chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Constipation
Clinical narrative: has had a hard time going to the bathroom.  (Asked what that meant: urination or defecation and he said defecation; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 26Aug2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. On an unspecified date in Aug 2021, since the vaccination the patient had a hard time going to the bathroom (defecation). He had only gone twice in the last 5 days. The clinical outcome of the event was unknown.  Information on lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Headache, Inflammation, Nasal discomfort, Pain
Clinical narrative: How important is it to get the vaccine at the 3 week mark? Should take a chance and get it tomorrow or not; Inflammation; pain; Headache; nasal burn; This is a spontaneous report from a contactable Consumer or other non HCP (patient). This 69-year-old female consumer reported that:   A 69 years old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 11Aug2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Active Drug substance names was reported as COVID 19 Vaccine, mRNA. She received the first Pfizer vaccine on 11Aug2021 and was scheduled to get the 2nd one tomorrow afternoon from the day of report. On an unspecified date, the patient experienced and enquired how important was it to get the vaccine at the 3-week mark and Should take a chance and get it tomorrow or not. She wanted to get protection. She felt bad after the first shot because of inflammation. She was holding a lot of fluid and it set up pain. She had headaches after the vaccination. She totally didn't get rid of the headaches. In August and September, she had headaches and nasal burn on an unspecified date in Aug2021. Initially came on with the shot but continued so was not sure if that was due to the shot or not. She started having problems from not taking the medications she needed to take. Outcome of events were reported as unknown.  Information on the lot batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: running nose; fever; This is a spontaneous report from a contactable consumer (parent). A 13-years-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration on 10Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the caller stated that patient is due for her second dose today but yesterday she developed a fever and running nose and called the pediatrician and they recommended she wait to receive the second dose and wanted to know how can reschedule this. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: severe adverse reactions such as swelling of the arms and legs; This is a spontaneous report from a contactable Physician.  A patient of unspecified age and gender received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 07Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient had severe adverse reactions such as swelling of the arms and legs. The patient had seen every type of specialists and none of them can't find any reason for the swelling (visit of physician office). Caller is needing some guidance and information on what to do with these allergic reactions. At the time of this report outcome of event was unknown.  Lot number for the vaccine, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: herpes; This is a spontaneous report from a contactable consumer (patient, self-reported). A 65-year-old female patient received first dose of BNT162B2 (PFIZ-ER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date in Feb2021, as a single dose for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an un-specified route of administration, on an unspecified date in Mar2021, as a single dose for COVID-19 immunization. The patient's medical history included autoimmune disorder. Concomitant medications were not reported. On an un-specified date, the patient experienced herpes. The patient asked if the booster dose was going to be the same as the original injections or something different and if her risk of getting herpes will increase if she got the booster dose of the covid vaccine. She reported having read that 1 side effect of getting the vaccine was herpes and stated, "she knew she had it, she saw her doctor and she had it in her notes on the portal, and she was put on Valacyclovir to get rid of it". The patient reported that she had an autoimmune disease and wanted to get the booster dose but asks if her risk of getting herpes will increase since she already had it twice since February. Outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be re-quested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction, Drug ineffective
Clinical narrative: have problems; all gotten covid 19; all gotten covid 19; This is a spontaneous report received from Pfizer sponsored program regulatory authority Support. A contactable consumer (sister) reported for male patient (brother).  A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Not reported), via an unspecified route of administration on unspecified date as a dose 2, single and dose 1, single for COVID-19 immunization. Patient medical history and concomitant medication were not reported. Reporter was seeking information receiving the 3rd booster shot for her and her husband. She had lupus and fibrosis of the heart and her husband was diabetic. On an unspecified the reporter stated that her brother, sister-in-law and nephew had all got COVID-19 after being fully vaccinated. Reporter stated that they were mostly healthy but they " had problems" her sister-in-law just had got out of the hospital and her brother was still there. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event following immunisation, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: All gotten covid 19; All gotten covid 19; Have problems; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a male patient(her nephew). A male patient of unspecified age received first dose BNT162B2 (PFIZER COVID-19 VACCINE, Solution for injection, Lot number were not reported) dose 1 via unspecified route of administration on unspecified date as DOSE 1, SINGLE and also received second dose BNT162B2 (PFIZER COVID-19 VACCINE, Solution for injection, Lot number were not reported) dose 1 via unspecified route of administration on an unknown date as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that about receiving the 3rd booster shot for her and her husband. She had lupus and fibrosis of the heart and her husband is diabetic. The reporter also reported that her brother, sister in law have all gotten covid 19 after being fully vaccinated. On an unspecified date patient (nephew) have all gotten covid 19 after being fully vaccinated. It was reported that they are mostly heathy but they have problems, her sister in law just got out of the hospital and her brother is still there. The outcome of the events are unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow up (02Sep2021): No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Lip swelling, Lymphadenopathy, Swelling face
Clinical narrative: swollen lymph nodes; headache; her face and lips are also swollen in the right side and her ear aches; her face and lips are also swollen in the right side and her ear aches; her face and lips are also swollen in the right side and her ear aches; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in left arm on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had the first dose of the Pfizer-BioNTech COVID-19 Vaccine on the 25th on her left arm and after 2 days on an unspecified date, the patient had swollen lymph nodes and terrible headache on the right side of her head, her face and lips were also swollen in the right side and her ear ached. She asked if these were caused by the vaccine. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: had a fever; body aches/was feeling very achy; Chills; This is a spontaneous report from a contactable consumer.   A 47-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: UNKNOWN), via an unspecified route of administration on 25Aug2021 (age at vaccination was 47-year-old) as dose 2, single for COVID-19 immunisation. The medical history and the concomitant medications of the patient were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date (age at vaccination was 47-year-old) as dose 1, single for COVID-19 immunisation. It was reported that, between Thursday and Friday after the vaccine, the patient had a fever chills body aches and um was feeling very achy and it went all the way to Saturday night. At the time of this report event outcome was recovered on 27Aug2021.   The lot number for the vaccine was not provided and will be requested during follow up.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Limb discomfort
Clinical narrative: his legs were like rubber, he couldn't walk, couldn't get to the bathroom; his legs were like rubber, he couldn't walk, couldn't get to the bathroom; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 87-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown; Expiry date, NDC number: unknown), via an unspecified route of administration at an unknown anatomical Location on an unspecified date in Jan2021 (reported as, Dec2020 or early Jan2021) (age at vaccination was 87 years) as dose 2, single for COVID-19 immunisation. Medical history included cholesterol and blood pressure; both were on an unknown date and ongoing. The patient had COVID and was in the hospital on an unspecified date. Concomitant medication were not reported. Historical vaccine includes the first dose of BNT162B2 (LOT: Unknown; NDC: Unknown; Expiry Date: Unknown) on an unspecified date (age at vaccination was 87 years) for COVID-19 immunisation. No other vaccines was administered on same date or 4 weeks prior of the Pfizer suspect vaccine. No adverse event prior vaccination. The patient states when he got the second shot, which was back in Dec2020 or early Jan2021. The patient had a reaction then and it lasted 12 hours and his legs were like rubber, he couldn't walk, couldn't get to the bathroom, it was an experience experienced on an unspecified date in Jan2021. No adverse events require a visit to emergency room and physician office. No investigation assessment reported. Outcome of the events was resolved on an unspecified date.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report from a contactable consumer or other non-HCP (reporting for daughter friend). A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose number unknown, single for COVID-19 immunization. Patient tested positive for COVID-19 yesterday, 30Aug2021 after reportedly having had the Pfizer Covid-19 vaccine. Reporter believed she was vaccinated shortly after the emergency use was granted. The only information reporter had was that her name and address. The outcome of COVID-19 was unknown.   Information on the Lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: persistent headache; This is a spontaneous report from a contactable consumer (patient). A 60-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history concomitant medications were not reported. Patient previously took first dose of bnt162b2 for covid-19 immunisation and experienced mild headache, arm pain, Stiffness and Vaccination site reaction. It was reported that states that the caller had a question about the vaccine because with his second shot he had a persistent headache and asked if it was normal. Outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood test, Chills, Facial pain, Headache
Clinical narrative: She got a headache which kept getting worse and worse; chills; shaking; Her neck and back hurt; Her neck and back hurt; Rash; Rash has gotten worse and is spreading and has gotten darker in color; Left side of her daughters face started being painful; This is a spontaneous report from a contactable consumer (mother). A 14-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 16Aug2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter states that her daughter received the vaccine on 16Aug2021 and by in Aug2021 on Friday the patient experienced she got a headache which kept getting worse and worse, chills, shaking, her neck and back hurt. They took patient to the emergency room where they did a rapid COVID test which came back negative. On Monday morning patient was covered with a rash so they took her to her primary care doctor who did blood work and another COVID test. They are currently awaiting the results and state that the rash has gotten worse and was spreading and has gotten darker in color. The reporter states that the doctor says it looks like a COVID rash. The reporter wants to know if the side effects were reported side effects from the vaccine. The reporter states that the left side of her daughter's (patient) face started being painful and was getting worse as well. Reporter also wants to know if it was contraindicated for her to get the vaccine. The patient underwent lab tests and procedures which included blood test: unknown result, sars-cov-2 test: negative, sars-cov-2 test: unknown result all on Aug2021. The outcome of the events headache, rash, darkened skin, facial pain was not recovered and unknown for events chills, shaking, neck pain and back pain.     The lot number for [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Rash, SARS-CoV-2 test, Skin discolouration, Tremor
Clinical narrative: She got a headache which kept getting worse and worse; chills; shaking; Her neck and back hurt; Her neck and back hurt; Rash; Rash has gotten worse and is spreading and has gotten darker in color; Left side of her daughters face started being painful; This is a spontaneous report from a contactable consumer (mother). A 14-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 16Aug2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter states that her daughter received the vaccine on 16Aug2021 and by in Aug2021 on Friday the patient experienced she got a headache which kept getting worse and worse, chills, shaking, her neck and back hurt. They took patient to the emergency room where they did a rapid COVID test which came back negative. On Monday morning patient was covered with a rash so they took her to her primary care doctor who did blood work and another COVID test. They are currently awaiting the results and state that the rash has gotten worse and was spreading and has gotten darker in color. The reporter states that the doctor says it looks like a COVID rash. The reporter wants to know if the side effects were reported side effects from the vaccine. The reporter states that the left side of her daughter's (patient) face started being painful and was getting worse as well. Reporter also wants to know if it was contraindicated for her to get the vaccine. The patient underwent lab tests and procedures which included blood test: unknown result, sars-cov-2 test: negative, sars-cov-2 test: unknown result all on Aug2021. The outcome of the events headache, rash, darkened skin, facial pain was not recovered and unknown for events chills, shaking, neck pain and back pain.     The lot number for [BNT162B2], was not provided and will be requested during follow up.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate irregular, Palpitations
Clinical narrative: Heart palpitations; Irregular heart beat; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Aug2021 at 11:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included lots of environmental allergies and eosinophilic esophagitis. The patient was allergic to sulfa drug, peanut (possibly) and wheat. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO), cetirizine hydrochloride (ZYRTEC), fluticasone propionate (FLONASE) and omeprazole (MANUFACTURER UNKNOWN); all taken for an unknown indication on an unknown date and unknown if ongoing. On 31Aug2021 at 16:00, on day 3 after vaccination, the patient experienced heart palpitations and irregular heartbeat which was going on since 12 hours (at the time of reporting). The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included treatment with aspirin and magnesium. The clinical outcome of the events heart palpitations and irregular heartbeat was not resolved at this time of this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Erythema, Headache, Hypoaesthesia
Clinical narrative: numbness in my cheeks and top palette,; numbness moved to my jaw bones; Weakness; swelling and redness of face, white around my lip area; immediate pain in the injection sight with  a severe headache; headache; In less 2 minutes dizziness and weakness; redness of face, white around my lip are; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 07Aug2021(at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any medication within two weeks of vaccination. The patient did not have any allergies to food, medications, or other products. On 07Aug2021, the patient experienced immediate pain in the injection site with a severe headache. The headache was never experienced before. In less 2 minutes, dizziness and weakness and the line monitor came to assist to a chair, swelling and redness of face, white around lip area (witnesses provided appears to along with concern) numbness in cheeks and top palette, numbness moved to jaw bones. The patient was afraid and wanted to go home and contacted to doctor and doctor informed not to take the second injection. Therapeutic measures were taken as a result of adverse events and included treatment with ice application to head and neck by nurse. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in the injection site, severe headache, dizziness, weakness, swelling and redness of face, numbness in cheeks and top palette, numbness moved to jaw bones was recovering at the time of this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Swelling face, Vaccination site pain
Clinical narrative: numbness in my cheeks and top palette,; numbness moved to my jaw bones; Weakness; swelling and redness of face, white around my lip area; immediate pain in the injection sight with  a severe headache; headache; In less 2 minutes dizziness and weakness; redness of face, white around my lip are; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 07Aug2021(at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any medication within two weeks of vaccination. The patient did not have any allergies to food, medications, or other products. On 07Aug2021, the patient experienced immediate pain in the injection site with a severe headache. The headache was never experienced before. In less 2 minutes, dizziness and weakness and the line monitor came to assist to a chair, swelling and redness of face, white around lip area (witnesses provided appears to along with concern) numbness in cheeks and top palette, numbness moved to jaw bones. The patient was afraid and wanted to go home and contacted to doctor and doctor informed not to take the second injection. Therapeutic measures were taken as a result of adverse events and included treatment with ice application to head and neck by nurse. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in the injection site, severe headache, dizziness, weakness, swelling and redness of face, numbness in cheeks and top palette, numbness moved to jaw bones was recovering at the time of this report.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Inappropriate schedule of product administration, Menstruation irregular
Clinical narrative: Period cycle went completely crazy after getting the vaccine and had period for 4 weeks straight, one week off, 2 weeks on, one week off, one week on and so forth; Period for 4 weeks straight; Inappropriate schedule of vaccine administered to Dose 1: 15May2021; Dose 2: 05Jul2021; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Jul2021 at 12:00 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 respiratory infection. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. 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 left arm on 15May2021 at 12:00 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. On 16Jul2021 at 12:00, the patient experienced period cycle which went completely crazy after getting the vaccine and had period for 4 weeks straight, one week off, 2 weeks on, one week off, one week on and so forth. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events period cycle went completely crazy after getting the vaccine and had period for 4 weeks straight, one week off, 2 weeks on, one week off, one week on and so forth and period for 4 weeks straight were not recovered at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Myocarditis
Clinical narrative: Died of cardiac arrest; Inflammation on his heart; This is a spontaneous report from a contactable consumer or other non-HCP (patient friend) via Medical Information Team. A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose number unknown single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient died recently and he was a bigger man. He experienced inflammation on his heart and died of cardiac arrest. It was unknown if an autopsy was done. The outcome of the event inflammation on his heart was unknown.   The lot number for [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: Died of cardiac arrest
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: arm hurt; rash at the injection site; swelling of her arm and armpit; chills; low grade fever; headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot number: unknown), via an unspecified route of administration on 31Aug2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2, dose 1 on an unspecified date for COVID-19 immunisation. The patient reported her arm hurt, rash at the injection site, swelling of her arm and armpit, chills, low grade fever and headache. She asked if she could take Tylenol after her second dose of the Pfizer-BioNTech COVID-19 Vaccine, yesterday (31Aug2021). The outcome of all events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: arm hurt; rash at the injection site; swelling of her arm and armpit; chills; low grade fever; headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot number: unknown), via an unspecified route of administration on 31Aug2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2, dose 1 on an unspecified date for COVID-19 immunisation. The patient reported her arm hurt, rash at the injection site, swelling of her arm and armpit, chills, low grade fever and headache. She asked if she could take Tylenol after her second dose of the Pfizer-BioNTech COVID-19 Vaccine, yesterday (31Aug2021). The outcome of all events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Neuralgia
Clinical narrative: whole body nerve pain; chills; This is a spontaneous report from a non-contactable consumer (other non-HCP).   A 46-year-old female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on 31Aug2021, as a single dose for COVID-19 immunization. Medical history included diabetes and neuropathy pain. Concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunization. On an unspecified date, the patient experienced whole body nerve pain and chills. Caller reported that she received the second dose of the Pfizer covid vaccine yesterday 31Aug and has been experiencing severe whole body nerve pain and chills. caller has Diabetes and has neuropathy pain but after the vaccine her whole body was hurting and she has never experienced it before. Caller wanted to know about severe never pain reported with diabetes. The clinical outcome of the events was unknown. No follow up attempts are possible; information about lot/batch number cannot be obtained.   No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy
Clinical narrative: Swelling in the left armpit; Dose 1 on 11May2021 and Dose 2 on 24Jun2021; This is a spontaneous report from a contactable other healthcare professional, the patient. A 38-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 24Jun2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the left arm on 11May2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 25Jun2021, the patient experienced swelling in the left armpit. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of event swelling in the left armpit was recovered on an unknown date in 2021.
Sex: U
Vaccine: COVID19
Symptoms: Overdose, Product preparation error
Clinical narrative: Per caller they have two patients who recieved the Pfizer Covid 19 Vaccine undiluted from two different vials.; Per caller they have two patients who recieved the Pfizer Covid 19 Vaccine undiluted from two different vials.; This is a spontaneous report from a Pfizer-sponsored program. A contactable pharmacist reported similar events for 2 patients. This report is for 1st of 2 patients. This pharmacist reported for a patient that:  A patient of unspecified age and gender received BNT162B2 (Comirnaty, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On unspecified date two patients received the pfizer COVID-19 vaccine undiluted from the two different vials. The event reported was medically significant. 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.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between event Overdose and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101142025 same reporter/product/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: his platelets dropped to 9k (9000) and went to the emergency room./He is having life threatening low platelets; This is a spontaneous report from a contactable physician. A 77-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 27Mar2021 (Age of vaccination: Unknown) as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection, Lot number/Expiration date: Unknown) on 05Mar2021 for covid-19 immunization. On 17Apr2021 the patient experienced his platelets dropped to 9k (9000) and went to the emergency room and he is having life threatening low platelets. The patient underwent lab tests and procedures which included platelet count: 9000 on 17Apr2021, his platelets dropped to 9k (9000) , platelet count: 200000 on 2021 this helped bring his platelets up to 200 (k) , platelet count: 400000 on 2021 they (the platelets) went up to 400 , platelet count: 1000 on 2021 platelets dropped down to 1000 , platelet count: 25000 on 2021 Last week it was 25k. Therapeutic measures were taken as dexamethasone 40mg for 4 days and Promacta as a result of his platelets dropped to 9k (9000) and went to the emergency room and he is having life threatening low platelets. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event platelet count decreased cannot be totally excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigued/ tired; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration in the right arm on 29Aug2021 at 11:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Aug2021 at 10:00, the patient was fatigued/ tired. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event fatigued/ tired was resolved on an unknown date in Aug2021.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling in fingers of arm that received the injection; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW 0169) via an unspecified route of administration in the left arm on 30Aug2021 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 31Aug2021, the patient experienced tingling in fingers of arm that received the injection. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether any therapeutic measures were taken for the event. The clinical outcome of the event tingling in fingers of arm that received the injection was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Localized pain in left arm where the injection was placed/mild throbbing pain in that area; Developing some tingling down arm to fingers; This is a spontaneous report from a contactable consumer, the patient. A 36-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 30Apr2021 at 10:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 15:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. On 16Aug2021, the patient started experiencing localized pain in the left arm where the injection was placed. The patient was experiencing mild throbbing pain in that area and developed some tingling down the arm to the fingers. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 17Aug2021, the patient underwent polymerase chain reaction (PCR) test for COVID- 19 and the result was negative. The clinical outcome of the events localized pain in left arm where the injection was placed/mild throbbing pain in that area and developing some tingling down arm to fingers were not resolved at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Vaccination site pain
Clinical narrative: sore arm; Hot flashes; This is a spontaneous report from a contactable consumer (Patient herself). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot Number: PAG780) via an unspecified route of administration in Left arm on 03Aug2021 as dose 1, single for COVID-19 immunisation. Patient medical history was reported as none. Concomitant medication included oxycodone taken for Medical Reasons. On 24Aug2021 patient experienced with sore arm and Hot flashes. Seriousness was reported as non-serious. Patient did not received any treatment for events. Outcome of events was recovering.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypomania, Mania
Clinical narrative: Mania and hypomania triggered since 2 days post injections in a bipolar naive patient. Positive mental health diagnosis of fluctuating major depression and dysthymia and PTSD for ~20 years. No cyclothymic, no bipolar dx or any other mood disorders present in history.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Dyspnoea exertional, Influenza like illness, Pyrexia
Clinical narrative: at night after vaccination, had chest tightness, tachycardia 140 with sob and oxygen 91% on pulse ox (with fever and flu like sx). still feels winded with exertion 9/7/21
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: at night after vaccination, had chest tightness, tachycardia 140 with sob and oxygen 91% on pulse ox (with fever and flu like sx). still feels winded with exertion 9/7/21
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Colonoscopy, Computerised tomogram, Hypophagia, Laboratory test, Oesophagogastroduodenoscopy
Clinical narrative: developed chronic pancreatitis with poor po intake and pain impacting QOL
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pancreatitis chronic, Quality of life decreased
Clinical narrative: developed chronic pancreatitis with poor po intake and pain impacting QOL
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Mechanical ventilation
Clinical narrative: WIFE CAME IN 5 DAYS AFTER PATIENT RECEIVED VACCINE AND REPORTED THE NEXT DAY PATIENT  WAS ADMITTED TO HOSPITAL WITH A VERY VERY HIGH BLOOD SUGAR (WIFE SAID 1500?) AND IS ON RESPIRATOR. PATIENT'S ENDOCRINOLOGIST STATED PATIENT SHOULD OF NEVER GOTTEN BOTH VACCINES AT THE SAME TIME
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: Breakthrough-Hospitalized
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Cough, Diarrhoea, Dry mouth
Clinical narrative: Headache with no fever; Coughing; muscle pains; chest discomfort; mucus; Diarrhea; mouth was like glue; got a weird smell and it was a nauseating smell; burning in her stomach; burning in her stomach,and she had some reflux; burning in her mouth; leg muscle aches; Chills; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3182), via an unspecified route of administration, administered in right deltoid (Right shoulder) on 24Aug2021 (at the age of 65-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient did not had any medical history and family history. The concomitant medication(s) included oxycodone (OXYCODONE) 5 mg taken 4 times daily taken for an unspecified indication started 7 years ago and ongoing. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: PAG780), via an unspecified route of administration, administered in left shoulder on 03Aug2021 (at the age of 65-years-old) as DOSE 1, SINGLE for covid-19 immunisation and the patient experienced sore arm and hot flashes that lasted a couple of days. The patient did not had any prior vaccination within a four weeks. On 24Aug2021, the patient experienced had some burning in her stomach and she had some reflux anyway and then, some burning in her mouth, and then it was gone. She went home and had some leg muscle aches and chills. She wants to know, her chills lasted for two days. Two days after she got a weird smell and it was a nauseating smell. It could have been the mucus. She clarified as a day later at 2 in the morning Thursday the 26Aug2021. Then everything went away, now yesterday. On 29Aug2021, the patient mouth was like glue. On an unspecified date, the patient reported headache with no fever. All subsided after a few days yesterday the night of the 30Aug2021 and she had a mouth breather and she will take a drink of water and it will be gone. She woke up on Monday night and it was like glue. On 01Sep2021, the patient had diarrhea and on unspecified date, she reported muscle pains, coughing, mucus, chest discomfort, and just sore. Patient reported going for a covid test tomorrow be-cause maybe it was covid. Patient did not any AE(s) require a visit to emergency room and physician office. The outcome of event for burning in her stomach,and she had some reflux, burning in her mouth, Chills, got a weird smell and it was a nauseating smell, was recovered on Aug2021 and, headache was recovered on 30Aug2021 and outcome of rest all events were unknown.