EN6203), via an unspecified route of administration in Arm Left on 09Mar2021 at 12:40 as single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. On 05Apr2021, it was reported by patient that he had an oral surgery after first dose of vaccine and as a precaution after his surgery HCP want him to take Augmentin for 5 days starting today which will take him until Saturday. His second shot was scheduled for Wednesday 07Apr2021 and he is wondering if there is any contraindication for using Augmentin and getting the vaccine on an unspecified date in 2021. he had a dental implant and states this surgery had been planned prior to receiving his first dose of the Pfizer COVID vaccine. Patient stated that he does take medications for heart issues and takes statins on an unspecified date in 2021. Outcome of events was unknown.  No follow up attempts are possible because patient declines to provide details. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Severe dizziness; Severe nausea; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO153) via an unspecified route of administration in the arm left on 06Apr2021 at 12:45 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. The patient had allergies to medications, food or other products (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine.  On 06Apr2021 at 23:30, the patient experienced severe dizziness and severe nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events severe dizziness and severe nausea were unknown at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, SARS-CoV-2 test, Vaccination site swelling
Clinical narrative: Light headedness; Swelling raised site; Difficulty breathing; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 06Apr2021 at 14:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included COPD, CHF, CAD, diabetes, hypertension, stroke, stent stenosis (Heart stent), and clot blood (blood clots). The patient received unspecified medication within two weeks of vaccination. The patient was allergic to unspecified medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 15Mar2021 at 15:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021, the patient underwent SARS-CoV-2 test (nasal swab) and the result was negative. On 06Apr2021 at 16:45, the patient experienced light headedness, swelling raised site and difficulty breathing. Therapeutic measures were taken as a result of events and included treatment with BENADRYL and pro air inhaler. The clinical outcome of the events light headedness, swelling raised site and difficulty breathing were recovering.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. known_allergies Yes added as Relevant Med History.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Extremely tender right arm around injection site.; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 2613) via an unspecified route of administration in the right  arm on 06Apr2021 at 15:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy, allergy to sulfa (sulfonamide) drugs and multiple food allergies. Concomitant medications included montelukast sodium (SINGULAIR), ethinylestradiol; levonorgestrel (CAMRESE LO) and paracetamol; hydrocodone bitartrate (LORTAB) all taken for unknown indications from unknown dates and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 06Apr2021 at 15:30, thirty minutes after the vaccination, the patient experienced extremely tender right arm around injection site. The patient reported that she felt like she was punched in the upper arm. The event did not result in a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event extremely tender right arm around injection site was unknown.  No follow-up attempts are needed. No further information is expected.